Sunday, August 20, 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.


 

Sunday, August 13, 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.  

Monday, 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. 

Thursday, 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




 

Thursday, July 20, 2017

Who Benefits from our Current Health Care Dysfunction? - Mallinckrodt's Leadership Maintains Impunity After Well Publicized Opioid Settlement

The Latest Mallinckrodt Settlement

Jeff Sessions, the current US Attorney General, is ginning up a lot of press coverage of his recent crackdown on makers of narcotics.  For example, per the Washington Post on July 11, 2017...

The Justice Department and Mallinckrodt Pharmaceuticals reached a $35 million settlement Tuesday to resolve allegations that the company failed to report signs that large quantities of its highly addictive oxycodone pills were diverted to the black market in Florida, where they helped stoke the opioid epidemic.

The agreement is the first with a major manufacturer of the opioids that have sparked a crisis of overdoses and addictions across the country. The Justice Department said the deal establishes 'groundbreaking' new standards that require the company to track its drugs as they flow through the supply chain to consumers in an effort to control the epidemic.

The company had argued that once it passed the drugs to wholesale distributors, it was not responsible for illegal diversion of the painkillers as they were sent to retailers and then pain patients.

'The Department of Justice has the responsibility to ensure that our drug laws are being enforced and to protect the American people,' Attorney General Jeff Sessions said in a statement. 'Part of that mission is holding drug manufacturers accountable for their actions. Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street.'

A Slap on the Wrist with a Wet Noodle

Hold them accountable? With a $35 million dollar settlement? That should really strike fear into the hearts of evil-doers.  After all, this settlement is tiny compared to the magnitude of the behavior.

At one point, the government calculated that it could have assessed the company $2.3 billion in fines for nearly 44,000 violations of the federal Controlled Substances Act, according to confidential government documents obtained by The Post.

And,

Between 2008 and 2012, about 500 million of Mallinckrodt’s pills ended up in Florida, 66 percent of all oxycodone sold in the state, The Post reported.

Nearly 180,000 people died of overdoses of prescription painkillers between 2000 and 2015, and the abuse of pharmaceutical opioids is widely blamed for a crisis that now involves many thousands of overdoses on heroin and fentanyl.

Then, the settlement is tiny compared with the company's revenues.  For example, according to a recent company press release, Mallinckrodt had

Fiscal 2016 net sales of $3.381 billion, up 15.7%, principally driven by volume in Specialty Brands;...

Furthermore, the settlement let the company deny wrongdoing, stating

'While Mallinckrodt disagreed with the U.S. government’s allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,' Michael-Bryant Hicks, the company’s general counsel, said in the release.

In addition, as we have seen in many other legal settlements arranged by US authorities, no individual at the company who oversaw, authorized, directed, or implemented the questionable actions paid any penalty. In fact, top executives at Mallinckrodt continue to make out like proverbial bandits.  Earlier this year the St Louis Post-Dispatch reported:

Mallinckrodt Chief Executive Mark Trudeau's pay jumped 29 percent to $12.6 million as the company rewarded him for a year when profits more than doubled.

Mallinckrodt, a drug company that is legally Irish but has its headquarters in Hazelwood, disclosed details of its executive pay in a proxy statement last week.

Trudeau's pay included a salary of $1.04 million and a bonus of $1.6 million, which was 127 percent of the target amount. He also received $5.9 million in stock and $3.9 million in options, with some of the stock depending on Mallinckrodt's revenue growth and total shareholder return between 2016 and 2018.

An earlier stock award, from 2014, paid out at 200 percent of its targeted amount. That brought Trudeau shares worth $2.5 million at current prices.

Trudeau also received $101,003 in contributions to a supplemental savings plan and $16,535 in tax reimbursement. The tax reimbursement was for executives whose spouses or partners attended a national sales conference.
So Mr Sessions  thought he was holding them accountable?

At least the Washington Post coverage added some dissent,

Joseph T. Rannazzisi, who supervised DEA efforts to control diversion of opioids for a decade before he retired in 2015, said Tuesday that multimillion-dollar fines have not deterred large pharmaceutical corporations accused of failing to report suspicious orders of pain pills to the DEA.

'These fines mean nothing to Fortune 500 companies,' he said. 'Large corporations see these fines as the cost of doing business. Unless there are meaningful sanctions brought against these companies, they will continue to violate the law.'

So the extremetly lenient treatment of Mallinckrodt and its top executives in this case will likely not deter health care corporate leaders from pursuing future bad behavior that is in the their self-interest.  Plus this case provides another example of the impunity of big health care organizations and their top executives. 

Just the Latest Mallinckrodt Settlement

And wait, there is more.  The latest settlement did not seem to be informed by any knowledge of the company's previous transgressions.  Like many other big health care organizations, Mallinckrodt and its predecessors have a long history of bad behavior which at worst has resulted in previous lenient settlements, wrist slaps, and executive impunity.  Consider some examples from this decade alone. 

The 2013 Settlement of Kickbacks to Doctors

As we noted in this post, for a few million dollars, Mallinckrodt settled allegations that it gave kickbacks to physicians to prescribe its antidepressants and sleeping tablets.

The 2015 Questcor Shareholder Suit Alleging Deception

As reported by the St Louis Business Journal,
Mallinckrodt PLC (NYSE:MKN) has announced a preliminary $38 million settlement in a shareholder lawsuit related to Questcor Pharmaceuticals Inc.

The settlement is pending approval by the U.S. District Court for the Central District of California. Mallinckrodt, a Dublin, Ireland, company with its U.S. headquarters in St. Louis, acquired Questcor in 2014 for $5.6 billion.

The settlement would resolve a class action lawsuit brought against Questcor alleging misstatements from former company officers and directors related to H.P Acthar Gel. Acthar, a drug used to treat autoimmune and inflammatory conditions, generated net sales for Questcor of $761.3 million in 2013.

Again, no individual who presided over, authorized, directed or implemented the misstatements suffered any negative consequences.

Note that H. P. Acthar gel, when marketed by Questcor, was one of the earliest examples of a company gaming the system to increase the prices of an old drug to outrageous levels (see our posts here).

The Questcor Anti-Competitive Practices Settlement

Then in early 2017 Mallinckrodt settled a case involving unfair competition, as reported by Reuters,

Mallinckrodt Plc (MNK.N) has agreed to pay $100 million to settle allegations that a subsidiary broke U.S. antitrust law by sharply increasing the price of a multiple sclerosis drug while ensuring that no rival medicine appeared on the market, the Federal Trade Commission said on Wednesday.

Mallinckrodt's share price dropped sharply to just under $43 from above $49 on a report Wednesday, which proved incorrect, that the FTC would sue Mallinckrodt. It spiked above $50 after news of a settlement and closed at $46.53, down 5.8 percent.

In 2001, Questcor bought the rights to Acthar, a type of hormone-based drug used to treat infantile spasms as well as multiple sclerosis. Over time, the company raised the price from $40 per vial to more than $34,000, the FTC said. Questcor was acquired by Mallinckrodt in 2014.

Acthar, which is off patent, represented 34 percent of Mallinckrodt's $3.4 billion in net sales for fiscal 2016, the company said in a government filing.

Per patient, Medicare spent more on Acthar than for any other drug in 2015, putting out $504 million for just 3,104 patients, according to the Medicare Drug Spending Dashboard.

Several U.S. drug makers have been criticized for sharp increases in drugs, notably Turing Pharmaceuticals' Daraprim and Mylan's (MYL.O) EpiPen. The U.S. Centers for Medicare and Medicaid Services reported 11 drugs saw price increases of more than 100 percent in 2015.

'This is an egregious case of a monopolist doing a deal to eliminate potential competition and keep its power over pricing. It is abhorrent that lifesaving drugs cost New Yorkers tens of thousands of dollars,' said Attorney General Eric Schneiderman in a statement.

Again, Mallinckrodt denied all wrongdoing,

'We continue to strongly disagree with allegations outlined in the FTC's complaint, believing that key claims are unsupported and even contradicted by scientific data and market facts,' a company representative said in a statement.

And of course, to repeat, no one at the company who presided over, authorized, directed or implemented the anti-competitive practices suffered any negative consequences.

After that settlement, Sy Mukherjee wrote in Fortune that the

$100 million fine [was] for purposefully maintaining a monopoly on a drug that brought in one third of Mallinckrodt's $3.4 billion net 2016 sales. Although Mallinckrodt will have to sell off its U.S. license for the competing Novartis therapy, it has no obligation to lower Acthar's list price or hit pause on the price hikes since drug makers have carte blanche over their pricing in the U.S.

This highlights a critical moral hazard in the biopharma industry and the system of using fines to punish bad actors. Back when I was the editor of the trade publication BioPharma Dive, I had a fascinating conversation with Patrick Burns, Acting Executive Director and President of Taxpayers Against Fraud, a group that brings forward whistleblower cases under the anti-fraud False Claims Act. Burns argued that fines are ultimately ineffective because in the U.S., we 'privatize the profits and we communitize or communize, if you will, the costs.'

What Burns means is that, ultimately, news of a big fine can cause a short-term (and relatively insignificant) dent in a company's revenue stream and some PR backlash that can drive its stock price down (Mallinckrodt's shed about 7% of its market cap since the settlement). But ultimately, most of the people who suffer from that stock dip are the public and investors, not the executives who chose to engage in the bad behavior in the first place. That helps explain why some drug companies have been repeat offenders on practices like bribery and kickbacks.

Burns presented a much more provocative alternative to the fines system: ban the executives responsible for the fraud or other bad behavior from working in the industry for a number of years, or actually send them to jail.

Of course, that would be hard to do as long as our top political leaders are the best buddies of the multi-millionaires and billionaires who run the big pharmaceutical companies and other huge health care organizations that generate our health care dysfunction.


Summary and Discussion

Mallinkcrodt made settlements of four legal cases since 2010, involving kickbacks to physicians, various deceptions, and anti-competitive behavior.  The settlements never involved severe enough penalties to the company to really affect its bottom line, never required admission of responsibility, or any accountability by top executives whose huge remuneration were doubtlessly based on the revenues brought in by bad behavior.  Yet US Attorney General continued the Kabuki performance by proclaiming he would "hold them accountable."  Sessions just slapped the company on the wrist again, with a wet noodle.

That will show them.

This shows that despite all the hoopla lately about health care reform, our political debate completely misses most of the causes of our health care dysfunction.


There is suddenly a brief lull in the ongoing battle about whether to "repeal and replace Obamacare."  This was cast as a health care reform debate, but really at best "Obamacare" (the Affordable Care Act, or ACA) was a somewhat jury-rigged attempt to increase health insurance coverage without any substantial decrease in the US dependence on large often locally dominant for-profit insurance companies to provide health care insurance.  There was no serious discussion of alternatives, including "single-payer" government health insurance, much less a return to smaller non-profit insurance which might have some local accountability (see this post about Wendell Potter's Deadly Spin for an account of how non-profit insurance executives sold their organizations out to for-profits, greatly personally profiting from the process).

Even more to the point, there was no serious discussion of why US health care is the most expensive in the world, yet provides thoroughly mediocre service and outcomes, and still leaves many patients uninsured (see this LA Times article summarizing the latest Commonwealth Fund  report).

But while so many people are making fortunes from the current system, and are able to use their money to influence the ongoing debate, do not expect much change.  The case above is just one example showing how executives of big health care corporations can make millions while avoiding accountability for their actions.


As I have said until blue in the face,...

We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it.  True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why.  But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position.  It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public. 

Monday, July 17, 2017

Inexact Sciences

Thoughts on the place of science in an era of false conviction

Some recent articles, noted by a few of us in journals regularly monitored by HCR bloggers, provide real food for thought in our New World Order of alternate facts, fake news and truthiness.

In a recent number of the still intrepidly pay-wall-free Guardian,  development economist John Rapley summarizes his new book Twilight of the Money Gods. This summary is the best we in the colonies can do until this month's UK publication of the full volume makes it to our shores. (Rapley, a true globalist, both an academic and a public intellectual experienced at teaching in several countries, is also a not infrequent Guardian contributor.)

Comes Rapley now to hammer home the point that research domains--his focus is economics--can ossify to the point that they become more like religions or belief systems, pace Mary Douglas's classic work Purity and Danger, than anything resembling exact sciences. By abandoning humility to project rigor and group-think, they undermine their own credibility. Think about the following statements, then, and mentally substitute "academic medicine" for economics.
"... [academic] departments were increasingly hiring and promoting young economists who wanted to build pure models with little empirical relevance."
One thinks, for example, about all the spurious metrics currently being applied to the assessment of "meaningful use" in electronic health records. Rapley goes on to elaborate and pose a partial solution. He notes that...
"...[w]hen the church retains its distance from power, and a modest expectation about what it can achieve, it can stir our minds to envision new possibilities and even new worlds. Once economists apply this kind of sceptical scientific method to a human realm in which ultimate reality may never be fully discernible, they will probably find themselves retreating from dogmatism in their claims.
By "power" one can read the unholy alliances with Big Money and managerialism oft-decried in HCR. By "retreating from dogmatism" one can read a renewal of alliances instead--well, let's go with Rapley's words: with "...social, demographic and anthropological work, and [the need] to work more closely with other disciplines."

His solution, then, through such alliances, is the restoration of narrative to a central role for poo-bahs of some of the more overly sterile reaches of EBM, medical informatics, and decision analysis. He quotes the authors of the recent Phishing for Phools, for whom "storytelling is a 'new variable' for economics, since 'the mental frames that underlie people’s decisions' are shaped by the stories they tell themselves."

Harvard cardiologist Lisa Rosenbaum, who's produced some admirable and at times controversial writing for years in NEJM and elsewhere, has a new piece that appeared simultaneously with Rapley's. She offers a way of refracting some of these same ideas through the lens of scientific medicine--or, more particularly, the crisis of trust by a "weary public" in the scientific process. Dr. Poses, in these e-pages of HCR, has frequently addressed this same issue of relativism where, to use Rosenbaum's example, people (this includes people with major political power in today's US of A) will be damagingly dubious about issues such as climate change. Yet at the same time we seem them devouring (so to speak) the claims of nutritional charlatans. Here I suppose she's speaking mainly of the views of those who both fund and popularize medical science, and the way the traditional establishment of science has been dethroned or at least, by many, seriously questioned.

It's a conundrum. The mandarins of science build their ivory tower and labor mightily in the effort of boundary maintenance (says Rapley); and yet they've lost ground (says Rosenbaum). "The fear of venturing into the fray," she observes, "means that the public hears far more from science’s critics than its champions. This imbalance contributes to 'science is broken' narratives ranging from claims about the pervasiveness of medical error to the insistence that benefits of our treatments are always overhyped and their risks underplayed."

Yet the prescriptions Rapley and Rosenbaum both offer seem rather similar: go back to telling the story. And here one can only agree most heartily. Telling the story works at two levels. At the level of domain knowledge, whether we're talking about economic behavior, clinical decision making, or the interpretation of Big Data, we need more interdisciplinary efforts to connect the dots between physiological, psychological, social and economic processes. And, then, at the level of telling the story about science itself--something about which Rosenbaum herself is greatly concerned--individuals in all the domains of science and medicine need to "learn to tell stories that emphasize that what makes science right is the enduring capacity to admit we are wrong. Such is the slow, imperfect march of science."

Thursday, July 13, 2017

Gutting the Health Care Corporate Strike Force

Health care corruption is a severe problem in the US, and globally.

For years, we have ranted about the US government's lackadaisical - to use an execessively polite term - approach to wrongdoing by big health care organizations.  The trend really got started back in the day when now Governor Chris Christie (R - NJ), then a federal prosecutor, started making deferred prosecution agreements available to corporations which appeared to have committed white collar crimes.  However, these agreements were originally meant to give young, non-violent first offenders a second chance.

Since then, 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  multibillion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

The Health Care Corporate Strike Force

The US Department of Justice during the Obama administration made some modest attempts to decrease such impunity.  One such measure was the formation of a Health Care Corporate Strike Force.

As reported by Law.com,

the strike force was created in the fall of 2015, with five dedicated lawyers working on about a dozen of the most complex corporate fraud cases in the health care space.

Andrew Weissmann, the then-chief of the DOJ’s fraud section, told a health care conference in April 2016 that the section was placing 'a heightened emphasis' on corporate health care fraud investigations. He pointed to the recently established Corporate Fraud Strike Force that he said would focus resources in investigation and prosecution of larger corporate health care law violations, as opposed to smaller groups or individuals.
The Downsizing of the Health Care Corporate Strike Force

But now, after candidate Donald Trump promised to 'drain the swamp,'





and railed against the supposed corruption of former Secretary of State Hillary Clinton (leading tochants of 'lock her up'), the Trump administration will further diminish this tiny attempt to reduce impunity, the Law.com report stated:

the DOJ, under the Trump administration and new U.S. Attorney General Jeff Sessions, has announced new priorities: violent crime, drugs and illegal immigration.

In restructuring to focus on those priorities, the DOJ has gutted the Health Care Corporate Fraud Strike Force, according to at least two high-level sources who worked at the Justice Department until recently. The sources declined to be named, as being identified could affect their current jobs and clients.

The sources said the strike force has been cut from five full-time lawyers to only two – assistant chief Sally Molloy and trial attorney William Chang. And both are splitting their time in the strike force with other duties.

The DOJ declined an interview request for this story. But DOJ spokesperson Wyn Hornbuckle issued this statement: 'The Health Care Corporate Strike Force, as with the entire health care fraud unit, is going strong under steady leadership—continuing to vigorously investigate and hold accountable individuals and companies that engage in fraud, including tackling an opioid epidemic that claimed 60,000 American lives last year.'

The Task Force had resolved one major case against for-profit hospital chain Tenet.  The Task Force alleged but Tenet actually admitted its

supervisors lied to in-house counsel about the purpose of millions of dollars in contracts, which purportedly were for 'services' but really were bribes and kickbacks to clinics and doctors for sending Medicaid patients to Tenet hospitals.

While its settlement included a non-prosecution agreement, the Task Force actions also resulted in two convictions and a pending indictment of actual people.

Still,

The lawyer openings on the strike force were exacerbated when, on April 14, Sessions imposed a hiring freeze on the DOJ’s Criminal Division as well as on U.S. Attorney Offices, as reported by The New York Times, which obtained a copy of the freeze memo.

Some DOJ lawyers believe, sources said, that white-collar crime and corporate fraud resources are being shifted to cover Sessions’ new priorities of violent crime, drugs and illegal immigration. That emphasis, they said, can be seen in who runs the DOJ’s criminal division.

Under former U.S. Attorney General Eric Holder, himself a white-collar crime prosecutor and then corporate defense attorney, assistant attorney general Leslie Caldwell led the division. Caldwell specialized in securities fraud and white-collar crime, and had participated in the Enron Corp. prosecution.

Under Sessions, himself a former law and order prosecutor in Alabama, the criminal division now reports to deputy assistant attorney general Kenneth Blanco. Blanco has a long history of bringing cases centered on drugs and violent crime in the Miami-Dade State Attorney’s Office, in the U.S. Attorney’s Office in Southern Florida, and in Main Justice in Washington, D.C., where he served as chief of the narcotic and dangerous drug section at the DOJ.

Discussion

So the Trump administration proposes two part time attorneys to drain the health care corporate swamp.  That seems like bailing out the Titanic with teaspoons. But should we expect anything else from an administration that is being increasingly identified with corruption and impunity itself?

We have frequently discussed outright corruption in health care as one of the most important causes 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.

The report did not get much attention.  Since then, health care corruption has been nearly a taboo topic in the US.  When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries.  On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic,. presumably mainly because its discussion would offend the people made rich and powerful by corruption.

As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,  there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure.  In the TI Report itself,

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.


I might as well repeat myself once again.  As I wrote in 2015, if we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.

Musical Interlude

What else, the Honey Island Swamp Band, playing "Prodigal Son,"