FDA TPSAC member Neal Benowitz grossly misrepresents evidence on tobacco harm reduction and smokeless tobacco

[Bill Godshall]

In an op/ed entitled "Smokeless tobacco as a Nicotine Delivery device: Harm or Harm Reduction?"
at http://www.nature.com:80/clpt/journal/v90/n4/full/clpt2011191a.html,
FDA TPSAC member Neal Benowitz (after writing 8 objective paragraphs) grossly misrepresented the scientific and empirical evidence about tobacco harm reduction and smokeless tobacco in the 9th paragraph by writing:

Although ST use increases the risk of some cancers, oral disease, disorders of pregnancy, and possibly cardiovascular disease, the major argument against its use for harm reduction is that it may result in dual use of ST and cigarettes, with fewer people quitting smoking. For example, ST may be used to relieve withdrawal symptoms when smokers are unable to smoke because of workplace or other restrictions, reducing the discomfort that would otherwise have prompted them to quit smoking. Another argument is that ST users who are able to reduce their cigarette consumption by this practice may believe that they are significantly reducing their smoking-related disease risk, when in fact that is not the case. Furthermore, there is evidence that ST use among US adolescents is a strong risk factor for becoming an adult smoker. A recent analysis modeling the benefit versus harm for the US population suggests that adoption of ST would not in the long term reduce harm for the population.2 Although anecdotally ST helps smokers quit, one controlled clinical trial found no long-term benefit for quitting.3 Therefore, at present there appears to be—at least at the population level in the United States—more risk than benefit in the use of ST for harm reduction or to aid in smoking cessation.

Then in the next two paragraphs, Benowitz touted the benefits of verenicline before acknowledging that he has received funding from drug companies that market smoking cessation products.

Unfortunately for objectivity and public health, Benowitz failed to mention and failed cite any of the many scientific articles that have found that:
- smokeless tobacco products are exponentially less hazardous than cigarettes,
- switching to smokeless reduces a smokers health risks nearly as much as quitting all tobacco,
- millions of smokers have already quit smoking by switching to smokeless tobacco,
- reducing cigarette consumption reduces health risks for smokers (and for those around them),
- dual usage of smokeless tobacco by smokers is a necessary prerequisite to switching,
- there are far more smokers who switch to smokeless than smokeless users who switch to cigarettes,
- smokeless tobacco is only a risk factor for smoking for those who believe the misleading warnings on smokeless tobacco products, and
- the most effective way to reduce the number of smokeless users who switch to cigarettes is by truthfully informing the public that cigarettes are far more hazardous than smokeless tobacco.

 

[Bill Godshall]

The American Council on Science and Health properly criticized Neal Benowitz for misrepresenting the evidence about tobacco harm reduction and smokeless tobacco products at
Dr. Benowitz stops short of advocating smokeless tobacco, yet again > Facts & Fears > ACSH

 

[Vocalek]

Wow. Maybe Dr. Benowitz could use a little nicotine to improve his own memory. On October 26, 2010, he testified at the FDA public hearing on Risks and Benefits of Long Term use of NRTs, reviewing the evidence on the safety of long-term use of snus and extrapolating from that evidence to indicate that long-term use of pharmaceutical nicotine would be just as safe. His slides can be viewd here: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf

"The lack of increase in common cancers in lifelong ST users indicates that nicotine is not a general cancer promoter." (Slide #7)

"Meta-analyses showing increased risk of MI and stroke in ST users are heavily weighted by CPS-I and CPS-II, which are older US studies with many methodologic problems. More recent Swedish studies and an NHANES study indicate minimal if any increased risk of CVD with ST." (Slide #13).

"Extrapolating ST Studies to Questions of Nicotine Safety
• No evidence that nicotine causes or promotes cancer
• Nicotine may slightly increase the risk of MI and stroke. If so the risks are far lower than those of cigarette smoking
• Nicotine likely has adverse effects on reproduction, including increasing the risk of pre-eclampsia and preterm birth" (Slide #15)

 

[rothenbj]

But Elaine, he was selling, er promoting, no, espousing the benefits of the pharmaceutical products that he gets paid, I mean knows have been proven "safe and effective" in the FDA's eyes. There, I think I have it worded properly.

 

[DC2]

I don't like Dr. Neal Benowitz, and would love the opportunity to tell him so.

 

[McCordRM]

Grr... you put the letters "D" and "R" in front of someone's name, and suddenly
they have a license to mis-inform the public. Shouldn't that be malpractice?