Thursday, January 27, 2011

Study Reveals Some Pharma Clinical Trial Results Remain Off-Grid

Is this a little scary or what?

Study Reveals Some Pharma Clinical Trial Results Remain Off-Grid

Results go unpublished in certain classes.

Investors and patients seeking data and information on experimental drugs regularly hunt for relative news that provides details on clinical trials, in order to determine safety and efficacy for such new therapies. However, it appears they may not always be getting the full story, according to a recent article published in Newsweek magazine citing a study that says clinical trial results for some particular classes of pharmaceutical drugs are often buried beyond accessibility.

Newsweek cites an analysis published in the Annals of Internal Medicine that states that results from at least one-third of the clinical trials of five classes of drugs are never released. These unpublished results thwart the efforts of investors and patients by making the outcome of many trials either difficult, or impossible, to uncover.

The classes of drugs identified in the study are antidepressants, antipsychotics, anticholesteremics, proton-pump inhibitors (for gastric acid reduction), and vasodilators (blood-vessel wall relaxers for hypertension).

This type of publication bias was meant to be dealt with by the legal requirement that all clinical trials be registered at, with the results posted upon submission. However, that still falls short of mandating publication.

A major hitch in getting those wayward results fully published is that doesn't appear on PubMed, the National Institutes of Health online database that serves as an industry-standard source of information on medical studies and publications. As a result, many searches for information will still only yield results for the trials that the submitting authors opted to publish. The article also indicates that specific patterns in the failure-to-publish problem are pointing to disconcerting trends. The study, led by Florence Bourgeois of Children's Hospital Boston and Kenneth Mandl of its Children's Hospital Informatics Program, reveals that of 546 drug trials conducted between 2000 and 2006, only 32 percent of those primarily funded by industry were published within 24 months of completion. That is in contrast to 56 percent published in the same timeframe for the trials funded by nonprofit or non-government organizations with no industry investment.

It could be construed that industry is handpicking the trials with the most favorable safety and efficacy results to publish, opting to leave out the trials that have more negative results that could render damaging consequences for investment opportunities, reputation, etc.

Good news was more likely to be reported in industry-funded trials than in those financed by non-industry entities. Industry-funded trials reported positive results in 85 percent of publications, compared to 50 percent positive outcomes for privately endowed or government-funded trials. Such publication bias that releases the positive, while suppressing the negative could distort the true merit of a drug by exclusively publishing its positive benefits and by neglecting to disclose its entire negative aspects.

This is not the first study to find that publication bias is still an issue, but it is the most complete one, according to the Newsweek article. A 2009 analysis in PLoS Medicine, a peer reviewed, open-access journal, examined a random 10 percent of registered clinical trials, and found that after at least two years from the study's completion, less than half (311 of 677, or 46 percent) had been published. Again, trials primarily sponsored by industry were less likely to be published than those funded by nonindustry/nongovernment sources (40 percent vs. 56 percent).

The stakes of cherry-picking clinical trial results for publication have been elevated to a new reality in an age of accessible high technology that allows masses of people to personally scour the Internet for health information. Harris Interactive reported that 175 million Americans searched online for health information in 2010 through September of that year. That figure represents 88 percent of all the adults online, and was substantial enough to inspire the term "cyber-chondriacs." The inherent dilemma is that not many of them have the applicable knowledge of medical terminology or the patience to sort through the raw data at Instead, they conduct searches that link to published papers or to sites that report on those published papers. Consequently, the result is that searchers are unaware that they may be prone to be misinformedabout a drug's efficacy because they may be getting the complete dossier on that drug.

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