1 Boring Old Man

If there were any heros in the CNS pharmaceutical industry during the quarter century between the approval of Prozac and the present, I don’t know who they were. In discussing his recent book, Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare, Peter Gøtzsche of the Nordic Cochrane Group says, "I call psychiatry the drug industry’s paradise" and "What I’ve seen in Psychiatry is worse than what I’ve seen anywhere else." And part of that story is the rise of the KOLs – a group of psychiatrists in high places who signed on to the industry written literature, opening access to our academic journals, traveling the country giving paid presentations as a part of an industrial marketing phalanx. While it seems monotonous to keep talking about it, unearthing new examples of what can only be called a betrayal of the public trust, it also feels irresponsible to talk about anything else.

Pfizer Pays $2.3 Billion to Settle Marketing Case

New York Times

By GARDINER HARRIS

September 2, 2009

…Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002. “Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,” said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again. “The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,” she said.

The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra® but also Geodon®, an antipsychotic; Zyvox®, an antibiotic; and Lyrica®, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.

Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin®, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave…

Racketeer Influenced and Corrupt Organizations Act, commonly referred to as the RICO Act or simply RICO, is a United States federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization. The RICO Act focuses specifically on racketeering, and it allows the leaders of a syndicate to be tried for the crimes which they ordered others to do or assisted them, closing a perceived loophole that allowed someone who told a man to, for example, murder, to be exempt from the trial because he did not actually commit the crime personally. RICO was enacted by section 901(a) of the Organized Crime Control Act of 1970 (Pub.L. 91–452, 84 Stat. 922, enacted October 15, 1970). RICO is codified as Chapter 96 of Title 18 of the United States Code, 18 U.S.C. § 1961–1968. Under the close supervision of Senator John Little McClellan, the Chairman of the Committee for which he worked, G. Robert Blakey drafted the "RICO Act," Title IX of the Organized Crime Control Act of 1970, signed into law by Richard M. Nixon.[1]While its original use in the 1970s was to prosecute the Mafia as well as others who were actively engaged in organized crime, its later application has been more widespread.

Supreme Court Rejects Pfizer In Neurontin Off-Label Marketing

Pharmalot

by Ed Silverman

12/10/2013

In a setback to Pfizer, the US Supreme Court has left intact a $142 million award to Kaiser Foundation Health plan for marketing the Neurontin epilepsy drug for unapproved uses [back story]. The court also allowed two other lawsuits – one brought by Aetna, the large insurer, and a class action that was filed on behalf of union health plans and other insurers – to proceed [see this]. The decision opens Pfizer to potentially still more payouts, especially if additional lawsuits are filed by other insurers or health plans that make similar claims. The lawsuits charged that Pfizer engaged in racketeering and induced physicians to prescribe the drug for unapproved uses.

The litigation was prompted after the drugmaker agreed to a $430 million settlement in 2004 with the US Department of Justice to resolve civil and criminal charges for off-label promotion. The illegal promotion stretched from 1995 to 2001, one year after Pfizer acquired Warner-Lambert, which first marketed the treatment, which became a blockbuster seller. In the years before the settlement, off-label sales of Neurontin were lucrative, rising from 15 percent of total sales of the drug in 1994 to 94 percent in 2002, according to court documents. From 1994 to 2002, for instance, Neurontin sales to the US Department of Veterans Affairs jumped from $287 000 to $43.2 million. By then, annual sales had reached $2.3 billion.

In arguing before the Supreme Court, Pfizer insisted a federal appeals court improperly lowered standards for winning a case under the US Racketeer Influenced and Corrupt Organizations Act, or RICO. The drugmaker maintained the court should have required explicit proof that its marketing directly affected the prescriptions issued by individual doctors [read the Pfizer petition here]. Until the appeals court rulings earlier this year, drug makers have regularly succeeded in convincing courts that it is impossible to prove that every physician who prescribed a drug had been influenced to do so by marketing messages. In fact, four other federal appeals courts have not awarded damages to third party payers claiming that they overpaid for drugs that were illegally promoted.

But the appeals court had been swayed by an unusual statistical analysis that showed the illegal promotion did cause economic harm, even though Pfizer correctly noted that no physician in the long-running and massive Neurontin litigation had ever testified that off-label marketing prompted a prescription to be written. Meredith Rosenthal, an associate professor of health economics and policy at the Harvard School of Public Health, had been retained to quantify the effect of the promotional activities on the number of off-label prescriptions written. And in compiling her data on promotional spending, she included Pfizer expenditures on detailing as well as advertising in professional medical journals.

Her analysis found that marketing Neurontin for such unapproved uses as bipolar disorder, neuropathic pain and migraines caused physicians to write 43 million off-label prescriptions and insurers to pay for these between 1995 and 2004, according to court documents in the Kaiser case. As an example, she calculated that 99.4 percent of prescriptions for bipolar disorder were caused by illegal marketing “Her regression analysis found a causal connection between the marketing and the quantity of the prescriptions written for off-label indications,” the appeals panel wrote in the Kaiser decision [read here]. And in the Aetna decision, the panel wrote that “evidence could be found by a reasonable fact finder to show that Pfizer’s marketing … for off-label indications caused a sharp increase in the number of prescriptions that Aetna paid for or reimbursed.”

A Pfizer spokesman sends us this: “While we are disappointed with the Court’s decision denying the petition, the company has strong defenses on the merits in the cases that will now proceed in the lower court. Plaintiffs face significant hurdles before they even reach trial.”