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.Īnd it’s those financial ties, of course, that Fauber is determined to ferret out. 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. If you’re wondering what problems could result from all of these applications, Fauber’s got a story for that too.Īccording to Fauber, the 2002 Infuse introduction was straight out of the classic drug industry playbook:įirst, a buzz is created about a potential new therapy. About 85% of that was off-label use, according to the study, which was presented in March at an orthopedic surgery meeting. 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.
It’s key component is BMP-2, a protein which “essentially turned whatever it touched into bone,” Fauber writes. 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.įirst approved for a relatively narrow application, Infuse now succeeds thanks to widespread off-label use. Medtronic is back at the FDA, asking for approval of another spine fusion product. Conflicts of interest + off-label use = Blockbuster
This entry was posted in Health journalism, Hot Health Headline and tagged missouri, Off-Label Use, pharmaceutical advertising, pharmaceutical companies, pharmaceutical industry, post-dispatch on Octoby Andrew Van Dam. It’s the same formula he used for his story on another imploding local drug-maker, KV Pharmaceuticals, earlier this year.Īndrew 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. The company has pleaded guilty to federal criminal charges and agreed to pay $300 million in criminal and civil penalties, Doyle reports.Īrmed with the breaking news, Dolye then goes deeper, finds the company’s local roots, charts its rise and tries to pinpoint where it went wrong. Louis Post-Dispatch, tells the story of Forest Pharmaceuticals (a subsidiary of Forest Laboratories), which has been accused by federal regulators of sketchy marketing practices, primarily involving its antidepressants Celexa and Lexapro and unapproved pediatric use. Midwest Health Journalism Program fellow Jim Doyle, a reporter at the St.
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