No Treatment or Vaccine for Ebola, but a $1000 Pill for Hepatitis C

The Ebola virus epidemic in West Africa continues to grow, and now appears to be the worst known epidemic of that disease to date.  In the US and Western Europe, press reports are now raising concerns that the disease could spread there.  For example, CNN, in an article entitled "Ebola Fears Hits Close to Home," was a section headed "Could Ebola spread to the US?" An ABC article was entitled, "How the US Government Could Evacuate Americans with Ebola."

Reasons for fear of spread are the increased mobility of people made possible by air travel, and the lack of specificity of early symptoms of Ebola, so infectious people may not realize the dangers their travel might pose.  A US citizen with Ebola was on his way back to the US via several connections, and made it as far as Lagos, Nigeria before becoming too ill to travel further (per CNN).  Making the fears worse are the high fatality rate of Ebola, the current epidemic included.  According to Vox, the current outbreak is the Zaire subtype of the virus, with an expected mortality rate of 68%.  Finally, there is no known effective treatment or vaccine for the Ebola virus.

Economics, not Science the Reason for Lack of Medical Options for Ebola

The reason there are no vaccines or treatments available for Ebola does not appear to be the scientific difficulty involved in developing them.  Vox also published a discussion for the economic genesis of the problem:

 Researchers have devoted lots of time to building a vaccine that could stop the disease altogether — and according to Daniel Bausch, a Tulane professor who researches Ebola and other infectious diseases, they're making really significant progress.

Bausch says that the obstacle to developing an Ebola vaccine isn't the science; researchers have actually made really great strides in figuring out how to fight back against Ebola and the Marburg virus, a similar disease.

'We now have a couple of different vaccine platforms that have shown to be protective with non-human primates,' says Bausch, who has received awards for his work containing disease outbreaks in Uganda. He is currently stationed in Lima, Peru, as the director of the emerging infections department of Naval Medical Research Unit 6.

The problem, instead, is the economics of drug development. Pharmaceutical companies have little incentive to pour research and development dollars into curing a disease that surfaces sporadically in low-income, African countries. They aren't likely to see a large pay-off at the end — and could stand to lose money.

Prof Bausch elaborated,

These outbreaks affect the poorest communities on the planet. Although they do create incredible upheaval, they are relatively rare events. So if you look at the interest of pharmaceutical companies, there is not huge enthusiasm to take an Ebola drug through phase one, two, and three of a trial and make an Ebola vaccine that maybe a few tens of thousands or hundreds of thousands of people will use.

Of course, that assumes that this outbreak, like previous ones, will remain relatively confined, at least to Africa.

The 10/90 Gap

So the implication is that had things been otherwise, those in developed countries now worried that Ebola could spread their way could have been reassured by the availability of a vaccine, or other treatment.

The irony, if that is the right word, is that we do not have an effective treatment or vaccine for a viral disease that is relatively easily spread, and could likely rapidly kill nearly 70% of those infected.  Yet in the last months, we have been arguing about how the use of an extremely expensive treatment for another viral disease that is difficult to spread, and may kill a few percent of its victims over up to 20 or 30 years after infection.

I am referring, of course, to Sovaldi, the recently announced $1000 pill for hepatitis C.  Hepatitis C does affect a lot of people, including relatively affluent people in developed countries.  As we noted previously, though, the majority of people infected with hepatitis C will never have serious medical repercussion from it.  Small proportions of patients will eventually develop severe liver disease, including cirrhosis, liver failure, and liver cancer, and may die from the disease.  (See the report by the Center for Evidence Based Policy). Yet the treatment is being promoted for all patients with hepatitis C, most of whom could not benefit from treatment.  Furthermore, the evidence that treatment will actually prevent bad clinical outcomes, cirrhosis, liver failure, liver cancer, and premature death, is weak (look here).   Yet considerable money was devoted to developing multiple hepatitis C treatments, with the expectation that huge amounts of money could be made from selling them.

This is an example of the 10/90 gap

A long time ago, in 1998, I was invited to Forum 2 of an organization called the Global Forum for Health Research  The GFHR was an organization dedicated to overcoming the "10/90 gap":

Less than 10% of the worldwide expenditure on health research and development is devoted to the major health problems of 90% of the population

Yet the 10/90 gap is probably getting worse.  In the US, our health care has now been heavily influenced by advocates of neoliberalism, or economism.  Health care is now largely run by generic managers trained in business schools, with no specific training or expertise in health care, and doubtful loyalty to its values.  Current business school dogma emphasizes the primacy of economic efficiency over all other goals (look here), to maximize "shareholder value," which usually practically means maximizing short term revenue, to the immediate advantage of shareholders sometimes, but nearly always to the great and immediate financial advantage of paid managers and executives.  The emphasis on short term revenue uber alles helps explain how we have multiple expensive hepatitis C drugs, and no Ebola drugs or vaccines.

The real irony is now that some very well paid managers may be worrying about the possibility of contracting Ebola whose transmission was facilitated by our increasingly global economy, globalized in part due to the advocacy of those advocating neoliberalism and economism.

Summary

Unfortunately, the fortunes of the Global Forum for Health Research seem to have faded.  It went into sudden decline in 2010, and was subsumed into COHRED, the Council on Health Research for Development.  The last Global Forum meeting was in 2012, although there seem to be plans for another next year.    Meanwhile, multiple international organizations. including Medicins Sans Frontieres, established a Drugs for Neglected Diseases initiative, although its progress seems to be slow (see Pedrique B, Strub-Wourgaft N, Some C et al.  The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment.  Lancet Glob Health 2013; 1: e371.  Link here.).

In my humble opinion, as long as much of the health care system is run so as to put short-term revenue ahead of all else, a manifestation of financialization encouraged by the generic managers who run so much of health, partly in their own self-interest, and by business schools promoting the shareholder value theory, we will not make much progress on the 10/90 gap.  Ironically, the realization that even rich generic managers may no longer be protected from some of the deadliest diseases that used to only afflict the poorest people in the world may have an effect on this problem.   

As I have said before,  true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

ADDENDUM - This was re-posted on the Naked Capitalism blog. 

New ONC Director Karen De Salvo seems no better than her predecessors - risk, harms and deaths due to health IT apparently OK for now, and all we need is a "Safety Center"

Karen De Salvo has assumed the role of Director of ONC, the office of the National Coordinator for Health IT at HHS (http://www.healthit.gov/newsroom/dr-karen-desalvo-md).

A pretty face, but here's evidence of the same old tired political hucksterism and spin concerning healthcare information technology. 

In response to perhaps the most candid exposé in the public media to date of the risks and defects of current commercial health IT, industry conflicts of interest, and injuries and deaths, that appeared on July 20, 2014 in the Boston Globe under the title "Hazards tied to medical records rush" (http://tinyurl.com/lm7x34h) by the Globe's Washington bureau chief Christopher Rowland, Ms. De Salvo authored a letter to the editor.

DeSalvo is new to the job, but not to the political message of unbridled health IT hyper-enthusiasm and pointless "Safety Centers", instead of formal regulation as in other mission critical industries using IT (including pharma, for one).

Her letter to the Boston Globe attempts to put lipstick on a pig regarding a technology largely reviled by physicians and nurses due to its poor user experience and defects (rampant due to the free-for-all of this healthcare sector's unprecedented regulatory accommodation, that is, no regulation) that cause patient endangerment.  See http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html, http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html and http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html as just a few examples.

What politicians do:  they spin like neutron stars

Her letter, with my comments:

http://www.bostonglobe.com/opinion/editorials/2014/07/26/many-health-success-stories-note/MyyGM3uq2LU0GqGLLqYJ7M/story.html

Letters | CHALLENGES IN THE MOVE TO ELECTRONIC MEDICAL RECORDS

July 27, 2014

Many health-IT success stories to note

I was disappointed to read “Risks, some dire, tied to medical records rush” (Page A1, July 20), as it failed to mention any examples of patients and their health care providers benefiting from the use of health information technology, including electronic health records. 

As to "disappointment", nearly the entire healthcare and lay press is filled with "success stories" and other propaganda.  There is, in fact, no need for artificial and industry-favoring "balance" in the rare article about the downsides. The industry has its own very large mouthpiece.  (This is the response we at HC Renewal give to critique that we're not "balanced" in every post.  It would be as if every article on defective avionics and pilot training issues that cause hundreds to die (e.g, Air France Flight 447, http://en.wikipedia.org/wiki/Air_France_Flight_447) should be accompanied by articles on just how many non-fatal flights there are, too; or as if every article about criminals has to mention there are good people, too.)

Such success stories are playing out across the country daily, including in Boston, and their omission from the article incompletely portrays the important role of electronic health records in improving patient safety and outcomes.

Is this and example of a far-left "you have to break an egg to make an omelette" (even if the 'egg' is a human being) thinking?   This statement, attempting redirection from the downsides, in effect says: "It's OK to sacrifice 100 in experimentation to (potentially) 'save' 10,000 - or 1,000 to 'save' 100,000."

Problem is, this is not how Western medicine is supposed to work - by HHS's own policies on research ethics, and international agreements and treaties based on work that arose after WW2's medical abuses, no less, e.g., the Nuremberg laws.

In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjects (http://grants.nih.gov/grants/policy/hs/regulations.htm), the World Medical Association Declaration Of Helsinki (http://www.wma.net/en/30publications/10policies/b3/) and others restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown.  

And health IT is decidedly experimental, considering we don't even know the true extent of harms, by multiple admissions (by FDA, IOM, ECRI etc., see http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

Also see my post Mar. 12, 2012 post "Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?" at http://hcrenewal.blogspot.com/2012/03/human-subjects-experimentation.html.  The highlights, emphases mine:

Directives for Human Experimentation
NUREMBERG CODE

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice [that is, to opt-out - ed.], without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person [information on HIT risk exists, such as on this blog - ed.] which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
3. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
4. During the course of the experiment the human subject should be at liberty to bring the experiment to an end [go back to paper - ed.] if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
5. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage [go back to paper - ed.], if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Perhaps they don't teach these things at Harvard?

Back to De Salvo's letter:

A fully electronic health system can help identify and prevent potential medical errors. The Office of the National Coordinator for Health IT has taken steps to address the safe use and implementation of electronic health records, including sponsoring the Institute of Medicine report referenced in the story.

And since that 2012 report, which acknowledges that bad health IT causes risks, errors and harms to a definite but unknown magnitude (see bottom section of my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html), ONC has done next to nothing. People are exposed to risk, harms and deaths and that seems just fine to ONC, for if it were not, they would have acted aggressively - say, as if a type of jet plane, or nuclear power plant had been revealed to pose risks and dangers to the community.

As Mr. Rowland himself pointed out in the Boston Globe article:

... In 2011, the Institute of Medicine said the lack of a central repository for reporting error-prone software, patient injuries, and deaths, combined with nondiclosure and confidentiality clauses in vendor contracts, “pose unacceptable risks to safety.”

It strongly recommended that the Obama administration mandate that vendors report “deaths, serious injuries, and unsafe conditions” to a centralized, government-designated entity. Such reports should be made available to the public, it said, without information that would identify individual patients and providers.

Three years later, no such reporting system exists.

Instead, ONC takes the GM ignition switch approach (http://en.wikipedia.org/wiki/2014_General_Motors_recall):

... On February 7, 2014, GM recalled about 800,000 of its small cars due to faulty ignition switches, which could shut off the engine during driving and thereby prevent the airbags from inflating ... GM says it expects to charge $1.2 billion against its second quarter earnings as a result of its ongoing recalls, and the charge could get worse as lawsuits and investigations continue. 

The fault had been known to GM for at least a decade prior to the recall being declared.  Some have suggested that the company actually approved the switches in 2002 even though they knew they might not meet safety standards.

The company is facing multiple investigations into why it did not attempt to fix these faulty ignitions sooner, including a federal criminal probe, as well as a probe led by Anton Valukas, the latter of which produced a report which GM made public on June 5, 2014.

Instead of a serious approach to safety, ONC and De Salvo champion window dressing:

Most recently, the Office of the National Coordinator, the Food and Drug Administration, and the Federal Communications Commission issued a proposed plan that would include the creation of a health IT safety center, which would assist in the voluntary reporting of health IT-related medical errors. Many patient advocates, medical professionals, and other stakeholders have expressed support for this approach.

"Many?" - The consensus views, often dominated by industry insiders and others with conflicts of interest, is how ONC and De Salvo apparently think safeguarding the public is to be done.  Those who veer from this "consensus" with facts of risk and harms are to be ignored.

As to the hypocrisy and absurdity of a toothless "health IT safety center", see my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.

The hundreds of thousands of providers successfully and safely using electronic health records today show that health IT can, and does, improve health and health care.

Dr. Karen DeSalvo
National coordinator for health information technology
Department of Health and Human Services
Washington

Ms. De Salvo apparently never got this Mar. 14, 2014 CMS memo that was sent in response to a query by the American Association  of Physicians and Surgeons:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

However, in politics, such issues do not seem to matter as compared to passing along the party line. 

In medicine, they do matter.  Very much so (see http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html).

-- SS

New Allegations About Universal Health Services Inc - Why We Should Not be Surprised

Current Allegations of Poor Treatment and Threats to a Whistle Blower

This month, a Boston Globe article reported trouble at a local hospital,

Arbour HRI, a Brookline psychiatric hospital in recent trouble with regulators, disciplined a mental health worker for talking to the Boston Globe about problems there — an action the employees’ union is fighting.

The hospital also required all staff to sign a policy forbidding them from speaking with the media about Arbour — or risk losing their jobs, according to the union.

An article that appeared in the Globe on May 30 described findings of federal investigators that the hospital failed to provide treatment for at least four patients during a February inspection. Instead of attending group therapy, the patients, whose diagnoses included bipolar disorder and paranoid schizophrenia, spent many hours sleeping or wandering the hallways.

One Tuesday afternoon, three patients on a unit for those diagnosed with both mental illness and a substance abuse disorder were in therapy. Inspectors found eight patients in bed.

Frank Barnes, a longtime mental health worker and a union representative for 1199SEIU, was quoted in the story saying that problems at Arbour HRI reflected the culture of an administration more focused on revenue than quality of care.

But then,

 Nine days later, according to documents the SEIU provided to the Globe, a nurse executive verbally warned Barnes. A 'counseling/corrective action form' stated that the consequences for failing to follow the media policy could include termination.

The policy warns employees they 'are not to speak to any member from the media on behalf of the facility or company,' and that they must immediately refer press inquiries to the chief executive.

Arbour spokeswoman Judith Merel said that the policy is intended to protect the privacy of patients and staff. 'These processes are put in place to ensure that the hospital complies with all patient confidentiality and privacy laws as well as to safeguard the trust placed in us by our patients, employees and staff,' she said in a written statement.

But the SEIU, in a complaint against the hospital filed with the National Labor Relations Board, charged unfair retaliation against Barnes and said the 'overly-broad' media policy violates employees’ rights.

'If Universal Health Services is treating the patients under its care with dignity and respect, then why would it prevent caregivers from talking to the media?' union executive vice president Veronica Turner said in a written statement. 'It raises serious questions about what the company is trying to hide.'

So far we have allegations that insufficient or poor care was provided, and that a hospital employee who discussed the allegations with the press was threatened, apparently based on a media policy that was more like a code of silence.

It turns out these are not the first problems reflecting badly on the management of the hospital.

Arbour HRI has a recent history of problems. Massachusetts regulators prohibited the hospital from accepting any patients in November, citing unsafe conditions. They allowed admissions to gradually resume two weeks later, in early December. But then in February, inspectors for the federal Centers for Medicare & Medicaid Services found serious shortcomings in the quality of treatment at the 66-bed hospital in Brookline.

The problems at Arbour HRI should not come, however, as a big surprise.  Arbour HRI is part of

Arbour Health System [which] operates five psychiatric hospitals and 12 mental health clinics in Massachusetts. Its for-profit parent, Universal Health Services [Inc], is a publicly traded company that earned more than $500 million last year....

Although not mentioned in the current Boston Globe report, Universal Health Services Inc seems to have a sorry record.

In 2012, Settlement of Allegations of Substandard Treatment, Falsified Records

About two years ago, Universal Health Services settled somewhat similar allegations about another of its hospitals.  As announced by the Department of Justice,

Universal Health Services Inc. (UHS) and two subsidiaries have reached a settlement in a False Claims Act lawsuit with the United States and the Commonwealth of Virginia, the Justice Department announced today.   Under the settlement, UHS and its subsidiaries, Keystone Education and Youth Services LLC and Keystone Marion LLC, which did business as the Keystone Marion Youth Center, a residential facility in Marion, Va., agreed to pay $6.85 million to the United States and the commonwealth to settle allegations that they provided substandard psychiatric counseling and treatment to adolescents in violation of Medicaid requirements, falsified records and submitted false claims to the Medicaid program.  UHS closed the Marion facility earlier this year.  

The allegations, made by multiple people, were actually quite lurid.  As reported by the Huffington Post, the lawsuit involved assertions that psychological therapy was provided in hallways;  the facility lacked a required education program and clinical direct; inmates were nearly unclothed; responses to resident complaints were sometimes met with "brutal force;" the staff performed an "exorcism" on an autistic boy; and staff sexually abused residents.


Previous Allegations of Neglect, Suicide Attempts, Rape and Murder

Note furthermore that according to the Huffington Post, 

Universal Health Services Inc., a large hospital chain which racked up dozens of allegations of abuse during that time -- including everything from rape to suicide attempts allowed by neglect to murder. Over the years, states have barred children from attending UHS facilities over safety concerns and the feds have put UHS on their radar. Department of Justice lawyers have filed two lawsuits accusing the chain of fraudulent activities. 

By the way, the reason the Huffington Post gave this case extensive coverage, however, was not apparently the grievous nature of the allegations.  It was that on Universal Health Services board sat a politician who was at the time of the report a credible candidate for the Republican nomination to be President of the US.

Former Sen. Rick Santorum (R-Pa.) has become a top-tier candidate for the Republican presidential nomination in recent weeks by appealing to evangelical voters as a man steeped in family values and his Christian faith. From 2007 to 2011, however, Santorum served on the board of directors of Universal Health Services Inc.,...

In 2009, Settlement of Allegations of Kickbacks to Physicians

Finally, also mentioned in the Huffington Post, was another settlement by Universal Health Care.  As reported in Modern Healthcare,

Universal Health Services agreed to pay the federal government $27.5 million to resolve allegations that its three hospitals doing business as South Texas Health System paid kickbacks to physicians in the form of sham medical directorships and leases, the U.S. Justice Department announced.  

Note further that this settlement

also requires South Texas Health System to enter a five-year corporate integrity agreement with HHS' inspector general's office. 

Summary

So given the record public since at least2009, should it be a big surprise that Universal Health Services is again facing allegations of poor and unethical treatment of patients and employees?

This is a familiar pattern.  Now that we have been following organizational misbehavior in health care for some years, we see that organizations that get into trouble once are very likely to get into trouble again.

This may be enabled by how government regulators and law enforcement give large health care organizations such  gentle treatment.  We have talked about the march of legal settlements by such organizations before.  Allegations are usually resolved with legal settlements that involve no admissions of guilt, small monetary penalties (compared with these organizations' total revenues), and sometimes apparently toothless corporate integrity agreements.  Settlements get desultory public notice, rarely informed by previous settlements or other evidence of previous misbehavior.  No individual who may have authorized, encouraged, directed, or implemented the bad behavior is likely to suffer any negative consequences.   It does not help that while nominally public, these settlements get little press, and what coverage there is usually fails to put the whole pattern together.

So we would urge the reporters who cover the next settlements by big health care organizations at least look to see if the organizations had been involved in similar settlements in the past.

Furthermore, as we have said all to often,...   The failure of the current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.  Pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.  So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

Sovaldi, a Quantum Leap... Backwards to the Days Before Randomized Controlled Trials?

The Sovaldi (sofosbuvir - Gilead) media circus is continuing.  The New York Times just reported that sales of the new drug for hepatitis C were about $3.5 billion for the last quarter, which should intensify the kerfuffle over its US price ($1000 per pill, $84,000 for a 12 week course of medication).

Meanwhile, reports of its wondrous properties continue to appear in medical journals.

The latest was announced this way in Bloomberg,

Gilead Science Inc Solvadi, controversial because of its price, helps cure hepatitis C in people with HIV, according to researchers who say the drug has the potential to limit a top cause of death in these patients.

In a study of 223 HIV-infected patients, Solvadi combined with ribavirin cleared the most common US strain of hepatitis C in 76 percent of newly treated patients over 24 weeks. Only seven participants stopped treatment because of side effects and there were no adverse effects on HIV treatment, according to a report in the Journal of the American Medical Association.

Not unexpectedly, the study investigators were thrilled,

This is 'the first clinical trial to demonstrate that we can cure hepatitis C in patients with HIV co-infection without the use of interferon,' said Mark Sulkowski, the study author and medical director of the John Hopkins Infectious Disease Center for Viral Hepatitis in Baltimore. 'It represents a transformative step in our approach to this therapeutic area.'

Furthermore, as noted in a Medscape report,

In an accompanying editorial,(1) Michael Saag, MD, also of the University of Alabama at Birmingham, said the finding is a 'quantum leap' forward for people coping with both viruses.

What Clinical Trial?

I have posted previously about the controversy over the high price of Sovaldi.  I noted that most of the arguments, even from people most incensed about paying $1000 per pill, assumed that the drug was nearly miraculous, e.g., "a triumph," or "a revolution" in medicine.  Yet my reading suggested that the published evidence from clinical studies of the drug was in fact weak.  Critical reviews of the evidence from groups in the US, the UK, and Germany (look here, here, and here) also questioned the evidence backing Sovaldi.  Yet doubts about the drug's benefits versus harms have yet to influence the public discussion, which is focused on whether $1000 a pill is too much to charge for a miracle drug.

So I thought that "quantum leap" demonstrated in the latest trial(2) would bear further scrutiny.

The most important feature of the "trial" is how its design is described,

In this multicenter, open-label, nonrandomized, uncontrolled phase 3 trial, all patients received 400 mg of sofosbuvir (Gilead Sciences) administered orally once daily along with ribavirin (Ribasphere, Kadmon) administered orally twice daily, with doses determined according to body weight....

Let me make very clear, in this "trial," all patients got the same therapy.  There was no comparison group.  The study description is therefore inherently self-contradictory.  In fact, this study was a case-series, not a clinical trial.  It had no control group.

The classic Users Guides to the Medical Literature suggests that the first question a critical reviewer should ask about a study to assess a treatment is "was the assignment of patients to treatment randomized?"(3) The rationale was that studies of patients for whom clinicians made treatment decisions could easily be confounded by the reasons clinicians used to make these decisions.  Clinicians are trained to individual treatment decisions, and thus patients prescribed a treatment are likely to greatly differ from those not assigned that treatment.  The ways they differ could have as much, or more effect on their outcomes than the treatments themselves.  Although complex statistical adjustment methods could be used to try to compensate for these differences, it is rarely possible to be assured that all important differences have been taken into account. 

However, this still assumes a comparison between patients getting different treatments, or treatment versus no treatment.  In the case-series of sofosbuvir, there were no patients getting alternative treatments.  Thus the study itself could not be used to make comparative assessments of sofosbuvir.  

Of course, one could imply comparisons with the results of other studies.  However, such comparisons would not only be susceptible to confounding by reasons for treatment decisions as above, but to bias due to  differences between the current case series and previous studies, e.g., in characteristics of patients recruited, details of treatments given, study settings, and changes in patients, diseases, and treatments over time.   

Thus, a very basic rule in critical review is thou shalt not draw any conclusions about therapy from case-series unless the results are truly extraordinary, i.e., patients clearly doomed to die suddenly become completely well.  There were no such extraordinary results in the case-series of patients with HIV treated with Sovaldi for hepatitis C. 

The latest study of Sovaldi for patients with HIV and hepatitis C is virtually useless to assess whether Sovaldi might be the preferred therapy for such patients.   

Comparable Results?

Yet in an accompanying editorial(1), Dr Michael S Saag asserted that this non-trial 

demonstrates the efficacy of the all-oral regiment of the directly acting agent sofosbuvir plus ribavirin in patients with HCV who are coninfected with HIV

To demonstrate efficacy means to show that the treatment caused good effects.  But without a control group, it is not possible to assess causation.

Also,

The PHOTON-1 trial demonstrates that the all-oral combination of sofosbuvir plus ribavirin yielded results comparable with those of standard pegylated-interferon-ribavirin-vased regimens for each of the genotypic groups, thereby demonstrating that an all-oral combination could achieve similar outcomes as those derived from an injectable therapy.

However, this case-series could not assess comparability, because it included no comparison.


There Goes the Neighborhood - Throwing Out Skeptical Evaluation in the Rush to Promote "Innovation"

For years, the randomized, and usually double-blind, controlled trial has been considered the scientific cornerstone of the evaluation of new treatments.  Yet in the rush to bring new "innovative" treatments to market, presaging often tremendous revenues for their manufacturers, suddenly the randomized controlled trial does not seem so necessary.  In the US, the Food and Drug Administration (FDA) no longer seems to require randomized controlled trials to demonstrate efficacy of new drugs deemed to be "breakthroughs."   As noted by Steinbrook and Redberg in the July, 2014, issue of JAMA Internal Medicine(4)

these drugs [for hepatitis C] were approved quickly based on the surrogate endpoint of sustained viral response rate; they were studied in limited populations without long-term follow-up.  Under the US Food and Drug Administration's breakthrough therapy designation, the marketing for sofosbuvir did not include requirements for randomized clinical trials.

Yet without such trials, how could one ever determine if the drug is really so efficacious as to constitute a "breakthrough?"  


As we noted earlier, the two real randomized controlled trials of sofosbuvir did not assess its effects long term, even though it is a drug meant to treat a chronic disease, and particularly did not assess whether it affect clinical outcomes, that is, reduce rates of cirrhosis, liver failure, or liver cancer.  In fact, there has never been a controlled trial meant to assess whether any treatment of hepatitis C affects these outcomes.  Furthermore, while the first author of the case-series above, and many others have claimed the Sovaldi cures hepatitis C, it has never been shown that SVR equals cure.  As Gluud et al wrote in a letter to Lancet,(5)

The claim of cure rests solely on sustained virological response (SVR).  Since some patients who achieve SVRs still go on to develop end-stage liver disease and might die from the interventions, this concept is not correct and might even be wrong in principle.

However, despite all the words written, the concernthat Sovaldi (and possibly other new drugs for hepatitis C) might not be wondrous quantum leaps, because there is really no good evidence to that effect, has remained anechoic.  Not only does the evidence about the benefits and harms of this new drug need to be part of the discussion whether its price is excessive, there needs to be a larger discussion of whether in our rush for "innovation," we will throw out the baby of scientifically valid assessment of new therapies with the bathwater.

Finally,  the Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will not buy us the promised miracles and triumphs.

As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.  

 References

1. Saag MS. Quantum leaps, microeconomics, and the treatment of patients with hepatitis C and HIV coinfection. JAMA 2014; 312: 347. doi:10.1001/jama.2014.7735.  Link here.

2. Sulkowski MS et al.  Sofosbuvir and ribavirin for hepatitis C for patients with HIV coninfection.  JAMA 2014; 312: 353.  doi:10.1001/jama.2014.7734.  Link here.
3. Guyatt GH, Sackett DL, Cook DJ et al. Users' Guides to the Medical Literature: II. How to Use an Article About Therapy or Prevention A. Are the Results of the Study Valid? JAMA. 1993; 270(21): 2598-2601. doi:10.1001/jama.1993.03510210084032. Link here.
4.  Steinbrook R, Redberg R. The high price of the new hepatitis c virus drugs.  JAMA Int Med 2014; 174: 1172.  Link here. 
5.  Gluud C, Koretz R, Gurusamy K. Hepatitis C: a new direction, but an old story? Lancet 2014; 383: 2122-2123.  Link here.

Money vs Mission - How Generic Managers vs Physicians Think

On Health Care Renewal, we emphasize problems in leadership and governance in large health care organizations, and how they affect health care professionals' attempts to carry out their mission, and ultimately how they affect patients' and the public's health.  Large health care organizations are increasingly led by people trained in business, not health care professionals, thus generic managers.  The stewards of these organizations, the members of their boards of directors or boards of trustees, are also increasingly current or former managers without direct health care experience. Yet all too often, health care leadership is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt.

Recently, in an effort to "bridge the gap" between physicians and MBAs, a new article in Becker's Hospital Review by Todd Kislak discussed differences in the thinking and values among business trained health care managers and physicians.  The author, an MBA, listed nine issues on which MDs and MBAs have different views.  I have summarized below what appear to me to be the main points, somewhat reorganized from how he did it. Whether he meant to or not, Mr Kislak showed why physicians may have reason not to trust their new generic managers. 

Making Widgets vs Treating Patients

Mr Kislak wrote that MBAs see health care in terms of orderly, uniform and standardized processes, while physicians see it in terms of the complexity and variability of patients, the ambiguity of diagnosis, and the unpredictability of outcomes.  

 2. Scalability. As a rule, MBAs tend to seek solutions to problems in a way that they perceive to be scalable and replicable, trained in the belief that the capacity to perform repetitively and consistently leads to better efficiency and quality. One-off situations are by definition outliers, and as such their importance tends to be downplayed.

Also,

 3. Centralization....   MBAs, ... tend to seek centralized approaches to decision-making, often appearing in the guise of policies, programs and processes. 

So, the gist is MBAs see health care as analogous to an assembly line.  The idea is to provide uniform, consistent services that conform to the policies, programs and processes that come down from central headquarters, run by MBAs.

On the other hand, he noted that physicians think that "every case has the potential to be unique in some way," while MBAs "view the unusual case as an unwelcome break in the routine, adding cost while slowing down the efficient care of other patients."

IMHO, common sense, and a raft of epidemiological data support the MDs.  Patients differ in demographics, biopsychosocial characteristics, co-morbid conditions, histories of previous treatment, responses to therapy, etc, etc, etc.  Patients, their complaints, and their situations are complex and variable.   Furthermore, acute illnesses, complications of chronic illnesses, accidents occur unexpectedly, in unexpected ways.  Diagnosis are often unclear and ambiguous.  Patients' prognoses and responses to therapy are unpredictable.  Thus, IMHO, seeing health care like an assembly, in terms of regularity and uniformity, seems dissociated from reality.  I have a hard time believing that MBAs who actually require medical care want to be treated as if they were identical to the next 10 patients.

"You Manage What You Measure" vs Complexity, Variability, Ambiguity, and Unpredictability of Patients, Diseases, Prognoses, and Treatments 

Mr Kislak suggested that MBAs emphasize measurement, especially the measurement of physicians' performance,

5. Performance. One of the healthcare MBA's favorite analytical tools is performance rankings of the MDs. Quantifying 'results' based on pre-determined metrics, assigning them a weight for averaging purposes and reducing performance down to a number is, to the MBA, how MDs and indeed all workers should be measured. 'You manage what you measure' is the MBA's mantra.

Also,

6. Productivity. MBAs look at MDs' productivity statistics (another performance measure) and wonder why so many MDs claim they are overworked. Looking at work hour statistics supplied by the Medical Group Management Association, one would not come away convinced that most MDs are logging more hours than, say, the typical healthcare MBA or indeed any high-caliber professional service provider.

Mr Kislak noted that physicians object to pay for performance and "may viscerally react to this uniform approach to performance assessment as inappropriate and even fundamentally at odds with the practice of medicine. Too much context is lost in the numbers, and too many factors beyond their personal control bear upon the performance 'data.'"   He did explain why MBAs are unconcerned about the accuracy and meaning of the measures they manage. 

The "you manage what you measure" heuristic seems based on the concept, or better yet fallacy that everything in health care is uniform and predictable.  This seems an extended version of what has been called the streetlight effect or the drunkard's search.  (See, for example, the version from Wikipedia, attributed to David H Freedman.  (2010). Wrong: Why Experts Keep Failing Us)  It begs the question of what is practical to measure is worth measuring, that is, is accurate, reliable, and meaningful.
 
Furthermore, there is now a considerable literature in medicine and health care showing that it is extremely difficult to develop performance measures that are reliable and meaningfully predictive.  (I cannot claim to have written comprehensively on this topic, but see posts here, and here.  For some good informal writing on why pay for performance [P4P] may not work, see Dr Robert Centor's blog DBs Medical Rants)

Considerable research has also shown that P4P rarely improves performance, and may make it worse.   For example, the results of a systematic review published in 2012 [Houle SKD, McAlister FA, Jackevicius CA et al.  Does performance-based remuneration for individual health care practitioners affect patient care? - a systematic review.  Ann Intern Med 2012; 157: 889-899.  Link here.] were that

The effect of P4P targeting individual practitioners on quality of care and outcomes remains largely uncertain.

Furthermore, a 2012 analysis of pay for performance [Glasziou PP, Buchan H, Del Mar C et al.  When financial incentives do more good than harm: a checklist.  Brit Med J 2012; 345: e5047. Link here.] included the summary statement,

Current evidence on the effectiveness of financial incentives is modest and inconsistent.

Thus, it would seem that the MBAs have neither good logic nor good evidence to support their faith in their current metrics, particularly those they use to assess physicians' performance. 



Power and Money vs Patients' and the Public's Health

Mr Kislak saw himself as supporting physicians in "their mission to provide high quality and effective care to their patients."  In the conclusion to his article, he asserted that physicians and MBAs "share the same overarching goals ... - effective healthcare delivery...."  However, in the body of the article, Mr Kislak suggested that MBAs see their goals in terms of power and money...  

4. Leadership. MBAs like to think of themselves as either nascent or actual leaders. It is understood that their intention is to build a career trajectory that will move them up in their organization (or in another organization) into positions of increasing authority and control. After all, this is an important reason why they become MBAs in the first place.

Furthermore, Mr Kislak wrote

8. Language. MDs and MBAs usually work for some type of business entity, whether that entity is for-profit, nonprofit, academic, government or sole proprietorship. To the MBA, however, it is all too apparent that with few exceptions MDs have little training in the language of business that all entities speak — the language of finance and accounting.

He noted that "this is a significant disconnect and a root cause of why MDs and MBAs often find themselves talking past each other on even the most basic business issues."  However, interestingly he did not even mention that MBAs may have as little facility with the language of medicine and health care as physicians have with the language of finance or accounting.  Furthermore, he seemed unaware that it makes as little sense to say that discourse in health care should be in the language of finance as to say discourse in finance should be in the language of health care. 

Finally, Mr Kislak made it very clear that to MBAs, money comes ahead of patient care,

9. Growth. MBAs are trained to look for ways to grow the organization's revenues and profits to the long-term benefit of the owners or stewards of that organization. Improvements to quality, efficiency, profits, revenues, technology and the like are generally viewed as a means to that end of growing,

Yet he noted that

the MDs sometimes wonder what all the growth talk may be costing their own priorities, including their compensation. This issue can become rather sensitive when it implies that the MD is less concerned with the long-term health of the organization than the MBA, and can devolve into finger-wagging about lack of engagement or weak physician-hospital alignment.

It is a measure of how much generic managers have taken over that the physicians may be blamed for lack of interest in the long-term "health of the organization," while the MBAs seem totally unconcerned about what effects the organization has on the real health of patients or the public.

Thus, fundamentally, MBAs running health care organizations are mainly interested in growing their organizations so that they bring in more money.  MBAs hope to leverage their organizations' financial performance so that they personally can rise to positions of greater power and wealth.  Health care is simply a "means to that end."  Mr Kislak seems to have confirmed my worst fears that most of health care's current generic managers put short-term revenue, and their own wealth and power, ahead of patients' and the public's health. 

Summary

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician. 


Now we have one MBA with considerable experience inside health care, and personal sympathy for the goals of high quality and effective care for patients, who. perhaps inadvertently, suggested why this managers' coup d'etat was a terrible idea, and why MBAs should not be allowed to lead health care organizations.  He corroborated our concerns that generic managers may be ill-informed and do not understand the health care context, particularly the variability and complexity of patients and their problems, the ambiguity of diagnosis, and the unpredictability of prognosis and response to therapy.  They believe in simplistic management approaches, particularly the usefulness of measurement and metrics, even in the absence of logic or evidence supporting them.  Furthermore, they may be heedless of the mission of health care, particularly of the primacy of the patient, and in fact put their own organizations' revenue ahead of patient care, and ultimately may pursue power and money rather than patients' and the public's health.  

As I have said before,  true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

ADDENDUM - This post was re-posted on the Naked Capitalism blog. 
 

For Hospital CEOs, Retirement May Mean Never Having to Lose Your Paycheck

 Dr Herbert Pardes was once one of the best paid CEOs of a US non-profit hospital system.  A new New York Times article reported that the hospital system continued to pay him millions after his retirement. 

Introduction - the Best Paid Non-Profit Hospital System CEO in 2008

In 2009, we first discussed the compensation given to Dr Herbert Pardes, the CEO of New York - Presbyterian Healthcare System, which appeared to make him one of the best paid, if not the best paid non-profit hospital system CEO in the US.  His total compensation for 2008 was $9.8 million, according to the NY Post.  While his compensation was lower in 2007, approximately $5.1 million, 9 other executives made over $1 million, and the 10 together made over $26 million.  This amount was approximately 20% of the system's total surplus, and 1% of its total budget.

The Times reported that since then, Dr Padres continued to do very well financially,

Dr. Pardes’s compensation has consistently been among the highest of any New York hospital C.E.O. His compensation in 2011, his last year as chief executive, was $4.1 million, including base pay of $1.7 million and a bonus of $1.8 million.

Retirement Means Never Having to Lose Your Paycheck

According to the Times, after Dr Pardes retired in 2011,

The next year, Dr. Pardes earned $5.6 million, which included $1 million in base salary, a $1.8 million bonus for his final year as chief executive and more than $2 million in deferred compensation, according to hospital tax records. That exceeded the amount earned by Dr. Pardes’s successor, Dr. Steven Corwin, who made $3.6 million that year.

Three years after retirement, Dr. Pardes is still employed by the hospital as the executive vice chairman of its board of trustees, a position that compensation experts say is rare in the nonprofit world,...

So the year after Dr Pardes retired, he made as much from what most people might have thought was his former employer as he did in 2007 as CEO, when he was one of the best paid non-profit CEOs in the country, and more than he made in 2011, the year of his retirement.

Why Pay a Retired CEO Millions More?

At least one prominent US Senator interviewed by the Times suggested that Dr Pardes' remunerative (non)retirement was questionable,

 Senator Charles E. Grassley, Republican of Iowa, who has been pressing for tax-exempt hospitals to be more accountable for the salaries they pay, said on Tuesday that Dr. Pardes’s compensation was an example of how 'major nonprofit hospitals often are indistinguishable from for-profit hospitals in their operations.' The senator added: 'It’s not enough to say high compensation is necessary and leave it at that. A nonprofit hospital should show how that compensation benefits its patients.'

Of course, supposedly non-profit hospitals escape corporate income taxes, and can solicit donations which provide tax deductions to the donors.  Non-profit hospitals are supposed to be more charitable than for-profit hospitals to deserve these benefits, but it seems hard to square the compensation given to top executives at New York - Presbyterian with is nominally charitable nature.  

Furthermore, the Times article noted how Dr Pardes' new position as a highly paid leader of the board of trustees of the hospital system may have detrimental effects on the system's leadership and governance.

'To have a former C.E.O. on the board is actually a big no-no,' said Uwe Reinhardt, a Princeton University health care economist. 'It’s not considered good board manners. Inevitably they begin to meddle and micromanage.'

The Times reporter asked the chairman of the hospital system board to justify the continued payments of millions to former CEO Pardes, 

Frank A. Bennack Jr., the chairman of the hospital and former chief executive of the Hearst Corporation (and executive vice chairman of the Hearst board, in a role similar to Dr. Pardes’s), said in a statement that Dr. Pardes was 'extraordinary' and was kept on for 'urgent fund-raising activities and a range of other institutional needs with which he could assist his superb successor.'

Furthermore, the Times article suggested that Dr Pardes' pay was justified based on comparisons with other executives,

The hospital’s tax return, which is public because the organization is a nonprofit, said that in paying its executives, NewYork-Presbyterian looked at compensation patterns in nonprofit and for-profit health care systems. Michael L. Wyland, a partner in a consulting firm to health care and other nonprofits, said that was permissible, because 'the I.R.S. explicitly allows comparison with for-profit as well as nonprofit entities.'

In addition, despite his comments above, Prof Reinhardt also found justification for the amount paid someone who is apparently his friend,

But Dr. Reinhardt, who said he was friendly with Dr. Pardes, and Mr. Wyland agreed that while Dr. Pardes’s position was unusual, it might not be unjustified. They said that after 12 years as chief, he had presumably forged strong relationships with donors that the board would consider worth paying handsomely to maintain.

They said that running a hospital was as challenging as running many corporations, because doctors tended to resent authority and because the job required not only management skills but also an understanding of government reimbursements, the insurance industry and medical and malpractice issues. 

The Talking Points Again

In 2011, we noticed that justifications of sky high compensation given to health care executives (especially hospital CEOs) seemed to follow a pattern.  As we just summarized,

It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy.   We first listed the talking points here, and then provided additional examples of their use here, here here, here, here, and here, and here. 

They are:
- We have to pay competitive rates
- We have to pay enough to retain at least competent executives, given how hard it is to be an executive
- Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job).

The talking points are usually supplied by hospital public relations personnel, sometimes by hospital trustees or executives, sometime by various health care consultants.  The talking points are rarely questioned.

Furthermore, we just found evidence that these really are talking points.  A former public relations executive for a major for-profit health insurance company acknowledged using almost these exact justifications as talking points to justify his company's executive compensation.  

Now we have our first example of the compensation given to a retired hospital CEO justified with these talking points:

- Competitive rates - see the comments by the consultant, Mr Wayland

- How hard it is to be an executive -  see the comments by Prof Reinhardt, especially, "the job required not only management skills but also an understanding of government reimbursements, the insurance industry and medical and malpractice issues"

- Brilliance - see how the board chairman called Dr Pardes "extraordinary"

Finally, note that the apologia for Dr Pardes' extraordinary post-retirement compensation provide no new support for the talking points.  

In particular, consider the comments by Prof Reinhardt about all the sorts of expertise required of a hospital CEO.  What he did not acknowledge was that modern hospital systems have lots of people other than the CEO to deal with these issues.  Reporting to the CEO are numerous top executives who are themselves paid very well, and their pay is presumably justified by their own expertise.  For example, in 2011, in addition to Dr Pardes, New York - Presbyterian not only had a CEO, Dr Steven J Corwin, whose total compensation was over $3.5 million, but also 13 other executives who each received compensation over $1 million, and another 14 with compensation greater than $500,000  (see the system's 2012 990 form).  In turn, each of those must have had numerous senior managers reporting to them.  So why should Dr Pardes have to be an expert in, for example, "malpractice issues" when he had "Kathleen M Burke Esq, VP Board Ret, Secr & Counsel," with total compensation of $346,153, and "Maxine Frank Esq, exec SVP, CLO & Gen Counsel," with total compensation of $1,639,739 to advise him? 

Instead, the real reasons for ballooning executive compensation in health care appear to be cronyism on the boards of trustees who are supposed to be exercising stewardship over the hospital and supervision over the executives; the ratcheting up of compensation due to comparison with other executives, as opposed to other kinds of employees, when all boards want to think their executives are above average; and the dogma that CEOs must be "great men," or even have some divine endorsement. (See this post.)

Summary

The compensation given top executives of health care organizations gets ever more floridly exaggerated.  More and more this compensation seems to denote how these organizations have been taken over by insiders who make it a priority to benefit themselves.  Prof Reinhardt, who is himself on the board of directors of Boston Scientific (look here), suggested that such compensation should not be a worry because it "would not affect the bottom line," and that those who protest it are suffering from "social envy."  However, as we noted, current trends in executive compensation in health care could cause declining morale of other employees, increasing isolation of top executives, poor organizational performance, income equality and a declining economy, and ultimately social unrest.     

Although the transition of executives into a new aristocracy is a society wide, if not a global problem, we in health care cannot be complacent that someone else will solve it.  True health care reform would enable accountable leadership that puts the health care mission and patients' and the public's health ahead of personal gain.   

 

When Money Talks, the Sick Will Walk, or Crawl - Three Illustrations of the Brave New World of Health Care

In the quaint days of yesteryear, there were those health professionals who thought of what they did as a calling.  The best care of the individual patient was supposed to come first, especially ahead of maximizing one's own income.  Now in the brave new world of neoliberalism, economism, unregulated, laissez faire capitalism - call it what you want - health care has become a business, an industry.  Protests that it still should be a calling are anechoic.

For example, who noticed when a very famous person wrote this in 2012?

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,'

For those who cannot tell who that was, see the end of this post.

Recently, some illustrations of how health care now puts money ahead of patients came to light.

Intellectual Property Rights Ahead of Sick Patients

The first example is from the KevinMD blog, written by medical and business student Samyutka Mullangi.

 My business ethics class recently discussed the case of Cipla Pharmaceuticals, an Indian generic drug manufacturer drawing the ire of big pharma by blithely ignoring international patents or employing workarounds to manufacture low-cost generics in direct violation of the patents. Cipla’s founder, Dr. Yusuf Hamied, stressed that Cipla’s goal wasn’t to steal from the bottom line of the likes of Merck and Eli Lilly, but rather to serve its mission of helping the world’s poor gain access to life-saving medications that they could otherwise not afford.

Of course,

 Students hailing from careers in pharma vehemently stated their opposition to Cipla’s cause, invoking the necessity for pharmaceutical companies to amortize their costs through sales. Though the incremental costs per pill of actual manufacturing were negligible, the high initial investments in research trials and production required a modicum of intellectual property protection.

The argument was briefly halted when 

 a classmate from the Middle East, who had been holding back furious tears through most of the discussion, raised a trembling hand and broke his silence. He told us of how his father, when he contracted diabetes, would not have survived if not for the availability of exactly such generic drugs.

He said, 'This entire discussion disgusts me.'  

However, very soon another student piped up and started talking about incentivizing.  Mullangi noted that

 At the business school, we use words like incentives, value proposition and return on equity. The liberals in the room had to couch their arguments in these terms. It would have been indelicate to talk about human rights and moral obligations.

While the end of the post suggested that medical students may not understand the language of business students, while business students may not understand the language of medical students.  However, it is clearly discussion of what matters to patients, empathy, ethics, morals that is "indelicate," and incentives, value propositions, and returns on equity have won out.


Efficiency Ahead of Patients' Needs

Just published online in JAMA was a commentary by Dr Christine K Cassel, and Robert S Saunders of the National Quality Forum summarizing recent findings by the US President's Council of Advisors on Science and Technology on Health Care [Cassel CK, Saunders RS. Engineering a better health care system; a report from the President's Council of Advisors on Science and Technology.  JAMA 2014; doi:10.1001/jama.2014.8906.]  While it started with the usual paean to

an increased need to ensure care remains high quality, affordable, and centered around the needs of patients and families.

What it was really about was how

systems engineering ... includes a range of tools to improve efficiency and reliability

So, for example, while some people dislike the US fee-for-service payment system because it may encourage unneeded, useless, or even dangerous care, these authors noted just that it

rewards inefficiency and serves as a disincentive to more efficient care.

The whole point was about increasing efficiency.  But efficiency according to economists is "the use of resources so as to maximize the production of goods and services." (per Wikipedia.)  It is not about health care outcomes, benefits versus harms, or health care quality.  And there was not a word in the paper about patients' values or preferences, benefits or harms, or adverse effects of medical interventions.


The Highest Bidder, not the Sickest Patient, Gets the Earliest Appointment

The starkest example appeared in a Bloomberg article, aptly titled "Doctors for the 1 Percent."  The new start-up HelloMD is

a company that connects patients with the best doctors in San Francisco, Los Angeles and Las Vegas, as determined through a selection process. HelloMD offers faster appointments than regular patients can get, for a price: Its customers pay the doctors higher rates than insurance plans offer. And they pay those rates in cash.

So,

HelloMD is a portal to the top specialists in every field, letting you buy your way to the front of the line.

So in the brave new world of HelloMD, presumably a wealthy patient with a chronic or even trivial problem could bid his or her way to specialty care ahead of a more acutely and severely ill patient who lacks the extra money (and even if the latter patient has full conventional health insurance.)   Most codes of medical conduct suggest that the needs (meaning clinical needs) of individual patients come first, presumably ahead of the wants of wealthier patients.  Yet HelloMD allows the wants of the rich trump the needs of the less rich.  (For any rich people who think that may be good for them, remember there is always somebody richer.)  To an old school doctor, this seems completely unethical.  (And some lawyers might think that participating doctors risk violating any contracts they have with health insurance companies.) 

(Note: see another post about HelloMD on the Health Business Blog.O

Summary

So right now those who believe that health care should be a business, not a calling, are winning.  In an era of deregulation and rampant suspicion of anything government can do to level the playing field, those with more money will win, and patients, no matter how sick, will lose.

By the way, anyone thinking that they are rich enough to buy their way to good care in this brave new world, remember there will always be someone ahead of you who is richer. 

Good health care will not survive long in a time when it is indelicate to talk about human rights and moral obligations.  Obviously, true health care reform will take more than talk.


Answer to Quiz - Pope Benedict XVI, see this post.