Apparent Conflict of Interest Sullies Panel of Patient Safety Experts

The National Quality Forum (NQF) reviews, endorses and recommends use of certain standards to improve the quality and delivery of health care. Its committee of patient safety experts, for example, is charged with defining guidelines for safe clinical practices that hospitals use to set protocols that minimize errors and promote good patient care. According to a recent investigation by ProPublica, the independent nonprofit news agency, one of the committee’s 12 members appears to have used his influence to benefit a company with which his own business had millions of dollars in contracts.

Although he was not a practicing physician, Dr. Charles Denham was a leading advocate for patient safety who, says ProPublica, invoked a study during discussions about preventing hospital infections endorsing ChloraPrep, an antiseptic skin cleanser made by CareFusion, the company in question. The panel’s 2010 guidelines ended up recommending the product.

Those guidelines remain in effect, although NQF officials say the endorsement did not corrupt them.

Denham did not disclose his relationship with CareFusion during the panel’s deliberations, despite rules requiring such disclosures. “The revelations,” says ProPublica, “call into question the inner workings of the Quality Forum, whose guidelines are regarded as the gold standard for best health care practices.”

In January, the U.S. Justice Department settled a $40 million whistleblower lawsuit with CareFusion. The suit called money paid to Denham’s business a “kickback” for him to influence NQF standards and boost sales of ChloraPrep.

Denham said the allegations were false, but, as ProPublica says, “[T] he 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, …”

Last week, ProPublica reports, Sen. Charles Grassley demanded copies of contracts and conflict-of-interest policies from the NQF in response to the allegations of kickbacks paid to influence its patient safety guidelines. Grassley is the senior member of the Senate Committee on Finance, which has oversight responsibility for Medicaid, Medicare and other government health programs.

The NQF severed its relationship with Denham in 2010, and said it took steps to protect its guidelines from commercial influence. But committee members told ProPublica they believe the process was compromised.

They said they were surprised to see the ChloraPrep-specific formula in the 2010 guidelines. The transcript of the committee’s discussion in 2009 shows Denham suggesting its endorsement, but no final agreement among members to recommend it.

Last month, the NQF told the news organization that it would review all the recommendations listed in its 2010 “Safe Practices for Better Healthcare” report.

The NQF was created in 1999 by presidential commission. The nonprofit accepts private donations and collects fees from members, including consumer groups, health plans and medical providers.

Five years ago, ProPublica reports, the federal government hired the NQF to endorse measures to show whether health-care spending achieves value for patients and taxpayers. By 2012, that initiative represented nearly three-quarters of the organization’s $26 million in revenue.

A product given an NQF endorsement can mean riches.

Dr. Peter Pronovost, head of patient safety at Johns Hopkins Medicine, is a member of the clinical practices committee. He told ProPublica that no one on it was aware of Denham’s financial ties to CareFusion. Denham did not mention them during the 2009 meeting when members were asked to disclose their financial relationships.

“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.”

Denham heads the Texas Medical Institute of Technology, a nonprofit that conducts patient safety research, and Health Care Concepts, a for-profit company involved in the whistleblower case. He’s renowned for his motivational speeches.

In 2007 and 2008, the NQF it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009. Between 2006 and 2009, Denham’s Institute donated $725,000 to the NQF.

The Justice Department lawsuit accused CareFusion of marketing ChloraPrep for off-label uses, and alleged that the money paid to Denham’s company was part of an effort to boost sales and included financing a study published in the New England Journal of Medicine.

Published in 2010, the study’s authors all reported ties to Cardinal Health, and found that ChloraPrep reduced the risk of surgical site infection by 41% compared to a common alternative.

Pronovost told ProPublica that the Denham mess shouldn’t poison all of the NQF’s work. He said the lack of scientific rigor of the safe practices committee reflected Denham’s influence, but that the process behind the NQF’s other measures is stronger.

But, he said, it does raise significant concern 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.”

Dr. Bob Wachter, a hospitalist at UC San Francisco and patient safety maven, has an interesting blog piece lamenting his own failure to realize that something didn’t quite add up with Denham. The main clue was pretty basic: There was a lot more money washing around the guy and his institute than fit with the nonprofit safety image.