Monday, February 6, 2017
Preying on the Scared and Desperate
Alzheimer's Disease is frequently in the news either promising another advancement toward a cure or presenting another story of heartbreak. It is dreaded by millions of older Americans, as they see this news or have personal experience of a friend or loved one wasting away. With so many people so scared, why not take advantage and make some money? At least that’s the way some thinking goes.
Major news organizations recently carried a story about Prevagen, a highly advertised memory supplement derived from jellyfish protein. “The Federal Trade Commission and New York's attorney general have charged the company with fraud and false advertising.” The makers sell the pill as a memory booster that can get into the human brain and protect it from deterioration. The FTC complaint goes on to say that the company “failed to show that Prevagen works better than a placebo for the nine cognitive functions that were tested.” They further accuse the company of preying on the fears of older consumers to the tune of $165 million.
In the specifics, the FTC charged that claims for clinical proof were invalid. In the study 218 subjects got either the pill or a placebo. They failed to find a difference within the whole group. They then “conducted more than 30 post hoc analyses of the results, looking at data broken down by several variations of smaller subgroups for each of the nine computerized cognitive tasks. This methodology greatly increases the probability that some statistically significant differences would occur by chance alone. Even so, the vast majority of these post hoc comparisons failed to show statistical significance between the treatment and placebo groups.”
The Alzheimer's Association did not comment specifically on Prevagen but noted that to date no product has been proven to help memory. They went on to express their “serious concerns about people using dietary supplements as an alternative or in addition to physician-prescribed, FDA-approved therapies.” That’s a pretty clear warning.
Immediately, “the company pushed back hard, insisting its product is safe and calling the FTC a ‘lame-duck’ federal agency with heads who are about to be replaced by the incoming administration.” But the FTC calls the supplement a hoax.
The resistance on the part of the company is no surprise. Over 4 years ago the Food and Drug Administration (FDA) sent them a warning letter about Prevagen. The Federal Trade Commission (FTC) gets involved in cases of false advertising and consumer protection, while the FDA gets involved in cases of safety and efficacy of drugs.
That letter said that though they are marketed as a supplement, therapeutic claims “establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.” Plus the company ran clinic trials without making the proper application. In addition, it cannot be classified as a supplement because the main ingredient no longer comes from jellyfish, but is synthetically produced and is “not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance.”
The company also failed to report complaints of side effects as required by law. Of more than 1000 adverse events and product complaints they received only two were reported. “Some of these adverse events resulted in hospitalization.”
This is an important lesson: Especially the scared and desperate need to exercise high levels of critical thinking and do some research, lest they become easy targets.
But in my own research on this subject, I found that too little research can also be dangerous.
The first entry in Google was labeled as an ad, but the source was Consumer Health Digest and it sounded reliable. Other articles on the same site gave some good advice and did not appear to be advertising for any particular product. “The Truth about Weight Loss Supplements,” for example, was responsibly presented. It included: supplements not being necessary if you have a healthy diet; those to avoid, like detoxes, water pills and laxatives; and what might be beneficial. It advised to check with your doctor first.
Their “Prevagen Review: How Safe and Effective is this Product?” however was in total conflict with the facts as presented above, calling it “a brain power supplement that has been clinically tested and found to improve health performance of the brain.” The multiple hospitalizations are not mentioned instead calling it “safe and effective” with “no known information regarding its possible side effects.” The only major drawback they mentioned was the price.
Then at the very bottom of the article, an article written by someone without any medical qualifications, they rate Prevagen sixth out of six memory supplements. And remember the Alzheimer’s Association expressed serious concern about all of them.
So we must be doubly careful, both about the marketers trying to lure us in based on scare tactics and deception, and about the quality of resources used to investigate.