DEATH BY PRESCRIPTION
F.D.A. Pushes for
Prescription Drug Guides
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Related Article
o The Boom in Medications Brings Rise in Fatal Risks (June 3)
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By SHERYL GAY STOLBERG
WASHINGTON -- The computer printout that Pat and Ben Christen picked up along
with their son's medicine included a string of warnings: Dry mouth.
Constipation. Blurred vision. Drowsiness. Dizziness. These were just a few of
the side effects of the drug imipramine, which a psychiatrist had prescribed for
the Christens' 7-year-old son, Cory, who suffered from attention deficit
disorder.
Cory had been taking the drug for several months when his second-grade teacher
noticed that his hands were trembling. His parents checked the warning sheet for
guidance, but "there was nothing in it," Mrs. Christen said. Soon after, while
he was leaning over a school water fountain to take a sip on the way to gym
class, Cory collapsed and died. "His heart just gave out," his mother said.
An autopsy concluded that Cory had overdosed; lawyers for the Christens and the
doctor, who settled a lawsuit with the parents without acknowledging wrongdoing,
disagree on who was responsible. But experts say Cory's tremors may have been a
sign he was getting too much of the drug: cardiac arrhythmia, a heart-rhythm
disturbance, is a well-known side effect that was not listed on the warning.
Cory's death in his tiny hometown, Weimar, Tex., on Sept. 19, 1996, highlights
what drug safety experts describe as a dangerous flaw in the way consumers are
informed of the risks of prescription medicines.
While officials at the Food and Drug Administration will soon begin requiring
standard, easy-to-read labels for all over-the-counter drugs and dietary
supplements, the Government does not control the information that patients
receive with their prescription medicines, which are typically much more
dangerous.
That is not for lack of trying. Four years ago, the F.D.A. announced a plan to
require drug manufacturers to publish "med guides," Government-approved patient
brochures for prescription drugs fashioned after the popular "nutrition facts"
labels on food. But the plan drew intense opposition from the drug industry and
pharmacists, and Congress rejected it in 1997, deciding that private companies
could do the job better.
As a flood of new prescription medications fills the nation's pharmacy shelves,
however, drug safety experts and F.D.A. officials are growing increasingly
concerned about deaths and injuries from the drugs that the agency approves. And
so on Tuesday the F.D.A. put into effect a rule allowing it to require med
guides for a handful of especially risky prescription medications, no more than
10 each year. The precise drugs will be announced later.
"Congress specifically said that we could not implement a comprehensive program,
but we felt that there was sufficient support for us to insure that people
taking these special drugs were warned," said Dr. Nancy Ostrove, the agency
official in charge of the med guides plan.
Dr. Ostrove said the guides "will become a signal to consumers that this is a
product that you really need to be careful about."
But experts in prescription drug safety say the new rule does not go nearly far
enough.
"On boxes of cereal we have a very standard label that tells the content, and it
is the same on every one of them," said Dr. Lucian L. Leape, a health policy
analyst at the Harvard School of Public Health. "I don't know why cereal is more
important than medicines."
Scientists estimate that more than 100,000 hospital patients each year die of
adverse reactions to their medication, and 2.2 million are injured. At least
some of those deaths, Dr. Leape and others say, could be prevented if patients
had clear, concise information about how to use their medication.
In the absence of Government-approved guides, consumers are left to rely
primarily on computer printouts of the sort the Christens received. But few
people realize that these printouts, "patient information leaflets," are
manufactured by private companies and are not required by any Government agency.
Drugstores distribute the leaflets voluntarily, but not all do so. And
authorities on drug safety complain that the leaflets are inconsistent; they say
the pamphlets vary from pharmacy to pharmacy and omit information or contain
errors that contribute to the deaths of patients like Cory Christen.
"If it had been on the warning labels we would have realized it was him being
overdosed," Mrs. Christen said. "I don't understand how a prescription that is
supposed to help people, how a label that goes with it, is not going to warn you
about toxic overdose or what the maximum amount is for a child."
She said she had kept the warning leaflet on her kitchen counter and had
referred to it often. "That's what you take home and look at."
The voluntary system is the result of more than two decades of debate among
regulators, the pharmaceutical industry and consumer advocates about how to
provide patients with accurate, complete information about the risks of
prescription drugs.
At the crux of the discussion is a delicate risk-versus-benefit analysis:
experts want consumers to be well-informed about the risks that drugs carry, but
they do not want to scare patients away from taking medicine that might save
their lives.
In the late 1970's, the F.D.A. tried to require drug companies to provide
written information for consumers, but the plan was quashed by the Reagan
Administration. In 1995, Dr. David A. Kessler, then the Commissioner of Food and
Drugs, resurrected the idea with the med guides plan.
"I went to pick up a prescription for my daughter the other day," Dr. Kessler
said in a recent interview. "There were all these little stickers on it and they
were covering each other and I had to peel them off. That's no way to provide
information."
But pharmacists complained about the F.D.A.'s plan to restrict the content of
the guides to information about Government-approved uses of the drugs. Doctors
can prescribe medications "off label" -- that is, in a manner not approved by
the F.D.A. -- for any condition; the drug thalidomide, for instance, is commonly
used to treat AIDS patients but was initially approved only for leprosy. The
agency's med guides, pharmacists argued, would leave many patients ill-informed.
Drug manufacturers also objected, fearing that they would be sued if they
provided patients with a condensed, simpler version of the risk information they
were already required to give doctors.
And, said Marjorie Powell, a lawyer for Pharmaceutical Research and
Manufacturers of America, a drug industry trade group, the manufacturers feared
that if the F.D.A. had to approve information given patients, it would take
longer to get new drugs approved.
"We didn't need to convert a commercial program into a Government-run program,"
Ms. Powell said.
Congress was sympathetic and rejected Dr. Kessler's plan.
One result was a compromise adopted by the Department of Health and Human
Services: by next year, 75 percent of all prescriptions must be accompanied by
leaflets that contain "useful" information; by 2006, the figure must rise to 95
percent. If those standards have not been met the F.D.A. will be free to propose
the med guides plan again.
In 1997, Public Citizen published an analysis of the patient information
leaflets for 18 different pain relievers in the class known as nonsteroidal
anti-inflammatory drugs. It found that only one-fourth of the leaflets warned
patients to stop the drug if they experienced abdominal pain, a symptom that can
signal serious, and potentially life-threatening, internal bleeding.
The leaflet that Cory Christen's parents were given, for example, lacked
information on serious, lasting side effects of imipramine.
Thomas J. Moore, a drug safety expert at the George Washington University
Medical Center, said this was not surprising; he said the leaflets typically
leave out information about the most dire side effects.
Historically, it has been left to doctors and pharmacists to educate their
patients about the dangers of prescription drugs. But with the rise of managed
health care, doctors have less time to talk to their patients.
In a 1997 survey of 1,000 patients, the F.D.A. found that only one-third had
received information from their doctors about the dangerous side effects of
drugs they were taking. Pharmacists, too, say they are often too busy filling
prescriptions to counsel patients.
Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, an
advocacy organization based in Washington, says this is all the more reason to
have Government-approved med guides for all drugs.
"You need to have some backup," Dr. Wolfe said. "And the backup is a mandatory
patient information leaflet."
The printout that accompanied Cory Christen's prescription was produced by Medi-Span
of Indianapolis, one of a number of commercial vendors that supply computer
software to pharmacies.
Citing the lawsuit, the company declined to comment. But Jim Breen, an official
at Medi-Span's parent company, First Databank, said the guides were "merely a
supplement for the pharmacist," and were not intended to replace the advice of a
doctor.
Even so, Susan Winckler, director of policy and legislation for the American
Pharmaceutical Association, which represents 52,000 pharmacists, acknowledged
that her profession could do better.
"We are trying to remind our members that we fought the mandate but they have to
do it voluntarily," Ms. Winckler said.
As to the quality of the leaflets, she said, "A lot of them are good." But she
added, "They all should be improving."
Copyright 1999 The New York Times Company
