BMJ analysis reveals widespread publication/selection bias in research
Filed under: Conflicts of interest, Government, Health data
Reporting on a study released by BMJ and characterized as an almost existential threat to the medical research system by Dr. Harlan Krumholz, the Milwaukee Journal Sentinel’s John Fauber writes that “Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing health care costs.” The emphasis is mine, the strong language Fauber’s.
The conclusions are based on a survey of meta-analyses of individual participant data, which the authors broke down by data source characteristics and publication status. The work is heavy on statistical analysis, but even lay readers can understand the broad strokes of what appears to be a widespread issue.
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug’s maker, GlaxoSmithKline, to turn over the data.
And it isn’t just pharmaceutical companies’ financial concerns driving the suppression, Nissen and his coauthors found. At that point, it may more of an issue of confirmation bias and other problems which have always lurked within academic research.
A surprising finding in the BMJ analysis was that serious lapses occurred even in clinical trials funded by the National Institutes of Health.
That research showed that less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.
Docs with Medtronic ties failed to disclose cancer case in trial report
Filed under: Conflicts of interest, Hot Health Headline, Public records
In the latest installment of his ongoing investigation for the Milwaukee Journal Sentinel and MedPage Today, John Fauber reports his discovery that physicians writing up a large-scale 2009 study “failed to identify a significant cancer risk” associated with Medtronic’s Amplify, a BMP-2 spine surgery product. At the same time, Fauber observes, Medtronic paid those same physicians millions.
The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.
…
The researchers had information showing that at two and three years after being implanted with the genetically engineered protein, significantly higher numbers of Amplify patients were being diagnosed with cancer, but they did not report it on their paper.
In addition to interviews with experts and ethicists, Fauber’s investigation was heavily informed by his review of federal documents.
The Journal Sentinel found a full airing of the cancer question in more than 1,000 pages of U.S. Food and Drug Administration records. That information included FDA reports and information filed with the agency by Medtronic as part of its application to win approval for Amplify.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse
Filed under: Conflicts of interest, Hot Health Headline
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.
Top docs spar over Medtronic research, Iraq service
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel’s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal’s recent Infuse issue devoted to the many complications and conflicts of Infuse.
The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.
The showdown began with Zdeblick’s defiant response to the Spine Journal’s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.
The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.
In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.
“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.
Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.
Pushback against Medtronic’s Infuse hits boiling point
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals, Public records, Studies
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.
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.
Medtronic attracts attention from Baucus, Grassley
Readers of Covering Health are likely familiar with medical device manufacturer Medtronic and John Fauber’s coverage of conflicts of interest surrounding the company’s Infuse product.
It seems that U.S. Senators Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) also are aware of the coverage.
The two, leaders of the Senate Finance Committee, have demanded “an extensive trail of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments.” [See the letter.]
Over the past year, Fauber, of the Milwaukee Journal Sentinel (see update), has reported that the company made payments to surgeons “involved in the clinical testing of Infuse or who wrote positive medical journal articles that failed to link the product to serious complications.” Those complications include unwanted bone growth outside the fusion site and sterility in men.
Infuse is a biological agent used in spinal fusion surgery that stimulates bone growth.
A professor of orthopedics at Dartmouth Medical School is pleased the Finance Committee is investigating, saying it is doing public health work because his profession and the FDA failed to prevent this circumstance.
It appears there is more news to come about Infuse:
Next week, independent researchers are expected to publish more papers revealing additional serious complications with Infuse that were not reported in numerous articles published over the last decade and co-authored by doctors with financial ties to Medtronic. The independent researchers said their research also was prompted in part by Journal Sentinel reports.
Update
This post should have mentioned that the Medtronic coverage is a joint project between the Milwaukee Journal-Sentinel and MedPage Today.
Medtronic, researchers failed to report known link to complication
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Medtronic, a medical device maker, and researchers with financial ties to the company have known for years that a “biological agent used in back surgery was linked to sterility in men,” reports John Fauber of the Milwaukee Journal Sentinel.
The doctors, who have received millions in royalties from Medtronic, failed to include the information in journal articles and instead claimed the sterility was caused by surgical technique, not the product. Information linking the product to the complication was included in what the company sent to the FDA as part of the approval process in 2002. But the doctors linked to Medtronic claimed there was “no relationship” as recently as last year.
Several independent doctors contacted by the Journal Sentinel say that while the surgical technique may be a factor in the development of the complication, the Medtronic authors should have stated Infuse also was linked to the condition.
The Journal Sentinel uses Document Cloud to share the documents – journal articles, letters of concern and commentaries – that explain the history of the product, Infuse. The documents are annotated, with key points highlighted and comments explaining the conflicts.
A study done by independent researchers, published today, links Infuse to retrograde ejaculation, a condition that causes sterility in men. Fauber reports the study was prompted in part by the Journal Sentinel’s earlier articles about Medtronic.
“To have such strong evidence that a life-changing complication of sterility exists and then cover it up in my opinion is obscene,” said Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics who has read the Stanford study.
Update
Read about the little -known Croatian doctor who pursued concerns about Infuse. Medical journals dismissed his concerns, including one reviewer who told him “as a Croatian he did not have the standing to make comments about Infuse.”
After Fauber’s story, pain group snips industry ties
Earlier this month, we blogged about Milwaukee Journal Sentinel reporter John Fauber’s work linking industry funding, local researchers and the rapid spread of painkiller use in America. Now Fauber’s written the best kind of follow up, with a story headlined “UW group ends drug firm funds.” Here’s the key paragraph:
UW made the announcement after an April 3 investigative report in the Journal Sentinel revealed that its UW Pain & Policy Studies Group had taken about $2.5 million over a decade from companies that make opioids. The money came while the group pushed for what critics say was a pharmaceutical industry agenda not supported by rigorous science: the liberalized use of narcotic painkillers for non-cancer chronic pain.
University officials claim they started cutting off industry funds in September, as part of a successful campaign to regain status as a World Health Organization collaborating center. However, they didn’t disclose that to Fauber during the course of his months-long investigation into the subject, saying that Fauber never asked about it. It’s worth reading the story for a more complete explanation of the change in funding.
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.
Related
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.
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