Can litigation change pharma practices that contribute to opioid epidemic?

Posted on by Corporations and Health Watch

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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:

  1. Blaming the industry for unreasonably interfering with public health by oversaturating the market with drugs and failing to guard against misuse and diversion,
  2. Charging the industry with deceptive marketing that makes false claims about effectiveness and addictiveness,
  3. Accusing the industry for lax monitoring of suspicious opioid orders, a potential violation of the federal Controlled Substance Act,
  4. Asserting that the industry continued to promote opioid use despite mounting evidence lining the product to adverse health outcomes,
  5. 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!

Say it Ain’t So: Supplement Companies Claim Their Vitamins, Minerals, and Herbs Can Help Reduce Opioid-withdrawal Symptoms

Posted on by Corporations and Health Watch

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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.

Growing Drug Industry Influence on FDA

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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.

Complexity and conflicts of interest statements: The Case of Coca Cola

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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 Affordable Medicines Is a Public Health Imperative, Says New Report

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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.”