How the Drug Industry Has Exploited Reforms Started in the Fight Against AIDS

Robert Bazell in Nautilus:

Three decades ago, a small group from within the AIDS activist organization ACT UP changed the course of medicine in the United States. They employed what they called “the outside/inside strategy.” The activists staged large, noisy demonstrations outside the Food and Drug Administration and other federal government agencies, demanding an acceleration of the drug-approval process. Others learned the minutiae of the science and worked quietly with receptive bureaucrats, bringing the patient’s perspective to the table toward the same goal of faster drug approval. These were desperate young people dying from a new disease for which there were few treatments and no cure. At first, federal bureaucrats and drug companies resisted, but eventually more AIDS drugs became available.

The push by AIDS activists for an effective treatment was a breakthrough in the medical industry. It showed the power of a grassroots movement to spur the government and Big Pharma to action. But it had a dangerous and lasting side effect. Over the ensuing decades, pharmaceutical companies learned that with the backing of patient advocacy groups, they could get more drugs approved more quickly with less robust data. The drug-approval process slackened considerably, and the result has been many products with minimal effectiveness generating enormous profits.

This trend, according to scientists, reached its nadir with the recent approval of Aduhelm (also known by its generic name aducanumab), a treatment for Alzheimer’s disease from the biotech company Biogen. The F.D.A. approved the treatment following intense lobbying by the Alzheimer’s Association patient group. A recent report from the Alzheimer’s Association reveals that it received a $275,000 donation from Biogen in 2020. Eisai, a Japanese company that partnered in the development of the drug, gave $250,000 in 2020. The Association also received large donations from other companies hoping to bring their own, similar, Alzheimer’s drugs to market. The F.D.A.’s decision is “abominable,” said Peter B. Bach of Memorial Sloan Kettering Cancer Center, an expert on drug policy and pricing. He told me the decision will lead to companies and lobbyists “acting as the arbiters of what is safe and effective,” and a health care system that is “more opaque, more inequitable, and deeply subject to conflicting financial and political interests.” Biogen originally declared the two critical Phase III trials of the drug failures. In fact, the company stopped the trials, and its C.E.O. Michel Vounatsos said, in a statement, “This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience.”

More here.