Some interesting news recently landed in Jeff Stier’s inbox.
“Today’s a good day to quit smoking!” proclaimed an email from NYC Quits, part of a statewide tobacco control program that gives away free nicotine patches and gum every year.
Stier, a risk analyst with the National Center for Public Policy Analysis, signed up for the program, not because he’s a smoker (other than the occasional cigar) but for research.
“I got a few free nicotine patches. I was interested in seeing if I could feel the nicotine,’ he told Watchdog.org. “But the next morning in the shower, I felt something strange on my skin and I was like, ‘Oh yeah, I forgot!’ It was imperceptible.”
Stier said the fact that the patch has government backing as a smoking cessation product is more alarming.
“If you’re a smoker and you want nicotine, this product is going to do nothing for most people,” he said.
The patch is one of four nicotine replacement therapies (NRT) approved by the FDA to help people quit smoking. Three others are prescription-only. Nicotrol NS is a nicotine nasal spray, while Chantix and Zyban are non-nicotine medications.
The FDA, however, does not report success rates for these products. And the best Smokefree.gov can do is say they “increase your chances of quitting successfully.”
Research varies, but one study found 9.2 percent of people who used the patch were still smoke-free after six months, versus 8.4 percent for Nicotine gum. According to WebMD, quit rates for all five NRTs range from 19 percent to 26 percent, while Chantix and Zyban are 33 percent and 24 percent effective, respectively.
Studies also show, however, that e-cigarettes might belong on the FDA’s list.
Researchers have found that e-cigarettes are not only 95 percent less harmful than the combustible version, but they have helped 6.1 million people in Europe quit smoking and another nine million have cut back on their habit.
In other words, 15.1 million smokers in the EU have either quit or curtailed an activity that kills 400,000 Americans per year, using a product that’s 95 percent less harmful.
But rather than add e-cigs to its nice list, the FDA — whose stated mission is “protecting the public health” — the agency warns against them for smoking cessation based on “potential health risks.”
Instead, the FDA is regulating vape products, possibly out of existence with the 2016 “deeming” rule that treats tobacco-less liquid nicotine products as tobacco products.
“So people who have tried to quit and failed, and tried to quit and failed, don’t have other choices that the public health establishment supports,” said Stier.
And that establishment is getting help from Big Pharma-funded medical research.
The prestigious Minnesota-based Mayo Clinic and its Nicotine Dependence Center, for one, has followed the FDA’s lead in calling e-cigarettes a method to avoid due to lack of risk data and “mixed results” of studies so far.
And Mayo Clinic addiction expert and researcher Dr. Jon Ebbert has been an outspoken critic for several years. The star of Mayo Clinic in-house podcasts and videos, Ebbert has repeatedly advised against e-cigs.
“I think we need to be very clear as clinicians that these electronic cigarettes have an unknown safety profile,” Ebbert said in Mayo Clinic videos in both 2015 and 2016,
And in a widely circulated 2013 column and a 2015 research paper, Ebbert advised clinicians to be “justifiably circumspect in recommending e-cigarettes” for smokers until there is more data.
But the fine print at the end of both lists the following “potential” conflicts of interest:
“Joe (sic) O. Ebbert, MD, MSc, reports receiving grants from JHP Pharmaceuticals, Orexigen, and Pfizer outside the submitted work; he also reports receiving personal fees from GlaxoSmithKline.”Pfizer makes Nicotrol NS, a nicotine nasal spray, and Chantix. The company’s website and a ProPublica database show Ebbert racked up $646,584 between 2010 and 2014 in research grants.
GlaxoSmithKline (GSK), which is responsible for Zyban and Nicorette gum and lozenges, paid Ebbert $7,129 in consulting fees in 2010 and 2011.
The Mayo clinic, Ebbert, and GSK did not respond to our requests for comment. Pfizer sent a statement saying physicians offer companies vital feedback and advice grounded in their expertise and clinical practice experience, and there’s nothing wrong with paying for it:
“Pfizer believes it is appropriate and ethical to fairly compensate healthcare professionals for the work they do with us. Pfizer does not pay healthcare professionals for prescribing our medicines or using our medical devices, or as an inducement for promoting our products.”
Appearance of bias
Boston University public health professor and tobacco control expert Dr. Michael Siegel agrees, drug company money doesn’t mean a researcher is going to consciously bias the results. But as the full-court press on e-cigarettes demonstrates, bias can still exist.
“Conflict of interest refers to a subconscious bias that the researcher isn’t aware of,” he said. “A conflict of interest creates the appearance of bias, whether it’s present or not”
Siegel spent two years at the Centers for Disease Control and Prevention and testified in the $145 billion lawsuit against the tobacco companies. He has long criticized conflicts of interest in tobacco research, documenting them on his blog, “The Rest of the Story.”
Siegel points out the Mayo Clinic website has made a number of misleading statements about e-cigarettes, as has Dr. Richard Hurt, the director of Mayo’s Nicotine Dependence Center. He says Hurt, who received nearly $65,000 in Pfizer and GSK money between 2009 and 2014, questioned the sanity of e-cigarette users.
“One of the solutions that the nicotine and the e-cigarette is dissolved into is called propylene glycol which is a cousin of antifreeze and why anybody would want to puff on something and put that in their mouth is amazing,” Hurt said in a 2013 video for the hospital.
But it’s not just Mayo and the FDA. Siegel says the vaping industry is getting hit by the CDC as well as many health organizations and departments.
“It’s a phenomenon in the entire e-cigarette industry,” he said, “Nowhere do [researchers] actually come out and say, ‘e-cigarettes are a lot safer than cigarettes and that there’s a huge relative risk difference between the two.’ They’re really using scare tactics to demonize e-cigarettes.”
And smokers will suffer.
“It’s going to convince many smokers who might otherwise have quit by switching to e-cigs, to not quit,” Siegel said.
In the meantime, facing a regulation that could cost $77 million in compliance costs each year, the vaping industry sees Big Pharma’s huge research footprint as more firepower to squeeze out competition.
Lou Ritter is the president emeritus of the American E-Liquid Manufacturers Association (AEMSA), a volunteer trade organization that creates safe manufacturing standards for the liquids used in vape products.
In 2014 he started the E-Research Foundation as a way for the industry to collectively fund science.
“Every other industry funds its own science. They’re just big corporations that are out there competing and they have a lot more money,” Ritter said on a conference call hosted by the E-Vaping Coalition of America. “This is the first industry that has really come up through consumer incentivization and consumer motivation, so there isn’t a lot of money in one place.”
Ritter was invited to a workshop in February held by the National Academy of Sciences, Engineering and Medicine as part of an FDA directive to review existing research on the health effects from using electronic nicotine delivery systems and identify future federally funded research needs.
The report is due for release at the end of this year or early 2018. And while Ritter is pleased the FDA has taken this step, he hopes it’s not too little, too late.
“I think this should have happened a year ago, before the regulatory time-clock started,” he said. “This is probably the last chance for this industry.”