A sad day for us all as the FDA continues to lose credibility

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.

Where to start?

The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. They are going to allow Biogen NINE years for follow-up clinical trials in which time our healthcare system is going to pay a TON of money for hope. The Financial Times said, “Michael Carome, director of the health research group at Public Citizen, said, “these costs to patients, to their families, are just not justified based upon what we know about this drug”. Carome said that the medicine’s approval was “one of the worst decisions the agency has ever made” and “eviscerates the . . . standards for approving new drugs”.

John Carroll, Editor & Founder of Endpoints also weighed in. “Where are the guard rails on this regulatory track? Nowhere to be seen. There are no efficacy data to clearly demonstrate this drug helps patients. In their reaction today, an unamused ICER just noted that: The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms.”

While opening up a motherlode of drug money, Biogen CEO Michel Vounatsos tells CNBC’s Meg Tirrell that they have up to 9 years to complete a validating study required by the FDA, confirmed here. Late-stage, post-approval studies do not require 9 years. It is a ridiculous amount of time. Over that 9 years, Biogen can squeeze patients and payers for their $56,000 price. And how many will have to dig deep, selling homes and liquidating assets, to cover a drug that may well do little or nothing, with a serious threat of physical harm over that 9 years?

John Carroll, Endpoints

Mr Carrol goes on to say “the FDA has seriously damaged real explorations in Alzheimer’s disease. Instead of pulling away from the amyloid theory, or going past it, they are now giving it a tremendous boost, despite a mountain of data that proves it’s the wrong path — at least on its own”.

Ultimately, this is a disaster that will once again create a serious atmosphere of financial toxicity, for everyone in biopharma. With millions of patients suffering from Alzheimer’s and Biogen going to extremes in exploiting these patients, how long before the backlash takes hold in new legislation that threatens real advances for patients?

John Carrol, Endpoints

Dr. Greicius is a professor of neurology at Stanford, and Dr. Alexander is an internist and professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health who served on a Food and Drug Administration advisory committee evaluating aducanumab, were also very critical of the Biogen’s product. Here is what they had to say:

“Despite support from patient advocacy groups and pressure from the manufacturer. It hasn’t yet been shown to work. What appears to be an unusually close collaboration between the F.D.A. and Biogen before and during the agency’s review only adds to our concern. The group Public Citizen has asked the Department of Health and Human Services’ inspector general to investigate, arguing that the collaboration “dangerously compromised the independence and objectivity” of the F.D.A.’s “senior staff and clinical reviewers.”

While there is precedent for the F.D.A. approving a treatment based on substantial evidence generated from a single trial, the limited evidence provided by the first of the two large aducanumab trials, the outright failure of the second and many other inconsistencies hardly meet this threshold. An F.D.A. advisory committee, on which one of us served, agreed and expressed with near unanimity serious concerns with the evidence to date.

Given our lack of effective treatments, some may argue that aducanumab is better than nothing. We strongly disagree. In the aducanumab trials, three out of 10 patients exposed to a high dose had brain swelling as a complication, and although this was usually asymptomatic, in some patients it led to confusion, disorientation and falls. The swelling was detected with the use of rigorous safety screening, including routine M.R.I. scans. Such regular screening is unlikely to occur outside of the clinical trials, and because similar symptoms can be seen in progressive Alzheimer’s, distinguishing these adverse effects from disease progression would be especially difficult.

Dr. Greicius, professor of neurology at Stanford & is an internist and professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health

The people who are going to be asking for [aducanumab] are going to pay $56,000 for hope. In addition patient advocacy groups have become weaponized by the biotech and pharmaceutical industries to promote bad science. Biogen has done everything it can in news releases and investor reports, and at scientific conference presentations, to explain away the uncomfortable and disappointing fact that this product has not been proved to work.

After the debacle around potential pandemic drugs the FDA has lost a great amount of credibility. The approval of this drug will only add to their credibility woes and send doctors onto social media and medical platforms asking how they explain to caregivers that this drug is nothing but false hope. It’s a sad day for us all.