Conflict-of-interest charges pose challenge to safety movement

In little more than a decade, the movement for greater patient safety has evolved from a compelling set of ideas into a full-fledged sub-industry within U.S. healthcare. Virtually every hospital and large physician practice is dedicating time, money and institutional attention to reducing errors and promoting better outcomes.

While that movement has been good for patients whose bloodstream infections and hospital readmissions are prevented, the increasingly influential field may not be doing enough to safeguard itself from the potentially corrupting influence of money wielded by firms developing safety-oriented products. Advocates for greater attention to patient safety are worried a recent U.S. Justice Department settlement addressing charges surrounding conflicts of interest on a high-profile National Quality Forum committee could erode public trust.

“The disclosure requirements for quality and safety are less mature than they are for a drug trial or a product trial,” said Dr. Peter Pronovost, senior vice president for patient safety and quality at Johns Hopkins Medicine in Baltimore. “This quality and safety effort has to be guided by the science. If it starts getting tainted by people with financial interest, it could really distort the field.”

Last week, prosecutors unveiled the details of a legal settlement with healthcare supplier CareFusion, which paid $11.6 million in an alleged kickback scheme to a well-known NQF committee co-chairman in 2008 in what the government called an attempt to influence its national quality-of-care standards. Internal records show the expert, Dr. Charles Denham, editor of the Journal of Patient Safety and chair of the Leapfrog Group's safe practices committee, failed to reveal the conflict when asked by the NQF committee, which ended up recommending use of a CareFusion skin-sterilization product called ChloraPrep in its draft recommendations.

The conflicts went deeper. Records and interviews show that Denham also runs a foundation called the Texas Medical Institute of Technology, which awarded grants to the NQF to develop the guidelines and simultaneously identified some of the “safe practices” considered by the committee. In other words, Denham received money from a supplier whose product was recommended by his NQF committee, which was getting its ideas and financial support from a foundation that Denham ran at the same time.

The NQF cut ties with Denham in 2010 and twice revamped its conflict policies. It didn't begin answering Justice Department inquiries about the matter until 2012. While Denham has not been sued or charged with a crime and says the committee's recommendation on ChloraPrep was based on an academic research paper, that paper itself was written by researchers who also had financial support from CareFusion's former owner, Cardinal Health.

Experts say the situation smacks of the kind of troubling conflicts that have been routinely uncovered and confronted over the years in drug and medical device trials, education and research grants to medical schools and for continuing medical education, and professional medical associations that receive industry support. Unlike those areas, though, the patient-safety field hasn't felt the sting of public scrutiny that led to clear barriers being established against untoward influence.

Congress recognized the inherent danger in tainted practice guidelines when it asked the Institute of Medicine to develop a set of best practices for avoiding or mitigating conflicts of interest in medicine. The IOM concluded that financial conflicts of interest were one of the greatest threats to organizations that publish guidelines intended to improve care.

“Most guidelines used today suffer from shortcomings in development,” according to the IOM report, published in 2011. “Guideline development groups optimally comprise members without conflict of interest.”

Of course it's not always possible, or even necessarily desirable, to exclude anyone who has financial conflicts with industry from working on guidelines committees, many say. The government can't afford to fund all studies on the effectiveness of best practices or new products, and sometimes those closest to industry are among the best- informed people in a field.

Effective management of conflicts is key, experts say. That includes asking members of studies and guideline committees to fill out detailed assessments of potential conflicts, and asking anyone with financial entanglements on particular issues to limit their participation when discussing or voting on those issues.

Moreover, “chairs or co-chairs of such committees should definitely not have conflicts of interest,” said Dr. Daniel Carlat, director of the Pew Charitable Trusts' Prescription Project, which seeks greater transparency in physician-industry relationships. “We want our committees to make decisions based on the medical evidence.”

Although the issue of guidelines-development hasn't gotten much attention outside of the IOM report, Carlat said it can be a critically important issue because the standards are explicitly intended to influence patient care nationally. “The composition of such committees should be looked at very carefully,” he said.

Officials at the NQF were quick to point out last week that their vetting process, even if it is flawed, did prevent the publication of the industry-tainted guideline after enough concerns were raised by observers to trigger an “ad hoc review” of the draft.

“We can look backward and say that the way we managed the process in those days wasn't as strong as it should have been,” said Dr. Christine Cassel, who took over as president and CEO of the NQF last summer. “In fact, the process worked. It ended with someone pointing the finger and saying there is not enough evidence.”

The NQF's new policies greatly limit the influence of grant-funders and beef up the conflict-disclosure process—changes that followed the Aug. 19, 2009 meeting where Denham was asked and failed to reveal the $11.6 million in payments from CareFusion to his for-profit company, Health Care Concepts, meeting minutes showed.

Johns Hopkins' Pronovost served on the same committee as Denham in 2009 and 2010, as did University of California at Davis professor Dr. Patrick Romano. In interviews with Modern Healthcare, both said they were uncomfortable with how the committee reached its decisions on what best practice to add or update in the 2010 report.

“Peter and I both had the view that the process seemed to be rushed and there were inadequate NQF resources in the process, and too much of the work was being done by Denham's own staff,” Romano said.

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