Excessive alcohol consumption contributes to an average of 4,350 deaths among people under age 21 each year, and is associated with many other health risk behaviors, including smoking, physical fighting, and high-risk sexual activity. At least 25 longitudinal studies affirmed that youth exposure to alcohol advertising is associated with the initiation of alcohol consumption by youth, the amount of alcohol consumed per drinking occasion, and adverse health consequences. A new report by the Center on Alcohol Marketing and Youth at the Johns Hopkins School of Public Health examined non-compliant alcohol advertising exposure on cable TV that aired in 2015 and 2016. The report identified 25 alcohol brands that were responsible for the largest amount of non-compliant alcohol advertising exposure, and assessed the brand-specific distribution of non-compliant exposure using no-buy list criteria. The report also identified 25 programs and network-dayparts that were responsible for the largest amount of non-compliant alcohol advertising exposure. The study found that in the 2-year period, about 1 in 13 alcohol advertising impressions viewed on cable TV by youth under the legal drinking age did not comply with the alcohol industry’s voluntary placement guideline. This resulted in 2.5 billion non-compliant underage impressions during these two years. Youth exposure to alcohol advertising has been associated with the initiation of underage drinking, consuming a larger amount of alcohol, and adverse health and social problems. Reducing this exposure is an important priority for the prevention of alcohol consumption and alcohol-related harms among youth.
Dr. Derek Yach at the launch of the Foundation for a Tobacco Free World credit
Last September, Phillip Morris International , which calls itself the “world’s most successful cigarette company”, announced that beginning in 2018, it would contribute about US$80 million annually over the next 12 years to create the Foundation for a Smoke-Free World with the goal of accelerating “progress in reducing harm and deaths from smoking worldwide.” Derek Yach, whose credits include serving as a key architect of the WHO’s Framework Convention on Tobacco Control and a stint as Senior Vice President for Global Health and Agriculture Policy at PepsiCo, was hired to serve as President of the new foundation.
Within the public health and tobacco control community reaction to the new foundation has been divided—mostly negative.
Writing in The Wire, an independent news platform based in India, Anoo Bhuyan summarized some of the reactions:
Philip Morris International is attempting to distribute nearly $1 billion for research on reducing smoking. But the grant is being called a “billion dollar bribe” of “blood money,” a “wolf in sheep’s clothing,” a “smokescreen,” a “public relations stunt” and the “height of hypocrisy.” The American Cancer Society has even called it a “new twist out of the tobacco industry’s deadly playbook”, while the World Heart Federation says it is a “vehicle for the tobacco industry.” One anti-smoking group said “the tobacco epidemic will never be ended by its perpetrators.” Another found it so unbelievable they said it “truly sounds like fake news.”
A number of top universities in the US and UK have said they will not be accepting this research funding as it clashes with their ethics policies. Columbia University remained non-committal on the issue. However, one scholar at Harvard’s prestigious T.H. Chan School of Public Health told The Wire that they are “discussing” if it violates their 15-year-old policy of rejecting funding from the tobacco industry. He added, however, that the university’s ban on tobacco industry funds remained firmly in place.
In a blog for the British Medical Journal, Richard Smith, who served as editor of that journal until 2004, offered a different opinion:
There is a logic to Yach’s move. It will probably never be possible to achieve a nicotine-free world, not least because people with severe mental health problems find benefit from nicotine…. But with the arrival of e-cigarettes it may be possible to achieve a tobacco-free world. E-cigarettes might be harmful, but even the most ardent anti-tobacco campaigner would agree that it’s the smoke not the nicotine that kills. The appearance of e-cigarettes is changing the world of tobacco as railways changed canals and digital images changed film. How should tobacco companies react? …Philip Morris International seems to have bet that e-cigarettes will be the future, and so there is business logic to funding a Foundation for a Smoke-Free world. Unfortunately, there is also a business logic to continuing to block attempts to reduce cigarette consumption in markets where e-cigarettes have yet to make inroads.
This two-faced attitude will seem unacceptable to many, but if the foundation can achieve real independence from the company then much can be achieved with $1 billion. Many foundations have little or no independence from their companies, but I believe that it is possible to achieve true independence with the right governance—at least if the money is committed for 12 years.
The debate about BMI’s billion dollar investment mirrors a larger dispute about e-cigarettes and the future of the tobacco/nicotine industry and of tobacco/nicotine control. A few recent reports illustrate the scope of the conflict.
In a special report on Philip Morris research on e-cigarettes, Reuters questioned the quality of the research PMI has sponsored to justify its new smoking devices to the US Food and Drug Administration and other regulatory agencies.
Tamara Koval, who worked at the company from 2012 to 2014 and helped coordinate clinical trials for the device, questioned the quality of some of the researchers and sites contracted to carry out those experiments. Koval was a co-author of the company’s protocol used to run the studies globally. When she highlighted an irregularity in one of the studies, Koval said, Philip Morris excluded her from meetings.
Reuters also found irregularities during interviews with some of the principal investigators contracted to conduct the trials for the company. One principal investigator said he knew nothing about tobacco. Philip Morris had to jettison the experiment that investigator performed after it emerged he hadn’t followed a basic procedure for obtaining informed consent from participants during clinical trials.
The allegations raise questions as to whether despite its new foundation, PMI is following its old strategy of distorting science to achieve its business goals. David Kessler, a former FDA commissioner told Reuters, “taken as a whole, it’s clear they do not have the sophistication to carry out adequate and well-controlled clinical trials.”
The conflicts about PMI and e-cigarettes also raise larger questions for the public health community:
- What might be the consequences of creating corporate sponsored research foundations at the same time as the federal government is cutting public health regulations and the agencies that support them?
- How will private corporate-sponsored philanthropy influence government decisions about public research funding?
- What effect will corporate -sponsored research foundations—however rigorous and independent their research—have on public trust of science and scientists?
As tobacco control activists debate the specific questions of how to respond to PMI’s new Foundation for a Smoke-Free World, it is important to also pay attention to the longer-term consequences of corporate funding for public health research.
Corporations and Health Watch
As journalistic and legislative scrutiny of the role of the pharmaceutical industry in the opioid epidemic continues, several new reports focus on the potential of litigation to curb Big Pharma abuses.
In The New England Journal of Medicine, Rebecca Haffajee and Michelle Mello, two public health lawyers, examine drug companies’ liability for the opioid epidemic. They describe five legal rationales for litigation against opioid makers and distributors that federal and state government agencies have used:
- Blaming the industry for unreasonably interfering with public health by oversaturating the market with drugs and failing to guard against misuse and diversion,
- Charging the industry with deceptive marketing that makes false claims about effectiveness and addictiveness,
- Accusing the industry for lax monitoring of suspicious opioid orders, a potential violation of the federal Controlled Substance Act,
- Asserting that the industry continued to promote opioid use despite mounting evidence lining the product to adverse health outcomes,
- Alleging that the industry accrued profits at the government’s expense through unfair business practices.
The authors outline some of the challenges facing litigation against opioid manufacturers but conclude that “litigation could help alleviate the opioid epidemic by changing industry practices and building public awareness.”
In an Oklahoma lawsuit recently described in The New York Times, a lawyer is using the Cherokee Nation tribal court to sue Walmart, Walgreens and CVS Health, as well as McKesson and other major drug distributors, for violating federal drug monitoring laws(reason 3 above) and enabling prescription opioids to flood into the Cherokee nation. “I believe these companies target populations” Todd Hembree, the Cherokee Nation attorney general, told The New York Times. “They know Native Americans have higher rates of addiction. So when they direct their product here, they shouldn’t be surprised to find themselves in a Cherokee court.”
The Washington Post and 60 Minutes investigated the failure of the U.S. Department of Justice to follow the recommendation of a Drug Enforcement Agency task force working across 11 states to revoke registrations to distribute controlled substances at some of the 30 drug warehouses of The McKesson Corporation, the nation’s largest drug company. The DEA team wanted to fine the company more than $1 billion and bring the first criminal case against a drug distribution company. Instead, reports The Post, “top attorneys at the DEA and the Justice Department struck a deal earlier this year with the corporation and its powerful lawyers, an agreement that was far more lenient than the field division wanted…. Although the agents and investigators said they had plenty of evidence and wanted criminal charges, they were unable to convince the U.S. attorney in Denver that they had enough to bring a case.”
Note to Corporations and Health Watch readers: Our next post will be on January 3,2018. Happy New Year!
In letters to the Food and Drug Administration and the Federal Trade Commission, Center for Science in the Public Interest reported that its tests of eight products marketed online as addressing the symptoms of opioid withdrawal showed the as were “riddled with pseudo-scientific jargon and frighteningly ill-informed.” CSPI urged the FDA to issue immediate warning letters and bring enforcement action that required “cessation of these sales and other such products and allow inspectors to seize products.” It also asked the two agencies to work together to ensure that these companies will not be able to mislead consumers and profit from bogus claims.
Has the growing reliance of the U.S. Food and Drug Administration on industry user fees changed how the pharmaceutical and medical device industries influence FDA regulation? A review in The New England Journal of Medicine charts changing industry influence from the Prescription Drug User Fee Act (PDUFA)of 1992 to the recent sixth re-authorization of PDUFA by President Trump this year. The authors conclude that although 25 years of industry funding have shortened regulatory timelines, the user-fee model has fundamentally changed the way the FDA interacts with the drug industry. These changes may increase the risk that unsafe or ineffective drugs or medical devices enter the market.
Statements on conflicts of interest provide important information for readers of scientific papers, write David Stuckler, Gary Ruskin and Martin McKee in the Journal of Public Health Policy in a case study of emails exchanged between Coca-Cola and the principal investigators of the International Study of Childhood Obesity, Lifestyle and the Environment. There is now compelling evidence from several fields that papers reporting funding from organizations that have an interest in the results often generate different findings from those that do not report such funding. The authors describe the findings of an analysis of correspondence between representatives of a major soft drinks company and scientists researching childhood obesity. Although the studies report no influence by the funder, the correspondence describes detailed exchanges on the study design, presentation of results and acknowledgement of funding. This raises important questions about the meaning of standard statements on conflicts of interest.
Consumer access to effective and affordable medicines is an imperative for public health, social equity, and economic development, but this need is not being served adequately by the biopharmaceutical sector, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report offers recommendations to improve the affordability of prescription drugs without discouraging the development of new and more effective drugs for the future. “Over the past several decades, the biopharmaceutical sector in the United States has been successful in developing and delivering effective drugs for improving health and fighting disease, and many medical conditions that were long deemed untreatable can now be cured or managed effectively,” said Norman Augustine, chair of the committee that conducted the study and wrote the report. “However, high and increasing costs of prescription drugs coupled with the broader trends in overall medical expenditures … are unsustainable to society as a whole. Our report seeks to address the market failures that currently permeate the biopharmaceutical sector, such as lack of competition due to distortions in the application of the patent protection process, the imbalance between the negotiating power of suppliers and purchasers, and the convoluted structure of the supply chain. Although changes within the current system will be demanding, they are likely to better serve the nation.”