Healthy Skepticism Library item: 17118

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Whalen J
Drug Marketing Remains an Issue
The Wall Street Journal 2010 01 29
http://online.wsj.com/article/SB10001424052748704194504575031122614926414.html?mod=rss_Health

Abstract:

Novartis settlement is the latest in a string of cases amid U.S. government crackdown on industry practices

Full text:

Novartis AG’s agreement to settle criminal allegations involving marketing of an epilepsy drug is the latest in a string
of cases showing that improper marketing practices are still a problem years after the U.S. government started cracking
down on them.

Pfizer Inc. and Eli Lilly & Co. paid big fines and pleaded guilty to illegal marketing of their drugs over the past
year, while AstraZeneca PLC in September reached a preliminary deal to pay $520 million to settle a federal
investigation into its marketing. It declined to say whether it would admit wrongdoing in the final settlement.

This month, the Justice Department charged Johnson & Johnson with paying “tens of millions of dollars in kickbacks” to a
nursing-home pharmacy company to boost sales of J&J drugs. J&J said its conduct was “lawful and appropriate.”

Novartis this week said its U.S. subsidiary struck an agreement with the U.S. Attorney’s Office in Pennsylvania to
settle a criminal investigation of the company’s marketing of the epilepsy drug Trileptal. Novartis agreed to plead
guilty to violating the U.S. Food, Drug and Cosmetic Act, and to pay a $185 million fine. Novartis had already disclosed
that the U.S. Attorney’s Office was investigating allegations that Novartis promoted the drug off-label, and
scrutinizing “payments made to health-care providers in connection with this medicine.” The settlement agreement is
“contingent on court approval,” Novartis said.

It added that it is still negotiating with the investigators “to resolve civil claims relating to Trileptal,” and said
it has set aside $397 million in provisions in connection with the Trileptal investigations. The same investigators are
also probing “potential off-label marketing” and payments to health-care providers involving five other Novartis drugs,
the company said: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. A Novartis spokeswoman declined to comment
further. A spokeswoman for the U.S. Attorney’s Office in Pennsylvania said she couldn’t comment on any investigations.

The U.S. government has been pursuing alleged wrongdoing in drug marketing for well over a decade, attempting to punish
the worst offenders in an industry that racks up sales of more than $300 billion a year in the U.S. But the recent
stream of high-profile cases shows that sales tactics are still an area of concern.

“Combating health care fraud is a top priority of the Department of Justice,” said Tony West, Assistant Attorney General
of the Justice Department’s Civil Division. “When it comes to marketing drugs that so many of us rely on, the government
expects pharmaceutical companies to be honest in the claims they make about the drugs they sell.”

Improper marketing often occurs when drug companies are promoting therapies that are similar to others on the market,
says Patrick Burns, director of communications at Taxpayers Against Fraud, a watchdog group in Washington, D.C. “In that
kind of marketplace, the business isn’t about the drug. It’s about the kickback and it’s about market expansion through
illegal
promotion,” he said.

One of the most common illegal tactics companies use is “off-label” marketing, when sales reps encourage doctors to
prescribe drugs for uses for which they aren’t approved by the Food and Drug Administration. Doctors themselves are
allowed to prescribe drugs any way they see fit, but the law says companies can’t promote them for unapproved uses.

The government has also accused companies of making payments to doctors to get them to prescribe certain drugs, both on
and off-label. These payments can take several forms that are often legitimate, including consulting fees and research
grants. Corporate whistleblowers often draw the government’s attention to alleged wrongdoing, sparking federal
investigations.

The industry’s main trade group in the U.S.-the Pharmaceutical Research and Manufacturers of America, or PhRMA-says it
is important for drug companies to be able to compensate doctors for legitimate advice and research that supports drug
development and medical practice. The group’s code of conduct says companies “should continue to ensure” that these
payments “are neither inducements nor rewards for prescribing or recommending a particular medicine or course of
treatment.” A PhRMA spokeswoman said she couldn’t comment on specific investigations facing certain companies. Some drug
companies have taken steps to make their relationships with doctors more transparent. GlaxoSmithKline PLC, for example,
recently began capping its annual payments to U.S. doctors at $150,000 and publishing the figures.

Glaxo had previously disclosed that federal investigators were probing its marketing of nine drugs between 1997 and
2004, including scrutinizing its financial relationships with health-care providers.

In a recent interview, David Brennan, chief executive of AstraZeneca, said government fines have made drug companies
“more sensitive than we’ve ever been” about preventing illegal promotion of drugs.

But Shelley Slade, a former Justice Department lawyer who now represents corporate whistleblowers through the firm
Vogel, Slade & Goldstein LLP, in Washington, D.C., said large criminal monetary penalties and civil settlements don’t
appear to deter companies sufficiently. “It’s not going to stop until the government puts some of these executives in
jail,” she said. “Many of these companies view the fines as a small fraction of what they have gained through illegal
schemes, and just a cost of doing business.”