A new Alzheimer’s drug exposes our broken prescription drug system.
Biogen’s new Alzheimer’s drug may not even work — but it’ll cost $56,000 a course.
Alzheimer’s is a terrible disease. Ravaging the brain, it slowly steals away memories, relationships, and personalities. It devastates families. That’s why it’s critical that we continue to press forward toward finding treatments that slow — or someday, reverse — Alzheimer’s. Effective treatments can’t come soon enough. The nearly six million Americans and their families suffering from Alzheimer's don’t have time.
That desperation is what the pharmaceutical company Biogen was exploiting when they set the price of their new prescription Alzheimer’s medication Aduhelm at an eye-popping $56,000 a course — not including the various scans required to assess whether or not a particular patient is a candidate for treatment. That price tag has nothing to do with the cost of manufacturing the drug, of course, but it has a lot to do with how much Biogen thinks it can make exploiting desperate patients and their families.
All for a drug that may not even work. The FDA approved Aduhelm on Monday through a process called “accelerated approval,” which is designed to fast-track new medications for rare diseases and cancers. It allows medications to target “surrogate” endpoints — biological markers of disease that usually map to disease symptoms — like tumor size for cancer, for example. In this case, Aduhelm targets beta-amyloid plaques which are thought to play a role in Alzheimer’s pathophysiology. The problem, however, is that reducing beta-amyloid hasn’t actually been shown to reduce Alzheimer’s symptoms.
Indeed, the scientific justification for approving Aduhelm is suspect at best. The FDA usually requires positive results from two clinical trials comparing the drug to either another drug or placebo. In the case of Aduhlem, two clinical trials were cut short by its manufacturer, Biogen, after preliminary evidence showed the drug would fail. However, Biogen reanalyzed the results of one of the trials and found a slim positive effect. Though the drug reduces beta-amyloid by 30%, the single trial found that it slowed symptomatic decline by a mere fraction of a point on an 18-point symptom scale. The FDA’s own advisory panel voted nearly unanimously (with one abstention) to recommend against approving the drug. They even rebuked the FDA in the process for reviewing the drug on such slim evidence.
Following the advisory panel decision, even Wall Street thought the FDA would do the right thing. “Approving [Aduhelm], in the face of such an overwhelmingly negative vote and commentary, is virtually impossible and would destroy the agency's reputation at a very tenuous time...” said Brian Skorney, a Wall Street analyst. “Honestly, the panel was a disaster for [Aduhelm]. And it is completely justified. There is no serious scientific argument in favor of anything other than a new prospective study of [Aduhelm]…” said another.
The FDA approved the drug anyway. The $56,000 price tag will yield a windfall for Biogen. Even if the drug reaches just 8% of Americans with mild Alzheimer’s disease, the corporation would make $7 billion every single year. But the price of this drug will wreak havoc on our healthcare system — potentially hitting families affected by Alzheimer’s hardest of all.
Most of the bill will be paid for by the U.S. taxpayer through Medicare. After all, Alzheimer’s tends to affect seniors who are Medicare-eligible. And because Medicare cannot negotiate the price of prescription drugs per federal law, the gargantuan price tag could triple Medicare’s budget for injectable drugs. Even beyond the enormous load on an already creaking Medicare system, there’s also the fact that private insurers could use the drug’s cost to raise premiums and out-of-pocket costs on families already struggling to care for a loved one with Alzheimer’s.
Even worse, this approval could have a potential chilling effect on research and development in the space. One neurologist told STAT News, “If we approve something where the data is not strong we have a risk of delaying good treatment and effective treatment for more than a couple years.”
Taken together, there is one clear winner here: Biogen. By arbitrarily setting the price of their barely-effective drug at $56,000 a year, they’re assuring that their quarterly bottom line will stay strong. For families looking, desperately, for an Alzheimer’s treatment, Aduhelm offers slim, perhaps false, hope — at a price tag that could devastate families and Medicare in the process.
The pharmaceutical industry spends more money lobbying politicians than any other industry. In the last 20 years, they spent
$4,450,373,773. Those with power and influence can affect, even control decision making. I volunteered at The Center For Study Of Responsive Law with Ralph Nader in 1970 as a senior in medical school. My mentor was Dr. Robert McCleery who had been a practicing surgeon and became so disgusted with the pharmaceutical industry that he gave up his practice and came to DC to address pharmaceutical practices. He became a high ranked official in the FDA during the presidency of Lyndon Johnson. The issues he dealt with over 50 years ago are alive and well, even thriving, today. Corporate and big money dollars MUST be prohibited from influencing our government decision makers. An investigation of how the decision was made to approve Aduhelm is vital.
Just a brief follow up. The FDA advisory committee consisted of 11 members. Ten members of the committee voted against approval and one was “uncertain.” Now 3 prominent members of the independent advisory committee have resigned in protest over the decision to approve the drug. The drug will be shipped to more than 900 sites across the country in about 2 weeks. Say what?