Tag Archives: Fauber

Independent reviews find less benefit, more harm than first reported for bone protein product

Brenda Goodman

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

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

When disease charities partner with drug companies, where does that leave patients (and reporters)?

Brenda Goodman

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

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

Even in treatment guidelines, pharma conflicts abound

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, and he has blogged for Covering Health ever since.

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.

Investigation: Medtronic paid millions to surgeons; ghostwrote papers

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, and he has blogged for Covering Health ever since.

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.

OxyContin’s early poster children: Where are they now?

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, and he has blogged for Covering Health ever since.

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.

Investigative reports lead to Senate investigation into painkiller promotion

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, and he has blogged for Covering Health ever since.

Following up on reporting efforts from the Milwaukee Journal Sentinel/MedPage Today and ProPublica, a Senate committee has launched investigation into the pharmaceutical industry’s conflict-of-interest-laden promotion of pain management drugs, one of which may or may not be related to one pharma-tied patient organization’s Tuesday announcement that is was closing up shop “due to irreparable economic circumstances.”

screen-shot-2012-05-09-at-73727-pmThus far, the investigation has consisted of strongly worded rebukes and requests for further disclosure to the abovementioned American Pain Foundation, among others, in the form of letters from Sens. Max Baucus and Charles Grassley. PDFs of the relevant letters can be found in this press release from Baucus’ Senate finance committee.

In the letters, the senators directly cite the investigative efforts of AHCJ members Charles Ornstein, Tracy Weber and John Fauber.

Sen. Max Baucus

Sen. Max Baucus

Ornstein, AHCJ’s board president, and Tracy Weber, his fellow ProPublica senior reporter, published their investigation into the American Pain Foundation in ProPublica and The Washington Post in December. As they write in their post on the foundation’s demise, “The group received 90 percent of its $5 million in funding in 2010 from the drug and medical-device industry, ProPublica found, and its guides for patients, journalists and policymakers had played down the risks associated with opioid painkillers while exaggerating the benefits.”

Fauber’s reporting, the result of a partnership between the Milwaukee Journal Sentinel and MedPage Today, focused on the tangled web of money, organizations and influence through which the pharmaceutical industry helped propel the runaway growth of painkiller prescriptions over the past decade and a half.

Sen. Charles Grassley

Sen. Charles Grassley

In his report on the senate investigation he helped inspire, Fauber writes that the finance committee is “seeking financial and marketing records from three companies that make opioid drugs, including Oxycontin and Vicodin, and seven national organizations.” The legislators are seeking records of financial transactions between pharmaceutical manufacturers and patient groups from as far back as 1997, as well as details on any federal funding provided to the groups.

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, and he has blogged for Covering Health ever since.

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, and he has blogged for Covering Health ever since.

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, and he has blogged for Covering Health ever since.

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, and he has blogged for Covering Health ever since.

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.