Tuesday, April 30, 2019

Broad Tobacco-Related Insurance Premiums Are Unjustified & Injurious

I recently received this email:

“I am a 29 year old male from Upper Michigan, married with 3 kids.  My wife and I recently signed on with [company name redacted] as this was one of the only affordable health care options for our family and I like most all of their ‘principles’ or values.

“Only 1 problem; they require that you don't use any drugs, drink, smoke, chew, nothing.  I consider myself a healthy individual as I'm 6'3", 200 lbs and fit. I haven't seen a doctor in years, frankly because I haven't a need.  I don't use drugs, drink, or smoke. However, I've chewed Copenhagen snuff for about 15 years and never had a problem with it. I was the one who had 2, maybe 3 small dips each day, a can would last me a week. It was never excessive and never a problem.

“For the sake of [company] I quit chewing snuff a few months ago. Since I quit, I've noticed I'm short tempered with my wife and kids.  My performance at work has decreased, and I started gaining weight, and losing sleep. I think about it every day, and I feel no better without it. I feel like [company]'s penalty is harsh for dipping.  And they penalize the same for smoking or other hardcore drugs that I'd never do.
“I found you online, and I admire your courage to speak the truth about smoking and chewing.

“Please let me know if you can help educate my health ‘insurance’ company on the truth about chewing tobacco. Any help is appreciated.”
This narrative is not unusual; over the years, I have received numerous similar complaints.  Many smoke-free tobacco users are pioneers; my research group published a study about them in 1995, and I have also told their stories in this blog. 
Unfortunately, smoke-free tobacco users continue to suffer from policies that consider all tobacco products – even medicinal nicotine – as equally dangerous, and all tobacco/nicotine users as high-risk.  This conflation of risks improperly raises premium costs, limits employment opportunities and degrades the quality of smoke-free tobacco users’ lives.  It also provides a financial windfall for insurers.
The federal government and health organizations often promote this conflation, and Obamacare legislation codified it, defining “smoking” as “using any tobacco product on average four or more times per week in the past six months.” (emphasis added)  It may be justifiable to charge smokers higher premiums, because they are at risk for many diseases that health insurance must cover and, on average, their lives will be shortened by 8-10 years, justifying higher life insurance premiums.  But use of smoke-free tobacco products which are associated with minimal or no added health risks should not incur such punitive premium treatment.
Many tobacco consumers avoid higher premiums by lying about their lifestyle choice.  Research shows that “tobacco users may be decreasingly likely to report their tobacco use status accurately to avoid surcharges” when enrolling in Healthcare.gov exchanges.  The problem for these individuals is that insurers and employers commonly require urine tests, which readily detect nicotine as long as three to four weeks after use. However, these tests do not distinguish how nicotine entered the body – via smoking or the use of smoke-free tobacco or medicinal nicotine.
As a health professional, I do not condone deliberate misreporting of tobacco use on insurance applications.  However, I do oppose the degradation of smoke-free tobacco users’ quality of life for no legitimate reason.

FDA Approves PMI’s IQOS Heat-Not-Burn Tobacco For U.S. Sales

Today the FDA approved Philip Morris International’s heat-not-burn tobacco system for sale in the U.S., saying in an agency press release:

“Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes. The products authorized for sale include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.”

The FDA approval was issued two years (alternatively, 1 million smoker deaths) after PMI’s application, which is about a year and a half past the agency’s own deadline.  IQOS is only the second product approved under the PMTA pathway.  The first was in 2015 for eight General snus products from Swedish Match

The FDA action is both good and bad news for e-cigarette and vapor manufacturers and retailers.  The good news is that the PMTA process works.  The bad news is that it took years, and hundreds of millions of research dollars, for PMI to obtain this approval.  By 2022 manufacturers and retailers, who already sell tens of thousands of e-cigarettes and vapor products but don’t have the resources of PMI, will be required to submit PMTAs to the FDA, or risk having them ordered off the market.  

Thursday, April 18, 2019

FDA Holds IQOS Heat-Not-Burn Hostage, As Market Forces & Smoke-Free Products Slash Japan Cigarette Sales

The media has been silent about an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales in Japan declined 12% in 2018, largely due to sales of reduced-risk products.  The dominant reduced-risk product in Japan is Philip Morris International’s IQOS heat-not-burn HeatStick.

David Sweanor, a veteran tobacco harm reduction advocate in Canada, observed: “Japan provides a great lesson in how tobacco control groups ‘doing nothing’ and ‘staying out of the way’ has led to outperformance in reducing cigarette smoking.  A key question is what could be accomplished if these groups actively facilitated transitions away from combustibles.  Japan has reduced cigarette sales dramatically in just three years, Iceland reduced prevalence of cigarette smoking by 40% in three years, Norway reduced the cigarette market by half in a decade, Sweden achieved by far the lowest rates of smoking in Europe, and the U.S. appears to have tripled the rate of decline in cigarettes sales. All this largely despite, not because, of, actions by mainstream tobacco control. That should be a wake-up call.”

Clive Bates, another veteran THR advocate from the U.K., remarked: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.” 

Meanwhile, in the U.S., smokers can’t buy IQOS because the FDA has not approved PMI’s marketing application (known as an PMTA), which was submitted in March 2017.  Approval requires the company to demonstrate “that the new tobacco product is beneficial to the population as a whole.”  Nothing benefits a population more than the rapid deterioration of cigarette sales, as seen in Japan.

An FDA official recently indicated that a decision on IQOS will be issued by the end of this year.  That would mark the passing of 2.75 years from submission, and the untimely deaths of 1.3 million American smokers.

The FDA took eight months (335,000 dead smokers) to grant Swedish Match a PMTA for eight snus products in 2015 (here).  What will happen in 2022, when the FDA receives thousands of PMTAs from vapor manufacturers and retailers?