PUMPING IRONY: Just Business as Usual

If you harbored any doubts about the bureaucratic machinations that led to the approval of Biogen’s now-notorious Alzheimer’s drug Aduhelm back in 2021, the findings of an 18-month congressional investigation released last week should clear things up for you. But if you’re seeking a modicum of reassurance that our newly chastised FDA is now ready to review more judiciously the benefits and costs of the next Big Pharma dementia dream, you may find yourself disappointed.

For those who have erased this tragicomedy from their still-functioning memory banks, a brief review:

Biogen executives lauded Aduhelm’s ability to reduce amyloid plaque — thought to contribute to dementia — in clinical trials, though the results were decidedly mixed. And then, in an achingly comic move, the company chose to publish the questionable data in an obscure journal run by one of the study’s authors.

This move, as well as a growing consensus among Alzheimer’s experts that reducing plaque doesn’t necessarily slow cognitive decline, raised a good deal of suspicion among members of the FDA’s independent advisory panel, who overwhelmingly recommended that the agency withhold its approval. FDA officials ignored their advice — arguing that the prevalence of Alzheimer’s and the lack of an effective treatment represented a public-health “emergency” — and granted the drug accelerated approval, so long as Biogen would produce more results from clinical trials in the following eight years.

Company officials, perhaps slightly delirious at this point, promptly announced it would make a year’s worth of Aduhelm infusions available to desperate dementia sufferers at the bargain rate of $56,000. A slew of major healthcare organizations immediately announced they would not prescribe the drug — even after Biogen chopped the price in half — and Medicare responded by limiting its coverage to those seniors participating in clinical trials. Biogen’s stock price plummeted, and layoffs ensued.

Congressional investigators dug deeply into the backroom negotiations between FDA officials and Biogen executives during the approval process, unveiling plenty of questionable practices and a few unsurprising glimpses into Big Pharma avarice. The process, as Pam Belluck reports in the New York Times, was “rife with irregularities” and raises “serious concerns about FDA’s lapses in protocol.”

Among the more notable findings:

• The FDA’s own internal evaluation of the deal admitted that its coordination with Biogen “exceeded the norm in some respects” and revealed that agency officials leading the assessment downplayed the views of colleagues who questioned the efficacy of the drug.
• The document presented to the FDA’s independent advisory panel, making the case for Aduhelm’s accelerated approval, was produced jointly by agency officials and Biogen. This was “a highly unusual move,” Belluck notes, made more unusual by the fact that “at least one point attributed to Biogen was actually written by the FDA.” The agency conceded that its approach was not appropriate “in this instance.”
• Biogen had not originally requested accelerated approval, investigators reported, but the FDA “abruptly changed course” and moved to hasten the process — and collect the $3 million application fee — three weeks after a group of senior agency officials agreed that the clinical trials did not produce sufficient evidence that the drug (also known as aducanumab) offered any benefits. They called for another clinical trial before evaluating its request. Without more data, one official argued, approval could “result in millions of people taking aducanumab without any indication of receiving any benefit, or worse, cause harm.”
• Though the drug had only been tested on people with mild cognitive dysfunction, the FDA initially pushed to approve it for all Alzheimer’s patients — against the advice of Biogen’s own advisers, who warned of safety risks and access issues for more appropriate patients. “Biogen’s Alzheimer’s disease team leaders expressed concern that the company could lose credibility by advocating for a broad label that exceeded the clinical-trial population,” the report noted. It would “be giving false hope to patients desperate for anything that might slow the progression of the disease.”
• Biogen officials knew that the original price it set for Aduhelm was unjustifiable and would burden both patients and Medicare, but they viewed it as a “blockbuster” marketing ploy that would “establish Aduhelm as one of the top pharmaceutical launches of all time.” The company planned to spend “up to several billion dollars” — more than two-and-a-half times the price of developing the drug — on a marketing push targeting everyone from doctors and patients to insurers and policymakers.

For all the embarrassing revelations, however, the report delivers little in the way of solutions. It recommends only that the FDA do a better job of documenting its interactions with companies seeking drug approvals and create more effective criteria for joint presentations with them. Pharmaceutical manufacturers seeking the agency’s blessing, meanwhile, should reveal safety and efficacy concerns and set drug prices based on the actual value of their products.

“The American people rely on [the] FDA for assurance on the safety and efficacy of the medications they take,” the report concluded, “and it is incumbent upon drug companies such as Biogen to ensure that the well-being and safety of patients are prioritized.”

The FDA responded to the report by noting its cooperation with the investigators and its intention to review their recommendations. Meanwhile, Biogen declared the company “stands by the integrity of the actions we have taken,” noting that “Alzheimer’s is a highly complex disease, and we have learned from the development and launch of Aduhelm.”

What exactly Biogen — and the FDA — have learned will become more apparent later this week when the agency is expected to consider granting accelerated approval of the latest dementia miracle drug, lecanemab, a joint project of Biogen and the Japanese pharmaceutical company Eisai. Results of the clinical trials are sketchy, and safety concerns have made headlines since three patients died of brain hemorrhages after taking the drug, but I’d be willing to bet there will be a strong push from inside the agency to get this into the hands of as many desperate Alzheimer’s patients as can reasonably afford it.

After all, what’s the worst that could happen? Another congressional investigation?

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