(TheRedWire.com) – Every year, the Food and Drug Administration (FDA) approves new drugs showing promise in curing diseases, relieving pain, or other health benefits. In 2020, the FDA approved 53 new drugs. Developing drugs is an expensive undertaking for pharmaceutical companies, deeply affecting their bottom lines. Through 2010, it cost approximately $2.6 billion to bring a new drug to market, and pharmaceutical companies earmarked over 20% of their revenues for research and development.
There’s a lot of money at stake for pharmaceutical companies hoping to make research investments back quickly and much more abundantly. The FDA serves as the final barrier to the public before doctors start prescribing drugs. The agency is supposed to ensure drug companies properly develop and test their pharmaceuticals. That’s why an FDA panel was shocked and furious to learn the agency approved a new medication despite their recommendation against it.
Committee Protests New Drug Approval
On Thursday, July 28, members of the Peripheral and Central Nervous System (PCNS) Advisory Committee published an article in the New England Journal of Medicine protesting the FDA’s decision to authorize Aduhelm. It’s a new, controversial, $57,000-a-year drug that allegedly helps Alzheimer’s patients.
The FDA overruled the panel’s recommendation to deny the drug’s approval. Not only did the behemoth agency not heed the warnings outlined by the investigators, but it also gave the drug an “accelerated approval.” The PCNS doctors warned the FDA’s decision was at odds with the evidence and the agency’s biostatistical review.
The board’s criticism centers around Aduhulm’s testing method and results. The research doctors suggested the drug manufacturer markers used to predict cognitive improvements were flawed. The pharmaceutical company used beta-amyloid to measure whether a person has Alzheimer’s disease. It’s a sticky plaque common in the brains of patients suffering from Alzheimer’s disease. Scientists believe the gooey substance interferes with the brain cells’ ability to process information.
The board members stated beta-amyloid isn’t a suitable surrogate marker to substitute for clinical trials. They argue it’s not reliable in predicting cognitive improvement. In addition, the article states none of the trials of other drugs using beta-amyloid produced evidence of benefits to patients.
Three of the six members on the panel were so disturbed by the FDA decision, they resigned in protest after the FDA approval of the drug on June 7. The FDA’s decision to approve Aduhulm on an accelerated basis is now highly controversial and contentious. FDA head Janet Woodcock is calling on the Inspector General to look into the matter. The House and Senate are also scheduling hearings on the matter.
On Tuesday, July 27, an expert panel of physicians presented their guidance at the annual Alzheimer’s Association International Conference in Denver, Colorado. However, the doctors admitted there were “incredible gaps” between the FDA labeled use and what most doctors in the field feel is needed or appropriate use because there is little to no clinical data on which physicians can rely. The panelists recommended caution moving forward.
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