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.  

How to Counter Medical/ Health Care/ Public Health Disinformation

It used to be so simple.  Yes, we had to cope with deception in marketing.  Commercial sponsors of clinical research were known to manipulate the research, and even suppress research with results unfavorable to them.  Key opinion leaders spun medical education and the media.  But it was all releatively straightforward in some senses.  It was all at least mostly based on medical knowledge and clinical research.  The purposes of the spin and deception were commercial: the goal was selling more products or services.  With some digging, the conflicts of interest sometimes could be discovered.

But that was before stealth health policy advocacy morphed into propaganda and disinformation (look here).  Disinformation campaigns were everywhere, and even in one case, were supercharged by a disinformation campaign run by a hostile foreign power, apparently meant to destabilize western democracies (look here).  We are now drowning in a sea of propaganda and disinformation.

What can health care professionals do before we go under?

How Medical/ Health Care/ Public Health Disinformation Works

A May, 2019, MedPage article entitled "a prescription for treating fake health news," noted how the rise of social media enabled disinformation:

Although patients' misconceptions, lack of logic, and superstitions have complicated the work of doctors since the first doctors existed, the advent of social media has taken the problem to a new dimension.

With social media, patients can more easily find misinformation, says Dominique Brossard, PhD, chair of the University of Wisconsin-Madison Department of Life Sciences Communication. They can also share that misinformation more easily.

The articles listed a series of factors that increased the potency of disinformation spread by social media:

Lies may spread faster than the truth. Researchers at the Massachusetts Institute of Technology analyzed a set of about 126,000 news stories disseminated on Twitter from 2006 to 2017. They found that more people retweeted false information than true information. The researchers speculated that people may have passed along the fake news more readily because it was more novel and evoked more emotion.

In addition, social media enhances repitition of false messages:

The wide dissemination means that some patients may receive the same false messages repetitively. In another study, Yale researchers found that the more often people receive the same message, the more likely they are to believe it, even when the message is labeled as disputed by social media fact checkers.

Also, people attend more to the immediate source of information than its origin:

when people are evaluating the reliability of health information shared online, they care more about who shared the information than they do about the original source, according to an American Press Institute study.

The article went on to discuss how individual physicians could help individual patients understand how disinformation may dupe them.  However, this is is a retail solution to a huge wholesale problem.

What Can Health Professionals Do on Social Media to Counter Disinformation?

Note that while we know something about how medical/ health care/ public health disinformation is spread, we still know little about the cause of the plague.  Unlike the old style of deception, it is not obviously based on the self-interest of companies trying to sell products or services.  Nonetheless, we need to fight disinformation even if we do not fully understand its causes.  And we know a little bit about how that could be done. The bottom line is that health care professionals need to use the same social media that is spreading disinformation to counter it with the truth.


Two recent articles specifically encouraged physicians to get online now (even if they are uncomfortable with the brave new world of the internet.)

[We cannot pretend the internet is only for computer nerds, as it may have been at the time of the debut of this original Compaq 286 Portable, the original Microsoft DOS based "portable," actually "luggable" computer]


In June, 2019, a CNBC article profiled one physician pioneer who urged all concerned health care professionals to confront disinformation on social media.

The antidote to fake health news? According to Austin Chiang, the first chief medical social media officer at a top hospital, it’s to drown out untrustworthy content with tweets, pics and posts from medical experts that the average American can relate to.

Chiang is a Harvard-trained gastroenterologist with a side passion for social media. On Instagram, where he refers to himself as a '“GI Doctor,' he has 20,000 followers, making him one of the most influential docs

Note that,

Every few days, he’ll share a selfie or a photo of himself in scrubs along with captions about the latest research or insights from conferences he attends, or advice to patients trying to sort our real information from rumors. He’s also active on Twitter, Microsoft's LinkedIn and  Facebook (which owns Instagram).

He exhorted his fellow physicians to get involved:

'This is the biggest crisis we have right now in health care,' said Chiang. 'Everyone should be out there, but I realize I’m one of the few.'

According to Chiang, doctors have historically been reluctant to build a following on social media for a variety of reasons. They view it as a waste of time, they don’t know how, or they fear they might say the wrong thing and get in trouble with an employer. Others prefer to spend their time communicating with their peers via academic journals.

But as Chiang points out, most consumers do not pore over the latest scientific literature. So health professionals need to take the time to start connecting with them where they do spend their time — and that’s on Facebook and Instagram.

So he’s working to recruit an army of physicians, nurses, patient advocates, and other health professionals to get online.

Similarly, a June, 2019, commentary in the Lancet by social media pioneer Dr Jennifer Gunter, an obstetrician-gynecologist, who described her realization

Clearly, we needed a better medical internet. So, I decided to help fix it. I started blogging to help parents navigate the gauntlet of prematurity, but greeted with so much misinformation and disinformation about vaccines I began to think about my own field, gynaecology. What disastrous information were my patients finding online?

The answer was

There was not just misinformation and disinformation about medical care. Practical day-to-day things, not typically addressed by medicine, were especially ripe for abuse—for example, how to select menstrual pads or pubic hair grooming. And many sites contained even greater dangers, notably, exposure to anti-vaccine or other medical conspiracy theories.

We have huge gaps in medicine—in both the science and how we communicate, especially in women's health—but much of what I found when I first started my online quest and what I still find today is exploiting those deficiencies, not fixing them.

Her exhortation was:

The more I see fake medical news, the more I realise we need to use all mediums and media to tackle it. The glut of medical misinformation is real and it harms. It turns people away from vaccines, fluoride, and leads them to useless products. And don't underestimate the weight of 'it can't hurt, so why not?' advice. Whether it is useless underwear changes or forgoing all sugar, it compounds desperation when it is ineffective. And snake oil peddlers are always standing by with a confidence we evidence-based practitioners can only dream to emulate.
Everything we read and share builds the internet, so we in medicine should especially take that to heart.

But Dr Jen, as she is now widely known, also had some practical advice for health care professionals out to defend the truth on social media:

First, a very simple beginning:

How does one even try? Find good medical content and post it on Facebook, Twitter, or the social media platform that works best for you. Even in a small circle of friends and family you can make a difference. If you read something accurate, well sourced, and bias free click the like button. The more clicks the greater the chance that piece will appear favourably in an algorithm. Ignore bad pieces—social extinction is the best strategy.

 Then learn some simple rules:

Everyone should learn the following four basic rules of internet health hygiene. The first is never read the comments as ad-hominem attacks beneath the content can lead people to question the very facts that were just presented. The second is avoid sharing bad information—even in jest. We are all primed to remember the fantastical and sadly medical truths are usually stodgy. Also, sharing makes the bad content more popular algorithmically speaking. The third is don't get information from anyone selling product. Bias has an impact. And finally, steer clear of content from practitioners who are against vaccination or who recommend homeopathy.

Meanwhile, do not neglect to provide your patients with accurate information, or spreading the truth by older means:

Guiding your patients to accurate information is also important. Find good online resources and offer them as handouts or e-mail the links directly if you can do that securely. Your patients are looking online, whether they tell you or not. Offering them curated content from trusted sites, such as the National Health Service in the UK or professional medical societies, validates their search efforts and I believe it makes people more likely to share with their health-care provider what they found online.

Create content, be it quality medical research in a journal or opinion pieces for the lay press. 

For those who heed these exhortations, know that fighting disinformation will not be easy.  In particular, expect strident opposition, as discussed in a commentary in the May, 2019, BMJ by David Oliver, using examples pertaining to debating anti-vaccination fanatics:

Persuading individual parents is one thing. But trying to debate with the more determined anti-vaccination activists can be a futile endeavour, not played by the rules healthcare experts are used to.

Every scientific paper in support of the cause (whatever its quality) and every commentator sympathetic to the cause (expert or not) is selectively harvested and cited. Allegedly hidden harms and risks of vaccination are highlighted. If you’re not a genuine content expert it’s impossible to wade through each individual source to appraise it or understand its limitations. If you really are a content expert, steeped in the science and leadership of mass vaccination—or an official body, from Public Health England through to WHO or the UN—you’ll be labelled as being close to (and influenced by) the vaccine manufacturers, and the impartiality of your advice will be questioned.

Reports of outbreaks and rising infections will be dismissed: 'How many of those cases were actually verified?' The severity of the disease we’re trying to prevent will also be questioned. Measles and other preventable childhood infections can kill or bring serious long term damage and disability, but these consequences will be minimised to suit the cause. You’ll be told that not all vaccinated people mount a sustained immune response (which is precisely why we need a high uptake for herd immunity).

Don’t be surprised if your defence of mass vaccination against refuseniks leads to attacks on social media or impassioned private correspondence. If you push back, the whole cycle will start again.

The idea of children developing natural, normal immunity through exposure to infections will be romanticised. Arguments about the collective societal need to vaccinate our own children so that we don’t put other children at risk will be either ignored or represented as a callous attack on parents and dismissal of their concerns—potentially a bad look for doctors and nurses, even when acting for a greater cause. And suggestions that vaccine refusers are putting their own children at risk will be used to make those doctors look even worse.

However, while it may not be reasonable to expect to convince whoever are the people who are central to the spread of disinformation that they are wrong.  Instead, the goal should be to decrease the spread of disinformation by informing those who have not yet become cultists.

Final Exhortations

However, this is not the time for the faint-hearted.  While one may not persuade the fanatics, but have some hope that it is possible to advance the truth.   Do not forget the importance of the battle.

To quote a June, 2019, Bloomberg op-ed about the the need to challenge disinformation in the political sphere,

The culture war gets a lot of attention, in part because it’s easy both to understand and to pick a side. But it’s the epistemology war – the partisan effort to break the power of facts, knowledge and expertise, and to destroy the means of assessing them -- that will determine whether the U.S. can secure a decent society in the future.

Have courage, because:

That war is Sisyphean, with victory perpetually subject to savage reversals.

What we have to do is

roll the stone uphill day after day.

So,

Speak. Repeat. Speak again. Lace up your Marine boots and put on your Republican suit. There’s a war on.

From "Forced Injections" to "Sorcery," - More Examples of Partisan Ideology and Religious Sectarianism Trumping Evidence in Health Policy and Public Health

Evidence-based medicine (EBM) is about medical-decision making based on critical review of the best applicable evidence from clinical research informed by knowledge og biology and medicine, of the patient's biopsychosocial circumstances, the patient's values, and of ethics and morality.  Advocating EBM, and evidence-based health care, public health, and health policy was sometimes slow going, but at least health care professionals often seemed open to these ideas.

Now we seem to be in an alternate universe.  We have discussed the rising tide of health care and public health policy unsupported by evidence, and sometimes supported only by nonsense.  This tide seems driven by ideology, partisanship, and religious sectarianism.  Furthermore, we see more and more examples of political leaders embracing such policies apparently without any input from health or public health professionals.  We discussed several relevant cases in March, and then April, and included them in an interval summary of the "new (ab)normal in health care dysfunction" in May.

Less than 10 days later, we have accumulated enough new examples to be worth summarizing, presented in alphabetical order by state.

Arizona Republican State Legislators Push Vaccine Exemptions in the Face of a Measles Outbreak, While Decrying Pornography as a Greater Public Health Hazard

In February, 2019, Arizona state legislators were pushing to further relax requirements for and even discourage vaccination.  According to CNN,

Arizona lawmakers voted last week to advance three bills that would make it easier to get exemptions from the state's vaccine requirements, and which would require doctors to provide much more information to patients and families about potential harms that vaccines pose.

The bills cleared the House's Health and Human Services Committee on a 5-4 GOP-led, party-line vote, and head to the Rules Committee on their way to the floor.

HB 2470 adds a religious exemption to the existing law requiring vaccinations, and carries an amendment that would eliminate the requirement for parents to fill out an exemption form that informed them of potential consequences of not vaccinating their children. Those consequences can include requirements to keep children who haven't received vaccinations out of school during disease outbreaks.

HB 2471 requires medical providers to give detailed information about vaccines, including the prescription's package insert, to parents.

It was not clear that any of the legislators pushing these measures based their arguments on evidence about vaccines, the diseases they may prevent, or public health in general. Instead, for example:

the bills' sponsor, Rep. Nancy Barto ... told Capitol Media Services: 'These are not, in my view, anti-vaccine bills. They are discussions about fundamental individual rights.'

In this case, was she expousing a fundamental right of a parent to increase the likelihood that the parent's child would get an unpleasant, and dangerous disease, and to transmit such a disease to others?  Soon after, in March Arizona recorded its first case of the measles, affecting an 11 month old child.

Meanwhile, Arizona state legislators decided to worry about the public health hazards, not of the measles outbreak, but of ... pornography.  We had noted also  in March that Republican legislators were pushing the notion, unsupported by evidence, that pornography is a public health crisis.  In May, CBS reported,

A Republican-backed measure in the Arizona State Senate to formally denounce pornography as a public health crisis has passed. The resolution, which does not require the governor's signature for approval, will now go to the secretary of state to be certified. According to text of the bill, the legislation claims that pornography 'perpetuates a sexually toxic environment that damages all areas of our society.'

It goes on to claim, without any medical citation, that pornography is 'potentially biologically addictive and requires increasingly shocking material for the addiction to be satisfied' leading to 'extreme degradation.'

Again, the resolution seemed to have only Republican support. It was "Introduced by Republican Rep. Michele Udall and backed by six other Republican co-sponsors...."

While there is very good evidence that measles vaccination prevents the disease, that the disease can have serious, sometimes fatal consequences, and that measles is easily transmitted to others; and there is no good evidence that pornography is harmful, the legislators treated the latter is a more serious threat.  I saw nothing to suggest they had any personal experience in medicine, health care, or public health, or that they consulted anyone with any expertise in their areas.  Although they cited "individual rights" to support vaccine exemption, they were silent about rights to free expression that might have been affected by their crusade against pornography.  Finally, all the legislators prominently involved in these moves were from one party.  


Oregon Republican Party Derides Vaccinations as "Forced Injections"

This story comes via Vice News on May 8. In response to a bill sponsored by Oregon Democrats that would remove the "moral exemption" for vaccination,

Oregon’s Republican Party isn’t on board with this whole 'forced injections' thing — otherwise known as mandating kids get their shots against life-threatening illnesses like measles, mumps and rubella.

'Oregon Democrats were just joking about 'my body, my choice' while rammimg (sic) forced injections down every Oregon parent's throat,' the state’s official GOP account tweeted Monday night, apparently referencing the Democrats’ argument that Republicans shouldn’t interfere with a woman’s ability to access abortion.

Note that parents are making decisions about measles vaccinations, which are injections, for their children, not themselves in this context.  Although Oregon apparently has not had its own measles outbreak, there is one in neighboring Washington state.  According to Vice News, the vaccination rate in some parts of Oregon may be as low as 80%, reducing herd immunity and making the risk of an outbreak high.  Again, I could find nothing to suggest whoever in the state Republican party coined the perjorative "forced injections" had any understanding of the data about vaccine effectiveness versus adverse effects, or the severe consequences and transmissability of measles.  Finally, again this seems to be making a discussion of public health partisan.

Texas Republican State Legislators Also Advocate More Vaccine Exemptions, While One Accuses Public Health Authority of "Sorcery"

In April, the Corpus Christi, Texas, Caller-Times reported that four Texas state legislators were introducing bills to make it easier to avoid vaccination,

H.B. 3857: by Rep. Tony Tinderholt, R-Arlington, would prohibit doctors from refusing to see unvaccinated patients. Pediatricians tend not to want unvaccinated children in their waiting rooms, exposing other children and their parents to preventable deadly diseases like measles. Pediatricians are kind of funny that way. So are parents who believe in vaccination.

H.B. 1490: by Rep. Matt Krause, R-Fort Worth, would make it easier for parents to opt out of vaccinations. But perhaps of bigger concern is that it would prevent the Texas Department of State Health Services from tracking non-medical exemptions. This would make it harder to respond to outbreaks and certainly harder to predict them by identifying potential hotspots.

H.B. 4274: the 'informed consent' bill by Rep. Bill Zedler, R-Arlington, would require doctors to explain the benefits and risks in detail, including ingredients in the vaccines. That may sound like a good thing on face value. But this is technical information that is more likely to cause confusion and fear than understanding and appreciation. It's like telling someone what's in menudo first, then trying to get them to eat it.

H.B. 4418: by Rep. Jonathan Stickland, R-Bedford, would let nurses rather than only doctors sign off on vaccination exemptions.

The reporters tried to understand the rationale for these bills.  The best they could do was to write

that it appears to be a mix of political opportunism and ignorance. Suspicion of vaccinations is suspicion, period, and suspicion helps drive votes. The ignorance part is best summed by Zedler, who told the Texas Observer that concerns about measles are overblown because it's beatable 'with antibiotics and that kind of stuff.' The punchline is that antibiotics don't kill viruses and measles is a virus.

Note that we had discussed Rep Zedler's remarkably wrong headed statement that measles can be treated with antibiotics here.

The Caller also noted that

not one of these bill sponsors is a medical professional or scientist. Nor are they acting on the advice of medical professionals or scientists. If they had listened to and heeded medical advice, they would not have filed these bills.

In May, a follow to this story was a bit wilder.  The Washington Post reported on the latest antics of Rep Strickland, who introduced the fourth bill in the list above,

 A Texas state legislator unleashed a vilifying attack on a leading vaccine scientist Tuesday, accusing the doctor of 'sorcery.'

It started with a report published Monday by the Texas Department of State Health Services that noted the state recorded a 14 percent rise in parents opting out of their children’s vaccinations. It was a new statistic that alarmed Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine.

'We have more than 64,000 kids not getting vaccinated in the state of Texas, and that doesn’t account for the over 300,000 home-schooled kids,' Hotez said during an interview with The Washington Post.

Hotez took his concerns about the report to Twitter. And then he received an unexpected, seething personal attack from the Republican state legislator, Rep. Jonathan Stickland.

New school #vaccine exemption numbers reported yesterday by @TexasDSHS. Now >64,000 kids not vaccinated, with #Austin schools, which can no longer be considered safe for kids. All to benefit outside #antivax groups from CA NY DC monetizing the internet. Where is our leadership? pic.twitter.com/x92gIZT3m9 — Prof Peter Hotez MD PhD (@PeterHotez) May 7, 2019

'You are bought and paid for by the biggest special interest in politics,' Stickland wrote. 'Do our state a favor and mind your own business. Parental rights mean more to us than your self enriching ‘science.’'

In a tweeted response, Hotez, a pediatrician and vaccine scientist, noted to Stickland that he does not receive money from the vaccine industry; instead, his work focuses on 'neglected disease vaccines for the world’s poorest people.'

Stickland, who told The Post he is 'not anti-vaccination,' tweeted his response to Hotez.

'Make the case for your sorcery to consumers on your own dime,' the Republican, who represents an area of suburban Fort Worth, snapped back Tuesday. 'Quit using the heavy hand of government to make your business profitable through mandates and immunity.'

(Hotez is not part of a for-profit business, either as a dean at the Baylor College of Medicine or as an endowed chair at the nonprofit Texas Children’s Hospital.)

What was the rationale for Strickland's position?

'It comes down to whether the government should be mandating what’s right for us,' Strickland said. 'I side with the individual.'

So note that Rep Strickland not only apparently falsely accused Dr Hotez, a recognized public health expert, of a conflict of interest, but of "sorcery," that is, witchcraft  The latter was apparently not clearly satirical, or metaphoric.  This suggests that underlying the ideology may be some very extreme religious sectarianism.  It looks like the idea of a witch hunt is not dead.

Discussion

As we noted above, here are three more cases in which politicians in three states, all Republican, none of whom had any obvious background or expertise, in medicine, health care, or public health, pushed public health policies that were unsupported by evidence and poentially harmful.

Their rationale seemed at best ideological, based on "individual rights."  Yet while focusing on the rights of parents to not vaccinate the children, they ignored how these rights could adversely affect the children, and anyone who might be exposed to disease the children might acquire.  In the case of Arizona, they also simultaneously ignored rights of free expression while they denounced pornography.

Since all the polticial leaders involved were Republicans, and in some cases their advocacy was in the context of deriding their Democratic political opposition, it seemed that their public policy stances were also partisan.  Such ideologically based and partisan arguments should alarm health care professionals who are sworn to put the patients' and the public's health ahead of other concerns, including political ideology.

Finally, the last case, which included a state legislator accusing a physician and public health expert not only of having a conflict of interest (which he apparently did not have), but of "sorcery," their public health stances also seemed to come from religious sectarianism, at its most extreme. Such  arguments are also concerning because they seem to be an attempt to use the govenrment to promote a particular set of religious beliefs ahead of patients' and the public's health, and to impose these beliefs on people of other faiths.  This apparently contradicts the US constitutional prohibition against governmental establishment of religion.

True health care reform would require government officials to use evidence, rather than personal ideology and particularly rather than their own religious beliefs when making health care and public health policy. 

    

The Rise of Ideologically or Theologically Based Medicine, Public Health, and Health Policy - Recent Examples

I have long been a proponent of evidence-based medicine (EBM), and evidence-based health care, public health, and health policy.  EBM, for example, is about medical-decision making based on critical review of the best applicable evidence from clinical research informed by knowledge og biology and medicine, of the patient's biopsychosocial circumstances, the patient's values, and of ethics and morality.  We have discussed challenges to EBM based on manipulation and suppression of clinical research, often in the financial interests of those hawking particular medical products of services.

A newer challenge to evidence-based medicine, health care, public health and health policy seems not to be commercial, but ideologically or theologically based.  I noticed the following recent cases that illustrate this concern. 


Theologically Based Medicine and Public Health Promoted at the DHHS

In July, 2018, we discussed the case of Dr Diane Foley, who was appointed Deputy Assistant Secretary for Population Affairs in the US Department of Health and Humas Services (DHHS).  At the time we noted that Dr Foley publicly proclaimed that adoption of children is harmful because it is a "double death;" and teaching children about barrier contraception is harmful because it is "sexually harassing."  Dr Foley also ran an organization called Life Network, which ran so-called "crisis pregnancy centers," which ran abstinence-only sexual education programs in part based on Dr Foley's beliefs about the harms of teaching about barrier contraception.  There seems to be no good evidence about the sort of harms Dr Foley attributed to adoption or barrier contraception.


Nonetheless, on April 4, 2019, ReWire reported that the DHHS would give control of  Title X federal family planning and teen pregnancy prevention and the Office for Adolescent Health (OAH), which administers the Teen Pregnancy Prevention Program to the Office of Population Affairs, which is run by Dr Foley.  In response, Senator Patty Murray (D-WA),

the ranking Democrat on the Senate appropriations subcommittee with oversight over HHS, questioned the Trump administration’s motivations behind the plan. 'It is unclear how the reorganization will result in better policies and services for those served by these offices, including adolescents, women, low-income communities, and individuals with infectious diseases, including HIV/AIDS,' she wrote. 'In fact, it is difficult to understand how this reorganization does anything other than consolidate control at HHS headquarters and prioritize ideology over the needs of the women, teenagers, and children the affected programs serve.'

In fact, there is reason to believe that Dr Foley based her beliefs more on her ideas about theology than on a political ideology.  Life Network's website has stated (see our post linked above) 

'Through our pregnancy centers we have the opportunity to see God use the miracle of ultrasound to change and save lives,' Life Network’s website says. The first element of its mission is 'presenting the gospel of Jesus Christ.'

Thus the Trump administration seems to be consolidating power over US government family planning programs in the hands of an individual who is basing her decision making not on medical or public health evidence, but on her version of a particular type of Christian theology.

Ideologically or Theologically Based Public Health Policy about Pornography Promoted in Another State Legislature

NBC Montana reported on April 16 that Montana legislators are the latest to join the quest to label pornography a public health hazard.  

One resolution state house lawmakers are taking up in Helena would label pornography as a public health hazard in Montana.

If passed, Montana would have to address pornography through education, research and state policy.

The state would have to implement measures to prevent pornography exposure and addiction, offer recovery help, and create programs that hold broader influences accountable.

The proposed resolution included assertions that, for example, pornography causes

violence and abuse of women and children by presenting rape and abuse of women and children as harmless

and

psychological and physical distress, deviant sexual arousal, difficulty in forming or maintaining intimate relationships, and problematic or harmful sexual behaviors and addiction

and

increases sex trafficking of women, sex trafficking of children, child sexual abuse, and child pornography;

Yet as we noted in March, 2019, there is no clear evidence supporting any of these assertions.  So Montana Republican legislators join those in Arizona, and also those in Kansas, Utah, and Idaho (look here)  in pushing legislation that attacks the "public health" hazards of pornography based on no clear evidence.

The genesis of the notion that pornography is a dire public health hazard is not clear.  As we noted here, though, in Utah, at least, beliefs about pornography could come from the doctrine of the Church of Latter Day Saints, which includes:

'depiction, in pictures or writing, that is intended to inappropriately arouse sexual feelings' to be 'a tool of the adversary,' the descriptor Mormons often use for Satan.

At any rate, since the proponents of these measures all seem to be Republicans, there also is suspicion that their beliefs about pornography are ideologically-based.

Ideologically Based Beliefs About Vaccination Policy Espoused by President Trump, the Governor of Kentucky, and in Multiple State Legislatures

We recently discussed how a Russian disinformation campaign has led parents in the US and elsewhere to avoid vaccinating their children for various diseases, in turn leading to outbreaks of measles in the US and other countries. Along with this disinformation campaign, various government leaders have also espoused views about the benefits and harms of vaccination, and vaccination policy that are virtually free of evidenciary support.

In March, 2019, the Louisville Courier Journal reported on the example set by the Republican Governor of Kentucky. 

Gov. Matt Bevin said in a radio interview Tuesday that he deliberately exposed all nine of his children to chickenpox so they would catch the disease and become immune.

'Every single one of my kids had the chickenpox,' Bevin said in an interview with WKCT, a Bowling Green talk radio station. 'They got the chickenpox on purpose because we found a neighbor that had it and I went and made sure every one of my kids was exposed to it, and they got it. They had it as children. They were miserable for a few days, and they all turned out fine.'

Governor Bevin seemed to imply that chickenpox is an annoying disease, but one that does not cause severe adverse effects.  However, varicella is not innocous.  According to the CDC clinical summary, it can cause secondary bacterial skin infections in children.  Rarely in children, but more commonly in adolescents, adults, pregnant women, and people with immunocompromise, it can cause severe complications including pneumonia, sepsis, and various other secondary bacterial infections.  Varicella is highly contagious, so unvaccinated children can infect other unvaccinated people who are more susceptible to complications.

Yet Governor Bevin ignored all that.  His rationale for not vaccinating his own children and not mandating varicella vaccine for other children was conveyed in his interview.

Bevin also suggested that the government stay out of mandating vaccines. In Kentucky, varicella (chickenpox) is among vaccines mandated for all children entering kindergarten, though parents may seek religious exemptions or provide medical proof that a child has already had the disease.

'And I think, why are we forcing kids to get it?' Bevin said in the radio interview, speaking about the chickenpox vaccine. 'If you are worried about your child getting chickenpox or whatever else, vaccinate your child. ... But for some people, and for some parents, for some reason they choose otherwise. This is America. The federal government should not be forcing this upon people. They just shouldn’t.'

So his ideology that "the federal government should not be forcing this upon people" seemed to trump any risks children run because their parents choose to not vaccinate them, even just "for some reason."

The Louisville Courier Journal also interviewed "Dr. Robert Jacobson, a pediatrician and expert in vaccines and childhood diseases at the Mayo Clinic in Rochester, Minnesota,

Before vaccination was available, chickenpox killed as many as 100 adults and children a year, he said.

'I think it is taking a big risk that you don’t need to take,' Jacobson said. 'It's not just a risk your children are going to have. You're putting other people in the community at risk because of your decision.'

 Note that this is not the first time that Governor Bevin expressed beliefs about public health that were not evidence-based.  In this post, we noted that in 2018 he suggested that mass school shootings are due to exposure to television shows about zombies, and in 2019 he suggested that exposing children to severely cold weather is risk free.  So he does seem consistent in the absurdity of his public health beliefs.  Unfortunately, he is in a position to endanger the public's health according to these beliefs. 

There are other US state level political leaders who seem to rely on idology rather than evidence in making decisions about health care and public health.  On April 16, 2019, Politico reported widespread attempts by Republican state legislators to free people from requirements that they vaccinate their children,

Democrats in six states — Colorado, Arizona, New Jersey, Washington, New York and Maine — have authored or co-sponsored bills to make it harder for parents to avoid vaccinating their school-age children, and mostly faced GOP opposition. Meanwhile in West Virginia and Mississippi, states with some of the nation’s strictest vaccination laws, Republican lawmakers have introduced measures to expand vaccine exemptions, although it’s not yet clear how much traction they have.

In Washington state, which has one of the biggest measles outbreaks, a bill in the state Senate to narrow vaccine exemptions passed through the health committee without the support of a single Republican. The same thing happened in legislative committees in Colorado and Maine over the past week.

Again, the Republicans seemed to base their attempts to decrease vaccination requirements on their ideology of expanding personal choice.

many are loath to diminish the right of parental control over their children’s bodies, and yield that power to the government.

Politico provided an example of a New York state legislative leader who opposed a bill that would limit religiosu exemptions to vaccination mandates.

Andrew Raia, ranking Republican on the New York Assembly’s health committee, said he wouldn't support the bill. While not totally convinced by constituents who link their children’s autism on vaccines, and unaware of any real religious injunction against vaccination, he said, 'I’m not a religious leader, and I’m not a scientist either, so it’s my job to weigh both sides.'

I suggest that his arguments are at best evidence free, but also could have been

complicated by the fact that President Donald Trump and two of his Republican primary foes, Sen. Rand Paul (R-KY) an ophthalmologist, and Ben Carson, a neurosurgeon who is now HUD secretary, both voiced support for disproven theories linking vaccine to autism during a 2016 debate.

In fact, as reported by the (UK) Independent in 2018,

On more than 20 occasions, Mr Trump has tweeted about there being a link between vaccines and autism, something experts at the government’s leading public health institute say is not true. He also repeated the claim during a Republican primary debate, a remark that was immediately dismissed as false by the Autistic Self Advocacy Network.

Summary

Outbreaks of infectious diseases previously considered controlled now bedevil the US and other developed countries.  They seem to be caused in part by parents' resistance to vaccinating their children, despite strong evidence that the vaccines are relatively effective and have harms that exceed their benefits, both for the children vaccinated and the public health.  In turn, the resistance to vaccination seems increasingly inspired by government leaders whose actions are based on ideology, or sometimes theology.

The ideologically based arguments seem to come from some sort of a crude libertarianism that holds that parents should be free to choose not to vaccinate, more or less regardless of the effects of their decision on their children, or other people.  Such arguments should alarm health care professionals who are sworn to put the patients' and the public's health ahead of other concerns, including political ideology.

The theologically based arguments are also concerning because they seem to be an attempt to use the govenrment to promote a particular set of religious beliefs ahead of patients' and the public's health, and to impose these beliefs on people of other faiths.  This apparently contradicts the US constitutional prohibition against governmental establishment of religion.

True health care reform would require government officials to use evidence, rather than personal ideology and particularly rather than their own religious beliefs when making health care and public health policy. 

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

Background: the Quiet Announcement of the Death of the Clearinghouse

On June 1, 2018, we wrote:

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

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

There was no further explanation.

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

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

We concluded

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

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

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

Further Media Coverage

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

Stat News

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

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

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

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

They also excerpted our conclusions above, and lamented,

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

Daily Beast

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

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

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

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

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

Other Coverage

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

The New York Times Weighs In

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

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

It concluded hopefully with:

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

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

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

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

Discussion

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

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

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

The Quiet Announcement of the Shut Down

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

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

There was no further explanation.

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

The Importance of the National Guideline Clearinghouse

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

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

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

The summary of the IOM report included:

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

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

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

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

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

Discussion

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

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


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

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

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

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

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

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

A Remedy for Corruption

Do I really have a remedy for corruption? I wish I did. But, I have lately found an effective balm for the sickening discouragement that it is easy to feel when confronted day after day with another instance of the medical industry’s price-gouging corruption, purposeful distortions, and callous disregard of patient  welfare. That remedy is a new podcast from Australia: Ray Moynihan’s The Recommended Dose. 

If you don’t already recognize Moynihan’s name, he’s an author of Selling Sickness and he’s had a persistent interest in overdiagnosis and medicalization. He describes the podcast as “interviews promoting healthy questioning in medicine” and most, though not all, of the interviewees are medical professionals somehow associated with evidence-based medicine and/or Cochrane. Many interviewees have practiced in unfamiliar countries and settings; hearing about problems and issues there is broadening for a U.S. listener.

So far there are eight episodes, and not a dud in the lot. Moynihan interviews the people as human beings, not just as experts, so you get a real feeling for their lives and motivations, including background, interests, and motivations. He doesn’t hesitate to go a bit afield, as in Episode 7 where he interviews a novelist! His conversation with Sarah Moss covered literature and themes related to medicine very enjoyably.

Other episodes I particularly enjoyed were: 

• Episode 2. Psychiatrist Allen Frances discusses mental health, including his role in the DSM and how he regrets the direction later editions have taken. On another topic, he thinks diagnosing Trump remotely with some psychiatric disorder is unenlightening; it’s more the US public, he says, that is insane than Trump.
• Episode 4. South African Jimmy Volmink recounts how Cochrane was contacted by the government to look into the evidence for using antiretrovirals for prevention of mother-to-newborn HIV transmission; government officials stressed they were particularly interested in harms of these toxic chemicals. A big project resulted, concluding that side effects were comparatively minor, and the treatment tremendously effective. Decision makers (who had clamored for the study) then proceeded to disregard the results. That was an interesting insight into an environment where the pressures were to make treatments look less effective than they are rather than more effective than they are, as is generally the case in the U.S. setting. Volmink comments that people are “very keen to use evidence when it supports what they already want to do.” (Fortunately the study was still of great use when the Treatment Action Campaign took the government to court.)
• Episode 6. Indian psychiatrist Prathap Tharyan discusses being on a team to assist people after a tsunami and what evidence shows people need after disasters (spoiler: it’s not mass debriefing/counselling for everyone). It concludes by a recording of Tharyan’s singing Leonard Cohen’s Alleluia; I feared it would be embarrassing, but it was sublime.
• Episode 8. An optimistic interview with Julian Elliot, who is working on access to evidence including in low-income countries. His reflections on working on HIV treatment in Cambodia were interesting. But the highlight of the episode for me was when Moynihan reflected that there are two elements in science, innovation and evaluation. The public, Moynihan says, appreciates medical innovation, but not evaluation, important though it is. (What a factor that is in the many “medical reversals” Vinay Prasad and Adam Cifu write so eloquently about!) 

I have to compliment Moynihan on his excellent diction. I usually find Australians really hard work to listen to. Although Moynihan’s accent is strong, he speaks so clearly that it’s a pleasure to listen to him and not difficult for this American to understand what he’s saying at all.  Such beautiful clarity is a fantastic asset in making accessible the meat of the podcasts.

The Recommended Dose vividly showcases some of the many people who make medicine and life still wonderful and beautiful (in parts); and who live with intelligence, determination, courage, and humor despite obstacles.  That’s an excellent medicine for the heart and mind, and I recommend it without reservation.