September 01, 2017

Information technology-naive defense lawyers vs. "strident critic of electronic health records"

A tale from the trenches.

In recent years, as a result of the 2010 IT-related injury and 2011 death of my mother, I have engaged myself as an independent EHR forensic expert regarding evidentiary and patient harm issues in medical malpractice litigation. 

Interestingly and disappointingly, I still often find that hospital attitudes towards health IT safety and information transparency have changed little since 2010 or, for that matter, the 1990s when I did my postdoc in medical informatics.  Hospitals and defense attorneys often (ab)use the lack of technology experience of judges to delay or prevent evidentiary transparency.  I'm thus frequently retained by injured patient's attorneys (or attorneys representing the executors of deceased patients' estates) to help overcome this phenomenon.

In doing so, I can find myself under attack in deposition, even before any proceedings begin.

For instance, I was recently asked in a deposition, as an attack geared towards injuring my credibility, if an assessment of me published in the literature, that I was a "strident critic of electronic health records" was fair.

I replied that it was not a fair assessment, that I was a critic of bad health IT, but juries potentially will hear only the one-liner.

I'd formally defined bad health IT in these pages and at my Drexel medical informatics teaching site as follows:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or evidentiary fitness, or otherwise demonstrates suboptimal design and/or implementation.

It appears the attorney attacking me in this manner found the phrase "strident critics of electronic health records" online in a Feb. 18, 2013 Kaiser Health News Article by Jay Hancock (that also appeared in the Philadelphia Inquirer) entitled "Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes." 

That article is at http://khn.org/news/scot-silverstein-health-information-technology/.  It is unfortunate that cherry-picking in an attempt to neutralize a proponent of caution and evidentiary fairness in health IT still occurs in 2017.   That 2013 article itself centers on my patient safety-centered critique of bad health IT.  At the heart of the article is this: 

... Silverstein “is an essential critic of the field,” said Dr. George Lundberg, editor at large for MedPage Today and former editor of the Journal of the American Medical Association. “It’s too easy for those of us in medicine to get excessively enthusiastic about things that look like they’re going to work out really well. Sometimes we go too far and don’t see the downside of things.”

A growing collection of evidence suggests that poorly designed software can obscure clinical data, generate incorrect treatment orders and cause other problems. Cases include the Lifespan glitch; a data-entry error that led to the 2010 death of a baby at Advocate Lutheran General Hospital in Illinois; and computers at Trinity Health System, a major Midwest chain, that logged doctors’ orders on the wrong patients’ charts.

Computer mistakes voluntarily reported to the Food and Drug Administration include those that researchers said were linked to 44 injuries and six deaths at unidentified institutions. Those problems included tiny fonts causing caregivers to click on the wrong medication; flipped images that led a surgeon to operate on the wrong side of a patient’s head; and lost or misdated test results that caused unnecessary surgery or delayed treatment.

The FDA’s Dr. Jeffrey Shuren has said that such cases “likely reflect a small percentage of the actual events that do occur.”

I'd also thought this attack vector - painting me as some sort of fanatical anti-EMR Luddite - obsoleted by the remarkable Jan. 2015 complaint letter about health IT from appx. 40 major medical societies to HHS at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.  I commented upon that letter in my Jan. 28, 2015 post "Meaningful Use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html.  Sadly, I was wrong. 

I perhaps should have asked counsel if they were a supporter of bad health IT that injures and kills people.  If the matter comes up again, I very well might.

I felt sorry for that attorney, however.  I was also asked if I still "kept records" on my 1977 Heathkit H8 computer or words to that effect, with a possible implication that maybe I was hiding things on that machine.  This is a computer I still have which said attorney must have seen on my web page of technology interests at http://cci.drexel.edu/faculty/ssilverstein/medinformatic1/ham.htm.

I replied to the attorney that I last used the H8 to teach Yale informatics postdoctoral fellows (about computer architecture) in the mid 1990's when I was faculty there, and that it has not been turned on since. 

I didn't go into how doing so would require me to carefully clean approximately 500 small tin-plated (a costs saving by Health by not using gold) pins and sockets that connect the daughtercards to the motherboard, and probably replace long-unused power supply electrolytic filter capacitors before even applying power.


My late 1970's Heathkit H8 computer, Intel 8080 CPU @ 2 MHz, 64K RAM

I also was not permitted the time to relate to the counselor that the computer is quite primitive, having 64 kilobytes of RAM, with its main mass storage being special hard-sectored (and now nearly unavailable, as opposed to the more common soft-sectored) single-density, single-sided 5.25" floppy disks, each holding about 80,000 characters of information.  80 kilobytes.  By comparison, the common cellphone today has 2,000,000 kilobytes = 2 Gb of built-in storage...

It's sad, but I almost broke out laughing at the bizarre technology-naive question.  These are the type of folks who are defending bad health IT and taking advantage of the lack of knowledge of many judges about the technology.

The attorney also for some reason demanded me to affirm that the health IT-related medical malpractice case in which I am substitute plaintiff, that of my late mother, had been dismissed.  He didn't ask me the case status, but instead in a declarative manner stated "and that case has been dismissed, is that right?"

God only knows where that misinformation came from.  IT industry/defense lawyer Listserv gossip perhaps?

It was my pleasure to inform him that he was entirely incorrect.  After many years of delay, pretrial conference is scheduled for early October, and trial sometime after that, regarding a travesty caused by bad health IT and careless clinicians.  In a gross medication reconciliation failure, my mother's critical cardiac medication, Sotalol hydrochloride was inexplicably terminated, resulting in cascading problems leading to disaster.

-- SS

Who Guards the Guardians? - From DeVry at a Time of Alleged Fraud to Anti-Fraud Enforcement for the Department of Education

There seems to be another fox ready to guard the already flustered educational, including medical educational hen house.

Dr Julian Schmoke to Lead Student Aid Enforcement Unit

According to Politico on August 30, 2017, the new head of enforcement for the Department of Education will be one Dr Julian Schmoke Jr,

The Trump administration has tapped a former for-profit college official to lead the Education Department unit that polices fraud in higher education.

Julian Schmoke Jr., who previously directed campus operations at West Georgia Technical College and served as a dean at DeVry University, will be the department’s new chief enforcement officer, according to an internal email obtained by POLITICO.

Schmoke will lead the Student Aid Enforcement Unit, which was established by the Obama administration to more aggressively combat fraud and deceptive practices at colleges and universities.

The unit has been without a permanent leader since the departure earlier this year of Robert Kaye, a former top consumer protection attorney at the Federal Trade Commission.

'Julian possesses over 16 years of experience in higher education leadership with extensive knowledge in the development and implementation of strategies for achieving student success, higher education policy and evaluation of academic programs,' the head of the Federal Student Aid Office A. Wayne Johnson wrote in an internal email last week.
Dr Schmoke's Work for DeVry University, and its Previous Fraud Settlements

Left unsaid by Department of Education officals was that Dr Schmoke had a significant role in DeVry University.  However, per Politico

Schmoke worked in various roles at DeVry University between October 2008 and April 2012, including as an associate program dean, according to his LinkedIn page.

DeVry’s parent company, which has since rebranded as Adtalem Global Education, last year agreed to pay $100 million to resolve allegations by the Federal Trade Commission that the for-profit college company misled students about their job and salary prospects.

The company also separately reached a settlement with the Education Department over similar allegations. Obama administration officials cited those cases against DeVry as they announced the formation of the Student Aid Unit last year.

The unit Schmoke will oversee is also responsible for processing debt relief claims filed by federal student loan borrowers who say they’ve been defrauded by their college. DeVry students had 1,872 'borrower defense to repayment' claims pending before the department, according to a July 7 letter from acting Undersecretary of Education James Manning.

A bit more about the fraud settlements made by DeVry appeared in the Atlanta Journal Constitution:

In December, the Federal Trade Commission announced a $100 million settlement with DeVry Education Group, parent of DeVry University. Under the settlement, DeVry will pay $49.4 million in cash to be distributed to qualifying students who were harmed by the deceptive ads, as well as $50.6 million in debt relief. The debt being forgiven includes the full balance owed —$30.35 million— on all private unpaid student loans that DeVry issued to undergraduates between September 2008 and September 2015, and $20.25 million in student debts for items such as tuition, books and lab fees, according to the FTC.

In 2016, we hadposted even more detail about the settlement here.

While Dr Schmoke had left DeVry by the time the settlement was made, he was there at the time DeVry was taking the actions that led to the lawsuits. Per the Wonkette blog,

Dr. Schmoke was a dean at DeVry between 2009 and 2012. During that time, the Federal Trade Commission sued the school for claiming that 90% of its graduates were employed in their field within six months of graduation. In fact, the real number dipped as low as 52%. Per WaPo,

According to the FTC lawsuit, DeVry counted graduates as working in their field when they were not, in order to boost its employment outcomes. A 2012 graduate who majored in business administration was working as a server at a restaurant, while another with a degree in technical management was working as a rural mail carrier.

Yet the creation of the unit of the Department of Education that Dr Schmoke is going to lead seems to have been inspired by the sorts of abuses that his former company, DeVry, was alleged to have committed, (see report by National Public Radio in 2016).

Discussion - In General

We could start a discussion of conflicts of interest, and even the revolving door, but,...

Thus, as an opinion piece in the Atlantic asserted, the appointment of Dr Schmoke "provoked complaints from critics who pointed out that DeVry recently settled several claims brought against it by regulators alleging it had engaged in some of the very abuses the unit is charged with eliminating."  A writer for Gizmodo put it  more bluntly,

the new student protection bureau of the federal government just hired a guy who worked at the same company whose malicious practices inspired the creation of that new student protection bureau. It’s like hiring one of Al Capone’s henchman to run the FBI!

Of course, the appointment was made by an administration headed by the man for whom Trump University was named, the same bogus university which also settled fraud allegations (see the New York Times story from November, 2016 here, and our post here).

The issue is no longer laxity or timidity in the protection of the public from fraud and deception.  The issue seems to be that the fraudsters are now to be in charge of the public's protection.  This has dire implications for the country.

Discussion - Implications for Off-Shore Medical Education

But we are focused on health care dysfunction, and this particular case also seems to have dire implications for medical eduction.

DeVry University, as we have posted, most recently here,  owns American University of the Caribbean School of Medicine, and Ross University School  of Medicine. These are off-shore medical schools that cater to US and Canadian students who wish to go back to the US and Canada to practice. However, they are located in various small Caribbean countries, and since they do not train doctors to practice in those countries, essentially operate without much regulation.

As we have said before,
Admission to US medical schools is increasingly difficult.  So many who seek medical careers may be tempted to apply to schools outside the US.  In the last 30 years, American entrepreneurs have opened offshore medical schools, mostly in the Caribbean, that cater to US students.  They teach in English, and do not require immersion in an unfamiliar culture, so may be more attractive than medical schools in other countries whose mission is to educate physicians to practice in those countries. In 2010, Eckhert documented that the number of offshore medical schools, "for-profit institutions whose purpose is to train U.S. and Canadian students who intend to return home to practice," but not to train physicians to practice in the countries in which these schools are located, was rapidly growing.(Eckhert NL.  Private schools of the Caribbean: outsourcing medical education.  Acad Med 2010; 85: 622-630.  Link here.)  By 2010, there were 33 such schools, 20 of which were new since 2000.

Such offshore medical schools exist in a grey area.  The small countries or colonies in which they are located usually do not seek to regulate them, since the physicians they produce are going to practice elsewhere. There is no requirement that these offshore medical schools be accredited in the US.  Such  accreditation is currently not required for individual graduates of such schools to be admitted to US house-staff programs or for US licensure.  So perhaps it is not surprising that little is known about these schools.

How they choose students, the qualifications or even names of their faculty, their curriculum, how they supervise clinical training (which is mostly done by affiliated North American hospitals), and what happens to their graduates are obscure.  Eckhert attempted to describe what is known, but noted 'variability exists in the availability of information on faculty; where data exists, it is noted that most of the permanent on-site basic science faculty are internationally trained, many have no documented medical education experience in the United States, and it is not uncommon for them to be OMS [offshore medical school] alumni.'

Since I wrote that, several anecdotes about life as an off-shore medical student have appeared (in February, 2017, and in March, 2017, in KevinMD).  Both stressed that the modus operandi of these schools is to have relatively lax entry criteria, make a lot of money from the tuition of the students initially enrolled, and then ruthlessly weed out the weakest, who may nonetheless be left with tremendous debt.  Furthermore, the March, 2017 post noted further signs of poor quality, including "mandatory lectures are nearly pathetic. There are so many mistakes made by the inexperienced professors, and the lecture becomes confusing and muddled."  Further, students who have any "emotional distress/burnout/sickness" are left to sink or swim, as the "staff is disconnected and said either repeat the term after you seek medical attention or just quit."    

Given that there are no widely accepted ways to measure the quality of medical schools, there are thus even more reasons to worry about the quality of the education received in off-shore medical schools than in US and Canadian schools. 

Things are likely to get much worse, though, if those in charge of US government agencies that are supposed to protect the public in general, and patients' and the public's health in particular are run by people who previously were involved in predations upon the public. 

It seems silly for me to go on about true health care reform at a time when crooks can be recruited into the police department.  

August 25, 2017

A Stealth Marketer Goes Through the Revolving Door to ... the President's Council of Economic Advisors?!

Stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies, have long been a subject of Health Care Renewal.  A relatively recently revealed example was the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This campaign included manipulating and suppressing clinical research, bribing physicians to prescribe the drug, use of key opinion leaders as disguised marketers, and manipulation of continuing medical education.  Other notable examples included Johnson and Johnson's campaign to sell Respirdal (look here),  and the infamous Pfizer campaign to sell Neurontin (look here and here).   Notably, stealth marketing seemed to be one reason for the growing popularity of narcotics (opioids) starting in the 1990s (look here). 

Such campaigns have gotten more exposure in the media and the scholarly literature, so we have not written as much about them in the last few years as previously.  So I confess we did not directly discuss a February, 2017,  investigative report by ProPublica about Precision Health Economics, a company that has orchestrated several such campaigns (although we did allude to it here).

Prof Tomas Philipson Named to President's Council of Economic Advisors

This week this report suddnely appears very salient, since Yahoo News just revealed that a top leader of Precision Health Economics, Prof Tomas Philipson, has been nominated to the President's Council of Economic Advisors by Donald Trump.

Donald Trump’s new senior economic adviser has helped pharmaceutical companies lobby to charge astronomical prices for crucial drugs.

Last Monday, the White House confirmed that Tomas J. Philipson, a health care economist, was joining the President’s Council of Economic Advisors.

That announcement was made just hours after Trump publicly accused Merck CEO Kenneth Frazier of charging patients 'ripoff prices' for drugs after he resigned from the President’s Manufacturing Council in protest at the president’s response to the violence at a white nationalist rally in Charlottesville, Virginia last weekend.

Now that Ken Frazier of Merck Pharma has resigned from President's Manufacturing Council,he will have more time to LOWER RIPOFF DRUG PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017


.@Merck Pharma is a leader in higher & higher drug prices while at the same time taking jobs out of the U.S. Bring jobs back & LOWER PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017

Precision Health Economics

Given the potential influence of Prof Philipson on the Council of Economic Advisors, it is worth summarizing what ProPublic said about his career at Precision Health Economics.

PHE as Orchestrator of Stealth Marketing and Policy Advocacy

First, the business of PHE is to help pharmaceutical and biotechnology companies market their products and influence public policy in their favor.

While collaboration between higher education and industry is hardly unusual, the professors at Precision Health Economics have taken it to the next level, sharpening the conflicts between their scholarly and commercial roles, which they don’t always disclose. Their activities illustrate the growing influence of academics-for-hire in shaping the national debate on issues from climate change to antitrust policy, which ultimately affect the quality of life and the household budgets of ordinary Americans — including what they pay for critical medications.

Furthermore,

'This is just an extension of the way that the drug industry has been involved in every phase of medical education and medical research,' said Harvard Medical School professor Eric G. Campbell, who studies medical conflicts of interest. 'They are using this group of economists it appears to provide data in high-profile journals to have a positive impact on policy.'

The firm participates in many aspects of a drug’s launch, both advising on 'pricing strategies' and then demonstrating the value of a drug once it comes on the market, according to its brochure. 'Led by professors at elite research universities,' the group boasts of a range of valuable services it has delivered to clients, including generating 'academic publications in the world’s leading research journals' and helping to lead 'formal public debates in prestigious, closely watched forums.'
Again, some people may naively imagine that academic publications are written by unbiased academics, not hired guns for industry, and that formal debates on major issues ought to again by led by people who are disintered and authoritative, not hired guns.  That would be very naive.

So PHE has set itself up as a vehicle to market and advocate on behalf of big corporations while making that work appear to be unbaised academic discourse.  In particular,

Precision Health Economics has counted at least 25 pharmaceutical and biotech companies and trade groups as clients. The roster includes Abbott Nutrition, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Gilead, Intuitive Surgical, Janssen [a subsidiary of Johnson and Johnson], Merck, the National Pharmaceutical Council, Novartis, Otsuka, Pfizer, PhRMA, rEVO Biologics, Shire and Takeda.
Note that many of these companies are known for perpetrating the kinds of marketing shenanigans that we discuss on this blog.  See the links above.

 PHE Has Been Accused of Biased Work for Pharma Prettied by Its Principals' Academic Credentials

To justify the value of expensive drugs, the professors affiliated with Precision Health Economics rely on complicated economic models that purport to quantify the net social benefits that the drugs will create.

However,

Critics have at times questioned the assumptions underlying the consultants’ economic models, such as the choice of patient populations, and suggested that some of their findings tilt toward their industry clients. For example, some have tried and failed to reproduce their results justifying the value of cancer treatments.

Precision Health Economics allows drugmakers to review articles by its academics prior to publication in academic journals, said a former business development manager of the consulting group. Such prior review is controversial in higher education because it can be seen as impinging on academic freedom.

In addition,

About 75 percent of publications by the firm’s employees in the past three years have either been funded by the pharmaceutical industry or have been done in collaboration with drug companies, a ProPublica review found.

Some academics worry that a tight relationship with industry might suggest bias. 'I personally find, when your enterprise relies so substantially on a particular source of funds, you will tend to favor that source,' said Princeton economist Uwe Reinhardt.

Thus several of the firm's campaigns have produced considerable controversy.  For example,

Advocating Increased Pricing for Oncology Drugs

Precision Health Economics raised its profile in 2013 when the president’s annual economic report cited a cancer study by several of the firm’s principals and consultants. To some critics, though, the study showed how industry funding can taint academic research.

Originally published in Health Affairs, where [PHE founder Dana] Goldman also serves on the editorial board, the study found that Americans paid more for cancer care than Europeans but had better survival gains.

As the study acknowledged, it was funded by Bristol-Myers Squibb, a company that at the time was developing a much-anticipated cancer treatment. It was priced at more than $150,000 per year when it eventually came on the market. All three founders of Precision Health Economics were listed as authors of the Health Affairs article, alongside one of their employees, yet none of the founders disclosed their ties to their consulting firm in the published study. In an interview, Goldman said this might have been an 'oversight.'

In addition,

As the cancer study gained national recognition, its methodology and findings came under fire. Researchers from Dartmouth College tried and failed to reproduce the results. Cancer care in the U.S., their research found, may actually provide less value than cancer care in Europe, considering cost.

'We know that [the U.S. health care system] is more disorganized and disorganization is more expensive, so it’s surprising to believe that the U.S. would perform better in a cost-effectiveness sense,' said Samir Soneji, one of the authors of the counter-study and an assistant professor of health policy at Dartmouth. The science in the original study, Soneji says, was 'questionable.'

Soneji was not alone in his criticism. Aaron Carroll, a pediatrics professor at the Indiana University School of Medicine, reviewed the methodology and concluded that the Precision Health Economics researchers had used a measure that can frequently be misinterpreted. Instead of relying on mortality rates, which factor in a patient’s age of death, the study employed survival rates, looking at how long people live after diagnosis. Cancer screening, which can increase survival rates, is more frequent for some cancers in the U.S. than in other countries, Carroll says.

'When they wrote that paper using survival rates, they were clearly cherry picking,' Carroll told ProPublica. 'If the arguments are flawed and people keep using them, I would be concerned that they have some other motive.'

PHE Work on Behalf of PCSK9 Inhibitors

Not long after the controversy over its cancer research, Precision Health Economics became embroiled in another academic spat related to a client’s product. This time, it was over a breakthrough treatment that, injected one to two times per month, could help millions of Americans with high cholesterol. At the $14,000-per-year price set by one of its makers, Amgen, the PCSK9 inhibitor could also hike the nation’s annual prescription drug costs by an unprecedented $125 billion, or 38 percent. Its price in the U.S. is twice as much as in the U.K.

The U.S. price of the drug has come under vigorous attack from the nonprofit Institute for Clinical and Economic Review. ICER, which began as a small research project at Harvard Medical School, studies the cost-effectiveness of drugs, balancing their value to patients against the impact of their cost on society. The Centers for Medicare and Medicaid Services proposed a new rule in March 2016 that includes the use of value-based pricing studies, specifically citing the work of ICER.

The industry has attacked many of the institute’s studies, particularly those that find a treatment is overpriced. 

PHE orchesterated an attack on the ICER conclusions.

ICER concluded in 2015 that the new cholesterol treatment, the PCSK9 inhibitor, should cost about one-fifth what Amgen is charging. A few months later, Philipson, the Precision Health Economics co-founder, and Jena wrote an op-ed in Forbes, citing the institute’s research and deriding its approach to value pricing as 'pseudo-science and voodoo economics.' Only Philipson disclosed his ties to Precision Health Economics, and neither academic disclosed that Amgen was a client of the firm.

PHE Principals Have Failed to Disclose Their Conflicts of Interest

The professors’ disclosure of their ties to the firm and to the pharmaceutical industry in scholarly articles is inconsistent: sometimes extensive, sometimes scanty. Members of Precision Health tend to reveal less about their paid work in blogs, public forums like conferences, and legislative testimony. At the Capitol Hill briefing last May on hepatitis C drugs, Lakdawalla didn’t mention his affiliation with Precision Health Economics, though it was listed in the journal issue, which was provided to attendees.
One can argue that failing to disclose relevant conflicts of interest is deceptive.

Prof Philipson's Role in PHE has Increased in Scope

PHE was sold in 2015 to a "privately held biotech company, Precision for Value."  Since the sale, "Philipson is listed as chief economist and the chair of the strategy and innovation board."

A Problem Beyond the Revolving Door



We have frequently railed about the revolving door affecting health care.  Prof Philipson clearly will be transiting the revolving door, in that he will be going directly from a responsible corporate position into a government role in which we will be able to influence policy that affects the corporation in question (as well as other corporate interests, of course).  Nowadays, people frequently transit the revolving door from or to US government positions.  We most recently posted about the revolving door affecting health care in the current US administration here.

We previously opined about the revolving door....

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,


The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
The ongoing parade of people transiting the revolving door from industry to the Trump administration once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still increasingly being run by a cozy group of insiders with ties to both government and industry. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

So, as we have said before.... The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.


However, the case of Prof Philipson raises issues beyond the revolving door.  Prof Philipson is not a mere corporate executive.  He is a master of stealth marketing/ lobbying advocacy.  Stealth marketing, in particular, has been one of the scourges of US health care.

Back in a 2006 blog post about the stealth marketing of Neurontin, I wrote:

Physicians must be increasingly skeptical about educational and scholarly activities that may be disguised efforts at drug marketing.

Shame on the companies that have implemented such stealth marketing programs. Shame on the academic physicians who have taken money to help them out without revealing their financial interests to their physicians colleagues.

In a 2008 blog post about the same case, I wrote:

 This unfortunately is another blow to the current paradigm of evidence-based medicine. The EBM paradigm calls for physicians to make optimal decisions for individual patients based on their knowledge of the clinical context, the patients' values and wishes, and a critical review of the best relevant evidence from clinical research. For the paradigm to work, the assumptions are that all relevant research can be found, and that the research studies, while imperfect, were not intentionally designed or reported to deceive the reader. Yet the case of gabapentin adds to fears that relevant evidence that is unfavorable to the interests of the drug, device, or biotechnology company which sponsored the work is likely to be suppressed by that sponsor, and that commercially sponsored research is often deliberately manipulated to make its results appear more favorable.

Also, as Professor Dickersin noted (reported by the WSJ), "in exchange for being experimented upon in trials, patients are told they are contributing to human knowledge. To withhold negative results from the public breaks that ethical obligation to such patients...."

I began to think in the years after 2008 that the increasing exposure of stealth marketing (and related stealth lobbying and policy advocacy) campaigns would lead to their eventual decrease.  Never in my wildest dreams in 2008 did I foresee a stealth marketing master transiting the revolving door to be appointed to the President's Council of Economic Advisors.  (But then again, back then I would have laughed out loud at the notion of Donald Trump as President).  I seem to be really bad at prophecy.

We are slipping farther and farther from my ideal of true health care reform.  

August 21, 2017

Health Care Non-Profit Organizations Ignored Conflicts of Interest or Potential Corruption Generated by Mar a Lago Fundraisers, But Drew the Line at Supporting Nazi Sympathizers

Leaders of big health care organizations have long made excuses for rampant conflicts of interest in health care.  Usually, their rationales included something about the need to collaborate with industry to spark innovation.  However, some leaders may have been directly benefiting from such conflicts (e.g., academic leaders on the payrolls of drug, device and biotechnology firms, even on the firms' boards).  Others may not have been, but were making millions in the current system, so why rock the boat?  Meanwhile, the risks these conflicts posed of health care corruption were not a subject of polite conversation. 

Thus it is no surprise that health care leaders are very resistant to suggestions they reduce conflicts of interest affecting their organization.  There was just a recent dramatic case of what it currently may take to break health care leaders from their conflict of interest habbit.   


The 2017 Mar a Lago Fundraising Events

It had long been a tradition for some non-profit health care organizations to hold gala fundraisers in Palm Beach, Florida at the Trump Organization's Mar a Lago club.  This was not remarkable when Mr Trump was a private citizen.  However, when he was elected President, but refused to divest himself of his ownership of the Trump Organization, these fundraisers suddenly looked like conflicts of interest, and possible corruption.  Large health care organizations, particularly hospital systems, but also disease advocacy groups, may daily interact with the executive branch of the US government, and may have interests in these interactions going in certain directions.  The acceptance by the President, the leader of the executive branch, of money from such organizations, even if in the form of payments to the family company he owns, clearly creates a conflict of interest.  If the payments are meant to or to create an impetus for the President to act in favor of the interests of the paying organization could be corruption (abuse of entrusted power for private gain). 

Regardless of such ethical concerns, the health care organizations that used Mar a Lago for fundraising were happy to continue their traditions.  For example, the Cleveland Clinic persisted in holding its fundraiser there despite protests by its own students, health care professionals, and patients' families, many of whom were particularly irate because of Mr Trump's attempt to ban travel to the US by Muslims, which had already prevented on Clinic physician from re-entering the US (look here).  Also, the Dana-Farber Cancer Institute similarly persisted despite similar protests (look here).  In neither case did the leaders of the two clinical institutions deign to even discuss the issues of  conflicts of interest, or corruption. 

Concerns about Next Year's Fundraising Events

On August 4, the Chronicle of Philanthropy summarized the issues.  In general, it seemed that the monetary returns of holding events at Mar a Lago trumped any puny concerns about conflicts of interest:

Fundraisers say Palm Beach events are among the most lucrative they hold and provide an opportunity to court donors who have the potential to give big sums long after the galas are over.

Mar-a-Lago offers more space than any other venue in the area, increasing the opportunity to attract more donors.

So,

A Chronicle analysis of permit data shows how lucrative events at Mar-a-Lago can be.

In 2016, when Mr. Trump’s unorthodox and often controversial presidential campaign was in full swing, the Cleveland Clinic raised $963,029, after expenses, at an annual ball; Susan G. Komen brought in $700,00 at its 2016 Mar-a-Lago event, and the Palm Beach Police Foundation raised $643,975.

More qualitatively,

For many charities, a Mar-a-Lago gala is one of the biggest fundraising events of the year.

'It’s definitely one of our highest-visibility events,' says Erik Levis, communications director for the American Friends of Magen David Adom. Revenue from the Mar-a-Lago event is comparable to dollars brought in through the charity’s galas in Los Angeles and New York City, he adds.

Many charities say the financial benefits of continuing to hold events at Mar-a-Lago make it difficult to consider moving them elsewhere.
The Chronicle did quote one expert who raised the possibility of conflicts of interest.

Doug White, a philanthropy adviser, is more blunt, arguing that charities should shun the venue because, on its face, renting a club owned by the president presents a conflict of interest.

Even if a charity does not intend to curry favor with the president, some people may perceive it that way, he says. 'It’s the symbolism of it more than the actual cash in [Mr. Trump’s] pocket for me,' Mr. White says.


However some argued that any conflict of interest were small, given Mr Trump's vast wealth

The president, who has declined to divest from his vast business holdings, could profit from some of the events held by charities at Mar-a-Lago — but only marginally.

Some further argued that holding any single event at Mar a Lago could not influence Mr Trump all that much.

If nonprofits hold events at Mar-a-Lago to influence Mr. Trump, that would be a bad tactic, says Leslie Lenkowsky, professor emeritus of public affairs and philanthropic studies at Indiana University. He notes that Mr. Trump earns profits in many ways from his businesses; charity events held at the club are small potatoes.

'Any charities that say ‘Let’s go do our fundraiser at Mar-a-Lago because Donald Trump will be grateful to us for the business’ is probably mistaken,' says Mr. Lenkowsky, a Chronicle of Philanthropy columnist....

It's fascinating that Mr Lenkowsky basically made his argument from a cost-effectiveness standpoint.  This was underlined by another expert, 

For many charities, the decision comes down to the bottom line. Phil Hills, president of the Marts & Lundy fundraising consulting firm, says that while charities should consider the potential for blowback among their supporters when selecting a venue like Mar-a-Lago, money should be the biggest consideration. 'You should probably hold it at whatever location gives you the best return,' he says.

So, this seemed to be an argument that non-profit organizations should not be concerned that holding fundraisers at a Trump venue could appear to be attempts to buy influence, as long as the fundraisers bring in a lot of money.

On the other hand, arguments used against specific organizations paying the Trump Organization to hold their charity events had more to do with how Mr Trump's stated policies, now elaborated more after as his presidency wore on, conflicted with the organizations' missions.  For example, an August 10, 2017 Cleveland.com article about the next Cleveland Clinic Mar a Lago fundraiser stated,

Whereas the primary complaint early this year was about Trump's immigration policy, it is about health care now.

Holding a fundraiser at Mar-a-Lago 'is unacceptable because it symbolically and financially supports a politician actively working to decrease access to health care and cut billions of dollars in research funding from the National Institutes of Health budget,' says the online petition, signed by more than 1,100 people since late July.

A social and fundraising event that helps enrich the private business interests of Trump should be contrary to the Clinic's core values, supporters of the protest say.

'Donald Trump has come out and said he would let the Affordable Care Act implode,' said Sandy Theis, executive director of Progress Ohio, one of the organizations helping circulate the letter on the website Medium. 'So there should be no health care provider, let alone major medical institution, putting money in that man's pocket.'
Note that the arguments against the Mar a Lago fundraiser were not that it would be wrong to "enrich the private business interests of Trump." The arguments were that it would wrong to enrich Mr Trump given that Trump's policies were perceived to be bad for health care.  This implies it would be acceptable to enrich Mr Trump if he were perceived to have more favorable policies.

That is really striking, and strikingly cynical. It suggests that fundraisers at Mar a Lago are intended to buy influence, and hence are not merely conflicts of interest, but corruption.  But it further suggests it is not worth purchasing such influence from someone who already opposes the purchaser's policies.  This could translate to: it is not worth trying to corrupt someone who is already your enemy. 

Eileen Sheil, executive director of corporate communications at the Clinic, did not clearly refute the implication that they were paying Mr Trump to influence him, saying only

'In no way is this about politics for us,' she said, adding that the Clinic is a nonprofit organization. 'The sole purpose' of the Mar-a-Lago event 'is to raise money.'

We Can't Do Business with, or buy the Influence of a Nazi Sympathizer

What finally undercut President Trump's business of selling the Mar a Lago venue for fundraising to health care non-profits which must have major interactions with the executive branch of the US government was not concerns about conflicts of interest, or the risks of corruption.  What ruined this year's gala business was the apparent heinousness of Mr Trump's political affinities.

As we noted here, after a rally by people openly carrying Nazi and Ku Klux Klan symbols, chanting slogans from Nazi Germany (e.g., "blood and soil," the translation of the old Nazi "blut and boden," look here), one of the apparent neo-Nazis ran down counter-protesters with his car, killing one and injuring many more, Mr Trump initially refused to label the car driver and his associates as neo-Nazis or white supremicists. Days later, after an unconvincing scripted oration, he declared that some neo-Nazis and white supremicists are "very fine people," earning the praise of former Ku Klux Klan leader David Duke (look here).

That did it.  Sonn after, the Cleveland Clinic announced that it "has decided that it will not hold a Florida fundraiser at Mar-a-Lago in 2018," (look here).  The public announcement did not elaborate on the reason. That same day, the Palm Beach Post reported that

Laurel Baker, executive director of the Palm Beach Chamber of Commerce, minced no words Thursday about whether charities should continue to hold their events at Mar-a-Lago this season following President Donald Trump’s statements about the recent violence in Charlottesville, Va.

'If you have a conscience, you’re really condoning bad behavior by continuing to be there,' Baker said. 'Many say it’s the dollars (raised at the events) that count. Yes. But the integrity of any or organization rests on their sound decisions and stewardship.'

Within days, health related non-profit organizations including the American Red Cross, the Susan G Komen Foundation, the Autism Project of Palm Beach County, the American Friends of Magen David Adom (an Israeli emergency medicine service), and the American Cancer Foundation had cancelled their Mar a Lago events, per the Washington Post. (Note that Dana-Farber had already announced it would not do a 2018 fundraiser there.)

So the bottom line appears to be that for health care organizations, generating conflicts of interest affecting political leaders, and buying political influence is unacceptable - if the political leaders are Nazi, Ku Klux Klan, or white supremicist sympathizers.

Summary

To what depths we have fallen.  The entire discusson of health care organizations continuing to hold gala fundraisers at a venue owned by the President of the United States of America seemed to assume that it is acceptable to do so to buy influence, i.e., that it is acceptable for health care organizations to purposefully generate conflicts of interest, to even corrupt politicans.  The only thing they should not do is buy influence from Nazis and the like.

If our only rule is Nazis are bad, count on continuing cynicism and resulting corruption will continue to generate Nazis, or their relatives.


 

August 14, 2017

Can We Challenge Health Care Corruption Under Morally Failed Government Leadership?

Introduction: Health Care Corruption

An important theme of Health Care Renewal has been health care corruption as a cause of health care dysfunction.

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.

Yet the report did not get much attention and 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 somewhere else, mainly benighted less developed countries.  At best, the corruption that gets discussed is low level.  In the US, frequent examples are the "pill mills"  and various cheats of government and private insurance programs by practitioners and patients that lately have been decried as a cause of the narcotics 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.

Because a few individual cases suggested discussion of health care corruption has recently become less taboo (look at this post from June, 2017), we thought we were making a little progress.  On the other hand, we worried that little progress would be made under an administration that is being increasingly identified with corruption and impunity itself?

You ain't seen nothing yet.


Nazis and Ku Klux Klan March, Deaths and Injuries Ensue, the President Equivocates

Worse, how could we function under a government led by the morally corrupt?  Yet in the last few days, this is the specter we face. 

The events in the US triggering this fear are well known.  A public demonstration by the "alt-right" protesting the planned removal of a statue of a Confederate general from a park in Charlottesville, Virginia, was populated by people carrying overtly Nazi, Ku Klux Clan and Confederate flags, chanting racist and anti-Semitic slogans.  The demonstrators clashed with counter-demonstrators.



A car driven by a demonstrator plowed into the crowd of counter-demonstrators, killing one and seriously injuring many.



Numerous US politicians, from the left and right, condemned the the attack as a terrorist act, perpetrated by open followers of Naziism and the KKK. (Look here for representative coverage.)

Yet the US President so far has refused to personally utter the words "Nazi," "Ku Klux Klan," "racist," "anti-Semitic," "terrorism," or anything similar about this attack.



Instead, he blamed some hypothetical "many sides."  Meanwhile, David Duke, the former leader of the Ku Klux Klan, had saluted President Trump during the rally:



After Mr Trump made the vague remarks above, Duke responded:

So, after decades of White Americans being targeted for discriminated & anti-White hatred, we come together as a people, and you attack us? https://t.co/Rkfs7O2Ykr — David Duke (@DrDavidDuke) August 12, 2017

I would recommend you take a good look in the mirror & remember it was White Americans who put you in the presidency, not radical leftists. https://t.co/Rkfs7O2Ykr — David Duke (@DrDavidDuke) August 12, 2017 
 Can Progress Be Made Under Morally Failed Leadership?

On the other hand, an op-ed by Michael Gerson in the Washington Post noted:

Ultimately this was not merely the failure of rhetoric or context, but of moral judgment. The president could not bring himself initially to directly acknowledge the victims or distinguish between the instigators and the dead. He could not focus on the provocations of the side marching under a Nazi flag.

Furthermore,

If great words can heal and inspire, base words can corrupt.



Sen. Orrin G. Hatch (R-Utah) tweeted:

We should call evil by its name. My brother didn’t give his life fighting Hitler for Nazi ideas to go unchallenged here at home.

Then there was Will Bunch in the Philadelphia Inquirer, who entitled his op-ed:

Trump's shameful moral void on Charlottesville leaves America without a leader

And the Guardian's editorial entitled:

Donald Trump and racism: a moral failure that shames America

Last Words 

Is it still possible to meaningfully address health care corruption in a land whose leader is so corrupt, a "moral failure," unable to "call evil by its name?" Maybe not until that leader is no longer in office. We will find out, but may not be able to survive a long wait.  

July 31, 2017

What the US "Health Care Reform" Debate Did Not Address

It looks like the bizarre process in the US Senate ostensibly to "repeal and replace Obamacare" (aka the Affordable Care Act, or ACA) may be ending, at least for now.  I can only hope that further discussion of health care reform will let sanity prevail, and start to address the major issues that have led to the massive dysfunction of US health care, but were not discussed during the latest kerfuffle (and not even discussed much in the real debate that preceded the introduction of the ACA.)

On Health Care Renewal we have discussed some of the issues that have received much less attention than the Senate process and the push by the Trump administration to get rid of Obamacare.  I submit the country needs to revisit these issues (and in some cases face them for the first time).

Health Care Dysfunction

Despite some protestations to the contrary (e.g., here), the US health care system has been plagued by dysfunction.  According to a recent Commonwealth Fund study, the US was ranked 11 out of 11 in health care quality, but 1 out of 11 in costs.  Traditionally, health care reform has targeted ongoing problems in the cost, accessibility and quality of health care.  The ACA notably seems to have improved access, but hardly addressed cost or quality.

Early on we noticed a number of factors that seemed enable increasing dysfunction, but were not much discussed.  These factors notably distorted how medical and health care decisions were made, leading to overuse of excessively expensive tests and treatments that provided minimal or no benefits to outweight their harms.

Threats to the Integrity of the Clinical Evidence Base

Evidence-based medicine advocates making decisions for individual patients based on critical review of the best evidence from clinical research to make decisions that will provide patients with the most benefits and the least harms.  However, the clinical evidence has been increasingly affected by manipulation of research studies, including aspects of their design, implementation, and analysis.  Such manipulation may benefit research sponsors, now often corporations who seek to sell products like drugs and devices and health care services.  Manipulation may be more likely when research is done by for-profit contract research organizastions (CROs) which may get more busines when they can produce results to fit the sponors' interests. When research manipulation failed to produce results to sponsors' liking, research studies could simply be suppressed or hidden.  The distorted research that was thus selectively produced was further enhanced by biased research dissemination, including ghost-written articles ghost-managed by for-profit medical education and communications companies (MECCs). Furthermore, manipulation and suppression of clinical research may be facilitated by health care professionals and academics conflicted by financial ties to research sponsors.  Clinical decision making based on evidence delibrately biased to favor particular products or services is liable to distortion, and the overuse of products and services that are excessively expensive, useless, and/or harmful.

Deceptive Marketing

The distorted evidence base was an ingredient that proved useful in deceptive marketing of health care products and services. Stealth marketing campaigns became ultimate examples of decpetive marketing.  Deceptive marketing was further enabled by the use of health care professionals paid as marketers by health care corporations, but disguised as unbiased key opinion leaders, another example of the perils of deliberate generation of  conflicts of interest affecting health care professionals and academics.  These extensive deceptive marketing efforts likely have induced again the overuse of products and services that are excessively expensive, useless, and/or harmful.

Distortion of Health Care Regulation and Policy Making

Similarly, promotion of health policies that allowed overheated selling of overpriced and over-hyped health care products and services included various deceptive public relations practices, including orchestrated stealth health policy advocacy campaigns.  Third party strategies used patient advocacy organizations and medical societies that had institutional conflicts of interest due to their funding from companies selling health care products and services, or to the influence of conflicted leaders and board members.  Some deceptive public relations campaigns were extreme enough to be characterized as propaganda or disinformation.  

Furthermore, companies selling health care products and services further enhanced their positions through regulatory capture, that is, through their excessive influence on government regulators and law enforcement.  Their efforts to skew policy were additionally enabled by the revolving door, a species of conflict of interest in which people freely transitioned between health care corporate and government leadership positions.


Bad Leadership and Governance

A major factor driving various distortions of medical and health care policy making which could have increased costs, decreased access, and threaten quality was bad leadership and governance of the organizations involved.

Health care leadership was often ill-informed.  More and more people leading non-profit, for-profit and government have had no training or experience in actually caring for patients, or in biomedical, clinical or public health research. One could view recent legislative efforts to "repeal and replace Obamacare," which largely shut out the input of health care professionals and health policy experts as a giant example of apparently deliberately ill-informed leadership.  Obviously health care and health policy decisions made by ill-informed people are likely to have detrimental effects on patients' and the public's health.

Health care leaders often were unfamiliar with, unsympathetic to, or frankly hostile to their organizations' health care mission, and/or health care professionals' values.  The most recent example we have posted was a hospital CEO who allegedly over-ruled medical leadership to hire a surgeon despite reports that his patients died more frequently than expected, gamed reports of clinic utilization, and associated with organized crime (look here).

Health care leaders were driven by perverse incentives that prioritized financial goals over patient care.  Executives may received millions of dollars despite reports of poor clinical results or unethical behavior.  We have seen executives get raises after their companies made huge legal settlements of allegations of kickbacks or fraud.  The hospital executive mentioned above was receiving $1.7 million a year, plus perks like a car and driver.  Obviously, providing incentives that disregard patients' and public health outcomes and unethical behavior can induce decisions that lead to excess costs, insufficient access, and poor health care quality.

Health care leaders often had their own conflicts of interest.  For example, leaders of academic medicine frequently had financial relationships with corporations that sold health care products or services. In one study, approximately 60% of academic department chairs had such conflicts.  These included being consultants, paid key opinion leaders (as noted above), or even serving as corporate executives or members of boards of directors (e.g., see our first post on this phenomenon in 2006 here, and this article documenting the frequency of such conflicts.)   The latter conflict of interest is particularly concerning because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).  Leaders who have such conflicts might be biased in favor of their corporate benefactors' interests even when they conflicted with their institutions' missions. 

Moreover, we have found numerous examples of frank corruption of health care leadership.  Some have resulted in legal cases involving charges of bribery, kickbacks, or fraud.  Some have resulted in criminal convictions, albeit usually of corporate entities, not individuals.  One would hardly expect corrupt leadership to put patients' and the public's health ahead of the leaders' ongoing enrichment.

Health care leaders in the private sector (non-profit or for-profit) are supposed to operate under the governance of boards of trustees or boards of directors.  However, these boards may be populated by the leaders' cronies, and fellow corporate executives, but often not by people who primarily represent the interests of patients or the public at large.  Such governance has proven to be opaque, fail to be accountable to patients and the public, and sometimes conflicted (e.g., non-profit trustees who are executives of for-profit health care corporations).  Such governance would be unlikely to restrain bad decision making driven by bad leadership. 

Over-Arching Trends

Finally, bad health care leadership and governance has been enabled by series of over-arching trends.


Concentration of Power

Health care increasingly dominated by ever larger and more powerful organizations.  Such concentration of power may be facilitated by uninformed regulatory changes, and regulatory capture by private interests.  Concentration of power in industries outside of health care, which may culminate in the formation of oligopolies and even monopolies, historically has led to increased prices and hurt consumers and workers.  Concentration of power may well be a major factor in rising health care costs, and declining access and health care quality.

Abandonment of Health Care as a Calling


A US Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members, leading to the abandonment of traditional prohibitions on the commercial practice of medicine.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition. Doctors were pushed to be businesspeople, and to give making money the same priority as upholding their oaths.  See posts  here and here.

Meanwhile, hospitals and other organizations that provide medical care are increasingly run as for-profit organizations.  The physicians and other health care professionals they hire are thus providing care as corporate employees, resulting in the rise of the corporate physician.  These health care professionals may befurther torn between their oaths, and the dictates of their corporate managers.  When corporate imperatives to increase revenue prevail, no matter what, the outcome is likely to be worse patient care, higher costs, less access, and worse outcomes.

Perverse Incentives Put Money Ahead of Patients, Education and Research

We have extensively discussed the perverse incentives that seem to rule the leaders of health care. Financial incentives may be large enough to make leaders of health care organizations rich.  Even leaders of non-profit organizations such as academic medical centers and the parent universities of medical schools often make many millions of dollars a year in the US.  Incentives often prioritize financial results over patient care.  Some seem to originate from the shareholder value dogma promoted in business school, which de facto translates into putting current revenue ahead of all other considerations, including patient care, education and research (look here).   Health care leaders may become "value extractors" who put revenue, and the positive incentives they receive from enhancing revenue, ahead of all else (look here).  This may be a leading cause of mission-hostile management.

Cult of Leadership

Top leaders of health care organizations, be they non-profits or at least publicly held for-profit companies, used to be considered hired managers beholden to the organizations' mission, its board, and its various constituencies.  However, such leaders, particularly CEOs, tend now to be regarded as  exalted beings, blessed with brilliance, if not true "visionaries," deserving of ever increasing pay whatever their organizations' performance.  This pheonomenon has been termed "CEO disease" (see this post).  Afflicted leaders tend to be protected from reality by their sycophantic subordinates, and thus to believe their own propaganda.  Leaders in these bubbles tend to make bad decisions, and put their self-interest ahead of patients' and the public's health.    

Managerialism

Leadership of health care organizations by managers with no background in actual health care, public health, or biomedical science has been promoted by the doctrine of managerialism which holds that general management training is sufficient for leaders of  all organizations, regardless of their knowledge of the organizations' fundamental mission.  Ill-informed management may result from leaders who have no background or training in actual health care.  Managers lacking understanding of or sympathy towards health care professionals' values may be more likely to practice mission-hostile management.

Impunity Enabling Corrupt Leadership

Leaders of health care organizations increasingly have conflicts of interest, as noted above. Such conflicts may be risk factors for actual corruption (as defined by Transpaency International, the abuse of entrusted power for private gain).   Also as noted above, we have found numerous examples of frank corruption of health care leadership.  Some have resulted in legal cases involving charges of bribery, kickbacks, or fraud.  Some have resulted in criminal convictions, usually of corporate entities.  Corrupt leadership obviously can distort, if not ruin decision making, and channel large sums of money into private pockets. 

In the US, nearly all cases involving corruption in large health care organizations are resolved by legal settlements.  Such settlements may include fines paid by the corporations, but not by any individuals.  Such fines are usually small compared to the revenue generated by the corrupt behavior, and may be regarded as costs of doing business.  Sometimes the organizations have to sign deferred prosecution or corporate integrity agreements.  The former were originally meant to give young, non-violent first offenders a second chance (look here).  However, in most instances in which corruption became public, are no negative consequences ensue for the leaders of the organizations on whose watch corrupt behavior occurred, or who may have enabled, authorized, or directed the behaviors.  Since no individuals suffer negative consequences, the deterrent effect of such settlements on future corrupt behavior is likely to be nil. 

Taboos

When we started Health Care Renewal, such issues as suppression and manipulation of research, and health care professionals' conflicts of interests rarely appeared in the media or in medical and health care scholarly literature.  While these issues are now more often publicly discussed, most of the other topics listed above still rarely appear in the media or scholarly literature, and certainly seem to appear much less frequently than their importance would warrant.  For example, a survey by Transparency International showed that 43% of US resondents thought that American health care is corrupt.  It was covered by this blog, but not by any major US media outlet or medical or health care journal.  We have termed the failure of such issues to create any echoes of public discussion the anechoic effect.

Public discussion of the issues above might discomfit those who personally profit from the status quo in health care.  As we noted above, the people who profit the most, those involved in the leadership and governance of health care organizations and their cronies, also have considerable power to damp down any public discussion that might cause them displeasure. In particular, we have seen how those who attempt to blow the whistle on what really causes health care dysfunction may be persecuted.  But, if we cannot even discuss what is really wrong with health care, how are we going to fix it?

Real Health Care Reform

After the ACA became law, we noted that while it had some worthwhile provisions, it hardly addressed the concerns we had been raising to that point. Nonetheless, these deficiences were hardly raised by any of those advocating "repeal and replace."

Now that perhaps more sober heads a are prevailing, maybe it is time to consider some of the real causes of health care dysfunction that true health care reform needs to address, no matter how much that distresses those who currently most personally profit from the status quo. 

July 27, 2017

The Mysterious Demise of World Health Networks - Fugitive Kazakhs, the Trump Organization, Dodgy Visa Applications, Oh My

A common justification for a market fundamentalist approach to health care is the promise of innovation.  Providing market-based incentives will inspire generations of entrepreneurs who will bring out new and wondrous health care products and services, or so the story goes.  So we are now daily bombarded with media coverage of the latest innovations by such entrepreneurs.  But after the initial hype these entrepreneurs and their innovations often seem to fade away.

I stumbled on a recent media story that suggests the outer limits of what may go wrong with such innovations.  Let me try to tell the story chronologically.

World Health Networks and the Airport Promotion of Healthy Behaviors

In 2013, Masslive reported on the newest innovation, kiosks providing health evaluations:

Holiday travelers passing through Boston's Logan International Airport can now get an impromptu health report while waiting for their flights.

Four new health stations that include detailed walking paths through the airport and a machine that measures blood pressure, body mass index and weight, were installed Wednesday in three terminals.

The intervention was the product of collaboration between various commercial health care corporations.

For-profit hospital system Steward Health Care is sponsoring the stations for one year as part of a new health and wellness initiative at the airport.

Nic Denyer, executive vice president of machine manufacturer World Health Networks says next year, people may be able to test for diabetes and glaucoma in the future.

A press release from nLIVEnHealth included promises of "potential life-saving services" from the CEO of World Health Networks:

'The core objective of our partnership is to tackle heart disease through easy access, early detection, education and empowerment of individuals,' says Lon von Hurwitz, President & CEO of World Health Networks. 'We provide this service free of charge to both airports and passengers through associated sponsorships. Airports will therefore be able to offer their customers potential life-saving services.'

Furthermore, Mr von Hurwitz said,

Individuals can begin to take more control of their own personal health and wellness, and airports/airlines can also benefit their employees with this service on site. The sponsorship of the health stations allows prominent companies engaged in the healthcare industry to impart information about meaningful health products and services to a vast user base. It is expected that over 1 billion air passengers will have access to the health stations when fully deployed in the next two years. This audience also provides the enormous and dynamic opportunity for mobile applications and the portability of personal health records that will be subscriber supported.


The press release noted the involvement on nLIVEnHealthalong with Airport Marketing Income (AMI) too:

With successful installations already at JFK’s Jet Blue Terminal, Houston George Bush Intercontinental and Mineta San Jose International, WHN has teamed up with nLIVEn & Airport Marketing Income (AMI) to provide a unique advertising platform for one of Massachusetts’s leading Health Care providers, Steward Health Care System at Boston Logan International.

Little Known About the Intervention's Effects

So here was an intervention apparently meant to empower people to a healthier life style in a way that could "tackle heart disease" and even be "life-saving."  What was not to like?  Of course, none of these messages suggested the existence of any evidence that the intervention could change behaviors, and that the behaviors could reduce the prevalence or severity of heart disease, much less improve life expectancy.

Further was the goal here really to improve health outcomes, or to advertise?

I was unable to find anything resenbling systematic evidence about health outcomes, but did find a January, 2014 blog post offering a somewhat jaundiced review from a marketing expert who traveled through Logan Airport.

If you travel through Boston Logan Airport, you know that Dunkin Donuts ads and banners are quite prevalent. If you’ve been through there lately, you may also be aware that Steward Healthcare has launched a Health & Wellness Sponsorship Program. The last couple of times that I flew in through the JetBlue Terminal I came into contact with the campaign. The first thing I noticed were Steward Healthcare announcements over the public address system. It struck me that the oxymoron presented by Steward’s health & wellness campaign and the Dunkin Donuts marketing speaks to the challenges we have as a society when it comes to healthy living. Of course, the other thing that struck me is that Steward’s campaign feels a lot more like a branding initiative rather than a true health and wellness program. As a frequent business traveler, the last thing I need is for a health system to tell me that I need to do more walking in airports – and from my observations, that is the primary thrust of the marketing campaign.

So apparently fast food powerhouse Dunkin Donuts was also in on this action, causing the blogger some cognitive dissonance, given the caloric content of their offerings.




(Dunkin Donuts shop in Peru)


As a somewhat frequent flier, I also agree that urging someone running through the airport to walk more seems a bit over the top.


So to summarize the story this far, a bunch of corporate entities, World Health Networks, nLIVEnHealth, and Airport Marketing Income teamed up to create a supposed health intervention that appeared more like an advertising campaign for its sponsors, for-profit hospital chain Steward Healthcare, and apparently fast food giant Dunkin Donuts.  World Health Networks boasted of the potential to reduce heart disease and even save lives, without providing any evidence to support these claims.  

After that in 2014, all was silent.  What happened to World Health Networks? I saw no further media coverage of this new innovation, much less publication of clinical evidence of its effects, until....

World Health Networks, Trump Organization Associates Felix Sater and Daniel Ridloff, Kazakh Fugitives, and Visas - Oh My

On July 21, 2017, McClatchy published a long investigative piece that provided a disconcerting followup.   It opened thus:
Two former associates of Donald Trump helped a family of wealthy Kazakh fugitives make extensive investments in the United States, some aimed at helping family members obtain legal residency here, a McClatchy investigation shows.

Felix Sater, an ex-con and one-time senior adviser in the Trump Organization, helped the Trump family scout deals in Russia. He led an effort that began in 2012 to assist the stepchildren of Viktor Khrapunov, who that year had been placed on an international detention request list by the global police agency Interpol.

Khrapunov is the former Kazakh energy minister and ex-mayor of Almaty, that nation’s most populous city. He fled to Switzerland a decade ago, after Kazakhstan’s leaders accused him and his wife of stealing government funds. They are now accused in civil lawsuits of laundering money through luxury properties, including Trump-branded condos in the Soho neighborhood New York.

McClatchy’s probe reveals that with the help of Sater and his then-business associate Daniel Ridloff, also formerly affiliated with the Trump Organization, the Khrapunov family invested millions in a short-lived company that sought to place biometrics machines in airports across the country.

The real aim of Khrapunov’s investment was obtaining US residency for at least one member of the family; the company submitted, with the help of the onetime Trump associates, at least three requests to obtain visas for foreign workers.

The McClatchy investigation reveals a deeper relationship than previously known between the former Trump Organization figures and the fugitive Khrapunovs — underscoring how little is known about many of those involved with the Trump Organization.

There is no evidence that Trump himself participated in the courting of the Khrapunovs, but the affair sheds light on the often murky activities of the associates with whom he did deals at home and abroad.

Oops.  The "short-lived company" that allegedly served as a vehicle for the sketchy Kazakhs to obtain visas was none other than World Health Networks, viz:

On the surface, a multimillion dollar investment by the Khrapunovs in a New York-based health technology company would appear to make little sense.

World Health Networks was formed from the ashes of a failed firm that had created health monitoring kiosks placed in pharmacies. The new company aimed to put similar devices in airports across the world, but first it needed capital.

Enter Sater. He was representing the Khrapunovs, who were looking for US investments, and was introduced to executives of World Health Networks through an intermediary who attended the same synagogue on Long Island, according to a person with intimate knowledge of the deal.

Company executives made a pitch to the Khrapunovs in April 2012, according to documents reviewed by McClatchy, and court documents show that the money started flowing into the New York firm soon after.

World Health Network’s business model evolved over the course of its short existence, from an early plan to attract sponsorships from health insurance companies to a later plan to sell advertising space on the machines.

'It was definitely a real company,' said Ken Williams, who helped develop the firm and sat on its board.

Sater installed Ridloff as the company’s chief operating officer, according to former employees who demanded anonymity because of several ongoing lawsuits.

McClatchy explained how World Health Networks could have been used to obtain visas for the Khrapunovs....

This much is known: Ridloff submitted three visa applications for highly skilled workers on the company’s behalf between March 2013 and March 2014, all seeking to hire foreign budget analysts.

Stopped on the street as he left his Manhattan office, Ridloff confirmed to McClatchy that the investment by the Khrapunovs – ultimately $6 million, according to court records -- was aimed at securing Kudryashova, Viktor’s stepdaughter, legal residence in the United States.

The company partnered with the Swiss-based World Heart Federation and managed to place its machines in several airports, including Detroit, San Jose and Sacramento, Calif. But former employees confirmed its revenue couldn’t keep pace with expenses.

The company spent liberally on international travel and a bloated payroll, they said, and it folded soon after funding from the Khrapunovs dried up in late 2014.

It’s unclear the visas were ever issued, or whether the Khrapunovs obtained legal U.S. residence through any other means. The State Department and Homeland Security did not immediately provide documents requested under the Freedom of Information Act about World Health Networks’ visa applications.

Elvira Kudryashova listed a Newport Beach, Calif., address on a 2016 incorporation document for an upscale toy store she owned called Anthill shopNplay. The property in Newport Beach was sold later the same year.
Note further that

On paper, Donald Trump’s business relationship with Sater ended almost a decade ago. But earlier this year, Sater re-entered Trump’s orbit when he and Michael D. Cohen, one of Trump’s personal lawyers, were involved with a Ukraine-Russia peace proposal that was presented to Michael Flynn, then Trump’s national security advisor.

Also,

This as Bloomberg reported Thursday that Trump Soho in New York, where the Khrapunovs invested, were among several Trump businesses being looked at by former FBI Director Robert Mueller in his probe of possible collusion between Russia and the Trump campaign in 2016.

Also,

Several key people in Trump’s orbit did business with the Kazakh clan, including the law firm of Trump campaign surrogate Rudy Giuliani and the Bayrock Group, which developed Trump-branded projects in New York, Florida and Arizona and was founded by Tevik Arif, a politically-connected former Soviet official from Kazakhstan.

Lincoln Mitchell, a political consultant who specializes in Russia and its neighboring countries, said virtually any investment from Kazakhstan warrants scrutiny.

'It would be hard to imagine getting Kazakh investment that wasn't close to the ruling family,' Mitchell said in a telephone interview from the former Soviet republic of Georgia.

Nursultan Nazarbayev has ruled resources-rich Kazakhstan since 1989, placing his children and their spouses in top government posts. Some of his family assets have been frozen in Switzerland, and a U.S. Justice Department settlement in 2015 spotlighted how bribes paid to senior Kazakh officials ended up in offshore accounts belonging to the Kazakh government.

Finally,

Both Sater and Ridloff had worked for Bayrock before joining the Trump Organization, Sater being one of its managing partners. Later, the two men facilitated the purchase in 2013 of three condos in the Trump SoHo for $3.1 million by companies tied to the Khrapunov children, Ilyas Khrapunov and Elvira Kudryashova. In 2012 and 2013 alone, Sater and Ridloff worked with the Khrapunovs on more than $40 million in real estate and investment deals. All came after Kazakhstan added Viktor to the Interpol wanted list in February 2012. Later, the former Trump associates and their Kazakh investors appeared to have a falling out, becoming mired in acrimonious lawsuits that ended in secret sealed settlements. Yet their business relationship appears to have continued after the settlements, and they continue to maintain a friendship via social media. Viktor Khrapunov’s wife, Leila, would be added to the Interpol wanted list later in 2012, and stepson Ilyas was added in May 2014.

The Khrapunovs – who declined to answer detailed questions from McClatchy — maintain that they are the victims of political persecution by the despotic Nazarbayev, who once offered Viktor the post of prime minister before their falling out.



Please note that based on the McClatchy article, whether the Khrapunovs were criminals or innocents fleeing from a despotic regime is not known. Or could the dispute between the regime and the Khrapunovs represent a falling out amongst cronies? Nor is it known whether top leaders of the Trump Organization, or Mr Trump himself, knew all the ramifications of what was going on.

Nonetheless, there at least appears to be a good argument that the World Health Networks' funding from the Khrapunovs depended on its potential ability to obtain visas for them and their family. Probably other aspects of its operations, including any ability to innovate in the health care sphere, were at best side effects of the main goal, and at worse window dressing.  When the company's main reason for being evaporated, so did it, and so did any chances for health care innovation, much less tangible health benefits to anyone.

But sic semper to most media hyped commercial health care innovations?  World Health Networks absorbed a lot of money, perhaps produced some visas useful to people with good or bad or indeterminate motives, produced no meaningful improvments in public health, and quietly died.  What was the use of it all?

Summary and Discussion

As we have previously discussed, based on the doctrines of neoliberalism or market fundamentalism, the US health care system is increasingly dominated by for-profit corporations.  The practice of medicine is increasingly corporate.  Hospitals and hospital systems are increasingly owned by for-profit corporations.  Health insurance is increasingly provided by for-profit companies.  Drug, device and biotechnology companies have been almost entirely commercial for a long time.  And touted as  sources of innovations, there are entrepreneurial start-ups everywhere offering new products and services.  All of this has been happening in a climate of deregulation, laissez faire, and laissez les bon temps roulez.

It may be that all this has produced a lot of innovation, but very little of it has proved to be capable of meaningful improvement in patient or public health outcomes.

Admittedly, the story above may be an extreme example.  However it does suggest that in a laissez faire envirnoment, an awful lot of churn is generated by fast buck schemes, some of which may not be entirely honest, or legal.  Furthermore, the tides of money rolling through the system may be attracting people much more interested in short-term returns than health care outcomes.  So we spend more and more, perhaps producing innovations, but without much obvious improvement in patients' or the people's health.

True health care reform might involve decreasing commercial involvement in selected aspects of health care, increasing transparency about the business operations of all health care organizations, and insisting that health innovations not be widely adapted without good clinical evidence that their benefits outweigh their harms.

For our musical interlude, The Cars, "Let the Good Times Roll," live