Tag Archives: Milwaukee Journal Sentinel

Even in treatment guidelines, pharma conflicts abound

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.

Investigative reports lead to Senate investigation into painkiller promotion

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

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.

Docs with Medtronic ties failed to disclose cancer case in trial report

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

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.