New Book Blasts FDA Tobacco Legislation

Michael Siegel on his “Rest of the Story” Tobacco News Analysis and Commentary on Friday wrote about a new book that blasts FDA Tobacco Legislation and argues that the Anti-Tobacco movement was burned by Philip Morris. Pretty interesting reading and a book I’m sure many will want to read. Here is the article from Michael Siegel. What are your thoughts about what he proposes? Do you think this book will have any affect on the future of this bill as it approachs the senate and the president? Do you agree with the books author? What are your thoughts?  

A new book soon to be released by the Democracy Institute provides the most comprehensive analysis and critique of the issue of FDA regulation of tobacco products ever produced. Patrick Basham, director of the Democracy Institute, analyzes the history of the FDA tobacco legislation, the nature of the negotiations that led to the crafting of the bill currently before Congress, the interest of Philip Morris in pursuing regulation, the likely effects of the bill, the basic policy issues involved in regulation of tobacco products, and the merits of the overall regulatory scheme created by the proposed legislation.

Citation: Patrick Basham. Butt Out! How Philip Morris Burned Ted Kennedy, the FDA & the Anti-Tobacco Movement. Washington, DC: Democracy Institute, 2009. Copyright 2009 by Patrick Basham.

Order from the Democracy Institute, or email: info@democracyinstitute.org.

Basham has taught tobacco regulation and policy courses at the Johns Hopkins University and his thinking was influenced by vigorous debates in his classes, in which various sides of the issue were considered. Thus, his opinions are informed by knowledge of the interests of both the public health advocates and the tobacco executives who negotiated the bill. The book is a must-read for anyone who is interested in the tobacco issue, and I believe it should be required reading for every organization that is supporting the legislation.

From his extensive and detailed analysis of the scientific, regulatory, and policy issues, Basham concludes that “giving the FDA the authority and the responsibility for a good chunk of the U.S. tobacco file is a mistake of epic proportions.”

He writes: “Handing tobacco regulation over to the FDA is tantamount to giving the keys of the regulatory store to the nation’s largest cigarette manufacturer, Philip Morris. that is because the legislation on FDA tobacco regulation has been cooked up out of public sight over the last few years by a partnership of Philip Morris, certain groups from the public health establishment, and Senator Edward Kennedy and Congressman Henry Waxman.”

“Kennedy, Waxman, and the public health establishment, led by the Coalition for Tobacco-Free Kids, are presenting their proposed legislation as a masterful regulatory stroke that will end tobacco marketing, prevent kids from starting to smoke, make cigarettes less enjoyable to smoke, and reduce adult smoking. But FDA regulation of tobacco will do none of these things. That is because Philip Morris skillfully hoodwinked a coalition of ‘useful idiots,’ including the Campaign for Tobacco-Free Kids, Senator Kennedy, and Congressman Waxman, at every turn. … FDA regulation of tobacco will serve the interests of Philip Morris, not the interests of the anti-tobacco movement nor their sage congressional partners, and most assuredly, not the interests of the American public.”

Basham defines “useful idiots” as “those members of the anti-tobacco movement whose naivete was exploited by, and to the benefit of, Philip Morris.”

How we got to such a situation, how the Campaign for Tobacco-Free Kids and other anti-smoking groups were hoodwinked into negotiating with Philip Morris and supporting the resulting legislation, is the fascinating subject of the first two chapters of “Butt Out!” Basham describes how FDA regulation of tobacco products was actually part of a plan by Philip Morris to capture regulation: giving it the public appearance of being a reformed company that is willing to subject itself to strict safety standards but through carefully crafted compromises, ensuring that the true effect of the legislation would be to further the company’s financial interests.

Basham reveals that the legislation was the result of a secret, carefully hidden negotiation between Philip Morris and the Campaign for Tobacco-Free Kids. These tough negotiations resulted in number of important compromises by the public health groups that severely limited FDA’s regulatory authority. Worse, the Campaign for Tobacco-Free Kids never told the truth about the fact that it was negotiating with Philip Morris, a fact that it has still not disclosed.

Importantly, Basham does not dismiss the legislation simply because it was negotiated with Philip Morris. That fact leads to his giving critical scrutiny to the details of the legislation. But his condemnation of the legislation is based on a detailed analysis of the actual provisions of the bill, which is provided in Chapter 3. Basham goes through a checklist of the potential public health benefits of the legislation, and based on a review of the scientific evidence, concludes that very few of the bill’s provisions will actually serve public health interests. He argues that the public health groups have indeed been outsmarted and that the bill serves the interests of Philip Morris, not those of the anti-tobacco movement.

Chapter 4 provides a detailed analysis of several of the central provisions of the legislation. The one measure which might legitimately be thought to have positive health benefits – the mandated warning labels – will likely not be effective, Basham argues, based on research into psychological reactance theory. The regulation of nicotine levels may actually be counterproductive, because lowering nicotine levels will result in greater tar exposure. Basham also offers some thoughts as to how and why the anti-tobacco groups got it so wrong.

In Chapter 5, Basham provides a more basic argument against FDA regulation of tobacco products: that the bill would burden an already troubled agency and undermine its basic mission.

Finally, in chapter 6, Basham shares his own thoughts about what a sensible, science-based, and effective national strategy for tobacco control might look like. I’ll leave readers to order the book to see the approaches that Basham suggests, but one point he emphasizes is that whatever the approach, unlike the current FDA legislation, it must be transparent, guided by accurate science rather than by ideology, blind faith, or politics, and it must communicate accurate scientific information to the public.

This book is a must-read for Rest of the Story readers and anyone interested at all in tobacco control policy.

The Rest of the Story

In light of the revelations brought forward in “Butt Out,” I challenge the Campaign for Tobacco-Free Kids and other anti-smoking and health groups which are supporting the FDA tobacco legislation to:

1. Publicly acknowledge that the legislation was the result of a Congressionally-mediated negotiation between the Campaign for Tobacco-Free Kids and Philip Morris.

2. Publicly acknowledge that the Campaign for Tobacco-Free Kids and other groups have been deceiving the public and their own constituents by hiding the fact that the legislation was crafted, in part, by Philip Morris, which played a major role at the negotiating table.

3. Publicly acknowledge that the many loopholes in the bill that severely limit the FDA’s authority represent compromises that were made to appease the financial interests of Philip Morris, and that they do compromise public health protection in order to retain Philip Morris’ support for the bill.

4. In light of the revelations and detailed analysis in “Butt Out,” to renounce their support of this legislation and instead, join me in helping to craft a truly effective science-based piece of federal legislation in an open, transparent, and inclusive process — guided by science and evidence, rather than ideology, blind faith, and politics — that will actually result in a significant reduction in adult and youth smoking, and therefore, in substantial public health protection.

6 comments ↓

#1 OTP Kid on 04.22.09 at 3:15 PM

The FDA remains a completely unaccountable agency. The FDA approves drugs, and yet when those drugs that they approved are found to kill people, they have zero liability while the pharma companies pay billions of dollars in lawsuits for products the FDA said were safe. Therefore, they seem like the perfect agency to regulate tobacco, don’t they?

I will not be surprised if they ban not only menthol, flavors, etc, but they may require a prescription to buy tobacco products since it would be within their right to do after they are handed the power to regulate.

#2 FEDUP on 04.22.09 at 8:49 PM

As much as I think you sometimes are off the wall with your comments in todays age government is run by folks worried about retaining the votes of those who are vastly becoming more and more dependent on the government to provide for them. When we live in a soceity that rewards folks for doing nothing as it rapes those who work hard it doesn’t surprise me at all!. Yep I can see it now, hey doc can you write me a script for a pack of Marlboro! Oh and just image can you put me on the 90 day plan and here’s my medical card I got from the welfare office! BRILLIANT!

#3 Copenhagen Charlie on 04.28.09 at 10:56 PM

It is most likely to late as look at how quick the democrats are moving to try to get a vote on it. Keep the folks dumb and don’t let them get the truth until its too late!

#4 Bill Godshall on 04.29.09 at 1:09 PM

Basham’s new book won’t have any impact until/unless its released.

#5 Bill Godshall on 05.07.09 at 2:16 PM

Sen. Kennedy has introduced his FDA tobacco bill (S. 982) and scheduled a Senate HELP Committee mark-up session on the bill beginning next Tuesday, May 12.

Please urge committee members (contact info below) to OPPOSE the bill unless/until it is amended to protect public health instead of cigarette markets.

Also below are Smokefree Pennsylvania’s letter to committee members, a suggested amendment, and two related news articles.

– – –

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880

May 7, 2009

Dear Senator

Smokefree Pennsylvania urges you to OPPOSE Senator Kennedy’s FDA tobacco bill (S. 982), a privately negotiated deal by Philip Morris and the Campaign for Tobacco Free Kids in 2004, because it protects the deadliest tobacco product (cigarettes) at the expense of far less hazardous smokefree tobacco/nicotine alternatives and public health.

Instead, please SUPPORT harm reduction amendments (see suggested amendment below) to:
– inform smokers that cigarettes are more hazardous than smokefree tobacco/nicotine alternatives,
– let smokefree alternatives (including electronic cigarette nicotine inhalers) remain on the market,
– encourage the industry to develop smokefree tobacco/nicotine alternatives to cigarettes.

As drafted, the Kennedy bill protects cigarette markets at the expense of public health because it:
– conceals the fact that cigarettes are far deadlier than smokefree tobacco/nicotine products,
– misleads consumers to believe that smokefree products are as hazardous as cigarettes,
– bans new and recently introduced (since 2007) smokefree tobacco products,
– allows/encourages FDA to ban smokefree nicotine products including electronic cigarettes,

Cigarettes are 100 times deadlier than smokeless tobacco products, while smokefree nicotine products (e.g. electronic cigarettes) pose even fewer risks. Switching from cigarettes to smokefree tobacco/nicotine alternatives reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use. Millions of smokers have already sharply reduced their health risks by switching to smokefree tobacco/nicotine alternatives. Unfortunately, 85% of smokers inaccurately believe that smokefree tobacco products are as hazardous as cigarettes. I coauthored a report “Tobacco harm reduction: an alternative cessation strategy for inveterate smokers” at http://www.harmreductionjournal.com/content/3/1/37

In contrast to claims by others, the Kennedy bill also would do little to reduce youth tobacco use (as it prohibits the FDA from banning tobacco sales to high school seniors, and prohibits the FDA from banning tobacco sales at stores accessible to minors). But at the very least, the bill should be amended to help save the lives of 45 million addicted cigarette smokers.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for tobacco victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

Thank you for your consideration, and feel free to contact me anytime.

Sincerely,

William T. Godshall, MPH
Executive Director

– – –

Suggested amendment to S. 982 to rank tobacco products according to health risks (adapted from Sec. 305 of the Burr/Hagan tobacco bill, S. 579). Please note that provisions to allow all smokefree tobacco/nicotine products to remain on the market need to be added to this suggested amendment.

In Section 911 of the Food Drug and Cosmetic Act (as added by Title I), insert
“(n) ESTABLISHMENT OF RANKINGS. –
“(1) STANDARD AND PROCEDURES. – Not later than 24 months after the date of enactment of this chapter, the Sectretary shall, by regulation, after consultation with an Advisory Committee established for such a purpose, establish the standards and procedures for promulgating rankings, comprehensible to consumers of tobacco products, of the following categories of tobacco products and also nicotine-containing products on the basis of relative risks of serious or chronic tobacco-related diseases and adverse health conditions those categories of tobacco products and also nicotine-containing products respectively present in –
“(A) cigarettes;
“(B) loose tobacco for roll-your-own tobacco products;
“(C ) little cigars;
“(D) cigars;
“(E) pipe tobacco;
“(F) moist
“(G) dry snuff;
“(H) chewing tobacco;
“(I) other forms of tobacco products, including palletized tobacco and compressed tobacco, treated collectively as a single category; and
“(J) other nicotine-containing products, treated collectively as a single category.
“(2) CONSIDERATION IN PROMULGATING REGULATIONS. – In promulgating regulation under this section, the Secretary –
“(A) shall take into account relevant epidemiologic studies and other relevant competent and reliable scientific evidence; and
“(B) in assessing the risks of serious or chronic tobacco-related diseases and adverse health conditions presented by a particular category, shall consider the range of tobacco products or nicotine-containing products within the category, and shall give appropriate weight to the market share of the respective products in the category.
“(3) PROMULGATION OF RANKING OF CATEGORIES – Once the initial regulations required by paragraph (1) are in effect, the Secretary shall promptly, by order, after notice and an opportunity for comment, promulgate and make available to the general public rankings of the categories of tobacco products and nicotine-containing products in accordance with such regulations. The Secretary shall promulgate the initial rankings of those categories of tobacco products and nicotine-containing products and make such ranking available to the general public not later than January 1, 2012. Thereafter, on an annual basis, the Secretary shall, by order, promulgate and make available to the general public updated rankings that are (1) in accordance with those regulations, and (2) reflect the scientific evidence available at the time of promulgation. The Secretary shall open and maintain an ongoing public docket for receipt of data and other information submitted by any person with respect to such annual promulgation of rankings.

– – –

Phone and fax numbers for Senate HELP Cmte members, and an e-mail address to contact all members of the committee.

Senate HELP Committee Phone Fax

Edward M. Kennedy (D-MA) 202-224-5465 202-224-5128
Chairman
Christopher J. Dodd (D-CT) 202-224-2823 202-224-1083
Tom Harkin (D-IA) 202-224-3254 202-224-9369
Barbara A. Mikulski (D-MD) 202-224-4654 202-224-8858
Jeff Bingaman (D-NM) 202-224-5521 202-224-2852
Patty Murray (D-WA) 202-224-2621 202-224-0238
Jack Reed (D-RI) 202-224-4642 202-224-4680
Bernie Sanders (I-VT) 202-224-5141 202-228-0776
Sherrod Brown (D-OH) 202-224-2315 202-224-6519
Robert P Casey, Jr (D-PA) 202-224-6324 202-228-0604
Kay Hagan (D-NC) 202-224-6342 202-228-2563
Jeff Merkley (D-OR) 202-224-3753 202-228-3997

Michael Enzi (R-WY) 202-224-5375 202-224-6510
Ranking Member
Judd Gregg (R-NH) 202-224-3324 202-224-4952
Lamar Alexander (R-TN) 202-224-4944 202-228-3398
Richard Burr (R-NC) 202-224-3154 202-228-2981
Johnny Isakson (R-GA) 202-224-3643 202-228-0724
John McCain (R-AZ) 202-224-2235 202-228-2862
Lisa Murkowski (R-AK) 202-224-6665 202-224-5301
Orrin G. Hatch (R-UT) 202-224-5251 202-224-6331
Pat Roberts (R-KS) 202-224-4774 202-224-3514
Tom Coburn (R-OK) 202-224-5754 202-224-6008

To send an e-mail to all members help_comments@help.senate.gov

– – –

A Discovery Channel Daily Planet interview with Dr. Carl Phillips on electronic cigarettes is at:
http://watch.discoverychannel.ca/daily-planet/may-2009/daily-planet-may-05-2009/#clip168932

– – –

Kennedy again proposes a bill to regulate the tobacco industry

By Richard Craver
Winston-Salem Journal
May 7, 2009
http://www2.journalnow.com/content/2009/may/07/kennedy-again-proposes-a-bill-to-regulate-the-toba/business/

The debate over whether to have federal oversight of the tobacco industry has resurfaced with the reintroduction of a bill in the U.S. Senate.

The bill, sponsored by Sen. Ted Kennedy, D-Mass., contains few major changes to the one he submitted last year that would put the industry under the auspices of the U.S. Food and Drug Administration.

That bill failed to pass the Senate because Sen. Richard Burr, R-N.C., threatened to tie up the bill with a filibuster and President Bush opposed the move.

The bill “would stop the marketing of tobacco products to children, require tobacco companies to list the poisons in their products and mandate larger and more effective warning labels on tobacco product packaging,” said John Seffrin, the chief executive of the American Cancer Society’s Cancer Action Network.

The latest version of the Kennedy bill does not include a separate category for smoke-free tobacco as a potential harm-reduction product.

Such a provision has been sought by some anti-smoking groups that view smoke-free products, such as moist tobacco, snus and dissolvables, as alternatives for tobacco users who can’t or won’t quit.

“We continue to believe that Sen. Kennedy’s bill is lacking,” said Maura Payne, a spokeswoman for R.J. Reynolds Tobacco Co.

“It would impede efforts to bring potentially reduced-risk tobacco products to market, would make it difficult for adult tobacco consumers to gain accurate information about the comparative risks between different types of tobacco products, and would task an already overburdened FDA with taking on regulation of a product category about which it has no expertise,” Payne said.

In March, Burr and Sen. Kay Hagan, D-N.C., introduced an alternative bill for federal regulation of tobacco products that would save cigarette companies billions of dollars over the next 10 years.

The proposed Federal Tobacco Act would create a new federal agency within the U.S. Department of Health and Human Services to solely regulate tobacco instead of assigning the task to the FDA.

Also in March, a key House panel approved legislation sponsored by Rep. Henry Waxman, D-Calif., to give the FDA oversight of tobacco, a move that set the stage for likely House approval later this year.

Both bills propose paying for the new regulation by imposing “user fees” on tobacco companies, with the largest share paid for by the nation’s two largest cigarette companies, Philip Morris and Reynolds.

Tobacco analysts said that the Burr-Hagan bill has only a slim chance of passing both the House and Senate, though some of its provisions could be incorporated into a final version of the Waxman bill.

Bill Godshall, the executive director of SmokeFree Pennsylvania, said that a drop-off in sponsorship for the Kennedy bill could open the door for an amendment aimed at smoke-free products.

“While Kennedy’s FDA tobacco bill last session had 59 co-sponsors, his new bill has only 40 co-sponsors, including just three Republicans,” Godshall said.

“I suspect that is why Kennedy delayed the bill’s introduction for more than two weeks — to try to get more co-sponsors and/or to get a lead Republican co-sponsor.”

Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.

#6 Bill Godshall on 05.08.09 at 3:07 PM

Here are names and phone numbers for Senate HELP Committe Staff to contact regarding Kennedy’s FDA Tobacco Bill.

All phone numbers begin with (202)-224

Senator Staffer Phone #
Kennedy Jeff Teitz 4-0767
Dodd Tamar Magarik Haro 4-2823
Harkin Daniel Stevens 4-3254
Mikulski Brigid Houton 4-4654
Bingaman Fred Isasi 4-5521
Murray Paula Burg 4-2621
Reed Seth GersonTopher Spiro 4-4642
Brown Jessica McNeice, Robert Downing 4-2315
Casey Morna Murray, Gillian Mueller 4-6324
Hagen 4-6342
Merkley 4-3753

Enzi Amy Mulberg 4-6770
Gregg Elizabeth Wroe 4-3324
Alexander Mary Sumpter Johnson 4-4944
Burr Josh MartinChris Wall 4-3154
Isakson Tyler Thompson 4-3643
McCain Talal Mir 4-2235
Hatch 4-5251
Murkowski Amanda Makki 4-6665
Coburn Stephanie Carlton, Evan Feinberg 4-5754
Roberts Alison Anway 4-4774

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