The PharmaCertify™ Team

Can you believe it is mid-May already? It’s the time of year for weekly release of blockbuster films. Last week’s contribution, Avengers, broke all box office records and we’re just one week in to the summer movie season. However, there is a bit of business to which we must attend before we head out the door to wait in line for this weekend’s premieres: this week’s News Week in Review. It promises to thrill, chill and offer laughs a plenty. All you could want, right? Lights… electrons…read!

The blockbuster news item of the week was the announcement of the federal government’s settlement with Abbott for $1.5 billion, to resolve a criminal and civil investigation into the illegal promotion of the drug, Depakote. The company pleaded guilty to a misdemeanor of misbranding the drug under the FDCA and paid $700 million in criminal fines and forfeiture. According to the government, Abbott promoted the drug for the off-label uses of treating aggression and agitation in dementia patients and for schizophrenia. The drug is approved to treat epileptic seizures, bipolar mania and migraines. Additionally, the company agreed to pay $800 million in civil fines for alleged violations of the False Claims Act and the Anti-kickback Statute. Of the $800 million, about $240 million will go to the states. The whistleblowers in the case will share an $84 million dollar payout, which is the second highest FCA-related payout since the law was revised in 1986.

Like any good blockbuster, there must be a sequel. And in the case of the Abbott settlement it was the litany of stories released from the Attorney Generals’ offices in the states receiving a piece of the settlement. So for your entertainment here’s just a preview of Settlement II, the States Strike Back: Tennessee, Arkansas, Oregon, Iowa and Rhode Island.

What would the summer movie season be without a story of corporate and government intrigue?  A House of Representatives committee widened its investigation into the deal struck between the West Wing and the pharma industry to support the administration’s healthcare reform efforts. Initially, the Republicans on the House Energy and Commerce committee contacted an industry trade group demanding to see documents related to the deal. When that failed, the committee went to drug companies directly to demand documents about the negotiations. At first, the group targeted Pfizer, but the inquiry has widened to include other companies like AstraZeneca, Amgen and Merck.

This week, the Senate green lighted an investigation into the relationship between manufacturers of narcotic pain meds and patient pain advocacy groups. The senate panel is interested in records about the links, financial and otherwise, between the industry and the groups that advocate the use of their products. The panel requested payment information for the past ten years from three drug manufacturers, five patient pain groups, the Joint Commission and the Federation of State Medical Boards. The interest in the relationship comes amid a growing concern about the overprescribing and abuse of narcotic pain killers. Media reports suggest the industry may be responsible, in part, for misuse due to the misrepresentation of the benefits and dangers of the drugs.

A happy ending appears to be on the horizon for the credibility of journal articles on industry sponsored clinical research.  A group representing industry and publishers made 10 recommendations for closing the credibility gap in reports of industry sponsored clinical research. The group says authors and publishers need to employ best practices and clearly communicate the standards and requirements of the studies in order to enhance transparency and credibility. A professor at York University in Canada claims that while the recommendations are a good start, they may have no affect on the problem. Citing non-emphatic language, and some weak recommendations, the professor said there is evidence to show a study funded by industry is more likely to have a positive outcome for the company sponsoring the study. He recommends clinicians consider this bias before applying the study results in their work.

Well we’re about to call it a wrap on this edition of the News Week in Review and this work week. But no blockbuster would be complete without some shameless product placement, so here it is: this week’s top story demonstrates that off-label promotion remains a crucial remains a focus for investigation. Pharmacertify offers a series of customizable off-the-shelf training modules and iPad apps to help integrate an awareness of on-label promotional policies into your staffs’ consciousness. You can learn more and even see a “trailer” at www.pharmacertify.com.

That’s a wrap folks! Cut, check the gate, print, weekend!