On May 13, 2004, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin (gabapentin) that violated state consumer protection laws. Among other things, the settlement provides for a $21 million Consumer and Prescriber Education grant program to be administered by a Special Committee of State Attorneys General pursuant to an Oregon Court Order and an Attorney General Memorandum of Understanding.
The Attorney General Consumer and Prescriber Grant Program (CPGP) is directed and overseen by a Special Committee of Attorneys General (or their authorized designees) that are comprised of the Neurontin Executive Committee (Florida, New York, Ohio, Oregon, Texas and Vermont) and two Attorneys General (or their authorized designees) from the remaining members of the lawsuit which are selected on a biannual rotating basis. All decisions on funding and administration of the Program rest with the Special Committee.
CPGP funds programs designed to provide health care professionals and consumers unbiased information relating to prescription drugs. Grants have been made in two major rounds. The first, focusing on prescriber education, resulted in nearly 30 projects being funded. The second, focusing on consumer education, has led to the award of a $4.4 million grant to Consumers Union in April 2008 to fund a public education campaign on prescription drug awareness.
A Critical Comment on Sponsorship
David Cohen, Ph.D., Principal Investigator, CriticalThinkRx
State-initiated litigation against pharmaceutical companies aims to punish these firms for deceptive promotion of prescription drugs that violate state consumer protection and fair trade laws. It also aims to recover the expenses states incur for physicians’ prescriptions of the illegally promoted drugs and for associated health care costs covered by states’ publicly funded health programs such as Medicaid. While these goals are reasonable and even laudable, they only focus on the “supply” and not the “demand” side of the problem.
Consider the following: Concerns about off-label prescriptions of atypical antipsychotics to youths have been repeatedly voiced in the most prestigious American medical journals since at least 2000. In the majority of cases it appears that these prescriptions conform to no established ethical or medical principles of care, and it is certain that some youths who receive these drugs and unstudied drug combinations will suffer serious harm and will require hospitalizations and prolonged additional care. Some will die. Moreover, Medicaid programs track precisely such prescriptions and can identify exactly which physicians are writing them, to which patients, and in combination with which other drugs.
Yet, as these lines are written in June 2008, doctors throughout the United States are prescribing antipsychotics off-label to children and adolescents, and their states’ Medicaid programs are dutifully reimbursing these services and products. This is apparently because the Centers for Medicare and Medicaid Services, the federal agency which administers the various partially federally-funded State health programs, mandates that all state Medicaid programs cover antipsychotic medications.
On March 11, 2008, Connecticut Attorney General Richard Blumenthal filed a lawsuit against Eli Lilly and Company for illegally marketing Zyprexa and concealing some of its severe risks for more than a decade, and for “fraudulently inducing” physicians to write prescriptions for Zyprexa. The 62-page complaint, which should be required reading for all practitioners, parents, and policymakers, is available at: http://www.ct.gov/ag/lib/ag/health/elililly-zyprexa.pdf
In the accompanying press release, Mr. Blumenthal summarized the charges:
"The illegal marketing campaign exploited children and senior citizens—causing severe weight gain, diabetes and cardiovascular problems. This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects.”
However, to be consistent in their wish to protect consumers for deception and injury resulting from illegal drug marketing strategies, states should pursue at least a three-pronged strategy:
1) they should sue drug makers for their violations of state consumer laws and their racketeering activities,
2) they should lobby federal officials at the Centers for Medicare and Medicaid to amend regulations concerning the unrestricted funding of off-label prescriptions for psychotropics, and
3) they should refuse to reimburse off-label prescriptions through their own publicly-funded programs like fee-for-service Medicaid, even at the risk of incurring sanctions, which would probably be inferior to the sums states subsequently seek to recover from drugmakers through litigation. (Many other initiatives to encourage rational prescriptions by physicians and to track the genuine health effects of off-label prescriptions of antipsychotics on children and the elderly could be undertaken, for a very small fraction of these sums.)
Unless such a comprehensive strategy is actively and urgently pursued, the sort of lawsuits that have funded projects like CriticalThinkRx may be analogized to the practice of enforcing laws against prostitution by prosecuting prostitutes, but leaving their clients alone.