Tuesday, September 07, 2021

More Large Health Care Corporations Are Again Funding Politicians Who Threatened Representative Democratic Governance

Introduction: Health Care Corporations' Political Contributions: From Bipartisan to Trumpian

 At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and political organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 


 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates. In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians. In March, 2019, we discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post, and this July 7, 2021, post).

Now yet another report shows continuing support by large health care corporations for Republican legislators who supported the nullification of the election.

 Health Care Corporate Funding of Politicians Who Would Overturn an Election

On August 17, 2021, Popular Information published The January 6 Corporate Accountability Index.  It promised to be results of a comprehensive monitoring efforts of corporate pledges to make changes in their political giving to the "147 Republicans who voted to overturn the election, setting the stage for the riot." It included several categories of pledge violations.  Its results included some of the companies who went back on their pledges as described in our April and July posts.  It also included many more companies that did not make it to previous reports.  The relevant results by category were as follows

Corporations that pledged to suspend donations to the 147 Republican objectors but directly donated to those Republicans

Not included in previous reports: none

Included in previous reports: Cigna, Eli Lilly

Corporations that pledged to suspend donations to all 147 Republican objectors but violated the spirit of the pledge

Not included in previous reports: 

"After January 6, Genentech [part of the "Roche group'] said it would suspend contributions to Republican objectors. Genentech donated $15,000 to the NRCC and $15,000 to the NRSC on June 30."

"After January 6, Sanofi said it would suspend contributions to Republican objectors. Sanofi donated $15,000 to the NRSC on 3/17."

Corporations that pledged to suspend all PAC donations and then directly donates to the 147 Republican objectors

Not included in previous reports:

DaVita 

Included in previous reports: Abbott Laboratories, Gilead, Novo Nordisk

Corporations that pledged to suspend all PAC donations and then indirectly donated to the 147 Republican objectors

Not included in previous reports:

Baxter International

Included in previous reports: United Healthcare

Corporations that pledged to reevaluate their donation criteria after January 6 and directly donated to GOP objectors

Not included in previous reports:

Amgen, Laboratory Company of America

Corporations that pledged to reevaluate their donation criteria after January 6 and then indirectly donated to the 147 Republican objectors

Not included in previous reports: none

Included in previous reports: CVS

Discussion

As we said before, most health care corporations publish high-minded aspirational statements that promise pluralism, support of the community, and of our representative democratic society.  For example, Sanofi Pasteur claims:

Sanofi’s social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people
However, the new data revealed above, and data discussed in our two previous posts showed that leaders of  more and more large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would challenge election outcomes in the absence of very clear evidence of election irregularities seem s to violate high-minded corporate pledges of inclusiveness like those above.   

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

On the other hand, maybe it is not just about money.  Again, as we said before, by virtue of being top managers corporations, particular individuals can control political funds far beyond what they would  be able to control as private persons, and to do so quietly and sometimes anonymously.  Corporate leaders may thus be able to promote their own interests through their corporations' political giving.  Those interests may go beyond just personal enrichment.   Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, authoritarian, even openly fascist national political leadership.  Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)

Leaders of large corporations now appear willing to wield large amounts of political power leveraged by the organizations they control.  Yet until recently they may have been able to do so without disclosure to society at large.  That society may be greatly affected by this power, but when it can be wielded quietly, have had little say in who has it and its uses.  

We as health care professionals, policy makers, patients and members of the public at large deserve to know how health care corporate leadership is directing money to political causes, and how they benefit from doing so. If they are not doing this in our interests, our we need to make sure things change.

Friday, July 23, 2021

Money and Aducanumab

In my previous posts, I haven't talked too much about the price set for aducanumab. Since I think it should not have been approved on current evidence regardless of price, the approval has been my focus. But of course the price is an issue, especially given that there is a HUGE pool of potential patients and that most are probably Medicare age, meaning that this drug can have huge impacts on Medicare costs.

Before and after approval, there was speculation that this "potentially zillion-dollar moneymaker" (as Sharon Begley called it in October 2019) might be the most lucrative drug ever. Last November it was noted that if it brought in even a fraction of potential patients, it could still realistically be a $60 billion/year drug, changing Biogen's revenue picture dramatically.

Taking a high-side estimate of $110 billion/year, Nicholas Bagley and Rachel Sachs speculated in The Atlantic that Aduhelm could be the drug that breaks Medicare, given that that cost exceeds total current Part D medication expenses of $90 billion dollars.

Even at a much lower total, Aduhelm's costs would still balloon Medicare costs and would exceed the total NASA budget of $23 billion. Regardless of the exact total, the hit to Medicare would be big.

The cost to Medicare...could be substantial.... In 2017, nearly 2 million Medicare beneficiaries used one or more of the currently-available Alzheimer’s treatments covered under Part D, based on an analysis by the Kaiser Family Foundation. If one-quarter of those beneficiaries are prescribed Aduhelm, or 500,000 beneficiaries, total spending for Aduhelm in one year would be nearly $29 billion. This assumes Medicare will pay 103% of the list price until an average sales price is established. In any event, the Kaiser estimate suggests the total cost would far exceed spending on any other drug covered under Medicare Part B or Part D, based on 2019 spending data. “To put this $29 billion amount in context, total Medicare spending for all Part B drugs was $37 billion in 2019,” Kaiser wrote.

We get to these high numbers because the company set the cost at $56,000/year. $56,000 is a very high price for a drug no one thinks has more than a moderate and subtle clinical benefit. I was struck by this reflection:

“I cannot think of a justification for that price for this drug given the evidence thus far except that Medicare will pay it,” said Walid Gellad, an associate professor of medicine who heads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “If $56,000 is a reasonable price for this drug, then what [would be] a reasonable price for a drug that has a large impact on changing the course of Alzheimer’s?"

That's an excellent question. Another meaningful question is whether anyone will put in the effort to develop really good drugs for Alzheimer's, if you can make this kind of money from a drug that is at best marginally beneficial and possibly not beneficial at all.

Because, for all this money, how meaningful are the benefits? In short:

“Absolutely tiny,” said UCL’s Howard. Aducanumab “didn’t stop dementia or reverse it, and even if we take the data at face value, the benefits are practically undetectable. As a clinician, it would be nearly impossible to tell if it works in one of your patients.”

Nonetheless, the Biogen CEO said he wasn't worried about blowback on the price, comparing the price to that charged for other monoclonal antibody treatments like Humira and Keytruda.

Even some who are enthusiasts, like the Alzheimer's Association, have questioned the high price of the drug, although there is some question about whether some of that is performative. This doubt partly arises because

months ago, the association also gave Biogen some cover for setting a higher price for its drug. It repeatedly sparred, for example, with the drug pricing watchdog ICER after the group suggested Aduhelm was only worth between $2,500 and $8,300 per year. (Meyer, the group’s spokesman, pushed back against the idea that its criticism of ICER had made it easier for Biogen set a higher price, calling the idea “patently false.”)

One thing that has not been much noted is that the price for many individuals will be HIGHER than $56,000/year, because the drug is dosed by weight, and $56,000 is the price per maintenance dose year for an "average weight" of 74 kg (about 163 pounds), so many will have higher costs (and higher co-pays).

Although it won't likely change the total financial impact, Biogen's share of the market may be reduced quickly, because after aducanumab's accelerated approval, other companies, including Eli Lilly and perhaps Roche, are hoping to speed up approval of other such drugs. Biogen too with its partner Eisai has another amyloid-clearing drug in the works.

There's more to say about spending so much money for so little benefit and I may or may not get around to another post on that topic. But meanwhile, I have been a bit gratified - and Biogen has been very put out - to see that there has been major pushback from multiple players on the accelerated drug approval and on the cost. Insurers and major hospital systems alike are reluctant to get the ball rolling on this. It's probably just a slowdown, but Biogen is whining a lot. In an open letter, Alfred Sandrock, their Research and Development head, wrote:

Unfortunately, ADUHELM’s approval has been the subject of extensive misinformation and misunderstanding. It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data. That is how science advances and we welcome these discussions. Recently, however, there has been a turn outside the boundaries of legitimate scientific deliberation.... ADUHELM is the first Alzheimer’s treatment approved since 2003. An important question is being overlooked by many: what would be the impact of deferring access to this treatment, despite the clinical data underlying its approval? Based on our current estimates of the progression rates of the disease, every day over 1,000 Americans will advance from early stages of disease to moderate and severe stages of disease, and thus may progress beyond the stages during which ADUHELM should be initiated. We feel a strong obligation to be able to offer new options to patients with this devastating disease.

And when Biogen is not whining, it's rolling out an aggressive marketing campaign to get people to worry about their memory capacities. Its website with a doubt-inducing quiz sends all comers (even if they answer all questions negatively!) to consult with their doctor for cognitive testing to determine if they may have early Alzheimer's and be a candidate to take Biogen's at-most-marginally-effective and expensive drug.

Thursday, July 08, 2021

The Future of Aducanumab - as a Medicine and as a Financial Product - What Happens Now?

To recap: the FDA recently (and foolishly) approved Biogen's monoclonal antibody aducanumab as a treatment for Alzheimer's. It did this on the basis of a surrogate endpoint, amyloid plaque reduction, even though, in NUMEROUS trials, that has not been associated with clinical improvement. The company is claiming that there IS clinical improvement based on high-dose patients in one of two clinical trials that were stopped for futility, based on a post hoc analysis. According to an NEJM Viewpoint article authored by three of the FDA advisory committee members, those patients had an absolute improvement of 0.39 on a clinical scale (the Clinical Dementia Rating-Sum of Boxes) but "the minimum clinically important difference [on this scale from 0 to 18] is generally considered to be 1 to 2." The FDA advisory committee was overwhelmingly unconvinced this showed the drug to be effective, but the FDA went the "accelerated approval" route and approved it anyhow, on the basis that it shrinks amyloid plaque.

Rescission of approval - best case future, but unlikely

Best case for what happens now is that approval is rescinded, and I think that we SHOULD absolutely push for that sliver of a chance that that could happen. The volume of informed voices protesting the accelerated approval is somewhat heartening, and might indicate wide support for such a move. All the same, that's a very remote possibility, with FDA leadership firmly opposed, even though a couple of congressional committees are supposed to be looking into the approval. So if rescission doesn't happen (and I'd have to say it won't), what now?

The future according to proponents

If one listens to the proponents of the drug, what happens next is likely to be a golden era of progress in treatment for Alzheimer's. Yes, maybe Aduhelm isn't very effective overall, but it's a start and may help some people much more than the average outcome indicates. As a start, it will be followed by better drugs and is the beginning of a new era. The high price is warranted because Alzheimer's is a huge problem, so even marginal help is of immense value, especially if it accelerates greater progress as more drugmakers jump on the bandwagon.

A more realistic rosy scenario

I think some people, including acting FDA head Janet Woodcock, have convinced themselves of the above golden future, but I believe this is a ridiculous fairy tale and about as likely as snow in July. So here's my version of a rosy scenario: insurers and legislators force down the price of Aduhelm somewhat, and it's prescribed to a large number of people but not as large as originally predicted. The brain swelling side effects prove to be not too troubling, and although clinical effects overall are marginal to none, it does help some people more than averages would indicate, and some individuals do realize a substantial benefit for themselves.

Even in this most rosy of realistic scenarios, the financial impact of the drug will be major, causing huge financial stress on both individuals with Alzheimer's and on the medical/insurance systems. As well, research on more promising avenues to treat Alzheimer's will likely be impeded, both because it will be more difficult and complicated to enroll people in clinical trials, and because if companies are incented to develop lousy drugs and can make a fortune that way, the incentive to produce really great drugs is thereby diminished. And, as Elizabeth Rosenthal pointed out in an excellent and interesting column, after the accelerated approval, we may in fact never learn whether Aduhelm actually works or not.

The most likely future

A less rosy but perhaps more probable scenario - the one I personally would wager on though I could be wrong - is that the drug will be approved, be widely prescribed, and provide no discernible or provable benefit to anyone, while worsening the lives of patients financially and by additional medical procedures and tests and side effects. Desperate people will be provided with false hopes and real costs.

I think this is most likely, because there is not something like an even chance that aducanumab is effective. Given the dicey nature of post hoc analyses and the many failures of amyloid-targeting drugs, the smart bet is that this drug doesn't work, although that's not a certainty.

Aducanumab and money

The future of aducanumab as a medical product is murky and uncertain, but the future of aducanumab as a financial product is something else. It looks to extract vast amounts of money from people in the form of premiums, taxes, and co-pays, and to greatly enrich Biogen and its stockholders.

Vinay Prasad had comments on drugs that are primarily financial products on a recent podcast (at 18.05 minutes in, but to get the full context, start listening at 15.51). He was not specifically addressing aducanumab, which had not been approved at that time, but thinking more of some cancer drugs. Prasad noted:

[When the FDA approves drugs without good evidence,] they keep so many people happy in the ecosystem, the companies are happy, the providers are happy, the people running the trials are happy, the patient advocacy groups, who are funded by the companies, they're happy, but the people who aren't happy are, the average person in society, whose premiums are going up, whose real wages are stagnating or declining. because we're paying more in health care, and this person is seeing more and more of their paycheck going off to health care, and what is that really saying?

it's saying that we're going to take this money from you, and we're going to collect it from everybody, and offer a service to everybody that we believe is a human right, the right to have good health care, and I actually support that, I believe that is a human right, but it's a human right to have things that actually benefit you - is it a human right to have snake oils or things that don't work? That I think is actually a financial product.

I mean, if I make a molecule, that is patentable, and I give it to cancer patients in a trial and I find some changing biomarker, and I give it to people in the real world, not a single one of them or nobody in aggregate lives a day longer and their quality of life is the same, what have I created? It's something that you call a medicine, you call it a medicine, but people aren't living longer, they're not living better, with my medicine, hypothetically - it's not a medicine, it's a financial product.

It's a product that actually collects wealth from lots of people, from middle-class people, from poor people, and it shovels that wealth into the hands of a few shareholders of this company, it is a reverse financial product, it's like a regressive financial product. ...there have long been feudal systems, where average workers kick up some of their wealth to the elites, and to some degree, when you have cancer drugs that don't work, you have created a feudal system, we're all kicking up our wealth, so that some people get really rich, and whether or not we get better health for it, is an uncertainty. and I think that's the crux of the issue.

We do not know if aducanumab is a medicine in any true sense of the word at all. We are pretty certain that it's a good business proposition and a money-maker, even if it might be snake oil. And we know that, like so many things nowadays, it will suction money upwards from the less well-off to the richer, and contribute to inequality.

And how MUCH money will it suction away from other uses? That too is an interesting question, although one with no certain answer other than "a lot," and perhaps the one that has caused the most speculation and discussion to date. I'll post more on the finances and perhaps some other aspects later.

Wednesday, July 07, 2021

Leadership of Big Health Care Corporations Go Back to Financially Supporting the Opponents of Democratic Governance

At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and poltical organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates. In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians. In March, 2019, we discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 


 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post).

Now two new reports show continuing support by large health care corporations for Republican legislators who also supported the nullification of the election, and legislation that might decrease voting by citizens who oppose Trump

Health Care Corporate Sponsorship of Voter Suppression

In April, 2021, Public Citizen published "The Corporate Sponsorship of Voter Suppression." It detailed support from direct corporate contributions and corporate political action committees (PACs) from 2015 through March, 2021, to state legislators who authored, sponsored or voted for 245 bills that could have made it more difficult for citizens to vote in elections. 

The 25 companies contributing the largest amounts of money to these legislators included UnitedHealth Group ($411,200 total); Pfizer ($308,085); and Centene Corp ($205,200).  Companies that gave somewhat less included Merck ($180,000),  CVS ($174,000), Anthem ($138,150) Eli Lilly ($124,000) and Cigna ($109,225).

Two health care related trade groups also gave significant funds to these legislators: the Virginia Dental Association ($223,000) and the  Pharmaceutical Research and Manufacturers Association of America/PhRMA ($200,000).   

Note that the data did not include personal contributions from corporate leaders, and could not include corporate money directed to dark money organizations that ended up supporting these legislators.

Health Care Corporate Sponsorship of the Attempt to Overturn the 2020 Election

In June, 2021, Citizens for Responsibility and Ethics in Washington (CREW) published "This Sedition is Brought to You By..." It detailed contributions from corporate PACS and trade groups to those in the US Congress who voted against certifying the results of the 2020 election and the two main party organizations that supported them, the National Republican Senatorial Committee (NRSC) and National Republican Congressional Committee (NRCC) since the vote not to certify.  

The largest contributions from health care corporate PACs included those tied to Fresenius Medical Care Holdings ($76,000); CVS ($45,000); Cigna ($42,500); Johnson & Johnson ($30,000); Pfizer ($20,000); and Humana ($15,000).

Note that the data also did not include contributions from corporate leaders, and could not include corporate money directed to dark money organizations that ended up supporting these legislators. 

Discussion

Most health care corporations profess to missions that are pluralistic and support the community and society as a whole.  For example, Pfizer's mission statement includes:

We partner with governments, non-profits, and other organizations to ensure that more people around the world have access to the medicine and resources they require.

UnitedHealthCare's mission statement includes:

UnitedHealthcare is dedicated to helping people live healthier lives and making the health system work better for everyone

Merck's mission statement includes:

We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships

However, leaders of some large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would restrict voting rights in ways likely to impact already disadvantaged groups, and challenge election outcomes without strong evidence of irregularities would seem to violate high-minded corporate pledges of inclusiveness like those above.    

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

However, there are problems with this formulation.  As we wrote before,  it is obvious why a pharmaceutical company might want to defeat legislation that would lower its prices or raise its taxes.  It is not obvious why it would want to consistently support actions by one party, or by people at one end of the political spectrum, even if some such people seem generally "pro-business."  After all, for years big corporations and their executives openly gave money to both US parties and their candidates, apparently in the belief that this would at least allow more visibility for the corporations' priorities no matter who was in power.

Maybe it is not just about money.  Again, as we said before, by virtue of being top management of a corporation, particular individuals can control political funds far beyond what they may be able to control as private persons, and to do so anonymously.  It may be that top corporate leaders are not just interested in making more money.  Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, if not openly fascist national political leadership.  Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)

At least health care professionals, policy makers, patients and the public at large deserve to know how health care corporate leadership is directing money to political causes, and how they benefit from doing so. 

 

    

Wednesday, June 30, 2021

Aducanumab Approval, Part 2

So how did a drug with such dubious benefit get approved? At best, another clinical trial might be warranted, but certainly not approval. It's a result
  1. of a huge campaign by a company (Biogen) that would not accept the failure of its drug
  2. and
  3. of pressure from patient organizations like the Alzheimer's Association (which receives major money from pharma, including Biogen and its Japanese partner, Eisai).

The company campaign began in spring 2019, after its Phase 3 trials were stopped for futility after an interim review. A long, detailed, and excellent STATnews article published this week, drawing on insider sources, tells a fascinating but troubling story. The last-ditch effort to get approval was originally called "Operation Phoenix," but was re-titled "Operation Onyx." Biogen managed to get Billy Dunn, Director of the Office of Neuroscience at the FDA, on their side, to the point that he worked closely with them to provide a roadmap for approval, very inappropriately.

After the groundwork was laid for an approval of aducanumab despite the negative advisory committee recommendation, and prior to the announcing of a final decision, the patient organization campaign was carefully timed. In early May, the Alzheimer's Association launched a big campaign seeking to build grassroots support for drug approval. The "More TIme" campaign worked to pull at heartstrings with celebrity endorsements and poignant personal stories. Full-page ads were taken out in the Wall Street Journal and USA Today, and focused on what "more time" would mean to Alzheimer's patients and their families. There were google search ads, Facebook and Twitter and Instagram and LinkedIn posts. The campaign succeeded in getting over a million people to express support in petitions.

After the approval, the Alzheimer's Association spoke of victory:

As the first FDA-approved drug that delays decline due to Alzheimer’s disease, the approval of aducanumab (Aduhelm™) is a victory for people living with Alzheimer’s and their families.

Comments on articles including this one give the flavor of the passion with which some people want to try this unproven therapy.

Denying a medicine which might work is far more worse than approving one that might not work! Do you agree in the case of Alzheimer’s?
The negativity of these old fashion mentality is what has driven new discoveries to a halt. I don’t suffer from Alzheimer’s nor know anyone close to have been dx w it but we need to start somewhere. Prescribing the pharma will only help w research. Get in line MD.
Alzheimer’s is a horrible disease. If the medicine has a chance of success then prescribe it.

And public officials seem to be buffaloed. A Politico article said that not only are public officials mute about the approval, they are hesitant even about making a fuss about the pricing (about which more in another post):

[Politicians are] worried they’ll be seen as dashing desperate patients’ hope for an Alzheimer’s treatment — even one that may provide little or no benefit. The FDA’s controversial approval of Biogen’s drug, known as aducanumab or Aduhelm, has caught both political parties flat-footed ...Everyone is a bit terrified by Alzheimer’s, so the average person hears about the FDA approval of a treatment, and they don’t know about the controversy over whether it works or not,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management who lambasted FDA’s Aduhelm approval. “They hear there’s a new treatment and, that’s great, it’s a sign of hope. Do you want to be the politician who says, ‘I want to take that away from you?’”

Evidently, the public opinion campaign with its drumming up of support for this bogus drug has had its desired effect, creating cowardice to speak about the realities. Subsequent to the publication of the Politico article, two senators did speak out about pricing, but were careful to praise the drug:

Even as they criticize the price, however, Cassidy and Warren still stopped short of directly criticizing Biogen. They offered praise for the drug’s approval, too, calling it a “historic, watershed moment” in the history of the disease.

Public Citizen - who does not have to get elected - did not share this hesitancy. Their long public letter to HHS Secretary Xavier Becerra - which I recommend reading in full - begins as follows:

Public Citizen is writing to express its outrage over the Food and Drug Administration’s (FDA’s) indefensible decision to approve Biogen’s aducanumab (Aduhelm) for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury. The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.

They go on to ask for resignation of key officials in approving aducanumab, including FDA acting head Janet Woodcock and Billy Dunn. They also ask that the Office of the Inspector General for HHS investigate the relationship and "close collaboration" between the FDA and Biogen prior to Aduhelm approval. In addition, they want rescission of the bogus approval:

You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.

Those who pushed for approval seem eager to foreclose any discussions of rescission. In an interview, there was this question and answer with Acting FDA Head Janet Woodcock:

Question: "There’s been some reaction that every time this criticism comes up, the FDA just dismisses it outright and doesn’t really meaningfully engage on it —doesn’t do soul-searching. … Should the FDA do some soul searching? Should you and the FDA be trying to respond more directly to these critics?" Woodcock's reply: "I think we will have some more public soul-searching type of discussions on accelerated approval itself, but the soul-searching when a decision is made goes on before the decision, and once we’ve made the decision, we’ve made the decision."

Similarly, the head of the Alzheimer's Association wants to end discussion of the approval:

Harry Johns is ready to stop talking about whether or not the Food and Drug Administration should have approved Aduhelm, the divisive new Alzheimer’s treatment that got the green light last week. “Dwelling on the approval at this point is not productive for those who can benefit from the treatment,” said Johns, the CEO of the Alzheimer’s Association. The “negative voices” focused on criticizing the decision, he said, are “not pro-patient.”

But, if the aducanamab approval is not rescinded, what will happen and what are the consequences? More on that in another post.

Tuesday, June 29, 2021

FDA Approval of Aducanumab

Almost twenty years ago, I was a volunteer nursing-home ombudsman. The doctor at the nursing home I visited was a huge proponent of preventive therapies, and prescribed as many preventive drugs as possible for residents (while frequently ignoring complaints about current medical problems that were bothering them). Among the drugs he very freely prescribed were cholinesterase inhibitors for Alzheimer's disease, then fairly new. I was stunned when I learned he prescribed one to a resident whom I knew well and who seemed fully oriented to me, but that was the case. From what I've learned since, these drugs don't have any really noticeable clinical benefits anyhow, so they are unimpressive.

But if prescribing those drugs so freely seemed like a dubious course of action to me then, they look almost good now by comparison to the latest drug approved by the FDA for Alzheimer's disease, aducanumab (Aduhelm). This drug doesn't have any convincing evidence that it benefits patients, AND it comes with potentially serious side effects that require a lot of monitoring.

The quality of life implications of this are troubling. As one doctor notes:

"This is a drug that medicalizes someone’s life,” said Mantyh. Besides the hourlong, once-monthly infusions, an Aduhelm prescription comes with frequent lab tests and brain scans to monitor for signs of swelling or bleeding. In two of Biogen’s clinical trials, more than one-third of participants who received Aduhelm developed painful brain swelling; about 17% to 19% had small bleeds in their brains. Headaches, dizziness, nausea — all might trigger more time spent in the hospital. Such constraints could make it difficult to travel internationally or spend time with family members in other states.
The article also notes that, except in the case of adverse side effects, it is hard to decide when to discontinue a drug when it's likely to be quite unclear whether it's benefitting the patient or not.

How did the FDA come to approve this drug without stronger evidence that it is actually beneficial? It used an "accelerated approval" pathway and based the approval on the fact that the drug diminishes the size of amyloid plaques. This was despite the fact that in multiple trials. reducing amyloid plaques has not been shown to improve things clinically for patients. As Derek Lowe wrote (and his whole post is well worth reading):

So the FDA has, for expediency’s sake, bought into the amyloid hypothesis although every single attempt to translate that into a beneficial clinical effect has failed. I really, really don’t like the precedent that this sets: what doesn’t get approved, now? I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while you turn a profit?

A commenter on the Lowe blog ("Radioactive Man") wryly noted:

All the other companies that successfully developed anti-amyloid drugs then discontinued them for lack of efficacy must be kicking themselves to realise they were approvable all along. It makes me wonder, could they just simply dust off their old phase 3 results and go straight to applying for approval without even doing any more clinical studies? If those results are comparable to aducanumab, why not?

Elsehere too, there was speculation on whether other companies could go back and now seek approval of similar drugs that cleared plaque without showing clinical improvement.

[Could] a slew of amyloid-reducing agents from the past...now be re-evaluated under the accelerated approval pathway?...In a public defense of her agency’s decision on June 22, Woodcock said future approvals under this pathway would be possible if the magnitude of plaque reduction was great enough.

Not one of the FDA advisory committee members voted to recommend approving aducanumab. Ten voted against, and one voted "uncertain." Three have since resigned in protest. In his resignation letter, one stated this is "was probably the worst drug approval decision in recent FDA history."

A professor who has served on many FDA committees commented:

“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson....“This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”

Despite the protests, proponents of the drug were breezy, lauding it as a great "breakthrough." The acting commissioner of the FDA, Janet Woodcock, said that she is “not that concerned” about criticisms of the approval. And meanwhile, the first patient got his first infused dose of aducanumab. Dr. Stephen Salloway, director of the memory and aging program at the Rhode Island hospital giving the infusion, stated at a press conference: "It's transforming how we treat Alzheimer's." He snottily added, "For those of you who don't know, it's a devastating disease."

Salloway's remarks make me really furious. A supposed medicine has to be judged by its results, not by the urgency or seriousness of the condition it is alleged to treat. And the "evidence" was totally cherry-picked post hoc after the failure of their Phase 3 trials, following the bad rule: "If you don't succeed, change the definition of success."

There's more to be said about the aducanumab approval, but this post is long enough. More in the next post.

Wednesday, May 26, 2021

The Plot Thickens - How Corrupt was the Trump Administration Under Which Health Care (and the Rest of the US) Operated from 2017 - 2021?

This week, reports appeared that former US President Donald Trump, the Trump Organization of which he is the principal owner, and other people connected to the Trump Organization are the subjects of a special grand jury investigation going on in New York City.  As the Washington Post reported,

 Manhattan's district attorney has convened the grand jury that is expected to decide whether to indict former president Donald Trump, other executives at his company or the business itself, should prosecutors present the panel with criminal charges, according to two people familiar with the development.

Furthermore,

 The move indicates that District Attorney Cyrus R. Vance Jr.’s investigation of the former president and his business has reached an advanced stage after more than two years. It suggests, too, that Vance thinks he has found evidence of a crime — if not by Trump, by someone potentially close to him or by his company.

Vance’s investigation is expansive, according to people familiar with the probe and public disclosures made during related litigation. His investigators are scrutinizing Trump’s business practices before he was president, including whether the value of specific properties in the Trump Organization’s real estate portfolio were manipulated in a way that defrauded banks and insurance companies, and if any tax benefits were obtained illegally through unscrupulous asset valuation.

The district attorney also is examining the compensation provided to top Trump Organization executives, people familiar with the matter have said.

To my knowledge, even though the grand jury could return no indictments, such an investigation of a former president and his business is unprecedented in modern times.  It suggests the possibility that this particular president was more unethical and corrupt than any other, and that he might turn out to be the only actually criminal president.  Thus it suggests that all our concerns about unethical practices, conflicts of interest, and corruption of the Trump administration, and their effects on corruption in other sectors, particularly health care, were not unfounded.

Thus, I will take this opportunity to review these concerns.

  Background: Health Care Corruption

As we wrote in August, 2017, Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.
the scale of corruption is vast in both rich and poor countries.
 
Also,
Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.
 
The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,
However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.

 Health Care Corruption in the Context of a Corrupt Government



Instead, things from 2017 - 2021 only seemed to be getting worse, given the increasing evidence that the Trump administration was corrupt at the highest levels.   In January, 2018, we first raised the question about how health care corruption could be pursued under a corrupt regime.  We noted sources that summarized Trump's. the Trump family's, and the Trump administration's corruption..  These included a website, entitled "Tracking Trump's Conflicts of Interest" published by the Sunlight Foundation, and two articles published in the Washington Monthly in January, 2018. "Commander-in-Thief," categorized Mr Trump's conflicted and corrupt behavior.  A Year in Trump Corruption," was a catalog of the most salient cases in these categories in 2017.

In July, 2018, we addressed the Trump regime's corruption again  By then, more summaries of Trump et al corruption had appeared.   In April, 2018, New York Magazine published "501 Days in Swampland," a time-line of  starting just after the 2016 presidential election. In June, 2018, ProPublica reviewed questionable spending amounting to $16.1 million since the beginning of Trump's candidacy for president at Trump properties by the US government, and by Trump's campaign, and by state and local governments. Meanwhile, Public Citizen released a report on money spent at Trump's hospitality properties.

In October, 2018, we summarized the content of the voluminous Tracking Corruption and Conflicts of Interest in the Trump Administration summary appearing in the Global Anti-Corruption Blog. The blog organized corrupt activities within the Trump administration into the following categories:

1. U.S. Government Payments to the Trump Organization

2. Use of the Power of the Presidency to Promote Trump Brands

3. U.S. Government Regulatory and Policy Decisions that Benefit Business Interests of the Trump Family and Senior Advisors

4. Private and Foreign Interests Seeking to Influence the Trump Administration Through Dealings with Trump Businesses

Not only was the report voluminous, the October, 2018, version of the report requiring 26 pages to print, it suggested that many examples of corruption by Trump et al were not one-offs, but were long-term activities.  For example, every time President Trump travels to on of the properties he owns through the Trump Organization, for example, has Mar-a-Lago resort in Florida, the US government is obligated to pay Trump himself through that organization for various expenses, e.g., the Secret Service renting golf carts at Mar-a-Lago.  Each time that happens it seems to violate the "domestic emolument clause" of the US Constitution, which prohibits state or US government payments to a President for anything other than his salary.  Also, foreign governments and corporations seeking to promote specific government policies in their self-interest, similarly seeking favorable regulations, or other seeking to influence government actions in their favor are making periodic payments to the Trump Organization, such as buying accommodations or paying for events at Trump properties.  When foreign governments do so, that appears to violate the "foreign emoluments clause" of  the US Constitution, which prohibits payments by a foreign government to the US President.

Further reports on Trump and associates' conflicts of interest and corruption appeared through 2019, as further documented in this post.

Discussion

We noted in our last summary post on conflicts of interest and corruption in the Trump administration that the topics of corruption, health care corruption, and the likely corruption of the Trump administration remained largely anechoic.   

Despite the extensive and ever-increasing list of apparently corrupt acts by the Trump and cronies, grand corruption at the top of US government, with its potential to corrupt not just health care, but the entire country and society, still seems like a taboo topic.  The US news media continues to tip-toe around the topic of corruption, in health care, of top health care leaders, and in government, including the top of the US executive branch.  As long as such discussion seems taboo, how can we ever address, much less reduce the scourge of corruption?  The first step against health care corruption is to be able to say or write the words, health care corruption.

Once Trump left office, there has not been much more discussion.  There have been brief reports in the media that many investigations of Trump and cronies are ongoing.  For example, an article in the
Washington Post in March 2021 noted "the [NY] state attorney general has subpoenaed his lawyers, his bankers, his chief financial officer — even one of his sons.... Former president Donald Trump is also facing criminal investigations in Georgia and the District of Columbia related to his efforts to overturn the 2020 election."  Also, "In Washington, D.C. Attorney General Karl A. Racine (D) has also opened a criminal investigation into Trump’s actions on Jan. 6" and "the Justice Department, in the meantime, is conducting a broad investigation of the Jan. 6 Capitol attack."  Yet, as we documented here, prior to becoming president, Trump and his associates enjoyed practical impunity, escaping convictions and penalties multiple times. There is no certainty he will not maintain his impunity in the future.

Trump is no longer president, but he enjoys continuing support from many in his party, and has suggested he might run again.  How will we ever make a meaningful dent in health care corruption if we cannot end the impunity of our top political leadership? 

Sunday, May 02, 2021

Guest Post: Advocating Restoring the Leadership of Hospitals by Medical Professionals, Thus Reversing the Managers' Coup D'Etat

Health Care Renewal presents a guest post by Dr. Gene Dorio.  Dr Dorio  is a geriatric physician from the Santa Clarita Valley in California,  providing house calls to older adults.  He has been an advocate and whistleblower for his community leading several causes from attempting to preserve the hospital Transitional Care Unit for seniors in 2006, to today trying to allow admission of teens to the psychiatric unit.

He is President of the Los Angeles County Commission for Older Adults, an elected Assembly Member of the California Senior Legislature, serves on the Triple-A Council of California, and member of the Santa Clarita Valley Senior Center Advisory Board.

For 5 years, Dr. Dorio served on his hospital’s Medical Staff Executive Committee in several leadership roles including 3 years as Chairman of the Department of Medicine. 

 Doctors are highly trained medical professionals trying to survive in a complex sociopolitical system.  We have been pawns utilized by hospitals and government for our knowledge and skills, yet more recently expected not to have a voice or opinion.

As a physician in private practice for 40 years, changes in the past 10 years have been difficult.  It was hard for me to hear non-medical business administrators force cut-rate medicine compromising evidence-based patient care.

I was elected to the hospital Medical Executive Committee (MEC) seven years ago with the hope from the inside I could improve threats against patient care.  This did not succeed and the fury coming from the hospital intensified as the self-governing MEC was swallowed up by the Board of Directors and Administration.

Doctor voices protecting patients diminished, and many whistleblowers were left to defend themselves from bullying and attacks.  

Lies and insults persisted, and the only power I had was knocking out keyboard articles to social media as a shield.  Throughout the country, there were scant physicians in the same situation, so we networked the best we could to survive.  “Never give up” was our mantra.

Periodically murmurs could be heard, but it was always muffled.

This year in California, a law was introduced in the State Senate to keep hospital administrators from “practicing medicine without a license.”   Most doctors don’t know about it, but of course the state hospital association is diligently fighting it.

It can be seen here.  

At the end of April, I was asked to testify at the State Senate Health Committee, and this is what I provided:

===

Good morning Mr. Chairman and members of the California Senate Health Committee.

My name is Gene Dorio, and I am a geriatric physician in Santa Clarita serving my community for 34 years.

Until two years ago, I was on staff at a local hospital which is a non-profit, but run like a for-profit hospital.  For 5 years, I served on the Medical Staff Executive Committee in several leadership roles including 3 years as Chairman of the Department of Medicine.  

During my time there, I witnessed administrators use manipulative, clandestine tactics to capture each voting facet of the health facility, including the Board of Directors, contracted physician groups, and the Medical Staff so business people could make patient-care decisions.

At my hospital, business community members were appointed to the Board of Directors and provided lucrative contracts in exchange for their vote.  Bankers were given hospital accounts; a real estate agent was given property to rent; and a doctor was given space for a dialysis unit.

Exclusive Contracts were signed by physician groups for emergency room care, radiology, and operating room anesthesia.  The hospital could not technically practice medicine, but they coerced these groups with the threat of severing contracts if they did not adhere to their orders, or vote as told. Needless to say the administration got their votes, while the Medical Staff became only a shell of a self-governing body once devoted to improving patient care.

Eventually, the Medical Staff was taken over too, and our policies were changed to bring in more revenue—even when it was terrible for patients. My patients are geriatric, and at times clinging to life. Nonetheless, staff started to leave daily notes on my charts forcing me to discharge patients even though they were not ready to leave the hospital. These notes included a printed statement “Not a Part of the Medical Record” which was removed later by the Medical Records Department erasing hospital culpability.

Hospital administrators also knowingly wrote orders without doctor consent for Palliative Consults, to place patients on hospice care which financially benefits the hospital by getting them out of the hospital for care.  

They also made decisions about medications patients could receive. They decided not to use insulin pens as they were too expensive, and instead jeopardized diabetic patient care using multi-source insulin vials which are less precise and easily contaminated.  The presiding CEO was released from their previous hospital after violating State Medi-Cal laws substituting inferior anesthesia in the labor and delivery department.

Hospitals also hold regular “throughput” meetings for physicians, where they publicly display the number of referrals, expensive tests, procedures, and overall revenue that each doctor is generating. They talk about productivity and efficiency—not the quality of patient care.

Because I tried to advocate for my patients, my hospital privileges were constantly in jeopardy. Typically, privileges are renewed every two years.  For me, it was every 4 months.

If hospital administrator actions were truly to improve healthcare for our patients, I would have no qualms.  But instead through abusive tactics and bullying, they interfere with physician decision-making, and ultimately increase administrator salaries, bankroll retirement portfolios, and yearly bonuses.

SB 642 is an important step to removing hospital administrators from practicing medicine without a license.  Their surreptitious plans taking over a non-profit hospital for their own personal benefit must be thwarted by this law.

Patients have entrusted physicians to be guardians of their health.  We are professionals that have taken a solemn oath to provide care in the best interest of the patient.  Therefore, SB 642 will serve Californians by putting medical decision-making back into the hands of patients and their doctors.

Thank you.

===

I have never testified before a legislative body, but this is where my keyboard has brought me.  There needs to be more voices fighting for patient care diminishing hospital administration power.  Doctors must be part of the balance providing better healthcare to citizens of our country, but we must hear you speak!  

Follow that mantra, “Never Give Up!”

Gene Uzawa Dorio, M.D.

[Editorial Note] For background on the managers' coup e'etat, managerialism and related issues, see this post.

Thursday, April 22, 2021

Disinformation: a Medical Meditation. Dander At Half Mast.


Are there no foes for me to face?

Must I not stem the flood?

Verse 3, Isaac Watts (1674-1748),
"Am I Not a Soldier of the Cross?"

Introduction

In what follows I expand on our ongoing series—most recently appearing here—on the crisis of fair and accurate information in science and medicine. I divide this meditation into four sections—"meditation" used to excuse a certain amount of meandering, hoping readers will bear with me. I enumerate these sections in order for those with less interest or time to pick and choose.

  • What's logical and what's illogical: the disciplinary messiness of disinformation, what else impacts the acceptance of disinformation?
  • What's the broad media problem, old and new?
  • Was there any responsibility on the part of elites, institutions and academics in bringing about the mistrust that now, ironically, lingers about them like a bad smell? And how did the elites treat their own innovators?
  • Within health care, what are the more narrow, "hidden" sources of disinformation and information asymmetry among actors, including patients?

For all of us, disinformation means information degradation around our health, both that of our populations (vaccination→autism) and that of individuals (nostrums→cure). Disinformation means intimidation of experts and the deprecation of expert knowledge. It means free communication in the arteries of our society suffers from a kind of thrombosis, as true believers latch onto all the niduses of nonsense that disinformationists increasingly spew, often with disastrous results.

A. Beyond Logic.

looking across so many different domains and disciplines, it's remarkable to see how much has been written about disinformation. It's all the more strange we've really only just scratched the surface, leaving us incredulous when Kennedys and Trumps alike smear it around. Enter the concept of disinformation as a search term in any engine. Or put it into an academic search engine. What comes back is a tsunami of attempts to wrestle with this phenomenon, crossing many disciplines.

So for this writer it's daunting to stare at a blank page and consider what more to say. At the beginning of this year, HCR's series editor, Dr. Poses, wrote a lucid piece on logical sources of disinformation. But the very vastness of the expanse of work on the subject, epistemologically, methodologically, its sprawling and protean nature, its slipperiness, may actually give us a clue to why disinformation seems so hard to pin down. (At the risk of being slightly off-kilter I'll treat it here as interchangeable with misinformation.*)

Yet as we enter this post-covid age of proliferating echo-chambers, with all this blather that seems meaningless to some yet somehow persuasive to others, ponder it we must. Political science, philosophy, computer and data science, sociology, cognitive psychology, social psychology, communications, legal studies, clinical medicine and more all help us focus on what disinformation might be, and what we might do about it. 

For starters, the philosophical science of logic is a good place to begin. Pretty quickly, however, dip into sources on "logical fallacies of reasoning" in science and medicine, such as this one, and an even cursory glance implicitly warns you: go further. Look beyond logic. "White skin causes inferior brain capacity" or "vaccine causes thrombosis" are classic examples of the post hoc propter hoc fallacy, the exposition of which goes all the way back to the Hippocratic Corpus in Greek antiquity. Logic! Illogic! Every freshman medical student comes across this in introductory medical decision making. But peruse the laundry-list of fallacies to which the human mind is inexorably drawn. Even in the "logic" laundry lists, you quickly see that many, if not most fallacies simply don't have a logical basis at all: they depend on a whole mug's gallery of social and psychological tendencies, misconceptions, and biases.

If lying is weaponized, then a major part of the problem must be how the human brain elaborates patterns of behavior to deal with real or perceived adversaries, to gain the upper hand in social conflict.  Far more than it is logical, such adversarialism is emotive and primitive-brain. Gaslighting for example has no real logical component. Indeed, its very illogic is part of its eerie power. So is the brain's poor track record when it comes to assessing risk. NY Times editor Jenée Desmond-Harris quotes these statements from her social media feeds:**

You say you won’t get the vaccine because you don’t know what’s in it but you'll eat a hot dog!

You think the government is using the vaccine to put a tracking device in your arm, but have you looked at your life and asked whether there’s anything worth tracking?

You’re afraid the vaccine might kill you, but guess what we know can kill you? Covid!

 What sets all of these apart is the illogic of risk assessment. We're hard-wired not to be logical. We're tuned in mainly to other things: fight versus flight; the over-privileging of gurus' opinions; big-name pretty-faces, sports stars and entertainment figures. We're also tuned in, as we've come to learn recently, to the pronouncements of blow-hard reality-show idols skilled at fanning the flames of illogic in our reptilian brains. These flames include fear of the Other, tribal shibboleths, the pursuit and possession of secret knowledge (e.g. QAnon); or pride in in-group belonging (Proud Boys, Boogaloo Bois, Three Percenters, many others).

There's another supra-logical bias that's less emotional but certainly not steeped in pure logic: historical. I speak to Black friends who explain vaccine hesitancy using the "remember Tuskegee" trope. Understandable, completely. But history doesn't repeat, it just rhymes, we've all heard it by now. And not just post-Tuskegee (or post-HeLa) suspicion of Big Science, but concern among many groups that the deck may be stacked in some way so let's just wait and see who springs for this newest-ride-in-the-park. Logical, but in a different way, really, coming from a different part of the brain: the social brain, exposing, let's say, its own different sort of logic. (On the Black experience see the excellent column, author What Doesn't Kill You Makes You Blacker.) For this author, Damon Young, the upshot is "weigh it all out, then decide." Of course.

If, say, you want to advocate for herd immunity, addressing historical bias requires some rudimentary knowledge of historical narratives and social circumstance. Then one might begin fully to understand their power as determinants of behavior. Historical, social and emotional foundations swirl powerfully around and beyond what's rational, and end up dictating behavior. They all impact the degree of presence or absence of that most basic commodity, trust. Trust is something that's in dangerously short supply in a fragmented society that never really was e pluribus unum. The importance of coherence, of a social compact, was something our teachers peddled in schools who had their own institutional interests in perpetuating certain myths.†


B. External Forces I. Media and Technology: the Disinformationist's Nidus of Nonsense 

1. Old Media.

I know it's nothing new for me to say this, but just because we have more forms of media proliferating, or more technologies to give us all the new flavors of megaphone, why would we expect the resulting information to be better? To quote Uncle Joe, come on, Jack! Not better information. Just a widening cornucopia. Just a louder, covid-spiked, Harley roar of intrusive noise.

Yet there are many who think they benefit. Actually, the media barons and tech bros clearly do benefit. Right in the wallet. It's absolutely beneficial for those acting as intermediaries for health (actually, all) information to put out there what's discomfiting, alarming, or otherwise stimulating in those places that dopamine seems to work its magic. What's perhaps less well recognized is just how calculating this is, even as some members of the "Great PR Families" (Sacklers, moreMurdochs, more) begin to show just an inkling of a superego long after the patresfamilias have done most of their damage.

Examples? Here are a couple. Start with those that preceded the current almost post-apocalyptic Fury Road of tech blogs and secret covens and digital echo chambers. One of the intriguing things about the early, print-only media moguls—or mogul wannabes—was how they seemed all to style themselves as Renaissance Men. The opiate kings, the Sacklers, spent lavishly on art and plastered their names everywhere—a common enough trait for the filthy-rich.‡

In any case, for those new to Health Care Renewal, the disastrous disinformation peddled by this media-savvy family revolved almost exclusively around a single trope that was pumped out through many subsidiary channels. Such channels includes speaking engagements by "pain specialists" at lavish detail-man sponsored dinners, touting the safety of these drugs that had made them multi-billionaires. Interestingly, the family got into trouble just a little too early—at least I think this is true, please write a comment below if you know otherwise—to benefit fully from the digital-channel revolution.

In 2014 a more recent example of the use of Old Media to flatter physicians into robot-prescribers was described in detail by physician-historians Scott Podolsky and Jeremy Greene, now respectively at Harvard and Johns Hopkins. They compare two media-savvy physicians from the 1950s, '60s, and '70s, the zenith of the print era in medicine and of post-war medical triumphalism. They contrast two roughly contemporary physician leaders, internist William Bean (1909-1989), a midwestern leader who tended to published in posh AMA journals, and immigrant psychiatrist Félix Martí-Ibañez (1911-1972) who tended to self-publish in his own Sackler-style "throw-aways" such as MD and his popular book Centaur. Both built careers out of flattering their medical brethren.

Yet "high road" Bean became notorious for his vicious assault on "low road" Martí-Ibañez for the latter's exercise of "a decline in taste, the faults of bombast, and flatulent writing. … [The author’s scholarly colleagues] must have winced at the polycythemic and apoplectic style of this literary centaur." What was interesting, though, was the fact that both of these "medical humanists" were furiously sucking at the teat of Big Pharma. Big Pharma has always been, one infers, to medicine what the Koch Brothers are to the Republican Party. (Or, let's say, fat-cat donors to both political parties.) Drs. Podolsky and Green conclude that the real argument was over what we might call "intention to inform." That is, disinformation. They conclude that for some, e.g. Bean, it was a bridge too far—open, overt pandering—when Martí-Ibañez declared that the "'whole operation [of running Martí-Ibañez's media] is done so artistically by our spellbinders that the reader, without knowing exactly what has happened, falls gratefully under the magic spell and reads, enjoys and remembers everything stated in MD. As a consequence of this special mood in which he is placed by the magazine we can logically assume, and I am sure it could be proved, that the reader is more receptive to advertising messages because their power is considerably enhanced by the mere fact of their being within the covers of MD'  With this," the authors conclude, "the fault lines between the humanistic visions of Martí-Ibañez and Bean are clearly exposed."

To some extent, then, information, even in public health and the current pandemic, is now seen by many as simply an arm of marketing. As we've seen, such an approach has its powerful antecedents, going back to the post-war period and probably before. Since when did marketing people feel the need to be truthful? For them, the mission's never been about putting out some semblance of the audience's actual reality. Rather it's been about "controlling the narrative" in order to achieve market dominance in any given domain. The "crime" of Martí-Ibañez was that he pulled the curtain aside and admitted overtly what he was doing.

And, as a sort of coda to the old-media story, let's recall the immediate past flowing right now into 2021. The team put together by the White House the to combat our still-ominous viral epidemic ended up only "spinning" the epidemic to benefit the Orange Man in the Oval Office. Hence the truly chilling story—a non-digital story—of the White House's efforts to muzzle the CDC and bowdlerize its message. How did that work out for the people of the United States? More on that in a minute.

2. New Media. To Each Person Their Own Megaphone

New media clearly has the edge when it comes to creating megaphones and echo chambers. This digital world of tiny communities and hermetically-sealed "pages" can and does spawn much larger cohorts of belief. It's all fractionated and atomized. Each person to their own echo chamber. A new report—thanks here to Anne Peticolas for this reference—on The Disinformation Dozen shows how new media have all but cornered the market, literally, on antivaccinationism. The entire antivax movement is dominated by a dirty dozen writers' names, individuals who've almost cornered the market. Two-thirds to three-quarters of all content originates with these twelve nattering nabobs of negativism. That's enough for herd immunity! In the era of Old Media—so much for Internet democratic leveling—it's hard to imagine even a Random House, Simon & Schuster or National Bible cornering the market for cult belief.

In a subsequent writing I'll address some of possible ways to combat this meretricious lack of information balance. In the meantime, one way to confronting it with awareness, at least a start, is to make a point of lurking somewhere you don't like to be. For me, that's here. The digital on-ramp is so, so much more accessible than its print predecessors, especially for digital "content creators."

Actually, all these digital rabbit-holes provide an answer—the wrong one—to the question I posed above, "how did that White House manipulation of the Covid narrative work out?"  The question could've been taken as rhetorical.  For example, more specifically, "how did White House disinfo affect the CDC?" Yet here we have the author of the entirely suspect Health Impact News complaining that the "medical tyrants now [2020] had Big Tech behind them, and it was time to make their main move: Seek to vaccinate every person on the planet using the fear of a 'pandemic' to accomplish their plans." For them, such manipulation was clearly a good thing, and everybody got to define for themselves what was signal and what was noise. If vaccination were just noise, then countering the "medical tyrants" was surely God's Work.

There are so many more new media like this, splintering off, every-man-his-own-megaphone, each decrying the conspiracies of  mainstream media, each purveying their own truth. If every man his own-megaphone, ergo every man his own truth. At which point, there is no truth, just truthiness, right? Um, not right. These new media mavens are the folks for whom, unlike the old-media Sacklers and Murdochs in their day, the benefit is harder to divine. Maybe, given the frictionless access to all these new media—WhatsApp? Slack me! No, SMS! No, Instagram!—it's enough to be a mini-mogul with your shiny new mini-megaphone. If you don't get rich, at least you'll be be famous, adorned in previously unimaginable numbers of followers.

And there's always the hope of becoming a Sackler, or even a Zuckerberg.§

[Note: six days after this blog posting was uploaded, the redoubtable Peter Hotez came out with a similar plea for stronger counter-measures in a well reasoned Nature piece. Entitled "COVID vaccines: time to confront anti-vax aggression," he avers "Halting the spread of the coronavirus will require a high-level counteroffensive against new destructive forces." Amen.]

Mostly, though, the digital infomeneurs, or infomanures, are going to have to settle for some lesser bit of notoriety and their perceived access to the special joys of secret knowledge. Mostly, they're followers masquerading as leaders. Followership itself, where there's a putative "leader" such as "Q" of QAnon, is incredibly strong, as we learn repeatedly from the burgeoning literature on cults, from Jim Jones to Scientology to antivax. Indeed, if we plunge into any of these rabbit-holes, sometimes it's hard to tell the leaders from the followers.

Oh, and here's the Oz-like, surreal part of that last assertion: followers versus leaders. Look at QAnon. Who is its mysterious "Q"? A recent bit of sleuthing, if what it purports to reveal can be confirmed, is instructive. In a new television documentary for HBO, it seems the medium really can be the message. All that secret knowledge about the Man in the High Castle, 'Q,' may well emanate from the guy who built the megaphone, Ron Watkins. Watkins is the guy behind the curtain, administrator of 8kun, a favorite online base for conspiracism. Seems there's one born every minute in the Land of the Paranoid. Watkins is the latest in a long line of salesmen. For every Jonestown there is a Jones, or, in Oz, "not a bad man just a bad wizard." Or, let's say, a bad man and bad wizard.

Next, during the post-pandemic transition, moving from BC (before covid) to AD (after disinfo), everyone's head will swivel in a permanent driving info-torrent. Billowing spam, social media rooms'n'zooms, spoofed identities, random come-ons for new health insurance. (And let's not forget your expired automobile warranty.) There's a weird and enervating synergy between the disinformation bubbling up out of those flickering screens and the cramped ennui seeping out of public health restraint. Little wonder then that such synergy, in the spring of 2021, draws antisocial behavior—Fury Road! Mass Murder du Jour!— from people we squint to encounter, and shrink back, as we venture out into the daylight.

The article goes on, “'[w]e really shouldn’t be all marching in lockstep like lemmings to go and do what the government tells us to do,' said [Chris Christie], positioning himself as a political outsider. 'They’ve [the experts?] screwed up too many times for us to do that. But I really do believe the facts that I’ve learned, and the experiences I’ve had, should make at least everybody … think hard' about getting a vaccination." Note the faux outsiderism in which politicians takes great pains to distance himself from those uppity experts, and gives only a qualified recommendation lest he be identified to closely with those Others.

There's nothing terribly new about this disinfo-fueled attitude. An aw-shucks, populist-tinged suspicion of government and of elites actually works. It produces effects that benefit the issuer. It pretty much deep-sixed Barack Obama but may save Joe Biden. It's actually nothing new in the least, having long ago been described by Richard Hofstadter in his 1963 landmark Anti-Intellectualism in American Life. But it has taken on a new cast in the twenty-first century, receiving impetus both from new technologies (every man his own platform) and Ronald Reagan's now-canonical 1980 inaugural dictum, "government is not the solution to our problem, government is the problem."

Reaganism was a major source of energy for the wave on which Donald Trump is just the more recent surfer. Just a little over a decade earlier, the Kennedy-Johnson years had come blasting to a close with shots heard around the world, political and scientific. Of course this doctrine's culmination came in the more debased form we saw, and sadly continue to see, in Trumpism.

You can fill in the blanks from here on out. What ensued? Disinformation. And it just keeps on coming. But maybe, just maybe, we could be coming to the end of a forty-year cycle of science- and government-bashing.

But here I'm offering here a meditation not on historical cycles, but on disinformation. It's not just Trumpism's right wing shock jocks and wrestling enthusiasts who're to blame. So we must turn next to some exploration of how, across multiple disciplines over these same forty or so years, academic elites may have contributed, to a national mistrust of science and medicine.


C. External Forces II. Academia and the Chattering Classes

At some point between Hofstadter's 1963 publication and Reagan's 1980 inauguration, in almost every discipline of social sciences and humanities and on both sides of the Atlantic, the academy began a radical shift. Academic thinkers, especially those who were the Oedipal young pupils of the postwar generation such as Hofstadter, turned against his approach to a positive narrative of what many thought of  as a postwar liberal consensus. They reasoned, not without justification, that that consensus had perpetuated a new war in Asia along with economic disparity, racial injustice and colonial domination. Arguably one upside of this revolt against the post-World War II regime was the partial melioration of some of these ills. But there was an equally clear downside. It had to do with the value of science, medicine, "progress" and the pursuit of "truth."

Heretofore, in approaching the way the public might view science and the quest for truth, Americans relied on narratives of progress. This so-called triumphalist view stemmed from a positive philosophy that emphasized both the reality of a goal and men's ability to home in on that goal through a combination of empirical practice and theoretical refinement. A new wrinkle was added in 1962 when Thomas S. Kuhn, a physicist with an interest in the history of science, injected a sort of Darwinian, punctuated idea of what he called paradigm shifts. In such shifts, Kuhn portrayed positive science lurching in new directions through generational and disciplinary change, leading to new communities of practice. For philosophers of science, he folded into the mix some important notions of social participation and discontinuity.

What Kuhn may or may not have anticipated was the fact that another, more radical and more nihilistic epistemology was about to supersede his own notion of how and why scientists change their world views. In some ways it was almost an anti-epistemology, because it was consonant if not causative in relation to the outcome we've been talking about: "every man his own truth." In another irony, the shift in many disciplines' outlook on "truth" was itself a sort of paradigm shift, both disciplinary and generational, away from a western-centric emphasis on elites and Heroic Dead White Men, and toward a rather insular and jargon-laden sociological analysis.

In a number of ways this was, in fact, a salubrious shift. It had a de-centering and iconoclastic effect. But as some of its own practitioners (vide infra, discussion of Bruno Latour) would come to point out, it went too far. Apart from loosing the grip of expertise on policy making—populists' insistence that we don't have to listen to those pointy-headed guys—more focally it loosened and deprecated scientific and medical institutions' valuation of the social sciences and the humanities. Around the United States, one by one, medical school departments examining the history of medicine and health care either ceased to exist or morphed into "medical humanities." Too often this last could be roughly translated into "Ethics Lite."

Only now, with the pandemic, are we seeing new pleas for, you guessed it, the reincorporation of such a "long view" back into medical education. We can expect to see more pronouncements such as Molly Worthen's recent analysis proclaiming that "A Once-in-a-Century Crisis Can Help Educate Doctors," urging an improvement on what has by now shrunk to "off the beaten track [discussions and courses] engaging a small, self-selecting group of students." A revived version of this study of the long view would goes well beyond the old paradigms, neither overly triumphalist nor overly cynical. It would emphasize topics as patients' own narratives, science as it is really practiced (see below), and far more complex stories of earlier epidemics. (Yale's new Covid-19 study group garnered 65 students: not bad.)

Long before Covid-19, mid-20th century scientific triumphalism had come crashing down with the notion of American virtue. A multicentric approach labeled variously as post-modernism, structuralism, deconstruction, post-structuralism, or "the Strong Programme," this new narrative dethroned the idea of progress as a peculiarly slippery and pernicious western instrument of domination. Replacing the idea of progress was a focus on scientists' and physicians' actual, often baser motives in conducting science. The new narrative revolved around social control and career ambition. From the French school came particular critiques of psychiatry and prisons. From the Scottish school came critiques of science and scientific communities, such as that exposed in Barry Barnes's and Steven Shapin's 1977 manifesto on Britain's Mechanics Institute.

Our purpose in this paper is to show how the founders of British Mechanics' Institutes thought a scientific education would aid in the social control of those artisans who were their designated target. We intend to elicit from the public statements of the movement's leaders the basis and structure of their own belief that a regimen of scientific education for certain members of the working class would render them, and their class as a whole, more docile, less troublesome, and more accepting of the emerging structure of industrial society.

An analogous and contemporaneous argument was made for medical care by Leicester sociologist Nicholas Jewson in his 1976 article on "the disappearance of the sick man." In this still oft-cited article, Jewson posited the inevitability of a loss of human and social relations by 19th century patients as the result of incursions into medical—especially hospital—care by technology and bureaucracy. And at the same time, medical science was suspect as new GMBs—Great Man Biographies, except delete the 'G,' these were anti-GMBs—tried to show not the actors' genius but, rather, their feet of clay. The net result of dethroning life sciences, exact sciences, and medical care was, within academia, a decline in interest in the narrative of progress, suspicion around clinical research, and at least possibly a decline, though I don't think anyone's ever quantified it, in actual boots on the ground to study these topics.

Interestingly, whatever the influence or lack thereof between post-modernism in academia and general population (or politicians') attitudes toward science and truth—and vaccines—it seems pretty clear that current events in the 2020s are clearly starting to reverse both trends. And this reappraisal, accompanied by a striving toward a more nuanced and realistic view of science and medicine, actually started before Covid-19 and the idolatrization of the appropriately scrappy truth-teller Anthony Fauci. In 2009 the whole Jewson "sick-man" concept, after it was invaginated by a whole generation of college students, was reassessed in an important critique. Some years later but still before the pandemic, the toppling of Louis Pasteur's statue, discussed below, was also upended.

What's wrong with bringing scientists and physicians down a notch? We do it all the time in this blog! The answer is tricky. Maybe nothing's wrong with it. (Maybe it doesn't even make a difference, so have at it!)  But for a generation, the leveling of the idea of progress was prevalent and could well have had some negative effects. The truth is that neither narrative was adequate to the task. Not "N1," the narrative of man inexorably pursuing inexorable progress across the ages. And not "N2," the narrative of science as social control and truth as hopelessly elusive, . A new narrative was called for and is just starting, with some assist from a virus and the people who study it, to emerge.

One wishes that someone I once briefly but enjoyably worked for, Anthony Fauci, the sharp-elbowed former basketball guard and gruff opponent of Capitol Hill swells, were here in a video. He'd pipe up and say, in that gravelly Brooklyn-inflected voice: "sure, we screw up, and there's plenty of career science-and-medicine types—go look at the White House in 2019-2020—puffing up their careers at the expense of the rest of us. But we're trying to get closer and closer to the reality here. We need to cut down on all those people dying out there. With a little help, we can do that."

Oh, wait, Fauci is here (here), sort of, in a video!

To see how medicine really works, pace all the earlier philosophers and sociologists of science, let's look at how the changes I've been describing rather abstractly were actually embodied in two key figures. Neither is American so US readers may not be familiar. Both are illustrative of important changes that actually calm my dander and give me cause for some optimism.

The first, Bruno Latour (b. 1947) is a Paris-based author with global reach. His Wikipedia page calls him, as befits the polymathic member of a celebrated French viticultural family, a "philosopher, sociologist and anthropologist." My Neeva search results page arrays his photograph alongside those of the much-older figures Thomas Kuhn and Michel Foucault, both born 1922. N1 and N2, side by side. I doubt that Latour, unlike some of his UK compadres of the iconoclastic "strong programme" ilk, ever really needed to work. But in his early years, based eccentrically at the School of Mines in Paris, work he did, profligately, publishing yet another heretical work on Pasteur and then a slew of subsequent books and articles including the important and still-available 1986 Laboratory Life. (This last was co-authored by UK sociologist Steve Woolgar and in the current edition introduced by none other than Jonas Salk.) That later book's subtitle was telling, reflecting Latour's own early program: "the deconstruction of scientific facts."

In recent years, however, Latour, much of whose current output seems to be positioned in the province of literature for the management community, seems to recant. And this is the interesting part. In the 20th century I met Latour, an astute, personable, and sensitive individual. I was fascinated when, in 2004, in Critical Inquiry—a journal not well known to science-and-medicine types—he published a piece called "Why Has Critique Run out of Steam?" In it he first posed a question that, by the turn of the century, must have bubbled up in many academic minds,

My question is simple: Should we be at war, too, we, the scholars, the intellectuals? Is it really our duty to add fresh ruins to fields of ruins? Is it really the task of the humanities to add deconstruction to destruction? More iconoclasm to iconoclasm? What has become of the critical spirit? Has it run out of steam?"

Latour has become less interested in science-as-crap and more in the effect of computers—and the effect of academia on the body politic. So at the end he answers his own question, cryptically but still tellingly, in this way:

[We wish to be] generating more ideas than we have received, inheriting from a prestigious critical tradition but not letting it die away, or “dropping into quiescence” like a piano no longer struck. This would require that all entities, including computers, cease to be objects defined simply by their inputs and outputs and become again things, mediating, assembling, gathering many more folds than the “united four.” If this were possible then we could let the critics come ever closer to the matters of concern we cherish, and then at last we could tell them: “Yes, please, touch them, explain them, deploy them.” Then we would have gone for good beyond iconoclasm."

As the pandemic finally started to rage and much of the world was in lockdown a decade and a half later—early summer 2020—Latour was interviewed by The Guardian. He was asked to meditate on three of that newspaper's cardinal concerns that haunted the new century's tumultuous third decade. Climate, coronavirus, and post-truth: call them the three horsemen, or "the revenge of the real." Here, in extenso, are his final two responses to queries put by the newspaper's interviewer.

Your work has often challenged the objective, God’s-eye view of science. You argue convincingly that humanity cannot be so detached. But the political right have twisted this approach to undermine all expert knowledge on the climate and nature crises. Any regrets?
A critique of how science is produced is very different from the post-truth argument that there are alternative truths that you can choose from. Post-truth is a defensive posture. If you have to defend yourself against climate change, economic change, coronavirus change, then you grab at any alternative. If those alternatives are fed to you by thousands of fake news farms in Siberia, they are hard to resist, especially if they look vaguely empirical. If you have enough of them and they are contradictory enough, they allow you to stick to your old beliefs. But this should not be confused with rational scepticism.

Has the Covid-19 crisis affected our belief in science?
The virus has revealed the number of things you need to know to decide what is factual and what’s not. The public are learning a great deal about the difficulty of statistics, about experiment, about epidemiology. In everyday life, people are talking about degrees of confidence and margin of error. I think that’s good. If you want people to have some grasp of science, you must show how it is produced.

Couldn't have said it better myself. Latour was, and is, the consummate observer of science and medicine. His writing has gradually evolved to a point where he can no longer be called either a triumphalist or an iconoclast. He seems to be suggesting a new, middle way, in which science and truth are always provisional, but if pursued within existing guardrails ought to be trusted. In lay terms we could call it the law of 20-20-hindsight-but-it's-the-best-we-got. To test this hypothesis we can next exam the career of another European scientific leader, this time an practicing scientist rather than a philosopher. Like Latour she has strong ties to the US but emerges from the European tradition.

In the mid-1908s, far removed from the issues of how either societies or their elites look upon truth, a Hungarian biochemist named Katalin Karikó (b. 1955), two year old daughter in tow, accepted an invitation to join the staff of Philadelphia's Temple University. With this choice she strove to pursue her research on the transcription of messenger RNA. At that point mRNA, yoked to very new technologies, promised much. But it did not yield results fast enough for US medical schools. Ten years later she transferred (1989) to the University of Pennsylvania's neurosurgery department. By 1995 she'd been demoted and removed from that department's faculty track. Not enough of her grant proposals had achieved funding. (My report here is assembled from many fine accounts of her work, two mentioned below, most of them based on interviews. All are available upon a simple name search. The NY Times also reported part of this story after the present blog was written. Best among them are from The Guardian and, especiallyThe Harvard Crimson.)

Karikó's work continued at Penn only because of certain contingent factors: first and foremost, she believed in the power of mRNA as an eventual therapeutic and soon thereafter vaccinology tool; second, she was tenacious and willing to accept a lesser post in order to pursue the work even after it repeatedly failed to yield the paramount coin of the realm, NIH largesse; and, third, a conviction about the  mRNA technology shared with her clinical colleague Drew Weissman. And, yes, fourth—maybe most significantly—she wanted to hang on to the tuition reimbursement benefits that allowed her daughter Susan, a promising athlete and rower, to attend college at Penn. 

It took another ten years, down into the middle of the first decade of the present century, for Karikó's mRNA work to come to fruition. She landed on her feet through the creation of Germany's BioNTech where she became a partner in 2013. The company now collaborates with Pfizer to produce and deliver the phenomenally effective mRNA Covid-19 vaccine. Thus, two small pharmaceutical houses, one led by European scientists (including two Muslim Turks) barely known until last year in the US, the other Moderna, a uniquely American success story with a Black female lead scientist, both came to the rescue.

Pause to consider how these stories might be written. Are being written. Much ink is being shed about the greed of Big Pharma. As if that were the whole story. There is another story. It is the story of the creation of mRNA vaccines. Blind luck, as some might have it? There is another story.

In 2008, three years after Karikó's breakthrough discovery of how mRNA might effectively be slipped into cells to crank up its protein synthesis machinery, her daughter Susan Francia (photo) went to Beijing and won Olympic gold in rowing. Four years later, in 2012, the year before Karikó left Penn's employ to join BioNTech, Francia pulled it off again, winning her second gold in London. Motivation, just maybe, enough. Meanwhile Karikó and her colleague Weissman are packed for Stockholm. But their intellectual property remains at Penn, which repaid her in 2013 by refusing to reinstate her to tenure-track status.

But of course now, as recognized Queen of mRNA and money-pump for Penn, in an appropriate but rather empty gesture Karikó is still pictured on the university's website as an adjunct. In a 2020 interview, she reflected that "I thought of going somewhere else, or doing something else. I also thought maybe I'm not good enough, not smart enough. I tried to imagine: everything is here, and I just have to do better experiments." And so she did.

Was it all a random walk? In no way does the mRNA vaccine story resonate with either of the traditional narratives of how science is "supposed" to work: 20th century triumphalism versus a leveling and often cynical postmodernism. Failure to explain or understand science has thrown the popular narrative, especially in our post-covid dawn, to the disinformationist wolves. Academic authors are just beginning to catch up by asserting more nuanced narratives of how science works, and hence why we should at least provisionally trust the Karikós and Faucis of the world.

To conclude these micro-biographies, I should add that the choice to spend substantial time on Latour and Karikó has a lot do with how each in their own way illustrates the problem of trust. Who can find a trustworthy overarching truth narrative in science? Especially once you actually personify it, take it down to the level of the individual life lived. In some ways we've outlived the usefulness of heroes. But, maybe, in some ways, not so much. Another recent biography to instruct us is a recent account by Johns Hopkins historian Daniel Todes of Ivan Pavlov's life lived. This work also conveys the same nuanced understanding.

In an interview Todes veered close to Latour, evidenced in this quote from his own university's magazine, describing himself as "... basically a realist. I believe that there's an objec­tive reality independent of our consciousness. I don't think science is just a matter of opinion. But it's a deeply human endeavor, and reality being infinite, there's an infinite number of ways into it. Metaphors define paths into this reality—the questions that are asked and aren't asked." Thus we're left with narratives of the search for truth in science and medicine that at some level are compatible with all of the flavors of meta-narrative, from Kuhn to the very latest attempt. That, to wit, is The Knowledge Machine, a promising new (2020) version of the narrative of science from NYU professor Michael Strevens. I hope to discuss it here soon.

One final irony seems worth pointing out before we move on. The academic critique of science and medicine was far from eroded by the forces of the right. The notion of "alternative truth" has in fact been embraced by the right. The year 2017 was a banner year for those open arms. Orwell had sort of predicted it in his "newspeak," but in 2017, after 45 was inaugurated, Donald Trump's senior advisor told Chuck Todd that the president's press secretary was merely disseminating a different flavor of truth: "alternative facts."

And speaking of irony: while the right embraced the possibility of "alternative fact," it was ultimately the left that found every-man-his-own-truth wholly discomfiting. Yet the "truth" as portrayed by the left, like Henry Ford's choice of Model T colors, could also prove pretty confining.


D. From the Ridiculous to the Sublime: The Provider and The Patient

In this final, shorter section I'd like to pull the focus back and away from the shambolic bloviators sprinkled across our political and intellectual elites. For elites of all persuasions, it seems the Covid-19 pandemic has been a pivotal time for public engagement: seeking either to emit or to combat disinformation. Pull the focus to a level more sublime, that of individual relationships between clinical actors. What's happening between physicians and patients as they migrate from face to face encounters to telemedicine? What's happening between physicians and patients as face to face encounters shrink down to fifteen minutes?  What happens when much of that fifteen minutes is deflected, for the physicians, from high-touch and hands-on to the creation of the perfect electronic note? What happens when that document creation is conducted with eyes deflected away from the patient and toward the flickering screen? How does trust between the two parties fare with these changes when they are coextensive with the outside rise of social media?

I found instructive hints in a recent piece in Media and Communication, an open-access journal of applied research in communications and media technology. In this article a team from Madrid and Bournemouth make the point that patients looking for a plan to understand their illness—e.g., some illness mimicking coronavirus—will more than likely be let down and leave the office confused. He or she will leave carrying a thick sheaf of papers purporting to convey the "after visit review," aka the AVR or "Clinical Summary." In the majority of instances, nowhere in that thick pile of papers, a cumbersome list-of-lists, lurks any real plan. Hence the AVR lacks any information even while "it takes only a few clicks to find a reputable health advice source to refute [disinformation]" that may include "virus spreading through mobile phone networks" or "radiation from such networks suppresses the immune system against the virus." It's not a fair fight. Lacking information they can actually use, the patient joins "many people [who] break lockdown rules [and] pour onto the street to smash ... phone masts in many countries."

[Note added post-publication, with thanks to fellow HCR blogger Anne Peticolas: A quite similar view was just expressed by the blogger and Down Mainer country doctor Hans Duvefelt. In his plaint, "Some People Don't Think Like Doctors," he notes that "in a patient’s medical record, we have a fundamental need to know in what order things happened. ... But [omitting] that seems to be how people with a bookkeeping mindset prefer to view the world." And indeed, the genesis of the electronic health record, and what sustains it to a significant degree, originate in hospital back offices. That's where managers—it's the CFO who finds the exorbitant scratch needed to pay for an EHR—have always counted the beans. And now, with the EHR, as Dr. Dorio's recent HCR piece amply demonstrates, that's where they can dictate their own chosen surrogate markers of "productivity."]

I suspect, however, that most patients and more than a few health care providers don't know is that new rules governing all such matters are now just around the corner for information sharing. As a result of the 21st Century Cures Act, starting this spring, access to their own electronic health records must now be given to patients. A decade or so ago, in anticipation of such information-sharing requirements, a new movement sprouted. However improbable it might have seemed at the time, the Patient Portal suddenly sprouted from small start-up companies. Soon they were being acquired by the large, "big iron" EHR companies, unless in some cases those folks decided to roll their own portal platforms. Either way, and with a few recent exceptions such as cross-institutional sharing, document uploads, limited messaging and future appointment requests, such portals continued to offer the same limited usefulness as the Clinical Summary.

The AVR was that big wad of paper handed to the patient as he or she left the office. The portal was more like a keyhole through which the patient could peer at their own living document, containing, however, often misdescribed, medication and other lists. Evolving as an afterthought, the AVR was—and still is—most useful for wrapping fish. Hiding in plain sight within it was a big, black hole at its center. What should have filled that hole was supposedly some description of the actual plan contemplated as the result of this particular visit. Not the incompletely reconciled meds list. Not the mostly-irrelevant list of earlier diagnoses of gouty toe and earwax. Not the irrelevant list of future routine follow-up appointments within a vast hospital-based system. In other words, not the wholesale data-dump that could be parsed by the computer, deemed to be sufficiently discrete to fit this list of lists—but was in fact wholly useless for this visit.

Garbage in, garbage out.

Why such a remedial oversight? The actual plan for the patient, in case after case, was either too slippery or too time- and energy-comsumptive for the provider within that fifteen minute stretch. The default alternative was hence just to push out a document with that black hole in the middle. Such a meaningful plan would have had to be discursive, likely to contain at least a couple of if-then statements and, above all, tell the story. The story, how to plan going forward, is what the patient needs. Conversely, the story, with at least an implied plan (don't succumb to the vaccine-mongers) and look-forward with rationale (conspiracy!): this is what the patient gets from disinformationists.

The story is what the physician lacks time to craft properly for the patient at some appropriate point late in that fifteen-minute visit. The patient is left vulnerable, an opportunity missed. As a physician I blush to think that other professionals, including most lawyers, notwithstanding their oft-contorted and -ontrived ways of near-impenetrable prose, fully understand the need to tell the plan. But we don't. Why? Why have we abdicated compliance with this obvious need? Are we that pervasively controlled by our paymasters? And why have our paymasters abdicated asking us to provide it?

Oh, wait. Maybe it's simple. Measure what you can count, simple as that. "Meaningful Use" of the EHR has required that everything be measured—viz., the numbers of e-prescriptions, the numbers of usually-inaccurate problem lists, "medication reconciliation" that is anything but reconciled. But what's most meaningful is what just happens to be less easily mensurable. 

And besides, lawyers actually get paid to do this stuff. Explaining and planning stuff. Sometimes in legalese. But they do it.

Doctors don't. Ever. Or ... hardly ever.

It turns out, however, that there are actually ways to empower providers and patients with beneficent technology to counter this sad lack of information symmetry. (It's asymmetry, think about it, both within and without the exam room.) With the advent of the Patient Portal the health professions have already yielded to the lately-acknowledged need for greater openness. Further, some patients are already beginning to benefit from an even more radical beneficent information initiative. A lucky few are now blessed with full access to their electronic records, through the OpenNotes movement pioneered by Harvard's Thomas Delbanco.

One next step must thus be the enhancement of the AVR so that it becomes a truly useful tool. In a future essay, I'll outline strategies with which to fashion such an enhancement. If successful, such methods could finally, along with portals and OpenNotes, level the information playing field. 

Disinformation is thus a broad and scalable concept with sort of fractal features. It works at the level of the dyad of physician and patient. It scales to institutions, then to societies with all their tribal animosities, and then, ultimately, to problems of international cooperation. Disinformation is like a virus. It's pernicious in the way it insinuates itself into life's interstices. But counter-measures are out there. Marshalling such counter-measures requires, however, a concerted effort of of will. Most critically, countering disinformation requires sheer perseverance. It requires the grit of people like Katalin Karikó, if trust is to be restored and this brackish disinformation flood is finally to be stemmed.

___________________

*Misinformation is a term often used to explain bad outcomes such as that experienced when homeless persons are unable to get assets such as stimulus payments or vaccinations. Disinformation seems to connote, for some, more agency on the part of the one seeking to impart "information" that's not merely disrupted but purposely distorted.

**New York Times "Opinion Today," 9 April 2021.

†Of course we're not alone in this myth-making. The French have their own cherished myth of laïcité. Once upon a time the Germans had the myth of cultural purity. Useful myths are remarkably persistent. The problem is that their stewards all too often preserved the wrong myths. On the other hand, now abandoned by many as unfortunate myths are notions such as "truth," and "science," actually the very ones we need to revive. Then perhaps struggle to agree on the basic meanings of other notions such as "infrastructure," "speech" or "bipartisanship."

‡The HCR piece referenced in the preceding sentence, with its link to the rag (1960-?) started by Arthur Sackler (1913-1987, features a link to his Medical Tribune. That link seems now to be broken. Some discussion of the family's playing on the culturati role as compensatory for the hard-driving PR behavior is in the still-available WaPo obituary. The magazine, which reached 600,000 physicians, is still available in one or more archives. In the paragraphs immediately following, see also my discussion of other pharma-associated actors' use, in high and low places, of the media megaphone, with a link to the superb recent article on which much of it is based. Just as I complete the writing of the present meditation, a new biography of Arthur Sackler and his family, New Yorker writer Patrick Radden Keefe's Empire of Pain, hits the bookstores. I have not seen an advance copy but it is getting much notice in traditional media. This includes a forthcoming NY Times review that states "Arthur may have been the first to blur the lines between medicine and commerce, and he pioneered modern drug marketing, but his sins pale compared with those of the OxySacklers."

§It's worthwhile recalling that only Zuckerberg, of course, became a Zuckerberg

¶Typically, on the street, one hears this particular trope translated as "mistrust of all science and mistrust of Big Medicine—but not my own doctor." [My paraphrasis.] This in itself can be a problem, given the number of resurgent medical messiahs we've been seeing.