Homeopathic remedies: perfectly legal, the perfect fraud, or both?

Homeopathic remedies: perfectly legal, the perfect fraud, or both?

Homeopathy took another well-deserved hit recently when the Australian National Health and Research Council concluded it doesn't work. The report said a lot more but that is the jist of it.  Maybe someone in authority in the U.S. will listen this time.  Hasn't worked before, but we can hope. 

If you are not familiar with homeopathic remedies, they come in two forms: water, and water evaporated on a tablet.  As Harriet Hall explained a few days ago in The Skeptical Inquirer

Scientific knowledge about chemistry, physics, and biology tells us it should not work; careful testing has shown that it does not work

To me, the most intriguing feature of homeopathy is not that people use it but rather that it can be sold at all.  By all rights, a company shouldn't be able to sell a small bottle of overpriced water or sugar tablets as a remedy for what ails you.  And no health care pracitioner should be allowed to prescribe it.

But they do.  How?  In the U.S., homeopathic remedies are considered a special class of drugs under federal law.  Back in 1938, a homeopathic physician named Royal Copeland succeeding in dumping the entire Homeopathic Pharmacopeia of the United States [HPUS] into federal law when Congress passed the Food, Drugs and Cosmetics Act, an otherwise admirable law that tried to bring effective oversight to the drug industry.  At the same time, though, homeopathic remedies were exempted from virtually all regulations governing drugs, including premarket testing for safety and efficacy, safe manufacturing practices, and reporting requirements. In fact, pretty much all meaningful regulation.  These exemptions have survived the many amendments to the orginal FDCA.

Apparently because of limited resources and lack of concern about safety (it is, after all,water), the FDA abandoned homeopathic regulation (what little there was in the first place) to the homeopathic remedy manufacturers.  A private agency run by and for manufacturers essentially regulates all aspects of the manufacture and sale of these products in the U.S., including the additional of new homeopathic products to the HPUS. This isn't just my opinion.  In 2011, a federal district judge ruled exactly that.

The Court is unaware of what standards, if any, exists to ensure that homeopathic OTC [over the counter] drugs are safe and effective. The FDA does not impose additional standards for strength, purity, quality, safety, or efficacy on homeopathic OTC remedies. . . As evidenced by the FDA guidance documents. . .the Court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs, and has instead attempted to delegate this authority to the non-governmental organization that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.

In other words, the fox is guarding the henhouse.  Which turns out to be quite lucrative.  

This ludicrous state of affairs is aided and abetted by the public's credulous acceptance of so-called complementary, alternative and integrative medicine in the U.S.  Only 3 states license homeopathic practitioners, but as the classical homeopaths have waned the naturopaths are taking up the slack.  Students spend hours in naturopathic "medical school" studying homeopathy and it is a mainstay of their practices.  It is perfectly legal for naturopaths to prescribe homeopathic products and sell them to their patients in states where they are licensed.  In fact, state licensing laws specifically include homeopathy in naturopathic licensing statutes.  (Of course, whether the practice of naturoapthy is actually legalized in a particular state doesn't stop them from practicing, or prescribing and selling homeopathic remedies and other pseudoscience.  Licensing is just icing on the cake.)

But whether a product is legal and whether its sale to the public is fraudulent are two entirely different questions. (Viz: cigarettes.) Selling anyone a homeopathic remedy as, well, a remedy for anthing, is fraudulent, unless you are going to tell your customer (or patient) it doesn't work.  That's right. It is a misrepresentation of fact to sell something that doesn't work and claim otherwise.  And claiming you didn't know that it doesn't work won't get you off the hook. When what you tell your customer (or patient) is as far afield from reality as homeopathy, from a llegal standpoint, you can't claim you didn't know. Even if you believe, with all your heart, that it does work.  Selling homeopathic remedies is no different from selling flying carpets.  You can swear all day long that you didn't realize the laws of physics apply to you.  Legally, that's a non-starter.

Plaintiffs' attorneys have discovered this and class actions against homeopathic remedy manufacturers have become something of a legal subspecialty. There are a number of suits pending or settled. For example, these suits against  Hi-Tech Pharmacal Co., Hylands and Standard, Boiron and Heel. To my knowledge, none of these cases have gone to trial since the surge in homeopathic product litigation began a few years back.  They are being settled.  A typical settlement stipulates that there is a class of all purchasers of, say, Coldcalm, over a certain time period spannning a number of years. Each customer is entitled to a small amount of money IF they make a claim.  The defendant company is responsible for notifying the class of its right to seek a refund via various means, such as publication in, for example, magazines that emphasize "wellness."  The attorneys for the class members are paid too, all out of a settlement fund amounting to a few million dollars.  In some cases, the manufacturer will agree to change its website to better "explain" the concept of dilution and succussion.  Nothing that would deter a customer, of course, who would need some basic knowlegde of chemistry to understand what it all means.  As you may be aware, knowledge of chemistry is not in abundant supply in the US population.

Settlement is not an indication that the plaintiffs would win. It is often a business decision that the cost of litigation plus the possibility of an adverse damage award make it financially prudent to settle. In fact, most litigation does settle.  Nor is it an indication that the plaintiffs' attorneys are doing anything wrong. It is not up to the plaintiffs' bar to solve the larger societal problem of having a product on the market that should never be sold in the first place.  These cases are expensive to try and the attorneys are going up against defendants with resources far in excess of their clients, each of whom is generally out only a few dollars.  Obviously, these  settlements do not resolve the question of whether selling homeopathic remediees to the public (or prescribing them) is fraud.  We know the answer to that one. It most certainly is.

Points of Interest: 5/05/2014
Battling Placebos, Wrong Conclusions