Commonwealth Report on U.S. Maternal Health Just Released.

Posted on | December 19, 2018 | Comments Off on Commonwealth Report on U.S. Maternal Health Just Released.

https://www.commonwealthfund.org/publications/issue-briefs/2018/dec/womens-health-us-compared-ten-other-countries?omnicid=EALERT1531955&[email protected]

The Decoupling of Health from Health Care

Posted on | December 18, 2018 | Comments Off on The Decoupling of Health from Health Care

Mike Magee

“Our health care system’s focus, at every phase of its development, but especially since its expansion and increasing sophistication since World War II, has been on maximizing opportunities for profit and/or career advancement for the players within it.” Code Blue: Inside the Medical Industrial Complex (Grove Atlantic Press, coming in Spring, 2019)

In this week’s Wall Street Journal, Stanford University Hoover Institution fellow, Dr. Scott W. Atlas, reveals, without intention, American health care’s “original sin.”

Atlas is a neuroradiologist and deeply entrenched in the Medical-Industrial Complex, collecting consulting fees for “advising entrepreneurs and companies in the life sciences, medical technology, and health information technology sectors.” His world view is more than adequately reinforced by the Hoover Institution which “seeks to improve the human condition by advancing ideas that promote economic opportunity and prosperity.”

The WSJ piece claims that U.S. health care’s dismal rankings on a global scale are “grossly flawed calculations.” Through Dr. Atlas’s lens, America’s ranking of 32nd of 35 nations in infant mortality is because we over-report compared to comparator nations; and because our mothers indulge in more harmful behaviors; and because America possesses higher rates of “racial and ethnic minorities.”

As for America’s plunging life expectancy rates (ranked 26th for men, and 29th for women), he, without irony, adopts a “Don’t blame us!” posture, pointing instead to “unhealthy lifestyle choices, violence, urbanization, marriage and economic inequality.”

As for treating the diseases that he blames on others, he celebrates America’s “superior results”, and our remarkable access to surgeries, screenings, diagnostics and drugs, without mentioning our remarkable over-consumption, our permissive risk/benefit calculus, our raging opioid epidemic, or our near half-million avoidable deaths a year in unsafe hospitals.

The reader is left with the feeling that we all live in an alternative universe, where health is decoupled from health care, where cause can not be linked to effect, and where a privileged world view comfortably co-exists with remarkable and growing levels of unconscionable inequity.

Dr. Atlas’s essay does little to advance his cause. Rather, it reveals a stubborn committment to the status-quo and adherence to American health care’s “original sin.” In the immediate post WWII period, we never asked the question, “How do we make America and all Americans healthy and productive?” We believed that we could “defeat disease” as we had “defeated the Nazis” – through high-tech, profit-driven, cross-sector collaboration. And that in defeating disease, health would be left in its wake.

Nearly seven decades later, this remarkable miscalculation is so well entrenched that members of the medical-scientific elite feel more than comfortable suggesting that America’s unhealthy culture is not their problem, and ignore the fact that our’s is the only developed nation that spends more on health care that all other social services (themselves determinants of health) combined.

Category: Uncategorized

AMA Tells Trump “No Way” on ACA

Posted on | December 15, 2018 | 2 Comments

MEMORANDUM TO: Reporters, Editors, Producers and Interested Parties FROM: American Medical Association

DATE: December 15, 2018

SUBJECT: Texas v. Azar Decision ______________________________________________________________________________ Judge Reed O’Connor’s decision is a stunning display of judicial activism. Judicial power does not extend to settling policy disputes or exercising general supervision over the other branches of the federal government. Congress declined to repeal the ACA on more than 70 occasions. Yet, this judge has stepped in and single-handedly done has what Congress chose not to do – with a weak, unprecedented interpretation of “standing,” a failure to grapple with binding legal precedent, and an indefensible understanding of the interplay between the ACA, the Supreme Court’s decision in NFIB, and the TCJA. This decision violates multiple precepts that guide and limit the exercise of the judicial power – and it sets a dangerous precedent that invites politicians to resort to the unelected, life-tenured judiciary when they cannot achieve their political goals through the democratic process. Elected and accountable officials at the federal and state level continue to debate how best to ensure the provision of quality health care to the American people.

1. The Decision Will Wreak Havoc on American Health Care If It Were Left to Stand Current Law Should Remain in Place Pending Resolution of All Appeals

If upheld, the consequences of Judge O’Connor’s decision will be staggering. The ACA expanded access to affordable, quality health insurance, and millions of Americans have gained coverage under the statute. The decision will strip health care from tens of millions of Americans who depend on the ACA; result in higher insurance costs; and sow chaos in the nation’s health care system.

The decision reverses the historic gains in health insurance coverage that have been achieved since the implementation of the ACA, which have benefited millions of patients and the American health system.

Empirical research demonstrates that the lack of insurance contributes to premature deaths, worse health outcomes and preventable patient suffering.

2. Plaintiffs Lack Standing

The decision disregards the fundamental doctrine of “standing,” which is intended to ensure that courts confine themselves to their properly limited role, and avoids embroiling courts in political disputes that our Constitution assigns to the democratically accountable branches of government.

As the judge recognized, the American Medical Association (AMA) explained why the plaintiffs in this case did not have standing to bring their case. The plaintiffs do not have standing because they have not suffered any real, concrete injury. They do not have to pay a penny in tax if they choose not to obtain health insurance. That unavoidable fact makes clear that the plaintiffs simply seek to change the federal government’s health care policy through the courts, rather than through the legislature.

In rejecting those common-sense arguments, Judge O’Connor offered an unprecedented theory of standing—that parties may bring suit to free themselves from what they subjectively view as “arbitrary governance.” No court has ever recognized such a radical theory.

3. The Minimum Essential Coverage Provision Remains a Constitutional Exercise of Congress’s Taxing Power

Judge O’Connor concluded that, in light of the TCJA, the Individual Mandate in the ACA is no longer fairly readable as an exercise of Congress’s Tax Power and, thus, the ACA is unconstitutional. His logic is fatally flawed.

A law need not raise “some revenue” to qualify as a tax under Congress’s taxing power. All that is required is that the authority to tax be preserved, even if no revenue is actually raised. That is precisely what Congress did when it amended § 5000A. By keeping the minimum coverage requirement and its provisions imposing a tax, but only reducing the amount of that tax to $0, Congress preserved the statutory power to tax.

Judge O’Connor ignores a critical Fifth Circuit case on this point (United States v. Ardoin, 19 F.3d 177 (5th Cir. 1994)), which is a sign he has no answer for it. The AMA cited that decision again and again in its amicus brief, but the judge did not bother to address those arguments—or the binding decision of the court of appeals that he is required to follow. The NFIB case cited by the judge did not displace judicial precedent (i.e. Ardoin ) that a law is constitutional where taxing authority still exists, but is merely not exercised.

4. The Minimum Coverage Provision Is Severable from the Remainder of the ACA

The severability inquiry turns on congressional intent. The actions of the 2017 Congress leave no doubt about its intent: Congress reduced to zero the tax liability for failing to have minimum essential coverage, but it left the ACA otherwise unchanged. Congress thus already decided that the remainder of the law’s provisions—the protections for people with pre-existing conditions, the Medicaid expansion, and the rest of the law—should continue to be enforced as they were before the Tax Cut and Jobs Act of 2017 was enacted.

Category: Uncategorized

“A” Rating from NRA – The New Scarlet Letter

Posted on | December 13, 2018 | 2 Comments

Mike Magee

“The NRA’s A-rating used to be a badge of honor. On Election Day, it was a scarlet letter.” Those were the words of Shannon Watts, founder of Moms Demand Action for Gun Sense. And she had facts to back it up. More than 1000 candidates in the 2018 Mid-Term elections ran and won on gun safety.

Gun safety advocates signed up more than 100,000 new voters. In 43 races that featured a head-to-head challenge with an NRA “A” rater, only 10 candidates with the now dreaded scarlet “A” letter prevailed.

If three strikes mean you are out, the NRA is remarkably close to being retired. Strike 1: They challenged physicians for the loyalty of patients, admonishing doctors who support gun safety to “stay in their lane.” Strike 2: The NRA, with this weeks guilty plea by Russian spy, Maria Butina, stands convicted of laundering Russian money into the hands of Trump and Republican candidates across the land in the 2016 elections. Strike 3: In the wake of childhood massacres from Sandy Hook to Parkland, parents across America and their kids have struck an electoral blow into the heart of the NRA “A” rating.

Facts don’t lie according to the American Academy of Pediatrics. At their annual conference in Orlando this month, they reviewed the tight link between childhood gun deaths and NRA dominated state legislatures.

Using 2017 statistics, authors correlated a state’s Brady score (a numeric reflection of the strictness of gun control laws) with CDC reports of avoidable gun deaths in children.

2,715 children died of gun shots in 2017 – 62% were homicides and 31% were suicides.

After adjusting for other factors like poverty, employment, and addiction, they isolated lax gun laws as a determining factor in the deaths.

States with the weakest protections had 5 child deaths per 100,000, compared to the best states who had half as many deaths.

In the 27 states that have laws forcing parents to secure access to firearms in their homes, there were only .63 deaths per 100,000 compared to the states without these laws that had 2.57 per 100,000.

In the 12 states with universal background checks for sale of guns, 3.8 children per 100,000 were killed, versus 5.7 per 100,000 in states without such protections. When background checks were extended in 5 states to the sale of ammunition, the death rates dropped further to 2.3 children per 100,000.

Doctors, nurses and health professionals across the land increasingly recognize that a largely armed American culture with a penchant toward violence is fundamentally unhealthy. They also are leaning toward universal health coverage and robust health planning (including the varied social determinants of health) as an expression of solidarity and the assurance of “life, liberty, and the pursuit of happiness” for all Americans.

Women across America are today’s political story, and they’ll tell you straight-up, the NRA is “so yesterday.”

Category: Uncategorized

When Employers Stop Drinking the Kool-Aid.

Posted on | December 5, 2018 | Comments Off on When Employers Stop Drinking the Kool-Aid.

Mike Magee

I recently sat down to lunch with a retired veteran health insurance exec and asked her, “Are there still large corporation CEO’s who want to be the providers of health insurance for their employees – and if so, why?” She replied that there were a few and the primary reason was “ego.” She says the few still believe they can do it better and fear encroachment of public funding on private enterprise.

But increasingly, employers are coming to appreciate the value of a single payer/multi-plan health system for themselves, their workers and economic fairness and opportunity for our society.

A few facts help flesh out their reasoning:

1. It now costs more than $10,000 to insure an employee, and $20,000+ for a family – 50%+ more than in other countries.

2. Employers and their insurance partners over the past three decades have employed a wide range of strategies to limit cost inflation – and none have worked.

3. One-fourth of the U.S. health expenditure is devoted to marketing, administration, billing and collections. Single payer/multi-plan methodology would slice off 10% to 15% of the cost.

4. Cost is closing in on $4 trillion a year. (By comparison, the U.S. spends $867 billion on defense and $1.1 trillion on education.)

5. Employer based insurance has been around for over 50 years and now covers 150 million Americans.

6. Employer based insurance exacerbates income disparity. For families living above 400% of poverty level, 83% have employer based insurance. For those with income between 100% and 250% of poverty, flip the numbers – only 38% have employer based plans.

7. Employer based plans skew risk (tending to insure the wealthy healthy) and in doing so raise the cost of insurance for the poor. The numbers reveal as much. Employers cover 1/2 the population but pay only 1/3 of the national bill for health care.

8. Tax policy enables this discriminatory system. The higher your tax bracket, the larger the government subsidy.

For years, employers have drunk the Kool-Aid. But in the era of Trump, we are rapidly approaching a “come to Jesus moment.” The truth is about to set us free. And the truth is, we’ve been suckered for over a half century into a flawed and corrupt system, and we could do much, much better.

Category: employer-based health care
Tags: cost of employer based health insurance > health reform > single payer > single payer/multi-plan

Medical Device FDA Regulation: The Basic Problem.

Posted on | November 27, 2018 | 2 Comments

Mike Magee

A global investigative report has shone an unwelcome light on a largely unregulated industry we exposed in detail almost one year ago – the medical-device industry. The report documented that the 190,000 devices currently on the market have been responsible for 1.7 million injuries and some 83,000 FDA reported deaths over the past decade.

In response to the report, FDA Commissioner Scott Gottlieb, pledged reform this week. But it’s unclear whether he will be any more effective with medical device CEOs than he has been with pharma CEOs who he sternly directed to “end the shenanigans.”

Here are the basics on medical device regulation:

1) Most Americans remain unaware that in the eyes of the FDA not all therapies are considered equal when it comes to regulatory approval and oversight. Drugs are one thing, but medical devices are quite another.

2) Even the most high-risk implantable devices are often approved after a single clinical research trial, and most of these are not randomized, controlled or blinded trials.

3) Some 15% of approved devices created by this $150 billion dollar industry in the U.S. are eventually removed from the market, but often not removed from the patients in whom they were implanted. Unlike drugs, devices often remain for a lifetime, subjecting their subjects to continued risk and worry.

4) The FDA regulatory framework is the product of a tragedy. In 1970, Dr. Hugh J. Davis sold his invention, a small fish like implantable uterine device which dragged a porous multifilament string, to the A.H.Robins Company. In 1971, it went to market as an IUD that would be a safer alternative to birth control pills considered high-risk at the time. Called the Dalkon Shield, it was implanted in 2.8 million women. But within five years, its association with infection, septic abortions and death was irrefutably established and linked to its’ mutifilament tail. Within the decade, there were 300,000 lawsuits and A.H. Robins went bankrupt.

5) In response to the public outcry, Congress passed the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, and for the first time required testing and approval of “medical devices.” The loose system they put in place had to deal with the fact that all the devices in use at the time had never been independently analyzed or approved. They were effectively grandfathered in.

6) All new products were placed in one of three classes. Class I included low risk devices like tongue depressors or forceps. Class II devices were “cousins” to other devices already in use like joint replacement devices and electrocardiographs. And Class III were new devices which appeared to carry some risk like pacemakers or heart replacement valves.

7) Class I and II required quick and inexpensive premarket review, little extra documentation, and simple “premarket notification”. Class III required that manufacturers provide some kind of evidence that the product was safe and effective, but this often came from scientific reviews that were less than rigorous and often anecdotal. In return the company received a “premarket approval.”

8) Liberalization of the process occurred in the years that followed with two tracts created for new product approval: 1) “premarket approval” requiring clinical testing and inspections, or 2) the 510(k) process requiring affirmation that the new device is essentially similar to a device already on the market.

9) User fees range from around $200,000 for “premarket approval” versus around $4000 for the 510(k) tract. But equivalency can be in the eye of the beholder. For example, the ObTape Vaginal Sling for operative repair of female stress continence sailed through on a 510(k) approval in 2003 based on the manufacturer’s contention that it was substantially equivalent to support tapes manufactured by J&J and American Medical Systems already in use. But when adverse reports of encapsulation and expelling of the material with infection began to surface in 2004, it became clear that the ObTape was made of a dense material poorly incorporated by biologic tissues while the comparators were porous materials that allowed for vessel in-growth.

10) The net effect was that 113 approved devices had to be recalled between 2005 and 2009 because of serious complications or death. Roughly 4 out of 5 of these had avoided vigorous review.

11) In 2010, 500 million individual devices were recalled nationwide, and a review by the Institute of Medicine found the approval process ”flawed based on its legislative foundation” and that the FDA lacked a “integrated premarket and post-market regulatory framework.”

12) The 21st Century Cures Act, which dramatically drew the support of Joe Biden in the wake of his son Beau’s cancer death, was also loaded with FDA changes that further liberalized approval of medical devices including the use of “data summaries” and “real world observational studies” to support device approval.

13) Add to the “green light” serious issues with Conflict of Interest. Take for example the case of pacemakers. Approximately 400,000 Americans have them implanted each year, with 80% over 65 and 20% over 80 years old. In 1984, there were 56 heart conditions for which the American College of Cardiology approved a pacemaker as treatment. Twenty-five years later, that list had bulged to 88 conditions. Only 5% of those indications were backed by double-blind studies. Some 60% of the approved indications were based on recommendations from a 17 member expert government panel. 11 of those 17 were on the payroll of medical device makers.

14) Medical devices are fundamentally different than pharmaceuticals in one important respect. If a drug is pulled from the market, a patient can stop the drug and it will eventually clear from the system in a relatively short period of time. In contrast, many devices either cannot be safely removed, or their removal comes at great risk.

15) Medical device manufacturers are part of the Medical-Industrial Complex which now controls 1 out of every 5 dollars in the American economy. Code Blue: Inside the Medical-Industrial Complex, due to be published by Grove Atlantic Press in April, 2019, will reveal that collusion and syndicated profit sharing extends well beyond the limits that Commissioner Gottlieb is prepared to admit.

Category: Medical Devices
Tags: 21st century cures act > dalkon shield > FDA > FDA regulation of medical devices > medical device > pacemakers > scott gottlieb

Giving Thanks: Medicine vs. the NRA

Posted on | November 19, 2018 | 2 Comments

Mike Magee

This Thanksgiving, I send a special “thank you” to physicians nationwide who refused to buckle to the NRA’s demand that they “stay in their lane”, and stood up for kids across America.

There can be little debate that gun violence is a serious health risk, and that the NRA is enabler in chief. Back on February 18, 2018, four days after the Parkland, Florida school shootings, the American Academy of Family Physicians (AAFP) challenged Congress directly to “take firm action to deal with gun violence as a public health epidemic.”

Now a Stanford study on pediatric gun violence has ignited additional physician resistance. The facts:

1. 2,715 children died of gun injuries in 2015 – 62% homicides and 31% suicides.

2. Twice as many kids died in states with weak gun control laws (5/100,000) compared to states with strong gun control laws (2.6/100,000).

3. In states with laws that require specific limits to child access to guns in the home, pediatric suicides were 4 times less likely (.63/100,000) than in states without protected access (2.57/100,000).

4. Nearly half of the states (23) have no Child Access Prevention (safe storage or gun lock) laws in place.

5. In the 12 states with universal background check laws, pediatric deaths from gunshot wounds were 1/3 less likely (3.8/100,000) than in the 38 states lacking these laws (5.7/100,000).

6. In the 5 states that require background checks to buy ammunition, there were only 2.3 deaths/100,000 compared to unprotected states (5.6/100,000).

In years past, doctors have been too timid on this issue. But two years of constant assault on human dignity, paired with an increasingly tone-deaf NRA in the wake of the Parkland shootings and other mass disasters, have pushed the majority of physicians into an activist stance.

The American College of Physicians targeted the NRA in a position paper on October 30, 2018 titled, “Reducing Firearm Injuries and Deaths.”

That drew the NRA response labelling the statement as “every anti-gunner’s public policy wish list, save for the outsized role given to doctors,” and accusing ACP members as “only interested in pseudoscience ‘evidence’ that supports their preferred anti-gun policies.”

Then, on November 7, 2018, as the dust was settling from the mass shooting at Thousand Oaks, CA, the NRA’s leadership felt comfortable taking on organized medicine and caring health professionals everywhere, tweeting “Someone should tell self-important anti-gun doctors to stay in their lane.”

Johns Hopkins trauma surgeon, Joseph Sakran blasted back, “I have Two Words for you Hell No! #Hell No for #ThousandOaks #Hell No for all black men that die & no one hears about it. #Hell No for all those that we still may be able to save.”

The CDC and AMA have taken a stand. And in the wake of the NRA scolding, the ACP invited physicians to sign on to a letter challenging the NRA. Within 48 hours, 23,000 physicians did.

As many commentators have noted, the one silver lining to the past two years has been that President Trump is stress testing the durability of our democratic institutions and our fundamental “goodness” as Americans.

Nearly twenty years ago, our studies clearly demonstrated that patients rely on doctors to deliver three things: compassion, understanding, and partnership. Traditionally, this has occurred in private, behind closed doors. But now we must not only heal and provide health, but also offer leadership that will keep our communities and America whole.

These are not normal times. I give thanks that we physicians understand that Americans and our form of government are now fundamentally at risk and need our full engagement. In rising to this challenge, we are discovering our public voice and our finer selves.