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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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.
Boulton explains comparative effectiveness
Filed under: Government, Health data, Health policy, Hot Health Headline
Next time somebody asks why the stimulus plan included $1.1 billion for comparative effectiveness research (and where all that money’s going), point them to Guy Boulton’s latest explanatory piece in the Milwaukee Journal Sentinel.
In this first installment, Boulton lays a strong foundation for the rest of his “occasional series” on comparative effectiveness by thoroughly answering the “how” and “why” of the massive research effort with carefully selected examples, experts and statistics. No word yet on where the series will go from here, but it’s a promising start.
Tip sheet for AHCJ members
Tracking health-related stimulus money: By Michael Grabell, ProPublica
Journal Sentinel creates overdose database
Tom Kertscher of the Milwaukee Journal Sentinel analyzed 1,200 fatal overdoses that occurred in the greater Milwaukee area over the past eight years and discovered that the majority of them were prescription drug-related. Kertscher puts the statistics in the context of the high-profile death of a local teenager, one which drew significant media attention to prescription drug abuse in the area.
Of the 1,200 deaths, which do not include suicides, just more than half were caused by prescription drugs.
An additional 19% of the deaths were caused by a mix of pharmaceuticals and illegal drugs, such as heroin.
…The victims of the most potent prescription drugs range from urban teens using anti-anxiety medications to get high to middle-age suburbanites who get hooked on narcotic painkillers after being injured on the job. They include residents of all 19 Milwaukee County communities and suburban county residents from Belgium to Kewaskum to Mukwonago.
Kertscher’s overdose database is available online and can be sorted through a search tool or overlaid on a Google map. The map can be sorted by race, age, sex, year and drug type.
Journal editor linked to spinal implant royalties
Filed under: Conflicts of interest, Hot Health Headline
John Fauber of the Milwaukee Journal Sentinel continues his coverage of conflicts of interest in medical research and journals with a look at journal editors. First, Fauber lays out the case in question:
- For seven years, a University of Wisconsin orthopedic surgeon (university bio | hospital bio) has been editor-in-chief of the Journal of Spinal Disorders & Techniques.
- During that time, he’s received more than $20 million in patent royalties thanks to spinal implants sold by Medtronic.
- Also during that time, an average of more than one Medtronic-related article appeared in each issue of the journal, most of them positive. Some were even co-authored by the editor/surgeon himself and related to the implant for which he gets royalties.
- Despite these coincidences, the journal never disclosed the potential conflict of interest.
Fauber then goes on to explore why journal editors aren’t mentioned more often in conflict-of-interest scandals, and then to explain exactly why those editors hold the sort of power that makes these conflicts particularly distressing. As Fauber explains, editors of medical journals can accept or reject manuscripts of studies involving drugs or devices - something that can make or break the product.
They can send a study out to peer reviewers who may be sympathetic to a particular drug or device by virtue of their own financial relationships with the companies that make those products. They can give authors more leeway to say positive things about a drug. They can turn down studies that say bad things about the product of a company they get money from.
The author of “On The Take: How Medicine’s Complicity with Big Business Can Endanger Your Health
Earlier coverage:
- Wis. researchers didn’t disclose conflicts to journals
- U. of Wisconsin conflict of interest policy gutted
- Wyeth paid university for ghostwritten articles
- University’s ties to testosterone therapy questioned
- Drug companies aim to sway docs through classes
- Wyeth-funded course promoted hormone therapy
- Academic docs collect money from manufacturers
Wis. researchers didn’t disclose conflicts to journals
Filed under: Conflicts of interest, Hot Health Headline
Milwaukee Journal Sentinel reporter John Fauber reports that conflicts of interest that local researchers disclosed to the university were not always disclosed when those researchers’ work was published.
Their investigation, a “spot check” of about 40 researchers, uncovered at least nine conflicts, such as the cancer specialist (bio) at the University of Wisconsin who “co-authored a medical article on TomoTherapy, a radiation therapy system developed by researchers at the university.” The article failed to mention that the physician had disclosed the university that he’d make $20,000 in 2008 consulting for TomoTherapy, and that he owned TomoTherapy stock options.
Fauber explores the causes of these failures to disclose conflicts of interest, which include systemic weaknesses in both research and publication and reliance on an “honor system.” He talks a little about his reporting method; it’s the sort of story that can be localized by anyone whose local university has a conflict of interest disclosure policy.
U. of Wisconsin conflict of interest policy gutted
Filed under: Conflicts of interest, Health data, Hot Health Headline
The Milwaukee Journal-Sentinel’s John Fauber reports that the University of Wisconsin’s proposed conflict-of-interest rules have been heavily watered down with the addition of an exception for doctors, including orthopedic surgeons, who implant devices. This is also a group of doctors who tend to bring in significant amounts of money for the university and thus tend to be rather influential.
Fauber:
After getting pressure from orthopedic surgeons, medical school and UW Medical Foundation officials amended the policy to allow doctors to make presentations for medical-device companies, provided they are paid no more than $500 an hour plus food, transportation and lodging.
In recent years, some of the most egregious ethical violations in the medical field, including allegations of kickbacks and extravagant payments, have involved orthopedic surgeons and companies that make implantable devices.
Journal Sentinel: STATS not as impartial as it claims
Filed under: Health data, Health journalism, Health policy, Hot Health Headline, Studies
The Milwaukee Journal Sentinel’s Susanne Rust and Meg Kissinger make the case that George Mason University-affiliated STATS, a media watchdog group that calls itself a “non-profit, non-partisan Statistical Assessment Service” actually has “a history of working for corporations trying to deflect concerns about the safety of their products.” They note that the organization contracted with Philip Morris at least twice to monitor news coverage on behalf of tobacco companies.
Photo by How can I recycle this via Flickr
STATS recently accused the media in general and the Journal Sentinel in particular of using sketchy science to over-inflate fears about bisphenol A. As Rust and Kissinger mention, “Gina Kolata of The New York Times and the Center for Health Care Journalists [sic]” repeated STATS’ claims of impartiality when writing about its report on BPA.
Rust’s and Kissinger’s research about STATS turned up documents, including an internal memo outlining Phillip Morris’ strategy for using STATS reports for their own PR purposes.
Rust and Kissinger also found that, while STATS does not disclose its donors, IRS documents showed that “the Sarah Scaife Foundation reported giving STATS $100,000 in 2007, an amount that equaled all of STATS’ assets - except for $435 in income interest. The Scaife Foundation funds a number of organizations that promote public policy against regulation, including the Heritage Foundation, the American Enterprise Institute and the Cato Institute.”
The reporters also chronicle an odd little incident in which they noticed that STATS listed the Hormone Society as a contributor on their Web site, a relationship which the foundation’s director vehemently denies.
Finally, reporters presented an interesting quote posted on the Poynter Institute’s Web site by STATS editor Trevor Butterworth, who they describe as “BPA’s fiercest advocate.”
“Forget conventional PR! If some bratty journalist gives you a whack, whack back with obscene, jaw dropping disproportion: knee him in the groin, pull what’s left of his hair out, tell him he writes in clichés, and misuses the semicolon, and stomp on his iPhone! A hack is like a bully, and charming a bully is a bit like reasoning with a psychopath or writing a novel on Twitter. For the tough cases, go Dada. . . . Defending the brand means exacting respect and that will come from fear not charm.”
Update
STATS has responded to the Journal Sentinel’s article, including a specific note about the use of Butterworth’s quote from the Poynter Institute’s Web site.
CJR: BPA truth lies in the middle
In the Columbia Journalism Review, Sanhita Reddy reviews a recent STATS critique of media coverage regarding Bisphenol A and the dangers it may hold. According to Reddy, both STATS and outlets like the Milwaukee Journal-Sentinel have taken overly extreme positions in the debate. While science hasn’t quite figured out the truth yet, Reddy says, it probably lies somewhere toward the center.
In an even-handed critique, Reddy disputes STATS’ attacks on popular anti-BPA source Frederick vom Saal’s credentials, but agrees that the media has been overly reliant on the University of Missouri scientist. Reddy also points out the fine line between placing more importance upon larger-scale, more valid studies (many of which are industry-sponsored) and identifying the conflicts of interest which may or may not exist alongside those industry connections.
In the end Reddy concluded that the conflict was a confusing one, but that as long as they brought a healthy dose of skepticism and took an extra look at the methods and materials sections of the research they were consulting, reporters should be able to give it fair coverage.
STATS: Media ignored science in BPA coverage
Filed under: Health data, Health journalism, Hot Health Headline, Studies
In a review of American media coverage of the controversy of bisphenol A, researchers at STATS (a nonprofit, nonpartisan Statistical Assessment Service affiliated with George Mason University), say the media failed to properly weight different studies based on their size and research methodology and relied too heavily on sources like the University of Missouri biologist Frederick vom Saal (bio page), a man STATS takes pains to discredit.
View the full 49-page pdf here.
The report’s thesis:
Scientists, regulators, and politicians in Europe, Australia, and Japan have all rejected the evidence that the chemical is harmful as methodologically flawed, badly conducted or irrelevant – with some warning that banning it could actually endanger the public. Now that the National Institutes of Health has acknowledged it funded a lot of poorly-designed research on BPA – the very research that activists touted as evidence that the chemical is deadly – it’s time to ask whether America has been spun by clever marketing rather than clever science.
STATS focused much of their effort on the Milwaukee Journal Sentinel’s coverage, critiquing the paper’s methodology and motivation in reporting and researching BPA.
Did the Milwaukee Journal Sentinel, which wrote over 30,000 words on BPA in 2008 get lost in the evidence, and end up being seduced by a storyline that made for great journalism but not very good science?
The 27,000-word review includes the case against Vom Saal (pages 10 through 18), a related critique on the Journal-Sentinel’s sources (pages 30 to 34), an illuminating tea analogy (page 15, infobox), and an explanation of how some studies are determined to be more valuable than others for risk-assessment purposes (pages 12 and 14, infobox). On pages 40 and 41, STATS mentions one of those valuable studies, from 2009, and questions why it was not covered in the media. Finally, those looking for the report’s most inflammatory language will find it in the conclusion (page 49).
It’s important to note that “STATS was contacted by Journal Sentinel reporter Meg Kissinger on June 15 with the complaint that the claim STATS contacted reporters at the paper was false because she has no record of being contacted.” STATS goes on to explain that it tried to contact Kissinger’s co-author, reporter Susanne Rust, and Mark Katches, deputy managing editor for projects, and that neither responded.
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