Tag Archives: medical devices

New Wisc. rules lead to interesting disclosures

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.

Thanks to new disclosure requirements from the University of Wisconsin’s doctor group, the Wisconsin State Journal‘s David Wahlberg was able to report that 10 UW-Madison doctors received $48,000 or more from drug and device companies.

Thomas Zdeblick, M.D., pulled in almost $1.7 million. In fact, most of them were orthopedic surgeons, a fact which shouldn’t surprise anyone who’s been following the State Journal‘s conflict-of-interest work, as well as that of the Journal Sentinel‘s John Fauber.

Before 2010, doctors only had to report that they’d received more than $20,000 from such industry associations. Now, they have to disclose specific amounts. The disclosure requirements are currently the most prominent component of the schools’ crackdown of conflicts of interest, but activists say conflict disclosure is only half the battle.

A policy adopted in 2009 by the UW Medical Foundation, the university’s doctor group, bans doctors from doing promotional speeches for companies and accepting gifts such as free meals. Surgeons, however, can use materials created by device companies to conduct government-required training sessions, Golden said.
The foundation’s policy prohibits doctors from receiving royalties for using products at UW Health, which removes any incentive to use the doctors’ products instead of others, Golden said.

An interesting side note: UW clinics post signs detailing how patients can obtain their doctor’s disclosure form, but such requests have been few and far between, Wahlberg found “14 in 2009, 18 in 2010 and seven” in 2011.

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.

NYT reporters tease hip replacement numbers from difficult data

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.

Writing for The New York Times, Barry Meier and Janet Roberts analyzed a particularly tricky batch of federal reports detailing a variety of complaints with popular metal-on-metal hip replacements. They found that, since January, the FDA has received more complaints (5,000-plus) about the devices than it did, total, from 2007 to 2010.

kidsPhoto by Michael Simmons via Flickr

While processing the data, the paper’s staff did their best to parse duplicate reports, international filings and other inconsistencies, but the reporters make it clear that the numbers are still best viewed in general terms. Even so, they demonstrate that the surge in complaints and lawsuits involving metal-on-metal hips — and the resulting mass defection of doctors who once implanted them — signals a broad shift in hip replacement surgery, one of the most common such procedures in the country. It also signals another blow for device manufacturers and patients, and a related windfall for the legal profession.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

Reporters find heart devices skipped FDA’s more rigorous approval process

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Deborah L. Shelton and Jason Grotto of the Chicago Tribune couldn’t help but wonder: How does a medical device get implanted into patients without first getting FDA approval?

Tricuspid valve in a model heart
Tricuspid valve in a model heart. (Photo by robswatski via Flickr)

That question led to their two-day series in late May that reported for the first time that certain heart valve repair devices had been “down-classed” from class III to class II, a regulatory category that required that they undergo less scrutiny, even though the devices are permanently implanted and life-sustaining.

One of the annuloplasty rings had been stitched into the hearts of at least 700 patients in Chicago and elsewhere without going through proper channels. In fact, even though the company could have submitted both rings for clearance through a less rigorous regulatory pathway, it didn’t even do that. In these two cases, the process was skipped in its entirety.

In this article for AHCJ members, the pair explains how they reported the story, including finding documents and persuading affected patients to speak on the record.

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.

Potential changes in regulation of medical devices would likely impact health care costs

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.

As the medical device industry ramps up its campaign against further government regulation, Merrill Goozner takes stock of the regulatory and business environment in that arena and explains what is at stake. The key battleground at present is possible modifications to the 1976 law which allows devices to bypass some rigorous testing as long as they’re similar to something that has already been approved for market. The problem? That similarity doesn’t always mean they’re safe, as Goozner points out.

glucose-testing

Photo by AlishaV via Flickr

A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only 19 percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.

Despite slipping onto market through the similarity provision, many of these new products claim to be improvements over their predecessors and thus come with commensurately higher price tags. According to Goozner and his sources, this little disconnect has done quite a bit to increase the cost of health care in America.

“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”

The device industry, often cited for its red-hot growth rates in the past, now posts numbers that, while huge, still lag behind the health sector at large. That may be why the industry is stepping up political pressure to reduce its regulatory burden and to sidestep a 2.3 percent excise tax that was passed as part of recent health care reform efforts. For more on the money and politics involved, see Goozner’s full piece, which was also published in The Fiscal Times.

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