- "...patients nationwide are being injured and killed
as doctors routinely prescribe drugs in ways the FDA never certified as
safe and effective."
-
- NEW BALTIMORE, Mich. -- For
the last three and a half months she was pregnant, Tammie Snyder had a
small medical device strapped to her thigh. It pumped a drug called terbutaline
through her body to prevent her from going into labor too soon.
-
- On Sept. 17, 2002, Snyder gave birth to two healthy girls.
Within days, however, her lungs filled with fluid, her heart began to fail
and she was told she might need a heart transplant. She recovered, but
she's been told she can never have a baby again. Her heart wouldn't stand
the strain.
-
- Terbutaline is an asthma drug, and the Food and Drug
Administration hasn't approved its use to prevent premature labor. The
FDA has warned doctors that the treatment is "potentially dangerous"
and may not be effective. Snyder said her doctor never told her about the
warning or that the FDA had approved terbutaline only to treat asthma.
-
- A six-month Knight Ridder investigation has found that
patients nationwide are being injured and killed as doctors routinely prescribe
drugs in ways the FDA never certified as safe and effective.
-
- Moreover, these unapproved prescriptions are soaring.
Over the last year, 115 million such prescriptions were written, nearly
double the number of five years ago, an exclusive Knight Ridder analysis
of prescriptions for the country's top-selling drugs found. The practice,
called off-label prescribing, often is driven by questionable research,
aggressive drug-company marketing and cavalier doctors, and condoned by
tepid regulators.
-
- Doctors are giving their patients epilepsy drugs for
depression and hot flashes and to help them lose weight. They use antidepressants
to treat premature ejaculation and pain, and powerful antipsychotics for
insomnia and attention deficit disorder. High blood-pressure pills are
prescribed for headaches and anxiety; antibiotics are used to treat viruses.
-
- Some drugs, in fact, are sold mostly for unapproved purposes.
Eight out of 10 prescriptions for the epilepsy drug Topamax aren't for
epilepsy. Thalidomide, the notorious morning-sickness drug that caused
horrible birth defects and ushered in today's FDA drug-safety rules, even
is on the market, and 99 percent of its prescriptions are off-label.
-
- Knight Ridder reviewed 15 top-selling classes of drugs
and found that some, such as cholesterol medicines, rarely are given as
unapproved treatments. But three-quarters of anti-seizure medications are
prescribed off-label, as are nearly two-thirds of antipsychotics and about
one-quarter of antidepressants, the analysis found.
-
- For patients with rare, intractable or fatal illnesses,
off-label prescribing is sometimes appropriate. In other cases, there may
be gold-standard studies backing an off-label use. But doctors routinely
are choosing unapproved therapies that are questionable at best. The practice
is perfectly legal, widely accepted and defended by doctors and the American
Medical Association - and it's taking a toll. Victims of off-label prescribing
whom Knight Ridder interviewed have suffered heart attacks and strokes,
had permanent nerve damage or lost their eyesight. Most said they never
were told that the FDA hadn't approved their treatments.
-
- Based on the FDA's own data, Knight Ridder estimates
that at least 8,000 people became seriously ill last year after taking
some of the nation's most popular drugs off-label. The true number is likely
to be many times higher.
-
- "Sometimes it may help, sometimes it may do more
harm than good and sometimes it may kill people," said Arnold Relman,
a former editor of the prestigious New England Journal of Medicine.
-
- Despite the rise in off-label drug use, the FDA has done
little to discourage it, and is considering whether to allow drug companies
greater leeway in pushing unapproved therapies.
-
- RISPERDAL WARNING TOOK TWO YEARS
-
- George Murphy's hands, made strong by years of climbing
utility poles for Houston Lighting & Power, shake with tremors. His
legs, now rigid, shuffle as he pushes his walker through his studio apartment
in Deer Park, Texas.
-
- "I wish I didn't have to use this thing," he
said as the walker snagged on his recliner while he was showing off his
Army dog tags from World War II, a plaque for 40 years of service as a
Mason, his Shriner fez and the oil paintings his wife did a few years before
she died.
-
- Murphy, now 85, began having the tremors last year after
he had a series of stroke-like attacks while taking Risperdal, a powerful
antipsychotic drug that the FDA has approved only for treating schizophrenia.
Murphy's family practitioner in Pasadena, Texas, Dr. Dennis Yaworski, prescribed
Risperdal for an off-label purpose: "cancer phobia," according
to case notes from an office visit on Sept. 9, 2002.
-
- The drug's maker, Johnson & Johnson, has marketed
Risperdal heavily to doctors who treat elderly patients. In 1999 the FDA
cited Johnson & Johnson for downplaying the drug's risks to the elderly
and making false and misleading claims that it could be used not just to
treat schizophrenia, but also "for psychotic symptoms associated with
a broad range of disorders." While doctors are free to prescribe as
they wish, the FDA prohibits drug-makers from marketing unapproved treatments.
-
- Despite the FDA's action, Risperdal has become a popular
off-label treatment for Alzheimer's disease and dementia. About 670,000
such prescriptions were written last year, up more than 350 percent from
1998, the Knight Ridder analysis found. Sixty-five percent of Risperdal's
prescriptions last year were for unapproved treatments, generating $929
million in retail sales.
-
- Murphy had been a familiar figure at his doctor's office,
complaining of stomach pains, arthritis and the like, often convinced that
any pain was a sign that he was dying of cancer. But he was otherwise fit,
his daughters said, enjoying family dinners, a recent trip to an alligator
festival and an active social life at his independent living center.
-
- The FDA hasn't approved Risperdal for the treatment of
hypochondria. But Murphy's family members said they weren't told this.
Yaworski declined to be interviewed.
-
- Within a month of starting the drug, Murphy had the first
in a series of stroke-like events, called transient ischemic attacks, according
to his family and hospital records. During the worst of them, on Nov. 14,
2002, Murphy suddenly couldn't walk, his speech became slurred and his
face drooped. He became easily confused, and doctors at the hospital added
dementia to his diagnoses. Attack followed attack, but Murphy kept taking
his Risperdal. He was still afraid of getting cancer, his family said.
-
- Then in April 2003, Johnson & Johnson sent a letter
to U.S. doctors warning that Risperdal may be associated with an increase
in strokes when prescribed off-label to elderly dementia patients. The
public warning came nearly two years after the drug maker privately alerted
the FDA that there was a problem with Risperdal, agency officials said
in response to questions from Knight Ridder. It came six months after drug
regulators in Canada issued a similar warning and urged doctors in that
country to reassess their use of Risperdal to treat dementia.
-
- FDA officials, in a written statement, said it took several
rounds of questions to the drug maker before they had enough evidence to
have the drug company issue the warning. Johnson & Johnson, based in
New Brunswick, N.J., had no comment.
-
- Murphy and his family have sued the drug company, which
in court filings denies any wrongdoing. His daughter, Robbie Murphy, said:
"Our father has been taken away from us. Basically the last enjoyable
times he could have with us are gone."
-
- PATIENTS AT GREATER RISK
-
- Dr. Raymond Woosley, the vice president of health sciences
at the University of Arizona, said off-label prescribing put patients at
greater risk than when doctors followed a drug's FDA-approved directions.
-
- "I have no doubt about it," said Woosley, who
also is the director of one of the national centers for drug research established
by the federal government. "The caveat is we can't quantify it."
-
- Few have even tried. One study that did was published
in 1999 in Great Britain.
-
- Examining about a thousand children, researchers found
that the number of side effects among those who were taking off-label prescriptions
was small, but more frequent than for those taking drugs for approved uses.
-
- "If you give a medicine in the right dose, and with
good information on how a patient with that illness will handle it, you
are less likely to get an adverse drug reaction than if you are prescribing
outside of those boundaries," said one of the study's authors, Imti
Choonara, a professor in child health at the University of Nottingham.
"Otherwise, there's no point to anybody studying medicine. You might
as well say, 'Here's a medicine, take it as you like and come tell me if
there is a problem.' "
-
- Doctors don't have to go very far off-label before they
can put patients in danger. Sometimes, simply prescribing a drug for longer
than it's approved for can cause problems.
-
- In 2001, Glenna Baker, a loan officer from Burke, Va.,
came down with a debilitating stomach disorder that was suspected to be
diabetic gastroparesis. She vomited repeatedly, prompting a specialist
to prescribe Reglan. The FDA has approved the drug to be used for less
than three months at a time, but studies have found that it's frequently
prescribed improperly and that long-term use exposes patients to unnecessary
side effects.
-
- One of the worst is tardive dyskinesia, a condition that
causes relentless body tremors and facial tics. Baker, now 55, said she
was never told about this, so when she moved into her fourth month on the
drug she didn't realize what was happening when she began to twitch every
now and then. In her fifth month on Reglan, her symptoms worsened. Her
primary care doctor quickly saw the connection.
-
- "It's the Reglan," she said he told her. "We
have to get you off it immediately." Her specialist, hearing the news,
called Baker at home, angry with her for not alerting him to the oncoming
symptoms. "Don't scream at me," she recalled saying during the
June 2001 phone call. "You didn't even warn me. You didn't tell me."
-
- Today, Baker is out of work; the tremors make holding
a job impossible. She can sit only for short spells; her right leg constantly
bounces, and she endlessly wrings her hands.
-
- She sued the specialist, Dr. Gabriel Herman of Fairfax,
Va., and drug maker Wyeth. Both declined comment. Wyeth, of Madison, N.J.,
has since sold its interest in the drug. In its court filings, Wyeth noted
that the drug's label mentioned both the risk of tardive dyskinesia and
that the drug is recommended for short-term therapy. In a court filing,
Herman has disputed Baker's lawsuit.
-
- A PERVASIVE PROBLEM
-
- The national prescription data that Knight Ridder examined
reveal the startling breadth of off-label prescribing. Virtually every
drug has been prescribed that way at some point, and many are regularly.
-
- Dr. Nancy Nielsen, an elected official of the American
Medical Association, doesn't think doctors have been "cavalier"
about it. "They have been in meetings," she said. "They
know it works."
-
- But individual doctors and patients aren't in a good
position to gauge the safety or effectiveness of off-label treatments,
experts say. Even in the busiest of practices, doctors see too few patients
to assess the drugs' range of side effects. They also have no way of knowing
whether the drugs are working, if it's a placebo effect or whether the
patients simply got better on their own.
-
- Medical history is filled with examples of doctors who
were convinced that an off-label therapy was safe and effective, only to
be proven disastrously wrong. Often, they based their certainty on secondhand
anecdotes, small published studies or observations from their own practices.
Off-label prescribing can continue for years before a thorough clinical
trial finds it's ineffective or even dangerous. Often such trials are never
done.
-
- In the 1990s, there was Fen-Phen, an unapproved cocktail
of two prescription appetite suppressants that was widely prescribed until
1997, when the Mayo Clinic noticed that some Fen-Phen patients were suffering
from a rare heart-valve disease.
-
- More recently, there was the rampant off-label prescribing
of hormone replacements. Though they were approved for treating specific
menopause symptoms, such as hot flashes, doctors put millions of women
on the drugs for life. They believed hormones would prevent heart disease,
breast cancer and Alzheimer's disease, uses the FDA hadn't approved. They
even started women on the drugs years after they had gone through menopause.
-
- A massive government-run study, the Women's Health Initiative,
found that hormone replacement therapy actually increases a woman's risk
of getting these diseases. Many doctors don't believe the findings, theorizing
that the study's outcome would have been different if the women in it had
started hormone therapy earlier and had taken it longer.
-
- Despite decades of off-label prescribing, drug makers
universally deny that they push these uses at doctors.
-
- "We don't track what you're calling prescribing
for unapproved uses," said Doug Petkus, a spokesman for Wyeth, which
makes an antidepressant in the Knight Ridder analysis as well as hormone
replacement therapy. "We don't recommend that our products be used
off-label."
-
- INEFFECTIVE TREATMENT
-
- Once it's on the market, a drug might be prescribed for
a dozen or more unapproved conditions.
-
- The FDA approved Topamax in 1996 as a supplemental treatment
for epilepsy. It has several potentially serious side effects. It often
causes numbness and tingling in the hands and feet. It can cause depression
and kidney stones. It can slow the thinking of many patients, impairing
memory and making it difficult to choose words. It can cause vision problems,
including a form of glaucoma that can result in blindness.
-
- To stop epileptic seizures, the FDA deemed these risks
acceptable.
-
- Knight Ridder's analysis of the last year of prescription
data for Topamax found that doctors are giving it to patients for migraine
headaches, schizophrenia, bipolar disorder, depression, pain, nerve damage
and to help them lose weight. In 1998, Topamax was prescribed only for
epileptic seizures, the data show. Now, 79 percent of Topamax prescriptions
are for illnesses and conditions that the drug hasn't been approved to
treat, Knight Ridder's analysis found. The firm has asked the FDA to approve
its use for migraines.
-
- Carolyn Bartley nearly went blind in June 2000 a week
after she began taking Topamax, which her psychiatrist prescribed as a
treatment for bipolar, a disorder characterized by bouts of depression
and mania. "Everywhere I looked, it was like a watercolor painting,
and somebody had smeared it," said the 44-year-old Annapolis, Md.,
bookkeeper. Laser surgery reduced the pressure in both eyes and restored
her sight.
-
- In 2001, the maker of Topamax sent a letter to doctors
warning about the kind of sudden glaucoma Bartley experienced. Bartley's
psychiatrist, Dr. Parviz Sahandy, said he hadn't researched the medical
literature on Topamax, but that he considered it effective for bipolar
disorder about 50 percent of the time. Those who've read the studies are
less certain.
-
- "Topamax is no better than a placebo," said
Dr. Joseph Goldberg, a research scientist at Zucker Hillside Hospital on
Long Island, N.Y., who published a review of epilepsy drugs as treatments
for bipolar disorder earlier this year while at Cornell University. "It's
giving an ineffective treatment for a potentially life-threatening illness.
It would be like giving Tylenol for pneumonia."
-
- Goldberg said that even studies by the drug's maker,
Johnson & Johnson, found it didn't work to treat bipolar disorder.
As a result, company spokeswoman Lesley Fishman said, the drug maker didn't
seek FDA approval for treating that condition. Over the last year, doctors
wrote 586,000 Topamax prescriptions to treat bipolar disorder, Knight Ridder
found.
-
- A 'CLINICAL CRAP-SHOOT'
-
- The terbutaline pump therapy prescribed for Tammie Snyder
in suburban Detroit last year is one of many off-label drug treatments
doctors use in an attempt to stop preterm labor. Nearly 500,000 babies
are born prematurely each year, but the causes and cures for preterm birth
largely elude science. Most of the treatments are based on hope and a desperate
desire to try something.
-
- Dr. John Thorp Jr. was part of a research team for the
federal government's Agency for Healthcare Research and Quality that reviewed
the scientific evidence for terbutaline and a host of other drugs in preventing
preterm labor.
-
- Their report, published in June, found that the drugs
weren't effective in prolonging pregnancy for a long term and can cause
a wide range of harms, including heart-rhythm disorders and heart failure.
"There really is no evidence," Thorp said, noting that early
contractions stop without any medical intervention 50 to 70 percent of
the time.
-
- Nonetheless, women across the country are taking these
drugs that doctors know very little about.
-
- "I think experiment is too good a word," said
Thorp, a professor of obstetrics at the University of North Carolina at
Chapel Hill. "It implies observation, measurement, alteration - that
you're actually conducting science. Clinical crap-shoot would probably
be better."
-
- The best use of terbutaline is a series of three injections
to calm contractions for about 48 hours or so, enough time to administer
steroids to help the babies' underdeveloped lungs, said Dr. Washington
C. Hill, the chairman of obstetrics and gynecology at Sarasota Memorial
Hospital in Florida and a member of the board of directors of the national
Society for Maternal-Fetal Medicine.
-
- But doctors still send women home with long-term prescriptions
for terbutaline pills. If they were candid, Hill said, those doctors would
admit: "I know it doesn't work, but it cuts down on the phone calls."
-
- Last year, 63 percent of the more than 392,000 prescriptions
for terbutaline pills were for pregnant women, despite pharmaceutical company
labels that warn against the asthma drug being used this way. While many
doctors and mothers passionately believe in the treatments, especially
in the terbutaline pump, the national company that is the largest provider
of the therapy is ambivalent. Dr. Gary Stanziano, the vice president for
medical affairs at Matria Healthcare, based in Marietta, Ga., said he had
no opinion about whether the therapy his company sold for about $10,000
a month worked.
-
- "There are studies out there that are positive and
studies out there that are negative," Stanziano said.
-
- Stanziano and Roberta McCaw, Matria general counsel,
said their company is in the business of following doctors' orders, since
physicians are the ones who write prescriptions for terbutaline pumps.
Matria is a middleman, supplying the drug and pumps, then having its nurses
hook up the women to the devices and monitor their progress. Stanziano
wouldn't say how many women use Matria's pump therapy each year, but said
he hadn't heard of any client who had been seriously harmed.
-
- In 1997, however, the FDA warned U.S. doctors that the
terbutaline pump "has not been demonstrated to be effective and is
potentially dangerous." Four years earlier, the FDA had warned Tokos
Medical Corp., one of the two companies that merged to become Matria, about
promoting unapproved preterm-labor therapies despite promises to stop.
"This case could be viewed as a conspiracy to circumvent the FDA approval
process," an FDA compliance officer wrote in a memo that year.
-
- Matria officials said they had no information about this,
because it happened before the merger. They said Matria doesn't promote
the off-label use of terbutaline to doctors.
-
- Snyder said she felt betrayed by her obstetrician, Dr.
Federico Mariona, a clinical professor at Wayne State University in Detroit
and a leader in the local medical societies. Mariona didn't respond to
repeated requests for an interview.
-
- Snyder's medical records from Matria include signed consent
forms that say, among other things, that some of the treatments being prescribed
by her doctor may involve the use of drugs "outside of their labeling."
Only after having congestive heart failure, Snyder said, did she learn
what those cryptic words meant.
-
- While her heart has improved enough that she doesn't
need a transplant, Snyder, 30, said her doctors had told her she couldn't
have more children; pregnancy would be too dangerous for her heart. Snyder
and her husband, Chris, had wanted to have more children. Because they
used in vitro fertilization to have their twins, they have other frozen
embryos. Now, those embryos remain in limbo.
-
- "I hate terbutaline. I hate what they did,"
Chris Snyder said.
-
- - Researcher Tish Wells contributed to this article
-
- © 2003 RealCities.com and wire service sources.
All Rights Reserved.
-
- http://www.twincities.com/mld/twincities/news/special_packages/riskyrx/7146578.htm
-
- Samples Pave Way For Rxes
-
- By Chris Adams and Alison Young Washington Bureau Pioneer
Press 11-6-3
-
- MEMPHIS, Tenn. -- Dr. Gary Murray, a cardiologist, was
faced with a common medical dilemma: He had no idea what was wrong with
his patient.
-
- Milton Cole, a 71-year-old man in generally good health,
was complaining of chest pains. A battery of cardiac tests couldn't pinpoint
the problem. To blunt the pain, Murray gave his patient a prescription
and some free samples of a drug.
-
- The drug Murray prescribed was Prozac, a popular antidepressant
that isn't approved by the Food and Drug Administration for treating chest
pain. Murray later said he had no idea that experts had debated for years
whether Prozac could induce suicidal tendencies.
-
- Thirteen days after that visit to the doctor, on June
28, 2001, Cole's wife, Amby, found him hanging from a beam in a back room
of their shop.
-
- "This was a patient of mine, and I was trying to
help him," Murray recalled. "I'm completely upset. ... I'll be
that way forever."
-
- That a heart specialist had free supplies of a psychiatric
drug says a lot about how drug marketing today encourages physicians to
prescribe medications for unapproved, or off-label, uses.
-
- By offering specialty drugs to nonspecialists, sending
salesmen to doctors' offices and medical conventions, and touting their
drugs' benefits on the slimmest of evidence, pharmaceutical companies have
sent off-label retail sales soaring.
-
- Off-label sales of the top-selling drugs Knight Ridder
studied hit $12.9 billion in the last year, producing nearly a quarter
of those drugs' retail sales.
-
- With an aging population, a shift to drug-based health
care and the prospect of a massive government prescription insurance plan,
prescriptions for unapproved uses are likely only to accelerate.
-
- Promoting this growth is a symbiotic relationship between
physician and drug makers in which sales representatives routinely target
doctors untrained in the basics of drug therapy and with little time, inclination
or independent information to assess a medication's usefulness or its risks.
-
- ABUNDANT SAMPLES
-
- The day Cole came in for his checkup, Murray had a drug
closet stocked with dozens of medicines that cardiologists commonly prescribe,
as well as some that general practitioners and other specialists use.
-
- With little to go on beyond Cole's complaints of chest
pain, Murray said, he had a choice between doing nothing and attempting
to ease his patient's pain.
-
- "I chose Prozac probably because I had samples of
it," he said in an interview. "I thought it was a pretty harmless
thing to do."
-
- The FDA has approved Prozac to treat depression, panic,
obsessive-compulsive disorder and an eating disorder, but not pain. Murray
didn't think Cole was depressed. The Brighton, Tenn., resident was upbeat,
busy with friends and church, preparing for a new grandchild and a new
house.
-
- Doctors have prescribed antidepressants off-label for
years to manage chronic pain, and as far as Murray knew, Prozac didn't
have any serious side effects. He said he had never heard it linked to
suicides. Articles debating the issue were published primarily in psychiatric
journals throughout the 1990s.
-
- A Knight Ridder analysis of government data found that
over the past decade, 40 percent of Prozac prescriptions were written by
nonpsychiatrists. In the last year, 500,000 Prozac prescriptions were for
off-label uses.
-
- Prozac didn't help Cole's chest pain.
-
- Soon, he complained of feeling jittery. His fingers tingled;
he became easily aggravated. Days later, he hanged himself.
-
- Amby Cole blames drug maker Eli Lilly for not warning
them of the links between Prozac and suicide, and her lawyer, Andy Vickery
of Houston, has accused Lilly of overpromoting Prozac to nonpsychiatrists.
Lilly settled the case earlier this year. The amount is confidential.
-
- Vickery said it was his third settlement with Lilly over
Prozac-suicide cases and off-label uses.
-
- Lilly officials said they had settled some lawsuits for
economic reasons, but wouldn't comment on specifics. Spokeswoman Tarra
Ryker said Lilly "does not condone or encourage off-label use of any
of our medications, including Prozac."
-
- THE PROFITS OF OFF-LABEL
-
- Federal law prohibits drug makers from advertising or
promoting off-label drug uses, and since 1998 the FDA has cited companies
nearly 70 times for improperly promoting their drugs that way, a review
of its records shows.
-
- Yet off-label promotions are commonplace, as was alleged
in a recent whistleblower lawsuit against a company that's now part of
Pfizer Inc. A former employee of the drug company said it employed a range
of tactics to boost off-label sales of the epilepsy drug Neurontin. The
widely reported case is pending.
-
- Getting around FDA marketing rules isn't difficult. The
agency acknowledges it's impossible to police the millions of conversations
between drug companies and doctors.
-
- One company that relies heavily on off-label sales is
Cephalon Inc., based near Philadelphia. A Wall Street analyst touted "significant
opportunities for off-label sales" as a reason to be bullish on the
company, and Cephalon at times has aggressively marketed its drugs off-label.
A 2002 letter from the FDA cited the company for making "misleading
claims" about a "variety of unapproved uses" for Provigil.
-
- The company's messages apparently got through to doctors.
In Maine, for example, state Medicaid officials in 2002 noticed a growing
amount of Provigil use.
-
- Although approved at the time only for patients with
narcolepsy, a disorder associated with pronounced sleepiness, Medicaid
officials were receiving claims for its use to treat multiple sclerosis
fatigue, attention deficit disorder, depression and "miscellaneous
fatigue."
-
- Maine Medicaid claims topped $1 million, with one doctor
responsible for $370,000 of them, state records show.
-
- From 2000 to 2003, 60 percent of Cephalon's sales were
of Gabitril or Provigil, two drugs for which the majority of the written
prescriptions are off-label. According to the prescription data that Knight
Ridder analyzed, 88 percent of last year's retail sales for Gabitril, an
anti-seizure drug, were off-label.
-
- Cephalon has told the Securities and Exchange Commission
that the "market for the approved indications of two of our three
largest products is relatively small."
-
- Even as the company begins to study whether Gabitril
works for pain, tens of thousands of prescriptions for that use were filled
in the last year, Knight Ridder's analysis showed.
-
- When asked for evidence that their drug may be useful
for pain, Cephalon officials cited five studies - four of them with 10
or fewer patients.
-
- MASSIVE MARKETING
-
- Court records contain dozens of comments by some of the
government's top health experts about off-label prescribing.
-
- The FDA's lawyers said in a 1998 brief: "While physicians
may believe that they are in a better position than FDA to evaluate off-label
claims, both the evidence and the law say otherwise. ... Physicians tend
to have confidence in their own ability to critically assess off-label
information. The studies demonstrate, however, that such confidence is
often unwarranted and incorrect."
-
- Michael Wilkes, the vice dean of the medical school at
the University of California, Davis, doesn't think that's surprising.
-
- "I think it is embarrassing that so much of our
practice is prescribing drugs, and it's a joke how little our students
and residents know about pharmacology," he said. "And once you
graduate, how does a doctor learn about new medicines? It's from the pharmaceutical
companies."
-
- Wilkes, who studied the issue of off-label promotion
for the FDA in the late 1990s, pointed to two rigorous studies that concluded
that doctors - despite their protestations to the contrary - are swayed
by pharmaceutical promotions.
-
- "What gets marketed hard is what gets prescribed,"
said Jay Cohen, an adjunct associate professor of family and preventative
medicine at the University of California-San Diego.
-
- The marketing is massive.
-
- Over the last decade, the number of drug company sales
reps has more than doubled to 94,000, one for every seven doctors in the
nation. In 2002, the value of the free drug samples passed out to physicians
reached $11.9 billion, up more than 140 percent since 1996.
-
- At the same time, pharmaceutical companies' spending
for advertising in the traditional medical journals fell, according to
IMS Health, a medical-data company.
-
- In addition, there's evidence that when the FDA tries
to get doctors' attention, they pay little heed.
-
|