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.

Where Will America Find Corporate Citizenship When She Needs It Most?

Posted on | November 22, 2016 | Comments Off on Where Will America Find Corporate Citizenship When She Needs It Most?

Mike Magee

We live in a world of false narratives – where words lose their meaning – and therefore their predictive value. Appeals to be open-minded compete with requests for vigilance. One would like to believe that sanity will prevail, but if that were routinely true, we would not need checks and balances.

In America, we rely on counter-balancing branches of government; on separation of church and state; on a free enterprise system constrained from over-reaching by rules and regulations. And when all else fails, we pray for active citizenship from our leaders in and out of government, our communities, ourselves

In the news today, on full display competing for space with Trump Tower and the rest, was a battle of giants: the Rockefeller Foundation (begun way way in the age of Standard Oil by the original Rockefeller himself) vs. ExxonMobil – documented climate denier in chief for the past three decades, with a play book right out of Big Tobacco. With our new President poised to appoint a “climate denier” as head of the EPA, a guy who is anxious to crush the Paris Accord, likely well-supported by the new President ready to “bring coal back”, it’s tempting to believe that our elective leaders have be “asleep at the switch”, paralyzed, incompetent.

But that too is a false narrative. Our leaders have been trying, and at times working across the aisle, to bring progress and security to our nation. And the press has been doing its job too. But, when you are up against the likes of ExxonMobil, it’s a tough order. Still, there is the truth and there is a record, in this case well-documented collusion dating back to the 80’s. But there’s also the issue of Breitbart News, with its head now perched firmly on the top of our political body. And yet, there is a letter, now a decade old, penned in black and white by a Republican and a Democratic Senator, to Rex W. Tillerson in 2006, a year after he assumed the role of CEO of the giant company. It’s worth a read – that’s why it’s printed in full below. It tells the truth, just as clearly as the cast of “Hamilton” did the other night in their respectful, but direct, appeals to our incoming Vice-President.

Here’s the letter from Senators Jay Rockefeller IV(D-WV) and Olympia Snowe(R-MA) dated  October 27, 2006:

Dear Mr. Tillerson:

       Allow us to take this opportunity to congratulate you on your first year as Chairman and Chief Executive Officer of the ExxonMobil Corporation. You will become the public face of an undisputed leader in the world energy industry, and a company that plays a vital role in our national economy. As that public face, you will have the ability and responsibility to lead ExxonMobil toward its rightful place as a good corporate and global citizen.

       We are writing to appeal to your sense of stewardship of that corporate citizenship as U.S.  Senators concerned about the credibility of the United States in the international community, and as Americans concerned that one of our most prestigious corporations has done much in the past to adversely affect that credibility. We are convinced that ExxonMobil’s longstanding support of a small cadre of global climate change skeptics, and those skeptics’ access to and influence on government policymakers, have made it increasingly difficult for the United States to demonstrate the moral clarity and needs across all facets of its diplomacy.

       Obviously, other factors complicate our foreign policy. However we are persuaded that the climate change denial strategy carried out by and for ExxonMobil has help foster the perception that the United States is insensitive to a matter of great urgency for all of mankind, and has thus damaged the stature of our nation internationally. It is our hope that under your leadership, Exxon Mobil would end its dangerous support of the “deniers.” Likewise, we look to you to guide ExxonMobil to capitalize on it significant resources and prominent industry position to assist this country in taking its appropriate leadership role in promoting the technological innovation necessary to address climate change and in fashioning a truly global solution to what is undeniably a global problem

       While ExxonMobil’s activity in this area as well-documented, we are somewhat encouraged by developments that have come to light during your brief tenure. We fervently hope the reports at ExxonMobil intends to end its funding of the climate change denial campaign of the Competitive Enterprise Institute (CEI) are true. Similarly we have seen press reports that your British subsidiary has told the Royal Society, Great Britain’s foremost scientific academy, that ExxonMobil will stop funding other organizations with similar purposes.

However,  a casual review of available literature, as performed by personnel for the Royal Society reveals that ExxonMobil is or has been the primary funding source for the “skepticism” of not only CEI, but for dozens of other overlapping an interlocking front groups sharing the same obfuscation agenda. For this reason, we share the goal of the Royal Society that Exxon Mobil “come clean” about its past denial activites and that the corporation take positive steps by a date certain toward a new and more responsible corporate citizenship

        Exxon Mobil is not alone in jeopardizing the credibility and stature of the United States. Large corporations in related industries have joined ExxonMobil to provide significant and consistent financial support of this pseudo-scientific, non-peer  reviewed echo chamber. The goal has not been to prevail in the scientific debate, but to obscure it. This climate change denial confederacy has exerted an influence out of all proportion to its size or relative scientific credibility. Through relentless pressure on the media to present the issue “objectively” and by challenging the consensus on climate change science by missstating both the nature of what “consensus” means and what this particular consensus is, ExxonMobil and it’s allies have confused the public and given cover to a few senior elected and appointed government officials who’s positions in opinions enable them to damage U.S. credibility abroad.

        Climate change denial has been so effective because the “denial community” has mischaracterized the necessarily guarded language of serious scientific dialogue as vagueness and uncertainty. Mainstream media outlets, attacked for being biased, help lend credence to skeptics views, regardless of their scientific integrity, by giving them relatively equal standing with legitimate scientists. ExxonMobil is responsible for much of this bogus scientific “debate” and the demand for what the deniers cynically refer to as “sound science.”

        A study to be released in November by an American scientific group will expose ExxonMobil as the primary funder of no fewer than 29 climate change denial font groups in 2004 alone. Besides a shared goal, these groups often featured common staffs and board members. The study will estimate that ExxonMobil is been more than $19 million since the late 1990s on a strategy of “information laundering” or enabling a small group of professional skeptics working through scientific-sounding organizations, funnel their viewpoints through non-peer reviewed website such as Tech Central Station. The Internet has provided ExxonMobil the means to wreak its have a con U.S. credibility, while avoiding the rigors of refereed journals.  While deniers can easily post something calling into question the scientific consensus on climate change, not a single refereed article in more than a decade has sought to refute it.

       Indeed, while the group of outliers funded by ExxonMobil has had some success in the court of public opinion, it has failed miserably in confusing, much less convincing, the legitimate scientific community. Rather, what has emerged and continues to withstand the carefully crafted denial strategy is an insurmountable scientific consensus on both the problem and causation of climate change. Instead of the narrow and inward-looking universe of the deniers, the legitimate scientific community has developed its views on climate change through rigorous peer-reviewed research and writing across all climate related disciplines and in virtually every country on the globe.

       Where   most   scientists’   dispassionate   review   of   the   facts   has   moved   past acknowledgment to mitigation strategies ExxonMobil’s contribution the overall politicization of science has merely bolster the views of U.S. government officials satisfied to do nothing. Rather than investing in the development of technologies that might see us through the crisis- and which may rival the computer is the wellspring of near-term economic growth around the world, ExxonMobil and its partners in denial have manufactured controversy, sown doubt, and impeded your progress with strategies all-too reminiscent of those used by the tobacco industry for so many years. The net result of this unfortunate campaign has been a diminution of this nation’s ability to act internationally, and not only in the environmental matters.

       In light of the adverse impact still resulting from the corporation’s activities, we must request at ExxonMobil end any further assistance or other support to groups or individuals whose public advocacy has contributed to the small, but unfortunately effective, climate change denial myth. Further, we believe ExxonMobil should take additional steps to improve the public debate, and consequently the reputation of the United States. We would recommend that ExxonMobil publicly knowledge about the reality of climate change and the role of humans in causing or exacerbating it. Second, ExxonMobil should repudiate its climate change denial campaign and make public its funding history. Finally, we believe that there would be   a   benefit   to   the  United  States   if   one   of   the   worlds   largest   carbon   emitters headquartered here devoted at least some of the money it has invested in climate change denial pseudo-science to global remediation efforts. We believe this would be especially important in the developing world, where the disastrous effects of global climate change are likely to have their most immediate and calamitous impacts.

Each of us is committed to seeing the United States officially reengage and  demonstrate leadership on the issue of global climate change. We are ready to work with you and any other past corporate sponsor of the denial campaign on proactive strategies to promote energy efficiency, to expand the use of clean, alternative, and renewable fuels, to accelerate innovation to responsibly  extend  a  useful  life  of  our  fossil  fuel  reserves,  and to  foster  greater understanding of the necessity of action on a truly global global scale before it is too late.

Cc.

J Steven Simon
Walter Shipley
Samuel J Palmisano
Marilyn Carlson Nelson
Henry A. McKinnell Jr.
Philip E Lippincott
William R.Lowell
James R. Houghton
Michael J. Boskin
William W. George

The corporate leaders were copied here, I suppose, in the hopes that they fairly consider the country’s long term interests. I am still hopeful that those who remain, and those who have followed, will represent the finest of Corporate Citizenship, and actively consider their individuals roles as “citizens” in this brand new world.

                                                                                                         

President-Elect Trump’s “Better Way”: Expanding Managed Medicaid or Medicare for ALL or….?

Posted on | November 17, 2016 | Comments Off on President-Elect Trump’s “Better Way”: Expanding Managed Medicaid or Medicare for ALL or….?

Image: KFF

Mike Magee

This is the week for speculation, especially when it comes to insuring the health of U.S. citizens. With President Obama’s departure, the Affordable Care Act is clearly at risk. The Republicans, with Paul Ryan at the helm, have attempted to challenge the bill over 50 times since its’ inception, the last being on January 16, 2016, when they threw in dissolution of Planned Parenthood funding for good measure.

Perhaps it’s best then to start with the facts. 91% of Americans now have some form of health insurance. 49% receive coverage through their employer. 20% rely on Medicaid. (That’s 77 million, including 12 million new ACA Medicaid beneficiaries, with 80% of all beneficiaries in some sort of capitated managed Medicaid.) 14% are Medicare enrollees. 7% maintain other private plans. 2% have CHIP, VA coverage, or other federal insurance. And 9% remain uncovered; that’s 28.5 million out of 318,896,000 citizens more or less.

The Affordable Care Act, for all the criticism, has managed to cover an additional 20 million during its opening years. That alone is a pretty remarkable feat considering that the many Republican led states sat on their hands, and the Republican Congress challenged the bill day in and day out for years. But that was then and this is now.

The first issue that is likely to be cued up is Medicaid for two reasons – one ideological, the other financial. On the ideological side, Republicans favor safety net solutions to be state run, free market oriented, and with strings attached like mandatory work and participant co-pays. On the financial side, Republicans favor small government, low taxes, and short term commitments.

Considering the above, it’s pretty remarkable that President Obama identified a sweet spot when it came to incentives to expand state sign-up’s for Medicaid as part of the ACA. True, 19 red states did boycott the program. But some Republican governors were all in, and their names are familiar by now.

Mike Pence’s program in Indiana demanded “personal responsibility” and insisted that beneficiaries fund their own health savings accounts. According to Medicaid.gov, “As of August 2016, Indiana has enrolled 1,481,869 individuals in Medicaid and CHIP — a net increase of 32.23%”

Chris Christie, who’s state is in financial ruins, was pleased to add some 500,000 Medicaid beneficiaries and cheered the fact that they now had “more and better health care”. According to Medicaid.gov, “As of August 2016, New Jersey has enrolled 1,757,341 individuals in Medicaid and CHIP — a net increase of 36.88% since the first Marketplace Open Enrollment Period and related Medicaid program changes in October 2013.”

The 12 million added to the Medicaid rolls through the ACA were funded through a sweet deal. 100% of the state costs would be covered for three years and then 90% after that. (Under the standard Medicaid arrangement, federal contributions vary by state with 1/2 to 2/3 of the bill currently paid by the federal government.) And even in the red states that thumbed their nose to expansion, they were pleased to have help funding an average 2/3 of their nursing home residents, and in some cases 1/2 of the maternal-fetal care of economically disadvantaged women.

Still, studies show that the non-participating states, most with outsize populations of economically disadvantaged citizens, passed up a staggering $423 billion in federal dollars over the first decade of the program to spite President Obama and his signature legislation. When you look at a poor state like Mississippi, you get a true feel for the cost of their willfulness. Over the first decade of the program, they will have declined an amount equal to just under $5000 for every man, woman, and child in the state.

With both money and coverage on the line, it will be interesting to watch the Republicans next move. They’ve already signaled their financial intents with Paul Ryan’s “Better Way” proposition. But then again, there’s the small issue of President-elect Donald Trump. He’s a free thinker and likes getting a bang for his buck.

He also detests bad deals, and if there was ever a poster child for a horrid one, it would have to be America’s jury-rigged, partly employer based, US health care system overflowing with inefficiencies, high cost, inequity, double-dipping, over-prescribing, spotty distribution, and variable quality.

Our President-Elect has already flirted in the past with a universal health care system. Maybe he has a “better way” of his own. If so, he’d likely find support similar to that voiced by Michael Sparer in this week’s NEJM who wrote, “Another idea that has emerged is to create a ‘public option’ — a new government plan that would either compete nationally or, more likely, provide a public-insurance safety net in markets lacking adequate private competition.” You never know. Maybe President-Elect Trump will go for broke. If so, two likely candidates for further expansion would be Managed Medicaid and Medicare for all.

The Future of Physician Prescribing: An Historical Perspective

Posted on | November 11, 2016 | Comments Off on The Future of Physician Prescribing: An Historical Perspective

Mike Magee

The right to prescribe medicines has been a privilege granted by our society with near exclusivity to physicians. It has been actively protected from encroachment by physician organizations usually on the basis that the physicians education and training is clearly superior to others and translates into better prescribing decisions. This privilege has also been actively supported by the pharmaceutical industry which has drawn comfort from tort law’s identification of the physician as a “learned intermediary”, a designation which provides some measure of liability protection from mishaps that occur in the use of their products. But as the recent issues surrounding the Oxycontin led opioid addiction and the Adderall led explosion of treatment of children and adults for ADHD reveal, the system is highly vulnerable to collusion, fraud and abuse.

When, how, and why were physicians granted the sole right to prescribe in America?

Part I: Stemming The Tide of Addictive Narcotics in the 19th Century

 

Part II: Prescription vs. Over-The-Counter (OTC) Drugs

 

Part III: The “Learned Intermediary” and Direct-To-Consumer (DTC) Advertsing

 

 

Substituting Robust Marketing For Scientific Evidence: Industry Pursues Legal “Free Hand” For Off-Label Promotion.

Posted on | November 3, 2016 | Comments Off on Substituting Robust Marketing For Scientific Evidence: Industry Pursues Legal “Free Hand” For Off-Label Promotion.

SOURCE: OFF LABEL: A FILM

Mike Magee

Over the past fourteen years, the pharmaceutical industry in the U.S. has successfully beaten back proposals to allow drug reimportation from Canada. These proposals were advanced by multiple members of Congress and big city mayors, and were supported by the majority of Americans. But President Bush, in negotiations for passage of the Medicate Modernization Act in 2003, and President Obama, in the negotiations for passage of the Affordable Care Act in 2009, were both willing to prohibit the practices on the basis of safety in return for industry support for their legislative initiatives.

Over time, it has become clear that America’s “arbitrage drug” gray market within our own borders makes any safety issues related to secure importation of Canadian drugs from a small number of approved vendors, infinitesimally small by comparison. The true purpose of the pharmaceutical industry’s opposition has little to do with counterfeit drugs, and everything to do with profitability. This reality is rarely admitted, but occasionally, as in this 2010 Wall Street Journal, does surface. 

The author said then, “But there is an even more important reason why importing drugs is dangerous. Importing foreign drugs or reimporting American-made drugs is a back-door way of introducing price controls in America. Many foreign countries, including Canada, impose price controls on drugs, which is why reimporting American-made drugs is cheaper than simply buying drugs that haven’t left the country.”

In fact, approximately 50% of the U.S. multi-national pharmaceutical industry’s profitability derives directly from sales inside U.S. borders. This differential financial success has little to do with the quality of the products (most are available throughout the developed world), and much to do with three other factors. First, the U.S. government is the only developed governing body in the world with no mechanisms to moderate drug prices within their borders. Second, the U.S. is one of only two nations in the world (New Zealand being the second is actively reconsidering this position) which allows Direct-To-Consumer advertising. Third, as the recent man-made opioid epidemic has so clearly demonstrated, U.S. physicians may just win the price as the most naive prescribers in the world, ready to believe crazy messages like the Purdue-Pharma backed  “pain is the 5th vital sign” message on a moments notice.

Unrestrained prices, “Ask Your Doctor” push ads, and naive sloppy prescribing do indeed spell enormous financial success. But as the recent scandalous price hikes for everything from Epi-Pen’s to insulin (up 200% in the past 8 years), industry’s avarice on American shores knows no bounds. Their leaders are unable to demonstrate restraint. The latest case in point is the drug and biologic industry’s moves to promote a loosening of regulations that have prohibited pharmaceutical representatives from promoting the use of their drugs for “off-label” purposes. 

The Food, Drug, and Cosmetic Act allows physicians to exercise their knowledge and judgement in prescribing drugs for purposes not listed on the drug’s approved label. What gets on that label must be supported by scientific evidence coming from approved clinical trials. This is the system in place to assure our medications are both safe and effective. But the government has permitted physicians as the “learned intermediaries” to wander into unapproved areas of use when they believed it was in the patients best interests. Studies have shown that a quite remarkable 21% of prescriptions doctors write in the U.S. are “off-label”. The same Act that permitted doctors this freedom at the same time outlawed pharmaceutical representatives from marketing their drugs for “off-label” use, allowing them only to respond to doctors specific questions and requests for “peer reviewed” information. Over the past few decades, the law has been strictly enforced, and the fines for wrong doing have been in the billions.

But now, with some success, industry backed suits have challenge these consumer protections. In 2012, a pharmaceutical representative named Alfred Caronia was proven to have pushed his companies drug, Xyrem, approved for narcolepsy, for a range of off-label conditions including insomnia, Parkinson’s and fibromyalgia. An Appeal’s court reversed their initial conviction by arguing that Caronia’s sales pitch was free speech protected by the First Amendment. Several other cases are now being argued on the same basis, and industry is simultaneously lobbying the FDA for liberalization of these historic regulatory constraints.

Congress enacted these regulations for a reason. They protect patients, and also incentivize industry to perform the proper scientific research if they wish to commercialize their discoveries. The system has worked, and industry frequently submits additional research to allow legal expansion of indications. Nearly have of the FDA’s approvals are for such expansions of existing products.

The current subversive attempts are based on greed, and would replace critical science with robust marketing. All of the evidence – from price gouging, to push advertising, to sloppy prescribing, to back-door subversive legal maneuvering – suggests the need for more government oversight, not less. “Trust me” doesn’t cut it. Evidence, science, responsible citizenship, mature professionalism, earned respect – these are the virtues that cut it and demand our support.

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