A Message from Executive Director Ann Woloson

As the health care reform debate continues, policy makers need to remain mindful of the manner in which the pharmaceutical industry continues to prioritize profits over patients. The recent announcement about the $2.3
billion settlement with pharmaceutical giant Pfizer, the largest health care fraud settlement in the Justice Department’s history, represents much more than a wake-up call to the industry. The settlement represents the largest fine ever imposed in a US criminal prosecution. Consumers, prescribers, and policy makers must consider what the settlement means, particularly in the context of health care reform in the effort to improve access to safe and affordable care, including prescription drugs.

Specifics of the settlement are enough to make most of us cringe. The settlement alleges Pfizer promoted the use of several of its drugs for unapproved purposes. It also contends the drug giant paid illegal kickbacks in the form of cash, high-priced dinners, and weekend getaways to induce prescribers to prescribe its drugs. Drugs named in the settlement include Bextra, Geodon, Zyvox, Lyrica, Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec.

While prescribing for an unapproved or “off-label” use is legal and merited in some cases, drug companies are not allowed to promote drugs for such purposes. The industry’s relentless strategy of off-label promotion is shameful, especially when it’s targeted at the most vulnerable patients, including children and the elderly.

The settlement contends, for example, that Pfizer marketed the anti-psychotic drug, Geodon, for a variety of unapproved conditions seen in children and adolescents, including attention deficit disorder, autism, and depression. Studies have linked the drug to significant weight gain and chronic disease, including diabetes. Another drug named in the settlement, Bextra, approved
for osteoarthritis and rheumatoid arthritis, but marketed for acute pain and at dosages not approved by the FDA, was pulled from the market after it was associated with increased risks of heart attack and stroke.

It doesn’t stop there. While the details of the $2.3 billion settlement were still emerging, another Pfizer settlement, totaling $33 million, was announced. This other settlement with 42 states and the District of Columbia was to resolve “state civil consumer protection allegations” regarding past activities relating to the promotion of Geodon. Once again, the drug was marketed for a number
of off-label uses, including pediatric use and at dosages not approved by
the FDA.

Promoting drugs for off-label use and offering monetary or other inducements to prescribers are common industry practices not limited to Pfizer. The constant flow of million-dollar, and now billion-dollar, settlements seem to indicate they are simply factored in as a cost of doing business. These examples highlight the need to focus on prescription drug policy as part of the
larger health care reform debate. As an organization providing objective
research, information and on-the-ground expertise on prescription drug policy, PPC is hard at work doing just that. We continue to promote policies we believe will help improve access to safe and affordable drugs in the US.

This issue of Perspectives offers information on measures being taken to counter dubious drug industry sales strategies. The state of Vermont, for example, passed strong industry gift disclosure legislation this year, serving
as a model for Congress which is contemplating similar legislation at the federal level. PPC’s work to promote evidence-based prescriber education continues, as does our legal work to defend policy at the state level intended to protect prescriber information. For more information and tools to help policy makers and consumers make informed choices about prescription drug policy, feel free to explore our Web site.