Tuesday, November 13, 2018

FDA to Announce Ban on Sale of Most Cigarettes in Convenience Stores Due to Addiction of Hundreds of Thousands of Youth to Cigarettes

Tomorrow, the FDA is expected to announce the strictest regulation of cigarettes sales in decades. Spurred by the data showing that nearly 8% of high school students are current cigarette smokers, the FDA will announce that from now on, with just a few exceptions, cigarettes may not be sold in any convenience store or gas station. Online sales of cigarettes will still be allowed, but it will be subject to advanced age verification procedures. The only stores that will be allowed to sell cigarettes without restriction will be those which are only open to adults (or which establish an area that is only open to adults).

The FDA said it was forced to take this drastic action because it has evidence that: "a new generation is being addicted to nicotine, and we can’t tolerate that."

The tobacco companies intentionally make cigarettes more addictive by adding ammonia to the product, which enhances nicotine absorption. Cigarettes are the most effective known product to deliver nicotine in a pattern that is capable of quickly initiating and then sustaining addiction.

According to the CDC, every day more than 3,200 youth smoke their first cigarette. It has been estimated that it only takes four to five cigarettes for a youth to become addicted to smoking. One out of every two long-term addicted smokers will die prematurely, primarily from lung cancer, lung disease, heart disease, stroke, or other cancers. 

The Rest of the Story

Actually, I got it wrong.

The FDA is not banning the sale of most cigarettes at convenience stores; it is banning the sale of most fake (electronic) cigarettes at convenience stores.

Convenience stores and gas stations can continue to sell real cigarettes - which, despite lower smoking rates, continue to addict a new generation to nicotine - but they will no longer be able to sell electronic cigarettes (with only minor exceptions).

Somehow, we have completely lost all sense of public health perspective. Every argument that the FDA is making in justifying a ban on the sale of electronic cigarettes in convenience stores and gas stations applies even more strongly for real tobacco cigarettes: you know, the ones that kill hundreds of thousands of Americans each year. Something is terribly wrong with our sense of perspective when we take the fake cigarettes off the shelf but allow the real ones to remain.

So let me attempt to correct this skewed perspective.

First, we need to recognize that the problem of youth addiction to electronic cigarettes is not a broad problem of youth becoming addicted to e-cigarettes; it is a very specific and narrow problem of youth becoming addicted to Juul. It is one specific product that is causing the problem.

Other than Juul, all other closed system electronic cigarettes do not have high addiction potential because they are actually quite poor at delivering nicotine. Specifically, there is no nicotine spike in the blood, and the nicotine level drops off quite slowly. In contrast, the Juul uses a specially formulated nicotine salt that is absorbed much more rapidly into the bloodstream, and the pattern of blood nicotine levels from Juuling mimics that of a real cigarette. Youth are becoming addicted to nicotine not because they are vaping generally, but because there is an epidemic of Juul use occurring in middle schools and high schools across the nation.

However, just four days ago, Juul announced that it would voluntarily stop selling flavored Juul products in all convenience stores and gas stations. In fact, Juul has agreed to stop selling flavored Juul products in any brick-and-mortar establishment. These products will only be available online and with age verification procedures.

So this sweeping action by the FDA is not necessary. It will not result in the elimination of flavored Juul sales from convenience stores because that is already occurring.

So the rest of the story is that what the FDA's action is doing is to make it much more difficult for adults who have quit smoking to continue to stay smoke-free using their favorite brands of electronic cigarettes, which will be taken off the shelves. Youth will not be able to purchase flavored Juul products from stores, but that was going to happen anyway. The other e-cigarettes that are being sold at these stores (i.e., products other than Juul) have low nicotine addiction potential. It makes no sense to take them off the shelves but to allow real cigarettes, which have extremely high addiction potential, to remain available for sale and distribution to the 3,200 youth who try these products every day.

I believe this action will have a net negative impact on the public's health because it will almost certainly result in many ex-smokers returning to smoking as their products disappear from convenience store shelves.

What the FDA should have done is to deal directly with Juul and demand that they voluntarily remove their flavored products from the shelf and bolster their age verification procedures for online purchases. But since Juul has already agreed to this, there is no need for this drastic regulation, especially because cigarette sales are being left unencumbered.

One might argue that the reason that Juul agreed to remove their flavored products from the shelf is that they anticipated this FDA regulation. If that is the case, then perhaps the threat of regulation was successful in achieving this result. But now that Juul has agreed to take most of their products off the shelves, the FDA should not proceed with the regulation. Unless it is sincerely concerned about youth becoming addicted to nicotine, in which case it should ban all cigarette sales in brick-and-mortar establishments that are not restricted to adults.

Monday, June 18, 2018

USC Ended Partnership with Anheuser-Busch InBev in April; Ohio State and San Diego State Should Follow Suit

I have been informed by the USC Suzanne Dworak-Peck School of Social Work that the School and its research team that had been involved in the Smart Drinking Goals project terminated its involvement with the project in April 2018 and that they are no longer associated in any way with the project.

The USC team had prepared toolkits summarizing the best current scientific thinking regarding environmental strategies for alcohol prevention. Although the team's involvement was apparently slated to last at least through 2018, they terminated their involvement in April and have completely disassociated themselves from the Smart Drinking Goals project.

I applaud USC and this research team for dissociating from the project.

The Rest of the Story

To the best of my knowledge, the Ohio State University is still involved with the Smart Drinking Goals program, and in addition, since yesterday I have learned that San Diego State University also seems to be involved with the program. Both of these institutions should immediately follow the lead and example set by USC and terminate their involvement with this project and their partnership with Anheuser-Busch InBev.

While public-private partnerships are sometimes tenable, in this case, you cannot have a credible partnership when the private corporation is bullying and disrespecting the autonomy of governments to implement their own public health measures to prevent excessive alcohol use and its associated harms. I cannot fathom an academic institution partnering with a company that went so far as to threaten a lawsuit against the city of Rostov in order to force it to allow the sale of beer at the World Cup soccer matches in Rostov Arena. Obviously, this completely undermines the supposed "smart drinking goals" initiative and exposes it for what it really is: a public relations hoax.

I have since learned that San Diego State University has apparently also partnered with Anheuser-Busch InBev to aid this public relations initiative. According to the university, it accepted a $200,000 grant from the alcohol corporation to be a part of the "implementation planning" for the Smart Drinking Goals project.

This grant completely exposes the hypocrisy of the alcohol company and demonstrates why this whole project is a hoax. Ironically, part of the San Diego State University project is to develop programs to reduce excessive alcohol consumption in sports arenas! Now you can see why this is a complete joke. At the same time that the company is, out of one side of its mouth, proclaiming that it cares about reducing alcohol consumption at sports arenas, from the other side of its mouth it is threatening to sue cities in order to force them to sell alcohol and facilitate excessive alcohol consumption in their sports arenas!

This hypocrisy boggles the mind, and it demonstrates that the Smart Drinking Goals program is not a sincere effort to address public health concerns but instead, a public relations hoax.

Hopefully, Ohio State and San Diego State will follow the example set by USC and immediately terminate their partnerships with Anheuser-Busch InBev.

Sunday, June 17, 2018

Anheuser-Busch InBev Proves that Its Smart Drinking Goals Program is a Complete Hoax: Ohio State and USC Have Fallen Prey

Two years ago, I explained why I think Anheuser-Busch InBev's Smart Drinking Goals program is a complete farce. Last year, I criticized the NIAAA for endorsing the alcohol industry's Smart Drinking Goals program. Today, I will show how Anheuser-Busch itself has proven that its Smart Drinking Goals program is a huge hoax, designed solely as a public relations ploy and devoid of any sincere intent to reduce alcohol consumption.

For brief background, senior employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) appeared in an Anheuser-Busch InBev promotional video that was designed primarily to serve the company's public relations interests. The video was brought to light in an article by Miriam Shuchman at Wired. In the video, Anheuser-Busch InBev boasts to the public about its "Smart Drinking Goals" program, which is purportedly designed to reduce "hazardous" drinking. Several Anheuser-Busch executives-- including its CEO, Chief "Health" Officer, and Chief Legal and Financial Officer--appear in the video, boasting about how wonderful this program is and implying how great a company Anheuser-Busch is for funding this program and how much it cares about the public's health.

But the Anheuser-Busch executives aren't the only ones who appear in this promotional, public relations video. Shockingly, this Anheuser-Busch PR effort (i.e., public relations effort) is also endorsed and promoted by senior officials of the Executive Branch of the United States government. And even worse, those senior officials are the Director and the Director of Global Alcohol Research of the NIAAA!

The Director of Global Alcohol Research at NIAAA provides a glowing endorsement of the program, describing it as "wonderful" (see 0:27-0:34 in the video). The Director of NIAAA also endorses the program, asserting that it will "go far in moving the field forward" (see 3:17-3:26).

However, the true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

The video is clearly marketing Budweiser and other beers produced by Anheuser-Busch. As the company acknowledges, they are running this international program because they don't just want to be a neighborhood's beer or a country's beer; they want to be the world's beer.

The Rest of the Story

According to a Mother Jones article published last Friday, in 2005, Russia took a major public health step by banning the sale of alcohol in sports stadiums. When Russia bid to host this year's soccer World Cup, FIFA insisted that the country repeal its ban on alcohol consumption in stadiums as a condition of hosting the World Cup. Russia complied by creating an exemption from the law. However, earlier this year the city of Rostov (home to one of the stadiums being used for World Cup competition) passed its own law that prohibited the sale of alcohol at Rostov Arena (it did this by declaring the stadium a place of "mass gathering," thus removing the exemption from the national ban.

The city of Rostov thus exercised its right as a sovereign local government to protect the health and safety of its citizens by preventing alcohol sales at Rostov Arena, which could fuel violence, especially in the setting of international soccer competition. The policy was evidence-based, as there have been numerous episodes of violence fueled by the sale of alcohol at such matches.

Rather than respecting the autonomy of the Rostov government, Anheuser-Busch InBev threatened to sue Rostov city authorities. There is obviously no legitimate legal grounds for such a lawsuit. Rostov certainly has the legal authority to enact reasonable measures to protect the health, safety, and security of the public. Nevertheless, Anheuser-Busch InBev threatened the lawsuit in order to try to intimidate Rostov. It worked. The city backed down.

These actions of Anheuser-Busch InBev are not those of a company that has any interest in protecting the public's health. They are the actions of a bully corporation that puts the sale and consumption of its products above the public health, public safety, and even the autonomy of local government bodies.

In light of this action, the Smart Drinking Goals program cannot be taken seriously. It is purely a public relations ploy. While I don't blame the company for designing this clever marketing scheme because it's job is to sell alcohol, I do blame the NIAAA for endorsing the scheme, and I also blame the universities that have agreed to participate in the scheme by serving as partners.

Specifically, I denounce the Ohio State University, the University of Southern California, and investigators at both institutions for accepting what appears to be more than $1 million to partner with Anheuser-Busch and help serve as implementation planning and technical assistance sites for the Smart Drinking Goals program.

By doing this, Ohio State and USC are participating in a marketing ploy of the company. Essentially, Ohio State and USC are helping Anheuser-Busch to market beer and achieve its goal of becoming the world's beer. These universities are acting as essentially a marketing branch for Anheuser-Busch. With the promotion of Anheuser-Busch's interests that Ohio State and USC are providing, the company hardly needs its own marketing division. It can simply call Ohio State and USC its de facto Marketing and Public Relations Department.

It appears that Anheuser-Busch InBev's implementation partnerships are with the College of Social Work at the Ohio State University and School of Social Work at USC. The grant appears to be primarily with Ohio State University; however, since the principal investigator recently moved from Ohio State to USC, both institutions are now involved. The co-principal investigator of the project, who is at Ohio State, reports Anheuser-Busch funding in the amount of $946,517. The amount of funding to the principal investigator, who is at USC, is not clear.

I can see how researchers can be easily deceived by the clever scheme of this leading international alcohol corporation. Offers of money, especially for academic researchers like me, can easily distort our judgment. As the tobacco industry has proven, researchers and universities can essentially be bought out. The tobacco industry used this strategy to its great advantage.

But in some ways, this is worse than universities accepting tobacco money for research. Here, the universities are accepting money to actually be a part of the implementation of this alcohol company initiative. By doing so, they become co-conspirators. This is why I refer to them as participating in this public relations ploy.

If Anheuser-Busch InBev was sincere about wanting people to reduce their alcohol consumption, it would not bully city authorities like those in Rostov and essentially force them to allow the sale of alcohol at mass public events where there is a legitimate concern for public safety. It would not disrespect the autonomy of a local government to implement its own public health and safety laws.

The rest of the story is that this is not a company that public health (and social work) researchers and institutions should be collaborating with. Believe me, Anheuser-Busch is successful enough in its marketing and public relations on its own. It doesn't need help from respected academic institutions that are supposed to be in the business of saving lives and improving health, not marketing a dangerous product.

What business does a school of social work have partnering with a company that insists upon destroying the autonomy of communities and forcing them to serve alcohol at an event for which the sale of alcohol creates a substantial safety and security risk? Is this the type of company that Ohio State's and USC's social work schools want to be teaming up with?

Just as the NIAAA renounced its funding by the alcohol companies for research after the issue was brought to public attention, I hope that Ohio State and USC will also cancel their funding from Anheuser-Busch InBev and avoid the negative publicity that is sure to follow from any continued association with an industry that is preying upon communities and their leaders in order to force them to sell beer in a situation that creates a great risk of violence to their citizens.

UPDATE (June 18, 2018 - 7:50 am): I have been informed by the USC Suzanne Dworak-Peck School of Social Work that the School and its research team that had been involved in the Smart Drinking Goals project terminated its involvement with the project in April 2018 and that they are no longer associated in any way with the project.

The USC team had prepared toolkits summarizing the best current scientific thinking regarding environmental strategies for alcohol prevention. Although the team's involvement was apparently slated to last at least through 2018, they terminated their involvement in April and have completely disassociated themselves from the Smart Drinking Goals project.

I applaud USC and this research team for dissociating from the project.

Saturday, June 16, 2018

NIH Disbands Alcohol Clinical Trial Because of Scientific and Ethical Breaches

In a decision that I applaud, NIH Director Dr. Francis Collins announced yesterday that based on the recommendation of his Advisory Committee after an extensive investigation, he is discontinuing the MACH15 (Moderate Alcohol and Cardiovascular Health) clinical trial of moderate alcohol consumption (see original news reports here and here).

In its report, the NIH Advisory Committee to the Director concluded as follows:

"To understand the context that led NIAAA to embark on the MACH trial, the ACD WG considered the nature and extent of interactions among NIAAA staff, select extramural investigators, and industry representatives before FNIH received approval to secure funding to support the trial. There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the engagement with industry representatives calls into question the impartiality of the process and thus, casts doubt that the scientific knowledge gained from the study would be actionable or believable."

"There were sustained interactions between the eventual principal investigator of the MACH trial and members of the NIAAA leadership prior to and during the development of FOAs for planning and main grants to fund the program. These interactions appear to have provided the eventual principal investigator with a competitive advantage not available to other applicants, and effectively steered funding to this investigator."

"Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption. Independent review of the trial plan raised concerns that there are insufficient patients and not enough follow-up time to allow for meaningful assessment of cancer endpoints. The composite primary endpoint does not include heart failure. Thus, the trial could show benefits while missing harms."

As a result, the Committee recommended that:
  • "The MACH trial be terminated."
  • "The NIH should examine additional measures to prevent NIH staff from soliciting external funding to support programs."
  • "NIH Institutes, Centers, and Offices (ICOs) should ensure that program staff do not inappropriately provide non-public information, or engage in deliberations that either give the appearance of, or provide, an advantage to any single, or subset of, investigator(s)."
The Rest of the Story

I want to thank all the individuals and organizations who helped bring this to the attention of the NIH director and the DHHS Inspector General and who have been working to maintain a high level of scientific and ethical integrity at the NIAAA, especially my colleagues Dr. David Jernigan, Dr. Rich Saitz, Dr. Tim Naimi, Dr. Ziming Xuan, and Dr. David Rosenbloom here at the Boston University School of Public Health; Dr. Tom Babor at UCONN Health; Dr. Jim Sargent at Dartmouth's Geisel School of Medicine; Dr. Michael Carome and Public Citizen; Bruce Livingston and Carson Benowitz-Fredericks and Alcohol Justice; Diane Riibe and the Alcohol Policy Alliance; Dr. Thomas Hilton, former NIH science officer; Dr. Josh Sharfstein at the Johns Hopkins Bloomberg School of Public Health; Jennifer Grodsky at BU Federal Relations; Senator Edward Markey and his outstanding staff; the minority staff of the House Energy & Commerce Subcommittee on Oversight and Investigations; and Representative Lucille Roybal-Allard and her amazing staff.

And also, my sincere thanks and appreciation to the investigative reporters who helped shed sunlight (the best disinfectant, according to Justice Louis Brandeis) on what was going on behind the scenes, especially Roni Caryn Rabin at the New York Times who blew open the most important aspect of the story -- the secret meetings between NIAAA officials and alcohol industry executives in which the future principal investigator and NIAAA solicited funding from the alcohol industry. This was the revelation that led to the NIH director's investigation that ultimately led to the termination of the study.

Thanks also to Sharon Begley at STAT News; Stephanie Mencimer at Mother Jones, Miriam Shuchman (who wrote an excellent story at Wired); Ed Cara at Gizmodo; Liz Borkowski at The Pump Handle and the George Washington University School of Public Health and Health Services; Beth Mole at Ars Technica; and Shawna Williams at The Scientist.

It takes a village -- it certainly did to bring down this scientifically fraudulent and unethical research.

Sunday, June 10, 2018

Alcohol Clinical Trial Continues to Crumble: Anheuser-Busch Pulls Its Funding

In another setback for the NIAAA's and alcohol industry's study of the "health benefits" of encouraging people to drink, Anheuser-Busch has pulled its funding from the clinical trial because recent controversy over how the research funding was solicited has undermined the study's credibility.

According to an article by Roni Caryn Rabin in the New York Times:

"Brewing giant Anheuser-Busch InBev, one of five alcohol companies underwriting a $100 million federal trial on the health benefits of a daily drink, is pulling its funding from the project, saying controversy about the sponsorship threatens to undermine the study’s credibility, the company announced Friday. ... Anheuser-Busch InBev had committed $15.4 million to support the trial, representing nearly one-quarter of the $66 million in funds pledged by beer and liquor companies to date."

Last month, the NIH halted the trial while it investigates potential violations of NIH policy committed by the NIAAA in soliciting funding from alcohol companies to conduct the research. Two NIH committees are expected to report on the results of their investigations later this month.

The Rest of the Story

This demonstrates why accepting alcohol industry funding for this research was so inappropriate. Clearly, the alcohol companies are not in it for the science. They are in it for its public relations value. As soon as they perceived that the public relations value for the research deteriorated, they abandoned the research - they couldn't have gotten out of town more quickly.

This is why it was wrong to accept alcohol industry funding for this study in the first place. It was tainted from the start. Not only was the scientific objectivity compromised, but the ethical integrity was compromised as well. Essentially, the NIAAA - as well as investigators from Harvard School of Public Health, Johns Hopkins, and Wake Forest University - had agreed to accept money to do the public relations work for these companies. It was never about the science. It was about trying to help the companies sell beer, wine, and liquor.

In addition to its double violation of NIH policy (the solicitation of funding from alcohol companies by NIAAA officials and the acceptance of corporate money for a study that would not otherwise have been conducted), its violation of ethical standards (the principal investigator apparently lying about having had contact with the alcohol companies prior to initiating the research), and its violation of scientific integrity (the principal investigator promising the industry positive results and pitching it to the companies based on the public relations value for these companies), the trial had multiple other problems, including a possible violation of federal law, as it is not clear to me that the sponsor had obtained an IND (investigational new drug application) prior to recruiting patients.

And I haven't even yet revealed what is perhaps the greatest ethical violation of the study - its failure to adequately inform human subjects of the potential risks of participation in the study. For example, the study recruitment site, in listing the risks of participation in the research, fails to even mention that alcohol consumption increases the risk of cancer, especially breast cancer among women. The study fails to meet the requirements for human subjects protection because it fails to justify exposing women to an increased risk of breast cancer and it fails to demonstrate that the potential benefits outweigh these risks.

The study also fails to inform the public (and presumably human subjects as well) that alcohol consumption at the levels required in the study has been associated with an increased overall mortality risk in a recent study.

I will be delving into the human subjects protection failures of the research in future commentaries.

For now, the most important point is this:

The rest of the story is that the NIAAA, Harvard, and the other participating institutions allowed the alcohol companies to use them as part of their public relations and marketing plan to increase the sales of beer, wine, and liquor. The motivation behind their funding of the research was never a purely academic one, and it is this - above all - that rendered the money tainted. Now that the public relations value of the study has been compromised, Anheuser Busch has dropped it as fast as a wide receiver with greased palms. It's going to take a long time for the NIAAA and the participating academic institutions to de-grease themselves from this fiasco.

Johns Hopkins Public Health Researchers Claim that Smoking May Be No More Hazardous than Vaping

In an article published in the Summer 2018 issue of the Hopkins Bloomberg Public Health Magazine, two researchers at the Johns Hopkins Bloomberg School of Public Health are denying that smoking is known to be any more hazardous than vaping.

According to the article, Dr. Ana Maria Rule, an assistant professor in the the Department of Environmental Health and Engineering, argued that: "Even if vaping proves safer than smoking, that's still a long way from a gold stamp for their safety." This of course implies that we don't currently know that vaping is any safer than smoking. In turn, this means the professor's claim is that we don't currently know that smoking is any more harmful than vaping.

In the same article, Dr. Joanna Cohen, a professor and director of the Institute for Global Tobacco Control, is quoted as stating: "They are likely safer than continuing to smoke combustible cigarettes, but without the long-term studies, we just don’t know." Thus, Dr. Cohen is claiming that we just don't know whether smoking is any more hazardous than vaping.

The Rest of the Story

This type of denialism is something you might expect from the tobacco industry, not from public health researchers. But ironically, even the tobacco industry hasn't sunk to the level of claiming that their combustible cigarettes, which kill more than 400,000 Americans each year and more than 6 million people worldwide, may be no more hazardous than devices which contain no tobacco and involve no combustion.

In fact, all the major tobacco companies have in fact admitted that combustible tobacco products are far more dangerous than non-combusted products that don't even contain any tobacco. And even Dr. Stan Glantz, who is about as opposed to e-cigarettes as one can be, acknowledges that e-cigarettes are safer than real ones. Perhaps more objectively, the National Academy of Sciences stated that there is "conclusive evidence" that vaping is safer than smoking.

What almost nobody in tobacco control is acknowledging is that most of the major brands of electronic cigarettes that are sold at retail stores in the U.S. and which account for well over half of the market share have been tested and no detectable levels of any dangerous chemicals have been identified in the aerosol. This includes the major cigarette company brands, such as Mark Ten and Vuse, as well as Juul and several other leading brands made by the largest independent vape manufacturers. With these brands, even the potential health effects we are talking about are mild, acute respiratory and cardiovascular irritation. There is no evidence that vapers are exposed continuously enough for these acute changes to result in chronic lung or heart disease, but even if the risk is slightly increased, there is no way that it could equate to the risks of active smoking.

The problem with this denialism is not merely that it is spreading misinformation. The problem is that this is exactly the kind of false propaganda that is deterring many smokers from trying to quit smoking using vaping products and is causing some ex-smokers to return to smoking. If we aren't sure that vaping is any safer than smoking, then why bother quitting smoking using e-cigarettes? You might as well just keep on smoking. And if you've already quit using e-cigarettes, then what's the point of staying on e-cigarettes? Why not just go back to smoking, since we're not sure that it's any more dangerous than vaping?

If a physician were to give the same advice to a patient, it would be grounds for malpractice. Can you imagine doctors discouraging their smoking patients from switching to e-cigarettes because they are not sure it is any safer? Can you imagine doctors telling ex-smoking patients that they might as well resume smoking because they're not sure that their vaping is any better for their health than smoking?

Whether they realize it or not, this is precisely the effect statements like those being made by these Johns Hopkins researchers are having on the public. In fact, several national surveys have demonstrated that the public is largely misinformed about the relative hazards of smoking vs. vaping.  And it is this misperception that has stunted what otherwise could have been a much more substantial shift from smoking to vaping in this country. In other words, this isn't just a question of misleading the public. It's a question of saving lives, or failing to do so.

Hopefully, these researchers will publish a correction or retraction of these claims so that we can begin the process of restoring some semblance of a science base in the field of tobacco control.

Tuesday, May 08, 2018

E-Cigarette Opponents Still Making Up False "Facts" to Demonize Vaping

We're well into 2018 and there is now substantial research on the health effects of vaping as well as a decade of experience with large numbers of vapers, yet e-cigarette opponents are still making up false claims to buttress their demonization of vaping.

In an article by Jia Tolentino published yesterday in the New Yorker, a Harvard professor was quoted as claiming that: "vaping can cause something called bronchiolitis obliterans, or popcorn lung."

He also stated that Juul is "a massive public-health disaster," likened e-cigarettes to “bioterrorism,” and "predicted that, eventually, a state’s attorney general would sue Juul 'for willfully designing and pushing a product that will cause harm to the children of the United States.'"

The Rest of the Story

While he may be able to fool the public, this professor was no match for the likes of Jia Tolentino, who did extensive background research and therefore pointed out that: "Popcorn lung has been linked to diacetyl, an organic compound that some companies use in their e-liquid, and that has been detected as a by-product of e-cigarette vapor. But diacetyl has also been detected in cigarette smoke, at a level hundreds of times greater, and no feasible amount of smoking has been found to cause popcorn lung."

Moreover, there has not been a single reported case of bronchiolitis obliterans linked to vaping in the United States, despite millions of users and a decade worth of experience with heavy use of the product.

Claiming that vaping causes popcorn lung is irresponsible, as there is no evidence to back up the claim. If you're going to tell the public that vaping causes a serious and often deadly progressive respiratory disease, you ought to have at least one -- just one -- case to back it up.

The truth is that there is no evidence that vaping causes bronchiolitis obliterans and despite having levels of diacetyl that are hundreds of times higher, smoking itself has not been linked to bronchiolitis obliterans.

As I've said before, there's plenty of room for differing perspectives on the net public health benefits of electronic cigarettes, but making up false information is not acceptable, nor is it consistent with the ethical principles of public health practice.

The comparison to "bioterrorism" is also irresponsible and inappropriate. Vaping companies are doing a tremendous service to millions of smokers throughout the U.S. who have been unable to quit using pharmaceuticals, but have succeeded in quitting thanks to electronic cigarettes. To call these companies bioterrorists is despicable.

It is also inappropriate to call Juul a massive public health disaster. True, Juul is a major problem because it is leading to widespread youth use with a significant potential for addiction. But Juul is also helping millions of adults quit smoking. Its market share is up to close to 60%, so it appears to be the most commonly used strategy for quitting smoking in the United States. That's hardly a public health disaster.

Finally, it is irresponsible and inappropriate to accuse Juul of "willfully designing and pushing a product that will cause harm to the children of the United States." First of all, Juul did not design the product with the intention of causing harm to children. The product was designed to help adult smokers quit smoking. That is a laudable goal, not an evil one. In fact, the Juul represents a major advance in the effort to promote smoking cessation because it is the first electronic cigarette to deliver nicotine in a manner that is similar to real cigarettes and therefore is acceptable to a larger number of smokers who reject traditional e-cigarettes because they fail to deliver a nicotine hit.

Second of all, if you're going to sue Juul, you ought to also sue every single alcohol company as well. Their products are also causing harm to the children of the United States. And what about the tobacco companies themselves? Their products are causing far more harm to the children of the United States than all e-cigarettes combined. Why would we even think about suing Juul but not file suit against the cigarette companies as well?

Sadly, the scientific evidence doesn't matter any more in tobacco control. Our pre-determined conclusion that vaping is terrible, based on an almost puritanical ideology, is now running the show. Worse still, the actual truth about the harm being caused by products like Juul is not enough. We have to make up false and alarming information to support our pre-determined conclusions.

Let's be clear. There are at least 2 million ex-smokers in the U.S. who have quit smoking because of electronic cigarettes. To call this a public health disaster is to throw these 2 million former smokers under the bus and to essentially conclude that their lives don't matter.

I, too, have been outspoken about the risks posed by the widespread adoption of Juuling. But you have to have a sense of perspective. Yes, this is a serious concern. Yes, action needs to be taken to try to stem the tide of Juuling. But the Juul isn't causing substantial health damage. There is no evidence that even long-term Juuling increases the risk for disease. And Juul is helping hundreds of thousands of smokers to quit and perhaps save their lives.

The rest of the story is that this Harvard professor has now misled the entire nation into thinking that vaping causes a serious, often fatal, progressive respiratory disease, without a shred of evidence that this is the case and with overwhelming evidence that it simply is not true. Whatever you think about vaping and Juuling, lying to the public is not what we do in public health.

Thursday, April 12, 2018

NIH Director Grilled at Appropriations Hearing About NIAAA Collusion with Alcohol Industry

At the House Appropriations Committee hearing on the NIH Budget, NIH director Dr. Francis Collins was grilled about the collusion between the NIAAA and the alcohol industry in planning a clinical trial to study the health benefits of alcohol use. Congresswomen Lucille Roybal-Allard (D-CA) expressed concern about the fact that NIAAA violated NIH policy by soliciting funding from the alcohol companies and asked Dr. Collins who authorized the solicitation of funding. While Dr. Collins did not answer the question, he did say that his office is conducting an investigation and will provide the Inspector General with any uncovered materials that are of concern.

The questioning begins at 51:30 of the video.

Sunday, April 08, 2018

Principal Investigator of Alcohol Clinical Trial is Hiding its Industry Funding from the Public and Potential Research Subjects

I have already explained why I think the Moderate Alcohol and Cardiovascular Health (MACH15) clinical trial should be immediately halted because of both scientific and ethical breaches in the way the research was planned. Today, I reveal what I believe is misconduct in the actual conduct of the trial: namely, in the communication of the research sponsors to the public.

I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.

The Rest of the Story

On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.

Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.

This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.

The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.

Sunday, April 01, 2018

Alcohol Clinical Trial Should be Halted Because It Was Designed to Promote Drinking, Not to Answer a Research Question

Digging Deeper into the Harvard/NIAAA Solicitation of Alcohol Company Funding

In a previous post, I noted that I had reviewed materials obtained by the New York Times and shared with me for the article revealing that the NIAAA solicited funding from alcohol companies for the clinical trial of potential benefits of alcohol. A deeper examination of those materials allows me to now reveal that the real purpose of the clinical trial is not to conduct research to answer a question, but to help the alcohol industry sell beer, wine, and liquor by producing newspaper headlines to get doctors to start recommending moderate drinking to their patients.

The document I reviewed is a slide presentation and accompanying summary information apparently intended for a sales pitch to alcohol companies to fund this clinical trial. According to the New York Times: "two prominent scientists and a senior federal health official pitched the project during a presentation at the luxurious Breakers Hotel in Palm Beach, Fla., in 2014." The lead scientist on the "presentation team" was Dr. Kenneth Mukamal, who is now the Principal Investigator of the clinical trial. The senior federal health official on the "presentation team" was Dr. Lorraine Gunzerath, the Senior Advisor to the Director of the NIAAA.

Importantly, according to the New York Times, Dr. Gunzerath stated that this research would not have been conducted without the support of the alcohol companies because "We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly."

Also, according to a previous New York Times article: "Dr. Mukamal, who has published dozens of papers on the health benefits of alcohol consumption, said he was not aware that alcohol companies were supporting the trial financially. “This isn’t anything other than a good old-fashioned N.I.H. trial,” he said. “We have had literally no contact with anyone in the alcohol industry in the planning of this.”"
 
Based on this information, it appears that we already have three areas of misconduct in this research study before the trial itself has even been initiated:

1. The NIAAA violated NIH policy by soliciting funding from the alcohol industry. The NIH policy does not allow institutes to solicit funding. (NIH Policy Manual 1135 [Gifts Administration] - "NIH policy prohibits employees, either directly or through another party, from requesting or suggesting donations to the NIH or to any of its components, of funds or other resources intended to support activities.")

2. The NIAAA also violated NIH policy by accepting funding for a study that would not have been conducted were it not for the alcohol company money. Institutes of the NIH may accept a contribution, but only to conduct research that is either already underway or that would have been conducted even in the absence of that contribution. (NIH Policy Manual 1135 [Gifts Administration] - "the NIH may accept a gift to support a mission-related priority if it is already conducting the activity or is prepared to conduct the activity even without the gift. However, the NIH is precluded from accepting a gift to support an activity that would not be conducted but for the gift and thereby reorders the programmatic priorities of the agency and diverts the use of appropriated dollars from activities with higher priorities.")

3. The trial's principal investigator appears to have lied about not knowing that alcohol companies were supporting the trial and "literally" not having had any contact with alcohol companies.

The Rest of the Story

These facts alone are sufficient to warrant an immediate halt to the clinical trial. But today, I am revealing that the story gets even worse.

The stated purpose of the clinical trial, according to the presentation materials, was not to conduct an impartial investigation into the health effects of moderate drinking, but to produce newspaper headlines that would get doctors to recommend that their patients start drinking. Here is how the primary aim of the research was described:

"The proposed clinical trial is designed to provide doctors with the scientific/medical justification to incorporate a moderate drinking recommendation into their advice to patients."

To execute the sales pitch, the presentation includes a slide entitled "The Ultimate Goal." What is the ultimate goal? The slide shows three newspaper headlines touting the health benefits of an olive oil diet and a Mediterranean diet. Apparently, the ultimate goal is to generate news headlines reporting that moderate drinking is part of a health diet.

In another slide, entitled "The Bottom Line," the presentation again explains that the primary purpose for the study is to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet..."

Yet another slide emphasizes that "What's missing" is "the type of convincing evidence that will show that moderate drinking is: 1) Safe 2) Part of a healthy diet to lower risk of common, important health problems. How do we do that?"

The rest of the story is that beyond even the violation of NIH policies and the ethical breaches committed in the planning of the study, the trial is scientifically compromised from the start because the researchers have essentially promised positive results to the alcohol industry, have demonstrated a substantial bias that undermines the objectivity of the study, and have stated that its purpose is not to answer a research question objectively but to provide the opportunity for newspaper headlines in order to convince doctors to start recommending moderate drinking to their patients.

That's a great sales pitch, and it's no surprise that it worked. If I were running an alcohol company, I would have been in on this marketing investment all the way. That the federal government -- and the nation's leading alcohol research agency to boot -- is offering this marketing opportunity is disillusioning.

Sunday, March 25, 2018

Congressional Investigation Needed into Scientific and Ethical Corruption at NIAAA

I used to think of the National Institutes of Alcohol Abuse and Alcoholism (NIAAA) as a highly-reputed, objective, science-based agency whose primary goal was to reduce alcohol consumption to improve the public’s health. The scientific integrity of the NIAAA is critical, as it describes itself as “the largest funder of alcohol research in the world.” The agency is funded by taxpayers to the tune of $480 million a year.

But then one day, all of that changed. On January 16, 2015, I was called into the office of the Director of NIAAA and was essentially reprimanded for conducting NIAAA-funded research that was detrimental to the alcohol industry. My NIAAA grant was focused on studying alcohol marketing and its possible link to underage youth drinking behavior. We identified the brands of alcohol that underage youth are consuming and found that their brand choices were related to their brand-specific advertising exposure. At the meeting, I was told that I would never again be funded to conduct research on alcohol marketing, regardless of how highly my research proposal was scored by the scientific review panel.

I later found out that the NIAAA director had extensive contact with the alcohol industry and that he promised the Distilled Spirits Council that this type of research would never be funded again: “For the record. This will NOT happen again. … I will NOT be funding this type of work under my tenure.”

Not only had the NIAAA director privately told an alcohol lobbying group that his agency would never fund research on alcohol marketing, but he then went on to participate in the industry’s marketing activities himself by appearing in a promotional video (at 3:17) for Anheuser-Busch InBev, creating the impression that the NIAAA is endorsing the alcohol company and its programs, which is a violation of NIH policy. The true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

Finally, the truth about the relationship between the NIAAA and the alcohol industry has come out. In a New York Times article published last Saturday, Roni Caryn Rabin revealed that the NIAAA actually solicited funding from alcohol companies to conduct a study to demonstrate the “benefits” of alcohol consumption and industry officials were essentially promised positive results.

The Times reported having obtained slides from a presentation by a Harvard researcher to alcohol executives in which he makes a pitch for funding to study the health benefits of alcohol. The NIAAA apparently facilitated the meeting, at which a senior agency official was present. In the slides, the researcher suggests that the study could result in newspaper headlines reporting that alcohol is now part of a healthy diet. Promising positive results before even initiating a study and pitching the study based on its potential economic benefits to the industry violate standards of scientific integrity.

The NIAAA’s solicitation of donations for this research from the alcohol industry was a clear violation of NIH policy, not only because NIH officials are not allowed to solicit donations, but also because they are not allowed to accept funding for a study unless the agency would conduct the research even without the donation. However, a former NIAAA official apparently admitted to telling alcohol industry executives that “the research could not be done without their support.”

The story gets worse. The principal investigator of the study apparently lied about having met with the alcohol industry. In a July 2017 New York Times article, he was quoted as stating: “We have had literally no contact with anyone in the alcohol industry in the planning of this.” However, his name is on a presentation delivered directly to alcohol companies to convince them that they had “a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.”

Apparently, the director of NIAAA was also dishonest, as he appears to have told the New York Times that the NIAAA did not solicit alcohol industry funds. This conflicts with the testimony of at least two high-level NIAAA officials—one of whom was the former director—who admitted that the meetings between NIAAA and the alcohol companies were “to determine if they had interest in taking part” as funders.

In fact, the advisor to the former NIAAA director apparently recognized that studying the benefits of alcohol was not even within the scope of legitimate NIAAA research: “We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly.” This is why it was so essential for the agency to convince the alcohol industry to fund the clinical trial.

The solicitation was successful. The NIAAA is now funding a $100 million clinical trial—largely funded by alcohol companies— designed to demonstrate the health benefits of alcohol, and the principal investigator is the researcher who gave the presentation.

Even if the study were a legitimate use of agency funds, it would still be inappropriate because many of its primary investigators have substantial financial conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial. Thus, the NIAAA also appears to be violating the NIH conflict of interest policy.

Finally, the study itself is misguided and a waste of money. Even if it were to find that moderate drinking can reduce heart disease risk, it would still not be clear that recommending that people who don’t drink start to drink is warranted. Alcohol is a known carcinogen that causes breast cancer even when consumed in extreme moderation. Recommending that people consume a known carcinogen is not something that we do in public health.

In short, the NIAAA is assisting the alcohol industry in a marketing ploy to increase the sales of its products. The research has no scientific integrity and is tainted from the start. Its principal investigator solicited money from the industry and boasted of a positive outcome before the research was even started. Multiple NIH policies have been violated in the planning of the research alone.

That the NIAAA was involved in this corruption is inexcusable. This behavior risks damaging not only the reputation of the alcohol institute, but of the entire NIH. Congress should initiate an investigation immediately to protect the scientific integrity of federal health research. Further, it is imperative that this clinical trial be immediately halted on both scientific and ethical grounds.

Disclosure: I was a recipient of a grant from the NIAAA for a project to study the effects of brand-specific alcohol advertising on youth alcohol brand consumption (R01 020309 – September 20, 2011 through June 30, 2015).

Monday, February 26, 2018

New Study Concludes that Vaping Causes Heart Attacks

A new study presented Saturday at the annual meeting of the Society for Research on Nicotine and Tobacco (SRNT) concludes that vaping causes heart attacks, increasing the heart attack risk for dual users beyond that of smoking alone. The research has not yet been published but was presented as a poster at the conference.

The study was a cross-sectional analysis of nearly 70,000 respondents to the combined 2014 and 2016 National Health Interview Surveys (NHIS), a nationally representative survey of health risk factors and outcomes in U.S. adults. Respondents were asked to report their current vaping and smoking statuses and to report whether they had ever had a heart attack. The researchers found that there was a significant association (odds ratio = 1.8) between daily e-cigarette use and having experienced a heart attack. The analysis controlled for level of current cigarette use.

Based on this observation, the study concludes that daily e-cigarette use doubles the risk of heart attacks.

The Rest of the Story

Hold your horses.

Before accepting the conclusion that vaping causes heart attacks in unsuspecting smokers, remember the old adage: correlation does not equal causation. This study is a perfect demonstration of that phenomenon.

Because this is a cross-sectional study, and because respondents were asked whether they had ever had a heart attack, one cannot determine whether the heart attacks followed e-cigarette use or preceded it. In other words, we do not know that vaping preceded the heart attack for any of the subjects. It is entirely possible that in most of these cases, the smokers suffered a heart attack and then started vaping in an attempt to quit smoking. In fact, I believe that is the most likely explanation for the observed study findings.

It is not even biologically plausible that vaping could increase the risk of cardiovascular disease beyond that of smoking. Why? Because the cardiovascular effects of tobacco smoke saturate at a very low level, meaning that it takes only a little exposure to increase your risk. But beyond that, there is little additional risk.

On the other hand, it is quite plausible that smokers make quit attempts after experiencing a heart attack and that in recent years, these quit attempts have often involved the use of e-cigarettes.

It is true that many of the adverse effects of smoking were first observed in cross-sectional studies. However, these were followed up with longitudinal studies that confirmed the findings. Before we reach a conclusion on whether vaping poses a heart attack risk, we need longitudinal studies. This single cross-sectional study is not enough because there is no way to tell the direction of the observed association between current use of e-cigarettes and having experienced a heart attack in the past.

Although I question the validity of the study's conclusions, it is still important to emphasize that smokers who use e-cigarettes should aim to quit smoking completely. The full health benefits of vaping will not accrue to smokers unless they quit smoking completely. Dual use - if the cigarette consumption drops substantially - will reduce respiratory disease risks, but it will not reduce cardiovascular disease risk because of the saturation phenomenon noted above.

Wednesday, January 24, 2018

WBUR Interview Regarding National Academy of Sciences E-Cigarette Report

Here is the link to an article on WBUR that includes edited excerpts from an interview I did regarding the new National Academy of Sciences report on electronic cigarettes.

National Academy of Sciences Report on Electronic Cigarettes Confirms that Vaping is Much Safer than Smoking and Has No Known Long-Term Health Effects

My commentary on the conclusions and implications of the National Academy of Sciences report on electronic cigarettes was just accepted as an op-ed piece in U.S. News & World Report. I expect it to be published tomorrow. For this reason, I have had to take down the original commentary. However, below I have posted the parts of the original blog post that had to be cut from the op-ed because of length concerns. Also, I will post a link to the op-ed as soon as it appears.

The key findings of the report are:

1. "There is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes."

2. "There is conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes."

3. "There is moderate evidence that risk and severity of dependence are lower for e-cigarettes than combustible tobacco cigarettes."

4. "There is moderate evidence that second-hand exposure to nicotine and particulates is lower from e-cigarettes compared with combustible tobacco cigarettes."

5. "There is no available evidence whether or not e-cigarette use is associated with clinical cardiovascular outcomes (coronary heart disease, stroke, and peripheral artery disease) and subclinical atherosclerosis (carotid intima media-thickness and coronary artery calcification)."

6. "There is insufficient evidence that e-cigarette use is associated with long-term changes in heart rate, blood pressure, and cardiac geometry and function."

7. "There is no available evidence whether or not e-cigarette use is associated with intermediate cancer endpoints in humans. This holds true for comparisons of e-cigarette use compared with combustible tobacco cigarettes and e-cigarette use compared with no use of tobacco products."

8. "There is no available evidence whether or not e-cigarettes cause respiratory diseases in humans."

9. "There is limited evidence for improvement in lung function and respiratory symptoms among adult smokers with asthma who switch to e-cigarettes completely or in part (dual use)."

10. "There is limited evidence for reduction of chronic obstructive pulmonary disease (COPD) exacerbations among adult smokers with COPD who switch to e-cigarettes completely or in part (dual use)."

11. "While the overall evidence from observational trials is mixed, there is moderate evidence from observational studies that more frequent use of e-cigarettes is associated with increased likelihood of cessation."

12. "There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults."

13. "There is conclusive evidence that, other than nicotine, the number, quantity, and characteristics of potentially toxic substances emitted from e-cigarettes is highly variable and depends on product characteristics (including device and e-liquid characteristics) and how the device is operated."

The Rest of the Story

I agree with all of the above conclusions, other than #12, which is not wrong on its face but needs careful interpretation.

Therefore, let me say a few words about conclusion #12 above ("There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults"). It is true that youth who experiment with e-cigarettes are more likely to also experiment with tobacco cigarettes and therefore, to become smokers. It would be shocking if this were not the case because we know that youth who experiment with one risky behavior are more likely to experiment with other risky behaviors. But this doesn't necessarily mean that the experimentation with e-cigarettes is causing the youth to start smoking.

For example, there probably are not many kids who use heroin who have never taken a sip of alcohol. If you did a study, you would find that alcohol use is associated with later use of heroin. But this doesn't support the conclusion that experimenting with alcohol causes kids to become heroin junkies. It simply reflects the fact that kids who take huge health risks are more likely to already have taken smaller health risks. A youth is not going to decide to rebel one day by injecting a drug into their veins. The rebellion process would likely start with a less hazardous behavior, such as taking a toke on a cigarette and then for a very small number of kids, they would end up progressing to hard drug use.

So the important question is not whether youth who experiment with e-cigarettes are more likely to end up smoking (of course they are!), but instead, whether youth who experiment with e-cigarettes are more likely to become addicted to vaping and then be led to smoking addiction, such that without having become addicted to vaping, they unlikely would have become smokers. So far, the evidence suggests that this is not the case: very few youth have been identified who started as nonsmokers, became regular vapers, and then progressed to smoking.

Sunday, January 07, 2018

International Scientific Forum on Alcohol Research (ISFAR) is Still Hiding Conflicts of Interest of Its Members

The International Scientific Forum on Alcohol Research (ISFAR) claims to be "an independent organization of scientists that prepares critiques of emerging research reports on alcohol and health." The Forum describes itself as "an international group of invited physicians and scientists who are specialists in their fields and committed to balanced and well researched analysis regarding alcohol and health." It is "a joint undertaking of Boston University School of Medicine in the United States and Alcohol in Moderation (AIM) of the United Kingdom. Its Co-Directors are R. Curtis Ellison, MD, Professor of Medicine & Public Health, Boston University School of Medicine, and Helena Conibear, Executive Director, Alcohol-in-Moderation (AIM), UK."

The Rest of the Story

About a year and a half ago, I reported that ISFAR was hiding its conflicts of interest with Big Alcohol. At that time, ISFAR published a scathing review of a meta-analysis which concluded that moderate alcohol consumption does not reduce mortality as previously thought. The review contained statements from 14 members of ISFAR, and every one of the 14 blasted the study, with the review concluding that the study "markedly distorts the accumulated scientific evidence on alcohol and CVD [cardiovascular disease]."

It turns out that five of the Forum members who reviewed the article had conflicts of interest by virtue of either their having received research funding from the alcohol industry or serving on advisory boards of alcohol industry-funded organizations, yet none of these conflicts were disclosed.

Not only did ISFAR hide its conflicts of interest with alcohol companies on its web site, but it also hid these conflicts in a public interview.

More recently, one of the Forum members and reviewers was forced to publish a correction to a journal article because he failed to disclose that he is a beer industry consultant.

Has ISFAR reformed itself, and is it now disclosing the conflicts of interests of the reviewers who write its critiques?

The answer, unfortunately, is no.

Nowhere on its website does it list the specific conflicts of interest of its members/reviewers. Nowhere in its critiques does it disclose these conflicts of interest. And to top it all off, the biographies provided for its members do not disclose their conflicts of interest.

For example, Dr. de Gaetano's bibliography fails to disclose that he consults for the beer industry -- the precise conflict of interest for which he was forced to publish a correction in the Journal of the American College of Cardiology.

Dr. Estruth's biography states that he is a member of the Advisory Board for "ERAB." The reader is not told what ERAB stands for, hiding from the public the fact that ERAB is "supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

Ms. Stockley's biography states that she works for the Australian Wine Research Institute, which it states is "an independent, not-for–profit research institution." But it hides the fact that this Institute is funded by the alcohol industry. Far from being independent, the Australian Wine Research Institute is actually the "wine industry’s own research organisation."

Dr. Teissedre's biography fails to disclose that his research group received alcohol industry funding.

Dr. Waterhouse's biography hides the fact that he has received alcohol industry research funding.

Dr. Skovenborg's biography fails to disclose that he was on the Board of ERAB, which is funded by the alcohol industry.

Dr. Mattivi's biography fails to disclose that he has received alcohol industry research funding.

Dr. Klatsky's biography fails to disclose that in the past, he received alcohol industry funding.

Dr. Lanzmann-Petithory's biography fails to disclose that in the past, she has received alcohol funding.

Dr. Gretkowsky's biography fails to disclose that in the past, she has received alcohol funding.

So of the supposedly "independent" and "balanced" reviewers, at least 10 of them have conflicts of interest with the alcohol industry that are not disclosed on the web site, even in their own biographies.

Unfortunately, ISFAR continues to be essentially an industry front group that is providing highly biased reviews without readily disclosing the intricate details of the financial connections of many of its reviewers to the alcohol industry.

They should not fool anybody any longer. The time to end this scam operation is now. Especially in a period in which the federal government has basically tossed scientific objectivity out the window.

Sadly, what ISFAR is doing bears a strong resemblance to the fraudulent public relations activities of the tobacco industry many years ago. 

On a personal note, I feel somewhat ashamed that the Boston University School of Medicine has been playing a role in this scam, as ISFAR has been hosted, in part, by our medical center.

On a larger note, this story illustrates why the alcohol industry-funded NIAAA study of the potential cardiovascular benefits of moderate drinking is so problematic. The background research that informs the study is tainted by serious conflicts of interest. But the worst is yet to come -- as I will reveal shortly, the research is not an objective attempt to get at the answer to this research question.

Tuesday, December 05, 2017

First Major Action of Foundation for a "Smoke-Free World" Shows that It is Largely a Scam

I have already written about why I refused to participate in the activities of the Foundation for a Smoke-Free World, which I believe is essentially a front-group created by Philip Morris International (PMI) primarily to promote its business interests. I explained that if PMI were serious about creating a smoke-free world, it would stop aggressively marketing its deadly products throughout the world and stop opposing public health policies to reduce tobacco use.

The Foundation for a Smoke-Free World recently released a call for research proposals for preliminary projects that entail research to help the Foundation obtain the background information necessary for it to proceed effectively in its supposed mission to create a smoke-free world. By reviewing the call for proposals, we are now able to understand just how the Foundation is essentially a scam operation.

The Foundation calls for “scoping projects” to study strategies to reduce smoking. But nowhere in the five-page document does it mention anything about interventions to: (1) severely restrict or curtail cigarette advertising and marketing; (2) require plain packaging; (3) substantially increase cigarette taxes; (4) promote 100% smoke-free environments; and (5) heavily fund aggressive, state-of-the-art anti-smoking media campaigns.

In fact, the word “industry” appears only once, and it is not clear that marketing, taxation, clean indoor air, or counter-advertising are what the Foundation has in mind (especially since it groups “industry” with “farming”).

In contrast, the Foundation does want to support research on the role of genetics, physiology, individual choices and activities and environmental influences.

Frankly, this is all essentially a waste of time. We already know what interventions are most effective in reducing smoking rates. We don’t need more research to find out what works. What we need to do is to heavily fund programs to promote these tried and true policy strategies.

If the Foundation were serious about wanting to create a smoke-free world, then instead of wasting this money on research into topics like genetics and individual choices and activities, it would use its money to fund programs to implement – worldwide – policies and programs that we know are effective. These are: 1) severely restrict or curtail cigarette advertising and marketing; (2) require plain packaging; (3) substantially increase cigarette taxes; (4) promote 100% smoke-free environments; and (5) heavily fund aggressive, state-of-the-art anti-smoking media campaigns. It would also provide funding to create or supplement tobacco control infrastructure in countries throughout the world and to support the development of grassroots coalitions to promote policies to fight the tobacco industry.

In other words, these are all the programs that the Foundation fails to mention at all in its call for proposals.

Sometimes, what you don’t say is more important than what you do say. That is certainly the case here. The Foundation says nothing about the most effective interventions to reduce smoking, while focusing almost exclusively on areas that have little to no relevance.

You might argue that the Foundation can’t fund programs to promote bans on cigarette marketing, high cigarette taxes, plain packaging, and aggressive anti-smoking media campaigns that attack the industry because it is funded by the tobacco industry. Well … that’s exactly the point. A foundation funded by a large, multinational tobacco company is not in a position to carry out the types of initiatives that are most effective in reducing smoking. This is why I believe the Foundation is essentially a scam operation.

Monday, November 27, 2017

Tobacco Control Researcher Calls for Boycott of Journal, Apparently Because the Editor Supports E-Cigarettes for Harm Reduction

In a comment posted on Dr. Stan Glantz's blog yesterday, Dr. Thomas Eissenberg--a researcher studying electronic cigarettes at Virginia Commonwealth University--called for a boycott of the journal Addiction because of his claim that the editor of the journal exhibited bias in fast-tracking an article that reported low levels of aldehydes in e-cigarette aerosol.

Specifically, Dr. Eissenberg called for researchers to boycott the journal by not submitting articles to it and not reviewing for it "until it has published the means by which it will manage the apparent conflicts of conscience among its editorial staff...". Presumably, Dr. Eissenberg is referring to what he views as a significant conflict of interest of the journal's editor--Dr. Robert West--who he claims violated the peer review process in fast-tracking a 2015 article that defended e-cigarettes against the claim that they expose users to high levels of formaldehyde.

The situation is a bit complex, so let me try to summarize the background as best as I understand it:

In May 2015, Dr. Konstantinos Farsalinos and colleagues published an article in Addiction which reported the results of an experiment showing that e-cigarettes only produce aldehydes (such as formaldehyde, a carcinogen) under dry puff conditions. A dry puff occurs when a vaping device overheats the e-liquid, resulting in an unpleasant taste. Most vapers will discontinue vaping when they experience a dry puff. Therefore, if aldehydes are present only under dry puff conditions, then they do not present a major health concern for vapers.

In September 2015, Dr. Eissenberg--along with Dr. Alan Shihadeh and Soha Talih--published a letter to the editor of Addiction in which they accused him of having a "conflict of conscience" that led to a lack of rigorous peer review and inappropriate fast-tracking of the Farsalinos et al. article. The authors' complaint was two-fold: (1) that the review period was only 11 days, which is uniquely brief for this journal; and (2) that the editor--Dr. West--has a significant conflict of interest because he was once quoted in a newspaper article as (according to Eissenberg et al.) stating that: "E-cigarettes are about as safe as you can get… E-cigarettes are probably about as safe as drinking coffee."

Eissenberg et al. went on to accuse Dr. West of exhibiting bias in handling what they call a "flawed" manuscript: "These statements suggest a potential conflict of conscience in the handling of a flawed report that reinforces Dr West's professed faith in e-cigarette safety...".

Addiction published the extremely long letter by Eissenberg et al. (which itself is unusual), along with a response from Dr. West stating that the accusation is false because he didn't even handle the paper: he designated the review to a different editor. Moreover, the paper went through the same peer review process as any other paper (although it was fast-tracked because of particular urgency of this topic). In fact, the authors went through not one, but two rounds of revisions before the manuscript was accepted for publication.

That is where the story stood until yesterday, when Dr. Eissenberg called for the boycott of the journal, apparently sticking to his accusation against Dr. West despite West's response.

The Rest of the Story

Ironically, while Dr. Eissenberg is accusing Addiction of unscientific and biased actions that threaten scientific integrity, it is actually Dr. Eissenberg's actions here that are inappropriate, biased, and a threat to scientific integrity.

First, Dr. Eissenberg makes a serious accusation against the editor of Addiction without sufficient evidence to justify the claim. He (and his co-authors) provide no substantial evidence that the peer review process was botched, that the Farsalinos et al. article was seriously flawed, or that a severe bias on the part of the editor led to a botched review and acceptance of an article that should not have been published.

As it turns out, Dr. West apparently had no role in the review of the manuscript, so Dr. Eissenberg's accusation was incorrect. Moreover, the paper did go through the normal review process, although in expedited fashion. It is perfectly legitimate for journals to fast-track articles of particular interest, and many journals do that all the time. The article was peer reviewed and the authors were required to respond to reviewer comments twice. Thus, there was nothing qualitatively different about this peer review process from the review of any other paper submitted to the journal. No evidence is provided to support the accusation that the review process was flawed in any way.

Dr. West ended his response by stating: "I hope that this will give them (Eissenberg et al.) pause for thought before making serious accusations about colleagues." I agree. The allegations against the editor and the journal were serious but no evidence was provided to support them. Making an unjustified accusation and then calling for a boycott of the journal based on that unsupported allegation is the threat to scientific integrity in this story.

Second, Eissenberg et al.'s claim that Dr. West has a "conflict of conscience" because he believes e-cigarettes are relatively safe is a perversion of the concept of conflict of interest. In fact, it would be impossible for any journal editor not to have a "conflict of conscience" according to the definition that Dr. Eissenberg and colleagues are asking us to accept. Everyone involved in tobacco control has some personal view on the relative safety of e-cigarettes. The idea that researchers should boycott the journal because the editor has expressed his personal views on the relative safety of e-cigarettes is ludicrous.

Interestingly, in making their accusation that Dr. West has some sort of unusual "conflict of conscience" that would make it inappropriate for the journal to consider papers on e-cigarettes, Eissenberg et al. only quoted a small portion of Dr. West's comments in the newspaper article. I could just have easily accused Dr. West of having a strong personal bias against e-cigarettes by selectively quoting him from the newspaper article as stating:

"This is a danger. Regulators should monitor this."

In fact, Dr. West's views as expressed in the newspaper article appear to me to be balanced and evidence-based. His full comment to the paper explains the scientific reasoning behind his view, which I find quite reasonable:

"We have such a massive opportunity here. It would be a shame to let it slip away by being overly cautious. E-cigarettes are about as safe as you can get. We know about the health risks of nicotine from studies in Sweden into the use of "Snus", a smokeless tobacco. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee. All they contain is water vapour, nicotine and propylene glycol [which is used to help vaporise the liquid nicotine]."

But more to the point, the entire concept of suggesting that researchers boycott a journal based on the scientific views of the journal editor is a dangerous one. It is basically setting up a system where the only journals that survive would be ones whose editors express opinions that are in line with the mainstream scientific opinion. In fact, the very idea that researchers should boycott journals based on the opinions of the journal editor is nonsensical. Should we boycott the journal Tobacco Control because the editor does not personally believe that e-cigarettes are orders of magnitude safer than real cigarettes? Once we start going down that path, we end up challenging the existence of scientific integrity in research reporting.

This is the reason why journals screen for financial conflicts of interest, rather than conduct a McCarthy-like witch hunt to determine whether a researcher may be biased because of opinions they have expressed. Believe me, we don't want to go down that path.

There may be unusual situations in which an editor may have such a personal connection to an issue that it may be appropriate to recuse themselves from review and ask a deputy or assistant editor to handle the review, but that's certainly not true in this case. Here, the review was apparently handed off to a different editor anyway, even though I don't see any reason whatsoever why that would have been necessary.

What is perhaps most ironic about the letter to the editor by Eissenberg et al. is that although they accuse the editor and the journal of a serious conflict of interest, the letter itself fails to disclose an apparent financial conflict of interest of one of its authors. The letter fails to disclose any conflicts of interest among its authors (this link is to the PDF version of the letter which I checked to make sure a disclosure statement wasn't just missing in the online version). Thus, one would assume that none of the authors has any connection to the tobacco industry, such as -- for example -- having received funding from an organization chaired by a tobacco industry executive.

But it appears that Dr. Shihadeh -- the lead author of the letter to the editor -- has failed to disclose that he has, in the past, received funding from an organization chaired by a tobacco industry executive. Dr. Shihadeh is the co-author of several papers that acknowledge funding from the International Development Research Centre, which -- at the time -- was chaired by Barbara McDougall, who was on the Board of Directors of the Imperial Tobacco Company.

In addition, Dr. Eissenberg -- the senior author of the letter to the editor -- also acknowledged having received funding from the same organization, which was at the time chaired by a tobacco company executive.

I find it ironic that the only real conflict of interest in this story is the fact that two of the authors of the letter to the editor have, in the past, received funding from an organization that was chaired by a tobacco industry executive. And that conflict of interest is not disclosed by the authors.

Now, to be very clear, I am not accusing Dr. Shihadeh or Dr. Eissenberg of voluntarily accepting tobacco industry-related funding. They stated that they were unaware, at the time of the funding, that the chair of the organization was a tobacco industry executive. So I'm not blaming them for accepting that funding. However, they were certainly aware in 2015 - when they wrote the letter to the editor - that they had been funded by an organization chaired by a tobacco industry executive. It seems to me that is a fact that should have been disclosed. That lack of disclosure, by the way, stands in contrast to Dr. West's full disclosure of his industry-related funding from pharmaceutical companies and his clear statement that he has never been funded by the tobacco or e-cigarette industries.

The rest of the story is that in my view, Dr. Eissenberg is falsely accusing the journal Addiction of having violated scientific principles of peer review because of a personal bias on the part of the editor. Worse still, he has now called for a boycott of the journal based on these unsupported allegations.

It would truly be a shame if researchers followed this misguided recommendation.

Monday, October 30, 2017

NIAAA Promotes Alcohol Industry Public Relations Program; Violates Ethical Standards by Appearing in Anheuser-Busch Promotional Video

In what I believe is a clear ethics code violation, senior employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) have appeared in an Anheuser-Busch InBev promotional video that is designed primarily to serve the company's public relations interests.

The video was brought to light in an article by Miriam Shuchman at Wired which was published last Thursday.

In the video, Anheuser-Busch InBev boasts to the public about its "Smart Drinking Goals" program, which is purportedly designed to reduce "hazardous" drinking. Several Anheuser-Busch executives-- including its CEO, Chief "Health" Officer, and Chief Legal and Financial Officer--appear in the video, boasting about how wonderful this program is and implying how great a company Anheuser-Busch is for funding this program and how much it cares about the public's health.

But the Anheuser-Busch executives aren't the only ones who appear in this promotional, public relations video.

Shockingly, this Anheuser-Busch PR effort (i.e., public relations effort) is also endorsed and promoted by senior officials of the Executive Branch of the United States government. And even worse, those senior officials are the Director and the Director of Global Alcohol Research of the NIAAA!

The Director of Global Alcohol Research at NIAAA provides a glowing endorsement of the program, describing it as "wonderful" (see 0:27-0:34 in the video). The Director of NIAAA also endorses the program, asserting that it will "go far in moving the field forward" (see 3:17-3:26).

Brilliantly, Anheuser-Busch intersperses promotional statements from its own executives with promotional statements from the NIAAA officials, thus creating a clear endorsement of the program by the NIAAA itself, which is a public relations coup for the company.

The true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

The video is clearly marketing Budweiser and other beers produced by Anheuser-Busch. As the company acknowledges, they are running this international program because they don't just want to be a neighborhood's beer or a country's beer; they want to be the world's beer.

There's nothing wrong with that aspiration. In fact, were I a shareholder, I would be very pleased with this amazing public relations ploy. I would be more than thrilled that the company was able to get the leadership of NIAAA to endorse this effort to make Anheuser-Busch the world's beer. However, there is something very wrong with NIAAA officials appearing in this promotional video and endorsing this marketing ploy.

The Rest of the Story

The rest of the story is that the Director of NIAAA and the Director of Global Research at NIAAA are essentially endorsing a public relations effort of the world's largest beer company by appearing in a promotional video whose true purpose is to expand Budweiser sales so that it becomes the world's beer.

This is entirely inappropriate, as the NIAAA has no business aiding Anheuser-Busch in its marketing efforts. Nor does the NIAAA have any business endorsing a public relations effort, or any other program, of this alcohol company.

Not only does the appearance of the Director of the NIAAA in this video undermine the public health mission of the National Institutes of Health, but in my view, it is a clear ethics violation.

According to Title 5, Chapter 45, Part 5501 of the Code of Federal Regulations--a section known as the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services--no employee of the NIH may:

"Engage in any employment or self-employed business activity that involves the sale or promotion of products or services of a substantially affected organization or a health care provider or insurer, except for the purpose of commercializing invention rights obtained by the employee pursuant to Executive Order 10096, 15 U.S.C. 3710d, or implementing regulations." 

[Section 5501.109 - Prohibited outside activities applicable to employees of the National Institutes of Health - at (c)(1)(iii)].

The appearance of the NIH Director and the NIH Director of Global Research in this Anheuser-Busch InBev promotional video violates this standard because it involves the promotion of a product or service of Anheuser-Busch, which is a substantially affected organization because its profits may be directly impacted by an activity of the NIAAA (namely, the agency's research on the health benefits or risks of alcohol use).

In his defense, the NIAAA director told Wired: "It always surprises me when people are critical of us even talking to industry."

If NIAAA was merely talking to industry, it wouldn't be a problem. But appearing in an Anheuser-Busch promotional video is not merely talking to industry. It is actually promoting and endorsing a company product or service. By doing so, the NIAAA has participated in a marketing ploy of the company. Essentially, NIAAA is helping Anheuser-Busch to market beer and achieve its goal of becoming the world's beer.

In my view, NIAAA has been corrupted by the alcohol industry because it is acting as essentially a marketing branch for Anheuser-Busch. With the promotion of Anheuser-Busch's interests that NIAAA is providing, the company hardly needs its own marketing division. It can simply call the director of NIAAA it's de facto Director of Marketing and Public Relations. The alcohol industry couldn't have a better friend in a higher place.