22 December 2021

Maybe the Good Guys Will Win This Time

Following a storm of criticism directed at the FDA for its approval of the Alzheimer's drug Aduhelm on the weakest of evidence, and a similar level of condemnation at Biogen's absurd price gouging, it appears that Biogen has been forced to cut the price of its drug in half, and even then almost no one is getting the prescribing the drug:

Biogen slashed the price of its controversial new Alzheimer’s drug Aduhelm on Monday as the drug faces weak sales and mounting criticism.

The price was reduced to $28,200 a year from $56,000 on the same day that a group of Alzheimer’s experts and health advocates called on the Food and Drug Administration to pull the drug off the market and said they were supporting an effort to file a formal petition with the agency to withdraw it.

“The F.D.A.’s decision to approve Aduhelm is indefensible in both scientific and clinical terms,” said a statement signed by 18 scientists, most of them doctors. “This drug should be withdrawn from the market immediately.”

The agency approved Aduhelm in June, even though a council of senior F.D.A. officials, an advisory committee of outside experts and many Alzheimer’s specialists said the scientific evidence showed that the drug did not provide a clear benefit to patients and that it carried risks of dangerous side effects.Major health systems, including Cleveland Clinic, Mount Sinai Health System, Mass General Brigham and the Department of Veterans Affairs have declined to offer Aduhelm, citing questions about its benefits and risks. In October, Biogen reported that Aduhelm had brought in just $1.9 million in revenue through September, a strikingly small amount given that about 1.5 million Americans have the mild Alzheimer’s-related dementia that makes them eligible for the drug.
Huh.  Let's run the numbers:  
  • $56,000.00 a year, so June through September would cost about $14,000.00.
  • Let's reduce this by 50% to account for people who got the drug later, and for profits of middlemen in the process, which gives us a cost per patient.
  • So, $1,900,000.00 ÷ $7,000.00 gives us 271 patients.

This is not what one would call a blockbuster.


But Brian Skorney, an analyst at Robert W. Baird & Company, said after the price announcement: “For the broad majority of people who are critical of Aduhelm, $56,000 and $28,000 are both exceptionally high prices for a drug that a lot of people perceive doesn’t work at all.”

The statement from Alzheimer’s experts and health advocates calling on the F.D.A. to withdraw Aduhelm grew out of a three-hour video meeting among the scientists last week.

“We’re not just saying the approval was probably the worst decision the F.D.A. ever made,” Dr. Peter Whitehouse, a neurologist and Alzheimer’s expert at Case Western Reserve University who led the Dec. 15 meeting, told attendees during the session. “It’s so bad that we should advocate for withdrawal.”


I get that Alzheimer's treatments are current mostly palliative, but approving the drug with little evidence of efficacy, and significant evidence that it cause things like brain bleeds, is simply irresponsible.

The FDA has been captured by big Pharma.


Post a Comment