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.