July 4, 2015
Hidden Financial Ties Rattle Top Health Quality Group
Posted on Jan 28, 2014
By Marshall Allen, ProPublica
When the team of patient safety experts volunteering for the National Quality Forum met in 2009, it was no exaggeration to say lives were on the line. The dozen committee members were updating “safe practice” guidelines that are taken as gospel by the nation’s hospitals, where mistakes and preventable complications cause hundreds of thousands of patient deaths a year.
Dr. Chuck Denham, one of the country’s most visible advocates for patient safety, co-chaired the session. Denham resembles a trim version of Dr. Phil but talks faster, lacing his speech with a mix of self-help and business jargon. Though he lacked the deep research credentials of some others on the panel, Denham had more than made up for it with evangelistic zeal, including a featured role in a patient safety documentary with the actor Dennis Quaid.
A transcript of the meeting shows that when discussion turned to preventing hospital infections, Denham twice brought up a study that endorsed a particular formula for antiseptic skin cleansers. What the committee didn’t know: A business run by Denham had contracts worth $11.6 million from a company whose market-leading product, ChloraPrep, used that same formula.
Earlier this month, the U.S. Justice Department settled a $40 million whistleblower lawsuit with CareFusion, the maker of ChloraPrep. The case claimed the money paid to Denham’s business was a kickback to get him to manipulate the National Quality Forum’s standards and boost sales of the drug.
Square, Site wide
Denham has called the allegation “blatantly false.” But the case has shaken the patient safety world, prompting speculation about a star figure’s motives and questions about the inner workings of the Quality Forum, whose guidelines are regarded as the gold standard for best health care practices.
The Quality Forum has said it halted dealings with Denham in 2010 and took steps to insulate its guidelines from commercial influence. Officials from the organization said they were confident that none of the guidelines was corrupted to favor the company that was paying Denham.
But two high-profile members of the committee told ProPublica they believe the process was compromised, resulting in an unintended endorsement of ChloraPrep. And a review by ProPublica found that the group’s final 2010 guidelines, currently in effect, still recommend the ChloraPrep formula.
Asked about the discrepancy last week, the Quality Forum said it was launching a new review of all the recommendations listed in its 2010 “Safe Practices for Better Healthcare” report.
Also in response to questions from ProPublica, the Quality Forum divulged that Denham’s nonprofit was one of its contributors, and that in 2007 and 2008 it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009.
The committee members who spoke to ProPublica said they were surprised to see the formulation specific to ChloraPrep in the 2010 guidelines. The transcript of the committee’s discussion in 2009 shows that Denham suggested the panel endorse the formula, but no final agreement to recommend it.
Dr. Patrick Romano, a professor and researcher at the University of California, Davis School of Medicine, said the recommendation “is likely to reflect improper commercial influence.”
Both Romano and Dr. Peter Pronovost, who leads a patient safety institute at Johns Hopkins Medicine, said they had been unaware of Denham’s financial ties with CareFusion. Quality Forum officials said Denham never reported them, nor did he mention them during the 2009 meeting when members were asked to disclose their financial relationships, the transcript shows.
“He clearly lied,” Dr. Christine Cassel, the Quality Forum’s president and CEO told ProPublica. “He just didn’t say anything about any of his business relationships.”
Cashing In On Patient Safety
As the medical community comes to grips with the persistent problem of patient harm, companies are selling solutions. Although many groups recommend best practices, and an endorsement by the Quality Forum can mean riches.
Created in 1999 at the behest of a presidential commission, the Washington, D.C.-based nonprofit takes private donations and collects fees from members, including consumer groups, health plans and medical providers.
Five years ago, the federal government hired the Quality Forum to endorse measures to show whether health care spending is achieving value for patients and taxpayers. The contract has since grown substantially and by 2012 made up nearly three-fourths of the organization’s $26 million in revenue.
The Quality Forum’s standards are widely adopted. The report produced by the committee Denham co-chaired included recommendations for best practices in 34 areas of care.
Denham is not a practicing doctor. He runs both the Texas Medical Institute of Technology, an Austin nonprofit that focuses on patient safety research, and a for-profit company called Health Care Concepts that figured in the whistleblower case. He’s known in patient safety circles for his fervent motivational speaking and appearances with Quaid, whose infant twins nearly died from a medication error.
Between 2006 and 2009, Denham’s nonprofit donated $725,000 to the Quality Forum. The group and Denham had a five-year contract, but the Quality Forum declined to provide a copy or explain the terms, saying only that it was ended three years early, in 2010, after concerns about Denham emerged.
In a response to questions from ProPublica, Denham attorney Larry Gondelman said the Quality Forum signed off on all the recommendations that appeared in the final 2010 Safe Practices report.
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