Did you read about the new review paper on medical marijuana published in the prestigious Journal of the American Medical Association? In case you missed it, the paper gave a less-than-ringing endorsement of marijuana’s therapeutic benefits.
I was surprised by the anemic media coverage. It should be of national interest given that 23 states, in addition to the District of Columbia, have legalized medical marijuana. According to the JAMA findings, many of the conditions for which medical marijuana is being officially used, from spasticity associated with multiple sclerosis to sleep disorders, are supported at best by either “moderate quality” data -- as the report put it -- or “low quality” data across the 79 randomized, placebo-controlled trials reviewed by researchers.
I found only CBS News and Reuters covered the report as hard news and the Denver Post published an editorial (“Moment of Truth for Medical Marijuana”). These are big outlets, to be sure, but they are conspicuously modest in number. By contrast, the media can be relied upon to cover potentially harmful effects of vaping. In January, for instance, the New England Journal of Medicine published a report entitled “Hidden Formaldehyde in E-Cigarette Aerosols.”
Media coverage ensued: “E-cigarettes Can Churn out High Levels of Formaldehyde,” read the NPR headline. “E-cigarettes can Produce More Formaldehyde than Regular Cigarettes,” warned the Los Angeles Times. “Before You Vape: High Levels of Formaldehyde Hidden in E-Cigarettes,” cautioned NBC News. “Study Links E-Cigarettes to Formaldehyde, Cancer Risk,” said The Wall Street Journal. The Baltimore Sun, Associated Press (appeared in Washington Post), Reuters (appeared in Scientific American), and CBS News also picked up on the NEJM report.
The NEJM authors’ notable conclusion was that vapers are endangered by formaldehyde in the course of normal use. More specifically, the authors showed that when a vaping device was heated at high voltage settings – that is, overheated -- the emitted vapor contained the carcinogen formaldehyde at five to 15 times the concentration found in cigarette smoke.
But – and this is key -- no user would ever actually heat an e-cigarette high enough to produce the recorded levels of formaldehyde in the study. The resultant vapor (known as a “dry puff”) would be intolerably irritating to the throat. Indeed, when the NEJM researchers tested the same device at a voltage level normally used by vapers, they detected no formaldehyde.
Then, in May, a study in Addiction confirmed that formaldehyde in vapor poses no danger at normal heat settings. Toast is a handy analogy here. “Most toasters have a setting which burns the toast to a crisp,” wrote Peter Hajek of the London School of Medicine and Dentistry in Addiction. “Although burned toast contains carcinogen, it is highly unlikely that New England Journal of Medicine would publish a paper demonstrating this and warning people that toasts are carcinogenic.”
I could find no mention in the mainstream media of the Addiction study, however, apart from the comment sections of specialty medical or vaping blogs. Like the unfashionable JAMA paper on medical marijuana, which ran counter to the generally benign national attitude towards marijuana, the reassuring article on formaldehyde did not jibe with the growing view that vaping is somehow harmful. While no strong, organized lobby opposes medical marijuana, such vocal and visible entities as the Centers for Disease Control, the California Department of Health, the American Lung Association and the Campaign for Tobacco Free Kids routinely denounce e-cigarettes, insisting that the devices will renormalize smoking in society and serve as a “gateway” to smoking for teens. To date, the vast bulk of evidence regarding smoking and vaping patterns suggests that neither fear has materialized.
And it’s not just a media double standard for medical marijuana and e-cigarettes that exists. The government has just made it somewhat easier for researchers to explore the effects of medical marijuana use, while nothing has been done to make clear a path to conduct randomized clinical trials on difficult e-cigarettes as therapeutic (i.e., smoking cessation) devices.
In mid-July, the Obama administration moved to facilitate randomized clinical trials research on medical marijuana by lifting the burdensome requirement that researchers submit study proposals to the U.S. Public Health Service for review. This step in the four-step research-approval process, it turns out, added another layer of review that contradicts an FDA review requirement. The streamlining will help a bit, although other hurdles (e.g. obtaining marijuana samples for the study from the National Institute on Drug Abuse ) do remain.
Meanwhile, the route to randomized clinical trials research on e-cigarettes remains blocked.
Let’s say, for example, a researcher wants to learn if people with schizophrenia, a population which smokes at triple the rate of the general population, succeed in switching partially or completely to vaping. The researcher is stuck. Why? Because in order to compare e-cigarettes to other forms of cessation interventions, the FDA requires an Investigational New Drug (IND) application. And completing the application requires the researcher to submit information on the chemistry of e-liquid as well as manufacturing and control information. Gathering these data is time consuming, if doable at all, given the scores of producers, many of whom are based overseas.
If researchers cannot investigate e-cigarettes as a smoking cessation tool, experts cannot definitively respond to one of the major objections of critics who claim e-cigarettes have no demonstrated therapeutic effect. There is massive evidence from individual smoker self-reporting that e-cigarettes enable users to quit smoking or to cut down markedly--a recent example is here--but few rigorous or realistic head-to-head comparisons with patches and gum.
Last February, a group of four research organizations, including the American Association for Cancer Research and the International Association for the Study of Lung Cancer, wrote a letter to then-FDA Commissioner Margaret Hamburg protesting this Catch-22. “This regulatory hurdle makes clinical research with most if not all commercially available products impossible because scientists do not have access to the required information that would allow them to obtain IND applications,” they wrote. Studies already approved by NIH review committees and in some cases funded by the NIH or FDA, cannot move forward.
So we find ourselves in an environment where research on e-cigarettes, a technology with the potential to spur a transformation in tobacco smoking is being stymied, and where news of its promise is considerably less headline-worthy than dubious evidence of its harm. Yes, marijuana, too, may have therapeutic value--we simply need better quality evidence. Too bad e-cigarettes don’t enjoy the same good will and favorable press coverage that, for better or worse, has been bestowed on marijuana.
Sally Satel is a psychiatrist and resident scholar at the American Enterprise Institute.
