Monday, October 17, 2016

RegulatorWatch Segment on the Vaping Controversy - Part Two

Here is the second part of a two-part series in which Brent Stafford interviews me about the vaping controversy. Brent did a fantastic job of covering all of the key issues in the debate, and I tried to explain the scientific reasoning behind my position on the major points of contention.

Friday, October 14, 2016

RegulatorWatch Segment on the Vaping Controversy

Here is the first part of a two-part series in which Brent Stafford interviews me about the vaping controversy. Brent did a fantastic job of covering all of the key issues in the debate, and I tried to explain the scientific reasoning behind my position on the major points of contention.

Thursday, October 13, 2016

Why is the Massachusetts Health Council Helping Coca-Cola in its Marketing of Soda?

This coming Tuesday, the Massachusetts Health Council will be hosting its annual "Dining with the Stars" awards gala. One organization that should not be getting any public health awards is the Massachusetts Health Council itself. While the Council's mission is to promote "prevention and wellness," it is actually helping the soda industry to market the very products which are contributing significantly to the nation's obesity epidemic.

The Rest of the Story

If you look at the list of sponsors of the Massachusetts Health Council's awards gala, you'll find a long list of health organizations, including my own Boston University School of Public Health, the BU School of Medicine, the Harvard University T.H. Chan School of Public Health, the University of Massachusetts Medical School, and the Dana Farber Cancer Institute. But if you look a little more carefully, you'll see that one of the "health organizations" that is sponsoring the awards gala is the Coca-Cola Company.

It was just this past Monday that Dan Aaron and I published an article explaining how the soda companies are using corporate sponsorship as a tool to improve their public image, divert attention from the role of their products in the obesity epidemic, hide the fact that they are lobbying vigorously against public health measures designed to fight obesity, and ultimately - to improve their bottom line: namely, the sale of Coke, their signature brand. We identified 96 different health and medical organizations that accepted funding from Coca-Cola or PepsiCo during the period 2011-2015. We also documented that due to this funding, many of these organizations softened or eliminated their criticism of the soda companies, downplayed the role of soda consumption in weight gain, and ended their support of policies to reduce soda consumption.

It looks like we can add the Massachusetts Health Council to the list, penciling them in for 2016.

By accepting this money from Coca-Cola, the Massachusetts Health Council is allowing itself to be used as a pawn in a grand marketing strategy taken right from the Big Tobacco playbook. The tobacco companies used corporate sponsorship as a marketing tool to "promote tobacco sales, and therefore, the bottom line, for the sponsoring companies. Increased awareness of cigarette brands creates brand familiarity, a factor known to influence consumer buying behaviour. ... The second outcome of the marketing functions achieved through tobacco sponsorship is enhanced corporate image, which in turn affects tobacco policy by influencing social attitudes and values regarding tobacco. Through its corporate sponsorship, a tobacco company may be able to create good will among the public, even given the recognition that tobacco is a harmful product. In other words, it may help put a “human” face on the corporation and point out its contributions to the community, taking the focus away from damage caused by its products."

Corporate sponsorship is being used the same way by the soda companies. By accepting this money, the Massachusetts Health Council is actually playing a role in the marketing of soda by these companies. Clearly, participating in the marketing of soda is not consistent with the mission of the Massachusetts Health Council.

The Massachusetts Health Council should follow the lead of other health organizations such as the Academy of Nutrition and Dietetics and the American Academy of Pediatrics and renounce its sponsorship by the Coca-Cola Company.

Wednesday, October 12, 2016

Dieticians are Being Paid Off to Promote Soda Consumption and Oppose Soda Taxes, Defiling their Profession; Soda Companies Following Big Tobacco Playbook

(Note: See addendum below)

Earlier this week, Dan Aaron and I published an article revealing that the major soda companies - Coca-Cola and PepsiCo - are using corporate sponsorship of medical and health organizations as a strategy to improve their public image and head off potential negative publicity and public policies that might reduce soda consumption. Our article focused on the sponsorship of organizations. Today, I discuss the fact that the soda companies are also paying individuals in an attempt to improve their public image and divert attention away from the role that their products play in the obesity epidemic.

According to an article published last week at Ninjas for Health, the Coca-Cola Company is paying a group of dieticians to downplay the significance of soda consumption in weight gain and to oppose soda taxes as a method to reduce soda consumption.

"You may remember the surprise last year that Coca-Cola had paid health experts and university researchers to deflect blame about the health harms of soda. Upon further analysis of the payola list, we found that the majority of them were dietitians. Specifically they were all paid to write articles, TV appearances, and social media content touting mini-Coke cans as a “healthy snack”. ...
So when a group of dietitians suddenly began offering their opinions on the #sodatax hashtag on Twitter this week, I got a little suspicious. Soda taxes are a strategy dietitians should (and do) support in order to decrease soda consumption and promote healthy options. Yet these dietitians were all posting content against the soda tax, including the industry talking point that a soda tax is a grocery tax. That’s just a coincidence right?" ...

"So I compared these tweeters against Coke’s payola list, and guess who appears? Carol Berg Sloan, Robyn Flipse, Pat Baird, Sylvia Klinger, and Kim Galeaz are all part of Coke’s paid dietitian network. And Rosanne Rust discloses her consulting with the American Beverage Association in her Twitter profile. In several of their tweets, they mention @cartchoice (Your Cart Your Choice), a project fighting soda taxes funded by the American Beverage Association and sugar industry. That’s just a coincidence, right?" ...
"It looks like Coke is doing it again: Paying dietitians to perpetuate lies that promote soda and swing public opinion against policy solutions to the obesity epidemic it helped cause. These aren’t “health experts”, they are paid promoters of the sugar industry."

I conducted my own investigation and found that there is a large group of dieticians who are essentially being paid by Coca-Cola to express opinions downplaying the role of soda consumption in weight gain and opposing soda taxes. Here is what I found:

Robyn Flipse, MS, RD: Robyn Flipse has advocated against soda taxes. While her web site boasts about her affiliations with organizations like the American Dietetic Association and a number of medical schools, it does not reveal that she is a paid consultant for the Coca-Cola company. And although she lists a number of business clients, she does not disclose Coca-Cola as being one of them. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Carol Berg Sloan, RDN, FAND: Carol Berg Sloan has advocated against soda taxes. Her January 25 article opposing soda taxes does not disclose that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Pat Baird, MA, RDN: Pat Baird has actually promoted soda consumption. In a recent article, she discloses that she is an "advisory partner" to the food and beverage industry, but does not explain that she, too, is a paid consultant of Coca-Cola. This fact is also hidden on her blog. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Amy Goodson, MS, RD, CSSD, LD: Amy Goodson has also promoted soda consumption.  Her bio conveniently hides the fact that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Kim Galeaz, RDN CD: Kim Galeaz goes as far as actually promoting soda consumption as a method of hydration. That article discloses that she is an "advocacy consultant for the food, beverage and agriculture industry," but does not reveal that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Amy Myrdal Miller, MS, RDN, FAND: Amy Myrdal Miller has also gone so far as to actually promote soda consumption. She is not listed as a paid consultant of Coca-Cola, but does consult with "a variety of food and beverage clients." Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity. 

Sylvia Meléndez Klinger, MS, RD: Sylvia Klinger has also written articles downplaying the importance of avoiding soda consumption. A recent article completely hides the fact that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Rosanne Rust, MS, RDN, LDN: Rosanne Rust has also recommended soda consumption, while at the same time hiding the fact that she is a paid consultant of Coca-Cola. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict. Moreover, she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity.

Neva Cochran, MS, RDN, LD: Neva Cochran also downplays the problems with soda consumption (even diet soda is linked to obesity) by promoting diet soda consumption. At the same time, she hides the fact that she is listed as a paid consultant to the American Beverage Association, a soda industry lobbying organization that opposes virtually every public health measure being considered to reduce obesity. Thus, she not only has a severe conflict of interest that has the perception of biasing her opinions, but she is not readily disclosing this conflict.

The Rest of the Story

This is right out of the Big Tobacco playbook. For many years, the tobacco companies paid a group of researchers to write articles downplaying the health effects of smoking and opposing public policies that would reduce tobacco consumption. The goal of this effort was to make it appear that these were independent, objective scientists who had come to the unbiased conclusion that smoking was not particularly harmful. The truth was that these scientists were on the tobacco payroll, their opinions were heavily biased, and these severe conflicts of interest were often hidden from the public.

The soda companies are now doing the same thing. There is a network of dieticians who are essentially being paid off to express opinions in which they downplay the role of the soda industry in the obesity epidemic, question the link between soda consumption and weight gain, and oppose public health policies that would reduce obesity by lowering soda consumption.

All of these dieticians are also consulting for the American Beverage Association, which we showed in our paper is an industry-funded group that vigorously lobbies against virtually all national, state, and local public health policies supported by the health community to address the obesity problem.

The rest of the story is that these dieticians are essentially paid hacks of the soda industry. Just like the tobacco industry hacks who were discredited many years ago, it is time that these soda company hacks be exposed to the public. These are not objective, independent scientists who happen to be expressing opinions. This is a paid and coordinated campaign by the soda industry to undermine the public's appreciation of the health consequences of soda consumption, to divert attention away from the soda industry's role in the obesity epidemic, and to create opposition to policies intended to reduce soda consumption.

While I was surprised by many of our findings on soda company sponsorship, I am frankly shocked to see that a group of dieticians would allow themselves to be used by the soda industry as hacks like this. In my opinion, this defiles the profession of dietetics.

While the Academy of Nutrition and Dietetics has rightfully decided to discontinue taking money from soda companies, it is pathetic to see that a group of supposed public health practitioners are allowing themselves to be used as paid hacks of the soda industry and that in many cases they are hiding these financial relationships.

I am not really blaming the soda companies for pursuing these sponsorships and these consulting arrangements. It is actually a brilliant strategy. It worked for Big Tobacco and it is working wonders for the soda companies. But Coca-Cola and PepsiCo are not in the business of public health. Their job is to sell soda, and these sponsorships and consulting arrangements help them to do that. Their job is to sell soda and I can't really blame them for using the most effective marketing strategies available to do that.

However, dieticians are supposed to be in the business of public health. They are not in the business of marketing soft drinks. It is an unacceptable conflict for them to be taking money from soda companies while pretending to give the public objective and unbiased information about nutrition science. That's just not possible when you're being paid off by the soda industry.

It's time for everyone in the public health community - both organizations and individuals - to stop enabling the soda companies to use them as pawns in their grand marketing strategy by rejecting soda company funding.


According to an article published on October 6 by the New York Times, Coca-Cola has discontinued its practice of paying scientists, and the American Beverage Association has at least temporarily suspended its payment of scientific experts pending further review. 

Monday, October 10, 2016

FDA Poised to Issue Rule that Will Be Devastating for Public Health, and Possibly Unconstitutional

It appears that the Food and Drug Administration (FDA) is preparing to issue a rule that would prohibit e-cigarette companies from suggesting that their products may be useful for smoking cessation. The proposed rule, as reported by The Hill, would classify as a drug/device any e-cigarette or vaping product that makes any claims related to quitting smoking.

According to the article: "The White House is reviewing a final rule from the Food and Drug Administration (FDA) on tobacco products. The rule aims to clarify when the FDA can regulate a product like nicotine gum as a drug or device versus a tobacco product like electronic cigarettes. For the agency it all comes down to the product’s intended use. The FDA sent the rule, first proposed in September 2015, to the White House Office of Management and Budget (OMB) on Monday. The proposed rule states that tobacco products intended for human consumption are regulated as a drug, device or combination product if intended for diagnosing or treating a disease. ... “Given the availability of FDA approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking,” the rulemaking said."

The Rest of the Story

This rule would be disastrous for the protection of the public's health because it would mean that vaping companies could not inform consumers that the primary purpose of e-cigarettes is to help smokers get off of cigarettes (i.e., quit smoking). They could not share testimonials about smokers who have quit using e-cigarettes because doing so would likely be interpreted by the FDA as making a cessation claim, which would subject the product to the regulations related to drugs, which would require clinical trials before the product could be marketed.

This rule will essentially force e-cigarette companies to market their products as cool, digital devices - a message that resonates with youth and will increase the appeal of these products to youth. The alternative - that the FDA allow cessation claims - would enable companies to tell the truth to consumers and to market these products based on their actual intended use. In other words, this rule would essentially force e-cigarette companies to lie to consumers and to withhold from them critical information.

Here is why I do not believe that this rule will pass legal muster, if challenged:

The FDA is making a false assumption. They are assuming that smoking is a disease. The agency is apparently going to state, correctly I would add, that an e-cigarette that is primarily intended to prevent or treat a disease is a drug/device. However, the agency goes one step further and rules that products which make claims related to smoking cessation are therefore intended to treat a disease. This of course assumes that smoking is a disease.

I disagree. I don't believe that smoking is a disease. Rather, it is a health behavior. Sure, it is a health behavior that is related to a number of diseases, but smoking itself is not a disease, per se.

Simply stated, a smoking cessation claim - in isolation - is not necessarily a drug claim - because the intention is not to treat a disease, but to help consumers change a health behavior. Since changing a health behavior is not treating a disease, the FDA has no legal authority to regulate e-cigarettes which make smoking cessation claims as drugs or drug/device combinations.

OK, so you may ask: If a smoking cessation claim is itself not a therapeutic claim, then why is the FDA able to regulate nicotine replacement therapy and varenicline as drugs? The reason is that these products are designed and intended to treat a disease: nicotine dependence. The DSM recognizes nicotine dependence as a disease and nicotine withdrawal is a health symptom. Since these products are primarily intended to treat nicotine dependence and to prevent withdrawal symptoms, they are rightfully considered to be drugs.

Of course, if e-cigarettes are marketing with a claim that the product is intended to treat nicotine dependence or to prevent withdrawal symptoms, then it's a different story. But by itself, a claim that vaping can help people quit smoking, or even that it is intended to help people quit smoking, is not a therapeutic claim, and the FDA must allow such claims to be made.

Hopefully, this rule will be challenged in court.

Here is a more detailed treatment of this issue:

What is a therapeutic claim? Under the Food, Drug, and Cosmetic Act, it is defined as: "Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act, section 201(g)."

The key point is that in order to be making a therapeutic claim, one either has to claim that the product will treat or prevent a disease or claim that the product will affect the structure or a function of the body.

A. Is Smoking a Disease?

Is claiming that electronic cigarettes can aid in smoking cessation a claim that these products can treat or prevent a disease? That depends on whether smoking is a disease.

Smoking itself is not a disease, but a behavior. Just as eating unhealthy food is not a disease, but a behavior. Or as not exercising is not a disease, but a behavior. Or as drinking alcohol is not a disease, but a behavior.

In and of itself, a claim that electronic cigarettes can aid in smoking cessation is therefore not a therapeutic claim.

As long as electronic cigarettes are marketed as an alternative to cigarettes which may help the user cut down or eliminate cigarette use, then it is simply claiming that it may affect a health behavior, rather than that it will treat or prevent a disease.

Consider the following scenarios:

1. An apple orchard decides to promote consumption of its apples by putting out advertisements which claim that buying apples from this orchard will help consumers to improve their diet and reduce their consumption of junk food. Does the FDA have jurisdiction over such claims under FDCA?

Of course not. The apple orchard is not claiming that is products (apples) will prevent or treat any disease. It is merely arguing that eating its apples is a healthy behavior. What is being claimed is that these products will improve health behavior, not that these products will treat or prevent a disease?

If the orchard claimed that eating its apples would reduce the risk of heart disease, then that could be interpreted as a therapeutic claim because it is claiming that its product will prevent a disease. But a simple claim that eating these products will improve one's diet is a behavioral claim, not a therapeutic one.

If we applied the FDA's reasoning, then the apple orchard would have to stop making this claim. One can easily see, I believe, that the FDA's argument does not hold.

2. I decide to sell a calendar that includes inspirational pictures of people exercising. It also contains reminders on certain days of the week to remind people to exercise on those days. I send out a flyer, advertising my calendar, in which I claim that this calendar may help people to exercise more often. Is that a therapeutic claim?

Of course not. Lack of exercise is not a disease. It is a behavior. I am not claiming that my calendar will treat or prevent any disease. I am only claiming that my calendar could influence one's health behavior. But again, by the FDA's argument, this is a therapeutic claim and renders my calendars subject to the FDCA.

3. I conduct an educational program about alcohol, inviting people to come learn about the potential harms of alcohol use. At the program, I offer for sale a booklet that I claim can help people reduce their alcohol use. Do I need FDA approval to sell my booklet?

Of course not. It is only claiming to help people alter their behavior. It is not making a therapeutic claim. But again, by the FDA's reasoning, since it is claiming to affect a health behavior, it is indeed a therapeutic claim and would not be allowed.

I have demonstrated that in and of itself, claiming that electronic cigarettes may be useful in smoking cessation is not a therapeutic claim. Of course, the companies must refrain from claiming that the use of electronic cigarettes will reduce the risk of disease (that would be a therapeutic claim). But as long as they restrict their marketing to claims that these products may influence smoking behavior, then the claim is not a "therapeutic claim."

B. Is a Smoking Cessation Claim One that the Product Will Affect the Structure or Function of the Body?

It depends. Specifically, it depends on the mechanism by which the company is claiming smoking cessation will be achieved. If the mechanism involves any alteration of the structure or function of the body, then the claim could be interpreted as a therapeutic one. However, if the company is not claiming that the structure or function of the body will be affected, then it is not a therapeutic claim.

Suppose that an electronic cigarette company markets its products by boasting that they are intended to deliver nicotine with the goal of relieving symptoms of nicotine withdrawal and therefore making it possible for the smoker to quit smoking. If the primary intended purpose of the device is to deliver nicotine in order to prevent withdrawal symptoms by occupying nicotine receptors, then this type of marketing claim could be interpreted as a therapeutic claim.

This is, in fact, the reason why NRT products are regulated under FDCA. These products are specifically designed and intended to affect the structure and function of the body. They are designed to bind to nicotine receptors and prevent nicotine withdrawal, thus aiding the smoking cessation process. Similarly, Chantix is designed as a nicotine agonist. It works by altering the structure and function of the body.

However, suppose that an electronic cigarette company markets its products not by intending that the product's purpose is to prevent nicotine withdrawal symptoms during quit attempts, but instead, by simply intending that the product's purpose is to serve as an alternative to cigarette smoking. Suppose that the marketing of the product is focused on providing an alternative to cigarette smoking that does not involve tobacco or combustion. Then it is not making a therapeutic claim because it is not claiming that this product is intended to affect the structure or function of the body.

Summary of My Argument

There is no such disease or medical condition as smoking dependence. Smoking is not a medical disease or condition, it is simply a behavior. Smoking isn't any more of a disease as is bungee jumping or eating Vienna Fingers. What is a medical condition is nicotine dependence and nicotine withdrawal. These are conditions clearly defined in the DSM.

I have acknowledged, above, that if the primary intended use of electronic cigarettes is to treat a disease or medical condition, then they are subject to FDA jurisdiction under FDCA. This means that if a company claims that electronic cigarettes are designed specifically to help smokers quit by treating nicotine dependence, then the product can be regulated as a drug. However, what if the company markets the product merely as a smoking alternative? In that case, the product is not a drug and cannot be regulated under FDCA.

Now let's take a middle ground case: suppose a company states that electronic cigarettes are a smoking alternative that may help smokers to quit smoking. In that case, are the electronic cigarettes being marketed to treat any medical condition? If the intent of the manufacturer is for the consumer to simply switch over to electronic cigarettes, then I believe the answer is no. Smoking dependence is not a medical condition. So if the primary objective is to get the consumer off of cigarettes, then no therapeutic claim is being made.

In fact, unless an electronic cigarette company is making a specific claim that its products will treat nicotine dependence by eliminating the symptoms of nicotine withdrawal - and that is the primary aim or use of the product - then I believe that it is making no therapeutic claim and that its products cannot be regulated under FDCA.

In other words, simply stating that electronic cigarettes may help smokers quit smoking is not, in my opinion, a therapeutic claim.

As long as the primary intent of the electronic cigarette company is to maintain the customer on its products, then it is not treating nicotine dependence, and I do not believe it is making a therapeutic claim. If the purpose of the product were to help someone get over the hump of quitting smoking and then discontinue use of the product, that would be a different story. But that's not the way I see most electronic cigarettes being marketed.

The rest of the story is that the world is not as simple as the FDA would like us to believe. A smoking cessation claim, in and of itself, is not necessarily a therapeutic claim. The situation is a lot more nuanced than that.

In my opinion, electronic cigarette companies should be allowed to truthfully inform consumers that their products may be useful for smoking cessation, as long as these claims are made within the general framework of marketing electronic cigarettes as an alternative to tobacco cigarettes. Such claims are not therapeutic claims as defined by section 201g of the FDCA.

Thursday, October 06, 2016

National Anti-Tobacco Groups File Feeble Lawsuit Against FDA While Continuing to Oppose Smoking Cessation via Vaping

Earlier this week, eight national anti-tobacco groups, headlined by the Campaign for Tobacco-Free Kids, filed a lawsuit against the FDA in an attempt to force the agency to re-issue a requirement for graphic warning labels on cigarette packs.

As the lawsuit explains, here are the key facts:

1. "The Tobacco Control Act became law on June 22, 2009. Section 201 required the FDA to  promulgate its final rule [regarding graphic warning labels] “not later than 24 months after the enactment” of the Act: June 22, 2011."

2. "On June 22, 2011, exactly two years after the Tobacco Control Act was enacted, the FDA promulgated a final rule designating nine graphic warning labels depicting the negative health consequences of cigarette smoking as required by Section 201 and set September 22, 2012 as the time by which such warning labels would be required."

3. "On September 2, 2011, a group of tobacco product manufacturers and sellers filed an action in the United States District Court for the District of Columbia alleging that the 2011 Rule was unconstitutional as applied because the specific required content, placement and type style of the mandated warning labels infringed their rights of free speech under the First Amendment."

4. "On February 29, 2012, the United States District Court for the District of Columbia found that the specific warning labels required by the 2011 Rule were unconstitutional and enjoined the  enforcement of the rule. On August 24, 2012, the Court of Appeals for the District of Columbia Circuit affirmed the judgment of the District Court and vacated the 2011 Rule. The Court of Appeals remanded the rule to the FDA and vacated the District Court’s permanent injunction."

5. "On March 15, 2013, Attorney General Eric Holder, in a letter to Congress, stated that, given the FDA’s plan to undertake research to support a new rule mandating graphic warning labels consistent with the Tobacco Control Act, the Solicitor General had determined not to seek Supreme Court review of the Court of Appeals’ ruling."

The lawsuit's complaint is that although "more than four years have now passed since the Court of Appeals vacated the 2011 Rule, the FDA has not even be gun rulemaking proceedings to promulgate a new graphic warnings rule as required by Section 201. No proposed rule even appears on the FDA’s Unified Regulatory Agenda for action during 2016."

The Rest of the Story

This is a very weak lawsuit. At this point, whether or not the FDA re-issues a rule regarding graphic warning labels is entirely up to the agency's discretion. The agency has already complied with the statute, which merely requires it to issue a graphic warning rule by June 22, 2011. The FDA did issue that rule, on June 22, 2011, as required. The rule was deemed unconstitutional by the D.C. District and Circuit courts and was vacated. Since the FDA issued the rule as required by the statute, it has fulfilled its obligation under the law and is not required to issue a subsequent rule. There is nothing in the statute indicating that if the initial rule is found to be unconstitutional, the agency must keep issuing additional rules until one finally passes Constitutional muster.

The key argument of the plaintiffs, which include the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and the American Academy of Pediatrics, is that the FDA has failed to comply with Section 201. I don't find that argument compelling because the agency has in fact complied with Section 201 by issuing a rule on graphic warning labels, as required, by June 22, 2011. The FDA is not in violation of Section 201.

While the plaintiffs have every right to use advocacy strategies to urge the FDA to re-issue a graphic warning label requirement that does not conflict with the First Amendment rights of the cigarette companies, their attempt to use the law to force the agency to re-issue a graphic warning label rule is unsupported by the facts of the case.

While not directly relevant to the legal issues in the case, the plaintiffs repeatedly claim that the scientific evidence shows that graphic warning labels are effective in getting smokers to quit. However, I do not believe that is the case. The evidence supporting the use of graphic warning labels to promote smoking cessation is weak. Moreover, there is substantial evidence that graphic warning labels are ineffective. A body of psychology and neurophysiology research suggests that graphic warning labels on cigarette packages will have very little effect in deterring smoking among existing smokers.

The Circuit Court recognized as much: "FDA has not provided a shred of evidence - much less the 'substantial evidence' required by the APA - showing that the graphic warnings will 'directly advance' its interest in reducing the number of Americans who smoke. FDA makes much of the 'international consensus' surrounding the effectiveness of large graphic warnings, but offers no evidence showing that such warnings have directly caused a material decrease in smoking rates in any of the countries that now require them. ... FDA's Regulatory Impact Analysis (RIA) essentially concedes the agency lacks any evidence showing that the graphic warnings are likely to reduce smoking rates. ... The Rule thus cannot pass muster under Central Hudson."

Thus, the lawsuit's claim that the failure of the FDA to issue a new graphic warning label rule is hindering the anti-tobacco groups' ability to carry out their mission is unsupported.

The rest of the story is that what is really hindering the ability of these groups to carry out their mission is their continued refusal to promote smoking cessation if that cessation involves anything that resembles smoking, even if no tobacco is involved. Of course, I am talking about their continued attack on electronic cigarettes and vaping, despite the evidence that vaping has helped millions of smokers to quit or substantially cut down on the amount they smoke.

The obsession of the anti-tobacco groups with graphic warning labels coupled with their vigorous protection of cigarette consumption by discouraging smokers to switch to vaping suggests that something else is going on beyond a simple desire to promote smoking cessation. It appears that the desire is to promote smoking cessation only in the way that these groups prefer. Whether the advocated strategy is actually the most effective or most helpful to smokers is not important. What is important, apparently, is not that smokers quit, but that they quit in the "right way."

Quitting using e-cigarettes is not the "right way" because it involves an activity that resembles the act of smoking (even though the product is tobacco-free). Quitting by being bombarded with graphic warnings is the "right way" because smokers are being punished and chided for what is viewed as an immoral or stupid decision to smoke (even though the approach has been shown not to be very effective).

These groups also continue to urge smokers to use other ineffective methods, such as nicotine replacement therapy, because they view these as a "right way" to quit. For the 90% of smokers who fail to quit using nicotine replacement therapy, and for whom e-cigarettes might be the only viable option, these groups still discourage vaping because it is just not the "right way" to quit.

Tuesday, October 04, 2016

IN MY VIEW: FDA is Partly to Blame for Explosion that Injured Teen on the Hogwarts Express

For several years, the FDA has been nagging us about how important it is that the agency claim jurisdiction over electronic cigarettes because of their safety hazards. Now that the FDA has that jurisdiction, it is the public health agency that is ultimately responsible for ensuring the safety of electronic cigarettes. And so far, it is doing a terrible job.

This past weekend, a teenager suffered burns after an e-cigarette exploded on the Hogwarts Express at the Universal Orlando theme park, sending a fireball in her direction. Since the FDA is responsible, upon its own insistence, for the safety of electronic cigarettes and this explosion occurred on its watch, the agency bears some responsibility for the girl's injuries.

After all, the agency has failed to set any standards, or even to issue a guidance or advisory, for electronic cigarette battery safety. Moreover, the FDA's Center for Tobacco Products has actually institutionalized the problem of exploding batteries because it promulgated regulations that prohibit e-cigarette companies from repairing the defects that are causing these explosions. Since August 8, companies have been prohibited from making any safety improvements on their products, including fixing the problem of exploding batteries. To correct such problems would amount to selling a new "tobacco product," something that is not allowed under the FDA's regulations.

Imagine being the president of the company that manufactured the product which injured this girl and having to explain to the girl's family that although a safety defect has been identified in your product, the FDA has prohibited you from fixing it. The idiocy of these regulations would be comical if they weren't causing so much human damage.

The Rest of the Story

The FDA regulations are so detrimental to the public's health that vape shops are interpreting the rules to mean that they cannot even fix defective e-cigarette devices of their customers: "In addition to talking about health benefits, the regulations now prohibit vape shops from working on customers' devices, which is something that shops charged money for as a service. "It's almost like going to a mechanic and the mechanic tells you what's wrong and how to fix it, but telling you that you have to do it yourself," said Jonathan Golin, a manager at Gorilla Vapes in East Brunswick."

So if a customer has a device that is overheating, leading to the release of formaldehyde, many vape shops apparently believe there is nothing they can do to fix these devices, which is going to harm the health of these customers unless they can fix the devices themselves, which is not something most people are able to do.

Suppose, for example, that a company or a vape shop discovered that it could prevent overheating, and therefore the formation of formaldehyde, by adding a second coil. Thanks to the FDA, the company or vape shop cannot do this because it would result in a "new" tobacco product, whose sale would be unlawful. While one might argue that if a customer already bought a device and then brought it back, the store could fix it; however, it would still essentially be selling a "new tobacco product."

As the official regulator of e-cigarette devices, including batteries, the FDA should be held responsible for its failed regulatory approach. Instead of regulating the safety of these products, the agency chose instead to take a prohibition approach -- wiping out 99% of the industry.

In the meantime, people riding the Hogwarts Express may want to practice their extinguishing spells, as the problem of exploding batteries is not going to be fixed any time soon, thanks to the FDA's Center for Tobacco Products shirking its responsibility for ensuring the safety of the products under its jurisdiction.

Monday, October 03, 2016

Medical School Researchers Criticize Campaigns Intended to Get Smokers to Quit

In a shocking and ironic development, a group of medical school researchers has attacked efforts to promote smoking cessation among adult smokers. Previously, I have only seen such an inappropriate attack coming from the tobacco companies. That in 2016, such an attack is coming from people in medicine, and not from Big Tobacco, is a surprising and troubling irony.

In this month's issue of Preventing Chronic Disease, researchers from the Washington University School of Medicine in St. Louis argue that: "Vaping poses a threat to smoking prevention progress, and it is important for those in tobacco control to understand and counter the tactics used by vaping companies to entice their consumers, especially on social media where young people can easily view the content."

They also argue that "the online use of price discounts or coupons that we observed on Twitter is a concerning practice from an industry that is rapidly growing and evolving."

Furthermore, the authors warned that: "We observed the promotion of flavored e-juices and images of colorful vape pens in our sample of tweets; these promotions and images could grab the attention of potential consumers and entice them to initiate use of these products."

In the introduction to the paper, the authors state that their primary objective in examining tweets about e-cigarettes and vaping is to investigate the marketing of e-cigarettes to young adults. They note that 32% of users are aged 18 to 29 years. Thus, this young adult group appears to be the primary focus of the article.

The Rest of the Story

It seems quite clear that the authors are opposed to the use of effective marketing techniques to promote electronic cigarettes. They attack e-cigarette companies for using price-based marketing, for trying to make their products taste good, and for trying to make their products look attractive. In other words, they are attacking electronic cigarette companies simply for promoting their products!

The authors conclude that we must "counter the tactics used by vaping companies to entice their consumers," implying that it is inappropriate for the vaping companies to be marketing their products.

The marketing campaigns of vaping companies, at least as they apply to adults, are aimed at achieving a single, primary objective: to get as many smokers as possible to quit smoking and switch completely to vaping. The clear financial incentive of vaping companies is to get smokers to switch completely because the fewer cigarettes smokers use, the more e-cigarettes they use. The avowed value proposition of NJOY is "to make smoking obsolete."

Vape shops are only going to stay in business if they can convince enough smokers to switch completely, or almost completely, to e-cigarettes. There is no market for adult nonsmokers to start vaping because the small number who do this are unlikely to vape with any frequency. The money is with smokers, especially those with long smoking histories or high tobacco consumption and dependence, who will vape early and often.

Thus, the rest of the story is that by opposing the efforts of vaping companies to promote their products, these researchers are opposing a major societal effort to entice smokers to quit smoking.

Would these authors also attack the pharmaceutical companies for using price discounts to promote nicotine patches or nicotine inhalers, to market nicotine replacement products with flavors, or to make their products look attractive? Their attack on e-cigarette companies for marketing to adult smokers, even if they are young adults, is the same as criticizing the promotion of smoking cessation drugs. Except it's probably worse because e-cigarettes are probably a little more effective than traditional nicotine replacement therapy.

The story would be different if this paper was focused exclusively on the marketing of vaping products to underage youth; that is, to minors. Everyone agrees that these companies should not be marketing to kids. But the study was not designed to examine the marketing of e-cigarettes to minors. The paper itself states that the primary audience of concerns is young "adults." This is the precise population for which electronic cigarettes are so important. If we can get young adult smokers to quit by switching to e-cigarettes, we can protect their health and save their lives before smoking has taken its toll.

The only thing that is not surprising to me about this story is that the article was published by the Centers for Disease Control and Prevention (CDC). From the get-go, the CDC has been vigorously opposed to smoking cessation via vaping products. Thus, it makes sense that they would publish an article which argues that we must counter all efforts to promote vaping products, even if the very purpose of that marketing is to try to make smoking obsolete.

Thursday, September 29, 2016

Article Defending Nicotine Replacement Therapy Fails to Disclose Author's Conflict of Interest with Big Pharma

In another example that demonstrates the hidden influence of Big Pharma on tobacco treatment policy and the extent to which many defenders of nicotine replacement therapy (NRT) are going to hide their conflicts of interest, an article (letter to the editor/reply) defending NRT from criticism that was published online ahead of print in the Journal of Clinical Epidemiology fails to disclose the serious conflicts of interest of its lead author.

The article is a response to a paper published recently in the Journal which concludes that once one accounts for publication bias, there is no significant effect of NRT on smoking cessation.

The published article (a PDF of the accepted manuscript) does not disclose any conflicts of interest that the authors may have. There is no conflict of interest statement at all.

The Rest of the Story

The rest of the story is that the lead author has a long string of financial relationships with pharmaceutical companies, including some that manufacture drugs for smoking cessation, such as NRT.

In 2016, the lead author was the recipient of a Pfizer research award for the study of nicotine dependence. That announcement reports that he "has received consulting fees, honoraria and grants from several for-profit and non-profit organizations that develop smoking-cessation devices, medications, and services, including Pfizer."

The lead author's online CV acknowledges that he has performed consulting services for: "Abbot Laboratories,Acrux Ltd, ALZA Corporation, American Cynamid, Anesta, Aradigm, BASF/Knoll, Begbies Traynor; Boehringer-Ingelheim Pharmaceuticals, Celtic Pharmaceuticals, Ciba-Geigy, Cygnus, DynaGen Corporation, Elan/Sano, Eli Lilly Pharmaceuticals, Glaxo Wellcome, Dupont Merck Pharmaceuticals, Hoechst Marion Rouseau/Marion Merrell Dow/Merrell Dow Lakeside, Lederle Pharmaceuticals, McNeil Pharmaceutical/McNeil Consumer, Nabi, Inc, Neuromedical Technologies, Inc., Neuroscience Ventures, Pacific Pharmaceuticals, Parke Davis Pharmaceuticals, Pfizer Pharmaceuticals, Pharmacia & Upjohn/AB Leo Pharmaceuticals/Kabi Pharmacia/Pfizer, Proctor & Gamble, Sano Pharmaceuticals, Propagate Pharmaceuticals, Sanofi/Synthelabo Pharmaceuticals, SmithKlineBeecham/Glaxo SmithKline Consumer Healthcare, Xenova Limited."

The lead author reports (in the online CV) having received grants from Pfizer (Chantix), McNeil Pharmaceuticals (Nicotrol inhaler and nicotine nasal spray), Pharmacia & Upjohn/Smith Klein Beecham Healthcare (nicotine gum), ALZA (Nicoderm), Marion Merrell Dow (Nicorette), and DynaGen (NicErase). 

There doesn't appear to be any question that this author's financial conflicts of interest are hugely significant and highly relevant to the subject matter of the manuscript. Therefore, these conflicts of interest should have been disclosed in the published article so that readers can be aware of the conflicts and take that potential source of bias into consideration when evaluating the validity of the paper's conclusions.

It is not clear whether the failed disclosure in the published article is the fault of the authors or of the journal itself (i.e., it is possible that the authors disclosed these conflicts during the submission process but that the journal failed to add these disclosures to the published article). However, it doesn't matter because either way, readers are deprived of knowing about these important conflicts of interest. In addition, I believe it is the authors' obligation to ensure that the conflicts of interest are disclosed in the actual published paper. The authors are able to make such a correction when reviewing the manuscript proofs.

This is not the first example I have highlighted on this blog of the hiding of financial conflicts with Big Pharma in papers defending nicotine replacement therapy or other smoking cessation drugs. This is a general pattern I have observed. To me, it suggests that many defenders of NRT really do have something to hide. The evidence supporting NRT as a population-based strategy for smoking cessation is already flimsy, and it becomes even more flimsy once one considers the severe conflicts of interest of so many investigators who are evaluating these drugs. So it makes sense that there would be an effort to hide these conflicts from the public. But it is not an ethical practice, and it does a great disservice to the public and to the public's health.

(Thanks to John Polito for the tip.)

Wednesday, September 28, 2016

FDA Issues New Draft Guidance on Regulation Compliance for Certain Types of E-Cigarettes; CDC Comments

The FDA took steps yesterday to clear a big point of confusion that has arisen concerning a subset of electronic cigarettes on the market. Due to novel technology that allows nicotine to be extracted in concentrated form from potatoes, a number of e-cigarette companies have switched to using potatoes as a source of nicotine for their e-liquids. Several companies have asked the FDA's Center for Tobacco Products for guidance on whether they need to comply with the tobacco product regulations, since their products do not contain tobacco and the nicotine used is not derived from tobacco.

Here is the relevant excerpt from the FDA's guidance document which explains how these products will be treated by the agency:

On May 10, 2016, the agency published a final rule that deems all products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to FDA's tobacco product authorities under chapter IX of the FD&C Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” and does not mean “an article that is a drug under subsection (g)(1), a device under subsection (b), or a combination product described in section 353(g) of this title.”

Products that contain nicotine derived from tobacco meet the definition of a tobacco product under the FD&C Act and are required to bear a health warning on packages and in advertisements stating: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” For products that are made or derived from tobacco (but do not contain nicotine), manufacturers may submit a certification to FDA and, instead, bear the statement “This product is made from tobacco.”

The definition of “tobacco product” as set forth in section 201(rr) of the FD&C Act includes all components, parts, and accessories of tobacco products (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory.

E-liquids that contain nicotine derived from potatoes do not meet the statutory definition of "tobacco product" unless they are reasonably expected to be combined with a tobacco product. However, since e-liquids that contain nicotine derived from potatoes are "potato products," the agency declares that such products must comply with Marketing Order No. 946, as amended (7 CFR part 946), regulating the handling of potatoes, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”  

Under the order, regulated potatoes must be inspected and certified by FSIS. As authorized under the order, the Committee uses information included on FSIS inspection certificates as a basis for collecting assessments and compiling industry statistics. The order requires handlers to submit reports to provide information on the volume of red types of potatoes handled for the fresh market. The order includes handling regulations for all varieties or varietal types of potatoes grown in the production area. These regulations can include minimum grade, size, quality, maturity, and inspection requirements. They can also provide for the size, capacity, weight, dimensions, pack, marking, or labeling of containers used in the handling of such potatoes. 

Because the agency has deemed e-liquids using nicotine derived from potatoes to be "potato products," these e-liquids and any vaping devices intended for use with these e-liquids are subject to inspection and certification by FSIS. These e-cigarette manufacturers must also submit reports to provide information on the volume of red potatoes handled for the fresh market. They must also comply with the handling regulations for all varieties or varietal types of potatoes grown in the production area.

The Rest of the Story

I have to give the FDA credit for at least following its own logic. If e-liquids that use nicotine derived from tobacco are "tobacco products," then e-liquids using nicotine derived from potatoes are "potato products," and their manufacturers should be subject to all regulations for potatoes, including handling, inspection, packaging, labeling, and production requirements. However, I have to question why the agency ignored the recent emergence of companies that are using nicotine derived from eggplants to prepare e-liquids. Clearly, these products should be deemed "eggplant products" and should be required to comply with all USDA regulations governing the production, inspection, and labeling of eggplants.

Understandably, many small business owners who are in the e-liquid potato nicotine extraction business were upset. The president of NicoSpud E-Liquids was quoted as saying: "These regulations are going to decimate the potato nicotine extraction business. As a small company, we cannot afford the expense of complying with the detailed reporting, inspection, packaging, and labeling requirements. The FDA has basically handed the entire market over to Big Potato." Indeed, the two largest potato manufacturers have each put their own brand of potato-derived e-cigarettes on the market. The R.D. Offutt Company is now selling its "E-Tater" brand in major convenience stores across the country. J.R. Simplot is test-marketing its "SafeSpuds" in Colorado and Utah.

But the national anti-vaping groups defended the FDA's action. According to the Campaign for Tobacco-Free Kids: "Following the playbook of Big Tobacco, e-cigarette companies are using sweet flavors to entice kids to what could turn into a lifetime addiction to nicotine." The Campaign called out "Sweet Potate," a Tampa-based company, for using the word "sweet" in the very name of the product (Sweet Potate Cigs).

The CDC also supported the new guidance, saying: "The use of nicotine in any form is hazardous and can cause impaired brain development in adolescence. The great gains we have seen over the past decades in reducing youth smoking are sadly being undermined by their increased use of potato products."

The CDC, in classifying e-cigarettes using nicotine derived from potatoes as "potato products," has recently documented a large increase in youth potato use. While actual youth consumption of potatoes has fallen significantly, overall potato use among high school students has increased over the past two years.

I do not understand why the FDA and CDC need to lie about these e-cigarettes. They are not potato products simply because the nicotine in their e-liquids happens to be derived from potatoes. And classifying the use of these e-cigarettes as "potato use" is disingenuous at best. Why do we need to lie in order to make our point? Wouldn't it be enough to tell kids that these products are not made from potatoes and therefore do not carry the same safety profile as potatoes. Already, there is evidence of widespread public confusion. More than 50% of youth surveyed believe that e-cigarette use is no more hazardous than eating candied yams.

The rest of the story is that by treating e-cigarettes like NicoSpud, SafeSpud, and SweetPotate exactly like potato products and by classifying them as potato products, the FDA and CDC are essentially telling the public, including our children, that the hazards of vaping these products are virtually identical to those of consuming potatoes.

What will it take for these agencies to understand that just because the nicotine in the latest generation of e-cigarettes happens to be derived from potatoes, that does not mean they are potato products? It is misleading if not outright dishonest to talk about these e-cigarettes as "potato products," to classify them as potato products in surveys, and to claim that youth who are using these products are engaging in potato use.

ADDENDUM: It has come to my attention that many readers did not realize that this is a parody  – my attempt at satire. It is a sad state of affairs that the FDA’s logic has been so terrible that my readers don’t know if this is true or not. That was my exact point in doing this piece. I wanted to show the absurdity of the FDA’s approach – and I think this analogy points it out in a way that many anti-vaping organizations would not understand in any other way. If there is any doubt about whether the deeming regulations are "arbitrary and capricious," this is the proof.

Tuesday, September 27, 2016

FDA and CDC are Lying About the Most Basic of Facts; How Can We Trust Them on More Complex Issues?

Donald Trump is not the only one who needs some fact-checking. My analysis of the September 22 article by the CDC's Office on Smoking and Health and the FDA's Center for Tobacco Products reveals that these agencies are misleading the public by lying to them about the most basic of facts: namely, whether or not electronic cigarettes contain tobacco.

According to the article: "e-cigarettes were the most commonly used tobacco product by middle (3.9%) and high (13.4%) school students. Use of tobacco in any form, whether it be combusted, noncombusted, or electronic, is unsafe."

Clearly, the CDC and FDA are telling the public that e-cigarettes represent the "use of tobacco" in electronic form. But this is untrue. Electronic cigarettes do not contain any tobacco. In fact, that is what distinguishes them from conventional cigarettes and from all tobacco products. In contrast to tobacco products, which contain tobacco, electronic cigarettes do not contain tobacco.

If you can't get past that most basic point, then there is no point continuing the discussion any further.

The FDA and CDC go on to state that: "Regardless of mode of exposure to nicotine (inhaling, chewing, or electronic), such exposure during adolescence (a critical time for brain development) may have lasting adverse consequences for brain development. Nicotine exposure during adolescence also causes addiction and may lead to sustained use of tobacco products." While there is evidence that this is true for cigarettes, I'm aware of no evidence that the use of e-cigarettes causes abnormal brain development. Further, I'm aware of no evidence that e-cigarettes cause nicotine addiction or that they lead to sustained use of tobacco products.

The study reiterates that it is examining "curiosity about tobacco." But curiosity about e-cigarettes is not curiosity about tobacco. In fact, it is the exact opposite. It is curiosity about a non-tobacco product. It is curiosity about a tobacco-free product. If the FDA and CDC can't be trusted to make that critical distinction and to communicate it accurately to the public, then how can they be trusted to address more complex issues such as developing policies on cigarettes and e-cigarettes that are going to maximize the protection of the public's health?

The Rest of the Story

A number of my colleagues have suggested to me that although the FDA and CDC are not telling the truth, the end goal of scaring kids into thinking that e-cigarettes are just as bad as cigarettes is a good one and will have a beneficial outcome, because it may help turn the tide of increasing experimentation with these products. I don't agree for three reasons:

1. Dishonesty is never justified in public health communication: The public health code of ethics requires that we be honest in our communications to the public. This is not simply an option that we have to consider among other possible options. This is an underlying principle that should not be discarded, even if we perceive that being dishonest may yield short-term public health gains.

2. Being dishonest risks losing public credibility and trust: Even if lying to the public - such as telling them that e-cigarettes are a form of tobacco use - were to produce short-term gains, these gains are far outweighed by the risk of doing long-term damage to the credibility and trust of public health. Once that credibility and trust are lost, it is not going to come back for a long time. And then, even when we do tell the truth, the public will not believe us.

3. The FDA and CDC's misleading the public about the fact that e-cigarettes contain no tobacco is actually having adverse public health consequences: Even if one were to throw concerns about honesty out the window, I don't believe that misleading the public by making them think that e-cigarettes are just another form of tobacco use has even short-term benefits. Conversely, by obscuring this critical difference between cigarettes and vaping products, this deception is leading many smokers to give up on attempts to quit smoking and it is causing many ex-smokers to consider returning to smoking because they don't see any benefit to vaping over smoking if they are simply alternative ways of using tobacco. Why continue vaping if it doesn't offer clear health benefits over smoking?

Would it kill the CDC or the FDA to once, just once, acknowledge that electronic cigarettes are tobacco-free products? I don't believe I have ever seen even a single communication, public statement, or article from either agency which acknowledges that e-cigarettes do not contain tobacco. This is absurd when you think about it because it is doing the greatest favor to cigarette profits that one could imagine: hiding the fact that there is a tobacco-free alternative which people can use by which they can avoid the use of tobacco as well as the combustion of tobacco.

The cigarette companies couldn't pay for a more effective marketing campaign to protect cigarette sales against competition.

Monday, September 26, 2016

American Lung Association Tells Public that Smoking May Be No More Hazardous than Vaping

Despite the abundance of scientific evidence, including clinical studies, which demonstrate that vaping is much safer than smoking, the American Lung Association - as recently as last week - told the public that smoking may be no more hazardous than vaping.

A UPI article quoted the American Lung Association's senior scientific advisor as stating: "We have no idea what the long-term effects are because they [e-cigarettes] haven't been around long enough, but there's no reason to consider e-cigarettes safe. Whether they're going to cause less disease than tobacco cigarettes, we'll eventually get that answer but it's going to take years."

The Rest of the Story

Unfortunately, in my view, the American Lung Association has completely lost any semblance of scientific credibility. They are telling the public that smoking may be no more hazardous than vaping, which is inconsistent with the scientific evidence, which definitively demonstrates that vaping is much safer than smoking. While one might argue about the exact magnitude of the decreased risk, there is no legitimate scientific argument that vaping is not drastically safer than smoking.

Even the fiercest vaping opponents - like Stan Glantz - agree that smoking is much more hazardous than vaping.

The evidence that vaping is dramatically safer than smoking continues to build. Recently, a study out of the Roswell Park Cancer Institute demonstrated substantial reductions in carcinogens and toxicants in vapers who had switched from cigarettes:

"Researchers measured levels of seven nicotine metabolites and 17 biomarkers of exposure to carcinogens and toxicants present in cigarette smoke. Their analysis revealed that while the nicotine metabolites remained unchanged among the majority of study participants – suggesting that e-cigarettes deliver nicotine effectively – the levels of the 17 toxicants and carcinogens measured dropped significantly after just one week of switching to e-cigarettes. For 12 of these 17 chemicals, the decline in was similar to the decline seen among tobacco users who quit smoking. “Toxins and carcinogens we measured in the body almost disappeared – the body cleared the 17 different chemicals we were looking for,” Goniewicz said. “They are safer, less toxic. It’s the first time we have very strong evidence that we will be able now to give (smokers) that the answer is, yes , this you should consider a transition, a substitute for your tobacco cigarette that will save your life.”"

You have to go back at least 16 years - and to the old playbook of the tobacco industry - to find another example of an organization lying so blatantly to the public about the severe hazards of smoking and undermining decades of education by public health officials. It is just far too ironic that the organization reverting to this tactic is a health group that is supposed to be fighting smoking in order to reduce lung disease.

It is highly irresponsible for the American Lung Association to be undermining the public's appreciation of the severe hazards of smoking in such a blatant and destructive way. This not only does a disservice to the American Lung Association's donors and contributors, but it also threatens the credibility of the ALA and other public health groups and undermines the stated mission of the ALA which is supposed to be to fight against, not for, lung disease.

The ALA should be jumping for joy to see a feasible alternative to smoking that is popular among smokers and which is successfully helping millions of smokers to quit smoking completely or to cut down substantially on the amount they smoke. They should be encouraging all smokers to quit, even those who want to try to quit using e-cigarettes. By demonizing these products, they are actually promoting smoking by deterring many smokers from trying to quit and by getting many former smokers who quit by vaping to think about going back to smoking, since if there is no clear health benefit, then why not just go back to smoking?

Anyone who cares about the integrity and reputation of the American Lung Association should be protesting this fallacious statement and urging the ALA to get back into the business of telling the truth.

Friday, September 23, 2016

FDA Violated Ethics Rules to Censor Dissenting Opinions about Its E-Cigarette Regulations

According to a shocking exposé in the October 16th issue of Scientific American written by Charles Seife, the FDA censored dissenting opinions about its e-cigarette regulations by prohibiting journalists covering the release of these regulations from speaking with anyone who might oppose them.

The FDA's e-cigarette regulations were initially released on April 24, 2014. On April 23, the FDA's Center for Tobacco Products held a press briefing for a select group of reporters to provide information so that they could publish news stories about the regulations at the expiration of the embargo, which was set for April 24th. It is not uncommon to set an embargo date and time for the release of a story by media outlets. It helps ensure that all media outlets have an equal opportunity to publish the story in a timely fashion and not to get "scooped" by one favored media outlet.

However, the FDA went beyond the simple step of setting an embargo date and time for the publication of media stories. First, the agency only invited a select group of reporters to the media briefing, ensuring that only reporters who were "friendly" to the FDA's position would be able to cover the story in a timely fashion and that such "friendly" reporters would get a scoop on the story.

Second, the FDA prohibited the reporters at the media briefing from talking to anyone else about the regulations prior to the embargo, meaning that in the articles coming out about the regulations at the expiration of the embargo, there was no possible way for reporters to provide quotes from individuals who might have dissenting opinions about the regulations. In other words, the FDA ensured that only its own position could be presented to the public.

The article explains that reporters at the briefing were told: "You will not be able to reach out to third parties for comment on this announcement."

In addition, reporters were sent an email stating that: "Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this. ... We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency."

The FDA thought that its little scheme to prevent the public from reading dissenting opinions about the regulations had worked to perfection. It apparently did work to perfection in terms of the nature of the media coverage, which of course failed to present any dissenting opinions from experts. However, one courageous reporter exposed the fact that the FDA was censoring media coverage by not allowing reporters to seek comments from experts who might have dissenting opinions. In  her article, she noted that:

"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."

According to Scientific American: "'I felt like I wanted to be clear with readers,' Sabrina Tavernise, the author of the story, later told Sullivan, the New York Times' public editor at the time. 'Usually you would have reaction in a story like this, but in this case, there wasn't going to be any.'"

The FDA then blasted Tavernise in an email to her, stating: "I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way."

The FDA was apparently not only prohibiting reporters from presenting an alternative perspective on its regulations but also prohibiting them from informing readers that they were not allowed to seek out alternative opinions. So the FDA was engaging not only in censorship but in a cover-up of that censorship.

At the time, Eric Boehm of wrote about the FDA's censorship: "Essentially, the Times agreed to feed the public information about new regulations, but without being able to talk to any of the people affected by the regulations. What did that leave them in terms of perspective? Only those who favored the new regulations, of course."

According to Seife, the FDA is violating its own ethics policy, established in 2011, which states that: "A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo."

In a revealing section of his article, Seife explains that:

"Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies."

Seife concludes that: "By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs."

The Rest of the Story

The rest of the story is that the FDA, including the Center for Tobacco Products, used censorship to ensure one-sided coverage of its e-cigarette regulations, thus denying the public the opportunity to receive a balanced perspective on the important public health issues at stake. In spite of the First Amendment, this censorship was successfully achieved by offering select reporters a sneak preview of the regulations and an opportunity to "scoop" other reporters, but forcing them to agree not to seek third party comments in order to secure this privileged status. In doing so, it appears that the FDA and CTP violated their own ethics rules. The end result was censoring any dissenting views on the e-cigarette regulations and ensuring that the public would only be presented with the FDA's side of the issue.

In my view, this is a clear violation of scientific ethics as well as the public health code of conduct. This is something you might expect out of the playbook of Big Tobacco or other corporations, not out of a federal agency charged with protecting the public's health.

Wednesday, September 21, 2016

Helena Miracle? Not So Much; New Study Casts Doubt on Conclusions of Anti-Smoking Groups

For many years, anti-smoking groups have been claiming that smoking bans result in an immediate and dramatic decline in hospitalizations for heart attacks. This claim is based on studies like that conducted in Helena, in which the authors concluded that there was a 40% reduction in heart attack admissions within 6-18 months after a bar and restaurant smoking ban was implemented.

When these studies were first published, I warned anti-smoking groups not to use these conclusions to promote smoking bans because I believed that the conclusions were not adequately supported by the data. In particular, I criticized these studies and questioned their conclusions because they did not adequately account for secular trends in heart attack rates that were occurring even in the absence of smoking bans.

I also argued that it was not plausible to see such large effects in so short a time span because it takes many years for heart disease to develop. In contrast, I noted that respiratory effects might be observed immediately.

Finally, I argued that these findings were largely a result of publication bias. Cities for study were not chosen randomly. Instead, in places where there appeared to be a dramatic decline in heart attacks, that community was chosen for study. The few studies that did systematically examine this research question failed to find an immediate effect of smoking bans on heart attack hospitalization rates.

This week, a new study was published in the journal Medical Care Research and Review which re-examines the relationship between smoking bans and heart attack hospitalization rates.

(See: Ho V, et al. A nationwide assessment of the association of smoking bans and cigarette taxes with hospitalizations for acute myocardial infarction, heart failure, and pneumonia. Medical Care Research and Review 2016. Published online ahead of print on September 12, 2016. DOI: 10.1177/10775587/16668646.)

The authors summarize the study as follows:

"We examine the association between county-level smoking-related hospitalization rates and comprehensive smoking bans in 28 states from 2001 to 2008. Differences-in-differences analysis measures changes in hospitalization rates before versus after introducing bans in bars, restaurants, and workplaces, controlling for cigarette taxes, adjusting for local health and provider characteristics. Smoking bans were not associated with acute myocardial infarction or heart failure hospitalizations, but lowered pneumonia hospitalization rates for persons ages 60 to 74 years."

The Rest of the Story

The results of this study support the arguments that I made back in 2006, and which I have continued to emphasize on this blog over the past 10 years. The key finding of the study is that once you account for time-specific local trends in heart attack hospitalization rates, there is no longer a significant observed decline in heart attack rates associated with the implementation of these smoking bans.

The key data are in Table 2. Helpfully, this table provides regression estimates both with and without the inclusion of region-specific (in this case, county-specific) time trends in the rate of hospitalization for heart attacks. Note that without the county-specific time trends, the authors do find a significant decrease in hospitalizations for heart attacks associated with the implementation of smoking bans. But once they control for these local time trends, there is no longer a significant effect.

What this suggests is that communities that implemented smoking bans happened to be those which had a higher pre-existing rate of decline in heart attacks and that once you adjust for that, there is no difference associated with the implementation of the smoking bans.

The authors further demonstrate that the previous conclusions were spurious by showing that when you examine the impact of smoking bans on hospitalizations for hip fractures (which are not plausibly related to smoking bans), you find a significant effect of smoking bans when you don't include regional time trends. That spurious effect disappears once you control for the regional time trends.

The regional time trends are important to consider in these models because without them, you are making the assumption that the secular rates of decline in heart attacks at baseline were the same in communities with and without smoking bans. Apparently, this is not a fair assumption because the nature of cities that enacted smoking bans differed from that of cities which did not enact such laws. And those differences were reflected in higher rates of decline in heart attacks in the intervention communities.

It is interesting to note that it was my expression of the above opinions about these studies back in the mid-2000's that led to my "expulsion" from the tobacco control movement, including being thrown off several list-serves, ostracized by many of my colleagues, accused of being a "tobacco mole," being characterized by my hero and mentor - Stan Glantz - as being "a tragic figure," having copyright to one of my articles violated by an anti-smoking organization, no longer being invited to speak at tobacco conferences, not being able to present at tobacco control conferences anymore, not being able to obtain further research grants, and having colleagues refuse to appear with me at conferences to discuss these or any other scientific issues. In fact, it was this censorship that led to the creation of the Rest of the Story in the first place.

Nearly three million page views later, perhaps these groups knew what they were doing because it appears that I may have been right all along. By silencing me, these groups were able to disseminate their pre-determined conclusions widely to the public through the media long enough for the conclusions to be generally accepted. Now, it is too late to undo the damage. The media and the public have already made up their minds, and one article noting the results of this new study is not going to correct or undo 10 years of dissemination of unsupported and errant scientific conclusions.

To be clear, this issue has nothing to do with my support for smoking bans. My readers understand that I have and continue to support 100% smoke-free policies for all workplaces (including bars, restaurants, and casinos). However, I do believe that we can advocate for such policies without misrepresenting scientific evidence or exaggerating findings beyond what is scientifically defensible.

Tuesday, September 20, 2016

FDA-Induced Crumbling of E-Cigarette Market Begins: NJOY Files for Bankruptcy

It didn't take long after the FDA enacted its deeming regulations for the first of many e-cigarette companies to lose their ability to stay in the market. Just one and a half months after the FDA's deeming regulations went into effect, NJOY - one of the largest independent e-cigarette manufacturers in the U.S. - has filed for bankruptcy.

While a major reason for NJOY's inability to stay afloat was the failure of its King cig-a-like product, the company also cites the "substantial expenses of preparing for the Food and Drug Administration (FDA) deeming regulations."

As I have argued for some time, the capital costs involved in preparing pre-market applications under the deeming regulations are prohibitive for all but the tobacco companies and perhaps the largest independent manufacturers. With the loss of NJOY, it is not even clear whether any of the independent companies will survive, and even if they do, whether there will be any significant diversity in the e-cigarette market that remains.

The result will be the devastation of the overall e-cigarette market and the squandering of an amazing opportunity to substantially reduce smoking-related disease and death.

Today's story illustrates how the change in the e-cigarette market away from cig-a-likes and toward more advanced vaping products - including open systems - has been the key to the growth of the market. By essentially making it impossible for the smaller companies that manufacture more advanced products like open systems to survive and restricting the market to the more traditional cig-a-likes, the FDA has ensured that market growth will be stunted, essentially blocking the shift from combustible cigarettes to safer alternatives.

It is a sad day for public health because the FDA has contributed toward putting an anti-smoking company out of business. NJOY's value proposition was to make smoking obsolete," which is exactly what the FDA should be trying to do.

The Rest of the Story

The rest of the story is that the FDA is perversely pursuing the exact opposite of what it should be doing. The FDA is committed to the preservation of cigarette smoking and to the protection of cigarettes from competition from much safer products. The agency's obsession with the pre-market approval process - which was never intended for e-cigarettes - is destroying the long-term potential to replace combustible tobacco products with much safer tobacco-free and smoke-free products, at the expense of the protection of the public's health.

The result of the FDA's actions will be the re-normalization of smoking as the predominant vehicle for nicotine use in the United States. It is becoming clear that this really could be about "a billion lives."