The CMS Aduhelm Decision: Why It Was Dead On
I adore The Wall Street Journal and often agree with its politics, but the editorial that led the Journal’s editorial page, Review & Outlook, on Monday January 24 misses the mark completely.
The Journal calls the Centers for Medicare and Medicaid Services (CMS) a “death panel” for being unwilling to pay for a new class of Alzheimer’s drug that was given accelerated approval by the FDA recently despite the advisory board’s recommendation not to do so. While it may be true that these new agents like Aduhelm decrease the amyloid in the brains of people with Alzheimer’s, they have not been conclusively shown to alter the course of the disease or the decline in cognitive function of its victims. Thus, CMS will pay for the drug IF the recipient is on a clinical trial—one that is randomized between drug and placebo. This is exactly as should be the case with a drug given accelerated approval. That approval basically says we need more data to know if this really works, but since it might and the target disease is one desperately needing treatment, a randomized, placebo-controlled trial is the best way to do it.
The Journal’s stance about “right-to-try,” another foolish concept, is well known. The conservative right that the Journal represents believes that the individual ought to have the final say when it comes to experimental drugs. I don’t.
The clinical trial and human subjects research protection system of the United States has its flaws, but it was the one that kept Thalidomide out of the medicine cabinets of many pregnant American women thus saving their babies from birth defects.
I’m not a huge fan of the FDA, but the advisory boards made up of experts from academia and industry provide the best chance that only safe and effective drugs and devices find their way to patients who have no way to know what will benefit them or harm them when a new treatment option is offered. There have been more than enough examples of unethical experimentation and medical care associated with novel treatments. The system may be flawed, but it’s better than most others and surely better than allowing every sick person to have to decide for him or herself whether a new treatment actually will benefit them without clear rules.
And then there’s the cost. The drug’s initial cost estimated was $56,000 per patient. It has since been reduced. There are hundreds of thousands who might qualify and most are over 65. Thus, Medicare would be on the hook for millions for an unproven therapy even at the new discounted rate. Unacceptable.
CMS made the right call on this even if my friends at the WSJ disagree. In essence, federal law says there is no “right-to-try.” Everyone cannot do anything he or she wishes to do when it comes to novel treatments, especially if the American people have to bear the cost. The FDA has grown and developed as an agency to protect the public. Is it perfect? No. Is it better than nothing? Much.
The WSJ is just plain wrong here. If they wrote about the price tag and the amount it would raise Medicare deductions from paychecks, perhaps they would be doing a better job of reporting than what they printed on January 24.