Ralph Snyderman Challenges the Status-Quo 100 Years After Flexner.

Posted on | January 2, 2017 | Comments Off on Ralph Snyderman Challenges the Status-Quo 100 Years After Flexner.

Credit: NEJM Catalyst

Mike Magee

In Hcom’s most read post of 2016, we challenged the notion of “personalized medicine” as often an empty  “branding exercise”, and subsequently noted a seeming disconnect between NIH supported scientific medical progress and human progress.

At around the same time, Ralph Snyderman and his team at Duke published an important paper in the NEJM titled, “To Adopt Precision Medicine, Redesign Clinical Care.” In it, he states, “the path from a scientific breakthrough to transforming health care is not straight”, and declares that “the basic approach to clinical care has to be re-envisioned to fulfill the promise of personalized medicine.”

In a series of accompanying illustrations, we see him peal back the onion toward prevention. He goes from “sporadic treatment of episodic disease” to “predicting disease” to “prevent and mitigate” disease. But to gain access to this new approach, policy makers must force us to enter the health care world through a different door. The new chamber, according to Snyderman, is “out of reach until the health care delivery system is designed for health promotion, comprehensive disease prevention, and efficient adoption of personalized and precision medicine (PPM) capabilities”.

The Duke team is optimistic professing that “with available and emerging tools, risk for disease can be quantified and prevention measures initiated before pathology develops”. One of the most interesting elements of the article is the illustration above focused on the “inflection curve” which demonstrates how late we come to the game of health delivery, and how this gives rise to unacceptable cost and irreversible human carnage. It also suggests the type of promise I described some years back with the Lifespan Planning Record.

LPR Video

If you follow the curve backward, you see limitless potential, if only we are prepared to no longer accept the status quo. But with the changing of the guard in Washington, that now seems a long way off. Clearly, Snyderman’s view is revolutionary, and it recognizes not only fundamental changes in the way we deliver care , but also the way we capture and advantage a range of personal, environmental and scientific data in real-time. As he says, “It aims to reorient front-line care so that health risks are identified and stratified early, healthful behaviors are promoted, and disease is either prevented or precisely treated.” And he admits that won’t be easy.

But the Chancellor Emeritus at Duke, and former President of the AAMC, comes at this with a deep historical perspective. He says, “The 1910 Flexner Report shocked the medical establishment into incorporating scientific advances to transform how disease is defined, diagnosed, and treated. More than a century later and a decade since the genomic revolution, it’s again time to redesign clinical care to also enhance health and prevent disease.”

Uncoupling Scientific Progress From Human Progress: Part III. The Loss of Checks and Balances: “Bayhing for blood or Doling out cash?”

Posted on | December 27, 2016 | 1 Comment

Mike Magee

The results of the Bayh-Dole Act were dramatic, at least for health care institutions. While 380 patents were granted to them in 1980, that number soared to 3088 by 2009. Those patents, now under the control of individual scientists and their parent academic institutions, were subsequently licensed to corporations for the development of a range of products and applications. According to one estimate, the resultant impact on the nation’s Gross Domestic Product (GDP) reached $47 billion in 1996, and soared to $187 billion a decade later. Since 1980, 2,200 new companies appeared and generated more than 1000 new products. As important, the new technologies spawned entirely new industries in the United States including the field of biotechnology.(1,2)

As a change agent, few legislative actions could compete with this one. The new industries spawned by the bill resulted in over 250,000 new jobs.(3) A second measure of the Bill’s impact was the fact that all universities involved in research today have a formal Office of Technology Management which oversees research related patents. In 1979, their trade association, the Association of University Technology Managers, had 113 members nationwide.(4) By the dawn of the new millennium, that number had swelled to 2,178.(5)

Of course, over time, it became clear that the legislation did have some unintended consequences. The licensing bounty for industry and academics was not insignificant.(6) It rapidly grew from just over $7 million in 1981 to $3.4 billion by 2008. And major pharmaceutical companies were at the top of the food chain. Over the first three decades with the Bayh-Dole Act in place, 154 new drugs were approved by the FDA with worldwide sales attributed to these products of $103 billion.

This led The Economist, in 2005, to headline their reappraisal of the Bill, “Bayhing for blood or Doling out cash?”(7) As the article states, “Many scientists, economists and lawyers believe the act distorts the mission of universities, diverting them from the pursuit of basic knowledge, which is freely disseminated, to a focused search for results that have practical and industrial purposes. Whether that is a bad thing is a matter of debate. What is not in dispute is that it makes American academic institutions behave more like businesses than neutral arbiters of truth… Researchers (and particularly their minders in university patent-licensing offices) are increasingly reluctant to share materials and knowledge with others unless such sharing is accompanied by legal agreements about ‘reach-through’ royalties on potential findings and the right to restrict publication of results.”

In the end, national competitiveness in the global economy had won out. Or as one critical review put it, “some critics have asserted that universities are only interested in the financial gain that can result from licensing technologies and ignore social considerations. It’s important to remember that Bayh-Dole was passed for economic development reasons, and as we have shown above, it has admirably fulfilled this mission.”(8)

As for Ted Kennedy, in the early stages of the Bill’s formulation, Bayh and Dole had decided strategically to limit the bill to universities and small companies. But at the time they originally presented their draft they were not certain that they would have the support necessary to advance the legislation. But the following day, Bayh’s staff received two independent calls from two senators’ offices offering to co-sponsor the Bill. One came from Strom Thurmond (R-SC) and the other from Ted Kennedy (D-MA).  As time would tell, the legislation would help give birth to the vibrant Rt. 128 biotechnology corridor in Massachusetts. On receiving the calls, Bayh’s chief of staff ran to the the Senate chamber to give his boss the good news. On receipt, Birch Bayh, peering over his reading glasses, wryly asked, “Are you sure this bill is OK?”(9)

In the political science of health care, the checks and balances of negative feedback loops are rapidly being replaced by positive feedback loops in the name of scientific progress and efficiency. And yet Americans pay more and get less in health than nearly all developed nations for all this “progress”. Integration and cooperation in the Medical-Industrial Complex is human mediated and profit driven. It has absolutely nothing to do with sound health system design, or rational and equitably delivery of population health. Kite Pharma’s corporate partnership with the National Cancer Institute, or Robert Califf’s former consultancy, funding, and financial relationships with Amylin, Lilly, Bristol-Myers Squibb, Janssen, Merck, Novartis Amgen, Bayer Healthcare, BMEB Services, Genentech, GlaxoSmithKline, Heart.org–Daiichi Sankyo, Kowa, Servier, Medscape/Heart.org, Regado, oche, N30 Pharma and Portola may yield profitable progress in science for investors. But this in no way assures, as we have seen over the past three decades in the U.S., that our human population will progress in tandem.

References on Request.

________________________________________________________________________________

Return to:

Part I: How Did We Arrive At This Place?

Part II. The Loss of Checks and Balances

Uncoupling Scientific Progress From Human Progress -The Loss of Checks and Balances: Part II – The Bayh-Dole Act

Posted on | December 25, 2016 | 2 Comments

 The Bayh-Dole Act from Nature.com

Mike Magee

Since Vannevar Bush presented his “Science the Endless Frontier” to President Truman, and the President had insisted on strong government control of federally sponsored research, there had been a prohibition on private ownership of patents that emerged from research discoveries supported by federal grant dollars.(1) As the thinking went, such discoveries, supported by public dollars, should be available to all, without the patent restrictions of a private company. But in reality, the lack of ownership of the intellectual property, and any market products or applications that would derive from it, frightened away private investors.

So the federally funded discoveries and their patents sat in the government vaults, largely unused and undeveloped. In fact, by 1978, with the economy still lagging, 28,000 scientific patents had accumulated. Over the years, fewer than 5% had been commercialized. (2) At that time, Indiana’s Purdue University was sitting on a number of new health related discoveries that had emerged from their research departments, supported by NIH grants. In face of the country’s “economic doldrums”, they decided to invest a bit of money on lobbyists to see if they might somehow wrest control of the patents, and future profitability tied to their inventions. They approached their senator, Birch Bayh (D-IN), and were delighted to see that he was receptive.(3)

At about the same time, the lobbyists discovered that Bob Dole had been exploring the same legislative territory.(4 Having been the unique recipient of life-saving health applications, and with a well established bias toward private investment and individual entrepreneurship over government management, Bob was delighted to conspire with Bayh on a possible fix for the problem. Together they fashioned a solution that would allow individual, small businesses and academic institutions to maintain ownership of their own intellectual property, even if it derived from government grant money. These liberalizations of the long standing restrictions on government funded discoveries would be justified on the basis of stimulating a rather moribund local economy and eliminating “bureaucratic regulatory waste”.(5) With Dole’s support, the technology transfer legislation swept through the Senate Judiciary Committee with unanimous support, and passed the Senate 91 to 4 on April 23, 1980.(6) Bayh then negotiated the Bill’s inclusion in the House’s version. But before merger of the two versions could be accomplished, the 1980 Presidential elections intervened. Ronald Reagan’s election displaced Jimmy Carter, and 12 Democratic senators as well, including Bayh.(7)

Not willing to give up, Bayh and Dole huddled, and seized on one remaining strategy to move the bill to closure before opposition could coalesce. Those opposed were mainly concerned that the bill, which was written to free up individuals and academics, would somehow be co-opted by large, profit-seeking corporations.(8)  Dole quickly saw an opening in the fact that Congress had failed to pass the budget that year which forced the need for a lame-duck session. Even though Bayh was on his way out, he would remain in place until Reagan was inaugurated. Bayh was well loved by his colleagues, and those in opposition to the bill agreed at least to allow the bill to come to a vote as a “farewell present.”(9) But when Senate Majority Leader Robert Byrd (D-WV) called for a vote and placed a 15 minute time limit on it, Bayh was caught by surprise, and was off site.(10) If they missed their time slot, the bill was lost. Bayh’s chief aide crossed the aisle to Dole, explaining the problem. Dole informed the leadership that he would be presenting their case. With bipartisan support, and with Dole having cleared all obstacles ahead of time, the bill was unanimously approved and sent on to the president.(11)

President Carter dragged his feet on the measure, and the lame duck session of Congress ended. Inaction by law would result in a pocket veto. Carter’s indecision on the bill had to do with his competing notions of what needed to be done. A notorious micro-manager, his preference was for a more comprehensive solution that cut across a range of intellectual property issues that plagued multiple sectors of the government. But with just a few days to spare, on December 12, 1980, he decided that “perfect was the enemy of the good” and signed the bill.(12) What were the results? I will address that in Part III of this three part series.

(References on Request)

Part I: Uncoupling Scientific Progress from Human Progress.

Uncoupling Scientific Progress From Human Progress: How Did We Arrive At This Place? A Three Part Series.

Posted on | December 22, 2016 | Comments Off on Uncoupling Scientific Progress From Human Progress: How Did We Arrive At This Place? A Three Part Series.

Source: studentblogs.med.ed.ac.uk

Mike Magee

A fundamental principle in human physiology and homeostasis is the negative feedback loop. When the body produces too much of something, a negative signal is transmitted back to the source which limits further production until peripheral over-production declines. These systems of checks and balances have evolved over the millennia to protect us and ensure our survival. But when it comes to political science, such protection is being dismantled through a system of strategic partnering from within the Medical-Industrial Complex.

The New York Times banner headline this week read, “Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits”. It documented the unusual partnership between Kite Pharma, a cancer immunotherapy start-up run by serial entrepreneur, Arie Nelldegrun, and the U.S. government. The fundamental underlying CAR-T immunotherapy research was the output of Nelldegrun’s mentor, Steven Rosenberg,  at the National Cancer Institute (N.C.I.). Taxpayers have contributed about $10 million to Rosenberg’s lab since 2012, and Kite has kicked in an additional $3 million a year to accelerate drug development by the N.C.I., but future profitability Kite’s control. In some of the deals (there have been 8 contracts since 2012), Kite receives patent use in return for promises of royalties paid to the N.C.I.

In the same week as these cozy relationships were revealed, the passage of the 21st Century Cures Act further greased the slide for accelerated drug approval by the NIH, and the new FDA Commissioner, Robert Califf, described in this weeks JAMA a cooperative arrangement between the FDA and the CMS that would blur the boundaries between the two organizations in exchange for efficient creation of future scientific advances. The moves are necessary, he says, to “help reduce current gaps in evidence that create uncertainty surrounding the approval or clearance of new therapies and their subsequent use in practice. It should also enable greater efficiency in medical product development and provide the higher-quality evidence needed in the emerging era of precision medicine.”

All this proceeds as daily we absorb case after case of over-marketing, over-pricing and over-selling of drugs and medical devices into an American market that consumes them at twice the rate of most civilized nations. Scientific progress appears to have been uniquely decoupled in our nation from human progress. How did we get here?

I’ll address that in Part II of this three part series.

A Sweet Deal: NIH Nutrition Research Task Force

Posted on | December 16, 2016 | 2 Comments

Mike Magee

“NIH Charts a Path for Nutrition Science” read the JAMA release offering on-air interviews with Griffin P. Rodgers, MD, chair of the new NIH Nutrition Research Task Force. “We hope that the strategic planning … encourages scientists to conduct innovative and really ground-changing studies in nutrition as they relate to health,” was the top line quote. Dr. Rodgers mentioned target areas like creating a strategic plan for research over the next 10 years, pursuing more accurate high-tech measurements of what people say they eat, nutrition effects on a wide range of diseases, genetic influences, the microbiome, and the impact of the timing of meals on metabolism.

Exercise garnered special mention by Dr. Rodgers. He said, “… we know that physical activity has many beneficial effects in terms of health and weight control, as well as metabolic and cardiovascular health, even cognition. But we don’t know at the moment the precise molecules or molecular mechanisms whereby exercise provides this beneficial effect.” Only a moment later he stressed our lack of certainty with these words, “There is a lot of confusion, obviously. You hear that you should be consuming certain types of foods and then you’re told that you shouldn’t. We hope that one of the goals is to try to really examine what we know, what we think we know, and the types of studies that might provide better guidance.”

These two comments, in juxtaposition, perked up my ears for four reasons. First, Michelle Obama’s nobel efforts to combat childhood obesity, driven in part by the food and beverage industries unhealthy food promotions in schools, were diverted soon after their initiation.  Industry lobbyists had offered exercise programs as a substitute for substantive nutritional reform.

Second, in 2016 it was revealed that the NIH had received 2 million in grants from CocaCola between 2010 and 2014. They were only one of 96 health organizations on the receiving end of CocaCola and PepsiCo, a list that included the American Heart Association ($400,000), the American Diabetes Association ($140,000), and the Academy of Nutrition and Dietetics ($875,000).

Third, it is unclear whether the new task force will supplant the already existing NIH Obesity Research Task Force which lists nearly identical leadership and organizational composition. 

Finally, the CDC has been reporting progress on the childhood obesity front. They noted a 43% decline in obesity in 2 to 5 year olds, from 14% to 8% when comparing the Bush to the Obama years. This progress directly tracked the decline in carbonated soda sales in the U.S. It struck me as odd that Dr. Rodgers interview in JAMA made no mention of carbonated beverages and the childhood ingestion of sugar calories, especially as the President-elect prepares to take office.

My experience with industry is that when times are tough, they invest more energy in government relations, ie. lobbyists. And make no mistake about it, times are tough, at least for non-alcoholic carbonated beverages. Over the past two decades, sales of full calorie soda sales have declined by 20%.

In 2015, the industry registered its 10th consecutive year of decline in soft drink sales in the U.S. In 2015, soda consumption declined by 1% to just under 13 billion gallons. That’s 36 gallons per American. The fact that overall sales of non-alcoholic beverages for the companies rose 2.2% owes a debt to bottled water consumption, up over 7%. By 2017, water sales will exceed carbonated beverages.

Originally CocaCola and PepsiCo thought they could buck the trends by going diet. But health concerns about ingestion large amounts of synthetic sweeteners like aspartame have limited that horizon. Diet Pepsi is down by over 5%, and Coke Zero down by 2%. And yet, revenues from carbonated beverages actually rose 1.4% in 2014 to over $77 billion. How is that possible? Marketing genius. Tipping their hats to weight concerns, the companies have pushed smaller 7.5-ounce cans, which deliver more profit per ounce than larger containers. Loyal customers associate the smaller portion size with health and are willing to pay a premium, at least for now.

Water on the other hand, generally derived from publicly available  community water sources, is booming. At the top of the list is Nestle’s Pure Life and Poland Spring, up by over 9%. Coke’s Dasani and PepsiCo’s Aquafina are not far behind. Not satisfied with plain old water, the companies are heavily marketing water tinged with a range of artificial chemical flavors. Energy drinks and sports drinks are hot as well, up 6.4% and 3%.

But the big activity is behind the scenes where the American Journal of Preventive Medicine has documented that 96 health groups received millions between 2011 and 2015, as the companies battled to defeat soda tax legislation like that proposed by then New York Mayor Michael Bloomberg, and dampen the spirit gathering around the First Lady’s campaign.

A year earlier, evidence revealed that Coke had taken a page out of the old playbook of public health nememes from tobacco to Oycontin and Adderall by paying scientists to produce research that undermined the connection between carbonated beverages and the obesity epidemic. 

CocaCola created a sham scientific platform, the Global Energy Balance Network, at the University of Colorado with a seed grant of $1.5 million. When the New York Times revealed the effort in 2014, the university returned the money. The company shut down the effort pledging new transparency, and dumped their chief science and health officer, Rhonda Applebaum, who had listed “cultivating relationships” as an overarching goal of the effort. 

As part of the “new transparency”, Coke admitted to $120 million in grants since 2010 to health organizations. These included the American Academy of Pediatrics ($3 million), the American Academy of Family Physicians ($3.5 million), the American Cancer Society ($2 million). They also revealed a $7.5 million grant over 5 years to Louisiana State University’s Pennington Biomedical Research Center. In August, 2015, Coke broadcasted the findings of an 12 nation study of 6000 children exploring the lifestyle factors related to childhood obesity. The culprits? Too little sleep, too little exercise, too much TV.

So you can see, with all this recent history, my concern with the JAMA interview. How does the optimistic announcement of the “NIH Nutrition Research Task Force” manage to field a range of questions that exclude focused research where preventive pay dirt has been firmly established with carbonated sugar beverages?

Let me close with JAMA’s final question, and Dr. Rodger’s response:

JAMA: “You recently moderated a panel on obesity and type 2 diabetes at the National Academy of Medicine’s annual meeting. Was there anything that came up that really caught your eye?”

Dr Rodgers: “Insulin resistance is such an interesting topic. Not only did [the speaker] cover this for obesity and diabetes, but he related the concept of insulin resistance to other conditions, such as certain types of cancers or polycystic ovary syndrome. Something that may not be well appreciated is that the brain, at least in animal models of Alzheimer disease, shows a striking pattern of insulin resistance. In fact, some people call Alzheimer disease type 3 diabetes. Another area covered was the intergenerational transmission of type 2 diabetes risk. And so the risk for type 2 diabetes not only lies in our genes but also in the environment to which we’re exposed. What this speaker discussed is that that environment actually begins in utero. What the mother is exposed to in terms of her metabolic status and her nutrition may imprint on the developing infant something that will be played out decades later in terms of diseases like diabetes or conditions like obesity.”

Or maybe it’s just sugar in the water.

Sloppy Prescribing and “Unlearned Intermediary” Law

Posted on | December 8, 2016 | Comments Off on Sloppy Prescribing and “Unlearned Intermediary” Law

Movantik Ad for OID

Mike Magee

The term “learned intermediary” is a legal term, first used in 1966, and defined by the Fifth Circuit Court as follows: “Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect.  As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient.  His is the task of weighing the benefits of any medication against its potential dangers.  The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.  Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a ‘learned intermediary’ between manufacturer and consumer.”

Grounding for this definition of responsibility, and potential liability, is the fact that consumers are unable to purchase prescription drugs without a physician encounter and physician consent to prescribe. Over the past half century, physicians have jealously guarded the near exclusive privilege of prescribing, more than willing to accept liability in return for market power. In short, patients want drugs, and in order to get them, they must pay for an office visit.

But this is not 1966. For one thing, in 1985, the FDA opened a crack in the door to allow pharmaceutical companies to market products directly to consumers through Direct-To-Consumer (DTC) advertising. The law was further liberalized in 1997, and drug company ads are now ubiquitous on television and the Internet, providing for medicalization of normal behavior and a constant “consumer push” to the doctor’s office.

The consumers have grown up as well, with study after study showing they are doing their own primary research from diagnosis through therapeutics, and increasingly double-checking physician recommendations rather than reflexly “following orders”.

And then there is the physician, whose “sloppy prescribing” for drugs like Oxycontin, with huckster prodding by bought and paid for “pain is the 5th vital sign” thought leaders, has managed to reverse the survival curve for Americans for the first time in 100 years. But it’s not just opioids. A 2016 report in JAMA of 58 Emergency Departments across the US identified nearly 43,000 cases of adverse drug reactions between 2013 and 2014. Over a quarter of the cases required hospitalization, with those over 65 requiring admission 43.6% of the time. For elders, anticoagulants, antibiotics, and diabetes medications were the major offenders, along with opioids.

Transparent databases are rapidly revealing that, in many cases, the physician’s prescribing habits reveal an “unlearned intermediary”. But it would be a mistake to single this group out either on the basis of ignorance, naivete, poor judgement, or carelessness. The truth is physicians are a relatively easy mark for the pharmaceutical industry, especially when the industry is enabled by paid academic physician “thought leaders”, and when AMA endorsed “specialty societies” which, once they gain Federation status without any rigorous quality control levers, are able to generate publications and CME activities as marketing arms of their industry benefactors.

One would think that, with the Purdue Pharma man-made opioid epidemic, the AMA and others would have gotten the message that, by allowing their “learned intermediaries” to become increasingly compromised, they are putting their prescribing franchise, and physicians future earning power, at risk. They have endorsed the stop gap measure of requiring physicians to check state prescribing databases before writing for opioids. But the prescribing problem is much bigger than opioids. There is no indication of increasing oversight, caution, or correction of the collusive behaviors of the Medical Industrial Complex, of which the AMA is a major marketing pillar.

Rather, the organization has focused on medicalizing “opioid addiction”, which is indeed compassionate for these victims, but does little to get to the heart of the problem. The drug industry is similarly unrepentant, instead doubling down on the sale of buprenorphine and naloxone here, there, and everywhere, and creating a new treatable disease entity, opioid induced constipation or OID. The creation of “new markets” and the selling into them is deliberate, insidious, and escalates day by day. Consumers addiction to poly-pharmacy is now firmly established in the culture, and physicians are historically compliant.

Leaders at the AMA should by now be able to read the tea leaves. Way back in 1999, in Perez v. Wyeth Laboratories, Inc, in a case involving the “learned intermediary” shield of liability on Norplant implants gone bad, (a product heavily DTC marketed), the New Jersey Supreme Court ruled that the companies aggressive marketing to consumers “alters the calculus of the learned intermediary doctrine.”

A Harvard Law expert characterized the result this way:

“The 5-2 majority relied on a novel understanding of the learned intermediary rule to justify its exception. It suggested that since the learned intermediary rule was announced in a Norman Rockwell setting where physicians still made house calls, the shift to managed care had rendered the rule less appropriate.[2] The majority also employed great creativity in locating the so-called premises of the learned intermediary doctrine in: (1) a reluctance to undermine the doctor-patient relationship; (2) an absence in the era of “doctor knows best” of the need for the patient’s informed consent; (3) the inability of the drug manufacturer to communicate with patients; and (4) the complexity of the subject.[3] This unique characterization of the rule enabled the majority to declare these four premises invalid in the context of DTC advertising and therefore to find the learned intermediary rule inapplicable in this context.”

But, of course, this is a two way street with potential bad outcomes for the House of Medicine. 1) “Unlearned intermediaries”, if they persist in this age of consumer empowerment and discoverable databases, will be increasingly vulnerable to liability. 2) The growing discovery that physicians, as a result of sloppy prescribing may be labeled “unlearned”, may well ignite expansion of the scope of practice of non-physician health professionals.

Fundamental Malpractice Reform Requires National Rational HC System

Posted on | November 29, 2016 | Comments Off on Fundamental Malpractice Reform Requires National Rational HC System

President-Elect and HHS Nominee

Mike Magee

President-Elect Trump announced today his nomination of Congressman Tom Price for HHS Secretary. Dr. Price, an orthopedic surgeon, steeped in organized medicine politics, has a conservative record of supporting small government, state’s rights, and malpractice reform. But if he truly wants to address medical liability and its impact on the Medical-Industrial Complex, he will need to think national and rational.

The power of the Medical Industrial Complex derives from shared resources, shared rewards, and shared career paths. But to leverage these assets, the various collaborators must also share liability. By choosing a decentralized system, whose credentialing and licensure and regulatory framework are largely controlled by fifty state regimes, doctors, hospitals and pharmaceutical manufacturers have had to accept a liability system based on state tort laws, one that all agree serves both patients and the Medical Industrial Complex poorly.

Ours is a system where an estimated 400,000 patients die each year due to hospital based medical errors, and where 1 in every 14 physicians is sued each year. The average physician in America can plan on a malpractice claim every seven years. The average time cost to a physician over 40 years in addressing these tort cases is over 4 years. Getting a case dismissed can take a year and a half, and settling a case out of court is still a three-year affair. Our system also extracts government penalties and awards in the billions almost continuously from the pharmaceutical and medical device industries, and this is without counting a continuous ongoing stream of class action suits whose ads rival the industry’s own DTC ads for frequency on the air.

The distinctly American choice to decentralize control of health care has limited the ability to rationalize the system, control costs, and standardize best practices across the nation. This choice has also accepted high levels of variability in quality, cost, coverage, and access in return for minimizing the potential for federal government induced price controls. In the cracks, collaborating members of the Medical Industrial Complex often find themselves deflecting blame and pointing fingers at each other.

Pharmaceutical companies have leaned heavily on “learned intermediary” law to limit their exposure. By “handing over” their product to doctors (primarily), and leaving the prescribing decisions to them, they embrace a “hands off” defense. But, as large judgments and penalties, through the government and class action suits originating in tort friendly states like Mississippi have demonstrated, they maintain significant exposure made worse by DTC advertising, aggressive marketing (including off-label) to doctors, CME and research ripe with conflicts of interest, and mergers and acquisitions that often purchase more liability than asset.

Physicians and hospitals, as well, pay a steep price in liability exposure for maintaining a privatized, de-centralized and disintegrate health care system. First, they insure that they and their patients will be dogged by ever increasing health care costs as compared to all other developed nations. Second, they must live with the fact that many of their neighbors in the community will be uninsured or underinsured. And finally, they must continue to manage the financial and psychological fallout of their individual state’s tort systems.

As one expert on medical malpractice commented, “Professional passions run high, and money and politics further inflame them…malpractice reform should be debated as a health policy issue, not as a political referendum on personal injury litigation.” For the past two decades, the business community and conservative think tanks have piggy-backed on this issue as a method of attacking personal injury lawyers who historically support the opposition party in large numbers.

Out of this has come occasional, state based reforms under the banner acronym “MICRA” or Medical Injury Compensation Reform Act, which generally cap payment for “pain and suffering” at $250,000 and limit a plaintiff lawyer’s contingency fees. California was the first to enact this in 1975. Texas created its’ version in 2003. In state’s with caps, the average decrease in settlements has been 15% , and malpractice insurance premiums have stabilized.

This sounds good, but does little to address the systemic issues of combating poor quality care, fairly compensating patients for injuries resulting from negligence, and imposing justice in a manner that would make future occurrences less likely. Plaintiff’s win only 25% of the time. It takes an average four years to gain a decision. And even in these cases, 54 cents of every dollar is diverted to legal and administrative fees.

The state-by-state approach to health care created a medical malpractice tort system that is fundamentally unsound. This becomes obvious if one compares this legal approach to current efforts to improve quality and safety in our health care system. The tort system uses litigation as its lever for change. The safety movement uses quality improvement analysis. Tort law focuses on the individual. Safety focuses on the process. The tort system’s punitive and adversarial style drives information down, encouraging secrecy. The safety movement uses a non-punitive and collaborative approach, which encourages openness, transparency, and continuous improvement. With tort law, exposing oneself can end one’s career and harm one’s mental health. In the safety movement, contributing is career-enhancing and therapeutic.

The medical malpractice system is fundamentally adversarial and built on a culture of blame. Doctors, hospitals, insurers and lawyers are locked into battle and patients are routinely caught in the crossfire. The most often-quoted study was conducted in 1984 when Harvard examined 30,000 medical records and 3,500 malpractice claims from New York hospitals. From the medical records they determined that four percent of patients had suffered adverse events, and that one percent rose to the level of negligence. But when they correlated these records with malpractice claims, they found that only two percent of the patients who had suffered from negligence had actually submitted claims, and only seventeen percent of the malpractice claims were in any way tied to negligence.

Proponents of medical malpractice reform have argued that state-by-state reform will limit the practice of “defensive medicine” and will be very beneficial in controlling health cost inflation. But one economist after the other pegs the savings at just over 2% of total health care spending. The Congressional Budget Office (CBO) estimated the savings if a package of 5 reforms were instituted at just .5%. There have also been state based arguments for reform based on enhanced statewide recruitment of doctors. But studies show that the gains in state’s that have MICRA have been small, in the range of 3%, and have not moved the needle on service to under-served populations.(5)

A rational national approach to malpractice reform could certainly include the rather crude MICRA provisions that the AMA Federation and state physicians support. But it could go far beyond that according to a proponent for creating federally funded special medical courts to handle claims quickly and efficiently. He says such reforms would address “reliability and consistency in rulings, costs associated with defensive medicine, fair and efficient compensation for injured patients, patient safety, and physician accountability.”

Legal experts also caution about a reform package based on the status-quo. Moving toward universal coverage, through whatever means, carries with it predictable demands to address proportionate increases in liability. They say, “The core difficulty is not that we lack sufficient courthouses, judges, or lawyers to accommodate such a throng. Rather, the problem is that tort doctrine itself is not structured to deal effectively with the legal problems that expansion will bring with it.”

So, as the President-Elect and the Republican controlled Congress poise to further privatize and divided our segmented system, and reinforce a state by state approach, they should seriously consider the costs. These are not just financial, but also a missed opportunity to fundamentally rethink a rational federal approach to medical liability with the potential to share risk across the Medical Industrial Complex.

Finally, even if it were possible to wall or fence populations within state borders, we should be mindful that information technology, whether in the form of patient-generated research, electronic medical records, or A.I. driven diagnostic and therapeutic devices, no longer respects geographic borders.

For HealthCommentary, I’m Mike Magee.

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