Nominee for New FDA Commissioner Derived Salary from Six Pharmaceutical Companies LAST YEAR

In President Obama's first inauguration speech, he promised to restore science to its proper place in government by shielding the regulatory process from corporate influence. One of his specific proposals to carry out this promise was to prevent anyone with a severe corporate conflict of interest from serving in the executive branch until at least one full year had gone by without the conflict in place. Thus, if you received salary from a pharmaceutical company in 2014, you would not be permitted to serve as the FDA Commissioner at least until 2016.

Unfortunately, as we have repeatedly seen campaign promises wither, this one too seems to have died a quiet death. For it was revealed yesterday by the Washington Post that President Obama's nominee for the Commissioner of the FDA - Dr. Robert Califf - received salary support from not one, not two, not three, not four, not five, but six pharmaceutical companies last year (2014). In addition, Dr. Califf was paid by eight pharmaceutical companies for consulting services and had personal equity in two pharmaceutical companies. In all, in 2014, Dr. Califf had significant financial interests in 14 different pharmaceutical companies!

To make matters worse, according to the FDA itself, a clinical trial led by Dr. Califf was sharply criticized by Public Citizen's Health Research Group for failing to quickly anti-coagulate patients treated with an experimental anti-coagulant drug who were then taken off that drug, resulting in an excess of 16 strokes among these patients. According to the FDA report: "The Division received comments from Public Citizen’s Health Research Group indicating concern that the applicant’s failure to “1) pre-specify criteria for transition to appropriate anticoagulation in the 30 days following study-drug discontinuation or 2) provide clear, standardized instructions to investigators on how to transition patients deemed eligible for further anticoagulation” exposed subjects to unnecessary harm and therefore was unethical. While it is obvious that the applicant can not have intended XARELTO subjects to have had a greater number of strokes while they were being followed because it worsens the apparent risk-benefit profile of XARELTO, it also true that lack of care in designing and conducting ROCKET could have resulted in some XARELTO subjects suffering unnecessary strokes." Recently, Project on Government Oversight (POGO) executive director Danielle Brian stated: "Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry."

The worst of the story, however, is that during his Senate confirmation hearings, Dr. Califf apparently defended his conflicts of interest with Big Pharma, demonstrated a misunderstanding of what conflict of interest is all about, and expressed no awareness of the severity of the problem of conflict of interest in making government regulatory decisions.

According to the Washington Post article: "President Obama’s nominee to lead the Food and Drug Administration defended his past ties to the pharmaceutical industry on Tuesday, saying that drug company dollars never influenced the outcome of his academic research and vowing to maintain the agency’s standards for ensuring that approved treatments are safe and effective. Robert Califf, a cardiologist and long-time Duke University researcher, acknowledged that pharmaceutical companies helped fund many of the clinical trials he oversaw. But the drug industry routinely funds such studies, he noted, and Duke’s contract requirements protected the independence of investigators to publish research outcomes, whatever the results."

This demonstrates a misunderstanding of the problem of conflict of interest. Conflicts of interest are a problem not because they lead to conscious manipulation of study findings by investigators, but because they could lead to subconscious bias in the conduct or reporting of the results of these studies. A conscious bias in reporting the results would represent academic misconduct, not merely conflict of interest. It is the subconscious bias produced by pharmaceutical company funding that is at issue here. That is what conflict of interest policies are designed to protect against - not the conscious manipulation of study findings, which is an ethical issue. Conflict of interest is not an issue about ethics as much as it is an issue about protecting the integrity of the research and regulatory process.

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It is difficult to understand how this nominee, who just last year had significant financial relationships with 14 different pharmaceutical companies, could - one year later - be confirmed as the head of the agency which regulates those 14 companies.

Clearly, Dr. Califf would have to recuse himself from any decisions regarding any of those 14 companies. However, since these represent some of the largest pharmaceutical companies in the nation (including Merck, Novartis, Roche, Eli Lilly, Bayer, Janssen, and Amgen, he would essentially have to recuse himself from all regulatory decisions made by the FDA. Therefore, it is apparent that because of his extensive financial conflicts of interest with Big Pharma, he is not qualified to serve as the FDA Commissioner.

Regardless of the integrity of his decision-making, the agency would always be under the public perception of a bias towards the pharmaceutical companies emanating from the Commissioner's conflicts of interest with these companies. This is simply not tolerable, and it is the precise reason why federal agencies have conflict of interest policies in the first place.

If Dr. Califf is appointed as the FDA Commissioner, I believe that he would be in violation of the Office of Government Ethics (OGE) regulations which state as follows: "a Federal employee may not personally and substantially participate in an official capacity in any particular matter which, to his knowledge, he or any other person (whose interests are imputed to the employee under 18 U.S.C. 208) has a financial interest if the particular matter will have a direct and predictable effect on that interest (5 CFR 2640.103(a))."

To avoid being in violation of this law, Dr. Califf would have to recuse himself from all FDA-related work.

Now, you might respond to this argument by pointing out that the prospective Commissioner is now divested of his financial interests and therefore, while he had financial interests in the past, he no longer holds them. So there is no violation of the government ethics regulations. Putting aside the point that this clearly violates the spirit of the law, though not the letter of the law, let's consider this further.

It is a good point. However, you are forgetting 5 CFR 2635.502(a), which clearly states that:

"Where an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household, or knows that a person with whom he has a covered relationship is or represents a party to such matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter, the employee should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee in accordance with paragraph (d) of this section."

So what is the definition of a "covered relationship" with a "person?"

First, please note that according to the definition of "person": under 5 CFR 2635.102(k), a "person" includes a "corporation," "company," or "firm."

According to 5 CFR 2635.502(b)(1)(iv), a covered relationship includes: "Any person for whom the employee has, within the last year, served as officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee."

Because it appears that Dr. Califf has, within the last year, served as a consultant and/or contractor for a number of pharmaceutical companies, it appears that his being appointed FDA commissioner at this time would violate 5 CFR 2635.502(a), unless he were specifically cleared for every activity he participates in by receiving authorization from the agency designee following a judgment that "the interest of the Government in the employee's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations." (see 5 CFR 2635.502(d)) He would have to receive such an authorization based on the above determination for each and every matter in which he participates. Obviously, this makes it clear that he is simply not in a position to be appointed as the FDA Commissioner given his extensive and recent history of Big Pharma conflicts of interest.

Finally, one might say: "Well, Dr. Siegel, I see your point but since it is almost 2016, it will be more than one year since the financial relationships so there is no problem and no technical violation of the law."

To which I would respond: "If that is the extent to which you have to go to defend this nomination and you still don't see a problem, then you are missing the forest for the trees."

The rest of the story is that the nominee for FDA Commissioner has such a severe, recent, and extensive history of financial interests with multiple pharmaceutical companies that it would violate all principles of scientific and regulatory integrity to appoint him to head the agency which regulates those very companies.

Nominee for FDA Commissioner Has Massive Conflicts of Interest and is Not an Appropriate Choice

President Obama's nominee for the position of FDA Commissioner - Dr. Robert Califf - has massive financial conflicts of interest that I believe should preclude him from being eligible for this position.

Because the FDA regulates drug companies, it is essential that the Commissioner of this agency not have severe conflicts of interest by virtue of having financial relationships with pharmaceutical companies; in particular, recent financial relationships. In fact, Dr. Califf's conflicts of interest are both severe and recent.

In his most recent disclosure in 2014 from his position as director of the Duke Translational Medicine Institute, Dr. Califf reported the following financial relationships with Big Pharma:

• Research funding from: Amylin, BMS, Ely Lilly, Janssen, Merck, and Novartis;
• Consulting fees from: Amgen, Bayer, BMEB Services, Medscape, Merck, Novartis, Regado, and Roche; and
• Equity in N30 Pharma, and Portola.

In his most recent published paper, which appeared just last week, Dr. Califf provided the following disclosure:

"Dr Califf currently holds the post of Deputy Commissioner for Medical Products and Tobacco, US Food and Drug Administration. Prior to holding this post, Dr Califf received grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the US Food and Drug Administration, Merck, Roche, Aterovax, Bayer, Janssen Pharmaceuticals, Eli Lilly & Company, and Schering-Plough; grants and personal fees from Novartis, Amylin, Scios, and Bristol-Myers Squibb/Bristol-Myers Squibb Foundation; and personal fees from WebMD, Kowa Research Institute, Nile, Parkview, Orexigen, Pozen, Servier International, Bayer Healthcare, Bayer Pharma AG, CV Sight, Daiichi Sankyo/Lilly, Gambro, Gilead, Heart.org–Bayer, Medscape, Pfizer, Regeneron, TMC, GlaxoSmithKline, Genentech, Heart.org–Daiichi Sankyo, and Amgen.

Dr Califf also reported holding equity in Nitrox/N30 and Portola. A full listing of disclosure information for Dr Califf for this interval is available at https://www.dcri.org/about-us/conflict-of-interest." 

The Duke Clinical Research Institute, for which Dr. Califf worked prior to joining the FDA as a deputy commissioner, reports receiving recent funding from more than 100 companies, most of them in the pharmaceutical or device business. According to an article in the New York Times, the multi-million dollar institute that Dr. Califf ran at Duke received more than 60% of its funding from industry.

According to the same article, Dr. Califf "has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory...".

The article notes that: "“He has amassed an extensive record of close collaboration with industry, through consulting fees, speaking fees and research grants supporting his salary,” said Dr. Michael Carome, the director of the health research group at Public Citizen, a consumer advocacy group. “This will color his views when it comes to making regulatory decisions.”"

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According to the New York Times article: "Through the F.D.A., where he has served as a deputy commissioner since March, Dr. Califf declined a request for an interview. A spokesman for the Department of Health and Human Services, Kevin Griffis, said that Dr. Califf had been through “a comprehensive screening process for conflicts of interest,” and that officials had “put in place measures to ensure that he is appropriately recused from matters that would give rise to conflicts,” including the new cholesterol medicines."

If this is what FDA's comprehensive screening process for conflicts of interest looks like, I would hate to see the agency's trimmed down screening process looks like. I could understand an agency missing one or two conflicts of interest, but how can you miss more than 20 of them?

The idea that these conflicts of interest can be managed by having Dr. Califf recuse himself from matters that would give rise to conflicts is inane. His conflicts do not only hold for new cholesterol medicines. They hold for all issues related to the regulation of pharmaceutical products. He would essentially have to recuse himself from every decision the FDA makes. It would be a plum job, as he wouldn't have to do anything. I should try that with my job. "I'm sorry, but I have to recuse myself from all of the work you've asked me to do." 

This does not bode well for electronic cigarettes because they represent a huge threat to pharmaceutical smoking cessation products.

To remind readers, this has nothing to do with Dr. Califf's integrity, character, or qualifications. It simply has to do with existing conflicts of interest, which in my opinion preclude him from occupying this position. The commissioner of the FDA clearly has to be an individual who does not have conflicts of interest with Big Pharma. We can't have someone with severe pharmaceutical conflicts of interests regulating the very companies from which he has received hundreds of thousands of dollars. It is like the fox guarding the hen house.

E-Cigarette Opponent Claims that E-Cigarettes are Causing Permanent Brain Damage among Youth Experimenters

According to an article on the Voice of America web site, e-cigarette use among youth can lead to permanent brain damage.

According to the article:

"Dr. Jonathan Winickoff, at Massachusetts General Hospital for Children and Harvard Medical School, compared teens' experimenting with any nicotine product, including electronic cigarettes, to "playing Russian roulette with the brain." Winickoff works with the American Academy of Pediatrics to protect children from tobacco and secondhand smoke. "Essentially, this drug creates a biologic need that can be permanent,” he told VOA. He said the effects include decreased working memory, tension problems as adults, and increased rates of depression and anxiety."

In the article, Jennifer Duke from RTI International made it clear that there is actually no evidence that e-cigarettes are a gateway to smoking. However, Dr. Winickoff apparently believes otherwise:

"Duke said there was "no definitive proof that the use of e-cigarettes will lead to the use of tobacco products," a statement shared in the Tobacco Control report. But Winickoff said his studies and experiences have led him to a different conclusion. "It also sets up the adolescent brain for more durable and stronger addiction pathways," he said, "not just for nicotine, but for other substances such as cocaine, marijuana and other drugs." Winickoff said the teen brain becomes dependent on nicotine much more rapidly than the adult brain. "The most susceptible youth will lose autonomy over tobacco use after just a few times. So before they even know they’re addicted, they’ll first start wanting, then craving nicotine whenever they go too long between uses," he said, "And more exposure to nicotine at an early age will up-regulate nicotine receptors more rapidly in those developing centers of the brain than in adults. More receptors mean more craving."

The Rest of the Story

It is very important for readers and the public to understand that this is hysterical propaganda that is completely unsupported by any actual scientific evidence. The e-cigarette opponents are just basically making this stuff up, and they are distorting the science in the process.

Here are the few kernels of truth in the above claims:

First, it is true that in animal studies, nicotine administration can cause impaired brain development. In "adolescent" animals, the main concern is interference with full development of the pre-frontal cortex. In the few studies that have examined potential effects related to nicotine's interference with pre-frontal cortex development in humans, these effects have been demonstrated only in smokers, and they are most profound in smokers who initiated at an early age.

It is critical to recognize that there is no existing evidence that nicotine exposure itself is capable of impairing brain development in human adolescents. More importantly, there is no evidence that occasional and sporadic exposure to nicotine, as seems to occur with virtually all nonsmoking youth who experiment with e-cigarettes, causes any acute or permanent brain damage.

The second kernel of truth is that youth are more susceptible to smoking addiction than adults, and that a youth could become addicted to smoking after as few as 4 cigarettes. However, this relates to addiction to smoking, not addiction to e-cigarettes. There have never been any studies which have shown that exposure to a small number of e-cigarettes can cause a nonsmoking youth to become addicted to nicotine.

In fact, evidence from the UK suggests that virtually all regular e-cigarette users, who might potentially be addicted, are pre-existing smokers. Researchers were unable to find any nonsmoking youth who experimented with e-cigarettes and then became addicted to nicotine. Furthermore, no study has documented that any nonsmoking youth became addicted to smoking because of their having experimented with e-cigarettes.

The rest of the story is that at this point, e-cigarette opponents are essentially making up the facts as they go along in order to scare policy makers and the public about fictitious risks of electronic cigarette use.

Sadly, this is doing substantial public health damage because it is undermining the public's (including youth's) appreciation of the severe hazards of smoking. It is also discouraging youth smokers from switching to e-cigarettes. Moreover, it is discouraging adult smokers from quitting via e-cigarettes. And finally, it is encouraging smokers to continue smoking rather than try quitting using e-cigarettes.

After all, if e-cigarettes cause permanent brain damage, then why would anyone bother to switch from real cigarettes to fake ones. You might as well take on the risks of heart disease, lung obstruction, stroke, and cancer. Doesn't that seem better than permanent brain damage?

Ironically, while the American Academy of Pediatrics is warning the public that occasional exposure to almost pure nicotine in e-cigarettes is going to cause permanent brain damage, nowhere on their web site can I find any similar claim that smoking can cause brain damage!

The only place I can find the AAP speaking out about nicotine's effects on the developing brain are in the context of maternal smoking and secondhand smoke exposure among youth. Apparently, the fact that smoking is causing permanent brain damage to adolescents is not something of particular concern.

Frankly, the e-cigarette opponents have become so singularly obsessed with their personal attack on these products that they have completely forgotten about the devastating impact of smoking on both youth and adults. Smoking, and not e-cigarette use, is the single greatest threat to adolescent health that we face in 2015.

Not so if you listen to the e-cigarette opponents. Apparently, the biggest problem is the permanent brain damage that is occurring to millions of youth who are experimenting with e-cigarettes. Ironically, perhaps if youth going back to using real cigarettes instead of fake ones, the e-cig opponents will stop scaring the public about nicotine and adolescent brain damage.

Two Prominent Tobacco Control Researchers are Not Sure Smoking is Any More Harmful than Vaping

According to an article from Healthline News, two prominent tobacco control researchers are telling the public they are not sure that cigarette smoking is any more harmful than vaping.

For reference, electronic cigarettes contain no tobacco, involve no combustion, have tobacco-specific nitrosamine levels that are two to three orders of magnitude lower than real cigarettes, eliminate most of the more than 10,000 chemicals and 60+ carcinogens that are present in tobacco smoke, have been shown not to cause acute changes in spirometry-measured lung function (unlike real cigarettes), are not known to have caused any deaths in the U.S (compared to more than 400,000 per year for real cigarettes), and have been shown to reduce respiratory symptoms and improve lung function in asthmatic smokers who switch to them.

According to the article:

"someone who quits smoking before they turn 40 can expect to live as healthy a life as someone who never smoked at all, according to Dr. Jonathan Samet, a pulmonary physician and epidemiologist at the University of Southern California. ... But how about people who quit smoking regular cigarettes and switch to electronic cigarettes? Does their health likewise improve? The short answer is medical researchers aren’t sure. “We just don’t have the data,” Samet, scientific editor of the 2014 Surgeon General Report on smoking, told Healthline. “Getting into issues of long-term harm reduction, it’s something we need to sort through.”

Also according to the article:

"Jed Rose is a professor at Duke University who specializes in addiction and behavioral science. He told Healthline it’s difficult to say anything conclusive about e-cigarettes because they vary from one brand to another. ... As for those who switch from smoking to vaping, the verdict on whether they truly are improving their health is still being studied. It’s a question researchers are competing for millions of dollars to investigate.
“Using an e-cigarette exclusively may be advantageous when the results come in,” Rose said."

The Rest of the Story

Apparently, according to these prominent tobacco control researchers, the question of whether cigarette smoking is any more hazardous than vaping is a difficult one to which we don't yet have an answer. We "just don't have the data." It's something "we need to sort through." We won't know until "the results come in."

I find it difficult to believe that in 2015, we are telling the public that we're not yet sure whether cigarette smoking poses any more of a hazard than using non-tobacco-containing, non-combusted electronic cigarettes. And we're telling the public this despite our knowledge that smoking is killing more than 400,000 people a year, that tobacco smoke contains more than 10,000 chemicals and more than 60 carcinogens, that e-cigarettes have been found to eliminate most of these chemicals and carcinogens, and that several clinical studies have demonstrated dramatic clinical improvement in smokers who switch to electronic cigarettes.

What exactly is it that we need to wait for?

In my view, it is not only wrong but irresponsible to tell the public that smoking may be no more hazardous than using an electronic cigarette. Even the tobacco companies are not telling people this to defend their products. In fact, if any cigarette company made such a statement, I can guarantee that anti-smoking groups would have them in court the next day.

To me, telling the public that smoking may not be any more harmful than vaping is essentially public health malpractice. It is negligent because it really doesn't take a rocket scientist to figure out that heating a solution of nicotine and propylene glycol (that does not even contain any tobacco) is not going to be nearly as dangerous as burning tobacco. Moreover, it ignores the overwhelming scientific evidence that smokers who switch to vaping experience immediate improvement in their health, as well as abundant evidence that the exposure to harmful chemicals and carcinogens is greatly reduced in electronic cigarettes compared to the real ones. Even the tobacco companies understand that their combustible tobacco products are much more hazardous than their heated non-tobacco products.

Furthermore, I believe this is essentially public health malpractice because it is not only negligent, but it is also harmful to the public's health. It undermines the dangers of smoking while exaggerating the risks of vaping, which is almost certainly going to deter many smokers from quitting using e-cigarettes and may even encourage smokers who have quit using e-cigarettes to return to smoking. After all, if we're not sure that smoking is any worse than vaping, then what's the point of vaping? You might as well go back to your Marlboros, Camels, and Newports rather than your Logic, NJOY, or Vuse.

These researchers obviously recognize that quitting smoking yields immeasurable health benefits. Why, then, could they possibly think that smokers who quit smoking (but by switching to e-cigarettes) might not experience any health benefit?

Perhaps the contradiction lies in the ideology rampant in the tobacco control movement that views a complete switch from smoking to vaping as a continuation of smoking. Numerous public health groups are telling smokers that they need to quit smoking "completely," by which they mean quitting not only smoking but vaping. But that view is inaccurate. Someone who quits smoking via electronic cigarettes is no longer a smoker. He or she is a successful quitter. And until the tobacco control movement finally recognizes that, we are going to continue to see this malpractice of public health.

Duke a Willing Collaborator in Defrauding the American Public

In agreeing to accept funding from Philip Morris for its Center for Smoking Cessation, Duke acted willingly as a collaborator in the defrauding of the American public.

A review of news articles announcing the funding of the Duke Center for Smoking Cessation by Philip Morris revealed that Philip Morris used this funding as an opportunity to improve its poor public image by making the public believe that the company was committed to getting smokers off of its products. And Duke happily gave Philip Morris a platform to make these fraudulent statements.

According to a 2004 article in the Duke Chronicle: "Philip Morris USA, however, hopes to show with this grant that it recognizes this fact and wants to help smokers who want to quit. "One of our goals is to reduce the harm caused by our products," said Jennifer Golisch, a spokesperson for Philip Morris."

According to a 2008 article in the Duke Chronicle: "Bill Phelps, a spokesperson for Philip Morris, emphasized that the money was given without caveats that could influence the findings. For example, Philip Morris cannot veto publication of research from the center. "We give grants to universities for a variety of reasons," Phelps said. "Some [grants] in the past have been for smoking- and health-related research. We have given a grant to Duke... that is related to our program which is called cessation." ... Phelps ... said Philip Morris is assisting its patrons in whatever way possible. "We think that if smoking is addictive and causes serious issues... we can be helpful in that role of acquittance," he said."

The Rest of the Story

Acquittance is a perfect Freudian slip. I think the word that should have been used was "assistance." But what is behind the Philip Morris grant is actually "acquittance." The chief aim of Philip Morris in funding this research is to be acquitted for the harm it is doing in selling products that kills hundreds of thousands of people each year. And what a perfect way to achieve acquittance: by getting the Duke Center for Smoking Cessation to promote Philip Morris to the public and give it a platform for making it appear that the company is committed to getting smokers to quit using its products.

I need to make it clear that I am not blaming Philip Morris for seeking out these public relations opportunities. It is a brilliant strategy and a wise business decision. All successful companies have strong public relations as part of their marketing activities. The entity I am blaming is the Duke Center for Smoking Cessation, because without their willingness to collaborate, this defrauding of the American public could not take place.

The rest of the story is that Duke willingly is collaborating with Philip Morris in defrauding the American public by making it appear that the tobacco company is sincerely committed to getting smokers to get off its products. Of course, that is nonsense. It would be a very bad business decision, would send its stock spiraling down, would jeopardize its dominant market share, and would lead to the firing of the Philip Morris executives. The company's job is to sell cigarettes, not to convince consumers not to use its products.

However, the job of the Duke Medical Center is not to sell cigarettes. Sadly, by collaborating with Philip Morris in the defrauding of the American public, the Duke University Medical Center is actually doing more to market cigarettes than to prevent or reduce their use.

And even more sad is that they just don't get it. In defending the acceptance of Philip Morris money, the Center's director, Dr. Jed Rose, stated: "I recognize that there are widespread opinions that people have about using tobacco funding for research. But the source of the money is less relevant than the conditions [with which] the money is being given."

Baloney. It is the source of the money that is in question here, not the conditions with which it is being given. Philip Morris is not so stupid as to give money in the current decade with many strings attached. That would make it easy for the public to criticize. The brilliance of the company's public relations strategy is that it gives this money without strings attached. Thus, it has the appearance of being part of a sincere effort to undermine its business when it is actually a public relations effort.

That physicians in the Center and at Duke Medical Center are unable to see the role they are playing in undermining efforts to protect the public's health from the chief cause of preventable death is truly sad. And that they are defending it by noting that there are no strings attached is shameful.

One of the "strings" that is attached is that by accepting the money, The Center is aiding Philip Morris in deceiving the public into thinking that the company is committed to getting its customers off of its products. That would be a severe violation of their stockholders' interests and of course, the company wouldn't and arguably is not charged with the responsibility of doing that. However, as part of a medical center, the Duke Center for Smoking Cessation is charged with some important ethical responsibilities. And one of those is not collaborating with Big Tobacco in defrauding the American public. One of those is not playing a role in the public relations and marketing strategies of the deadliest consumer product.

Duke Center for Child and Family Policy is Aiding Public Relations Efforts of Big Tobacco

Earlier this summer, I revealed that the Duke Center for Smoking Cessation is still accepting Big Tobacco funding and not prominently disclosing it.

I wrote: "Since [Judge Kessler's] decision, it has become very difficult to find an academic medical or public health institution that is willing to accept tobacco funding. There is still, however, a last refuge for tobacco industry-sponsored research. There is a last bastion of acquiescence in the historical tobacco industry scheme to gain a public relations victory by allying itself with academia and pretending to be an objective, scientific voice in the smoking debate. There is still one academic center that is allowing itself to be used as a pawn in the marketing of cigarettes. That last bastion is the Duke Center for Smoking Cessation."

Today, I reveal that another center at Duke University - the Duke Center for Child and Family Policy - is also taking Big Tobacco funding.

The Rest of the Story

At the Duke Center for Child and Family Policy, "faculty and staff work together to discover and evaluate strategies to improve outcomes for children and families and to share their discoveries with policymakers and public agencies."

One of the strategies to improve outcomes for children and families that you won't see the Center sharing with policymakers is increasing cigarette taxes or imposing financial penalties on tobacco companies to fund aggressive anti-smoking media campaigns that demonstrate to youth the role of the tobacco industry in the smoking epidemic.

The Center's hands are tied because it is funded by Philip Morris.

Moreover, by accepting this funding, the Duke Center for Child and Family Policy is serving a public relations function for Philip Morris. It is helping Philip Morris to improve its public image by associating the tobacco company with the academic name and reputation of Duke.

In United States of America v. Philip Morris USA, Inc., et al. (Civil Action No. 99-2496 [GK]), the United States District Court for the District of Columbia found that tobacco industry funding of university research has long been part of an illegal enterprise that violates federal anti-racketeering law. The Court found that tobacco industry funding of university research was essentially a public relations ploy to undermine the public’s appreciation of the harms of smoking while making it appear that the tobacco companies were concerned corporate citizens interested in advancing objective scientific research.

The most important role of industry funding of research has been to refurbish the public image – especially the scientific image – of the tobacco companies: “Robert Seligman, Vice President of R&D of Philip Morris, described how Defendants used institutional grants to refurbish their scientific image. Seligman reported that … Shook, Hardy & Bacon attorney William Shinn had stated: “CTR began to lose their luster in the mid-60’s and the tobacco industry looked around for more beneficial ways to spend their research dollars on smoking and health. It was at this time that special projects were instituted at Washington University, Harvard University, and UCLA. … The industry received a major public relation ‘plus’ when monies were given to Harvard Medical school.” (page 148)

In fact, the chief public relations advantage gained by the industry granting money to an institution is the good will associated with the university’s name: “Arnold Henson of American [Brands Tobacco Company] acknowledged that one of the main reasons for the Harvard project was the ‘PR value of the Harvard name.’” (page 148)

In the opinion of the Court, the external research funding of the tobacco companies served as a way for the tobacco companies to coordinate their fraudulent activities, in violation of federal law (page 1541).

Brown & Williamson was quite explicit in acknowledging that the Council for Tobacco Research - the major research funding arm of the tobacco industry for many years - was essentially a public relations ploy, saying that “CTR was organized as a public relations effort” (page 50).

By accepting funding from Big Tobacco, the Duke Center for Child and Family Policy is allowing itself to serve as a pawn in Philip Morris' public relations strategy.

The rest of the story is that rather than being a model for child and family policy for the nation, Duke is instead an example of exactly the opposite. It is perhaps a model, but a model for the most egregious violation of academic ethics. Duke is allowing itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke is allowing itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

By associating its name with that of Duke University, Philip Morris is using Duke to gain public relations marketing value from that association. This is public relations 101. Using corporate funding to secure public credibility and respect. It was part of Philip Morris' (and the other tobacco companies') playbook for decades.

The rest of the story is that Duke continues to undermine its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a child policy center - should not play a role in marketing the most deadly consumer product. But that is exactly what Duke is doing.

Rather than being recognized as a model for child and family policy, the Duke Center for Child and Family Policy should instead be entered into the Hall of Shame as a center that puts money over ethical integrity.

The Last Refuge: Duke Center for Smoking Cessation Still Accepting Funding from Philip Morris, and Not Prominently Disclosing It

For more than a decade, tobacco control advocates have understood that it is unethical for universities - especially medical and public health schools - to take tobacco industry funding for research because the support of university research has long been a centerpiece of the tobacco industry's public relations strategy: a part of its attempts to undermine the public's appreciation of the hazards of smoking and the industry's role in the epidemic and to gain legitimacy by allying itself with prominent research institutions.

More than a decade ago, Joanna Cohen wrote that: "by accepting money from the tobacco industry recipients not only benefit directly from the sale of cigarettes but also promote the interests of tobacco companies by facilitating their ability to sell cigarettes. The acceptance of funding provides these companies with respectability by association; recipients may also act as de facto spokespersons for the industry, defending its interests, or, more subtly, remaining silent on issues that may impact negatively on the industry. This helps maintain the “legitimacy” of this industry and its products. ... Moreover, some maintain that by taking tobacco money, universities are shirking their responsibility as moral institutions entrusted with contributing to a healthy, productive, and just society."

"The arguments against accepting tobacco money are compelling, particularly to members of the health community, who are acutely aware of the enormous health toll caused by tobacco and the even greater number of tobacco related casualties that await us. Many are also aware of the unethical conduct of the tobacco industry and its long campaign of denial, obfuscation, and deceit over the harmful effects of its products. This group may be best positioned to understand that, even if a particular university may come out ahead by accepting tobacco money and even if there is some advancement of knowledge, there is still a net loss for society through the support of this industry's interests."

This was written prior to Judge Kessler's decision noting a long history of the industry using the funding of research at universities as part of a coordinated plan to defraud the American public.

Since that decision, it has become very difficult to find an academic medical or public health institution that is willing to accept tobacco funding.

The Rest of the Story

There is still, however, a last refuge for tobacco industry-sponsored research. There is a last bastion of acquiescence in the historical tobacco industry scheme to gain a public relations victory by allying itself with academia and pretending to be an objective, scientific voice in the smoking debate. There is still one academic center that is allowing itself to be used as a pawn in the marketing of cigarettes.

That last bastion is the Duke Center for Smoking Cessation.

To my surprise, I just found out that the Duke Center for Smoking Cessation will be funded by Philip Morris - on a no-cost extension basis - through May 31, 2014. This means that contrary to my previous understanding, the Duke Center for Smoking Cessation is still funded by Philip Morris.

The rest of the story is that since 2004, Duke has continuously served as a public relations arm for Philip Morris, accepting $37 million in funding from Big Tobacco to help the nation's leading tobacco company achieve its marketing goal of legitimizing itself as a corporation sincerely interested in helping smokers to quit. And Duke continues to serve that role today.

Note that according to the agreement between Duke and Philip Morris, the director of Duke's nicotine research center (or a designee) became a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

The rest of the story is that rather than being a model for tobacco control for the nation, Duke is instead an example of exactly the opposite. It is perhaps a model, but a model for the most egregious violation of medical ethics. Duke allowed itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke allowed itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

By associating its name with that of Duke University, Philip Morris used Duke to gain public relations marketing value from that association. This is public relations 101. Using corporate funding to secure public credibility and respect. It was part of Philip Morris' (and the other tobacco companies') playbook for decades.

The rest of the story is that Duke continues to undermine its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what Duke will continue to do, well into the year 2014.

Rather than being recognized as a model for tobacco control, Duke should instead be entered into the Hall of Shame as a medical center that puts money over ethical integrity. 

And to make matters worse, the Center still does not prominently disclose its massive funding from Philip Morris - or the fact that this funding continues at the present time and will continue into next year. There is still no disclosure on the Center's home page, which is the appropriate place for such a disclosure.

The sole disclosure on the website is a new page called "Timeline" which graphs the historical funding for the Center. But readers are unlikely to navigate to this page unless they have a specific interest in the history of the Center. Even on this page, the link to the document which reveals the continuation of the funding into 2014 is so small that you almost literally need a magnifying glass to see it. (Even with my new $400 "progressive" lenses, I didn't even notice this link until my fourth viewing of the page.)

Moreover, members of the public who are being recruited to be human subjects in Center research are not readily informed of the current Philip Morris funding. You can go through the entire online screening process and still not have any idea that you are being asked to participate in a smoking cessation study by an academic center that is funded by Big Tobacco! I would think that if many members of the public found this out, they would be outraged. Particularly those who have lost loved ones to cancer or other diseases caused by Big Tobacco products. 

Even if they are informed later in the enrollment process, I find the failure to disclose the Big Tobacco funding up front to be a travesty, as well as an ethical breach. The same holds for the failure to disclose the Big Tobacco funding for the Center on its home page.

In Ultimate Irony, Duke is Recognized for Smoking Cessation Programs

In an irony of epic proportions, Duke has been recognized by the North Carolina Prevention Partners for its model smoking cessation efforts.

According to an article in Duke Today: "Duke's tobacco cessation programs for employees have been recognized by the NC Prevention Partners with the designation as a Gold Star Standard Hospital. The Gold Star Standard recognizes Duke's efforts to refers employees to effective quit programs, provide comprehensive benefits such as nicotine replacement therapy and prescription medications and offer attractive incentives to encourage employees to quit tobacco use. ... 'Duke University Medical Center continues to set a high bar in terms of their cessation program for employees,' said Anne Thornhill, director at NC Prevention Partners. 'They are doing a great job in supporting their employees in quitting the use of tobacco. I applaud their great effort.'"

The Rest of the Story

The rest of the story is that for about 8 years (from 2004-2012), Duke served as a public relations arm for Philip Morris, accepting $37 million in funding from Big Tobacco to help the nation's leading tobacco company achieve its marketing goal of legitimizing itself as a corporation sincerely interested in helping smokers to quit.

According to Philip Morris: "Since 2004, PM USA has supported the Duke Center for Nicotine and Cessation Research. PM USA expects to provide a total of $37 million to the center through June 2012 to develop, evaluate and disseminate improved methods for quitting smoking."

According to the agreement between Duke and Philip Morris, the director of Duke's nicotine research center (or a designee) became a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

The rest of the story is that rather than being a model for tobacco control for the nation, Duke is instead an example of exactly the opposite. It is perhaps a model, but a model for the most egregious violation of medical ethics. Duke allowed itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke allowed itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

Clearly, since the purpose of this research funding was demonstrably not to dramatically reduce the number of smokers, its purpose was therefore to serve as a public relations ploy - by which Philip Morris could improve its public image by being able to argue that it really cares and that it is a responsible corporate citizen which is trying to help its customers break their addiction to its products. By associating its name with that of Duke University, Philip Morris used Duke to gain public relations marketing value from that association. Clearly, there was no sincere research interest operating here on the part of Philip Morris. This was public relations 101. Using corporate funding to secure public credibility and respect. It was part of Philip Morris' (and the other tobacco companies') playbook for decades.

The rest of the story is that Duke undermined its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what Duke did.

Rather than being recognized as a model for tobacco control, Duke should instead be entered into the Hall of Shame as a medical center that put money over ethical integrity.

Duke Center for Smoking Cessation Hiding Its Funding from Philip Morris, Violating Basic Public Health Ethics

One of the great cover-ups in history in tobacco control is occurring before our very eyes. Ironically, this time it is not a tobacco company engaging in the deceptive cover-up, but an anti-smoking organization: the Duke Center for Smoking Cessation (CSC).

Most organization web sites have an "About Us" link that provides historical information about the group, such as who founded it and what its funding sources have been. I couldn't find any such page on the CSC web site.

Most organizations have a funding, sponsors, or disclosure page where they list the sources of their financial support over the years. I couldn't find any such page on the CSC web site.

In fact, if you casually peruse the CSC web site, you will get the impression that this is a legitimate, run-of-the-mill anti-smoking organization that is dedicated to smoking cessation.

But that couldn't be further from the truth.

The Rest of the Story

If you look at the web site of the Duke Center for Smoking Cessation, you will be hard-pressed to identify one of the major founding corporate supporters of the center: Philip Morris. Despite extensive searching, I was unable to find any prominent page on the site with a disclosure that the Center received $37 million from Philip Morris between 2004 and 2012 (as acknowledged and boasted by Philip Morris). A search for "Philip Morris" on the web page's search engine came up empty.

According to Philip Morris: "Since 2004, PM USA has supported the Duke Center for Nicotine and Cessation Research. PM USA expects to provide a total of $37 million to the center through June 2012 to develop, evaluate and disseminate improved methods for quitting smoking."
 
There is a donation page, but little would potential donors know that they are adding themselves to a list that is dominated by the nation's largest tobacco company. Nowhere on this page does it disclose that the Center was largely created and supported by a $37 million grant from Philip Morris.

The schedule of activities for the Center's 2012 research conference fails to acknowledge or disclose this whopping amount of funding for the Center from Philip Morris.

The information page for the conference fails to acknowledge this massive Philip Morris financial support.

The summary page for the Center's director also fails to disclose the Philip Morris funding.

A couple of lapses in disclosure might be attributed to poor memory, or to a minor oversight, but the extent of the Center's hiding of Philip Morris' support from 2004-2012 is, in my opinion, beyond a simple mistake.

In my opinion, what we have here is an immense cover-up of the Center's wrongdoing.

The mistake Duke made is that it allowed itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke allowed itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

Clearly, since the purpose of this research funding was demonstrably not to dramatically reduce the number of smokers, its purpose was therefore to serve as a public relations ploy - by which Philip Morris could improve its public image by being able to argue that it really cares and that it is a responsible corporate citizen which is trying to help its customers break their addiction to its products. By associating its name with that of Duke University, Philip Morris used Duke to gain public relations marketing value from that association.

This research center couldn't have been any better planned for Philip Morris than had it been designed by Philip Morris' own public relations department.

Actually, in a way it was, because Duke University served as a PR arm for Philip Morris, by virtue of its accepting this tobacco money to conduct a research program that had the effect of diverting attention away from areas where we could really make a difference in getting people to quit smoking (such as developing aggressive, anti-smoking media campaigns rather than studying the biology of nicotine addiction).

For tax or accounting purposes, Philip Morris should really have classified these research dollars under "public relations." And they sure got their money's worth.

The rest of the story is that Duke undermined its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what this Duke center did for 8 years.

Now, rather than acknowledge its mistake and apologize for the disservice it did to the public's health and to the integrity of academia and of scientific research, the Center appears to be attempting to erase this sorry chapter in tobacco control history.

Anti-Smoking Researchers Argue that Mathews Study Shows Significant Effect of Smoking Bans on Acute MI; Lack of Scientific Rigor Apparent

Last week, I reported on a study, by Dr. Robin Mathews of the Duke Clinical Research Institute, that examined rates of heart attacks among persons ages 65 and older in 74 cities across the U.S. which adopted strong smoking bans during the period 2000-2008. The researchers compared the heart attack rate in each city during the year before and after the smoking ban was implemented.

When Mathews included all 74 cities that enacted smoking bans during the study period (regardless of strength of the ordinance), he found an overall decline in heart attack rates of just 3%. However, when the analysis was restricted to the 43 cities whose newly enacted ordinances represented a significant increase in protection from secondhand smoke, Mathews reports that there was absolutely no change in the heart attack rates across the sample of cities. A figure shows that heart attacks decreased in some cities and increased in others. All told, heart attack rates decreased by an insignificant 1% among these 43 cities.

Based on these findings, I pointed out that the study fails to support the conclusion - being widely disseminated by anti-smoking groups - that smoking bans result in dramatic, immediate reductions in hospital admissions for acute myocardial infarction. The Institute of Medicine report, for example, cites a reduction of 17% in heart attacks across the studies that it evaluated.

Now, a number of anti-smoking researchers, presumably in response to my blog post, have argued that the Mathews study actually supports the prior research, demonstrating that while small (3%), there is a "significant effect" of smoking bans on heart attacks within one year of implementation of these laws.

The Rest of the Story

There are two reasons why the argument disseminated by these anti-smoking advocates is scientifically flawed.

1. The argument ignores the relevant analysis, relying on the result of an essentially meaningless analysis.

First, it ignores a major result of the study, choosing instead the one result which found a significant effect but ignoring what is actually the most relevant analysis, which failed to find an effect.

The analysis of all 74 cities, which did find a significant decline in heart attacks of 3%, included cities that had enacted ordinances that failed to "meaningfully" increase protection from secondhand smoke. Thus, these cities were misclassified. Rather than being in the intervention group, they should have been considered to be communities that did not increase their secondhand smoke protection.

The relevant analysis is the analysis of the 43 cities in which the level of protection from secondhand smoke meaningfully increased after implementation of the smoking ordinance. It was that analysis which found only a 1% (non-significant) decline in heart attacks.

If an ordinance provides no meaningful increase in protection from secondhand smoke, then why would one classify it as an intervention community?

2. The study lacks a control or comparison group.

Second, because the study lacks a control group, all one can conclude from it is the change in heart attacks from before to after the ordinances. One cannot infer that this change was due to the ordinance because there is no evidence that these declines exceed those that were occurring simultaneously in communities without smoking bans.

Even if we accept the results of the full analysis of 74 cities (a 3% decline in heart attacks overall in these cities), the only way one could credibly conclude that this 3% decline was due to the smoking bans is to compare this decline to that in communities without smoking bans and show that the heart attack decline in the intervention (i.e., smoking ban) communities was significantly greater.

The rest of the story is that heart attack rates during the study period declined substantially throughout the United States, even in communities without smoking bans, and the average annual rate of decline in heart attack admissions among 65+ year olds during the study period appears to be in the approximate range of 3% per year.

Based on data from the Health Care Utilization Project, I calculated the year-to-year declines in heart attack admissions among persons ages 65 and up nationally for the years 2000 to 2006 (more recent data are not yet available on admissions). The average annual decline in admissions was 3.4%.

Thus, the observed decline in heart attacks in the 74 communities that enacted smoking bans during the study period appears to be a little lower than the decline in heart attacks that occurred nationally, with or without smoking bans in place.

To demonstrate how "meaningless" the observed 3% decline in heart attacks is in the context of a control group (the United States as a whole), the annual decline in heart attack admissions among 65+ year-olds during the more recent years was as follows:

2002-2003: -4.5%
2003-2004: -8.0%
2004-2005: -7.0%
2005-2006: -4.5%

Without even seeing these data, the anti-smoking researchers have nevertheless concluded that a mere 3% reduction in heart attacks in a one-year period is a significantly greater decline than what was occurring nationally anyway based on secular trends, in the absence of a smoking ordinance.

Of course, what we really need as a comparison group are cities that are similar to those which enacted smoking bans in other ways, but did not themselves enact smoking bans. The national data include cities with and without smoking bans.

My point is simply that without the comparison data from communities that did not enact smoking bans, one cannot possibly conclude that the observed 3% decline in heart attacks in the cities that enacted smoking bans was greater than what would have occurred in the absence of these bans.

The Mathews study certainly cannot be used to support the contention that smoking bans result in a significant short-term decline in heart attacks. At best, all it can support is the conclusion that in the cities which enacted smoking bans, there was an overall average decline of 3% in heart attacks during the first year of implementation. This 3% decline could be more than, less than, or the same as what would have occurred in the absence of the smoking bans (i.e., the observed change in heart attacks during the same period of time in comparison cities without smoking bans).

While I am a passionate supporter and promoter of smoking bans, I do my best to try not to let that interfere with my interpretation of the scientific evidence. As is hopefully apparent to regular readers, I will report findings to the public, even if they are "unfavorable" to us in tobacco control.

I want to close by emphasizing that in the long-term, smoking bans will almost certainly reduce heart disease (and therefore heart attacks). The question is whether this effect can and will happen immediately (within one year). Even if we fail to see an effect on heart attacks within one year, this does not argue against the enactment of smoking bans. In fact, even if smoking bans had no long-term effect on heart disease, the respiratory effects of secondhand smoke alone would be enough to support protecting the public from secondhand smoke exposure.

I do hope, however, that we in tobacco control will base our support of smoke-free policies on credible scientific evidence, rather than on a study like the Mathews one which lacks a control group and makes the conclusion being disseminated by these researchers an unsupportable one.

New Study Finds that Smoking Bans Have No Short-Term Effect on Heart Attack Admissions

A study presented at the American Heart Association annual meeting found that smoking bans have no effect on the incidence of heart attacks during the first year after implementation.

The study, by Dr. Robin Mathews of the Duke Clinical Research Institute, examined rates of heart attacks among persons ages 65 and older in 43 cities across the U.S. which adopted strong smoking bans during the period 2000-2008. The heart attack rates were compared from one year prior to the smoking ban to the year following implementation of the smoking ban. Mathews reports that there was absolutely no change in the heart attack rates across the sample of cities. A figure shows that heart attacks decreased in some cities and increased in others. All told, heart attack rates decreased by an insignificant 1%.

When Mathews included all 74 cities that enacted smoking bans during the study period (regardless of strength of the ordinance), he found an overall decline in heart attack rates of just 3%.

The study concludes that the actual effect of smoking bans on heart attacks is much lower than has been reported in the previous literature.

The Rest of the Story

While there have been individual studies that reported a significant, and sometimes very large, decline in heart attacks in communities following the implementation of a smoking ban, every study that has systematically examined the relationship between smoking bans and heart attacks across all communities that implemented smoking bans in a given time period has found no major effect.

It seems clear that the explanation for the discrepancy is publication bias. There are many factors operating which discourage researchers from reporting "negative" findings. It is also much more difficult to get negative findings published, especially on this topic. No researchers are running out to publish a study showing no decline in heart attacks following a smoking ban.

The studies which have systematically examined the effect of smoking bans on heart attacks in all cities across the country that have implemented such bans have found that while heart attacks have declined in many cities, they have increased in others. The overall effect is nil, or very close to it. However, the only studies being published are the ones which have found a positive effect. This is a classic presentation of publication bias.

The effect is compounded by the fact that the media are less interested in covering "negative" studies (and researchers are less excited about going to the media with "negative" results). For example, the current study is a case in point. I could find no newspaper articles that reported the results of this "negative" study. In contrast, when a study with "positive" findings is presented at a scientific conference, it tends to be widely publicized.

In addition, anti-smoking groups only report the results of the "positive" studies. To the best of my knowledge, no anti-smoking group has reported the results of the Mathews study. And they won't, because it is not scientific accuracy which is driving the movement these days. I won't even go through the motions of offering my usual $100 reward to the first anti-smoking group that reports these "negative" findings because it just isn't going to happen. The interest is not in reporting the science, but in reporting "favorable" results.

The shame is that there are no "favorable" or "unfavorable" results. The truth is the truth. The science is the science.


NOTE: Christopher Snowdon has a very nice summary and commentary of this research over at Velvet Glove Irong Fist. Tim Worstall writes about the issue here in Forbes magazine.

Duke University "Branch" of Philip Morris Puts Out Study that Perpetuates Focus on Nicotine Biology and Obscures Need for Effective Cessation Approach

An academic research unit that is apparently serving as the "Duke University branch" of Philip Morris has just put out a study which perpetuates the blinding focus on nicotine biology, thus obscuring the importance of an approach to smoking cessation that actually works and would make a dent in Philip Morris' profits.

The work was carried out by the Duke Center for Nicotine and Smoking Cessation Research (or "Philip Morris South," as I would call it), which received multi-million dollar funding from Philip Morris. As I revealed earlier, according to the agreement between Philip Morris and its "southern affiliate," the director of Duke's nicotine research center (or a designee) becomes a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

The focus of the Duke Center's work has been on nicotine replacement therapy. It makes sense that the company would be happy to support such research because we know that nicotine replacement therapy (NRT) is dismally effective in getting smokers to quit. There is considerable research that cold turkey and unplanned, unaided quit attempts are more effective in achieving smoking cessation than the use of NRT. Thus, any research which continues to perpetuate the research community's focus on nicotine biology is a win, win situation for Philip Morris. The company not only gets to boast that it is funding research to "help smokers quit," but it can do so while funding a research program that actually impedes progress towards effective cessation strategies by taking the focus off the need for aggressive strategies to promote cessation, rather than a pure reliance on pharmaceuticals.

The research released last week, which was funded by Philip Morris, makes the major contribution of informing us that smokers take up nicotine in their brains more slowly than previously thought.

The implications? A continued need for more research on nicotine biology, taking the focus away from the need for aggressive anti-smoking programs, which are the only effective way of actually making a difference in quit rates.

The Rest of the Story

This research couldn't have been any better planned for Philip Morris than had it been designed by Philip Morris' own public relations department.

Actually, in a way it was, because Duke University is now serving as a PR arm for Philip Morris, by virtue of its accepting this tobacco money to conduct a research program that is clearly going to have the effect of diverting attention away from areas where we could really make a difference in getting people to quit smoking.

For tax or accounting purposes, Philip Morris should really classify these research dollars under "public relations." And they are sure getting their money's worth.

Duke University Sends Message that Philip Morris is Serious About Getting Smokers to Quit; Becomes Public Relations Arm for Big Tobacco

Philip Morris has a new public relations arm and it has been brilliantly placed in as reputable an institution as the company could have dreamed about: a major research institution -- Duke University.

Duke University accepted multi-million dollar funding from Philip Morris to establish the Duke Center for Nicotine and Smoking Cessation Research (CNSCR). According to the letter of agreement between Philip Morris and Duke which is posted on the Center's web site, the tobacco company agreed to provide an initial award of $15 million to establish the Center in 2004, agreeing to pay $5 million annually for the first three years. It is not clear whether the Center continues to receive Philip Morris funding, but the letter of agreement with Philip Morris is still posted on the web site and the Center acknowledges that it is receiving tobacco industry funding for a 2009 scientific conference. Also, a recent article written by researchers at the Center acknowledges support from Philip Morris.

According to the agreement, the director of Duke's nicotine research center (or a designee) becomes a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

According to an article written by the Center: "The CNSCR, originally established at UCLA as the Nicotine Research Program, became a part of Duke in 1989. In 2004, with financial support from Philip Morris, USA, it was expanded into the CNSCR. The main goal of the expansion has been to allow for the development of more advanced research. Over the years, the Nicotine Research Program's work led to several smoking cessation treatments, including the nicotine skin patch."

The Center is sponsoring a research conference (The 15th Annual Duke Nicotine Research Conference) on September 10, entitled "Personalized & Adaptive Treatment Strategies for Smoking Cessation." The premise for the conference is described as follows: "It is widely recognized that current smoking cessation treatments do not yield success for the majority of smokers. Even with the growing armamentarium of pharmacologic treatments, which include five forms of nicotine replacement therapy (NRT) as well as the prescription pharmaceuticals bupropion SR and verenicline (Chantix), less than 25% of smokers remain abstinent one year after attempting to quit smoking. A promising strategy for improving the effectiveness of smoking cessation treatments is to personalize treatment according to smokers' genotypic and phenotypic characteristics, and to modify the treatment adaptively over time based on early indicators of therapeutic response. This conference will review the rationale underlying personalized and adaptive approaches to smoking cessation treatment as well as clinical findings supporting the utility of this strategy. Data will be presented from animal models as well as clinical trials and clinical practice. The attendees will gain an in-depth understanding of the research directions being pursued to promote the development of more effective personalized smoking cessation treatment algorithms."

According to the conference description, it is being funded in part by "donations from pharmaceutical and tobacco companies."

The Rest of the Story

This Philip Morris-funded Center is a complete and utter joke. You mean to tell me that we are to now believe that Philip Morris is so concerned about getting its customers off of cigarettes that it has a legitimate research interest in finding the most effective methods for smoking cessation? You mean to tell me that Philip Morris really wants to help smokers quit?

If Philip Morris is really so concerned about getting smokers to quit, then why does it continue to use menthol flavoring and addictive nicotine at high levels in cigarettes, why does it continue to use ammonia to enhance the delivery of nicotine, and why has the company spent no money on advertising to help smokers quit? When was the last time you saw a Philip Morris communication to its customers urging them to quit smoking due to the severe health effects? When was the last time you heard Philip Morris acknowledge in a courtroom that smoking is extremely addictive? Have you ever heard Philip Morris admit in court that a particular smoker was addicted to nicotine? Has Philip Morris ever acknowledged to the public that the company used ammonia and other ingredients to alter the pH of tobacco smoke in order to enhance the delivery of nicotine?

And this is the company that Duke apparently wants us to believe is now deeply committed to finding a way to get smokers off of cigarettes?

I'm sorry, but Duke can't be taken seriously if they are going to try to convince us that Philip Morris is a reformed company that now is dead serious about helping its smoking customers to get off of cigarettes entirely.

You see, Duke is in a catch-22 situation here. They are between a rock and a hard place. Either they have to argue that Philip Morris is serious about getting smokers to quit (which is untenable, essentially a complete joke) or they have to admit that the true company-based purpose of the funding they are accepting is different from its stated purpose of helping find the most effective ways to help smokers quit.

And if the research funding is being given without the actual intention of achieving its stated purpose, then it is not a legitimate scientific research operation after all. Instead, it is simply an extension of the public relations branch of Philip Morris.

The mistake Duke has made is that it is allowing itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke is allowing itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

Clearly, since the purpose of this research funding is demonstrably not to dramatically reduce the number of smokers, its purpose is therefore to serve as a public relations ploy - by which Philip Morris can improve its public image by being able to argue that it really cares and that it is a responsible corporate citizen which is trying to help its customers break their addiction to its products. By associating its name with that of Duke University, Philip Morris is using Duke to gain public relations marketing value from that association.

Clearly, there is no sincere research interest operating here on the part of Philip Morris. This is public relations 101. Using corporate funding to secure public credibility and respect. It has been a part of Philip Morris' (and the other tobacco companies') playbook for decades.

In United States of America v. Philip Morris USA, Inc., et al. (Civil Action No. 99-2496 [GK]), the United States District Court for the District of Columbia found that tobacco industry funding of university research has long been part of an illegal enterprise that violates federal anti-racketeering law. The Court found that tobacco industry funding of university research was essentially a public relations ploy to undermine the public’s appreciation of the harms of smoking while making it appear that the tobacco companies were concerned corporate citizens interested in advancing objective scientific research.

The Court’s opinion is that “the Defendants established a sophisticated public relations vehicle – based on the premise of conducting independent scientific research – to deny the harms of smoking and reassure the public. That essential strand of their long-range strategy was developed and implemented in 1953-54, and guided their activities for more than forty years.” (page 26)

The most important role of industry funding of research has been to refurbish the public image – especially the scientific image – of the tobacco companies: “Robert Seligman, Vice President of R&D of Philip Morris, described how Defendants used institutional grants to refurbish their scientific image. Seligman reported that … Shook, Hardy & Bacon attorney William Shinn had stated: “CTR began to lose their luster in the mid-60’s and the tobacco industry looked around for more beneficial ways to spend their research dollars on smoking and health. It was at this time that special projects were instituted at Washington University, Harvard University, and UCLA. … The industry received a major public relation ‘plus’ when monies were given to Harvard Medical school.” (page 148)

In fact, the chief public relations advantage gained by the industry granting money to an institution is the good will associated with the university’s name: “Arnold Henson of American [Brands Tobacco Company] acknowledged that one of the main reasons for the Harvard project was the ‘PR value of the Harvard name.’” (page 148)

In the opinion of the Court, the external research funding of the tobacco companies served as a way for the tobacco companies to coordinate their fraudulent activities, in violation of federal law (page 1541).

Brown & Williamson was quite explicit in acknowledging that the Council for Tobacco Research - the major research funding arm of the tobacco industry for many years - was essentially a public relations ploy, saying that “CTR was organized as a public relations effort” (page 50).

Remember, it was just two months ago that the D.C. Court of Appeals upheld the finding that Philip Morris and other tobacco companies were guilty of racketeering, including hiding the addictiveness of nicotine from the public. At the same time that Philip Morris was being found to be guilty of racketeering and fraud by virtue of its denial that nicotine is even addictive, Duke was accepting money from the same company under the pretense that Philip Morris now wants to help smokers quit?

The supposedly scientific conference on smoking cessation has also prostituted itself by apparently taking money from pharmaceutical companies. How can you have an objective discussion of smoking cessation when your conference is funded by Big Pharma?

The bias in the conference is readily apparent from the conference description. The description acknowledges that "current smoking cessation treatments do not yield success for the majority of smokers." If current treatments are dismal in their effectiveness, then why not seek new treatments? Why not, for example, consider ways of increasing smokers' motivation to quit? Why not put resources into mass media campaigns that have been documented to enhance smoking cessation at a level never seen in nicotine replacement therapy? Why not, for example, consider the use of cold turkey quitting, which has time and again proven to be the most effective cessation method?

But no - instead, the conference is committed to finding a way to keep pharmaceutical products the centerpiece of smoking cessation. But what else would you expect from a conference that is apparently being funded by pharmaceutical and tobacco companies?

The funding of the conference by "tobacco companies" is yet another public relations opportunity for these companies. Obviously, they have no sincere interest in helping smokers to stop using their products.

The rest of the story is that Duke is undermining its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what this Duke center is doing.


CLARIFICATION: I want readers to understand that there is no "sinister plot" that I am accusing the Center or any Duke researchers of crafting. The "sinister plot," if there is one, is on the part of Philip Morris and what this tobacco company is doing to make the public believe that it is a changed company that has a sincere interest in finding ways of getting smokers to quit more effectively. I am not maligning the Duke researchers' intentions or those of the university, or those of the research itself. It is specifically Philip Morris' intentions which I am maligning. The only role that I am arguing Duke has played is serving as a pawn by which Philip Morris can achieve its aim of legitimizing itself in the discussion over smoking cessation. So when I say that the research money has no intention of accomplishing its stated purpose, I do NOT mean that the researchers or the Center have no intention of accomplishing the stated purpose, I mean that PHILIP MORRIS has no intention of accomplishing its stated purpose in funding the research.

This is why I argue that Duke is between a rock and a hard place. It either has to argue that Philip Morris is suddenly a changed company that truly cares about getting smokers to quit, or it has to admit that Philip Morris' purpose in funding the research is not a sincere one: that the company's true intent is different from its stated intent. The former argument would be untenable based on everything we know about the company and its current actions. The latter argument is problematic because it means that the research funding is essentially illegitimate (i.e., the funding entity is disguising the real purpose behind the funding, which seems inappropriate).

Landmark Research Demonstrates Effectiveness of "Truth" Campaign; Time to Call Off FDA Legislation and Mobilize Around an Evidence-Based Strategy

A groundbreaking article published in the International Journal of Environmental Research and Public Health provides strong evidence that the "truth" anti-smoking media campaign - at high enough levels of exposure - is effective in preventing smoking initiation among adolescents (see: Davis KC, Farrelly MC, Messeri P, Duke J. The impact of national smoking prevention campaigns on tobacco-related beliefs, intentions to smoke and smoking initiation: results from a longitudinal survey of youth in the United States. International Journal of Environmental Research and Public Health 2009; 6:722-740).

The article presents the results of a 3-year longitudinal survey of more than 16,000 adolescents in grades 6 through 12, in 7 communities in 5 states. Youths were interviewed at baseline in 2000 and then at follow-up in 2001 and 2002. The likelihood of progressing to current smoking (having smoked at least once in the past 30 days) and to established smoking (having smoked at least 20 days in the past 30 days) were compared between youths who had high, medium, and low levels of recall of the "truth" campaign commercials, controlling for a host of factors that affect smoking behavior, including age, sex, race, baseline smoking status and intentions to smoke, television viewing, smokers in the household, friends' smoking behavior, risk-taking behavior, sports participation, exposure to tobacco advertising, in-school tobacco use prevention programs, perceived academic performance, and parental attitudes toward smoking.

Compared to youths with low recall of the "truth" campaign, youths with medium recall were no less likely to initiate smoking or to become an established smoker (odds ratio [OR] = 0.99 and 0.98, respectively). However, youths with high recall of the "truth" campaign were about 25% less likely to initiate smoking and to progress to established smoking (OR = 0.75 and 0.73, respectively; both statistically significant).

Using the same methodology, this study also assessed the effect of the Philip Morris "Think, Don't Smoke" television ads which aired nationally during this time period. Recall of this tobacco industry campaign was not significantly associated with the likelihood of initiating current smoking or progressing to established smoking.

The Rest of the Story

Despite the fact that this study was conducted in part by the American Legacy Foundation and funded by Legacy (something which should be disclosed in any communications about the research), I believe it presents strong evidence (the strongest to date) that the "truth" campaign, at high enough exposure levels, is effective in reducing youth smoking.

To understand why I call this groundbreaking research, one needs to look at the previous work that has been done on this research question. All of the previous research - which Legacy has relied upon to support its contention that the "truth" campaign is effective - has essentially been based on comparisons of smoking rates between youths living in media markets with varying levels of exposure to the "truth" campaign. For example, a 2005 article published in the American Journal of Public Health and two recent articles published in the American Journal of Preventive Medicine used such an approach.

The problem is that there are many other differences between youths living in different media market regions, other than simply exposure to the "truth" campaign advertisements. Most importantly, there are likely differences in smoking prevalence, smoking-related attitudes and norms, and tobacco control policies (especially smoke-free restaurant laws) between these regions. If smoking prevalence is lower, smoking-related attitudes and norms are more anti-smoking, and tobacco control policies are more prevalent in the media markets with higher "truth" campaign exposure, then it could well be these factors - rather than the "truth" campaign itself - that explain the finding of reduced smoking prevalence in these locations.

Interestingly, if one looks at the areas with very high and very low cumulative exposure to the "truth" campaign between 2000 and 2004, one may note that the locations with the highest exposure tend to be in states that either have smoke-free restaurant laws or many communities with such laws. The locations with the lowest exposure appear to be in states without smoke-free restaurant laws and with few local-level clean indoor air laws. Thus, from this research alone, one cannot conclude whether it is actually the "truth" campaign or different community policies and social norms regarding tobacco use that explain the decreased smoking among youths living in these media markets.

The present research addresses the above limitation because it actually measures differences in campaign exposure on an individual level, not a media market level. Thus, it removes as an alternative explanation for the study findings the hypothesis that differences in the media markets with higher and lower campaign exposure explain the observed differences in smoking behavior among the study subjects.

The methodology of this study is similar to that used by Dr. Lois Biener and myself in our study of the effects of the Massachusetts anti-smoking media campaign on progression to established smoking among Massachusetts youths. In that paper, we found that 12-13 year-old youths who recalled the televised anti-smoking media campaign were half as likely to progress to established smoking (defined as having smoked 100 cigarettes in their lifetime) as youths who did not recall the campaign.

Another strength of this new study is that it improves upon the methodology in my and Dr. Biener's study by specifically adjusting for the high rates of attrition (loss to follow-up) in the study. It also adjusts for clustering in the data by using a multilevel analytic technique and it employs robust standard error estimates, which further account for the clustered nature of the sample data.

I must also note that in our study, the outcome variable was progression to established smoking, as defined by having smoked 100 cigarettes in one's lifetime. We found that exposure to the media campaign had a greater effect on progression to established smoking (defined in this way) than on current smoking or near-daily smoking. Thus, I suspect if the newer research were to employ having smoked 100 cigarettes as an outcome variable, the observed effect of media campaign exposure would be substantially greater. Youth smoking is very episodic and unlike heavily addicted adults, adolescents may smoke intermittently during the initiation process. Thus, using current smoking as an outcome variable is a less sensitive measure of the actual construct of adopting smoking as a behavior than the use of a threshold of total number of cigarettes smoked.

The finding that recall of the "Think, Don't Smoke" campaign was not associated with smoking behavior also strengthens the study findings, because if it were the case that youths who are less prone to smoke have higher recall of anti-smoking ads, then one would have expected to find a similar relationship for the tobacco industry anti-smoking ads as well.

Finally, the finding that only the highest level of recall of the "truth" campaign was associated with an effect on smoking initiation adds further evidence of the validity of the study findings. If the results were due to a confounding factor that is related to the level of campaign recall, one would have expected to find more of a gradient of smoking risk. The finding that the observed effect on smoking is specific to the high exposure group supports the conclusion not only that the effect is a real one, but that there is a threshold below which the campaign exposure is not sufficient to prevent smoking initiation. This is similar to the recent finding in a study I co-authored recently which found that only complete restaurant smoking bans, not partial bans, reduce youth smoking initiation.

Of note, the time frame of this study is such that it examined the effects of the "truth" campaign during a period of high overall exposure (the funding peak for the campaign occurred in 2001, and funding since then has almost been cut in half). Thus, it is unlikely that the magnitude of any campaign effects is close to what is being observed in this study. The observed effects only occur at the highest levels of exposure and it is unlikely that the campaign at its current level is reaching many youths at such a requisite level.

Finally, it is important to point out that the effects of the "truth" campaign, at least on smoking-related attitudes and intention to smoke, are being observed among African American and Hispanic youths, and not just white youths (see this recent paper which assesses differences in campaign effects by race/ethnicity). In fact, the campaign's effects upon youths who had never smoked were statistically significant only for African American youths.

The Implications of this Research for Tobacco Control

These results should make it painfully obvious to everyone in tobacco control how stupid and absurd it is that the movement is obsessed with legislation that is based on the regulation of the ingredients and components of the tobacco product, rather than on actually trying to reduce the use of that product.

Here we have an intervention available that could, based on actual evidence, reduce smoking initiation by 25% or more, and our response is to put all of our resources and energy into worrying about trying to take a few particular components of the smoke away (without a shred of evidence that such an approach would result in a safer product).

The implications of this research are very simple, then: the movement should scrap its focus on the FDA legislation and instead, should take advantage of this rare political opportunity to secure a piece of legislation that will ensure that every region in the country has a high level of exposure to the "truth" campaign.

I have proposed exactly such a program, which relies upon penalties on tobacco companies for failure to reach targeted reductions in youth smoking. The revenues are allocated not only towards ensuring that the national "truth" campaign (whose funding has been cut by 50% since 2001) can provide high exposure levels across the nation, but also towards a new (in many cases) infrastructure that would allow grassroots, community-based tobacco control activism to flourish. The proposal would use the revenues from penalties to tobacco companies based on youth smoking to fund a national tobacco control campaign as well as campaigns in all 50 states. Much of the funding would be used for state-of-the-art media campaigns that would provide the air cover for the ground attack of community-based coalitions and groups. Funding would specifically be allocated towards communities of color, representatives of which would be requisite partners in all aspects of program planning and revenue allocation. Targeted initiatives to support community development would be a key part of the strategy. Elimination of disparities within population subgroups would stand side-by-side with overall population reductions in tobacco use as dual goals of the program. The potential role of harm reduction (no, I don't persume to have any answers) could be discussed in an informed, inclusive manner to determine the appropriate nature, scope, and targeting of particular harm reduction messages.

The presence of community coalitions would allow local and state-level tobacco legislation to continue on as well. Legislation related to tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products would still be allowed. States, for example, could decide to eliminate menthol from cigarettes (New Jersey recently considered a bill that would have eliminated cigarette flavorings, but as expected, menthol was exempted in the legislation). Fire-safe cigarette standards could also continue to be enacted. And of course, the movement to promote smoke-free workplaces for all employees in the nation would receive a huge boost. This is especially important, because the safety of working conditions are becoming a huge source of disparity in health protection between people living in different regions of the country.

Further research into the effect of the campaign on different racial/ethnic groups is also important, as it is essential that we avoid the pitfall of using a mainstream intervention that might leave out communities of color. Inclusion of representatives from these communities in the design of campaigns at the national, state, and local levels would be vital.

We have all heard a lot of talk recently about evidence-based medicine. Well, I think it's time that we started practicing evidence-based public health. The FDA legislation is based on a premise that is without any shred of scientific support: that a federal agency can find a way to make cigarettes safer by simply requiring the reduction or elimination of certain constituents, when the product contains over 4,000 chemicals and over 60 carcinogens and we have no idea which constituents and in what combinations cause what diseases. It is, frankly, both an absurd and a stupid proposition. What a tremendous waste of resources.

Instead, we have at our disposal a proven intervention that we know works. Actually, two proven interventions because smoke-free restuarant laws have been shown to be the most effective policy that reduces youth smoking. The combination of funding high-exposure national and state anti-smoking campaigns and local community coalitions that provide support for smoke-free restaurant laws is a powerful, evidence-based appraoch that is unmatched by anything that the FDA legislation would do. It is a shame that this moment of opportunity is being squandered because of a scientifically baseless obsession with a particular approach favored by one organization that negotiated a deal with Philip Morris and refuses to back down from that deal, even in the light of strong evidence that the tobacco control community itself is now rejecting it.

I hope that my efforts to re-focus the tobacco control movement on an evidence-based course will be enhanced by today's courageous statement by Dr. Stanton Glantz, who - in receiving the Luther Terry Distinguished Career Award from the American Cancer Society - admonished the ACS for its support of the FDA legislation and challenged the ACS to withdraw its support for the legislation (at least in its current form).

Dr. Glantz stated that the FDA legislation contains all the provisions that Philip Morris wants because it will "help them sell more cigarettes." Dr. Glantz also opines that "the damage that this bill will do extends far beyond the narrow confines of product regulation and could do great damage to tobacco control, not only in the United States, but globally."

Why is the tobacco control movement using this rare political opportunity to pursue legislation that someone like Dr. Stan Glantz says will help Philip Morris sell cigarettes and will do great damage to tobacco control in the United States and internationally, when we could just as easily mobilize and unite around a piece of legislation that would apply the tobacco control research evidence base to the creation of a truly effective national tobacco control strategy that would, based on solid evidence, greatly reduce youth smoking in the United States?