Flawed approval process led to flawed jaw implants
Filed under: Conflicts of interest, Hot Health Headline
In the Milwaukee Journal Sentinel, reporter John Fauber proves that it’s possible to do cutting-edge reporting on conflicts of interest and tie those conflicts to clinical trials of devices that hit the market a few decades ago.
His targets? Jaw joint devices that were initially grandfathered in, and for which newer treatments were approved in the late ’90s and early 2000’s. These trials, Fauber found, were too small, too conflicted and too inconclusive to provide real data, yet the devices were approved anyway. Now, he has found, patients are paying the price.
I’ll just include the first sentence here, as I’m confident that nobody will be able to resist reading the rest of Fauber’s story.
Before implanting a third artificial jaw joint in Heidi Clark’s head, doctors had to remove particles of plastic from the second failed joint that had broken apart and become embedded in muscle.
Health stories top Investigative Business Journalism awards
Health-related investigations (including one by an AHCJ member) snagged both top spots in the Barlett & Steele Awards for Investigative Business Journalism this year. The awards, funded by the Donald W. Reynolds National Center for Business Journalism, judge stories based on “investigative enterprise, strong business theme, writing style, clarity and impact.”
Reuters’ Murray Waas took the top spot, called the Gold Award, for “Diagnosed with Breast Cancer, Dropped by Insurer (PDF),” a four-month investigation of WellPoint’s rescission algorithm. He’ll get $5,000.
The Silver Award, meanwhile, went to AHCJ member John Fauber, of the Milwaukee Journal Sentinel, for “Side Effects: Money, Medicine and Patients,” the long-running conflict of interest investigation we’ve covered extensively on this blog.
There was no Bronze Award, but another health story — “Inside the Health-Care Crucible: Reports from a Hospital in a Time of Upheaval,” by the Philadelphia Inquirer’s Michael Vitez — did earn an honorable mention. We’ve mentioned Vitez’ dispatches before, he’s the reporter who spent months “embedded” in a suburban Pennsylvania hospital.
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.
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.
Related
- Article looks at evidence behind back surgery
- Uncovering conflicts of interest in medicine, research
- Journalists encounter obstacles in identifying conflicts of interest in medical research
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.
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