Four years before his name surfaced in a legal settlement over an alleged kickbacks scheme involving CareFusion (NYSE:CFN), officials at an influential non-profit patient safety group asked Dr. Charles Denham to step away from his role as co-chairman on 1 of its committees, uncomfortable with his interest in including a CareFusion antiseptic skin wipe in national standards, officials told MassDevice.com.

The U.S. Justice Dept. claimed in a Jan. 9 press release that CareFusion paid $11.6 million to induce Denham to "recommend, promote and arrange for the purchase" of its ChloraPrep wipes to healthcare providers.

At the time of the alleged payments, Denham was co-chairman of the Safe Practices Committee at the National Quality Forum, a group that reviews and endorses standardized healthcare practices and performance measures for hospitals in the interest of improving patient safety. The forum’s recommendations are "often invisible at the clinical bedside but quietly influence the care delivered to millions of patients every day," according to the NQF website.

In 2010, the NQF’s Safe Practices Committee recommended ChloraPrep for skin preparation prior to surgery to reduce surgical-site infections in a draft release of the forum 2010 Safe Practices Report. After prosecutors named Denham earlier this month, the NQF sought to distance itself from Denham and ChloraPrep, saying it had pulled the ChloraPrep recommendation before issuing its final 2010 report.

"The Safe Practices Committee initially recommended endorsement of a safe practice that included use of a particular type of skin preparation prior to surgery, a preparation sold by CareFusion," according to the release. "The reference to this specific type of skin preparation was removed from the draft Safe Practices report after an NQF ad hoc review did not find sufficient evidence to support 1 skin preparation over another."

Yesterday, Ann Grenier, NQF’s vice president of public affairs, told MassDevice.com that the ad hoc review was begun after concerns arose over the inclusion of ChloraPrep in NQF’s 2010 update of its Safe Practices for Better Healthcare report.

"There was discomfort in [Denham’s] engagement with the process, which led us to want to sever our relationship with him in 2010," Grenier told us.

The CareFusion settlement

Two weeks ago CareFusion put the lid on a 2-year federal probe into the sales and marketing of its ChloraPrep antiseptic skin wipes.

The agreement resulted in the San Diego-based medical device company paying out $41 million to settle accusations of off-label promotion and a kickbacks scheme. Federal prosecutors claimed that CareFusion, under a 2008 agreement with its predecessor Cardinal Health, paid Denham specifically to "recommend, promote and arrange for the purchase" of the ChloraPrep skin antiseptic to healthcare providers.

For CareFusion, which admitted no wrongdoing in the settlement, that’s likely the end of it.

Kristen Cardillo, CareFusion’s vice president of corporate communications, told MassDevice.com in an email that the company would not comment further on the government’s allegations, but that CareFusion has ” made significant investments in our compliance programs and are pleased to bring final closure to this matter. As part of the final settlement agreement, the company is not admitting wrongdoing.”

CareFusion had assumed a consulting agreement with Denham after the spinoff from Cardinal Health in 2009, she added, explaining that “all projects with Dr. Denham were completed years ago.”

Denham and the NQF

Denham was co-chairman of the Safe Practices Committee at the NQF as the organization was preparing the 2010 update of its Safe Practices for Better Healthcare report.

The report, originally released in 2003, was updated in 2006 and 2009 and then again in 2010. The recommendations made in the report are "defined to be universally applied in all clinical care settings in order to reduce the risk of error and harm for patients," according to an author’s foreword.

Inclusion of a specific technology in the report can be a boon to a drug or device company, Grenier told us.

As the committee was preparing its update in late 2009, the NQF’s Safe Practices Committee specifically recommended ChloraPrep by name.

Grenier said concerns were raised following ChloraPrep’s inclusion and the ad hoc process was initiated. She said the committee convened a 3-person expert panel to review the recommendations, and, by a vote of 2-1, struck ChloraPrep from the final report.

"Two of the committee members said the evidence wasn’t strong enough," to include ChloraPrep, Grenier said. "Because of that input,NQF changed that practice. The process worked."

"The measures and the safe practices that NQF endorses, they are meaningful to the industry, so we have to really be very careful, and are very careful, to ensure the integrity of our processes," she said.

Denham’s interest in the ad hoc committee’s decision on ChloraPrep raised a red flag at NQF and he was asked to step down, Grenier said.

"We felt, ‘Gosh, he’s really very interested in the outcome of the ad hoc review. This just does not feel right.’"

A leading voice in patient safety

Prosecutors have not detailed how any alleged payments to Denham were made, naming him only in a press statement announcing the agreement with CareFusion. He has not been charged with any crime or named in subsequent lawsuits. Attempts to reach Denham were unsuccessful.

Denham’s attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, told Modern Healthcare that reports that the underlying lawsuit named Denham were "blatantly false."

Denham’s company was paid $11.6 million under 2 contracts, which "covered an array of services," Gondelman told the publication. Officials at CareFusion also declined to specify what duties and services the $11.6 million consulting contract covered.

Although Denham was not named in any of the unsealed documents in the CareFusion case, it’s not unusual for doctors who are accused of taking kickbacks to be left out of prosecutions. A 2011 ProPublica report, which studied 15 court cases involving settlements between the feds and life science companies, found that none of the 75 physicians named in kickbacks cases were sanctioned "despite allegations of fraud or of conduct that put patients at risk."

"Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits," ProPublica reporters Tracy Weber and Charles Ornstein wrote. “After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians’ behavior."

Denham is a high-profile patient safety advocate. He’s chairman of the Texas Medical Institute of Technology, a non-profit organization that recommends healthcare performance solutions, and editor-in-chief of the Journal of Patient Safety. In 2010 Denham helped produce a documentary called Chasing Zero: Winning the War on Healthcare Harm.

The documentary featured several patient safety advocates, including film actor Dennis Quaid, whose twin children were accidentally overdosed in a hospital shortly after their birth. Quaid merged his foundation into TMIT in 2010. CareFusion financed the film and also owns the trademark to the term "Chasing Zero."

Problems emerge with ChloraPrep study

In February 2010, Denham moderated the "2010 National Quality Forum Safe Practices for Better Healthcare" webinar to discuss NQF’s updated recommendations for central lines, bloodstream infection and surgical-site infections. That webinar featured a discussion with Dr. Rabih Darouiche on the benefits of using ChloraPrep to combat SSIs, according to the transcript. Federal prosecutors say Darouiche was the author of an "invalid and off-label" study of ChloraPrep, paid for by CareFusion and published in 2010 in the New England Journal of Medicine.

The study, "Chlorhexidine–Alcohol versus Povidone– Iodine for Surgical-Site Antisepsis," compared the impact of disinfection with ChloraPrep versus Betadine infection rates in clean-contaminated surgical wounds. Darouiche et al concluded that ChloraPrep was effective in preventing infections by 41%.

Prosecutors claim that the Darouiche study was invalid for several reasons, including the fact that Cindi Crosby, CareFusion’s medical affairs vice president at the time, is listed as an author and was allegedly responsible for analyzing and editing the reports data. The prosecutors also claim that the investigators failed to "review, evaluate and report safety information" and failed to obtain and maintain accurate records showing all financial transactions from CareFusion to Darouiche, further alleging that CareFusion paid Darouiche large sums to promote the study’s results and act in a sales capacity for ChloraPrep.

"CareFusion failed to secure the required contracts with Darouiche. To ensure that no improper payments or kickbacks are being made to the study investigators, drug manufacturers that sponsor clinical studies must have contracts with the investigators that detail the scope of services that the investigator is to provide and the fair market value of those services," prosecutors wrote in court documents. "CareFusion is using Darouiche as a sales vehicle by securing speaking engagements for him around the world to promote ChloraPrep products with the invalid and off-label study. CareFusion also pays for Darouiche to entertain doctors on these trips. These actions are in violation of statutes prohibiting kickbacks to doctors and investigators."

CareFusion officials said the company has no current projects with Darouiche.