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Not All Clinical Trial Results Published: Study

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Washington, DCA recent issue of Newsweek contains a disturbing revelation with regard to the publication of clinical trial results and other information inherent with pharmaceutical drugs. According to an analysis published recently in the Annals of Internal Medicine, results from a third of clinical trials inherent with five classes of drugs are never published.

The allegation is that such 'cherry picking' of data results in less-than-accurate information and provides some drugs with lofty reputations they made not fully deserve.

It's important to note that the publication of clinical trial data has no bearing on whether or not a drug is approved by the US Food and Drug Administration (FDA). The government agency requires all clinical trial data--both published and unpublished--before a drug is approved for use in the US.

The concerns, then, lay in the information readily available to doctors and others in the medical community—even the general public, searching online—that may be required in order to properly manage a patient's care.

It was also found that sources of funding appear to have a direct connection to the likelihood of full publication and disclosure of results. In other words, a clinical trial funded by the pharmaceutical industry is less likely to see full disclosure from a publication sense, than that funded by government.

The study was led by Florence Bourgeois of Children's Hospital Boston and Kenneth Mandl of the Children's Hospital Informatics Program. They found that, out of 546 trials conducted between 2000 and 2006, about 32 percent of industry-funded trials were published within 24 months of conclusion. For trials funded by government, or not-for-profit entities, the percentage rises to 56 percent.

Another finding of the study is equally worrisome. About half, or 50 percent of all trials with public funding reported positive outcomes. Compare that with industry-funded trials. Here, positive outcomes were reported 85 percent of the time. That's a 35 percent increase.

The bottom line, according to the Newsweek analysis of the situation, is that clinical trials funded by the pharmaceutical industry (with a vested interest in the performance of the drug) are less likely to be published than those funded by the government, or the not-for-profit sector.

Such control of information can not only affect a medical professional's opinion of a drug, but also an investor's opinion of the manufacturer's performance.

The study found that five classes of popular drugs appear to be particularly affected by this phenomenon: anticholesteremics, antidepressants, antipsychotics, proton pump inhibitor (which reduce gastric acid), and vasodilators (to reduce blood pressure).

Advocates and supporters of the pharmaceutical industry might suggest that the Big Pharma sector is better at conducting trials and achieving positive outcomes. However, critics suggest that "bias may be creeping in that causes these drugs to appear to have more positive outcomes than they actually do," Mandl told Newsweek.

"The practice of medicine is heavily dependent on the published literature, which is synthesized into guidelines and recommendations."

The alternative is akin to attempting to navigate a strange road without a map.

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