By law, one
of the duties
of the Minister of Health is "the protection of the people of Canada against risks to health and the
spreading of diseases." Mostly, we hope, he or she
succeeds. But every once in a while the Health Department fails its Minister and
fails big time.
One such
occasion was in the 1990s when early scientific evidence was ignored, and tainted
blood was allowed into the blood transfusion supply. Thousands became ill
or died. The Krever
Commission of Inquiry slammed Health Canada for being too slow to act.
As a result, Health Canada was substantially re-organized. It was a
career-ending debacle for several senior health bureaucrats.
On an
earlier infamous occasion, federal officials acted too quickly in approving the
sale of Thalidomide. Early evidence was ignored, and approval was given on the
basis of manufacturers’ claims that regulators in the United States found
insufficient. Health Canada officials responsible for that tragedy had long
retired before
the federal government moved to make amends in 2014.
A new crop
of health officials seem prepared to make a similar high-stakes public health gamble
on thin scientific ground. This fall, Health Canada is preparing draft regulations that would allow Big Nicotine companies to say that electronic
cigarettes are safer than they really are.
New draft regulations are in development that would allow manufacturers of e-cigarettes to use one or
more of the following proposed statements in their advertising and on packages of their
products:
1. If you are a
smoker, switching completely to vaping is a much less harmful option.
2. While vaping
products emit toxic substances, the amount is significantly lower than in
tobacco smoke.
3. By switching
completely to vaping products, smokers are exposed to a small fraction of the
7,000 chemicals found in tobacco smoke.
4. Switching
completely from combustible tobacco cigarettes to e-cigarettes significantly
reduces users’ exposure to numerous toxic and cancer-causing substances.
5. Completely
replacing your cigarette with a vaping product will significantly reduce your
exposure to numerous toxic and cancer causing substances.
6. Switching
completely from smoking to e-cigarettes will reduce harms to your health.
7. Completely
replacing your cigarette with an e-cigarette will reduce harms to your health.
These statements
have some truthiness, but they are not the whole truth. They are likely
not true in a public health sense, as using any of them is likely to do more
harm than good. In the all-too-brief period allowed for comments from the
general public (September 6-17, 2018), Stan
Glantz and Physicians for a Smoke-Free Canada collated the evidence showing
that current science does not support the use of any of these statements. This
evidence demonstrates:
·
Every study that has examined whether kids who start nicotine use with
e-cigarettes are at increased risk of smoking has shown a strong positive
effect.
·
The evidence that e-cigarettes pose substantial cardiovascular and
pulmonary disease risk is piling up.
·
There is also evidence that e-cigarettes may increase cancer risk.
·
While some people do successfully quit smoking with e-cigarettes, for
most people e-cigarettes reduce the odds of smoking cessation.
·
The dominant behavior is dual use, with people using both e-cigarettes
and conventional cigarettes at the same time. In this circumstance, risks
are not reduced. One risk adds to the other.
Other
reputable public health voices agree. On August 30, 2018, the European Public
Health Association issued a concise summary of current e-cigarette science
entitled "Facts
and fiction on e-cigs." The EUPHA report concluded:
"Given the
available evidence, EUPHA strongly supports the precautionary approach taken in
the EU Tobacco Products Directive and in statements by WHO. It is not possible,
at this point, to make any claims about the relative safety of e-cigs compared
to traditional cigarettes. The overall effect may well be to worsen the tobacco
epidemic first by deflecting smokers from using proven smoking cessation
strategies and shifting them to e-cigs, which, for most smokers, reduce
successful smoking cessation, and second by deflecting discussion from measures
opposed by the tobacco industry.
E-cigarettes are
expanding the nicotine market by attracting youth who were at low risk of
initiating nicotine use with conventional cigarettes, but many of whom are now
moving on to those conventional cigarettes. Even if they do not progress,
promoting nicotine use to youth is bad public health policy."
Health Canada’s 180
degree turn
In the
version of Bill S-5 first presented to Parliament in November, e-cigarette
manufacturers were banned from making any statements comparing the health
effects of their products. (“No person shall promote a vaping product, including
by means of the packaging, by comparing the health effects arising from the use
of the product or from its emissions with those arising from the use of a
tobacco product or from its emissions.”)
The first 90 degree turn was taken during
the Senate review of the bill when Senator
Chantal Petitclerc, on behalf of the government, proposed an amendment that
gave the federal government the power to regulate comparative statements. The
amendment was adopted and survived all the way through the Parliamentary process
to Royal
Assent.
The second 90 degree was
taken earlier this year, when Health Canada made it a regulatory priority to design comparative
statements for use by e-cigarette manufacturers. The haste with which this is
being done is all the more staggering, considering the usual pace of regulatory
development. S-5 authorizes much-needed regulation on tobacco and nicotine
sales, but only ‘relative risk’ statements have been given the fast track.
On September
28, 2018 Canada officially notified the World
Trade Organization of its intention to approve the seven "draft" statements. Notification
to the WTO is a routine step in the regulatory process - but it usually occurs
late in the process and is usually an indication that domestic consultations
are over. If Health Canada had wanted to send a signal that its consultation on
these statements was a sham, the WTO notice would have been a very good choice.
The evidence is
going in the opposite direction to Health Canada’s proposed regulations.
Although
the scientific evidence was lacking when the amendment to allow these
statements was first considered by the Senate, there was the hope that research
would soon justify nicotine users receiving statements about the relative harms
of e-cigarettes in comparison with their conventional predecessors.
In fact, the
opposite has happened. In the eighteen months since Senator Petitclerc's
amendment, the scientific evidence that has accumulated support the conclusion
of EUPHA:
"It is not possible, at
this point, to make any claims about the relative safety of e-cigs compared to
traditional cigarettes."
This seems
to have deterred Health Canada not at all. They are stubbornly insistent on
allowing nicotine companies to make statements that will lull many smokers and
non-smokers into thinking that e-cigarettes are safer than they really are. (As
with Thalidomide, the U.S. government is taking a more cautious approach.)
The seven
proposed statements zero in on the narrow question of the reduced harm to
smokers that can arise if one switches completely from combustible cigarettes
to e-cigarettes, while ignoring the wider context of widespread dual use,
ineffectiveness of e-cigarettes as a smoking cessation aid, widespread use by
never smokers and their more likely subsequent uptake of conventional
cigarettes. When asked about this strategy,
Health Canada officials indicated that the seven statements were deliberately
designed to address only one narrow question.
All other problems would be addressed by other programming and
regulatory actions to be implemented months and years later. But e-cigarettes are causing unaddressed harms
here and now. Regrettably, Health
Canada’s chosen strategy, by getting the priority order wrong, risks increasing,
not decreasing harm.
Unusually,
inaction on comparative statements would be the best course of action for
federal tobacco regulators. Health Canada should and could simply do nothing
for the time being to push these statements forward. Nothing in law compels
them to approve comparative statements. No scientific consensus exists to give
them the confidence to permit the wording they propose.
Instead, they
could usefully turn their attention to developing programming and regulations
where they are truly needed. To be sure,
work is already proceeding on a campaign to prevent vaping among youth. Regulations are being developed for health
warnings on vaping products, vaping promotion restrictions and vaping product
reporting. But it will be months and
years before any of this work comes to fruition. A better plan would be to speed up
implementation of all these activities.
Once they were in place, then consideration could be given to whether or
not prescribed comparative statements were needed, and if so, what they might
say in the new context of a comprehensive set of vaping products programming
and regulations.
