Research conducted by researchers at the Yale School of Medicine back in 2017 discovered that almost 33% of the FDA-approved drugs between 2001 and 2010 had multiple issues with safety- even after the medication had been passed on to the markets for consumers. This problem is believed to have roots in the 21st Century Cures Act, signed into law by President Barack Obama. 71 of the 222 FDA-approved drugs were affected by postmarket safety events.
For those who are wondering, the drugs had been approved in the 2000s, with some of them also requiring a black box warning on the side effects – or needing a safety announcement that would bring up the newer risks. This was reported by Dr. Joseph Ross, an associate professor of medicine at the Yale School of Medicine, back in 2017.
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Postmarket Safety Events Among Novel Therapeutics
The Associate Professor whose further mentioned that while the then-administration was constantly pushing for faster approvals and lesser regulatory methods, the decisions came with far-reaching consequences. Earlier studies conducted by the researchers also concluded that the drugs had been approved by FDA at a faster rate than any counterpart agency in Europe. They also discovered that the majority of the drug trials involved fewer than 1,000 patients and lasted for just six months or less.
The study, conducted in 2017, found that it took an average of 4.2 years after the drugs had already been approved for the safety issues to come to the forefront. Interestingly, the issues were most common in biological drugs, psychiatric drugs, drugs that were close to the deadline for approval, and drugs that were given approval at a faster rate.
Needless to say, the FDA drugs which were withdrawn, were also the same drugs that came in through an accelerated process of approval- as they needed a higher rate of safety interventions. For those who are unaware, the approvals usually relied on surrogate endpoints, which meant that researchers would be working on something else- other than the survival of the patient- such as the size of any malignant tumor in order to see if the drug worked or not.
In his 2017 interview, Dr. Ross further said that the study findings could be the greatest relationship to policy in that day and age. According to the 21st Century Cures Act, there was a massive push to have the FDA constantly moves towards supporting surrogate markets- but there was a lot to discuss in the post-market setting.
On the 13th of December, 2016, President Barack Obama signed the 21st Century Cures Act and turned it into law. For those unaware, this Act put up ways to speed up the approval process for drugs by pushing the FDA to look at evidence that lay beyond the conventional phases of a traditional clinical trial. As it turns out, the process did make a whole host of researchers anxious about what it could potentially spell for those drugs which hadn’t been tested adequately.
Researchers Believe Drugs Aren’t The Best Place For One To Cut Corners
Dr. Vinay Prasad, a hematologist-oncologist and professor working at the Oregon Health and Sciences University, stated that this was probably not the best place to cut corners when it came to the safety, as well as the efficacy of a drug before it came to the markets. Interestingly, the FDA uses a voluntary system for reporting any issues with drugs, or device-related problems.
Sometimes the reports aren’t verified, and critics believe that the system is completely underutilized, incomplete, and extremely delayed. The FDA also has the added responsibility of monitoring all the available studies and reports to determine if a particular drug needs to be withdrawn- something that they ended up doing anyway.
The study also included a few FDA-approved drugs that had been withdrawn- Bextra, the anti-inflammatory drug, Raptiva, the psoriasis drug, and Zelnorm, which was used to deal with IBS. Zelnorm and Bextra were withdrawn because they posed a cardiovascular risk. Raptiva was withdrawn due to the risk of a fatal and rare infection that could cause brain damage.