Sunday 18 November 2018

What will history say? Health Canada rushes approval of pro-vaping messages.

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.