Thursday, January 17, 2008

Unpublished Drug Studies

In this morning’s New York Times, there is an interesting report on the publication of results from drug companies seeking FDA approval of antidepressant drugs. According to the article, drug companies are becoming very selective when presenting reports to the FDA in order to increase the apparent success of their drugs and ensure that these drugs may be placed on the market in the quickest time possible.

According to the article, the reports presented to the FDA suggest that “about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills.” However, when looking at reports not presented to the FDA, the difference in results between placebos and the drug are not as significant. In order to skew results and gain approval, drug companies apparently report approximately 94% of positive studies, while only reporting 14% of tests results that do not substantially evidence the effectiveness of the drug.

While the report mentioned in the article discusses solely antidepressants, there apparently is similar concern about other tests for other drugs being represented in a similar manner; unfortunately, more thorough studies have yet to be run on these other drugs. With this report on antidepressants, it is expected (and hoped) that the manner in which drug tests are presented comes under greater scrutiny.

It is unfortunate that pharmaceutical companies apparently have skewed their test results in order to expedite the marketing of potentially ineffective drugs in order to turn a profit. While we do live in a capitalist society, where motivation is derived from earning such a profit, companies that have dedicated themselves to providing effective medicines and drugs would seem to have greater responsibilities to their consumers and should ensure that they meet these responsibilities in an appropriate manner.

Many people count on such antidepressants for several psychological and personality disorders. Without proper presentation of results, it is unknown if these people are actually obtaining the treatment they require. Outside of this specific report, concerns have already been raised regarding the presentation of study results for other drugs; if incomplete results are presented to the FDA for any drug, a proper evaluation by the FDA, doctors and patients cannot be made in order to ensure that the proper drug is prescribed for the disorder/illness. Unless pharmaceutical companies present all, or at least a more representative sample of, their results from studies, many people may not be receiving the best treatment available for their specific illness/disorder.

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