More Food For Thought

Almost three years ago I wrote about the widely advertised supplement, Prevagen. The Federal Trade Commission (FTC) challenged the company’s claims about the product’s safety and effectiveness in improving memory. That FTC action followed a number of warning letters to the company from the FDA expressing similar concerns.

Supplements in general cause regulatory headaches for the FDA. “In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise.” (I wonder how many lobbying dollars were spent on that law.) The government may stop a company from selling a supplement if they can prove it “poses a significant risk,” that is, usually “only after they cause harm” to customers. Even then they may face a fight.

Because they are not drugs, rigorously tested for safety and effectiveness, at the end of their advertising they are required by law to carry the disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease." Many get around this by making weak promises such as the supplement reduces the risk of certain health problems or it promotes a healthy condition. 

As far as that one and others that claim to improve memory, the Alzheimer’s Association finds such products, not approved by the FDA to be particularly troubling. “One of the biggest problem areas for unsubstantiated claims are dietary supplements...that claim to be beneficial for Alzheimer’s or other dementia symptoms.” But the promotion of these products and introduction of new ones hasn’t slowed down. “In the past five years, the FDA has issued more than 40 warning letters to companies illegally marketing over 80 products claiming to prevent, treat or cure Alzheimer’s disease.” Furthermore, the FDA recently warned that cognitive enhancement supplements “may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment.”

Now the problems and dangers surrounding the sale of supplements to prevent memory loss or to improve memory has been raised again in the November issue of JAMA Internal Medicine. A research team tested for the presence of Piracetam, a supposed brain-enhancing substance that “is not approved as a drug and is prohibited as a dietary supplement ingredient in the United States.” They found inconsistent labeling with errors ranging from 85% to 188%. This substance has known adverse effects including: anxiety, insomnia, agitation, depression, drowsiness, and weight gain.

These marketing techniques are truly unconscionable. They make every attempt to prey on older Americans who are already scared at the prospect of contracting some form of dementia by the ads, news stories, shared experiences of friends and personal experience with elderly relatives. Some are concerned about the prospect of mentally fading away. Others worry about being a burden on their family. 

Feelings of anxiety every time a name or fact is not at one’s finger tips make it easy to fall into the trap of buying these unproven products with the hope that maybe it really works. Action of the placebo effect on friends and acquaintances whose minds have fooled them into believing in it compound the problem. But reading and understanding the fine print that follows the ads and knowing that now there's a possibility of some products being adulterated with unapproved drugs should act as sufficient deterrent to critical thinkers.

A Caution And A Question

Two recent news items bear a little additional reflection.

The first is the release of a new study on dementia.  This should come as no surprise.  Each year around this time researchers meet for the Alzheimer's Association International Conference.  Hence, each year around this time we get results of the latest research as the reports and papers are presented at that meeting.

The headline from Reuters reads: “Brain Games Might Cut Alzheimer's Risk.”  Note the use of the word might.  For years companies have been trying to sell us various brain games to make us smarter and especially to help fight dementia.  They have been doing this without firm scientific support.  Now they have a might on their side, which is better than the pure skepticism they faced in the past.

The study design sounds like a good one.  The original study, funded by the National Institutes of Health (NIH) and “known as Active, examined the effects of cognitive training programs on 2,785 healthy older adults.”  They gave each of three groups a different exercise based on:  reasoning, speed of recognition or memory.  Some participants got follow-up sessions.  Reviewing progress after one, two, three, five and 10 years, they found “modest benefits” in cognitive and functional abilities for only the first two groups.

Frustrated by the lack of attention to the potential benefit of brain games, one scientist, who is also a paid consultant for a brain game company, “did a secondary analysis of the 10-year data, looking at the time it took individuals to develop dementia.”  She found “that the group that did speed training showed 33 percent less risk of dementia relative to the control group.”  This is an encouraging result, but it was presented to the conference before peer review and publication in a scientific journal.  The structure of the second analysis is not clear, and the motivation for it seems a bit suspicious.

The caution, therefore, is to watch out for a new wave of brain game advertising following on the heels of this latest, more encouraging but not definitive review.

That was the caution, now the question.

The question comes from a report about artists objecting to politicians using their music for campaign events.  Last year a Rolling Stone headline read:  “Stop Using My Song: 35 Artists Who Fought Politicians Over Their Music.”  More recently, in light of some vocal objections to music used at the Republican Convention, another report pointed out “there have been 30 instances of artists objecting to presidential candidates' use of their music since 1984.”  (Of these two were against Democrats.)

The question, especially for these left-leaning musicians is, how do those objections to using your (legally purchased/licensed) music in a way that is contrary to your conscience and values differ from the objections of a privately owned bakery to provide a wedding cake for a same-sex wedding?  It seems that the same laws should apply in both cases and any objections should evoke the same level of outrage.

Please don’t misunderstand.  I have no problem with same-sex marriage (nor am I a republican or a democrat.)  I only question how certain principles (like we serve everybody) can be embraced on one hand, with corporations withdrawing support and public demonstrations, whereas they are ignored or overturned on the other.  Principles as a matter of convenience or personal preference are not principles at all.