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.”
Eleven years ago, writes historian Robert Proctor in The New York Times, a Federal District Court judge in Washington concluded after a nine-month trial that cigarette makers had committed fraud and violated racketeering statutes in a decades-long conspiracy to deceive the public about the dangers of smoking. Judge Gladys Kessler didn’t mince words, ruling that Philip Morris and other tobacco companies had “marketed and sold their lethal product with zeal, with deception, with a single-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted.” This week, newspapers and television networks will begin carrying five “corrective statements” ordered by the court, shown above as printed in The Times. Altria, R. J. Reynolds, Lorillard and Philip Morris will be required to run statements five times a week on weekdays for one year on CBS, NBC and ABC; the statements will also appear in full-page ads on five Sundays between now and March in more than 50 leading newspapers.
Despite the corrective statements, tobacco companies still spend far more money persuading people to smoke than warning of the dangers. And, as Wall Street Journal columnist Jo Craven McGinty noted, “the nation’s 92 million millennials and teenagers may not get the message because the ads will run primarily on network television and newspapers. ‘That’s not where young people’s eyeballs are’, said Robin Koval, CEO and President of Truth Initiative, a nonprofit organization that campaigns against youth smoking.”
Why is the National Rifle Association so powerful? asks The Guardian in an in-depth analysis of the political role of the NRA in resisting efforts to reduce gun violence. Here’s a clue: it’s not (just) about the money. The vast majority of Americans support gun control, and yet Congress has failed to toughen laws even in the wake of a series of mass shootings. With the NRA pouring money into political races at record levels it is an easy argument to make that the gun lobby has bought Washington – but that fails to paint a full picture… “The NRA has money that it uses to help its favored candidates get elected. But the real source of its power, I believe, comes from voters,” said Adam Winkler, professor of constitutional law at the UCLA School of Law and author of Gunfight: The Battle over the Right to Bear Arms in America. By choosing its battles wisely, the NRA has shown an ability to swing primary elections in favor of pro-gun candidates, Winkler said. “That’s the real source of their strength,” he said. That and its use of a relatively small number of highly motivated people to push an agenda that appears out of step with the general population, which, according to recent polling, is in favor of stricter gun laws.
Corporations use a range of strategies to dispute their role in causing public health harms and to limit the scope of effective public health interventions. This study analyzed alcohol, food, soda and gambling industry documents and websites and minutes of reports of relevant health select committees, using standard document analysis methods. Two main framings were identified: (i) these industries argue that aetiology is complex, so individual products cannot be blamed; and (ii) they argue that population health measures are ‘too simple’ to address complex public health problems. However, in this second framing, there are inherent contradictions in how industry used ‘complexity’, as their alternative solutions are generally not, in themselves, complex. Corporate arguments and language may reflect the existence of a cross-industry ‘playbook’, whose use results in the undermining of effective public health policies – in particular the undermining of effective regulation of profitable industry activities that are harmful to the public’s health.
Petticrew M, Katikireddi SV, Knai C, Cassidy R, Maani Hessari N, Thomas J, Weishaar H. ‘Nothing can be done until everything is done': the use of complexity arguments by food, beverage, alcohol and gambling industries. J Epidemiol Community Health. 2017;71(11):1078-1083.