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Homeopathic regulation diluted until no substance left

Homeopathy is quackery but it is perfectly legal to prescribe homeopathic products and to sell them directly to consumers in the United States as well as other supposedly civilized countries such as the United Kingdom and Germany. This makes as much sense as allowing the sale of batteries that don’t produce electricity.

What makes this state of affairs even stranger is that homeopathic products are classified as drugs under U.S. law. Does this mean that they undergo the same pre-market approval process and are subject to the same post-market requirements as pharmaceutical drugs? No, not by a long shot. In fact, the federal government and the FDA have pretty much handed regulation of homeopathic products over to their manufacturers.

How did this happen?

In 1938, Congress passed the Food, Drugs and Cosmetics Act. The Act’s principle author was Senator Royal Copeland, a physician who practiced homeopathy. He managed to include all articles monographed in the Homeopathic Pharmacopeia of the United States (HPUS) in the definition of drugs within the FDCA, although why he did so remains in dispute. The HPUS is a source for monographs, identity, methods of manufacture, standards and controls and potency levels of homeopathic products, both prescription and OTC. (The vast majority of homeopathic products are OTC.) In short, if the product is in the HPUS, it’s legal.

Since the FDCA’s enactment, any attempt at imposing any reasonable regulation of these products has failed. As noted in a previous post, a federal district judge found that:

“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.”

As explained in one excellent review of homeopathic product regulation reprinted on Quackwatch, part of the reason is that, all along, regulators and politicians thought that surely the demise of homeopathy was right around the corner and the problem would solve itself. Here they were partially correct. The practice of traditional homeopathy has all but died out, and only three states actually license practicing homeopaths, who must be medical doctors. Unfortunately, no one seemed to see the boom in over-the-counter homeopathic product sales coming, which in the U.S. amounted to $3.1 billion in 2007. And while traditional homeopaths may go the way of the horse and buggy, “integrative” medical doctors and naturopaths are taking up the slack.

Both the lack of regulation and the sales boom are directly attributable to the visionary leadership of the homeopathic product industry, specifically one John A. Borneman, III.  Borneman made these claims during his Founder’s Day Address at the University of the Sciences in Philadelphia, upon the occasion of his being awarded an honorary doctorate. The University of the Sciences was formerly known as the Philadelphia College of Pharmacy and Science, and holds an honored place in the history of pharmacy education as the first college of pharmacy in the U.S., established in 1821. SBM’s own David J. Kroll, Ph.D., obtained his undergraduate degree in toxicology there and was, needless to say, distressed to learn that his alma mater was awarding an honorary Doctorate of Science degree to this man. In 2009, Kroll protested to the University’s president in a characterization that may inform your opinion of Mr. Borneman when we return to his explanation of how homeopathy has escaped regulation.

I wish to register my strongest objection to the recognition and University endorsement of an individual who has led an organization dedicated to the most egregious form of pseudoscience in pharmacy: homeopathic medicines. Awarding Mr. Borneman an Honorary Doctor of Science is an affront to every scientist who has ever earned a degree from the University and, I would suspect, all current faculty members who are engaged in scientific investigation.

Homeopathy is a fraudulent representation of pharmacy and the pharmaceutical sciences that continues to exist in the United States due solely to political, not scientific, reasons. . .But scientifically, homeopathic remedies are nothing more than highly-purified water misrepresented as medicine based upon an archaic practice that is diametrically opposed to all pharmacological principles. The mental gymnastics required to teach chemistry, pharmacology, and therapeutics while also embracing homeopathy are beyond the skills of anyone trained in the scientific method.

In awarding an Honorary Doctor of Science to Mr. Borneman, the University will be endorsing an “entrepreneurial spirit” that seeks to defraud health care consumers with “potentized” water as a medicine to treat and prevent disease. . .To reward Mr. Borneman’s leadership of a pseudoscience practice and its marketing to a public that holds pharmacy among the most trusted of professions is to return to the days of snake oil and deception that our founders worked tirelessly to remedy.

(You can read about University president’s response here.)

Borneman was a principal in his family’s homeopathic products company. He then joined Standard Homeopathic Company, of which Hyland’s is a subsidiary, as well as creating Homeopathic Laboratories of Pennsylvania and TxOptions Pharmacy, which also provides advice to consumers about homeopathic remedies.

In his Founder’s Day remarks, Borneman spoke of three pivotal events which guaranteed that the homeopathic products industry would be in complete control of their own regulation.

First, in the 1980s, there was an attempt to regulate all homeopathic products as prescription drugs. The FDA postponed any action toward that end by consulting with the homeopathic product manufacturers. The FDA ultimately decided it didn’t have the expertise to know what to do, so the agency left it up to the industry to draft a Compliance Policy Guide (CPG), which are directives from the agency to personnel providing guidance on a particular issue. The industry naturally obliged, the result being Compliance Policy Guide (CPG) 7132.15, “Conditions Under Which Homeopathic Drugs may be Marketed.” Borneman is refreshingly (although perhaps unintentionally) honest about how the industry wrote the rules in this instance:

We sent them a streamlined document in 1983, and a revision in June 1986. They [FDA] circulated it internally for review & comment, including the Justice Department, and published a document in the Federal Register in June 1988. It was enforced in 1990 and still, unmodified, continues to be effective today. The CPG put to rest the OTC/Rx controversy. . .With the CPG well established, homeopathy in the US was investable and the Europeans seized the opportunity and purchased outright or appropriated almost all of the languishing American firms.

Fortunately for the Borneman family, the “investable” companies included his own, Borneman & Sons, which entered into a joint venture with Boiron, a French company and the world’s largest manufacturer of homeopathic products.

That task out of the way, Borneman next concentrated on “refurbishing” the HPUS and the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). The HPCUS decides what can be included in the HPUS, which, as you recall, is incorporated wholesale into the definition of “drug” under federal law. As I said, if it’s in the HPUS, it’s legal. As he explained:

I understood that regulators would not act favorably if it appeared I was looking out for the industry or myself. Economics could not be an issue. I had to make the argument that the consumer had rights and FDA could not disenfranchise them. They were obligated to accommodate the consumer. This struck a chord and the work began.

And here I was thinking that the FDA had some duty to actually protect the consumer, not accommodate. What really occurred was that the FDA apparently felt it had an obligation to accommodate the homeopathic product manufacturers. What happened next exceeded Borneman’s most optimistic expectations and was the third and final step in assuring that the industry gained control of its own regulation.

Borneman and other industry representatives met with Mark Novitch, MD, Deputy Commissioner of the FDA, and put on their dog and pony show. Two presenters were practicing MD homeopaths, Sandra Chase and David Riley, who explained “Basic Tenets, Corollaries, basic features, provings and methods of Cure.” (Cure?) Others were homeopathic pharmacists. Borneman continues:

I believed the meeting went well, but was not prepared for what was to follow. Dr. Novich told us the Agency was not prepared to run a new drug review and approval process for homeopathic drugs. . .Dr. Novich liked what he had seen and heard and asked if we would serve as the gatekeeper for new homeopathic drugs. We eagerly accepted the task and have been rigorous in its implementation since.

Having already dumped the entire homeopathic formulary into federal law in 1938 and succeeded in fending off regulation of original or added products since then, the homeopathic industry was thus poised to secure its future as the sole arbiter of what homeopathic products could be legally sold in the U.S. And all of this with only occasional interference by the FDA when products were, say, harming infants or causing loss of the ability to smell.

So, how does the HPCUS operate? Does it, for example, include public or consumer representatives? Does it have a process for insuring that those who do not share the view that homeopathy is safe or effective are included to provide a more balanced view? Let’s find out by looking at the organization’s own Bylaws and Procedure Manual.

The HPCUS is a non-profit corporation. It controls both the addition of new products and changes to existing ones. Application for inclusion of a new product must be supported by a monograph which goes through various committees for review and there is a period for public comment, although access to the monographs for comment is via homeopathy journals. Changes to the products already listed in the HPUS also go through a committee review process.

Products are reviewed for safety and effectiveness by these committees. As to the latter, according to one journal article, while the traditional homeopathic proving is one way to approach this,

Overall, adequately designed and well-controlled clinical trials have become the norm for homeopathic medicine as they are for most allopathic [sic] medicines.

I don’t know of any such trials, but perhaps adequately designed and well-controlled has a different meaning in homeopathic research. Of course, the conclusion of this same article was

Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.

So it is advisable to take the article’s conclusions with a grain of undiluted salt. Of the two authors, one was John P. (“Jay”) Borneman, John A. Borneman’s son. Jay is a principal owner of Standard Homeopathic Company and CEO of Hyland’s.

Once a product or change is approved, that information is incorporated into the HPUS, which is sold by the HPCUS to the public through subscription. For $100, you can get access for 24 hours. It is $1,000 per year for an individual and $15,000 per year for a corporate subscription.

More interesting than the process are the persons who are making these decisions. Membership in the HPCUS is vetted by the Board of Directors. Committees responsible for reviewing both new products and changes to the HPUS are appointed by the President, who is a member of, and chosen by, the Board. All final decisions on what is and isn’t included in the HPUS must be approved by the Board. And who chooses the Board? The Board. It is self-perpetuating and not elected by the members, so each Board elects new Board members. While a Board term is three years, there is no limit on the number of terms a Board member can serve.

So let’s see who is on the Board of the HPCUS. Because it has been granted charitable organization status (501(c)(3)) by the IRS, it does not pay federal income tax on contributions or earnings from subscription sales but it must file a federal tax return, which becomes public information. These returns list the current Board of Directors and are available for the last three years (2011, 2010, 2009) through Guidestar.

For 2009-2011, Chair of the Board is none other than John A. Borneman III, who has to be at least in his 80s. President of the Board (that is, the person who appoints all the committees reviewing HPUS additions and changes) is his son Jay. But they are not they only two Standard/Hyland’s connected directors. Another is Mark S. Phillips, who is Standard’s President. (A 2011 warning letter from the FDA to Phillips can be viewed here.) The Secretary and Treasurer are Sandra Chase and William Shevin, respectively, the two MD homeopaths who helped convince the FDA to allow self-regulation back in 1993. Rounding out the Board are David Riley, a homeopathic physician and “integrative medicine” consultant, and Eric Foxman, a homeopathic pharmacist. The Executive Director in 2009, since deceased, was Andy Bormeth, who also worked for a homeopathic products manufacturer before he opened his own homeopathic products consulting service. For 2010 and 2011, Todd Hoover, another homeopathic physician, served on the Board.

In summary, all decisions on the content of the HPUS (and therefore what may be legally sold or prescribed as a homeopathic product) are made by either practiticing homeopaths, homeopathic pharmacists, or current or former officials or owners of homeopathic products manufacturing companies. And three are from a single company! Does this seem a bit too cozy? Does anyone think the Board is going to elect Board members who will rock the boat? Or who might be the least bit interested in telling the public the truth about homeopathy?

To be fair, the HPCUS does have a conflict of interest policy which requires disclosure of conflicts and recusal from deciding issues which may affect them financially. (Which makes me wonder how they get anything done, considering.) Even so, it is appalling that the federal government has totally defaulted in its responsibility for determining what homeopathic drugs can be prescribed and sold to a private non-profit completely controlled by industry insiders.

In my last post, I suggested that instead of the Quack Miranda Warning a more accurate disclaimer of FDA involvement in dietary supplement regulation might be:

FDA WARNING: Safety and effectiveness unknown. Use at your own risk.

Perhaps a more accurate FDA disclaimer for homeopathic product regulation might be:

FDA WARNING: Safety unknown. Effectiveness unknown but highly unlikely. Use at your own risk. 

Posted in: History, Homeopathy, Legal, Naturopathy, Politics and Regulation

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