Conflicts of interest
Drug Companies Reduce Payments to Doctors as Scrutiny Mounts
This is part of our year-end series, looking at where things stand in each of our major investigations.
Some of the nation's top medical schools cracked down on professors who give paid promotional talks for drugmakers last year, and the firms themselves cut back on such spending in the wake of mounting scrutiny.
Last year began with the University of Colorado Denver and its affiliated teaching hospitals launching an overhaul of conflict-of-interest policies after ProPublica found that more than a dozen of its faculty members had given paid promotional talks.
"We're going to just have to say we're not going to be involved with these speakers bureaus because they're primarily marketing," Dr. Richard Krugman, vice chancellor for health affairs, said in an interview in January 2011.
A few months later, Stanford University took disciplinary action against five faculty members identified by ProPublica who had taken money to deliver drug company speeches, a violation of university policy.
And by last fall, there were indications that pharmaceutical companies were also reducing the money they spent on doctor speakers.
ProPublica first published its Dollars for Docs database in October 2010 listing payments to doctors from seven drug companies. When we updated it this September -- with data from five additional companies -- spending by some of the firms was down.
Cephalon, a relatively small Pennsylvania company that specializes in pain, cancer and central nervous system drugs, paid physicians nearly $9.3 million in 2009 for speaking and consulting. That figure dropped to $5 million in 2010.
AstraZeneca cut its spending on speakers from roughly $22.8 million in the first half of 2010 to about $9.2 million in the second half. Both companies cited business reasons for the decline.
Throughout 2011, ProPublica also examined the hefty financial support drug and medical-device makers give to medical societies and health advocacy groups and the impact it has on the groups' positions.
At the national conference of the Heart Rhythm Society in San Francisco, companies sponsored much of what doctors saw -- hotel key cards, bus banners, ads on staircases, even motorcyclists driving mini-billboards in a continuous loop around the Moscone convention center. Nearly 50 percent of the society's funding in 2010 came from the drug and medical device industry. (We even created a neat interactive graphic that allows you to virtually tour the hotel and exhibit hall.)
The society, which represents doctors who treat abnormal heart rhythms, said its funders don't influence its positions, but it unveiled a new policy requiring more detailed disclosure of board members' industry ties.
Then, last month, ProPublica reported about the extensive ties between makers of narcotic painkillers and the American Pain Foundation, which bills itself as the nation's largest organization representing patients afflicted by pain. The foundation received nearly 90 percent of its income in 2010 from drug and device makers and takes positions that closely align with the companies.
Despite a steep rise in overdose deaths tied to the drugs, the foundation has said the risk of addiction to the drugs has been overhyped and that, if anything, they are underused.
Like the heart society, the pain foundation said its funders have no influence on its positions.
ProPublica also investigated why physicians were not disciplined or prosecuted after they were accused in federal lawsuits of taking kickbacks from drug or device companies or pushing drugs for unapproved uses.
We reviewed lawsuits against 15 drug and device companies that were settled since 2006. None of the more than 75 doctors named as participants in alleged schemes were sanctioned by state medical boards or pursued by prosecutors, ProPublica found.
Last year, dozens of news outlets around the country used our data to localize stories about conflicts of interest in medicine -- bringing the discussion to communities large and small.
Source : Propublica (4 Jan 2012)
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Medical Groups Sign on to Tough Ethics Rules
Head honchos at medical societies and top editors at their associated journals will have to sever direct financial ties with industry as part of new ethics rules rolled out today. Here’s how the Associated Press describes the changes.
The Council of Medical Specialty Societies says the new code – which covers conflicts of interest, financial disclosure, independent program development and independent leadership – has already been adopted by 13 of its 32 member societies. Among the early signers-on: the American Society of Clinical Oncology, American College of Physicians, American College of Cardiology, and American College of Obstetricians & Gynecologists.
The provision affecting leadership of the group and industry ties says “key society leaders”, defined as the presidential line of succession, CEO of a group’s membership organization and editor-in-chief of any associated journals can’t have “direct financial relationships” with companies during their terms. Societies can set a “reasonable period” after election or appointment to cut ties, and anyone elected or appointed before his or her group signs the code can keep ties, but must disclose them. Leaders can still provide uncompensated services to companies, accept “reasonable” travel reimbursements related to those services, and accept research support as long as it’s paid to an institution or practice.
Jeanne Sheehy, executive director of CMSS, writes in an email that the new rules weren’t specifically modeled on one society’s code. Some groups already have codes that are as tough or tougher as this one. Any votes for which group has the strictest regulations?
Source: The Wall Street Journal Blog April 2010
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Junk Medicine; an American Fandango
by Dan Agin
The term "off-label" refers to use of a drug for treatments not approved by the Food and Drug Administration (FDA). In the US, physicians are essentially autonomous, and when a drug is approved by the FDA for use in the treatment, for example, of epilepsy, any physician can write a prescription for the same drug to be used in the treatment of any other disease or condition, no matter what the evidence (or lack of it) supporting that use.
Let's draw a parallel. A research scientist in an advisory capacity, to government or industry, for example, who recommends a course of action purportedly based on his scientific knowledge, when he knows but hides the fact that there is no evidentiary scientific support for his recommendation, and that given the absence of data, his recommended course of action may be harmful -- that scientist is practicing junk science.
Similarly, a physician, in an advisory capacity to a patient, who writes a prescription for a drug for that patient, a recommendation purportedly based on the physicians's medical knowledge, when the physician knows but hides the fact that there is not sufficient evidentiary medical knowledge to justify the use of that drug in the case of this patient, and the physician is aware that because of the possibility of unknown side effects the drug may be harmful to the patient -- that physician is practicing junk medicine.
The crux of one of the important problems of modern medicine is clear: junk medicine, as described above, is rampant, just as useless and as potentially dangerous to the patient as witchdoctoring, and in the large a public danger of the first magnitude. Physicians are too often mere devices to facilitate a commercial transaction between their patients and drug companies, and the drug companies are well aware of this and devote an enormous amount of energy, time, and money to capturing and using their physician sales-facilitators. The drug business has succeeded in thoroughly corrupting the practice of medicine. To pharmaceutical companies, physicians practicing clinical medicine are sales-facilitators essentially bought the way actors are bought to wear white coats in front of television cameras while pretending to be physicians.
A second problem concerns medical research, or more aptly biomedical research, since these days so much medical research is coupled to modern biology, to molecular biology and biochemistry. During the past twenty-five years, we have witnessed a dangerous corruption of biomedical research by private enterprise, particularly by the large pharmaceutical companies -- "big pharma." Most observers agree that this corruption began in the US with the passage of the Patent and Trademark Amendments Act of 1980, known as the Bayh-Dole Act (named after Senator Birch Bayh [D-Ind.] and Senator Robert Dole [R-Kans.]). By enabling universities and small businesses to patent discoveries emanating from research sponsored by the National Institutes of Health (NIH) and then grant exclusive licenses to drug companies, this act set in motion processes that completely altered research in biomedicine, brought large research universities into partnerships with biotechnology companies and pharmaceutical companies, and pushed a large and important area of modern academic science to focus more on profits than on public benefit. The goose has laid a pile of golden eggs and the eggs may eventually rot and kill us.
In the past, the arena of financial frenzy in America was land, then transportation, then manufacturing. These days the arena of financial frenzy is science and medicine. With a suddenness that has left many older scientists and physicians dizzy, science and medicine have moved to center stage as a focus of commerce. Money flows. A river of money flows into the fields of the knowledge-producers, promotes growth in some places and greed in other places.
This is our era and we cannot go backwards. The age of bedside doctoring in the middle of the night is past, the image a museum-piece of medical history. We live in a time when scientists and physicians strive for large financial rewards for their work, and it's doubtful that will change in the near future. American science and medicine have become profit-oriented endeavors. The problem, however, is not so much profit itself but the effects of the striving for profit by both industry and universities. We need to struggle to ensure that the quest for financial gain does not corrupt the scientific and medical enterprises to a point of destruction. So far, the outcome of our struggle does not look promising.
Source : Huffington Post - 3/8/2010
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Conflicts of interest bedevil psychiatric drug research
By Marilyn Elias,
USA TODAY (FULL ARTICLE)
Does it matter if most of the experts who are creating definitions of mental disorders, and standards for the best way to treat them, receive money from pharmaceutical companies? That question is hotly debated in scientific journals, but it isn't just academic. It also cuts to the core of public welfare by making it possible for financial profit to affect decisions about who needs treatment, whether they are prescribed medicine and which ones, says Lisa Cosgrove, a psychologist at the University of Massachusetts-Boston.
Critics such as Cosgrove say there's a damaging conflict of interest in the financial ties between drug companies and leaders who are revising the "bible" of psychiatric diagnoses, the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), as well as guidelines on the best treatments.
About 160 experts appointed by the American Psychiatric Association are doing the heavy lifting on the updated manual, expected in 2012. They're tops in their field, and because industry pays for two-thirds of research, many of them consult for drug companies or do corporate-funded studies, says Darrel Regier, research director for the group. "There's this assumption that a tie with a company is evidence for bias. But these people can be objective," he says.
This is the first time the psychiatry association has required members of 13 working groups on diagnoses, as well as the leadership task force, to publicly disclose all industry ties.
Sixty-eight percent of task-force members report economic ties with drug companies, Cosgrove says. And of those with links, about four out of five don't just get research funding, they're on corporate boards, hold stock or collect money as advisers, she says. She and Harvard Medical School psychiatrist Harold Bursztajn have criticized these ties in The New England Journal of Medicine and Psychiatric Times.
Even small changes in the symptoms for diagnosis of a problem can greatly increase prescriptions for drugs, Cosgrove says, so anyone who could benefit from changes has a potential conflict.
More than half of the members on the 13 working groups also have such ties, according to Cosgrove's analysis. She says no group should have a majority with drug company links.
But Regier argues: "We want the best people. We don't want quotas or an artificial litmus test." He says potential conflicts are limited by a rule that panel members can't receive more than $10,000 from drug companies while at work on the new DSM.
The $10,000 limit "is not a particularly sensible idea," says Daniel Carlat, a Tufts psychiatrist who publishes an independent monthly, The Carlat Psychiatry Report, on trends in the field. "They've had lucrative relationships in the past, and they know they're going right back to them."
Carlat says it's unrealistic to exclude people with industry-research funding, but he favors limits on those who give promotional talks on drugs, "the real hired guns," and others with a direct financial interest in firms. "Maybe no more than 30%, maybe no more than 50%. These panels shouldn't be stacked the way they are now," he says.
Another flash point: clinical guidelines. Cosgrove led a study on 20 authors of treatment standards for major depression, bipolar disorder and schizophrenia: 90% of them had financial ties to firms that make drugs recommended for the disorder.
But the psychiatry group casts a net to hundreds of reviewers for every guideline, says John McIntyre, who chairs the guidelines committee. The depression and bipolar standards are being updated, "and we've gotten thousands of comments online," Regier says. So any bias gets diluted by diverse voices, McIntyre says; plus, the guidelines are based on evidence.
But there's the rub, critics say, because drug company-funded studies consistently come out with more positive results for their drug than do independent studies.
"In psychiatry, many diseases are treated equally well with medication or therapy," Carlat says. "But the guidelines tend to be biased toward medication" because it's costly to make and study drugs.
Much is at stake. Antipsychotics, which had $14.6 billion in sales last year, were the top-selling class of U.S. medicines; antidepressants brought in $9.6 billion, says IMS HEALTH.
The debate over whether economic self-interest may bias the DSM and treatment guidelines leads to a root issue: Drug companies pay for gathering evidence, and there's no major alternative on the horizon, says Paul Appelbaum, an expert on ethics in psychiatry at Columbia University. He's concerned about potential conflicts. But other financing suggestions — for example, companies contributing money for studies run independently by the government — have gone nowhere, he says.
"We're a capitalist society built on competition, and that has led to many successes," Appelbaum says. "But this conflict-of-interest issue shows the side effects of the system we have."