By David Michaels
The state of Pennsylvania has filed lawsuits against three drug manufacturers, claiming the firms fraudulently marketed antipsychotic drugs. According to Bloomberg News, the state alleges that Eli Lilly & Co. âhid the risks and exaggerated the benefits of its antipsychotic medication Zyprexa while persuading doctors to prescribe it for unapproved uses.â AstraZeneca and Johnson & Johnson’s Janssen Pharmaceutical are accused of doing the same for other drugs:
The defendants cost Pennsylvania’s Medicaid and drug assistance for the elderly program millions of dollars for “reimbursing for non-medically accepted indications and non- medically necessary uses of Zyprexa, Seroquel and Risperdal,” as well as “significant sums of money for the care and treatment” of patients injured by the drugs, the state said in a complaint.
State law suits (Louisiana, West Virginia, Alaska and Mississippi have filed similar suits against Eli Lilly) are an important component of the ongoing saga of the anti-psychotic drugs that cost too much and are more dangerous than their manufacturers like to admit.
For Pump Handle readers who havenât been following the Zyprexa issue, hereâs a very fast summary of some recent developments: In December 2006, the New York Times published a blistering article by reporter Alex Berenson alleging that Lilly withheld from the public information that Zyprexa use increased risk of weight gain and diabetes. The Times article was based on confidential materials released by Dr. David Egilman, who was an expert witness in Zyprexa litigation. Lilly requested that Judge Jack Weinstein order those who have the papers released by Dr. Egilman to return them to the manufacturer and stop disseminating them. Judge Weinstein ruled that Dr. Egilman must return the papers to Eli Lilly, but the jurist made no effort to stop others from disseminating copies of the papers.
At the Project on Scientific Knowledge and Public Policy (SKAPP), weâve been following the controversy about the release of the Zyprexa papers with great interest, since it addresses one of our favorite topics: Sequestered Science. What are the Consequences of Undisclosed Knowledge?
In October, 2004, we held a conference on this topic, and the Sequestered Science papers are published in the latest issue of the prestigious journal Law and Contemporary Problems.
At that meeting, we wrestled with the question of whether courts should allow information vital to protecting the publicâs heath to be hidden from the public as part of a settlement. In many instances, attorneys representing both the plaintiffs and the defendants prefer to seal documents. The defendants may avoid public embarrassment and further suits; the plaintiffs (and their attorneys) get larger monetary awards by agreeing.
The drug maker Lilly has paid $1.2 billion to more than 28,000 individuals who claimed they developed diabetes or other diseases from taking the anti-psychotic drug Zyprexa. The attorneys on both sides, those representing Eli Lilly and those suing the drug manufacturer, agreed to seal the studies and other documents that supported these claims. Does the publicâs right to this information trump the right of the parties to the litigation to secrecy?
Richard Zitrin, the founder of the Center for Applied Legal Ethics at the University of San Francisco, answers my question in a terrific Op Ed in The Los Angeles Times:
From Zomax and Halcion in the 1980s to shredding Firestone tires and GM gas-tank fires in the 1990s, to Vioxx and Zyprexa today, when lawyers cut secret deals behind the public’s back, what we don’t know can and does hurt us. The civil justice system belongs to all of us, and no one should be allowed to use it to keep the public in the dark.
Ironically, we wonât know the full public health impact of Zyprexa unless the information about the settlements is unsealed. Since more than 28,000 claimants received payments from Eli Lilly, it appears to be quite substantial. Since state governments will be far less willing than individual defendants to agree to sealing documents in exchange for better settlements, this new round of litigation is likely to unseal any still secret papers on Zyprexa and the other anti-psychotics.
UPDATE: William Childs at TortsProf Blog has posted “Zyprexa: Pennsylvania Sues and Thoughts on Sequestered Science” in response to this; he raises some important points about how clinical trials registries and adverse event reporting tie into this case.
David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.