Thread by @HollyBlomberg

The US is hiking Medicare premiums due to the $56,000/year price of Biogen’s new Alzheimer’s drug Aduhelm HT ⁦@JenD1974⁩ cnn.com/2021/11/12/hea…

Given the drastic step of hiking Medicare premiums to cover that huge cost, you would think that Aduhelm showed definitive promise for combating the terrible effects of Alzheimer’s disease, right?

Harvard Medical School Professor Dr. Aaron Kesselheim, an expert on pharmaceuticals that address diseases of the brain, & 2 other members of the FDA advisory committee resigned in protest after after the agency approved Aduhelm cnn.com/2021/09/26/pol…

The FDA advisory committee had voted to REJECT Aduhelm because 1) 2 of Biogen’s own studies had to be shut down early after showing no significant benefit to patients, 2) the drug showed significant side effects including brain swelling in about 1/3 of study subjects

“Kesselheim, along with the other experts CNN interviewed, could not recall a single occasion when the FDA had rejected the unanimous conclusion of an advisory committee -- which is what happened here”

“Given the number of Alzheimer's patients in the United States, the cost for widespread use of this treatment could quickly run into the many billions of dollars -- much of which would go to Biogen and its partner in the project, Eisai, a Japanese pharmaceutical company”

Did the potential for windfall profits for BigPharma control the FDA’s decision to approve Aduhelm? Contested medical evidence & an “apparent coziness of the FDA and Biogen representatives” suggests that is a very strong possibility

To understand how things have gotten this bad, how a government agency tasked with insuring that drugs approved for use in the US show substantial evidence of efficacy & do not carry unacceptable risks, we have to consider a phenomenon known as regulatory capture

Regulatory capture is a “fox guarding the henhouse” problem that occurs when a government agency is dominated by the industries or interests that it is supposed to be regulating investopedia.com/terms/r/regula…

The door to regulatory capture of the FDA opened wide in 1992 with the passage of the Prescription Drug User Fee Act. This legislation amounted to “pay to play” — pharmaceutical companies pay “user fees” to expedite FDA review. These fees are a huge funding stream for the agency

“User fees are increasingly central to the funding of the drug, biologic and device review programs, and in some cases these fees account for a larger proportion of the FDA budget than congressionally appropriated monies” avalere.com/press-releases…