January 25, 2018

Stanton A. Glantz, PhD

FDA advisors say evidence doesn't back Philip Morris' claim that IQOS cuts disease risk

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) just voted not to accept Philip Morris' claims that its new heat-not-burn product, IQOS, is less dangeous than cigarettes.   As the press coverage (summarized below courtesy of Stan Shatenstein:), this is an important development.

As followers of this blog know, UCSF has submitted 10 public comments supporting the scientific conclusion that IQOS is not safer than conventional cigarettes and that even allowing "reduced exposure" claims would be misinterpreted as reduced harm claims.  (You can see my plain English language summary of why Philip Morris' own data does not support the claim that IQOS is safer than cigarettes.)  For the same reasons, FDA should not approve PMI's premarket application to to sell IQOS in the US because doing so would not be "good for public health," which is the standard in the law.

Other countries should not be tricked by PMI's claims.

Here is the press coverage:

"A U.S. Food and Drug Administration advisory panel said evidence doesn't support Philip Morris International's claim that its heat-not-burn tobacco product cuts the risk of tobacco-related diseases. The committee voted against the claim 8-0 with one abstention. The panel also rejected a claim that iQOS is less risky than continuing to smoke cigarettes in a 5-4 vote. The committee voted 8-1 in favor of Philip Morris' claim that iQOS reduces the body's exposure to harmful or potentially harmful chemicals. Members who approved of the measure then voted 5-2 with one abstention against the claim that reductions in exposure are reasonably likely to translate to a measurable and substantial reduction in morbidity and or mortality." [Angelica LaVito, In high-stakes vote, FDA advisors say evidence doesn't back Philip Morris' claim tobacco product cuts disease risk, CNBC]

In high-stakes vote, FDA advisors say evidence doesn't back Philip Morris' claim tobacco product cuts disease risk

https://www.cnbc.com/2018/01/25/philip-morris-stock-falls-as-committee-reviews-iqos-claims.html

U.S. panel rejects Philip Morris claim iQOS reduces disease risk

https://www.reuters.com/article/us-health-tobacco-pmi/u-s-panel-rejects-philip-morris-claim-iqos-reduces-disease-risk-idUSKBN1FE2IQ

Philip Morris Falls as Tobacco Device Hits Snag on Health Risks

https://www.bloomberg.com/news/articles/2018-01-25/high-tech-tobacco-gadget-hits-snag-in-push-to-disrupt-smoking

Comments

Comment: 

PMI's TPSAC presentation is here.  It's nice that TPSAC didn't get blown away with the fancy graphics.  I was particularly taken by slides 56 and 57 in which PMI says that IQOS lowered biomarkers of harm without pointing out that most of the changes were not statistically signifcant (i.e., within random fluctuation). 

Add new comment

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.