Saturday, August 30, 2014
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Organize health care as if it was war

Does the private control of drug development and health care in general bestow better health and prosperity on Americans? For people in the C-suites, their bluestocking shareholders and some others, it undoubtedly does. For most Americans, it doesn't appear to work so well.

Organize health care as if it was war

Does the private control of drug development and health care in general bestow better health and prosperity on Americans?  For people in the C-suites, their bluestocking shareholders and some others, it undoubtedly does.  For most Americans, it doesn't appear to work so well.

Earlier this year the US National Research Council and Institute of Medicine issued a report (see here) that compared the health status of Americans to fifteen other affluent, democratic countries.  These include Australia, Canada, France, Italy, most of the Nordic countries, Spain, and the UK.

Echoing the findings of many previous studies, the Council found that despite spending the highest per capita amount on health care, Americans don't live as long.  In fact, compared to people in the other democratic countries, people here are the least likely to reach the age of 50.  Throughout the course of their lives, Americans suffer poorer health from birth all the way to age 75.

On a range of factors, Americans have higher rates of disease and injury.  The Council found that people here fare worse on infant mortality, low birth weight, injuries and homicides, teenage pregnancies and sexually transmitted infections, HIV/AIDS prevalence, drug-related deaths, obesity and diabetes, heart disease, chronic lung disease, and disability (see here).

Conventional wisdom holds that the inferior health among people in this country applies mainly to the poor, the homeless, the uneducated, and those without insurance.  That too is a myth.  Less robust health exists here across the board.  It applies to people with health insurance and to those without it, to Americans with college educations, high incomes, and healthy living patterns as well as to those lacking such advantages.  Even more distressing, America's health has been falling farther behind levels in the other countries for thirty years, particularly among women.

A particular example of how private enterprise fails health care appears in the area of drug development.  The fact that the pharmaceutical industry funds a majority of the world's biomedical research causes several problems.  First, unless research can lead to a drug for which there is a huge profit potential, no pharma company will fund it and the necessary development won't happen.  That means inadequate funding is available for research on diseases and conditions that are scourges to millions of poor people around the world.  Biomedical research in a profit-making system is linked to sales and a puny sales potential means little or no research.

Then there is the problem of secrecy and hidden research.  Openness is an essential element of good scientific research.  It serves to both expose weaknesses and attract innovative contributions.  But in a research system built on profit, one organization's gain is often another's loss, so openness and collaboration are replaced by secrecy. 

The secrecy that shrouds drug development causes some significant problems.  In the first place it suppresses information about flaws with compounds under development, such as side effects.  It also makes the whole R&D process considerably slower because each competing organization must go down the same blind alleys instead of benefitting from the learning experiences of others.

Now the fact that drug development in a private enterprise system results in dysfunctional secrecy, needless delays and a broken moral compass is not to say that a system run completely by government is the best alternative.  As those who follow the FDA and, more recently, the IRS can attest, government agencies can be sclerotic, self-serving, unresponsive to popular needs and either woefully timid or outrageously power hungry. 

But a solution emerges from the fact that health care in the US is now approaching almost 20% of the country's GDP.  When any single endeavor occupies such a sizeable proportion of national activities and resources, it starts to represent a version of total war.  In this respect one can paraphrase Clemenceau's statement about the First World War to describe health care -- it is too important to be left to either professionals or amoral CEOs. 

As with war, government must run health care by enlisting and coordinating the private sector's best innovations and its most zealous efforts.  If America wishes to remain economically competitive and avoid becoming a Spartan state where one-fourth of its workers carry bedpans for the rest, the country must finally remove health care from business profiteering and from political opportunism.  The 19th century's black or white notions about private ownership versus socialized control cannot work effectively in the 21st century.

In a recent issue of The Atlantic, Brian Till provided an example of how this mixed, public-private approach to health care might work.  It appears that several foundations, think tanks and patient advocacy groups proposed a plan to overcome the problems of drug development inherent in a competitive system.  The plan's proponents include the Gates Foundation, Public Citizen, Doctors Without Borders and several other groups.  Its basic premise involves what the public interest groups term as "delinking" drug R&D from the commercial demand to generate profit through marketing and sales.

The way it would work involves the world's governments contributing cash prizes for discovering and developing medications that treat designated conditions/diseases.  Essentially the scheme would eliminate the pernicious effects of drug marketing such as off-label promotion, bribes to physicians, distorted and ghostwritten articles.  Instead R&D would become its own marketplace.  The international community would determine the amount to be awarded for each new medication, depending on GDPs of the respective countries and the costs that the various conditions/diseases create for those countries. 

Successful R&D would thereby become a moneymaking venture, but one without the need for marketing and sales that inevitably encourage misdeeds.  Because drug development would no longer be dependent on selling the approved drug, R&D could stand on its own as a profit center by using the most promising scientific approaches to develop therapies for diseases and conditions that merit the effort.

To eliminate the problems of secrecy, hidden research, and duplicative efforts, the plan would also create an open platform for all researchers "to pool data and coordinate their work."  If anyone proposes a useful idea to advance a compound's development, he/she would apply for an international research grant.  The money would stipulate that the researcher deposit all work done under the grant in an IT cloud that permits open access to other researchers.

After a new drug is successfully developed and approved, another market would swing into operation.  In this one manufacturers will compete to produce the new drug as inexpensively as possible while meeting specified quality standards.

This plan for grants and open access contains several appealing features.  Nevertheless, as with any large and complex venture, the implementing details are what can make it either a beneficial piece of public policy or a harebrained scheme.  But that perennial contingency doesn't excuse the Obama administration's effort at trying to block the World Health Organization from even discussing the policy. 

On this matter the current administration has followed the policies of the two previous ones.  As a result of this US roadblock, Till reported that "negotiations on actual language for an R&D treaty" never even began. 

The proposed treaty would require member nations to commit one one-hundreth of one percent of their respective GDPs to the kitty for research prizes on "neglected diseases."  Although the "U.S. already spends at that level and would have no further financial obligations...the idea of binding financial commitments by way of treaty has been a centerpiece of US opposition." 

So far the Obama administration's intransigence in blocking it on pharma's behalf has consigned the treaty to "limbo at the WHO in Geneva."

While a segment of people think of this delinking approach to developing and distributing drugs as strictly benefitting impoverished nations, they are mistaken.  As noted in the U.S. National Research Council's report, the health and well being of Americans can stand some significant upgrading and better access to the right medications can be a useful part of that. 


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Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
About this blog

Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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