Wednesday, August 12, 2009

Pharma-Physician Relationships Rethink...

Industry gift bans slammed for overreaching

Some physicians criticize the bans as going too far and harming innovation.

By Kevin B. O'Reilly, AMNews staff. Posted Aug. 10, 2009.

Pressure is mounting on Capitol Hill to reveal the financial relationships among doctors, drug companies and devicemakers through the Physician Payments Sunshine Act.

Six states already have enacted payment-disclosure laws or bans on gifts to doctors. Meanwhile, more medical centers are restricting doctors' and students' interactions with industry, as calls grow for medical societies and educators to turn down drugmakers' dollars.

But now some doctors and physician organizations say the push to police financial relationships with industry has gone too far.

In late July, a new organization called the Assn. of Clinical Researchers and Educators held its charter meeting before a 200-plus crowd in an amphitheater at Brigham and Women's Hospital in Boston. Participants assailed conflict-of-interest rules that they argue impede physician-industry collaboration.

Recent statements from organizations representing cardiologists and endocrinologists also have defended the value of industry funding in helping to develop better treatments and improve medical practice.

Massachusetts has the nation's most restrictive law on industry gifts to physicians.

One ACRE founder, Thomas P. Stossel, MD, said critics of physician-industry relationships are "pharmascolds" who aim to bring about a "conflict-of-interest police state." ACRE represents the views of many doctors who had steered clear of the public debate, he said.

"There's been this unanswered barrage of criticism saying that physician-industry interaction is corrupt and harmful to patient care," said Dr. Stossel, a professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women's. "The tipping point came when some of these states started to pass confusing and demeaning laws, and when the academic health centers started telling people who they can associate with."

New Massachusetts regulations -- the most restrictive in the country -- took effect in July. They bar drug- and devicemakers from providing gifts to physicians and require public disclosure of most payments exceeding $50.

What especially has some physicians upset, Dr. Stossel said, is the Assn. of American Medical Colleges' 2008 stand that industry-sponsored speakers' bureaus not include medical faculty. Many ACRE leaders have been paid by drugmakers for research, speaking and consulting.

"These rules are not helping patients, and prohibitions are being imposed on activities that have real social value," Dr. Stossel said.

ACRE has not yet taken positions on issues such as the Sunshine Act, though members said they generally favor transparency, if it is not used to demonize physicians who work with industry. On its Web site, ACRE said it wants "to reverse policies instituted curtailing or minimizing interaction between industry and physicians, educators and researchers."

The trend of increasing Industry support for CME reversed in 2008.

One of the speakers at ACRE's charter meeting was Carey Kimmelstiel, MD, director of the cardiac catheterization laboratory and interventional cardiology at Tufts Medical Center. He said industry-funded quarterly educational meetings of interventional cardiology fellows in the Boston area have been put on hold indefinitely, thanks to the state's new regulations.

"The funding's dried up," he said. "In the current environment, where physicians are squeezed every which way, if you lose industry funding, it's very difficult to make that up on your own with your own dollars."

Nationally, industry support for CME fell 14% from $1.2 billion in 2007 to $1 billion in 2008, according to a July report from the Accreditation Council for Continuing Medical Education. The 2007 figure was a quadrupling of the $302 million spent in 1998.

The AMA House of Delegates has twice in the last year considered Council on Ethical and Judicial Affairs reports aimed at ending industry influence on CME. CEJA will take up the matter again in late August.

Meanwhile, AMA policy on gifts to physicians says it's OK for doctors to accept items from industry that are worth less than $100 as long as they are related to care and benefit patients.

An April 1 Journal of the American Medical Association article called on medical societies to aim for zero dollars from drugmakers.

This didn't sit well with American College of Cardiology President Alfred A. Bove, MD, PhD. Such proposals "assume [physicians] all are easily influenced by relations with industry and need to be regulated," he wrote in a July editorial in the Journal of the American College of Cardiology.

"There must be a middle ground," Dr. Bove wrote. "Physicians should be able to conduct industry-funded clinical trials or consult with industry without being tainted with an assumption of lifelong misbehavior."

The American Assn. of Clinical Endocrinologists and the American College of Endocrinology issued a joint statement in June saying, "There is no inherent conflict of interest in the working relationship of physicians with industry and government."

Houston endocrinologist Steven M. Petak, MD, led the task force that developed the statement. "There have been some abuses, but for the most part, physicians have the best interest of their patients in mind," he said. "We are concerned about insulating physicians from being able to learn about new products and how they fit into their armamentarium, and that patient care will suffer because patients will be locked into a certain set of choices that may not represent the best choice for that individual."

Denying problems?

Defenders of doctor-drugmaker financial ties are operating on a flawed premise, said Howard Brody, MD, PhD, director of the Institute for the Medical Humanities at the University of Texas Medical Branch.

"There is this total denial of any systemic problem, or any real reason to be cautious or concerned or have any real guidelines that have any real teeth in them," said Dr. Brody, author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. "I just wonder, 'What planet are these people living on?' "

Nothing is stopping physicians from working with drug- or devicemakers, Dr. Brody said. "There's absolutely nothing in any of these guidelines or recommendations that prevents fruitful exchanges of information and knowledge between anyone in academia and industry. All we are talking about is when you line your pockets as a result. If what you want to do is, in fact, discover new drugs, no one's stopping you."

The print version of this content appeared in the Aug 17, 2009 issue of American Medical News.



Assn. of Clinical Researchers and Educators (

"President's Page: Relations With Industry: Thoughts on Claims of a Broken System," Journal of the American College of Cardiology, July 7 (

"Professional Medical Associations and Their Relationships With Industry," abstract, Journal of the American Medical Association, April 1 (

"Conflict of Interest in Medical Research, Education, and Practice," Institute of Medicine, April 28 (

"PharmFree Scorecard 2009," American Medical Student Assn. (


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