Natural Health Products: Prescription Required?

by Paul H. LeMay
Source: Health Action, Summer 2010

A few weeks ago, I went into a Vancouver herb shop to buy some gotu kola herb to help manage a health condition. Though gotu kola--also known as asiatic acid and Indian pennywort--has long been prescribed for a variety of health conditions in both traditional Chinese and Indian ayurvedic medicines, and has gained the more recent interest of Western science, the store clerk informed me that Health Canada had banned gotu kola from non-prescription sale.

It came as a surprise in view of more than a dozen high-quality studies in the scientific literature looking at gotu kola and its extract, asiatic acid, conducted over the past two decades and more.

Yet, after doing some digging through Health Canada's website, I found an October 2005 drug recall for a Canadian product containing gotu kola. The recall stated gotu kola posed an "unacceptable risk to health," and classified the herb as an "unapproved drug product containing a Schedule F ingredient (gotu kola)." Schedule F is a federal list of medicinal ingredients that, according to our Food and Drug regulations, require a prescription for human use.

Weighty side of caution
Given gotu kola's significant and wide-ranging physiological effects, it is understandable why Health Canada might wish to err on the side of caution, and why also it might object to consumers using gotu kola as casually as they might a multivitamin supplement. However, does that mean gotu kola should be ­completely banned, especially given the recent science supporting its effectiveness in the use of serious illness? 

Research suggests, for example, that gotu kola may be effective in slowing the progression of brain cancer while increasing the effectiveness of chemotherapy. Wouldn't you want the option of using gotu kola if you faced such a serious disease? Of course you would.  Indeed, from the perspective of someone in need of gotu kola, it's ironic to think Health Canada's restriction might actually harm ­rather than protect health.

Thankfully, Schedule F does allow accredited medical doctors to prescribe asiatic acid, extracted from gotu kola, to treat various medical conditions. Problem is, there are no approved asiatic acid medications in Canada. Fortunately, this Catch-22 might change if Health Canada follows through on its December 2009 notice of intent to drop gotu kola from Schedule F of Canada's Food and Drug Regulations, allowing non-prescription status. Unfortunately, gotu kola isn't the only natural medicine being restricted from Canada consumers.

Amino freedom
south of the border
The amino acid acetyl-L-carnitine is another banned supplement in Canada. In its simpler, naturally occurring L-carnitine form found in the body, it's used to break down fats for use in energy production. Both laboratory and human double-blind placebo-control studies of acetyl-L-carnitine suggest it plays an important role in slowing, reversing and even preventing a variety of wide-ranging diseases, including Alzheimer's. Research has also shown that acetyl-L-carnitine can accelerate nerve regeneration after injury and likely assists in recovery from stroke; minimize neuropathy in diabetics and in HIV/AIDS patients receiving a cocktail of anti-viral meds; protect the brain from the neurotoxic effects of alcohol; and help patients suffering from cardiomyopathy. 

In the United States, both L-carnitine and acetyl-L-carnitine are approved for over-the-counter sale. Here at home, Health Canada deems both to be drugs available by prescription only.

So what accounts for the difference in regulatory perspective between Canada and the US? Much is due to our differing political histories and the underlying political and economic philosophies shaping them. One key difference is how each country views individual versus state authority. Historically speaking, the US placed a greater premium on the importance of individual rights than did Canada. The US enshrined its Bill of (an individual's) Rights into its constitution in 1791. Canada only got around to adopting its own constitutionally enshrined Charter of Rights and Freedoms in 1982--191 years after the US.

What took us so long?
Canadians have inherited a much different world view compared to our American cousins, one devoid of political revolution and founded (in English-speaking Canada at least) on preserving our colonial ties to the British crown. Though Canada did, over time, assert its right to self-rule and bring about its own elected colonial parliaments, much of the psychological residue of the crown's authority over individual rights is still with us today.

In the US, it is assumed that government is "of the people, by the people and for the people," such that citizens are both seen and treated as responsible participants in that process and mature enough to make choices about how to live their lives. In contrast, when framing of much of Canada's public policy, government, like an over-protective parent, tends to presume to always know what's best for its citizens, regardless of what those citizens might personally think. Of course, there is merit to be found in both perspectives. Not all cautionary actions by government are ill-advised. Nor do all consumers take the time to make responsible informed decisions. So the reality of things often lies somewhere in between. 

Still the question remains: Do gotu kola and acetyl-L-carnitine find themselves in that more credible "in between" middle? For Canadians wishing to use these products, the answer is "not yet."

Sensible natural product
health policy
When a life hangs in the balance, the "criteria pendulum" should swing in favour of an individual's right to choose which products he or she can use. When preventing harmful side-effects is at stake, it behoves government to fund the research necessary to confirm if such side-effects actually exist, and not prevent access to such products until such time clear evidence exists in this regard. 

And in an effort to accumulate strong data for the ultimate benefit of the general public, the government might consider establishing an online reporting site where those who have chosen to use natural health products can report, on a voluntary basis, any negative effects they may have experienced so Health Canada is in a credible position to issue health advisories and instigate timely publicly funded research, rather than overreact by banning products outright. 
 
 
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