By Carey Wedler
One-third of FDA-approved drugs were later found to have safety risks, according to a recent analysis of drugs cleared by the agency between 2001 and 2010.
According to the study, published in the Journal of the American Medical Association, “Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (32.0%) were affected by a postmarket safety event.”
A postmarket safety event includes “(1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications.”
The researchers, many of them from Yale University, found these events were more common among biologic and psychiatric drugs, as well as those granted access to the FDA’s expedited approval process. The Washington Post summarized the researchers’ findings:
Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.
“We seem to have decided as a society that we want drugs reviewed faster,” he told the Post, adding that for this reason, it’s vital “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively.”
Further, according to a 2014 study published in the British Medical Journal, the industry directly funds the FDA, and this is likely a factor in the agency’s willingness to approve pharmaceutical drugs. That study explained:
In 1992, because of widespread concern that the US Food and Drug Administration was taking too long to approve drugs, the Prescription Drug User Fee Act (PDUFA) was enacted, authorizing the FDA to collect user fees from drug companies to expedite the approval process. Besides providing funding for an increased FDA staff, the act established performance goals during the approval process to ensure more rapid review.
The analysis noted that “As of the current fiscal year (October 2013 to September 2014), $760m (£450m; €570m) in drug industry money is allocated to the FDA’s Center for Drug Evaluation and Research, comprising a large proportion, more than 60%, of the center’s drug review expenditure.”Though it is highly questionable that pharmaceutical companies directly fund the FDA, that study concluded it could not establish a definitive causal relationship between industry funding and increased safety issues. Still, it acknowledged “that the faster post-PDUFA drug approvals were associated with a higher rate of subsequent safety withdrawals and black box warnings.”
Perhaps another reason for the FDA’s inability to prevent drugs with adverse health effects from reaching the market is its acceptance of industry-backed research. For example, the agency recently approved a new drug for multiple sclerosis, Ocrevus (the generic version is called ocrelizumab), based on two studies. One of those studies was sponsored by Roche, the company that owns ocrelizumab’s manufacturer, Genetech. That study was conducted by scientists who disclosed financial ties to Roche and countless other pharmaceutical companies. STAT News reported that this study provided the bulk of the agency’s decision to approve the new drug.
The FDA acknowledged that side effects of Ocrevus include “upper respiratory tract infection, skin infection, and lower respiratory tract infection.” Another potential side effect is cancer, which the FDA failed to note in its press release touting the drug’s approval. Further, as CBS News reported, “the new drug only modestly slowed decline” in symptoms of MS but was still considered a breakthrough.
Keeping with the findings of the recent analysis published in JAMA, this study was granted fast-track approval process and priority review.
Despite ever-growing volumes of research — usually conducted with moldy, low-quality weed provided by the government — the FDA refuses to budge.
Rather, in fact, the agency has approved synthetic cannabis produced by pharmaceutical companies — one of which spent hundreds of thousands of dollars lobbying against cannabis legalization in Arizona last year and also manufactures fentanyl, a powerful opioid painkiller.
Meanwhile, despite the lack of serious side effects cannabis causes in individuals who find relief from it, last year the FDA actually advised the DEA to keep it on the list of Schedule I drugs, which are designated to have no medicinal value.
As the failures of the FDA continue to mount — including the pharmaceutical industry’s infiltration of the department — Americans have increasing reasons to avoid trusting their government and to do their own research before consuming potentially dangerous treatments.