I believe in personal autonomy, a cornerstone of the consent process in the health care system. Each person has the inherent right to decide what to put in their body, what treatment to have, or to refuse any treatment they are offered by their chosen healer.
That right is not under question, though some may have you think so.
The Natural Health Products Directorate, the agency charged with approving natural health products under Health Canada, announced the end to the backlog of applications for product licensing of 60,000 NHPs as well the release of the final edit of the new Pathway for Licensing document -- the rules for approving new NHPs for licensing. These rules leave a lot to be desired.
This has been a long time coming, with the process starting with a report from the federal Parliamentary Standing Committee on Health in 1997, to the start of the bridging process in 2004 to a public consult and a rush to sweep away any temporary product license numbers in favour of final approval over the past year. Along the way there has been an erosion of the original principles in favour of assisting industry to bring products to market, and what I would characterise as an abandonment of any reasonable standards of efficacy, with safety and quality just barely above board.
Bad Science Watch, a new national science advocacy group my colleagues and I founded last year, sent a letter to the NHPD detailing what we considered to be the three biggest problems with the new Pathway to Licensing and the related regulations. We feel that the risk-based efficacy standards do little to tell the consumer if their product is actually going to work, that the ability of the manufacturer to label their product as containing small ineffective doses of any herb or chemical with no requirement to prove any effect is very misleading, and that the currently voluntary inspection standard is not even below that for drugs, but also below that of food inspections, and they leave the consumer at risk while they wait for someone to get hurt before mandating plant inspections.
You can read the letter for yourself, but not surprisingly not everyone agrees with us. There is a growing "health freedom" movement in Canada that thinks that 60,000 products do not give the consumer enough choice (your average supermarket stocking 38,000 items). They think that there is a conspiracy to take away health products and they think that every consumer should have the right to choose for themselves what is safe and effective. The conspiracies include raids on health food stores and a government nanny-state intent on tearing your personal autonomy from your hands.
It sounds very compelling on the surface, but the argument is rife with vested interest. Those making the arguments cry about big pharma conspiracies and corporate greed, but those promoting these efforts include the manufacturers, distributors and sellers of these products: "big herba," if you will. Therefore, the very same anti-corporate logic can be applied here, we cannot trust these arguments because those profiting from the sale of these dubious products are same entities spreading fear about the government taking away your NHPs.
This is not a movement centred on the consumption of NHPs, it is a movement that wants the right to sell you anything they want, without government oversight, or any standard to actually prove that what they sell is safe and legitimate.
The NHPD needs to drop the risk-based evidence standard and adopt a more rigorous risk-benefit approach. Currently, if a company cannot provide evidence for the claims about their product, all they have to do is make the claims more general then they do not have to provide any solid scientific evidence. If a company is selling an herb-based drug that they claim cures your cancer, then this is considered a high risk-claim and they must submit high-order evidence in line with the current standards of evidence in pharmaceuticals. If they do not want to go through this hassle, or don't care, all they have to do to get the drug approved is make a very general health claim; "supports immune-system health" for example, and get any expert opinion from a licensed naturopath or homeopath. No study and no other evidence of plausibility other than "I think it works" from a naturopath. This makes the claim almost useless, and not at all scientific.
We need to demand a risk-benefit approach that balances the risk of the product (yes, just because it is natural, does not mean it does not have risks) with the benefits of the product. This is a key idea: if the benefits of the product are nil, or cannot be proven, then even small risks are too high; you are taking a risk without any benefit. This is how we truly support personal autonomy; informed consent means that you must know all of the benefits and risks before being able to make a decision. In the case of medicine, the physician, nurse, paramedic or other licensed therapist is charged with informing the patient. In the case of self-care products on the shelf at your local store, it needs to be the government to ensure an unbiased and complete process.
Researchers, academics, science advocates, and those members of the public who care about the truth and true informed consent need to step up and tell Health Canada that they have to fulfil their mandate to protect the public. We need to turn the hospital ship of state back to the course it was on at the beginning, instead of toward the shoals of misinformation and ineffectual pro-industry legislation.
