Friday, January 20, 2017

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.

Wednesday, January 18, 2017

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:



Wednesday, January 11, 2017

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.


Monday, January 09, 2017

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.  

Tuesday, January 03, 2017

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.

Thursday, December 29, 2016

Follow the Money: Nominee for Secretary of Health and Human Services Traded Health Care Stocks and Owned Tobacco Stocks While in Congress

At least the US president-elect seems to be making the problems of conflict of interests and health care corruption less anechoic.

Dr Price's Stock Portfolio

The latest relevant big story was first picked up by Sheila Kaplan writing in Stat. It seems that Dr Tom Price, once a practicing orthopedic surgeon, then a Congressman, and now Mr Trump's pick for Secretary of DHHS, owned and owns lots of health care related stocks:

his stock portfolio includes investments in pharmaceutical, medical device, and health insurance companies, the heart of the industries he would be overseeing as secretary.

In particular,

Among Price’s holdings are some in Innate Immunotherapeutics, Ltd., a biomedical company in which another lawmaker is a major shareholder. According to his financial disclosure statements, on Aug. 31 he bought between $50,001 and $100,000 worth of stock the firm.

Representative Chris Collins, a New York Republican, is a director of the company, which develops drugs to treat multiple sclerosis. He lists assets in the firm worth between $5,000,001 and $25 million. Price also purchased a smaller amount of stock in Innate Immunotherapeutics in 2015.

Collins is also a member of Trump’s transition team.

In March, Price invested between $1,001 and $15,000 in Amgen; Eli Lilly and Co.; Pfizer; Biogen; Bristol-Myers Squibb; Zimmer Biomet, a medical device company; Aetna; and Athenahealth. Also that month, Price sold the same amounts in Gilead, Abbott Laboratories, and Thermo Fisher Scientific.

So for readers of Health Care Renewal, this is very familiar.  We have discussed ad infinitum the conflicts of interest that may affect physicians, particularly due to financial relationships with big health care corporations.  The issue is that physicians swear oathes to put the health of their individual patients first, and to support the public health in general.  Yet the interests of, for example, drug, biotechnology, device companies may be at odds with this primary mission.  Such companies in this age of promoting "stock holder value" may primarily be about increasing revenue by selling as much of their products as they can, and let the Devil take the hindmost.  Yet physicians ought to use drugs and devices judiciously, and only when their benefits for individual patients outweigh their harms.  The concern is that physicians who have financial interests in such and other health care related companies may consciously or unconsciously allow their professional decisions to be influenced by their personal financial advantage.


Dr Price appears to be a member of the US House of Representatives full time, and no longer a practicing physician.  But he has not relinquished is Georgia medical license (look here).  So he should still be bound by his oath as a physician.

Dr Price's Active Stock Trading

But wait, there's more.  Last week, the Wall Street Journal noted that Dr Price was not simply a long-term owner of stocks, he was an active trader.   

President-elect Donald Trump’s pick to run the Health and Human Services Department traded more than $300,000 in shares of health-related companies over the past four years while sponsoring and advocating legislation that potentially could affect those companies’ stocks.

Rep. Tom Price, a Georgia Republican, bought and sold stock in about 40 health-care, pharmaceutical and biomedical companies since 2012, including a dozen in the current congressional session, according to a Wall Street Journal review of hundreds of pages of stock trades he filed with Congress.

In the same two-year period, he has sponsored nine and co-sponsored 35 health-related bills in the House.

His stock trades included Amgen Inc., Bristol Myers Squibb Co., Eli Lilly & Co., Pfizer Inc. and Aetna Inc.

This raises more issues.  First, that Dr Price was actively trading these stocks suggests that his financial holdings might have been more salient to him than, say, a long-term investor who just buys stocks and puts them away in a retirement portfolio.  This increases the likelihood that his stock holdings, and their recent performance, may well have influenced his decision making.

Moreover, this emphasizes that we should be concerned not so much about the effect of financial relationships on Dr Price's clinical decisions - in fact, it appears that he is a full time Congressman, and hence is not practicing - but on his decision making as a national legislator with considerable influence on health policy and the public health.  As a congressman, Dr Price also took an oath to "support and defend the Constitution of the United States against all enemies, foreign and domestic; that I will bear true faith and allegiance to the same; that I take this obligation freely, without any mental reservation or purpose of evasion, and that I will well and faithfully discharge the duties of the office on which I am about to enter."  So the concern is that the immediate profitablity of his actively traded stock portfolio might influence how Dr Price legislates.


As the WSJ article noted,

Mr. Price, an orthopedic surgeon who chairs the House Budget Committee, has played an influential role in shaping health legislation. He sits on the Ways and Means Committee’s health panel, which oversees Medicare. He also is a member of the Republicans’ Congressional Health Care Caucus that has called for repeal of the Obama administration’s landmark health overhaul.

Beyond just the issue of conflict of interest is that of Dr Price's apparent comfort with the ethical and sometimes criminal track records of the companies from whose stocks he appears to have profited.  We on Health Care Renewal have been documenting the ethical misadventures, and sometimes crimes committed by large health care organizations which claim they operate for the good of patients and the public, but seem more to operate for the benefit of their insiders, particularly top management.  Many of the companies held by Dr Price have lengthy lists of such bad behavior.  See the links above to some  individual companues for many more, sometimes sordid details.

If Dr Price, who is not only a physician but a legislator with significant influence on health policy, is unaware of these companies' track records shame on him.  If he owned these stocks with full knowledge of the companies' track records, more shame on him.

Dr Price's Tobacco Stocks

But wait, there's more. 

The WSJ article also noted:

Mr. Price also has traded in shares of ... tobacco stocks, including Altria Group Inc., whose products are regulated under the Food and Drug Administration, a part of HHS.

An article in Wired implied that Dr Price's tobacco holdings may have affected his legislative decision making.  Price voted against

a law that now requires the FDA to regulate tobacco as a drug.

That now goes beyond just a relatively simple set of conflict of interest issues. At least drug, biotechnology, and device companies make products meant to benefit patients and the public's health, if used properly and judiciously.  For that matter, insurance companies, like Aetna, are supposed to help patients afford needed medical care.

But tobacco companies are different.  Although they are legal in the US, there is overwhelming evidence that their products are harmful to health, and this harm is not outweighed by any health benefits, nor any benefits to society other than the money tobacco companies can make from them.  Most doctors now would recommend their patients stop smoking and, if they are not smoking, never start to smoke.  It is extremely hard to reconcile Dr Price's professional status and his ownership of tobacco stocks.

A physician legislator with a powerful role in health policy owning tobacco stocks may appear to be abusing his entrusted power for private gain.  That is the ethical definition of corruption used by Transparency International (although it is not a legal definition.)  No wonder that in a commentary in New York Magazine on Dr Price's stock holdings suggested that they mean in Dr Price's eyes

The appearance of corruption is totally fine.
Conclusions


Mr Trump's ongoing behavior does have some silver linings.  It is making the public more aware of the dangers of conflicts of interest and corruption, not just in health policy or health care. And it is also making the public aware how we have to follow the money, all the money that flows around our new plutocrat-in-chief to be, and his rich and well connected cronies.

If we cannot restrain the increasing pile of conflicted and possibly corrupt political appointments, we will be in for much worse than the health care dysfunction Health Care Renewal has been lamenting for more than 10 years.  

Wednesday, December 21, 2016

DeVry Education Group, Owner of American University of the Carrbbean and Ross University Schools of Medicine, Settles Allegations of Deceptive Marketing

The parade of legal settlements made by large health care organizations just keeps stepping along.  The latest entry in it was DeVry Education Group, which owns two for-profit offshore (from the US and Canada) medical schools: American University of the Caribbean School of Medicine, and Ross University School  of Medicine.

The Case

In early 2016, we first discussed the deceptive marketing charges against DeVry University and DeVry Education Group here.  The charges have now been settled. The lede of the AP story about the settlement (via ABC News) was:

DeVry University and its parent company are paying $100 million to settle a federal lawsuit alleging the school misled students through deceptive ads.

The allegations that led to the settlement were:

The lawsuit focused on two marquee ad claims that DeVry used for years but dropped in October in a settlement with the U.S. Education Department.

Since at least 2008, the chain had advertised that 90 percent of its graduates who actively sought employment landed jobs in their field within six months of graduation.

But federal investigators found that DeVry was counting students who found jobs outside the fields they studied, and who already had jobs before they enrolled.

Included in the statistic was a graduate who studied in the health care field but found work as a restaurant server and another who worked as a car salesman, according to the FTC lawsuit.

The commission also challenged a claim that DeVry graduates earn 15 percent more than alumni at other schools a year after graduation.

So these were relatively straightforward allegations of deceptive marketing. The penalties included fines for the company as a whole.

Under the settlement, DeVry agreed to pay more than $49 million to the FTC, which says it will distribute the money to students 'harmed by DeVry's conduct.'

The chain also agreed to forgive more than $30 million in loans issued before September 2015, and $20 million in debt owed by former students.

Also,

Going forward, DeVry has promised not to misrepresent job and income prospects of potential students, and not to count jobs that students found more than six months before graduation.

That seems a bit strange, because

officials for Devry, which is based in Downers Grove, Illinois, denied all wrongdoing but said they are 'pleased this matter is reaching resolution.'

If there was no wrongdoing, why did they need to pledge no further wrongdoing? In fact, if there was no wrongdoing, why did company management agree to pay $100 million? It seems to me that if there was no good evidence supporting the charges, the company could have defended the suit for a lot less than that.

Of course, the managers knew that the settlement would be paid by other peoples' money. As is usually the case nowadays, it did not include any negative consequences for any company managers who might have enabled, authorized, directed or implemented any deceptive marketing.

The Implications

So once again we have an example of a legal settlement involving a large, US based health care related - at least in part - organization.  The settlement involved allegations of unethical behavior that likely harmed students.  Yet the amount of the settlement amounted to a slap on the wrist for a corporation with over $1.8 billion in revenue (2015-2016, per Yahoo).  Furtheremore, the nature of the settlement demonstrated the continued impunity of managers of large health care organizations, none of whom in this case had to suffer any negative consequences, yet some must have enabled, authorized, directed or implemented the deceptive marketing. 

This case also raises even more questions about the American (and to some extent Canadian) reliance on offshore, for-profit medical schools to train many of their physicians.  As we have frequently discussed, (most recently here),...

 Admission to US medical schools is increasingly difficult.  So many who seek medical careers may be tempted to apply to schools outside the US.  In the last 30 years, American entrepreneurs have opened offshore medical schools, mostly in the Caribbean, that cater to US students.  They teach in English, and do not require immersion in an unfamiliar culture, so may be more attractive than medical schools in other countries whose mission is to educate physicians to practice in those countries. In 2010, Eckhert documented that the number of offshore medical schools, "for-profit institutions whose purpose is to train U.S. and Canadian students who intend to return home to practice," but not to train physicians to practice in the countries in which these schools are located, was rapidly growing.(1)  By 2010, there were 33 such schools, 20 of which were new since 2000.

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

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

Concerns about how offshore medical schools are run, and how well they educate their students can only be heightened by the settlement of the latest DeVry case.

The DeVry statement about the settlement included the assertion that "at no time has the academic quality of DeVry University education been questioned."  This is a bit disingenuous.  The case was brought by the Federal Trade Commission, which has no particular role overseeing educational quality, and was specifically about deceptive marketing.

One wonders, however, what sort of education might be provided by a large corporation whose corporate culture did not recoil from what appeared to be grossly deceptive marketing.

That statement also specifically only mentioned DeVry University, which is one of many for-profit "educational" organizations under the Devry umbrella (look here).  It said nothing about how such a corporate culture might affect educational quality at the other subsidiaries. 

It certainly did nothing to help answer questions that were previously raised about the two DeVry owned and operated for-profit medical schools.  In 2013, we posted about a Bloomberg investigative article about the two DeVry owned medical schools, at the American University of the Caribbean and Ross University.  The article focused on multiple issues:
-  high attrition rates of students compared to those in US based schools
-  inability of many students to complete clinical training in the customary two years
-  low rates of students matching to US residencies compared to US graduates
-  high costs for students, presumably a cause of their high levels of debt

Keep in mind that some of these concerns were based on statistics supplied by DeVry.  Yet now there is a new reason to be doubtful about their statistics, and any other information coming out of DeVry about its medical education offerings.  Furthermore, while Eckhert wrote in 2010 that the increasing presence of offshore medical graduates in the US "obligates U.S. medicine to take a closer look at these educational programs," no such scrutiny has occurred since then.

So, we see another aspect of the US health care system in which money seems to trump mission, facilitated by an unseemly alliance between wealthy corporate executives and bad US government policy.  We need to reexamine our fascination for "market based" approaches to health care, when almost nothing about any part of health care resembles, or could resemble a free market.  We need to make health care more transparent, and shine more sunshine on the nooks and crannies, like off-shore but US corporate owned medical schools.  We need to facilitate health care leadership and governance that puts patients' and the public's health first, way ahead of the personal enrichment of the participants.

This may be a pipe dream in 2016, since the US at least just voted in what seems to be the most market fundamentalist, plutocratic administration yet.  As the AP article noted, "some for-profit colleges see President-elect Donald Trump as a champion of the private sector who could spur a rebound for the [for-profit education] industry.  In the weeks after Trump's election, sharing in DeVry's parent company surged 30 percent."
 
Thus, as long as the US continues its light touch regulation if, or even further deregulates the outsourced offshore system which now educates increasing numbers of US doctors(2), Americans who want to become doctors ought to be very skeptical about the futures they may face if they choose to go to such offshore schools.

References

1.  Eckhert NL.  Private schools of the Caribbean: outsourcing medical education.  Acad Med 2010; 85: 622-630.  Link here.
2.  Eckhert NL, van Zanten M.  U.S.-citizen international medical graduates - a boon for the workforce? N Engl J Med 2015; 372: 1686-7.  Link here.

Friday, December 16, 2016

Suppose the Pope Condemned Health Care Corruption - and Hardly Anyone Noticed?

Introduction - Health Care Corruption as a Taboo Topic

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.

Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here).  But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries.  Health Care Renewal was practically the only source of coverage in the US of the survey's results.

"Corruption is Cancer to Health Industry, Pope Tells Hospital Staffers"

Yesterday, this story appeared in the Catholic News Service. It opened with:

VATICAN CITY (CNS) -- Corrupt business practices that seek to profit from the sick and the dying are a cancer to hospitals entrusted with the care of the most vulnerable, especially children, Pope Francis said.

Doctors, nurses and those who work in the field of health care must be defined by their ability to help their patients and be on guard against falling down the slippery slope of corruption that begins with special favors, tips and bribes, the pope told staff and patients of Rome's 'Bambino Gesu' children's hospital Dec. 15.

'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.'

One might think that this condemnation of health care corruption by the leader of a huge Christian religious group would get considerable attention, but one would be wrong. The only other coverage of the Pope's message was an extremely brief (6 sentences) item by the AP (see here via Business Insider.)

Note that Pope Francis not only condemned corruption in the strongest terms, but he linked it the transformation of medicine and health care into a business, with the presumptive result in an era of the "shareholder value principle" that revenue has become more important than caring for patients.  He also implied that the road to corruption begins with conflicts of interests.

Note that Pope Francis' predecessor, Pope Benedict XVI, also decried the transformation of medicine and health care into a business.  As we noted here, he wrote

during the current economic crisis 'that is cutting resources for safeguarding health,'... Hospitals and other facilities 'must rethink their particular role in order to avoid having health become a simple 'commodity,' subordinate to the laws of the market, and, therefore, a good reserved to a few, rather than a universal good to be guaranteed and defended,'

Furthermore,

'Only when the wellbeing of the person, in its most fragile and defenseless condition and in search of meaning in the unfathomable mystery of pain, is very clearly at the center of medical and assisted care' can the hospital be seen as a place where healing isn't a job, but a mission,...

Pope Benedict's call for health care to be restored to being a calling, not a business, remained anechoic too.   

Discussion

Recently, I became just a bit more optimistic that health care corruption would start getting the attention it deserved.  That may have been premature.  The world seems to becoming ever more friendly to market fundamentalism or neoliberalism.  The notions that every human activity, including medicine and health care, should be conducted as a business, and that in business, revenue come first is likely to be helped by the election of an ostensibly billionaire businessman to the presidency of the US.  That said president-elect once called Pope Francis "disgraceful" after the Pople questioned how Trump's proposal to "build a wall" to keep out supposedly deplorable Mexican immigrants squared with Christian beliefs (look here).

Yet 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.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks.  It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.


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.


Wednesday, December 14, 2016

Despite Long Record of Misadventures, Johnson and Johnson to Receive Award for "Ethical Leadership?!"

What does it take for a big pharmaceutical/ device/ biotechnology company to get an ethics award?

Reported by Sheila Kaplan at Stat (but for subscribers only), and first noticed by Carl Elliott and just discussed on his Fear and Loathing in Bioethics blog, it appears that the giant Johnson and Johnson pharma/ device/ biotech company will get an award in "ethical leadership" from and "organization called Fellowships at Auschwitz for the Study of Professional Ethics, or FASPE."

The Stat report, quoted by Dr Elliott, stated:

FASPE Chairman David Goldman, an attorney in New York, said he was aware of the pharma giant’s various ethical tangles, but believes the company has moved beyond them. 'We do think they’ve acknowledged their failures and taken the apropriate steps to resolve them,' he said. 'They know what they’ve done; we talked to them about it and they’ve taken the right action.'

However,

Others disagree, noting that in 2013, J&J and its subsidiaries agreed to pay $2.2 billion to resolve criminal and civil allegations of improperly promoting several prescription drugs, including paying kickbacks to physicians. That was one of the largest health care fraud settlements in US history. The company has also lost recent product liability cases involving allegations of its talcum powder causing ovarian cancer.

If only it were just that.

In fact, we have been writing about the ethical misadventures of Johnson and Johnson for a long time.  Our collected posts are here.  An updated version of their legal record since 2010 is at the end of this post. Their misadventures go well beyond those listed in the Stat article, and new cases of them have been appearing regularly, most recently this year.

Perusing the list suggests that this giant company (with about $70 billion in yearly revenue) is a poster child for bad behavior by health care organizations.  Despite the multitude of allegations leading to settlements, and sometimes findings of guilt, the company has never faced a penalty of significant size, given its revenue.  Furthermore, almost no company leaders who enabled, authorized, directed or implemented the various misadventures have suffered any negative consequences, therefore appearing to enjoy impunity

There are many more examples on this blog of legal settlements, and even episodes involving bribery, fraud, kickbacks, and other crimes that demonstrate the continuing impunity of leaders of large health care organizations.  It is likely that such impunity has led to the general concerns that the system is "rigged" in favor of the wealthy, the well-connected, and the insiders. 

(And now we have a president-elect who has promised to act against the "rigged system," but seems to be bent on appointing wealthy, well-connected people to run his executive branch, but in any case, as we have said before...)

We once again see the perverse incentives at work that drive bad behavior by health care oragnizational leaders.  One can obviously become very rich by directing this bad behavior.  Up to now, the likelihood that one would eventually pay any penalty for doing so was tiny.  Now it is slightly higher.  Whether those up the ladder, who might have authorized the behavior, turned a blind eye to it, or avoided enquiring about anything that could be bad behavior, as long as the money came in, will suffer any negative consequences from these actions or inactions in the future is still unclear.

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. 


 Appendix - Johnson and Johnson Legal Record since 2010
 2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
2011
- Guilty pleas to bribery in Europe  by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
2012 
  - Testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
2013
-  Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
 -  Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
- Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
- Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
2014 
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post).
2015
-  Johnson & Johnson found by jury to have concealed harms of Risperdal.
-  Johnson & Johnson Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
-  Johnson & Johnson McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)
2016
- Johnson & Johnson subsidiary Aclarent settled allegations that it sold its Stratus device for unapproved uses.  Two former executives of that subsidiary also were found guilty of distributing misbranded and adulterated devices (see this post

Monday, December 12, 2016

Our Holiday Appeal: Speaking Out on Conflicts of Interest, Corruption, and Attacks on Science Since 2003

In 1998, I learned of the plight of Dr David Kern, my colleague and friend at Brown.  Dr Kern ultimately lost his job because a local company took offense when he presented data about a new occupational disease that occurred at the company's factory (see summary here).  Thus I was alerted to the growing dysfunction of US health care. 

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


Since then, my colleagues, some of who were original interviewees, and I have tried to raise awareness of these and related issues, now mainly through the Health Care Renewal blog.   For a long time, many of these issues remained relatively anechoic, partly because discussion of them offended those with vested interests in keeping the system the way it was.  After the economic crash of 2008, we began to realize that related issues were causing wider dysfunction, in the political economy, in the US and globally.

Who would have thought, though, that such issues would be in headlines every day, mainly pertaining to a presidential campaign, and now the presumptive incoming US administration?  Conflicts of interest, corruption, attacks on science, and even attacks on just plain facts are the stories of the day.  But you heard it here first on Health Care Renewal.

Maybe this will lead to some progress now on health care dysfunction, if the world does not blow up.

On that happy note, in this holiday season, I once again ask for contributions to FIRM - the Foundation for Integrity and Responsibility in Medicine.  We set up FIRM,  a US non-profit organization, to try to provide some financial support for HCR.   Despite the grandiose name, FIRM does not have an endowment, and is almost exclusively dependent on individual contributions.  (In the US, charitable foundations interested in health care or ethics seem to also regard health care corruption as a taboo topic, and have not been exactly forthcoming.)  So please consider contributing to FIRM.  FIRM is a US 501(c)3 non-profit organization, and so if you are in the US, contributions may be tax deductible according to US law.  Please send contributions to FIRM at 16 Cutler St, Suite 104, Warren, RI, 02885, and any questions or comments to me by email, rposes at firmfound dot org.

Friday, December 09, 2016

Efficacy, We Don't Need No Stinking Proof of Efficacy - Says Apparent Trump Candidate to Lead FDA

Multiple media reports suggest that US president-elect Donald Trump is considering a most unusual candidate for commissioner of the Food and Drug Administration (FDA).  The basics, as reported by Bloomberg:

President-elect Donald Trump’s transition team is considering a Silicon Valley investor close to billionaire Peter Thiel to head the Food and Drug Administration, according to people familiar with the matter.

Jim O’Neill, the Thiel associate, hasn’t been officially selected, according to the people, who asked to remain anonymous because the decision process is private, and the Trump team could still go in another direction.

O’Neill is a managing director at Thiel’s Mithril Capital Management, and last served in government during the George W. Bush administration as principal associate deputy secretary at the Department of Health and Human Services. He’s also a board member of the Seasteading Institute, a Thiel-backed venture to create new societies at sea, away from existing governments.

Thiel’s spokesman Jeremiah Hall said O’Neill is a good candidate. 'Jim O’Neill has extensive experience in government and in Silicon Valley. He is a strong candidate for any of several key positions,' Hall said in an e-mail. Separately, Politico and CNBC reported that O’Neill could be under consideration for various positions.

Mr O'Neill would be a very unusual candidate to lead the FDA

Ill-Informed

Mr O'Neill has no medical, health care, or biomedical research background.  As Bloomberg noted, "the head of the FDA for the last five decades has either been a trained physician or a prominent scientific researcher."   However, Mr O'Neill's relevant track record is that he

did his undergraduate studies at Yale University, where he was a member of the concert band and played the horn, and has a masters degree from the University of Chicago, both in the humanities. He joined the Health and Human Services Department under Bush in 2002, first as a speechwriter, rising in the final years of the administration to head some policy functions,...

We have frequently discussed how current leaders of health-care organizations are often ill-informed about biomedical science, health care, medicine, public health and related issues.  Mr O'Neill would fit right in with them were he to run the FDA.  

About to Transit the Revolving Door

Mr O'Neill seemed to be on Mr Trump's radar since he was "a close associate of [Trump confidant Peter] Theil for nearly a decade." More recently, Mr O'Neill

served as a managing director at Clarium Capital -- Thiel’s hedge fund that made a mint by correctly predicting the housing bubble and then crumbled -- and since 2012 has worked at Mithril Capital, Thiel’s late-stage venture firm, where he is a managing director.

His recent work would imply that to become FDA commissioner would transit the revolving door.  As reported by the International Business Times,

'He brings strong ties to industry and would reflect a tremendous bias in their favor at the FDA,' Dr. Michael Carome, director of the public health research group at the consumer watchdog Public Citizen, told International Business Times. 'He’s senior executive in a hedge fund investing in medical healthcare products. That alone should be disqualifying.'


In particular,

In the private sector, O'Neill has a clear financial stake in the outcome the regulatory process — a process he could oversee as head of the FDA.

For example, in 2014, Mithril invested $15 million in the German medical device company MagForce which manufactures cancer treatment technologies — in exchange for 23 percent ownership in its U.S. subsidiary. In June, the company announced it filed for an 'Investigational Device Exemption' with the FDA — basically a permit to use its unapproved product to gather evidence for clinical trials. MagForce’s profitability could very well hinge on how the FDA regulates its products: According to 2015 financial filings, MagForce is 'working with the FDA to update preclinical studies, which were conducted approximately ten years ago, to current US regulatory standards.'

Challenging Evidence-Based Medicine, with Dangerous Implications

Perhaps because of his lack of understanding of health care and medicine, and his financial interests, Mr O'Neill has advocated for radical changes at the FDA, particularly for allowing drugs and devices to be marketed without any good evidence of their efficacy, that is, that they provide any benefits to patients.

 In a 2014 speech, he said he supported reforming FDA approval rules so that drugs could hit the market after they’ve been proven safe, but without any proof that they worked, something he called 'progressive approval.'

'We should reform FDA so there is approving drugs after their sponsors have demonstrated safety -- and let people start using them, at their own risk, but not much risk of safety,' O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. 'Let’s prove efficacy after they’ve been legalized.'

It might sound plausible, at least if you know nothing about medicine.

The big problem with it is, as I was taught in medical school, that all medical interventions, including drugs and devices, have their risks.  No intervention is free of all potential to cause harm.  So we advocates of evidence-based medicine suggest that no intervention should be given to patients without clear evidence that its benefits outweigh its harms.  You cannot show benefits outweigh harms without having some good evidence about benefits.

Even big pharma has become reconciled to this notion.  An article in the Hill quoted one Mr Peter Pitts thus,

'People need to understand that safety doesn’t exist without the balance of risk,' said Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner under President George W. Bush.

He said that 'every drug has risks,' so the important consideration is balancing the risks against how effective the drug will be. Side effects that would never be approved for Aspirin might be approved for a lung cancer drug, he noted.

And this from someone who did public relations for big pharma for a long time (look here).  Mr Pitts still works for CMPI, which historically obtained much of its money from the pharmaceutical industry (look here). 

Furthermore, the studies of treatments usually done prior to efficiacy trials are not designed to assure their safety, just that they do not have catastrophic adverse effects for a lot of patients.  Phase I and II trials do not enroll enough patients or follow them long enough to rule out rare but dangerous adverse effects occurring early, or any adverse effects occurring late.

So the International Business Times noted that

Dr. Aaron S. Kesselheim, associate professor of medicine at Harvard Medical School and the director of Brigham and Women’s Hospital program on regulation, therapeutics, and law, says O’Neill’s proposals could transform the drug market into an unregulated space that resembles the vitamin and supplement market. 'You’d have all these expensive products out there without being shown to work while presenting substantial safety risks — and being pushed on physicians and patients by overzealous marketing,' Kesselheim told IBT.

'He’s coming at things from an agenda-driven and non-evidence -based point of view,' Kesselheim said. 'That should be very scary for patients and physicians.'
By the way, this just underlines just how Mr O'Neill would be a prototypical ill-informed leader were he to be appointed to run the FDA.

Also, per the Hill article,

Dr. Michael Carome, director of Public Citizen’s health research group, said he was 'just stunned' when he heard O’Neill’s name reported to be in consideration for FDA.

He said O’Neill’s proposals would bring the country back to 19th century 'snake oil salesmen' being able to fool people into using ineffective products.
Just to ice the cake, O'Neill's bright idea would apparently violate the law.  As Matthew Herper wrote in Forbes,

the 1962 Kefauver amendment ... said drugs must be proved safe and effective before they can be sold. This law was put in place after an FDA reviewer kept a drug for morning sickness, thalidomide, from being sold in the U.S. The medicine caused birth defects in the rest of the world.
So not only would Mr O'Neill be an tremendously ill-informed leader of the FDA, he has the potential of being a prototypically mission-hostile leader were he to try to carry out his idea of eliminated prospective efficacy testing.  We have also frequently written about the havoc that can be wrecked on health care by such leaders.

So Mr O'Neill's bright idea would effectively make all patients into guinea pigs.  What would happen if a large number of patients received treatments that might be useless, and whose harms doubtless exist, but are unknown?  Some, whether they were Democrats or Republicans, whether they supported Mr Trump, Secretary Clinton or someone else in the last election,  might end up here:



So add anyone who might be or ever become a patient to the long list of people who should be worried about a future Trump administration.

Discussion

We could do our usual rant about the revolving door here.   Obviously, the revolving door pheonomenon is a serious conflict of interest, if not form of corruption, that should have no place in our government, particularly in its agencies that are concerned with health care. Similarly, we could rant about how ill-informed and mission-hostile leaders have to take much responsibility for our currently dysfunctional health care system.

It should be no surprise that Mr Trump, a businessman who has no experience in government, and who often seems at ignorant , if not contemptuous of the US Constitution he may be sworn to uphold, would appoint similarly ill-informed and mission-hostile cabinet secretaries and agency leaders.  Ill-informed, mission-hostile leadership of the FDA could harm a lot of patients.  Such an FDA commissioner, acting in concert with other members of an equally ill-informed and mission-hostile Trump administration could do catastrophic damage to patients, citizens the country and the world. 

Maybe we would all be better off if Mr Tump finds something else to do for the next four years.  Maybe he should stick to being executive producer of the Apprentice