Posted on | February 15, 2017 | No Comments
America’s attention is once again on health reform. Even as Republican governors preach caution, the Republican controlled Congress continues to vow to repeal the Affordable Care Act and turn Medicaid into block grants. The U.S. doesn’t exactly have a great track record when it comes to health policy decisions. Compared to Canada, we’ve consistently chosen “free enterprise” approaches that have been singularly disappointing in performance. Scientific progress has become unlinked from human progress. And the Medical-Industrial Complex continues to grow in size and appetite, while health outcomes and value for the dollar are hard to come by. In the next few weeks, we’ll take a look at our two countries to see what we can learn. We begin with an analysis of critical decisions at four moments in history – 1947, 1957, 1964, and 1984.
In 1947, in the wake of WW II, the Canadian Province of Saskatchewan launched the first provincial universal public hospital insurance plan. South of the border, the U.S. chose a very different path. With inducements in the tax code, and exemption from war time wage and salary controls, our government encouraged private employers to provide their workers with health insurance as part of what would become a standard benefit package.
A decade later in 1957, Canada passed the Hospital Insurance and Diagnostic Services Act which provided 50/50 cost sharing between the federal government and any of 13 provinces and territories that chose to participate in universal coverage of their respective populations. In the U.S. employer based insurance had now been extended to nearly 70% of Americans, pharmaceutical profiteers were being lined up for interrogation by Senator Kafauver’s Commission, and the AMA was mapping out its strategy to defeat “socialized medicine”.
In 1964, against the opposition of the Canadian Medical Society, Canada’s Royal Commission on Health Services, recommended and soon succeeded in launching a comprehensive and universal national health program. The program, called Medicare, covered everyone but not everything (pharmaceuticals,eyeglasses, dental care, and home care were exempted). They did however include federal planning and standards to promote and maintain optimal preventive health of all Canadians. A federal governance body was in charge of standards, but the delivery of care was strictly deligated to the provinces and territories who themselves managed and prioritized annual budgets, and designed their own governance systems.
In the U.S. at the same time, President Johnson in the wake of President Kennedy’s assassination, and with some skillful maneuvering by veteran legislator Wilbur Mills, passed our own Medicare, a universal program as well, but only for citizens over 65. It was federally funded and federally directed, having proven a few years earlier that voluntary enrollment programs controlled by individual states would fail. They also passed Medicaid, which like the Canadian program included a mix of federal and state funding, and delegation of responsibility for care delivery to the states. Standard setting was weaker than in Canada, and wide variability became immediately apparent both in the definition of who qualified, what was covered, and the level of each states financial commitment to services.
The Canadian government at the time held tightly to the principle of universality and public funding with federal and territorial governments serving as “single-payers”. This decision was grounded in the philosophy that Canada’s success ultimately depended on the health of Canadians, that this health was a human right, and that excessive administration would drive up cost and complexity, placing an undue burden on their citizens. Fee schedules were standard across geography and population, and negotiations with doctors and hospitals in each province or territory, as part of the budget setting process, allowed for prioritization and full transparency. Providers submitted bills for services. Government paid the bills. And the patient was left alone.
The U.S. chose an opposite course. With full faith in capitalism and competition, they reasoned that inclusion of private insurance companies, who were already deeply entrenched in their employer based health insurance system, would through competition with each other hold costs in check. U.S. doctors as well billed fees for services, but there were no annual budgets, highly variable rules and coverage, and remarkable complexity and variability that confused everyone. It also didn’t hold down costs, as insurers, responding to their shareholders managed to remove at their peak 25 cents on the dollar for their services.
In 1984, as part of their national commitment to continuous thoughtful evolution, the Canadian government passed the Canada Health Act which combined their hospital and medical acts and refined and reinforced their administration of the program as well as four anchoring pillars – portability, accessibility, universality and comprehensiveness. The deliberations were out in the open and fully transparent.
In 1984, with U.S. health care costs careening out of control, and an AIDS epidemic gaining steam absent government leadership, the U.S. once again placed all her cards on “private enterprise”. Four years earlier, in the waning days of a one term presidency mired in recession, President Carter had reluctantly signed the Bayh-Dole Act. The legislation released 26,000 federal patents (derived from federally funded research) for private use by industry and academic health centers. The scientific progress unleashed was undeniable, but the loss of checks and balances and the realignment of values and power within premier academic health centers uncoupled entrepreneurship and scientific progress from human progress. An unholy alliance at the center of a medical-industrial complex had been consummated.
Next Week: Canadian Health Care: Facts and Fiction.
Posted on | February 10, 2017 | No Comments
Off-Label Prescribing – Where Lupron is the Rule, Not the Exception – and Doctors Never Have To Say They’re Sorry.
Posted on | February 8, 2017 | No Comments
After a remarkably turbulent decade in the shadows of America’s Medical Industrial Complex – a span that has witnessed the creation of a manmade opioid epidemic, the treatment of thousands of 2 and 3 year old’s with Adderall, the placement of EpiPen’s out of the financial reach of Middle America after convincing most public schools that they were essential as portable defibrillators, the approval of an HHS secretary with a documented track record of insider trading reinforced by his own sponsored beneficial legislation while a Congressman – after all that, we are now poised to further liberalize the FDA in the name of “innovation”.
Unless one lives in an alternate reality where “alternate facts” prevail, there is no reason to further reward purveyors of off label marketing, physician profiled targeted sales, and sloppy prescribers. As Christina Jewett of Kaiser Health News has so well documented, this is the World of Lupron.
Lupron is the brand name for leuprorelin, an injectable blocker of gonadotropin releasing hormone. By interrupting the pulsed release of LH and FSH from the pituitary, the medication causes dramatic reductions of estradiol and testosterone. In adults, it’s most often used to treat prostate cancer and certain types of breast cancer, and sometimes is part of the therapy for endometriosis. Leuprorelin was first approved for use by the FDA for prostate cancer in 1985. Eight years later, it was approved for the treatment of precocious puberty in children, described as the onset of sexual characteristics “before age 8 in girls and before 9 in boys.” The cost for two years of treatment today can approach $40,000.
The FDA approving medical officer in 1993, Alexander Fleming, in retrospect later termed his approval “regrettable”. His regret was likely fueled by two factors. First, shortly after Lupron’s approval for the treatment of precocious puberty in 1993, doctors, with the blessing of manufacturers, began to treat children of “short stature” off-label with the drug. This is entirely legal in the U.S. The manufacturers are prohibited from marketing the product for unapproved uses, but they are allowed to provide doctors with information regarding off-label use if requested. The controlling company back then, TAP Pharmaceuticals, apparently pushed the envelop a bit too hard leading to government fines for “fraudulent pricing and marketing practices” of $875 million in 2001.
Dr. Fleming’s second regret, related to the first, was that manufacturers had systematically downplayed complications and side effects of the drug. Most notable were the omissions of significant bone disorders and fractures. Over the past decade, more than 20,000 reports of Lupron side-effects have been registered with the FDA, 900 in children under 13. In 2003, a NEJM article raised the alarm that kids on the drug were losing bone density at an alarming rate. Then in 2009, an international body including pediatric endocrinologists questioned the safety of using the puberty delaying drug to add inches to children’s stature. A 2011 study at Children’s Hospital of Los Angeles echoed the concerns about osteoporosis. Still the practice continued. How was that possible?
An industry 2010 study, published in a non-peer reviewed journal by Dr. Peter A. Lee of Penn State, reported side-effects with the drug between 1991 and 2009, but no bone issues. A subsequent independent review of the NIH clinical research repository revealed omission of bone fractures and disorders under complications. Further investigation in the Medicare Open Payments database revealed that Lupron’s now owner, AbbVie, paid Dr. Lee $157,066 from 2013 to 2015 to travel and promote Lupron to health professional groups. 2015 sales of Lupron netted $826 million for AbbVie.
For the Medical-Industrial Complex, which has systematically dismantled checks and balances, Lupron is the rule, not the exception. And too many doctors are cogs in the wheel, remarkably naive and susceptible to slick pitches and value laden inducements. Precocious puberty occurs in about 2000 American kids each year. And yet, doctors wrote 24,000 prescriptions for pediatric Lupron in 2015. America’s patients need the FDA to stand tall. Now is exactly the wrong time to go weak and wobbly on us.
Channeling New Jersey’s “Bridgegate” – The Muslim Ban “Shock Event” Undermines Safety and Security in America.
Posted on | February 2, 2017 | 2 Comments
Heather Richardson, Boston College
When Republicans waved through Tom Price this week, the AMA & AAMC got exactly what they desired. Business interests trumped their highest ideals. But as my father used to say, “Careful what you wish for.” In achieving their ethically compromised goal, they tied themselves to the Trump/ Bannon regime.
Their new business partners staged the Muslim Ban “shock event”, a national version of New Jersey’s “Bridgegate”. And the nation’s patients, for whom the House of Medicine continues to profess an undying commitment, absorbed a fountain of stress that did little for their overall health and well being.
Consider the measured assessment of Boston College historian and political scientist, Heather Cox Richardson, who this week exposed on Facebook the rationale behind the Muslim Ban and its methodology:
“I don’t like to talk about politics on Facebook– political history is my job, after all, and you are my friends– but there is an important non-partisan point to make today.
What Bannon is doing, most dramatically with last night’s ban on immigration from seven predominantly Muslim countries– is creating what is known as a “shock event.”
Such an event is unexpected and confusing and throws a society into chaos. People scramble to react to the event, usually along some fault line that those responsible for the event can widen by claiming that they alone know how to restore order.
When opponents speak out, the authors of the shock event call them enemies. As society reels and tempers run high, those responsible for the shock event perform a sleight of hand to achieve their real goal, a goal they know to be hugely unpopular, but from which everyone has been distracted as they fight over the initial event. There is no longer concerted opposition to the real goal; opposition divides along the partisan lines established by the shock event.
Last night’s Executive Order has all the hallmarks of a shock event. It was not reviewed by any governmental agencies or lawyers before it was released, and counterterrorism experts insist they did not ask for it. People charged with enforcing it got no instructions about how to do so. Courts immediately have declared parts of it unconstitutional, but border police in some airports are refusing to stop enforcing it.
Predictably, chaos has followed and tempers are hot.
My point today is this: unless you are the person setting it up, it is in no one’s interest to play the shock event game. It is designed explicitly to divide people who might otherwise come together so they cannot stand against something its authors think they won’t like.
I don’t know what Bannon is up to– although I have some guesses– but because I know Bannon’s ideas well, I am positive that there is not a single person whom I consider a friend on either side of the aisle– and my friends range pretty widely– who will benefit from whatever it is.
If the shock event strategy works, though, many of you will blame each other, rather than Bannon, for the fallout. And the country will have been tricked into accepting their real goal.
But because shock events destabilize a society, they can also be used positively. We do not have to respond along old fault lines. We could just as easily reorganize into a different pattern that threatens the people who sparked the event.
A successful shock event depends on speed and chaos because it requires knee-jerk reactions so that people divide along established lines. This, for example, is how Confederate leaders railroaded the initial southern states out of the Union.
If people realize they are being played, though, they can reach across old lines and reorganize to challenge the leaders who are pulling the strings. This was Lincoln’s strategy when he joined together Whigs, Democrats, Free-Soilers, anti-Nebraska voters, and nativists into the new Republican Party to stand against the Slave Power.
Five years before, such a coalition would have been unimaginable. Members of those groups agreed on very little other than that they wanted all Americans to have equal economic opportunity. Once they began to work together to promote a fair economic system, though, they found much common ground. They ended up rededicating the nation to a “government of the people, by the people, and for the people.”
Confederate leaders and Lincoln both knew about the political potential of a shock event. As we are in the midst of one, it seems worth noting that Lincoln seemed to have the better idea about how to use it.”
When Christie staff staged “Bridgegate”, the public outcry caught him and his aides in a serious undertow. Some are on their way to jail, and Christie, if he avoids prosecution, has forfeited his political career. With time, Trump and Bannon may suffer the same fate. For a profession that relies on public trust for their privileged position in society and the right to function with great latitude and independence, associating with this crowd seems a very bad political bet. If they have their way, vulnerable patients will soon be left out in the cold, and the public will remember these moves as clearly as they do the attempts to scuttle Medicare a half century ago.
Posted on | January 31, 2017 | No Comments
If Tom Price and the Republican Congress plan to roll over health care, they are in for a fight. That is becoming increasingly clear. The latest messenger was the powerful AARP – not commenting (yet) on Medicare, but rather putting out opposition markers to the idea of Medicaid block grants.
The complete AARP statement is available HERE. Their salient point: “AARP opposes Medicaid block grants and per capita caps because we are concerned that such proposals will endanger the health, safety, and care of millions of individuals who depend on the essential services provided through Medicaid.”
Last month, the Commonwealth Fund released a study on Medicaid as well. In their summary they said:
“Medicaid plays a unique role in our health system, acting not only as insurance but as the nation’s most important health care financing safety net. Repeal legislation could eliminate coverage for poor adults who do not meet the program’s traditional eligibility standards while rolling back to pre-ACA levels the financial eligibility standards for parents of minor children, which hovered around 50 percent of the federal poverty level in many states. Furthermore, Medicaid repeal could eliminate coverage of former foster care children, roll back improvements in long-term services and supports, and end the federal funding essential to streamline enrollment for tens of millions of children and adults.
A legislative repeal effort could be accompanied by an aggressive strategy to redesign Medicaid through Section 1115 demonstrations, which could in some respects have even more far-reaching consequences. Aggressive use of such powers that goes beyond the limits of the law could trigger judicial challenges, but such litigation is difficult to mount, and its outcome cannot be predicted. If the Administration uses its Section 1115 powers to tighten eligibility criteria and reconfigure Medicaid along the lines of private insurance, these changes would have enormous consequences.
Since its enactment, Medicaid has been exempt from the types of market constraints essential to a private insurance market, such as enrollment only at specified time periods. Because of Medicaid’s safety-net mission, those who qualify can enroll when they need care. Medicaid also has placed strict limits on patient cost-sharing, precisely because beneficiaries are, by definition, impoverished and highly vulnerable to financial barriers to care. Were legislative repeal of the ACA reforms coupled with demonstrations that tighten eligibility and impose the private insurance model on Medicaid, the effects would be far-reaching, not only for millions who need coverage, but on the health care system itself, which depends on the program to finance health care for the nation’s poorest and most vulnerable children and adults.”
Posted on | January 31, 2017 | 4 Comments
The AMA and AAMC two months ago offered a full throated endorsement of primo anti-immigrant Tom Price to lead HHS. But this weekend’s radical actions by Price’s potential boss, Donald Trump and his chief political adviser and National Security Council member, Stephen Bannon, apparently was a bridge to far.
AAMC CEO went public today proclaiming the organization’s opposition to the lock out of immigrants from 7 Muslim majority countries. Darrell Kirch, MD said, “We are deeply concerned that the Jan. 27 executive order will disrupt education and research and have a damaging long-term impact on patients and health care…The United States is facing a serious shortage of physicians. International graduates play an important role in U.S. health care, representing roughly 25 percent of the workforce…Because disease knows no geographic boundaries, it is essential to ensure that we continue to foster, rather than impede, scientific cooperation with physicians and researchers of all nationalities, as we strive to keep our country healthy.
The AMA response was considerably more anemic and wobbly. AMA president, Andrew Gurman, MD said, “The American Medical Association is assessing the administration’s executive order and how it may affect physicians, medical students, residents and patient care. Guidance is urgently needed from the administration to clarify that this order will not impact patient care or prevent travelers’ access to timely medical treatment.” In a profession known for decisiveness, even when challenged by sleeplessness and life or death urgency, this seems a strange and needy plea for outside help.
Both organizations federation followers have begun to find their own voices. American College of Cardiology president Richard Chazal, MD said, “The ability to share ideas and knowledge necessary to address this epidemic is imperative. Policies that impede this free-flow of ideas will have a detrimental impact on scientific discovery, as well as the lives of patients around the world.”
The American College of Physicians (ACP) president Nitlin Damle, MD said “In 2016, 3,769 non U.S. citizen international medical graduates obtained first-year residency positions. If the executive order prevents medical residents from being able to come to the U.S., this could potentially affect the care for thousands of patients. The College is greatly concerned about the devastating impact on public health of a ban on refugees from war-torn countries that are most at risk of injury, death, persecution, and deprivation.”
Tufts University president Tony Monaco said “We are deeply concerned about the impact of this Executive Order. We take great pride in the global nature of our community and have always embraced and valued our international members from around the world. As we have stated previously … we will not provide information or assist in the enforcement of immigration laws except as mandated by a subpoena, warrant, or court order.”
The American Hospital Association president Rich Pollack said “…we are concerned that, without modification, President (Donald) Trump’s executive order on immigration could adversely impact patient care, education and research. We are hopeful that the administration will find solutions to preserve patient access to medical and nursing expertise from across the globe, ensuring care is not disrupted.”
Now it is time to connect the dots. Some of the above, notably the AAMC and AMA, stood down or supported Tom Price’s nomination for HHS. He is a driving force behind the anti-immigrant movement in America. If you are against Trump and Bannon’s weekend assault, it is time to stand up and oppose Tom Price.
Posted on | January 30, 2017 | 4 Comments
Kaparaboyna Ashok Kumar, M.D.
When the AMA and AAMC made the decision to announce their “strong support” for Tom Price to head HHS, they were fully aware of his support for armour piercing bullets, for not regulating tobacco as a drug, against mental health care parity, against SCHIP, for privatizing Medicare, against the reauthorization of the Violence Against Women Act, against stem cell research….and his uncompromising stance on immigration.
Their organizational voices were strong and clear as they blessed what others have defined as a “guild” candidate. And some of their institutional members went along – a few COTH teaching hospitals like Emory, and a few specialty and state societies like the AAFP and the Texas Medical Society. But most went mute.
With Trump’s latest assault on human dignity, a clumsy and disruptive ban on immigration from 7 Muslim majority countries, both the AMA and the AAMC have suddenly lost their voice. And its not as if they have nothing at stake.
Let’s just focus on Texas for a moment, the home of the AMA member Texas Medical Society which declared on November 19, 2016 that “The physicians of Texas are extremely pleased” with Price’s nomination.
This is Texas – the 45th worst state in the union for access to a physician. (They have 177 doctors per 100,000 citizens when the national average is 236.) This is the state whose doctor shortage was so severe in 2007 that the Texas Medical Board instituted a “fast-track” scheme to attract doctors to the state who would focus on under-served patients. Over the next three years 1000 were licensed with 400+ being IMG’s. The numbers from Pakistan educated doctors outnumbered those educated in neighboring states like Oklahoma or Louisiana. 20% of all Texas doctors are IMG’s and that number is growing with nearly 25% of new physician entrants having attended medical school outside the US.
Now, of course, there is nothing wrong with that. Although the AAMC has, from time to time expressed concern about it, the AMA has seen membership of IMG’s as a potential growth area. They even have a separate International Medical Graduates Section whose current president is India trained gastroenterologist Bhushan Pandya. Dr. Pandya has been a strong supporter of organized medicine, strong enough to be elected this year as president of the Medical Society of Virginia which asserts that “No other organization better understands the needs of physicians today. That’s because we’re a diverse group of physicians who know that medicine now extends beyond caring for patients. Today, physicians must be business people, insurance experts, community leaders and regulatory watchdogs.”
But back in Texas, after Trump’s weekend performance, some AAMC COTH teaching hospital execs are getting nervous. University of Texas at Austin president, Greg Fenves, commenting on Trump’s 7-state surprise to Seema Yasmin at the Dallas News said, “We have 110 students, faculty members and scholars who are citizens of the seven affected countries — Iran, Iraq, Libya, Syria, Yemen, Somalia and Sudan. The talents that brought them to UT are deeply valued, and their perspectives represent an essential part of the university.” Baylor College of Medicine professor, Peter Hotez MD, said the policy sent a “chilling message”, adding that, “My concern is that any doctor or scientist from an Arab or Muslim country will now think twice about coming to the US for post-doctoral study or a faculty position. I’m concerned that two months from now the ban will extend to other countries in the Middle East.”
As for the medical students the AAMC so proudly represents, consider Texas College of Osteopathic Medicine, MS1 Suna Burghul, a 22 year old Palestinian American, who said “I’m scared for so many people and not just in the countries he put the executive ban on but people who even look like they could be Muslim. I even mentioned it in my medical school interviews and now I’m like, should I hide it in case it will affect my career? I worry what people will think if they know I’m Muslim.” By the way, the American Osteopathic Association reacted to Tom Price’s nomination with “cautious optimism”.
This weekend, proud AAMC member, the Cleveland Clinic, had to absorb the embarrassment of their new incoming internal medicine resident, Suha Abushamma, 26, who holds a Sudanese passport, being held up this weekend by TSA guards dangling deportation papers in front of her face. That must have hurt. Did they call the AAMC lawyers and lobbyists for help?
Finally, before the American Academy of Family Physicians congratulated anti-immigrant Tom Price , they might have sought council from one of their own – Kaparaboyna Ashok Kumar, M.D. – you remember, the one the Texas Academy of Family Physicians honored as 2016 Physician of the Year. After medical school in India, and additional training there and in Edinburgh, he did a family medicine residency at UT Health Northeast in Tyler. On IMG importance in 2010, he said, “The impact is not only in Texas, but nationwide. These are the doctors who are going to serve Texas’ rural patients, urban patients, underserved patients.”
By endorsing Tom Price, the AMA and the AAMC have tied themselves to an individual who may be compatible with their business interests, but whose policy positions are antithetical to their highest ideals. Tom Price is intolerant on many levels – his anti-immigrant stance is just one. But it has the potential to disrupt manpower needs for caring and scientific advancement, and that could generate serious blowback.keep looking »