StopC51 and Fuzzy Math

The StopC51 website shows a large pie chart with an 11% slice cut out under the heading “Percentage of Products Currently Approved.”  The title of the article is “Government Report Shows It’s Worse Than We Thought.”
Worse?  That’s saying a lot, given StopC51’s penchant for hyperbole.  In fact, what the “Worse” refers to is an overstatement they have made in the past about unlicensed natural health products (NHPs), 60% at the time, claiming that they would be pulled off the shelves once Bill C-51 goes through.*  This unsubstantiated threat continues to appear in propaganda that gets passed uncritically around the Internet, such as in the poorly researched article “Canada’s C-51 Law May Outlaw 60% of Natural Health Products; Big Pharma Pushing to Criminalize Supplements” on

“A new law being pushed in Canada by Big Pharma seeks to outlaw up to 60 percent of natural health products currently sold in Canada”

Although StopC51 does not refer to pulling NHPs from shelves in their “Worse than We Thought” article, they did not restrain themselves from cherry-picking data or drawing imaginative conclusions.

Health Canada periodically publishes NHPD Status of Submissions Reports concerning the licensing of NHPs.  For their article, StopC51 cites the March 2008 report, which is the last published report on the Health Canada website.  They take the total number of NHPs that have been licensed as of that report, which is 6,303, and compare that to the total number of NHPs for sale in Canada as estimated by Health Canada (see NHPD Quarterly Report (Spring/Summer 2005)):

“by far our greatest challenge and greatest priority continues to be finding effective means of managing and facilitating compliance of an industry comprising of over 50,000 unique and diverse products”

Using these figures, you come up with 12.6%, which I would have said is more like 13% than 11%, but let’s not quibble over difficult math.  So what is this 11%-ish figure intended to signify?  Something scary, I suppose, given StopC51’s propensity for spin.
Does the low figure mean that 89%-ish of NHPs will never get licensed?  No.  The process is ongoing.  Half the applications have not even been submitted by industry yet.  Both Health Canada and the NHP industry understand that they are working their way collectively through the NHP inventory and that more licensing is yet to come.
Does the low figure mean that 89%-ish of NHPs will be outlawed once Bill C-51 is approved?  No.  The product licensing regulations for NHPs have been in force since 2004 and will continue in force once Bill C-51 is passed.  If all unlicensed NHPs (i.e., with submissions being reviewed, reworked or initiated) had to be taken off the shelf, it would have happened already.  In fact, by that reasoning, all NHPs would have been illegal in 2004 when the NHP Regulations initially came into effect.  StopC51 really missed their chance to do some scare mongering back then, I guess.  Given that only 11%-ish of NHPs are currently licensed and yet the NHP shelves are not empty, Health Canada has obviously worked out a licensing process with industry that will continue on through Bill C-51.
Does the low figure mean that Health Canada wants to eliminate most NHPs in Canada?  No.  Health Canada, who embrace the notion that 70% of Canadians use NHPs, continue to demonstrate a commitment to working with industry to license all appropriate NHPs in accordance with the safety, quality and effectiveness standards that the two sides have mutually developed over the past decade.  It is difficult to understand why Health Canada would establish an NHP Directorate, which is staffed, led and advised by CAM practitioners, and then wade through 26,000 NHP submissions over four years only to secretly intend to remove most NHPs from the market in the end.  If this is all a conspiracy, it’s a pretty inefficient one.
Is the low figure some type of failing grade for Health Canada concerning NHPs?  Not really, although Health Canada must accept its share of responsibility for the progress to date.  Certainly, it indicates the ongoing challenge that both the NHP industry and Health Canada have ahead of them to get all NHPs licensed.
Of the estimated 50,000 NHPs, close to 26,000 applications have been submitted, and of those, a little over 12,000 were being processed at the time of the report.  The 6,303 licenses granted were out of the 13,843 submissions reviewed, or 46%.  I guess that 46% isn’t as scary as 11% for StopC51 to use, but in reality, both numbers are only single data points and so are fairly meaningless.
If StopC51 really wants to portray the licensing progress of NHPs in Canada, it should do some trend and process analysis.  How quickly are NHPs being processed, and how are those rates changing over time?  What are the reasons for licensing failures – improper application completion, insufficient information, unsubstantiated health claims?  Is the NHP industry getting better at submitting the applications over time?  Is Health Canada overcoming bureaucratic bottlenecks – clearer guidance, better training, more reviewers, more streamlined process?  What types of NHPs are achieving better rates of licensing and why?  What types of NHPs characterize the unsubmitted half of the NHP inventory compared to the submitted half?  To what extent is any lack of licensing progress due to the initial surge of the new licensing process?  What collaborative strategies have Health Canada worked out with industry to improve processing?  These are the types of questions to ask to understand how Health Canada and the NHP industry are working together to process the licenses for the NHP inventory.  However, StopC51 doesn’t really want to understand the process; they just want to cast doubt on it.
Is the low figure an indication that little progress is being made with NHP licensing?  Not across the board.  For example, since September 2007, the rate of licensing for Compendial NHPs (i.e., licenses granted to NHPs with ingredients for which the health claims have already been proven and entered into a Compendium) has risen sharply, resulting in 83% of reviewed submissions being licensed.  In the Non-compendial category, Transitional DIN products and TPD Category IV products have both caught up with their submission rates, resulting in closing rates of 98% and 70% of received submissions respectively.  So there are some optimistic trends.
However, in two important Non-compendial categories – Traditional and Non-traditional products – licensing shows steady progress over time but the overall rates are low, with only 38% and 40% of submissions processed.  It would be interesting to know why these rates are low.  Traditional NHPs are those products that have health claims based only on proof of 50 consecutive years of usage within a traditional medicine system, such as Traditional Chinese Medicine, Ayurvedic Medicine or Aboriginal Medicine.  Non-traditional NHPs are those products that have a scientific-based health claim that has not already been accepted in the Compendium.
Does the low figure mean that Health Canada should be lowering its standards in order to get more NHPs licensed?  No.  Product licensing is the way of ensuring that NHP consumers will receive accurate information about the safety, quality and effectiveness of the products they ingest, such as:

  • What the product’s ingredients are
  • How the product is to be administered
  • What the dosage amount, duration and frequency are
  • What are the product’s recommended uses (i.e., health claims)
  • What are the product’s risks of usage

Surely, all NHP users would want to know this information and would want to know that it is true and not just invented.  Manufacturers wouldn’t just make stuff up, would they?  Lowered standards would put this information at risk.
Is the low figure the result of making NHPs undergo the same approval process as pharmaceuticals?  No.  After all, NHP consumers keep saying that NHPs are inherently safe, and so Health Canada has adopted a much less rigorous licensing process for them owing to their reduced risk.  This is the case under the current NHP Regulations and will continue to be the case after Bill C-51 is passed.  NHP health claims do not have to be proven by repeated, double-blinded and controlled clinical trials, although there is nothing preventing manufacturers from doing so.  NHP health claims can be based simply on historical traditional use references, proven claims already accepted in the Compendium, or non-traditional claims previously published in peer-reviewed scientific journals.  NHP manufacturers don’t have to do the testing and trials; they just have to cite the appropriate reference material that supports the claims they intend to make.
In the end, the 11% pie wedge is a meaningless gimmick that StopC51 is using to hint at some scary implications.  I can’t imagine that they care whether the number is meaningless or not, as long as it has the chilling effect that they want.  In reality, Health Canada and the NHP industry do have their work cut out for themselves, but when they complete the licensing of the the NHP inventory, they will be giving to Canadians the ability to make healthcare choices informed by knowledge of the safety, quality and effectiveness of their NHPs.

[ * After some searching, I found the old StopC51 affiliated website.  They actually said that 70% of NHPs would be removed, not 60%.  Don’t bother clicking on the link unless you want to read more StopC51 silliness.  (4 Aug 08) ]

02. August 2008 by barry
Categories: Alt. Med, Topics | Comments Off on StopC51 and Fuzzy Math