From the Editor's Desk

Responsible companies should have a mission to help weed out noncompliant claims

By Hank Schultz contact

- Last updated on GMT

The CDC has increased its estimate of the prevalence of autism to 1 in 59 children. Getty Images.
The CDC has increased its estimate of the prevalence of autism to 1 in 59 children. Getty Images.
Making unsubstantiated disease claims is not only illegal, but as they can prey upon vulnerable populations, they should be considered highly immoral to boot.

I know talk of morality has become a bit passé and something of a political football these days.  The national political debate now includes racist and xenophobic statements which are either seen as a watershed moment or lighthearted bluster, depending on your point of view.

But there are still lines in the sand that should not be crossed, and misleading consumers desperate for answers is one of those.

Will disease claims always be with us?

Disease claims continue to be a focus for regulators. It is one of the most common facets of warning letters, and it’s a rare warning letter that does include at least a passing mention of these. Funny how manufacturers who can’t seem to get their GMP ducks in a row also have a hard time laying off the noncompliant claims.

The US Food and Drug Administration’s primary goal in enforcing these is the danger that a consumer might be misled into declining or stopping treatments which have been shown to be effective, or even life saving. These would include things like chemotherapy and surgery for cancer patients or insulin for diabetics.

I’ve never seen any data on how many consumers have actually been injured or killed by swapping out a weakly substantiated dietary supplement for a proven drug. I do know of at least one consumer who relied on natural therapies instead of proven treatments for an otherwise fairly benign and easily treated form of cancer with disastrous results. How many more are there out there who are like her? FDA certainly considers it to be a true danger, as the agency cites it over and over again.

Dealing with autism

But how about when there are no proven drug therapies?  What we are talking about then is a particularly pernicious form of fraud, rather than medical endangerment.

There are any number of conditions for which no good drug therapies exist.  Take autism, for example.  The prevalence of this profound neurological condition has been on the rise in recent years, though whether it’s because the condition is better understood and diagnosed or whether there are other factors at work is unclear.  In any case, the CDC last year revised its estimate of the prevalence of the condition upwards by 15%, to 1 in 59 US children.  That is up from 1 in 166 children in 2004, meaning the rate has almost tripled in a bit less than 15 years.

There have some indications that there might be a dietary component to this condition.  One meta analysis from 2013 did find nutrient deficiencies among children with autism​, such as low calcium and protein, but these were related more to the difficulty of getting the children to eat a variety of foods rather than to an underlying metabolic process of the condition itself. 

Some families have taken to gluten free or other kinds of limited diets​ in an effort to deal with their children’s condition, which can also include digestive symptoms. This begs the question of whether there might be a microbiome tie in.  But are autistic kids’ well-documented issues with gut health the cart, or the horse? Only further research will tell the tale, and responsible marketers should steer clear in the meantime.

This topic hits home to me as the father of child who was on the autism spectrum. I know first hand the desperation parents can feel when looking for an ‘answer’ for this condition, which has repercussions for the entire family.  Without much in the way of proven therapies (especially back then), families were left with the latest protocol hawked by some celebrity couple in a supermarket tabloid.  I think I could have easily fallen under the sway of dietary supplement marketer who might have claimed that he or she had the magic pill for my son’s problem.

Or how about eating disorders?  I recently had a friend tell me the in patient care for a family member battling an eating disorder is running $70,000 a month. Don’t you think he might leap at a supplement that might claim to restore a healthy appetite and outlook on food?  I haven’t heard of such a one, but if shady marketers are trumpeting cancer claims, why stop there?

When fraud becomes something more

When talking about fraud, such as products that don’t meet label claim or adulterated with non bioactive filler material, industry stakeholders often speak of the damage to the reputation of the whole industry when consumers put their trust in these products and they don’t do what they say they will, by not helping with their disturbed sleep, their inability to relax, their logy immune response or what have you.

In my view, that’s penny ante stuff compared to the rage a parent or family member might feel when they find they’ve been duped about how a supplement was going to fix their child’s autism or ADHD, or was going to stop the progression of a grandparent’s Alzheimer’s disease.  

If an ethical formulator has good scientific evidence to make claims along these lines, and keeps the claims reined in to match the evidence, then by all means. But the shady players have the capability of creating a Greek chorus chanting “supplements don’t work.”

If responsible companies come across noncompliant claims in the marketplace the standard practice seems to be to heave a resigned sigh and wait for the regulators to step in.  In these highly emotionally charged instances, maybe something more is called for.  What about referring such a company to the National Advertising Division, or sending a head’s up note directly to FDA?

It could be seen as self-interest, by protecting a responsible, trustworthy marketplace.  But in my view, it’s also the right thing to do.

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