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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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.
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:
PepsiCo sparks controversy on ScienceBlogs
Study authors don’t always have access to raw data
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals, Studies
John Fauber of the Milwaukee Journal Sentinel reports on outside authors of drug company-funded studies who do not have access to the raw data behind the study.
In the latest installment of Side Effects, a series examining doctors, drug companies and conflicts of interest, Fauber reports that a researcher who co-authored a study of Multaq that led to the drug’s FDA approval “vouched for the accuracy and completeness of the study despite not seeing the raw data.”
The researcher, Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, says he trusts the Sanofi-Aventis, the drug’s manufacturer.
Fauber delves into the differing editorial policies of the Journal of the American Medical Association and the New England Journal of Medicine when it comes to studies in which drug company employees perform the data analysis.
In the case of the Multaq trial, published by the New England Journal of Medicine, the FDA got unanalyzed raw data and did its own analysis. Fauber reports that “one FDA panel member questioned differences between the information included in the published February 2009 study and what was submitted to the FDA.”
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Roche linked to doctor praising drug in the media
Filed under: Conflicts of interest, Health journalism
Crikey.com, a news Web site based in Melbourne, Australia, calls our attention to some recent reporting about Mabthera, a drug used to treat non-Hodgkins lymphoma.
Nick Miller, health editor of The Age, recently reported that Mabthera, manufactured by Roche, “has been found to nearly double the number of [leukemia] patients who go into remission.”
In that article, Miller quoted a doctor as saying, “This is the largest single advance in the treatment of this disease in the last 30 years.”
Miller was rebuked by oncologist Dr. Ian Haines, who wrote a letter to the newspaper. Haines points out that the article was “an exaggeration of the benefits of the treatment with no presentation of the downsides … which is that it’s incredibly expensive, it’s not without risk,” according to Flint Duxfield, a student at the Australian Centre for Independent Journalism.
Duxfield goes on to explain how events unfolded and reveals that the promotion of Mabthera is being driven by Roche, which provides financial support to Peter MacCallum Cancer Centre, which employs the doctor who originally touted the drug in Miller’s article.
In fact, sections of the press release issued by the cancer center and the press release from Roche’s public relations company are identical and contain the same comments from the doctor quoted by Miller.
Duxfield also reports that warnings that have been issued for the use of Mabthera that have gone unreported in the print media.
The story says “the engagement of third parties in providing a link between a drug company and the media is all too common in health journalism.”
Veteran health reporter Ray Moynihan agrees: “It happens enormously often because third party endorsements are PR 101 for drug companies.”
Duxfield also points to other examples of these so-called “third=party endorsements” and how they have been reported in the media.
WebMD, Eli Lilly and a quiz about depression
Filed under: Conflicts of interest, Health journalism
Sen. Chuck Grassley, the prolific writer of public letters who often assumes the mantle of health consumer advocate, is at it again. This time he’s taking on consumer health information giant WebMD, whose ties with Eli Lilly seem to stretch back for some time. At issue is a WebMD quiz that purported to determine a user’s risk of depression. The fishy part? Until WebMD modified the quiz following Grassley’s letter and other outcry, even users who answered “no” to every question would be given the warning that “You may be at risk for major depression.”
As Daniel Carlat points out on his blog, the following disclaimer appeared at the top of the page: “This content is selected and controlled by WebMD’s editorial staff and is funded by Lilly USA.” As Carlat points out, 9 of the 10 symptoms in the quiz are taken from standard diagnostic criteria, but the one that isn’t (which relates to physical pain) just happens to dovetail perfectly with the pain-relief market Lilly is trying to carve out for Cymbalta.
Because Lilly markets Cymbalta as the “go to” antidepressant for patients who have both depression and physical pain. This is not really a “depression screening test” at all. Instead, it is a “Cymbalta-requester” screening test.
WebMD is telling the public a big lie. The say that “this content is selected and controlled by WebMD’s editorial staff” when in fact the crucial aches and pains questions was selected by Eli Lilly’s marketing team to encourage patients to ask their doctors for Cymbalta.
Grassley’s letter requested that WebMD respond with the details of their relationship to Eil Lilly by March 4. I didn’t find any evidence that such a response has yet been received.
Reporter finds conflict in N.Y. reform effort
Filed under: Conflicts of interest, Health care reform
A Syracuse University professor charged with reforming health insurance reimbursements gave up her position on an insurance company’s board on Friday after James T. Mulder, a reporter with The (Syracuse, N.Y.) Post-Standard, started looking into her ties.
Deborah Freund, a health economist and professor at Syracuse University, is overseeing a project intended to reform the health insurance system and eliminate conflicts of interest.
However, she has been on the board of Excellus since 2004 and received more than $61,000 from the health insurance company last year.
Freund oversees “FAIR Health Inc., a New York City-based nonprofit that is supposed to come up with a new, fair reimbursement system that will be used by insurers nationwide.” The project is funded by settlements from 13 insurers that used reimbursement data that rigged the system “to benefit insurers at the expense of consumers and doctors.”
At a news conference last year, [state Attorney General Andrew] Cuomo said the FAIR Health project will bring “ … transparency, accountability and fairness to a broken reimbursement system …”
Despite earlier statements from Excellus, the university and Cuomo’s office that Freund’s board position did not post a conflict of interest, a view not shared by consumer advocates, the professor resigned from the board Friday afternoon after Mulder spend several days looking into the situation.
Rule limits Harvard docs’ conflicts of interest
Harvard doctors will now be limited to making $5,000 a year for serving as board members for drugmakers and biotech companies, under a new rule intended to reduce the conflicts of interest in medical research.
Scott Hensley explains and rounds up the coverage on NPR’s Shots blog, with links to stories in The New York Times and The Boston Globe. Hensley writes that the new rules also prohibit taking company shares as compensation and from serving on drug companies’ speaker bureaus.
MIWatch.org calls for real disclosure reform
Filed under: Conflicts of interest, Pharmaceuticals, Studies
Phyllis Vine at MIWatch.org, a site that follows news about mental illness, asks whether drug company disclosures about payments made to doctors go far enough and whether anyone actually pays attention to such disclosures.
Vine raises the question of doctors taking part in “educational settings, including grand rounds, courses at professional conferences, or continuing education programs that pharma spends billions of dollars underwriting.”
She addresses the disproportionate number of psychiatrists who represent pharmaceutical companies and dominate the upper bracket of paid speakers. Vine also notes that, while many schools have drafted or are drafting policies about faculty-industry relations, enforcement of those policies is questionable.
Read the whole post on MIWatch.org.
Covering Health: First year’s most popular posts
With a year of posts behind us, we thought it would be a good time to look back and see what posts proved to be the most popular – or at least the most read:
- Lewin group linked to private insurers
- Autism news raises question: When is an embargo not an embargo?
- Hensley joins NPR’s expanding health team
- Report: $25,000 buys access to Post’s health reporters
- CDC monitors H1N1 swine flu-human reassortment
- Oransky to take helm at Reuters Health
- Top N.Y. neurosurgeons suspended, sued
- Pharma industry still finding its way in social media
- Hospital says it gives content to short-staffed media
- Kuklo scandal spotlights DoD/Medtronic ties
- ‘Playing through’ concussions is damaging
- Where to find the facts on health care reform
- CBS questions CDC’s H1N1 prevalence estimates
- VA officials seize reporter’s audio recording
- Oprah’s health advice needs a shot in the arm
- Autism and vaccines: A failure to communicate
- Will pharmacists play a role in H1N1 vaccinations?
- Covering Obama’s stance on stem cell research
- Appleby to report for Kaiser Health News
- Prevention vs. treatment in global health
- FDA staff calls for end to corruption, wrongdoing
- Mentally ill patients, elderly mix in nursing homes
- Three health-care issues Obama, Congress will face
- Jost discusses consumer-driven health plans
- Tim Tebow’s head fuels concussion debate
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Spend a week at the CDC studying public health, meeting sources. Apply for the AHCJ-CDC Health Journalism Fellowships today!
- Reporting on the intersection of health, environment
- Tip sheet: Covering cuts to Medicare reimbursements
- Briefing: Reporting on health reform between now and 2014
- Covering high-risk insurance pools: Tips for reporters
- Health care reform has passed: What's next?
- Health and education: Covering these intersecting beats
- Reporting on the business of health care
- Health reporting resources for journalists on state and local government beats
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