Bowl of drugs and supplements

They may look similar, but drugs and supplements are regulated very differently.

A recurring topic at this blog is the regulation of “dietary supplements” and other forms of complementary and alternative medicine (CAM). CAM is not medicine, but may be used alongside, or instead of conventional medicine. And despite the “mom and pop” image that some firms project, CAM is a huge industry. In fact most Americans today take some sort of dietary supplement. This is despite that fact there’s little evidence to demonstrate the vast majority of CAM offers any meaningful or proven health benefits. So how are these products allowed for sale? The answer lies with the regulator. In most countries, CAM is the “Wild West” of health care, where a deliberate double-standard has been created for anything considered to be a dietary supplement or natural health product. Now that double-standard may be changing. In the past few months, there has been encouraging signs in both the United States and Canada that pro-consumer changes may be coming, one that helps CAM purchasers make more informed health decisions. Now Australia has announced a new framework that will create a new licensing category for CAM: products that are supported by good evidence.

A regulatory double-standard for CAM

Regulators must balance different responsibilities when determining the commercial “rules” for the sales of CAM and other health products. In general, governments around the world have tended to tilt the rules towards a company’s desire to sell CAM, rather than to a consumer’s right to access products that are proven to be safe and effective. That is, manufacturers of CAM face relatively light regulation (compared with drug products), with the expectation that consumers will make their own self-care decisions effectively. Different countries take slightly different approaches, with generally the same intent. There’s no question that this “light hand” has led to a boom for the vendors of CAM. Supplements used to be a niche product in pharmacies– now they’re found in almost every store, sometimes with more than one aisle dedicated to herbal remedies, vitamins and products that make me think that patent medicines are back. Even homeopathy, which is an elaborate placebo system masquerading as medicine, is routinely stocked alongside real medicine in many pharmacies in Canada and the United States.

There are numerous problems with lax regulatory standards for CAM. Consumers may not be able to distinguish between products that are approved based on scientific standards, and those that are based on prescientific ideas of medicine. As Steven Novella noted in a recent post,

If we look at the big picture, society is being harmed by increasing acceptance of loose scientific standards in health care specifically designed to allow for dubious products and practices. The consumer is being harmed by this, and each piece of lax regulation contributes to the overall phenomenon. This phenomenon includes convincing the public (and even many scientists and practitioners) that placebo effects alone justify a treatment, that anecdotes are useful, that unblinded studies can determine efficacy, and that certain special magical kinds of treatments cannot be tested by standard scientific methods. The alternative medicine phenomenon is playing off of and contributing to public scientific illiteracy. There is therefore also societal harm, which further includes wasting tremendous resources researching, regulating, and purchasing treatments that cannot possibly work.

What principles for CAM are important?

Before examining the regulatory frameworks for CAM, it’s worth considering some key ethical principles of commercial markets, including the market for health care products. In a paper that Professor Chris MacDonald and myself published in the peer-reviewed journal Bioethics, “Alternative Medicine and the Ethics of Commerce“, we acknowledged two important principles that provide support for the sale of CAM:

Respect for individual (consumer) autonomy: It is morally good to respect the choices that people make in marketplaces, and it is generally better to avoid paternalism. More choices in the “marketplace” for health mean more unique needs can be met. If consumers prefer CAM, then it is good that these products be available to purchase.

The respect for a competitive marketplace: Markets tend to work effectively when there are lots of choices from many vendors. Competition keeps prices low and keeps firms competitive. Restricting CAM restricts markets. By definition, these products are alternatives to medicine and in particular, often considered to be legitimate substitutes for products and services considered “conventional” medicine.

In that paper, we proposed the following commercial framework:

Participants in commerce should endeavor to:

  1. Offer a product that works – a product that is, in the language of commercial law, ‘merchantable.’
  2. Only sell products to people who understand their fundamental characteristics, and who are reasonably capable of understanding (either on their own or with suitable professional help) whether that product will meet their needs. This implies a general demand for honesty on the part of sellers, and a refusal to profit from the ignorance of consumers.
  3. Take reasonable steps to ensure that third parties (those who do not consent to participate in a particular market exchange) are not harmed.

It’s worth pointing out that these principles not only benefit consumers and health professionals, but can benefit manufacturers as well. CAM manufacturers that make high-quality products that are backed by good evidence must currently fight to stand out among products with exaggerated claims and unclear product quality and safety. Looking at a bottle on the shelf, it’s not easy for consumers (or health professionals) to determine if that product is safe, or if it even contains what it says on the label. A marketplace that allows consumers to easily identify high-quality CAM products from those that are more dubious offers a potential advantage to those products and could potentially help to improve the overall quality of the CAM marketplace. That’s the approach that regulators seem to be taking with recently proposed changes.

Positive signals in Canada and the USA

A few months ago I wrote about potential changes to the regulatory system in Canada. Health Canada, which is Canada’s drugs (and natural health products) regulator, noted that the level of evidence required to make a similar effectiveness claim was much higher for a drug that for a “natural” product, where non-scientific evidence is currently acceptable. Health Canada is now proposing to regulate products with similar risk profiles in the same way, regardless of whether they’re “natural” or not. Effectiveness claims will need to be backed by scientific evidence – not anecdote and “long history of use” claims. Health Canada’s consultation on the new framework ended in October, and we’ll see what the final framework looks like.

There has also been encouraging signals from the FTC in the United States regarding homeopathy. Following a review by the FDA and FTC of the regulation of homeopathic remedies, the FTC announced it would require the same standard of evidence as is required for conventional drug products. In short, homeopathic manufacturers must provide scientific evidence to substantiate health-related claims. We’re still waiting to see what the FDA’s position on homeopathy may be.

Australia moves to strengthen regulation

The Government of Australia has now announced a consultation on a number of reforms that are proposed to enhance the regulation of CAM through the creation of a new category of products:

Australia currently has a two-tiered system, which is fairly similar to Canada and the United States, where medicines are subject to strict regulations, including the pre-testing requirements and the submission and review of clinical evidence for any health claims. CAM is considered low-risk and subject to few regulatory requirements. There is no pre-marketing review by the regulator at all for CAM.

The consultation proposes a new, middle tier. Sitting between drugs and the current CAM category, this tier is intended for CAM that is backed by good scientific evidence. Manufacturers wishing to sell products in this tier will be required to submit evidence of efficacy, just as occurs with drug products. Products approved under this framework will be flagged with specific statements and potentially even a visual symbol (e.g., a green check) to distinguish these products from other CAM.

Under the new proposal, the low-risk category will remain, but with more controls and limits on any form of claims of effectiveness. CAM in this category will not be able to make that claim that products have been assessed by the regulator for efficacy.

The regulator is also proposing market exclusivity changes for companies that develop and test new products, in an effort to develop the evidence-based for CAM products. This will support more research and development into CAM, and may encourage more clinical trials.

Science-based changes ahead?

While science-based CAM manufacturers may welcome these changes, others will likely lobby hard to maintain the status quo. If implemented, Australia’s approach may not only improve the marketplace for health professionals and consumers, it has the potential to promote more appropriate, science-based use of these products. I’d encourage anyone interested in promoting rational CAM regulation to review the consultation document and consider commenting before the March 28 deadline.

Photos via flickr user Steven Depolo and the Wikimedia Commons used under a CC license.

Posted by Scott Gavura