Tag Archives: off-label prescription

Antipsychotic use booms among Canadian kids

Writing for The Vancouver Sun and Postmedia News, Sharon Kirkey and Pamela Fayerman, report that, in an environment where the rate at which physicians are recommending certain antipsychotics for children has doubled since 2006, a local children’s hospital has launched what the reporters call “the world’s first clinic to help children cope with the side effects of such medications.

The clinic, which helps children and their parents prepare for antipsychotic use or cope with its side effects, opened in April and has a four-week waiting list.

(Dr. Jana Davidson, a child and adolescent psychiatrist who helped establish the specialized clinic) said she helped create the clinic because of her increasing alarm over the side effects of treatment in her patients. While she believes the medications are sometimes prescribed inappropriately, they are often useful for a range of disorders including severe aggression, mania in bipolar disorder and schizophrenia. But the side effects can be serious.

“I would see kids with psychosis in the emergency department and then I would see them again 10 months later and they would be 30 to 50 pounds heavier,” she said.

Despite sometimes serious neurological side effects, more Canadian families are turning to the drugs and antipsychotic drug recommendations for youth jumped 114 percent in Canada from 2005 to 2009.

The drugs — which have not been approved in Canada for use in children under 18 — are being used for attention-deficit/hyperactivity disorder, conduct disorders, irritability related to autism, mood disorders, physical or verbal aggression and other behavioural problems.

Drug-funded research group failed to disclose ties to makers of painkillers

In his latest conflict of interest investigation, Milwaukee Journal Sentinel reporter John Fauber takes on a challenge that, even by his standards, is an ambitious one.

Photo by somegeekintn via Flickr.

He attempts to show the effect pharmaceutical money and the local researchers who received it had on national opinions toward powerful prescription painkillers and how it all influenced the American epidemic of opiate abuse.

He focuses on the University of Wisconsin Pain and Policy Studies Group, which has received millions from painkiller manufacturers while publishing drug-friendly research and warning against increased regulation of OxyContin and its ilk. Many of these millions, Fauber found, appear not to have been disclosed in relevant publications even as the group was paving the way for the rapid rise of painkiller prescriptions in America.

The drugs had initially been approved for a very narrow range of uses, but became extremely popular as off-label use for the management of chronic pain spread like wildfire. It’s not easy to draw clean lines between the Wisconsin group and off-label use, but Fauber’s deft investigative work and careful sourcing make a strong case.


Read more of Fauber’s work

Feds take aim at off-label marketing

The Wall Street Journal‘s Jeanne Whalen writes that a recent string of charges against drug companies, including heavyweights like Pfizer, Eli Lilly, AstraZeneca, Johnson & Johnson and Novartis, shows that a decade of aggressive prosecution hasn’t deterred them from some shady marketing practices. [Article require subscriber access]

Whalen says the promotion of off-label prescriptions is still at the core of the most common offenses, and that, according to says Patrick Burns, director of communications at Taxpayers Against Fraud, problems are most likely to crop up “when drug companies are promoting therapies that are similar to others on the market.”

Photo by somegeekintn via Flickr.

Whalen reports that the Justice Department, which often relies on corporate whistleblowers to spark investigations in this arena, has made such cases a priority.

“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

Drug companies have apparently taken notice. GlaxoSmithKline recently started “capping its annual payments to U.S. doctors at $150,000 and publishing the figures” while AstraZeneca’s CEO said the crackdown had made pharmaceutical companies “more sensitive than we’ve ever been” when it comes to preventing illegal drug promotion. Whalen writes that these steps may not be enough.

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.”

How marketing turned Zyprexa into blockbuster

Ben Wallace-Wells of Rolling Stone uses the story of the rise of Zyprexa, Eli Lilly’s blockbuster schizophrenia treatment, to look into the marketing of medication, the history of anti-psychotic drugs and the ability of the FDA to serve as an effective watchdog without the resources to conduct independent trials. The magazine also provides an interview, in which Wallace-Wells tells a little more about the reporting that went into the extensive report and the conclusions he’d drawn from his research.

Eli Lilly staked its future on Zyprexa, even though it had been shown to cause dangerous side-effects like excessive weight gain and was only approved for the treatment of schizophrenia. The total market for the treatment of schizophrenia and related illnesses sits in the tens and hundreds of millions of dollars. Through off-label prescriptions, careful manipulation of government regulation and aggressive marketing emphasizing the drug’s novelty, Lilly eventually sold more than $4 billion worth of Zyprexa annually.

“The goal for sales reps, according to Lilly’s strategy document, was to ‘expand the market of Zyprexa by redefining how primary-care physicians help reduce mood, thought and behavioral disturbances.'”