Tag Archives: Fauber

Network drives increase in painkiller prescriptions

Andrew Van Dam

About Andrew Van Dam

Andrew 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.

In the latest installment of his ongoing investigation for the Milwaukee Journal Sentinel and MedPage Today, John Fauber looks for the source of America’s prescription painkiller boom (graphic), outlining what he describes as “a network of pain organizations, doctors and researchers that pushed for expanded use of the drugs while taking in millions of dollars from the companies that made them.”pills-and-money

Beginning 15 years ago, the network helped create a body of dubious information that can be found in prescribing guidelines, patient literature, position statements, books and doctor education courses, all which favored drugs known as opioid analgesics.

Apparently, that network has been effective. Federal data shows that prescription painkiller sales have quadrupled in the past decade or so, Fauber found, and some of those sales may not have been warranted.

A band of doctors who get little or no money from opioid makers has begun to challenge the hype behind the drugs. They say pharmaceutical industry clout has caused doctors to go overboard in prescribing the drugs, leading to addiction, thousands of overdose deaths each year and other serious complications.

Several of the pain industry’s core beliefs about chronic pain and opioids are not supported by sound research, the Journal Sentinel/MedPage Today investigation found. Among them:

  • The risk of addiction is low in patients with prescriptions.
  • There is no unsafe maximum dose of the drugs.
  • The concept of “pseudoaddiction.”

That concept holds those who display addictive behavior, such as seeking more drugs or higher doses, may not be actual addicts – they are people who need even more opioids to treat their pain.

His investigation dips deep into each of those beliefs and how they helped push painkillers. For a case study, see this companion infographic.

BMJ analysis reveals widespread publication/selection bias in research

Andrew Van Dam

About Andrew Van Dam

Andrew 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.

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

Andrew Van Dam

About Andrew Van Dam

Andrew 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.

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

Andrew Van Dam

About Andrew Van Dam

Andrew 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.

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

Andrew Van Dam

About Andrew Van Dam

Andrew 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.

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.

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Pushback against Medtronic’s Infuse hits boiling point

Andrew Van Dam

About Andrew Van Dam

Andrew 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.

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.

spine
Photo by attila acs via Flickr

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.