Friday, September 14, 2018

Remembering Dr Bernard Carroll



Dr Bernard Carroll passed away on September 10, 2018.  Dr Carroll had a distinguished career, so it was a surprise and delight that he also chose to be a stalwart Health Care Renewal blogger.  He was with us since 2005, contributing insightful, pithy, provocative and important posts.  He also authored some of our most widely read posts.  Most viewed was: JAMA Jumps the Shark.   His most recent post was Corruption of Clinical Trials Report: A Proposal.   All his posts can be found here.


His obituary just appeared in the British Medical Journal. It began

A pioneer in biological psychiatry, more recently Bernard Carroll (‘‘Barney’’) became a withering critic of its compromised ethics and corruption by industry.

He was a scientific skeptic

A rigorous scientific sceptic, even about his own work, he refrained from claiming that the DST explained the aetiology of melancholia. He was critical of ill informed challenges to its clinical uses but opposed exaggerated claims for its role as a screening test.

He was a renowned teacher, mentor, and academic leader

Barney was a great clinical teacher and mentor, who never hesitated to say: 'I don’t know the answer to that—let’s look into it.' No one had a better command of the scientific literature or was better able to translate it to the complex exigencies of clinical practice. By his quiet example, Barney influenced hundreds of psychiatrists, psychologists, social workers, and nurses, as well as basic neuroscientists, to become better clinicians, researchers, and educators. He was rigorous and demanding, but in the most nurturing and affable way.

In 1983 Barney accepted the chair of psychiatry at Duke University. He turned a respected department of psychiatry into a great one—recruiting new faculty members, increasing external grant support 10-fold (raising it to sixth in the US), improving clinical services, and forging research and residency training partnerships with the public sector. I followed Barney as chair and found it to be one of the easiest jobs in the world. All I had to do was coast on his coat tails.

He was a campaigner for accountability, integrity, transparency, honesty and ethics

During the past 20 years, Barney became a critic of weak science, of ethical lapses, and of industry’s corruption of the research enterprise. He coined the term 'experimercial' to describe clinical trials that were really disguised exercises in marketing. He relentlessly exposed undisclosed conflicts of interest, hidden commercial promotions, inadequate research designs, biased analyses, misleading conclusions, exaggerated claims, and ghost writing.

Barney became the conscience of psychiatry. With the frequent collaboration of Robert Rubin, he outed many high profile academic opinion leaders who had been co-opted by commercial interests.

Barney never flinched in his David and Goliath battle to restore truth and integrity to the psychiatric research enterprise. His exposés comprised ethics critiques as well as aesthetic disapproval of degraded standards and tawdry behaviour.

Barney’s 'right' prevailed against institutional and commercial 'might.' He helped to force the current upgrades of editorial oversight and full disclosure now demanded by Nature Publishing Group, by AMA journals, and most journals. The publicity surrounding Barney’s exposés triggered the conflict of interest inquiries conducted by Charles Grassley, chair of the US Senate Finance Committee, which had a profound impact on recalibrating ethics standards in all medical specialties. As he left us, Barney was encouraged by current trends towards improving transparency and increased integrity.

He persisted

Looking to the future, on the scientific side Barney cautioned against the loss of independent investigators and the diversion of research resources by 'big science' consortiums. On the ethics side, Barney’s main unfinished work is an ongoing petition to Congress to update US Food and Drug Administration oversight of analyses and reporting of clinical trials.

Barney is remembered as a fair and generous colleague, an honest broker in review committees, a generative and avuncular mentor, a constant source of good ideas, a meticulous academic craftsman, and a tireless servant to the field. He did endless pro bono advocacy, editorial and committee work, and served as president of three professional societies. Barney was a great raconteur, a jolly companion, a dedicated writer of limericks, a courtly gentleman, a devoted husband and father, a wonderful friend, and a man for all seasons. He died as he lived—with grace, courage, and fortitude. Barney leaves his wife, Sylvia; a daughter; and a son.

Bernard J Carroll (b 1940; q 1964; MD, PhD), died from cancer on 10 September 2018

Investigative journalist Paul Thacker provided these memories:

Since Barney retired as Chair of Psychiatry at Duke, he became a very important resource to a small number of reporters and experts trying to understand corruption in medicine. I was just watching the documentary 'Bleeding Edge' about the medical device industry, and one of the devices profiled was the Vagal Nerve Stimulator (VNS). I was watching the documentary thinking, 'God, that VNS crap made it on the market. Barney blew it up in the Wall Street Journal back in 2006.' Barney was critical to a lot of movement in trying to fix things behind the scenes.

A couple years back, I was talking with Barney and asking him why he thought so many people in medicine behaved the way they did, doing things when it was obvious patients were either going to harmed or given some treatment that was likely pointless but expensive. Barney always had a colorful way of explaining these things.

"When you get old, much of what you'll have are memories of what you did, and what you added during your time here. These people won't have s* but f* money. They didn't add a f*ing thing!'

I think Barney added a lot. He was a great guy, who added a whole lot to our understanding of medicine while retired.

 We will all miss him.

Wednesday, September 05, 2018

Fake Reform Foisted on Us by Those who Benefit Most from the Current Dysfunction



Introduction - No Funding for You

To better understand health care dysfunction, I interviewed doctors and health professionals, and published the results in Poses RM.   A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14(2): 123-130. (link here).  In that article, I postulated that US physicians were demoralized because their core values were under threat, and identified five concerns:
1. domination of large organizations which do not honor these core values
2. conflicts between competing interests and demands
3.  perverse incentives
4. ill-informed, incompetent, self-interested, conflicted or even corrupt leadership
5.  attacks on the scientific basis of medicine, including manipulation and suppression of clinical research stuides

After that my colleagues and I have tried to raise awareness of these and related issues, now mainly through the Health Care Renewal blog.  We also set up FIRM - the Foundation for Integrity and Responsibility in Medicine,  a US non-profit organization, to try to provide some financial support for the blog.

Since we were mostly health care academics, we assumed we could get some financial support for the blog and FIRM from foundations with interests in improving health care.  Had we not identified important causes of health care dysfunction that had been largely anechoic, but once identified could be addressed, thus presumably improving health care costs, quality, and access?  It seemed reasonable at the time.

However, we failed to find any prominent foundations willing to help.  We have occasionally gotten small amounts of money from a few small foundations, but not recently.  Meanwhile we have not seen any major health care foundations supporting any iniatives by anybody meant to address any of the issues we discuss on Health Care Renewal.  In particular, while outright health care corruption seems one of the most outrageous issues we discuss, we have never found a foundation willing to take that on - at all.

 We should not have been surprised.  We later discovered that the leaders of many health care foundations had conflicts of interests which likely decreased their enthusiasm for even considering issues such as ... conflicts of interest and their risk of generating health care corruption.  (See below for further discussion.)  Recently, however, we have found some enlightenment on how such foundations, and other change agents and do gooders working the health care sphere, have managed to ignore such important problems

Why Expect Those Who Profit from Current Dysfunction to Lead Real Reform?


Last week, the New York Times published an essay by Anand Giridharadas, author of  the just published Winner Take All: Elite Charade of Changing the World.  The author's thesis was that society has handed over the responsibility for reform to those who benefit most from the status quo.

'Change the world' has long been the cry of the oppressed. But in recent years world-changing has been co-opted by the rich and the powerful.

He posited,

America might not be in the fix it’s in had we not fallen for the kind of change these winners have been selling: fake change.

Fake change isn’t evil; it’s milquetoast. It is change the powerful can tolerate. It’s the shoes or socks or tote bag you bought which promised to change the world. It’s that one awesome charter school — not equally funded public schools for all.

He suggested that the very wealthy seduce us with their dedication to change, even while sponsoring

world-changing initiatives funded by the winners of market capitalism do heal the sick, enrich the poor and save lives. But even as they give back, American elites generally seek to maintain the system that causes many of the problems they try to fix — and their helpfulness is part of how they pull it off. Thus their do-gooding is an accomplice to greater, if more invisible, harm.

What their 'change' leaves undisturbed is our winners-take-all economy, which siphons the gains from progress upward.

They have

a strong interest in convincing the public that they can help out within the system that so benefits the winners.

After all, if the Harvard Business School professor Michael E. Porter and his co-author Mark R. Kramer are right that 'businesses acting as business, not as charitable donors, are the most powerful force for addressing the pressing issues we face,' we shouldn’t rein in business, should we?

This is how the winners benefit from their own kindness: It lets them redefine change, and defang it.

In a 2017 essay in Medium which previewed the ideas that would appear in the book, Giridharadas had summarized the problem thus

change-makers [focus] on the difference they make to those they choose to help. Yet they risk avoiding the causes of the disease and remedies that would actually cure it. And they avoid these things in part because facing them could implicate powerful people, or perhaps even themselves.
This is a powerful idea.  As a society, at least in the US, we have abandoned true reform, including reform of health care, for faux reform controlled by those who would lose the most were true reform to take place instead.  We have handed the problem of excessive drug prices over to the executives of pharmaceutical companies who benefit most from currently outrageous pricing.  We have handed the problem of a dysfunctional health care insurance system over to executives of insurance companies who benefit most from high cost commercial insurance plans that cover as little as possible.  We have allowed corporations accused of unethical and criminal practices to make lax legal settlements that pretend they will be able to improve themselves without penalties accruing to the managers on whose watch the bad behavior occurred.  And we have let health care foundations led by top health care corporate managers and their cronies to sell change that matters. 

Broadening Understanding of the Conflicts of Interest Affecting Leadership of Health Care Foundations

Gridharadas has given us a broader view that explains why many big foundations fail to fulfill their glorious mission statements.

Example: the Robert Wood Johnson Foundation

For example, the Robert Wood Johnson Foundation boasts,

The inspired vision of our founder, General Robert Wood Johnson II, was to improve health and health care in America, especially for those most in need. Energized by our legacy of taking on challenging issues, we are dedicated to building a Culture of Health that provides everyone in America a fair and just opportunity for health and well-being.

Has the foundation ever really addressed ill-informed, incompetent, self-interested, conflicted or even corrupt health care leadership, or attacks on the scientific basis of medicine, including manipulation and suppression of clinical research studies?

Should we expect anything more - or less - from a foundation whose current 15 person board of trustees is chaired by:
- a retired corporate vice president and general counsel of Johnson & Johnson

and which otherwise includes:

- a retired corporate compliance officer and vice president, Technical Resources, of Johnson & Johnson

-   a surgeon who was  founder of the for-profit Columbia/ HCA, now HCA hospital system

- a retired vice president of government affairs and policy responsible for federal, state, and international relations for Johnson & Johnson.

- a retired vice president, chief information officer, and a member of and the first woman to serve on the Johnson & Johnson Executive Committee.

- and another retired retired corporate vice president of Johnson & Johnson

Example: the Bill and Melinda Gates Foundation

The Gates Foundation boasts

We see equal value in all lives. And so we are dedicated to improving the quality of life for individuals around the world.

Yet in 2006, Transparency Internationa 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.
Has the Gates Foundation ever addressed health care corruption and the conflicts of interest that are risk factors for corruption?  Should we expect more, or less from foundation that is now run by a multi-millionaire former pharaceutical executive as foundation CEO?

As we noted here, Dr Susan-Desmond Hellmann, the CEO of the Gates Foundation was previously President of Drug Development at Genentech, Dr Desmond-Hellmann had defended the then sky high pricing of bevacizumab.  Of course, Dr Desmond-Hellmann, as a top executive, personally profited from such pricing.  In her last year at Genentech while the company was still independent, her total compensation was over $8,000,000.  As we discussed in 2014, while she was the Chancellor of UCSF, questions arose about her committment to public health when it was revealed she and her husband had large stock holdings in the tobacco company Altria.  Yet she continued to dismiss the importance of her many apparent conflicts of interest.And there have been many accusations that the foundation she runs is more about promoting corporate interests in health care than actually promoting health, see the 2016 Global Policy Forum report per this Guardian article, this article in the Independent that accused the foundation of having a

ideological commitment to promote neoliberal economic policies and corporate globalisation

and  a PLoS Medicine article [Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020.  doi:10.1371/journal.pmed.1001020.  Link here. ]

'There is a revolving door between the Gates foundation and pharmaceutical corporations. Many of the foundation’s staff had held positions at pharmaceutical companies,' the report adds.
For more details about Dr Desmond-Hellmann, look here.  

As we noted, in 2012,  the Global Fund to Fight AIDS, Tuberculosis, and Malaria as struggled with corruption issues, but even after these wake up calls, the Gates Foundation, one of its major donors, has done nothing to address corruption beyond its doors.  Likewise, while the Health Alliance International  has also struggled with corruption, the Doris Duke Foundation has shown no interest in health corruption initiativies (look here).

Other Foundations

As we noted in 2011, uninterested in health care conflicts of interest and corruption are the Ford, Rockefeller, Kellogg and Robert Wood Johnson Foundation which were noted to have significant holdings in Coca-Cola, Kellogg, PepsiCo, Pfizer, GlaxoSmithKline, McDonalds, Nestle, NovoNordisk, YumBrands, Pizza Hut, KFC, Johnson & Johnson, and Sanofi-Aventis, while the Ford Foundation held shares in a tobacco company, Lorillard, and the Kellogg and Rockefeller Foundations "were indirectly invested in tobacco corporations through conglomerate equity funds...."

So health care interested foundations, which may derive financial benefit, and may be led or governed by people who mightily benefited from the dysfunctional health care status quo, are likely to continue fake reform to appear socially responsible, but avoid challenging their and their cronies sources of wealth.

Conclusion

Giridharadas suggested in an interview in New York Magazine,

What all that does is create this moral glow. And under the haze created by that glow, they’re able to create a probable monopoly that has harmed the most sacred thing in America, which is our electoral process, while gutting the other most sacred thing in America, our free press. And they do it under the cover of changing the world.

Unfortunately, he apparently has not come up with what to do about this problem.  The best conclusion I can reach derives from the end of a review of his book by Joseph Stiglitz in the New York Times,

Democracy and high levels of inequality of the kind that have come to characterize the United States are simply incompatible. Very rich people will always use money to maintain their political and economic power. But now we have another group: the unwitting enablers. Despite believing they are working for a better world, they are at most chipping away at the margins, making slight course corrections, while the system goes on as it is, uninterrupted.

So I say first, beware of fake reform pitched by those who benefit most from the current dysfunction, call it out, and whatever you do, do not continue enabling it.



Monday, September 03, 2018

Michael Fine's Health Care Revolt

Michael Fine, M.D., HealthCare Revolt: How to Organize, Build a Health Care System, and Resuscitate Democracy – All at the Same Time (Oakland, CA: PM Press, 2018).

Dr. Michael Fine is a man on fire. He’s on fire with anger about a healthcare marketplace that serves well to maximize the profits of investors and CEOs, but violates the values of many of those working in it. He’s on fire with enthusiasm about the potential of public health and prevention and about the value of integrated primary care. He’s on fire with determination to work to change our scattered health care marketplace into an actual health care system that could monitor and manage every citizen’s health. And he has concrete suggestions and a vision of how to work toward that end.


And, from what’s recounted here, Dr. Fine has an admirable practical record of implementing health care change on a local level in Rhode Island and in the Scituate area. In Scituate, he organized the non-profit Scituate Health Alliance and worked with residents and local officials to provide primary medical and dental care to all town residents. He envisions small local health care systems like his serving as a model that will show the feasibility of a better health system to both conservatives and liberals and eventually enable scaling up to a better national system. (This is quite reminiscent to me of how the great Nye Bevan, in the middle of the last century, successfully used the model of the Tredegar Medical Aid Society  and similar organizations to plan the NHS at its inception.)
What I liked best about the book is that Dr. Fine has an accurate gut understanding of just how much money we do spend on healthcare and of how harmful it is that we have let the “healthcare” sector balloon to such a large part of our economy. He realizes too how much of this - including many foolish things - is supported by public tax monies. And he really gets that this comes at a huge cost to the other things we could be spending that money on – and spending it on other things instead that are just as important to health would enhance people’s health, not diminish it. As he said in a related interview: “[To improve health,] we need to spend money on education … housing … community development … the environment. These …matter most for health. The paradox is that the more we spend on medical service expenditures that we don’t need, the less we spend on those things. In a certain way, healthcare is at war with health.”

I love Dr. Fine’s suggestion that one of the things we need to do to move toward healthcare improvement is to constantly highlight these costs and the damage done. Once we get to where everyone really understands this, we will have moved a big step forward. Working hard to publicize and delegitimize the cruelly extractive techniques of health care profiteers is worthwhile.


There’s all the difference in the world between making a living, including an excellent living, from people’s medical needs and making a killing from them – and in recent years the balance has shifted where we can fairly say that pharmaceutical companies, large hospital organizations, and many other medical sector big players are doing the latter.  I also like how he points out that “with …few exceptions, no health care market actor has a public portfolio (p. 84).” He’s right, and the corrupt marketplace – what Dr. Fine terms a “wealth extraction system” – has not gotten us to a good place for the public – at all.

So, in some ways, this book is inspiring – but in other ways, it is quite irritating. Dr. Fine is so wrapped up in his own perspective that he often is blind to and discounts the value of those parts of medicine that have not been his personal focus. Although I certainly agree with him that there are too many specialists and too much medical overuse, Dr. Fine seems insultingly unappreciative of valuable, needed services that specialists also offer, suggesting that one of the main ways generalists help their patients is by keeping them out of the clutches of specialists who may injure them. He seems, too, to class highly-paid specialists with high earners like CEOs where in my opinion this is ridiculous (specialists are after all basically pieceworkers and are not really similar to administrators, investors, and pharmaceutical executives – even if you think – and I do - they could rightly earn a bit less). Similarly, although I agree with him that the incorporation of a profiteering infrastructure into Obamacare and its lack of universality diminished its value, it’s unseeing to contend that it helped only a few people and that hardly counted. Dr. Fine grudgingly concedes that he likes that Obamacare funded more preventive services, ignoring the far more important benefits it provided to some of those MOST in need of medical care, those with clinical problems and issues. Dr. Fine should talk to some of the people who literally moved to Medicaid expansion states to save their lives first, before minimizing Obamacare’s benefits.

And, Dr. Fine doesn’t seem to have a grip on how unappealing many of us would find the world he dreams of. “Let’s close all center cities to private cars during normal working hours; let’s find ways to provide incentives for people who are not disabled to use the stairs rather than elevators (p. 71).”  He also suggests heavily taxing industrial food products, as well as the production of wheat, corn and sugar (p.70), oddly suggesting that we don’t need any of these crops any more for human consumption (which is news to me). Many readers, unlike Dr Fine, would have less than zero enthusiasm for living under such a heavy-handed, dictatorial regime and would (I believe fairly) consider some of their freedom lost.

As I read this book, I couldn’t help but compare it to a book by another strong advocate of more primary care, Richard Young’s American Health$care: How the healthcare industry’s scare tactics have screwed up our economy – and our future. Dr. Young is the single other person I can recall being as angry and as perceptive as Dr. Fine about the damage done from monies that could and should be spent on other things for more benefit – including health benefit – but which instead are being sucked away by what he calls the “government-medical-industrial coalition.”



Both really believe in primary care. But Dr. Young also realizes, as Dr. Fine does not, that “prevention” – just as truly as medical care for the sick - has many limits and can itself be a waste of money and inordinately expensive. (His discussion of what costs vs. benefits would be of an imaginary Texas tetanus initiative is sound.) And to Dr. Young, the primary purpose of medical care is care for the SICK.  (No matter how much prevention we have, at some point sickness or injury will happen to all - and this is the crux of medicine.) I recommend reading these two books together, to understand how two capable, decent, intelligent, and sincere doctors can have so much agreement on some things and such intense lack of agreement on others.

I know one thing – if I had to choose one as my primary care doctor, I’d be very comfortable choosing Dr. Young and would absolutely avoid Dr. Fine. Clearly, Dr. Fine would have his own agenda for me (he sees primary care doctors as mostly health nags), but Dr. Young, by contrast, would be responsive to what matters to me and my agenda, so we would be able to work together to manage any ailments in a “minimally disruptive” way that would be actually helpful. And although I personally agree with Dr. Fine’s desire to have more publicly-run, genuinely non-profit healthcare such as community health centers (and ultimately nationalized health care) and to legally rein in health profiteers, there are some definite “stoppers” for me in buying off on his whole vision and signing up to his plan.

Fine’s insensitivity and rigidity in some areas and his impersonality is the reason that if I’m going to introduce a friend to the concept of health care revolt I’ll give them instead Victor Montori’s book: Why We Revolt: A patient revolution for careful and kind care. Dr. Montori’s down-to-earth compassion for the ill inspires more trust, and, like Dr. Fine, Dr Montori too insists on the role of patient as citizen in reforming health care to a system more consonant with patient and physician values, but in a more persuasive way that is more convincing in making me like his healthcare vision.


Sunday, September 02, 2018

Apologizing for Problems with Commenting

My apologies!

I discovered a few days ago that our Google overlords had stopped notifying me about pending comments some months ago.  No indicator of the number of pending comments appears on my Blogger dashboard. 

I just realized I had a large backlog of pending comments, most of which were spam, but some of which were not.  I just posted all those that were not obvious spam.  I am now getting notified of new comments again, so I hope that your submitted comments going forward will not be unduly delayed. 

Sorry again

EHR evidentiary mayhem

A short post.

I am encountering, in my legal work, electronic medical records systems that either allow ex post facto note alterations by clinicians - for example, after a catastrophe - and/or alteration of the apparent date/time a note was entered. The alterations (e.g., a version history) or fake times don't appear on the printed records, and usually are not in the audit trails as well.

Some of the systems don't even bother saving prior versions of edited notes, AND/OR defense attorneys make production of the the note version history and actual times of entry very difficult to obtain, AND/OR judges do not understand the issues and are not compelling the release of note edits and time-of-entry data.

Even *Facebook* retains edits of postings that you can view!

In the paper record world, the edits were inseparable from the records. Cross outs, comments over carat marks, erasures, ink color differences, spacing, etc. made them obvious. Attempts to conceal the edits in the paper world, if attempted, would have constituted evidence tampering and would have caused penalties and/or lost cases.

Electronic medical records are not entirely the patient's friend when mishaps occur, because of the evidentiary mayhem they can create.

This is another unintended consequence of the rush to EHR's in an unregulated industry.  As those in the field of Social Informatics long observed (see, for example Kling, Crawford, Rosenbaum, Sawyer, Weisband (2000). "Learning from Social Informatics: Information and Communication Technologies in Human Contexts" here), adoption of any new ICT - Information & Communications technology - will always create winners and losers [1].  (The citations refer to organizational "politics" as well as the governmental variety.)

In this case, unscrupulous clinicians and lawyers and the winners, and patients are the losers.

-- SS

[1] "It is common for ICTs to have systematic political repercussions with winners and losers"” (Danziger, Dutton, Kling & Kraemer, 1982; Markus 1981, 1983):

Danziger, James N., William H. Dutton, Rob Kling, and Kenneth L. Kraemer. Computers and Politics: High Technology in American Local Governments. New York: Columbia University Press, 1982.

Markus, M. Lynne 1981. Implementation Politics: Top Managment Support and User Involvement. Systems, Objectives, Solutions 1(4) (November): 203-215. 

Markus, M. L. 1983. Power, Politics, and MIS Implementation, Communications of the ACM, 26, 6 (June): 430-444.