The US Dept of Health and Human Services inspector general’s report published January 12 said FDA’s screening system is “unreliable” because of researchers’ conflicts of interest. The report focused on 118 new drug applications approved by the FDA in 2007.
The report found that 42% of the applications for new drug approval lacked complete financial information. Only 206 of 29,691 clinical drug investigators (less than 1%) disclosed potential financial conflicts, according to the report. The report indicated that such omissions “could result in the FDA being unaware of a clinical investigator’s financial interest, and thus unable to gauge its potential bias on clinical trial results.” The death of a teen involved in experimental gene therapy in 1999 prompted the financial disclosure requirements. Many of the scientists had financial ties to the drug company, though there were other problems with that clinical trial as well.
Outside scientists and physicians are hired by drug makers to test the safety and effectiveness of medications seeking FDA approval. The tests these experts perform using human patients provide the FDA the raw data to decide whether to approve a drug. The tests are designed to be regulated by strict scientific and ethical rules, including financial disclosure. Scientists can be tempted by profits related to rewards that include honoraria and stock options if the drugs they study become blockbusters once approved by the FDA.
The HHS inspector general’s report found that for the scientists who did report potential financial conflicts of interest, the most common financial reward was consulting fees or honoraria which averaged $47,252. A $3.9 million donation to the institution with which one researcher was affiliated was the highest financial amount reported. Researchers who reported gifts of company stock averaged $65,000, with the highest grant $148,751. Moreover, a study published in the Journal of the American Medical Association found that 23% to 28% of university researchers had financial ties to the drug industry.
Because of the financial rewards involved in a new drug successfully going to market, the potential for corruption in the studies that get the drug approved is significant. This is all the more worrisome when you read studies like the one published in a recent issue of the Archives of Internal Medicine. That study reported a dramatic increase in the incidence of reported deaths and serious injuries associated with prescription drug use between 1998 and 2005: serious adverse drug events increased 2.6-fold from 34,966 to 89,842, and fatal adverse drug events increased 2.7-fold from 5,519 to 15,107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005.
A 2006 study published in the New England Journal of Medicine indicated that regular screening of smokers for lung cancer with the high-speed CT scans could yield marked benefits; an earlier Mayo Clinic study had found just the opposite. No financial conflicts were disclosed in the New England Journal of Medicine article, but a 2007 Wall Street Journal article revealed the payment of royalties to the Cornell University researchers involved in the study. The researchers said the New England Journal of Medicine was told of the royalties when they submitted the article for publication, but the Journal declined to mention it at the time. The Journal finally issued a correction a full two years after the article was published.
Vested interests color medical research, medical school education, medical journal publication, and medical clinical practice, as Pulse of Health Freedom has frequently documented. This HHS inspector general’s report shows just how marred the FDA’s drug approval process is by such conflicts of interests. The FDA appears to serve the interests of the companies they monitor, and not the interests of consumers whom they are tasked to protect. It is time to reform the FDA from the ground up. We invite you visit ReformFDA.org to learn more and sign our petition. With the arrival of the Obama administration, we need to get as many signatures as possible as soon as possible.