Will Trump's Leadership Picks Smack Down Health Care? - A Drug Company Lobbyist, an Entrepreneur Who Wants to Weaken Drug Testing, and a Mysterious Billionaire Who Settled Fraud Charges

President Trump in his inauguration speech promised to reach out to "struggling families" and to benefit "American workers and American families," and promised all Americans "you will never be ignored again."  Yet the Trump transition team, and now presidential administration continues to consider individuals for health care policy leadership roles remarkable for their conflicts of interest, which often did not merely arise from small financial transactions but from their roles as corporate insiders, and in some cases, association with dubiously ethical practices.  They are particularly remarkable for their lack of interest in, if not ignorance of American workers' and families' health, except perhaps as a vehicle for personal profit. 

Discussed in order of increasing potential power.

Jack Kalavritinos for FDA "Beachhead Team"

As reported by StatNews (unfortunately behind a paywall) on January 19,

Former pharmaceutical lobbyist Jack Kalavritinos, who also worked in various capacities for the George W. Bush administration, will take a major role on the 'beachhead' team that the incoming Trump administration is sending to run the Food and Drug Administration following Friday’s inauguration, transition team sources say.

Kalavritinos spent seven years as director of global lobbying for the Irish pharmaceutical and medical device company Covidien, which sells a wide array of hospital supplies around the world.  The US company Medtronic bought Covidien in 2014 and promptly moved its headquarters to Ireland, which had a lower corporate tax rate.

Mr Kalavritinos worked in Department of Health and Human Services as the Director of the Office of Intergovernmental Affairs as until 2007 before moving to Covidien in 2008 (look here), and stayed until 2015 (look here).

Thus he is a frequent traveler through the revolving door, going from the Department of Health and Human Services to Covidien, and now back to the DHHS.  Some experts consider the revolving door to be a form of health care corruption (look here).

Further note that he secured this new position despite the fact that he worked in a leadership position at Covidien during its "tax inversion":

Such 'inversions' - deals structured to let American companies take advantage of lower tax rates overseas - began to draw heavy public ire around the time of the Medtronic-Covidien deal.  The Obama administration has sought to crack down on such transactions with new rules from the Treasury Department.

President ... Donald Trump seemed to be referring to such deals, as well as the outsourcing of manufacturing, when he recently accused the pharmaceutical industry of 'getting away with murder.'

Finally, note that Medtronic has quite a history of misbehavior, as documented here, including settling multiple cases alleging its use of kickback, and hiding device safety information. 

Thus, Mr Kalavritinos has been a corporate insider for years, and an insider of a corporation which used financial maneuvers and apparently unethical actions for financial benefit.  In his track record are no indications he has any particular interest in improving the health of American workers and American families. 


Dr Joseph Gulfo for Commissioner of the Food and Drug Administration

Dr Gulfo appears to be the latest person to be vetted by the Trump administration to be FDA Commissioner.  As reported by the Boston Business Journal on January 24,

In an interview today, Dr. Joseph Gulfo — an author and former CEO of drug and medical device companies — confirmed that he has spoken with two members of President Donald Trump’s transition team about being the named commissioner of the Food and Drug Administration.

While Dr Gulfo is a physician, it seems he has not practiced in years.  Instead, he has mainly been an entrepreneur and executive.  As noted in his online biography,

Dr. Gulfo has more than 25 years of experience in the biopharmaceutical and medical device industries. As President & COO of Anthra Pharmaceuticals and Chairman of its UK subsidiary, he was responsible for the 1998 NDA approval of Valstar, a drug for superficial bladder cancer, which had sales of $27 MM in 2012, 14 years after its approval. Dr. Gulfo was also instrumental in the development of ProstaScint (Cytogen Corporation), a BLA-approved monoclonal antibody for prostate cancer. He was CEO and Chairman of Antigen Express, an immunotherapy and immunodiagnostics company in the field of vaccines for cancer therapy, antiviral therapy, and asthma, and led its merger. In 2012, he received the American Business Awards’ Maverick of the Year Award....

Note that his personal biography emphasizes the sales of the drugs his companies sold, not their benefits to patients.

More recently,

he served as President & CEO of MELA Sciences (2004-2013), and was Chairman of the Board (2011-2013).

Currently,

 He is Executive Director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University (FDU) [within the School of Pharmacy and Health Sciences].

His personal biography did not explain how any of his products or corporate accomplishments improve health of American workers of families.

So were he appointed, Dr Gulfo might be considered as transiting the revolving door, with implications as above.  Again, Dr Gulfo did not merely have financial relationships with health care corporations, but was top executive of several corporations, and thus was obviously a corporate insider.

Furthermore, as former top executive of multiple pharmaceutical and biotechnology companies, Dr Gulfo seems interested in making FDA standards for drug approval more lenient.  In particular, he has argued for approving drugs based only on their ability to make patients' "biomarkers," that is laboratory test results that may be correlated with clinical outcomes or patient-centered outcomes, but not absolutely.  So he would allow drugs that have never been shown to improve symptoms or functional status, or to reduce disease morbidity, complications, or early death. And it is likely that many drugs approved in this manner would never be proven to have any such benefits.  But all drugs have side effects, so this policy would expose patients to risks, without the chance of obtaining any benefits.  This is not what one should really call patient-centric.

Nothing in his track record suggests any great interest in the health of American workers and American families, except as consumers of his products.


Dr Patrick Soon-Shiong for "Health Care Czar"

As StatNews reported on January 24, 

Dr. Patrick Soon-Shiong, an audacious biotech billionaire who has pledged to 'solve health care,' has been in talks with the Trump administration about the possibility of serving in a senior role overseeing the US health care system, according to individuals familiar with the discussions.

Soon-Shiong, a trained surgeon, has met with President Trump and his advisers at least twice in recent weeks. During those discussions, he raised the possibility that he could serve as a 'health care czar' with a broad portfolio in the administration as it seeks to reshape the health care system and replace the Affordable Care Act, according to two individuals, who spoke on the condition of anonymity.

Far from solving health care, Dr Soon-Shiong seems known for making inflated claims that are never borne out.

In the early 1990s, Soon-Shiong claimed that he may have cured diabetes in a patient named Steven Craig by implanting cells that secrete insulin. The treatment worked, for a while — launching an outpouring of media attention for Soon-Shiong’s diabetes company, VivoRx. But he faced criticism in ensuing years, as the results were not reproducible.

'It’s far too early to view this as a cure, or even a therapy,' Dr. James Gavin, then-president of the American Diabetes Association, once said of Soon-Shiong’s therapy. 'We don’t need this kind of inappropriate hype.'

So this may be why

he now has a reputation for talking more than doing. 'Every time I hear his name uttered by an academic oncologist, it’s with an eye roll,' Dr. Vinay Prasad, an oncologist at Oregon Health and Science University, told STAT late last year. 'If you asked a dozen oncologists what they think of him, his general reputation is that of a shameless self-promoter.'

In fact, his claims have gone from inflated to allegedly fraudulent,

Generic drugmaker Mylan had invested in VivoRx to support its diabetes work, but much of the money was actually used to support a separate company Soon-Shiong set up — VivoRx Pharmaceuticals, which researched cancer drugs instead. That resulted in a fraud lawsuit from Mylan and Terrence Soon-Shiong, Patrick’s business partner.

Patrick Soon-Shiong paid $32 million to settle the lawsuit.

Furthermore, while he apparently became a billionaire, there is some controversy about how he did so. As another StatNews article reported on January 25,

The core of Soon-Shiong’s enterprise is called NantWorks, from which at least 10 interconnected biotech companies have grown. Each has raised hundreds of millions of dollars, and each tends to make deals with other firms under Soon-Shiong’s umbrella.

But not one has successfully developed a drug, and investor enthusiasm has waned.

Nonetheless, apparently Dr Soon-Shiong has paid himself handsomely, presumably in part of using other peopeles' money:

But Soon-Shiong personally has done well. In 2015, NantKwest paid him more than $148 million in stock and options, and he still owns a roughly 50 percent share of the company. He also owns about 57 percent of NantHealth, according to a regulatory filing, a stake worth more than $500 million.

All told, Bloomberg estimates he’s worth $8.8 billion.

The one drug with which he is most identified was apparently just an old drug repackaged, but sold for a then extremely handsome price:

It seems a little quaint now: More than 10 years ago, Soon-Shiong’s signature cancer drug, Abraxane, came under fire for being too costly. The medical community was outraged at Abraxane’s $4,200 price tag, describing the drug as 'old wine in a new bottle' because it’s an updated version of the long-used chemotherapy drug paclitaxel. Of course, considering the pricing of cancer drugs today, that’s practically a bargain.

Thanks to the commercial success of Abraxane, Celgene bought Soon-Shiong’s company, Abraxis, for a stunning $2.9 billion. That’s where he got most of his wealth.

Note that Abraxane is simply paclitaxel "protein bound." While it was not very innovative, Dr Soon-Shiong made it very pricey, leading to his own financial benefit, but not clearly to big benefits for patients. 

So Dr Soon-Shiong is the ultimate corporate insider, a multi-billionaire corporate CEO, an "entrepreneur" who has mainly benefited from financial manipulation, a great "innovator" who has never developed an innovative product that actually has been shown to improve human health.  Again, there is nothing in his track record demonstrating concern for the health of American workers and American families. 


Summary

These latest examples show that the Trump transition team and now the Trump administration seem to have affinity for health care advisers and leaders with numerous and severe conflicts of interest, whose expertise may be more in marketing and public relations that biomedical science, medicine, public health, or health policy, and who are known to make outrageous claims, even to the point of carrying whiffs of fraud.  They are all rich corporate insiders.  The administration's latest flirtations include a former lobbyist for a biotechnology firm, and two non-practicing physician-entrepreneurs.  The former worked for a company with a long history of ethical lapses.  One of the latter has promised many breakthroughs, none of which has so far apparently panned out, and settled allegations of fraud.  Nothing made public about any of them at this point suggests that they have deep underlying concerns for patients' and the public's health. 

While their flamboyant histories may appeal to someone like Mr Trump, with his own history of outrageous marketing stunts, and of marketing dubious health schemes (look here), their potential to put the health needs of patients and the public first is not obvious.  None of the three people discussed above are credible candidates to lead any part of any US government agency involved in health, health care, or public health, in my opinion.  None of these three people displayed any great concern for patients' or the public's health, despite Mr Trump's fervent claims that he will not ignore American workers and American families.

To repeat, true health care reform requires well-informed leaders who uphold health care professionals' values, put patient's and the public's health ahead of all other considerations, avoid self-interest and conflicts of interest, are honest and ethical, and surely are not corrupt.  They need to work in the context of a government that is of, by and for the people, not of, by and for a demagogic leader.

US health care may be heading for not better health for American workers and families, but for a Trump administered smackdown, like the one he delivered on a professional wrestling show:




Maybe it would have been better had Mr Trump ignored us American workers and families.

Making Research Suppressed Again - US Secretary of Health Candidate Accused of Suppressing Clinical Research at Behest of Campaign Donor

Introduction - Research Suppression

An early impetus for us to start Health Care Renewal in 2004 was our perception that the integrity of clinical research was under threat.  In particular, we noted increasing number of cases in which  commercial marketing concerns seemed to result in the manipulation of clinical research to enhance the apparent attractiveness of specific products, usually drugs or devices.  When such manipulation failed to make products look good, research could be simply suppressed. 

My personal introduction to health care dysfunction was the case of my own supervisor and friend, Dr David G Kern, who ultimately lost his academic position because he refused to go along with the suppression of research he had done on a new occupational disease, research that offended the company at whose site the disease occurred (look here).

Per the tenets of evidence-based medicine, health care professionals and patients should rely on the results of the best clinical research, sceptically appraised, to make clinical decisions.  Suppressed or manipulated research could lead to bad decisions, hence patients failing to get the best tests and treatments, or getting unncessary or dangerous tests and treatments, and ultimately harming patients.

Since then, research manipulation and particularly suppression have become well known issues.  For example, the international AllTrials campaign aims to prevent suppression of randomized controlled trials.  Since these issues are now widely discussed, Health Care Renewal has not posted so much about them recently.

But suddenly it apprears that research suppression is again a national issue for the US.  Dr Tom Price,  just nominated by the Trump administration to be the US Secretary of Health and Human Services, the highest government health policy position, has been accused of involvement in an effort to suppress dissemination of clinical research at the behest of a campaign donor.  

Background - Bildil

Back in 2005, we posted about the strange story of the promotion of Bildil.  Briefly, Bildil is a fixed combination of two very old vasodilator anti-hypertensive drugs, hydralazine and disosorbide dinitrate.  Back in the 1980s, these two drugs were shown to prolong life for patients with congestive heart failure (CHF) and systolic dysfunction.  In 1991, another class of drugs, angiotensin converting enzyme (ACE) inhibitors (or ACEIs) were shown to better prolong life than hydralazine - isosorbide dinitrate.

In 2004, a company called Nitromed sponsored a trial of Bildil.(1)  It recruited only patients who self-identified as "black," and showed that the fixed combination of the two old drugs was superior to placebo in prolonging survival for patients already taking the current conventional therapy for heart failure (that now usually includes an ACE inhibitor or an angiotensin receptor blocker [ARB]).

There were some issues with that trial, as we noted in 2005, NitroMed got the US Food and Drug Administration (FDA) to approve a trial limited to only a single racial/ethnic group, but the US National Institutes of Health (NIH) has for years required clinical trials to include a broad selection of under-represented minorities (i.e., groups other than African-Americans), and prohibited exclusion of such groups unless there is a clear reason to do so. (See the policy here.) If NitroMed had included patients who were diverse in terms of race/ ethnicity, it might have been possible to see if hydralazine - isosorbide dinitrate actually works differently in patients with differing race/ ethnicities. But allowing only "black" patients in the trial prevented drawing any conclusions about whether the drug would work better, similarly, or not as well in, for example, Asian-Americans, Latinos, American Indians, and whites. 

Dr Tom Price, Arbor Pharmaceuticals, and the Attempted Supression of Dissemination of Clinical Research

Since then, Bildil has not sold well.  As ProPublica reported

The $3 pill [now] known as BiDil was already a difficult sell when a Georgia-based pharmaceutical company bought the marketing rights a few years ago. A treatment for African Americans suffering from heart failure, BiDil had never really caught on, forcing the drug company that developed it to take a buyout offer.

The issue was a study done in 2009.

The study led by Karl Hammermeister, a cardiology professor at the University of Colorado School of Medicine, and originally published in the journal Clinical Therapeutics in 2009, found that BilDil was not actually associated with a significant reduction in death or 2009 hospitalization.(2) The study found that in all but one of its test groups the drug was associated with significantly increased risk of hospitalization for heart failure.

The drug's new manufacturers had new ideas about marketing it.

So last summer, the new owner of the drug, Arbor Pharmaceuticals LLC of Atlanta, sought to get the study taken down from a government website. For help, the company turned to the office of a congressman to whom the CEO had given the maximum $2,700 campaign donation — Rep. Tom Price, the Georgia Republican nominated by Donald Trump to become head of the Department of Health and Human Services.

Over the next few months, one of Price’s aides emailed the federal Agency for Healthcare Research and Quality at least half a dozen times, asking at one point 'what seems to be the hold up' in getting the [2009 Hammermeister] study removed from the website, which aims to help patients, health care providers and policy makers make 'better treatment choices.' In the end, the agency, which is part of the Department of Health and Human Services, kept the study online but added a note: 'This report is greater than 5 years old. Findings may be used for research purposes but should not be considered current.'

In particular,

Gary Beck, a policy assistant to the congressman, first reached out to the federal research agency about the study in July, emails show. 'I have been in contact with representatives from Arbor Pharmaceuticals based in Georgia in regard to some issues they have with the study that is linked below,' he wrote, adding that the company told him 'the study might be outdated' and they wanted it removed from the website.

'I wanted to get in touch with you to get a better grasp on the situation and what seems to be the hold up,' Price’s aide wrote.

Francis Chesley, an official at the agency, responded to Beck, saying he would check into the matter. Three days later, Beck followed up again. Chesley told him the agency was examining its website archiving policy to ensure the public had access to up-to-date information, and offered to talk to the pharmaceutical company directly.

Beck then pressed him: 'Is it in the opinion of the Center for Evidence and Practice Improvement,' he wrote, referring to the division doing the review, 'that the BiDil study could be determined as out-of-date once the examination is completed?'

Beck sent four more emails over the next four months. In November, seemingly exasperated by the fact that the study was still online, he asked: 'Would someone else at AHRQ be able to provide me with an update to this situation?'

There was a big problem with this.  While the 2009 study is no longer new, it cannot be considered outdated, because it has not been superseded by new evidence.

Since 2009, there seems to have been little original research done on hydralazine - isosorbide dinitrate for CHF.  A 2013 Cochrane Collaboration systematic review (3) concluded there was no clear evidence that this combination was superior to other drugs for CHF.  A study done using a clinical registry (not a randomized controlled trial) published in 2016 also showed no advantage from the combination, particularly for black patients.(4)

Furthermore, ProPublica quoted

Jonathan Kahn, a professor at the Mitchell Hamline School of Law in Minnesota who wrote a 2013 book about BiDil’s fraught history, has been a critic of marketing BiDil as a race-specific drug, arguing it was pitched as such for legal and commercial reasons, not to improve patient outcomes. He said he hasn’t independently assessed the 2009 study posted by the federal agency, but added in an email, 'there is NO WAY this study is outdated. It is much more recent than the studies underlying the approval of BiDil itself.'

Nonetheless, Arbor Pharmaceuticals persisted in its efforts to get Rep Price's office to suppress the AHRQ's dissemination of the apparently still relevant results of the 2009 study, and Dr Price appeared to gladly cooperate. 



Summary

Dr Tom Price, was once a practicing orthopedic surgeon, now is a US congressman with important health care policy responsibilities, and the current nominee to be US Secretary of Health and Services, the highest health care policy position in the US government.  Now there are credible allegations that Dr Price, as a congressman, aided a pharmaceutical company owned by a campaign donor in the company's attempt to suppress relevant information from clinical research on the company's product because that information questioned the product's usefulness.

We recently discussed some of Dr Price's other apparent conflicts of interest, involving his ownership of health care related stocks.  It appears that Dr Price had another conflict of interest, in that he was taking campaign money from a pharmaceutical company while he had responsibilities as a legislator in the health policy arena. 

ProPublica also noted, 

Last month, The Wall Street Journal reported that Price had traded more than $300,000 in shares in health-related companies as he played a role in legislation that could have affected their share prices.

Last week, Kaiser Health News reported that Price was given a “sweetheart” deal to invest in an Australian biotech company — a stake that has since showed a 400 percent gain. That company could benefit from the 21st Century Cures legislation Price supported. And this week, CNN reported that Price invested in Zimmer Biomet before introducing a bill that could have helped the medical device manufacturer. The company’s political action committee then donated $1,000 to Price’s campaign.

And now appears that Dr Price also had a role in trying to suppress dissemination of potentially useful clinical research based not on considerations of patient benefit, but based on commercial concerns of a pharmaceutical company.  Such research suppression could have led patients to get BiDil when better treatments are available, potentially denying them the best possible outcomes.

This suggests that Dr Price abused his entrusted power (to be part of a government of the people, by the people, and for the people) for private gain.  This appears to be corruption, at least in an ethical if not a legal sense, using the Transparency International definition (corruption is abuse of entrusted power for private gain).

Dr Price's conflicts of interest are disturbing.  His attempts to suppress dissemination of clinical research are more disturbing.  That he is now the nominee to be the Secretary of Health and Human Services is even more disturbing.

Our new US President famously declared his intention to "drain the swamp" in Washington DC.  What would be the point if he then plans to refill it, and stock it with new swamp dwellers?

References

1.  Taylor AL et al. Combindation of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004; 351: 2049 -

2.  Hammermeister KE et al. Effectiveness of hydralazine/isosorbide dinitrate in racial/ethnic subgroups with heart failure. Clin Ther. 2009 Mar;31(3):632-43. doi: 10.1016/j.clinthera.2009.03.019. Link here.

3. Wakai A et al. Nitrates for acute heart failure syndromes. Cochrane Database Syst Rev. 2013 Aug 6;(8):CD005151. doi: 10.1002/14651858.CD005151.pub2. Link here.

4. Khazani P et al. Clinical Effectiveness of Hydralazine-Isosorbide Dinitrate Therapy in Patients With Heart Failure and Reduced Ejection Fraction: Findings From the Get With The Guidelines-Heart Failure Registry. Circ Heart Fail. 2016 Feb;9(2):e002444. doi: 10.1161/CIRCHEARTFAILURE.115.002444. Link here.

Sympathy for the Devil - Mr Trump's Adviser on FDA Leadership Prefers Corruption to Boredom

Please allow me to introduce myself I'm a man of wealth and taste I've been around for a long, long year Stole many a man's soul and faith - Keith Richards, Mick Jagger

Mr Peter Thiel, a Silicon Valley billionaire, apparently a man of wealth and taste, has become a major adviser to the transition team for US President-Elect Donald Trump about candidates for important government positions, including the leadership of the US Food and Drug Administration.  As we noted here, Mr Theil apparently supported the candidacy of one Jim O'Neill, one of Mr Theil's business associates, for this position, despite Mr O'Neill's apparent complete lack of experience or training in medicine, health care, public health, or biomedical research, and Mr O'Neill's obvious conflicts of interest.

Boredom Without Corruption?

A few days ago, Maureen Dowd interviewed Mr Thiel for the New York Times, at which time Mr Theil displayed some views about ethics that were unusual, so to speak.  Most striking was

There's a point where no corruption can be a bad thing.  It can mean things are too boring.

Think about that for a minute.


We have written about health care corruption for a long time.  We use the Transparency International definition of corruption as abuse of entrusted power for private gain.  We have summarized, again and again, the bad effects of corruption on health care.

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.

Very recently, Pope Francis said to an audience at a Catholic hospital (look here):

'The worst cancer in a hospital like this is corruption,' he said. 'In this world where there is so much business involved in health care, so many people are tricked by the sickness industry, 'Bambino Gesu' hospital must learn to say no. Yes, we all are sinners. Corrupt, never.'

But according to Mr Thiel, it is worse to be bored than corrupt.  I suppose this may have been meant as ironic, and Mr Theil may have been affecting an Oscar Wilde like pose of cynicism.  If Mr Thiel were an avant garde writer, the matter might rest there.

However, Mr Thiel is quite wealthy, and with great wealth comes power.  Furthermore, Mr Thiel is now quite powerful due to his position vis a vis Mr Trump.

For someone with so much influence on the American government to say this is more than disturbing.  It is despicable.

Mr Trump repeatedly proclaimed that he would drain the swamp in Washington DC.  Now it seems that his proposed infrastructure projects include creating a much deeper swamp.

No Expertise Without Conflicts of Interest?

But just to ice the cake, Mr Thiel also discussed conflicts of interest.

I don’t want to dismiss ethical concerns here, but I worry that ‘conflict of interest’ gets overly weaponized in our politics. I think in many cases, when there’s a conflict of interest, it’s an indication that someone understands something way better than if there’s no conflict of interest. If there’s no conflict of interest, it’s often because you’re just not interested.

We have written ad infinitum about the web of conflicts of interest that ties together many people who make health care or health care policy decisions and rich and powerful organizations with vested interests which may conflict with patients' or the people's health.  Such conflicts of interest can be regarded as the major risk factors for true corruption.

Those who want to create conflicts of interest, or who financially benefit from them, often argue that conflicts cannot be avoided, because the best and the brightest people will always have conflicts.  This cynical view, apparently shared by Mr Theil, has not, to my knowledge, ever been buttressed with evidence, at least in the health care field.

Yet, as Ms Dowd pointed out, Mr Thiel

has invested in many biotech companies and has been advising the Trump transition team on science.

He is the wrong man for the job.  His apparent amorality, or at best his amoral attempt at irony, predict an even more conflicted and corrupt health care system.  Mr Theil may profit, but ordinary people will suffer.

Our distressing musical interlude, 2006 live official version:

Bozos on the Trump Health Care Bus: An Evidence-Denying Advocate, Former CEO of a Company Which Committed a $1.7 Billion Fraud, and An Internet Troll

Normally, the sorts of people who are responsible for health policy for the US government are not the most flamboyant in the world.  Government advisers and officials show up on the Health Care Renewal,  an equal-opportunity offender, usually because of conflicts of interest issues, particularly the revolving door.  But left unsaid is that even those we criticize are usually well-informed, capable and sane.

We live, however, in interesting times.  Over the past few days, a number of stories about advisers for the Trump transition have appeared that go beyond the usual.  I will present them in approximate order of outre-ness, low too high.

Rick Scott, Governor of Florida, Health Care Adviser, Presided Over $1.7 HCA Fraud, Guilty Plea by Company

Gov Scott was one of then Mr Trump's early fans (see Miami Herald, March 16, 2016).  On Jan 7, the Miami NBC affiliate announced Gov Scott would advise Mr Trump:

Florida Governor Rick Scott told NBC2 exclusively he will have a hand in the health care reform process with the new Health and Human Services Director to improve Florida’s healthcare.

Also,

Scott, who once once rumored to be a potential pick for Health and Human Services Director in the Donald Trump administration, said he’s working with Dr. Tom Price.

'I’m going to work with Congressman Price, who is going to be the Health and Human Services Secretary to come up with a plan that is one, going to improve our Medicaid program in our state,' the governor said. 'We’ll have more flexibility.'

Scott, a former health care CEO, said reforming the ACA is personal.

Gov Scott was a former health care CEO, to be sure.  However, the brief news item omitted that his experience ended badly.

As we discussed most recently in a 2011 post, Mr Scott was once the CEO of what was then called Columbia/ HCA, a for-profit hospital system.  While he was CEO, the company took actions that later resulted in the largest health care fraud case in history.  As described by the Department of Justice in 2003:

 HCA Inc. (formerly known as Columbia/HCA and HCA - The Healthcare Company) has agreed to pay the United States $631 million in civil penalties and damages arising from false claims the government alleged it submitted to Medicare and other federal health programs, the Justice Department announced today.

This settlement marks the conclusion of the most comprehensive health care fraud investigation ever undertaken by the Justice Department, working with the Departments of Health and Human Services and Defense, the Office of Personnel Management and the states. The settlement announced today resolves HCA's civil liability for false claims resulting from a variety of allegedly unlawful practices, including cost report fraud and the payment of kickbacks to physicians.

Previously, on December 14, 2000, HCA subsidiaries pled guilty to substantial criminal conduct and paid more than $840 million in criminal fines, civil restitution and penalties. Combined with today's separate administrative settlement with the Centers for Medicare & Medicaid Services (CMS), under which HCA will pay an additional $250 million to resolve overpayment claims arising from certain of its cost reporting practices, the government will have recovered $1.7 billion from HCA, by far the largest recovery ever reached by the government in a health care fraud investigation.

Just to underline: the company pleaded guilty to criminal charges.  The allegations included fraud and kickbacks to physicians.  Mr Scott was in charge of the company.


We reviewed these events in 2010, when Scott was running for Governor.  Scott was not criminally charged at the time (but recall that in the last 10 years, almost all top managers of large health care organizations in the US have demonstrated impunity.)  Surely, as CEO, he should have been held accountable for its actions.  He was not, however, and now, after once presiding over the largest health care fraud in history (at the time), will be advising the Trump administration on health care reform.  While his record as HCA manager was surely tainted, his big qualification for this advisory position seemed to be his early political support of Trump.

Katy Talento, member of the Whitehouse Domestic Policy Council, Evidence Denier

Per the TalkingPointsMemo, January 5,

Katy Talento, who will serve on Trump's Domestic Policy Council working on healthcare policy is 'an infectious disease epidemiologist with nearly 20 years of experience in public health and health policy, as well as government oversight and investigations and program evaluation,' according to the announcement by the Trump transition team. She has served the Trump campaign since July 2016 and has spent 12 years working in the Senate.

Ms Talento was known for her less than evidence-based advocacy against birth control.

Talento's advocacy against birth control was first surfaced when she has hired as a legislative director for Sen. Thom Tillis (R-SC). In an article she published at The Federalist in January 2015, Talento preached about the risks of birth control, some of which are founded in facts, like the risk of cardiovascular problems. But she also made bogus claims, including that birth control pills may cause miscarriages.

'Preventing a fertilized egg (i.e. after conception) from hunkering down in the wall of the uterus, where it can grow normally,' she wrote. 'Progestin in birth control thins the endometrial lining (uterine wall), but a fertilized egg needs a thick, fluffy, blood-rich uterine wall to attach to and begin growth. Without it, the embryo can’t survive, and a miscarriage occurs.'

What she wrote seems to be a description about how birth control works to prevent conception, but does not explain how previous use of birth control could cause future miscarriages, let alone prove that it does.   The TPM article also noted,

There is no link between miscarriages and taking birth control pills before a pregnancy, according to The American College of Obstetrics and Gynecology.

Furthermore,

 Talento also claimed in the article that birth control may limit a person's ability to have children in the future.

'Let’s say your life stage changes and you’re ready to try to have a baby," she wrote. 'You go off the Pill or the intrauterine device or whatever you’re taking. It takes a few months for the effects of the birth control to wear off and then you’re good to go, right? Wrong.'

However,

Talento cited one study from 2012, but most other studies and experts have found no link between taking birth control and getting pregnant once going off the pill.

Note that the first article cited above was about the effect of long-term birth control on endometrial thickness.  While endometrial thickness might predict future fertility, the article did not provide evidence that birth control could cause infertility.

So this Trump health care policy adviser was known for advocating clinical/ policy positions that were hardly evidence-based, although were perhaps justified in her mind by ideology or religious beliefs.

Charles "Chuck" Johnson, Adviser on Appointments, Including for FDA Commissioner, Deceptive Internet Troll

A Forbes columnist wrote on Jan 9,

Charles 'Chuck' Johnson, a controversial blogger and conservative online personality, has been pushing for various political appointees to serve under Donald Trump, according to multiple sources close to the President-elect’s transition team. While Johnson does not have a formal position, FORBES has learned that he is working behind the scenes with members of the transition team’s executive committee, including billionaire Trump donor Peter Thiel, to recommend, vet and give something of a seal of approval to potential nominees....

In particular,

Beyond recommending candidates, Johnson has also helped set up meetings between potential appointees and transition team members. He has worked with Jim O’Neill, who is being considered to head the Food and Drug Administration and is currently employed by Thiel at San Francisco-based investment firm Mithril Capital. Johnson has tried to arrange for O’Neill to meet with conservative influencers and political groups in an effort to build support for his potential FDA nomination. O’Neill declined to comment.

Recall that we discussed Mr O'Neill's apparent candidacy for leadership of the FDA. Mr O'Neill has no clinical, other direct health care or public health experience, no background in biomedical, health care or public health research, and no background in health care policy. He currently runs a hedge fund, which owned a medical device company, thus creating conflicts of interest for Mr O'Neill should he become FDA Commissioner.

Furthermore, Mr Johnson's qualifications to give advice about executive branch appointments, particularly health care appointments are singular, to say the least. The Forbes article summarized his background,

An internet troll, who was once called 'the most hated man on the internet' and is banned from Twitter....

Furthermore, it called him

a self-described 'journalist, author and debunker of frauds,' who has made a name for himself by peddling false information and right-wing conspiracy theories online. In the months leading up to the election, Johnson, 28, used social media and his website GotNews.com to stump for the President-elect while also publishing misinformation on Trump’s detractors.

Also,

While Twitter banned Johnson in May 2015 after threatening a Black Lives Matters activist, he made a name for himself as an internet troll, or an online personality who antagonizes others by posting inflammatory or misleading information. Among his exploits, Johnson has published the home addresses of New York Times reporters, wrongly identified a woman he thought was the source of Rolling Stone’s now-retracted story of an alleged rape at the University of Virginia and claimed that President Barack Obama is gay.

In addition, in 2014, MotherJones did a profile on him, characterizing him as a:

26-year-old provocateur, who is impatient with journalistic ethics and possessed with an insatiable appetite for personal destruction. He is a subject of mockery on the left and the right due to his blustery self-promotion ('I'm making a list, checking it twice, gonna find out who is naughty…'), baseless speculation (he thinks Barack Obama may be secretly gay), and regular face plants. Last week, he mistakenly claimed to have found a photo of Jackie at an anti-rape rally; it was someone else. Still, he defended his 'batting average.' (The woman in the photo says she will sue Johnson.) But he is adept at digging up dirt on public and private figures, and even when he's at his most egregious, he's hard to ignore.

His other recent antics have included suing for access to Mike Brown's juvenile records, making the unproven claim that the Ferguson police shooting victim had once been charged in a second-degree murder.⁠ Citing police sources, he accused 'street thug' Eric Garner, the Staten Island man who died after being put in a chokehold by a New York City police officer, of domestic abuse. He incorrectly reported that New Jersey had an Ebola case; he then reported that a nurse quarantined in the state was a 'left-wing Democrat.' He hijacked the Mississippi Republican primary by offering $1,000 for photos of Sen. Thad Cochran's wife, who was in a nursing home. And he's trained his sights on other journalists, such as Wesley Lowery of the Washington Post, whom Johnson said was 'obsessed with race' and had shown 'overt friendliness in his reporting about Michael Brown.' Johnson revealed that Lowery had once received a speeding ticket. 'We are going to use auctions to set the price on the head of each journalist we take down,' he tweeted.

Needless to say, it appears that Mr Johnson has absolutely no knowledge or experience in health care, public health, health policy, or biomedical research, which may partially explain his advocacy of someone only marginally more knowledgeable for leader of the FDA.  On the other hand, he did seem to have the qualification of having "published misinformation on Trump's detractors."

Summary

People who work in high leadership of advisory positions in government in the health care sphere traditionally have been people who are at least well-informed and knoweldgeable about health care.  Yet here are three examples of people who are influential on health care policy during the Trump transition who seem to have been selected more for political loyalty than knowledge about health care.  Only one had any experience in related science (but she appears to reject scientific evidence in favor of ideology or religious dogma).  One did manage a health care organization, but one that pleaded guilty to crimes, and settled allegations of fraud and kickbacks.  One has had no conceivable relationship to health care, but seems to have a talent for deception on the internet.  And all three appear to be early Trump political supporters.


One would hope that a government of the people, by the people, for the people would put the people's care and the public health ahead of personal political loyalty.  Yet at least based on this limited example, when choosing people to lead and inform health care policy, the incoming administration seems to put loyalty to the new fearless leader ahead of any knowledge about health care, and maybe ahead of honesty and ethics.

True health care reform requires well-informed leaders who uphold health care professionals' values, put patient's and the public's health ahead of all other considerations, avoid self-interest and conflicts of interest, are honest and ethical, and surely are not corrupt.  They need to work in the context of a government that is of, by and for the people, not of, by and for a demagogic leader. 

Good luck to us.  We appear to be with the Bozos on a bus going off a cliff.

Heath IT Mismanagement: MD Anderson to cut about 1,000 jobs due to "financial downfall officials largely attributed to its EPIC EHR implementation project"

At numerous posts on this blog I link to stories of health IT expense putting hospital financial stability at risk, e.g.:

"What is more important in healthcare, computers, or nurses and other human beings? Southcoast Health cutting dozens of jobs on heels of expensive IT upgrade" at http://hcrenewal.blogspot.com/2016/04/what-is-more-important-in-healthcare.html

"Lahey Health: hospital jobs lost, but computer vendors prosper" at http://hcrenewal.blogspot.com/2015/05/lahey-health-hospital-jobs-lost-but.html,

"Monetary losses and layoffs from EHR expenses and EHR mismanagement" (http://hcrenewal.blogspot.com/2013/06/monetary-losses-and-layoffs-from-ehr.html),

"Financial woes at Maine Medical Center: Reading this blog might have saved them millions of dollars, and prevented massive 'cost saving initiatives'" (http://hcrenewal.blogspot.com/2013/05/financial-woes-at-maine-medical-center.html),

and "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" (http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html)

Here's another recent example:

MD Anderson to cut about 1,000 jobs 
Becker's Hospital Review 
Ayla Ellison
Jan. 5, 2017
http://www.beckershospitalreview.com/hospital-management-administration/md-anderson-to-cut-1-000-jobs.html

The University of Texas MD Anderson Cancer Center in Houston plans to eliminate about 1,000 jobs, or 5 percent of its 20,000-person workforce, as it tries to improve its financial health.

At a press conference Thursday, MD Anderson officials said between 800 and 900 workers will be laid off, and an additional 100 to 200 jobs will be cut through retirement and attrition, according to the Houston Business Journal. The job cuts will not affect any physicians.

"We primarily focused on those areas where we could make staff reductions, re-engineer administrative support, and not impact quality of patient care," officials said at the press conference, according to the report.

The job cuts are expected to save MD Anderson about $120 million a year.

MD Anderson is scaling back its workforce after it reported a combined $102 million operating loss in September and October and a $9 million operating loss in November. At the press conference Thursday, MD Anderson CFO Dan Fontaine said the organization likely does not have a positive operating margin for December, according to the report.

MD Anderson's financial troubles began in early 2016 when it rolled out a new Epic EHR system. The organization recorded a 76.9 percent drop in adjusted income for the 10 months that ended June 30, 2016, a downfall officials largely attributed to its EHR implementation project.

It appears MD Anderson failed to estimate health IT costs and impacts properly, and/or failed to write safeguards for seller-caused cost overruns into its contracts. 

That is known as "mismanagement" by definition.  

It's not as if information important to such planning was unavailable.  In fact some of it is free at this very blog, e.g., the 30 or so posts under the query link http://hcrenewal.blogspot.com/search/label/EPIC.

Despite its sagging financials, MD Anderson officials said Thursday the organization's long-term financial health remains strong.

"We are innovating to develop novel care delivery models, adopting enabling technologies and diversifying revenue streams," said MD Anderson in an emailed statement. "MD Anderson will be here for patients and their families today, tomorrow and long into the future."

Not if those efforts are mismanaged as badly as this one.

Finally, perhaps the cost of commercial EHR software needs to be critically investigated. 

That it could put an organization of the stature of an MD Anderson in jeopardy seems to me to be a red flag, mismanagement or not.

-- SS

Note:  I have not posted in awhile due to being occupied with EHR forensic and evidentiary issues.  

If You See Something, Say (and Do) Something - Don't Just Grumble to Your Friends About Health Care Dysfunction

During the US presidential campaign, and after its results, I have heard from a lot of people who were unhappy. They were unhappy with the choice of candidates, their policies, or or their qualifications or character.  They were unhappy about media coverage, about the political parties' leadership, etc, etc. But most of them only expressed their unhappiness to a small group of friends.

Similarly, while blogging for Health Care Renewal over the years, I have heard lots of people who are unhappy about the issues we cover, mainly as they affect health care, but also as they affect the larger political economy, for example:
- concentration and abuse of power
- conflicts of interest, and health care corruption
- health care leadership that is ill-informed, fails to uphold health care professionals' values, mission hostile, self-interested, conflicted or corrupt
- health care governance that is opaque, unaccountable, or dishonest
- deceptive marketing and public relations, propaganda and disinformation
- threats to the integrity of science, including manipulation and suppression of research
-threats to dissenters and whistle-blowers, and generally to free speech and expression, to free association

Yet again, most of their unhappiness was expressed to a small group of friends or colleagues.

I know that it can be scary to express such concerns openly. There is risk of offending friends, family, colleagues, and particularly bosses. Whistle-blowers in health care are treated badly, and may end up losing their jobs, fighting lawsuits, etc. So many cases providing evidence for the severity of the above problems, and the problems themselves remain anechoic. It is particularly taboo to discuss health care corruption.

But if most individuals who care about these issues remain silent, why expect any improvement?

After blogging for Health Care Renewal for more than 11 years, I have seen our issues get more recognition, but there have been only a few changes that might mitigate them. Now in the US we are looking at unprecedented threats of worsening times.

Bad or lacking health care and neglect of public health problems may kill many Americans, and injure many more.  These numbers likely dwarf those who are injured or killed by terrorism.  Yet to combat terrorism, the slogan "if you see something, say something" seems to have goaded people to action.

So, if you "see something" that causes health care dysfunction, particularly something outrageous, "say something," do something.

Don't just grumble to your friends. Don't just grumble when you read Health Care Renewal. Take up a public role. Write letters to the editor, call or write your local or national legislators, use social media (but so it has a public impact), blog for us or start your own blog, organize with other like-minded people, demonstrate, boycott, strike, etc, etc, etc.

Make some noise people, or don't expect any change. As individuals, we each can accomplish a little, but together, we can accomplish a lot.