The new, $56,000-a-year, Alzheimer’s
drug is questionable at best.
Like many in my generation, I have been touched by the life-altering affects of a loved one who experienced the progressively debilitating, cognitive decline induced by the condition we refer to as Alzheimer’s. Those of you who have been patients of mine or have been reading my newsletter for years already know this.
More than 10 years ago, I assisted my father after he received his Alzheimer’s diagnosis. I combined the accepted medical knowledge at the time with related functional-nutrition protocols to slow down the inevitable. Since then, there has been much more research on the multiple causes and functional treatments for the condition. I now incorporate those treatments with my dementia and Alzheimer’s patients who I care for in the Center.
PAST DRUG ATTEMPTS
Over the last decade, there have been many attempts by various drug manufacturers to develop a single drug to slow or reverse the progression of Alzheimer’s. However, virtually every one has been futile. Some of the drugs were actually found to cause the condition to advance more rapidly. This was the case with one particular drug developed by Glaxo-Smith-Kline (GSK). This drug, like many, attempted to remove the amyloid beta plaques that forms in the brain of Alzheimer’s patients. When patients in the trial of the drug progressively worsened at an accelerated rate, the multimillion-dollar research study was scrapped.
That drug study and others since seemed to indicate that the plaques were actually neuro protective. In other words, they seemed to work like a scab on a wound, which not only protects but also heals. At the time, this seemed to be the consensus about the amyloid plaques that form in the brains of Alzheimer’s patients.
LATEST DRUG ATTEMPT
Well gang, hold onto your seats, because here we go again. Enter the latest and greatest drug recently approved by the FDA to treat Alzheimer’s. The drug is called Aduhelm (generic name is aducanumab). Interestingly this drug, like the previous ones that made patients worse, works to remove the amyloid beta plaque from the brain.
I don’t know: perhaps the researchers thought that, in the years of halted study, people had forgotten how ineffective this method of treating the condition actually was. At any rate, Aduhelm was given accelerated approval after much debate and after 10 of the 11 experts on the FDA’s Advisory Committee declined to recommend doing so. The one other member voted ”uncertain,” noting that the effectiveness of the drug for improving brain function in patients with Alzheimer’s is exactly that. The passionate debate over this drug at the FDA has caused three of the experts to resign their positions on the advisory panel.
DRUG TRIALS AND COST
Biogen, the manufacturer of the drug performed two trials on it, which demonstrated that it was not having any beneficial effect on the patients’ memory. However, after reviewing all of the data from the studies, the company announced that the drug appeared to help some of the Alzheimer’s patients who received the highest dose.
So, we have one study showing no beneficial effects from the drug and one showing that there might be some positive effect but only at the highest dose of the drug. Therefore, we have one study negating the other. In spite of this information, accelerated approval was given ... with a condition, one that needs to be met in order for full approval to be given for the drug. What is that condition you might ask? Biogen must prove that removal of the amyloid beta plaques from the brains of Alzheimer’s patients actually improves the cognitive decline in these individuals.
I don’t know about you, but it seems that they have the cart before the proverbial horse on this one. It would be more logical to me to prove the hypothesis before developing the drug. I may be old fashioned in my thinking, but I think that you would want to identify the method for the solution of the problem before you develop the treatment to accomplish that method.
At any rate this infusion drug costs $4666 per month. That’s right; it costs $56,000 per year and is now on the market. Perhaps there was another motivation for Biogen to push for approval of their questionably tested drug.
Oh, and by the way, the trials of Aduhelm showed that it can cause brain swelling and bleeding. Would you pay that fee for a potentially swollen and bleeding brain? I am sorry to sound insensitive, but I know that when you are backed into a corner with the potential for significant worsening of a condition like Alzheimer’s, you are willing to try almost anything. Biogen has given you something, albeit a significantly questionably, ineffective drug.
Meanwhile, the "price gouging" by Biogen and the unusual approval of this drug is being investigated by Congress.
A DRUG FALLACY
One last thought for you to ponder: the rational used to justify the approval of the drug was that there is an “unmet need” in treating Alzheimer’s. Really? The FDA feels it needs to put a drug on the market so that we can say that at least we have something.
However, the single-solution-drug hypothesis for a condition with multiple overlying causes hasn’t worked. And in my opinion, it never will.
In our current world, I am continuously challenged to question whether we have any common sense left in the minds of those not diagnosed with Alzheimer’s.
See what you think about this one!