Unfavorable drug studies don't get into print

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Unfavorable drug studies don't get into print: report

By Gene Emery Wed Jan 16, 10:19 PM ET

BOSTON (Reuters) - Nearly a third of antidepressant drug studies are

never published in the medical literature and nearly all happen to

show that the drug being tested did not work, researchers reported on

Wednesday.

In some of the studies that are published, unfavorable results have

been recast to make the medicine appear more effective than it really

is, said the research team led by k of the Oregon Health &

Science University.

Even if not deliberate, this can be bad news for patients, they wrote

in their report, published in the New England Journal of Medicine.

" Selective publication can lead doctors to make inappropriate

prescribing decisions that may not be in the best interest of their

patients and, thus, the public health, " they wrote.

The idea that unfavorable test results are quietly tucked away so

nobody will see them -- sometimes call the " file drawer effect " -- has

been around for years.

The team used a U.S. Food and Drug Administration registry in

which companies are supposed to log details of their drug tests before

the experiments are begun.

" It tells you where they placed their bets before they saw the data, "

said in a telephone interview.

Of the 74 studies that started for the 12 antidepressants, 38 produced

positive results for the drug. All but one of those studies were

published.

REWRITTEN STUDIES

However, only three of the 36 studies with negative or questionable

results, as assessed by the FDA, were published and another 11 were

written as if the drug had worked.

" Not only were positive results more likely to be published, but

studies that were not positive, in our opinion, were often published

in a way that conveyed a positive outcome, " said the authors.

For example, of the seven negative studies done on GlaxoKline's

Paxil, five were never published. The researchers found three studies

for GSK's Wellbutrin SR, but the two negative ones never reached print.

There were five studies for Pfizer's Zoloft, but the three showing the

drug to be ineffective were not published. A fourth study, ruled

questionable by the FDA, was written and published to make it appear

that the drug worked.

A Glaxo spokeswoman said the company posts the data from all of its

trials, positive or negative, on the Internet.

" GlaxoKline agrees that public disclosure of clinical trial

results for marketed medicines is essential and fully supports

registration of all trials in progress, " she said.

" Pfizer is committed to the communication of results of all registered

clinical studies, regardless of outcome. More specifically, we have

committed to disclose clinical trial results within one year after

study completion for all of our marketed products, " Pfizer spokesman

Jack said in an e-mail.

and his colleagues did not find out who was to blame for not

publishing the studies. He said medical journals may have played a

role by deciding they would rather publish favorable results.

" There's an expectation that if you get a positive result, that's what

you're supposed to do, and if you get a negative result you have

failed, " said . " The first impulse is to say, 'I was wrong.

Maybe I should move on to something more interesting " ' so the results

may never get written up

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