Reform opponents got millions from industry
Filed under: Conflicts of interest, Health care reform, Health policy, Hot Health Headline, Public records
Caitlin Ginley, of the Center for Public Integrity, used data from the National Institute on Money in State Politics to demonstrate that the state officials who have joined forces to file a lawsuit challenging American health care reform have, together, received more than $5 million in campaign contributions from hospitals, pharmaceutical companies, doctors and insurers. Among the governors and attorneys general in the 20 states supporting the suit, a few stood out.
… the Center found that top recipients of industry money include Texas Attorney General Greg Abbott, who has received more than $1 million from health care professionals since 1996, and former Georgia Governor Sonny Perdue, who took in at least $970,163 from the industry starting in 1992, when he was a state senator, until he left the governor’s office this week. Other major recipients involved in the lawsuit include former Pennsylvania Attorney General and newly-elected Governor Tom Corbett, who has received about $830,000, and Mississippi Governor Haley Barbour, with more than $770,000.
Ginley provides details on the donations each of those officials received, as well as several others. No word on how this compares to other samples of 40 high profile state politicians. Physician groups and private doctors played a major role in many of the cases she examined.
Taking stock of big pharma in Canada
Filed under: Hot Health Headline, Pharmaceuticals
CBC and Radio-Canada have cooperated to produce a comprehensive look at the nation’s pharmaceutical industry, which centers on Montreal, Canada’s second largest city.
Pharma’s Canadian outposts have sputtered in recent months, and Quebec’s government has struggled to keep the companies in-country.
Part 1: Government incentives to pharmaceutical companies.
Part 2: Regulation of clinical trials.
Part 3: Pharma’s role in continuing medical education.
In addition to the stories, be sure to take a look at the top few comments below the story. Also, the “Quick Fact” box, which taught me that “Montreal has the largest number of clinical trial organizations of any city in North America.”
Anti-fraud guide may be useful to reporters
A just-issued 31-page guide for new physicians from HHS’ Office of the Inspector General teaches doctors how (and why) to avoid defrauding their patients and the federal government. As their public-facing antifraud campaign ramps up, the office is responding to a need for better education of medical students. It makes sense, as physicians are generally the gatekeepers for medical spending. The government doesn’t often restrict their actions on the front end, which means physicians need to know the rules before they act.
The guide is fairly engaging reading, as OIG reports go, and it may serve as a primer to reporters looking into Medicare and Medicaid fraud. It covers doctors’ relationships with payers, other providers and vendors, as well as a summary of the five primary anti-fraud statutes.
False Claims Act
Doctors shouldn’t submit claims they know are wrong, or they’ll get socked with an $11,000 fine for every little item billed falsely, in addition to repaying the cost of the item several times over. This includes upcoding, or billing for a more severe (and expensive) illness than the patient really had, or billing for an item already included in a larger overall reimbursement.
Anti-Kickback Statute
Don’t pay for patient referrals or anything else that generates business. And yes, all forms of payola are covered, not just cash.
This also extends to getting paid, whether it be by pharmaceutical companies or the college buddy who’s getting all the referrals.
Note: Doctors can waive patient copays in specific situations (they’re uninsured, can’t afford it or the doctor can’t collect), but physicians can’t do it systematically as a way to gain patients.
Physician Self-Referral Law (aka the “Stark law”)
With a couple of gigantic exceptions, doctors can’t refer patients to imaging centers that they or family members own. The rules also apply to physical therapy, prosthetics, home health services and hospital services, among other things.
Physicians can invest in health care business ventures, but they should look out for possible conflicts of interest, especially if they’re getting the sort of preferential treatment not afforded to ordinary investors.
Red flag: If the money you’re getting paid is out of proportion to the work you’re doing, then something shady is probably going on. Especially if it in any way influences the treatment your patients get.
Remember, nearly all gifts and payments from drug and device companies will be disclosed starting in 2013.
Exclusion Authorities
Doctors shouldn’t deal with folks who have already been convicted of Medicare or Medicaid fraud, patient abuse or neglect, or any related offenses. If you don’t want to get on their black list, don’t violate the other four key fraud laws.
Civil Monetary Penalties Law
CMS can seek civil monetary penalties (and black listing) if doctors violate any of the above, or provide them with false information. Physicians also need to provide adequate screening to emergency patients.
Finally, the guide ends with instructions for doctors on how to report themselves, emphasizing that doing so “allows providers to work with the Government to avoid the costs and disruptions entailed in a Government-directed investigation.”
Study considers role of impact factor, income in journal editors’ decisions
A newly published study looks at medical journals and whether the publication of industry-supported trials might cause a conflict of interest by improving the journals’ importance or income.
Researchers looked at “impact factor” – a measure of a journal’s importance based on how often its articles are cited – and they looked at income from the sale of reprints to drug companies.
While they found that the publication of industry-supported randomized controlled trials is associated with an increase in both the impact factor and income from reprints, they do not conclude that editors’ decisions are affected by those increases.
Importantly, these findings do not imply that the decisions of editors are affected by the possibility that the publication of an industry-supported trial might improve their journal’s impact factor or income.
Despite that conclusion, the researchers do suggest that journals routinely disclose information on the source and amount of income they receive.
In that spirit, PLoS Medicine discloses its sources of income for 2009 and the editors discuss the issue in an editorial.
Related
More about conflicts of interest in publishing
Doctors quietly get millions from device makers
Filed under: Health journalism, Hot Health Headline, Studies
The Archives of Internal Medicine recently published a study on conflict of interest disclosures by surgeons receiving more than $1 million in 2007 from one of any five medical device makers. And by “conflict of interest disclosures,” I, of course, mean “or lack thereof,” a sentiment which would apply in almost half of the cases studied.
The findings mirror similar investigative stories the Milwaukee Journal Sentinel published so, as you might have expected, reporter John Fauber was all over the story.
For the analysis, Rothman and his co-authors looked at publicly listed payments made to doctors in 2007 by five orthopedic firms: Biomet, DePuy Orthopedics, Smith & Nephew, Stryker, and Zimmer.
Using the listed payments, the new study found that in 2007 those companies made 1,654 payments totaling $248 million. The 41 orthopedic surgeon researchers got payments ranging from $1 million to $8.9 million.
Those payments then were used to check disclosures in 95 articles authored by 32 of the surgeons. The disclosure rate was 46%.
Such disclosures will be federally mandated starting in 2013, and Fauber writes that journal editors can already use lists published by device-makers to double-check the disclosures that accompany journal submissions.
Ethics professor takes on clinical trials, marketing
Filed under: Hot Health Headline, Pharmaceuticals
Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.
Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.
…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.
Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.
From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?
Australia lagging in conflict-of-interest disclosures
Filed under: Conflicts of interest, Health journalism
When a country is holding up the United States as a model of progress on medical conflict of interest issues, you might suspect there are some serious systemic issues there. Such seems to be the case in Australia, based on Melissa Sweet’s recent post on the Croakey blog. At present, there’s little baseline research into industry funding and influence in Australia, though what little there is seems to indicate a situation similar to what we’ve found in the United States. The lack of research seems to stem from a lack of awareness and perhaps even indifference.
Photo by acediscovery via FlickrThe catalyst for this post seems to be the Walkey Media Conference, a media industry confab sponsored by the national journalists’ union that generated a bit of controversy thanks to a sponsorship from Exxon Mobil.
Sweet found a University of Sydney seminar in July that was to look at conflicts of interest to be less than packed, and inferred that Aussie “academics seem to regard (COI) as irrelevant, tedious or confronting.” Furthermore, she wrote, “Australian universities are dragging the chain in dealing with their staff’s conflicts of interest, at least compared with institutions in the US.”
The post makes a strong, well-researched case for COI disclosure and serves as a sort of roundabout compliment to the dogged American journalists (we’re looking at you, John Fauber) who are creating mainstream awareness of conflicts of interest.
Pfizer-funded workshop raises questions of ethics
Filed under: Conflicts of interest, Health journalism, Pharmaceuticals
Christopher Weaver, in a piece from Kaiser Health News and NPR, writes about a Pfizer-funded seminar for journalists. To attend the annual seminar about cancer, hosted by the National Press Foundation, 15 journalists get an all-expenses-paid trip to Washington, D.C.
Health care journalists, including HealthNewsReview.org’s Gary Schwitzer and AHCJ president Charles Ornstein, say reporters need to be careful and avoid even the appearance of a conflict of interest.
Foundation president Bob Myers says the pharmaceutical company does not have input on the meeting and an attendee of last year’s meeting, AHCJ member Joy Robertson, says she doesn’t remember Pfizer ever being mentioned at the event.
Commenters on the KHN/NPR include AHCJ members Ornstein; Andrew Holtz, M.P.H. (also a board member); Elaine Schattner, M.D.; and Schwitzer. Schattner, a licensed, non-practicing physician and medical educator, says “This is precisely how Pfizer and other companies try to influence physicians who, in their sometimes-arrogance, tend to think they’re “above” subtle persuasion. Are journalists any better?”
Journalist Merrill Goozner also has written about the seminar and says that that Pfizer has dictated the overall agenda:
Pfizer didn’t make an unrestricted grant to a journalism training organization. The money is being spent to train journalists in how to cover cancer.
Goozner points out, as does Holtz in his comment on the NPR/KHN piece, that “journalism spends less on training than almost any other profession” and that journalists have few opportunities to get out of the newsroom for professional education.
Covering Health wrote about this seminar and this issue last year. It’s worth noting, as we did then, that the Association of Health Care Journalists and the Center for Excellence in Health Care Journalism seek to minimize the possibility and appearance of inappropriate influence from outside parties. Pharmaceutical companies, insurance companies and medical device makers are examples of organizations with with AHCJ will not partner. Read AHCJ’s complete fundraising policies.
AHCJ’s Statement of Principles, which identifies challenges that health care reporters face and suggests how to meet those challenges, addresses the topic:
- Refuse gifts, favors, and special treatment. Refuse meals from drug companies and device manufacturers and refuse to accept unsolicited product samples sent in the mail.
- Weigh the potential benefits involved in accepting fees, honoraria, free travel, paid expenses from organizers of conferences or events against the desire to preserve our credibility with the audience and the need to avoid even the appearance of a conflict of interest.
- Also weigh the potential benefits of accepting awards from organizations sponsored by an entity with a vested interest in health care against our need for credibility.
- Weigh the potential conflict in accepting support from public, private, or foundation sources.
Conference walks back description of partnership with heart news website
A medical conference has retreated from a claim suggesting a trade website was being used to promote it and that supporters would be able to “reach new audiences” through a partnership between the conference and the website.
The 2010 Dallas-Leipzig International Valve conference has issued a correction after it came to light that it was promoting its partnership with theheart.org as a “highly influential source of publicity” and said theheart.org will “cover the benefits of attending DLIV 2010; it will forecast key aspects the meeting will offer; it will report on the highlights of the two-and-half day event - and more.”
Conference organizers have since posted the following note on its website (emphasis added):
Given the success of DLIV 2009 and its potential to grow in years to come, the meeting organizers have partnered with theheart.org to promote DLIV through their banner advertisements and e-blasts. [Correction: the previous material erroneously stated that industry would have the opportunity to gain exposure through theheart.org's news and editorial programs: this is incorrect, and the meeting organizers apologize for the error. theheart.org had no other involvement with DLIV's offers to industry.]
Shelley Wood, managing editor for Heartwire news and theheart.org, said, “There is a firm firewall between news activities and any advertising or sponsored content on theheart.org and at no point would outside parties be able to dictate the news or editorial content of theheart.org.” She pointed out theheart.org includes a staff of seven journalists.
Larry Husten, on his CardioBrief blog, pointed out details about sponsorships at the conference, including the opportunity for supporters to pay large amounts of money to meet with faculty members. He noted that its website linked to an Industry Prospectus, a document listing opportunities for exhibitors and sponsors. Sometime after he published the post with a link to the Industry Prospectus (now archived on Husten’s site), conference organizers removed it from the website.
In the prospectus the conference announced its partnership with theheart.org:
Given the success of DLIV 2009 and its potential to grow in years to come, theheart.org recognizes the impact the meeting has in the field of cardiac care. Through its website, online blog and print publications, theheart.org will cover the benefits of attending DLIV 2010; it will forecast key aspects the meeting will offer; it will report on the highlights of the two-and-half day event - and more.
With this highly influential source of publicity, DLIV 2010 offers to its supporters new benefits. By participating in DLIV 2010, you will not only reach the physician leaders who attend the meeting; you will also have the opportunity to make contact and establish relationships with a worldwide audience. Don’t miss out on the chance to reach new audiences, gain additional media benefits and connect your company with the specialty source for news and information.
Theheart.org’s editorial policy says it is committed to providing “balanced, accurate health information” and it “employs editorial professionals who are responsible for content selection, development and maintenance process.” It says it discloses “sources of funding and site contributors’ possible conflicts of interest.” It also says it complies with the HONcode standard for health information (more here).
It should be noted that Husten (aka @cardiobrief on Twitter) is the former editor of theheart.org, something he is quite open about.
Related
- AHCJ’s Statement of Principles
- Health on the Net Foundation’s Code of Conduct for medical and health Web sites
AAMC gives recommendations for clinical COI
After taking on continuing medical education and medical research, the Association of American Medical Colleges is now tackling conflicts of interest related to clinical care with its latest report, “In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making” (46-page PDF). If you’re just looking for the Big Recommendations, the most salient of which are paraphrased below, fast forward to pages 24 and 25. Warning: They’re vague.
- Medical centers should compensate doctors in a way that promotes the patients’ best interests.
- Professional medical societies and medical institutions (such as teaching hospitals) need to take a long, hard look at their own relationships with the industry.
- Institutions should identify their physicians’ industry relationships, set thresholds for their disclosure, and identify situations in which disclosures should be made directly to the patient. These regulations should all have teeth.
- Centers and physicians should work with patients to figure out how best to disclose industry ties.
The AAMC committee that produced the report wrote that, while they focused on academic medicine, their recommendations could (and should) be applied to all of clinical medicine.
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