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Doctors with financial conflicts often have big say in developing medical guidelines, journalists find

The Milwaukee Journal-Sentinel looked at 20 clinical-practice guidelines issued for conditions treated by the 25 top-selling drugs in the U.S.

Epogen, an anemia drug and once Medicare's most expensive, was recommended in guidelines issued in 2006 by the National Kidney Foundation.
CC/Flickr/with a hook

In the latest installment in its terrific “Side Effects” series, the Milwaukee Journal-Sentinel, in conjunction with MedPage Today, reports on how the financial relationships between doctors and drug companies heavily influence medical treatment guidelines in the United States.

“Issued by leading medical associations and government institutions, treatment guidelines are supposed to be based on rigorous science,” write reporters John Fauber and Ellen Gabler. “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.”

For its investigative report, the Journal-Sentinel looked at 20 clinical practice guidelines issued for conditions treated by the 25 top-selling drugs in the U.S., such as Nexium (acid reflux), Lipitor (high cholesterol), Cymbalta (depression) and OxyContin (pain). The expert panels that issued those guidelines involved 293 physicians.

Here’s what Fauber and Gabler found:

  • Nine guidelines were written by panels where more than 80% 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% 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.

“The findings offer the latest glimpse into how pharmaceutical companies, with billions in sales at stake, exert a powerful but often unrecognized influence over the practice of American medicine,” the reporters conclude.

“At the end of the day, the drug companies own medicine,” a Harvard Medical School professor who has researched conflicts of interest in treatment guidelines, told Fauber and Gabler. “We’ve created a system that allows this.”

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Guidelines that harm

In the article, the reporters detail four examples of how guidelines panels whose members had strong financial ties with the drug industry “recommended treatments that have not been proven to make a meaningful difference — or that could even harm patients.” These treatments include opioid painkillers (such as OxyContin) for long-term chronic pain, Advair for asthma, erythropoietin-stimulating agents (such as Epogen) for anemia, and drugs known as glitazones (Avandia and Actos) for diabetes.

Here, for example, is part of what Fauber and Gabler uncovered about industry ties to the medical guidelines regarding Epogen:

An anemia drug, once Medicare’s most expensive, was recommended in guidelines issued in 2006 by the National Kidney Foundation.

The guidelines provided recommendations for treating anemia in chronic kidney disease patients and endorsed a class of drugs including Epogen. The drug helps raise levels of hemoglobin, a protein in red blood cells that carries oxygen. Epogen is marketed by Amgen and had 2011 sales of $2.8 billion.

On almost every level, the drug company was financially linked to the guideline process.

Fifteen of 18 panel members who wrote the guideline for the Kidney Foundation had financial ties to drug companies. Ten of those members, including both co-chairs, had financial relationships directly with Amgen.

Amgen paid $1.7 million in 2004 and 2005 to fund the guidelines for the Kidney Foundation. All told, foundation records show the group received $8.7 million from Amgen in those years.

As Fauber and Gabler point out, “Concerns about the safety of Epogen and drugs in its class have grown steadily over the past 10 years. Such drugs can increase blood clots and the risk of heart attack, stroke, heart failure and death.”

Attempts at reform

In 2011, the Institute of Medicine issued a report in which they recommended that no more than 50 percent of experts on guideline-writing committees should have financial ties with drug companies. The report also recommended that the chair of the committees should be entirely conflict-free.

But there has been strong resistance in the medical community to making that change, as Fauber and Gabler note:

Some medical societies have agreed to adopt the Institute of Medicine’s recommendation, but many others complain it is too difficult, costly and contentious among members, said Sheldon Greenfield, chairman of the group that issued the report titled, “Clinical Practice Guidelines We Can Trust.”

“By and large, most of the societies have ignored it,” said Greenfield, a professor of medicine and executive co-director of the Health Policy Research Institute at University of California, Irvine.

You can read the Fauber/Gabler article in full on the Journal-Sentinel’s website. Accompanying the article is a searchable database of top-selling drugs, guidelines and doctor conficts. Previous articles in the “Side Effects” series (which has been running since 2009) can also be found on the site.