Saturday, September 29, 2012

New Commenting System in Place as Haloscan Will Be Discontinued as of Monday

The good news is that as my previous commenting system - Haloscan - will be defunct as of Monday, we now have a new commenting system in place: Disqus, which has received excellent reviews.

The bad news is that although Disqus advertised that comments from Haloscan could be migrated over, it has not worked so far. I have a request in to the support team and hopefully will be able to resolve it.

Fortunately, I've been able to save the XML file with all the comments, so I can search them if anyone has specific things they are looking for and I can even share the file with those who are interested, as a last resort if we are unable to get them imported.

The new commenting system required that I change the template, so we have a new look as well.

Friday, September 28, 2012

Potential Elimination of Early Childhood Programs in Kansas Demonstrates Folly of Tying Program Funding to Cigarette Revenues

Rather than spend the money on tobacco-related programs, as it was originally intended, most states have been diverting money from the Master Settlement Agreement to fund other essential government programs, plugging budget shortfalls and avoiding having to find other sources of revenue. As a result, I have been arguing that the Master Settlement Agreement was a public health disaster because it tied state fiscal solvency to continued high levels of cigarette consumption. If cigarette consumption falls substantially, then funding for essential government programs evaporates.

Yesterday, the Kansas City Star reported that the bulk of funding for early childhood programs in Kansas may go up in smoke because of an expected decrease in cigarette company revenues from the Master Settlement Agreement.

According to the article: "The Kansas Children's Cabinet and Trust Fund, which promotes early-childhood programs in the state, has been warned that it could lose up to 75 percent of its budget next year because of a drop in money from a national lawsuit against tobacco companies. Amanda Adkins, chairwoman of the cabinet, told the board Wednesday to prepare two recommendations — one that would assume the group would continue to receive $56 million in tobacco funds, with a second assuming it would receive only $12 million, The Topeka Capital-Journal reported. "That is just the hard reality in which we find ourselves," Adkins said. Kansas and 30 other states are currently in arbitration over provisions in the tobacco case settlement, leading to speculation that funding for the trust will be cut." ...

"The cabinet receives its funding from a 1998 settlement with major tobacco companies. One of the provisions of that settlement required states to force smaller cigarette manufacturers to pay a $6 per carton fee to keep them from undercutting the bigger companies. The major manufacturers contend the states haven't enforced that agreement."

The Rest of the Story

This story illustrates the brilliance of the Master Settlement Agreement (from the perspective of the cigarette companies). The states are now fiscally dependent on a steady stream of cigarette revenues. Any substantial drop in cigarette smoking threatens the state's fiscal situation. Thus, there is no incentive to take any action that will substantially reduce cigarette sales. Perhaps this is why we haven't seen many major anti-tobacco initiatives at the state level since the Master Settlement Agreement was signed. We've seen mostly minor initiatives that dilly dally around the margins, but very few which actually aim to put a major dent in cigarette sales.

Big Tobacco could not have scripted a happier (more favorable) ending to the Master Settlement Agreement saga. If they had sat down and tried to figure out a way to institutionalize tobacco consumption and to find a way to make the states become dependent upon tobacco sales for their economic survival, they could not have come up with a better scheme than this.

Out of their greed for political and economic gain, the Attorneys General have done a tremendous service for the tobacco companies. They have created a financial partnership between their states and Big Tobacco, by which the fiscal solvency of the states depends on continued high levels of cigarette consumption. They have destroyed the incentive for states to take any action that might substantially reduce cigarette use.

This explains why so few states are running effective tobacco control programs, why so few states are allocating their MSA money to anti-tobacco programs, and why Congress (aiming to protect the states they represent) crafted tobacco legislation that does very little to actually make a dent in cigarette consumption

In direct contrast to what the Attorneys General predicted, the Marlboro Man isn't riding into the sunset on Joe Camel. Instead, they're both having a beer and a good laugh together as they enjoy their trip to the bank.

Thursday, September 27, 2012

Americans for Nonsmokers' Rights Publicly Claims that Electronic Cigarettes are Not Useful in Smoking Cessation, Despite Any Scientific Support for Its Statement

In a press release issued yesterday, Americans for Nonsmokers' Rights (ANR) publicly claimed that electronic cigarettes are not helpful for smoking cessation, despite the lack of any scientific evidence to back up its assertion (and in the presence of much scientific evidence to contradict its statement).

According to the press release, entitled "Electronic (e)-cigarette manufacturers shamelessly promote untested product for use in "smokefree" environments; make false claims about efficacy as cessation device too":

"Proponents of electronic cigarettes, commonly known as "e-cigarettes," are misleading the public about these products through paid press releases, advertorials, and online social media by making unsubstantiated claims about their benefits and offering deep discounts and coupons to entice people to use them, despite their potential health risks. E-cigarette manufacturers and proponents appear to be the PR machine behind an onslaught of daily press releases that tout the benefits of e-cigarettes despite a lack of independent peer-reviewed scientific evidence demonstrating the safety or efficacy of the products for smoking cessation." ...

"'What I find most egregious are the direct advertisements with false and misleading claims, including that e-cigarettes are effective smoking cessation devices' ... said Cynthia Hallett, MPH, Executive Director."

ANR goes further than this, however. It links to its fact sheet about electronic cigarettes, which claims that: "E-cigarettes are widely promoted as a way for people to quit smoking, but ... there is no scientific evidence that e-cigarettes are an effective cessation tool."

The Rest of the Story

There are two major problems with ANR's statements. First, ANR claims that e-cigarette companies are lying when they argue that these products can be helpful in smoking cessation. Thus, ANR is asserting that we know that e-cigarettes are not useful in smoking cessation. The problem is that ANR has no evidence to back up this assertion.

Can ANR cite a single study which demonstrates that electronic cigarettes are not useful in smoking cessation? If not, then how can it claim that e-cigarette companies are lying when they suggest to customers that these products may be able to help them with smoking cessation?

The second major problem is that ANR is lying when it states that there is no scientific evidence that e-cigarettes are an an effective cessation tool.

There is abundant evidence that literally thousands (if not tens of thousands) of electronic cigarette users have successfully used these products to either quit smoking or to cut down substantially on the amount that they smoke. A clinical trial has demonstrated that among smokers who were not motivated to quit, 54% were able to quit completely or to cut down by at least half on the amount they smoke.

In light of the existing clinical trial evidence, how can ANR deceive the public by asserting that there is no evidence for the potential of electronic cigarettes in smoking cessation? To do so is to completely ignore the results of the clinical trial evidence, as well as to ignore the multitude of anecdotal evidence based on personal reports of ex-smokers. Ignoring the anecdotal evidence may not be all that troubling, but ignoring the clinical trial evidence is gravely problematic.

Apparently, ANR either has not read or is ignoring the Polosa study, which provides exactly the kind of scientific evidence that it claims does not exist. In that study, electronic cigarettes were found to be useful in smoking reduction or smoking cessation in a majority of smokers who were not even motivated or attempting to quit.

If ANR had asserted that the effectiveness of electronic cigarettes in smoking cessation has not been proven, that would be fine. But to claim that there is no evidence that electronic cigarettes may be helpful in smoking cessation is simply a lie. 
 
The rest of the story is that ANR's press release complains about e-cigarette companies misleading or lying to the public, ANR itself is lying to the public in claiming that there is no evidence that e-cigarettes can help smokers quit and is misleading the public in asserting that electronic cigarettes are not useful for smoking cessation:

(1) It is incorrect to state that there is no evidence that these devices are useful in smoking cessation or reduction. Clinical trial evidence suggests that these products could be very useful, even among smokers with little motivation to quit.

(2) It is misleading to assert that electronic cigarettes have been shown not to be an effective smoking cessation aid. They are for many people. What remains to be seen is exactly what proportion of smokers will be successful in quitting or cutting down substantially.

Wednesday, September 26, 2012

No IVF for Smokers or Overweight Prospective Parents in Fife

According to an article in the Express, the National Health Service in Fife, Scotland is set to impose new rules by which couples will be denied in-vitro fertilization (IVF) treatment if either prospective parent smokes or if the woman has a body mass index of greater than 30.

Fife is apparently the first health board in Scotland to dictate that both partners must be nonsmokers in order to be eligible for IVF, as well as the first to dictate that the woman must be within certain body mass index parameters.

According to the article: "Dr Brian Montgomery, medical director of NHS Fife, said: 'Treatment criteria have been revised to improve the success of the treatment and the outcomes for mothers and babies. Both partners must be non-smokers and the female body mass index should be less than 30kg/m2.'"

The Rest of the Story

Well of course it will improve the success of the treatment and the outcomes if you limit the availability of the treatment to the healthiest couples. So why not also limit IVF to couples where both partners consume less than 150 grams of fat per day? And why just limit the BMI to 30? Why not set an age limit at 30 as well to improve the success and outcomes?

While the Fife National Health Service is at it, why not also limit IVF to persons who have a body mass index of at least 20, as underweight is known to reduce fertility? And why prohibit IVF for women who consume five or more drinks of alcohol per week, since that has been shown to significantly reduce fertility?

Other people who should not be eligible for IVF, in order to improve treatment success, include:
  • those with autoimmune disorders, such as lupus, diabetes, and thyroid disease;
  • those taking anti-depressants, which have an adverse effect on fertility; and
  • those under high levels of mental stress, which severely impairs fertility.
Imagine the success rates and wonderful outcomes the Fife NHS could achieve with IVF therapy if it were only available to nonsmokers who were thin, but not too thin, consumed less than five drinks of alcohol per week, were less than 30 years old, consumed less than 150 grams of fat per day, did not have lupus, diabetes, or thyroid disease, were not taking anti-depressants, and were living relatively stress-free lives.

Revising the treatment criteria in that way would drastically "improve the success of the treatment and the outcomes for mothers and babies."

Not only that, but waiting times for treatment would decrease precipitously and lots of money would be saved. Plus, population growth would slow, which itself would yield significant societal benefits. It would truly be a win-win situation for all involved. 

Tuesday, September 25, 2012

Anti-Smoking Groups that Opposed Electronic Cigarettes Accepted Money to the Tune of $2.8 Million from Pfizer Alone in 2011-2012

The eight anti-smoking organizations that have opposed electronic cigarettes and called for their removal from the market pocketed a total of $2.8 million from Big Pharma's Pfizer during 2011 and the first half of 2012, according to figures being released today by The Rest of the Story.

Based on financial contribution reports published by Pfizer, the anti-smoking groups that have called for a ban on electronic cigarettes have received millions from the pharmaceutical manufacturer of Chantix, a smoking cessation product that stands to lose enormously if electronic cigarettes become increasingly popular. These organizations have repeatedly failed to disclose their financial interests in Big Pharma when making statements opposing electronic cigarettes.

The numbers compiled by The Rest of the Story are as follows (these represent Pfizer money received by each anti-smoking group during 2011 and the first two quarters of 2012):

American Academy of Pediatrics: $720,800
American Cancer Society: $252,750
American Heart Association: $136,000
American Lung Association: $190,250
Campaign for Tobacco-Free Kids: $100,000
American Medical Association: $857,500
American Legacy Foundation: $300,000
Action on Smoking and Health: $200,000

GRAND TOTAL: $2,757,300

The Rest of the Story

These figures illustrate how strong a financial interest the major national anti-smoking groups have in Big Pharma and help explain the entrenched position of these groups against electronic cigarettes. These data also help explain why these groups continue to promote drug therapy for smoking cessation despite evidence of its dismal rates of effectiveness.

These are the primary anti-smoking groups that called for the removal of electronic cigarettes from the market. Each of these groups, for example, submitted an amicus brief urging the D.C. District Court to allow the FDA to ban electronic cigarettes by regulating them under the Food, Drug, and Cosmetic Act, even in the absence of therapeutic claims made by product manufacturers. Had the recommended action of these groups been taken, literally thousands of ex-smokers would instead be smokers today because electronic cigarettes have been their means to achieve smoke-free status.

In their amicus briefs, none of these anti-smoking groups disclosed their financial ties to Big Pharma. Nor have they disclosed these severe financial conflicts of interest in public statements or website pages opposing electronic cigarette use.

Today, we find out that each and every one of these eight anti-smoking groups has accepted funding from Big Pharma and more importantly, from a Big Pharma company that manufactures a smoking cessation drug that is a direct competitor to electronic cigarettes.

Moreover, the amount of money involved is substantial. Each of these groups received at least $100,000 in an 18-month period alone, and the total amount of money received by the eight groups during this period from Pfizer alone exceeds $2.75 million.

Now it is starting to make sense why these groups opposed a product that is helping literally thousands of ex-smokers to remain smoke-free and helping hundreds of thousands more to greatly reduce the amount of cigarettes that they smoke.

When public health groups start to oppose public health measures, you need to start suspecting that money is playing a role. Today's revelation demonstrates that in the case of anti-smoking group opposition to electronic cigarettes, the money being received from Big Pharma is working to perfection. These groups are vigorously protecting pharmaceutical profits, even at the expense of severe harm to the public health and their abrogation of ethical integrity by failing to even disclose their conflicts of interest to the public.

Monday, September 24, 2012

ADA, AAP, AAFP, and ADA: Whose Side are You On? Rest of the Story Challenges Health Groups to Reject Big Soda Money After Coke and Pepsi Deny Link Between Sugar-Sweetened Beverages and Obesity

Today, the Rest of the Story has a question for the American Dietetic Association (ADA), American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), and American Diabetes Association (ADA2):

Whose side are you on?

The side of the public's health, or the side of helping to market sugar-laden soft drinks?

In response to a salvo of articles published in the prestigious New England Journal of Medicine which demonstrate -- using the most rigorous methodology available -- a strong link between the consumption of sugar-sweetened beverages and obesity, the Coca-Cola Company and PepsiCo, Inc. responded by denying that there is any link between sugar-sweetened beverage consumption and obesity.

In the first study, investigators examined the interaction between genetic predisposition to obesity and consumption of sugar-sweetened beverages. Their findings were as follows: "In two prospective cohorts of U.S. women and men, we found that greater consumption of sugar-sweetened beverages was associated with a more pronounced genetic predisposition to an elevated BMI and an increased risk of obesity. The findings were further replicated in an independent large cohort of U.S. women. In all three cohorts, the combined genetic effects on BMI and obesity risk among persons consuming one or more servings of sugar-sweetened beverages per day were approximately twice as large as those among persons consuming less than one serving per month. These data suggest that persons with greater consumption of sugar-sweetened beverages may be more susceptible to genetic effects on adiposity. ... Our findings further underscore the need to test interventions that reduce the intake of sugary drinks as a means of reducing the risk of obesity and related diseases."

The authors conclude that "these data support a causal relationship among the consumption of sugar-sweetened beverages, weight gain, and the risk of obesity."

In the second study, normal weight children ages 4-10 were randomized to receive 8 ounces of either a sugar-sweetened or sugar-free beverage each day at school. After just 18 months of providing merely 8 ounces of this beverage a day, there was a significant weight difference between the two groups. The researchers conclude that: "Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children." They note that: "Children in the United States consume on average almost three times as many calories from sugar-sweetened beverages as the amount provided in our trial. We speculate that decreased consumption of such beverages might reduce the high prevalence of overweight in these children."

In the third study, obese and overweight adolescents were randomized either to receive or not receive an intervention which consisted mainly of providing them with non-caloric beverages. Children in the intervention group greatly reduced their consumption of sugar-sweetened beverages and after one year, had significantly lower body mass indices. The effect was attenuated after two years, with children in the intervention group still having lower weights, but there was not a statistically significant difference between the groups.

An accompanying editorial which synthesizes the findings of all three studies emphasizes that: "These randomized, controlled studies — in particular, the study by de Ruyter et al. — provide a strong impetus to develop recommendations and policy decisions to limit consumption of sugar-sweetened beverages, especially those served at low cost and in excessive portions, to attempt to reverse the increase in childhood obesity. ... Taken together, these three studies suggest that calories from sugar-sweetened beverages do matter. ... The time has come to take action and strongly support and implement the recommendations from the Institute of Medicine, the American Heart Association, the Obesity Society, and many other organizations to reduce consumption of sugar-sweetened beverages in both children and adults."

The Rest of the Story

Despite this strong evidence that sugar-sweetened beverages contribute to obesity, two major corporations which produce such drinks - the Coca-Cola Company and PepsiCo, Inc. - continued to deny any link between consumption of sugar-sweetened beverages and obesity. The companies responded by stating: "Sugar-sweetened beverages are not driving obesity. By every measure, sugar-sweetened beverages play a small and declining role in the American diet."

The statement of the soft drink companies is analogous to the repeated denials of the tobacco industry in past decades that its products contribute to lung cancer, heart disease, and chronic obstructive lung disease. In light of evidence to the contrary, the tobacco industry continued to deny any link between smoking and disease.

Now, the soft drink companies are acting exactly like Big Tobacco. In the face of strong evidence - from multiple independent studies - published in a reputable medical journal, these companies publicly deny that there is any link between consumption of sugar-laden beverages and obesity. Furthermore, they have the chutzpah to suggest that sugar-sweetened beverages play a small role in the American diet and that their consumption is going down.

These claims are in stark contrast to the boasting proclamations of the Coca-Cola Company that its sales volume grew 4% last year in North America. It's funny because I don't see anything in this investment report about how sugar-sweetened beverage consumption is declining in America. These companies are talking out of both sides of their mouths: one side for the damage control due to the New England Journal studies; the other side for their investors.

There's More to the Story

It would be great if this were the end of the story. But it doesn't end here.

Four public health organizations - the American Dietetic Association, American Academy of Pediatrics, American Academy of Family Physicians, and American Diabetes Association - have accepted money from the Coca-Cola Company and/or PepsiCo and have forged corporate partnerships with these companies, in some cases going so far as to call these companies leaders in the movement to reduce obesity.

American Academy of Family Physicians

The American Academy of Family Physicians (AAFP) has entered into a corporate partnership with the Coca-Cola Company, in which Coca-Cola is providing money to AAFP in return for public recognition, improvement of its public image, distraction of public attention away from the role of Coca-Cola's products in the obesity epidemic, a lucrative marketing opportunity for Coke, and ultimately, an increase in its bottom line (Coke sales).

The large expenditure on the part of Coca-Cola is very well spent, and should be applauded vigorously by Coca-Cola stockholders. The corporation is already starting to reap the benefits of this rare marketing opportunity.

On the web site that is apparently being supported by Coca-Cola, the AAFP actually goes so far as cautioning people not to necessarily limit their consumption of soda: "Sugar-sweetened drinks, such as fruit juice, fruit drinks, regular soft drinks, sports drinks, energy drinks, sweetened or flavored milk and sweetened iced tea can add lots of sugar and calories to your diet. But staying hydrated is important for good health."

American Academy of Pediatrics

The American Academy of Pediatrics accepted funding from Coca-Cola to sponsor its "Healthy Children" web site. On that site, the AAP states that the Coca-Cola Company is committed: "to better the health of children worldwide."

Whatever Coca-Cola contributed to the American Academy of Pediatrics to garner that statement and recognition as a leader in the child health movement internationally was nowhere near enough. This is blatant prostitution, where the AAP is essentially selling its site to the highest bidder. Do you want to be recognized as a leader in children's health internationally? Simply pay off the AAP. Never mind the fact that you market a product which is a major contributor toward childhood obesity.

American Dietetic Association

According to a press release issued on August 31 by the Coca-Cola Company, the American Dietetic  Association has accepted $125,000 from Coca-Cola. This donation was originally reported over at the Fooducate blog in a post entitled "Here's How Coke is Buying the Silence of Health Organizations. For Pocket Change."


I defy anyone to find information on the ADA's web site about the billions of dollars that Coke is spending annually to market its sugar-laden products. Given the role of soda marketing in the obesity epidemic, that is what I call total silence.

In fact, the public's health would be better served if the ADA were completely silent. The media outreach that it is doing stands in opposition to what many of us in public health are trying to accomplish through policy measures to reduce soft drink consumption. Concurrent with its acceptance of money from Coca-Cola, the ADA has actually become an enemy of critical public health measures to reduce obesity, not merely an innocent bystander, and at the far extreme from being a leader in the nutrition policy movement.

American Diabetes Association

According to a press release issued on August 31 by the Coca-Cola Company, the American Diabetes Association has accepted $125,000 from Coca-Cola. This donation was originally reported over at the Fooducate blog in a post entitled "Here's How Coke is Buying the Silence of Health Organizations. For Pocket Change."

The Challenge

Today, I am issuing a challenge to the American Academy of Pediatrics, American Academy of Family Physicians, American Dietetic Association, and the American Diabetes Association:

Now is your chance to change sides on this issue. Right now, you have chosen to take the side of aiding in the marketing of sugar-laden soft drinks and other sugar-sweetened beverages by partnering with corporations that are spending millions of dollars to market these drinks and to oppose every reasonable measure introduced at the state and local level to improve school nutrition. You have chosen to serve as a pawn in the marketing and public relations efforts of corporations that to this day, are publicly denying that there is even a link between sugar-sweetened beverage consumption and obesity. And which even have the gall to publicly claim that sugar-sweetened beverages play a minor and declining role in the American diet, despite their investor reports which boast the exact opposite.

I challenge these four organizations to switch sides, and to come over to the side of the public's health by renouncing their corporate partnerships with Coca-Cola and Pepsi, returning their checks, and vowing not to accept funding from these companies.

Political Corruption in St. Louis Health Department Opens Door: Now All Bars and Restaurants Can Ask for Exemptions

The St. Louis health department's decision to cave in to pressure from wealthy and politically connected constituents at the Missouri Athletic Club by agreeing not to enforce the law as it regards that establishment has now opened the door to all St. Louis bars and restaurants to request similar arrangements. After all, a precedent has now been set that for no health-related justification at all, the City of St. Louis is willing to look the other way if your business complains loudly enough, or at least has the right political connections.

As our own Bill Hannegan has pointed out, the Missouri Athletic Club kicked off its negotiations with the city health department by actively flouting the ordinance. In how much better a position, then, are the hundreds of bars and restaurants that have been following the law? Should they not be in a better position to negotiate with the city, since they have taken the moral high ground and diligently followed the law? Should they City not consider their good behavior in negotiating with these establishments? And if the bad behavior of the MAC resulted in the city agreeing to look the other way, should not the good behavior of these other bars be rewarded by the city happily looking the other way?

Now that it has established that businesses can successfully negotiate with it to get out of having to follow health ordinances, the St. Louis department of health is going to need to set up an "Exemptions Department" to handle all these negotiations. The line will be out the door.

St. Louis is now the only city I am aware of where if you don't like a health regulation, you can negotiate with the city health department to be excused from having to adhere to the law.

The Rest of the Story

The irony of the situation was not lost to cartoonist Dan Martin of the St. Louis Post-Dispatch who mockingly depicts health director Pam Walker sitting at a desk signed "Smoking ban exemption application division," taking requests from local businesses to get out of having to comply with the smoking ban.


Friday, September 21, 2012

European Union Poised to Ban Electronic Cigarettes, Forcing Smokers to Be Able to Use Only the Most Hazardous Possible Nicotine-Containing Products

According to a working document leaked to the Tobacco Journal International, the European Union's revised Tobacco Products Directive contains a recommended ban on the marketing of all electronic cigarettes. More broadly, the Directive contains a ban on the marketing of all smokeless nicotine-containing products with the one exception of Swedish snus. This means that not only electronic cigarettes, but dissolvable tobacco products, orbs and strips, and all smokeless tobacco other than Swedish snus would also be banned.

According to the leaked draft of the Directive: "Only NCP [nicotine-containing products] that are authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive benefit/risk balance are allowed on the market. Otherwise, marketing of NCP is banned."

Because electronic cigarettes (as well as other nicotine-delivering products such as dissolvable tobacco products) have not been authorized as medicinal products (i.e., drugs), they would not be allowed on the market under this draft directive.

Christopher Snowdon first broke this story last Friday. At that time, no actual text of the document was available so I chose not to blog this. Now that Tobacco Journal International has released the text of the leaked document, I can confirm that the directive does indeed recommend a ban on all smokeless nicotine-containing products (other than Swedish snus).

The Rest of the Story

What the Tobacco Products Directive is basically saying is that the EU wants to make sure that the most hazardous nicotine-containing products (cigarettes) - and only the most hazardous nicotine-containing products - remain on the market and available to Europe's nicotine users. This is essentially a strategy to maximize disease and death in Europe.

Does it not make more sense to ensure the availability of the safest nicotine-containing products, allowing them to compete with cigarettes and to encourage smokers to quit? This is especially true of electronic cigarettes, which contain no tobacco, have a decent toxocological profile, and have been shown to result in high rates of cessation or smoking reduction, even among unmotivated smokers.

The strategy also ensures that the least effective smoking cessation products remain available to smokers in Europe and that more promising strategies (such as electronic cigarettes and any subsequent innovations based on the e-cigarette concept) do not see the light of day.

This proposal protects the interests of the cigarette and pharmaceutical industries at the expense of the public's health.

In a column entitled "Smokers only allowed to buy deadly tobacco cigarettes in New Zealand? – Ministry of Health moves to ban nicotine electronic cigarettes," Dr. Murray Laugesen explains why a similar proposal by the New Zealand Ministry of Health that would ban electronic cigarettes makes no sense and would harm the public's health. According to the article: "Dr Laugesen says it is clearly not in the public interest to run a prosecution against sellers of nicotine e-cigarettes which the Ministry of Health itself says are "far safer" than tobacco cigarettes, when banning them is expected to send hundreds of users back to smoking tobacco cigarettes.  In 2010 End Smoking NZ identified e-cigarettes as one of the top four policies for ending tobacco smoking in New Zealand in an article in the New Zealand Medical Journal."

Dr. Laugesen goes on to write: "Persistent tobacco smokers face a lifetime 50 percent risk of dying early, and according to End Smoking NZ are entitled to have access to buy whatever nicotine product would most help them quit. Nicotine products do not cause cancer or heart disease, unlike smoked tobacco products. If there is a tiny risk from nicotine, many smokers are prepared to take that risk, rather than run the deadly risks of smoking tobacco. Smokers interested in switching to nicotine electronic cigarettes should be able to buy them over the counter at any dairy or supermarket, just like tobacco cigarettes."

I can only echo Dr. Laugesen's comments and note that they apply equally well to the European Union.

Thursday, September 20, 2012

Political Corruption in the Gateway City: If St. Louis Health Department Won't Stand Up for Health, Then What Will It Stand Up For?

In my 25 years in tobacco control, I have seen many cities and towns grant exemptions from smoking bans to certain types of establishments. But never have I seen a health department unlawfully exempt a particular establishment, thus willfully violating the law.

That all changed this week, when St. Louis city health department director Pam Walker decided to allow smoking at the downtown Missouri Athletic Club, in direct violation of the ordinance passed by the St. Louis City Council. That ordinance bans smoking in all bars and restaurants, including private clubs, unless there are no employees. Since the Missouri Athletic Club has multiple employees, it is subject to the smoking ban. However, after threatening a lawsuit (that would have no legal basis) and flexing its muscles, and after some apparent back-room deal-making, the health department announced that it would allow the Missouri Athletic Club to violate the law.

What is this? Chicago in the 1960's? Can wealth and prestige simply buy off policy makers? Apparently so.

David Hunn, the reporter who covers St. Louis government and politics for the St. Louis Post-Dispatch, covered this important story in yesterday's paper.

He wrote: "No other city in the country has enacted a smoking ban and then willingly broken the ban to make an exception for one business, said Dr. Michael Siegel, who has tracked tobacco laws for 25 years. Siegel, a professor at Boston University’s School of Public Health, said city health director Pam Walker’s decision to allow smoking at downtown’s Missouri Athletic Club is the first of its kind. “I’ve never seen a health department essentially fight to provide an exemption for an entity,” Siegel said. He doesn’t even consider Walker’s decision an exemption. If the city scrapped the existing law, wrote a new bill, added an exemption for the MAC, and got it passed into law by the Board of Aldermen, that’d be one thing, Siegel said. “This is simply looking the other way,” he said. “They’re essentially saying they’re not going to enforce the legislation for this particular business.” “It really sours the entire integrity of the health department, I think,” he said."

If you haven't already seen it, please read my previous coverage of this issue:

In Backroom Deal, St. Louis Health Director Agrees to Exempt Missouri Athletic Club from Smoking Ban (link)

St. Louis Health Director Shows that Money and Lawsuit Threats Do Talk, Suspends Smoking Ban for One Business Only (link)


The Rest of the Story

If the city of St. Louis wants to avoid being guilty of political corruption and the St. Louis Department of Health wants to retain any integrity, this decision needs to be revoked immediately and the law needs to be enforced as written. Otherwise, St. Louis is going to quickly become the laughing stock of public health nationally.

The rest of the story is that in one of the most egregious examples of political corruption affecting public health in my lifetime, the St. Louis Department of Health has succumbed to political pressure and agreed to knowingly look the other way in the face of recurrent and willful violation of city law.

In my opinion, not only is this a public health travesty, but the Department of Health and the Mayor's office need to be investigated by the Missouri Attorney General's office. Willful failure to enforce the law is in my view an abrogation of the responsibility to uphold the law.

Note: By stating that the health department was essentially "bought off," I am not suggesting that there was any payment of money in exchange for this agreement. Instead, I am arguing that by virtue of the wealthy status of the Downtown Athletic Club and its membership, this business was able to achieve the equivalent of an exemption, while other businesses that have less money and are less well politically connected, have no hope of getting the health department to look the other way. 

Wednesday, September 19, 2012

Providence Mayor Praises Himself for Banning Flavored Cigars, But He Fails to Remove Exemption for Most Flavored Cigarettes

Claiming that "we will not let our children be harmed by the tobacco industry’s deceitful tactics to attract new users," Providence's mayor and city council president praised themselves - in a letter to the editor of the New York Times - for closing a loophole in the FDA tobacco regulations which permit the sale of flavored cigars.

The FDA bans the sale of some flavored cigarettes, but this ban does not extend at all to cigars. To close part of that loophole, Providence enacted an ordinance that bans the sale of flavored cigars.

Praising themselves, the mayor and city council president wrote: "Like New York City and Maine, Providence, R.I., is fighting to protect our children from tobacco. We took the ruling by the Food and Drug Administration banning flavored cigarettes a step further by banning the sale of other candy- and fruit-flavored tobacco products. Tobacco products that entice children with flavors like bubble-gum and chocolate will no longer be sold in stores in Providence. Beyond cigars, there are many emerging tobacco products that deceive people of all ages with their mint and colorful candy-like packaging. Most smokers begin before they turn 18, and we will not let our children be harmed by the tobacco industry’s deceitful tactics to attract new users. The City of Providence is standing strong to protect the health and wellness of our youth. Although our efforts have drawn a lawsuit from the tobacco industry, we will not back down."

The Rest of the Story

If the city of Providence is standing strong to protect the health and wellness of its youth, then why did it not close the biggest loophole in the FDA tobacco law: the exemption of most flavored cigarettes, including those most favored by the youth of Providence, Rhode Island?

If the city of Providence is fighting to protect its children from tobacco, then why did it not choose to ban the sale of all flavored cigarettes, rather than to focus its efforts on cigars, which are far less of a long-term health problem for Providence's youth than cigarette smoking?

How can Providence continue to allow flavored cigarettes to attract, seduce, and addict the majority of its youth smokers, and at the same time, praise itself for putting an end to the tobacco industry's attempts to attract new users?

The rest of the story is that the mayor and city council president are not truly standing up to Big Tobacco. They are not truly protecting their children from tobacco. They are not truly putting an end to the tobacco industry's attracting new users.

Instead, they are taking a politically easy step that ignores the larger problem: about 50% of Providence's youth smokers are using flavored cigarettes -- namely, menthol cigarettes. And about this problem, the Mayor and City Council chose to look the other way.

Rather than close the loophole which exempted menthol cigarettes from the FDA's flavored cigarette "ban," the Providence City Council chose to look the other way, while distracting attention from its decision to ignore the problem by praising itself for getting rid of chocolate cigars.

Tuesday, September 18, 2012

St. Louis Health Director Shows that Money and Lawsuit Threats Do Talk, Suspends Smoking Ban for One Business Only

Proving that policy makers can still essentially be bought off by wealthy and influential individuals and scared off by the veiled threat of lawsuits, City of St. Louis Health Director Pam Walker has granted an exemption to a private club that serves wealthy people in the city, while requiring all other bars, restaurants, and private clubs to remain smoke-free as called for by a city ordinance.  

A smoking ban went into effect in St. Louis in 2011, barring smoking in all restaurants and other places of employment, but not including bars whose square footage is less than 2000 or private clubs without employees. The Missouri Athletic Club in St. Louis does not qualify as a small bar, nor as a private club without employees. Thus, it is subject to the smoking ban, or at least it is supposed to be subject to the ban.

However, after threatening the city with a lawsuit and apparently holding backroom meetings with the city, the downtown Missouri Athletic Club was able to win an exemption from the smoking ban from the City Health Department.

City health department director Pam Walker acknowledged that she was granting an exemption to the aristocratic club earlier this week.

The Rest of the Story

There is no ambiguity about the law and whether it applies to the Missouri Athletic Club. It applies. The Club is neither a private club without employees nor is it a bar. Thus, it is subject to the ban. Or ... it should be.

Clearly, what happened here is exactly what Bill Hannegan (one of our own Rest of the Story readers and commenters) said happened: This is the result of a backroom deal that, with no legal basis, excluded one establishment from the law in order to appease a privileged and influential sociopolitical class of individuals: the city's politicians.

This is the worst kind of political elitism. It is exactly the kind of back-door negotiating between government officials and private aristocracy that democratic polity despises.

And it therefore the worst kind of hypocrisy. The St. Louis Health Department is basically saying that employees and the public need to be protected from the hazards of secondhand smoke, but not if the establishment is an elitist one which serves politicians. Then, public health principles go out the window and a backroom deal can buy you an exemption from the law.

In St. Louis, the law only applies, I guess, to "lower-class" establishments that serve the 99%. Elitist joints that serve the 1% aren't subject to the same laws. They can essentially buy their way out of having to follow the law by using their political, economic, and legal clout. Threaten a lawsuit and be able to back up the threat with money and the public health department will back down. No longer will the public health principles of protecting people from the hazards of secondhand smoke be paramount.

This is hypocrisy at the highest level. If the Missouri Athletic Club is granted an exemption when there is no lawful exemption written into the city ordinance, then why shouldn't Pat's Bar & Grill and hundreds of other establishments in the city be allowed to negotiate for exemptions through their own backroom deals?

As Hannegan asks: "It opens the door for bars to petition for their own exemption. If she can do this for the MAC, why can’t she do this for other establishments?"

Why didn't the ordinance simply specify (in a new section - section 17) that any establishment with political and economic clout could apply for an exemption from the law through a special exception that could be arranged through a backdoor deal? That's exactly what the Health Department is doing, and that is why its director - Pam Walker - has joined a private club of her own - the Colonel Benjamin Church Hypocrisy Hall of Shame - as a gold club member.

Note: By stating that the health department was essentially "bought off," I am not suggesting that there was any payment of money in exchange for this agreement. Instead, I am arguing that by virtue of the wealthy status of the Downtown Athletic Club and its membership, this business was able to achieve the equivalent of an exemption, while other businesses that have less money and are less well politically connected, have no hope of getting the health department to look the other way.

Thursday, September 13, 2012

Campaign for Tobacco-Free Kids' Argument that Sixth Circuit Validated Graphic Warning Labels is Not Entirely Correct; Supreme Court Will Never Affirm Sixth Circuit's Reasoning on the Actual Proposed Warning Labels

Last month, I reported on the U.S. Court of Appeals for the District of Columbia upholding a district court decision that invalidated the graphic cigarette warning labels proposed by the Food and Drug Administration (FDA).

The Campaign for Tobacco-Free Kids has argued that the D.C. Circuit's ruling is "wrong on the law" and "wrong on the science" and urged the FDA to appeal to the Supreme Court.

The Campaign wrote: "The Justice Department should quickly appeal today's ruling by the U.S. Court of Appeals for the D.C. Circuit that struck down the large, graphic cigarette warnings required by the landmark 2009 law giving the FDA authority over tobacco products. Today's ruling is wrong on the science and law, and it is by no means the final word on the new cigarette warnings. The only other appellate court to consider the issue, the U.S. Court of Appeals for the Sixth Circuit, upheld the graphic warnings requirement in March. ... The Sixth Circuit found that the law's requirements for graphic warnings "are reasonably related to the government's interest in preventing consumer deception and are therefore constitutional." That court found that the warnings "do not impose any restriction on Plaintiff's dissemination of speech, nor do they touch on Plaintiffs' core speech. Instead, the labels serve as disclaimers to the public regarding the incontestable health consequences of using tobacco."

There seems to be a widely-held perception that the D.C. and Sixth Circuit court rulings are in direct contradiction. Because of this, many anti-smoking groups have played down the significance of the D.C. Court's ruling, asserting that the Sixth Circuit upheld the graphic warning labels and that there is therefore a good chance that the Supreme Court will side with the Sixth Circuit's opinion.

The Rest of the Story

Not so fast.

While there clearly is a discrepancy in the two Circuit Court rulings, making it very likely that the Supreme Court would take the case if the FDA appeals, it is not as simple as arguing that the Sixth Circuit approved the graphic warning labels proposed by the FDA.

Importantly, the Sixth Circuit was ruling on the general principle of the use of graphic warning labels on cigarette packages, rather than on the specific warning labels proposed by the FDA. The Court ruled that warning labels, even those that incorporate pictures to enhance the understandability of the warning, are factual and non-controversial disclosures that are subject to only light scrutiny under Zauderer. There must only be a rational basis for the requirement, which there clearly is with regard to warning people about the hazards associated with cigarette use.

However, the Court did not rule on the specific warning labels proposed by the FDA and perhaps did not even see the labels that FDA proposed, which are not mentioned in the decision. Instead, the decision relates to textual warnings that are accompanied by pictures used to illustrate the warnings, such as one might encounter in a medical textbook.

The Court writes: "Without any specific graphic images to challenge, Plaintiffs’ argument is and must necessarily be that the graphic warning requirement on its face violates the First Amendment." Thus, the Court is making it clear that it is only evaluating the general concept of requiring a graphic component to a warning label, not the specific warning labels proposed by the FDA.

Furthermore, the district court made it clear that it, too, was ruling just on the general concept of requiring pictures to accompany a warning: "In finding that the new warnings were permissible under the First Amendment, the court stated that it “does not believe that the addition of a graphic image will alter the substance of [the new warnings], at least as a general rule. Accordingly, . . . the Court finds that the warning requirement is [constitutional]."

Moreover, the Court writes: "Supreme Court precedent dictates that we review Plaintiffs’ challenge to
the Act’s warnings as a facial one." Again, the Sixth Circuit makes it exquisitely clear that it is ruling only on the idea of requiring pictures as part of a warning, not on the specific graphic warning labels designed by the FDA.

The actual meaning - and limited scope - of the Sixth Circuit decision is made explicit by the Court's own language: "Because Plaintiffs bring a facial challenge to the warning requirements, our concern is not the specific images the FDA chose—those are under review elsewhere—but rather whether
Plaintiffs can show that “ no set of circumstances exists under which [the statute] would be valid, or that the statute lacks any plainly legitimate sweep.”"

Obviously, this is a very broad criterion, and it is almost certainly possible to demonstrate at least one example of a pictorial warning label that would convey factual and non-controversial information. In fact, the Sixth Circuit court is able to imagine such a situation: the use of pictures such as in a medical textbook.

Here is what the Sixth Circuit is imaging in upholding the graphic warning label requirement: "Students in biology, human-anatomy, and medical-school courses look at pictures or drawings in textbooks of both healthy and damaged cells, tissues, organs, organ systems, and humans because those pictures convey factual information about medical conditions and biological systems."

What the Sixth Circuit has in mind is a textual warning accompanied by a simple demonstrative picture: "a picture or drawing of a nonsmoker’s and smoker’s lungs displayed side by side; a picture of a doctor looking at an x-ray of either a smoker’s cancerous lungs orsome other part of the body presenting a smoking-related condition; a picture or drawing of the internal anatomy of a person suffering from a smoking-related medical condition; a picture or drawing of a person suffering from a smoking-related medical condition; and any number of pictures consisting of text and simple graphic images."

The actual graphic warning labels proposed by FDA go far beyond these simple descriptive pictures. Moreover, they include a 1-800 telephone number designed to refer smokers for medical treatment, something that was clearly not an example conjectured by the Sixth Circuit.

The FDA is not going to win any argument that its actual proposed graphic warning labels, accompanied by the 1-800-QUIT-NOW placard, are merely pieces of factual information. The FDA itself admits that the warnings are intended to convince smokers to quit, and the inclusion of the 1-800 referral number cinches this fact.

In other words, the Supreme Court will never apply the Zauderer standard to the actual warning labels proposed by the FDA, rendering the Sixth Circuit's decision almost moot with respect to the Supreme Court's review.

The rest of the story is that the Sixth Court's opinion was merely a facial review of the general idea of requiring a simple picture as part of a textual warning, not an evaluation of the actual graphic warning labels proposed by the FDA. The simple, pictorial, graphic warning labels envisioned by the Sixth Circuit appeals court are far removed from the emotion-invoking, medical referral-providing warnings promulgated by the FDA. The U.S. Supreme Court will never apply the Zauderer standard to these graphic warning labels. While the Sixth Circuit decision does make it more likely that the Supreme Court will take the case, it does not in any way provide legal reasoning that can play a role in the Supreme Court's consideration of the issue at hand. It is the Campaign for Tobacco-Free Kids, then, that I believe is "wrong on the science" and "wrong on the law."

Wednesday, September 12, 2012

American Dietetic Association to Hand the Microphone to Coca-Cola at Its Annual Conference; It's Like an Anti-Smoking Group Inviting Philip Morris to Present on Its Initiatives to Reduce Youth Smoking

On Sunday, October 7th, the American Dietetic Association will hold a press conference at its annual meeting in Philadelphia to highlight the work of groups which it claims are upholding the organization's "vision of optimizing the nation's health through food and nutrition."

Naturally, many of you are now curious as to who these groups are which are upholding the vision of optimizing the nation's health. The answer, according to the American Dietetic Association, is:

The Coca-Cola Company: A company which sells 1.25 billion bottles of Coke each year and spends $4.5 million annually lobbying against public health measures to improve nutrition and reduce obesity

PepsiCo: A company whose signature sugar-laden soft drink is responsible for $20 billion in annual sales and which spends $1.7 million annually lobbying against public health measures to improve nutrition and reduce obesity.

The Rest of the Story

What do these two companies have in common? Why are they being honored as champions of the public's health rather than one of the leading organizations that actually fights soft drink consumption and obesity, such as the Rudd Center for Food Policy and Obesity or one of the hundreds of other organizations devoted to improving nutrition and fighting obesity?

The answer is simple...

... money.

Both the Coca-Cola Company and PepsiCo are heavy funders of the American Dietetic Association. This money has not only purchased the ADA's silence on the corporate role in the obesity epidemic and the importance of policy change, but has also purchased a marketing endorsement from the ADA and a golden opportunity to address the media - with the ADA's help - as a leader in the movement to improve nutrition.

Had these sponsorships by Coca-Cola and Pepsi merely bought the ADA's silence on the role of these corporations in the obesity epidemic, it would have been bad enough. But far from being silent, the ADA is now serving as an active marketing arm for these soft drink companies, and therefore, for soft drinks.

This is a dream come true for Big Soda. They now have the ADA as a marketing partner.
vision of optimizing the nation's health through food and nutrition. Read more: http://www.eatright.org/FNCE/content.aspx?id=6442469221&terms=coca-cola
vision of optimizing the nation's health through food and nutrition. Read more: http://www.eatright.org/FNCE/content.aspx?id=6442469221&terms=coca-cola

Tuesday, September 11, 2012

American Diabetes Association and American Dietetic Association Sell Themselves Out, Sacrificing their Health Mission for Money

Two national organizations that were previously committed to improving the public's health by fighting unhealthy eating have sacrificed their health missions, selling out to Big Soda in order to yield tens of thousands of dollars, while at the same time allowing themselves to be used as a public relations and marketing tool for the Coca-Cola Company.

According to a press release issued on August 31 by the Coca-Cola Company, the American Diabetes Association has accepted $125,000 from Coca-Cola and the American Dietetic Association has accepted $100,000 from Coca-Cola. These donations were originally reported over at the Fooducate blog in a post entitled "Here's How Coke is Buying the Silence of Health Organizations. For Pocket Change."

In the Fooducate post, Hemi Weingarten writes: "This is simply unfathomable. How can the American Diabetes Association in its right mind take money from the company that contributes the most to this terrible disease? More than 20 million Americans suffer from Type 2 diabetes, and most of them acquired it from overloading their bodies with junk foods and drinks. Liquid candy like Coke shares the responsibility. Another 75 million Americans are well on their way to diabetes because of excess consumption. Please, please, please, don’t bring up the “moderation” angle, or tell us that there are no bad foods (drinks). Sugary soft drinks cannot be consumed in moderation when they are pushed into our faces with $10,000,000,000.00 worth of marketing spend every year. Do you really think a measly education pamphlet or 30 minute community center class has a chance against the marketing might of Coke’s top notch ad agencies?"

"Coke has paid less than a hundredth of a percent of its marketing budget to buy the silence of these organizations and their leaders. How can they now be firm and adamant when they shook hands with Coke executives and took their money? The American Dietetic Association has an annual budget of around $100 million. Does it really need to take money from Coca Cola?"

According to the Fooducate blog, the American Dietetic Association responded to the post, arguing that the Coca-Cola donation is not buying their silence: "Ryan O’Malley, spokesperson for the American Dietetic Association (now know as the Academy of Nutrition and Dietetics) emailed us with the following response:
…to say that Coca-Cola’s donation is buying our silence is just factually inaccurate and irresponsible. To demonstrate, here are several examples from the Kids Eat Right website itself encouraging families to limit and stop their consumption of sugary beverages and soft drinks.
http://www.eatright.org/kids/article.aspx?id=6442468566,  
http://www.eatright.org/kids/article.aspx?id=6442467733
You just cannot honestly say that their support buys our silence, as we always have and will continue to encourage consumers to reduce and even omit sugary beverages from their diet."

The Rest of the Story

Actually, Weingarten has understated the case against the American Dietetic Association (ADA) and the American Diabetes Association (ADA2). Not only has their silence been bought, but they now have effectively become marketing arms of the Coca-Cola corporation. By accepting Coca-Cola's money, the ADA and ADA2 are allowing Coca-Cola to use them as part of its marketing plan. Corporate sponsorships not only buy silence from public health organizations, but they also allow the companies to boast about their support of "health causes," thus boosting their public image and ultimately, their bottom line: sales.

While O'Malley tries to argue that the ADA's silence has not been bought because the organization is apparently "bold" enough to come out publicly and suggest that families limit their consumption of soft drinks, the ADA has never supported evidence-based policies that have been shown to actually reduce soft drink consumption, such as taxes on soft drinks. In fact, the ADA has virtually opposed soft drink taxes. Moreover, the ADA has been silent on Coca-Cola's role in lobbying against almost every effective school nutrition bill in state legislatures. And I defy anyone to find information on the ADA's web site about the billions of dollars that Coke is spending annually to market its sugar-laden products. Given the role of soda marketing in the obesity epidemic, that is what I call total silence.

In fact, the public's health would be better served if the ADA were completely silent. The media outreach that it is doing stands in opposition to what many of us in public health are trying to accomplish through policy measures to reduce soft drink consumption. Concurrent with its acceptance of money from Coca-Cola, the ADA has actually become an enemy of critical public health measures to reduce obesity, not merely an innocent bystander, and at the far extreme from being a leader in the nutrition policy movement.

The American Diabetes Association's acceptance of money from Coca-Cola is perhaps even more mind-boggling. If there is a way that the ADA2 could more effectively undermine its message about the role of diet in diabetes prevention and treatment, I certainly can't think of one.

Corporate marketing - including the billions of dollars spent annually by Coca-Cola - undeniably contribute significantly to the public health problems of poor nutrition, obesity, and diabetes. The silence of the American Dietetic Association and American Diabetes Association has been effectively bought by Coke because these organizations are not going to highlight the role of this corporate marketing in the causation of the public health problems which they purport to be fighting. Instead, they will continue to focus on education: an approach we know is failing as sugar-sweetened beverage consumption increases yearly despite all of the education we are doing.

Hemi Weingarten said it best: "Sugary soft drinks cannot be consumed in moderation when they are pushed into our faces with $10,000,000,000.00 worth of marketing spend every year. Do you really think a measly education pamphlet or 30 minute community center class has a chance against the marketing might of Coke’s top notch ad agencies?"

We can now rule out the American Dietetic Association and American Diabetes Association as public health partners in the fight to take on the Big Soda industry and counteract its marketing. Instead, these organizations are now serving as pawns in Big Soda's marketing strategy. And even worse, the ADA is praising Coca-Cola and helping market its sugar-laden soft drinks by helping to improve the company's public image.

The American Diabetes Association now pays homage to Coca-Cola on its web site: "Like ADA, Coca-Cola understands that a healthy lifestyle involves balancing many different elements — staying physically active, consuming a balanced diet, getting enough rest — and even keeping a positive attitude. We are proud to partner with ADA to help provide Americans with information that allows them to make informed decisions about their personal well-being."

Yes - Coca-Cola, the company that spends billions of dollars promoting sugar-laden soft drinks, opposes school nutrition legislation, and lobbies against taxes that would reduce soda consumption is truly providing Americans with what they need to make healthy decisions.

What crap! The American Dietetic Association has sacrificed all semblance of public health principles, and it's clear that the money from Coca-Cola has contributed to its defection from public health to becoming a marketing partner for the sugar-laden soft drink industry.

And now, standing shoulder to shoulder with Coca-Cola and the ADA in the marketing of soft drinks through their participation in its corporate sponsorship initiatives is the American Diabetes Association. With enemies like these, the corporations that are contributing to deteriorating diet and increased obesity and diabetes do not even need friends. These so-called health groups are playing a greater role in the marketing of soft drinks than soft drink companies could ever imagine. The $225,000 or so that the Coca-Cola company has spent to silence the American Dietetic Association and American Diabetes Association was well-spent. It has resulted in health organizations joining with Coca-Cola in the marketing and public relations activities of the Coca-Cola corporation.

Monday, September 10, 2012

European Respiratory Society Hides Multiple Financial Conflicts of Interest in Statement Opposing Electronic Cigarette Use

Last week, I revealed that the European Respiratory Society issued a statement that opposes the use of electronic cigarettes, but failed to disclose that the chair of the Society's tobacco control committee has received research funding from Pfizer, a pharmaceutical company that makes a product (Chantix) which is a competitor to electronic cigarettes in the smoking cessation market and thus stands to lose enormously if electronic cigarettes become more popular.

Today, I reveal that the European Respiratory Society is also hiding from the public its own financial conflicts of interest with multiple pharmaceutical companies that manufacture competing products to electronic cigarettes and that, in short, the Society failed to disclose in its statement opposing electronic cigarette use that it is basically a marketing arm of the pharmaceutical industry.

The Rest of the Story

The European Respiratory Society's 2012 annual meeting was sponsored, in part, by a number of pharmaceutical companies, including:
  • GlaxoSmithKline
  • AstraZeneca
  • Boehringer Ingelheim
  • Actelion
  • InterMune
  • United Therapeutics
Sadly, this was just for the prizes awarded at the meeting. A fuller list of ERS sponsors is provided in its sponsor benefits handbook, which boasts of tons of sponsorship opportunities, including evening symposia, mini-symposia, industry expert forums, practical workshops, the Congress bag, the final program smartphone app, notepads and pens, and even post-it tags for the front cover of the program book. Listed sponsors include:

  • Actelion Pharmaceuticals Ltd
  • AlmirallAstraZeneca
  • Bayer HealthCare Pharmaceuticals
  • Boehringer Ingelheim
  • Chiesi Farmaceutici SpA
  • Eli Lilly & Company
  • GlaxoSmithKline Pharmaceuticals
  • Grifols (formerly Talecris Biotherapeutics GmbH)
  • InterMune
  • MSD
  • Mundipharma
  • Novartis Pharma AG
  • Nycomed
  • OM Pharma SA
  • Pfizer Ltd
  • United Therapeutics Europe LTD
If you look at the conference program, you'll see that it is a virtual marketing bonanza for pharmaceutical companies. Numerous scientific meetings, workshops, and other events are sponsored by a multitude of different pharmaceutical companies.

Despite this immense financial relationship between the European Respiratory Society and Big Pharma, the ERS statement on electronic cigarettes does not disclose these relationships. In my view, this is a serious ethical breach. Because smoking cessation products made by a number of these pharmaceutical companies are direct competitors to electronic cigarettes, the public deserves to know about the ERS' financial connections with these companies.

The rest of the story is that the European Respiratory Society is yet the latest organization to oppose electronic cigarettes while hiding the fact that it receives money from pharmaceutical companies that manufacture and market competing products. In this light, it is little surprise that the ERS opposes e-cigarettes. 

Friday, September 07, 2012

European Respiratory Society Publicly Claims that Electronic Cigarettes Cause Cancer and Lies About Tobacco Industry Involvement in Creation of These Products

In a statement entitled "European Respiratory Society statement on E-cigarettes and emerging products," the European Respiratory Society tells the public that electronic cigarettes cause cancer.

According to the statement: "The European Respiratory Society, ERS is opposed to the use of all tobacco and unapproved nicotine delivery products such as cigarettes, chewable tobacco, and emerging products that include electronic cigarettes (e-cigs), snus, dissolvable tobacco and waterpipes. In response to the successful increase in tobacco-free policies, the tobacco industry has developed these new products, allowing consumers to obtain nicotine without the use of a cigarette. ... In general, ERS subscribes to the medical principle of primum non nocere and holds that Tobacco users "should not trade one carcinogenic product for another..."

The Rest of the Story

The rest of the story is that the European Respiratory Society is lying to the public. The Society claims that electronic cigarettes were developed by the tobacco industry. This is false. The tobacco industry played no role in the creation of electronic cigarettes and for the past four years, has had no involvement at all in the electronic cigarette industry. It was only recently, when Lorillard acquired Blu cigs, that the tobacco industry entered the electronic cigarette market. The claim that electronic cigarettes were developed by the tobacco industry is an outright lie.

Not only is the European Respiratory Society lying about the origin of electronic cigarettes, but it is also making a completely unfounded and scientifically unsupported assertion about the carcinogenicity of these products. The claim that electronic cigarettes cause cancer is without scientific evidence. While it is true that trace levels of tobacco-specific nitrosamines have been detected in electronic cigarettes, similar trace levels are also present in nicotine gum and nicotine patches. If electronic cigarettes can be said to cause cancer, then so can nicotine replacement therapy.

There is simply no scientific evidence that NRT causes cancer, because it is unclear that the trace levels of tobacco-specific nitrosamines in these products have any clinical significance, are capable of inducing cancer, or that there has ever been a human case of cancer caused by NRT.

Similarly, there is simply no scientific evidence that electronic cigarettes cause cancer, because it is unclear that the trace levels of tobacco-specific nitrosamines in these products have any clinical significance, are capable of inducing cancer, or that there has ever been a human case of cancer caused by electronic cigarettes.

The statement that the European Respiratory Society is "opposed" to the use of electronic cigarettes is shameful because thousands of people are using these products to successfully stay off cigarettes. Apparently, the Society would rather have these ex-smokers return to smoking than continue to remain ex-smokers with the help of electronic cigarettes. This is an irresponsible position that violates the Society's proclaimed adherence to the principle of "to do no harm." In fact, with this position and advice, the Society is doing tremendous harm. 

One possible reason that the European Respiratory Society is taking such an irresponsible position on electronic cigarettes and lying to and misleading the public about these products is that the Chair of its Tobacco Control Committee is Dr. Christina Gratziou, who has collaborated with and received research funding from Pfizer for a study of a competing smoking cessation product: varenicline. Pfizer stands to lose tremendously if electronic cigarettes increase in popularity.

This conflict of interest is not disclosed on the web page where the European Respiratory Society's position on electronic cigarettes is posted. This is inappropriate because the public has a right to know about this conflict of interest in order to properly evaluate the validity and soundness of the Society's position. This is yet another example of the hiding of Big Pharma conflicts of interest by opponents of electronic cigarettes.

Thursday, September 06, 2012

Researcher Who is Unsure that Smoking is Any More Hazardous than Vaping has Hidden Her Big Pharma Conflict of Interest

Over the past few months, I have revealed numerous examples of electronic cigarette opponents who have turned out to have financial conflicts of interest with Big Pharma and who, in some cases, have hidden those connections. These conflicts are important because pharmaceutical companies that manufacturer and/or market smoking cessation drugs stand to lose enormously if electronic cigarettes become more popular.

Today, I discuss the latest example of what I believe is misrepresentation of scientific evidence on the safety of electronic cigarettes by a researcher who turns out to have a conflict of interest with Big Pharma and to have hidden that conflict of interest at least once, but possibly twice.

The Rest of the Story

Yesterday, I discussed an abstract presented at the annual meeting of the European Respiratory Society earlier this week, in which the research was misrepresented as indicating that electronic cigarette use has been shown to damage the lungs and that electronic cigarette use is not known to be any safer than smoking. In searching for a reason why the press release misrepresented the findings of the paper, the first thought that came to my mind is that perhaps there is a financial conflict of interest with Big Pharma. And indeed, it turns out that one of the study authors - Dr. Gratziou - was lead author of a study that was funded by, and conducted in part by Pfizer, maker of Chantix, a drug which stands to lose considerable sales if electronic cigarettes become popular.
 
It turns out that the story may not end there. It appears that Dr. Gratziou was an investigator on this Pfizer-funded clinical trial of Chantix which was initiated in November 2007. She is listed as a co-author on one manuscript reporting the results of this trial and lead author of another manuscript reporting the results of this trial.

In a study published in 2009 on the effectiveness of buproprion for smoking cessation, the financial disclosure statement reads: "All the authors of this paper declare that they have no financial or other potential conflicts of interest concerning the subject of this manuscript."

It appears, however, that Dr. Gratziou did have a financial conflict of interest, as it appears that she was an investigator on the Pfizer-funded clinical trial of varenicline which was initiated in 2007.

As I pointed out yesterday, Dr. Gratziou's financial interest in Pfizer was not disclosed in the abstract to her 2012 presentation at the annual meeting of the European Respiratory Society on the acute respiratory effects of electronic cigarettes, nor was it disclosed in the press release reporting the results of that study.

Thus, it now appears that on two occasions, the financial interest in Pfizer was not disclosed in research evaluating products that are potential competitors to those made by Pfizer for smoking cessation.

The failure to disclose this conflict of interest is an important breach, because it hides from the public the potential bias introduced by the conflict, and thus does not allow the public to properly evaluate the validity of the study and its conclusions.

Wednesday, September 05, 2012

"Experts" from University of Athens Tell the Public They Are Not Sure if Smoking is Any More Hazardous than Vaping, Despite Lack of Demonstration of Clinically Significant Effects on Airways and Improvement in Respiratory Symptoms in Many Vapers

Despite the fact that no clinically significant effect of electronic cigarettes on pulmonary function has been demonstrated while many vapers experience an improvement in respiratory symptoms, self-proclaimed "experts" from the University of Athens are telling the public they are unsure that smoking is any more hazardous than vaping.

Moreover, despite the finding that electronic cigarettes contain only traces of tobacco-specific nitrosamines and that the level of these carcinogens is two orders of magnitude lower than in Marlboros, these "experts" are telling the public that they may be just as healthy smoking Marlboros as quitting smoking completely and using electronic cigarettes instead.

In a press release issued earlier this week entitled "Experts warn that e-cigarettes can damage the lungs," a group of researchers from the University of Athens report the results of a study of the acute effects of vaping on airways resistance in smokers with and without existing lung disease. They studied 24 smokers, 11 with normal lung function and 13 with COPD or asthma. Subjects used an electronic cigarette for 10 minutes. Airway resistance was measured before and after e-cigarette use.

The main finding was that: "In smokers with normal spirometry there was a statistically significant increase from a mean average of 176% to 220%. In COPD and asthma patients the use of one e-cigarette seemed to have no immediate effect to airway resistance."

Based on these findings the researchers concluded: "We do not yet know whether unapproved nicotine delivery products, such as e-cigarettes, are safer than normal cigarettes, despite marketing claims that they are less harmful."

The results and conclusions of the study were released to the media and the public via press release, apparently prior to peer review and publication of the study. In fact, there is no actual written study available, merely the abstract as this was an abstract presented at a scientific conference: the 2012 meeting of the European Respiratory Society.

The conclusions of the study, as disseminated by the media, were more drastic than presented in the actual abstract. Many of these headlines warned that electronic cigarette use was found to "harm the lungs," "damage the lungs," or to "cause less oxygen to be absorbed by the blood."

The Rest of the Story

Before going any further, let's correct the misrepresentation of the study findings by the media and then the misrepresentation of the study findings by the study authors.

The media claimed that the results indicate that electronic cigarettes cause "damage" to the lungs and/or cause "less oxygen to be absorbed by the blood." This is incorrect. The study found that use of an electronic cigarette for 10 minutes increased airway resistance in smokers without existing lung disease (although there was no effect on airway resistance in those with existing obstructive lung disease). A temporary increase in airway resistance does not equate to "lung damage."

For example, breathing hot, humid air has been found to increase airway resistance in some healthy subjects, but one would not claim that breathing humid air damages the lung. Obviously, a behavior such as smoking, with prolonged exposure to chemicals that cause airway inflammation can ultimately lead to lung damage and a condition of chronic obstructive lung disease with permanent increases in airway resistance that cause clinical symptoms. But a transient increase in airway resistance due to an exposure does not necessarily translate into a clinically meaningful effect, or to "harm" or "damage" to the lungs.

Even more fallacious is the claim that the study found that electronic cigarettes cause hypoxemia (lowered oxygen in the blood). The study did not even measure oxygen levels in the blood, and a small increase in airway resistance is not going to cause hypoxemia (otherwise, millions of people in Tampa would be walking around constantly with hypoxemia due to the constant heat and humidity). Tampa has other issues, but chronic hypoxemia among the majority of the population is not one of them.

Importantly, the misrepresentation of the study results regarding oxygen levels in the blood appears to be the fault of the media, as nowhere in the press release does it suggest anything about hypoxemia. However, that the media got the impression that this study demonstrates lung damage is directly attributable to the misrepresentation of the study by the authors, who titled their press release: "Experts warn that e-cigarettes can damage the lungs," rather than "Researchers warn that e-cigarettes increase airway resistance."

Readers should be aware of the fact that this finding is not new. A previous study - which was actually peer-reviewed and published - reported that electronic cigarette use can cause a mild increase in airway resistance. As I commented on that article: "The rest of the story is that a propylene-based electronic cigarette system has been shown to produce airways inflammation in users, resulting in subclinical evidence of increased airway resistance. Whether long-term use of electronic cigarettes would lead to clinical manifestations due to actual airway obstruction is unclear, and more research is necessary to make such a determination. What we do know, however, is that long-term continuation of cigarette smoking will almost certainly lead to clinically significant airway obstruction. The bottom line: if a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice."

The same comment is relevant to the present study. Readers should be aware that in the previous study, the authors were careful to point out that their research only detected subclinical evidence of increased airway resistance and that it remained unclear whether electronic cigarettes cause any clinically significant manifestations: "We must state, however, that although the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."

No such caveat is given by the authors of the present study. But the bottom line is the same. If a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice. And in fact, this is the choice that most electronic users are facing. The idea that any substantial proportion of electronic cigarette users will quit smoking if they take the article's advice and stick to approved NRT or pharmacotherapy products is unsupported by the scientific evidence.

Although the claim that they found lung damage as a result of electronic cigarette smoking is a misrepresentation of the study findings by the authors, there is a far worse and more damaging misrepresentation. The authors, based on their finding of a possible small increase in airways resistance in some smokers, have concluded that cigarette smoking may be no more harmful than vaping. This is a sweeping conclusion that even the tobacco companies would not dare make. You would never hear a tobacco company claim that their products may be no more dangerous than inhaling nicotine and propylene glycol from a tube that contains no tobacco and involves no combustion process. However, anti-smoking researchers are making precisely that assertion.

The claim is ridiculous, damaging, and ignores all of the existing evidence. While electronic cigarettes have been shown to cause mild increases in airway resistance with uncertain clinical implications, we know that cigarette smoking causes chronic obstructive lung disease. So even if you look only at respiratory effects, there is strong evidence that smoking is more dangerous than vaping. Moreover, many vapers have experienced dramatic improvement in respiratory symptoms, which is not consistent with the argument that smoking may be no more hazardous than vaping in terms of respiratory effects.

There are no known effects of electronic cigarette use on heart disease. And the levels of tobacco-specific nitrosamines and formaldehyde (the only two carcinogens detected in electronic cigarettes) are much lower than in tobacco cigarettes. How these researchers could claim that the carcinogenic risk associated with vaping could be equivalent to that associated with cigarettes, which contain an additional 58 known carcinogens, is beyond me.

That this study was released using the "science by press release" method is also problematic. As I have argued before, scientific results should not be released to the media and the public unless either: (1) the study has been peer-reviewed and published; or (2) the entire study is made available publicly so that the work can be properly evaluated. In this case, there is no actual study I am aware of, merely an abstract. Thus, we have no way of evaluating the validity of the findings. But the results have already been widely disseminated. If the paper is subsequently peer-reviewed and the authors are told to tone down their conclusions (as I would if I were reviewing the paper), it is too late. The conclusion of these experts that vaping causes lung damage has already been disseminated. If the authors later come back and tell the media: "Sorry, we misspoke. Actually, the study only shows subclinical evidence of airway resistance and it is not clear whether this translates into any clinically meaningful effect," it will not matter. The word is already out there on the street.

In searching for a reason why the press release misrepresented the findings of the paper, the first thought that came to my mind is that perhaps there is a financial conflict of interest with Big Pharma. And indeed, it turns out that one of the study authors - Dr. Gratziou - was lead author of a study that was funded by, and conducted in part by Pfizer, maker of Chantix, a drug which stands to lose considerable sales if electronic cigarettes become popular.

Thus, this co-author of the study has a significant financial conflict of interest with Big Pharma that has the appearance of having biased the interpretation and presentation of the study findings. However, that conflict was not disclosed, either in the abstract or in the press release.

The failure to disclose this conflict of interest is inappropriate, because it essentially is hiding this important financial relationship from the public. Not only has the author been funded by Pfizer, but she has worked directly with Pfizer on the research. Thus, she has a substantial financial interest in a company whose products are a direct competitor of the product this study examines. This is a great example of why conflict of interest disclosure rules exist in the first place. It is breaches like this which led the Department of Health and Human Services to adopt a financial disclosure policy for all academic research.

The rest of the story is that the media has misrepresented the study findings, due in part to misrepresentation of the study findings by the authors themselves. Even worse, the press release disseminates a completely unsupported conclusion that runs contrary to all existing scientific evidence and which - if made by a tobacco company - would be considered fraudulent. Finally, all of this misrepresentation and deception occurs in the existence of a severe financial conflict of interest which was hidden from the media and the public.


(Thanks to Bill Godshall, Farrell Delman, Riccardo Polosa, and Dave Ryder for insights and information that have been incorporated into this commentary.) 

Tuesday, September 04, 2012

Column in Atlantic Monthly Criticizes Appeals Court Ruling in Graphic Cigarette Warning Case Because It Means "Government Can Do Nothing" to Combat Smoking

In an article in The Atlantic, reporter, novelist, and legal scholar Garrett Epps criticizes the D.C. Appeals Court's ruling on the proposed graphic cigarette warning labels, arguing that the ruling is "terrifying" because it means the government "can do nothing" to combat smoking.

Epps writes: "The majority claims to be rejecting only these specific images -- of a man smoking a cigarette through a tracheotomy tube, or a baby wreathed in smoke -- but their hostility to the entire anti-smoking enterprise is ill concealed: "We are skeptical that the government can assert a substantial interest in discouraging consumers from purchasing a lawful product, even one that has been conclusively linked to adverse health consequences," they sniff. If there is no such "substantial interest," of course, then no government warnings can be required."

"What is terrifying is not just the radical nature of the statement: that government can do nothing to combat the single greatest public health threat of our time. The hidden message of the opinion -- a message correctly deduced from much of the Roberts Court's First Amendment jurisprudence -- is that the Constitution requires us to live in a make-believe world, where, for example, gross imbalances of wealth have no effect on political campaigns, and 'smoking isn't addictive' is as protected as 'I pledge allegiance to the flag.'"

"I yield to no one in my devotion to free speech. But a legal system that can't differentiate between political opinion and the sale of cigarettes has forfeited any claim to relevance to the nation it supposedly serves."

The Rest of the Story

I find this to be a great example of a commentary that begins from an ideological viewpoint and proceeds to try to draw a legal argument out of it, rather than the opposite: starting with a grounded legal argument and using it to express a viewpoint on a legal issue.

Here, Epps misconstrues the Court's ruling as well as its implications in an apparent attempt to express an ideological opinion of his own.

Epps makes three mistakes in his construction of the Court's decision:

1. He conflates the government's interest in discouraging consumers from smoking with its interest in ensuring that consumers are warned about the health effects of cigarettes.

Epps argues that because the Court does not see a legitimate government interest in reducing smoking, then "no government warning can be required." But he takes the Court's statement out of context. The Court is not asserting that there is no government interest in reducing smoking. It is asserting that the government cannot use cigarette pack warnings as the means to achieve an aim of discouraging smoking. The cigarette pack warnings could be used to achieve the aim of warning smokers about the hazards of cigarette use. But the warnings cannot be used as anti-smoking billboards. Requiring companies to actively discourage consumers from purchasing their products is an infringement of commercial free speech. Especially when there is no evidence that the proposed approach will achieve its proclaimed aim.

By no means is the Court arguing that no government warnings can be required. It is only holding that government warnings must be warnings, not anti-smoking billboards.

2. Epps misinterprets the decision as meaning that the government can do nothing to combat smoking.

This is precisely the opposite of the Court's ruling and the plaintiff's successful argument. The entire point of the defendant's argument was that if the government wants to discourage smoking, it is free to run anti-smoking campaigns of its own. It can, for example, use anti-smoking billboards to discourage smoking. But it cannot require the cigarette companies to put out those anti-smoking billboards for it, and it certainly cannot require that the cigarette companies turn their packaging into anti-smoking billboards.

In fact, the lesson of this decision is that the federal government and anti-smoking groups have been barking up the wrong tree. Instead of devoting their resources to graphic warning labels, which have not been shown to be effective, they should instead be putting resources into anti-smoking media campaigns, for which there is strong evidence of effectiveness. The government is not taking an evidence-based approach. Instead, it is trying to gain political victory without having to actually put a real dent in cigarette sales.

Were the Congress truly interested in reducing smoking rates, it would have put its eggs into a different basket: allocating funds for a substantial anti-smoking media campaign, along the lines of the "truth" campaign run by the American Legacy Foundation. Instead, it tried to score political points through a flashy, but non-effective intervention (the graphic warning labels).

3. Epps incorrectly asserts that the decision protects the companies if they state that "smoking isn't addictive."

Epps bemoans the decision because it puts us in a situation where "'smoking isn't addictive' is as protected as 'I pledge allegiance to the flag.'" This is not true and again, is the exact opposite of what the court rules. The court's ruling, in fact, indicates that if the cigarette companies were stating "smoking isn't addictive" on their packages, then the government could require labeling that compels certain speech: namely, the correction of this inaccurate and deceptive information. In that situation, in fact, the court makes it clear, the compelling of speech would fall under the lenient Zauderer standard. That is in fact what the Zauderer case is all about!

The rest of the story is that Epps apparently is intent upon making a political statement of his own, rather than reasonably interpreting the court's decision. He argues that a legal system needs to "differentiate between political opinion and the sale of cigarettes," but should not legal analysis be able to differentiate between political opinion and solidly constructed legal arguments?