HealthCommentary

Exploring Human Potential

Fundamental Malpractice Reform Requires National Rational HC System

Posted on | November 29, 2016 | No Comments

trump-tompricePresident-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 | No Comments

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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.

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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 | No Comments

screen-shot-2016-11-16-at-5-41-57-pmImage: 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 | No Comments

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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 | No Comments

drug_sales_rep_limitations_reduce_off_label_drug_uSOURCE: 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.

Testosterone: Another Case of Physician Enabled Drug Abuse

Posted on | October 27, 2016 | 2 Comments

article-low-tAd From MedicineNet.com

Mike Magee

Is testosterone the next Oxycontin? It certainly has many of the same earmarks. It’s widespread abuse is being aided and abetted by sloppy prescribers. Its’ benefits are being exaggerated and its’ risks understated. It is associated with heavy marketing by pharmaceutical companies and a range of profit seeking intermediaries. And it promises psychic relief from reality.

As with Oxycontin, the FDA has, until recently, exhibited a very light touch. But this week they attached additional warnings to the product. The official statement said that this action “will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health.” But what the AMA, its’ Federation members, and medical educators ought to be asking is, “Why do our prescribers require FDA messages to absorb facts that the public has already internalized? Why are our physicians so out of touch, so far behind the trends?”

To most consumers “Low T” is a joke. And yet doctors in 2013 prescribed it to 2.3 million patients, a 75% jump in just four years. A quarter of those scripts were written for men who never had a blood test for testosterone. There is also ample evidence that doctors are prescribing this in large numbers as a hedge against aging with no evidence that it is useful, but plenty of evidence that it is harmful.

The FDA this week listed all the bad things it does: “Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido and insomnia”. But the reality is that injections and pills and gels now sell in the billions in the US.

As with Oxycontin, this is physician enabled drug abuse, pure and simple. The National Institute of Drug Abuse said as much. Their appraisal: “Long-term steroid abuse can act on some of the same brain pathways and chemicals — including dopamine, serotonin and opioid systems — that are affected by other drugs. This may result in a significant effect on mood and behavior.”

Over the past century, the AMA has vigorously defended and ligated the sole right of the physician to “prescribe”. Their defense has rested on the fact that this is an awesome responsibility, one that has potential life and death consequences for America’s patients. The pharmaceutical industry has been their reliable ally through all these many years, more than happy to transfer liability for their products to the physician “learned intermediary”. But as the manmade opioid epidemic revealed, and as the explosion of testosterone use confirms, physicians in large numbers are more aptly described as “sloppy prescribers”  than “learned intermediaries”. What the AMA, the AAMC, academic medical centers and their training programs, and medical schools need to be asking is, “Why?”

Predicting the Future of Obamacare Post-Election: Wilensky and Oberlander

Posted on | October 11, 2016 | No Comments

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Gail Wilensky and 
Jonathan Oberlander

Mike Magee

Negative leaders can deny change, resist it, ignore it – for a period of time. But they can’t escape it. And inevitably, they are eventually overtaken by it. Witness the current Trump dilemma. The leadership of the Republican party, following the defeat in the 2012 election, correctly acknowledged the demographic reality of a change in majority white control of elections in America, and suggested a course correction that would acknowledge that change. But they were unable to implement their own recommendations. What they are witnessing four years later is that, while their current candidate can fan the fires of fear to secure support by a portion of that electorate, the reality of constantly advancing change assures that their loyal voter block will continue to shrink. While they can not change, change itself – its direction and its destination – continues unabated.

If that harsh reality is true for political parties and their candidates, it is equally true for the country and its institutions designed to address citizens needs. And of these institutions, none is more powerful, has a greater financial reach, or is more essential to reaching full human potential than our health care system. It too, must adjust to change and demographic realities. For example, nothing can change the current reality that we are aging, and as we age, the health care needs of America’s multi-generational families will grow in size and complexity. In the same vein, nothing will stop the progress of information technology and its role in exposing non-transparency in pricing and lobbying and hidden coalitions, whose exposure will increasingly force our citizens to confront inequities in access, quality, and outcomes.

In this week’s New England Journal of Medicine, veteran health policy experts Jonathan Oberlander and Gail Wilensky reflect on health care legislation’s unique pivot point, Obamacare or the Affordable Care Act, and look at the likely impact on the legislation with a Democratic (Oberlander) or a Republican (Wilensky) victory.

A Democratic Victory:

1. While the ACA has resulted in a decline in the nation’s uninsured rate from 48 million to 27 million, the rising cost of insurance, especially for those at the upper levels of poverty (200% of the Federal Poverty Limit), where a family plan on average now costs more than $20,000 a year, is untenable. Translation: some changes will be required to address their needs.

2. There is also a problem with rising deductibles. This averaged $303 in 2006, but hit $1,077 in 2015. Hillary Clinton’s plan is to provide a refundable tax credit for citizens with high out-of-pocket deductibles.

3. Three major insurers (UnitedHealthcare, Humana, and Aetna) are planning to curtail their involvement with the ACA exchanges. They complain that the pricing differential they are allowed between the healthiest and sickest enrollees (3 to 1) is not adequate to cover their financial risk. In their view, we should go back to 5 to 1. It is unlikely they will force the government hand on this, any more than reversing the provisions that prevent exclusion based on prior conditions. Instead their stance will likely move both the federal government and state governments toward “public options”, whether through downward extension of age eligibility for Medicare, or expansion Massachusetts-like universal coverage plans to other states.

4. A Democratic victory would likely cause most Republican led states that have resisted Medicaid expansion under ACA to give up their resistance. Their abandonment of a stance that has been financially self-destructive to their states could be hastened by changes that assure permanent, near 100% federal funding of Medicaid into the future. This would come with greater standardization of rules nationwide governing the coverage package. Any move toward nationalization would carry with it more focus on cost and efficiency, with data transparency leading the charge to address price gougers, research result hiders, sloppy prescribers, and outcome outliers.

A Republican Victory:

1. Gail Wilensky predicts the likely outcome of the presidential race to be a Democratic victory, with the House remaining under Republican control, but the Senate majority potentially shifting to the Democrats. In this light, she outlines the current Paul Ryan’ health care plan versus Donald Trump’s which bundles an outright repeal of the ACA with allowance of drug reimportation and negotiation of Medicare Part D drug prices.

2. Were the Ryan plan to be implemented, unchanged by a Democratic controlled Senate or presidential veto, we could expect:

a) Medicare age eligibility would gradually increase to age 67, and Medicare would become a “premium support” , partially privatized program.

b) High deductible plans, which deliberately increase consumer focus on cost, would be promoted through government supported Tax Savings Accounts, housing tax-exempt funds to cover excess medical costs.

c) The current prohibitions on exclusion for prior conditions or excessive cost profiles would remain in force. But insurers would be allowed a 5 to 1 cost ratio spread based on age.

d). Medicaid would be funded by a federal grant at “X” dollars per person, and states would have substantial leeway on how to prioritize spending as well as the ability to require “able bodied adult recipients to work”.

3. But in the likely outcome of divided government, with its history of stalemate, where might there be compromise?

a) Maintenance of 3 to 1 risk and increased federal funding to “stabilize exchanges” might be offered in return for increased state “innovation waivers” in the running of their Medicaid programs, expanded federal funding, and co-mingling of Medicaid and ACA insurance exchange programs and funding.

Should the current trajectory continue, and the Republicans loose large, the party will not only have to consider how best to acknowledge the demographic realities they outlined in 2012, but also face a likely irreversible schism of their party into two opposing segments.

How exactly they would choose to address or avoid that challenge is unclear. What is more certain is that the demographic changes that created the need for Obamacare will only grow in the future, and the need for efficiency, integration, cost-effectiveness and reliable quality outcomes will become more pressing – not less.

You can deny change – but ultimately, you can not stop it.

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