Trumping the Evidence - The Donald Denies Asbestos Related Disease, Post-Traumatic Stress Disorder, Chronic Traumatic Encephalopathy but Asserted Vaccines Cause Autism Health Service Home

One of the main causes of health care dysfunction identified by demoralized health care professionals in our 2003 qualitative study was threats to evidence-based medicine, and by extension, evidence-based public health and health policy.(1) Since then, we have frequently discussed threats such as manipulation and suppression of clinical research to further vested interests, and distortion of research dissemination, such as ghost written articles, often enabled by individual and institutional conflicts of interest.

These and other causes of health care dysfunction which we discuss, however, have hardly been the stuff of political debates. In particular, US presidential campaigns often feature very bland discussions of health care, when they feature them at all. These discussions, furthermore, usually are limited to health insurance, but rarely challenge the unusual American system which relies on for-profit health care insurance.

So Health Care Renewal usually does not provide much content relevant to political campaigns.

The 2016 presidential election season has not been usual. True, one campaign, that of Hillary Clinton, has featured the detailed, but relatively bland policy points that we usually see.

Her opponent, Donald Trump, is very different. He is known for wide ranging unscripted comments. In particular (barely) reported instances, his comments have included apparent attacks on the clinical or public health research evidence base. (I used the word "appearent" since nothing Mr Trump writes or says is ever that clear.)

Denied Asbestos Related Disease

The best reported example is the oldest. A Mother Jones article from June, 2016, noted that in Mr Trump's presumably ghost-written book, Art of the Comeback, he wrote that asbestos is "100 percent safe, once applied," and it "got a bad rap." He also claimed that

the movement against asbestos was led by the mob, because it was often mob-related companies that would do the asbestos removal.

It is possible that these comments arose from Mr Trump's resentment of the costs of asbestos removal from his many real estate holdings.

Nonetheless, the evidence that asbestos is a major health hazard is old, but quite clear. (See summaries by The National Cancer Institute, the Agency for Toxic Substances and Disease Registry, the Occupational Safety and Health Adminstration.) Asbestos can cause asbestosis, which may lead to severe respiratory insufficiency, lung cancer, and mesothelioma. The application of asbestos can be very hazardous, but once applied it can still endanger not only those who remove it, but firefighters, other first responders, etc.

Ridiculed the Concept of Post-Traumatic Stress Disorder (PTSD)

On October 3, 2016, the Washington Post reported,

Donald Trump told a group of military veterans on Monday that some members of the military develop mental health issues because they are not 'strong' and 'can't handle it.

'When you talk about the mental health problems, when people come back from war and combat, they see things that maybe a lot of the folks in this room have seen many times over. And you're strong and you can handle it, but a lot of people can't handle it,' the Republican presidential nominee told an audience of military veterans at an event in Northern Virginia on Monday morning.

Allowing for Mr Trump's famously chronically garbled syntax, he appeared to say that PTSD is not a mental illness, but simply a manifestation of weakness. However, there seems to be no data to support this assertion, rather the contrary seems more likely to be true (for example, see the links in this article.)

Scoffed at Chronic Traumatic Encephalopathy (CTE)

In a story apparently only reported in the sports sections of the media (for example, here in USA Today on October 12, 2016), Mr Trump appeared to dismiss the dangers of concussions,

Trump likewise demonstrated a poor grasp of concussions and lashed out at the NFL when he commented on a woman who passed out in the crowd.

From the speech:

'That woman was out cold, and now she’s coming back. We don’t go by these new, and very much softer, NFL rules. Concussions..’oh, oh! Got a little ding on the head. No, no, you can’t play for the rest of the season.’ Our people are tough.'

This isn’t the first time Trump has ridiculed the NFL for its increased awareness of brain injuries. At a rally in Iowa earlier this year, he made similar comments.

Via Mic:

'Football’s become soft. Football has become soft,' GOP presidential candidate Donald Trump said (twice) at a rally in Iowa on Sunday.

'But football’s become soft like our country has become soft,' he added to cheers and nods. 'It’s true. It’s true.'

'What used to be considered a great tackle, a violent head-on [tackle]. … You used to see these tackles and it was incredible to watch, right?' Trump said.

Rather than being a "little ding on the head," there is pretty convincing evidence that concussions can lead to real neurological problems. See the website of the Boston University CTE (chronic traumatic encephalopathy) Center, which provides this summary,

Chronic Traumatic Encephalopathy (CTE) is a progressive degenerative disease of the brain found in athletes (and others) with a history of repetitive brain trauma, including symptomatic concussions as well as asymptomatic subconcussive hits to the head. CTE has been known to affect boxers since the 1920s. However, recent reports have been published of neuropathologically confirmed CTE in retired professional football players and other athletes who have a history of repetitive brain trauma. This trauma triggers progressive degeneration of the brain tissue, including the build-up of an abnormal protein called tau. These changes in the brain can begin months, years, or even decades after the last brain trauma or end of active athletic involvement. The brain degeneration is associated with memory loss, confusion, impaired judgment, impulse control problems, aggression, depression, and, eventually, progressive dementia.

The Center's personnel wrote a 2009 review article(2), available here, which supplies considerably more detail.

Asserted Vaccines Cause Autism

A September, 20, 2016, Huffington Post article noted that Mr Trump has been a proponent of the theory that vaccines cause autism at least since 2012,

The Republican nominee is a full-blown proponent of the notion that vaccines cause autism, a theory that researchers have studied and rejected over and over after a medical journal helped launch the notion with a 1998 article since retracted.

Lots of autism and vaccine response. Stop these massive doses immediately. Go back to single, spread out shots! What do we have to lose.
— Donald J. Trump (@realDonaldTrump) October 22, 2012

I am being proven right about massive vaccinations—the doctors lied. Save our children & their future.
— Donald J. Trump (@realDonaldTrump) September 3, 2014

Again, at best, the link between vaccines and autism is very controversial at best.  Most reviews suggest that the evidence supporting any relationship is very limited, for example, see the 2003 review by Wilson et al(3) and the 2016 review by Taylor et al.(4)

The Republican Party Platform Which Trump Presumably Approved Asserted that Pornography is a Public Health Hazard

At least partially related is this story, as reported by CNN in July, 2016,

The Republican Party will declare internet pornography a 'public health crisis' under an amendment added to the draft party platform Monday at preliminary meetings in Cleveland.

North Carolina delegate Mary Frances Forrester successfully proposed the amendment in a subcommittee of the platform committee Monday morning.

'The internet must not become a safe haven for predators,' the provision states. 'Pornography, with its harmful effects, especially on children, has become a public health crisis that is destroying the life of millions....'

It appears that this provision conflates adult and child pornography.  There seems to be no good evidence that adult pornography creates health risks.

(Note: there is some irony in this story, as Mr Trump has appeared, albeit fully dressed, in several softcore porn videos, see stories here and here.  He also nominally wrote a racy novel, which was actually ghost written, see story here.  Also, his current wife also has appeared in one "lad mag" photo shoot sans clothes, see story here.)  

Comments

We have been discussing threats to the clinical and public health evidence base for a while.  We are used to discussing distortions of the evidence base that serve to support vested interests.

However, I cannot recall casual attacks on specific parts of the evidence base by apparently woefully uninformed political candidates.  It is not unusual for candidates for public office to talk about health care, public health, and related policies.  It is unusual for them to make assertions about specific evidence about particular diseases, and their risk factors and causation.

It is disturbing when one candidate for the most powerful political office in the US repeatedly disregards the best clinical and public health evidence, and offers ill considered opinions about public health that could potentially harm patients.

But Mr Donald Trump is a very unusual candidate.  Perhaps this is why Scientific American, which "is not in the business of endorsing political candidates," took a strong position against what Mr Trump has been saying about science.

'If it disagrees with experiment it is wrong.'
—Richard Feynman

Four years ago in these pages, writer Shawn Otto warned our readers of the danger of a growing antiscience current in American politics. 'By turning public opinion away from the antiauthoritarian principles of the nation's founders,' Otto wrote, 'the new science denialism is creating an existential crisis like few the country has faced before.'

Otto wrote those words in the heat of a presidential election race that now seems quaint by comparison to the one the nation now finds itself in. As if to prove his point, one of the two major party candidates for the highest office in the land has repeatedly and resoundingly demonstrated a disregard, if not outright contempt, for science. Donald Trump also has shown an authoritarian tendency to base policy arguments on questionable assertions of fact and a cult of personality.

Americans have long prided themselves on their ability to see the world for what it is, as opposed to what someone says it is or what most people happen to believe. In one of the most powerful lines in American literature, Huck Finn says: 'It warn't so. I tried it.' A respect for evidence is not just a part of the national character. It goes to the heart of the country's particular brand of democratic government. When the founding fathers, including Benjamin Franklin, scientist and inventor, wrote arguably the most important line in the Declaration of Independence—'We hold these truths to be self-evident'—they were asserting the fledgling nation's grounding in the primacy of reason based on evidence.

While this election may have effects that go way beyond science, particularly the integrity of the clinical and public health evidence base, those concerned about these issues need to take heed now before the voting is finished.  

References

1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14 (2003) 123–130.  Link here.

2. McKee AC, Cantu Rc, Nowinski CJ et al. Chronic Traumatic Encephalopathy in Athletes: Progressive Tauopathy following Repetitive Head Injury. J Neuropathol Exp Neurol. 2009 July ; 68(7): 709–735. doi:10.1097/NEN.0b013e3181a9d503.

3. Wilson K, Mills E, Ross C et al. Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine: A Systematic Review of Current Epidemiological Evidence. Arch Pediatr Adolesc Med. 2003;157(7):628-634. doi:10.1001/archpedi.157.7.628. Link here.

4. Taylor LE, Swerdfeger AL, Eslick GD. Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies. Vaccine 2016; 32: 3623–3629. Link here.

from Health Care Renewal http://ift.tt/2fdy4WO Trumping the Evidence - The Donald Denies Asbestos Related Disease, Post-Traumatic Stress Disorder, Chronic Traumatic Encephalopathy but Asserted Vaccines Cause Autism Health Service Home

The Good and the Bad of Obamacare wholehealthsource

from Health Care Policy and Marketplace Review http://ift.tt/2efzeje The Good and the Bad of Obamacare wholehealthsource

Legal Settlements to Remind Us How Our Health Care System Became Rigged: by GSK, Novartis, CVS Health Service Home

Amidst the sound and fury of the US election season, almost under the radar sneak legal settlements demonstrating continuing bad behavior by big health care organizations, and the continuing lack of accountablity of these organizations' leaders.

We note three cases involving unethical practices leading to overuse of pharmaceuticals that appeared in the last two months, in chronological and alphabetical order.


GlaxoSmithKline Settles Charges of Bribing Chinese Doctors

A summary from Stat by Ed Silverman on September 30, 2016,

GlaxoSmithKline on Friday agreed to pay $20 million to settle charges of violating the Foreign Corrupt Practices Act for what authorities called a pay-to-prescribe scheme in China. In doing so, Glaxo becomes the latest global drug maker to face such accusations as part of a long-running probe by US authorities into companies that paid bribes overseas in order to boost sales of their medicines.

The settlement is an outgrowth of the bribery scandal that rocked Glaxo and resulted in a $490 million fine two years ago after a Chinese court found the company guilty of bribing doctors, hospital officials, and other non-governmental personnel. The former head of the Glaxo unit in China also pleaded guilty to bribery-related charges and was given a three-year suspended sentence.

As part of the scheme, Glaxo employees allegedly funneled kickbacks through trade groups and travel agencies that planned events. Between 2010 and June 2013, Glaxo spent nearly $225 million on planning and travel services. But after reviewing a sample of invoices, authorities found about 44 percent were inflated and approximately 12 percent were for events that did not occur, according to an SEC order.

In 2010, Glaxo hired a Chinese company to develop a project to provide clinics with tools to store and administer vaccines that required refrigeration. Instead, the project was used to give laptops and other electronic devices as gifts to clinics that were believed to have the potential to market still other Glaxo drugs. In all, the drug maker spent about $2.3 million doing this.

Articles in the Wall Street Journal and Reuters stated the bribes were explicitly meant to boost sales of drugs.  However, I am not able to find any information in the few media reports or the US Securities and Exchange Commission order about which products were so promoted.  It appears likely, however, that these alleged practices led to overuse of drugs that at best did patients no good and at worst caused direct harm. 

Although proceedings in China resulted in punishment of a GSK official there, the US proceedings did not subject any individual to negative consequences for enabling, authorizing, directing or implementing any bribes.

Note that our posts on previous misadventures by GSK can be found here.

Novartis Settles Charges of Illegally Promoting Skin Cream for Infants in the US

Again, as summarized by Ed Silverman in Stat on October 5, 2016,

Novartis has agreed to pay $35 million to settle charges of illegally promoting a prescription skin cream for use with infants and toddlers. The deal marks the second time in the past year the drug maker has struck a deal with US authorities to resolve allegations of improperly marketing its medicines.

The agreement, announced on Wednesday, stems from a whistleblower lawsuit filed by a former Novartis sales representative, who accused the company of deliberately trying to widen the market for Elidel by encouraging prescriptions for children younger than 24 months, even though the medicine was not approved for that patient population. At one point, regulators issued a warning about the risk of cancer in small children.

'We were instructed that Elidel was so safe it could be put on up to 80 percent of a baby’s body. And we were never told that it might cause cancer,' said Donald Galmines, 44, the former rep, in a statement. He added that he was trained to invite doctors and their families or staffs to dinners at expensive restaurants, even though during the course of the meal, Elidel might not even be brought up.

The illegal marketing occurred between 2002 and 2009,...

So this case involved allegations of deceptive marketing.  In particular, the deception was potentially dangerous to infant patients, since it appears that the drug promoted was unduly dangerous.

In this settlement, however, the company got to explicitly deny wrongdoing.

Novartis denied the allegations in the settlement agreement.

Novartis has had considerable recent legal trouble involving unethical behavior.

The settlement comes amid a difficult stretch for Novartis. The drug maker last year paid $390 million to settle charges of paying kickbacks to boost sales of two other drugs. And the company is facing a trial stemming from yet another whistleblower lawsuit filed by a different former sales rep, who similarly alleged Novartis illegally marketed medicines.

Those cases gained considerable attention because US Attorney Preet Bharara, who is based in New York, claimed Novartis is a repeat offender when he announced the government had joined the lawsuits in 2013. He was referring to a 2010 case in which the company paid $422.5 million for allegedly marketing six drugs off-label and paying kickbacks to health care professionals.

The United States is not the only venue where Novartis has encountered such charges. Last March, the drug maker agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act by making illegal payments to health care providers in China. Employees gave money, gifts, vacations, and entertainment to health care professionals between 2009 and 2011, according to US authorities.

Furthermore, an even more extensive list of previous Novartis misadventures can be found in our post here.

Despite all that, however, the settlement did not subject any individual to negative consequences for enabling, authorizing, directing or implementing the allegedly illegal promotion.

Omnicare Settles Charges of Accepting Kickback to Help Illegally Promote Depakote

Finally, as yet again best summarized by Ed Silverman on StatNews on October 17, 2016,

Omnicare, which is the nation’s largest nursing home pharmacy, agreed on Monday to pay more than $28 million to resolve charges of seeking kickbacks from Abbott Laboratories in exchange for boosting prescriptions for a medicine that the drug maker had promoted illegally.

As part of the scheme, Omnicare disguised the kickbacks from Abbott as grants and educational funding, and took rebates from the drug maker based on the amount of Depakote that was prescribed for each nursing home resident. In addition, Abbott paid for Omnicare management meetings at a Florida resort and offered tickets to sporting events, according to the US Department of Justice.

The arrangement between Omnicare and Abbott began after the drug maker launched a new initiative in 1997 to boost prescriptions for the drug, which is approved for treating seizures, bipolar mania, and migraines, but not uncontrollable behavior due to dementia. The following year, Omnicare began soliciting kickbacks from Abbott and the scheme lasted about three years, according to court documents.

The settlement is the latest in a long-running probe by the feds into Omnicare, which is now owned by CVS, and the interplay between nursing home pharmacies and drug makers.

In 2012, Abbott reached a $1.5 billion global civil and criminal settlement that resolved, among other things, alleged kickbacks paid to nursing home pharmacies. At the time of the agreement, the feds noted that Abbott promoted Depakote for controlling behavioral disturbances in dementia patients, even though the US Food and Drug Administration never approved the pill for this particular use.

'Kickbacks to entities making drug recommendations compromise their independence and undermine their role in protecting nursing home residents from the use of unnecessary drugs,' said Benjamin Mizer, the principal deputy assistant attorney general in the Justice Department’s Civil Division,...

So it appears that at best the kickbacks led to prescription of drugs that did patients little good, and may have caused adverse effects.  

An article in the Cincinnati Business Courier noted that CVS, of which Omnicare is now a subsidiary, avoided admitting any responsibility for the alleged acceptance of kickbacks,

CVS 'agreed to settle this matter to avoid the expense and uncertainty of protracted litigation,' spokesman Mike DeAngelis said of the suit against Omnicare. 'The activities, which were alleged to have violated anti-kickback laws, all occurred prior to CVS Health’s acquisition of Omnicare. These matters involved Omnicare only, and no allegations were made against any of CVS Health’s other businesses, including CVS Pharmacy and CVS Caremark. CVS Health is committed to the highest standards of ethics and business practices, and there was no admission of wrongdoing.'

An Associated Press article noted Omnicare's previous track record,

Omnicare has spent hundreds of millions of dollars resolving kickback litigation in recent years. In 2014, it agreed to pay more than $124 million to settle lawsuits alleging it gave kickbacks to some facilities so they would keep the company as their drug provider for elderly Medicare and Medicaid recipients.

In 2009, Omnicare said it would pay $98 million to settle allegations that it solicited or paid a variety of kickbacks. That included an accusation that it received kickbacks from Johnson & Johnson for recommending that doctors prescribe to nursing home patients the antipsychotic Risperdal, which can hasten death in elderly people with dementia.

Furthermore, an extensive list of parent company CVS' misadventures can be found in this post.


Despite all that, again, the settlement did not subject any individual to negative consequences for enabling, authorizing, directing or implementing the alleged acceptance of kickbacks.

Summary

Three settlements in two months by three major health care corporations involved allegations of unethical behaviors that were meant to increase prescribing of various pharmaceuticals, whether or not patients needed them, or were more likely to be harmed by them.  Despite the unsavory nature of the behaviors, and the likelihood of patient harms, the companies involved had to pay fines that were tiny relative to their multi-billion dollar revenues.  The companies did not have to admit responsibility, and company managers and leaders did not suffer any negative consequences for enabling, authorizing, directing or implementing the bad behavior.  Thus they exhibited impunity.

These cases are just the latest in a long march of legal settlements to remind us of the continuing bad behavior of large health care organizations, and the continuing impunity of their managers and leaders.

This adds to the evidence suggesting that US health care, at least, is rigged to benefit its top insiders and cronies, and as such, is part of a larger rigged system.  We have previously discussed how market fundamentalism (or neoliberalism) led to deregulation, which enabled deception, fraud, bribery, and intimidation to become standard business practices, and allowed increasing concentration of power by large corporations. Managerialism allowed the top leaders of these corporations and their insider cronies to amass increasing power and money. Everyone else, other employees, stockholders of public corporations, customers, vendors and suppliers, and the public at large lost out. In health care, these changes led to an increasingly costly system which produced increasingly bad results for patients and the public.

We have called for years for what we sometimes term "true health care reform" to derig the system.  Little has changed, while perceptions that the system is rigged have become more common.

Unfortunately, perceptions of a rigged system may not always inspire honest reform. Instead, they can enable the rise of demagogues and would be dictators who promise only they can solve the problem. This appears to have happened in the US. Now honest people who want to unrig the system must first prevent an even worse result, authoritarianism or frank dictatorship.  Never has Benjamin Franklin's warning that we only have "a republic, if you can keep it" been more salient.

However, should we be successful in fending off despotism, the original problems that led the system to be rigged will remain, and new men on white horses may appear, unless we truly reform the system. 

So let us not forget how we got here in the first place.  And should we successfully preserve our republic, let us remember the need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, particularly when these organizations misbehave.

from Health Care Renewal http://ift.tt/2do8Zut Legal Settlements to Remind Us How Our Health Care System Became Rigged: by GSK, Novartis, CVS Health Service Home

Petitions for Research Integrity and Against Corruption Available for Signature Health Service Home

Recently, two petitions relevant to the goals of Health Care Renewal have become available. 

US Petition to "Stop False Reporting of Drug Benefits & Harms by Making FDA & NIH Work Together"

Health Care Renewal blogger Dr Bernard Carroll, along with Dr Mickey Nardo, who blogs on 1BoringOldMan, and Emeritus Professor John H Noble Jr have authored a petition to improve the reporting of clinical research in the US, and hence combat the manipulation of clinical research, a topic we often discuss.

Its essence is:

We now petition Congress to require the FDA and NIH to coordinate their monitoring and sharing of key information through ClinicalTrials.gov. Working together, the two agencies could enable stakeholders to verify whether purported scientific claims are faithful to the a priori protocols and plans of analysis originally registered with the FDA. Publication of analyses for which such fidelity cannot be verified shall be prohibited unless the deviations are positively identified (as in openly declared unplanned, secondary analyses). This prohibition shall include scientific claims for on-label or off-label uses made in medical journals, archival conference abstracts, continuing education materials, brochures distributed by sales representatives, direct-to-consumer advertising, and press releases issued by companies or their academic partners. It shall extend to FDA Phase 2, Phase 3, and Phase 4 clinical trials. By acting on this petition, Congress will create a mechanism for stakeholders independently to verify whether inferences about clinical use suggested by the unregulated corporate statistical analyses can be trusted.

The full petition is available online, and is sponsored by the Science and Evidence Council of the Right Care Alliance.

Transparency International Declaration Against Corruption

Transparency International is sponsoring a declaration, valid globally, against corruption.  We often discuss health care corruption, despite the apparent taboo against doing so.  As we just noted, this comes as Transparency International is launching a major initiative against health care corruption.

Its essence is:

I will not pay bribes
I will not seek bribes
I will work with others to campaign against corruption
I will speak out against corruption and report on abuse
I will only support candidates for public office who say no to corruption and demonstrate transparency, integrity and accountability.

It is available for signature here.  



from Health Care Renewal http://ift.tt/2e1XDOi Petitions for Research Integrity and Against Corruption Available for Signature Health Service Home

ONC to Boost Oversight over EHR Usability, Patient Safety Woes Health Service Home

Did the US Dietary Guidelines Cause the Obesity Epidemic? healthpolicyandmarket

A popular argument holds that the US Dietary Guidelines caused our obesity epidemic by advising Americans to reduce fat intake.  Does the evidence support this idea, or is it simply a fantasy?

Introduction

Read more »

This post was written by Stephan Guyenet for Whole Health Source.

from Whole Health Source http://ift.tt/2ecZD5t Did the US Dietary Guidelines Cause the Obesity Epidemic? healthpolicyandmarket

Transparency International Once Again Takes on Health Care Corruption Health Service Home

I am happy to report that Transparency International is making a big new push against health care corruption.

Health Care Corruption as a Taboo Topic

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.

The Transparency International Pharmaceuticals & Healthcare Programme


In June, 2016, Transparency International showed it was back in the fight against health care corruption.  At that time, it published a report on corruption in the pharmaceutical sector.  We discussed it here.  Unfortunately, that report also got little notice in the media or in the medical or health care literature.

This report was actually one of the first efforts from a new Transparency International initaitive to address health care corruption, entitled the Transparency International Pharmaceuticals & Healthcare Programme.  Its mission statement begins [italics added by me]:

Every day, all around the world, people suffer and die due to corruption in the pharmaceutical and healthcare sector. Our vision is a world where less corruption leads to improved global health and healthcare outcomes, leaving no one behind.

Building on twenty years of experience in this and other sectors, Transparency International’s Pharmaceuticals & Healthcare Programme is taking up the challenge of understanding, identifying and combatting corruption in this vital sector. The Programme wants to achieve genuine change in the pharmaceutical and healthcare sector through reducing corruption and promoting transparency, integrity and accountability.

On its new website is its next major report, Diagnosing Health Care Corruption. Its introduction updates the 2006 report, and begins with:

Every day, all around the world, people suffer and die due to corruption in the healthcare sector. It disproportionally affects vulnerable groups, who do not have the knowledge, money or connections to access the care or products they need. While corruption can occur in every area of a health system, corruption from the highest levels will trickle down to effect healthcare received by patients at local health care facilities.

There are several broad effects of corruption in healthcare. Distorted policy, legislative andclinical priorities; a loss of money from health systems; denied or delayed access to health care services and treatment; and a loss of trust in national health facilities, personnel and to a wider extent national governance as a whole.

However, the specific cost of corruption is almost impossible to measure. Like other forms of white-collar crime corruption is inherently hidden from sight and even when some forms of corruption are discovered it is hard to quantify their impact.

The report was motivated by the finding that:

individuals in the healthcare sector do not always understand what corruption is and how it may undermine their work. Conversely, anti-corruption specialists do not always understand and appreciate the complexity of the health care system. This map – a project that will be kept updated – attempts to bridge that gap by providing for the first time, a comprehensive and accessible guide to a health system and the types of corruption that may occur.

The report discussed how corruption affects eight different aspects of the health care system:
- health system governance
- health system regulation
- research and development
- marketing
- procurement
- product distribution and storage
- financial and workforce management
-delivery of healthcare services

For each aspect, it discusses specific types of corruption, 37 in all.  An interactive map of the eight aspects of the health care system and 37 types of corruption affecting them starts on the main page of the website.

In the future, the Pharmaceuticals & Healthcare Programme

activities will be prioritised around five areas in health systems: research & development; manufacturing; procurement and distribution; marketing; and service delivery. These were identified following extensive stakeholder engagement and the programme’s foundational research.

The Pharmaceuticals & Healthcare Programme will target global, national and local interventions. Ongoing research and the lessons drawn from regional and national projects will be used to influence global policy to produce structural change within the health sector; promote global best practice standards to strengthen transparency and accountability; and support national and local interventions and solutions.

Comments

Transparency International's re-engagement with the problem of health care corruption argues for the importance and magnitude of this problem.  I hope its new report is not as anechoic as Transparency International's previous efforts were, that it helps to end the taboo on even discussing health care corruption, much less addressing it.  I dare to hope that the new initiative might actually lead to some action to reduce health care corruption. 

As I have said before, and now once more with feeling... 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.



from Health Care Renewal http://ift.tt/2diA6pb Transparency International Once Again Takes on Health Care Corruption Health Service Home

Ransomware and incompetence in backups leads to medical data loss...but the thieves were honest thieves! Health Service Home

"An honest thief!" said Caledon Hockley of Jack Dawson, after planting the Heart of the Ocean diamond necklace in Jack's pocket.  https://www.youtube.com/watch?v=G5UEwCHUHjg

The headline of this posting may sound absolutely insane, but it is factual.

But don't worry, your precious medical data is far safer than it ever was on that 5,000-year-old invention, papyrus.

Marin patients’ medical data lost after cyber attack
By Richard Halstead, Marin Independent Journal   
September 30, 2016
http://ift.tt/2dzbmLI

The Marin Healthcare District and Prima Medical Foundation are notifying more than 5,000 patients that some of their medical data was lost due to a glitch that followed a ransomware attack in August.

There's that all-purpose euphemism again, "glitch", which in this case is a euphemism for negligence.  See blog query link  http://ift.tt/TNpySo for more on "glitches."

Prima Medical Foundation supports the Prima Medical Group, many of whose doctors work closely with Marin General Hospital.

I covered the wondrous EHR at Marin General Hospital at my May 17, 2013 post "Marin General Hospital nurses warn that new computer system is causing errors, call for time out" at http://ift.tt/2ejggvv, and my May 20, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at http://ift.tt/2dOgZ5u.

The computer records of Marin Medical Practice Concepts, a Novato company that provides medical billing and electronic medical records services to many Marin physicians, were hacked on July 26. As a result, some Marin doctors were unable to access their patients’ medical records for more than a week.

More than a week with no records is, needless to say, putting patients at great risk.

Responding to questions from the Independent Journal on Aug. 4, Lynn Mitchell, CEO of Marin Medical Practice Concepts, confirmed the malware attack. In her email, Mitchell wrote, “Ransom was paid. For security reasons we will not be releasing the amount or denomination paid.”

That really inspires confidence.

Typically in such ransomware attacks, a sophisticated computer virus finds its way into a victim’s system when an unsuspecting employee opens an email attachment. The virus encrypts the system’s data and attackers essentially hold the data hostage until the owners of the information pay a ransom, typically in an untraceable digital currency such as Bitcoin.

A virus "finds its way" into a victim's system?

Let me rephrase into the politically incorrect, but factually correct, "due to incompetence in computer security. evil people are able to infiltrate the virus into a life-critical EHR system."

The Marin Healthcare District and Prima Medical Foundation issued nearly identical press releases on Wednesday, stating, “The third-party forensic firm hired to investigate this incident found no evidence that patient personal, financial, or health information was accessed, viewed, or transferred.

I guess they never considered that such evidence could have been removed by the hackers, who obviously had just a bot more IT expertise than the average high schooler.

But, of course, the thieves were honest thieves who would NEVER steal valuable medical charts for profit on the black market...

Here's what I consider the very worst part of this incident:

“However, during the restoration process, one of MMPC’s backup systems failed, causing information to be lost that was collected at the district’s nine medical care centers between July 11, 2016 and July 26, 2016.”

I note that a "backup system failing" causing data loss is a "never" event.  Incompetence...

The release went on to say: “This information includes vital signs, limited clinical history, documentation of physical examinations, and any record of the communication between patients and their physician during a visit in that 15 day period. Results of diagnostic tests were not lost and patients do not need to be re-tested.”

But patient safety was not compromised...

Jamie Maites, a spokeswoman for Marin General Hospital, said, “The ransom unlocked the data; however, at the time of the incident, we were in the middle of a system upgrade. The data loss occurred at the time of the system restore due to a faulty backup system — not due to the malware.”

Well, that's certainly reassuring.

Maites said Marin General’s systems were unaffected by either the ransomware or the failed backup systems. The patients being notified are patients of physician practices that are part of the Marin Healthcare District Medical Care Centers and Prima Medical Foundation.

The hackers were generous in sparing the hospital.

In a statement, Lee Domanico, chief executive of the Marin Healthcare District, said, “Our community can rest assured that the Marin Healthcare District will continue to work side by side with our vendors to ensure that all of our data is protected with today’s most advanced technology to reinforce their security systems against the most aggressive threats.”

Lee Domanico is the same CEO who I cited in my aforementioned posts who in 2013, after dire nurse warnings, brilliantly assured the board that the hospital was safe, despite "glitches" in the new system and that "I'm confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."

In a similar statement, Dr. Robert Newbury, chief executive of the Prima Medical Foundation, said, “It is unfortunate that these types of cyber-attacks have become so common.”

I would more precisely state that it is unfortunate that health IT leaders are so incompetent that they cannot secure their own life-critical systems.

... According to a report issued by the Attorney General’s Office in February, in the past four years the attorney general has received reports on 657 data breaches affecting a total of more than 49 million records of Californians.  The report said that malware and hacking present the greatest threat, accounting for 54 percent of the breaches. The report added that health care, which accounted for 16 percent of breaches, is starting to see an increase in hacking breaches as the sector transitions to electronic medical records. And it said that the “most vulnerable information in health care was medical information, such as patient records, and Social Security numbers.”

I really have to ask if the (increasingly elusive) benefits of EHRs warrant this level of security risk - let alone the known risks of bad health IT aside from security issues.

-- SS



from Health Care Renewal http://ift.tt/2ejftej Ransomware and incompetence in backups leads to medical data loss...but the thieves were honest thieves! Health Service Home

From my totally nonprofessional viewpoint, it looks like at least the first two of these hospital deaths were directly related to EHR failures. Health Service Home

The Connecticut "Health I-Team" site (http://ift.tt/2cVbpk4) provides access to a database sourced from the Connecticut Department of Public Health that includes reports of violations at Connecticut hospitals found during inspections, as well as corrective actions taken to prevent similar future violations.

Their Mission Statement is as follows at http://c-hit.org/about/:

Mission Statement
The non-profit Connecticut Health Investigative Team [C-HIT] is dedicated to producing original, responsible, in-depth journalism on issues of health and safety, in Connecticut and the surrounding region.

Who We Are
A team of award-winning journalists, based in Connecticut, who have come together to provide the public with informative stories about health, safety and medical issues.

They've reported the following at http://ift.tt/2dy5cIC, dated Oct. 5, 2016:

Several patient deaths, including the death of a newborn who was given an overdose of medication, were among various violations found at Connecticut hospitals, according to newly released inspection reports from state health officials.

The reports, which can be found in C-HIT’s Data Mine section, cover inspections that took place at hospitals statewide in late 2015 and the first four months of this year. Some of the violations detailed in the reports resulted in death and injuries to patients.

Department of Public Health (DPH) inspectors regularly make unannounced visits to all hospitals, during which they tour facilities, observe staff and examine documents. Though the most recently released reports document inspections that took place this year and last, some of the violations they include happened several years ago.

All hospitals where violations were found submitted corrective action plans that the DPH has accepted.

Several violations occurred at Yale-New Haven Hospital. A newborn admitted to the New Haven hospital’s Neonatal Intensive Care Unit from another hospital on July 8, 2015, died after being given too much amiodarone, according to DPH. The newborn had an irregular heartbeat and had failed the Critical Congenital Heart Defect screening soon after birth; the medication is used to treat irregular heart rhythms.

A physician assistant said the newborn may have been given too much of the medication because of a default frequency that was automatically entered in a computer system, according to the inspection report.

Also at Yale-New Haven Hospital, a patient having eye surgery on Jan. 16, 2015, died after having a heart attack during the procedure. DPH found the hospital did not document the patient’s vital signs or CPR efforts properly.

From my "totally nonprofessional" viewpoint (that's sarcasm, of course), it looks like at least the first two of these hospital deaths were directly related to bad health IT.

Yale is a relatively recent adopter of the EPIC EHR.

The true rate of near-misses and actual patient harms less than or equal to death is unknown, as random inspections and voluntary reporting are generally unreliable towards complete numbers.

However, based on voluntary evidence such as the ECRI Deep Dive Study (see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html), the rate is likely far higher than the simple stats reported above show.

The myths around electronic medical record systems have caused the expenditure of billions of dollars and the enrichment of the IT industry at the expense of healthcare.  Benefits are still dubious.  This money could likely have been better spent on healthcare provision itself, especially to the disadvantaged.

The patients mentioned above might be considered sacrifices to the narcissism of the cybernetic hyper-enthusiasts.

-- SS

Another observation.  Through my legal work I have now reviewed the current technical and user manuals to a number of EHR systems in both general and medical subspecialty areas. The nuances, complexity, arbitrary rules, "gotchas", workarounds, etc. of the software that needs to be learned and supported by clinicians (not to mention the technical support personnel) is staggering.  That is not even considering frequent changes.  This is increasingly frightening to me, a Medical Informatics specialist, considering clinicians have far more important matters to attend to, have little free time, and may need to learn multiple systems - sometimes in several hospitals.  These manuals make manuals to the most complex appliances (e.g., advanced professional digital cameras, or car repair manuals) seem like child's play.

Hospitals seem to be becoming a computer laboratory for cybernetic experimentation and a billing mill, rather than a patient care facility.  Clinicians are becoming "software buccaneers" for bad and overly complex health IT. 

All to replace a pen and paper forms.

This is not what the EHR pioneers who taught me Medical Informatics  intended.

-- SS

from Health Care Renewal http://ift.tt/2cVb5lu From my totally nonprofessional viewpoint, it looks like at least the first two of these hospital deaths were directly related to EHR failures. Health Service Home

Not So Wondrous Drugs? - New Warnings about Severe Adverse Effects of New, Heavily Marketed Drugs for Hepatits C, Health Service Home

Background - Wonder Drugs for Hepatitis C

In our April, 2014, post we noted how Sovaldi (sofosbuvir), the new antiviral drug made by Gilead for hepatitis C was touted as a "triumph of of medical technology."  In that, and subsequent posts we discussed how such claims were not buttressed by much good data from clinical research.

We could find only one published randomized clinical trial of sofosbuvir (and ribavirin), which compared it to the older drug used to treat hepatitis C, peg-interferon (and ribavirin).  At best, the new drug showed about the same ability to eliminate detectable virus from the patients' blood in the short-term as did the older drug.  The new drug also produced fewer unpleasant side effects, but possibly more severe adverse effects.  Just like all previous known published trials of hepatitis C treatments, this trial of sofosbuvir did not follow patients long enough to determine if the drug had any effect on the serious, but not inevitable long-term complications of hepatitis C infection, severe hepatitis, cirrhosis, liver failure, liver cancer, and premature death. 

I could find no other published trials of sofosbuvir versus either older drugs or placebo.  Most of the subsequently published, and loudly hyped studies of the drug were of highly selected patients, and did not include control groups which did not receive sofosbuvir.  So the very high short term "cure" rates - which were really rates of elimination of detectable virus from the blood, could have been mainly a function of these studies' highly selected patient populations.

Yet the lack of strong evidence that sofosbuvir, and subsequent competing drugs actually made patients better, i.e., feel better, function better, avoid serious subsequent medical problems, or live longer, did not stop tremendous enthusiasm in the media for the new drug.  Much of it doubtless stemmed from huge marketing and public relations expenditures.  Nor did did the lack of evidence stop Gilead and other drug makers from pricing the new drugs in the stratosphere.  Initially a 12 week course of of Sovaldi cost $84,000.

Since then, there has been tremendous buzz about the price of these new antiviral drugs for hepatitis C, and tremendous anxiety about the consequent difficult access to these presumptively "life saving" therapies.  However, my and others' questions about whether these drugs actually benefit patients, and whether any benefits might be worth their harms, remained anechoic (See appendix below.)

The Harms of the "Wonder Drugs" Begin to Appear

Nowadays new drugs, devices, and other health care technologies are often touted based on little evidence.  What evidence is produced mainly comes from commercially sponsored clinical trials.  Commercial sponsors may manipulate the design, implementation, analysis and dissemination of these studies to increase the likelihood that they will make their products look good.

In particular, such trials may fail to detect adverse effects of the new products to be hyped.  The trials  often enroll only small numbers of patients, decreasing the likelihood of finding rare but serious problems.  Often patients who have any health problems other than the disease of interest are excluded from trials, decreasing the likelihood of detecting adverse events that might affect patients with multiple morbidities or on other treatments.  Trials may fail to follow patients long-term, so they may fail to detect adverse effects that appear only after prolonged therapy.  These sorts of problems certainly afflicted the very few real clinical trials of sofosbuvir, and other new antiviral drugs for hepatitis C.   

So it should not have been surprising that sofosbuvir has now been found to produce two kinds of severe adverse events that were undetected, or at least undisclosed when it was launched.  The second kind of adverse event was just announced, and also seems to occur after administration of other new anti-hepatitis C drugs.

Severe Heart Rhythm Abnormalities

In March, 2015, as discussed by Dr John Mandrola in Medscape,

As reported by heartwire , the US FDA recently announced a change in labeling for the hepatitis-C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after their manufacturers reported bradycardia, pacemaker intervention, and even death in patients who took the medications along with amiodarone. Notably, six of these nine cases occurred within 24 hours of sofosbuvir dosing.

While Dr Mandrola was concerned about this adverse effect, the news media put more emphasis on the Wall Street analysts who thought the problem would have "zero impact" on sales of the fabulously expensive antiviral drugs. (See this post by Ed Silverman on PharmaLot.)

So all remained serene, until this week.

Reactivation of Hepatitis B Infection

On October 4, 2016, Medscape reported

Patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation if they take any of nine direct-acting antivirals for hepatitis virus C (HCV) infection, the US Food and Drug Administration (FDA) announced today.

The agency will require a boxed warning for the drugs advising clinicians to screen patients for evidence of a past or current HBV infection before ordering antiviral treatment for HCV.

Also,

The FDA said in a news release that it had identified 24 cases of HBV reactivation in coinfected patients treated with these antivirals from November 22, 2013, to July 18, 2016, in reports to the agency and published literature. Two patients died, and one needed a liver transplant.

Why were we not made aware of this before?  Failure to detect this adverse effect was apparently due to the exclusion of patients with a history of hepatitis B from previous studies of the new drugs.  As we mentioned above, commercially sponsored trials often exclude patients with nearly any medical conditions other than the one of interest.  Yet hepatitis C patients often have comorbidities.  I

clinical trials for the HCV drugs in question did not report HBV reactivation because they excluded patients infected with HBV.

Will this prompt a reexamination of our enthusiasm for new antiviral hepatitis C treatments? I suspect not. Even FDA officials suggested we should not be too alarmed. In particular, Dr. John Farley, deputy director of FDA's Office of Antimicrobial Products, said according to NBC News,

I think it is important to recognize that these hepatitis C drugs are lifesaving medications. What we don't want to do is discourage patients with hepatitis C from getting treatment,...

But remember, there has never been a controlled trial that showed that treatment of hepatitis C with anything actually reduced the risk of later severe hepatitis, cirrhosis, liver failure, liver cancer, or premature death. And there may be other adverse effects of this new treatment that remain unknown.

Even government regulators, who are supposed to put the public health ahead of the profits of the pharmaceutical industry, seem to have fallen for the life saving miracle drug meme in this case.

Summary

The ongoing story of hepatitis C treatment demonstrates how hype and buzz, largely generated by marketing and public relations, and likely fueled by financial relationships among commercial health care firms and health care professionals and academics, has triumphed over rigorous skeptical evaluation of the best available evidence from clinical research.

There has never been good evidence that hepatits C treatments prolong life, or prevent severe liver disease in the long run.  There has never been good evidence that these drugs' clinical benefits outweigh their harms.  Yet they have been relentlessly promoted as game changers, miraculous, triumphant lifesaving medicines.

One obvious lesson is that health care professionals, policy makers, and the public at large have to be much more skeptical about commercial claims for drugs, devices, tests, etc.  We need to figure out when claims are coming from marketing departments and public relations hacks.  We need to figure out when researchers and professionals who are supporting these claims could be influenced by financial relationships with the firms benefiting from the claims.

Furthermore, it is high time to revisit all the regulatory and policy changes over the last 30 years that have put manufacturers in charge of the research meant to test their own health care products.

In conclusion, evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender could lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. If only such skepticism were easier to find.


.......
APPENDIX - Clinical Research about Hepatitis C Treatments

Starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA Internal Medicine from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts here,  here, and here.)

References

 1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014;174(7):1170-1171. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.

from Health Care Renewal http://ift.tt/2dvEguc Not So Wondrous Drugs? - New Warnings about Severe Adverse Effects of New, Heavily Marketed Drugs for Hepatits C, Health Service Home

Our ED wait times wil be longer than usual this weekend (and beyond) so we can attend to the computer. Health Service Home

A hospital system, Pinnacle Health, not all that far from me in the Harrisburg, PA area is rolling out EPIC this weekend.

The following banner is at the top of their homepage at http://ift.tt/2dF55Ow:

ALERT: Due to our transitioning of a new computer system this weekend, ER wait times may be longer than normal.  Click to enlarge.

! ALERT: Due to our transitioning of a new computer system this weekend, ER wait times may be longer than normal. If you have a minor illness that doesn’t require a trip to the ER, you can visit one of our Express or FastCare clinics or if unsure where to go, contact our free 24/7 Nurse Advice Line at (717) 988-0074


So, besides delaying affairs in a critical care environment, in order to take care of the computer's needs, they're asking patients to decide if they have "a minor illness that doesn't require a trip to the ER" and, in so doing, redirecting patients with possibly serious problems to a doc-in-the-box urgicare center,

These two matters raise risk on its face.  If patients are harmed or die, then, are their injuries or death a worhty sacrifice in the name of achieving cybernetic uptopia?


It would seem far more logical to roll out a "new computer system" gradually, in a manner that does not require crazy workarounds (e.g., asking patients to decide if they need the ER or not) and causing delays and confusion that, in an ED environment, can and do lead to missed findings, lost information, harm and death,

This will go on for far longer than a weekend.

It's amazing how the naive public has been sold the mantra that computers are a great thing in medicine, and worth the risks, when increasingly, as posted in numerous essays on this website and othersm the data does not support such declarations, and computers serve as more of a distraction than a boon to busy clinicians.

-- SS

from Health Care Renewal http://ift.tt/2dgZs6t Our ED wait times wil be longer than usual this weekend (and beyond) so we can attend to the computer. Health Service Home

Cars as a metaphor for understanding obesity healthpolicyandmarket

If we want to understand the accumulation of excess body fat, it's tempting to focus our attention on the location that defines the condition: adipose tissue.  Ultimately, the key question we want to answer is the following: why does fat enter adipose tissue faster than it exits?

It follows that if we want to understand why obesity occurs, we should seek to understand the dynamics of fat trafficking in adipose tissue, and the factors that influence it.  Right?

I don't think this is right, and here's a metaphor that explains why.

The speed of a car depends primarily on the force that its wheels exert on the asphalt below them.  If we want to understand why cars move quickly sometimes, and slowly at other times, we should seek to understand the dynamics of how force is transferred from the wheels to the asphalt, and the factors that influence it, right?

As you may have already surmised, that wouldn't be a very effective way of understanding car speed. To understand car speed, we have to move up the causal chain until we get to the system that actually regulates speed-- the person in the driver's seat.  Looking at the problem from the perspective of the wheels is not an effective way of understanding the person in the driver's seat.  Once we understand the driver, then we also understand why the wheels move how they do.

Similarly, in obesity, we have to move up the causal chain until we find the system that actually regulates body fatness.  The only known system in the human body that regulates body fatness is the brain.  Once we understand how the brain regulates body fatness, we'll understand why fat enters adipose tissue faster than it exits sometimes, eventually leading to obesity.

We already know a lot about how this process works, and that's why I focus my attention on the brain and behavior rather than the biochemical mechanics of adipose tissue.

This post was written by Stephan Guyenet for Whole Health Source.

from Whole Health Source http://ift.tt/2dxh40X Cars as a metaphor for understanding obesity healthpolicyandmarket

Will the Administration's Making Good on Billions of Dollars Due the Health Plans Solve Obamacare's Exchange Problems? wholehealthsource

from Health Care Policy and Marketplace Review http://ift.tt/2duZshM Will the Administration's Making Good on Billions of Dollars Due the Health Plans Solve Obamacare's Exchange Problems? wholehealthsource

Whose Hospitals Are They, Anyway? - Steward to Sell Off, but Continue Operating All Its Hospitals Health Service Home

This looks like the latest trend in the financialization of and diffusion of accountability for health care organizations.  The case involves good ol' Steward Health Care, which was the subject of quite a few Health Care Renewal posts back in the day.

Background - Caritas Christi Bought by Cerberus Capital Management, Became Steward Health Care

[Cerberus, the three headed dog, per William Blake]

Steward is what used to be Caritas Christi Health Care System, formerly a Catholic, non-profit health care system in Massachusetts.  In 2010, Caritas Christi was purchased by Cerberus Capital Management, a private equity, aka leveraged buyout firm, which was known for its not very successful run managing Chrysler (look here) and GMAC (look here).  Cerberus also had enlarging holdings in the gun industry, later expanded into the Freedom Group, and in military contracting, specifically including DynCorp which hired armed "security forces" and was involved in multiple scandals in Iraq, all of which might strike some health care professionals as inappropriate (look here and here). 

Steward Health Care, as run by Cerberus, was one of the earlier leaders in hiring corporate physicians, whom it pressured to avoid "leakage" of patients to other hospitals and doctors, even if some might question whether the care provided elsewhere might be better for those patients (look here).  The multimillion dollar a year CEO of Steward suggested the health care had become a commodity, objectionable to those who thought that health care should be a mission-based calling (look here).

After Steward consolidated, operational misadventures began.  In 2013, it closed the pediatric unit at Morton Hospital (look here).  In 2014, it closed Quincy Hospital, despite promises that it would expand health care services, and specifically not close that hospital so quickly (look here).  Starting in 2014, Steward stonewalled state requests to disclose financial data as required by state regulations after the private equity takeover (look here).  In 2016, Steward continued to withhold financial data (look here), and closed the short-lived family medicine residency program at Carney Hospital,  amidst complaints by the residents about poor organization, and inadequate numbers of faculty (look here).

Steward to Sell All its Hospitals, but Keep Running Them

This week, the Boston Globe reported a stunning example of financial engineering:

Steward Health Care System said Monday that it lined up $1.25 billion from a real estate investment firm that will help the Boston-based company finance a national expansion, pay off debt, and return money to the private equity firm that bought it almost six years ago.

Steward said Medical Properties Trust Inc. would buy all of its hospital properties for $1.2 billion and pay $50 million for a 5 percent equity stake in the company. Steward will lease the properties from MPT, based in Birmingham, Ala.

Note that nearly all the "financing" was obtained by selling all the hospital properties, which somehow sound like the core assets of a hospital system.

Of course, current Steward management thought it was a great idea:

Steward’s chief executive, Dr. Ralph de la Torre, said the MPT investment will give Steward a second source of capital funding and allow it to grow its model of community-based care in other states. 'This validates the model,' he said in an interview.

Presumably he was talking about a financial model, maybe the model used by private equity firms (see below).  It did not appear that this model had anything to do with providing health care to patients.

On the other hand, perhaps Dr de la Torre was enthused because he stood a chance of personally profiting from this deal, which

is also designed to allow top Steward leaders to have a 'substantially larger stake' in the company.

The implication is that Dr de la Torre would end up with some piece of Steward, Cerberus, and or MPT.

Furthermore, the deal apparently would let Cerberus Capital Management recover all the money it initially put into its buyout of Caritas Christi:

The entire initial investment to Cerberus will be paid back, but the amount is proprietary, de la Torre said. The deal will also pay down all of the company’s $400 million in debt, he said.

This would apparently now render the initial take-over of Caritas Christi financially risk-free for Cerberus Capital Managment, but perhaps not risk-free for patients and health care professionals (who essentially were not mentioned in the article.)  

Summary - What Happens When Private Equity Owns Hospitals

We have previously described the private equity playbook here, and here.  The main points were:

-  Private equity is just the new name for leveraged buyout firms (the type of firm described the book, and later movie Barbarians at the Gate.)

-  Therefore, when they buy out firms (e.g., the primary care practices discussed above), they use borrowed money.

-  But they leverage in two senses.  Once firms are bought, the private equity owners makes the firms take out further loans, and the money from them may go back to the owners, usually in the form of a special dividend, to pay down the debt originally incurred by the private equity owners.  This leaves the bought out firms heavily in debt, but frees the private equity firm from its original debt.  If the firm is eventually sold, the new buyers take over the debt.  In a worst case scenario, however, the bought out firm goes bankrupt, the private equity's firm stock in it becomes worthless, but the private equity firm need not be responsible for its financial obligations.

-  If the private equity firm desires more money while it still owns the acquired firm, it may sell parts of it off.

-  To make the finances of the acquired firm look more attractive to the next buyer, the private equity firms often undertakes short term cost cutting measures that may involve layoffs, increased workload on remaining workers, etc.

Other dark aspects of private equity are discussed on the Naked Capitalism blog here.


So Steward Health Systems, which bought out by Cerberus Capital Management, has now largely followed this playbook.  Cerberus initially infused hundreds of millions into Steward, ne Caritas.  Steward then closed facilities and programs, and otherwise cut costs.  Now Steward is going to sell off its biggest assets, the actual hospital facilities that one might think are at the core of hospital systems.  Doing so apparently would allow Cerberus to at least break even on the deal, while still remaining in control.


But now Steward Health is split.  It is still owned by Cerberus.  Its major facilities would be owned by Medical Properties Trust Inc.  Apparently, Steward would have no assets other than its employees.  Of course some employees, that is, top  management, would be more equal than others, since they are likely being paid millions in compensation, and would have the opportunity to enlarge their stakes in "the company," although whether that company is Steward, Cerberus, or even MPT is not clear.


Thus, a hospital system which ostensibly exists to take care of acutely and chronically ill patients, often in their hours of need and vulnerability, would now be split among multiple corporate entities.  Who woud actually be in charge of upholding the mission?  Who would be accountable when things go wrong?  Those questions are not clear. 

But it does seem likely that top executives of Steward, Cerberus Capital Management, and perhaps Medical Properties Inc stand to personally gain from this bold bit of financialization.  Whether patients may benefit, or health care professionals work and ability to care for patients might be facilitated by all this is not clear, and was not addressed in the current article.

As we have said again and again,...

Physicians need to realize that to fulfill their oaths to put patients first, they have to reduce the influence of rich and powerful organizations with other agendas, like health care corporations, and especially corporations owned by private equity.  The metastasis of private equity into the corporate practice of medicine and into hospitals and hospital systems should make us all rethink the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.




from Health Care Renewal http://ift.tt/2ddibk3 Whose Hospitals Are They, Anyway? - Steward to Sell Off, but Continue Operating All Its Hospitals Health Service Home

You Cannot Worry About Health Care Reform When You Must Bow Down to a Tyrant Health Service Home

We started Health Care Renewal to highlight major health care problems whose discussion had previously been nearly taboo, with the hopes that this discussion would lead to true health care reform.  These problems included concentration of power within health care organizations; leadership of such organizations that was often generic, and hence ill-informed, unsympathetic or hostile to the values of health care professionals, self-interested, conflicted, or outright criminal or corrupt; and threats to the scientific basis of health care, including manipulation and suppression of clinical research.

We have come a long way in our understanding of these issues since we began in 2004.  But until now, we never needed to discuss some fundamental assumptions underlying what we were doing.  In particular, we could only pursue such discussions within societies that, however imperfectly, respected individual rights, particularly the rights to free speech, free press, free expression, and free association; operated under the rule of law; and were representative democracies.

People who live in anarchy, in societies torn by civil conflicts, or under dictatorships have much more pressing concerns that the niceties of improving health care.  So we knew that while our discussions might well have some relevance to many countries outside of the US, they were not going to be relevant everywhere.

Now maybe we should not feel assured that these discussions will continue to be useful in the US.  So far, reported only in a few outlets has been a crucial interview that appeared in a trailer for the Public Broadcasting System (PBS) documentary Frontline episode that will air tomorrow (September 27, 2016) on the two candidates running for the US presidency.   



At about 3 minutes into this trailer, Ms Omarosa Manigault, who was on the original Apprentice, and who is now Director of African-American Outreach for the Trump campaign, is heard to say:

Every critic, every detractor will have to bow down to President Trump.

As reported in a brief story from the Huffington Post, she followed that up with:

It’s everyone who’s ever doubted Donald, who ever disagreed, who ever challenged him. It is the ultimate revenge to become the most powerful man in the universe.

These statements were also covered briefly by Talking Points Memo, and a number of entertainment sites, but has gotten almost no coverage and generated almost no discussion from larger general media outlets.

There was a brief story on MSNBC by Rachel Maddow who called the interview with Ms Manigault "creepy."    

As far as I can tell, this statement has not been retracted or repudiated by Ms Manigault or the Trump campaign.

This story is more than creepy.  Here is an apparently senior, paid staffer for the campaign of a major party candidate for the US presidency threatening that anyone who disagreed with her candidate will have to "bow down" should he become president.  That seems to be an overt threat of dictatorship should that candidate win.  I do not recall ever hearing any such statement made by any such staffer in any such campaign in the past. 

As I noted above, niceties of health or any other policy discussion would be pointless, and probably extremely hazardous to one's health under a totalitarian regime that expects all critics to bow down, presumably under threat of force.

Those who care about true health care reform, and many other important causes, should be aware of this threat, and act accordingly. 



from Health Care Renewal http://ift.tt/2dmrlwS You Cannot Worry About Health Care Reform When You Must Bow Down to a Tyrant Health Service Home

Someone wasn't listening to me at my 2012 Keynote to the Health Informatics Society of Australia Health Service Home

In late July 2012 I gave an invited keynote presentation to the Health Informatics Society of Australia (HISA) at the annual Health Informatics Conference (HIC 2012), that year in Sydney.

I wrote up my presentation at http://ift.tt/1dyxt02 and my slide deck is online at http://ift.tt/2cZpGuT.

My message included the following:

• Critical thinking is essential at all times in healthcare ... or your patient's dead.
• Critical thinking is not mindless criticism; on the contrary, it is reflective, inquisitive, logical thinking that is focused on deciding what to believe or do.
• Health IT must be trusted by users and patients [and be free of major downsides] - as a primary step before HIT can optimally benefit healthcare 
• I pointed out I am not suggesting anything new and that, in fact, I am suggesting something old:  "First, do no harm."
• I pointed out the "revolutions" usually have downsides, and IT always produces winners...and losers (per the empirical research of Social Informatics). 

It seems this organization was either absent or not listening, and this debacle is the result.

Just about every point I raised in 2012 was violated or ignored.  The story speaks for itself, and I have nothing further to say about it other than this type of scenario is unfortunately still occurring worldwide.

The myth of cybernetic magic is a devilish one, and must be expunged from healthcare if this technology is ever to meet even a fraxtion of the promises made about it for decades.

====================

CAIRNS Hospital’s Digital Hospital program was deemed defective within two weeks of being rolled out with health staff saying it resulted in “significant adverse impacts” upon patient safety and care.

Daniel Bateman
The Cairns Post
September 22, 2016 7:03pm
http://ift.tt/2dpDZqJ

The controversial eHealth software program, which went live earlier this year, has been blamed for putting the Cairns and Hinterland Hospital and Health Service on the path towards its $80 million budget blowout.

The hospital’s board resigned as a result of the gaping deficit on Monday and an administrator is expected to be appointed today.

Results from a staff survey about Digital Hospital leaked to the Cairns Post says the program did not “meet stakeholders’ needs for an intuitive, user-friendly system that supported the provision of personalised patient care at the bedside”.

The report also identifies specimen order and collection workflow as a result of the new system as being “convoluted and time consuming, with significant adverse impacts on patient safety and care.”

Cairns Hospital board resigns

The lack of system testing has been identified by stakeholders as the root cause of continual defects after Digital Hospital went live and the report says there has not been adequate support staff to help with problems.

Senior clinicians raised alarm bells about Digital Hospital earlier this year, warning if the problems were not fixed, it would become a major headache for the health service.

Last Friday hospital board chairwoman Carolyn Eagle described Digital Hospital as a “financial challenge” for the health service.

However, the service’s chief executive Clare Douglas said yesterday the program did not contribute to the 2015/16 budget deficit, nor was it a major contributor to the projected budget deficit for the 2016/17 financial year.

“Queensland Health has committed to the establishment of a digital health system and Cairns Hospital is an important part of that system,” she said.

“We are working to improve and embed the system as part of business as usual.”

She said there were benefits of the program, including visibility and ease of access to patient information.

=================================

That's akin to saying there are benefits to train wrecks.  Yes, it gets the tracks and signals fixed.  But....

-- SS



from Health Care Renewal http://ift.tt/2cZplbw Someone wasn't listening to me at my 2012 Keynote to the Health Informatics Society of Australia Health Service Home

Cancer is just a software platform problem: Microsoft will 'solve' cancer within 10 years by 'reprogramming' diseased cells Health Service Home

A short post.

Hand a computer scientist a computer and some genetic data, and the world then becomes a deterministic, binary place:

Microsoft will 'solve' cancer within 10 years by 'reprogramming' diseased cells
Sept. 20, 2016
Sarah Knapton, Telegraph science editor
http://ift.tt/2cqAYHH

Microsoft has vowed to “solve the problem of cancer” within a decade by using ground-breaking computer science to crack the code of diseased cells so they can be reprogrammed back to a healthy state.

Chris Bishop, laboratory director at Microsoft Research, said: “I think it’s a very natural thing for Microsoft to be looking at because we have tremendous expertise in computer science and what is going on in cancer is a computational problem.

"What is going on in cancer is a computational problem" sounds like a form of cybernetic scientism (http://ift.tt/1lPnYfe) in this sense:

Scientism ... is a term that is used, often pejoratively, to denote a border-crossing violation in which the theories and methods of one (scientific) discipline are inappropriately applied to another (scientific or non-scientific) discipline and its domain. 

We are only scratching the surface in genomics, and to state it is merely a "computational problem" as if biology worked like a deterministic, binary digital computer is, in my mind, wishful thinking.

It would be great if genetics were just one big Intel Core I7 that one could program in binary assembly language after decoding its instruction set, but I have doubts it's that simple.

-- SS



from Health Care Renewal http://ift.tt/2cmCCf6 Cancer is just a software platform problem: Microsoft will 'solve' cancer within 10 years by 'reprogramming' diseased cells Health Service Home