Drug pills
Most of us believe that prescription drugs are tested for safety. And we believe that theses tests are reviewed and drugs which are not safe are not prescribed. Yet, according to a recent review of over 900 clinical drug trials, most failed clinical trials are never published. In fact, more than half the studies showing a drug was ineffective were never published.

Sponsors seek approval by submitting a new drug application (NDA) to the Food and Drug Administration (FDA). The application includes information about the ingredients, pharmacology, manufacturing, processing, and packaging of the drug. It also includes clinical trial information.

The FDA assumes that sponsors submit all data, including data from failed trials, so that the FDA can decide whether to approve the drug based on the sponsor´s conclusion that it is safe and effective. However, this is not the case according to a recent study.

Favorable studies are more likely to be published than unfavorable studies. It stands to reason after spending huge sums of money to test a drug that the pharmaceutical company intends to sell enough of it to return their investment and hopefully earn a profit.

Ineffective drugs or drugs with dangerous side effects may eventually be pulled from the market. However, this sell now and reveal the truth later approach may earn significant profits for pharmaceutical companies at the expense of public safety.

Research has shown that the primary reason for publication bias is that pharmaceutical companies don´t submit the negative studies for publication. Many medical journals are also owned in part by large pharmaceutical companies, furthering the chances of publication bias.

The FDA Amendments Act 2007 requires the basic results of clinical trials to be publicly posted by the National Institute of Health. However that does not mean this misinformation will be published in medical journals where prescribing doctors will receive the information.

Out of 90 approved drugs reviewed, seven were pulled from the market.

Children, the elderly, and persons with asthma, allergies, and multiple chemical sensitivity are at increased risk for ill effects from poorly researched drugs.

Patients can help protect themselves by doing their own research into drugs and requesting drugs which have been on the market longer.

A copy of the study may be downloaded here

Reference

Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008 Sep 23;5(9):e191.