Jul 25, 2013

The problem of lack of information

Did you ever think all the work behind the marketing of a drug? Have you considered the number of results generated before a drug —as we know it— reaches our pharmacies? Have you considered all the negative results that will never see the light?

This article talks about how drug companies are deliberately keeping the public —and the medical community— in the dark about “unfavorable” clinical trials. About half of all drug trials aren’t made publicly available, and positive findings are twice as likely to be published as negative findings for the same drug. It could lead doctors to believe that drugs are much safer or much more effective than they actually are.

Well known cases as the cholesterol drug “Vytorin” —whose manufacturer deliberately hid results showing that the drug didn’t improve artery health— or the trial on Multaq —a drug that treated irregular heartbeat andstopped because more patients who received the drug were dying than those who received a placebo— show the importance of publishing negative results, and this is without taking into account the high cost that also implies the lack of information.

In many cases, drug studies are retracted after they are published. Researchers found that nearly 75 % of retracted drug studies were pulled because of scientific misconduct such as data falsification or fabrication, questionable veracity, unethical author conduct, or plagiarism. Surprisingly, such scientific fraud is on the rise: according to the most recent data, the number of scientific retractions is fifteen times higher than in 2001.

The FDA requires drug manufacturers to submit basic results of all the clinical trials to approve a drug. The problem appears when companies can sponsor trials which can have negative results and so long as two of the trials show that the drug is effective, the drug could be approved! Even worse, this requirement only applies to drugs approved after 2007 and most drugs currently on the market were approved before 2007.

This is why it is so important that all results have to be publicly available and not to contribute to publication bias, which is a handicap for scientific progress.


Written by Dr. Belén Suárez for The All Results Journals.

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