If enacted, the IOM recommendations will essentially sever the financial ties that bind American medicine–its practitioners, researchers, academic institutions, journals, professional association and so-called "advocacy groups" from industries that have derailed American medicine from its humanitarian public mission.
Dr. David Rothman, whose Institute on Medicine as a Profession at Columbia University (which is bankrolled by financier George Soros) is quoted saying:
“With the I.O.M.’s endorsement, issues that were once controversial now are indisputable; conflicts of interest in medicine are no longer acceptable.”
Most important, the IOM report calls upon Congress to pass legislation that would require drug and device makers to publicly disclose all payments made to doctors–thereby lending important support for the Physician’s Payment Sunshine Act, sponsored by Senators Charles E. Grassley, and Herb Kohl who head the Senate Finance Committee that would do just that.
The IOM report acknowledges that:
"financial ties between medicine and industry may create conflicts of interest. Such conflicts present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine. Recent news stories have documented troubling interactions between industry and physicians, researchers, and medical institutions."
Though not identified, many of those news stories laid bare gross and pervasive financial conflicts of interest by psychiatry’s leadership, its professional associations, diagnostic and therapeutic practice guidelines, and the academic institutions they are affiliated with–all have been shown to be tainted by industry’s tentacles. In no other field of medicine have doctors sworn to "do no harm" knowingly prescribed toxic drugs that carry warning labels about induce suicide, metabolic syndrome, diabetes, and cardiac death.
Just last week, Gabriel Myers, a seven-year old boy committed suicide. The child was treated by a "board certified" child psychiatrist in Florida who prescribed four psychotropic drugs for the boy including: the antidepressant, Lexapro, the antipsychotic, Zyprexa, and Eli Lilly’s deadly combination Symbiax (Zyprexa and Prozac). These three drugs were not approved for use in children though they are recommended by the most influential industry-paid child psychiatrists–all carry Black Box warnings which the treating psychiatrist ignored.
Clearly, the IOM committee–including the deans of Emory University and Stanford University who served as external reviewers of the draft report, according to Dr. Bernard Carroll–now recognize that financial relationships with industry are extensive and self-regulation by academic institutions has failed to rein in the most serious conflicts of interest. Indeed, as Dr. Carroll notes on his blog, HealthCareRenewal, both of these deans were confronted with evidence uncovered by the Senate Finance Committee that their institutions’ prominent (now former) chairmen of psychiatry were shown to have multi-million dollar undisclosed financial interests that posed serious conflicts of interest undermining both human subject safety and the integrity of the research findings. http://hcrenewal.blogspot.com/2009/04/institute-of-medicine-report-on.html#links
To combat the current state of confusion created by variable conflict of interest policies adopted by various academic institutions, journals and professional societies, the IOM committee recommends a real universal overhaul that would prohibit financial ties between industry and researchers conducting human research; end industry funding for continuing medical education programs (within two years); end industry payments physician practice guidelines:
"Congress should create a national reporting program that requires pharmaceutical, medical device, and biotechnology companies to make public all payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, and providers of continuing medical education. Public reporting will enhance accountability by allowing academic medical centers, medical journals, and others to verify disclosures made to them by faculty members, article authors, and others."
Research: "as a general rule, that researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. The only exceptions should be if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research."
Continuing medical education: "a broad-based consensus process to develop a new system for funding high-quality accredited continuing medical education that is free of industry influence….”a new system of funding … should be developed that is free of industry influence.”
Community physicians: "should also follow the restrictions described previously regarding gifts, including meals, from companies; presentations or articles whose content is controlled by industry; meetings with sales representatives; and use of drug samples."
Clinical practice guidelines: "influence physician practice, quality measures, and insurance coverage decisions. Given this influence, clinical practice guidelines need to be developed with greater transparency and accountability.
"The committee recommends that professional societies and other groups that develop practice guidelines not accept direct industry funding for guideline development and generally exclude individuals with conflicts of interest from the panels that draft the guidelines
"To reduce the risk for bias within the learning environment, academic medical centers and teaching hospitals should prohibit faculty from accepting gifts, making presentations that are controlled by industry, claiming authorship for ghost-written publications, and entering into consulting arrangements that are not governed by written contracts for expert services to be paid for at fair market value."
The committee also recommends that: "the Department of Health and Human Services develop a research agenda to create a stronger evidence base for future conflict of interest policies. Such research should evaluate the impact of conflict of interest policies, including both desired outcomes and possible unwanted consequences."
"Decisions about biomedical research, medical education, and patient care directly affect the public’s health. The public needs to be able to trust that physicians’ decisions are not inappropriately influenced by their financial relationships with industry."
Although the IOM does not have the power to enforce its recommendations, the Institute usually carries great weight within the medical profession and health-care industry.
See: IOM. Conflict of Interest in Medical Research, Education, and Practice
REPORT BRIEF • APRIL 2009 http://www.iom.edu/Object.File/Master/65/981/COI report brief for web.pdf
See also, Peeling the onion: Is more conflict of interest disclosure getting us closer to the truth?
April 24, 2009 | Shelley Wood, The Heart.org WebMD:
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THE NEW YORK TIMES
April 29, 2009
Institute of Medicine Calls for Doctors to Stop Taking Gifts From Drug Makers
By GARDINER HARRISWASHINGTON — In a scolding report, the nation’s most influential medical advisory group said doctors should stop taking much of the money, gifts and free drug samples they routinely accept from drug and device companies.
The report, by the Institute of Medicine, part of the National Academy of Sciences, is a stinging indictment of many of the most common means by which drug and device makers endear themselves to doctors, medical schools and hospitals.
“It is time for medical schools to end a number of long-accepted relationships and practices that create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy,” the report concluded.
The institute’s report is even more damning than a similar one released last year by the Association of American Medical Colleges, which proposed tough new rules governing interactions between companies and medical schools.
In the wake of the association’s report, many schools and medical societies toughened their policies. The institute’s imprimatur is certain to accelerate this process.
“With the I.O.M.’s endorsement, issues that were once controversial now are indisputable,” said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Conflicts of interest in medicine are no longer acceptable.”
The report calls on Congress to pass legislation that would require drug and device makers to publicly disclose all payments made to doctors. Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin, have co-sponsored legislation that would do just that.
Both senators said they welcomed the institute’s endorsement.
“It’s a shot in the arm to the reform movement to have the prestige and policy heft of the Institute of Medicine on the side of transparency,” Mr. Grassley said. “The more disclosure, the better, for holding the system accountable and building public confidence in medical research and practice.”
Drug companies spend billions of dollars wooing doctors — more than they spend on research or consumer advertising. Much of this money is spent on giving doctors free drug samples, free food, free medical refresher courses and payments for marketing lectures. The institute’s report recommends that nearly all of these efforts end.
The largest drug makers agreed last year to stop giving doctors pens, pads and other gifts of small value, but company executives have defended other marketing tactics as valuable to both doctors and patients. Medical device and biotechnology companies have yet to swear off free trips or even pens.
A 2007 survey found that more than three-quarters of doctors accepted free drug samples and free food, more than a third got financial help for medical refresher courses and more than a quarter were paid for giving marketing lectures and enrolling patients in clinical trials.
Among the most controversial of the institute’s recommendations is a plan to end industry influence over medical refresher courses. At present, drug and device makers provide about half of the financing for such courses so that doctors can often take them without charge. Even as they have acknowledged the need for other limits, many medical societies and schools have defended subsidies for education as necessary.
“As science progresses, it’s going to get harder and harder to get doctors to keep pace,” said Dr. Jack Lewin, chief executive of the American College of Cardiology. “I think industry has some responsibility toward education.”
By contrast, the American Psychiatric Association recently announced that it would phase out industry financing for medical refresher courses at its conventions.
The institute acknowledged that many doctors depended on industry financing for refresher medical courses but said that “the current system of funding is unacceptable and should not continue.” The report recommended that a different system be created within two years.
Mr. Kohl said that he had been investigating refresher medical courses, and that the industry’s role has tainted some courses with bias.
Dr. Bernard Lo, the director of the Program in Medical Ethics at University of California, San Francisco, who served on the institute’s committee that wrote the report, said in an interview that doctors “need to do a better job in addressing conflicts of interest that would lead to bias or threaten public trust.”
Dr. P. Roy Vagelos, a former Merck chief executive, said he had worried for years that drug and device companies wielded too much influence over doctors.
“I think medical centers and companies will start to listen to these recommendations and to take them very seriously,” Dr. Vagelos said.
The institute recommended that doctors stop giving free drug samples to patients unless the patient was poor and the doctor could continue to provide the medicine to the patient for little or no cost. By contrast, many free drug samples go to patients with insurance coverage or to doctors and their families, the report said.
Copyright 2009 The New York Times Company
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April 28, 2009
Medical Experts Want Crackdown on Drugmaker Money
By THE ASSOCIATED PRESSFiled at 12:40 p.m. ET
WASHINGTON (AP) — Millions of dollars in gifts, travel and consulting fees from the pharmaceutical industry should be eliminated to stop companies from influencing how doctors practice medicine, a report by the government’s top medical advisers says.
The sweeping recommendations from the Institute of Medicine call on medical professionals — from university professors to family doctors — to shun financial arrangements with companies that have flourished over the past three decades.
Taking free lunches from company salespeople, giving paid lectures on their behalf and other practices ”erode public trust while providing no meaningful benefits to patients or society,” institute panel chair Dr. Bernard Lo said in a statement.
The report calls on medical schools, hospitals and physician groups to:
— publicly report funding they receive from companies.
— not accept free meals, gifts or other items from companies.
— prohibit doctors who have a financial conflicts of interest from testing new therapies on people.
The 353-page document arrives as lawmakers bolster efforts to require companies to publicly report the money they spend courting physicians. The report could give them more leverage in their push to untangle the knotty relationships between industry and physicians, which some say drive up the cost of medicine.
The American Medical Association and other groups have taken some steps in that direction, for instance, phasing out company-paid trips to luxury resorts. And Stanford University, the University of Pennsylvania and other medical schools are disclosing more about faculty members’ conflicts of interest. But consumer advocates say more dramatic changes are needed.
”I think there may be some sparks that fly from this report, since many industry and medical groups had already been moving in this direction,” said Steven Findlay of Consumers Union. ”But I think this will accelerate the movement towards full disclosure of these conflicts.”
The IOM advises the federal government on health care matters. While its recommendations are not binding, many executives and physicians are likely to heed the advice to avoid scrutiny from lawmakers.
In the last year, Sen. Charles Grassley, R-Iowa, has uncovered more than a half-dozen questionable arrangements between leading researchers and drug companies. In one case, the chairman of Emory University’s psychiatric department was removed after failing to report hundreds of thousands of dollars in payments from a company whose drugs he was studying. The head of Stanford University’s psychiatry department stepped down after similar payments came to light.
Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100. But the IOM report goes even further, calling for the disclosure of payments to patient groups and other nonprofits that are often funded by industry dollars.
While making payments public will not immediately stop the flow of money, panelists say it’s an important first step.
”By bringing things out into the light of day, it’s believed people will simply refuse to do things that their colleagues and others might find out about,” Dr. Eric Campbell said at a press conference Tuesday.
The Pharmaceutical Research and Manufacturers of America trade group is trying to head off regulation by reining in marketing efforts. Earlier this year the group asked members to voluntarily stop handing out mugs, pens and other freebies in doctor’s offices, though modest lunches and textbooks are still allowed. Nearly all the largest drugmakers are members.
Executive Vice President Diane Bieri cautioned about the unintended consequences of adopting the institute’s recommendations.
”Reports such as this can have far-reaching effects,” said Bieri, who is also the group’s general counsel. ”And when they admit in the report itself that they don’t have a lot of data to support these recommendations, we have to be aware of the negative effect they could have.”
Perhaps the most vigorously defended practice is company support for so-called continuing medical education conferences, where doctors learn about the latest treatments. Most state medical boards require physicians to attend a certain number of sessions each year to maintain their licenses.
While the panel stopped short of calling for a ban on industry-funded education, it stated that ”a new system of funding … should be developed that is free of industry influence.”
Industry’s share of funding for medical education has swelled from 34 to 48 percent in the last 10 years, according to IOM. Opponents of the practice argue that physicians need to pay their way more often.
”Lots of professions pay for their own education — for example, lawyers,” said Allan Coukell of the Pew Prescription Project.
But medical specialists argue they are responsible for keeping up with more information than those in other professions.
”The acceleration of science is going to make it tougher and tougher for physicians, nurses and other health care professionals to stay current,” said Dr. Jack Lewin, President of the American College of Cardiology.
Copyright 2009 The Associated Press
~~~~~~~~~~~APRIL 28, 2009
Institute of Medicine Seeks Limits on Industry Influence on Patient Care
By JONATHAN D. ROCKOFFThe Institute of Medicine recommended Tuesday that doctors, medical schools, professional groups and drug makers make far-reaching changes to prevent industry gifts and payments from influencing patient care and research.
The IOM, part of the National Academy of Sciences, proposed the elimination of many now-common practices. It said doctors, for example, shouldn’t accept meals, trips or other gifts from companies. Nor should physicians participate in clinical trials if they have a financial interest in the outcome, or sign on to ghost-written articles.
The IOM also said professional societies shouldn’t accept direct industry funding for the development of guidelines on treating patients. And it recommended that companies disclose payments publicly, and in a central place.
The recommendations, contained in a 353-page report, come amid heightened concern and investigations — often led by Iowa Republican Sen. Charles Grassley — about the impact that industry gifts and payments have on doctors, medical schools, professional groups and journals. (See a brief on the report.)
"Certain things should not happen," Eric Campbell, an associate professor at Harvard Medical School who served on the IOM panel that produced the report, said in an interview. He cautioned, however, that some ties were productive and the key was making them public so abuses could be prevented.
The IOM doesn’t have the power to enforce its proposals, but its recommendations usually carry great weight within the medical profession and health-care industry.
Some medical schools, professional societies and journals have already adopted stricter codes of conduct. A few states have begun posting company payments to physicians. And several companies have agreed to disclose payments and eliminate pens, mugs and other gifts.
But the IOM’s recommendations would go beyond current steps in many cases. Companies, for example, would disclose payments in a central location such as a single Web site, rather than on their own Web sites, under the recommendations.
Write to Jonathan D. Rockoff at jonathan.rockoff@wsj.com
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