(TargetLiberty.org) – The process for gaining US Food and Drug Administration (FDA) approval for new drugs and medical devices is skewed in favor of the industry at best and outright corrupt at worst. Here’s how it works and how it goes into a new drug.
Pharmaceutical companies seeking FDA approval must first test their new drugs at their own expense. The FDA sets standards for clinical trial phases and the like, but it’s up to drug companies to conduct their own clinical testing and trials.
Then, the drug company packages up its findings and submits them to the FDA’s Center for Drug Evaluation and Research (CDER). Comprised of physicians, chemists, pharmacologists, and other scientific experts, the CDER then makes a recommendation to the FDA regarding new drugs. Unfortunately, it’s at that point that things recently broke down with the approval of a new Alzheimer’s drug.
CDER Panel Unhappy With FCA Approval of Aduhelm
Various advisory committees operate within the CDER and examine drug companies’ research and clinical trials. In late 2020, the Peripheral and Central Nervous System Advisory Committee (PCNSA) reviewed all the data on Aduhelm and recommended against its approval.
However, in June 2021, the FDA overruled that finding and decided to approve Aduhelm anyway using an accelerated process, which was designed as part of an effort to provide fast access to new drugs for individuals with serious afflictions.
Unsurprisingly, blowback from the PCNSA was swift. Three of the seven committee members resigned in protest over the decision by the FDA to approve Aduhelm despite their recommendation.
They also published an article in the prestigious New England Journal of Medicine on July 28. According to them, the “FDA’s decision [was] at odds with the evidence and with the agency’s… review.”
The crux of their issue was the FDA’s use of a beta-amyloid, a plague commonly found in the brain of Alzheimer’s patients, as a “surrogate marker” when testing Aduhelm. Scientists use surrogate markers as a substitute for clinical results.
PCNSA member Dr. Caleb Alexander, an epidemiologist at John Hopkins, related that the FDA “never carefully and comprehensively explained” the basis for its decision to use beta-amyloid “as a surrogate.” According to him, several key points of evidence call the use of beta-amyloid for that purpose into question.
In light of the ongoing controversy, FDA Director Janet Woodcock asked the agency’s Inspector General to launch a probe into Aduhelm’s approval. In addition, the appropriate oversight committees in both the House and Senate are also in the process of scheduling hearings on the situation.
On July 27, a panel of expert physicians presented their guidance on Aduhelm’s use at the Alzheimer’s Association’s annual international conference in Denver, Colorado. Noting that there were significant “gaps” between the FDA’s labeling of the drug and its anticipated use by healthcare professionals, they recommended taking a “cautious” approach moving forward with its use.
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