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.
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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.
CMS releases hospital-by-hospital data on never events
Filed under: Health data, Health journalism, Hot Health Headline, Public records, Studies, Tools
About nine months after its original due date, the Centers for Medicare and Medicaid Services have overcome industry opposition and made data for hospital acquired conditions publicly available online. The data come in a 1.2 MB zip file, inside of which you’ll find a hulking 26,889-line spreadsheet.
The sheet breaks down the nation’s 4,700 or so hospitals, using Medicare fee-for-service claims from October 2008 through June 2010, based on the rates of eight different “never events,” each of which is compared with the national rate for the event in question. The hospitals can be sorted by name and state. Below, I’ve illustrated the national rates for all included HACs.
According to MedPage Today’s Emily Walker, CMS published the data to help patients make informed decisions and to help hospitals improve their quality of care. They did so, she points out, over strenuous industry objections.
The data was originally scheduled to be published in September 2010 but was met with strong resistance from hospital groups such as the American Hospital Association (AHA); the groups say that CMS never made specifics available for how it calculates the HAC rates, making “fundamental assessments of the accuracy of capturing the incidence of these conditions” impossible to conduct.
“Hospitals continue to urge CMS not to publish these data,” read a March 31 joint statement from the AHA, the Federation of American Hospitals and the Association of American Medical Colleges.
Newspaper, news service team up for medical news
The Milwaukee Journal Sentinel and MedPage Today, a medical news service for doctors, will collaborate to produce articles on medical news, according to a report from EditorAndPublisher.com.
The report says AHCJ member John Fauber, a health and science reporter for the Journal Sentinel, will lead the partnership. “Journal Sentinel Editor Marty Kaiser said giving Fauber the resources of two news organizations will benefit readers.”
E&P says the first story is scheduled to appear in March and will be released simultaneously by MedPage Today and the Journal Sentinel.
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