Public Concerned by Big Pharma's Dominion over Clinical Drug TrialsOct 3, 2013
With the pharmaceutical industry sponsoring about 90 percent of published clinical trials, there is public concern that industry-sponsored trials are more likely to produce positive results than are 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, and, because profits for an approved drug go to the drug company, many argue that the expenses of testing should properly be borne by drug makers.
The NIH does conduct some clinical trials, such as the recent GRADE trial evaluating diabetes treatment that combined metformin with other currently available diabetes drugs. GRADE will probably cost the NIH more than $50 million, according to Forbes. Running a trial to enable the study of how these combinations impact the disease’s progression, including its complications, would likely cost five to 10 times as much.
Critics believe that Big Pharma manipulates the trials so that the resulting data clearly support a New Drug Application (NDA) for the U.S. Food and Drug Administration (FDA), while casting the drug in the most favorable light possible. Negative data are hidden, the critics claim, leaving doctors and the public with inadequate information about new medicines. But FDA oversight allows the agency to refuse to review the NDA for any drug that it believes has not been properly tested, and the agency can ultimately refuse approval.
All drug trials must be registered on the ClinicalTrials.gov website and trial results must be posted on the site, though there are complaints that results are not posted in a timely manner. In addition, the FDA receives all data generated from trials for review, diminishing the possibility of hiding adverse events. But until the mammoth pharmaceutical industry repairs its reputation, Forbes says, the public will continue to believe industry control of drug trials is hazardous to health.