When the FDA convened an independent commission in 2020 to decide whether a new Alzheimer’s drug called Aduhelm (generic name aducanumab) should be approved, ten out of the 11 experts on the commission said “No.”
As for that eleventh expert?
This commission member said the verdict on the drug’s efficacy in improving the brain health of folks with Alzheimer’s is “uncertain.” Hardly a ringing endorsement.
But the FDA approved the drug for use anyway. Since then, the drug has been at the center of controversy and resulted in doctors leaving their posts at the FDA. Here’s what you need to know…
As I’ve pointed out before, although drug companies have tried to come up with pharmaceuticals that can alleviate Alzheimer’s by eliminating amyloid-beta plaques in the brain that often occur during the disease, there’s a problem.
Plaque Clearance Doesn’t Work
Numerous studies have shown that this plaque clearance does not stop the progression of Alzheimer’s disease. Furthermore, as we’ve reported in this newsletter, some varieties of plaque many actually work to protect the brain against memory loss and cognitive decline.
But that’s exactly what this new drug is designed to do – move plaque out of the brain. The drug is what’s called a “monoclonal antibody” that’s given intravenously and binds to some forms of amyloid beta proteins and leads to their removal.
Drugmaker Halts Clinical Trials
Originally, Biogen, the maker of the drug, stopped its two clinical trials of the drug before they were even finished and concluded that the treatment wasn’t having a beneficial effect on memory. However, the company reviewed the data and later announced that in one of the trials Aduhelm helped some Alzheimer’s patients who were getting the highest doses of the drug. Still, the other trial didn’t find any benefit at any dose.
Even Paul Aisen, a Biogen consultant and director of the University of Southern California’s Alzheimer’s Therapeutic Research Institute, who thinks the drug is effective, admits that the data given to the FDA is not a great argument for the drug’s approval. Mr. Aisen is quoted as saying, “This was a problematic data set. It was a very fraught situation.”1
Other experts are less polite about the untrustworthiness of Biogen’s trials. They point out that when one trial seems to give some positive results while the other, equally valid trial, finds nothing, there’s no reason to believe that the positive study outweighs the negative one.
Scott Emerson, a University of Washington biostatistician who was one of the naysayers on the FDA’s independent panel, says that claiming that the supposedly positive results are an argument for approval is like “firing a shotgun at a barn and then painting a target around the bullet holes.”2
The FDA’s Approval Comes with a Condition
Another aspect of the FDA’s approval of this new drug that has many experts concerned is that it comes with strings attached. For example, the FDA says that Biogen will now have to run a trial that shows getting plaque out of the brain actually improves memory and cognition in Alzheimer’s patients.
If that can’t be shown, the FDA reserves the right to take away the drug’s approval. (And you can be certain that can’t be shown. Because as far as I know, no study has ever found that eliminating plaque improves memory for those with Alzheimer’s disease.)
That type of conditional approval goes against the way the FDA has traditionally regulated pharmaceuticals. Drugs are supposed to be proven to work before they get approved, not after!
The rationale for approving the drug in this conditional way, says the FDA, is that there is an “unmet need” for treating Alzheimer’s disease. That, of course, is not a good reason to approve a drug that doesn’t work.
“I’m quite surprised,” says Caleb Alexander, an epidemiologist at Johns Hopkins, who was another expert on the FDA panel who voted against the drug. “The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards. It’s hard to find any scientist who thinks the data are persuasive. Unmet need is an important contextual factor but it’s not an evidentiary threshold.”
FDA “Partnering” with Biogen
The disdain for the new Alzheimer’s drug isn’t only about it’s lack of efficacy.
A few of the independent experts on the FDA drug review panel went further than merely voting “no” to the drug’s approval.
They also objected to the relationship between the FDA and the drug’s maker, Biogen. Instead of being an independent judge of the effectiveness and safety of the drug, say the panelists, the FDA was acting as a partner of Biogen.
This is no surprise to me. Long-time readers know that a number of doctors and healthcare professionals in the alternative health community have long pointed to the blurred lines between the FDA’s drug approval process and the pharmaceutical industry. Sadly, it all comes down to money. And it appears in the case of Aduhelm, nothing has changed.
Costs a Whopping $56,000 a Year
Biogen is planning on charging $56,000 a year, or $4,666 a dose, for the twelve monthly intravenous infusions necessary to treat an Alzheimer’s patient. In addition, there’s the added cost of regular MRIs to check for dangerous side effects — Aduhelm can cause brain swelling and bleeding according to the clinical trials.
I think it’s pretty obvious that the FDA has blundered big time in allowing this drug on the market. Just because there’s no drug available that can treat Alzheimer’s doesn’t justify approving one that is ineffective, outrageously expensive and possibly even dangerous.
As David Knopman, a neurologist at the Mayo Clinic and one of the two members of the FDA panel who have resigned their panelist position in disgust over the FDA’s decision, put it, “Perfection may be the enemy of the good, but for aducanumab, the evidence doesn’t even rise to ‘good.'”3