BY JOEL THURTELL
It is a truth universally acknowledged that a single disease that afflicts a vast portion of the world’s population must be in want of a cure.
According to the FDA, that single disease is Alzheimer’s, and the cure is a new drug called aducanabab, trade-named “Aduhelm” by its manufacturer.
It is equally axiomatic that the first drug manufacturer to market an FDA-approved cure for Alzheimer’s disease will be the winner of profits beyond imagining. The FDA has approved other drugs such as Arisept, Namenda and Exelon that treat symptoms of Alzheimer’s, but do not stop the disease. No drug has been approved that actually stops the disease.
Aduhelm’s manufacturer, Biogen, has set a stunning cost of $56,000 a year per patient.
Biogen’s FDA coup will be a huge moneymaker both for the company and for other profit-oriented parts of the medical establishment.
There are two hitches. Normally, the FDA demands that a new drug be proven safe and effective. The rationale for creating a Pure Food and Drugs Act in the early twentieth century was that the government needed to protect the public from mendacious claims of miracle-working, money-grasping drug makers. But Biogen has not proven Aduhelm to be safe or effective for treatment of Alzheimer’s. Moreover, clinical trials have shown that any minimal gains from the drug have been nullified by evidence of “swelling or bleeding in the brain the drug caused in the trials,” according to The New York Times.
The FDA’s own advisory committee along with Alzheimer’s experts warned the agency that Aduhelm is not effective.
Apparently, the FDA anticipated blowback. It required Biogen to complete an additional clinical trial of Aduhelm’s effectiveness, and declared it might withdraw its approval. However, there is no requirement that the FDA reverse its decision, according to the Times.
It is not clear from the Times article why the FDA approved this non-cure. The newspaper reported that “patient advocacy groups lobbied vigorously for approval because there are so few treatments available for the debilitating condition.” Several drugs that show more promise than Aduhelm are years from approval, according to the Times.
I suspect many readers, like me, are puzzled about why the FDA selected one manufacturer as the beneficiary of an approval that will give Biogen a huge lead in marketing a product it can claim “cures” Alzheimer’s. It seems like a throwback to the 1800’s, when drug makers were free to make the most audacious and fallacious claims about products without oversight from a government empowered to force testing of the drugs’ contents, safety, and effectiveness.
It may seem too soon to express suspicion about the FDA approval process. The federal government could not be anything other than fair and decent in its oversight of the clinical trials of a drug with such obvious consequences both for patients suffering with Alzheimer’s.
Right?
Do we know of any past FDA history where the agency was less than honest in its dealings with rival manufacturers and the public?
As a matter of fact, yes.
In my next column, I will discuss my own and other reported findings in a 1980’s case involving improper relations between a drug manufacturer and the FDA. In subsequent columns, I will discuss additional FDA scandals and outline procedures I think reporters should follow as they — hopefully — investigate FDA’s odd approval of a drug that doesn’t get its job done.
Stay tuned.
Drop me a line at joelthurtell(at)gmail.com
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