Senate Probes Drugmakers Over Painkillers

The US Senate Finance Committee is investigating drugmakers that sell prescription painkillers as well as several patient advocacy groups and various physicians due to "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers." Among the drugmakers is Purdue Pharma, which sells OxyContin. Five years ago, a subsidiary pled guilty to felony misbranding in connection with a scheme to boost sales.

Meanwhile, one of the advocacy groups, the American Pain Foundation, last night posted a notice on its web site that it is dissolving "due to irreparable economic circumstances." The notice says its board voted on May 3 to shutdown thanks to a "significant gap between available financial resources and funds needed to remain operational. Unfortunately, the economic situation has not changed in any meaningful way, despite our best efforts" (here is the notice).

To what extent, if any, the move is tied to the Senate probe is unclear. We left a message for comment. In any event, the group received 90 percent of its $5 million in funding in 2010 from drug and device makers (see page 16 of the annual report here), and guides distributed to patients, journalists and policymakers played down risks associated with opioid painkillers, while exaggerating benefits, according to ProPublica, which first reported the Senate probe.

The Senate probe reflects "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers," according to the letters sent by Chuck Grassley, an Iowa Republican, and Max Baucus, a Democrat from Montana. And they suggest there is growing evidence that drugmakers "may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs' safety and effectiveness."

Besides Purdue, the senators sent letters to Johnson & Johnson and Endo Pharmaceuticals, which markets Opana; the American Pain Foundation, American Academy of Pain Medicine, American Pain Society, Wisconsin Pain & Policy Studies Group, the Center for Practical Bioethics, the Federation of State Medical Boards and The Joint Commission, an independent nonprofit that accredits hospitals, along with academic experts (here is their statement and a link to the letters).

[UPDATE: We would like to note that the Senate probe was propmted, in part, by a series of stories that were undertaken by The Milwaukee Sentinel-Journal and MedPage Today, which peeled the curtain back on the ties between the pharmaceutical industry and the various advocacy groups. You can read some of those stories here, here, here and here].

The debate over prescription painkillers intensifies each year. A 2010 report from the US Centers for Disease Control and Prevention noted that the rise in overdose deaths in the US paralleled a 300 percent increase since 1999 in the sale of prescription painkillers. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. And the misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the CDC (read here).

"I'm very glad the Senate is investigating this issue," Andrew Kolodny, who chairs the psychiatry department at Maimonides Medical Center in New York and heads Physicians for Responsible Opioid Prescribing, tells us. "My concern about the pain organizations is they played a role in bringing on the epidemic of opioid addiction. By exposing relationships between manufacturers and these organizations, it will make it a lot harder for them to lobby and stand in the way of bringing this problem under control.

"If you look at the work of some of these organzations over the past decade, they played a role in encouraging physicians to prescibe these medications overly aggressively. They share blame for a serious public health crisis. And many of them are still saying many of the same things that should be clear are incorrect... And they've worked against efforts to bring the problem under control.

"The best example is the opioid REMS saga. In 2009, FDA announces proposal for a REMS for extended release opoids, and the proposal had elements that might have helped turn things around, such as mandate training for doctors... Industry hated it and worked against incorporating some of the proposals. They used these organizations being investigated and called themselves the Paincare Forum," he continues. "They met with FDA and were able to convince FDA to remove some elements they didn't like...In 2010, advisory panel voted it down because it had no teeth."

A report by the US Government Accountability Office in 2003 pointed out that The Joint Commission partnered with Purdue to distribute pain educational materials nationwide, ProPublica notes. Purdue, by the way, avoided criminal charges by striking a so-called nonprosecution agreement and paying $600 million in fines, and was also allowed to pursue government contracts because its subsidiary pled guilty.

We should note that three former Purdue execs are fighting a court ruling that upheld a decision by the US Department of Health & Human Services to bar them from working for any company that does business with Medicare, Medicaid and other federal health care programs for 12 years. They argue they were innocent third parties, because there was no personal wrongdoing and that excluding them from doing business with federal health care programs was inconsistent with the law (see here).

A Purdue spokesman sent us this statement: "We have received the letter form Chairman Baucus and Senator Grassley and are in the process of reviewing it. We look forward to cooperating with the committee on this matter." We await word from J&J and Endo Pharmaceuticals, and will update you accordingly. [UPDATE: A spokesman for the J&J Janssen unit sends us this: Janssen "is committed to the responsible prescribing and appropriate use of opioid pain medications. For several years, we have developed and supported educational programs, including PrescribeResponsibly.com, LetsTalkPain.com, and SmartMovesSmartChoices.org, which generate awareness about the safe and responsible use of these medicines... We are reviewing the letter from the U.S. Senate Finance Committee and will work with them to fulfill their request for information."]