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.
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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.
Public Citizen: Pharma tops government defrauders
Filed under: Health policy, Hot Health Headline, Studies
The nonprofit consumer group Public Citizen has conducted an analysis that indicates that the pharmaceutical industry has passed the defense industry as the biggest defrauders of the American federal government. They looked all the way back to 1991, writing that “the total size, varied nature, and potential impact of these illegal and potentially dangerous activities have not been previously analyzed.” Their findings indicate that, not only is pharma fraud dominant, it’s also skyrocketing. Two of the most salient bullet points:
- Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
- Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
We learned about the study from Milwaukee Journal Sentinel reporter John Fauber, who also blogged about Public Citizen’s findings.
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.
Doctors quietly get millions from device makers
Filed under: Health journalism, Hot Health Headline, Studies
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
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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Australia lagging in conflict-of-interest disclosures
Filed under: Conflicts of interest, Health journalism
When a country is holding up the United States as a model of progress on medical conflict of interest issues, you might suspect there are some serious systemic issues there. Such seems to be the case in Australia, based on Melissa Sweet’s recent post on the Croakey blog. At present, there’s little baseline research into industry funding and influence in Australia, though what little there is seems to indicate a situation similar to what we’ve found in the United States. The lack of research seems to stem from a lack of awareness and perhaps even indifference.
Photo by acediscovery via FlickrThe catalyst for this post seems to be the Walkey Media Conference, a media industry confab sponsored by the national journalists’ union that generated a bit of controversy thanks to a sponsorship from Exxon Mobil.
Sweet found a University of Sydney seminar in July that was to look at conflicts of interest to be less than packed, and inferred that Aussie “academics seem to regard (COI) as irrelevant, tedious or confronting.” Furthermore, she wrote, “Australian universities are dragging the chain in dealing with their staff’s conflicts of interest, at least compared with institutions in the US.”
The post makes a strong, well-researched case for COI disclosure and serves as a sort of roundabout compliment to the dogged American journalists (we’re looking at you, John Fauber) who are creating mainstream awareness of conflicts of interest.
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