Information Is the Best Medicine

[Guest guest]

THE NEW YORK TIMES

 

September 18, 2004

OP-ED CONTRIBUTOR

 

Information Is the Best Medicine

 

http://www.nytimes.com/2004/09/18/opinion/18abramson_.html?th= & pagewanted=print & \

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By JOHN ABRAMSON

 

 

Measures to make the results of drug trials more accessible to

doctors and the public, as well as the federal government's probable

stiffer warnings on the use of antidepressants for children, are

definitely steps in the right direction. But my experience as a family

doctor on the front lines of medicine leads me to believe that these

moves won't be enough to curb the influence of the drug companies on

our health care.

 

The impetus for these changes comes largely from revelations in

the Food and Drug Administration's review of the new class of

antidepressants, known as selective serotonin reuptake inhibitors, in

the treatment of depression in children and adolescents. Many studies,

the review found, show that the drugs are no more effective than

placebos, but significantly increase the risk of suicidal tendencies.

So why are doctors writing millions of prescriptions each year to

treat depressed children with these drugs?

 

Much of the problem stems from drug companies' unequal treatment

of the clinical trials they sponsor. Findings that support drug sales

tend to get published in medical journals, and become accepted as

fact. Unfavorable findings often don't see the light of day. This

leaves even the most dedicated doctors and best informed patients (and

parents) unaware of important evidence about the drugs they're

prescribing and using.

 

In response, the editors of 11 of the world's leading medical

journals have agreed to publish only studies that are registered at

the outset. Registration creates a trail, making it more difficult to

suppress unfavorable results. Legislative efforts are also under way

to make completed studies available to the public.

 

There are many examples, however, of drug sales skyrocketing

despite the availability of research showing negative results or

serious side effects. An article published in the Archives of General

Psychiatry in April 2000 provides a preview of the limited effect that

we can expect from registering and posting results of all studies. In

this case, researchers obtained the results of all clinical trials of

new antidepressants like Prozac, Paxil and Zoloft done from 1987 to

1997, published and unpublished, from the F.D.A. under the federal

Freedom of Information Act.

 

The pooled results showed that an older class of

antidepressants, known as tricyclics, was actually more effective,

belying all the hype about the " revolutionary'' new antidepressants.

The researchers reported that among the longer-term studies (which

better reflect actual use), the new antidepressants were 8 percent

more effective than placebos, while tricyclics like Elavil were 12

percent more effective. The most disturbing finding was that more than

twice as many depressed adults on new antidepressants kill themselves

than those taking placeboes. The difference was 8.4 versus 3.6

suicides per 1,000 patients a year, respectively.

 

How much impact did the availability of these results have on

doctors' prescribing patterns? Evidently not much: the new

antidepressants remained the best-selling class of drugs in the United

States in 2000 and 2001.

 

The medical journal editors understand that just registering

studies isn't enough. Their real goal is full transparency in clinical

trials, meaning that research plans and complete data from studies

should be available for independent review. But even this is not

sufficient to counteract commercial influence, as the cases of the

blockbuster drugs Celebrex and Vioxx demonstrate.

 

The results of large manufacturer-sponsored studies of these two

arthritis drugs were published in The Journal of the American Medical

Association and The New England Journal of Medicine, respectively, in

2000. The original data upon which both articles are based have been

posted on the F.D.A. Web site since February 2001.

 

Both drug-company sponsored articles led doctors to believe that

their patients would be better served by prescribing the new drugs.

But the data posted on the F.D.A. Web site tell a very different

story. Patients on Celebrex did not have significantly fewer serious

gastrointestinal problems than those who took the older types of

arthritis medicine.

 

In fact, during the second six months of treatment (data not

even mentioned in the article), users of Celebrex developed serious

gastrointestinal problems more often than users of the older drugs.

The bottom line is that Celebrex is much more expensive, provides no

better relief of arthritis symptoms, and overall causes 11 percent

more serious complications than the other drugs.

 

The data about Vioxx offer an answer to the supposedly

unresolved question - whether it increases the risk of heart attacks,

strokes and blood clots. Even among people without elevated risk,

those taking Vioxx suffered twice as many serious cardiovascular

complications as those who took naproxen (sold as Naprosyn or Aleve).

Most important, the data on the F.D.A. Web site show that patients

taking Vioxx developed 21 percent more serious complications than

those who took naproxen.

 

Since that data was posted more than three years ago, American

doctors have prescribed more than $15 billion worth of Celebrex and

Vioxx. Full transparency, it appears, doesn't solve the problem of

commercial influence either.

 

Given the drug industry's domination of our medical knowledge,

nothing short of an oversight board - modeled after the Federal

Reserve Board, will make a real difference. The board's members must

serve lengthy terms to avoid political influence and have no

commercial ties. This body would make use of the excellent work

already being done by the reviewers within the F.D.A. (though too

often their analyses remain invisible to the public) as well as the

commercial, nonprofit, and government-sponsored research that is

already being done.

 

Like the National Institute of Clinical Excellence in Britain

(which has a budget of less than $30 million a year), this board would

independently evaluate scientific evidence relevant to selected

diseases and treatments to determine optimal medical care including

lifestyle changes. The board's recommendations would define the

standards of medical care based on what is best for Americans' health,

not what will generate the most profit.

 

If the latest round of reforms relating to drug research stops

with registering and posting the results of clinical studies, it will

stand only as window-dressing on a method of producing and

disseminating medical knowledge that is better designed to serve drug

makers' interests than to improve Americans' health.

 

 

John Abramson,a clinical instructor at Harvard Medical School,

isthe author of the forthcoming " Overdosed America: The Broken Promise

of American Medicine.''

 

 

 

Copyright 2004 The New York Times Company