Fight for Lumbrokinase

Dear Canadian health care professionals and patients:

This is an open letter asking all Canadians to stand up and fight for our rights to access safe and effective natural health products. Specifically we are asking for your support to bring lumbrokinase (a complex earthworm protein extract) back to Canada. Why is this Important?

Subtitle: Fight for lumbrokinase

As Canadians, we are proud of our medical system that takes care of the rich and the poor

without prejudice. However, many of us believe in the philosophy of preventative natural health care, instead of the current pharmaceutical approach of disease care. Many integrative health practitioners also depend on the availability of natural health products in order to provide effective health care for their patients. Without a doubt, as Canadians we cherish our rights to self-care and the rights to access natural health products in order to achieve that goal. 

The Natural Health Product Directorate (now renamed NNHPD) was established exactly for that reason (as stated on NNHPD’s website): to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity. However, some may argue that the establishment of NHPD (now changed to NNHPD) has done exactly the opposite. Since the enactment of the Natural Health Product Regulations in 2004, Canadians have lost many products and brand names. Unfortunately, Boluoke (lumbrokinase) is one of those products no longer available for sale in Canada.  For more info, please click here. 

What is lumbrokinase? Most consumers or patients probably have never heard of it, let alone knowing what it is used for. Fundamentally, lumbrokinase is a complex protein extract from earthworms. Earthworms are an ingredient used in Traditional Chinese Medicine (TCM) for hundreds of years to treat stroke patients with great clinical benefits and no safety concerns. According to ancient TCM texts, earthworms are thought to “dredge the channels” and “remove blood stagnation”, which can be loosely translated as “having fibrinolytic activities” and “reducing blood viscosity” as shown by modern clinical studies. Elevated blood viscosity and impaired fibrinolytic system are two major hallmarks of patients at risk of developing cardiovascular diseases, which are the top health issue facing all Canadians. Thus, we believe earthworm enzymes (lumbrokinase) can be very useful in managing those risks in Canadians. If you look into the available clinical research of lumbrokinase, you will surely be amazed by the potential benefits of this time-tested enzyme. Canada RNA Biochemical Inc. was the first company that introduced lumbrokinase under the trade name Boluoke® to Canadian and US health care practitioners in the fall of 2001. Since then, we have been promoting the awareness of hypercoagulation (an imbalance in the coagulation system leaning towards clot formation) and the importance of correcting it through oral fibrinolytic enzymes like lumbrokinase. However, in 2006 we were issued a stop-sale order by NHPD because lumbrokinase had not been approved in Canada as a Natural Health Product. Since then we have been working with NHPD and supplied them with many safety and efficacy evidence showing that lumbrokinase is both safe and effective. The evidence submitted including Traditional Chinese Medicine texts, pre-clinical animal toxicity data, pharmacokinetics data, Phase I-III clinical trials data, double-blind placebo-controlled data, systematic reviews, and post-marketing safety data from China and North America. However, for the past eight (8) years NHPD (and current NNHPD) has refused to issue an NHP license to lumbrokinase citing that it is a potential bleeding risk (in contrary to currently available data) without providing any solid evidence to back up its accusation. NNHPD also thought that lumbrokinase is so dangerous that it is not safe even when used under the guidance of health care practitioners! Basically NNHPD is saying that no practitioners in Canada are competent enough to supervise its use. What an insult this is to all Canadian health care Practitioners!

In 2012, NHPD (before changing the name to NNHPD) made a similar argument regarding another fibrinolytic enzyme nattokinase, an enzyme extracted from traditional Japanese fermented soybean called natto. NHPD argued that nattokinase was too dangerous (without any solid supportive evidence) for sale in Canada, and totally disregarded the history of safe traditional use of natto and the excellent safety record of nattokinase. Yet, nattokinase is readily available in countries all over the world! NHPD demanded drug-like evidence to support the safety and efficacy of natural health products, and this action is completely contradictory to the number one founding principles of NHPD (as documented in the Standing Committee’s Report on NHPs of 1998): natural health products must not be treated like pharmaceutical products! As a result of NHPD treating nattokinase as a drug, it is no longer readily accessible to Canadian patients and health care practitioners.

As a company that produces a lumbrokinase product, we do have a vested interest in the outcome. However, if we are successful, then it shall open the door to all companies. Other ingredients that were unjustly removed from Canadian market may also have a chance to come back. We have been working hard to bring back lumbrokinase for Canadian doctors and patients in the past 8 years. We believe that we are near the end of our application assessment process, and that NNHPD will likely make its final decision within the next few months regarding the status of lumbrokinase in Canada. However, after dealing with NHPD (and now NNHPD) for so many years we have little faith in NNHPD fulfilling its mandate and doing what is right. If Canadians are again unjustly denied access to this safe natural enzyme - lumbrokinase, we will likely never see any oral fibrinolytic enzymes on the Canadian market in our lifetimes. That would be a truly sad day!

Canadians lost the rights to access safe enzymes like nattokinase and lumbrokinase before. Now, we have a chance to make our voice heard and bring back lumbrokinase. If Canadian consumers and practitioners do not stand up and fight for our rights, then those products that were unjustly removed will never see the light of day again in Canada. Unfortunately there is no way to bring back the lost products all at once unless NNHPD is abolished. On the other hand if we can successfully bring back lumbrokinase for Canadian doctors and patients, then there may still be some light at the end of the tunnel for those natural health products that were removed from Canadian market without a just cause (e.g. nattokinase, pleurisy root, shark liver oil, emu oil in capsule form, etc.). Therefore, WE URGENTLY NEED YOUR HELP!

We need you to tell the Minister of Health and your local Member of Parliament that you want your right to self-care protected, and that you also demand the right to access products that are reasonably safe and effective. Specifically, you would like to have access to the enzyme lumbrokinase, which was once available to Canadians. Last time NHPD took away your right to access lumbrokinase you might not have known about it. But this time, please stand up and fight for your right before NNHPD takes lumbrokinase away from you forever.

We urge you to write a letter to the Minister of Health and to your local MP that you demand the right to access lumbrokinase (a complex earthworm protein extrac), and urge them to allow the sale of lumbrokinase in Canada again. We would encourage that you write the letter in your own words, but have provided some sample letters for your reference. We have also started an on-line petition to the Minister of Health; please click on the following link to sign the petition: www.change.org/ ...... We would appreciate that you spread the words and ask your colleagues or friends to join the letter campaign or sign the on-line petition.

If you would like to learn more about this campaign, lumbrokinase enzyme, or have any questions/comments, please feel free to contact us at info@CanadaRNA.com. Thank you very much for visiting this website and fighting for your right to access safe and effective natural health products in Canada!


Sincerely,


Martin Kwok, ND, DrTCM
Vice-President