RxP Weekly Reader #41
Hopkins bans gifts, drug samples
Johns Hopkins has banned some types of gifts, meals and drug samples from pharmaceutical companies, says the WSJ HealthBlog. The policy, which extends not only to the University’s medical school but also to its affiliated hospital and clinics, also prevents consulting payments without legitimate research aims and keeps sales reps out of patient-care areas.
But wait a second, says fellow blogger Dr. Daniel Carlat, PhRMA already bans its own reps from giving the pens and tchotchkes Hopkins put on the do-not-accept list — it’s in the industry’s new voluntary code on Interaction with Healthcare Professionals. And on closer inspection, the meal limits still allow Hopkins faculty members to eat quite well on a drug rep’s dime (and maybe have a sip of his martini), Carlat says.
FDA calls for safety, efficacy tests of risky medical devices
The FDA announced this week that it will require makers of the riskiest class of medical devices, called Class III devices, to prove their products are safe and effective, though a grandfathering system established before 1976 allowed many of them to be marketed and sold without establishing such evidence. The New York Times has more here.
According to the Times, “The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness.”
Sen. Grassley looks into pharma ties of mental health advocacy group
And Sen. Charles Grassley (R-IA) has asked the National Alliance on Mental Illness for information on all funding it receives from pharmaceutical companies or pharma-funded foundations. According to Bloomberg, the group, which calls itself the largest national grassroots organization for those with mental illness, came under fire after 1999 report that it received $11.7 million over 3 years from 18 drug companies, and still has a host of support from high-octane drug makers.
“Destroy them where they live”: email in Vioxx lawsuit reveals company plans to discredit critics
An email from Merck employees released in a federal court in Melbourne, Australia this week reveals a hit list of doctors and researchers who raised questions about the painkiller Vioxx. According to a report in the Australian, the email uses the words “neutralize” and discredit” in reference to those who criticized the blockbuster drug before it was pulled from the market in 2004 for lethal cardiac side effects.
“We may need to seek them out and destroy them where they live,” the email said, according to an excerpt read in court by plaintiff’s attorney.
The email was released as part of a class action lawsuit brought by 1000 Australians who allege they were injured by taking Vioxx between 1999 and 2004.
What DTC, drug labeling does and doesn’t say
The average American watches 16 hours of drug ads on TV each year, reports the Boston Globe in this in-depth look at direct-to-consumer drug ads. The story explores not only the persuasiveness and dangers of the marketing strategy, but a series of proposals from researchers on how to make drug risks and facts clearer in ads and in labeling.
Iowa biotech attacks data-mining bill
The Iowa Biotechnology Association argues in this Des Moines Register column that an Iowa Senate bill to end commercial data-mining would stifle innovation in the state. But the only kind of data-mining that the bill (SF 389) would prevent is marketing: in other words, the use of prescribing records by drug companies to target their sales pitches to doctors – often without the doctor’s knowledge. For more on prescription data-mining, check out our fact sheet.