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

March 26, 2013
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Alzheimer drugOK. 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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7 Responses to “FDA Proposes to Drop the Effectiveness Test for Alzheimer’s Drugs”

  1. Katie says:

    Won’t that make everyone guinea pigs? How about going after the Cures that look promising Like the olfactory study in England. These are end of life patients. I for one don’t want my Alzheimer’s relative to become sick due to a lax medical policy. This would truly be the dark ages.

    WE need to report all negative studies to eliminate bad findings.

       1 likes

  2. ACurtis says:

    Do some reading up on Eastern (Chinese) Medicine. A congested liver will interfere with nutrient absorption, which in turn can and does lead to Alzheimer’s Disease. Do a liver cleanse and clean out the liver (and kidneys and gallbladder) and guess what? You will have cleaned out your system and thwarted any degeneration known as Alzheimer’s Disease. Does it help for people who already have Alzheimer’s? I would suspect it would depend on how far advanced their Alzheimer’s is, as the person would have to be amendable to doing the treatments.

    There are many other things that can cause/interfere/manifest as Alzheimer’s Disease. Until people start educating themselves about real, natural, alternative healthcare and how to actually take care of their body and what/what not to put in it, dis-eases like Alzheimer’s will continue to pop up.

    Alzheimer’s, like other chronic dis-eases, does not get “cured” through pharma drugs. It is the body’s way of crying out that it has too much inflammation and the body systems are out of whack. Start repairing/putting the body systems back into order naturally and curing inflammation and you’ll start to see a great reduction in chronic dis-ease.

       3 likes

  3. Well that will be a big savings for the drug companies. They can reduce their research and development (R&D) costs and focus on advertising even beyond what they are doing today. They are good at selling lies such as, “heart disease is caused by high cholesterol levels ” and “depression is caused by a chemical imbalance in the brain.” The public and doctors swallowed those two stinkers hook line and sinker and most still do. Now that they don’t have to even prove a drug works they can focus on developing even bigger lies then ever and leave R&D to Ghost Writers and phony research scientists, what is the FDA’s job?

    Like the Lipitor advertisment ($260 million) for drug company Pfizer. Some important facts were left out of the ad. Dr. Robert Jarvik, the distinguished “doctor” in the boat, had never been licensed as a medical doctor, could not legally prescribe anything and was not the inventor of the artificial heart (according to three former colleagues at the University of Utah). It later turned out that he hadn’t even rowed the boat. Welcome to the world of direct-to-consumer advertising.

    Doc Blake

    Ref
    -Busted: Wyeth Used Ghostwriters To Place Over 40 “Scientific” Articles In Medical Journals, Natural News, Thursday, July 08, 2010 by: David Gutierrez, staff writer
    -WHO | Direct-to-consumer advertising under firewww.who.int/bulletin/volumes/87/8/09-040809/…/index.html

       3 likes

    • Red Steiner says:

      WE have long known that the FDA wasn’t a Government Agency and didn’t have the best interest of the public at heart. We also know that no governmental agency, at any level, has an interest in anything but their own self perpetuation at the expense of the tax payer. They are parasites one and all. Unless and until the public at large demands accountability at all levels these situations will continue to worsen. The AMA and Big Pharma control the FDA and they as well as the FDA will do their best to stop any attempt to be held accountable, and this includes criminal actions against those who oppose them. I’m not referring to just civil crimes. These agencies and other Federal Entities have, in the past, through their associations with other agencies committed crimes which include coersion, through the use of threats of imprisionment loss of liscensure etc supressed the effectivness of many natural cures for very serious ailments including cancer. Look up laetrile for example. The time has come for the public at large to demand accuracy and accountability from those who “Claim” to represent them.

         2 likes

  4. J.S. MacCutcheon says:

    It is mystifying that this country can continue to fall behind so many others. While other countries sensibly require that products placed on the market must be proven safe, members of the government of this country rush headlong pell-mell, experimenting on our most valuable resources, our people and environment.

    How can there be any sense in placing drugs on the market that have no proven validity as to safety and effectiveness? This especially when natural supplement and food companies are thwarted from claiming effectiveness against disease that has been proven by sensible studies, as well as experience. We protest the FDA’s proposal to allow drugs on the market that haven’t even had the usual, imperfect “proper evaluation.” Certainly the record for even so-called “properly evaluated” drugs is abysmal, lets not compound the maiming and killing. We have enough on our hands to correct.

       2 likes

  5. Dale Must says:

    The FDA seems to have become too apolitical since George Bush 2nd became president. Some time ago(Bush was the president), I went to the FDA website to inquire about a sinus medicine proposed for approval. This submission was actually put on an “expedite” basis. I followed up with the FDA 2 months later. The drug was approved. I sent the FDA email asking pertinent questions about the approved drug. The FDA replied by saying I would have to contact the pharmaceutical company. How objective could they be in testing over 3 to 4 months. No wonder there are so many attorneys advertising class action lawsuits.

       1 likes

  6. Wayne Paul says:

    Keep to the present standard. we don’t need to PAY for drugs that are ineffective. I don’t believe the drug companies are hurting too much to continue testing for effectiveness. It goes without saying natural supplements are a different story. I don’t need FDA labeling of prunes to guarantee any degree of effectiveness on my bowels.

       2 likes

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