A few weeks ago a new drug to treat Alzheimer’s disease hit the market. The FDA announced it had approved aducanumab marketed under the brand name Aduhelm by the biotech company Biogen.
Predictably the Alzheimer’s Association, a patient advocacy group, hailed the news as a “victory for people living with Alzheimer’s and their families” and one that “ushers in a new era in Alzheimer’s treatment and research.”
Such glowing statements from patient advocacy groups are common when a new pharmaceutical hits the market. So it’s no wonder the Alzheimer’s Association announced that it “enthusiastically welcomes” the drug’s “historic FDA approval.”
But is aducanumab really such a drug?
It would appear that it is not — judging from the flood of negative reaction from the media and well-known and knowledgeable academics including three members of the FDA’s advisory committee for drugs who resigned from those positions to protest the FDA’s approval process for the drug.
My experience is the media almost never has anything negative to say about a new drug. This time it was different with news outlets all over the country questioning the FDA’s potentially very costly decision.
Dr. Michael Carome, who heads Public Citizen’s Health Research Group, sent an eight-page letter to the Secretary of Health and Human Services blasting the FDA’s decision. He wrote the agency’s “non-evidence-based decision” to approve the drug “represents the pinnacle of the agency’s egregious disregard for science.”
While the public needs to know if the drug works on patients with more severe Alzheimer’s disease, Biogen tested the drug only on patients with mild cognitive impairment. The drug was first approved a few weeks ago for use in patients with all forms of Alzheimer’s disease.
Perhaps nodding to public backlash against the agency’s decision, the FDA announced Thursday that it is changing the prescribing label to restrict the drug’s use only to patients with mild forms of the disease.
Biogen found discrepancies between the trials it was conducting. Those trials were stopped early because both failed what is called a “futility” analysis meaning the chances of any clinical benefit would be very small if the study continued to the end, according to Dr. Joel Perlmutter, a member of the advisory committee who resigned.
Nevertheless, the company reanalyzed the data, and the decision to approve the drug was made based on those new numbers.
As for side effects, Perlmutter noted in the proposed dose, they “included localized brain swelling in 35% of clinical trial participants and microhemorrhages in 20%.”
What makes the FDA’s decision even more suspect is that the agency gave Biogen nine years to do a further study to see if the drug really works. That’s a long time, but it allows the company to rake in big money while a new study is ongoing. The drug is projected to bring in a potential $56 billion for treating one million patients in the first year alone.
Furthermore, a drug like this is likely to have negative consequences for Medicare and Medicaid, which will pay out zillions of dollars and then find the drug doesn’t work after all.
Carome told me this is one of the most irresponsible and egregious decisions the agency has made in its history.
“It sets a new low bar for approving new drugs,” he said.
He added: “We have regulatory capture. The industry has captured the regulation.”
Many people may not understand Carome’s point, so here’s an explanation. The drug industry’s capture of the FDA began some 30 years ago when Congress passed the Prescription Drug User Fee Act, which allowed drug companies to fund the FDA’s work to speed up the approval of new drugs.
Today, 65 percent of the agency’s budget revenue to regulate drugs for humans comes from the industry. It’s kind of a fox-in-the-henhouse arrangement.
Then in 1997, Congress passed the FDA Modernization Act whose passage was orchestrated by conservative think tanks. Before this law passed, two or more studies were required to gain FDA approval. Now one is all that may be necessary. The goal was to get drugs to market faster.
In 2016, Congress passed yet another law with essentially the same goal. The 21st Century Cures Act loosened regulations even more.
So where does all this loosening of the drug regulatory apparatus leave us?
Obviously, consumers of health care can’t police the FDA, We can, however, be skeptical and vigilant about what’s being prescribed for us. It’s important to ask lots of questions and do research on any new drug you’re offered.
It boils down to: Patients beware when it comes to new drugs.
Trudy Lieberman, a journalist for 40 years, is a fellow at the Center for Advancing Health. Has the Affordable Care Act impacted your family? Write to Trudy at [email protected]. Send comments to [email protected].