Friday, July 24, 2009

The FDA Crusade Against E-Cigarettes

On July 22, 2009, the FDA released the results of laboratory tests of e-cigarettes, which were conducted by the Division of Pharmaceutical Analysis at the FDA’s Center for Drug Evaluation and Research. In a press release, the FDA said: “These tests indicate that these products contained detectable levels of known carcinogens…” The FDA report can be downloaded here.

For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agency’s new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.

The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and Njoy (there are many other manufacturers). With respect to “carcinogens,” the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; I’ll abbreviate the agents here as NNN, NNK, NAT and NAB.

I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.

The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the company’s products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that weren’t tested simply had blank boxes in the results chart. A footnote says, “Open boxes indicate the sample was not available for testing.” Another note in the methods section admitted that “…not all sample lots were available for analysis…as they were consumed in other testing.” In other words, the FDA didn’t purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe it’s a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.

The FDA tested 3 out of 4 Njoy products for TSNAs.

What the FDA didn’t test is even more important than what the agency tested. The report noted that the “Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods.” That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didn’t test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, it’s been known for almost 20 years that nicotine medications contain TSNAs.

Why did the FDA analyze e-cigarettes for carcinogens, when there is no evidence the agency ever conducted carcinogen studies of products that they have regulated for over 20 years? Is it possible that the FDA approved medicines that contained TSNAs, but the agency is now disapproving e-cigarettes because they contain the same contaminants? To answer this important question, we have to know how high – or how low – the TSNA levels are in these products.

Unfortunately, the agency did not report TSNA levels. Instead, it reported that TSNAs were either “Detected” or “Not Detected,” which is entirely inadequate. For hundreds of years, one of the basic tenets of medicine has been “the dose makes the poison.” Mere detection of a contaminant is meaningless; the critical question is: At what concentration is it present?

So what does “Detected” mean in the FDA analysis? In other words, what was the lowest TSNA concentration that the test detected?

As I noted earlier, many tobacco products have TSNA levels in the single-digit parts per million range, a level at which there is no scientific evidence that TSNAs are harmful. According to the report, the FDA used an analytic method published in 2008. The report notes that “the published method is quite sensitive for the TSNAs…” and it goes on to explain that the level of detection is 40 parts per TRILLION.

The implications of this are astounding. Apparently, the FDA tested e-cigarette samples using a method that detects TSNAs at about 1 million times lower concentrations than are even possibly related to human health.

In summary, the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.

These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes. According to Dr. Murray Laugesen, a respected New Zealand researcher, “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

The FDA and anti-tobacco extremists who support it should be held accountable for their prohibitionist actions.

The FDA has a legitimate interest in two matters involving e-cigarettes: assuring that cartridges contain the advertised quantity of nicotine, and that they do not contain contaminants.

I welcome the FDA to correct any errors in this critique. I attempted but was unable to reach the scientist who conducted the analyses.

Wednesday, July 8, 2009

FDA: Futzing and Diddling Around with Nicotine

Last month Congress passed, and President Obama signed legislation giving the FDA regulatory authority over tobacco products. There is doubt about whether the FDA is the appropriate agency to oversee tobacco use among 45 million Americans. But one thing is certain: The agency has already botched the regulation of nicotine, the highly addictive but otherwise virtually harmless drug found in all tobacco products.

Nicotine replacement medications for smokers have been around for over 20 years. Almost 15 years ago, the agency moved some forms from prescription to over-the-counter status, which typically makes medicines more affordable and more available to consumers. Not this time.

Nicotine medications remain very expensive, they provide only a fraction of the nicotine available in cigarettes, and the FDA limits their use to only 10-12 weeks. In effect, the FDA is telling smokers: “Achieve abstinence (from tobacco and nicotine), or take your chances with cancer, heart attacks and emphysema.”

Doesn’t the FDA know that it’s the smoke that kills? Nicotine is not the cause of any smoking-related disease. It’s about as safe as caffeine, another addictive substance enjoyed by millions of consumers of coffee, tea and cola drinks.

The FDA has assured that nicotine medications are expensive and unsatisfying. First, they are exorbitantly expensive. Smokers struggle to afford $5 to $10 for a pack of cigarettes, so how can they fork out $30 to $50 for a box of nicotine gum or patches? Second, nicotine medications are extremely low-dose, so they don’t provide the nicotine spike that smokers get when they light up. Finally, smokers can only use nicotine medications for 10 to 12 weeks – a period that many find too short to enable them to quit smoking. 

 With a regulatory framework like this, no wonder nicotine medications are successful for only about 7% who try them. For what other medications does the FDA accept a 93% failure rate? It is outrageous that the agency and, for the most part, the public health community are complacent with this dismal statistic.

There are simple fixes for this mess, but the FDA has shown little interest. In 1995, I published an open letter in the Pittsburgh Tribune-Review to FDA commissioner David Kessler, urging him to make pharmaceutical nicotine products more available to smokers. The FDA did nothing over the next 12 years to make these medications more effective and more affordable.

In February 2008, New York State Health Commissioner Richard Daines filed a petition requesting minor revisions in package labeling and sale of nicotine that would greatly expand consumer awareness and availability. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA responded by… Well, they didn’t respond at all. It is hard to imagine how the agency could do worse than to not approve these simple changes. And now Congress has given the FDA regulatory authority over all tobacco products.

The FDA signaled in April that it was about to make another mistake -- banning e-cigarettes, which are battery-powered devices delivering pure nicotine vaporized with propylene glycol (both of which are already approved for human consumption by the agency). The FDA rationale for the ban: “We don't want the public to perceive them as a safer alternative to cigarettes,” said FDA spokeswoman Rita Chappelle.

Apparently, the FDA does not want the public to know that e-cigarettes are safer, which is depressing, coming from the federal agency dedicated to “protecting and promoting your health.” Tobacco users who are looking to the FDA for science-based regulation cannot be impressed. Compared with combustible products, e-cigarettes are definitely minimal risk. For more information, visit End Smoking New Zealand, which has conducted laboratory tests on e-cigarettes.

The vast majority of e-cigarette users are former smokers. The FDA intends to ban a virtually risk-free nicotine delivery system, forcing users to resume cigarette smoking. This move is more bad news for those trying to quit, and it betrays President Obama’s inaugural pledge to “restore science to its rightful place.”
Cigarette smoking will continue to be a leading cause of death in this country until the public health community and government agencies drop their anti-nicotine agenda and start helping, rather than punishing, smokers who are desperate to quit their deadly habit without quitting nicotine altogether.

Thursday, July 2, 2009

Tobacco Prohibition in the U.S. Military

A newly released report from the Institute of Medicine (IOM) provides more evidence that the federal government is steadily moving toward prohibition of tobacco. The report, requested by the Department of Defense (DOD), calls for implementation of “state-of-the-art programs to achieve tobacco-free military and veteran populations.” Some of the draconian measures include:

• Stop selling tobacco products in military commissaries and exchanges.
• Prohibit tobacco use anywhere on military installations.
• Treat tobacco use in the same way as …alcohol abuse and poor physical fitness, which impair military readiness.

The report acknowledges that deployment of military forces is a primary factor in high prevalence of tobacco use. War has been associated with increased use of tobacco for centuries. During the Revolutionary War, George Washington pleaded to the Continental Congress: “If you can't send money, send tobacco.”

Cigarettes were considered to be effective for dealing with the stress of trench warfare in the First World War; they were given to soldiers in 1917 and 1918. General Pershing said at the time, “Tobacco is as indispensable as the daily ration; we must have thousands of tons without delay.” In World War II, cigarettes were included in soldiers’ rations.

For deployed soldiers, the health hazards of smoking are far in the future. In stark contrast, the hazards of combat, both physical and mental, are endured each and every day they are deployed. Those who have never seen combat cannot comprehend the psychological toll it exacts, but we can appreciate how soldiers deal with the stress. Tobacco and nicotine are powerful psychoactive agents that help our troops manage extreme stress, grief, boredom and suffering.

There is one scientific fact that the IOM report completely ignores: The adverse health effects and long-term financial impact of soldiers’ tobacco use are almost exclusively the result of smoking, not smokeless tobacco use. The report suggests that smokeless tobacco use as risky, but it cannot refute the scientific evidence that smokeless use is 98% safer than smoking.

While no tobacco product is completely safe, cigarette smokers in the military are routinely misinformed by health professionals and government officials about the relative safety of smokeless products. As discussed in earlier posts, smokeless tobacco does not cause lung cancer, heart disease or emphysema. The risk for mouth cancer with smokeless is far lower than it is with cigarettes. In fact, the risk is vanishingly small; nine epidemiologic studies published in the last decade, including one from the American Cancer Society, have concluded that smokeless tobacco use is not associated with mouth cancer.

A growing number of health care and policy experts have endorsed the concept of encouraging smokers to use tobacco in a far safer way. For example, a 2007 report by Britain's Royal College of Physicians, one of the most prestigious medical societies in the world, concluded “that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.” In 2008, the American Association of Public Health Physicians officially endorsed this strategy.

Smokeless tobacco is a satisfying and far safer substitute for cigarettes. So why is the military moving toward total tobacco prohibition? Perhaps it is because DOD’s stop-smoking programs have been unsuccessful. In desperation, the agency awarded a researcher $3.7 million to develop a video game for smoking cessation.

Our armed forces put their lives on the line every day; they use tobacco to help manage the resulting stress. The answer isn’t video games and tobacco prohibition. It's time for DOD and other agencies to stop the misinformation campaign about tobacco. Show soldiers respect by giving them truthful information about smoking and smokeless tobacco use.