My response to ATTUD's Letter to the FDA

[gep]

It's long (10,000 words) but I wanted to rebut their letter as much as possible.

I have posted it to my blog here on the forums.

http://www.e-cigarette-forum.com/forum/blogs/gep/

I've also sent an abbreviated copy to my Senators and will be sending out as much of the complete letter to as many people in D.C. that I can.

I don't expect one letter to change anyone's mind, but many letters can. Please write to your representatives and to the FDA acting chairman. It doesn't have to be long, just polite and factual.

Thanks!

GEP

[Vicks Vap-oh-Yeah]

Well done, Gep.....Well done indeed!

[TheEmperorOfIceCream]

Very nice Gep. Polite, rational and informative.

Emp

[gep]

Thank you.

I appreciate the kind words.

[yvilla]

Just read it. Great going Gep! Thanks.

[Bill Godshall]

I sent this to my e-mail list today, which includes many officers and members of ATTUD, Senate HELP Cmte staff, news reporters, and smokefree policy advocates.
Siegel's blog contains weblinks to cited documents.


Per Mike Siegel's commentary below, it appears that all of those urging the FDA to ban electronic cigarettes (i.e. Sen. Lautenberg, CTFK, ACS, AHA, ALA, ATTUD) failed to disclose (in their misleading rants against e-cigarettes) that they've received huge amounts of money from drug companies that market nicotine gums/lozenges/patches, and also failed to disclose that 93% of smokers who used these NRT products switched back to cigarettes within 6 months Tobacco Control -- Sign In Page and that 98% switched back within 20 months Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis -- Moore et al. 338: b1024 -- BMJ

Neither Smokefree Pennsylvania nor I have ever received funding from any tobacco, drug or e-cigarette company.

Bill Godshall
Smokefree Pennsylvania
- - -

Tobacco Treatment Organization Writes FDA and Issues Press Release to Promote Ban on Electronic Cigarettes

By Michael Siegel, MD, MPH
May 14, 2009
The Rest of the Story: Tobacco News Analysis and Commentary: Tobacco Treatment Organization Writes FDA and Issues Press Release to Promote Ban on Electronic Cigarettes

The Association for the Treatment of Tobacco Use and Dependence (ATTUD) yesterday issued a press release to promote a ban on the sale of electronic cigarettes in the United States. The press release highlighted a letter written from the organization to the FDA requesting that the Agency remove electronic cigarettes from the market.

The press release states: "The Association for the Treatment of Tobacco Use and Dependence (ATTUD), the premier professional organization of tobacco treatment specialists, today announced its support of the FDA ban on so-called "electronic" or e-cigarettes. The letter addressed to Acting Commissioner Sharfstein (see below) stated that there is no scientific evidence that the e-cigarettes are safe and effective. "As tobacco treatment professionals we are concerned that smokers desperate to quit will place their faith in unproven therapies," said John Hughes, MD, President-elect of ATTUD and professor of psychiatry at the University of Vermont College of Medicine. "Money spent on unproven treatments is money unavailable for proven, FDA-approved treatments," Dr. Hughes continued. Furthermore, an unsuccessful attempt can precipitate a sense of failure, which can delay another quit attempt for years. Unfortunately, this can mean that some smokers will die or suffer serious disease after an unsuccessful quitting effort. While ATTUD supports the quit attempts of all tobacco users, it strongly encourages all smokers to use FDA-approved and proven medications with the support of tobacco treatment professionals."

The letter to the FDA states: "The Association of Tobacco Use and Dependence (ATTUD) is a non-profit organization of providers dedicated to the promotion of and increased access to evidence-based tobacco treatment for the tobacco user. As such, we are writing to support the Food and Drug Administration (FDA) enforcement action against manufacturers of "electronic cigarettes". These products should be removed from the market until and unless they are proven safe and effective. As you know, these "electronic cigarettes" are being marketed as alternatives to cigarettes and other tobacco products. Manufacturers and retailers of these products claim that electronic cigarettes are safe, and even that these products can help smokers quit traditional cigarettes. Simply stated, there is no scientific evidence whatsoever that these products do what these manufacturers and distributors claim nor is there evidence published in peer reviewed scientific journals that these products are safe. ... As the foremost organization of tobacco treatment professionals, ATTUD's position is to encourage only those attempts (evidence based) with the highest probability of success. Fortunately, there are seven (7) FDA approved tobacco treatment medications."

The Rest of the Story

What the Association for the Treatment of Tobacco Use and Dependence fails to disclose, in either its press release or its letter to the FDA, is that the organization has a severe financial conflict of interest regarding the electronic cigarette issue, by virtue of the conflicts of interest of at least two members of its executive board who have financial relationships with pharmaceutical companies that manufacture nicotine replacement products and stand to lose out in a major way if electronic cigarettes become popular.

For example, the incoming president of ATTUD - Dr. John Hughes - who is one of the co-signers of the letter to the FDA, apparently has conflicts of interest by virtue of his having consultancies, honoraria, and research grants/contracts with pharmaceutical companies.

Elsewhere (Drug and Alcohol Dependence, Volume 98, Issue 3, 1 December 2008, Pages 169-178), Dr. Hughes has disclosed that: "In the last 3 years he has received research grants from the National Institute on Health and Pfizer Pharmaceuticals and Sanofi-Synthelabo Pharmaceuticals both of whom are developing smoking cessation treatments. In the last three years, he has accepted honoraria or consulting fees from the following profit or non-profit institutions regarding nicotine or other drug abuse topics: Academy for Educational Development, Acrux DDS; American College of Chest Physicians, Adelphi Consulting, Aradigm; Atrium, Baltimore Research, Campus Consulting, Cambridge Press, Cline, Davis and Mann; Concepts in HealthCare, Constella Group; Consultants in Behavior Change; Cowen Inc, Cygnus, Edelman, Fagerstrom Consulting; Free and Clear; Healthwise, Health Learning Systems, International Marketing Systems, Insyght; Johns Hopkins University; Maine Medical Center, McNeil, Medicus, Nabi, National Institutes on Health; NCI Consulting, Pfizer Pharmaceuticals; Pinney Associates; Research Triangle Institute, Shire Health London; Temple University of Health Sciences; University of Arkansas, University of Auckland; University of Cantabria; University of Greifswald; University of Kentucky, University of Memphis, Warner Pharmaceuticals, Wolters Press, Xenova, and ZS Associates."

Thus, Dr. Hughes is essentially a walking conflict of interest with Big Pharma.

None of this is disclosed in the letter to the FDA or the press release as they appear on the internet.

The current ATTUD president - Dr. Michael Burke - the other co-signer of the letter to the FDA, has apparently recieved honoraria from Pfizer Health Solutions, a subsidiary of the pharmaceutical company Pfizer, according to a disclosure posted on the ATTUD web site. This is not disclosed in the letter to the FDA or the press release as they appear on the internet.

The position taken by the Association for the Treatment of Tobacco Use and Dependence is an absurd one. They are essentially stating that they'd rather see smokers continuing to remain on cigarettes rather than use electronic ones, even though the latter are demonstrably much safer. The stated reason for this preference is that the electronic cigarettes have not been proven to be safe. But as Jacob Sullum pointed out, this is like telling a drowning person not to use a lifeboat because the lifeboat has not been studied to see if it might have a leak.

In my opinion, what the Association for the Treatment of Tobacco Use and Dependence is really doing is protecting their profits and those of the pharmaceutical companies with which they have significant financial relationships. To be sure, electronic cigarettes represent a huge threat to these pharmaceutical companies, because for once, we have a form of nicotine replacement therapy (NRT) that is actually effective.

Rates of long-term success with pharmaceutical company nicotine replacement therapy are dismal, somewhere on the order of 6-8% and even lower for smokers with lower levels of motivation to quit. However, there is abundant evidence that electronic cigarettes can be very effective in keeping smokers off cigarettes, even heavy, long-term smokers who have had little or no success with traditional NRT in the past.

The accuracy of the letter to the FDA from the Association for the Treatment of Tobacco Use and Dependence is highly questionable where it states that "ATTUD's position is to encourage only those attempts (evidence based) with the highest probability of success." The evidence base shows that those quit attempts with the highest probability of success are cold turkey attempts which are unplanned and taken without the aid of pharmaceuticals. In fact, if ATTUD was truly doing what it says it is doing, it would not be recommending the use of NRT products, but instead would be trying to find ways to motivate smokers to make dramatic cold-turkey quit attempts.

The rest of the story is that ATTUD appears more concerned with serving the interests of its own practitioners, who largely depend upon pharmacetical money and traditional pharmaceutical-based smoking cessation programs for their livelihood than with serving the interests of smokers and of the public's health.

This has the appearance of an organization which is sacrificing the public's health in order to protect Big Pharma profits, motivated by a bias created by a significant financial conflict of interest with the pharmaceutical companies.

I believe it is unethical for a "health" organization like ATTUD to try to influence public policy with a press release and letter to the FDA without disclosing these significant financial conflicts of interest.

While it is shameful that health organizations are taking the position that a demonstrably safer product should be denied to smokers because of absolute proof of their safety, leaving them to return to smoking the clearly proven to be much more hazardous conventional ciagrettes, it is extremely problematic that such a position should appear to be motivated in part by a financial conflict of interest with Big Pharma and that this conflict of interest is not disclosed in communications to the public, the media, and policy makers that are designed to affect public policy.

[NicoNut]

Bill can we copy Dr. Siegel's commentary, to use in additional (follow up) letters to our Senators?

Thanks,
Julie

[yvilla]

Nico, I think it would be perfectly okay to use quoted sections of Dr. Siegel's writings, as long as you cite to the URL of the article you are quoting, as did Bill above.

[sherid]

Interesting comment on the Siegel blog today.
We want to thank Dr. Seigel for pointing out that we should have more explicitly disclosed potential conflicts of interest. ATTUD does have its finanical disclosures available on our website and this website was referenced in our letter to the FDA. In addition, usually policy statements and press releases do not include disclosures. Our failure to more explicitly disclose was not due to an attempt to decieve but rather to lack of clarity about when to explicitly disclose or due to simple negligence on our part. Nevertheless, we agree it would have been better to explicitly disclose and we have sent an addendum letter to the FDA with this disclosure. We hope the validity of our statement will be based on the science and logic of the statement and not on our failure to more explicitly disclose.

John Hughes for ATTUD
John Hughes/ ATTUD | 05.15.09 - 7:56 am

I made this comment to that letter.
"We hope the validity of our statement will be based on the science and logic of the statement"
Which part of the letter showed either science or logic? Do you support Chantix, a drug that has brought misery to hundreds perhaps thousands of families? If your goal is to provide a safe way to quit smoking, have you demanded that the FDA take Chantix and Wellbutrin off its list of approved products?