Tag Archives: Milwaukee Journal Sentinel

Reporter looks at black infant mortality in Wis.

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

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

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

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.