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FDA Proposes to Drop the Effectiveness Test for Alzheimer’s Drugs

FDA Proposes to Drop the Effectiveness Test for Alzheimer’s Drugs
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OK. If they do, how about dropping the effectiveness test for food or supplements used to treat Alzheimer’s? Action Alert!

The US Food and Drug Administration was originally charged only with ensuring the safety of foods and drugs. But in 1962, Congress passed the Kefauver-Harris Amendment, also called the Drug Efficacy Amendment. It put the FDA in charge of also ensuring the effectiveness of the drugs they approve—a task the agency has never shown itself qualified to handle. It also caused the cost of approval to soar because of the requirement to prove effectiveness with double-blind random-controlled trials (RCTs). This in effect created the “Catch 22” we talk about so often, the fact that only drug companies with synthetic patented medicines can afford to pay as much as $1 billion for approval. This in turn makes the agency hostile to natural (and therefore unpatentable) medicines.
Now FDA is planning to loosen guidelines in approving new treatments for Alzheimer’s drugs. Companies would no longer have to show that the drugs improved daily, real-world functioning (such as dressing, feeding, etc.), which was an earlier requirement. FDA reasons that it has been too difficult for the pharmaceutical industry to test drugs meant for people either in the early stages of Alzheimer’s or at risk for it. Drug development for late-stage Alzheimer’s has also been very slow, as many drugs are failing to show improved real-world functioning in clinical trials.
Under the new proposal, drugs in controlled clinical trials can qualify for approval if people at very early stages of disease subtly improve performance on memory or reasoning tests, before they develop any obvious impairments. The FDA would then require companies to study the drugs after they are placed on the market, to check whether they are truly preventive in warding off Alzheimer’s in the long-term. However, these post-marketing studies might not require RCTs.
Critics note that it’s hard to test objectively for subtle cognitive changes. Billions may be spent on drugs that accomplish little or even do harm. It may take years to learn the safety, much less the effectiveness, of a drug.
The new proposal appears to be timed to benefit companies like Eli Lilly, which is currently conducting clinical trials for an early-stage Alzheimer’s drug called solanezumab. The drug failed to show any improvement for late stage- Alzheimer’s, but under the FDA’s proposed new rule, it will be easier to get approval for it. We recently told you about another product Eli Lilly was testing for Alzheimer’s diagnosis called Amyvid.
We aren’t comfortable with the timing of the FDA proposal, which is clearly intended to give drug companies a lucrative market monopoly for unproven but vastly expensive products created to take advantage of the widespread fear of developing Alzheimer’s. But we are not opposed at all to dropping the effectiveness requirement for FDA approval, in effect returning to the days before the Kafauver Act.
Once the FDA has decided that something is safe enough to introduce, it should be left to doctors to decide what is effective and what isn’t. It isn’t that there won’t be studies—in fact, doctors won’t be convinced without them. The plain reality is that FDA is simply not qualified to make these decisions, no matter how many billions they throw at the problem, billions they get from drugs companies they are supposed to be reviewing, in order to present evidence to panels in many cases composed of people paid by the same drug companies. The Kefauver Act system is broken; it needs major reform and change.
Meanwhile, if the FDA is going to lift the proof-of-effectiveness requirement for drugs, they need to do the same for supplements and food! Supplements cannot, according to FDA, claim to treat or prevent any disease unless they go through the full drug approval process and pay millions or hundreds of millions dollars to prove both safety and efficacy with new RCTs. No matter that humans and human ancestors have consumed vitamin C for millions of years and that we can’t live without it! It too would have to prove its safety and effectiveness as if it were a drug. Now, however, this standard is going to be lifted for certain drugs—no proof of effectiveness for real-world functioning needed before approval, with perhaps no RCTs required even after approval—and if so, at least let the same standard apply to natural foods and supplements!
The reason supplements can’t meet the safety test is not that they are unsafe, nor the proof-of-effectiveness test because they don’t work. It’s because without patent protection and the ability to charge exorbitant prices for their products, nutritional supplement companies can never recoup their investment in the clinical trials.
If the proposal for Alzheimer’s drugs were applied to natural foods and supplements, supplement manufacturers would be able to prove effectiveness without RCTs, while also having the opportunity to prove long-term effectiveness in post-marketing (i.e., observational) studies.
Whatever the FDA does, it is important to include natural supplements and foods in any Alzheimer’s prevention or treatment plan, such as

Anyone worried about Alzheimer’s should be taking such natural preventive approaches—not taking hugely expensive, new-to-nature, and potentially toxic synthetic drugs even before they have the disease.
Action Alert! There is a sixty-day comment period on the FDA’s proposal. Write to the FDA and tell them if they’re going to allow Alzheimer’s drugs to be approved without being able to prove their effectiveness, they need to follow the same standards for food and supplements that treat Alzheimer’s. Allow natural substances to make disease claims without having to spend a billion dollars to prove their effectiveness! Please send your message today!

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