Conflicts of interest + off-label use = Blockbuster
Filed under: Conflicts of interest, Health journalism, Hot Health Headline
Medtronic is back at the FDA, asking for approval of another spine fusion product. Not coincidentally, the Journal Sentinel’s John Fauber is also hard at work, this time exposing the conflicts of interest and off-label applications which helped make Medtronic’s first spine fuser, Infuse, into a dubious blockbuster.
First approved for a relatively narrow application, Infuse now succeeds thanks to widespread off-label use. It’s key component is BMP-2, a protein which “essentially turned whatever it touched into bone,” Fauber writes.
One recent study found a fourfold increase in the use of all BMP products in five years, from 24,000 procedures in 2003 to 103,000 in 2007. About 85% of that was off-label use, according to the study, which was presented in March at an orthopedic surgery meeting.
If you’re wondering what problems could result from all of these applications, Fauber’s got a story for that too.
According to Fauber, the 2002 Infuse introduction was straight out of the classic drug industry playbook:
First, a buzz is created about a potential new therapy. Then, research - often by doctors with financial ties to the product - is presented to the FDA for a specific use in a narrow group of people. Once the product is on the market, other uses for it are promoted in articles and presentations, often by doctors with financial ties to the company.
And it’s those financial ties, of course, that Fauber is determined to ferret out. He starts with a man whose name (and photo) will already be familiar to Fauber fans: Thomas Zdeblick.
Conflicts of interest involving Thomas Zdeblick, a prominent surgeon at the University of Wisconsin-Madison, are at the heart of the BMP-2 story. He and a small group of doctors from around the country with financial ties to Medtronic have paved the way toward the product’s approval and widespread use.
Zdeblick holds patent rights to a key component of the product and has received more than $22 million dollars in royalties and other payments from Medtronic since 2002. He also is co-author of research reports about the pivotal FDA clinical trial that led to the approval of Infuse.
When Infuse was first approved, it was noted that physicians with financial ties to Medtronic produced results twice as good as those of their independent counterparts. At the time, the panel dismissed it with a joke about how every physician should have a stake in Medtronic, as it sure seemed to improve outcomes. When Fauber tried to find out more about these early concerns and disclosures, however, he ran up against a wall of FDA obfuscation, intentional or otherwise.
The FDA redacted sections of its 2001 file listing the financial disclosures of the Infuse investigators, and it repeatedly told the Journal Sentinel that information no longer was available.
An FDA spokesman first e-mailed this reply: “The information you are asking for was part of the sponsor’s presentation and FDA did not require submission nor did the agency maintain copies.”
Then Friday, a different FDA official said the agency erred and the records were available, but they would be difficult to find.
With a similar BMP-2 based Medtronic product, Amplify, now under consideration, the story of Infuse is more relevant than ever.
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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.
Most EU patient groups get industry money
Filed under: Conflicts of interest, Europe, Health journalism
Over at Pharmalot, Covering Health veteran Ed Silverman reports on one European activist group’s survey of corporate sponsorship and disclosure in patient and consumer groups across that continent. The report focuses on the 23 groups eligible to work with the European Medicines Agency, an agency responsible for the scientific evaluation of medicines developed for use in the European Union. The EMA has clear transparency guidelines, but this report gives a strong indication that they’re often neither followed nor enforced.
Photo by dimnikolov via FlickrHAI [the advocacy group] notes the EMA introduced transparency guidelines in 2005, but by March 2010, 20 of the 23 eligible groups that were surveyed had not yet reported 2006 income online. “Despite the lack of compliance, all organizations were invited to participate in the EMA annual meeting in December 2009,” HAI adds. One problem cited: EMA guidelines do not stipulate a reporting deadline or cycle, and so some groups have not yet met requirements established five years ago.
- Fifteen organizations were either partly or almost entirely funded by industry-related groups, only seven had fully independent funding. One was unknown.
- Contributions went up over the three years examined in the study. From Silverman: “The average donation rose from 185,500 EUR (about $235,500) per sponsored organization in 2006, to 282,090 EUR (about $358,00) in 2007, and to 321,230 EUR in 2008 (about $407,800). In percentage terms, the increases amounted to 47 percent, 51 percent and 57 percent, respectively (please note the dollar figures are expressed in today’s values).”
- Most groups didn’t follow EMA transparency guidelines. Only six seem to have complied with the full letter and spirit of the rules.
The full report is available here (20-page PDF). If you’re just looking for the juicy stuff, scroll to the results table on page 10.
Related
For more news about health care and news coverage in Europe, be sure to visit AHCJ’s new Covering Europe pages.
Article looks at evidence behind back surgery
Filed under: Conflicts of interest, Health care reform, Hot Health Headline
In the Star Tribune, Janet Moore seeks to counter aggressive spinal surgery with equally aggressive journalism. It’s a comprehensive take on a subject which journalists have been hammering away at piecemeal for some time now. Her anecdotes are strong, and her numbers doubly so. For example:
Photo by planetc1 via Flickr
Four out of five Americans will suffer from disabling back pain during their lifetimes, according to the National Institutes of Health. Spending on back care soared between 1997 and 2005, reaching $86 billion — just shy of what Americans spent battling cancer.
As those numbers have multiplied, so have questions about the more aggressive forms of back treatment. A 2008 study in the Journal of the American Medical Association, for example, noted that the increase in back-care spending occurred “without evidence of corresponding improvement” in patients’ health.
As Moore points out, this is a debate that will continue as health reform is implemented because the new legislation will “require doctors and hospitals to demonstrate that their services are cost-effective. In that vein, the New England HealthCare Institute estimates the United States could save roughly $1 billion a year by eliminating unnecessary back surgeries.”
Minnesota is home to Medtronic, a leading maker of devices used in spinal surgery. Medtronic has consultation arrangements with a number of doctors and some experts question whether that relationship has an effect on how many spinal surgeries are done. The head of the Association for Ethics in Spine Surgery, says these financial incentives create demand for certain brands of product.
It’s a lengthy piece, and the numbers are just one component. The whole package is definitely worth a read.
Related
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.
J-S settles records suit; docs rebel against COI rules
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Public records
As a result of the Milwaukee Journal Sentinel’s now-settled lawsuit against the University of Wisconsin, John Fauber was able to review newly public e-mails which show just how angry a segment of the faculty became when faced with the university’s new, stricter conflict of interest regulations. The regulations came, of course, in the wake of Fauber’s investigative reporting on the subject.
The newspaper’s lawsuit argued that the faculty comments were public records under Wisconsin law and sought a court order to obtain them. To settle the lawsuit, the newspaper agreed to accept the 41 e-mails with the names of the doctors blacked out. The foundation also provided a separate list with the names of the 28 doctors who wrote the e-mails.
The (UW Medical Foundation) also agreed to pay the newspaper’s attorneys’ fees of about $12,400.
The e-mails make for good reading, and Fauber wastes no time in deploying the liveliest phrases in his story.
For example, some physicians complained about the 18-month exemption for orthopedic surgeons and other implanters of medical devices, including one who said “Allowing our docs to shill for device companies is a complete perversion.” An orthopedic surgeon responded with a different take, saying it was “clearly ridiculous” to limit his hourly take from device makers to just $500.
For an explanation from Fauber on how he has been able to consistently produce groundbreaking stories on the conflict-of-interest beat, see the article he wrote for AHCJ.
U. of Michigan president sits on pharma board
On The New York Times Prescriptions blog, Duff Wilson reports that while her school has taken a lead in limiting conflicts of interest, University of Michigan President Mary Sue Coleman herself sits on the board of Johnson & Johnson, a post which earns her $229,978 each year. Her defense is that she’s openly disclosed the relationship, and that the world of pharma and that of university administration rarely intersect.
Responding to questions on Ms. Coleman’s behalf Monday, Kelly E. Cunningham, a spokeswoman for the university, said the president satisfied the policy by disclosing her outside work. Ms. Coleman has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her, Ms. Cunningham said.
“The same is true at J&J,” she added. “There has never been a discussion or decision at the board level that involved something related to the UM. But, of course, if there were, she would recuse herself.”
It’s not uncommon for university presidents to sit on corporate boards, Wilson found, but it appears that pharmaceutical companies are a special case given the major role universities play in medical research and health care delivery.
Thomas Donaldson, a corporate governance expert and professor of business ethics at the Wharton School of the University of Pennsylvania, reviewed the case on Monday for The Times. He said many university presidents serve on corporate boards, but biomedical company boards pose special issues because of the possible ties to university research and medical schools.
“Because of the role of research and also the entrepreneurial interest that lies behind a lot of modern advances in medicine, this is a very difficult issue,” Professor Donaldson said in a telephone interview. “We’ve been aware for decades really that this potential for conflict of interest exists, but we haven’t as a moral community or even inside universities gotten our arms around it yet.”
ScienceBlogs reverses course, evicts Pepsi blog
PZ Myers of the Pharyngula blog on ScienceBlogs reports that Seed CEO and editor-in-chief Adam Bly has sent a letter to its bloggers saying that the PepsiCo blog that caused a number of high-profile bloggers to flee the site has been removed.
Myers quotes from the e-mail:
We apologize for what some of you viewed as a violation of your immense trust in ScienceBlogs. Although we (and many of you) believe strongly in the need to engage industry in pursuit of science-driven social change, this was clearly not the right way.
Bly continues, asking questions about how to better include industry-funded scientists in social media and the ongoing public health discussions that take place in the online community.
Earlier:
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