Showing posts with label neoliberalism. Show all posts
Showing posts with label neoliberalism. Show all posts

Thursday, July 31, 2014

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

Tuesday, July 15, 2014

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.

Tuesday, July 1, 2014

Health Care Corruption, "No Dirty Little Secret," but "An Open Sore" - Lessons from India for the US

Health care corruption is widely prevalent around the globe, but remains the great unmentionable.

Introduction: Global Health Care Corruption

We have discussed health care corruption whenever we have an opportunity, but rarely does the topic appear in the English language media or in English language medical and health care journals, particularly in the US.  Some might think that this is because health care corruption is not so prevalent in the US and other "developed" countries.  However, our most read post of all time was about a Transparency International global survey that found that fully 43% of Americans believe our health care is corrupt. 

A recent editorial in the BMJ(1) opened thus,

Healthcare is a high risk sector for corruption. Best estimates are that between 10% and 25% of global spend on public procurement of health is lost through corruption. This is big bucks. Total global spend on healthcare is more than $7 trillion each year. Corruption takes many forms, depending on the country’s level of development and health financing system. The United States, for example, lost between $82bn and $272bn in 2011 to medical embezzlement, mostly related to its health insurance system. No country is exempt from corruption. Patients everywhere are harmed when money is diverted to doctors’ pockets and away from priority services. Yet this complex challenge is one that medical professionals have failed to deal with, either by choosing to enrich themselves, turning a blind eye, or considering it too difficult. Transparency International, a watchdog on these matters, defines corruption as the abuse of entrusted power for private gain, which in healthcare encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. This is no dirty little secret. It is one of the biggest open sores in medicine.

When health care corruption is actually discussed in polite circles, including the scholarly literature about medicine and health care, the discussion usually refers to corruption elsewhere.  In particular, in developed countries, discussion of health care corruption usually focuses on less developed countries.
Thus, maybe it should not be a surprise that the editorial by Jain et al accompanied another BMJ article about health care corruption in India. Yet by reading between their lines, both articles have global application, and are just as relevant to those nations in which the powers that be seem to have smugly concluded that health care corruption is only a problem in benighted third world countries.

A Personal View on Health Care Corruption in India

David Berger a UK trained general practitioner (GP), discussed the corruption he found while volunteering in India.(2)  His introduction was,

'The corruption strangles everything, Sir. It’s like a cancer.' Accompanied by apologetic shrugs and half smiles, statements like this are commonly heard in India. I knew this was the case before I went to work as a volunteer physician in a small charitable hospital in the Himalayas, but what I didn’t realise was how far the corruption permeates the world of medicine and the corrosive effect it has on the doctor-patient relationship.

Berger raised several issues:

Neoliberalism and Privitization


The healthcare system itself is a model of inequity; it is one of the most privatised in the world, with out of pocket expenditure on healthcare at more than 70%, far higher even than in the United States. This phenomenon is at least partly the result of the neoliberal World Bank policies of the 1990s, which mandated a reduction in public financing of healthcare, fuelling growth of the private sector. The latest in technological medicine is available to people who can pay, albeit at a high price,...

Kickbacks to Physicians for Referrals

This is a common form of corruption in India.

all investigations attract a 10-15% kickback to the referring doctor. One day, the marketing executive for this clinic had turned up at the hospital with an envelope full of cash—the commission for investigations ordered in the past few months. The senior doctor refused it and stipulated that in future the commission was to be paid back to patients, which is why the resident had to sign the form. The country’s doctors and medical institutions live in an 'unvirtuous circle' of referral and kickback that poisons their integrity and destroys any chance of a trusting relationship with their patients.

Kickbacks from Pharmaceutical Firms

There is also widespread corruption in the pharmaceutical industry, with doctors bribed to prescribe particular drugs. Tales are common of hospital directors being given top of the range cars and other inducements when their hospitals sign contracts to prescribe particular antibiotics preferentially.

I met a former pharmaceutical sales executive who left the industry, sickened by the corrupt practices he was supposed to employ. Working for one of the largest drug companies in the country, he was expected to bribe doctors with money and luxury goods. The crunch came when a doctor demanded that the company fly him to Thailand for a holiday and then provide him with prostitutes at his home. When the company representative queried this, his manager told him to comply, and he felt he had no choice but to resign, protesting that he was 'not a pimp.'

Huge Fees Charged to Medical Students

Endemic corruption extends to medical studies themselves. In another 'unvirtuous circle,' students can have to pay very large “donations” (perhaps $200 000 or more, some 20 times the average doctor’s annual salary) to get into the rapidly increasing number of private medical colleges and to get on to sought after postgraduate training schemes. This means that doctors can have high levels of debt or family obligation when qualifying, which is a strong incentive against working as generalists in rural areas and favours them practising technological medicine for maximum profit in urban areas to try to recoup their investment.


The US Parallels

All the issues above have clear parallels in the US.  But in the US, hardly anyone talks about health care corruption as a local or national problem.  

 Neoliberalism and Privitization

The US is known for its increasingly private health care system, pushed by the ideology of "neoliberalism" or "economism."  US health insurance is mostly provided by private, for-profit corporations, not non-profits, or government agencies.  US hospitals and hospital systems are increasingly private, as are other organizations that provide direct health care, e.g., hospices.  US physicians are increasingly corporate employees.  India may be more privatized, but the US is close behind.

 Kickbacks to Physicians for Referrals

We have frequently posted about cases in which there was good evidence that physicians in the US got kickbacks, or bribes.  Most involved legal settlements of cases in which there were allegations of widespread kickbacks.  Some of them involved kickbacks for referrals (e.g., the settlement involving Omnicare in 2013, look here).  On the other hand, resolution of cases involving kickbacks to small groups of physicians for referrals are so common in the US that we rarely discuss individual examples. For example, I found the following headlines from the last few weeks:

NJ Arrests More than 12 in Alleged Kickback Scheme
Randolph Doctor Jailed for 20 Months for Role in Massive Kickback Scheme
O.C. Grand Jury Indicts 15 Doctors   

We have also written extensively about how corporate physicians are pushed to avoid "leakage," that is referral of patients to health care facilities not owned by their corporate employees (e.g., look here). 


Kickbacks from Pharmaceutical Firms

We have posted about numerous examples of widespread kickbacks given by health care corporations, particularly pharmaceutical, biotechnology, and medical device companies, to physicians to enhance their prescriptions for or use of their products.  Most recent examples include legal settlements by Pfizer about kickbacks to promote use of Neurontin (one of many by that company, look here); by Medtronic to promote use of its pacemakers and defibrillators (look here); and by Johnson and Johnson to promote use of Risperdal (look here).  Moreover, we have discussed many examples of physicians paid as "consultants" or given "honoraria" for talks by companies whose goal was to use these physicians as "key opinion leaders," actually covert marketers for their drugs or devices.  Many of the conflicts of interest we have discussed actually seemed to involve kickbacks or bribes, even though some physicians and policy-makers like to refer to them as "collaborations" with industry to increase "innovation." 

Huge Fees Charged to Medical Students

The huge tuition charged US medical students, their huge resulting debt, and their resulting tendency to pursue procedural specialties rather than cognitive specialties, particularly primary care, have become cliches.

So it seems that the US has some of the same possible risk factors for corruption as does India, that there are many cases in the US of activities that are called corruption in India, and that a near majority of US citizens feel their health care is corrupt.  But health care corruption remains a largely taboo topic in the US. 

Summary: Some General Approaches

The editorial by Jain et al that to its authors' credit emphasized that health care corruption is a global problem suggested some general approaches to corruption(2)

Good governance, transparency, and zero tolerance must form the basis of any anti-corruption strategy. Changes must be implemented in society at large for reform to be sustained. Better governance requires rigorous legislation and functioning administrative mechanisms to provide fiscal oversight. Ethical standards of conduct must be explicitly established and staff held accountable for their performance. Punitive measures should be available to serve as a deterrent. Honest behaviour must be rewarded. These policies may be ineffective, however, unless healthcare professionals are assured of a decent salary and fair opportunities for professional growth

Also

Simple and effective channels for complaints must be established, and appropriate legal support and protection provided to whistleblowers. Looking deeper, underlying issues such as education and social justice must not be forgotten if the battle against corruption is to be sustained and eventually won. Answers may also lie outside the world of medicine.

Note that we have discussed all these approaches: accountability, transparency, governance, boards of trustees, boards of directors, ethics and integrity policies , impunity, legal settlements, and education about corruption (look here). 


Not that any of them have been widely adopted.

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.

References

1.  Jain A, Nundy S, Abbasi K. Corruption: medicine's dirty open secret.  Brit Med J 2014.  Link here

2.  Berger D. Corruption ruins the doctor-patient relationship in India.  Brit Med J 2014.  Link here.