Posted on | February 24, 2017 | No Comments
During the Hillary Clinton health care debate of the 1990’s, our approach to health care delivery was compared to multiple other nations – including Canada. Supporters of our status quo worked hard to emphasize other nations differences and weaknesses.
The criticism of Canada, which even then was registering demonstrably better outcomes at a fraction of our cost, was twofold. First our health leaders accused the Canadians of rationing services and delaying life-saving treatments. And second, they claimed that our neighbors were able to get away with this because we were on their southern border, and Canadians in large numbers emigrated to our institutions to get access to services denied by their own niggardly system. Additionally we claimed that Canadian doctors were so dissatisfied with their system that they were routinely relocating to the U.S. to practice medicine.
These paired and interdependent false realities were presented with such certainty, and reinforced by our own medical elites so consistently, that physicians like myself bought into the propaganda without critically examining the facts. It was a full decade before these false claims were analyzed in earnest. In 2002, four health policy experts, with the support of the Canadian Medical Council, which had renamed itself the Canadian Institutes of Health Research, established unequivocally that the claims of medical migration, by either patients or their doctors, were bogus.
The Health Affairs publication, titled “Phantoms in the Snow: Canadians’ Use of Health Care Services in the United States”, didn’t mince words. Backed up with an array of facts and figures, and exhaustive documentation, the authors stated, “Results from these sources do not support the widespread perception that Canadian residents seek care extensively in the United States. Indeed, the numbers found are so small as to be barely detectible relative to the use of care by Canadians at home.”
On the Canadian side, only 90 of 18,000 citizens surveyed had used American services, and the vast majority of these were tourists seeking emergency care while traveling. Surveys of major U.S. academic centers, including those in border states reinforced the same conclusion: few if any Canadians. In the end, the authors concluded, “The numbers of true medical refugees—Canadians coming south with their own money to purchase U.S. health care—appear to be handfuls rather than hordes.” The same held true for Canadian doctors who had little to no interest in relocating.
Concurrent studies did reveal that Canadian waits for certain elective procedures and access to high tech diagnostics were longer than in the U.S. This fully transparent trade-off, made by provincial and territorial health governing bodies, was largely supported by Canadians as necessary and responsible budget management of priorities. They never hid the fact, but rather raised it in the public square. And recent corrective measures have not been entirely successful. (Message: Canada’s health care system does continue to have its own challenges.)
Absent proof of an escape valve migration south, U.S. detractors continued to wave the bloody flag of rationing, even as studies of our own system revealed that our population is more likely than citizens from other developed nations to put off needed treatment because they can’t afford it – de-facto financial self-rationing if you will.
In 2003, the U.S. under President George W. Bush continued to struggle to control health care costs. The nation’s response, with the opaque support of PhARMA, the AMA and AAMC, and the hospital and insurance industries, was to approve Medicare Part D’s non-negotiable coverage of pharmaceuticals for seniors at prices roughly 150% of the cost of Canadian counterparts.
Gallop polls at the time found that 57% of Canadians were “very” or “somewhat” satisfied with their health care system compared to 25% of Americans. 44% of our citizens were “very dissatisfied” while only 17% of Canadians felt the same. Part of the reason for relative calm up north was that their system was continuing to evolve in the full light of day. What were they up to?
In 2004, Canada’s Prime Minister and the provincial and territorial leaders announced “A 10-Year Plan to Strengthen Health Care”. Their opening statement? “As a nation, we aspire to a Canada in which every person is as healthy as they can be-physically, mentally, emotionally and spiritually.” Their guiding principles don’t sound like ours – no words like innovation, entrepreneurship, precision health or highly leveraged technologic wonders; no battles for ever increasing research funding by competing diseases; no academic goliaths with million dollar CEO’s overseeing patent producing enterprises as patient care takes a back seat.
What are their benchmarks and how is Canada performing compared to the US these days? More on that next week.
Posted on | February 15, 2017 | 2 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.keep looking »