Showing posts with label pharma-physician links. Show all posts
Showing posts with label pharma-physician links. Show all posts

Monday, January 11, 2010

Pharma Medical Industry Influence & Continuing Medical education

Using a Pfizer Grant, Courses Aim to Avoid Bias

NY Times Published: January 11, 2010

Stanford University on Monday will announce plans to develop new continuing education programs for doctors that will be devoid of the drug industry influence that has often permeated such courses.
The work is being done with a $3 million grant — from the drug maker Pfizer.

Dr. Philip Pizzo, dean of the Stanford medical school, says Pfizer will have no say on how the three-year grant will be spent. The university plans to set up unbiased programs of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.

“It’s a fundamental change,” Dr. Pizzo said Sunday, criticizing the drug industry for poisoning educational programs with marketing messages and doctors for “complicity” in taking speaker fees and expenses-paid trips. He called the grant “a novel rebooting.”

Stanford’s move was applauded by David J. Rothman, a professor and president of the Center on Medicine as a Profession at Columbia.

“It’s fair to say Stanford is once again leading the pack,” said Professor Rothman, who has written in The Journal of the American Medical Association about conflicts of interest in academic medicine.
“I will also confess I am surprised Pfizer is doing it,” he added, “and I don’t know how many more times they will give money with no strings attached.”

Pfizer, in a statement, said it wanted to help redefine how continuing medical education was financed to ensure the independence and patient benefit of the programs, which most doctors are required to take to maintain their state medical licenses.

Still, some saw inherent conflicts in the Pfizer connection.

“The announcement is self-satirizing,” said Dr. Adriane Fugh-Berman, a Georgetown University medical professor who has researched and written about industry influence in continuing medical education. “Pfizer’s interest in better ways to manipulate physicians is well-known.”

Stanford said the curriculum would focus on areas that needed improvement, like diabetes, cardiovascular disease, smoking cessation and infections. The university plans to use advanced technologies, including a simulated hospital, rather than lecturing.

“The Pfizer grant comes with no conditions, and the company will not be involved in developing the curriculum,” according to a medical school press release.

But Dr. Fugh-Berman said that Pfizer has major products in two of the four areas that the Stanford press release suggested might be pursued: smoking cessation and heart disease.

Dr. Pizzo, the Stanford dean said he was aware that the grant from Pfizer would receive some skepticism. “I think that’s appropriate because I have a certain guarded skepticism or optimism about this, too,” he said. “It remains to be seen how this eventually works.”

Drug and medical device companies have paid more than $1 billion a year for continuing medical education through universities, disease associations and private vendors, about half the total cost of the programs. The industry’s influence on topic selection, tone of presentations and advice given to doctors has spurred calls for reform from the Institute of Medicine, the Association of American Medical Colleges and the inspector general of the Department of Health and Human Services.

Pfizer has a checkered history of using such education courses to promote off-label use of its drugs. For instance Pfizer paid $2.3 billion last year to settle government fraud charges of deceptive marketing, including sponsoring supposedly independent programs promoting off-label uses for the pain drug Bextra.

In 2008, it became the first drug company to say it would no longer provide such money directly to
profit-making medical education companies, but only to universities and other nonprofits. But a $780,000 grant from Pfizer to the Canadian Medical Association for educational programs drew criticism because the company was given two seats on a six-member supervisory board. And a $3.4 million grant last year for the California Academy of Family Physicians to sponsor stop-smoking educational programs was questioned because Pfizer makes Chantix, a smoking cessation drug.

Dr. Arnold S. Relman, a former editor of The New England Journal of Medicine, a Harvard professor emeritus, an outspoken critic of industry conflicts and a friend of Dr. Pizzo, said he could not understand the rationale behind the arrangement.

“If it is true — a big, big if — but if it is true that this money is being given without any strings at all
and without any obligation on the part of Stanford to please Pfizer, then it’s arguable that it’s O.K.,” Dr. Relman said.

“But it’s just not a good idea for a profession that says it wants to be independent and trusted, a reliable source of information to the profession and the public about drugs, to take money from the drug company under any conditions.”

In September 2008, the Stanford medical school became the first in the nation to stop accepting industry financing for specific topics in postgraduate educational programs. It will accept only industry money that was pooled in a general fund for the education programs.

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.


ADDITIONAL INFORMATION:

Weblink

Assn. of Clinical Researchers and Educators (www.acreonline.org)

"President's Page: Relations With Industry: Thoughts on Claims of a Broken System," Journal of the American College of Cardiology, July 7 (content.onlinejacc.org/cgi/content/full/54/2/177)

"Professional Medical Associations and Their Relationships With Industry," abstract, Journal of the American Medical Association, April 1 (jama.ama-assn.org/cgi/content/abstract/301/13/1367)

"Conflict of Interest in Medical Research, Education, and Practice," Institute of Medicine, April 28 (www.iom.edu/cms/3740/47464/65721.aspx)

"PharmFree Scorecard 2009," American Medical Student Assn. (www.amsascorecard.org)

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