Attempts to Transform the CDC into a Propaganda Outlet and the Silence of the Health Care Leaders

First they came for the CDC staffers, but I was not a CDC staffer so I did nothing...

Then they came for me. And there was no one left to speak for me.

- with apologies to Martin Niemoller (look here) 

The US is continuing to suffer during the coronavirus pandemic.  Meanwhile, the lead US government public health agency, the Centers for Disease Control and Prevention (CDC) has suffered two attempts by the Trump administration to transform it into a propaganda outlet.

Mysterious Revisions of Pandemic Management Guidelines to Hinder Testing of Exposed Persons

This story broke in late August, 2020.  As reported by the New York Times on August 25, 2020:

The Centers for Disease Control and Prevention quietly modified its coronavirus testing guidelines this week to exclude people who do not have symptoms of Covid-19 — even if they have been recently exposed to the virus.

The new guidelines went against public health practice for managing epidemics.  People who have been exposed are at increased risk of infection.  Infected people may not have symptoms but may still transmit the virus to others.  Identifying infected people allows them to be quarantined, and any further contacts to be traced.  In particular, as the NYT article pointed out:

Although researchers remain unsure how often asymptomatic people unwittingly transmit the coronavirus, studies have shown that the silently infected can carry the virus in high amounts. The evidence is more clear-cut for pre-symptomatic people, in whom virus levels tend to peak just before illness sets in — a period when these individuals might be mingling with their peers, seeding superspreader events. Notably, experts can’t distinguish asymptomatic people from those who are pre-symptomatic until symptoms do or don’t appear.

No Obvious Justification and No One Accountable for the Change

The CDC did not initially provide a clear justification of the change:

The reasons behind the surprise shift in testing recommendations are unclear. In response to an inquiry from The New York Times, a representative for the C.D.C. directed the questions to the U.S. Department of Health and Human Services. 

A report from ABC News on August 26 quoted Admiral Brett Giroir of the White House coronavirus task force:

This is evidence-based decisions that are driven by the scientists and physicians, both within the CDC, within my office in the lab task force, and certainly amongst the task force members

However, he did not provide any of the evidence on which it was supposedly based, or any logic underlying the change based on this evidence.  Nor did he make clear who was accountable for the change

 I worked on them. Dr. Fauci worked on them. Dr. Birx worked on them. Dr. Hahn worked on them. Dr. Atlas provided input. So, it's kind of hard to know how much was written by one person at this time

On the other hand, a CNN report from the next day suggested that the change came due to political pressure:

A sudden change in federal guidelines on coronavirus testing came this week as a result of pressure from the upper ranks of the Trump administration, a federal health official close to the process tells CNN, and a key White House coronavirus task force member was not part of the meeting when the new guidelines were discussed.

'It's coming from the top down,' the official said of the new directive from the Centers for Disease Control and Prevention.

 

An AP article from August 26 included speculation about the real reasons for the change:

 

Dr. Carlos del Rio, an infectious diseases specialist at Emory University, suggested in a tweet that there are two possible explanations.

One is that it may be driven by testing supply issues that in many parts of the country have caused widely reported delays in results of a week or more, he suggested.

 Admitting problems providing testing might be a reason to consciously temporarily limit testing, of course, but not to pretend the testing would not be useful.  Then

Another possible explanation for the change is that President Donald Trump simply wants to see case counts drop, and discouraging more people from getting tested is one way to do it, del Rio said in his tweet.

A Washington Post article on August 27, 2020 explained this further:

The revised guidelines come as President Trump has feuded with the CDC and the Food and Drug Administration, both parts of the Department of Health and Human Services, and marginalized officials who would ordinarily play leading roles in a pandemic response. He has repeatedly said that he did not like that more testing had revealed more cases.

'I said to my people, ‘Slow the testing down, please!’ ' Trump said at a rally two months ago. Aides said he had been speaking tongue-in-cheek. But asked later whether he had been kidding, Trump replied, 'I don’t kid.'

Reducing testing, of course, would reduce the number of apparent, not real cases, allowing Trump to exaggerate his ability to manage the pandemic

On September 17, 2020, the source of the controversial change in the CDC guideline was somewhat clarified again according to the New York Times:

A heavily criticized recommendation from the Centers for Disease Control and Prevention last month about who should be tested for the coronavirus was not written by C.D.C. scientists and was posted to the agency’s website despite their serious objections

The source of the change was 

the Department of Health and Human Services [which] did the rewriting and then 'dropped' it into the C.D.C.’s public website, flouting the agency’s strict scientific review process.

'That was a doc that came from the top down, from the H.H.S. and the task force,' said a federal official with knowledge of the matter, referring to the White House task force on the coronavirus.

Yet neither that nor earlier reports explained who at "the top" directed the change.

And soon the change it self disappeared as mysteriously as it appeared.  On September 18, 2020 per the AP:

U.S. health officials on Friday dropped a controversial piece of coronavirus guidance and said anyone who has been in close contact with an infected person should get tested.The Centers for Disease Control and Prevention essentially returned to its previous testing guidance

Criticism of the Change

 Public health and health care professionals criticized the changes, e.g.,  per the AP article of August 26, 2020:

Dr. Tom Frieden, who was head of the CDC during the Obama administration, said the move follows another recent change: to no longer recommend quarantine for travelers coming from areas where infections are more common.

'Both changes are highly problematic' and need to be better explained, said Frieden, who now is president of Resolve to Save Lives, a nonprofit program that works to prevent epidemics.

Also, Dr Leana Wen wrote an op-ed for the Washington Post on August 26, 2020:

you don’t have to be a public health expert to know the CDC’s guidance is nonsensical.  

In MedPage Today of August 28, 2020:

pulmonologist William Janssen, MD, section head of Critical Care Medicine at National Jewish Health, said the new guidance recommending testing for fewer people 'flies in the face of everything we have been told and understand about this disease.'

Also,

Another pulmonologist at National Jewish Health, Kenneth Lyn-Kew, MD, called the CDC move 'a step backwards.'

'The CDC was flat out wrong and the epidemiologists there know this,' he said, adding that testing and tracing are cornerstones of epidemiology.

Major health care organizations also criticized the change. The AMA issued a statement:

Suggesting that people without symptoms, who have known exposure to COVID-positive individuals, do not need testing is a recipe for community spread and more spikes in coronavirus. When the Centers for Disease Control and Prevention (CDC) updates a guidance the agency should provide a rationale for the change. We urge CDC and the Department of Health and Human Services to release the scientific justification for this change in testing guidelines

The American Association of Medical Colleges asserted:

These CDC guidelines go against the best interests of the American people and are a step backward in fighting the pandemic. The AAMC urges the CDC to return to its earlier testing recommendations

The Chair of the Board of Regents of the American College of Physicians wrote that the organization:

supports the use of science, based on the best available evidence, in the fight against COVID-19. Public health agencies should not be subjected to pressure or be influenced to issue policies that are not based on evidence and expert recommendations of their own scientists.

 Also

The recent revision of the CDC’s COVID-19 testing guidelines of asymptomatic individuals lacks transparency and clarity, sending a confusing message to both physicians and the public on appropriate and necessary testing that will ultimately help to mitigate the spread of COVID-19.

Summary

So far we only know that someone at "the top" of the government directed the change in the CDC guidelines.  No person or group has stepped forward as accountable. No one at any US government agency has explained the rationale for the change, much less provided clear evidence and logical reasoning underlying it.  The best explanation for the change seems to be that it fit President Trump's message. It would have made his administration's problems organizing adequate testing for coronavirus less apparent.  By reducing testing, it would make the rate of the spread of disease temporarily appear lower, allowing Trump to exaggerate his ability to manage the pandemic.

Yet I could find no health care or public health professional, or any leader of a health care organization willing to criticize "the top" of the US government for directing the change, to criticize the opaque, apparently evidence-free process that produced the change, or to question whether the change was meant to fit with Trump's propaganda, that is, his claims of brilliant management of the pandemic. 

Trump Political Appointees Attempt to Intimidate CDC Staff to Manipulate Publications in the Morbidity and Mortality Weekly

White House Installed Pro-Trump Propagandist with No Health Care or Public Health Background as Head of Public Relations for DHHS

 The second case began in April, 2020.  Then Politico reported:

 The White House is installing Trump campaign veteran Michael Caputo in the health department’s top communications position

Caputo was given the title of Assistant Secretary for Public Affairs. He has an unlikely background to have been named head of public relations for the Department of Health and Human Services (DHHS). He has no apparent background in health care or public health. Also, Politico noted:

Caputo is an intense Trump loyalist whose recent book 'The Ukraine Hoax,' alleged a conspiracy behind Trump’s impeachment.

Furthermore

 Caputo is a longtime friend of Trump ally Roger Stone and former Trump campaign chairman Paul Manafort, both of whom were convicted of crimes in the last two years. 

Then CNN reported:

The new spokesman for the Department of Health and Human Services in a series of now-deleted tweets made racist and derogatory comments about Chinese people, said Democrats wanted the coronavirus to kill millions of people and accused the media of intentionally creating panic around the pandemic to hurt President Donald Trump.

In particular,

In a series of tweets on March 12, Caputo responded to a baseless conspiracy theory that the United States brought the coronavirus to Wuhan, China, by tweeting that 'millions of Chinese suck the blood out of rabid bats as an appetizer and eat the ass out of anteaters.'

 

CNN had many more graphic examples.  

 

Also, Mother Jones reported more about Caputo's involvement in Russia and Ukraine:

 

A longtime Republican operative who was ousted from a job on Trump’s 2016 campaign, Caputo recently worked to boost discredited claims alleging that Ukraine, not Russia, meddled in the 2016 election.

 

In particular, Caputo was alleged to have been involved in political dirty tricks on behalf of Trump in 2016:

 

In June 2018, the Washington Post reported that ... [Caputo] and Stone had met in 2016 with Henry Oknyansky, a Russian expat living in Florida, who wanted to sell damaging information about Hillary Clinton. Caputo, in text messages with Stone the Post obtained, referred to Oknyansky as 'the Russian.' Though no deal was reached, news of the meeting seemed to contradict claims both Stone and Caputo had made in testimony to the House Intelligence Committee. Both men denied any contact with Russians during the 2016 campaign.

 

Also, Caputo was alleged to have been involved in creating propaganda or disinformation about Ukraine's supposed intervention in the 2016 campaign, and Hunter Biden's actions there:

 

Last year, Caputo, along with other figures in Trump’s orbit, turned his focus to Ukraine. He says he travelled there last August to try to bolster the theory that Ukrainians interfered in 2016 election to help Clinton. He subsequently wrote a book, titled The Ukraine Hoax: How Decades of Corruption in the Former Soviet Republic Led to Trump’s Phony Impeachment, which pushes discredited allegations, including claims that former Vice President Joe Biden intervened in Ukrainian affairs to help his son, Hunter. Caputo produced a documentary offering similar allegations that aired in January on the rabidly pro-Trump One America News. Giuliani starred in a separate OAN series which pushed similar claims based his own trip to Ukraine.

 

Yet  despite Caputo's record as an unscrupulous political operator, and allegations that he was involved in peddling propaganda and disinformation, his appointment drew no outcry.

Assistant Secretary for Public Relations of DHHS Orchestrated Intimidation to Distort the Morbidity and Mortality Weekly Report

Somehow Caputo and the associates he brought to the DHHS managed to avoid much public notoriety for a few months.  Then on September 11, 2020 Politico reported that Caputo and his associates had been quietly busy.  Their apparent mission was to turn the respected CDC public health publication, the Morbidity and Mortality Weekly Report, into a vehicle for pro-Trump propaganda.  Politico noted that:

The CDC's Morbidity and Mortality Weekly Reports are authored by career scientists and serve as the main vehicle for the agency to inform doctors, researchers and the general public about how Covid-19 is spreading and who is at risk. Such reports have historically been published with little fanfare and no political interference, said several longtime health department officials, and have been viewed as a cornerstone of the nation's public health work for decades.

But since Michael Caputo, a former Trump campaign official with no medical or scientific background, was installed in April as the Health and Human Services department's new spokesperson, there have been substantial efforts to align the reports with Trump's statements, including the president's claims that fears about the outbreak are overstated, or stop the reports altogether.

In particular, Caputo et al tried to

retroactively change agency reports that they said wrongly inflated the risks of Covid-19 and should have made clear that Americans sickened by the virus may have been infected because of their own behavior

and

halt the release of some CDC reports, including delaying a report that addressed how doctors were prescribing hydroxychloroquine, the malaria drug favored by Trump as a coronavirus treatment despite scant evidence

To underscore that the effort was to promote Trump's political self-interest

an aide to Caputo berated CDC scientists for attempting to use the reports to 'hurt the President' in an Aug. 8 email sent to CDC Director Robert Redfield and other officials that was widely circulated inside the department and obtained by POLITICO. 'CDC to me appears to be writing hit pieces on the administration,' appointee Paul Alexander wrote, calling on Redfield to modify two already published reports

Alexander tried to gain control of the contents of the MMWR, calling

 on Redfield to halt all future MMWR reports until the agency modified its years-old publication process so he could personally review the entire report prior to publication, rather than a brief synopsis. Alexander, an assistant professor of health research at McMaster University near Toronto whom Caputo recruited this spring to be his scientific adviser, added that CDC needed to allow him to make line edits — and demanded an 'immediate stop' to the reports in the meantime.

Apparently CDC staffers resisted Caputo, Alexander et al, so that eventually contents untouched by their manipulations did become public.

One day after the Politico article, the New York Times  confirmed its essential findings

Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies said on Saturday that meddling from Washington was turning widely followed and otherwise apolitical guidance on infectious disease, the Morbidity and Mortality Weekly Reports, into a political loyalty test, with career scientists framed as adversaries of the administration.

The Times called Caputo's work a "bullying operation."  

The Washington Post also confirmed the Politico report after gaining access to emails sent by Alexander.

The Assistant Secretary's Actions Became Bizarre, and He Resigns Citing Mental Health Issues

As soon as the story of his attempts to "bully" the MMWR became public, Caputo's actions became more bizarre.  On September 14, 2020, the New York Times reported:

The top communications official at the powerful cabinet department in charge of combating the coronavirus made outlandish and false accusations on Sunday that career government scientists were engaging in 'sedition' in their handling of the pandemic and that left-wing hit squads were preparing for armed insurrection after the election.

Michael R. Caputo, the assistant secretary of public affairs at the Department of Health and Human Services, accused the Centers for Disease Control and Prevention of harboring a 'resistance unit' determined to undermine President Trump, even if that opposition bolsters the Covid-19 death toll.

Then he announced:

he personally could be in danger from opponents of the administration. 'If you carry guns, buy ammunition, ladies and gentlemen, because it’s going to be hard to get,' he urged his followers.

He went further, saying his physical health was in question, and his 'mental health has definitely failed.'

'I don’t like being alone in Washington,' Mr. Caputo said, describing 'shadows on the ceiling in my apartment, there alone, shadows are so long.'

 One day later Politico reported an announcement:

Today, the Department of Health and Human Services is announcing that HHS Assistant Secretary for Public Affairs Michael Caputo has decided to take a leave of absence to focus on his health and the well-being of his family

Alexander also left the agency 

Since Caputo's departure, Politico published an article detailing how he placed "his own loyalists and Trump veterans" into public relations positions at the DHHS. 

Also, the New York Times published an article detailing some of his efforts to bully CDC staff,

Mr. Caputo moved to punish the C.D.C.’s communications team for granting interviews to NPR and trying to help a CNN reporter reach him about a public relations campaign. Current and former C.D.C. officials called it a five-month campaign of bullying and intimidation.

For instance, after Mr. Caputo forwarded the critique of Dr. Schuchat to Dr. Redfield, C.D.C. officials became concerned when a member of the health department’s White House liaison office — Catherine Granito — called the agency to ask questions about Dr. Schuchat’s biography, leaving the impression that some in Washington could have been searching for ways to fire her.

In another instance, Mr. Caputo wrote to C.D.C. communications officials on July 15 to demand they turn over the name of the press officer who approved a series of interviews between NPR and a longtime C.D.C. epidemiologist, after the department in Washington had moved to take ownership of the agency’s pandemic data collection.

'I need to know who did it,' Mr. Caputo wrote. A day later, still without a reply, Mr. Caputo wrote back. 'I have not received a response to my email for 20 hours. This is unacceptable,' he said.

Efforts to Turn the MMWR Into Propaganda Criticized byAcademics in Public Health and Health Care, and the CEO of the Robert Wood Johnson Foundation

Per the Politico article above, Jennifer Kates, leader of the Kaiser Family Foundation's global health work

defended the CDC's process as rigorous and said that there was no reason for politically appointed officials to review the work of scientists.

Per the New York Times article above, Dr. William Schaffner, an infectious disease specialist at Vanderbilt University who sits on the external editorial board of the Morbidity and Mortality Weekly Report, said Caputo's operation 

undermines the credibility of not only the M.M.W.R. but of the C.D.C. And the C.D.C.’s credibility has been tarnished throughout Covid already

Per USA Today on September 13, 2020:

The interference is not just anti-science but disinformation intended to deceive the American public, said Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California.

'This is outright egregious. It’s despicable,' Topol said, accusing Redfield and other leaders of allowing the agency to be hijacked by politics.

Also,

 On Twitter, Dr. Sherri Bucher, a global health researcher, wrote, 'There are no words to articulate how horrific this is. Trust & credibility, shattered, overnight. MMWR has been, for a long time, one of the most reliable, steadfast, scientific resources; unquestioned veracity, impeccable reputation for quality of data/analysis. No longer.

The Washington Post published an op-ed by Dr Erin Marcus, a professor of clinical medicine at the University of Miami Miller Medical School:

Caputo’s manipulation is appalling. If left unchecked, it could have disastrous consequences for the reputation and reliability of the CDC, which has already been battered by the U.S. response to covid-19. It could also prove devastating for medical practice in the United States more broadly.

In Scientific American, Dr Richard Besser, the CEO of the Robert Wood Johnson Foundation, wrote an op-ed entitled "We can't allow the CDC to be tainted by politics," noting:

 To meddle with, delay or politicize these [MMWR] reports would be a form of scientific blasphemy as well as a breach of public trust that could undermine the nation’s efforts to fight the coronavirus.

Summary

So to summarize, the White House put a pro-Trump political operative who had allegedly been involved in producing propaganda and disinformation in support of Trump to oversee all Department of Health and Human Services communications.  He and his hired cronies tried to bully and intimidate DHHS, particularly CDC staff, and to distort the contents of the renowned MMWR to support the Trump message.  Had these efforts succeeded they would have seriously impeded efforts to control the coronavirus pandemic by undermining the dissemination of scientific evidence needed for pandemic management and clinical care for affected patients.  

I found several academic public health and health care professionals willing to criticize Caputo and cronies' actions.  I found one leader of a prominent health care foundation willing to at least implicitly criticize them.  I found no one willing to hold accountable anyone at the "top" of the government who hired Caputo or encouraged his actions.  On this case, I could find no leader of a health care organization other than Dr Besser willing to say anything at all.   

Conclusions

Last month, we noted how disinformation about the coronavirus pandemic is being disseminated by the US president. 

Since then, two major efforts to use the CDC, the lead US public health organization, to support President Trump's political messaging, in effect, to function as a political propaganda outlet.  Individual US academic and practicing public health and health care professionals have been willing to decry these efforts, though not to directly hold Trump and his top lieutenants in the executive branch accountable.  In some cases, leaders of major medical organizations have been willing to state the principles that should have been upheld within the government.  

However, no chairpersons, deans, chancellors, vice-presidents for health affairs, university presidents; or journal editors, hospital executives, leaders of professional societies, executives of health care corporations, etc, etc were willing to publicly challenge Trump and his top collaborators.  Such leaders so far have also been unwilling to challenge Trump's efforts to spread disinformation.

To be charitable, such leaders may be to used to a kinder, gentler era to be able to fully comprehend that parts of the US government meant to be apolitical advocates for public welfare, such as the CDC, are being pushed to become part of an incipient Ministry of Propaganda.  

Fighting a deadly pandemic is hard enough.  It is gut wrenching that the fight is being subverted by political leaders spreading propaganda and disinformation.  It is sad that front line public health and health care professionals are hardly supported in their work by those who claim to lead them.  Where is the courage?  Where is the outrage?

"If not now, when?"

 

Chipping Away at the Anechoic Effect: Now the New York Times Protests the Demise of the AHRQ National Guidelines Clearinghouse

Background: the Quiet Announcement of the Death of the Clearinghouse

On June 1, 2018, we wrote:

Apparently as of late April, a terse announcement appeared on the website of the US AHRQ National Guideline Clearinghouse:

The AHRQ National Guideline Clearinghouse (NGC, guideline.gov) Web site will not be available after July 16, 2018 because federal funding through AHRQ will no longer be available to support the NGC as of that date. AHRQ is receiving expressions of interest from stakeholders interested in carrying on NGC's work. It is not clear at this time, however, when or if NGC (or something like NGC) will be online again. In addition, AHRQ has not yet determined whether, or to what extent, the Agency would have an ongoing role if a stakeholder were to continue to operate the NGC. We will continue to post summaries of new and updated evidence-based clinical practice guidelines until July 2, 2018. For any questions, please contact Mary.Nix@ahrq.hhs.gov.

There was no further explanation.

This announcement has been largely anechoic, noted only by a few blogs and websites, e.g. the American Bar Association.

We went on to summarize the importance of this clearinghouse as a reasonably comprehensive source of material about the myriad clinical practice guidelines that have been promulgated ostensibly to improve medical care.  Its importance was recently enhanced by the addition of ratings of the trustworthiness of particular guidelines derived from standards developed by the US Institute of Medicine (look here).  In turn, these standards were necessary because many published guidelines were afflicted with methodologic problems.  Some amounted to little more than informal recommendations of experts.  Many guidelines were suspected of being influenced by commercial sponsors or by the financial relationships of the people involved in developing them.  Pharmaceutical, biotechnology, device and other firms that market health care goods and services have long been interested in meddling in guideline development to assure that guidelines put their products and services in a favorable light.

We concluded

Now we will lose an important resource for teaching, research, and evidence-based practice, whose loss will make it easier to hucksters to promote drugs, devices, and programs that are not as efficacious or safe as advertised.  But the good times will continue to roll.

We could call for the reinstatement of the AHRQ National Guideline Clearinghouse.  Ah, but we may as well try and catch the wind.

Again, note that as of June 1, 2018, nothing about the shutdown of the clearinghouse had appeared in the media, or in medical or health care scholarly journals.  We hoped maybe the post in our humble blog would start some discussion.

Further Media Coverage

At the time, despite our hopes, experience suggested nothing much would happen.  This time, however, we were wrong.

Stat News

The topic was picked up on June 13, 2018 by Stat News.  Ivan Oransky and Adam Marcus opened with:

Diagnostic and treatment guidelines aren’t sexy, but they play a vital role in the practice of medicine.

Oransky and Marcus found that the NGC was actually fairly heavily used, drawing 200,000 visitors a month.  After further summarizing the issue, they noted the ambiguous official justification for the closure of the clearinghouse.

'The decision to end support for the NGC was an Agency decision based on assessing how best to use our current resources, including both appropriated dollars and dollars from the Patient-Centered Outcomes Research Trust Fund,' the AHRQ spokesperson told STAT. The AHRQ budget for the 2019 fiscal year, as proposed by the Trump administration, 'will re-focus support to only the highest priority research programs.'

They also excerpted our conclusions above, and lamented,

With the date of death for the NGG barely a month away, America’s doctors — and their patients — may, to paraphrase another clearinghouse, already be losers.

Daily Beast

One month later (July 12, 2018) the Daily Beast published a longer account of the then impending shut down of the clearinghouse, written by Jon Campbell, an investigator for the Sunlight Foundation.  Campbell noted how

medical research like that maintained by the NGC can be politicized, [so] AHRQ drew the ire of then-congressmember Tom Price in 2016 when it published a study critical of a drug manufactured by one of his campaign donors. According to ProPublica, one of Price’s aides emailed 'at least half a dozen times' asking the agency to pull the critical research down. Price was the first director of HHS, AHRQ’s parent agency, under the Trump Administration, before resigning under pressure last year over his spending on chartered flights.

Note that we had discussed then Representative Price's intervention here.

Campbell interviewed several people, including your humble scribe, about the meaning of the AHRQ's actions, and concluded with

'Losing [the NGC] is really losing a valuable resource,' said Ana Maria Lopez, President of the American College of Physicians. She said the NGC is a primary source for her organization’s research, and noted that digital repositories like the NGC are only more critical today.

Other Coverage

Since then, Vox and CNN have covered the issue on July 16, the day of the planned shutdown. The surge of concern about the topic did not apparently prevent it from happening, however.

The New York Times Weighs In

Today, however I was surprised by the lead editorial in the New York Times today about the demise of the NGC, entitled "Want Reliable Medical Information? The Trump Administration Doesn’t." It included this pithy comparison:

The official explanation is maddening enough: a budget shortfall that roughly equals the amount Tom Price spent on travel during his brief tenure as department secretary. The site costs just $1.2 million a year to operate, and is maintained by an agency with a budget of more than $300 million.

It concluded hopefully with:

A better solution would almost certainly be for Congress to appropriate the money needed to keep the database up and running. It could do that simply by renewing the Affordable Care Act fund that was covering the database’s operating costs, and that is scheduled to expire in 2019.

Of course, Congress will take that action only if constituents demand it. But in a country that has voted representatives in and out of office based on their health care policies, and that prides itself on drawing attention to intractable diseases (we dump ice buckets on our heads to raise funds to fight A.L.S., and walk countless miles for breast cancer), evidence-based medicine should be an easy sell. 

I am not holding my breath.  However, I never thought this issue, perhaps a small on given the huge political dysfunction that grips the country, would make it much farther than my blog post of June 1.  So we can hope. 

Furthermore, there has been movement towards preserving some of the clearinghouse's functions.  As discussed in Modern Healthcare on July 17, 2018, the ECRI Instsitute plans to resurrect the site.  It would no longer be free, but will be based on a subscription model which ECRI hopes will keep the costs reasonable.  So at least that is real progress since June 1.  

Discussion

Many people bemoan the current political situation, but some feel there is nothing they could possibly do the improve things.  We have been publishing this blog since 2004 with the hopes that chipping away at the anechoic effect which has hid the severity and nature of health care dysfunction might actually help to improve things.  However, at times we wondered if we were having any effect.  What good are individual actions like blog posts? 

It seems that most of us have little individual power.    Collectively, though we may have more than we realize.  Small individual actions can add up. I hope the at least partial resurrection of the National Clinical Guidelines Clearinghouse will provide an example that will inspire further individual actions to address health care dysfunction, and the much larger political and economic dysfunction that generate it, and that now threatens us all.  

The Stealth Shutdown of the US Agency for Healthcare Quality and Research (AHRQ) National Guideline Clearinghouse

The Quiet Announcement of the Shut Down

Apparently as of late April, a terse announcement appeared on the website of the US AHRQ National Guideline Clearinghouse:

The AHRQ National Guideline Clearinghouse (NGC, guideline.gov) Web site will not be available after July 16, 2018 because federal funding through AHRQ will no longer be available to support the NGC as of that date. AHRQ is receiving expressions of interest from stakeholders interested in carrying on NGC's work. It is not clear at this time, however, when or if NGC (or something like NGC) will be online again. In addition, AHRQ has not yet determined whether, or to what extent, the Agency would have an ongoing role if a stakeholder were to continue to operate the NGC. We will continue to post summaries of new and updated evidence-based clinical practice guidelines until July 2, 2018. For any questions, please contact Mary.Nix@ahrq.hhs.gov.

There was no further explanation.

This announcement has been largely anechoic, noted only by a few blogs and websites, e.g. the American Bar Association.

The Importance of the National Guideline Clearinghouse

The shutdown is significant because the Clearinghouse was an important source of information on diverse practice guidelines useful to clinicians, but also to medical and health care educators and researchers.

It is noteworthy that AHRQ has recently endeavored to assure the trustworthiness of the posted guidelines. While guidelines have been long and widely touted as a way to improve the quality of health care, there have been continuing questions about their validity and usefulness. In particular, there was accumulating evidence that many available guidelines were biased by conflicts of interest, based on an incomplete sample of available evidence, and were not necessarily informed by rigorous review of the available evidence, as we discussed here. 

In response, in 2011, the US Institute of Medicine (IOM) published standards for trustworthy guidelines (look here).  These standards were more rigorous and better justified than any prevous attempts to assure guideline quality.

The summary of the IOM report included:

Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should:
• Be based on a systematic review of the existing evidence;
• Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
• Consider important patient subgroups and patient preferences, as appropriate;
• Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest;
• Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations; and
• Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations.
Additionally, as reflected in the committee’s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The committee recognizes that in some circumstances, a guideline development group may not be able to perform its work without members who have conflicts of interest—for example, relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the guideline. Therefore, the committee specifies that members of the guideline development group who have a conflict of interest should not represent more than a minority of the group.

However reasonable these standards may have appeared, by 2012 the IOM standards were largely ignored (as discussed here).

Yet, in 2017, at least one study appeared suggesting that many guidelines in the Clearinghouse did not meet the IOM standards (look here).  That year the AHRQ proclaimed that it would start assessing guidelines' adherence to the IOM standards (look here).

This is noteworthy again considering that the standards have had otherwise unfortunately little impact.

And now it seems the AHRQ's worthwhile effort to disseminate guidelines whose trustworthiness can be assessed will end.

Discussion

So it seems that the report on clinical practice guidelines emphasized two issues highly relevant to Health Care Renewal, the need for transparency in guideline development, and the need to avoid conflicts of interest affecting the development process.

Perhaps more because than despite that, as we noted above, by 2012 the IOM standards were largely ignored (as discussed here).  We speculated that these standards may have discomfited many people.  They could have cost a lot of medical societies considerable commercial funding, and a lot of health care professionals on guideline panels considerable personal wealth.  These standards could probably also have cost a lot of companies whose products and services were addressed by guidelines to lose revenue.  Their implementation could have cost too many people who are financially benefiting from the status quo too much money.  And these people, that is, leaders of professional societies dependent on commercial outside funding, health care professionals and academic used to financial support from commercial interests, and health care corporations are good at making sure their interests are not ignored, even if their interests conflict with those of patients, the public, and well-intentioned health care professionals.


The Trump regime has exhibited great coziness with those who lead large corporations, including health care corporations, and other such plutocrats (look here).  The Trump regime appointed a person who was a manager of commercial information technology firms, not a health care professional or researcher, as head of the AHRQ (look here).  So it should come as no surprise that the AHRQ leadership under that regime was unable to maintain a Guideline Clearinghouse that attempted to uphold such standards of guideline trustworthiness.

Now we will lose an important resource for teaching, research, and evidence-based practice, whose loss will make it easier to hucksters to promote drugs, devices, and programs that are not as efficacious or safe as advertised.  But the good times will continue to roll.

We could call for the reinstatement of the AHRQ National Guideline Clearinghouse.  Ah, but we may as well try and catch the wind.  

We have been writing about health care dysfunction since 2003, and publishing this blog since 2004.  A major concern all along has been how threats to health care professionals' core values generate  health care dysfunction.  Up through 2016, these threats came principally from large private health care organizations.  While the US government was not always as good at defending these values as it could have been, at least it rarely presented its own set of active threats.  Under Trump, that situation has been changing for the worse.  This is obviously hugely dangerous, (and made more so by the regime's threats to other core values of US society, to US law, and the US Constitution.)

To prevent the decline and fall of US health care, and maybe the entire US experiment in representative democracy, health care professionals, academics, patients and citizens concerned about health care will have to join up with the larger populace to defend our core values while they still have any force.  

Musical Interlude - Donovan, Try and Catch the Wind, 1973

Clinical Practice Guidelines: Still Conflicted After All These Years

Background: Untrustworthy Clinical Practice Guidelines

Since the 1990s, clinicians have been exhorted to follow clinical practice guidelines (CPGs) to improve their decision-making and patients' outcomes.  When Dr Wally Smith and I started teaching a short course (often at the Society for Medical Decision Making meetings) about changing physician behavior, we naively set out to improve decisions by increasing adherence to such guidelines.  We first thought that physicians' apparent shortcomings in guideline adherence were due to their lack of knowledge of the guidelines and the underlying evidence, and to their human cognitive limitations.

That approach, however, failed to yield ways to improve adherence.  After a while, it occurred to us that there might be other reasons physicians did not follow guidelines, including their lack of trust of the guidelines or the evidence supposedly incorporated within them.  We learned that integrity of  the clinical evidence base has been severely degraded due to the manipulation of clinical studies by those with vested interests, and the outright suppression of trials for which manipulation does not produce the desired results.

Furthermore, as we became less naive, we learned that the integrity of the guideline development process was also suspect, again due to the influence of those with vested interest.  No wonder physicians were suspicious of guidelines, and resisted adhering to them.

In 2011, the prestigious Institute of Medicine released a report on the development of  better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust.  Link here.)  We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect.  The IOM report cited conflicts of interest (COIs) affecting the guideline development process as a major reason such guidelines might be untrustworthy, and suggested a variety of ways to reduce COIs affecting guidelines.

These included in particular:
- Guideline committee members should disclose their conflicts of interest in detail, and these should appear in the guidelines (Standard 2.1, 2.2)
- The number of conflicted committee members should be minimized, and in no case should be a majority of the committee (2.3, 2.4)
- Funders should have no role in guideline development (2.4)

This week, an original article(1) and editorial(2) in PLoS Medicine discussed how guidelines published since the report was produced addressed conflicts of interest.

Article Summary

Below I summarized the article, but presented results somewhat differently than did the authors.

Design

Campsall et al did a cross-sectional study of clinical practice guidelines that appeared in the US Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse in 2012 from national or international organizations, excluding guidelines produced by organizations restricted to allied health professionals, guidelines produced by corporations, or guidelines that had no specific recommendations.  They obtained information from the guidelines, the organizations' websites, and surveys sent to the organizations.

Study Population

The study population was 290 guidelines produced by 95 organizations. The response rate for the surveys was 68%.  The organizations were primarily professional societies (67%) or disease advocacy groups (21%).

My comment is that therefore this study assessed guidelines mainly produced by non-profit organizations which ostensibly uphold health care professionals' values and/or primarily support patients' interests.

Industry Funding

63% of organizations reported receiving funds from biomedical companies.  (It was not clear whether the remainder denied receiving such funding, or provided no information about funding.)

My comment is that the majority of such ostensibly "do-gooder" organizations are nonetheless at least somewhat supported by commercial firms that market health care products, presumably mainly drugs or devices.

Conflict of Interest Policies

Please note that the authors provided results to emphasize the positive, for example, they provided the proportion of organizations which provided specific types of information about COIs or had particular policies to reduce COIs.  In most cases, I simply did subtractions to emphasize the negative.  Furthermore, the authors further emphasized the positive by choice of denominator, as noted below.

20% of organizations did not provide any information about conflict of interest policies, and 7% asserted the existence of such policies, but did not disclose them.  A majority, 55%, did not have disclosed policies that specifically dealt with with conflicts of interest affecting guidelines.

My comment is thus that a majority of these do-gooder organizations did not apparently even begin to address, at least in terms of clear, transparent written policy, the recommendations of the IOM report on trustworthy guidelines.

Measures to Improve Guidelines Trustworthiness by Decreasing Influence of Conflicts of Interest

The authors provided the number of organizations with disclosed policies that addressed particular issues of concern to the IOM in their report on trustworthy guidelines, but made the proportions of such organizations seem larger by using as a denominator the number of organizations that disclosed their entire policies, rather than the total number of organizations which produced the guidelines.

Therefore, they found that of the 60 (out of 95 total) organizations that fully disclosed their conflict of interest policies:
98% required committee members to disclose conflicts of interest;
90% required review of conflicts of interest before guideline publication; 
68% required that a majority of guideline committee members be free of conflicts of interest;
92% reported publishing committee members' conflicts of interest within guidelines;
78% did not allow direct industry funding of guideline development
82% did not allow industry participation in selection of committee members
67% did not allow industry to review guidelines prior to publication.

That all sound good, but consider what happens when one uses the total sample of organizations in the denominators.

Therefore, the article also found that of all 95 organizations that produced the guidelines of interest:

38% did not require CPG committee members to disclose conflicts of interest
43% did not require review of committee members' conflicts of interest prior to guidelines development
57% did not require that a majority of guideline committee members be free of conflicts
44% did not report publishing committee members' conflicts of interest within guidelines
48% did not report preventing direct industry funding of guidelines
51% did not report preventing industry participation in selection of committee members
61% did not report preventing industry review of guidelines prior to publication.

My comment is that thus the results suggested that substantial numbers of organizations that produced CPGs did not demonstrate that they were committed to measures that would improve guidelines trustworthiness by reducing the influence of conflicts of interest.

Disclosure of Conflicts of Interest Within Guidelines

Again, it was necessary to recalculate some proportions using the full population of guidelines reviewed as the denominator.

Of the 290 guidelines reviewed:
65% "included disclosure statements regarding direct funding and support"
37% specifically disclosed the absence or presence of direct funding from biomedical companies
However,
49% did not disclose committee members' financial relationships
99% did not disclose relevant financial relationships of the organization (that is, institutional conflicts of interest) that produced the guidelines as a whole

My comment is that substantial numbers of published guidelines were not clearly produced so as to increase their trustworthiness by reducing the influence of conflicts of interest on them. 

Did the Guidelines Follow the Organizations' Stated Policies?


The authors commendably provided information about whether the guidelines produced by organizations that disclosed conflict of interest policies followed those polices.  They found:

16% of organizations "that reported that committee member conflicts of interested were published in guidelines" produced guidelines that did not include committee members' COI disclosure

61% of organizations that "reported the majority of committee members must be free of conflicts of interest" produced guidelines by committees with majorities of conflicted members

6% of organizations that "reported that industry partners were not permitted to directly fund clinical practice guideline development" produced guidelines which disclosed such funding.

My comment is that thus even of the organizations that stated they had policies in place to improve the trustworthiness of the guidelines they produced by reducing the influence of conflicts of interest, they allowed guidelines to be produced that did not follow those policies.

Authors' Conclusion

Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appear to be common. These relationships are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers. We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies.

Editorialists' Conclusion

The editorial by Bastian(2) was sharper in tone.  It included an observation that reinforced my confession of naivete above:

With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It seemed so self-evident, it got barely a mention even in national policy on guideline development

She also noted that the Campsall study did not address all the ways conflicts of interest can influence guideline development:

Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients’ organizations.

She noted that the failure of guidelines to report their developers' conflicts of interest is a continuing problem.  The rate of failure to report found by Campsall et al was

about the same rate that Taylor and Giles found in 2004 and Norris and colleagues found in 2010.

Finally, she emphasized that we are still a long way from having guidelines that health care professionals and patients can trust:

Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it’s a case of caveat lector: let the reader beware.

My Summary

So should physicians trust clinical practice guidelines?  At least this article suggests they ought to be very very skeptical of them.  The IOM report meant to improve the trustworthiness of practice guidelines seems to be honored mainly in the breach.  The likelihood that any given guideline was produced so as to reduce the influence of conflicts of interest on it is low.  Even organizations that ostensibly put professional values and patients first in their efforts to develop guidelines seem to often be financially beholden to companies that want to sell drugs and devices.  Physicians and patients ought to be concerned that most new clinical practice guidelines may be as much about marketing commercial products as improving medical practice or patients' outcomes.

The current US presidential race has made it evident that we have a lot of disgruntled citizens, many of whom believe our system is rigged to favor the "establishment."  I suggest that the more we know about clinical practice guidelines, the more it appears that the health care system is rigged to favor certain parts of the "establishment," the big corporations that market drugs and devices, and their paid part-time hands within medical societies and patient advocacy groups who have turned these ostensibly idealistic, do gooder organizations into part-time marketing machines.

The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system.  True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.

Musical Interlude

To dispel the darkness a bit, Paul Simon, "Still Crazy After All These Years," 1992 acoustic version:





References

1.  Campsall P et al.  Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study.  PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002029    Link here.

2.  Bastien H. Nondisclosure of financial interest in clinical practice guideline development: an intractable problem? PLoS Medicine 2016;  DOI;10.1371/journal.pmed.1002030  Link here.

Health Care Renewal Bloggers to Present

Course on Trustworthiness of Clinical Practice Guidelines

Dr Roy Poses and Dr Wally Smith will be teaching a course on Trustworthiness of Clinical Practice Guidelines at the Annual North American meeting of the Society for Medical Decision Making, Doral, Florida, 18-22 October, 2014.

Particularly relevant to Health Care Renewal, the course will focus on reasons physicians may fail to trust clinical practice guidelines, including  concerns about the integrity of the evidence base supporting the guidelines, particularly due to manipulation and suppression of clinical research, and concerns about the guideline development process, including conflicts of interest. Furthermore, we will discuss measures that might improve the trustworthiness of the CPG development process, with emphasis on the recent report by the US Institute of Medicine, of which Dr Smith was an author.

Special Symposium on Understanding and Challenging Health Care Corruption

Dr Roy Poses and Dr Wally Smith will be presenting a special symposium,  Defense against the Dark Arts: Understanding and Challenging Health Care Corruption at the Annual Meeting of the Society for General Internal Medicine, Toronto, Ontario, Canada, 22- 25 April, 2015. 

We plan to summarize the scope of health care corruption, and discuss the impunity of those involved, and how discussion of it became taboo, before brainstorming ways to begin to challenge corruption.

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss..

Background


As we noted yesterday, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the latest appearing today.

In summary prior to the latest article,
-  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision

We noted that the NQF policy on conflicts of interest for its standard writing committees seemed somewhat weak.  The current (October, 2013) policy asks members to internally disclose conflicts and recuse themselves from " discussion of the applicable measure or measures, and in some instances competing and related measures."  However it does not ban members with conflicts, nor require public disclosure of conflicts.  We also noted that NQF has several board members who have full-time leadership positions with health care corporations, financial firms that invest in health care, or health care trade associations, and NQF received funding from pharmaceutical companies and their in-house foundations.  Thus NQF appears to have its own institutional conflicts of interest. 

So we thought that the case raised questions about how well NQF standards are protected from the influence of conflicts of interest, and whether they should remain so influential in the absence of stronger protections?

NQF Clarifies its Conflicts of Interest Policies

As reported by Modern Healthcare, it took only a day for the NQF to issue yet another press release to clarify its conflict of interest polcies.  In particular,

I n response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010:

• Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;
• Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;
• Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;
• Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and
• Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;

So NQF appeared to react ad hoc to concerns that Dr Denham was too avid about the use of a particular product.  Its response included strengthening its COI policy and banning one particular type of conflict, receiving funding from an organization controlled by a member of a standard writing committee.  However, as we noted above, the 2013 policy still has its weaknesses.  

Furthermore, an NQF executive volunteered to inform me that while the current written COI policy does not require public disclosure, in practice the organization requires public verbal disclosure of conflicts at the beginning of each committee meeting, and that the transcripts of these disclosures are available on the organization's website.  However, how to reach these disclosures is not obvious, and I so far have not been able to find the transcript that supposedly contains the disclosures for the meeting which Dr Denham co-chaired


Summary and a Few Optimistic Thoughts (Rare as They are for Us)

What I must say is now most unusual in the CareFusion/ Dr Denham/ NQF case is that NQF leadership, rather than  hunkering down in a defensive posture we have seen many other leaders adapt, seems to be trying to take steps toward addressing problems posed by conflicts of interest affecting its standard setting, guideline development, and quality assurance.  First, it is clear that NQF leaders did react to concerns about Dr Denham, and did somewhat tighten up their conflict of interest policies in response to them.  Second, it is clear that they are willing to listen to public questions and criticism, and at least consider further change in response to them.  They thus appear far more open than do leaders of many other organizations.

IMHO, NQF leadership is to be congratulated for this more transparent approach.  If only the leaders of other health care organizations would do as much. 

Since they do seem open to criticism and change, in the spirit of constructive criticism, I do hope that NQF leaders might also consider:
-  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
-  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching
-  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives

Health care leaders who see transparency and reduction of conflicts of interest as important goals show us that true health care reform might actually be possible.

ADDENDUM (24 January, 2014 - I was told that many people may need an explanation of the title.  "Putting in the ski lifts" is a shortened version of an old college saying.  The location for the ski lifts was a place that is traditionally very hot, think fire and brimstone.  The phrase refers to an extremely improbably event.  Sorry about any confusion.   

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared.

The Basic Story: Off-Label Marketing 

The story was initially briefly reported in the media.  A report in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete,

CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep.

Under the terms of the settlement with Washington, other states, and the federal government, CareFusion will pay a total of $40.1 million.

In particular,
 

When the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer can’t market or promote it for an 'off-label' use – any use not approved by the FDA.

Chloraprep was approved for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or an injection. The FDA rejected its use for prepping the skin prior to inserting catheters into veins for administering medications, or cleaning the skin as part of closing wounds.

The lawsuit alleges that from Sept. 1, 2009 to Aug. 31, 2011, CareFusion promoted Chloraprep for improper uses. CareFusion also allegedly publicized unverified information about Chloraprep during the same time period, Ferguson said.

So this follows a template we have seen before, most recently here.  A company promotes a drug or device for "off-label" uses.  While physicians are legally allowed to prescribe a drug or use a device for reasons other than its official indications, companies are not legally allowed to promote such uses.  Sometimes it turns out that the drug has benefits that outweigh its harms when used off-label, in which case the violation could be considered technical.  In other cases, the drug might turn out to be useless or even net harmful when used off-label, so the violation indicates putting revenue ahead of patients' welfare.  

The reporting on the CareFusion Chloraprep settlement did not clearly suggest that the off-label use was harmful to patients.

Allegations of Kickbacks to Promote Off-Label Use, but How?

It gets more interesting.  The Post-Intelligencer also noted,

The states also contend that in 2008 CareFusion’s predecessor corporation entered into agreements that CareFusion assumed legal and financial responsibility for. This included payments to Health Care Concepts Inc., payments that were allegedly made to hide kickbacks to the physician-owner of HCC for promoting and influencing providers to use Chloraprep, he said. This violates federal and state anti-kickback laws.

Now the allegations also include kickbacks to the "physician-owner" of a company to facilitate off-label promotion.  So the issue goes beyond a technical violation of the law.  The Post-Intelligence report, however, did not make clear what Health Care Concepts Inc actually did to contribute to off-label promotion.

A quick attempt to find out more about this company via the web was not fruitful.  There are lots of companies/ organizations called Health Care Concepts or some variant.  The most relevant may be this one, which lists CareFusion as a "partner" on its main web-page.  What this company actually does is a bit unclear.  Its business model is described as "a private incubator of early products, services, and technologies, as well as an accelerator of mature solutions that will be taken to scale." What that has to do with off-label promotion of a product of a big established company like CareFusion is not clear.  How this company could have influenced providers is not clear, given that it is not an advertising firm, public relations firm, or medical education and communication company (MECC).

So what is going on here?  

Allegations of a $11.6 Million Payment to Manipulate the National Quality Forum Standards


Yesterday, 21 January, 2014, Modern Healthcare began to explain the mystery.   

Many healthcare companies have been accused of paying kickbacks to influence physicians' medical decisions, but one major supplier allegedly tried to steer an entire industry by influencing the recommendations of the National Quality Forum

The NQF, which reviews medical evidence and makes recommendations for improving healthcare, acknowledges that a well-known patient safety advocate is alleged to have received millions of dollars to promote a surgical sterilization product while co-chairing an NQF committee that suggested hospitals use that product. 

Federal officials say Dr. Charles Denham, co-chair of NQF's Safe Practices Committee in 2010, received $11.6 million from San Diego-based CareFusion to promote the company's ChloraPrep line of skin-preparation products. Denham's committee at the NQF also recommended surgeons use ChloraPrep products to prevent surgical infections, the NQF said.

The allegations about the role of Dr Denham in the NQF also did appear in the the official US Department of Justice press release.

Allegations of Bogus Contracts, and Non-Denial Denials

The allegations produced some non-denial denials (in the phrase found in All the President's Men).

Dr Denham responded, but through a lawyer:

A statement from Denham's attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, said reports that the underlying lawsuit involved Dr. Denham were 'blatantly false.'

Denham was not accused of wrong-doing in the whistleblower lawsuit, and Gondelman said Denham has and continues to cooperate with investigators in the case.

Note that while the attorney denied that Dr Denham was named in the underlying lawsuit, he did not apparently specifically deny the allegations.

The NQF also reponded,

 An NQF review committee removed the reference to the specific product before final publication of 'Safe Practices for Better Healthcare' in 2010.

'An NQF ad hoc review did not find sufficient evidence to support one skin preparation over another,' a statement from the organization said. 'The ad hoc review effectively served its role of rapidly responding when a potential issue is identified.'

Note that the NQF press release did not deny that the CareFusion money was given to Dr Denham's organization, nor that the NQF report might have promoted the use of a class of products in which CareFusion's Chloraprep resides.

A follow-up story in Modern Healthcare noted that Dr Denham confirmed the payment of the money to his company, but not its purpose,

 Renowned quality expert Dr. Charles Denham confirms that CareFusion paid his company more than $11 million, but Denham says he was surprised to see the U.S. Justice Department describe the money as kickbacks intended to influence national quality-of-care guidelines published by the National Quality Forum.

Dr Denham's lawyer confirmed the payment, but did not further explain it:

Denham's lawyer, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, acknowledged that CareFusion did pay Denham's company under two contracts. 

And,

Gondelman said the $11.6 million paid to Denham's company covered 'an array of services' and that he could not elaborate.

Again, note that Mr Gondelman did not specifically deny that the money served as a kickback.

Meanwhile, the Department of Justice alleged something more elaborate, and nefarious, 

The Justice Department, though, says the contracts were written to look as though CareFusion was buying consulting, software development and strategic marketing services, as well as the completion of three unnamed projects. The value of the deals, the government alleges, far exceeded the fair-market costs of those services, and that one of the actual purposes of the deals was to conceal kickbacks to Denham while he served on the National Quality Forum.

Interval Summary

So what is clear so far is that:
-  CareFusion agreed to a $40.1 million settlement of allegations that it provided kickbacks to promote off-label use of its product.
-  CareFusion paid $11.6 million to Health Care Concepts
-  Health Care Concepts is run (and possibly owned) by Dr Charles Denham, who chaired a National Quality Forum committee that recommended use of CareFusion's product ChloraPrep in a performance standard and the final version of the NQF standard recommended use of a group of products including ChloraPrep

We have frequently discussed how health care corporations may promote goods, particularly drugs and devices and services through deceptive and unethical practices, including inducements ranging form creation of conflicts of interest to outright bribes and kickbacks.   We have also discussed the influence of individual and institutional conflicts of interest on clinical practice guidelines.  This has become an important enough problem for the US Institute of Medicine to weigh in with standards for trustworthy guidelines that markedly limit such conflicts of interest. 

This case seems notable because it may link the problems of deceptive and unethical promotion with the influencing of clinical practice guidelines.  It is particularly notable because the organization generating the guidelines in question, the National Quality Forum, has become large, influential, and authoritative.  Re the latter point, the latest Modern Healthcare article affirmed,

The NQF is a standards-setting organization for the healthcare provider industry. It holds the exclusive contract to provide Medicare and Medicaid with recommendations on a national quality-of-care strategy and the measures used to gauge improvements.

In fact, while the NQF performance standards can function as guidelines, they also may be bases for pay for performance schemes that attach real incentives to guidelines, which could become perverse if the guidelines have been manipulated.

Can the NQF Defend Against Conflicts, and If Not, Should it Remain So Authoritative?

So the big question is whether the NQF, given its unique influence, has any meaningful approach to prevent its standards from being influenced by conflicts of interest?

The NQF does have a recent conflicts of interest policy. However, according to my reading, it neither bans committee members with conflicts of interest, nor even requires public disclosure of conflicts of interest.  All it seems to require is that committee members disclose conflicts internally and voluntarily recuse themselves from deliberations which may be affected by them.  Although the policy states that conflicts of interest may be made public, I could find nothing in the report which Dr Denham co-authored about conflicts of interest or competing interests affecting any of the authors, including Dr Denham

Furthermore, a very quick look at information publicly available on the NQF web-site suggests the organization itself may have major institutional conflicts of interest.  The NQF is one of those "public-private partnerships" that have become all the rage.  Several members of its board of directors have leadership positions in large health corporations, financial firms with large health care interests, or trade associations for large health care corporations: 

- Elizabeth J. Fowler, PhD, JD, is Vice President, Global Health Policy, in the Government Affairs & Policy group at Johnson & Johnson.

- Robert Galvin, MD, is Chief Executive Officer, Equity Healthcare, at The Blackstone Group.

 - Karen Ignagni, President and Chief Executive Officer of America’s Health Insurance Plans (AHIP), is the voice of health insurance plans....

- J Mark Overhage MD, PhD,  Chief Medical Informatics Officer, Health Services, Siemens Healthcare


Thus it is conceivable that they could personally profit, and that their organizations could institutionally profit from standards that favor their organizations' interests.  

Furthermore, NQF receives funding from the US government and private foundations, but also from pharmaceutical companies and their in-house foundations:

the Bristol-Myers Squibb Foundation, the Cardinal Health Foundation, Pfizer Inc., Sanofi-aventis,...

Unless the current case leads to big changes in the prevalence of conflicts of interest among the NQF board, the continuation of its institutional conflicts of interest generated by its sources of funding, and its weak policy on conflicts affecting committee members, the question becomes whether it should continue to have such an authoritative role?

As we have said over and over, pervasive conflicts of interest affect health care decision-makers and policy makers and the organizations within which they function.  Such conflicts threaten to put various private interests way ahead of patients' and the public's health.  If we really want health care that will put patients' and the public's health first, we need to end such arrangements that favor private gain.  

 Roy M. Poses MD on Health Care Renewal

ADDENDUM (23 January, 2014) - A closer re-reading of the NQF conflict of interest policy made it clear that recusal is not voluntary, and that conflicts of interest may be revealed publicly, but that such disclosure is not mandatory.  The paragraph above dealing with these issues was revised accordingly.