Babies, Belladonna, and Big Bucks

“We got a letter from the Feds today.”

Those are always interesting words to hear from a client. Often such a letter is anticipated, because many physician or scientist clients are investigators in studies designed to obtain FDA approval for a device or drug. Others have to do with potential violations of the Stark law, or the Anti-Kickback Statutes, or the False Claim Act.  Data breaches invite scrutiny under HIPAA. Certain prescribing practices invite scrutiny for DEA. The list of reasons, like a list of acronyms for Federal agencies, is seemingly endless. Generally, my clients know when such a letter is cause for alarm - or not - even before they contact me. 

Many of you who follow this blog have noted another set of initials tossed into the mix: FTC.

Recently we discussed how FTC is involved in regulating medical apps. Many of you may not know FTC has a significant history of regulating other health products. FDA and FTC have recently been engaged in actions against the many fabulous weight loss claims made by marketers of homeopathic over the counter HCG dietary supplements. For those of you who have not seen the advertisements for these miracle cures, some claim to help you “lose 30 pounds in 30 days, using all natural HCG.” I won’t link to them – I do not want someone to think I endorse these in any way. I do endorse the FDA’s statement that claims supporting the diet are bovine scatology. HCG diets just do not work. 

What will cause one to lose weight is the starvation diet “required” by the spectacular dietary supplement in order to optimize the redistribution of fat. Also required is the dismissal of all sanity and reason.  The weight you lose is from near starvation, and arguably a lighter wallet.

From FDA’s website regarding medication health fraud:

“HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity.  There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”   FDA press release

Now, I mentioned FTC was involved in this matter, and most of you may not even have wondered why. We are so accustomed to FDA acting to regulate medications; most don’t even realize that they are not alone in this particular sector. They have some powerful allies, and while they often scuffle a bit over turf, there is no doubt the two can pack a powerful one-two punch, no matter who is the primary agency on the matter.

That long introduction leads to the real focus of this article. It is not FDA, nor HCG. It is FTC.

Health care providers rarely think of FTC, and I suspect even among consumers the role of FTC is unclear. In health care, FTC’s role is two-fold:

1.       FTC enforces the FTC Act, which prohibits deceptive or unfair acts or practices in or affecting commerce, including those relating to privacy, and those involving false or misleading claims about safety or performance.

2.      FTC enforces the FTC Health Breach Notification Rule, which requires certain businesses to provide notifications following breaches of personal health record information.

Most health care professionals are so focused on HIPAA that they immediately recognize the privacy implications. That is good, as these regulations are often overlooked. To do so is a grave mistake. Yet while it is always tempting to forge ahead on the topic of data security and privacy, the issues we address today are those of deceptive practices and misleading claims.

Homeopathic medications have a special place in our health care system. Almost everyone can recite a litany of remedies used in their family or social circle, and are unable to provide scientific support for the therapy when challenged. (Yes, this means “because Mom said so” is classified as generally non-scientific, but avoid discussing this at holiday dinners.) All it takes is a trip to the local supplement store and we are met with a host of “natural” remedies that are used to “treat” a host of maladies.  Want to see more?  Head over to the pharmacy.  Need more? Wander through the health section of your grocery store.  Still not enough? One word: internet. Homeopathic remedies are everywhere. 

The obvious question taking form on the rational reader’s lips is not “What is the big deal?” but “How much money is involved here?”  Take a moment to review this 2007 report from the CDC.  No matter how you approach the figure, we can all agree that a largely unregulated 3 Billion Dollar industry consumes a significant portion of our health care spending.  Goodness, for a fraction of 3 Billion Dollars some might even be tempted to take advantage of our gullible nature and lighten our wallets.

In a press release issued this week, FTC announced its new policy to guide its regulation of OTC homeopathic products.  For those of you who are pounding your keyboard angrily insisting this is governmental overreach, take a deep cleansing breath, balance your chakra, and focus your inner eye on these cold, hard facts. The FTC only cares about claims that are unsubstantiated by scientific evidence. FTC reminds us that (from the policy)

[T]he promotion of an OTC homeopathic product for an indication that is not substantiated by competent and reliable scientific evidence may not be deceptive if that promotion effectively communicates to consumers that: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. (emphasis added)

It should come as no surprise that most, no, few, no, probably none of the homeopathic remedies you see for sale are supported by valid scientific evidence.  The most common homeopathic inference, that some remedy must be safe because it has been around for so long (since the 1700s!!!) is not quite the same as valid scientific evidence of a beneficial nature. To those of you in the throes of apoplexy over this, I am, well, I am not sorry.  It is the truth.  Proponents of these products may take solace in the fact that this scientific deficiency is tolerated as long as the labels on these products clearly say so – the disclaimer above is probably sufficient.  Personally, I prefer the much briefer"There is no proven benefit to this product, so don't complain to anyone if this heads south on you."

Now you wonder "what is valid evidence?" From the policy, FTC defines this:  “competent and reliable scientific evidence,” defined as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and [that] are generally accepted in the profession to yield accurate and reliable results.”  Taking a cue from the regulation of medications by the FDA, this translates into clinical trials in humans, not the insight of some late night shill who has discovered some ancient secret to peace, harmony, colon cleansing, and dietary adjustment, all of which can be yours for the low price of most of your hard earned money. 

Recently a popular homeopathic teething remedy was linked to 10 infant deaths. This prompted a press release from FDA cautioning against the use of the “natural” products to treat teething pain. The manufacturer was quick to claim that the product is regulated as a drug by FDA, with the consumer left to infer FDA validated the product's safety, and all was right in the universe. Go back and read the FDA release again – Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy.” How awful for the families of those ten infants.  

FTC has long had the power to regulate advertising, and could have acted sooner. There are a lot of reasons they have not, and deconstructing them is a topic for another day. It is important that FTC has acted now.  Why?  Well, years ago, FDA opted to allow the homeopathic industry to regulate itself.  As the Food, Drug, and Cosmetic Act is enforced today, FDA cannot “pull” homeopathic products from the market.  FDA cannot prevent these products from being marketed once they meet certain easily attained standards.  Why this is the case is beyond this brief note, but FDA is reassessing this limit.

In this enforcement void stands FTC.  FTC may not be able to prevent a product from being marketed, but FTC can apply its "truth in advertising" standard to the products. In other words, if you want to sell sugar tablets to treat the flu, you have to show they work, or explain that there is no scientific evidence to support their use.  If you want to sell a product that utilizes some diluted extract of poison ivy to treat arthritis or market some extract of deadly nightshade to treat teething pains, well, FTC wants consumers to think twice. 

Some homeopathic remedies might work. Some manufacturers may choose to subject their products to the rigorous testing and clinical trials needed to obtain FDA approval as a proper drug. Kudos to manufacturers that choose this scientific path to validation. To those afraid to subject their products to real scientific scrutiny; shame on you. 

We can utilize homeopathic remedies; FTC wants us to make informed decisions. We should not need some sketchy brain booster to help us with this one.  Its a no-brainer.



Spiers Group works to help professionals deal with the many complex regulations governing their professions. To discuss how this may affect you and your profession, contact Spiers Group today.