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Hidden Financial Ties Rattle Top Health
Quality Group
by Marshall Allen | @marshall_allen by Marshall Allen
ProPublica, Jan.
28, 2014, 12:18 p.m.
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After an adviser is accused of taking kickbacks, the
National Quality Forum launches a review of its widely used patient safety
guidelines.
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,
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 endorsed a
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
endorsementin 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 Dehnam 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.”
http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-quality-group?utm_source=et&utm_medium=email&utm_campaign=dailynewsletter
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.
More coverage: Patient Safety: Exploring Quality of
Care in the U.S.