Sunday, November 03, 2019

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,'


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.'


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.


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.


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.'


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.




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.


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.


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.  

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