Just about every segment of the medical community is piling on the pharmaceutical industry these days, accusing drugmakers of deceiving the public, manipulating doctors and putting profits before patients.
Recent articles and editorials in major medical journals blast the industry. Medical schools, teaching hospitals and physician groups are changing rules to limit the influence of pharmaceutical sales reps. And three top editors of the prestigious New England Journal of Medicine last month publicly sided against the drug industry in a U.S. Supreme Court case over whether patients harmed by government-approved medicines may still sue in state courts.
As more voices have called for change, new guidelines for how drugmakers and doctors should interact are coming from all sides, and doctors say some abuses of the past have ended. But the industries’ dealings remain fraught with potential conflict because the sectors depend on each other so much – medicine on drugmakers’ research dollars and drugmakers on the credibility researchers give them.
“The influence that the pharmaceutical companies, the for-profits, are having on every aspect of medicine … is so blatant now you’d have to be deaf, blind and dumb not to see it,” said Journal of the American Medical Association editor Dr. Catherine DeAngelis, a longtime industry critic. “We have just allowed them to take over, and it’s our fault, the whole medical community.”
In an April editorial in her journal, DeAngelis noted two studies indicated past reports about Merck & Co.’s withdrawn pain reliever Vioxx frequently were penned by ghostwriters and that reports on some Vioxx studies minimized the risk of death. Merck has denied the charges. “Manipulation of studies and publications by the pharmaceutical and medical device industries is either increasing or there has been more exposure of these practices,” she wrote.
She said industry influence includes swaying doctors and medical students to their brands with gifts, funding research at top teaching hospitals but keeping control of the studies and results, failing to disclose study authors’ conflicts of interest, even taking over the continuing medical education system for doctors by running courses on new treatments. Critics say such courses are taught by company-paid speakers who often promote expensive new drugs over older, cheaper ones.
“We should all get together and say, ‘Enough!”‘ DeAngelis said.
Already, top journals are listing study authors’ conflicts of interest, and dozens of medical schools and medical specialty societies are barring gifts to doctors and limiting their other financial ties to industry. Some schools bar professors from being paid drug company speakers. And one expert noted drugmakers have stopped giving cash prizes to medical students for presenting favorable research on their drugs at conferences.
Still, no one is suggesting anything as drastic as cutting off industry funding for academic research on new drugs. Those billions help pay lab and other expenses at virtually all U.S. teaching hospitals, medical schools and affiliated practices, while giving the drugs’ developers the cachet of having big-name academic researchers running their studies.
The industry’s trade group, in an apparent response, in July revised its 2002 “Code on Interactions with Health-care Professionals” to ban giving out pens, mugs and other noneducational gifts, taking doctors to restaurants and giving them tickets for shows or sports events. Bringing meals to their offices and donating anatomical models and textbooks will still be allowed when the voluntary code takes effect in January.
“America’s pharmaceutical companies devote many years and billions of dollars to researching and developing life-saving medicines,” and help drive progress and economic growth, said Diane Bieri, general counsel for Pharmaceutical Research and Manufacturers of America. “We will always face criticism and at times deserve it but our companies remain committed to listening to and learning from parties with divergent points of views.”
Hollie Gilroy, spokeswoman for the HealthCare Institute of New Jersey, a trade group including many top drugmakers, said the industry is an easy target, but criticisms about gifts to doctors, beyond logo-bearing pens and similar items, are either outdated or exaggerated. She said the industry is quick to police itself and tries to keep high ethical standards when dealing with health-care professionals.
“There is no industry far and away that has been more generous than the pharmaceutical industry,” Gilroy added, noting companies give away medication samples, fund large prescription assistance programs for the poor, have helped African countries get AIDS medications, and donate drugs and medical supplies after major disasters.
But pharmaceutical analyst Steve Brozak of WBB Securities said drugmakers will find ways to adapt to new rules.
“The earlier you can hook one of these doctors, the more loyal they are” to a brand, Brozak said.
Medical groups have been fighting industry influence harder since a 2006 JAMA editorial by 11 prominent doctors urged teaching hospitals to lead in cleaning up conflicts of interest between medicine and industry.
David Rothman, president of the Institute on Medicine as a Profession, said about one-fourth of U.S. medical schools now have policies on industry gifts “that really pass muster.” Some bar sales reps from giving doctors drug samples – but allow donations to a central supply office – and don’t let them wander their halls to speak to doctors.
“You’re not being bribed, you’re being gifted,” doctors may think, but industry freebies influence prescribing patterns, Rothman said.
On Wednesday, his group launched the first public database showing conflict of interest policies at most of the 125 U.S. academic medical centres.
At University of Pittsburgh School of Medicine, possibly the strictest, pharmaceutical reps since February have had to get a perfect score on an online training program about its rules to get appointments. Some reps have been warned about infractions, but none have been banned, said Dr. Barbara Barnes, head of industry relations.
Rothman said there’s a new effort to “clean up” continuing medical education of doctors, the only professionals he knows who don’t pay for it themselves.
In June, the Association of American Medical Colleges put out guidelines that bar drugmakers from paying for continuing medical education sessions on specific topics but allow donations to a central fund.
The Council of Medical Specialty Societies, which represents 32 specialty groups, this summer started collecting each group’s best practices on disclosure and limitations on speaking and other activities by their officers. Council CEO Dr. Norman Kahn said a new council policy should be ready in November.
Meanwhile, Senator Charles Grassley of Iowa, a frequent industry critic, is sponsoring a bill to require drugmakers to report all payments to doctors – from buying meals to flying them to conferences at resorts.
Doctors say there’s more to be done, but see an impact.
Dr. Marc Siegel, an internist and associate professor at New York University School of Medicine, said the school has fewer drugmaker-sponsored events, and he no longer gets offers of baseball tickets or paid junkets as a consultant at a doctors’ meeting – things he turned down anyway. He said some colleagues no longer let drug sales reps in their offices, but he does.
“I don’t mind – I like my staff to get a free lunch,” Siegel said. “I don’t think it influences one iota what I prescribe.”
Institute for Medicine as a Profession site: http://www.imapny.org/coi-database)
-with a report from CP