Fauber: FDA to review data on jaw implants
Filed under: Government, Health journalism, Health policy, Hot Health Headline
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.
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
Filed under: Conflicts of interest, Health data, Health journalism, Hot Health Headline
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.
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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.
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WSJ details conflicts that drive spine fusion surgery
Filed under: Conflicts of interest, Health data, Hot Health Headline, Public records
The Wall Street Journal’s John Carreyou and Tom McGinty have taken advantage of their paper’s Medicare data stockpile to look at the conflicts of interest and piles of royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed. Their work centers on Medtronic, which the Milwaukee Journal Sentinel’s John Fauber also has written about.
Photo by planetc1 via Flickr
For surgeons, the financial incentives to perform spine fusions can be strong. Though hospitals often lose money on the procedure when it’s performed on Medicare patients due to the high cost of the implants, the surgeons themselves can get paid as much as $12,000 per surgery.
Complex fusions … are reimbursed by Medicare at a sharply higher rate than decompressions, to account for the elaborate spinal devices used and the longer length of surgery. Complex fusions increased 15-fold among Medicare beneficiaries with spinal stenosis from 2002 to 2007, according to the JAMA study.
A big part of many surgeons’ income lies in their consulting and royalty arrangements with device makers, although disclosure of these arrangements remains piecemeal for now. Medtronic began releasing information about its payments to surgeons on its website in June, after coming under intense scrutiny from Sen. Charles Grassley (R., Iowa).
They’re required to keep some details under wraps, but the WSJ duo still manages to unleash anecdotes, including one about a surgeon who received “between $400,000 and $1.3 million in royalty, consulting and other payments from three spine-device makers.”
For reporters looking to understand the medical issues surrounding these procedures and why these conflicts can be detrimental to patients, see Janet Moore’s work in the Star Tribune.
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.
Trade group says conflicts negate GPOs’ leverage
A recent GAO report looked at group purchasing organizations and established that they were pervasive, and that they’d adopted some internal ethics rules. It did not, however, substantially evaluate charges that GPOs can increase cost and stifle innovation.
However, a medical device trade group picked up where the GAO left off. According to a study published last week by the Medical Device Manufacturers Association (53-page PDF), repealing the special GPO exemption to a general ban on kickbacks in situations where federal health spending is involved would result in as much as $25 billion in annual savings. The study’s a quick, forceful and engaging read, but it comes, of course, from an organization that clearly has a dog in the fight.
The Health Industry Group Purchasing Association, a trade association representing 16 GPOs, has – not surprisingly – a different view, evidenced by its website, GPOsSaveMoney.org.
Medicare competitive bidding ramps up
Filed under: Health care reform, Health journalism, Hot Health Headline
The California HealthCare Foundation Center for Health Reporting and the San Bernardino County (Calif.) Sun teamed up for a package of stories explaining the local roll-out of a Medicare program that’s testing a competitive bid process for medical devices and equipment.
On Jan. 1, 2011, Medicare will implement the program in nine metropolitan areas nationwide. Bids are already underway. In the series’ flagship story, Deborah Schoch, of the Center for Health Reporting, and the Sun’s Monica Rodriguez looked into the program’s potential for controlling costs and cutting down on fraud. For an illustration of potential savings and payment amounts, see the graphic that ran alongside their work.
The potential savings of going from a set fee schedule to a competitive one should be fairly evident. The anti-fraud measures, on the other hand, require a bit of explaining. According to Schoch and Rodriguez, the system promises to prevent fraud by requiring vendors to be bonded and insured, and to have legitimate storefronts for their durable goods. It will be harder for vendors to upsell seniors into buying needlessly elaborate equipment, and the smaller community of suppliers will be easier to police overall.
Local reporters can refer to the CMS site for precise zip code maps of the round one bidding areas.
Competitive bidding is nothing new to government agencies, and the duo’s sources believe that they’re ready to make it work in Medicare as well.
After working for Medicare for 32 years, (regional Medicare administrator David Sayen) believes the new plan contains the elements to make it work, Sayen, 57, said in a recent telephone interview. “It’s got the three legs - a mechanism to set pricing, a mechanism to provide quality assurance, and one to prevent waste and fraud.”
The ambitious program has, of course not gone unchallenged, though officials seem confident they will be able to resist the last-minute push from vested interests this time. Some, they write, were inefficient enterprises that were sustained only by Medicare’s generous fee schedule. They will probably not survive in a competitive environment.
Industry groups are pointing to a Sept. 26 letter signed by 166 economists, including two Nobel Prize winners, addressed to California Rep. Pete Stark, Democratic chairman of the powerful health subcommittee of the House Ways and Means Committee.
The signers lambaste what they call four key problems with the program: a lack of binding commitments, the use of composite bids, and what they call flawed pricing and a lack of transparency.
The program could degenerate if vendors become unreliable, product and service quality lags and supplies dwindle, they wrote.
Medicare recipients will be advised of the changes by mail, and through a series of educational sessions.
And, for the record, here’s a list of items up for bids in this first round:
- Oxygen supplies and equipment
- Standard power wheelchairs, scooters, and related accessories
- Complex rehabilitative power wheelchairs and related accessories
- Mail-order diabetic supplies
- Enteral nutrients, equipment and supplies
- Continuous positive airway pressure (CPAP), respiratory assist devices (RADS) and related supplies and accessories
- Hospital beds and related accessories
- Walkers and related accessories
- Support surfaces (Miami only)
If you work in one of the nine bidding areas and have written something about the process, let us know in the comments! We’re hoping to feature more local stories on the program as the new year draws nearer.
X-ray regulation, inspections a patchwork
The Investigative Reporting Workshop’s Caroline Stetler explains what she calls “the patchwork regulation of technicians who perform imaging exams,” and the risks that come with it.
In short, there’s no national standard for training or performance of such technicians, 12 states don’t have any requirements at all, and standards in the other 38 vary wildly. As the medical imaging industry continues to flourish, and Americans’ exposure to radiation increases, regulations have failed to keep pace. Likewise, imaging equipment has proliferated, but inspection rules have not. Only mammography machines are subject to federally mandated annual inspections, though the Joint Commission and other organizations will begin accrediting imaging centers in 2012.
The story package also includes an excellent, interactive state-by-state breakdown of licensing numbers and variations, as well as a number of related videos.
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FDA, device makers, patient advocates lock horns
Filed under: Government, Health data, Health policy
In MedPage Today, Joyce Frieden breaks down the FDA’s day-long town hall meeting that brought together device makers, federal officials and patient advocates last week. Frieden’s report points to more contention than consensus, with the debate crystallizing around a few key issues, most of them related to the FDA’s device approval process.
Predictably, the device makers’ griped about the FDA approval process, one which patient advocates say is lacking in clinical trials, especially long-term ones.
“The overall tone is that the predictability and certainty of our interactions with the FDA are worsening,” Paul LaViolette, venture partner at SV Life Sciences, said at the session, which was part of the Transcatheter Cardiovascular Therapeutics meeting. “Where is the problem? It’s at the review level.”
LaViolette, who is also a member of the board of directors of AdvaMed, a trade group for the medical device industry, said he had “a sense that turnover at the reviewer level is intensifying. Companies report that four out of every 10 submissions experience turnover at the reviewer level. So we have reviewers that are less confident in making a decision, and more meetings are required.”
The FDA blames the slowing approval process in part to the increased reliance on clinical trials conducted outside the U.S., which introduces a swarm of additional variables which regulators must take into account. The recession and an accompanying blow to the venture capital supply and investor confidence also helped reduce the number of devices approved, an industry representative said.
Other topics of discussion included the industry’s request that the FDA’s approval for use and CMS’ approval for Medicare reimbursement be “harmonized,” as well as the FDA’s request that industry look into ways to increase minority patient participation in clinical trials, which is disproportionately low at present.
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.
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Identical tubing demonstrates FDA’s inaction
In The New York Times, Gardiner Harris outlines the problem of medical tubing that looks very similar – leading to medical errors – then deftly works his way up the chain in an attempt to find the source of device regulator’s failure to solve a problem that seems entirely solvable.
Many medical device tubing looks the same, which leads to horrific mix-ups like the delivery of food straight into the bloodstream. In 2007, The Wisconsin State Journal’s David Wahlberg earned first place in the medium newspapers category of AHCJ’s Awards for Excellence in Health Care Journalism for his Medical Misconnections series, which detailed the same problems. He even wrote an AHCJ article teaching journalists how to investigate patient safety problems.
Photo by bennylin0724 via FlickrSince then, not much has changed. Which is not all that surprising, when you consider that not much had changed in the decades before Wahlberg’s story either. Harris’ mission is to dig past the finger-pointing and figure out why. In the end, it all seems to point to some remarkable systemic flaws in the FDA’s device approval system, as well as an unwillingness on the industry to change without the threat of brute regulatory force. In addition to compelling analysis, Harris punctuates each argument with a few spicy quotes.
You’ll have to read Harris’ story to truly understand the perversity of the FDA system and how its lent such inertia to the status quo, but here’s a sample:
Dr. Robert Smith, an F.D.A. device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which has gone on for decades, was another example of how the agency failed to protect the public. “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Dr. Smith said.
And, from Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who believes that “Nurses should not have to work in an environment where it is even possible to make that kind of [tubing] mistake.”
“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”
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