Finally, U.S. House of Representatives Holds FDA Tobacco Officials Accountable for Regulatory Missteps

 

This blog has long detailed the FDA Center for Tobacco Products’ (CTP) continuing campaign against vastly safer cigarette substitutes. 

Now House Committee on Oversight and Accountability Chairman James Comer (R-KY) has written FDA Commissioner Robert Califf demanding “documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions.”  This is a key paragraph:

“In conjunction, FDA must also clearly and accurately communicate information regarding the relative risk that products, to include ENDS [electronic nicotine delivery systems] and smokeless products, pose—and do not pose—to the adult nicotine product user population. Since 2005, the percentage of adult smokers in the United States has fallen from 20.9 percent to 12.5 percent. Nevertheless, there are still 30 million adult smokers in the United States, and nearly half a million Americans die from smoking related disease every year. This is a population that could benefit from accurate information and access to potentially safer FDA authorized products.”

FDA officials will likely deflect and assert that definitive relative risk information for ENDS and smokeless products is uncertain or inconclusive.  In fact, the relative risks for smokeless tobacco products like Swedish snus and American dip/chew products are roughly 2% of those for cigarettes, and 5% or less of those for vapor products. 

I hope Chairman Comer’s letter elicits other important information, such as why FDA officials didn’t publish clear guidelines for pre-market tobacco applications (PMTAs) prior to the deadline for PMTA submissions.  The agency perversely insisted that manufacturers of each new product first prove that it was “appropriate for protection of the public health,” without the benefit of any guidance.  That process resulted in millions of applications and gross review mismanagement by FDA staff.

The agency has until April 11 to respond to Chairman Comer’s demands.  That’s about two weeks, when some 18,400 more American smokers will die.

 

 

American Cancer Society & CDC Withheld Evidence on Safer Smokeless Products

The Centers for Disease Control (CDC) and the American Cancer Society (ACS) have a long history of suppressing information about the relative risks of smokeless tobacco (ST) products. (CDC example here)

CDC and ACS researchers in 2007 jointly published a mortality study of smokers who had switched to ST (here).  Using data from the ACS 2^nd Cancer Prevention Survey (CPS-II), they reported that smokers who switched to ST had slightly higher risks than smokers who became abstinent.  However, the authors omitted a critically important comparison group: smokers who continued smoking. 

The ACS and the CDC had always avoided direct comparison of smokers with ST users because they knew that ST users incurred vastly lower risks.  This time, their omission was glaring.   

In February 2007, I filed a federal Freedom of Information Act request for access to the ACS dataset.  The CDC denied my request seven months later, claiming that the CDC authors had not had access to the data.

A month later, in October 2007, I filed an appeal with the HHS Deputy Assistant Secretary for Public Affairs, raising two issues:

• CDC co-authors would not willingly violate the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, a mandate that authorship be based on substantial contribution to the conception and design, acquisition of data, or analysis and interpretation of data.  My position was that CDC authors were effectively co-owners of the data.

• There was incontrovertible evidence that the CDC possessed or had access to the CPS-II Dataset.  I noted, “The CDC maintains the SAMMEC website, which ‘calculates annual smoking-attributable deaths, years of potential life lost, smoking-attributable expenditures, and productivity losses for adults in the United States, individual states, and user-defined populations.’  The methodology section of SAMMEC states that it ‘uses unpublished age-adjusted RR estimates for persons aged 35 years and older from the second wave of the American Cancer Society's Cancer Prevention Study (CPS-II), 6-year follow-up.’”

More than two years later, in June 2010, HHS denied my appeal, asserting, “These primary data are in the possession of the ACS. CDC did not have any role in collecting or defining these data and never had possession of it. ACS never sent CDC its CPS-II primary data and it never allowed CDC to access the data or to submit computer programs to access the data. The ACS never showed any intent to relinquish control over the data.”

For 30 years, the CDC has been the source for smoking-related U.S. and global mortality estimates (discussed here).  Critical measures used to generate these numbers are the relative risk estimates from CPS-II, which are apparently the private property of the ACS and which have never been validated by external experts, even those at the CDC. 

I wrote ACS CEO John Seffrin in 2010: “I urge the ACS to release comparable risk estimates for male smokers, smokeless tobacco users and switchers in CPS-II…In addition, the ACS should release the CPS-II data, so that the risk estimates for all tobacco users can be validated by external scientists.”  I pointed out, “Earlier this year, Lawrence Deyton, director of the FDA Center for Tobacco Products, Principal Deputy Commissioner Joshua Sharfstein and Commissioner Margaret Hamburg authored a commentary about tobacco regulation for the New England Journal of Medicine, in which smoking and tobacco use were used synonymously (here). These physicians wrote that ‘tobacco use causes more than 400,000 deaths in the United States annually…,’ and they described ‘tobacco products’ as ‘the leading cause of preventable death in the United States.’”

I explained, “When FDA officials characterize all tobacco products as equally lethal, they are effectively denying smokers lifesaving information about safer cigarette substitutes…The public health is not well served when information that can save lives is buried and/or ignored. The selective and incomplete provision of risk information by the ACS is contrary to its public health mission and will only serve to hamper the FDA from undertaking an independent assessment of this issue in pursuit of its overarching mission: reducing the harm associated with tobacco use.”

ACS Chief Medical Officer Otis Brawley denied my information request, writing, “We have not found it productive to share the CPS-II data with researchers supported by the tobacco industry, because of their repeated misuse and misrepresentation of the data.”  Both letters were copied to Deyton, Sharfstein and Hamburg.

I described the ACS correspondence in my blog (here), where I noted, “I have conducted research on tobacco harm reduction for almost 20 years; published numerous studies in professional journals; written dozens of articles in the general media; and given hundreds of lectures. No one has ever accused me of misusing or misrepresenting any data.”

This is how the CDC and ACS have for years ignored and buried evidence documenting that smokeless tobacco use is vastly safer than smoking.

British Government Tells Smokers & Vapers the Tobacco Truth

While U.S. government health agencies include e-cigarettes in their decades-long attack on tobacco harm reduction and safer tobacco alternatives, public health leaders in Britain are telling the truth about e-cigarettes. 

The UK’s National Centre for Smoking Cessation and Training last week issued e-cigarette recommendations for practitioners and services via a “briefing” document.  As Clive Bates noted (here), it “represents a new worldwide high point in the blending of evidence with empathy in official public health advice.”  Furthermore, it represents a powerful antidote to the dangerous misinformation campaign being waged by the FDA, CDC, NIH and other U.S. agencies and organizations.

The new briefing follows positive British government reports on e-cigarettes issued in 2011 (here), 2014 (here) and 2015 (here).

Britain’s message is clear: “We begin by acknowledging that e-cigarettes are considerably safer than smoking cigarettes, are popular with smokers and that they have a role to play in reducing smoking rates.”  The briefing dispels dark myths that are the staple of tobacco abolitionists, including the shibboleth about nicotine.

“Nicotine does not cause smoking related disease, such as cancers and heart disease. These are caused by other chemicals found in tobacco smoke. Nicotine is addictive however and it is why people continue to smoke despite knowing about the harmful effects of tobacco. Nicotine in e-cigarettes poses little danger to adult users.”

The briefing addresses, in common sense terms, the risk of e-cigarette-related poisoning of children, a subject that is wildly exaggerated in the U.S. (here):

Should health professionals recommend e-cigarettes to smokers?  This is anathema in the U.S.; in Britain, practitioners are encouraged to:

“Familiarise yourself with e-cigarettes…Be positive when speaking about e-cigarettes. When you say: ‘We can’t recommend e-cigarettes’, people hear: ‘E-cigarettes are no good’. Instead choose words that convey a positive message such as: ‘We can’t supply them, but we can certainly offer the extra support that will help you stop smoking if you buy your own e cigarette’… Don’t push people to come off their e-cigarette…Some practitioners feel it is important to get people off nicotine as soon as possible, but in fact longer-term e-cigarette use can be a protective factor against relapse back to smoking.” (original emphasis)

 Regarding the chance of exploding e-cigarettes, the briefing advises:

“As with any rechargeable device, like mobile phones and laptops, it is important to charge with the correct charger and not to leave an e-cigarette unattended whilst charging. Ensure that you buy from reputable suppliers and avoid generic charging equipment.”

What about harmful chemicals and secondhand vapor?

“Some studies have detected chemicals in e-cigarette vapour that are known to cause health problems. However, these chemicals have been found at very low levels that are unlikely to represent a serious risk to health. When e-cigarettes are used within normal operating levels (e.g. not overheated), there are far fewer harmful chemicals present in their vapour than in tobacco smoke. If the e-liquid is being overheated it tends to produce an acrid, unpleasant taste – you will know if this happens!...There is no evidence that secondhand vapour is dangerous to others; however, it helps to be respectful when using e-cigarettes around others, especially non-smokers.”

These are only a few examples of the “evidence and empathy” offered in this enlightened British report.  Available here, it should be required reading for all federal, state and local authorities in the U.S.