Docs with Medtronic ties failed to disclose cancer case in trial report
Filed under: Conflicts of interest, Hot Health Headline, Public records
In the latest installment of his ongoing investigation for the Milwaukee Journal Sentinel and MedPage Today, John Fauber reports his discovery that physicians writing up a large-scale 2009 study “failed to identify a significant cancer risk” associated with Medtronic’s Amplify, a BMP-2 spine surgery product. At the same time, Fauber observes, Medtronic paid those same physicians millions.
The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.
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The researchers had information showing that at two and three years after being implanted with the genetically engineered protein, significantly higher numbers of Amplify patients were being diagnosed with cancer, but they did not report it on their paper.
In addition to interviews with experts and ethicists, Fauber’s investigation was heavily informed by his review of federal documents.
The Journal Sentinel found a full airing of the cancer question in more than 1,000 pages of U.S. Food and Drug Administration records. That information included FDA reports and information filed with the agency by Medtronic as part of its application to win approval for Amplify.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse
Filed under: Conflicts of interest, Hot Health Headline
John Fauber follows up his previous investigations into the myriad problems and conflicts of interest surrounding Medtronic’s Infuse product with a story on the emerging national epidemic of what pain specialists are calling “failed back surgery syndrome.” One local pain specialist Fauber contacted said that a full 10 percent to 15 percent of his patients suffered from the condition.
To bring the whole thing full circle, Fauber spends much of the body of this latest installment explaining how conflicts of interest and other questionable ethical situations, including off-label use, propelled the early and sustained success of Medtronic’s spine-fusion blockbuster and set the stage for the emerging pain epidemic.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
Top docs spar over Medtronic research, Iraq service
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel’s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal’s recent Infuse issue devoted to the many complications and conflicts of Infuse.
The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.
The showdown began with Zdeblick’s defiant response to the Spine Journal’s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.
The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.
In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.
“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.
Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.
Pushback against Medtronic’s Infuse hits boiling point
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals, Public records, Studies
Medtronic’s ongoing woes with its blockbuster spine fusion product Infuse have been a staple of Covering Health for as long as we can remember, but things have reached a crescendo this week.
The first blow came with the publication of John Fauber’s in-depth report (read it at the Journal Sentinel or in MedPage Today) on the conflicts of interest and regulatory weak points that kept Infuse going strong despite serious questions about medical outcomes.
The next day, The Spine Journal made the unprecedented move of dedicating an entire issue to repudiating the failures of science and medical journal publication that made Infuse what it is today. For the record, both those links point straight to journal press releases. If you’re looking for more context, you’ll find it in Fauber’s followup to The Spine Journal’s Infuse issue. HealthNewsReview editor and publisher Gary Schwitzer also blogged his take on the releases.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
MJS finds attempts to improve infant mortality rates are fragmented
Filed under: Health journalism, Hot Health Headline
This year, a team at the Milwaukee Journal Sentinel launched “Empty Cradles,” a yearlong reporting effort to find out why infant mortality is so high in the region and whether it must be that way. As we near the halfway point, their effort has already produced some powerful journalism and given new impetus to an issue that had been simmering, almost ignored, on the front burner all long.
Lakisha Stinson holds her daughter, Rashyia, in their Milwaukee home. Stinson’s first daughter, Kelviana, died of sudden infant death syndrome in 2004. Photo: Rick Wood/Milwaukee Journal Sentinel
In their latest major installment, in which they explore potential solutions to the crisis (and the recent lack thereof), reporters Crocker Stephenson and Ben Poston sum up the reason for their investigation in two damning paragraphs.
In Central Harlem, babies once died at a rate twice that of Milwaukee. But through a unified effort, the community has slashed its infant mortality rate by 78% since 1990. The rate there is now about 6 deaths per 1,000 births, lower than the state of Wisconsin as a whole.
In Milwaukee – where tens of millions of tax dollars have been spent in the past decade – 11 out of every 1,000 infants die before their first birthday. The city continues to have one of the worst infant mortality rates in the nation, especially for African-Americans, whose babies die at a rate about 2.5 times that of whites.
The problem, it seems, is that while the state supports 110 infant mortality reduction initiatives, they have so far failed to coalesce into a united public health effort.
Milwaukee and a few other urban areas are looking to change that, starting with the Lifecourse Initiative for Healthy Families which began in 2009. Modeled on successful programs in places like Harlem, the effort seeks to address the full spectrum of social factors that lurk behind high mortality rates.
In an earlier installment, reporters Mark Johnson and Tia Ghose looked at a medical mystery: African Americans in the United States are at a much higher risk than white Americans to have premature births, babies with low birth weights and infant mortality.
A married, college-educated African-American woman faces worse odds than a white, unmarried woman who dropped out of high school.
For more on how the series came together, see the background article editor Greg Borowski wrote for AHCJ this spring. It’s a great explanation of how to take a problem that everyone regards and common knowledge and report it into a deep, engaging, yearlong series. For more on previous installments in the series, see our coverage from January.
Drug-funded research group failed to disclose ties to makers of painkillers
In his latest conflict of interest investigation, Milwaukee Journal Sentinel reporter John Fauber takes on a challenge that, even by his standards, is an ambitious one.
He attempts to show the effect pharmaceutical money and the local researchers who received it had on national opinions toward powerful prescription painkillers and how it all influenced the American epidemic of opiate abuse.
He focuses on the University of Wisconsin Pain and Policy Studies Group, which has received millions from painkiller manufacturers while publishing drug-friendly research and warning against increased regulation of OxyContin and its ilk. Many of these millions, Fauber found, appear not to have been disclosed in relevant publications even as the group was paving the way for the rapid rise of painkiller prescriptions in America.
The drugs had initially been approved for a very narrow range of uses, but became extremely popular as off-label use for the management of chronic pain spread like wildfire. It’s not easy to draw clean lines between the Wisconsin group and off-label use, but Fauber’s deft investigative work and careful sourcing make a strong case.
Related
Faltering Wis. transparency law has national lessons
Filed under: Health care reform, Health data, Health policy, Hot Health Headline, Public records
Journal Sentinel reporter Guy Boulton’s investigation of Wisconsin’s ongoing failure to properly implement a statewide health care transparency law that went into effect on Jan. 1 covers the local details well, but is really set apart by Bolton’s careful explanation of why hospital pricing transparency is so tricky. You’ll have to read straight through to the last paragraph to get the full effect, so be patient.
The law in question is an “incremental” measure that was all legislators could push through in the face of industry lobbying. It requires hospitals to “provide price information on request,” but Boulton writes that there’s a problem with that, namely, “That information just doesn’t have any relation to what you and your health insurance plan will actually have to pay. Rather, it requires disclosing the equivalent of a sticker price or manufacturer’s suggested retail price – a price that almost no one pays.”
The law does require physician practices with four or more doctors to disclose prices that are closer to what commercial health plans actually pay, on average, for 25 conditions. But compiling that information proved impractical in the time allotted.
The Department of Health Services didn’t even try implementing the law’s provisions for other health care providers this year, concluding that it wasn’t practical.
As Boulton points out, “price information also has become more important as more people have health plans with high deductibles,” but setting prices in health care is tricky and varies widely. To compound the problem, “prices negotiated by health plans and health systems are confidential.”
Wisconsin may provide a cautionary tale about what could happen in other states or nationally.
Reporter looks at black infant mortality in Wis.
Filed under: Children, Health data, Hot Health Headline
The Milwaukee Journal Sentinel’s Crocker Stephenson took a look at disparities in infant mortality in that area and explored both their cases and ramifications. In Wisconsin, black babies die at twice the rate of white babies, a finding which may just be the tip of the iceberg. For national and international comparisons, see the companion infographic. According to Stephenson, infant mortality rates are an early indicator of a community’s degeneration. When mortality rises, so do other dire indicators.
The bottom third - the group of ZIP codes with the most poverty and lowest college graduation rates - had the highest infant mortality rate.
It also had the highest premature death rate, chlamydia rate, HIV rate and teen birthrate.
It had the greatest percentage of low birth weights; preterm births; uninsured adults; people who hadn’t seen a dentist in a year; births to mothers who received no prenatal care during their first trimester; smokers; pregnant smokers; obesity; violent assaults within the past year; single-parent households; and children who tested positive for lead poisoning.
Milwaukee’s health commissioner called it a “crisis,” one that Stephenson found is as much a social matter as it is one of access to proper care. For more, see the “Problem Areas” section of the story.
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.
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