Public Concern Over Pharmaceutical Industry Control of Clinical Drug Trials

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drug_trials_company_controlledWith the pharmaceutical industry reportedly sponsoring about 90 percent of published clinical drug trials, there is concern that industry-sponsored trials are more likely to produce positive results and suppress negative data than in the case of independently run experiments.

Consumer groups worry that skewed results allow dangerous drugs to reach the market. But can the government run all the necessary trials?  Drug trials cost hundreds of billions of dollars a year, Forbes reports, but the annual budget of the National Institutes of Health (NIH) is about $60 billion. It would be impossible for government agencies to fund trials for every new drug in development, and since profits for approved drugs go to the drug companies, many argue that they should bear the expenses of testing.

The NIH does conduct some clinical trials; a recent example is the GRADE trial evaluating diabetes treatment combining metformin with other currently available diabetes drugs. GRADE will probably cost the NIH over $50 million, according to Forbes. A trial to study the impact of drug combinations on the progression and complications of diabetes would likely cost 5 to 10 times as much.

Critics believe that Big Pharma manipulates trials so that the resulting data clearly support a New Drug Application (NDA) to the Food and Drug Administration (FDA) and put the drug in the most favorable light. Negative data are hidden, they claim, leaving doctors and the public with inadequate information about new medicines. But the FDA approval process allows the agency to refuse to review the NDA for a drug it feels is not being properly tested and the agency can ultimately refuse approval to a drug.

All drug trials must be registered on the ClinicalTrials.gov web site and trial results must be posted on the site, though there are complaints that results are not posted in a timely manner. The FDA receives all data generated from trials for review, diminishing the possibility of hiding adverse events. But, Forbes says, until the mammoth pharmaceutical industry improves its reputation, the public will continue to believe industry control of drug trials is hazardous to health.