NYTimes
May 21, 2006
Diagnosis
Flower Power
By LISA SANDERS, M.D.
1. Symptoms
Dr. Jon McGhee, a second year E.R. resident, casually greeted the patient and her fiancé as he entered the darkened hospital cubicle. "So, what's going on?" he asked the patient, who was also a doctor and a friend. The two had suffered through their internship year together — an experience that is the start of many enduring friendships.
She looked O.K., the resident thought to himself, a little relieved. But her heart was racing — 150 beats per minute. Her blood pressure was high, and she seemed anxious. But she didn't look sick. Then she began to speak. A wild river of words poured from her. Random words, meaningless sentences. There were snatches of sense scattered throughout, but they were drowned in the rushed torrent. McGhee looked at the young man, who nodded. This was why they had come.
The patient had been fine all day, the fiancé explained, but after dinner she started saying that she felt queasy and lightheaded. Within an hour, these symptoms began to worsen. She felt weak, she told him, sick and hot. Then she began crying uncontrollably, and when she spoke, she made no sense. That had really scared him. +
The patient was 27, had an athletic build and no significant medical problems. The year before, she fainted a couple of times, but an extensive cardiac work-up hadn't revealed anything. She was taking an antidepressant, Paxil, and occasionally used another antidepressant, Elavil, to help her sleep. She didn't smoke, rarely drank, never used illicit drugs and jogged daily.
When the doctor turned on the light to examine the patient, she cried out. The light had been bothering her since they got there, her fiancé told him. McGhee turned the lights down and began to examine the patient. She had no fever. Her mouth was dry, and her skin was quite warm though not sweaty. The rest of her exam was normal. An EKG showed no abnormalities beyond the rapid heart rate.
2. Investigation
McGhee thought carefully about his friend. For almost anyone with a change in mental status, illicit drugs had to be on the list of possible causes, as unlikely as it seemed in this case. In addition, she took Elavil, which could cause many of these symptoms when taken in large quantities. Could she have taken an overdose? That could cause the rapid heart rate and confusion. But the most dangerous side effect of an Elavil overdose is dangerously low blood pressure. Hers was dangerously high. Perhaps the patient was bipolar and had moved from depression to mania? Or could it be something different? Could she have too much thyroid hormone? The thyroid is the flesh-and-blood version of a carburetor, regulating how hard the body's machinery works. Too little of this hormone, and the body slows down. Too much, and it speeds up.
He questioned the patient's fiancé. Had she shown signs of mania? She had a history of insomnia, and sleeplessness was one sign of both mania and thyroid overload. How was she sleeping? Until this evening she had been fine, he insisted. She had been depressed, but not since starting the Paxil. And her sleeping was no worse than usual. He paused. There was one other thing: after dinner, he had felt a little funny, too. Not as sick as the patient, but his heart had been racing, and he had felt nauseated and jittery, though he felt fine now. They had eaten some lettuce from their garden that night. Could their symptoms be related to that? The resident immediately thought of a recent patient who had almost died from pesticide poisoning. He had been delirious like this patient, but had not had the elevated heart rate or blood pressure and had been sweating profusely. Still uncertain, the doctor ordered a few routine blood tests to look for the presence of an infection or an abnormality in her blood chemistry or thyroid hormone. He also ordered a urine test to look for illegal drugs and Elavil, the medication she used for sleep.
As he waited for the results, the patient became more agitated. She kept getting out of bed and walking into the chaotic hub of the emergency room, putting on gloves and picking up charts as if she were at work. At times, she seemed to hallucinate.
Over the course of the night, the patient's test results trickled in. The blood tests were normal. Her thyroid hormone wasn't too high. The drug screen was completely negative. What was going on?
By dawn, the patient's blood pressure came down. She was less confused. Her speech cleared. But she was still far from normal. Was this part of some underlying illness? Could it be linked to her earlier fainting spells? Was she having tiny strokes? Was she showering her lungs with little clots? Her symptoms weren't typical of any of these, but they didn't seem typical of anything else either. Her cardiologist and a neurologist were consulted. She had an M.R.I. of her brain to look for a stroke and a CT of her chest to look for tiny clots. Normal. After four days, the patient recovered, and she was discharged, her diagnosis still unknown.
3. Resolution
At home, the patient worried about her brief descent into madness. That afternoon, she wandered out to the garden to do some weeding when her attention was drawn to an uninvited guest growing there. Among the green and purple lettuce she had planted were several strikingly beautiful white and yellow flowers. Blossoms that hadn't been there before and that she was certain she had never sown. Before it had flowered, could this plant have been mistaken for lettuce and ended up in her salad? She pulled the plants up by their roots, put them in a baggie and drove to a nearby nursery. As she pulled the plants from the bag to show the owner, the woman exclaimed: "Don't touch those! They're highly toxic. That's jimson weed." Also called the devil's trumpet and sometimes locoweed, this plant has been known for centuries to cause a temporary kind of madness, the woman explained.
The symptoms caused by this class of plant are well known, and a mnemonic is taught in medical school to identify them: Mad as a hatter, blind as a bat, dry as a bone, red as a beet. As it turned out, the patient had had all the classic symptoms. The plant's toxin affects the eyes because it dilates the pupils and makes them very sensitive to light. She was also quite flushed, according to her fiancé, though both these symptoms were missed by McGhee, it seems, because he had turned down the light for his friend's comfort. He noted that her mouth and skin were dry and the madness was clear, but alone they weren't enough. By the time the other doctors saw her, most of these symptoms had resolved themselves.
The doctor was being kind in keeping the lights low, but I think there's more here. McGhee didn't insist on being able to see — the way he would have insisted on drawing blood or getting the CT scan — because in this age of high-tech medicine, I think we no longer really believe that the physical exam can be an important diagnostic tool. Too often we simply go through the motions, never imagining that what we can observe will provide the kinds of answers that our machine-driven tests routinely do. Ultimately, that loss of faith can become a self-fulfilling prophecy.
In this case, the patient did fine without a diagnosis. She figured it out herself. I asked her recently why she thought she had been so much more affected by the jimson weed than her fiancé. "I'm not really sure," she answered. "Maybe I ate more of it. Or maybe it was the plant plus the Paxil. Antidepressants can cause some similar side effects." She told me that she hopes to publish her story as a case report in a medical journal.
Sunday, June 25, 2006
Diagnosis: Broken Heart
NYTimes
June 18, 2006
Diagnosis
Heart Ache
By LISA SANDERS, M.D.
1. Symptoms
"I'm not going to lose my mom," the young man's voice cracked with feeling. Beside him a half-dozen men and women in scrubs swarmed around the gurney rolling the woman into a cubicle in the I.C.U. The patient's face had a deathly pallor, her light brown hair was dark with sweat, her mouth was open and her chest heaved as she struggled to breathe. "We'll do our best," the doctor assured him, as he observed the woman and the monitors that showed just how sick she was. The young man, who was in his mid-20's, grabbed the doctor's arm as he turned to follow the patient. "No — you have to save her," he answered fiercely. "You have to."
His mother had been fine that morning, the young man told the doctor. She went to work just as she did every day. But then the phone rang, and she learned that her husband of more than two decades had been killed in a crash. She rushed to the site, found his body and collapsed next to him, sobbing and shouting his name as if she were trying to wake him. She lay next to her husband, cradling him in her arms until his body was taken away. Two hours later, she collapsed again, and this time she couldn't get up.
The son paused and roughly rubbed the tears from his face with his sleeve. When she got home, his mother told his sister that her chest hurt and that she felt as if she couldn't breathe. The ambulance rushed her to the nearest hospital. "The doctors there told us she'd had a heart attack," the young man continued, "and that she was fixing to have another one." He and his two sisters were terrified. They had already lost their dad — they just couldn't lose them both. They decided to have her transferred here, to the regional hospital with a specialized cardiac-care unit.
The doctor in the I.C.U. glanced through her chart and turned his attention to the patient. She was 45 years old and a smoker. She had recently been told she had narrowing of the arteries that carried blood to her legs and feet — called peripheral vascular disease — but otherwise she was healthy. She took no medicines and worked full time now that her children were grown up.
2. Investigation
On examination, she appeared younger than her 45 years. But her tanned, unlined face was shiny with sweat, and her pale blue eyes were open and unfocused. Her heart was beating rapidly, and a blood-pressure cuff that inflated automatically beeped its warning that her pressure was dangerously low. An oxygen meter on her finger showed that although she was breathing rapidly, she wasn't getting enough air. Her skin was clammy to the touch and pierced by thick intravenous needles delivering saline and medicines to raise her blood pressure.
It was clear that the patient's heart was failing. She was young to be having a heart attack, but she was a smoker and had a history of clogged arteries in her legs, which put her at risk of having the same problem in her heart. A heart attack occurs when one of the arteries supplying blood to the heart gets blocked. Without blood, that part of the heart dies rapidly. Her EKG was abnormal, and blood tests revealed damage to the heart cells — all consistent with a heart attack.
Dr. Conard Failinger, the cardiologist on call, was worried by the grainy images of the sonogram that showed the patient's heart in motion. Her heart was pumping with only a fraction of the expected strength. In fact, most of the heart muscle wasn't pumping at all; the patient was dying. The only way to treat her would be to quickly find and clear the blockage so that blood could flow once more. There are chemical clot busters that can do this, but a more effective way is to thread a tiny catheter into the affected artery, locate the blockage and then use the tiny tube to blast the vessel open. Done quickly enough, this process, known as cardiac angioplasty, can save the heart muscle and save the life. The patient was quickly transported from the I.C.U. to the "cath" lab.
Once there, Failinger watched another doctor rapidly thread the tiny catheter through a large artery in the patient's leg into her heart. He carefully placed the catheter into one of the major vessels of the heart and pressed the plunger of the attached syringe, which shot a tiny amount of contrast dye into the artery to determine the site of the blockage. On a monitor, the cardiologists stared in wonder as the arteries brightened, lighted by the dye flowing through them. There was no obstruction. The doctor manipulated the catheter again, moving it to another vessel. Again, the dye flowed through the artery, completely unimpeded. Several more tries produced the same result. There were no blocked arteries. The patient was not having a heart attack.
What else could cause such profound heart muscle weakness? Alcohol can do this, but the patient had no history of heavy alcohol use. A number of drugs — most commonly those used to treat certain cancers — can cause this type of damage, but this patient had never been exposed to any of those medications. Infection could do this, but the patient reported no symptoms other than those caused by the failing heart itself.
3. Resolution
Failinger immediately realized that it was none of these. He recognized what it was, though he had never seen it. He had read about it a short time before in The New England Journal of Medicine. This was stress cardiomyopathy, also called "broken-heart syndrome." First described by the Japanese 15 years ago, this disease occurs when an emotional trauma causes the brain to release high doses of stress hormones. This hormonal blast paralyzes the muscle cells of the heart, preventing them from working to pump the blood. Typically only one section of the heart is spared this devastating paralysis — the part closest to the aorta so that with each heart beat only the upper portion contracts and the heart looks like a narrowed-necked vase. The Japanese called it takotsubo after a type of trap that is used to capture octopus and has the same vaselike shape. For reasons that no one understands, this mostly affects post-menopausal women.
There is no cure. There is no clot to bust, no bugs to kill. Like its metaphorical counterpart, the only treatment is support and the passage of time. The initial burst of hormones subsides and the patient must be kept alive until the heart recovers. For those who survive long enough to reach the hospital, the prognosis is good. Once she made it to the hospital, this patient needed additional oxygen and medicine to keep her blood pressure up. On arrival at the hospital, her heart was able to pump out only 5 to 10 percent of the blood it contained (normal is 50 to 60 percent). After several days, it was pumping well enough for the doctors to stop the medications that increased her blood pressure. By the end of the week, her heart's capacity had doubled. Just days later, it was nearly normal.
"If anyone had told me that you could die of a broken heart," the patient told me recently, "I'd never have believed it. But I almost did." Reflecting on those couples you hear about, when one dies and the other one follows a few days later, she said, "I bet their hearts were broken, just like mine was."
It's an interesting idea: perhaps the metaphors we use to speak of devastating loss grew out of physiological truth. But if love lost almost took this patient's life, she says she believes that it was also love that brought her back. "I remember when I was in the hospital, I was in the most peaceful rest," she told me. "I didn't see any light or anything, but it was just as beautiful and peaceful a rest as I could ever imagine. I just wanted to stay there forever. But then, way off in the distance, I heard my kids calling to me, and I knew I couldn't stay. They're the ones who really saved my life.
June 18, 2006
Diagnosis
Heart Ache
By LISA SANDERS, M.D.
1. Symptoms
"I'm not going to lose my mom," the young man's voice cracked with feeling. Beside him a half-dozen men and women in scrubs swarmed around the gurney rolling the woman into a cubicle in the I.C.U. The patient's face had a deathly pallor, her light brown hair was dark with sweat, her mouth was open and her chest heaved as she struggled to breathe. "We'll do our best," the doctor assured him, as he observed the woman and the monitors that showed just how sick she was. The young man, who was in his mid-20's, grabbed the doctor's arm as he turned to follow the patient. "No — you have to save her," he answered fiercely. "You have to."
His mother had been fine that morning, the young man told the doctor. She went to work just as she did every day. But then the phone rang, and she learned that her husband of more than two decades had been killed in a crash. She rushed to the site, found his body and collapsed next to him, sobbing and shouting his name as if she were trying to wake him. She lay next to her husband, cradling him in her arms until his body was taken away. Two hours later, she collapsed again, and this time she couldn't get up.
The son paused and roughly rubbed the tears from his face with his sleeve. When she got home, his mother told his sister that her chest hurt and that she felt as if she couldn't breathe. The ambulance rushed her to the nearest hospital. "The doctors there told us she'd had a heart attack," the young man continued, "and that she was fixing to have another one." He and his two sisters were terrified. They had already lost their dad — they just couldn't lose them both. They decided to have her transferred here, to the regional hospital with a specialized cardiac-care unit.
The doctor in the I.C.U. glanced through her chart and turned his attention to the patient. She was 45 years old and a smoker. She had recently been told she had narrowing of the arteries that carried blood to her legs and feet — called peripheral vascular disease — but otherwise she was healthy. She took no medicines and worked full time now that her children were grown up.
2. Investigation
On examination, she appeared younger than her 45 years. But her tanned, unlined face was shiny with sweat, and her pale blue eyes were open and unfocused. Her heart was beating rapidly, and a blood-pressure cuff that inflated automatically beeped its warning that her pressure was dangerously low. An oxygen meter on her finger showed that although she was breathing rapidly, she wasn't getting enough air. Her skin was clammy to the touch and pierced by thick intravenous needles delivering saline and medicines to raise her blood pressure.
It was clear that the patient's heart was failing. She was young to be having a heart attack, but she was a smoker and had a history of clogged arteries in her legs, which put her at risk of having the same problem in her heart. A heart attack occurs when one of the arteries supplying blood to the heart gets blocked. Without blood, that part of the heart dies rapidly. Her EKG was abnormal, and blood tests revealed damage to the heart cells — all consistent with a heart attack.
Dr. Conard Failinger, the cardiologist on call, was worried by the grainy images of the sonogram that showed the patient's heart in motion. Her heart was pumping with only a fraction of the expected strength. In fact, most of the heart muscle wasn't pumping at all; the patient was dying. The only way to treat her would be to quickly find and clear the blockage so that blood could flow once more. There are chemical clot busters that can do this, but a more effective way is to thread a tiny catheter into the affected artery, locate the blockage and then use the tiny tube to blast the vessel open. Done quickly enough, this process, known as cardiac angioplasty, can save the heart muscle and save the life. The patient was quickly transported from the I.C.U. to the "cath" lab.
Once there, Failinger watched another doctor rapidly thread the tiny catheter through a large artery in the patient's leg into her heart. He carefully placed the catheter into one of the major vessels of the heart and pressed the plunger of the attached syringe, which shot a tiny amount of contrast dye into the artery to determine the site of the blockage. On a monitor, the cardiologists stared in wonder as the arteries brightened, lighted by the dye flowing through them. There was no obstruction. The doctor manipulated the catheter again, moving it to another vessel. Again, the dye flowed through the artery, completely unimpeded. Several more tries produced the same result. There were no blocked arteries. The patient was not having a heart attack.
What else could cause such profound heart muscle weakness? Alcohol can do this, but the patient had no history of heavy alcohol use. A number of drugs — most commonly those used to treat certain cancers — can cause this type of damage, but this patient had never been exposed to any of those medications. Infection could do this, but the patient reported no symptoms other than those caused by the failing heart itself.
3. Resolution
Failinger immediately realized that it was none of these. He recognized what it was, though he had never seen it. He had read about it a short time before in The New England Journal of Medicine. This was stress cardiomyopathy, also called "broken-heart syndrome." First described by the Japanese 15 years ago, this disease occurs when an emotional trauma causes the brain to release high doses of stress hormones. This hormonal blast paralyzes the muscle cells of the heart, preventing them from working to pump the blood. Typically only one section of the heart is spared this devastating paralysis — the part closest to the aorta so that with each heart beat only the upper portion contracts and the heart looks like a narrowed-necked vase. The Japanese called it takotsubo after a type of trap that is used to capture octopus and has the same vaselike shape. For reasons that no one understands, this mostly affects post-menopausal women.
There is no cure. There is no clot to bust, no bugs to kill. Like its metaphorical counterpart, the only treatment is support and the passage of time. The initial burst of hormones subsides and the patient must be kept alive until the heart recovers. For those who survive long enough to reach the hospital, the prognosis is good. Once she made it to the hospital, this patient needed additional oxygen and medicine to keep her blood pressure up. On arrival at the hospital, her heart was able to pump out only 5 to 10 percent of the blood it contained (normal is 50 to 60 percent). After several days, it was pumping well enough for the doctors to stop the medications that increased her blood pressure. By the end of the week, her heart's capacity had doubled. Just days later, it was nearly normal.
"If anyone had told me that you could die of a broken heart," the patient told me recently, "I'd never have believed it. But I almost did." Reflecting on those couples you hear about, when one dies and the other one follows a few days later, she said, "I bet their hearts were broken, just like mine was."
It's an interesting idea: perhaps the metaphors we use to speak of devastating loss grew out of physiological truth. But if love lost almost took this patient's life, she says she believes that it was also love that brought her back. "I remember when I was in the hospital, I was in the most peaceful rest," she told me. "I didn't see any light or anything, but it was just as beautiful and peaceful a rest as I could ever imagine. I just wanted to stay there forever. But then, way off in the distance, I heard my kids calling to me, and I knew I couldn't stay. They're the ones who really saved my life.
Sunday, June 11, 2006
Employers using online info to reject candidates
NYTimes
June 11, 2006
For Some, Online Persona Undermines a Résumé
By ALAN FINDER
When a small consulting company in Chicago was looking to hire a summer intern this month, the company's president went online to check on a promising candidate who had just graduated from the University of Illinois.
At Facebook, a popular social networking site, the executive found the candidate's Web page with this description of his interests: "smokin' blunts" (cigars hollowed out and stuffed with marijuana), shooting people and obsessive sex, all described in vivid slang.
It did not matter that the student was clearly posturing. He was done.
"A lot of it makes me think, what kind of judgment does this person have?" said the company's president, Brad Karsh. "Why are you allowing this to be viewed publicly, effectively, or semipublicly?"
Many companies that recruit on college campuses have been using search engines like Google and Yahoo to conduct background checks on seniors looking for their first job. But now, college career counselors and other experts say, some recruiters are looking up applicants on social networking sites like Facebook, MySpace, Xanga and Friendster, where college students often post risqué or teasing photographs and provocative comments about drinking, recreational drug use and sexual exploits in what some mistakenly believe is relative privacy.
When viewed by corporate recruiters or admissions officials at graduate and professional schools, such pages can make students look immature and unprofessional, at best.
"It's a growing phenomenon," said Michael Sciola, director of the career resource center at Wesleyan University in Middletown, Conn. "There are lots of employers that Google. Now they've taken the next step."
At New York University, recruiters from about 30 companies told career counselors that they were looking at the sites, said Trudy G. Steinfeld, executive director of the center for career development.
"The term they've used over and over is red flags," Ms. Steinfeld said. "Is there something about their lifestyle that we might find questionable or that we might find goes against the core values of our corporation?"
Facebook and MySpace are only two years old but have attracted millions of avid young participants, who mingle online by sharing biographical and other information, often intended to show how funny, cool or outrageous they are.
On MySpace and similar sites, personal pages are generally available to anyone who registers, with few restrictions on who can register. Facebook, though, has separate requirements for different categories of users; college students must have a college e-mail address to register. Personal pages on Facebook are restricted to friends and others on the user's campus, leading many students to assume that they are relatively private.
But companies can gain access to the information in several ways. Employees who are recent graduates often retain their college e-mail addresses, which enables them to see pages. Sometimes, too, companies ask college students working as interns to perform online background checks, said Patricia Rose, the director of career services at the University of Pennsylvania.
Concerns have already been raised about these and other Internet sites, including their potential misuse by stalkers and students exposing their own misbehavior, for example by posting photographs of hazing by college sports teams. Add to the list of unintended consequences the new hurdles for the job search.
Ana Homayoun runs Green Ivy Educational Consulting, a small firm that tutors and teaches organizational skills to high school students in the San Francisco area. Ms. Homayoun visited Duke University this spring for an alumni weekend and while there planned to interview a promising job applicant.
Curious about the candidate, Ms. Homayoun went to her page on Facebook. She found explicit photographs and commentary about the student's sexual escapades, drinking and pot smoking, including testimonials from friends. Among the pictures were shots of the young woman passed out after drinking.
"I was just shocked by the amount of stuff that she was willing to publicly display," Ms. Homayoun said. "When I saw that, I thought, 'O.K., so much for that.' "
Ms. Rose said a recruiter had told her he rejected an applicant after searching the name of the student, a chemical engineering major, on Google. Among the things the recruiter found, she said, was this remark: "I like to blow things up."
Occasionally students find evidence online that may explain why a job search is foundering. Tien Nguyen, a senior at the University of California, Los Angeles, signed up for interviews on campus with corporate recruiters, beginning last fall, but he was seldom invited.
A friend suggested in February that Mr. Nguyen research himself on Google. He found a link to a satirical essay, titled "Lying Your Way to the Top," that he had published last summer on a Web site for college students. He asked that the essay be removed. Soon, he began to be invited to job interviews, and he has now received several offers.
"I never really considered that employers would do something like that," he said. "I thought they would just look at your résumé and grades."
Jennifer Floren is chief executive of Experience Inc., which provides online information about jobs and employers to students at 3,800 universities. "This is really the first time that we've seen that stage of life captured in a kind of time capsule and in a public way," Ms. Floren said. "It has its place, but it's moving from a fraternity or sorority living room. It's now in a public arena."
Some companies, including Enterprise Rent-a-Car, Ernst & Young and Osram Sylvania, said they did not use the Internet to check on college job applicants.
"I'd rather not see that part of them," said Maureen Crawford Hentz, manager of talent acquisition at Osram Sylvania. "I don't think it's related to their bona fide occupational qualifications."
More than a half-dozen major corporations, including Morgan Stanley, Dell, Pfizer, L'Oréal and Goldman Sachs, turned down or did not respond to requests for interviews.
But other companies, particularly those involved in the digital world like Microsoft and Métier, a small software company in Washington, D.C., said researching students through social networking sites was now fairly typical. "It's becoming very much a common tool," said Warren Ashton, group marketing manager at Microsoft. "For the first time ever, you suddenly have very public information about almost any candidate."
At Microsoft, Mr. Ashton said, recruiters are given broad latitude over how to work, and there is no formal policy about using the Internet to research applicants. "There are certain recruiters and certain companies that are probably more in tune with the new technologies than others are," he said.
Microsoft and Osram Sylvania have also begun to use networking sites in a different way, participating openly in online communities to get out their company's messages and to identify talented job candidates.
Students may not know when they have been passed up for an interview or a job offer because of something a recruiter saw on the Internet. But more than a dozen college career counselors said recruiters had been telling them since last fall about incidents in which students' online writing or photographs had raised serious questions about their judgment, eliminating them as job candidates.
Some college career executives are skeptical that many employers routinely check applicants online. "My observation is that it's more fiction than fact," said Tom Devlin, director of the career center at the University of California, Berkeley.
At a conference in late May, Mr. Devlin said, he asked 40 employers if they researched students online and every one said no.
Many career counselors have been urging students to review their pages on Facebook and other sites with fresh eyes, removing photographs or text that may be inappropriate to show to their grandmother or potential employers. Counselors are also encouraging students to apply settings on Facebook that can significantly limit access to their pages.
Melanie Deitch, director of marketing at Facebook, said students should take advantage of the site's privacy settings and be smart about what they post. But students may not be following the advice.
"I think students have the view that Facebook is their space and that the adult world doesn't know about it," said Mark W. Smith, assistant vice chancellor and director of the career center at Washington University in St. Louis. "But the adult world is starting to come in."
June 11, 2006
For Some, Online Persona Undermines a Résumé
By ALAN FINDER
When a small consulting company in Chicago was looking to hire a summer intern this month, the company's president went online to check on a promising candidate who had just graduated from the University of Illinois.
At Facebook, a popular social networking site, the executive found the candidate's Web page with this description of his interests: "smokin' blunts" (cigars hollowed out and stuffed with marijuana), shooting people and obsessive sex, all described in vivid slang.
It did not matter that the student was clearly posturing. He was done.
"A lot of it makes me think, what kind of judgment does this person have?" said the company's president, Brad Karsh. "Why are you allowing this to be viewed publicly, effectively, or semipublicly?"
Many companies that recruit on college campuses have been using search engines like Google and Yahoo to conduct background checks on seniors looking for their first job. But now, college career counselors and other experts say, some recruiters are looking up applicants on social networking sites like Facebook, MySpace, Xanga and Friendster, where college students often post risqué or teasing photographs and provocative comments about drinking, recreational drug use and sexual exploits in what some mistakenly believe is relative privacy.
When viewed by corporate recruiters or admissions officials at graduate and professional schools, such pages can make students look immature and unprofessional, at best.
"It's a growing phenomenon," said Michael Sciola, director of the career resource center at Wesleyan University in Middletown, Conn. "There are lots of employers that Google. Now they've taken the next step."
At New York University, recruiters from about 30 companies told career counselors that they were looking at the sites, said Trudy G. Steinfeld, executive director of the center for career development.
"The term they've used over and over is red flags," Ms. Steinfeld said. "Is there something about their lifestyle that we might find questionable or that we might find goes against the core values of our corporation?"
Facebook and MySpace are only two years old but have attracted millions of avid young participants, who mingle online by sharing biographical and other information, often intended to show how funny, cool or outrageous they are.
On MySpace and similar sites, personal pages are generally available to anyone who registers, with few restrictions on who can register. Facebook, though, has separate requirements for different categories of users; college students must have a college e-mail address to register. Personal pages on Facebook are restricted to friends and others on the user's campus, leading many students to assume that they are relatively private.
But companies can gain access to the information in several ways. Employees who are recent graduates often retain their college e-mail addresses, which enables them to see pages. Sometimes, too, companies ask college students working as interns to perform online background checks, said Patricia Rose, the director of career services at the University of Pennsylvania.
Concerns have already been raised about these and other Internet sites, including their potential misuse by stalkers and students exposing their own misbehavior, for example by posting photographs of hazing by college sports teams. Add to the list of unintended consequences the new hurdles for the job search.
Ana Homayoun runs Green Ivy Educational Consulting, a small firm that tutors and teaches organizational skills to high school students in the San Francisco area. Ms. Homayoun visited Duke University this spring for an alumni weekend and while there planned to interview a promising job applicant.
Curious about the candidate, Ms. Homayoun went to her page on Facebook. She found explicit photographs and commentary about the student's sexual escapades, drinking and pot smoking, including testimonials from friends. Among the pictures were shots of the young woman passed out after drinking.
"I was just shocked by the amount of stuff that she was willing to publicly display," Ms. Homayoun said. "When I saw that, I thought, 'O.K., so much for that.' "
Ms. Rose said a recruiter had told her he rejected an applicant after searching the name of the student, a chemical engineering major, on Google. Among the things the recruiter found, she said, was this remark: "I like to blow things up."
Occasionally students find evidence online that may explain why a job search is foundering. Tien Nguyen, a senior at the University of California, Los Angeles, signed up for interviews on campus with corporate recruiters, beginning last fall, but he was seldom invited.
A friend suggested in February that Mr. Nguyen research himself on Google. He found a link to a satirical essay, titled "Lying Your Way to the Top," that he had published last summer on a Web site for college students. He asked that the essay be removed. Soon, he began to be invited to job interviews, and he has now received several offers.
"I never really considered that employers would do something like that," he said. "I thought they would just look at your résumé and grades."
Jennifer Floren is chief executive of Experience Inc., which provides online information about jobs and employers to students at 3,800 universities. "This is really the first time that we've seen that stage of life captured in a kind of time capsule and in a public way," Ms. Floren said. "It has its place, but it's moving from a fraternity or sorority living room. It's now in a public arena."
Some companies, including Enterprise Rent-a-Car, Ernst & Young and Osram Sylvania, said they did not use the Internet to check on college job applicants.
"I'd rather not see that part of them," said Maureen Crawford Hentz, manager of talent acquisition at Osram Sylvania. "I don't think it's related to their bona fide occupational qualifications."
More than a half-dozen major corporations, including Morgan Stanley, Dell, Pfizer, L'Oréal and Goldman Sachs, turned down or did not respond to requests for interviews.
But other companies, particularly those involved in the digital world like Microsoft and Métier, a small software company in Washington, D.C., said researching students through social networking sites was now fairly typical. "It's becoming very much a common tool," said Warren Ashton, group marketing manager at Microsoft. "For the first time ever, you suddenly have very public information about almost any candidate."
At Microsoft, Mr. Ashton said, recruiters are given broad latitude over how to work, and there is no formal policy about using the Internet to research applicants. "There are certain recruiters and certain companies that are probably more in tune with the new technologies than others are," he said.
Microsoft and Osram Sylvania have also begun to use networking sites in a different way, participating openly in online communities to get out their company's messages and to identify talented job candidates.
Students may not know when they have been passed up for an interview or a job offer because of something a recruiter saw on the Internet. But more than a dozen college career counselors said recruiters had been telling them since last fall about incidents in which students' online writing or photographs had raised serious questions about their judgment, eliminating them as job candidates.
Some college career executives are skeptical that many employers routinely check applicants online. "My observation is that it's more fiction than fact," said Tom Devlin, director of the career center at the University of California, Berkeley.
At a conference in late May, Mr. Devlin said, he asked 40 employers if they researched students online and every one said no.
Many career counselors have been urging students to review their pages on Facebook and other sites with fresh eyes, removing photographs or text that may be inappropriate to show to their grandmother or potential employers. Counselors are also encouraging students to apply settings on Facebook that can significantly limit access to their pages.
Melanie Deitch, director of marketing at Facebook, said students should take advantage of the site's privacy settings and be smart about what they post. But students may not be following the advice.
"I think students have the view that Facebook is their space and that the adult world doesn't know about it," said Mark W. Smith, assistant vice chancellor and director of the career center at Washington University in St. Louis. "But the adult world is starting to come in."
Wednesday, June 07, 2006
JD Power Car quality ranking
June 7, 2006
Toyota Dominates 2006 Quality Rankings
By THE ASSOCIATED PRESS
Filed at 11:04 p.m. ET
DETROIT (AP) -- Toyota Motor Corp. held onto its dominant position in annual vehicle quality rankings, which were revamped to highlight design and layout problems that can irritate consumers as much as defects.
Toyota and Lexus, the automaker's luxury brand, took the top spot in 11 out of 19 vehicle categories in the survey released Wednesday by J.D. Power and Associates. Porsche AG came in first in the overall ranking of brands, averaging 91 problems per 100 vehicles. That compared with an industry average of 124 problems per 100 vehicles.
The study, in its 20th year, was revised to isolate consumers' concerns about design flaws, as distinct from defects and malfunctions. The change in methodology makes year-to-year comparisons impossible.
However, a parallel survey conducted using the old methodology found that as a whole, the industry improved 8 percent from 2005, said Joe Ivers, executive director of quality and customer satisfaction research at J.D. Power.
Lexus came in second in the overall nameplate rankings, with 93 problems per 100 vehicles, while the Toyota brand was fourth with 106. The two brands scored particularly well on the defect side of the equation.
''They're the closest thing to defect-free,'' Ivers said Toyota and Lexus.
On the other hand, Porsche's top ranking had a lot to do with good design: It had the least number of design problems of any brand, but was behind Lexus when it came to defects and malfunctions.
The design issues that tended to irk people most were those having to do with ergonomics and the integration of technology into a vehicle, Ivers said.
A prime example was BMW AG's BMW brand, which had an average of 142 problems per 100 vehicles. It ranked among the best for defects and malfunctions, but took a beating from survey respondents in the design area. In particular, Ivers cited BMW's iDrive system, through which many different controls are operated by a single knob.
Bob Lutz, vice chairman for global product development of General Motors Corp., criticized ''systems where you gather everything under one control and then you are asked to scroll through menu after menu trying to do things.
''We are used to having certain vehicle controls in certain places,'' Lutz said Wednesday at an auto interiors show in Detroit prior to the release of the J.D. Power results.
BMW spokesman Dave Buchko defended iDrive, saying customers expect cutting-edge technology from the brand.
''New stuff is new,'' he said. ''It takes a bit of time to gain some familiarity with it.''
But Ivers argued it is possible to integrate new technology in a way that doesn't make a vehicle less user-friendly. ''Porsche has all the functions but none of the complaints,'' he said.
Even Toyota and Lexus could improve when it comes to technology and ease of use. Jim Lentz, group vice president for Toyota's U.S. sales division, said some complaints focused on use of the handsfree system for cell phones and even the clocks in vehicles.
In vehicle segments, Toyota had five winners, including the Corolla for compact car, the Camry for midsize car, and the Sequoia for large sport utility vehicle. Lexus had six top vehicles, including the IS 250 and IS 350 for entry premium car, the SC 430 for premium sporty car and LX 470 for large premium SUV.
Of the Big Three domestic automakers, General Motors made the strongest showing. Its vehicles won in two segments: large pickup (Chevrolet Silverado LD) and large car (Pontiac Grand Prix).
DaimlerChrysler AG's Chrysler Group had a hit with the Chrysler Town & Country, which was the top-ranked van. Ford Motor Co. also won a segment with the Ford Ranger for midsize pickup.
Hyundai Motor Co. scored a sleeper hit with consumers, with the Hyundai brand coming in No. 3 with an average 102 problems. The Hyundai Tucson took the top spot for compact SUV or crossover.
J.D. Power, based in Westlake Village, Calif., collected responses from 63,607 purchasers and lessees of new 2006 model-year vehicles after 90 days of ownership for the study. This year's survey included 217 questions, up from 135 in previous years.
Toyota Dominates 2006 Quality Rankings
By THE ASSOCIATED PRESS
Filed at 11:04 p.m. ET
DETROIT (AP) -- Toyota Motor Corp. held onto its dominant position in annual vehicle quality rankings, which were revamped to highlight design and layout problems that can irritate consumers as much as defects.
Toyota and Lexus, the automaker's luxury brand, took the top spot in 11 out of 19 vehicle categories in the survey released Wednesday by J.D. Power and Associates. Porsche AG came in first in the overall ranking of brands, averaging 91 problems per 100 vehicles. That compared with an industry average of 124 problems per 100 vehicles.
The study, in its 20th year, was revised to isolate consumers' concerns about design flaws, as distinct from defects and malfunctions. The change in methodology makes year-to-year comparisons impossible.
However, a parallel survey conducted using the old methodology found that as a whole, the industry improved 8 percent from 2005, said Joe Ivers, executive director of quality and customer satisfaction research at J.D. Power.
Lexus came in second in the overall nameplate rankings, with 93 problems per 100 vehicles, while the Toyota brand was fourth with 106. The two brands scored particularly well on the defect side of the equation.
''They're the closest thing to defect-free,'' Ivers said Toyota and Lexus.
On the other hand, Porsche's top ranking had a lot to do with good design: It had the least number of design problems of any brand, but was behind Lexus when it came to defects and malfunctions.
The design issues that tended to irk people most were those having to do with ergonomics and the integration of technology into a vehicle, Ivers said.
A prime example was BMW AG's BMW brand, which had an average of 142 problems per 100 vehicles. It ranked among the best for defects and malfunctions, but took a beating from survey respondents in the design area. In particular, Ivers cited BMW's iDrive system, through which many different controls are operated by a single knob.
Bob Lutz, vice chairman for global product development of General Motors Corp., criticized ''systems where you gather everything under one control and then you are asked to scroll through menu after menu trying to do things.
''We are used to having certain vehicle controls in certain places,'' Lutz said Wednesday at an auto interiors show in Detroit prior to the release of the J.D. Power results.
BMW spokesman Dave Buchko defended iDrive, saying customers expect cutting-edge technology from the brand.
''New stuff is new,'' he said. ''It takes a bit of time to gain some familiarity with it.''
But Ivers argued it is possible to integrate new technology in a way that doesn't make a vehicle less user-friendly. ''Porsche has all the functions but none of the complaints,'' he said.
Even Toyota and Lexus could improve when it comes to technology and ease of use. Jim Lentz, group vice president for Toyota's U.S. sales division, said some complaints focused on use of the handsfree system for cell phones and even the clocks in vehicles.
In vehicle segments, Toyota had five winners, including the Corolla for compact car, the Camry for midsize car, and the Sequoia for large sport utility vehicle. Lexus had six top vehicles, including the IS 250 and IS 350 for entry premium car, the SC 430 for premium sporty car and LX 470 for large premium SUV.
Of the Big Three domestic automakers, General Motors made the strongest showing. Its vehicles won in two segments: large pickup (Chevrolet Silverado LD) and large car (Pontiac Grand Prix).
DaimlerChrysler AG's Chrysler Group had a hit with the Chrysler Town & Country, which was the top-ranked van. Ford Motor Co. also won a segment with the Ford Ranger for midsize pickup.
Hyundai Motor Co. scored a sleeper hit with consumers, with the Hyundai brand coming in No. 3 with an average 102 problems. The Hyundai Tucson took the top spot for compact SUV or crossover.
J.D. Power, based in Westlake Village, Calif., collected responses from 63,607 purchasers and lessees of new 2006 model-year vehicles after 90 days of ownership for the study. This year's survey included 217 questions, up from 135 in previous years.
Tuesday, May 30, 2006
Claritin approval process
NYTimes
March 11, 2001
The Claritin Effect; Prescription for Profit
By STEPHEN S. HALL
It had been yet another miserable, nose-dripping, red-eyed spring a couple of years ago, when I finally went to see an allergy specialist. I've been battered by seasonal allergies all my life but relied on family doctors and, more recently, ''primary-care physicians'' for relief. In a kind of a pharmaceutical version of playing catch with Dad, my father and I shared his hay-fever pills when I was growing up. They were smooth, round yellow tablets, etched with a tiny red corporate symbol that was as delicate as a Chinese ideograph. At a time before people routinely gobbled down a half dozen medicines a day, those pills held a kind of mythic power for me, not only because they could make the misery of allergies disappear but also because they were prescription drugs -- inherently more powerful, more inaccessible, more special.
Those yellow pills were called Chlor-Trimeton, manufactured by the Schering-Plough Corporation, first as a prescription drug and then, after 1976, as an over-the-counter medication. It definitely worked, but it knocked me out. I remember days when I felt glazed by sleepiness. Even as the high tide in my nose and throat subsided, I felt mentally waterlogged.
For the most part, I managed to get by with over-the-counter medications until that spring in 1999, when I decided I needed something stronger. After rummaging through a cabinet in the examining room, my new allergist handed me a week's supply of Claritin, also made by Schering-Plough. Claritin was, and still is, the most frequently dispensed drug sample in the United States, part of the nearly $8 billion worth of free drug samples that pharmaceutical companies distribute to doctors annually. I had seen the ads on TV -- who hadn't? I figured I'd give it a try.
Claritin had several other distinctions: it was by then the best-selling antihistamine in the United States, indeed the most profitable antihistamine of all time, with annual sales of more than $2billion. And it was the most aggressively marketed drug to American consumers. Claritin is a drug for our time: designed to relieve symptoms and improve ''quality of life,'' hardly lifesaving or even curative, expensive as hell. A month's supply of Claritin currently costs about $80 or $85 in the United States, even though it is an over-the-counter drug in dozens of other countries, where it usually costs $10 or $15. The high domestic price is paired with an enormous potential market: an estimated 35 million Americans suffer seasonal allergies, and many of us will be feeling that first tickle of dread later this month, when spring tree pollen begins to barge into our air passages like molecular roustabouts.
So I went home and tried it. The little white pill was easy to swallow and had to be taken only once a day. There was just one problem: it didn't work. It didn't relieve my runny nose and red-rimmed, gunked-up eyes. When I told my allergist, he didn't seem particularly surprised. Only about 30 to 40 percent of his patients, he said, found the drug helpful. And, he added, that estimate was ''generous.'' I was surprised, perhaps naïvely, by this remark. I figured a ''blockbuster'' drug would be efficacious in more than 50 percent of the people who took it. The percentage he mentioned, incidentally, is certainly debatable; in fact a debate broke out later between my allergist and his partner, who thought 50 or 55 percent was more like it. Even so, it made me wonder: $80 for a drug that works only half the time?
Claritin has been singled out as a prime example of greed by the American pharmaceutical industry, notably last summer by Al Gore during his presidential campaign, and there has been a constant stream of negative press about Schering-Plough's efforts to get the basic patent on Claritin extended beyond its 2002 expiration. Schering-Plough has argued that the patent should be extended because the Food and Drug Administration review of Claritin was unusually ''protracted'' (which, in fact, it was). To press its case in Washington, the company has paid millions of dollars in political contributions and assembled a high-powered, strange-bedfellows team of lobbyists (including the former senators Howard Baker and Dennis DeConcini, the Gore confidant Peter Knight and Linda Daschle, wife of the Senate minority leader, Tom Daschle); it has also encouraged repeated attempts by Congressional supporters to insert language favorable to Schering into legislation at the last instant.
Claritin's 77-month odyssey through the F.D.A. approval process was indeed lengthy, as a General Accounting Office report, issued last August, documents. That report prompted me to read through the transcripts of old F.D.A. meetings, obtain other documents through Freedom of Information requests and speak to doctors about allergy medications in general. As I learned more about the approval of Claritin, I realized that the biography of this one drug reveals a great deal about why prescription drugs cost so much to bring to market, and also why health-care economists like Uwe E. Reinhardt of Princeton University argue that we are paying premium prices for new drugs like these without actually knowing if they are better than the drugs they've replaced. The Claritin story is an unauthorized biography, in the sense that Schering-Plough declined to grant any interviews and responded only to written questions.
It is above all a case study of how a drug company creates a blockbuster. There are no villains, no broken laws -- just an enormous expenditure of money, a highly sophisticated understanding of food and drug laws, daring marketing, a great deal of luck. Making it all possible is a financial system that ultimately passes along the high price of a modest drug to third-party payers -- and you.
Claritin's journey from lab bench to marketplace was nearly epic in the time it took, the vicissitudes encountered and the plot twists along the way. In June 1980, when Schering filed a patent for the group of chemical compounds that included the drug that would eventually be known as Claritin, the world of drug development was quite different. It typically cost a pharmaceutical company roughly $200 million to $250 million to develop a new drug; that cost is estimated to be closer to $500 million today, a figure that also accounts for failures along the way. A patent lasted 17 years from the date it was issued; it now lasts 20 years from the date the application is filed. And the effective patent life of a new drug -- the amount of time a company can expect to enjoy an exclusive run in the marketplace -- was about eight years; the average effective patent life of a drug has nearly doubled since then. The Schering patent, issued Aug. 4, 1981, stated that the compounds, including the future Claritin, were ''useful as antihistamines with little or no sedative effects.'' Pharmaceutical companies rarely disclose the cost of bringing a specific drug to market, but it's a safe bet that it took at least several hundred million dollars to deliver on the promise of those nine words.
Loratadine (pronounced ''low-RAT-a-deen'') -- the generic name for Claritin -- was one of several second-generation antihistamines that emerged from drug-company laboratories in the 1980's. They worked by essentially the same simple mechanism as the first-generation antihistamines developed immediately after World War II, like Chlor-Trimeton. When pollen bumps into certain immune-system cells just beneath the lining of the nose, eyes or respiratory passages, it provokes an immunological overreaction in susceptible people. Thus perturbed, these ''mast cells'' shudder with the molecular equivalent of uncontrollable weeping; they churn out at least 15 different inflammatory molecules, many of which contribute to the allergic reaction. One of those molecules, unleashed instantaneously, is called histamine.
When these roving histamine molecules attach to receptors on nearby nerve cells, you feel an itch or a sneeze or a scratchy, ticklish palate. When they dock onto receptors in nearby blood vessels, the vessels become porous and leaky, and fluids begin to ooze into the tissues of your nose and eyes. Antihistamine drugs work because the active ingredient is a molecule that fits like a cap onto the histamine receptor, blocking the signal that causes itchy, watery symptoms.
Everyone agrees these drugs are effective, but just how effective is very difficult to say. All the antihistamine drugs, new and old, are plagued by high placebo effects. ''It's a question of how bad a placebo effect you have,'' says Dr. Peter S. Creticos, head of the allergy and clinical immunology division at the Johns Hopkins University School of Medicine. ''The placebo effect can be anywhere from 20 to 40 percent.''
Complicating the process of determining efficacy is how the data are gathered: patients in these trials typically assess their own degree of symptom relief, which many allergists concede makes the data somewhat subjective.
Then there's the sponsorship of the science. Because the placebo effect is so high, large numbers of patients must be enlisted in clinical trials to achieve a robust, or statistically ''significant,'' result, which means that only drug companies can afford the expense. Studies sponsored by drug companies tend to show an advantage for the company's own products. Zyrtec, an antihistamine produced by Pfizer, for example, has been shown to be more potent than other drugs in its antihistamine effect -- in a study sponsored by Pfizer. Desloratadine, currently awaiting F.D.A. approval as the next generation ''super-Claritin,'' is said to relieve nasal stuffiness, unlike other antihistamines -- in a study done by Schering. And Allegra, produced by Aventis, was recently shown to be equal to Zyrtec -- in a study sponsored by Aventis. ''They're going to take that study all the way to the bank,'' one academic allergist chuckled. Which is precisely the point. Scientific studies of these drugs serve as marketing tools, providing drug-company salesmen with their best lines.
The first-generation antihistamines, now sold over the counter as Chlor-Trimeton, Benadryl, Tavist and others, are still considered pretty effective medicines. In fact, many allergists told me that they are at least equivalent in medical potency to newer drugs like Claritin and Allegra. But the first-generation molecules cross the blood-brain barrier and get into the central nervous system, causing drowsiness. The second-generation drugs have been medicinally engineered to stay out of the brain. As a result, they cause little or no sedation.
A nonsedating antihistamine was clearly a desirable drug, and Schering-Plough had been looking for one since the 1960's. In fact, the company thought it had one in a compound called azatadine. The drug is still sold as Optimine, and if you've never heard of it, that's because the compound looked deceptively nonsedating when it was tested in cats and showed its true, somnolent colors only during human testing. Next came loratadine. Following years of testing, Schering formally submitted what is known as a New Drug Application, or N.D.A., to the Food and Drug Administration on Oct. 31, 1986, seeking approval of loratadine.
Schering was not the first company to knock on the F.D.A.'s door with a nonsedating antihistamine. Seldane (terfenadine), manufactured by Marion Merrell Dow, had been approved the year before, and Hismanal (astemizole) was already under F.D.A. review. Because a similar nonsedating antihistamine was already on the market, the F.D.A. assigned Claritin its lowest priority for review -- it was considered, according to an F.D.A. classification system no longer in use, a drug that ''essentially duplicates in medical importance and therapeutic usage one or more already marketed drugs, offering little or no therapeutic gain over existing therapies.'' Technically, Claritin started out as a ''me too'' drug.
Schering-Plough doggedly pursued the approval of Claritin, spurred, no doubt, by the phenomenal success of Seldane. But it wasn't easy. Over six and a half years, Schering filed 37 major amendments to its application. The company decided to switch the formulation from capsules to tablets, and it took more than two years to show that the capsules used in clinical trials were pharmacologically identical to the tablets it intended to sell. Among the many obstacles Schering had to overcome, the first was to convince F.D.A. reviewers of the drug's main selling point: that it could be effective without causing drowsiness.
To approve a new drug, the F.D.A. must be convinced that it is both safe and effective. As a practical matter, that often means arriving at a balance between potency and side effects. Drug companies routinely submit notebooks of dictionary girth full of experimental results establishing a drug's safety profile, first in animals and then in human subjects. In establishing the effectiveness of a new drug, however, a company has only to show in well-designed trials that a drug is more effective than a sugar pill, and if there is already an equivalent drug on the market for the same use, that it is at least equally effective.
The effectiveness of loratadine had been an area of F.D.A. concern as early as January 1987, just months after Schering filed its application. Dr. Sherwin D. Straus, the F.D.A. medical officer assigned to review the drug, told the company that a 10-milligram dose of Claritin -- the amount marketed today -- did not appear to be very effective. He reiterated that point in public on Oct. 23, 1987, when the F.D.A.'s Pulmonary-Allergy Drugs Advisory Committee met at the agency headquarters in Rockville, Md., to consider Schering's application for loratadine. (This panel of outside experts doesn't formally approve new drugs, but makes influential recommendations to the agency.)
Establishing a drug's safety and efficacy is not a pretty business. A parade of Schering representatives described a staggering amount of data from animal tests in mice, rats, guinea pigs, cats and monkeys, including the ''mouse-paw edema test'' (in which mice have their paws cut off and weighed to see how successfully an antihistamine inhibits swelling). In several studies, extremely high doses of the drug, consumed daily for up to two years, produced borderline evidence of liver-tumor formation in rats and male mice, but otherwise loratadine appeared very clean. Indeed, the company maintains that the drug's ''excellent safety profile is well established'' by 10 billion ''patient days'' of experience in the marketplace.
After preclinical animal tests, Schering began to test loratadine in thousands of human patients, first to establish its safety and then to prove its effectiveness. The company ultimately submitted three so-called ''pivotal'' clinical trials to support the drug's safety and efficacy. Schering conducted what is considered the gold standard in drug testing -- randomized, double-blind trials pitting Claritin against both placebo and one of several already approved antihistamines -- and the results reveal just how vexing the placebo effect can be. In one study, for example, people taking Claritin experienced a 46 percent improvement in symptoms at the end of the trial; patients taking a placebo reported 35percent improvement. In another trial, Claritin produced 43 percent improvement versus 32 percent on placebo. As part of these same studies, physicians examined the patients and, unaware of which treatment each had received, assessed their condition; these doctors concluded that anywhere from 37 to 47 percent of patients taking the sugar pill showed a ''good or excellent response to treatment.''
When it was his turn to speak, Straus engaged in a little bureaucratic soft-shoe, complimenting the Schering team's presentations as ''a tough act to follow.'' Then he tried to demolish the heart of Schering's application. Straus didn't doubt that loratadine worked as an antihistamine, he said; he just doubted that it worked at the 10-milligram dose. In fact, at one point he claimed that ''10 milligrams is not very different than placebo clinically.'' The reason the dose was so low, he argued, is that evidence of sedation began to crop up at higher, more effective doses.
What he didn't say -- but what everyone understood -- is that using a higher, more effective dose of Claritin would affect how the drug was described on the label. The term ''nonsedating'' was considered a critical marketing point. A single adjective or phrase contained in the F.D.A.-approved label -- no more sedating than a sugar pill,'' for example -- can form the basis of claims made by company salesmen to doctors, the basis of words that throb in the bold type of advertisements, even the basis of lawsuits filed against competitors. Those seemingly eye-glazing, hairsplitting distinctions provide the foundation for multimillion-dollar marketing campaigns.
The clash over effectiveness was crystallized in one edgy exchange between Straus and Dr. Anthony Nicholson, a British neuroscientist, one of the Schering-sponsored clinical researchers, over the interpretation of a study that compared loratadine to a sedating antihistamine called tripolidine. ''We are not actually in the business of saying one drug is better than the other,'' Nicholson told Straus. ''We are in the business of saying whether a drug is acceptable in terms of its performance profile.''
''But how can you say it is acceptable in terms of its performance profile,'' Straus replied, ''without comparing it to what else is out there?''
''We compare it with placebo,'' Nicholson said.
''So you compare it to nothing.''
''Yes.''
''And it is better than nothing.''
''Yes.''
''All right,'' Straus said. ''I can't argue with that.''
The Schering representatives gave as good as they got. One suggested that Straus was guilty of statistical mischief; he had selectively looked at variables, subsets and time points, ''and this is, as I am sure everybody in this audience knows, the perfect method of proving any claim one wants.'' Dr. William Darrow, a senior vice president at Schering, acknowledged that Straus's concerns were legitimate, ''but for us the question is whether we have demonstrated consistently superiority and adequate efficacy over placebo by the 10-milligram dose. And we stand on our data there.''
In a sense, they were both right. Schering had shown, according to the requirements of the law, that a 10-milligram dose of loratadine was more effective, and no more sedating, than placebo. And Straus had argued, to the satisfaction of at least some people on the committee, that while the drug might be more effective than placebo, it was not a whole lot more effective.
Perhaps the most startling assertion made at that 1987 meeting came not from Straus, however, but from Leslie Hendeles, a pharmacology professor at the University of Florida, and it is as relevant to allergy sufferers today as it was back then. He suggested that most of the patients in Schering's Claritin studies would have been better off being treated with a different class of allergy medication altogether -- steroid nasal sprays. ''Certainly, in this kind of patient that was selected for this study,'' he said to the gathering, ''most clinicians would probably use intranasal steroids to provide very prompt and sustained relief, rather than antihistamines.'' To treat full-blown allergy symptoms with an antihistamine, he continued, was ''pharmacologically irrational.''
Hendeles and other experts made a similar point to me recently: steroid nasal sprays, like Flonase and Schering's own Nasonex, shut off an allergic reaction that's already under way. In 1998, the Annals of Allergy, Asthma and Immunology published treatment guidelines stating that these nasal sprays ''are the most effective medication class for controlling symptoms'' of allergies. The popular antihistamines are valuable at preventing an allergy attack from getting under way if taken ahead of time and seem to be effective against eye symptoms, but they rarely bring quick and substantial relief of nasal symptoms once histamine has already begun to wreak havoc. ''We don't use these medicines correctly,'' said Peter Creticos of Johns Hopkins. ''As I tell patients, by the time the process starts, the horse is already out of the barn in terms of the antihistamines. You turn the process off by using a nasal steroid.''
Although the F.D.A. advisory committee recommended approval of loratadine, Straus remained skeptical. In the conclusions of a 321-page ''medical officer review'' dated Nov. 9, 1987, he described the proposed 10-milligram dose of Claritin as ''minimally effective versus placebo'' and added that 40 milligrams appeared to be ''the minimum effective dose.'' He also argued that the label ''must include sedation as an adverse reaction and include warnings to this effect.'' A former F.D.A. official, who requested anonymity, said that the agency informally asked Schering to test a higher dose of loratadine but lacked the regulatory authority to mandate it.
By May 1988, however, the F.D.A. had come to the conclusion that the 10-milligram dose was no more sedating than a placebo pill, and by July 1989, as the General Accounting Office report puts it, ''a consensus had developed at F.D.A. that 10 milligrams was effective.'' It is impossible to determine whether Sherwin Straus had changed his mind. Around the time he was assessing loratadine, according to former colleagues, he developed multiple sclerosis and became seriously ill, eventually dying of the disease.
''Schering-Plough always believed that loratadine was safe and effective at the 10-milligram dose,'' William O'Donnell, a company spokesman, wrote in reply to a question, ''and felt that the clinical studies that were done fully supported that conclusion.''
Pharmaceutical executives rarely talk about luck as a feature in the process of drug development, but in 1989 alone, Claritin's fortunes were buffeted like a grain of pollen in an early spring breeze. In September of that year, the acting division director at the F.D.A., reviewing the drug's status, concluded that all outstanding issues regarding safety, efficacy and the equivalence of tablets and capsules had been resolved. Claritin should have been nearing approval. But earlier in the year, as part of an F.D.A. reorganization, the Claritin application was transferred to a different division within the F.D.A.; with the transfer came a new pharmacology reviewer. This reviewer revisited some toxicology issues Schering thought had been settled.
Around this time, according to Schering, tests on other products being conducted at the F.D.A.'s National Center for Toxicological Research in Jefferson, Ark., were showing that high doses of doxylamine, an antihistamine and sleep aid, produced liver tumors in rodents. These findings apparently prompted the F.D.A. to reconsider results of animal experiments with both loratadine and cetirizine (the active ingredient in Zyrtec); they, too, had shown increases in liver adenomas, abnormal growths that were then considered to be a ''larval'' form of malignant tumor.
The stakes for Claritin were high. If a prescription drug caused cancer in animals but was of medical importance, and if no satisfactory alternative existed, the usual procedure would be to approve the drug and describe the findings on the drug's label, said Paula Botstein, then a deputy F.D.A. director, at a 1991 meeting. But if similar drugs were already on the market and were not carcinogens, she said, the F.D.A. would ''ordinarily'' not approve a new drug if it caused cancer in animals. Both Seldane and Hismanal were already on the market, and neither caused cancer in animals. Because of this situation, said a former F.D.A. official who asked not to be named, the Claritin approval was ''certainly'' in doubt -- even after an advisory panel concluded that it was unlikely to pose a cancer risk to humans. (The other two drugs, doxylamine and cetirizine, were also cleared of suspicion.) Nevertheless, the F.D.A. still insisted on further tests, which eventually convinced agency officials that the drug was safe. Schering-Plough has always insisted that Claritin is not a carcinogen.
While these safety concerns were being investigated, a fateful new chapter in the Claritin story began to unfold. On a night in November 1989, in what first looked like an unrelated event, a 39-year-old woman was brought to the National Naval Medical Center in Bethesda, Md., after fainting while driving on the Washington Beltway. She had lost consciousness four times in a two-day period. She was taking the antihistamine Seldane (not for allergies but for a sinus condition) and then began using an antifungal drug, ketoconazole, to prevent a vaginal yeast infection. ''And that turned out to be a deadly combination,'' recalled Dr. Brian P. Monahan, who treated the woman for potentially fatal cardiac arrhythmias.
As doctors investigated this unusual case, they uncovered previous reports of dangerous irregularities in heartbeat among Seldane patients. Later they found that risk in Seldane patients to be associated with ketoconazole or erythromycin, a widely used antibiotic. In August 1990, at the F.D.A.'s urging, Seldane's manufacturer, Marion Merrell Dow, sent letters to doctors warning of these potentially fatal drug interactions, and in 1992 the F.D.A. ordered warning statements, outlined by a prominent black box, to appear at the top of the label and packaging on Seldane and Hismanal.
This turned out to be very good news for Claritin. Because of growing concerns about the two other nonsedating antihistamines, the F.D.A. ''started to believe that it would be beneficial to have Claritin for sale,'' according to G.A.O. investigators. (Schering said in a statement, ''We do not believe that loratadine was the result of a balancing of product-safety issues.'')
In the span of several years, therefore, Claritin had gone from being a me-too drug, to one that looked possibly unapprovable, to the only game in town. This regulatory roller coaster finally came to a rest in April 1993 when, 77 months after Schering applied, the F.D.A. approved loratadine.
At least one analyst, Mara Goldstein of C.I.B.C. World Markets, estimates that Schering-Plough lost $4billion in revenues because of the delay. But I heard
a different view from a pharmacologist who, although insisting on anonymity, was familiar with these unfolding events. ''I think they've grossly benefited from the delay at the agency,'' this researcher told me. ''Because terfenadine'' -- the generic name for Seldane -- was getting blasted, they looked like a good alternative, and I think they actually got a much larger share when they hit the market because of it.''
Since Claritin's approval, the marketing campaign for the drug has rewritten the rules for pharmaceutical promotion. The brand is ubiquitous: watching the World Series in 1999, viewers frequently saw Claritin proclaimed the ''official allergy medication of Major League Baseball''; the bag the pharmacist gives you when you fill almost any prescription suggests that you ''ask your pharmacist about Claritin-D 24 Hour.''
The direct-to-consumer ads seen on TV and in magazines are only the tip of the iceberg. The bulk of pharmaceutical marketing goes on behind closed doors, where drug salesmen tout their products to doctors, and pharmaceutical companies now spend more than $13 billion a year on such promotion, according to I.M.S. Health, a company that tracks the pharmaceutical business. The language of those presentations is constrained by the language on the F.D.A.-approved label -- in other words, all the battles over efficacy and sedation at those obscure F.D.A. meetings in the 1980's define the sales vocabulary of the 1990's.
Once again, Claritin was the beneficiary of some lucky timing. In August 1997, the F.D.A. relaxed its rules governing television advertising; rather than having to run the same fine print required in magazine ads, commercials could satisfy F.D.A. rules by giving a toll-free number, mentioning a magazine advertisement and instructing viewers to ''ask your doctor'' for more information. In a daring move closely watched by the rest of the industry, Schering-Plough poured $322 million into pitching Claritin to consumers in 1998 and 1999, far more than any other brand, according to the National Institute for Health Care Management Foundation, a nonprofit group in Washington.
''That campaign was a landmark,'' says the group's Steven D. Findlay. ''The Claritin campaign, along with Viagra, Prilosec and a few other high-profile drugs, was very influential. Claritin was clearly the most visible, the most expensive and skillfully executed, and the bottom-line results were immediately apparent. It had a huge impact, because everybody is watching everybody else very closely.'' Drug companies spent an estimated $2.5 billion on consumer advertising in 2000; these ads may have brought in as much as a $5-to-$6 return for each dollar spent.
Yet critics point out that direct-to-consumer advertising illustrates an embarrassing paradox: marketing may be most indispensable in categories where new drugs may actually be less innovative. ''Marketing is meant to sell drugs,'' Marcia Angell wrote in an editorial in The New England Journal of Medicine last June, ''and the less important the drug, the more marketing it takes to sell it. Important new drugs do not need much promotion. Me-too drugs do.''
But promotion works. Sales in the United States of the entire Claritin family -- not just the 10-milligram tablets, but a syrup, quick-dissolving RediTabs and both 12-hour and 24-hour Claritin-D versions with a decongestant -- which stood at $1.4 billion in 1997, jumped to $2.6 billion by 2000. It accounts for nearly 30 percent of Schering-Plough's annual revenues.
Schering had a magnificent cash cow. Now the trick was to milk it as long as possible.
Almost from the moment Claritin was approved in 1993, with only five years remaining on its basic patent at the time, Schering-Plough and its competitors began to tussle over the drug's afterlife -- and, more important, when it would begin. Generic drug companies typically gear up to produce a cheap version of a drug about five to seven years before a patent is due to expire. Schering, at that same time, began to mount its expensive legislative campaign to extend Claritin's patent. This fundamental conflict, played out in Congress and in court, is shaping the golden years of Claritin's already eventful career as a drug.
The Claritin patent has been extended several times already, each extension reflecting laws passed by Congress in the last two decades that have modernized the F.D.A. review process and significantly extended the effective life of drug patents. The extensions began with the Drug Price Competition and Patent Term Restoration Act of 1984, known informally as the Hatch-Waxman Act. Despite its dense legal provisions, Hatch-Waxman is an essential element of any conversation about drug prices in this country. The law was a legislative high-wire act designed to reward innovation at major pharmaceutical companies and protect intellectual property while at the same time promoting lower drug costs, primarily by making it easier for generic drug makers to get to the American marketplace. As part of Hatch-Waxman, new drugs being developed after the law was enacted in 1984 could receive automatic patent extensions of five years. More than 100 drugs, including Claritin, were already in development when the law was passed; these products, known as ''pipeline'' drugs, were eligible for only two years. That reset the clock for Claritin's patent expiration to the summer of 2000.
In 1994, the Uruguay Round Agreements Act, an obscure addendum to the GATT treaty, added 22 months to the patent life of Claritin, pushing the expiration back to June 2002. And just last August, the basic patent on Claritin was extended yet another six months, to December 2002, because Schering-Plough conducted pediatric trials of the drug. If six months doesn't sound like a lot, consider the economic incentive here: for the price of a modest clinical trial in children (costing at most $3 million), Schering can extend the life of its basic patent half a year and earn close to $1billion. By one unofficial estimate, these three patent extensions will ultimately translate into additional Claritin revenues totaling about $13 billion.
Since 1996, there have been at least a half dozen attempts to extend Claritin's patent life even more. There was an attempt, for instance, in the summer of 2000 to slip language at the last minute into a military-appropriations bill. Schering's lobbying efforts have not been the most persistent, ''just the crudest,'' according to Bruce Downey, C.E.O. of Barr Laboratories, a generic drug maker based in Pomona, N.Y., who has also testified against extending the Claritin patent.
Representative Waxman has derided the legislation proposed to provide Schering relief as the ''Claritin Monopoly Relief Act.'' But the case for some of the pipeline drugs may not be as outrageous as some critics have suggested. Peter Barton Hutt, the former chief counsel at the F.D.A. and now a lawyer at the Washington firm Covington & Burling, has argued that limiting loratadine and several other pipeline drugs to a two-year extension was ''completely arbitrary'' and assumed much speedier approval.
As has been true of so much of this drug's history, however, timing is everything, and Schering-Plough's efforts to extend its monopoly has coincided with surging public discontent about the cost of drugs. As a result, each attempt by the company to get Congressional patent relief has become a rallying cry for opponents, including consumer watchdogs, health insurers and generic drug makers. Since the 1996 election, Schering has spent $19.9 million on lobbying and campaign contributions, according to the watchdog group Public Citizen. Yet the most tangible achievement to date of that $20 million lobbying campaign may be the way that it has galvanized the generic drug industry and attracted the attention of lawmakers. Last fall, Senators John McCain and Charles Schumer introduced legislation designed to close loopholes in Hatch-Waxman.
For all the closed-door maneuvering in Washington, an equally revealing pharmaceutical endgame has been playing out, slowly, in a courtroom in New Jersey.
A chilly day in January, about two dozen dark-suited patent attorneys gathered in the United States District Court in Newark, in what has become a typical chain of events toward the end of a prescription drug's life: patent litigation. Unlike the arguments made by Schering-Plough's lobbyists in Washington, however, those made by its lawyers in court documents maintain that Claritin's patent protection extends beyond 2002.
Last August, Teva Pharmaceuticals became the first company to receive tentative approval from the F.D.A. to market a generic version of Claritin. The key word here is ''tentative.'' Teva must wait for the basic loratadine patent to expire next year. It must wait for the resolution of a lawsuit filed against it by Schering, which could conceivably stretch into 2003. And it must wait for Geneva Pharmaceuticals, a generic company based in Broomfield, Colo., to bring its version of Claritin to market; Geneva is entitled to an exclusive 180-day run as the only generic in the market, a monopoly that the company receives as Hatch-Waxman's reward for being the first generic drug maker to challenge a brand drug's patent. The moment the first generic enters the market, industry experts estimate, the cost of generic Claritin will drop to about 80 percent of current prices. When everyone else jumps in six months later, the price will fall off a cliff. ''With so many competitors,'' one generic executive told me, ''the price will drop to $10 very quickly.''
Generic companies fill about 42 percent of all drug prescriptions in this country, but the price disparity with brand-name drugs is striking. That market share accounted for slightly less than $20 billion in drug sales in 1999; brand company sales accounted for more than $90 billion. Industry advocates claim that if generic sales inched up to 52 percent, American consumers would save an estimated $11 billion a year in drug costs. If the generic industry is beginning to mature, as some maintain, one of the main factors in that process has been, oddly, Schering-Plough. ''I think loratadine is one of the first examples,'' said Dr. Carole Ben-Maimon, head of the Generic Pharmaceutical Industry Association and until recently a vice president at Teva. ''We were really able to make it an issue.''
Much of the industry's current disgruntlement involves patent litigation -- or as George S. Barrett, president and C.E.O. of Teva USA puts it, ''the way the patent system has just been abused.'' When Congress devised the language of Hatch-Waxman back in 1984, the notion of a drug coming ''off patent'' was as simple as it sounds: once the patent for a basic compound expired, other companies were free to enter the market. But it's not that simple anymore, said Ben-Maimon, a physician who now heads a research division at Barr.
Brand companies now patent the process of manufacturing the raw material. They patent the medical uses to which the drug can be applied. They patent the formulation of the medicine (the other ingredients used to stabilize the drug). They can patent what's known in the industry as ''trade dress'' -- the color, size and shape of the pill. They patent metabolites -- the chemicals into which a drug breaks after being metabolized by the human body.
So drugs don't come ''off patent'' the way the 1984 law envisioned; they come off as a series of strategically staggered patents, a practice known as layering. And here's where Hatch-Waxman has inadvertently turned into a playbook for complicated, time-consuming -and, according to generic drug makers, frivolous -- patent litigation.
On Feb. 5, 1998, Geneva Pharmaceuticals filed what's known as an abbreviated new drug application, or ANDA, seeking F.D.A. permission to sell a generic version of Claritin. Several days later, as obliged by Hatch-Waxman, Geneva notified the patent holder, Schering, of its plans. On March 19, Schering-Plough sued Geneva and its parent corporation, Novartis, claiming that two of its Claritin patents had been infringed. Since then, seven other drug makers -- Zenith Goldline, Teva Pharmaceuticals, Mylan, Andrx, Impax, American Home Products and Apotex-Novex -- have gone to the F.D.A. seeking approval to sell generic versions of Claritin. Although the issues vary from case to case, Schering has sued all of them.
Some critics make the case that since Hatch-Waxman, an inordinate amount of innovation has been displaced from research to litigation strategies. A lawsuit is far cheaper (about $5million per case) and less risky than research, and the return on investment can be very high. ''It's always cheaper to litigate than to lose market share,'' said a former top-level F.D.A. official who asked not to be named. ''If you can keep a generic off the market for one day, three days, five days, two months or two years, that's a lot of revenue. Certainly a lot more than it would cost to pay your lawyers.'' A Schering spokesman says, ''Schering-Plough believes that its patents are valid and enforceable.''
William Fletcher, president of Teva North America, knows how frustrating this can be. ''You know, people here have asked us several times, 'Why bother doing Claritin?''' he said. ''There are going to be at least 10 competitors out there. The price is going to be, you know, 5 percent of Claritin. Why bother doing it? One reason is that we are a broad-line supplier, and we have to have every product in our line. The other reason is that we're just bloody-minded about it, quite frankly. Stubborn. You know, you're damned if you're going to let Schering-Plough get away with it!''
There's a larger game in play in the Newark courtroom, too, according to the generic companies, and it became more interesting a few weeks ago. As Schering-Plough holds the generics at bay with one hand, it had hoped to receive F.D.A. approval in time to introduce desloratadine, its second-generation version of Claritin that will be marketed as Clarinex, this spring. ''The longer the litigation is dragged out,'' says Elliot F. Hahn, president of Andrx, ''the more opportunity they have to market desloratadine to physicians and switch them from the Claritin line to the desloratadine line.'' But that plan ran into a major snag in mid-February, when Schering-Plough revealed that the approval of desloratadine was being held up until the company corrects manufacturing deficiencies cited by the F.D.A. at four of its plants.
What to do in a crisis? Market! Several days later, as the company's stock plunged and attorneys hustled to organize shareholder lawsuits, Schering-Plough announced big new ''consumer education'' and pharmacy programs for Claritin -- the ''largest and most comprehensive allergy initiative of its kind.'' The company plans to distribute 35 million free drug samples to doctors, 6 million allergy brochures, 65,000 drugstore displays and, yes, 350 million more of those little blue pharmacy bags.
Finally, an edifying case of sticker shock. Late last fall, my allergist prescribed a month's supply of Claritin-D to clear up some congestion before I started my first round of allergy desensitization shots. The pharmacy had misplaced my insurance number, so when I went to pick up the prescription, the clerk handed me a bill for $103. This is the consumer's trickle-down tab for the roughly $250 million in drug development, more than $100 million a year in consumer advertising, many millions in closed-door marketing, $20 million in lobbying and political contributions, $5 million a year for litigation. I was stunned that it was so expensive, and I asked myself a question that is a normal part of every marketplace but health care. If I had to pay $103 out of my own pocket, would I buy this medicine? Was it worth it?
With the exception of elderly people on Medicare and the uninsured, most of us never ask that question. In a recent conversation, Gillian Shepherd, a Manhattan allergy specialist, addressed the same point, noting that antihistamines like Claritin and Allegra are about equal in potency to over-the-counter drugs like Chlor-Trimeton. And while some patients experience sedation with these drugs, many do not. ''Fifty percent of the population can tolerate most of them without any sedation,'' she explained. ''The feeling is that if there's a chance of sedation and third parties are paying, why not use the nonsedating drugs? If people were paying out of pocket, the story would be completely different.''
As I labored to sort through all the clinical data and all the confusing advertising, I found myself wishing that we had reviewers who would talk bluntly about new drugs, who could discuss efficacy, safety and value from the consumer's point of view, who could deconstruct the advertising, who would include cost as a criterion. But those are medical judgments, some would say, and only doctors should dispense them. True, but many doctors, it turns out, have largely abdicated that responsibility -- they rarely know what a drug costs, and as Shepherd mentioned, many learn about the properties of a given drug not from the medical literature but from company salesmen, who are paid to tell one-sided stories.
And so what? Richard Kogan, Schering's C.E.O., testified before Congress two years ago that drug companies need constant and ample revenue streams to support their enormous and dicey R&D enterprise, and he's right. In order to be competitive in this post-genomic era, large pharmaceutical companies need to spend $2 billion to $4 billion a year on research to develop new drugs. The industry has developed many remarkable medicines, and more are on the way.
But if high drug prices are a kind of innovation tax for American consumers, we should at least demand innovation in return. Many high-priced, successful drugs, like Zyrtec, are developed overseas and simply marketed here by American companies. Moreover, a significant amount of pharmaceutical innovation currently occurs in the biotech sector, where small, cutting-edge companies typically license their discoveries to big pharma, which has the marketing expertise. What innovative new drugs does Schering, for example, have in the pipeline, subsidized by the billions of dollars earned from Claritin? Financial analysts are mixed on the company's potential treatments -- for cancer, asthma, high cholesterol and several other major diseases -- but a leading candidate for future blockbuster status is . . . desloratadine, the chemical that is the principal metabolite, or breakdown product, of Claritin. Anyone who has taken Claritin has already had desloratadine in his or her body.
No one has seen much clinical data on the new drug, but many pharmacologists told me that metabolites rarely possess significantly more potency than their parent compounds, and one allergist confided, not for attribution: ''The only reason I can see scientifically for bringing this out is that their patent is about to expire. There have been about 20 abstracts published for desloratadine, all from Schering and all saying there's a little edge here, a little edge there, none of which strike me as terribly important.'' But then, as the Claritin story makes clear, it's not always about innovation but rather about finding little edges here and there and then marketing the hell out of them.
Meanwhile, the laboratory of Raymond Woosley of Georgetown University has done research on an over-the-counter antihistamine, Schering's own Chlor-Trimeton -- the same one my father shared with me decades ago. The lab has shown through sophisticated molecular-binding experiments that Chlor-Trimeton is more potent at grabbing and hanging onto the histamine receptor than any other antihistamine it has tested. For several years, the lab has wanted to test a lower -- and possibly nonsedating -- dose of the drug, to no avail. ''We did a grant for four years for the N.I.H., and we didn't get it funded,'' Woosley said. ''We assumed the innovator company didn't want to do it because they were making Claritin, and the generic companies didn't want to do it because it would cut into their profit margins even more.''
Woosley's study might work; it might not. The issue is that our health-care system has evolved to the point where there is no economic incentive even to try. For an industry that prides itself on taking risk, the risk of discovering that cheaper, older medicines might be just as good, and perhaps even better, than expensive new versions is apparently one risk too great to take.
Stephen S. Hall is a contributing writer for the magazine. He is working on a book about the molecular biology of aging.
March 11, 2001
The Claritin Effect; Prescription for Profit
By STEPHEN S. HALL
It had been yet another miserable, nose-dripping, red-eyed spring a couple of years ago, when I finally went to see an allergy specialist. I've been battered by seasonal allergies all my life but relied on family doctors and, more recently, ''primary-care physicians'' for relief. In a kind of a pharmaceutical version of playing catch with Dad, my father and I shared his hay-fever pills when I was growing up. They were smooth, round yellow tablets, etched with a tiny red corporate symbol that was as delicate as a Chinese ideograph. At a time before people routinely gobbled down a half dozen medicines a day, those pills held a kind of mythic power for me, not only because they could make the misery of allergies disappear but also because they were prescription drugs -- inherently more powerful, more inaccessible, more special.
Those yellow pills were called Chlor-Trimeton, manufactured by the Schering-Plough Corporation, first as a prescription drug and then, after 1976, as an over-the-counter medication. It definitely worked, but it knocked me out. I remember days when I felt glazed by sleepiness. Even as the high tide in my nose and throat subsided, I felt mentally waterlogged.
For the most part, I managed to get by with over-the-counter medications until that spring in 1999, when I decided I needed something stronger. After rummaging through a cabinet in the examining room, my new allergist handed me a week's supply of Claritin, also made by Schering-Plough. Claritin was, and still is, the most frequently dispensed drug sample in the United States, part of the nearly $8 billion worth of free drug samples that pharmaceutical companies distribute to doctors annually. I had seen the ads on TV -- who hadn't? I figured I'd give it a try.
Claritin had several other distinctions: it was by then the best-selling antihistamine in the United States, indeed the most profitable antihistamine of all time, with annual sales of more than $2billion. And it was the most aggressively marketed drug to American consumers. Claritin is a drug for our time: designed to relieve symptoms and improve ''quality of life,'' hardly lifesaving or even curative, expensive as hell. A month's supply of Claritin currently costs about $80 or $85 in the United States, even though it is an over-the-counter drug in dozens of other countries, where it usually costs $10 or $15. The high domestic price is paired with an enormous potential market: an estimated 35 million Americans suffer seasonal allergies, and many of us will be feeling that first tickle of dread later this month, when spring tree pollen begins to barge into our air passages like molecular roustabouts.
So I went home and tried it. The little white pill was easy to swallow and had to be taken only once a day. There was just one problem: it didn't work. It didn't relieve my runny nose and red-rimmed, gunked-up eyes. When I told my allergist, he didn't seem particularly surprised. Only about 30 to 40 percent of his patients, he said, found the drug helpful. And, he added, that estimate was ''generous.'' I was surprised, perhaps naïvely, by this remark. I figured a ''blockbuster'' drug would be efficacious in more than 50 percent of the people who took it. The percentage he mentioned, incidentally, is certainly debatable; in fact a debate broke out later between my allergist and his partner, who thought 50 or 55 percent was more like it. Even so, it made me wonder: $80 for a drug that works only half the time?
Claritin has been singled out as a prime example of greed by the American pharmaceutical industry, notably last summer by Al Gore during his presidential campaign, and there has been a constant stream of negative press about Schering-Plough's efforts to get the basic patent on Claritin extended beyond its 2002 expiration. Schering-Plough has argued that the patent should be extended because the Food and Drug Administration review of Claritin was unusually ''protracted'' (which, in fact, it was). To press its case in Washington, the company has paid millions of dollars in political contributions and assembled a high-powered, strange-bedfellows team of lobbyists (including the former senators Howard Baker and Dennis DeConcini, the Gore confidant Peter Knight and Linda Daschle, wife of the Senate minority leader, Tom Daschle); it has also encouraged repeated attempts by Congressional supporters to insert language favorable to Schering into legislation at the last instant.
Claritin's 77-month odyssey through the F.D.A. approval process was indeed lengthy, as a General Accounting Office report, issued last August, documents. That report prompted me to read through the transcripts of old F.D.A. meetings, obtain other documents through Freedom of Information requests and speak to doctors about allergy medications in general. As I learned more about the approval of Claritin, I realized that the biography of this one drug reveals a great deal about why prescription drugs cost so much to bring to market, and also why health-care economists like Uwe E. Reinhardt of Princeton University argue that we are paying premium prices for new drugs like these without actually knowing if they are better than the drugs they've replaced. The Claritin story is an unauthorized biography, in the sense that Schering-Plough declined to grant any interviews and responded only to written questions.
It is above all a case study of how a drug company creates a blockbuster. There are no villains, no broken laws -- just an enormous expenditure of money, a highly sophisticated understanding of food and drug laws, daring marketing, a great deal of luck. Making it all possible is a financial system that ultimately passes along the high price of a modest drug to third-party payers -- and you.
Claritin's journey from lab bench to marketplace was nearly epic in the time it took, the vicissitudes encountered and the plot twists along the way. In June 1980, when Schering filed a patent for the group of chemical compounds that included the drug that would eventually be known as Claritin, the world of drug development was quite different. It typically cost a pharmaceutical company roughly $200 million to $250 million to develop a new drug; that cost is estimated to be closer to $500 million today, a figure that also accounts for failures along the way. A patent lasted 17 years from the date it was issued; it now lasts 20 years from the date the application is filed. And the effective patent life of a new drug -- the amount of time a company can expect to enjoy an exclusive run in the marketplace -- was about eight years; the average effective patent life of a drug has nearly doubled since then. The Schering patent, issued Aug. 4, 1981, stated that the compounds, including the future Claritin, were ''useful as antihistamines with little or no sedative effects.'' Pharmaceutical companies rarely disclose the cost of bringing a specific drug to market, but it's a safe bet that it took at least several hundred million dollars to deliver on the promise of those nine words.
Loratadine (pronounced ''low-RAT-a-deen'') -- the generic name for Claritin -- was one of several second-generation antihistamines that emerged from drug-company laboratories in the 1980's. They worked by essentially the same simple mechanism as the first-generation antihistamines developed immediately after World War II, like Chlor-Trimeton. When pollen bumps into certain immune-system cells just beneath the lining of the nose, eyes or respiratory passages, it provokes an immunological overreaction in susceptible people. Thus perturbed, these ''mast cells'' shudder with the molecular equivalent of uncontrollable weeping; they churn out at least 15 different inflammatory molecules, many of which contribute to the allergic reaction. One of those molecules, unleashed instantaneously, is called histamine.
When these roving histamine molecules attach to receptors on nearby nerve cells, you feel an itch or a sneeze or a scratchy, ticklish palate. When they dock onto receptors in nearby blood vessels, the vessels become porous and leaky, and fluids begin to ooze into the tissues of your nose and eyes. Antihistamine drugs work because the active ingredient is a molecule that fits like a cap onto the histamine receptor, blocking the signal that causes itchy, watery symptoms.
Everyone agrees these drugs are effective, but just how effective is very difficult to say. All the antihistamine drugs, new and old, are plagued by high placebo effects. ''It's a question of how bad a placebo effect you have,'' says Dr. Peter S. Creticos, head of the allergy and clinical immunology division at the Johns Hopkins University School of Medicine. ''The placebo effect can be anywhere from 20 to 40 percent.''
Complicating the process of determining efficacy is how the data are gathered: patients in these trials typically assess their own degree of symptom relief, which many allergists concede makes the data somewhat subjective.
Then there's the sponsorship of the science. Because the placebo effect is so high, large numbers of patients must be enlisted in clinical trials to achieve a robust, or statistically ''significant,'' result, which means that only drug companies can afford the expense. Studies sponsored by drug companies tend to show an advantage for the company's own products. Zyrtec, an antihistamine produced by Pfizer, for example, has been shown to be more potent than other drugs in its antihistamine effect -- in a study sponsored by Pfizer. Desloratadine, currently awaiting F.D.A. approval as the next generation ''super-Claritin,'' is said to relieve nasal stuffiness, unlike other antihistamines -- in a study done by Schering. And Allegra, produced by Aventis, was recently shown to be equal to Zyrtec -- in a study sponsored by Aventis. ''They're going to take that study all the way to the bank,'' one academic allergist chuckled. Which is precisely the point. Scientific studies of these drugs serve as marketing tools, providing drug-company salesmen with their best lines.
The first-generation antihistamines, now sold over the counter as Chlor-Trimeton, Benadryl, Tavist and others, are still considered pretty effective medicines. In fact, many allergists told me that they are at least equivalent in medical potency to newer drugs like Claritin and Allegra. But the first-generation molecules cross the blood-brain barrier and get into the central nervous system, causing drowsiness. The second-generation drugs have been medicinally engineered to stay out of the brain. As a result, they cause little or no sedation.
A nonsedating antihistamine was clearly a desirable drug, and Schering-Plough had been looking for one since the 1960's. In fact, the company thought it had one in a compound called azatadine. The drug is still sold as Optimine, and if you've never heard of it, that's because the compound looked deceptively nonsedating when it was tested in cats and showed its true, somnolent colors only during human testing. Next came loratadine. Following years of testing, Schering formally submitted what is known as a New Drug Application, or N.D.A., to the Food and Drug Administration on Oct. 31, 1986, seeking approval of loratadine.
Schering was not the first company to knock on the F.D.A.'s door with a nonsedating antihistamine. Seldane (terfenadine), manufactured by Marion Merrell Dow, had been approved the year before, and Hismanal (astemizole) was already under F.D.A. review. Because a similar nonsedating antihistamine was already on the market, the F.D.A. assigned Claritin its lowest priority for review -- it was considered, according to an F.D.A. classification system no longer in use, a drug that ''essentially duplicates in medical importance and therapeutic usage one or more already marketed drugs, offering little or no therapeutic gain over existing therapies.'' Technically, Claritin started out as a ''me too'' drug.
Schering-Plough doggedly pursued the approval of Claritin, spurred, no doubt, by the phenomenal success of Seldane. But it wasn't easy. Over six and a half years, Schering filed 37 major amendments to its application. The company decided to switch the formulation from capsules to tablets, and it took more than two years to show that the capsules used in clinical trials were pharmacologically identical to the tablets it intended to sell. Among the many obstacles Schering had to overcome, the first was to convince F.D.A. reviewers of the drug's main selling point: that it could be effective without causing drowsiness.
To approve a new drug, the F.D.A. must be convinced that it is both safe and effective. As a practical matter, that often means arriving at a balance between potency and side effects. Drug companies routinely submit notebooks of dictionary girth full of experimental results establishing a drug's safety profile, first in animals and then in human subjects. In establishing the effectiveness of a new drug, however, a company has only to show in well-designed trials that a drug is more effective than a sugar pill, and if there is already an equivalent drug on the market for the same use, that it is at least equally effective.
The effectiveness of loratadine had been an area of F.D.A. concern as early as January 1987, just months after Schering filed its application. Dr. Sherwin D. Straus, the F.D.A. medical officer assigned to review the drug, told the company that a 10-milligram dose of Claritin -- the amount marketed today -- did not appear to be very effective. He reiterated that point in public on Oct. 23, 1987, when the F.D.A.'s Pulmonary-Allergy Drugs Advisory Committee met at the agency headquarters in Rockville, Md., to consider Schering's application for loratadine. (This panel of outside experts doesn't formally approve new drugs, but makes influential recommendations to the agency.)
Establishing a drug's safety and efficacy is not a pretty business. A parade of Schering representatives described a staggering amount of data from animal tests in mice, rats, guinea pigs, cats and monkeys, including the ''mouse-paw edema test'' (in which mice have their paws cut off and weighed to see how successfully an antihistamine inhibits swelling). In several studies, extremely high doses of the drug, consumed daily for up to two years, produced borderline evidence of liver-tumor formation in rats and male mice, but otherwise loratadine appeared very clean. Indeed, the company maintains that the drug's ''excellent safety profile is well established'' by 10 billion ''patient days'' of experience in the marketplace.
After preclinical animal tests, Schering began to test loratadine in thousands of human patients, first to establish its safety and then to prove its effectiveness. The company ultimately submitted three so-called ''pivotal'' clinical trials to support the drug's safety and efficacy. Schering conducted what is considered the gold standard in drug testing -- randomized, double-blind trials pitting Claritin against both placebo and one of several already approved antihistamines -- and the results reveal just how vexing the placebo effect can be. In one study, for example, people taking Claritin experienced a 46 percent improvement in symptoms at the end of the trial; patients taking a placebo reported 35percent improvement. In another trial, Claritin produced 43 percent improvement versus 32 percent on placebo. As part of these same studies, physicians examined the patients and, unaware of which treatment each had received, assessed their condition; these doctors concluded that anywhere from 37 to 47 percent of patients taking the sugar pill showed a ''good or excellent response to treatment.''
When it was his turn to speak, Straus engaged in a little bureaucratic soft-shoe, complimenting the Schering team's presentations as ''a tough act to follow.'' Then he tried to demolish the heart of Schering's application. Straus didn't doubt that loratadine worked as an antihistamine, he said; he just doubted that it worked at the 10-milligram dose. In fact, at one point he claimed that ''10 milligrams is not very different than placebo clinically.'' The reason the dose was so low, he argued, is that evidence of sedation began to crop up at higher, more effective doses.
What he didn't say -- but what everyone understood -- is that using a higher, more effective dose of Claritin would affect how the drug was described on the label. The term ''nonsedating'' was considered a critical marketing point. A single adjective or phrase contained in the F.D.A.-approved label -- no more sedating than a sugar pill,'' for example -- can form the basis of claims made by company salesmen to doctors, the basis of words that throb in the bold type of advertisements, even the basis of lawsuits filed against competitors. Those seemingly eye-glazing, hairsplitting distinctions provide the foundation for multimillion-dollar marketing campaigns.
The clash over effectiveness was crystallized in one edgy exchange between Straus and Dr. Anthony Nicholson, a British neuroscientist, one of the Schering-sponsored clinical researchers, over the interpretation of a study that compared loratadine to a sedating antihistamine called tripolidine. ''We are not actually in the business of saying one drug is better than the other,'' Nicholson told Straus. ''We are in the business of saying whether a drug is acceptable in terms of its performance profile.''
''But how can you say it is acceptable in terms of its performance profile,'' Straus replied, ''without comparing it to what else is out there?''
''We compare it with placebo,'' Nicholson said.
''So you compare it to nothing.''
''Yes.''
''And it is better than nothing.''
''Yes.''
''All right,'' Straus said. ''I can't argue with that.''
The Schering representatives gave as good as they got. One suggested that Straus was guilty of statistical mischief; he had selectively looked at variables, subsets and time points, ''and this is, as I am sure everybody in this audience knows, the perfect method of proving any claim one wants.'' Dr. William Darrow, a senior vice president at Schering, acknowledged that Straus's concerns were legitimate, ''but for us the question is whether we have demonstrated consistently superiority and adequate efficacy over placebo by the 10-milligram dose. And we stand on our data there.''
In a sense, they were both right. Schering had shown, according to the requirements of the law, that a 10-milligram dose of loratadine was more effective, and no more sedating, than placebo. And Straus had argued, to the satisfaction of at least some people on the committee, that while the drug might be more effective than placebo, it was not a whole lot more effective.
Perhaps the most startling assertion made at that 1987 meeting came not from Straus, however, but from Leslie Hendeles, a pharmacology professor at the University of Florida, and it is as relevant to allergy sufferers today as it was back then. He suggested that most of the patients in Schering's Claritin studies would have been better off being treated with a different class of allergy medication altogether -- steroid nasal sprays. ''Certainly, in this kind of patient that was selected for this study,'' he said to the gathering, ''most clinicians would probably use intranasal steroids to provide very prompt and sustained relief, rather than antihistamines.'' To treat full-blown allergy symptoms with an antihistamine, he continued, was ''pharmacologically irrational.''
Hendeles and other experts made a similar point to me recently: steroid nasal sprays, like Flonase and Schering's own Nasonex, shut off an allergic reaction that's already under way. In 1998, the Annals of Allergy, Asthma and Immunology published treatment guidelines stating that these nasal sprays ''are the most effective medication class for controlling symptoms'' of allergies. The popular antihistamines are valuable at preventing an allergy attack from getting under way if taken ahead of time and seem to be effective against eye symptoms, but they rarely bring quick and substantial relief of nasal symptoms once histamine has already begun to wreak havoc. ''We don't use these medicines correctly,'' said Peter Creticos of Johns Hopkins. ''As I tell patients, by the time the process starts, the horse is already out of the barn in terms of the antihistamines. You turn the process off by using a nasal steroid.''
Although the F.D.A. advisory committee recommended approval of loratadine, Straus remained skeptical. In the conclusions of a 321-page ''medical officer review'' dated Nov. 9, 1987, he described the proposed 10-milligram dose of Claritin as ''minimally effective versus placebo'' and added that 40 milligrams appeared to be ''the minimum effective dose.'' He also argued that the label ''must include sedation as an adverse reaction and include warnings to this effect.'' A former F.D.A. official, who requested anonymity, said that the agency informally asked Schering to test a higher dose of loratadine but lacked the regulatory authority to mandate it.
By May 1988, however, the F.D.A. had come to the conclusion that the 10-milligram dose was no more sedating than a placebo pill, and by July 1989, as the General Accounting Office report puts it, ''a consensus had developed at F.D.A. that 10 milligrams was effective.'' It is impossible to determine whether Sherwin Straus had changed his mind. Around the time he was assessing loratadine, according to former colleagues, he developed multiple sclerosis and became seriously ill, eventually dying of the disease.
''Schering-Plough always believed that loratadine was safe and effective at the 10-milligram dose,'' William O'Donnell, a company spokesman, wrote in reply to a question, ''and felt that the clinical studies that were done fully supported that conclusion.''
Pharmaceutical executives rarely talk about luck as a feature in the process of drug development, but in 1989 alone, Claritin's fortunes were buffeted like a grain of pollen in an early spring breeze. In September of that year, the acting division director at the F.D.A., reviewing the drug's status, concluded that all outstanding issues regarding safety, efficacy and the equivalence of tablets and capsules had been resolved. Claritin should have been nearing approval. But earlier in the year, as part of an F.D.A. reorganization, the Claritin application was transferred to a different division within the F.D.A.; with the transfer came a new pharmacology reviewer. This reviewer revisited some toxicology issues Schering thought had been settled.
Around this time, according to Schering, tests on other products being conducted at the F.D.A.'s National Center for Toxicological Research in Jefferson, Ark., were showing that high doses of doxylamine, an antihistamine and sleep aid, produced liver tumors in rodents. These findings apparently prompted the F.D.A. to reconsider results of animal experiments with both loratadine and cetirizine (the active ingredient in Zyrtec); they, too, had shown increases in liver adenomas, abnormal growths that were then considered to be a ''larval'' form of malignant tumor.
The stakes for Claritin were high. If a prescription drug caused cancer in animals but was of medical importance, and if no satisfactory alternative existed, the usual procedure would be to approve the drug and describe the findings on the drug's label, said Paula Botstein, then a deputy F.D.A. director, at a 1991 meeting. But if similar drugs were already on the market and were not carcinogens, she said, the F.D.A. would ''ordinarily'' not approve a new drug if it caused cancer in animals. Both Seldane and Hismanal were already on the market, and neither caused cancer in animals. Because of this situation, said a former F.D.A. official who asked not to be named, the Claritin approval was ''certainly'' in doubt -- even after an advisory panel concluded that it was unlikely to pose a cancer risk to humans. (The other two drugs, doxylamine and cetirizine, were also cleared of suspicion.) Nevertheless, the F.D.A. still insisted on further tests, which eventually convinced agency officials that the drug was safe. Schering-Plough has always insisted that Claritin is not a carcinogen.
While these safety concerns were being investigated, a fateful new chapter in the Claritin story began to unfold. On a night in November 1989, in what first looked like an unrelated event, a 39-year-old woman was brought to the National Naval Medical Center in Bethesda, Md., after fainting while driving on the Washington Beltway. She had lost consciousness four times in a two-day period. She was taking the antihistamine Seldane (not for allergies but for a sinus condition) and then began using an antifungal drug, ketoconazole, to prevent a vaginal yeast infection. ''And that turned out to be a deadly combination,'' recalled Dr. Brian P. Monahan, who treated the woman for potentially fatal cardiac arrhythmias.
As doctors investigated this unusual case, they uncovered previous reports of dangerous irregularities in heartbeat among Seldane patients. Later they found that risk in Seldane patients to be associated with ketoconazole or erythromycin, a widely used antibiotic. In August 1990, at the F.D.A.'s urging, Seldane's manufacturer, Marion Merrell Dow, sent letters to doctors warning of these potentially fatal drug interactions, and in 1992 the F.D.A. ordered warning statements, outlined by a prominent black box, to appear at the top of the label and packaging on Seldane and Hismanal.
This turned out to be very good news for Claritin. Because of growing concerns about the two other nonsedating antihistamines, the F.D.A. ''started to believe that it would be beneficial to have Claritin for sale,'' according to G.A.O. investigators. (Schering said in a statement, ''We do not believe that loratadine was the result of a balancing of product-safety issues.'')
In the span of several years, therefore, Claritin had gone from being a me-too drug, to one that looked possibly unapprovable, to the only game in town. This regulatory roller coaster finally came to a rest in April 1993 when, 77 months after Schering applied, the F.D.A. approved loratadine.
At least one analyst, Mara Goldstein of C.I.B.C. World Markets, estimates that Schering-Plough lost $4billion in revenues because of the delay. But I heard
a different view from a pharmacologist who, although insisting on anonymity, was familiar with these unfolding events. ''I think they've grossly benefited from the delay at the agency,'' this researcher told me. ''Because terfenadine'' -- the generic name for Seldane -- was getting blasted, they looked like a good alternative, and I think they actually got a much larger share when they hit the market because of it.''
Since Claritin's approval, the marketing campaign for the drug has rewritten the rules for pharmaceutical promotion. The brand is ubiquitous: watching the World Series in 1999, viewers frequently saw Claritin proclaimed the ''official allergy medication of Major League Baseball''; the bag the pharmacist gives you when you fill almost any prescription suggests that you ''ask your pharmacist about Claritin-D 24 Hour.''
The direct-to-consumer ads seen on TV and in magazines are only the tip of the iceberg. The bulk of pharmaceutical marketing goes on behind closed doors, where drug salesmen tout their products to doctors, and pharmaceutical companies now spend more than $13 billion a year on such promotion, according to I.M.S. Health, a company that tracks the pharmaceutical business. The language of those presentations is constrained by the language on the F.D.A.-approved label -- in other words, all the battles over efficacy and sedation at those obscure F.D.A. meetings in the 1980's define the sales vocabulary of the 1990's.
Once again, Claritin was the beneficiary of some lucky timing. In August 1997, the F.D.A. relaxed its rules governing television advertising; rather than having to run the same fine print required in magazine ads, commercials could satisfy F.D.A. rules by giving a toll-free number, mentioning a magazine advertisement and instructing viewers to ''ask your doctor'' for more information. In a daring move closely watched by the rest of the industry, Schering-Plough poured $322 million into pitching Claritin to consumers in 1998 and 1999, far more than any other brand, according to the National Institute for Health Care Management Foundation, a nonprofit group in Washington.
''That campaign was a landmark,'' says the group's Steven D. Findlay. ''The Claritin campaign, along with Viagra, Prilosec and a few other high-profile drugs, was very influential. Claritin was clearly the most visible, the most expensive and skillfully executed, and the bottom-line results were immediately apparent. It had a huge impact, because everybody is watching everybody else very closely.'' Drug companies spent an estimated $2.5 billion on consumer advertising in 2000; these ads may have brought in as much as a $5-to-$6 return for each dollar spent.
Yet critics point out that direct-to-consumer advertising illustrates an embarrassing paradox: marketing may be most indispensable in categories where new drugs may actually be less innovative. ''Marketing is meant to sell drugs,'' Marcia Angell wrote in an editorial in The New England Journal of Medicine last June, ''and the less important the drug, the more marketing it takes to sell it. Important new drugs do not need much promotion. Me-too drugs do.''
But promotion works. Sales in the United States of the entire Claritin family -- not just the 10-milligram tablets, but a syrup, quick-dissolving RediTabs and both 12-hour and 24-hour Claritin-D versions with a decongestant -- which stood at $1.4 billion in 1997, jumped to $2.6 billion by 2000. It accounts for nearly 30 percent of Schering-Plough's annual revenues.
Schering had a magnificent cash cow. Now the trick was to milk it as long as possible.
Almost from the moment Claritin was approved in 1993, with only five years remaining on its basic patent at the time, Schering-Plough and its competitors began to tussle over the drug's afterlife -- and, more important, when it would begin. Generic drug companies typically gear up to produce a cheap version of a drug about five to seven years before a patent is due to expire. Schering, at that same time, began to mount its expensive legislative campaign to extend Claritin's patent. This fundamental conflict, played out in Congress and in court, is shaping the golden years of Claritin's already eventful career as a drug.
The Claritin patent has been extended several times already, each extension reflecting laws passed by Congress in the last two decades that have modernized the F.D.A. review process and significantly extended the effective life of drug patents. The extensions began with the Drug Price Competition and Patent Term Restoration Act of 1984, known informally as the Hatch-Waxman Act. Despite its dense legal provisions, Hatch-Waxman is an essential element of any conversation about drug prices in this country. The law was a legislative high-wire act designed to reward innovation at major pharmaceutical companies and protect intellectual property while at the same time promoting lower drug costs, primarily by making it easier for generic drug makers to get to the American marketplace. As part of Hatch-Waxman, new drugs being developed after the law was enacted in 1984 could receive automatic patent extensions of five years. More than 100 drugs, including Claritin, were already in development when the law was passed; these products, known as ''pipeline'' drugs, were eligible for only two years. That reset the clock for Claritin's patent expiration to the summer of 2000.
In 1994, the Uruguay Round Agreements Act, an obscure addendum to the GATT treaty, added 22 months to the patent life of Claritin, pushing the expiration back to June 2002. And just last August, the basic patent on Claritin was extended yet another six months, to December 2002, because Schering-Plough conducted pediatric trials of the drug. If six months doesn't sound like a lot, consider the economic incentive here: for the price of a modest clinical trial in children (costing at most $3 million), Schering can extend the life of its basic patent half a year and earn close to $1billion. By one unofficial estimate, these three patent extensions will ultimately translate into additional Claritin revenues totaling about $13 billion.
Since 1996, there have been at least a half dozen attempts to extend Claritin's patent life even more. There was an attempt, for instance, in the summer of 2000 to slip language at the last minute into a military-appropriations bill. Schering's lobbying efforts have not been the most persistent, ''just the crudest,'' according to Bruce Downey, C.E.O. of Barr Laboratories, a generic drug maker based in Pomona, N.Y., who has also testified against extending the Claritin patent.
Representative Waxman has derided the legislation proposed to provide Schering relief as the ''Claritin Monopoly Relief Act.'' But the case for some of the pipeline drugs may not be as outrageous as some critics have suggested. Peter Barton Hutt, the former chief counsel at the F.D.A. and now a lawyer at the Washington firm Covington & Burling, has argued that limiting loratadine and several other pipeline drugs to a two-year extension was ''completely arbitrary'' and assumed much speedier approval.
As has been true of so much of this drug's history, however, timing is everything, and Schering-Plough's efforts to extend its monopoly has coincided with surging public discontent about the cost of drugs. As a result, each attempt by the company to get Congressional patent relief has become a rallying cry for opponents, including consumer watchdogs, health insurers and generic drug makers. Since the 1996 election, Schering has spent $19.9 million on lobbying and campaign contributions, according to the watchdog group Public Citizen. Yet the most tangible achievement to date of that $20 million lobbying campaign may be the way that it has galvanized the generic drug industry and attracted the attention of lawmakers. Last fall, Senators John McCain and Charles Schumer introduced legislation designed to close loopholes in Hatch-Waxman.
For all the closed-door maneuvering in Washington, an equally revealing pharmaceutical endgame has been playing out, slowly, in a courtroom in New Jersey.
A chilly day in January, about two dozen dark-suited patent attorneys gathered in the United States District Court in Newark, in what has become a typical chain of events toward the end of a prescription drug's life: patent litigation. Unlike the arguments made by Schering-Plough's lobbyists in Washington, however, those made by its lawyers in court documents maintain that Claritin's patent protection extends beyond 2002.
Last August, Teva Pharmaceuticals became the first company to receive tentative approval from the F.D.A. to market a generic version of Claritin. The key word here is ''tentative.'' Teva must wait for the basic loratadine patent to expire next year. It must wait for the resolution of a lawsuit filed against it by Schering, which could conceivably stretch into 2003. And it must wait for Geneva Pharmaceuticals, a generic company based in Broomfield, Colo., to bring its version of Claritin to market; Geneva is entitled to an exclusive 180-day run as the only generic in the market, a monopoly that the company receives as Hatch-Waxman's reward for being the first generic drug maker to challenge a brand drug's patent. The moment the first generic enters the market, industry experts estimate, the cost of generic Claritin will drop to about 80 percent of current prices. When everyone else jumps in six months later, the price will fall off a cliff. ''With so many competitors,'' one generic executive told me, ''the price will drop to $10 very quickly.''
Generic companies fill about 42 percent of all drug prescriptions in this country, but the price disparity with brand-name drugs is striking. That market share accounted for slightly less than $20 billion in drug sales in 1999; brand company sales accounted for more than $90 billion. Industry advocates claim that if generic sales inched up to 52 percent, American consumers would save an estimated $11 billion a year in drug costs. If the generic industry is beginning to mature, as some maintain, one of the main factors in that process has been, oddly, Schering-Plough. ''I think loratadine is one of the first examples,'' said Dr. Carole Ben-Maimon, head of the Generic Pharmaceutical Industry Association and until recently a vice president at Teva. ''We were really able to make it an issue.''
Much of the industry's current disgruntlement involves patent litigation -- or as George S. Barrett, president and C.E.O. of Teva USA puts it, ''the way the patent system has just been abused.'' When Congress devised the language of Hatch-Waxman back in 1984, the notion of a drug coming ''off patent'' was as simple as it sounds: once the patent for a basic compound expired, other companies were free to enter the market. But it's not that simple anymore, said Ben-Maimon, a physician who now heads a research division at Barr.
Brand companies now patent the process of manufacturing the raw material. They patent the medical uses to which the drug can be applied. They patent the formulation of the medicine (the other ingredients used to stabilize the drug). They can patent what's known in the industry as ''trade dress'' -- the color, size and shape of the pill. They patent metabolites -- the chemicals into which a drug breaks after being metabolized by the human body.
So drugs don't come ''off patent'' the way the 1984 law envisioned; they come off as a series of strategically staggered patents, a practice known as layering. And here's where Hatch-Waxman has inadvertently turned into a playbook for complicated, time-consuming -and, according to generic drug makers, frivolous -- patent litigation.
On Feb. 5, 1998, Geneva Pharmaceuticals filed what's known as an abbreviated new drug application, or ANDA, seeking F.D.A. permission to sell a generic version of Claritin. Several days later, as obliged by Hatch-Waxman, Geneva notified the patent holder, Schering, of its plans. On March 19, Schering-Plough sued Geneva and its parent corporation, Novartis, claiming that two of its Claritin patents had been infringed. Since then, seven other drug makers -- Zenith Goldline, Teva Pharmaceuticals, Mylan, Andrx, Impax, American Home Products and Apotex-Novex -- have gone to the F.D.A. seeking approval to sell generic versions of Claritin. Although the issues vary from case to case, Schering has sued all of them.
Some critics make the case that since Hatch-Waxman, an inordinate amount of innovation has been displaced from research to litigation strategies. A lawsuit is far cheaper (about $5million per case) and less risky than research, and the return on investment can be very high. ''It's always cheaper to litigate than to lose market share,'' said a former top-level F.D.A. official who asked not to be named. ''If you can keep a generic off the market for one day, three days, five days, two months or two years, that's a lot of revenue. Certainly a lot more than it would cost to pay your lawyers.'' A Schering spokesman says, ''Schering-Plough believes that its patents are valid and enforceable.''
William Fletcher, president of Teva North America, knows how frustrating this can be. ''You know, people here have asked us several times, 'Why bother doing Claritin?''' he said. ''There are going to be at least 10 competitors out there. The price is going to be, you know, 5 percent of Claritin. Why bother doing it? One reason is that we are a broad-line supplier, and we have to have every product in our line. The other reason is that we're just bloody-minded about it, quite frankly. Stubborn. You know, you're damned if you're going to let Schering-Plough get away with it!''
There's a larger game in play in the Newark courtroom, too, according to the generic companies, and it became more interesting a few weeks ago. As Schering-Plough holds the generics at bay with one hand, it had hoped to receive F.D.A. approval in time to introduce desloratadine, its second-generation version of Claritin that will be marketed as Clarinex, this spring. ''The longer the litigation is dragged out,'' says Elliot F. Hahn, president of Andrx, ''the more opportunity they have to market desloratadine to physicians and switch them from the Claritin line to the desloratadine line.'' But that plan ran into a major snag in mid-February, when Schering-Plough revealed that the approval of desloratadine was being held up until the company corrects manufacturing deficiencies cited by the F.D.A. at four of its plants.
What to do in a crisis? Market! Several days later, as the company's stock plunged and attorneys hustled to organize shareholder lawsuits, Schering-Plough announced big new ''consumer education'' and pharmacy programs for Claritin -- the ''largest and most comprehensive allergy initiative of its kind.'' The company plans to distribute 35 million free drug samples to doctors, 6 million allergy brochures, 65,000 drugstore displays and, yes, 350 million more of those little blue pharmacy bags.
Finally, an edifying case of sticker shock. Late last fall, my allergist prescribed a month's supply of Claritin-D to clear up some congestion before I started my first round of allergy desensitization shots. The pharmacy had misplaced my insurance number, so when I went to pick up the prescription, the clerk handed me a bill for $103. This is the consumer's trickle-down tab for the roughly $250 million in drug development, more than $100 million a year in consumer advertising, many millions in closed-door marketing, $20 million in lobbying and political contributions, $5 million a year for litigation. I was stunned that it was so expensive, and I asked myself a question that is a normal part of every marketplace but health care. If I had to pay $103 out of my own pocket, would I buy this medicine? Was it worth it?
With the exception of elderly people on Medicare and the uninsured, most of us never ask that question. In a recent conversation, Gillian Shepherd, a Manhattan allergy specialist, addressed the same point, noting that antihistamines like Claritin and Allegra are about equal in potency to over-the-counter drugs like Chlor-Trimeton. And while some patients experience sedation with these drugs, many do not. ''Fifty percent of the population can tolerate most of them without any sedation,'' she explained. ''The feeling is that if there's a chance of sedation and third parties are paying, why not use the nonsedating drugs? If people were paying out of pocket, the story would be completely different.''
As I labored to sort through all the clinical data and all the confusing advertising, I found myself wishing that we had reviewers who would talk bluntly about new drugs, who could discuss efficacy, safety and value from the consumer's point of view, who could deconstruct the advertising, who would include cost as a criterion. But those are medical judgments, some would say, and only doctors should dispense them. True, but many doctors, it turns out, have largely abdicated that responsibility -- they rarely know what a drug costs, and as Shepherd mentioned, many learn about the properties of a given drug not from the medical literature but from company salesmen, who are paid to tell one-sided stories.
And so what? Richard Kogan, Schering's C.E.O., testified before Congress two years ago that drug companies need constant and ample revenue streams to support their enormous and dicey R&D enterprise, and he's right. In order to be competitive in this post-genomic era, large pharmaceutical companies need to spend $2 billion to $4 billion a year on research to develop new drugs. The industry has developed many remarkable medicines, and more are on the way.
But if high drug prices are a kind of innovation tax for American consumers, we should at least demand innovation in return. Many high-priced, successful drugs, like Zyrtec, are developed overseas and simply marketed here by American companies. Moreover, a significant amount of pharmaceutical innovation currently occurs in the biotech sector, where small, cutting-edge companies typically license their discoveries to big pharma, which has the marketing expertise. What innovative new drugs does Schering, for example, have in the pipeline, subsidized by the billions of dollars earned from Claritin? Financial analysts are mixed on the company's potential treatments -- for cancer, asthma, high cholesterol and several other major diseases -- but a leading candidate for future blockbuster status is . . . desloratadine, the chemical that is the principal metabolite, or breakdown product, of Claritin. Anyone who has taken Claritin has already had desloratadine in his or her body.
No one has seen much clinical data on the new drug, but many pharmacologists told me that metabolites rarely possess significantly more potency than their parent compounds, and one allergist confided, not for attribution: ''The only reason I can see scientifically for bringing this out is that their patent is about to expire. There have been about 20 abstracts published for desloratadine, all from Schering and all saying there's a little edge here, a little edge there, none of which strike me as terribly important.'' But then, as the Claritin story makes clear, it's not always about innovation but rather about finding little edges here and there and then marketing the hell out of them.
Meanwhile, the laboratory of Raymond Woosley of Georgetown University has done research on an over-the-counter antihistamine, Schering's own Chlor-Trimeton -- the same one my father shared with me decades ago. The lab has shown through sophisticated molecular-binding experiments that Chlor-Trimeton is more potent at grabbing and hanging onto the histamine receptor than any other antihistamine it has tested. For several years, the lab has wanted to test a lower -- and possibly nonsedating -- dose of the drug, to no avail. ''We did a grant for four years for the N.I.H., and we didn't get it funded,'' Woosley said. ''We assumed the innovator company didn't want to do it because they were making Claritin, and the generic companies didn't want to do it because it would cut into their profit margins even more.''
Woosley's study might work; it might not. The issue is that our health-care system has evolved to the point where there is no economic incentive even to try. For an industry that prides itself on taking risk, the risk of discovering that cheaper, older medicines might be just as good, and perhaps even better, than expensive new versions is apparently one risk too great to take.
Stephen S. Hall is a contributing writer for the magazine. He is working on a book about the molecular biology of aging.
Saturday, May 13, 2006
Quick clinics in stores
NYTimes
May 14, 2006
Attention Shoppers: Low Prices on Shots in the Clinic Off Aisle 7
By MILT FREUDENHEIM
Everyday low prices on strep-throat exams.
That is the basic idea behind a retail approach to routine medical care now catching on among consumers and entrepreneurs. At Wal-Mart, CVS and other chain stores, walk-in health clinics are springing up as an antidote to the expense and inconvenience of full-service doctors' offices or the high-cost and impersonal last resort of emergency rooms.
For a $30 flu shot, a $45 treatment for an ear infection or other routine services from a posted price list, patients can visit nurse practitioners in independently operated clinics set up within the stores — whose own pharmacies can fill prescriptions.
"It was a lot easier to know you can just drive up the block to a clinic, rather than spend time in the pediatrician's waiting room," said Liz Lyons, who recently took her 9-year-old son to have a sore throat swabbed in a clinic at a CVS drugstore in Bethesda, Md.
She made a $10 co-payment, with her husband's insurance picking up the rest of the $59 tab.
About 100 of these clinics, which typically lease space from the host stores, are now operating around the nation. Hundreds more are in the works, bankrolled by a range of competing entrepreneurs who include Stephen M. Case, the former AOL chairman; Richard L. Scott, who once ran the nation's largest hospital chain; and Michael Howe, a former chief executive of the Arby's restaurants group.
Despite their diverse backgrounds, those executives and others share a concept of "consumer-directed health care" — a marketing and political term that usually means higher out-of-pocket medical costs — as a mass-market opportunity. Even some family physicians say the clinics may have their place in the array of American medical offerings.
And most insurers so far are welcoming retail clinics as a way to save money. The uninsured, meanwhile, typically find the clinics more affordable than most alternatives — including the for-profit storefront clinics that have long offered a full range of physician-provided medical services to a walk-in clientele.
Uwe E. Reinhardt, a professor of economics and public affairs at Princeton University, said that the store chains, with their reputations on the line, would insist that the clinics maintain high standards and low error rates. "Primary care is a neglected field in the United States, lagging other economically advanced countries," he said. "The clinics can teach the rest of our health system how primary care could be done and brought to the public. That is very important." Whether a fad or the beginning of a fundamental shift, the retail clinic trend comes in response to an erosion in employer-sponsored insurance benefits that is forcing people to pay more or all of their own health costs. It is also a reaction to the growing perception that conventional medical service for routine and preventive care has become too costly and inefficient.
" Starbucks has 10,000 locations; health care is certainly more important," said Mr. Case, who made his name and fortune on the Internet but is now betting that his chain of RediClinics at Wal-Mart, Walgreens and other retailers can be the next big thing.
Mr. Case says his epiphany came a few years ago when he took his young daughter to an emergency room on a Sunday for an ear infection. "We waited four hours and they just weren't able to see us," he recalled. "This is crazy: a society in which everything is convenient other than what people care most about, which is taking care of their health."
Mr. Case's company, Revolution Health Group, has 11 RediClinics now running, including one at a Duane Reade pharmacy on West 50th Street in Manhattan. He plans to open 90 others in various retail chains by the end of this year, and 500 within three years.
Other executives bringing their names and money to the field include Hal Rosenbluth, who sold a highly automated travel business to American Express and is now behind a clinic chain called Take Care Health Systems. It has clinics in 16 stores, and Mr. Rosenbluth has raised $77 million with an eye toward expanding to 1,400 in the next few years.
Another in the game is Dr. Glen D. Nelson, a Minneapolis surgeon and investor whose health care résumé includes 11 years as president of the Park Nicollet Medical Center in Minneapolis, head of a managed health care company and later vice chairman of the medical device maker Medtronic.
"The clinic concept is a microcosm of what you could do to the whole system to improve it and make it more consumer friendly and economical," said Dr. Nelson, the chairman of MinuteClinic, which has branches in 73 stores.
The licensed nurse practitioners who run most of the clinics typically have advanced training and referral arrangements with local doctors for cases beyond the clinics' scope. Patients with major illnesses or in need of emergency care or follow-up for a chronic condition are typically referred to doctors, hospitals and urgent care centers. Infants and toddlers will usually be sent to pediatricians or family physicians.
When Ms. Lyons recently brought her son, Daniel, to the MinuteClinic at the CVS in Bethesda, the nurse practitioner on duty was Trish Hughes, who performed a quick swab test to check for a streptococcal bacterial infection. In less than three minutes, that preliminary test came up negative; the swab was retained for further testing.
Ms. Lyons said she was pleased with the clinic experience. "I will be back," she said.
For Beth Brauning, 54, a self-employed house cleaner who is uninsured, the prices at a clinic in a CVS near Columbus, Ohio, were a big attraction. The nurse practitioner took her blood pressure and wrote two allergy prescriptions she needed.
The bill was $49 — "probably half what my doctor would have charged me," Ms. Brauning said. "It was such a good experience for me. You go to an emergency room, it's $300 to walk in the door."
Having someone in the store writing prescriptions could be a boon for pharmacy chains. "Pharmacy is 70 percent of our business," said Jim Maritan, a CVS vice president for strategy and business development. "It is a great experience having a nurse practitioner clinic on site."
But some doctors say the clinic-pharmacy relationship could create conflicts of interest. "We want to make sure that the patient is protected," said Dr. Joseph P. Annis, an anesthesiologist in Austin, Tex., who is the chairman of an American Medical Association council that studied the clinics for an A.M.A. report due out later this month.
Dr. Anne B. Francis, a pediatrician in Rochester added that it was important for children to have a physician who gets to know the family and keeps a complete health record that can help point to underlying causes of some ailments. "All ear aches are not ear infections," she said.
Although some physicians are fearful of losing business to the clinics, others say that the clinics may fill a need. Larry S. Fields, a family doctor in Ashland, Ky., who is president of the American Academy of Family Physicians, said that if the clinics "stick to this limited scope, they may have a small role in providing acute health care to people who are mildly ill, when their only other alternative at the time might be an emergency room."
The academy has issued a list of "desired attributes of retail health clinics," which the big clinic operators say they have embraced, including provision of a well-defined and limited scope of services; a formal connection with local physicians to provide "continuity of care" and supervise the nurse practitioners; and electronic health records that can be transmitted to a doctor's office.
With no need for expensive medical equipment or office space, the clinics tend to be cheap to operate — particularly since the nurse practitioners are paid $30 to $45 an hour, compared with the $65 or much more an hour that a primary care doctor can command. A store clinic can be profitable with 25 patients over a 12-hour day, clinic executives said.
Employers and insurers also see opportunities for savings. The power-tool maker Black & Decker, a self-insured employer, has subtracted $10 from its usual $25 co-payments when employees patronize MinuteClinics around Baltimore, rather than visit a doctor.
"We have had an overwhelmingly positive response from our employees," said Raymond Brusca, the vice president of benefits at Black & Decker, adding, "my medical plan comes way out ahead financially."
A clinic company with somewhat grander ambitions is Solantic. Its clinics are staffed by doctors and provide a wider range of services that include X-rays at $90 apiece (or two for $150).
For routine services, Solantic's prices may be slightly higher than at other clinics — $55 or more for a Solantic doctor visit compared with $45 to be seen by a nurse practitioner at a rival's clinic. But having doctors on staff "dramatically increases the number of services we can provide to a patient," said Richard L. Scott, the chairman of Solantic, which is based in Jacksonville, Fla.
Mr. Scott built Columbia- HCA Healthcare into the nation's largest hospital chain before being forced out in a 1997 boardroom coup fueled by government allegations of Medicare fraud. Three top officers of the company were indicted, although Mr. Scott was not cited in the case. In a separate tax dispute over deductions for executive pay, the company agreed to pay a $71 million settlement to the Internal Revenue Service."I always wanted to create a clinic business when I was in the hospital business," Mr. Scott said.
Glenn Habern, Wal-Mart's senior vice president for business development, said that Solantic and three of its rivals — RediClinics, MedPoint Express and Quick Quality Care — would be among the clinic companies leasing space in about 60 of Wal-Mart's 1,300 "superstores" by the end of this year.
"It's still a test for us," Mr. Habern said. "If customers like it we may open more. So far, we've not seen any reason not to do so." But a big Wal-Mart competitor, Target, has evidently seen drawbacks.
At the end of this month Target plans to close the 11 MinuteClinics in stores in Maryland and Minnesota; the company would not explain why. "Target will begin remodeling to open new health clinics in these stores in fall 2006," the company said in an e-mail message, without specifying who would manage the new clinics.
Dr. Nelson, at MinuteClinic, said in an interview before the breakup with Target was disclosed that "the pharmacy business is a small percentage of the Target footprint."
"Target also is very disciplined," he added. "They like to have things totally designed and controlled to their own specifications. They struggled with whether they want somebody else talking to their clients."
May 14, 2006
Attention Shoppers: Low Prices on Shots in the Clinic Off Aisle 7
By MILT FREUDENHEIM
Everyday low prices on strep-throat exams.
That is the basic idea behind a retail approach to routine medical care now catching on among consumers and entrepreneurs. At Wal-Mart, CVS and other chain stores, walk-in health clinics are springing up as an antidote to the expense and inconvenience of full-service doctors' offices or the high-cost and impersonal last resort of emergency rooms.
For a $30 flu shot, a $45 treatment for an ear infection or other routine services from a posted price list, patients can visit nurse practitioners in independently operated clinics set up within the stores — whose own pharmacies can fill prescriptions.
"It was a lot easier to know you can just drive up the block to a clinic, rather than spend time in the pediatrician's waiting room," said Liz Lyons, who recently took her 9-year-old son to have a sore throat swabbed in a clinic at a CVS drugstore in Bethesda, Md.
She made a $10 co-payment, with her husband's insurance picking up the rest of the $59 tab.
About 100 of these clinics, which typically lease space from the host stores, are now operating around the nation. Hundreds more are in the works, bankrolled by a range of competing entrepreneurs who include Stephen M. Case, the former AOL chairman; Richard L. Scott, who once ran the nation's largest hospital chain; and Michael Howe, a former chief executive of the Arby's restaurants group.
Despite their diverse backgrounds, those executives and others share a concept of "consumer-directed health care" — a marketing and political term that usually means higher out-of-pocket medical costs — as a mass-market opportunity. Even some family physicians say the clinics may have their place in the array of American medical offerings.
And most insurers so far are welcoming retail clinics as a way to save money. The uninsured, meanwhile, typically find the clinics more affordable than most alternatives — including the for-profit storefront clinics that have long offered a full range of physician-provided medical services to a walk-in clientele.
Uwe E. Reinhardt, a professor of economics and public affairs at Princeton University, said that the store chains, with their reputations on the line, would insist that the clinics maintain high standards and low error rates. "Primary care is a neglected field in the United States, lagging other economically advanced countries," he said. "The clinics can teach the rest of our health system how primary care could be done and brought to the public. That is very important." Whether a fad or the beginning of a fundamental shift, the retail clinic trend comes in response to an erosion in employer-sponsored insurance benefits that is forcing people to pay more or all of their own health costs. It is also a reaction to the growing perception that conventional medical service for routine and preventive care has become too costly and inefficient.
" Starbucks has 10,000 locations; health care is certainly more important," said Mr. Case, who made his name and fortune on the Internet but is now betting that his chain of RediClinics at Wal-Mart, Walgreens and other retailers can be the next big thing.
Mr. Case says his epiphany came a few years ago when he took his young daughter to an emergency room on a Sunday for an ear infection. "We waited four hours and they just weren't able to see us," he recalled. "This is crazy: a society in which everything is convenient other than what people care most about, which is taking care of their health."
Mr. Case's company, Revolution Health Group, has 11 RediClinics now running, including one at a Duane Reade pharmacy on West 50th Street in Manhattan. He plans to open 90 others in various retail chains by the end of this year, and 500 within three years.
Other executives bringing their names and money to the field include Hal Rosenbluth, who sold a highly automated travel business to American Express and is now behind a clinic chain called Take Care Health Systems. It has clinics in 16 stores, and Mr. Rosenbluth has raised $77 million with an eye toward expanding to 1,400 in the next few years.
Another in the game is Dr. Glen D. Nelson, a Minneapolis surgeon and investor whose health care résumé includes 11 years as president of the Park Nicollet Medical Center in Minneapolis, head of a managed health care company and later vice chairman of the medical device maker Medtronic.
"The clinic concept is a microcosm of what you could do to the whole system to improve it and make it more consumer friendly and economical," said Dr. Nelson, the chairman of MinuteClinic, which has branches in 73 stores.
The licensed nurse practitioners who run most of the clinics typically have advanced training and referral arrangements with local doctors for cases beyond the clinics' scope. Patients with major illnesses or in need of emergency care or follow-up for a chronic condition are typically referred to doctors, hospitals and urgent care centers. Infants and toddlers will usually be sent to pediatricians or family physicians.
When Ms. Lyons recently brought her son, Daniel, to the MinuteClinic at the CVS in Bethesda, the nurse practitioner on duty was Trish Hughes, who performed a quick swab test to check for a streptococcal bacterial infection. In less than three minutes, that preliminary test came up negative; the swab was retained for further testing.
Ms. Lyons said she was pleased with the clinic experience. "I will be back," she said.
For Beth Brauning, 54, a self-employed house cleaner who is uninsured, the prices at a clinic in a CVS near Columbus, Ohio, were a big attraction. The nurse practitioner took her blood pressure and wrote two allergy prescriptions she needed.
The bill was $49 — "probably half what my doctor would have charged me," Ms. Brauning said. "It was such a good experience for me. You go to an emergency room, it's $300 to walk in the door."
Having someone in the store writing prescriptions could be a boon for pharmacy chains. "Pharmacy is 70 percent of our business," said Jim Maritan, a CVS vice president for strategy and business development. "It is a great experience having a nurse practitioner clinic on site."
But some doctors say the clinic-pharmacy relationship could create conflicts of interest. "We want to make sure that the patient is protected," said Dr. Joseph P. Annis, an anesthesiologist in Austin, Tex., who is the chairman of an American Medical Association council that studied the clinics for an A.M.A. report due out later this month.
Dr. Anne B. Francis, a pediatrician in Rochester added that it was important for children to have a physician who gets to know the family and keeps a complete health record that can help point to underlying causes of some ailments. "All ear aches are not ear infections," she said.
Although some physicians are fearful of losing business to the clinics, others say that the clinics may fill a need. Larry S. Fields, a family doctor in Ashland, Ky., who is president of the American Academy of Family Physicians, said that if the clinics "stick to this limited scope, they may have a small role in providing acute health care to people who are mildly ill, when their only other alternative at the time might be an emergency room."
The academy has issued a list of "desired attributes of retail health clinics," which the big clinic operators say they have embraced, including provision of a well-defined and limited scope of services; a formal connection with local physicians to provide "continuity of care" and supervise the nurse practitioners; and electronic health records that can be transmitted to a doctor's office.
With no need for expensive medical equipment or office space, the clinics tend to be cheap to operate — particularly since the nurse practitioners are paid $30 to $45 an hour, compared with the $65 or much more an hour that a primary care doctor can command. A store clinic can be profitable with 25 patients over a 12-hour day, clinic executives said.
Employers and insurers also see opportunities for savings. The power-tool maker Black & Decker, a self-insured employer, has subtracted $10 from its usual $25 co-payments when employees patronize MinuteClinics around Baltimore, rather than visit a doctor.
"We have had an overwhelmingly positive response from our employees," said Raymond Brusca, the vice president of benefits at Black & Decker, adding, "my medical plan comes way out ahead financially."
A clinic company with somewhat grander ambitions is Solantic. Its clinics are staffed by doctors and provide a wider range of services that include X-rays at $90 apiece (or two for $150).
For routine services, Solantic's prices may be slightly higher than at other clinics — $55 or more for a Solantic doctor visit compared with $45 to be seen by a nurse practitioner at a rival's clinic. But having doctors on staff "dramatically increases the number of services we can provide to a patient," said Richard L. Scott, the chairman of Solantic, which is based in Jacksonville, Fla.
Mr. Scott built Columbia- HCA Healthcare into the nation's largest hospital chain before being forced out in a 1997 boardroom coup fueled by government allegations of Medicare fraud. Three top officers of the company were indicted, although Mr. Scott was not cited in the case. In a separate tax dispute over deductions for executive pay, the company agreed to pay a $71 million settlement to the Internal Revenue Service."I always wanted to create a clinic business when I was in the hospital business," Mr. Scott said.
Glenn Habern, Wal-Mart's senior vice president for business development, said that Solantic and three of its rivals — RediClinics, MedPoint Express and Quick Quality Care — would be among the clinic companies leasing space in about 60 of Wal-Mart's 1,300 "superstores" by the end of this year.
"It's still a test for us," Mr. Habern said. "If customers like it we may open more. So far, we've not seen any reason not to do so." But a big Wal-Mart competitor, Target, has evidently seen drawbacks.
At the end of this month Target plans to close the 11 MinuteClinics in stores in Maryland and Minnesota; the company would not explain why. "Target will begin remodeling to open new health clinics in these stores in fall 2006," the company said in an e-mail message, without specifying who would manage the new clinics.
Dr. Nelson, at MinuteClinic, said in an interview before the breakup with Target was disclosed that "the pharmacy business is a small percentage of the Target footprint."
"Target also is very disciplined," he added. "They like to have things totally designed and controlled to their own specifications. They struggled with whether they want somebody else talking to their clients."
Tuesday, May 09, 2006
Men's facial traits
May 9, 2006
Women Get Paternal Clues in Men's Faces
By THE ASSOCIATED PRESS
Filed at 9:48 p.m. ET
CHICAGO (AP) -- Women looking for a long-term relationship like men who like children -- and they can tell which guys might be interested in becoming fathers just by looking at their faces. Those are among the findings of a study of college students published Wednesday in a British scientific journal.
''This study suggests that women are picking up on facial cues that are perhaps related to paternal qualities,'' said James Roney, a University of California at Santa Barbara psychologist and lead author of the study. ''The more they perceived the men as liking kids, the more likely they could see having a longer-term relationship.''
Experts said evolution has apparently programmed women to recognize men who might be interested in propagating the species by raising a family.
The study wasn't all bad news for men not interested in settling down. It found that women can look at men's faces and figure out which of them have the highest testosterone levels. Those men -- rated the most masculine by the women -- turn out to be just the kind of guys they would want for a fling.
''Women make very good use of any information they get from a man's face,'' said co-author Dario Maestripieri, an associate professor of comparative human development at the University of Chicago. ''Depending on what they want and where they are in their lives, they use this information differently.''
In the study, published in Proceedings of the Royal Society B: Biological Sciences, researchers looked at a group of 39 men, ages 18 to 33, at the University of Chicago. Each man was shown 10 pairs of photographs and silhouettes, one of an adult and the other of an infant, and asked to rate their preferences. Meanwhile, their saliva was tested to determine testosterone levels.
Photographs of the men's faces were then shown to 29 women, ages 18 to 20, at the University of California at Santa Barbara.
The women were asked to rate the men on four qualities: ''likes children,'' ''masculine,'' ''physically attractive'' and ''kind.'' Then they were asked to rate how attractive they found each man for short-term and long-term romance.
The study found women did well at rating men on their interest in babies, and those they rated masculine generally had higher testosterone levels than the others.
For example, the men who indicated they liked children the most were rated as above average in liking children by 20 of the 29 women. The men who showed no interest in children were correctly rated as below average in that category by 19 of the women.
The higher the women rated the men for masculinity, the higher they were rated as potential short-term romantic partners. The higher they rated men for their interest in children, the higher they were rated for long-term romance.
The features that research has suggested denote high testosterone levels include a prominent jaw and a heavy beard.
The findings came as no surprise to those in the business of studying human behavior -- and love.
''What this study illustrates is that there are genetic programs that increase survival of the species because there are hormones in women that are cuing their reactions to the hormones of the men,'' said Dr. Daniel Alkon, scientific director of the Blanchette Rockefeller Neurosciences Institute in Morgantown, W.Va., and Washington.
Or as Kristin Kelly, a spokeswoman for the online dating service Match.com, put it: ''They call it `love at first sight' for a reason. They don't say `love at first sentence,' `love at first word.'''
It is unclear just what about the men's faces tipped the women off about their interest in children. While Maestripieri guessed it might have something to do with ''a more rounded face, a gentler face,'' Roney said the answer might be found in the expressions on the men's faces.
He explained that after the study was completed, five graduate students were asked to rate on a scale of 1 to 7 whether the men looked angry or happy. Though the men were instructed to have a neutral look on their faces when photographed, some apparently looked happier than others.
''It seemed that the men who picked more infants in that test had a happier or more content look on their face,'' he said.
Women Get Paternal Clues in Men's Faces
By THE ASSOCIATED PRESS
Filed at 9:48 p.m. ET
CHICAGO (AP) -- Women looking for a long-term relationship like men who like children -- and they can tell which guys might be interested in becoming fathers just by looking at their faces. Those are among the findings of a study of college students published Wednesday in a British scientific journal.
''This study suggests that women are picking up on facial cues that are perhaps related to paternal qualities,'' said James Roney, a University of California at Santa Barbara psychologist and lead author of the study. ''The more they perceived the men as liking kids, the more likely they could see having a longer-term relationship.''
Experts said evolution has apparently programmed women to recognize men who might be interested in propagating the species by raising a family.
The study wasn't all bad news for men not interested in settling down. It found that women can look at men's faces and figure out which of them have the highest testosterone levels. Those men -- rated the most masculine by the women -- turn out to be just the kind of guys they would want for a fling.
''Women make very good use of any information they get from a man's face,'' said co-author Dario Maestripieri, an associate professor of comparative human development at the University of Chicago. ''Depending on what they want and where they are in their lives, they use this information differently.''
In the study, published in Proceedings of the Royal Society B: Biological Sciences, researchers looked at a group of 39 men, ages 18 to 33, at the University of Chicago. Each man was shown 10 pairs of photographs and silhouettes, one of an adult and the other of an infant, and asked to rate their preferences. Meanwhile, their saliva was tested to determine testosterone levels.
Photographs of the men's faces were then shown to 29 women, ages 18 to 20, at the University of California at Santa Barbara.
The women were asked to rate the men on four qualities: ''likes children,'' ''masculine,'' ''physically attractive'' and ''kind.'' Then they were asked to rate how attractive they found each man for short-term and long-term romance.
The study found women did well at rating men on their interest in babies, and those they rated masculine generally had higher testosterone levels than the others.
For example, the men who indicated they liked children the most were rated as above average in liking children by 20 of the 29 women. The men who showed no interest in children were correctly rated as below average in that category by 19 of the women.
The higher the women rated the men for masculinity, the higher they were rated as potential short-term romantic partners. The higher they rated men for their interest in children, the higher they were rated for long-term romance.
The features that research has suggested denote high testosterone levels include a prominent jaw and a heavy beard.
The findings came as no surprise to those in the business of studying human behavior -- and love.
''What this study illustrates is that there are genetic programs that increase survival of the species because there are hormones in women that are cuing their reactions to the hormones of the men,'' said Dr. Daniel Alkon, scientific director of the Blanchette Rockefeller Neurosciences Institute in Morgantown, W.Va., and Washington.
Or as Kristin Kelly, a spokeswoman for the online dating service Match.com, put it: ''They call it `love at first sight' for a reason. They don't say `love at first sentence,' `love at first word.'''
It is unclear just what about the men's faces tipped the women off about their interest in children. While Maestripieri guessed it might have something to do with ''a more rounded face, a gentler face,'' Roney said the answer might be found in the expressions on the men's faces.
He explained that after the study was completed, five graduate students were asked to rate on a scale of 1 to 7 whether the men looked angry or happy. Though the men were instructed to have a neutral look on their faces when photographed, some apparently looked happier than others.
''It seemed that the men who picked more infants in that test had a happier or more content look on their face,'' he said.
Monday, May 08, 2006
It's expensive to live in California
NYTimes
May 7, 2006
The Least Affordable Place to Live? Try Salinas
By ALINA TUGEND
IN 2005, the least-affordable place in the country to live, measured by the percentage of income devoted to mortgage payments, was Salinas, Calif.
The second was the Santa Cruz-Watsonville area of California.
The third? Santa Rosa-Petaluma, Calif.
In fact, California has the distinction of having the 11 least-affordable metropolitan areas in the country. One would need to go all the way down to 12th place — and across the country to the New York region's northern suburbs — to find a non-California metropolitan area on the least-affordable list of 2005.
Much of California is pretty. It has beaches and the mountains and, of course, the weather. But why are places like Salinas, which is surrounded by agriculture, topping places like Honolulu (No. 17) and Miami (No. 22) on the out-of-reach list?
There is no one answer, but demographers and public planners who study such trends say that a confluence of factors in California — both artificial and natural — have combined to create a particularly acute problem.
"California has both political and geographical constraints on building," said Dowell Myers, professor of policy, planning and development at the University of Southern California. "That drives up prices, and then it snowballs."
The geographical limits on developable land are the hills and the coast, while the political restrictions are state and local regulations that prevent building new homes, in response to both environmental and congestion concerns.
"One of the key factors here is the basic law of supply and demand," said James W. Hughes, dean of the Edward J. Bloustein School of Planning and Public Policy at Rutgers University. "California is in marked contrast to Florida, where you can expand without constraint. It's more like the New York suburbs, where too many dollars are chasing too few homes."
While many states have regulations on growth, California is a leader, Dean Hughes says.
California is also in the forefront of population growth, but it is not driven, as might be expected, by envious Easterners and Midwesterners escaping snowbound winters. Nor is it driven by long-term Californians. In fact, census figures show that over the past decade, more people have left California — emigrating to neighboring states like Nevada and Arizona and farther away, to Texas and Florida — than have moved in from other parts of the country.
The population increase is driven primarily by births and foreign immigration. According to census statistics, from April 2000 to July 2005, California experienced a net natural increase — taking into account births and deaths — of 1.5 million people.
And an additional 1.4 million moved in from other countries.
While California's birth rate is not the highest in the nation — Utah's is — it is near the top.
"New York has the constraints but doesn't have the population growth," Professor Myers said. "Florida has the population growth but doesn't have the constraints."
While it is difficult to build new houses in California, that isn't to say none are going up. According to the California Association of Realtors, there have been increases in the number of housing units built over the past nine years — from 94,283 in 1996 to 207,154 in 2005.
That is substantially more than the low in 1993, when California was in the throes of a severe economic recession and only 84,656 units were built. But it's not as prolific as in 1988, when 255,559 went up.
There are a number of reasons for the restraints on home building, including the fact that many desirable areas in the state are already "built out" and the permit process is more complex and drawn out now than it was a few decades ago.
Leslie Appleton-Young, chief economist for the Realtors group, said the state needs about 250,000 units a year to meet housing demand. "We've been below that every year over the past 10 years," she said.
The high demand and low supply created a perfect breeding ground for investors and speculators, which became "the last straw" in driving housing prices up, said David Seiders, chief economist for the National Association of Home Builders.
Another quintessentially California issue is Proposition 13, the 1978 measure that slashed property taxes by more than 50 percent and ignited a national property tax revolution.
The measure, which was supposed to facilitate home buying, has backfired to some extent; local governments prefer that land be used for retailing rather than housing because they collect more from sales taxes than from property taxes.
"Proposition 13 is a big stop sign saying 'no housing needed,' " said Peter Dreier, professor of public policy at Occidental College in Los Angeles and an author of "Place Matters: Metropolitics for the 21st Century" (University Press of Kansas, 2001). "Every municipality is engaged in a bidding war for retail — they're battling for Wal-Mart, to keep the libraries open."
It is unlikely that will change, Professor Dreier and others say, calling Proposition 13 "the third rail of government — it's untouchable."
Although it is no surprise that house prices have gone through the roof in places like Los Angeles, San Diego and San Francisco, what is more unexpected is that less-popular areas away from the coast are also topping the list of least-affordable places to live.
"There's a huge movement away from L.A. County and from San Francisco and the great beneficiary is the Inland Empire" in Southern California, and in Sacramento and points east in northern California, said William Frey, a demographer at the Brookings Institution.
The migration is happening both among high-skilled and middle-class residents, as well as low-skilled and lower-class ones, so the cost of housing is exploding even in areas of the state that most people do not think of as traditionally expensive, he said.
"Baby boomers are getting older and moving into the higher-income bracket and into the top-dollar markets," Professor Myers said. "Immigrants have high ownership rates at the bottom of the market. It's a recipe for a bubble."
These noncoastal communities are no longer simply attached to established cities, but in many cases have become job centers in their own right, Ms. Appleton-Young said.
The Inland Empire, made up of Riverside and San Bernardino Counties, has been in a 30-year transition from a bedroom suburb to a metropolitan area, she said.
"People are now working where they live," Ms. Appleton-Young said. "It's not a commuter area."
The San Joaquin Valley, in central California, on the other hand, still has a way to go to attract an educated work force and to create a diverse and thriving economy. But Ms. Appleton-Young said it appears to be following in the footsteps of the Inland Empire: "As we say, jobs follow housing."
The final paradox in this state of paradoxes is that traditionally, many Californians are not homeowners; the state ranks 48th, behind only New York and Hawaii, in terms of homeownership, and about 10 percent below the national average. But over the past several years, even as housing prices have increased, more people are buying.
Home sales climbed fairly steadily from 1996 through 2005, with only a slight downward blip in 2001, said the California Realtors' association.
Hans Johnson, a demographer with the nonprofit Public Policy Institute of California, said, "It's counterintuitive." But apparently typical. Those familiar with home-purchasing trends say that people buy when the market is going up, not when it is going down.
If houses are so costly, how are people managing to make the leap and become homeowners?
In some cases, they use methods of financing that were not previously available, Mr. Johnson said. Instead of fixed-rate 30-year mortgages, they take, for example, variable-rate interest-only loans, which have lower monthly payments.
In many cases, he said, homeowners are paying far more on mortgages than the 30 percent of income recommended by the Department of Housing and Urban Development.
A study by the Public Policy Institute of California found that 40 percent of all households in California, the most anywhere, exceeded this recommended threshold. "In some cases, they're even paying more than half," Mr. Johnson said.
New homeowners are buying smaller homes or condominiums; according to the study, only 15 percent of long-term homeowners in California live in multifamily housing units, like condominiums, while 26 percent of recent buyers do.
"In some ways it's good, because people own a house and have equity," he said. "In other ways it's bad," he explained, because "if interest rates go up, there will be a large increase in monthly rates."
"If there's a bubble that bursts or slowly leaks," he added, overextended owners may not be able to sell and recover enough to pay off the loan.
Professor Dreier of Occidental College said he also blamed state government and business leaders for failing to support the creation of moderate-priced housing — not just for low-income residents, but also for middle-class people, like teachers and nurses, who cannot buy into the overheated housing market.
When he was a city official in Boston, the state government, businessmen and bankers "understood that affordable housing was part of a healthy work force," Professor Dreier said. "In California, businesses and the Chambers of Commerce have not embraced housing issues like they have embraced other issues, such as health care. We won't see the political will to solve the housing crisis until the organized business community weighs in and says it's unacceptable."
The big question now is whether the housing market will deflate while the economy stays strong, which would enable more Californians to buy. The answer seems as elusive as predicting the next earthquake.
The signs point toward a slowdown: interest rates are going up, and investors and speculators, who drove up prices by buying and selling houses, seem to be pulling back in hot markets nationally. But everyone, even those who study the subject, knows it is dangerous to predict.
Ask Professor Myers of U.S.C., who sold his house in Los Angeles last year. "I was convinced it was going to peak," he said. "After I sold, it rose another 15 percent."
May 7, 2006
The Least Affordable Place to Live? Try Salinas
By ALINA TUGEND
IN 2005, the least-affordable place in the country to live, measured by the percentage of income devoted to mortgage payments, was Salinas, Calif.
The second was the Santa Cruz-Watsonville area of California.
The third? Santa Rosa-Petaluma, Calif.
In fact, California has the distinction of having the 11 least-affordable metropolitan areas in the country. One would need to go all the way down to 12th place — and across the country to the New York region's northern suburbs — to find a non-California metropolitan area on the least-affordable list of 2005.
Much of California is pretty. It has beaches and the mountains and, of course, the weather. But why are places like Salinas, which is surrounded by agriculture, topping places like Honolulu (No. 17) and Miami (No. 22) on the out-of-reach list?
There is no one answer, but demographers and public planners who study such trends say that a confluence of factors in California — both artificial and natural — have combined to create a particularly acute problem.
"California has both political and geographical constraints on building," said Dowell Myers, professor of policy, planning and development at the University of Southern California. "That drives up prices, and then it snowballs."
The geographical limits on developable land are the hills and the coast, while the political restrictions are state and local regulations that prevent building new homes, in response to both environmental and congestion concerns.
"One of the key factors here is the basic law of supply and demand," said James W. Hughes, dean of the Edward J. Bloustein School of Planning and Public Policy at Rutgers University. "California is in marked contrast to Florida, where you can expand without constraint. It's more like the New York suburbs, where too many dollars are chasing too few homes."
While many states have regulations on growth, California is a leader, Dean Hughes says.
California is also in the forefront of population growth, but it is not driven, as might be expected, by envious Easterners and Midwesterners escaping snowbound winters. Nor is it driven by long-term Californians. In fact, census figures show that over the past decade, more people have left California — emigrating to neighboring states like Nevada and Arizona and farther away, to Texas and Florida — than have moved in from other parts of the country.
The population increase is driven primarily by births and foreign immigration. According to census statistics, from April 2000 to July 2005, California experienced a net natural increase — taking into account births and deaths — of 1.5 million people.
And an additional 1.4 million moved in from other countries.
While California's birth rate is not the highest in the nation — Utah's is — it is near the top.
"New York has the constraints but doesn't have the population growth," Professor Myers said. "Florida has the population growth but doesn't have the constraints."
While it is difficult to build new houses in California, that isn't to say none are going up. According to the California Association of Realtors, there have been increases in the number of housing units built over the past nine years — from 94,283 in 1996 to 207,154 in 2005.
That is substantially more than the low in 1993, when California was in the throes of a severe economic recession and only 84,656 units were built. But it's not as prolific as in 1988, when 255,559 went up.
There are a number of reasons for the restraints on home building, including the fact that many desirable areas in the state are already "built out" and the permit process is more complex and drawn out now than it was a few decades ago.
Leslie Appleton-Young, chief economist for the Realtors group, said the state needs about 250,000 units a year to meet housing demand. "We've been below that every year over the past 10 years," she said.
The high demand and low supply created a perfect breeding ground for investors and speculators, which became "the last straw" in driving housing prices up, said David Seiders, chief economist for the National Association of Home Builders.
Another quintessentially California issue is Proposition 13, the 1978 measure that slashed property taxes by more than 50 percent and ignited a national property tax revolution.
The measure, which was supposed to facilitate home buying, has backfired to some extent; local governments prefer that land be used for retailing rather than housing because they collect more from sales taxes than from property taxes.
"Proposition 13 is a big stop sign saying 'no housing needed,' " said Peter Dreier, professor of public policy at Occidental College in Los Angeles and an author of "Place Matters: Metropolitics for the 21st Century" (University Press of Kansas, 2001). "Every municipality is engaged in a bidding war for retail — they're battling for Wal-Mart, to keep the libraries open."
It is unlikely that will change, Professor Dreier and others say, calling Proposition 13 "the third rail of government — it's untouchable."
Although it is no surprise that house prices have gone through the roof in places like Los Angeles, San Diego and San Francisco, what is more unexpected is that less-popular areas away from the coast are also topping the list of least-affordable places to live.
"There's a huge movement away from L.A. County and from San Francisco and the great beneficiary is the Inland Empire" in Southern California, and in Sacramento and points east in northern California, said William Frey, a demographer at the Brookings Institution.
The migration is happening both among high-skilled and middle-class residents, as well as low-skilled and lower-class ones, so the cost of housing is exploding even in areas of the state that most people do not think of as traditionally expensive, he said.
"Baby boomers are getting older and moving into the higher-income bracket and into the top-dollar markets," Professor Myers said. "Immigrants have high ownership rates at the bottom of the market. It's a recipe for a bubble."
These noncoastal communities are no longer simply attached to established cities, but in many cases have become job centers in their own right, Ms. Appleton-Young said.
The Inland Empire, made up of Riverside and San Bernardino Counties, has been in a 30-year transition from a bedroom suburb to a metropolitan area, she said.
"People are now working where they live," Ms. Appleton-Young said. "It's not a commuter area."
The San Joaquin Valley, in central California, on the other hand, still has a way to go to attract an educated work force and to create a diverse and thriving economy. But Ms. Appleton-Young said it appears to be following in the footsteps of the Inland Empire: "As we say, jobs follow housing."
The final paradox in this state of paradoxes is that traditionally, many Californians are not homeowners; the state ranks 48th, behind only New York and Hawaii, in terms of homeownership, and about 10 percent below the national average. But over the past several years, even as housing prices have increased, more people are buying.
Home sales climbed fairly steadily from 1996 through 2005, with only a slight downward blip in 2001, said the California Realtors' association.
Hans Johnson, a demographer with the nonprofit Public Policy Institute of California, said, "It's counterintuitive." But apparently typical. Those familiar with home-purchasing trends say that people buy when the market is going up, not when it is going down.
If houses are so costly, how are people managing to make the leap and become homeowners?
In some cases, they use methods of financing that were not previously available, Mr. Johnson said. Instead of fixed-rate 30-year mortgages, they take, for example, variable-rate interest-only loans, which have lower monthly payments.
In many cases, he said, homeowners are paying far more on mortgages than the 30 percent of income recommended by the Department of Housing and Urban Development.
A study by the Public Policy Institute of California found that 40 percent of all households in California, the most anywhere, exceeded this recommended threshold. "In some cases, they're even paying more than half," Mr. Johnson said.
New homeowners are buying smaller homes or condominiums; according to the study, only 15 percent of long-term homeowners in California live in multifamily housing units, like condominiums, while 26 percent of recent buyers do.
"In some ways it's good, because people own a house and have equity," he said. "In other ways it's bad," he explained, because "if interest rates go up, there will be a large increase in monthly rates."
"If there's a bubble that bursts or slowly leaks," he added, overextended owners may not be able to sell and recover enough to pay off the loan.
Professor Dreier of Occidental College said he also blamed state government and business leaders for failing to support the creation of moderate-priced housing — not just for low-income residents, but also for middle-class people, like teachers and nurses, who cannot buy into the overheated housing market.
When he was a city official in Boston, the state government, businessmen and bankers "understood that affordable housing was part of a healthy work force," Professor Dreier said. "In California, businesses and the Chambers of Commerce have not embraced housing issues like they have embraced other issues, such as health care. We won't see the political will to solve the housing crisis until the organized business community weighs in and says it's unacceptable."
The big question now is whether the housing market will deflate while the economy stays strong, which would enable more Californians to buy. The answer seems as elusive as predicting the next earthquake.
The signs point toward a slowdown: interest rates are going up, and investors and speculators, who drove up prices by buying and selling houses, seem to be pulling back in hot markets nationally. But everyone, even those who study the subject, knows it is dangerous to predict.
Ask Professor Myers of U.S.C., who sold his house in Los Angeles last year. "I was convinced it was going to peak," he said. "After I sold, it rose another 15 percent."
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