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.
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.
According to Gondelman, Denham’s nonprofit was obligated to provide financial and staff support for Quality Forum projects, including evidence-based medicine reviews, hosting webinars and creating multimedia presentations about the safe practice recommendations.
Denham declined an interview request. He said in a separate statement that the $11.6 million came via two contracts in 2008 with Cardinal Health to develop performance models and software to help reduce infections. CareFusion was a subsidiary of Cardinal Health at the time.
The 2010 film with Quaid, "Chasing Zero," was made and promoted by Denham’s nonprofit and partially funded by CareFusion. The film features interviews with prominent patient safety experts, including Janet Corrigan, former chief executive officer at the Quality Forum.
ChloraPrep is not named in the film, but in one scene it is being applied while an expert talks about its ability to prevent surgical-site infections. According to Denham’s website, a copy of "Chasing Zero" was to be sent to every hospital in the country.
CareFusion officials declined to comment for this story. The Justice Department case, filed in U.S. District Court in Kansas, accused CareFusion for marketing ChloraPrep for off-label uses. Documents in the case describe the antiseptic as the No. 1 drug in its class in 2010 with sales of $193 million. The government alleged that the money paid to Denham’s company was part of an effort to boost sales and included financing in a study published in the New England Journal of Medicine.
The January 2010 study, whose authors all reported ties to Cardinal Health, found that ChloraPrep — a combination of 2 percent chlorhexidinegluconate with isopropyl alcohol — reduced the risk of surgical site infection by 41 percent compared to a common alternative.
Company promotional materials went on to portray the finding as a 41 percent reduction in infections, and a 41 percent reduction in costs, the Justice Department said in court papers.
The 2 Percent Solution
At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a "major journal" would show the effectiveness of the 2 percent chlorhexidine antiseptic.
Pronovost said it wasn’t necessary to actually identify ChloraPrep because it was well known as the product with the 2 percent chlorhexidine formulation.
The committee members agreed that chlorhexidine was an effective antiseptic – guidelines by the Centers for Disease Control and Prevention (CDC) say so as well. But studies show it also works in other concentrations and combinations.
Discussion turned to recommendations for preventing infections caused by central lines, the thin tubes inserted into a vein to deliver fluids or medications. Dr. Gregg Meyer of Massachusetts General Hospital in Boston, the co-chair of the committee with Denham, brought up the forthcoming study.
"Chuck (Denham) made me aware of it," Meyer said. He then asked Pronovost, a leading expert on preventing central-line infections, what he thought.
"There has been a systematic review in a number of studies that show chlorhexidine reduces risk by about half," Pronovost said.
Denham replied that the upcoming study showed a 40 or 50 percent reduction. "The specifics," he added, "were the 2 percent."
Pronovost noted that studies have shown other methods also reduce infection rates. "My own recommendation would be to follow the CDC guidelines," he said.
The 2002 CDC guidelines said a 2 percent chlorhexidine antiseptic is preferred, but that other skin cleansers, such as iodine, can also be used. Newer 2011 CDC guidelines recommend an antiseptic with greater than 0.5 percent chlorhexidine combined with alcohol.
The committee never delved into the merits of the ChloraPrep study or whether one particular concentration of chlorhexidine was better than another, the transcript shows.
In interviews, Pronovost and Romano both said they were uncomfortable with the way the Quality Forum’s panel operated. The process wasn’t as scientifically rigorous as it should have been, they said, and it was hurried, without enough time to carefully review all the evidence.
The transcript shows the committee moving through dozens of complex topics, from improving hand hygiene and decreasing wrong-site surgery, to safety culture, pediatric imaging and infections.
Pronovost said he complained to the Quality Forum about the process and questioned at the time whether he should continue to participate.
"The NQF has a big voice and a lot of credibility," Pronovost said. "I wanted to make sure that whatever we recommended would truly be beneficial and wise because it would change practice in America — hospitals would do it. I felt we lacked a formal process for revising and grading the evidence of recommendations for these safe practices."
Ultimately, he decided not to leave the committee because he believed in the Quality Forum and wanted to influence the process, he said. Something might be put into place that doesn’t save lives, he said, or something might be recommended that doesn’t help but uses tremendous resources.
"When you’re doing these things you have to be extremely mindful," he said.
The committee members were volunteers, Romano said, and some felt burdened with the responsibility of reviewing so much material without the help of the Quality Forum staff. Romano said staffers from Denham’s Texas Medical Institute of Technology performed the committee’s administrative functions, selecting the studies to review and drafting the versions of the guidelines.
"It was all a bit of a mystery to us that Chuck Denham was so generous with his time and his staff time to support this process," Romano said.
A Competitor Objects
After the meeting, when the committee’s draft report was published in late 2009, a recommendation for preparing surgical sites to prevent infection did not name ChloraPrep but did specify its telltale formula – a 2 percent chlorhexadine and alcohol antiseptic.
That draft recommendation was challenged by 3M, a company that makes a competing product. A scientific review of the evidence by a Quality Forum ad hoc committee found a lack of clear evidence to support one skin prep product over another. As a result, the recommendation to use the ChloraPrep formulation on surgical sites didn’t make it into the final 2010 safe practices report.
On the separate issue of reducing central-line infections, the 2009 draft report endorseda chlorhexidine antiseptic but did not specify any one concentration – just as the committee decided. Yet the final 2010 report does call for a 2 percent chlorhexidine and alcohol antiseptic like ChloraPrep.
Although Quality Forum officials seemed surprised to learn this last week from ProPublica, the group is listed as a co-host, with Denham’s nonprofit, of a webinar where the 2010 safe practices guidelines for central-line and surgical site infections are presented.
The presentation, posted on the website of Denham’s nonprofit, states that the Quality Forum recommends the ChloraPrep formulation to protect against both central-line and surgical site infections.
CareFusion also cites the Quality Forum’s endorsement in at least one brochure on its website.
Since the financial ties between CareFusion and Denham’s business became public, the Quality Forum heard from "a wide range of people in the community," spokeswoman Ann Greiner said. That feedback led to the decision to review the entire safe practices process over the next 30 days, she said.
"We’re taking a very affirmative action here," Greiner said.
Pronovost said the controversy over Denham should not call into question all of the Quality Forum’s work. He said the lack of scientific rigor of the safe practices committee reflected Denham’s influence, but the process behind the Quality Forum’s other measures is more robust.
All the same, he said, it raises significant concerns about oversight of the burgeoning quality improvement industry.
"It’s an enormous business," Pronovost said. "Hundreds of millions or billions of dollars are at stake, but our transparency procedures haven’t matured."
Editor’s note: ProPublica is investigating health care quality and welcomes your input. Medical providers – help us by completing a brief Provider Questionnaire. Patients can complete ProPublica’s Patient Harm Questionnaire.