Jul 19, 2021
Janet Woodcock, the current head of the U.S. Food and Drug Administration (FDA), called for an “investigation” into links between FDA staff and pharmaceutical company Biogen after the approval of a controversial Alzheimer’s drug, called Aduhelm.
The FDA should never have approved this drug in the first place. FDA’s own experts and eleven advisors unanimously warned that Biogen had not shown that this drug slows the brain-destroying disease. FDA’s own statistician recommended the drug be rejected. Three FDA advisers later resigned over the decision. One of them, Harvard University’s Dr. Aaron Kesselheim, called it the "worst drug approval decision in recent U.S. history."
Not only was this drug not effective in treating Alzheimer’s disease, but it also had worrisome side effects. Biogen’s clinical trials showed that patients treated with the drug were three times as likely to suffer brain swelling and hemorrhages compared to those not treated with the drug. Other side effects included painful headaches, vision loss, disorientation and falls.
But this drug is a very profitable product, costing $56,000 a year. Considering that the vast majority of about 6 million Americans with Alzheimer’s are old enough to qualify for Medicare, this drug will allow Biogen to use the U.S. health care system as a cash cow, with which the FDA had no desire to interfere.
No, the FDA is not there to protect the “little guy.” Senior pharmaceutical executives leave their jobs to join the FDA to influence the agency in enacting decisions favorable to corporate profits. For example, FDA’s Patrizia Cavazzoni, who oversaw the approval of this Alzheimer’s drug, joined FDA in 2018 after working many years for drug giants Pfizer, Sanofi, and Lilly. Also, these companies provide FDA officials with cushy industry jobs after they leave the FDA.
The current FDA commissioner, Janet Woodcock, is yet another example. She, as a director of FDA’s drug department, approved the opioid drug Opana without adequate evidence of safety or long-term efficacy, among other questionable decisions.
Over nearly four decades, the pharmaceutical companies hired nine out of the last ten FDA commissioners. This revolving door speaks louder than words to show the immense influence for-profit companies have on the FDA.