It’s Official: Big Pharma is Lobbying Against Electronic Cigarettes- Dr. Michael Siegel

I have long argued that tobacco control advocates who have financial ties to Big Pharma must disclose these ties if they opine about national strategies for electronic cigarette regulation because these ties represent a conflict of interest. My argument was based on the premise that electronic cigarettes represent a major form of market competition with pharmaceutical cessation aids and that drug companies therefore have a financial interest in seeing electronic cigarettes squashed.

Today, I reveal that this speculation about pharmaceutical financial interests in the demise of e-cigarettes was not just speculation, but it has now been confirmed.

According to an article in the London Times, GlaxoSmithKline – a major player in the pharmaceutical smoking cessation industry – has lobbied vigorously on behalf of stringent electronic cigarette regulation in the European Union. Specifically, a leaked memo apparently showed that Glaxo was telling policymakers that electronic cigarettes could be a gateway to smoking and that these products should be regulated as medicines, not as a type of nicotine or tobacco product.

According to the article: “One of the world’s biggest pharmaceutical companies has warned lawmakers that electronic cigarettes could act as a “gateway to tobacco”. The leaked correspondence from GlaxoSmithKline, whose nicotine patches, gums and lozenges are being undermined by the burgeoning e-cigarette market, reveals the opposition from the pharmaceutical industry to impending regulation of e-cigarettes across the European Union. The pharmaceutical industry wants medicines licences to be mandatory for e-cigarettes, as they are for nicotine products. Instead, the EU is set to introduce a system in which e-cigarette companies can opt in for medicines regulation or be regulated in a similar way to traditional cigarettes.”

Christopher Snowdon reported the details of the story here back in February. He wrote:”This is a blatant attempt at rent-seeking by an obvious vested interest. We know that the pharmaceutical industry has been lobbying hard to hamper the growth of e-cigarettes so it comes as no surprise to find Glaxo using the tired old gateway argument. The truth is that e-cigarettes will only “seriously disadvantage” the NRT market if they work better as quitting aids. In my experience—and the experience of countless other people—e-cigarettes are much better substitutes for smoking. If they were really a “gateway” to smoking, e-cigarettes would be good for companies like Glaxo as they would create more smokers (NRT companies need there to be smokers just as much as cigarette companies do).”Snowdon also noted that the UK National Smoking Cessation Conference was funded by GlaxoSmithKline and Pfizer. He wrote:

“As usual, both these companies are main sponsors of the conference—apparently there is no problem having corporations that are vociferously opposed to the most promising development in smoking cessation paying for a conference about smoking cessation.”

The Rest of the Story

Financial interests in Big Pharma must now be recognized as conflicts of interest for any organization or individual who is offering opinions about national strategy, policy, or regulations regarding electronic cigarettes. Therefore, the authors of all scientific articles regarding electronic cigarettes must disclose any financial interests with pharmaceutical companies. Furthermore, organizations must also disclose any financial ties to Big Pharma when they offer recommendations regarding electronic cigarette policy.

Unfortunately, there have been numerous violations of this disclosure standard, as several commentators on electronic cigarette policy have failed to disclose their Big Pharma ties in published articles. I have highlighted many of these stories on my blog, but for one demonstrative example, see my column on failed disclosures by an individual and an organization in the New York Times debate on electronic cigarettes.

Another inexcusable conflict of interest is the fact that Mitch Zeller, the director of the FDA’s Center for Tobacco Products and therefore the chief author of the proposed electronic cigarette regulations, came to the FDA directly from a consulting job with GlaxoSmithKline and therefore has a severe conflict of interest regarding the electronic cigarette issue.

Moreover, several former members (and one current member) of the FDA’s Tobacco Products Scientific Advisory Committee have (or have had) financial conflicts of interest with Big Pharma, and thus are not in a position to offer opinions about national tobacco product regulation in the context of this expert advisory panel.

And finally, it appears that most of the national tobacco control conferences continue to be funded by pharmaceutical companies. There is no way that these conferences can be objective about smoking policy, especially regarding electronic cigarettes and smoking cessation, when they are funded by Big Pharma.

5 comments ↓

#1 harleyrider1978 on 06.25.14 at 12:23 PM

EPA & FDA: Vapor Harmless to Children

April 3, 2014 matt black

In the continued war on e-cigarettes, we hear about the “potential dangers” of e-cigarette vapor and the “unknown public health risks.”

First, I find it absolutely absurd that we’re attempting to pass laws based on unknowns, but what makes it even more absurd is the fact that there’s very little that isn’t known about e-cigarette vapor at this point. The primary ingredient of concern to those who wish to see e-cigarettes banned is the propylene glycol vapor, which has been studied for over 70 years.

I recently came across a document titled, “Reregistration Eligibility Decision For Propylene Glycol and Dipropylene Glycol“, which was created by the United State Environmental Protection Agency (EPA).

Catchy title. I was intrigued.

This quote caught my eye:

Propylene glycol and dipropylene glycol were first registered in 1950 and 1959, respectively, by the FDA for use in hospitals as air disinfectants. (page 4, paragraph 1).

In a previous post, I had shared the summary of research that had been done in 1942 by Dr. Robertson regarding the antibacterial properties of vaporized propylene glycol, but I had never heard that the FDA wound up approving it for the purpose of an air disinfectant in hospitals.

Indoor Non-Food: Propylene glycol is used on the following use sites: air treatment (eating establishments, hospital, commercial, institutional, household, bathroom, transportational facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; (page 6, paragraph 2)

Continued…

Method and Rates of Application

….

Air Sanitizer

Read the directions included with the automatic dispenser for proper installation of unit and refill. Remove cap from aerosol can and place in a sequential aerosol dispenser which automatically releases a metered amount every 15 minutes. One unit should treat 6000 ft of closed air space… For regular, non-metered applications, spray room until a light fog forms. To sanitize the air, spray 6 to 8 seconds in an average size room (10′x10′). (page 6, paragraph 6)

A common argument used to support the public usage ban is that, “Minnesotans have become accustomed to the standard of clean indoor air.” However, according to the EPA and FDA, so long as there’s a “light fog” of propylene glycol vapor in the air, the air is actually more clean than the standard that Minnesotans have become accustomed to.

General Toxicity Observations

Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol. This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed.

Carcinogenicity Classification

A review of the available data has shown propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies conducted up to the testing limit doses established by the Agency; therefore, no further carcinogenic analysis is required. (page 10, paragraphs 1 & 2)

Ready for the bombshell? I probably should have put this at the top, as it could have made this post a lot shorter, but I figured the information above was important, too…

2. FQPA Safety Factor

The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in infants and children to specific pesticide residues in food, drinking water, or residential exposures, or to compensate for an incomplete database. The FQPA Safety Factor has been removed (i.e., reduced to 1X) for propylene glycol and dipropylene glycol because there is no pre- or post-natal evidence for increased susceptibility following exposure. Further, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol based on the low toxicity observed in studies conducted near or above testing limit doses as established in the OPPTS 870 series harmonized test guidelines. Therefore, quantitative risk assessment was not conducted for propylene glycol and dipropylene glycol.

In a paper published in the American Journal of Public Health by Dr. Robertson in April of 1946, Robertson cites a study published in the Edinburgh Medical Journal, which was conducted in 1944:

The report of the 3 years’ study of the clinical application of the disinfection of air by glycol vapors in a children’s convalescent home showed a marked reduction in the number of acute respiratory infections occurring in the wards treated with both propylene and triethylene glycols. Whereas in the control wards, 132 infections occured during the course of three winters, there were only 13 such instances in the glycol wards during the same period. The fact that children were, for the most part, chronically confined to bed presented an unusually favorable condition for the prophylactic action of the glycol vapor.

An investigation of the effect of triethylene glycol vapor on the respiratory disease incidence in military barracks brought out the fact that, while for the first 3 weeks after new personnel entered the glycolized area the disease rate remained the same as in the control barracks, the second 3 week period showed a 65 percent reduction in acute respiratory infections in the glycol treated barracks. Similar effects were observed in respect to airborne hemolytic streptococci and throat carriers of this microorganism.

I don’t expect the prohibitionist lawmakers to delve this deeply into this subject on their own, but I certainly hope that when presented with this data that they reevaluate their stance on the subject and consider what science has to say. If they don’t, they’re simply basing their judgement off of rhetoric, misinformation, and personal bias and we all know where that gets us.

http://mnvapers.com/2014/04/epa-fda-vapor-harmless-children/

#2 harleyrider1978 on 06.25.14 at 12:24 PM

This pretty well destroys the Myth of second hand smoke:

http://vitals.nbcnews.com/_news/2013/01/28/16741714-lungs-from-pack-a-day-smokers-safe-for-transplant-study-finds?lite

Lungs from pack-a-day smokers safe for transplant, study finds.

By JoNel Aleccia, Staff Writer, NBC News.

Using lung transplants from heavy smokers may sound like a cruel joke, but a new study finds that organs taken from people who puffed a pack a day for more than 20 years are likely safe.

What’s more, the analysis of lung transplant data from the U.S. between 2005 and 2011 confirms what transplant experts say they already know: For some patients on a crowded organ waiting list, lungs from smokers are better than none.

“I think people are grateful just to have a shot at getting lungs,” said Dr. Sharven Taghavi, a cardiovascular surgical resident at Temple University Hospital in Philadelphia, who led the new study………………………

Ive done the math here and this is how it works out with second ahnd smoke and people inhaling it!

The 16 cities study conducted by the U.S. DEPT OF ENERGY and later by Oakridge National laboratories discovered:

Cigarette smoke, bartenders annual exposure to smoke rises, at most, to the equivalent of 6 cigarettes/year.

146,000 CIGARETTES SMOKED IN 20 YEARS AT 1 PACK A DAY.

A bartender would have to work in second hand smoke for 2433 years to get an equivalent dose.

Then the average non-smoker in a ventilated restaurant for an hour would have to go back and forth each day for 119,000 years to get an equivalent 20 years of smoking a pack a day! Pretty well impossible ehh!

#3 vapor vixen on 06.26.14 at 1:48 AM

not sure why Harley posted what he posted – where did this post reference second hand smoke did I miss something

#4 Copenhahen Charlie on 07.18.14 at 11:50 PM

I actually think that when your in a room with a lot of vapers the air becomes weirded-out

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