RxP Weekly Reader: Undebatable edition #32
Cold season cautions
On Tuesday, the Consumer Healthcare Products Association announced it would label its combined cough and cold products so as not to be used in children under four, citing health risks from improper use and dosage, reports the Star-Tribune. The move comes a week after the FDA held a hearing and chose not to demand such products be pulled from shelves entirely, citing the need for more review.
Last October, the CHPA voluntarily pulled products labeled for children under two after the filing of a citizen’s petition with the FDA cited a lack of safety and efficacy evidence for such products in children under 12, and a rash of child fatalities and hospitalizations tied to the drugs’ use.
New Neurontin reports paint picture of data spin
This week, new documents in a class action suit around the off-label marketing of Warner-Lambert’s infamous epilepsy drug Neurontin show company officials suppressed studies that found the drug to be ineffective and doctored other data, strengthening the case that when it came to Neurontin, Warner-Lambert’s marketing department was running the show and the science.
The Prescription Access Litigation blog has all the goods – including the full reports by experts – on the latest revelations to come out of the pending class action lawsuit in the U.S. District Court in Massachusetts. In 2004, Pfizer (which acquired Warner-Lambert in 2000) paid $430 million to settle civil and criminal allegations around off-label promotion of Neurontin in the 1990s.
According the PAL blog, “The documents that were recently released were part of “expert reports” submitted by the lawyers for the plaintiffs in the case. The reports both contain and analyze documents from Pfizer about its alleged illegal off-label promotion of Neurontin.”
MedPAC to vote on disclosure recommendations
This month, the Medicare Payment Advisory Commission discussed recommendations that include a federal disclosure law that would require pharmaceutical and device manufacturers to report payments to health care providers, continuing medical education companies, and the like in a publicly accessible database, according to Modern Healthcare. Many of the recommendations being considered mirror the Physician Payments Sunshine Act proposed last year in Congress. MedPAC will vote on the recommendations at its November meeting.
Virtue and Device
Sen. Charles Grassley (R-IA) is pressing Medtronic for more information about its consulting agreements with physicians around a bone graft device called Infuse. According to the Bureau of National Affairs Health Care Daily Report, a letter sent by the Senator to the Minneapolis-based devicemaker recently “asked the company to provide the names of all doctors with whom Medtronic has consulting agreements for the Infuse product, as well as the copy of all consulting agreements and the total amount of the payments.”
Sen. Grassley is also still petitioning the Department of Justice to give him more dirt on two qui tam cases filed against Medtronic in 2002; though the cases were dismissed in 2006 as part of a separate kickback settlement agreement, one is still sealed, and the other’s dismissal has been appealed by the whistleblower. For a taste of the juicy kickback allegations in the sealed complaint, obtained by the Wall Street Journal last month, check out our earlier blog post.
And former U.S. Attorney General John Ashcroft is one of the five appointed compliance monitors working with medical devicemakers to undertake corporate reforms mandated in a deferred prosecution agreement with the federal government in 2007 for (more) settlements over kickbacks to doctors. According to the BNA Health Care Daily Report, Ashcroft told attendees at a health care fraud and compliance forum in Baltimore this week that one of his challenges is “ensuring the plans are not at odds with sales goals.”
“Surely you remember”
The Atlanta Journal-Constitution has a good follow-up story here on exactly how hard officials at Emory tried to get Dr. Charles Nemeroff to disclose his multitudinous industry ties. Last week, Dr. Nemeroff stepped down as chair of Emory’s psychiatry department after a Senate Finance Committee investigation revealed he’d received some $900,000 in undisclosed payments and expense reimbursement by GlaxoSmithKline for giving talks on its psychiatric drugs between 2000 and 2007, even as he was a principal investigator on a National Institutes of Health trial on a GSK drug.
The end of doodads
The Kansas City Star looks this week at the state of industry-physician relations on the eve of PhRMA’s new voluntary code, which will ban its salespeople from bringing docs on their circuit doodads or making dinner reservations for them after January 2009.
“Generally, the pharmaceutical representatives are very good,” AMA trustee Rebecca Patchin told the Star, defending the AMA’s voluntary guidelines of accepting gifts, which are weaker than the industry’s code and many academic medical centers. “They know their products and they provide good information,” Patchin said. “They know their role and physicians know their role.”
See above on Neurontin, Nemeroff, and Medtronic, and assorted devicemakers for proof otherwise.