I’ve written more times that I want to about homeopathy, the elaborate placebo system of “remedies”. It looks like medicine, and pharmacies stock it on shelves alongside products that contain medicine. But with homeopathy the common “strengths” or “potencies” of products are usually so dilute there’s no possibility of a single molecule of the original substance remaining in the remedy. What’s further, the original substance isn’t medicine, either. They can be derived from from substances like Stonehenge (yes, that Stonehenge), shipwrecks, ascending colons, light bulbs, and even vacuum cleaner dirt. While homeopathic products are deemed “safe and effective” by Health Canada’s Natural Health Products Directorate, the awareness that homeopathic products contain no active ingredients and have no medicinal effects has become increasingly well known. In 2011, I noted that manufacturer Boiron had been served by two class action lawsuit, and that this might be the beginning of a trend.
The legal action route seems to be having an effect – which is good, given pharmacies and even regulators have refused to act. Homeopathy manufacturer Heel has decided to exit the North American market completely:
In the USA and Canada, manufacturers of OTC homeopathic medicinal products have been confronted with accusations through class action lawsuits. Heel Inc., the Heel Group’s U.S.-based subsidiary, was also faced with two such attempts recently. Both cases have been settled without conceding the allegations. The financial burden on Heel Inc., however, was substantial.
In a subsequent risk-benefit analysis of its global activities, the Heel Group decided to focus on strengthening its excellent position in South America, Central Europe and Eastern Europe and to withdraw from business activities in the USA and Canada for the time being.
The class action sought refunds for consumers that purchased Heel products. Here’s a few excerpts from the original complaint [PDF]:
Health care costs in the United States reached almost $2.6 trillion in 2010, with 10% of that amount spent on retail and prescription drugs. But unless drug manufacturers disclose the complete truth to consumers, consumers are unable to make informed decisions about where to spend their limited healthcare dollars. Most consumers who purchase homeopathic drugs in the OTC aisles of retail stores are unaware of homeopathic dilution principles, and are merely seeking a natural alternative to prescription or other OTC non-homeopathic (i.e., allopathic) drugs. Accordingly, the homeopathic drug industry strives to market its wares as natural, safe, and effective alternatives to prescription and nonhomeopathic OTC drugs. But this latter category of drugs, which are all allopathic, have undergone rigorous scrutiny by the FDA and its appointed scientific committees. In contrast, homeopathic drugs undergo no FDA approval of efficacy or labeling claims. Indeed, the FDA, itself, has publicly stated that it is aware of no scientific evidence that homeopathy is effective.
Generally, Defendant advertises its Pain Relief Products through misrepresentations and omissions, including but not limited to, claims that the Products:
- provide “Natural” pain relief when, in fact, the Products contain large portions of non-natural ingredients;
- provide “On the Spot” pain relief when, in reality, homeopathic products allegedly work by aggravating symptoms initially;
- are “Proven” or “Clinically Proven” as “Effective” when such clinical proof, if it even exists, consists either of biased studies performed by investigators compensated by Defendant or its parent or subsidiary corporations or studies that fall short of relevant agency advertising standards, facts which are not disclosed to consumers;
- as being “Doctor Recommended,” “Used By Doctors,” and “Used by Doctors Worldwide,” which is untrue, or even if true, is communicated to the public without disclosing whether these doctors are allopathic practitioners or homeopathic practitioners.
There’s more details at heelclassactionsettlement.com, which notes that Heel has settled the lawsuit for $1 million USD, including some amazing concessions agreed to by the manufacturer. It’s not surprising they’ve decided to exit the market completely, rather than comply with these conditions of sale:
i) FDA Disclaimer: Defendant will include the following language on the same outer label or package panel that bears the Drug Facts box: “These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.” (ii) Dilution Disclaimer: The back panel of each Product’s outer label or package shall be modified to include the following language: “X is a homeopathic dilution. For more information, see the Settlement Agreement in the documents section of this website.” (iii) “Natural” claims: Unless the Product contains all natural ingredients, Heel shall use the term “natural” in a manner that is appropriately qualified (e.g., by using an asterisk that links to the phrase: “Contains [X] natural active ingredients out of [X] actives, see Drug Facts”). (iv) “Clinically Proven” claims: Heel will cease using the words “Clinically Proven,” “Proven … Effective” or any similar representation that expressly or impliedly asserts medical, scientific or clinical proof on any Products for which it does not have at least two clinical studies performed by independent researchers that utilize generally accepted protocols such as randomized, double-blind placebo-controlled trials, with publication and peer review; further, if any clinical trial are sponsored by Heel, Heel shall adequately disclose this fact to consumers. (v) “Doctor Recommended” claims: Heel shall cease using the words “Doctor Recommended” and “[U]sed by doctors worldwide” unless it also discloses to consumers the percentage of those doctors who are homeopathic practitioners and the percentage who are allopathic or any other type of medical practitioners.
This is a tremendous win for consumers. I wrote about the Heel product Traumeel a few years ago and noted that it was Health Canada approved despite any persuasive evidence to show it was actually effective. This class action lawsuit has forced Heel to disclose the facts of homeopathy, something regulators like Health Canada’s Natural Health Products Directorate refuse to do. Even though Heel is leaving the USA and Canada, the regulations still haven’t changed: Homeopathic products are still allowed for sale to consumers yet these “remedies” are not labelled to show that the product has no medicine in it. Pharmacies and other retailers magnify the confusion by stocking these products alongside actual medicine. How can consumers make informed, rational decisions about their health when manufacturers and retailers don’t honestly disclose the facts about the products they sell? Like Randall Munroe noted,
I just noticed CVS has started stocking homeopathic pills on the same shelves with–and labeled similarly to–their actual medicine. Telling someone who trusts you that you’re giving them medicine, when you know you’re not, because you want their money, isn’t just lying–it’s like an example you’d make up if you had to illustrate for a child why lying is wrong.
The continued sale of homeopathy in pharmacies is disgraceful and I’m disappointed that the pharmacy profession continues to prioritize profits above ethical patient care. I’m thrilled to see lawsuits bringing the harsh light of reality on to homeopathy manufacturers, and hope that we’ll see more consumers using the courts to accomplish what regulators refuse to do.