Recently I was reading my local paper and spotted an ad, recognized by the very small print saying it was an ad, about a product called Prixelin. In the ad they touted that this newly discovered “drug” miraculously helps reverse memory problems of dementia and that it is newly available by just calling a phone number and ordering your supply! A new discovery!
These ads infuriate me. They prey on people who have the diagnosis of dementia, but don’t realize how drug testing works. Yes, experiencing the beginning signs of memory loss can be a scary thing, and these ads are directed at your fear. Most of the items that appear in these types of ads are not really considered drugs. They are classified as supplements. Since the explosion of cases of dementia in the baby boomer population have skyrocketed in the last 10-15 years, so have the sales of supplements touted as memory boosters. Supplements do not go through the same scrutiny and testing for efficacy, and side effects that drugs do. These claims are not supported by hard data!
The FDA is not authorized to review the supplements that are on the market for safety or for effectiveness before the supplements are released to market. There is no certification that the supplements actually do what their manufacturers claim, or whether they can do harm. Is there enough active ingredient in one brand vs. another? Just because the specific compound provided is taken also doesn’t guarantee that it will be able to be absorbed by the gut of the human it is meant for. Many supplements we take are merely excreted and have no effect at all. They are better taken in a natural food source that is high in that particular compound.
Supplements are not supposed to be sold for the purpose of diagnosing, treating, preventing, or curing disease. The simple reason is that they are not put through rigorous testing and then approved by the FDA. And yet there are all these products on the market, like Prixelin, and Prevagen….another supplement touting to enhance memory made “from jellyfish”, as if in the commercials that statement makes it safe or effective. The manufacturers make their claims, and there is no agency responsible for proving them right or wrong. It is up to the manufacturers to label their products responsibly, and not contain impurities, etc.
Before a new supplement ingredient comes to market, they are reviewed for safety only, and are not given the “approved” label by the FDA. If serious problems occur with one of the supplements one should 1) stop taking the product, 2) report the reaction to their personal physician, and 3) report the finding to the FDA through a Consumer Complaint Coordinator.
It is always a good idea to have any supplements you are taking reviewed by your family doctor and by any specialists you normally see before beginning your regimen. Some supplements can enhance or reduce the effectiveness of an approved drug you might already be taking for some malady. For example, some supplements reduce your clotting ability and if you neglected to tell your doctors, you might run into a severe problem in surgery controlling the bleeding. This can be life threatening. Just because you are taking a supplement does not mean it is a harmless product.
Drugs, however, go through an approval process and a review of the trials that is standardized and rigorous by 1) performance of the drug first in animals to discover how the drug works and whether it is safe, and does what is expected, 2) trials in humans to see if it is still safe and well tolerated (just because it passes the animal test does not mean it will have the same result in humans), 3) does it do what researchers expected it to do, and 4) at what dosage should it be given. The trials in humans must be double blind meaning that neither the person giving the “drug” or the patient receiving the drug knows if they got the real product or a placebo until after the trial is closed. That prevents any undue influence muddying the test results. Only after all that testing is performed and the drug is found to be effective and without severe side effects is the drug given FDA approval.
So when you see adds for compounds boasting all sorts of claims that seem too good to be true, and not associated with articles coming out of medical school universities where drug trials are performed, you should be circumspect about their claims. Not all supplements are bad, some have value if taken for the right purpose with the knowledge of your physician. But just because it’s on TV or the web does not mean it really works. The same is true for medical devices…they also don’t go through intense trials before they may be used on you! You must be your own best advocate and do your homework. Determine if the product being advertised is approved by the FDA or not. If it doesn’t say that it has FDA approval, then it is probably a supplement. And because supplements are not highly regulated, buyer beware.
Instead, it is better to focus on your overall health by eating better (a Mediterranean diet with less prepared foods, less red meat, and lower fat content), getting good exercise several times a week, controlling blood pressure (and eating less salt), getting a good 8 hours or more of sleep each day, and exercising your brain as well as your body (puzzles, games, etc). You will find if you do these things, your overall health will be better and you will feel happier too!