[h2]Removing natural products would harm millions of people[/h2]
On June 24, the Herald ran a column by Kashif Ahmed and Eric Miller criticizing the federal health minister for Bill C-36, the proposed consumer safety legislation. Their criticism focuses on an amendment to the Bill which explains that it does not apply to natural health products (NHPs).
They assert this leaves a "safety" gap. This is unfair criticism of the minister. Bill C-36 was first introduced as Bill C-52 in April of 2008. The bill in its original form never covered NHPs or anything else regulated under the Food and Drugs Act. The amendment did not "exempt" NHPs as the authors claim. Rather it restated the obvious.
It is also difficult to understand how Canadians would be served by subjecting NHPs to consumer protection legislation which is not structured to regulate health products. Currently NHPs are regulated under the Food and Drugs Act and the NHP Regulations. Contrary to the assertion of Ahmed and Miller, NHPs are not exempt from safety regulations. Before an NHP can be licensed for sale, both its safety and its efficacy must be proved. The complaint of a large number of Canadians is not that the regulation of NHPs is too soft. Rather the complaint is that regulation is so strict that the majority of NHPs are being taken away.
NHPs are not being driven off of the market by Health Canada for safety concerns. This is not surprising. As far as I am aware, there has never been a documented death caused by a natural health product in our 143 years as a country. This does not mean that NHPs do not carry a risk. Risk is, however, relative. We know for example that nuts and shellfish cause a number of deaths and hospitalizations each year. It is a statistical fact that NHPs for which we cannot point to a single documented death in all of our history, are safer than peanut butter and shrimp which cause a number of deaths each year. If Ahmed and Miller were really concerned for our safety, they should be petitioning the minister for stricter regulation of peanut butter rather than of NHPs.
The authors are also silent on the risks of removing NHPs from the market. According to Health Canada, the majority of Canadians use NHPs. Currently, 17,602 NHPs have failed the strict licensing requirements imposed six years ago. These 17,602 products are being taken away from consumers who rely on them, in some cases for serious health conditions. How can we remove tens of thousands of products people are using to manage their health without there being health consequences? Health Canada has not done a single risk analysis to show the health risk of removing NHPs. I am aware of one case where, if the Canadian Mental Health Association is to be believed, the removal of a single NHP led to deaths.
Removing NHPs through over-regulation also forces those relying on them to switch to chemical drugs which are sometimes extremely risky.
How does this protect Canadians?
The authors also criticized the NHP industry for not wanting to be held to the same level of evidence as chemical pharmaceutical drugs. Chemical pharmaceutical drugs, which as a group are responsible for a very large number of deaths, can only be approved if there are randomized controlled trials ( "RCTs") showing that their benefit outweighs their risk. An interesting issue that Canadians are going to have to address is whether in the area of health, science has ceased to be a tool for discovery, and instead has become a mechanism of control.
NHPs have natural ingredients which cannot be patented. Because of this, it is exceptional for an RCT to be done on a natural health product. The reality is, that imposing RCTs on NHPs is the same as banning NHPs, and/or banning truthful claims that NHPs can treat serious conditions.
We also need to ask whether our blind acceptance of RCTs as the apex of "good science" is correct. The privileging of RCTs in the evidence-based medicine movement is based on the assumption that RCTs provide evidence that is less biased than other forms of evidence such as case series. Many researchers would question our position. I have yet to hire an expert who agrees with this assumption.
Perhaps one of the more sobering opinions comes from Dr. Marcia Angell in her article, Drug Companies & Doctors: A Story of Corruption, where after explaining how RCTs are biased she writes: "It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine." If that is the authors' vision for NHP research, I want no part in it.
By Shawn Buckley, For The Calgary Herald
July 29, 2010