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Archive for February, 2013

US Food & Drug Administration appoints new director of Center for Tobacco Products

24 Feb, 13 | by Marita Hefler, News Editor

The US Food and Drug Administration (FDA) has announced that Mitchell Zeller, J.D., will assume the role of director of the Center for Tobacco Products on March 4, 2013. He will replace Dr Lawrence Deyton, who, as the first head of the Center for Tobacco Products, led the unprecedented charge by the FDA to implement the Family Smoking Prevention and Tobacco Control Act. The Act gave the federal government authority to regulate tobacco for the first time.

Legacy President and CEO Cheryl Heaton has warmly welcomed the FDA’s decision to appoint Zeller, who is an accomplished lawyer, tobacco control strategist and advocate for public health. Zeller was the former associate commissioner of the FDA under David Kessler and previously served as health policy expert with Pinney Associates as well as Executive Vice President at Legacy during its formative years.

Zeller helped lead The Strategic Dialogue on Tobacco Harm Reduction (the Dialogue) among public health experts. “Zeller’s thought leadership and foresight on the regulation of tobacco and reducing smokers’ health risks will be an invaluable asset to the FDA as it moves forward with its tremendously important mission”, said Dr Healton.

Read the full legacy statement here.

Imperial Tobacco awarded for “social and economic contribution to Polish society”

20 Feb, 13 | by Becky Freeman, Web Editor

Seems this business award committee forgot about all of Imperial’s sick, dying and dead customers. I wonder if the local community contributions included addicting children to tobacco and breaking up families? This latest award provides yet further evidence of the tobacco industry using corporate social responsibility programs to polish is tarnished image and avoid government regulation.


Tobacco Reporter writes:

Imperial Tobacco’s operation in Poland has been handed a prestigious award by the nation’s leading business organisation.

The ‘Diamond to the Gold Statuette of the Business Leader’ was awarded in recognition of Imperial’s social and economic contribution to Polish society.

The award was made at the annual Grand Gala of Business Leaders held in Warsaw by the national Business Centre Club.

Imperial was chosen by a jury of leading business people who looked at how companies take care of their employees, contribute to local communities and engage with stakeholders.

The award, which builds on the gold statuette Imperial received last year, was accepted by Grażyna Sokołowska, corporate and legal affairs manager Poland.

“I’m delighted we’ve been recognised as a responsible business making a valuable contribution, which can only be achieved through the efforts of all our employees,” said Sokołowska.


New Zealand government to introduce tobacco plain packaging

19 Feb, 13 | by Marita Hefler, News Editor

The New Zealand government has announced it will introduce tobacco plain packaging. The announcement follows cabinet consideration of a public consultation process, held in late 2012, which received approximately 300 substantive submissions together with an additional 20,000 responses. The announcement puts New Zealand on track to become the second country in the world to introduce plain packaging. In order to manage potential legal risks, the government will wait to see the outcome of legal processes in Australia, with the intention of introducing legislation before the end of 2013. According to the government, tobacco is responsible for approximately 5000 deaths per year.

Read the full New Zealand government statement here.

Nicotine replacement therapy isn’t all it’s cracked up to be

19 Feb, 13 | by Marita Hefler, News Editor

This article was originally published at The Conversation. The original URL is here.

Ross MacKenzie, Macquarie University

A study published in the latest edition of the journal Tobacco Control confirms what we’ve long suspected about nicotine replacement therapy (NRT): smokers don’t need to resort to these pharmaceuticals to quit.

Researchers at the Harvard School of Public Health and the University of Massachusetts analysed relapse rates among 787 Massachusetts smokers who had recently quit, in three waves of interviews between 2002 and 2006. Participants were asked how they quit smoking, if they used NRT and in which form – gum, patch or inhaler. They were also asked to describe the longest period of continuous use of the product and if they received any form of cessation counselling.

Accounting for variation by gender, race, age, education and level of nicotine dependence, the researchers found that people who relapsed into smoking did so at equivalent rates, whether or not they had used NRT to assist in their quit attempt.

The findings add to the growing literature that questions the effectiveness of NRT to help people quit smoking.

What does the evidence say?

Clinical trials have reported that NRT increases the success rate of quitting by 50% to 70% compared to those receiving placebo. But these impressive results have not been replicated in real-world settings. Population-level studies have found no beneficial effect of the use of nicotine replacement therapy.

Selection criteria covering trial participants and the terms of their participation are among the key reasons for the marked difference in findings.

Research shows that unassisted cessation, or cold turkey, remains the most successful method of quitting. Yet questions about the efficacy of NRT often provoke intense debate within the tobacco control community, with clear implications for countries with high smoking rates which are yet to implement comprehensive tobacco-control regulations.

Perceptions of the effectiveness of NRT are also relevant to Australia and other countries that have enacted advanced legislation. Australia’s adult smoking rate is at a historic low of 15.1%, but tobacco consumption remains a leading public health concern. Some 3.3 million adults continue to smoke daily or weekly, and 15,000 Australians die annually from smoking-related diseases. The total social cost to the national economy is estimated to be $31.4 billion.

More than 15,000 Australians die annually from a smoking-related diseases. Image from


Tobacco control policy

Despite the growing evidence of the limitations of NRT in “real-world” situations, pharmaceutical patches, inhalers and gums continue to play a key role in smoking cessation policy.

The Quit Victoria website states that smokers “who have the best chance of quitting are those who get some coaching and use quitting medications”; while NSW Health says proper use of NRT products can be “the key to successfully quitting for good.”

The Commonwealth Department of Health and Ageing’s National Tobacco Campaign states that smokers can double the chances of quitting successfully by using cessation medication, but questions the veracity of ex-smokers’ claims to have quit without medication:

Though many people will say that they have quit cold turkey, often they have used medication or advice and support to help them through.

Support for NRT has been translated into government policy, following a submission to the Pharmaceutical Benefits Advisory by Cancer Council Australia, Heart Foundation, Australian Council on Smoking, and Health and Quit Victoria. Nicotine patches have been subsidised on the Pharmaceutical Benefits Scheme as a prescription smoking-cessation aid since 2011, at a cost of $9 million in the first year of subsidisation.

Another promoter of NRT is, of course, the pharmaceutical industry. The 2011 global sales of NRT were worth an estimated US$2.4 billion. In Australia, patches, gum, and other forms of NRT have been available over the counter for years, and the market continues to expand. Sales increased by 7% in 2011 to $174 million, and market analysts predict continuing strong sales, due in part to the growing range of NRT products available in supermarkets.

Time for evidence-based policy

Pharmaceutical cessation products continue to attract support disproportionate to their usefulness. This distracts attention from the reality that the most common method used by most ex-smokers remains unassisted cessation.

Perhaps most importantly, it threatens funding for evidence-based population level interventions – such as tax increases and media campaigns – that have been primarily responsible for the precipitous drop in smoking rates in Australia in recent decades.


Same meeting, different day – FDA fails to make real change to tobacco product consultation

6 Feb, 13 | by Becky Freeman, Web Editor

Following Ruth Malone’s earlier letter declining to be part of a “facilitated dialogue” with the tobacco industry sponsored by the US Food and Drug Administration (FDA), the FDA revised the schedule and invited her again to a meeting with public health, academic and government tobacco control leaders on the first day and invited tobacco industry presentations on the second day. In the letter below, she explains why she is again declining to participate:


Dear Dr. Deyton and tobacco control colleagues,

I do appreciate the attempts of the Center for Tobacco Products to respond to the issues raised in my previous letter declining the invitation to be part of the planned “dialogues” panel with the tobacco industry. But while I applaud the dropping of the “facilitated dialogues” meeting characterization, the proposed revised format (which clusters invited presentations from government, academics and public health representatives on day one, followed by invited presentations from the tobacco industry on day two) does not adequately address the substantive issues raised in my letter. It remains the same meeting, with the same agenda and purpose, merely rearranging the program. Therefore, I must again respectfully and regretfully decline your invitation to attend this particular meeting.

The first point raised in my previous letter related to regarding tobacco companies as equivalent “stakeholders” with public health. I see nothing in the revised format that changes this, since public health and tobacco company representatives continue to be placed on the same meeting agenda as coequals, albeit now on different days. Tobacco companies are stakeholders only in the promotion of tobacco product use, not promoting public health, which is the purpose of the Family Smoking Prevention and Tobacco Control Act. While the tobacco companies have every right to express their opinions and submit materials for the FDA’s consideration, you are not required to treat the regulated industry “equally” as though they had demonstrated materially that they share the goal of protecting public health. They have not done so.

My second point addressed the absence of mutual understanding of what constitutes legitimate science and ethical conduct in science. The revised format does nothing to reassure me that a reasonably comprehensive understanding of Judge Kessler’s extensive Findings of Fact in her ruling in the Department of Justice RICO case (USA v. Philip Morris et al.) is now informing the FDA’s activities or has been incorporated into the agenda. (These Findings of Fact are clearly relevant for the FDA to consider in its decision making, as indicated by the fact that Congress included three findings (numbers 47, 48, and 49) from Judge Kessler’s ruling in the Family Smoking Prevention and Tobacco Control Act.) While there has been a proliferation of smaller tobacco and nicotine device companies that are not defendants in the RICO case, the fact remains that the major cigarette companies continue to dominate the market both in this country and in the world, that they continue patterns of acquisition of the more promising smaller companies, and that the federal court found their fraudulent conduct was continuing and likely to continue into the future. This is highly material to any discussion of industry-sponsored tobacco products research.

Third, it is clear that this meeting has indeed had the effect of contributing to divisions within tobacco control, as some invitees now feel they must attend and others (including me) feel they must decline. Whether it is officially called “facilitated dialogue” or “public workshop” seems less important in this regard than the fact that it is still one and the same meeting with the chairs rearranged, and it did not have to happen this way. It is disturbing when public health agencies contribute to such divisions.

Fourth, the tobacco companies have every right to make comments and one would expect them to do so, and the FDA has a responsibility to give comments from the regulated industry fair consideration. But legal colleagues have advised me that while the FDA is certainly permitted to invite industry speakers to present at a meeting on how to deal with industry science, there is no legal requirement that they do so, and in the absence of such a requirement, I continue to question why FDA feels it must give the industry a stage. They certainly do not have such status even on the TPSAC, where they are separated by being non-voting members. Your legal mandate is to regulate this industry in the service of public health, not to provide it a podium for its propaganda.

The leading tobacco companies have repeatedly demonstrated antipathy to the FDA, creating multiple obstacles to its ability to carry out its responsibilities for implementing the Family Smoking Prevention and Tobacco Control Act. Far from being equal “stakeholders” in the FDA’s mission, some have sued to block implementation of health warning labels and others are openly flouting FDA’s regulations banning the use of “light” and “mild” and other descriptors, simply replacing these words with color coding. These are only the most obvious examples.

Our current moment does not call for a cautious, prolonged and exorbitantly expensive replay of the infamous “safer cigarette” debacles of the past, in which the tobacco industry “partnered” with health researchers in a cynical ploy to buy decades more time at the expense of millions of lives. What is called for now is the political courage to acknowledge and incorporate decisively in policy planning the vast evidence demonstrating that tobacco companies are untrustworthy—hence the need for strong, rapidly enacted and well-enforced regulations to protect the public from suffering another century of tobacco-caused deaths. What is called for now is informed, savvy leadership. I urge FDA to provide it.

Please enter this letter and the earlier letter to which it refers into the record of the meeting. If necessary, I would be willing to arrange for someone to attend and read these into the record.

Thank you for your consideration.

Ruth E. Malone, RN, PhD, FAAN
Professor and Chair, Department of Social & Behavioral Sciences
Editor-in-Chief, Tobacco Control

Download PDF of Letter to FDA

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