FDA under renewed fire over dubious approval of Alzheimer’s drug

aduhelm-300x250Taxpayers and patients are suffering the rising negative consequences of the federal Food and Drug Administration’s dubious decision to overrule its own independent expert advisors and to approve on scant evidence Aduhelm. It is a prescription drug targeting Alzheimer’s disease, and concerns are rising about the medication’s safety and costs, not to mention whether it really works.

FDA advisors had argued against the drug, cautioning  that it carries significant potential side effects including swelling and bleeding in the brain. Those taking Aduhelm have been warned to undergo frequent, regular, and pricey brain scans as safeguards.

Still, experts have been startled by a much-discussed death of a 75-year-old Canadian woman, who was taking the drug as part of a clinical trial. She suffered seizures, was hospitalized, had brain scans, and was diagnosed with brain swelling shortly before she died.

The death of the unnamed patient, the New York Times reported, has “intensified” problems that experts had zeroed in on with Aduhelm, a product of drug maker Biogen. The drug’s minimal benefits and high risks were issues identified in clinical trials conducted before the FDA approved it, with regulators cozying up to Biogen and arguing Aduhelm offered at least a glimmer of hope in dealing with a disease that many seniors dread and for which no successful treatment exists.

The newspaper reported, though, that reports of the patient death, combined with other problems that have surfaced with it — including instances in which doctors have reported issues with concerning changes in brain scans of those taking Aduhelm — have turned specialists back on what already was known:

“Most data available about Aduhelm comes from two nearly identical Phase 3 clinical trials that Biogen conducted before applying for FDA approval of the drug. Both trials were shut down in 2019 because an independent monitoring committee concluded that the drug did not appear to be helping patients. A later analysis by Biogen found that participants receiving the highest dose of the drug in one trial experienced a very slight slowing of cognitive decline, but participants in the other trial did not benefit at all.

“Safety data from those trials was published … in the journal JAMA Neurology in a study whose authors included eight Biogen employees. The data showed that 425 of 1,029 patients, or 41% who received the high dose of the drug — the dose that the FDA later approved — experienced either brain swelling or bleeding. Sixty-four patients had to stop participating in the trials because of swelling or bleeding. Most of the affected patients, 362, experienced swelling, and 94 of those reported symptoms, according to the study, which also said that most cases of brain swelling resolved within 16 weeks. In a statement, Biogen noted that most swelling emerged early in the treatment period, either while patients were being ramped up to the high dose or shortly after they reached that dose.”

The drug maker, for now, is battling with a financial analyst for a global investment bank over how to view the Canadian patient’s death, the New York Times noted. The analyst, who specializes in biotech investments and is a medical doctor, has written that he has obtained through public records’ requests more information on the case. He faults the drug for the patient’s problems — a claim that Biogen disputes, saying more investigation needs to occur.

What has occurred already with Aduhelm indicates that the high promise regulators held for the drug is failing to materialize.

Biogen has told its investors that, instead of reaping a planned windfall estimated at $14 million in Aduhelm revenue in a quarter, the drug — reviled by prominent specialists and rejected by notable academic medical centers, as well as insurers and the Department of Veterans Affairs — produced $300,000. The company’s stock has fallen by 40% since Aduhelm first won approval and as doubts have grown about the drug.

Taxpayers and seniors on Medicare are feeling the financial shock of the controversial approval of the drug, a monoclonal antibody that is supposed to reduce what medical researchers have theorized but failed to prove is a major factor in Alzheimer’s — an excess of amyloid proteins in the brain.

The federal Centers for Medicare and Medicaid Services (CMS) announced recently one of its largest increases in what seniors pay for Medicare, blaming an increase in the standard monthly payment to $170.10, up from $148.50, in large part on the possibility that big numbers of older patients with federal health coverage would be prescribed a $56,000-a-year treatment with Aduhelm.

Once the FDA approves a drug for U.S. markets, experts have noted, CMS has little option but to cover its prescribed costs. Biogen far exceeded independent analysts’ estimates as to a possible price for its Alzheimer’s therapy, which, for taxpayers, also carries added expenses. That’s because the drug is given by monthly infusion — a therapy that can be given only in doctor’s offices, clinics, or hospitals. Further, as discussed, if patients and their doctors follow recommended protocols for Aduhelm use, individuals must undergo regular exams, including brain exams, to ensure they are not suffering negative side effects.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by dangerous drugs, especially prescribed products like opioids from Big Pharma.

Medicine, alas, has become an ordeal for the sick and injured due to its soaring complexity, uncertainty, and costs. Patients — yes, and even their doctors — need real help these days in dealing with powerful forces in U.S. health care, especially Big Pharma. We spend billions of dollars each year for the FDA to play a major part in this role — in protecting us from unsafe, unhelpful products with bankrupting costs. The Aduhelm approval has done little to shore up sagging confidence in the agency, which has gone far too long with credible, authoritative, and excellent leadership.

President Biden took too long to nominate Robert Califf as his FDA commissioner, and who knows how a riven U.S. Senate will handle the confirmation process. Cardiff, a cardiologist and a familiar face at the agency he headed for a year under President Obama, likely will take heat about his disclosed and extensive ties Big Pharma, many of these fostered as he became a respected builder of Duke’s clinical research efforts.

The FDA needs leadership, and we need the agency to function far better than it has, sadly for too many years now.

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