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?"

 

How Can We Promote Evidence-Based Medicine Under a Regime that Insists on Its Power to Say "2+2=5"?

Introduction: Evidence-Based Medicine

We have consistently advocated for Evidence-Based Medicine (EBM), which is about medical-decision making based on critical review of the best applicable evidence from clinical research informed by knowledge of biology and medicine, of the patient's biopsychosocial circumstances, the patient's values, and of ethics and morality. Since EBM depends on the availability of evidence from the best clinical research, we have advocated for the integrity of clinical research, and decried  manipulation of clinical research done to increase the likelihood that its results would please vested interests, and suppression of research whose results offended such vested interest, sometimes done when manipulation did not succeed in producing such pleasing results.

Addressing such threats to the evidence-based required challenging the role of large for-profit corporations, principally pharmaceutical, biotechnology, and device companies, in clinical research.  In doing so, we depended on support from other concerned health care professionals and scientists.  Sometimes, when manipulation and suppression crossed over the line to become fraud and deceptive marketing, government regulators and lawyers stepped in.  We have discussed numerous legal settlements involving penalties - admittedly, often less severe than we would have preferred  - on particular corporations.

So we have counted on governments having a shared interest in promoting the integrity of clinical research, and more broadly of clinical and public health science, and when necessary, acting to enforce such integrity.  

However, we have increasing reason to doubt these shared interests under the current US regime.



Administration Comfort with Suppression of Speech about Research

Consider episodes in which political appointees of the Trump regime seemed comfortable with the suppression of speech about medical, health care and public health research.

In 2016, we discussed several cases in which officials at the Department of Health and Human Services stifled responses to journalists about scientific issues.  In particular, employees of the Center for Disease Control (CDC) were told not to respond to any journalists' requests for information, even "simple data-related questions," in lieu of responses from agency public relations personnel.

In 2017, we discussed how President Trump's first Secretary of Health and Human Services, Dr Tom Price, had been involved in attempted suppression of the results of research about the drug Bildil at the behest of a previous campaign donor.

In addition, three recent episodes, one from August, 2019,  two more in late October, suggest that under Trump, open discussion of the science pertaining to health care and public health, and the pursuit of scientific truth in these areas have been increasingly subordinated to politics, and particularly to supporting the notion that the President is sole keeper of all truth. 

Silencing National Intstitute of Mental Health (NIMH) Scientists about the Relationship of Mental Health to Violence to Avoid Contradiction of a Trump Tweet


Per a Washington Post article from August 20, 2019, after mass shootings in El Paso, TX and Dayton, OH,

'Mental illness and hatred pull the trigger. Not the gun,' Trump said immediately after the shootings. In the following days, he reiterated that statement, arguing that the United States should reopen mental institutions shuttered decades ago as a way to address mass shootings.

But then,

federal health officials made sure no government experts might contradict him.

A Health and Human Services directive on Aug. 5 warned communication staffers not to post anything on social media related to mental health, violence and mass shootings without prior approval.

The particulars were as follows:

On Aug. 5, Trump was scheduled to speak following the weekend shootings. That morning, some HHS employees, including those at the National Institutes of Health, received an email asking those who contribute to official social media accounts to hold off on posts until 'we get the green light from HHS,'

Then,

some employees received another email from Renate Myles, an NIH spokeswoman. Social media posts could resume, the note said, butemployees were asked to 'please send any [social media] posts related to mental health, violence or other topics associated with mass shootings for review before posting.'

The second directive applied most directly to the National Institutes of Mental Health, where nearly all of the agency’s social media activities relate to mental health. It remains unclear how many people received that instruction, which was lifted by week’s end.

The administration's explanation was:

'It’s the department’s long-standing practice to not get ahead of the president’s remarks,' HHS spokeswoman Caitlin Oakley said. 'This allows the president to share his message first with the nation. Any suggestions that this was a formal policy put in place related to social media, or meant to stymie work on this issue, are factually inaccurate. These were staff-level discussions seeking to be sensitive and respectful to the victims and their families affected by tragedies of that weekend.'

However,

By contrast, two former senior health officials in the Obama administration said they did not recall ever receiving such a directive after a mass shooting.

Also,

In the days and months following the mass shooting at Sandy Hook Elementary School in Newtown, Conn., which killed 20 first-graders and six staff members, the National Institutes of Mental Health spoke extensively about mental illness and violence. 'The conversation has evolved, recognizing that violence most often associated with mental illness is suicide, and that most violence is unrelated to mental illness,' the NIMH director said at a meeting three months later. NIMH also hosted a special panel discussion, How Sandy Hook is Changing the Conversation,' during which mental health experts worked to dispel stereotypes that link mental illness to violence.

After this month’s shootings, however, NIMH and its director were largely silent on the shooting. The only mention on the official NIMH Twitter account was a retweet of the NIH account, directing those struggling with grief and emotional distress to the Substance Abuse and Mental Health Services Administration for counseling and support.

Furthermore,

An HHS employee who spoke on the condition of anonymity to describe internal discussions said he had 'no doubt this was meant to prevent anybody from making any statements that might contradict the president.'

The Post consulted one ethics expert:

'To say that scientists and experts who know the data and facts best are not allowed to speak — that’s very concerning,' said Dominic Sisti, a University of Pennsylvania professor who studies ethics in mental health and psychiatry.

Silencing the Director of the National Institute of Environmental Health Sciences (NIEHS)  and National Toxicology Program to Support Industries Favored by the Administration

The case had to do with the health risks posed by PFAS, industrial chemicals found in the environment.

Per an October 24, 2019 article in The Intercept, the background is:

the company that first developed both PFOA and PFOS and sold PFOA to DuPont for many years, still argues that the compounds do not cause health problems. In her testimony before the House Committee on Oversight and Reform in September, Denise Rutherford, 3M’s senior vice president of corporate affairs, said that 'the weight of scientific evidence has not established that PFOS, PFOA, or other PFAS cause adverse human health effects.' The company also requested that The Intercept remove the word “cause” in a recent article about PFAS. That request was denied.

However, Linda Birnbaum, recently retired director of the National Institute of Environmental Health Sciences and the National Toxicology Program, thought

'In my mind, PFAS cause health effects because you have the same kind of effects reported in multiple studies in multiple populations,' she said in a phone interview. Birnbaum pointed in particular to longitudinal studies, which follow populations’ exposures and health over time. 'You have longitudinal studies showing the same effects in multiple populations done by multiple investigators and you have animal models showing the same impact,' said Birnbaum. In addition, she pointed to studies that show the mechanism through which PFAS chemicals cause harm in people.

'That is pretty good evidence that PFAS or certain PFAS can cause health effects in people. It is not as strong for every effect, but there are quite a number of effects where they’re strong enough to say ‘caused,’' Birnbaum said. She pointed in particular to the relationship between the chemicals and immune response, kidney cancer, and cholesterol in humans, saying, 'That data is very clear.'

Dr Birnbaum had upset industry in the past, but in particular,

Her run-in with Republicans on the House Science Committee last year may have had the most severe consequences. Reps. Andy Biggs and Lamar Smith accused Birnbaum of lobbying based on an editorial in the journal PLOS Biology. In it, Birnbaum wrote that 'U.S. policy has not accounted for evidence that chemicals in widespread use can cause cancer and other chronic diseases, damage reproductive systems, and harm developing brains at low levels of exposure once believed to be harmless.' She called for more research on the risks posed by chemicals and noted that 'closing the gap between evidence and policy will require that engaged citizens — both scientists and non-scientists — work to ensure that our government officials pass health-protective policies based on the best available scientific evidence.'

Under the Trump administration, there were consequences:

'everything was scrutinized that I did. Everything I did required clearance. Even in my lab,' said Birnbaum. 'All of a sudden, everything had to go up at least to building 1,' she said, referring to the Bethesda building that serves as the administrative center for the National Institutes of Health. Birnbaum was also denied a salary increase after the incident and became aware that her job was at stake. 'I was told that they were trying to fire to me.'

Also,

Birnbaum was not allowed to use the word 'cause' when referring to the health effects from PFAS or other chemicals.

'I was banned from doing it'” said Birnbaum. 'I had to use ‘association’ all the time. If I was talking about human data or impacts on people, I had to always say there was an association with a laundry list of effects.' Birnbaum said this restriction 'was coming from the office of the deputy director. His job hinged on controlling me.'

Again, while there is room for debate about whether PFAS causes the problems, or are simply associated with the problems.  However, the accusation is not that there was debate within the government, but that Dr Birnbaum's government supervisor silenced her opinions about causation, whaterver the evidence on which she based them.

Silencing the Director of the Centers for Disease Control and Prevention (CDC) Climate and Health Program About "Climate Change"

On October 29, 2019, CBS News reported that Dr George Luber, Director of the CDC Climate and Health Program, had to stop talking about "climate change," particularly its health consequences,

In late 2016 Luber was organizing a climate change conference. Al Gore was to be the keynote speaker. But right after Donald Trump was elected president, Luber's boss called him in.

Luber recalled, 'I was told the optics are not good and that I needed to cancel it.'

Correspondent Mark Strassmann asked, 'Did he explain what the optics issue was?'

"That the meeting was happening three weeks after the inauguration."

'And that the White House would be unhappy?'

'Yeah,' Dr. Luber said.

America's new president had a dim view of Luber's science, referring to climate change as a hoax, 'created by and for the Chinese.'

Dr. Luber said his boss wanted something else: 'Just don't say 'climate change.' Can you call it 'extreme weather?' Can you call it something else?'

Strassmann said, 'You're saying that the Centers for Disease Control was suddenly afraid to use the term 'climate change'?'

'Yeah. Absolutely. I was told to use a different term,' he said.

CBS confronted Dr Patrick Breyesse, Dr Luber's manager, who essentially gave a non-denial denial:

He's the senior manager who Dr. Luber said ordered him to scuttle the science conference.

'It wasn't cancelled; we postponed it,' Dr. Breysse said.

'You didn't feel any pressure at all?' Strassmann asked.

'No.'

'Politically?'

"No."

That conference happened, but without CDC sponsorship.

Strassmann asked, 'Were any CDC employees ever told, 'Stop using the phrase 'climate change'?'

'Not to my knowledge,' Dr. Breysse replied, 'but we did discuss it.'

'That you change from 'climate change' to 'extreme weather,' because 'climate change' was more radioactive?'

'We talked about making the change, but we never made the change.'

Meanwhile, it appears that CDC leadership retaliated against Dr Luber,

In March 2018 the CDC revoked Dr. Luber's badge, phone and credentials. He was escorted off the property. The CDC moved to fire him. He faced more than 30 'troubling allegations,' from falsifying timecards to seeming hung over. Dr. Luber refuted all but one charge, and was allowed to stay.

However,

Dr. Luber still works at the CDC, but potentially faces up to a four-month suspension. He has to work from home, where he reviews scientific papers unrelated to climate change.

When asked about that, Dr Breyesse responded

'I can't talk about personnel matters, I'm sorry, Mark,' he responded.

'Has he been banned from the campus?'

'So, that's a personnel matter that I can't discuss.'

'Is the CDC retaliating against him?'

'I'm just not going to comment on that,' he said.

A Larger Pattern

To summarize, in the second half of 2019, we have seen three episodes of scientists/ health care professionals at the premier US government health and public health agencies silenced about relevant issues to apparently avoid contradicting Trump administration political goals and/or the pronouncements of the President himself.  There is reason to suspect that agency leaders punished or retaliated against the scientists and health professionals for speaking out.

These appear to be part of a larger pattern.  There have been a lot of similar episodes involving other kinds of science.  For example, there was the infamous case of government climate scientists attacked after they contradicted a Trump tweeted his erroneous take on the course of Hurricane Dorian.  As the New York Times reported on September 8, 2019:  

The Secretary of Commerce threatened to fire top employees at the federal scientific agency responsible for weather forecasts last Friday after the agency’s Birmingham office contradicted President Trump’s claim that Hurricane Dorian might hit Alabama, according to three people familiar with the discussion.

That threat led to an unusual, unsigned statement later that Friday by the agency, the National Oceanic and Atmospheric Administration, disavowing the National Weather Service’s position that Alabama was not at risk. The reversal caused widespread anger within the agency and drew accusations from the scientific community that the National Weather Service, which is part of NOAA, had been bent to political purposes.

After that episode, the National Task Force on Rule of Law and Democracy developed a report on government attaacks on the integrity and rigor of government research, as summarized in an op-ed in the Washington Post on October 3, 2019, entitled "Under Trump, the integrity of government research is in shambles." The authors wrote,

This isn’t the first time this administration has retaliated against scientists for doing their jobs. The Agriculture Department recently decided to relocate an entire staff of career economists from Washington to the Kansas City area after they published reports on the financial harms of Trump’s trade policies. The Interior Department moved a climate scientist to an accounting role after he stressed the dangers of climate change to Alaska’s Native communities. A recent tally by the Union of Concerned Scientists listed more than 120 attacks on science by the Trump administration.

The report called for a variety of legislative solutions, but these may be insufficient.

The pattern may be even larger.  In the Atlantic, Quinta Jurecic, the managing editor of Lawfare, wrote on September 11, 2019,

The saga of Dorian is a snapshot of Trump’s refusal to accept the reality of a world that looks any different from what he wants to be true, and a demonstration of how such an instinct in a leader is incompatible with the requirements of democracy.

Furthermore,

Trump’s behavior regarding Dorian is yet another example of his strained relationship with the truth, something that is at this point so routine as to be barely worth commenting on. In the language of the philosopher Harry Frankfurt, he is a 'bullshitter'—someone who does not so much lie in order to consciously obscure the truth as make statements without any thought or care to what the truth might be. Bullshit, Frankfurt argues, is careless, in that it requires no commitment to a stable universe of facts. And Trump’s falsehoods are careless insofar as he makes them without any regard for consistency or internal logic, but there is also a stubbornness to them. His bullshit is a way of insisting that the world take the shape he wants it to have, regardless of the facts on the ground.

Government by BS is not just a threat to science and scientific discussion.

Democracy, as Arendt writes, depends on the existence of a shared universe of mutually agreed-upon facts—like whether or not it is raining in Alabama. It also depends on the willingness of leaders to acknowledge that some things, including the weather, are beyond their control. That is not Donald Trump’s way. He is the strong man standing alone at the front of the crowd, who is strong only when there is no one there to tell him differently.

Trump seems to want to be like the Inner Party in Orwell's 1984. In Part III, Chapter 2, when Inner Party member O'Brien interrogates and tortures Winston Smith, he says:

reality is not external.  Reality exists in the human mind, and nowhere else.  Not in the individual mind, which can make mistakes, and in any case soon perishes: only in the mind of the Party, which is collective and immortal.  Whatever the Party holds to be truth, is truth.  It is impossible to see reality except by looking through the eyes of Party.  

So when O'Brien holds up his hand with four fingers extended, and Smith says he sees four fingers,

And if the Party says that it is not four but five - then how many?

The Party says the answer must be "five"

So the answer to the question posed by the title of this post is "we can't"

As long as we are led by a President who believes he has the power to make 2 + 2 equal "5," we will be unable to meaningfully promote clinical research integrity, much less evidence-based medicine.  Any progress will only come with a new President.  

"The Censorship That It is" - Now Threatens US Government Health Agencies (DHHS, CMS, CDC)

On Health Care Renewal we discus the dark side of health care, particularly of the leadership and governance of health care, that has enabled health care dysfunction.  Our discussions are based on publicly available information, often produced by dogged health care journalism.

Uur work has become more difficult as journalism is challenged by economic circumstances.  Yet now there are worse threats.  Despite First Amendment protections of freedom of speech and the press, journalism is now under fire from the highest reaches of US government.

Information Blockade at the Department of Health and Human Services

Two recent articles in the Columbia Review of Journalism pointed to specific problems  The first, "Under Trump, Health Reporters Confront an Information Blockade," September 7, 2017, focused on decreasing transparency at the US Department of Health and Human Services (DHHS), and its Center for Medicare and Medicaid Services (CMS).  It provided numerous examples of officials failing to respond to apparently straightforward requests for legitimate health care information.  For example,

Washington Post healthcare reporter Paige Winfield Cunningham recently raised a few serious questions about how the Trump administration planned to manage Obamacare’s fall enrollment season. 'The six-week sign-up period will be the first handled exclusively by an administration that’s hostile to the Affordable Care Act,' Cunningham wrote, 'and one that hoped by now to see Congress pass legislation unraveling much of the law.'

Any reporter might have asked the questions Cunningham put to the Department of Health and Human Services, some of which she published in her daily Health 202 column:

Will the government contact current enrollees to alert them that sign-ups will last just 45 days, about half as long as in the past three years? Will HHS run call centers for consumers who need help as they look for plans? Will the HealthCare.gov computer system be adjusted to accommodate a possible crush of shoppers given the shorter sign-up period? And how will automatic enrollment be handled?

HHS offered no answers, although a spokesperson for the department’s communications staff did provide Cunningham with a statement: 'As open enrollment approaches, we are evaluating how best to serve the American people who access coverage on HealthCare.gov.' Even that statement did not stand for long, reported Cunningham:

An hour later, the spokeswoman, Jane Norris, requested that the statement be withdrawn, saying that she did not have permission to release it. When I asked her again for detailed answers, neither she nor anyone else at HHS responded further.

'Nobody at HHS ever reaches out to me,' Cunningham told CJR during an interview.

Also,

Matt Wynn, data reporter for MedPage Today, went public with his troubles prying loose the data underlying a series of maps CMS sent out this summer. One map published in early June identified counties without insurers selling policies on healthcare.gov this fall, and a news release announced at least 35,000 active Exchange participants live in counties projected to be without coverage in 2018.' Wynn asked CMS to see the numbers supporting those conclusions.

I shot an email to the media relations office in the department, asking for the data behind the map.

About an hour later I got a response. No further information would be shared at this time, wrote Shelby Venson-Smith, a public affairs specialist. Adding insult to injury, the non-response was not to be used as a direct quote, the email said.

However, while DHHS and CMS officials resisted responding to uncomplicated requests for information,

they seem to have plenty to say in their news releases and email blasts, which disparage the health law and sound more like campaign propaganda and GOP talking points than routine communications from a federal agency. The Obama administration was not shy about using the same PR tools to boost the ACA. But messages from HHS now feel substantively different, perhaps because they are aimed at denigrating a law they have a legal responsibility to administer.

Thus officials at DHHS seem to now be more interested in following the party line of the current administration than in providing basic information to the public.

Many other health care journalists experienced similar problems, including Charles Ornstein from ProPublica, Dan Diamond of Politico, Harris Meyer of Modern Healthcare, and Noam Levy of the Los Angeles Times.

Trudy Lieberman, the author of the CJR article, wrote,

HHS and CMS are powerful agencies that could decide the future of critical programs like Medicaid and Medicare, the Obamacare insurance marketplaces, and whether or not hospitals are considered safe. But when agency press officials avoid interviews and refuse to answer questions, it’s hard to present their positions fairly and understand whose side they are on. Government agencies are supposed to be objective about industry practices under their jurisdiction. But if reporters cannot get honest information about the industries they regulate, where can they go?

Kathryn Foxhall, who "works with the Society of Professional Journalists on freedom of information issues," put it this way,

I don't see the administration ever stopping what they are doing, unless we as journalists pull out all stops and call it the censorship that it is.

Public Health Without Public Information?

Worse, one week later, CJR published another article  on the US Centers for Disease Control (CDC).  The CDC is the lead US public health agency.

Axios published text from a late August email by a CDC public affairs officer that directs staff to route any correspondence with journalists—'everything from formal interview requests to the most basic of data requests'—through the communication office at its Atlanta headquarters:

'The message—sent by public affairs officer Jeffrey Lancashire and dated Aug. 31—instructs all CDC employees not to speak to reporters, ‘even for a simple data-related question’… Lancashire did not respond to requests for comment about the policy. But I’d love to know what harm was being done by CDC employees answering ‘the most basic of data requests.’'

Thus CDC officials now seem to want to substitute public relations for straightforward information provision.  Given that the mission of CDC is public health, this seems to be an example of mission-hostile management, a concept we have used most often to refer to the management of private health care organizations, not US government agencies.  Charles Ornstein of ProPublica commented

This is genuinely disturbing. The idea that someone at CDC headquarters needs to sign off on responses to basic data requests shows a level of media control beyond which I have ever seen. What’s next?

Felice Freyer of the Boston Globe tweeted

CDC is employed by taxpayers. Why shouldn't its work be readily shared with them?

At Health Care Renewal, we have often discussed the anechoic effect, a taboo against public discussion of many aspects of health care dysfunction, particularly those that might discomfit people who are personally profiting from the current system.  In particular, the currently dysfunctional health care system has made the leaders of big health organizations, particularly for-profit corporations,  hugely wealthy.  Furthermore, big health care organizations have been eager to develop financial relationships with health care professionals, academics, leaders of non-profit organizations and NGOs, etc, leading to a web of conflicts of interest draped over health care.  Who wants to speak out when doing so may offend not only distant CEOs, but also one's colleagues, bosses, friends, relatives etc who may have financial ties to those CEOs' corporations?  Furthermore, who wants to speak out when large corporations command huge marketing and public relations operations that can be used to drown out unwanted ideas, and legal departments ready to threaten litigation?

Now government health care officials seem to be enlarging their own public relations efforts while shutting off access of honest information.  This will only make open discussion of the true causes of health care dysfunction more difficult. 

Even more chilling is the threat that health care officials now may be attempting actual censorship.  We have depended on health care journalists to root out bad behaviors that lead to health care dysfunction, and by doing break taboos about discussion such behaviors.  Up to now we have assumed at least that government would not make it harder for journalists to do their job, protected by the Bill of Rights protections of free speech and a free press.  But now the current administration seems to be taking the side of censorship.

From Censoship to Incitement of Violence?

Even worse, some worry that the regime's hostility to journalists  threatens their actual harm.  In early September, the New York Times reported on comments by the United Nations High Commissioner for Human Rights, who

was reacting to Mr. Trump’s recent comments at a rally in Phoenix during which he spoke of 'crooked media deceptions' in reports of the violent clashes at a white nationalist rally in Charlottesville, Va., that resulted in the death of a counterprotester.

In Phoenix, the president’s words also appeared to whip up audience hostility toward journalists.

The failing @nytimes writes false story after false story about me. They don't even call to verify the facts of a story. A Fake News Joke! — Donald J. Trump (@realDonaldTrump) June 28, 2017

'It’s really quite amazing when you think that freedom of the press, not only a cornerstone of the Constitution but very much something the United States defended over the years, is now itself under attack from the president himself,' [UN official] Mr. al-Hussein said. 'It’s a stunning turnaround.'

Furthermore,

'To call these news organizations fake does tremendous damage,' Mr. al-Hussein added. 'I believe it could amount to incitement. At an enormous rally, referring to journalists as very, very bad people — you don’t have to stretch the imagination to see then what could happen to journalists.'

Ominously, the response from the White House included more unsubstantiated charges of "false narratives," and threatened media tha fails to be responsible as judged by the regime, never mind the First Amendment and its promise of free speech and a free press. 

the White House press secretary, Sarah Huckabee Sanders, said in an emailed statement, 'We believe in free press and think it is an important part of our democracy, but the press also has a big responsibility to the American people to be truthful. Their job is to report the news, not create it.

'Is it not ‘dangerous’ for the media,' she continued, 'to create false narratives and overzealous attacks against the president that the American people chose to be their leader? The president is focused on growing our economy, creating jobs, securing our border and protecting Americans. Since those are also the priorities of most Americans, hopefully the media will make covering them theirs.'

Strong, even overzealous verbal and written attacks on politicians, the president included, have been essential parts of American democracy since the Bill of Rights was ratified.  The First Amendment shows that our political system values such boisterous discourse.  The White House press secretary thus threatened not only the press but the fundamental US system of government.  

Strategic Hostility

Finally, there is an argument that the regime's attacks on the media may not be just reckless, but  strategic and calculated.  The UN Special Rapporteur on the promotion and protection of the right of freedom of opinion and expression, Prof David Kaye of University of California - Irvine School of Law, wrote,

The President’s attacks may be reckless – who knows whether someone in his audience will take the President’s word as license to take action against enemies of the American people? – but they are not without purpose. They have concrete aims: to intimidate reporters into certain kinds of coverage, or clarify for his favored outlets what coverage he desires, or plant the seeds of doubt about news stories (such as the Russia investigation led by Robert Mueller).

Also,

However, when we tie together the jeremiads and rhetoric with what the Trump administration is doing in other governing spaces, the practice of attacking the press becomes clearer as policy than solely reckless rant.

First, the attack on the press is not merely rhetorical; it is increasingly reflected in policy.

And,

Second, Trump’s incendiary statements work in tandem with a pattern of lying and disinformation, both aiming to limit the accessibility of truthful information. 

And,

Third, the administration operates as if it has something to hide.

Who knows what they might be hiding.  But there certainly have been plenty of accusations of  severe conflicts of interest and corruption affecting the Trump presidency?

Summary

Up to last year, I was cautiously optimistic that the anechoic effect was starting to erode, enabling the health care discussion to begin to encompass the deeper causes of health care dysfunction.  Since November, however, we seem to be going backward.  What little openness and transparency that were developing are at risk of sinking under a new tide of propaganda and censorship.  My concerns have primarily been about health care and health care dysfunction, but the larger trends threaten our whole society and the ability of the US to maintain itself as a republic.  Ben Franklin's warning becomes more acute.  What we have is only 

A republic if you can keep it. 

That will now take some work.  

Stealth Public Relations and Health Advocacy, Special Pleadings and the Opposition to Guidelines Discouraging Overuse of Narcotics

As I have written before as a physician who saw too many dire results of intravenous drug abuse, I was amazed how narcotics were pushed as the treatment of choice for chronic pain in the 1990s, with the result that the US was once again engulfed in an epidemic of narcotic abuse and its effects.  In mid-December, 2015, as reported in the Washington Post,

The nation continues to suffer through a widespread epidemic to prescription opioids and their illegal cousin, heroin. The CDC estimated that 20 percent of patients who complain about acute or chronic pain that is not from cancer are prescribed opioids. Health-care providers wrote 259 million prescriptions for the medications in 2012, 'enough for every adult in the United States to have a bottle of pills,' the CDC wrote.

Last week, the National Center for Health Statistics reported that the number of overdose deaths from legal opioid drugs surged by 16.3 percent in 2014, to 18,893, while overdose fatalities from heroin climbed by 28 percent, to 10,574. Authorities have said that previous efforts to restrict prescription drug abuse have forced some people with addictions to the medications onto heroin, which is cheaper and widely available.

This rising tide of death and morbidity seems to have been fueled by reckless, sometimes deceptive, sometimes illegal marketing by the pharmaceutical companies that produced narcotics other than heroin.

Background - Legal Drug Pushing

As I wrote in 2013,

the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an 'ethical' drug company.  In the earlier days of Health Care Renewal, we first posted (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population.  Then in 2007 came the spectacular case of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for 'misbranding' Oxycontin,  that is, promoting it far beyond any medically legitimate use in severe chronic pain.  Following that various investigations, well chronicled in the Milwaukee Journal Sentinel, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more 'legal' narcotics  For example, see the Journal Sentinel reports the subversion of :  medical schools and their faculty; .medical societies, disease advocacy groups, and foundations; and guideline writing panels.  In 2012, we posted about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.

As I described in that 2012 post, the new narcotic pushers relied on only the most sketchy evidence about the safety of prescription narcotics.  In the 1990s, they taught that the rate of addiction caused by prescribing legal narcotics was only 1%, but this was based on a tiny flawed case series of a mere 38 patients.  In 1996, a consensus statement from the American Academy of Pain Medicine and the American Pain Society, entitled "The Use of Opioids for the Treatment of Chronic Pain," included the following statements,

Pain is often managed inadequately, despite the ready availability of safe and effective treatments.

Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.

Yet one of the primary proponents of profligate use of narcotics to treat chronic pain later admitted he

erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'

Also,

'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.

In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.

The CDC Attempts to Moderate the Use of Opioids for Chronic Pain

So to me it seems quite reasonable the US Center for Disease Control and Prevention (CDC), being cognizant of the rising toll of narcotic addiction, would attempt to do something about it.  As reported by the Washington Post,

The government on Monday urged primary-care physicians who prescribe opioids for pain relief to rein in their use of the drugs, proposing new guidelines that call for a more conservative approach than the one that has led to a crippling epidemic of addiction to the powerful narcotics.

Just a few days after a new report showed a surge of drug-related overdoses in 2014, the Centers for Disease Control and Prevention suggested in draft recommendations that physicians tackle chronic pain with other methods, such as physical therapy and non-opioid analgesics, before turning to the powerful medications. If opioids, such as OxyContin and Percocet, are necessary, the agency recommended short-acting versions over extended release formulations, the lowest possible dose and short-term prescriptions.

It also suggested that doctors ask patients to take urine tests before prescribing opioids and additional urine tests at least once a year if they continue on the drugs, to ensure that they aren't secretly taking other opioids or illegal drugs.

'What we want to just make sure is that doctors understand that starting a patient on an opiate is a momentous decision,' said CDC director Tom Frieden. 'The risks are addiction and death, and the benefits are unproven.'

Based on the events since they 1990s, the lack of clear data from well performed randomized controlled trials of the effectiveness of opioids in chronic pain, and their obvious, known risks, that seems like common sense to me.

The Strong but Obscure Opposition to the CDC Guidelines

However,others disagreed.  The guidelines attracted immediate opposition, for reasons that were not immediately obvious.  Four days after the Post article, the Associated Press reported that the guidelines were in big trouble,

A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.

Also,

Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as 'shortsighted,' relying on 'low-quality evidence.' They said they planned to file a formal complaint.

The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.

Anti-addiction activists worry the delay could scuttle the guidelines entirely.

This, however, did not make much sense.  I repeat, the evidence that narcotics are effective for chronic pain other than that due to terminal cancer is very weak.  The evidence that opioids have multiple side effects, some fatal, and can cause addiction, which has more side effects, and bad societal consequences, is strong.  So the evidence that narcotics have benefits that are worth their harms, both to individuals and society, in this setting is essentially non-existent.  So why did these guidelines go too far?  Why invoke low quality evidence, when the evidence that is low quality is about the benefits of the drugs?  Who should be sued?  Furthermore, why did the CDC cave in so readily to these critics?

The AP noted,

But industry-funded groups like the U.S. Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals.

Of course they could reduce access.  The whole point of the guidelines is to reduce access.  But who would want more access to medicines that do more harm than good?

Then there was the issue of just who it was who opposed the guidelines. Much of the opposition seemed to come from rather obscure organizations with authoritative names.  Some of the opposition was chronicled by equally obscure, apparently journalistic organizations. (From now on, I will highlight these mysterious organizations by using bold, italic text in this color.)  For example, according to the Washington Post,

Many of the patient and physician groups opposing the CDC guidelines are part of a larger coalition called the Pain Care Forum, which meets monthly in Washington to strategize on pain issues. Officials from the White House, the FDA, NIH and other agencies have met with the group over the years, according to documents obtained by The Associated Press under the Freedom of Information Act.

The Pain Care Forum presents itself as a leaderless collective that does not take formal positions. But most members receive funding from drugmakers, including OxyContin-maker Purdue, whose chief lobbyist helped found the group and remains at its center.

The mission of the Pain Care Forum, its organizational nature (informal group, membership society, non-profit advocacy group, etc), its leadership, and its sources of funding were not entirely obvious from this article.  But certainly the drift of the article was that the organization maybe represents pharmaceutical manufacturers, particularly the previously discredited Purdue Pharma (see above) more than others.  So why not take what it says with many grains of salt.

But who threatened to sue?  Which FDA officials chimed in, and why, given that the FDA does not have a mission that includes writing guidelines?   That was not clear from the AP story.

My attempts to gain further clarity produced more mystification.  A Medscape article also claimed that the opposition to the CDC guidelines included Dr James Madara, the Executive Vice-President and CEO of the American Medical Association, and "some members of the Interagency Pain Research Coordinating Committee [who] criticized the process, according to the Pain News Network."  It was not clear whether Dr Madara's viewpoint had broad support in the AMA, which members of the Interagency Pain Research Coordinating Committee opposed the CDC guidelines, and whether this opposition was personal, or reflected the considered viewpoint of the committee.  Furthermore, that committee's purview does not obviously include clinical guideline development or public health, so why it was commenting on this issue was also unclear.  

The Pain News Network story which apparently was the source used by the Medscape in turn referred to a Politico story, but one which is only available to subscribers.  The Pain News Network also credited a survey by "the Pain News Network and the Power of Pain Foundation."

The Medscape article said nothing more about the Pain News Network.which is not exactly a household word in health care journalism.  The Pain News Network story did not give more detail about the Power of Pain Foundation, whose mission, nature, leadership, funding etc was not obvious.   

The Pain News Network story also quoted the Washington Legal Foundation's chief counsel.

The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers.

Similarly, the Washington Post article also credited the Washington Legal Foundation's opposition to the CDC guidelines,

The Washington Legal Foundation, a public interest law firm dedicated to protecting the free enterprise system, accused the CDC of trying to formulate them secretly by failing to make public the work of its original advisory committee, the Core Expert Group. The CDC disputes that accusation, but issued the recommendations in draft form Monday and will have them reviewed by another advisory panel after receiving more comment over the next 30 days, Frieden said.

Yet, neither the Pain News Network nor the Post explained why a group supporting "free enterprise" was so concerned about this issue, or what expertise it might have in this area.  It is ironic that a group that proclaims opposition to secrecy seems less than transparent about its involvement in this issue.

Finally, the nature of the Pain News Network, which claims to be a "non-profit, independent news source," is also obscure.  It appears to be one of those non-profits that has no physical address per its web page of contact information, does not disclose its sources of funding, and if it files US Internal Revenue Service 990 forms, I cannot find them.

The most detailed article I could find about the substance of the complaints about the CDC guidelines was in another obscure source, the Legal News Line.  The article mostly described the concerns of

Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of the Center for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.

Pitts' main issue was that a member of the group that developed the CDC guidelines was biased. He said,

'So you have to have as open of a mind as possible.'

And that’s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC’s “Core Expert Group,” which played a key role in developing the agency’s opioid guidelines.

Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.

PROP’s mission, according to its website, is to 'reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.'

'Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,' Pitts said.

'For the CDC to say, we’re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?'

The Legal New Line's example of supposed journalism did not apparently ask Pitts what was "lunatic" about wanting to promote cautious and responsible prescribing of opioids.  That seems to me like common clinical sense, the opposite of insanity.  

Also, Pitts complained that beyond this alleged bias, Dr Ballantyne had a conflict of interest,

Pitts noted Ballantyne’s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.

Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.

Note that in the first paragraph above, the writer apparently meant that the law firm donated to the campaigns of the attorney generals.

More importantly, why the apparent conflict of interest affecting a single member of a large group - the core expert group of which Dr Ballantyne sat included 17 people - was so important was not apparent from Mr Pitts' argument.  Mr Pitts did not explain how any sort of advisory group that included experts in the field could avoid people who already had strong opinions about that field.  The Legal News Line article did not discuss Mr Pitts' own background, or provide any information about the Center for Medicine in the Public Interest, which he leads.  

I could not find reporting in major news outlets or medical/ health care scholarly publications about the opposition to the CDC guidelines beyond the stories in the Washington Post, AP, and Medscape, and a brief report in Modern Healthcare.  I did find numerous articles on yet another little known website called the National Pain Report, (e.g. see this one).

So to summarize so far, the opposition to the new CDC opioid guidelines was apparently strong enough to delay, if not derail them.  Yet who was in the opposition, their funding, and their interests remains obscure.  The arguments of the opposition remain unclear.  Even some of the purported journalists reporting on the opposition remain mysterious.  There seems to be a tremendous amount of fog surrounding the opposition to more conservative prescribing of narcotics for non-cancerous chronic pain.

The Common Thread - Stealth Health Policy Advocacy


It was striking that much of the opposition seemed to come from rather mysterious organizations, the Pain Care Forum, Power of Pain Foundation, Washington Legal Foundation, and Center for Medicine in the Public Interest.  However, the reporting on these organizations was minimal.  Furthermore, some of the news sources reporting on the opposition to the CDC guidelines also were rather mysterious, such as the Pain News Network, National Pain Report, and Legal News Line.

One recent media article, and some of our previous blogging, though suggest that the opposition organizations all have ties to the pharmaceutical industry, and in several cases, directly to one of the major producers of legal opioids.  On December 23, 2015, Lee Fang wrote in the Intercept by way of an introduction,

The pharmaceutical companies that manufacture and market OxyContin, Vicodin, and other highly addictive opioid painkillers — drugs that have fueled the epidemic of overdoses and heroin addiction — are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.

In particular,

An investigation by The Intercept has found that the pharmaceutical companies that dominate the $9 billion a year opioid painkiller market have funded organizations attacking reform of the prescribing guidelines:

The Washington Legal Foundation, a nonprofit that litigates to defend 'free-market principles,' threatened the CDC with legal action if the agency moved forward with the proposed opioid guidelines. The WLG claimed the CDC’s advisory panel for the guidelines lacked 'fair ideological balance,' because it included a doctor who is part of an advocacy effort against opioid addiction. The WLF does not disclose donor information, but has filed friend-of-the-court briefs on behalf of Purdue Pharma, the makers of OxyContin. In a recent article with Pain News Network, a spokesperson for Purdue Pharma conceded: 'We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants.'

The Pain Care Forum organized opposition to the CDC prescribing guidelines, mobilizing regular meetings among stakeholders opposed to the idea, according to an investigation by AP reporter Matthew Perrone. A recently re-filed complaint by the City of Chicago found that Burt Rosen, the chief in-house lobbyist for Purdue Pharma, controls the Pain Care Forum. A former drug company employee allegedly told investigators that Rosen tells the Pain Care Forum 'what to do and how we do it.' The Pain Care Forum is funded through contributions by Purdue Pharma, as well as major opioid manufacturers Cephalon, Endo, and Janssen, a subsidiary of Johnson & Johnson.

 The Power of Pain Foundation, a group funded by Purdue Pharma, asked supporters to contact the CDC in opposition to the guidelines, claiming that 'taking away pain medication and making providers afraid to prescribe due to your guidelines is only going to make more abusers, increase suicides, and tear apart the lives of millions.'

Fang also noted that the Legal News Line, the source of the story documenting Peter Pitts' problems with the CDC guidelines, also is tied to the pharmaceutical industry:

The U.S. Chamber of Commerce, a corporate lobbying group that represents opioid manufacturers, including Johnson & Johnson, issued a press release masquerading as a news story [published by the Legal News Line] criticizing the CDC guidelines. (The U.S. Chamber operates a public relations effort dressed up as a bona fide media outlet called Legal Newsline, which it uses to disseminate stories that support the political priorities of its member companies.)

In addition, on Health Care Renewal we have previously discussed the Center for Medicine in the Public Interest.  Back in 2008, we noted that when writing for the New York Times, Mr Pitts had to disclose that the Center for Medicine in the Public Interest receives pharmaceutical industry funding, including from Pfizer and the PhRMA.  At that time, Mr Pitts' day job was  Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee had many big pharmaceutical accounts  Since then, he moved on to become director for global healthcare at Porter Novelli, also a public relations/ communications company with many health care corporate clients, including pharmaceutical companies, and now appears to be a consultant in the life sciences area for YourEncore.  I cannot find any updated information on current Center for Medicine in the Public Interest funding, but there is no reason to think that it is not still funded by the pharmaceutical industry.

Mr Pitts' published objections to the CDC guidelines had to do with the supposed bias and conflicts of interests of a single member of the guideline expert panel, and the alleged lack of transparency of the guideline project.  Yet Mr Pitts was not very transparent about his own background, and his and his organizations' financial interests.  For Mr Pitts to condemn the guideline panel member's conflict while hiding his own conflict amounts to a garish example of the logical fallacy of special pleading.  Similarly, the Washington Legal Foundation's objections to the alleged biases of the guideline panel, given that  foundation is apparently funded by Purdue Pharma, is another garish example of the same logical fallacy.

On the other hand, the Pain News Network and the National Pain Report remain obscure.   The former claims to be a non-profit organization, but I cannot find its federal 990 filing, identify its board of trustees, or even determine its physical address. It does claim an affiliation with the Power of Pain Foundation.  The National Pain Report at least has a physical address, which it shares with the equally obscure American News Report. Other details, like its ownership, remain obscure.  The failure of supposedly journalistic organizations to publicly reveal basic information about their nature and operations does raise suspicions that they are not really so journalistic.

Summary

In summary, the organizations most widely mentioned as opposing the new CDC guidelines that recommend more conservative use of opioids for chronic pain seem to be heavily involved with the pharmaceutical companies that make such opioids.  Thus, the opposition to the guidelines seems to be arising from a stealth public relations campaign leading to stealth health policy advocacy.  Furthermore, at least so far, the objections to the guidelines do not seem clearly based on logic and good evidence from clinical research, again suggesting they are more about financial interests than improving patient outcomes and reducing risks.

Overuse and misuse of opioids, which may lead to all the individual and social consequences of opioid addiction, are clearly major, worsening medical and public health issues.  We need earnest effort to address these problems, which should be informed by a logical, evidence-based discussion of the clinical and social realities.  Such a discussion is only hindered by the growing fog of objections launched by mysterious organizations funded by the companies who have made the most money selling narcotics.  So we also need some societal response to the growing domination of the public debate by marketing and public relations, often based on emotional manipulation, logical fallacies, and outright deception.

We cannot address our worsening health care dysfunction when public discussion and policy making blunders about in the fog of stealth health policy advocacy, stealth lobbying, and stealth marketing.  If the leaders of big health care corporations really believe they are making good products and providing good services that add value and improve patients' and the public's health, they ought to be able to rely on honest and open communications.  If they cannot disavow stealth public relations and stealth marketing, we ought to disavow the companies that practice them.

Not So Cheerful Musical Interlude

Unfortunately, given the topic of this post, here is Lou Reed singing Heroin



ADDENDUM (4 January, 2016) - This post was republished on the Naked Capitalism blog, sadly without Lou Reed. See the interesting comments appended to that version.

Also, this post was republished in its entirety on OpEdNews.