Drug industry ties to doctors weaken as disclosure, gift rules spread
■ More physicians are saying no to free lunches, drug reps and consulting relationships, new data show.
Increased scrutiny of the potential conflicts of interest posed when physicians accept gifts and payments from industry -- combined with greater pay disclosure and a sputtering pharmaceutical pipeline -- have led to a significant drop in doctors' financial ties to drugmakers.
Among the indicators of a declining link between physicians and industry:
- Commercial support for continuing medical education dropped 20%, from a little more than $1 billion in 2004 to $856 million in 2009, according to the Accreditation Council for Continuing Medical Education.
- The amount drugmakers spent on drug rep details dropped 10%, from $6.9 billion in 2005 to $6.3 billion in 2009, the health data firm IMS Health reports.
- Nearly a quarter of physician practices refuse to see drug reps, according to an ongoing survey of 237,000 U.S. clinics conducted by SK&A, a prescriber-profiling firm. Nearly half of practices see reps only with an appointment, up from 40% in February 2009.
The latest evidence demonstrating the changing relationship between physicians and industry comes from a May 2009 survey of nearly 1,900 doctors whose results were published in the Nov. 8 Archives of Internal Medicine.
The article, a follow-up to a 2004 survey of more than 1,600 doctors, reports that -- across the board -- physicians are taking fewer gifts and payments from the pharmaceutical industry. Most doctors still accepted drug samples and free lunches from industry, but the number of physicians who took samples dropped 20% from 2004, while 13% fewer doctors ate industry-provided meals. About half as many physicians accepted industry-subsidized admissions to CME events or were reimbursed for meeting expenses such as food and lodging.
The percentage of physicians taking industry pay to serve on advisory boards and speakers' bureaus and as consultants fell by more than half. Consulting relationships declined the most, dropping 61% between 2004 and 2009. Fewer than 10% of doctors reported agreeing to any of these financial arrangements in 2009.
A changing environment
The weakening in physician-industry financial ties has emerged as influential organizations such as the Institute of Medicine and the Assn. of American Medical Colleges issued guidelines calling for closer scrutiny of, and in some cases outright bans on, practices such as accepting drug rep-provided meals and serving on industry speakers' bureaus.
Adding another layer of scrutiny: greater disclosure of industry payments to physicians -- by choice among a growing number of medical centers and drugmakers during the last few years and by federal mandate under the "sunshine" provisions of health system reform.
"This is really a dramatic difference in only five years," said Adriane Fugh-Berman, MD, director of PharmedOut, an anti-drugmaker project founded with a $400,000 grant from the Warner-Lambert settlement over allegations of deceptive off-label marketing of Neurontin (gabapentin). "Physicians are starting to realize that there's no such thing as a free lunch, and that says good things about the future of medicine. It will have a beneficial impact on patient care."
The survey findings were unsurprising given the changes in the "broader environment" in medicine regarding conflicts of interest, said Eric G. Campbell, PhD, lead author of the Archives study.
"I'd like to think the reason this is happening is that physicians are engaged in the tenet of professionalism that talks about self-regulation of conflicts of interest," said Campbell, director of research at the Massachusetts General Hospital's Mongan Institute for Health Policy.
Another factor contributing to the falling number of physicians working for drugmakers as speakers, consultants or advisers is the slowing pipeline for new drugs, said John Mack, a former marketing executive who consulted for drug companies and now is publisher of the monthly Pharma Marketing News. The Food and Drug Administration has said it expects 118 new drug applications by the end of the year, a record low and down from 140 in 2009. The number of new drugs approved is down 32% from last year.
"The time drug companies will be hiring lots of consultants is when they have a new drug nearing to market that they need to educate other physicians about," Mack said. "With fewer innovative drugs coming on the market, there has been less need for that."
Prominent medical schools such as Stanford University School of Medicine in California and Johns Hopkins University School of Medicine in Baltimore have taken a hard line on relationships with industry and may have influenced the broader physician population, said Tim Anderson, director of the American Medical Student Assn.'s PharmFree Scorecard, which grades medical schools' conflict-of-interest policies.
"They have been removing some things like the availability of samples or meals from a lot of physicians," said Anderson, a third-year medical student at Case Western Reserve University School of Medicine in Cleveland. "This also has put in place in the minds of young trainees who've gone through medical school in the last five years this question about whether they'll take these kinds of gifts or meals."
At least one school has taken the dividing line a step further. The University of Michigan Medical School has adopted a policy not to accept industry funding for CME courses starting in January 2011.
Nearly a third of the 149 medical schools reporting in 2009 received "A" or "B" grades on the PharmFree Scorecard, up 19% from 2008. The 2010 report will be released in December, and 75 medical schools have submitted new or revised conflict-of-interest policies, Anderson said. A 2008 AAMC report called on medical schools to centralize their distribution of drug samples, turn down gifts and meals from drug reps, and bar faculty from participating in pharma speakers' bureaus.
"Many of the largest and most important academic medical centers in the U.S. have banned promotional speaking for companies," said Daniel J. Carlat, MD, assistant clinical professor of psychiatry at Tufts University School of Medicine in Boston and a critic of physicians who give industry-paid lectures. "In that case, it's pretty straightforward. If you want to keep your job, you have to just stop speaking for drug companies."
Preserving beneficial relationships
A voluntary drug industry code that took effect in January 2009 banned gifts to doctors such as pens and notepads and has helped assure that consulting, speaking and advising arrangements are bona fide, said Diane Bieri, executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America.
"By helping to ensure that these relationships are ethical, these and the many other recommendations in the [PhRMA code] help to maintain the important value that they provide -- the ability to help physicians stay up to date with the latest scientific data, including new uses of medicine, clinical trials and emerging risk information," Bieri said.
American Medical Association policy on gifts from industry says "modest meals" are OK, as are gifts worth less than $100 that benefit patients. It also says that "individual gifts of minimal value ... related to the physician's work" are permissible. The AMA Council on Ethical and Judicial Affairs is re-examining the gifts policy.
"While relationships between the pharmaceutical industry and physicians can benefit patient care, they also can create ethical dilemmas for physicians," said AMA Board of Trustees Chair Ardis Dee Hoven, MD. "The AMA has clear ethical guidelines to help govern the relationship between physicians and industry, minimizing potential conflicts of interest and ensuring that these relationships are in the best interest of patients."
Some physicians said the decline in physician-pharma collaboration is baleful. The contention that relationships with industry are unprofessional is "insulting," said Thomas P. Stossel, MD, director of the Division of Translational Medicine at Brigham and Women's Hospital in Boston and co-founder of the Assn. of Clinical Researchers and Educators, which defends physician-pharma relationships.
Dr. Stossel said costly settlements related to off-label marketing allegations have made drugmakers shy away from working with doctors, resulting in drastic cuts to physician education and research projects. "The bottom line -- bad for patient care," he said.