Efforts to correct biased and dangerous medical studies are making more headlines.
Shortly after I posted about a new idea to correct missing and misreported research, I got an email from AHCJ member John Fauber, an investigative reporter at the Milwaukee Journal Sentinel.
His latest story for the Journal Sentinel and MedPage Today involves an extensive undertaking coordinated by Yale University to correct the record on a product made by Medtronic called Infuse. The project is called YODA, for Yale Open Data Access. (Read more..)
Infuse — officially a device — consists of a metal cage fitted around a sponge that is soaked in a genetically engineered protein. The protein is supposed to promote bone growth and healing. It works, but perhaps too well. Side effects linked to its use include bone overgrowth that can trap and irritate nerve roots causing chronic pain. It has also been tied to a complication called retrograde ejaculation, which leads to sterility in men. Patients who receive infuse also experienced more problems with wound healing and more cancer.
All in all, pretty devastating outcomes for patients who were hoping to feel better after their back surgeries. Continue reading
A few weeks ago, I reached out to a disease charity for comment on a story I was working on. Disease charities are nonprofits like the American Heart Association, the Cystic Fibrosis Foundation, etc., that raise money to support the research, care and awareness of people who live with a given condition.
The story was about a rare but very dangerous side effect that was tied to new drug. The side effect is considered so serious that other drugs that cause it have been yanked off the market because of the risk.
I expected the scientific officer I spoke with to react to this news, which was published in a top-tier medical journal, with alarm and concern for patients who were taking the medication, which is poised to become a blockbuster. Instead, though, he was largely dismissive of the reports. He extolled the potential benefits of the newly approved medication for patients.
As reporters, we all have those moments when our spider senses tingle. You may not be able to put your finger on exactly why, but something just doesn’t feel right. Continue reading
As part of the ongoing Milwaukee Journal Sentinel and MedPage Today series “Side Effects” John Fauber and Ellen Gabler “examined 20 clinical practice guidelines for conditions treated by the 25 top-selling drugs in the United States” and unearthed yet another tactic by which “pharmaceutical companies, with billions in sales at stake, exert a powerful but often unrecognized influence over the practice of American medicine.”
Issued by leading medical associations and government institutions, treatment guidelines are supposed to be based on rigorous science. But the committees that write them have been dominated by doctors who have worked as paid speakers, consultants or advisers for companies selling the recommended drugs.
In their investigation, the duo found:
- Nine guidelines were written by panels where more than 80 percent of doctors had financial ties to drug companies.
- Four panels did not require members to disclose any conflicts of interest. Of the 16 that did, 66 percent of doctors on the panels had ties to drug companies.
- Some guidelines written by conflicted panels recommend drugs that have not been scientifically proven to safely treat conditions, leading to inappropriate or over prescribing. Medical experts have raised such questions about guidelines for anemia, chronic pain and asthma.
For extensive anecdotes and examples, dig into the full piece.
Over at the Milwaukee Journal Sentinel and MedPage Today, John Fauber updates Side Effects, his long-running investigation into conflicts of interest, with coverage of a Senate inquiry which Fauber’s work helped inspire.
The Senate investigation, led by the familiar bipartisan duo of Max Baucus and Chuck Grassley (2,315-page PDF | press release), involved the review of about 5,000 pages of documents from medical device maker Medtronic (a frequent subject of Fauber’s reporting) over the course of 16 months.
Fauber, who is uniquely qualified to do so, summarized the report’s key findings:
Medtronic marketing employees were secretly involved in drafting and editing favorable medical journal articles about the company’s lucrative back surgery product while the company paid millions to the surgeons whose names lent weight to the studies, documents from a U.S. Senate investigation reveal.
The company’s undisclosed manipulation of information about its genetically engineered spine surgery product, Infuse, included overstating its benefits and downplaying concerns about serious complications.
Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product.
More than a decade into America’s new age of opiates, the long-term effects of the ubiquitous prescription painkillers are starting to be felt on a real, measurable scale. As part of an evolving investigation for the Milwaukee Journal Sentinel and MedPage Today, John Fauber and Ellen Gabler drive this home by following up on seven patients – and one physician – featured in an early promotional video for OxyContin maker Purdue Pharma.
Originally conceived as a teaching aid, the video was ultimately used in a marketing campaign in which Purdue sent it to about 15,000 doctors. A Purdue subsidiary has since paid $634 million in penalties for misbranding OxyContin in its various promotional campaigns but, as the reporters found, the patients who used the drug sometimes paid an even steeper price, as demonstrated by the subsequent lives of the seven “poster children” featured in that video. I’ll let Fauber and Gabler take it from here.
The subjects who spoke glowingly of their experiences with OxyContin in the video 14 years ago offer a case history of sorts.
Two of the seven patients were active opioid abusers when they died. A third became addicted, suffered greatly, and quit after realizing she was headed for an overdose. Three patients still say the drug helped them cope with their pain and improved their quality of life. A seventh patient declined to answer questions.
The doctor who enlisted his patients for the video and played a starring role, now says some of the statements went too far.
Within this broad sketch, the reporters find much room for story and nuance, touching upon everything from the impact of the drug on patients with a history of addiction to the legitimate success stories of patients who had their lives changed by the powerful narcotic. It’s a well-drawn, big-picture portrait of the swath opiates have cut through modern American, told through the lens of a unique and fascinating narrative device.