Tag Archives: milwaukee

Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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.

Pushback against Medtronic’s Infuse hits boiling point

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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.

spine
Photo by attila acs via Flickr

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

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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 newborn daughter, Rashyia, in their Milwaukee home. Stinson’s first daughter, Kelviana, died of sudden infant death syndrome in 2004. Infant mortality is a problem that plagues the Milwaukee area. Photo: Rick Wood/Milwaukee Journal Sentinel
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.

Fauber: FDA to review data on jaw implants

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Milwaukee Journal Sentinel‘s reporter John Fauber reports on the FDA’s order to review the long-term performance of certain joint implants. Fauber’s story on the agency’s failure to adequately test and regulate these products came out in late November.

lower-jaw

Photo by Jacob Enos via Flickr

The implants in question treat certain ailments affecting the joint that connects jaw and head, a disorder Fauber says “affects more than 10 million Americans, including a small number who undergo radical surgery to implant an artificial jaw joint.” And those people, Fauber reported and the FDA now acknowledges, have had a rough time in the long term.

Among the medical device reports it has reviewed, 52% of the devices that had to be removed were taken out less than three years after they were implanted, the agency said in an e-mail to the Journal Sentinel.
Device problems included the need for removal or replacement, loosening, difficulty removing, noise, fracture and breaking, the FDA said.
Patient problems included pain, surgical procedure or repeat surgical procedure, additional therapy and nonsurgical treatment or treatment with medication, infection, swelling, hospitalization and headache, it said.

At this point, the FDA isn’t talking about taking the devices off the market, but it is reviewing the existing data and beefing up its repeated requests that device makers supply long-term market data about the implants they’ve sold.

Beginning in 1999, the FDA approved four such devices made by three companies. At the time of approval it ordered the firms to collect the market data it now is reordering.
That data was inadequate, the agency said, noting that it did not show why or how soon the devices were being replaced. In addition, the companies had lost contact with many of the patients who had received the devices.
Without knowing that information, the agency cannot determine the true safety and effectiveness of the products or whether any of them should be removed from the market.

Diana Zuckerman, president of the National Research Center for Women & Families, credited Fauber’s reports in the Journal Sentinel and MedPage Today, a medical news website that partners with the newspaper, with prompting the FDA’s action.

Doctors tied to manufacturer report better outcomes, may influence spinal surgery

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

After using a FOIA request to obtain documents the Food and Drug Administration had labeled “confidential,” Milwaukee Journal Sentinel reporter John Fauber has found that conflicts of interest may have played a role in the outcomes of clinical trials for Medtronic’s much-debated spinal fusion product BMP-2.

In a review of the study’s summary data for the newspaper, researchers at Dartmouth-Hitchcock Medical Center found 91 of the 364 patients in the trial – 25% – were implanted by surgeons who had a financial connection with Medtronic. Those doctors reported an 80% overall success rate, compared with 63% for doctors with no ties to the company.

Fauber also notes Medtronic’s response, which was to simply point to comments the company had made for a previous Fauber story.

At the time, [Medtronic spokeswoman Marybeth Thorsgaard] said the company fully disclosed the success rates of the doctors with financial ties to the company to the FDA. She noted that those doctors also had better results with the patients in the trial who did not get BMP-2.

In a companion story Fauber writes that, much like in the clinical trials, the journal articles published to push BMP-2 (and its off-label use) were riddled with conflicts of interest. One of his sources even called one article “egregious” for “blowing off” complications.

Related

Bloomberg’s Peter Waldman and David Armstrong write about the “national boom in costly fusion surgeries” and how “surgeons have prospered from performing fusions, which studies have found to be no better for common back pain than physical therapy is – and a lot more dangerous.” The pair also look at Medtronic’s payments and other ties to doctors who perform the surgery, as well as some of the risks of the surgery.