What AMA President Patrice A. Harris MD Needs to Say Tomorrow.

Posted on | April 6, 2020 | Comments Off on What AMA President Patrice A. Harris MD Needs to Say Tomorrow.

Mike Magee

The lead in this morning’s New York Times story read that Rudolph W. Giuliani, personal attorney to Prsident Trump, had assumed a “new role: as personal science advisor to a president…” But if that is a suggestion that this is uncharted territory for Giuliani, nothing could be farther from the truth. More on that in a moment.

But first, let’s turn to preparation for AMA president, Patrice A. Harris’s speech tomorrow at 11 AM at the National Press Club. The promo reads, that Dr. Harris “will deliver a live national address via a National Press Club livestream on Tuesday, April 7 at 11 AM EDT, about the essential need for relying on science and data to protect public health, particularly in the face of the COVID-19 pandemic.”

My message to the AMA speech writers: Come down hard on two Americans who are prescribing without a license – Trump and Giuliani.

That defining power to prescribe, as I explain in Code Blue: Inside the Medical Industrial Complex, was intended to correct abuses of medications, but instead became the ultimate market differentiator for the profession.

As I write: “The Harrison Narcotic Act of 1914, which required prescriptions for products exceeding an allowable limit of narcotics, mandated increased record-keeping for physicians and pharmacists who dispensed such drugs. Before Harrison, the right to prescribe came with the license to practice medicine, which was a state-granted affair. The federal government now wanted to prevent doctors from treating addicts simply by piling on the opioids, and to prevent them from selling drugs and remedies out of their own offices.”

The right to prescribe has been jealously protected by the profession ever since, notably against pharmacists and nurses, seen as using the tool to expand their scope of practice and compete economically with doctors.

Unfortunately, though the original legislation required physician prescriptions and an orderly paper trail, regulation alone has been unable to prevent our modern-day opioid epidemic.  Which brings us back to Dr. Guiliani.

Most Americans are aware that, following 9/11, the former New York mayor launched a security firm called Giuliani Partners. Few may be aware that during its first five years, their largest and most lucrative client was Purdue Pharma, the maker of Oxycontin. Fewer still appreciate that interventions between Giuliani and members of the Goerge W. Bush administration, especially DEA lead Asa Huchinson, have been credited with getting the DEA to back down and lower fines on Purdue Pharma for illegal activity from a projected $20 in 2002 million to $2 million in 2004.

At the time, Purdue Pharma’s lead lawyer admitted without reservation that, “We believe that government officials are more comfortable knowing that Giuliani is advising Purdue Pharma. It is clear to us, and we hope it is clear to the government, that Giuliani would not take an assignment with a company that he felt was acting in an improper way.”

Giuliani not only enriched himself, but arguably played a role in adding several years to the manmade opioid epidemic leading to the needless loss of thousands of lives.

Some fifteen years later, Giuiliani finds himself once again in a role defending a drug on behalf of its makers, and in collusion with the White House. On April 5th, another unlicensed presecriber, Donald Trump, advised Americans to try an unproved treatment for Covid-19, hydroxychloroquine in combination with zithromax, coming back to the topic three or four times, and preventing Dr. Anthony Fauci from answering a reporters question on the matter.

Specifically, Trump the doctor said:

 The drug combo was one of “the biggest game changers in the history of medicine.”

“The known and potential benefits to treat this serious or life-threatening virus outweigh the known and potential risks when used under the conditions described in [the order].”

And offered that “I hope they use it, because I’ll tell you what, what do you have to lose? I may take it. I’ll have to ask my doctors about that.”

Dr. Guiliani gamely reported the same day that he has spoken in favor of the unproven therapy three or four times with Trump. It was one of at least 14 messages Giuliani has posted during the past three weeks endorsing the combination of the anti-malarial drug and the antibiotic azithromycin for covid-19.

On April 3rd, he let his hair down on “FOX and Friends” in acknowledging Dr. Fauci’s opposition to the therapy, saying, “We’ve got thousands of people dying, sweetheart. And by the time you blind test it, we’ll have 100,000 people who are dead. Why don’t we get in the real world of being a doctor instead of being an academic? We’ve got to take a little risk, god dammit, if we want to save lives. We are looking at a slaughter.”

Guiliani has also taken the time during this crisis to attack appropriate regulatory checks and balances by the FDA in attempts to ensure that our prescribed drugs are safe and effective. He recently said, “The general reputation of the FDA — and I don’t mean to be critical at a time like this — but that it’s very slow. I’ve represented pharmaceutical companies in very, very difficult situations, and it was my observation that they just took forever.”

As our AMA President takes the podium tomorrow, here is what she will confront:

1. A President and his personal lawyer, both practicing medicine without a license.
2. A run on supplies of hydroxychloroquine ignited by the President.
3. A clear intent to further undermine a century of safeguards and thoughtful regulation to insure the safety and effectiveness of the medicines our physicians prescribe.
4. And an expansion of the scope of practice to non-physicians on a scale well beyond any we could have imagined.

Dr. Harris’s voice and words must be clear and direct, “Mr. President, you (and your lawyer) are not authorized to practice medicine in these United States.”

100,000 – 240,000 Deaths? Are you sure about that?

Posted on | April 3, 2020 | 2 Comments

Mike Magee

We all sort of knew this was coming. A President, who is TV bound and a (somehow) entertaining pathologic liar, gets caught up in a life or death crisis where truth and trust are prerequisites.

This leaves Americans (and Cable News networks for that matter) with a difficult choice:

a) Turn him off.

b) Leave him on but ignore him and trust but verify Fauci and Birx.

c) Seek out other reliable sources with a truthful track record.

Medical journalists are increasing choosing c), and specifically turning to a few institutions including Columbia, Harvard and the University of Washington. The University of Washington received an unexpected glaring light when Dr. Deborah  Birx displayed a single screen shot of their interactive Covid-19 case maps, focused on the “peak” or the “hump.”.

As the Washington Post reported today, “Almost the entirety of what the public knows about the death projection was presented on a single slide at a briefing Tuesday, from the White House coronavirus task force. A White House representative said the task force has not publicly released the models it drew from out of respect for the confidentiality of the modelers, many of whom approached the White House unsolicited and simply want to continue their work without publicity.”

That was confusing enough since the source is a public-facing site with broad exposure and a $280 million 10-year endowment from the Bill and Melinda Gates Foundation. It is the Institute of Health Metrics Evaluation (IHME) at the University of Washington directed by widely recognized public health professional, Dr. Chris Murray.

Murray’s fame was well earned in his ground breaking statistical work with the WHO in charting the Global Burden of various diseases in nations across the Globe. This vertical study, covering the last two decades, is a landmark in design and import, defining the challenge and strategies that work in pursuing population health on a nation by nation basis.

When Covid-19 hit, Murray, with full support from the University of Washington and the Gates Foundation, wasted little time in refocusing all their resources on the pandemic that was now at their doorstep.

Those who still tune in to the President’s afternoon briefings continue, along with beleaguered reporters, to question basics numbers like: How many have been tested? How many likely have the disease? How many will be hospitalized? How many will require an ICU and/or a ventilator?

As Dr. Deborah Birx pointed to the screen shot, she affirmed that If everyone does their part perfectly, between 100,000 and 240,000 Americans will die.

Yet multiple anonymous White House reports this morning quote Dr. Tony Fauci as saying to his colleagues, “I’ve looked at all the models. I’ve spent a lot of time on the models. They don’t tell you anything. You can’t really rely upon models.”

Epidemiologists and health statisticians at Columbia and Harvard are on record as stating they’ve been contacted on short notice to provide death projections as well but that time and data limitations and absence of testing make it difficult to project.

At the very least, Americans deserve a visit to the University of Washington’s IHME site. So here it is. If you move the timeline to current peak date, April 21, you will find Dr. Murray’s projections which include that day –  2448 deaths nationwide, and 242,537 hospitalized covid-19 patients with 14% occupying ICU beds.

The projections assume full social distancing in the U.S. through May 20, 2020.

The House of God Has Become a House of Cards.

Posted on | April 2, 2020 | Comments Off on The House of God Has Become a House of Cards.

Mike Magee

In a career that included exposure to every level of America’s vast and collusive Medical Industrial Complex, I spent nearly two decades enmeshed in the senior management of hospitals.  These ranged from a 90 bed rural hospital just south of Brattleboro, VT, to the prestigious and historic Pennsylvania Hospital in Philadelphia, the nation’s 1st hospital.

From this experience, I take no pleasure in reporting that “The House of God” is a “House of Cards” in the process of crumbling under the weight of the Covid-19 pandemic.

As I lay out in my book, “Code Blue: Inside the Medical Industrial Complex”, as of 2018, there were 5,534 hospitals in the United States, 87 percent of which are designated as community hospitals. These provide close to 90 percent of the nation’s hospital beds and handle 92 percent of the admissions. Only 430 hospital institutions are designated as academic medical centers.

They are a disparate group of institutions, disorganized among themselves, some for-profit, some non-profit, sharing only one thing in common – extreme variability.

As the 2016 New York Times headline blared, “Go To The Wrong Hospital and You’re 3 Times More Likely to Die.” The article was reporting the findings of a PLOS One study that examined 22 million hospital admissions and found that a trip to the “wrong hospital” versus the “right hospital” assured a 3 times greater chance of death and a 13 times greater chance of complications during hospitalization.

Not surprisingly, the “system” is also marked by wide variance in financial stability. Take the case of Detroit and Southeast Michagan’s Beaumont Health System, which operates an 8-hospital system. It’s daily operating costs under normal circumstances are $12 million. It’s reserves to survive 200 days seemed more than enough. But since halting all elected procedures with the crisis, they expect loses of $70 million a month.

Covid-19 is a triple whammy for these institutions. First, they lose lucrative elective surgeries in return for lower Medicare reimbursement for elderly pandemic ICU patients. Second, their outpatient office visit revenue (roughly 50% of doctors now work for hospital systems) is all but shut down by the crisis. And finally, the material costs of medical supplies, rampant with hoarding and profiteering, and absent any federal planning or guidance, are skyrocketing.

Strangely, paying more doesn’t get you more. In a RAND sponsored survey this week, 73% of physicians nationwide say they are unable to quickly and easily access Covid-19 testing.

While hospitals may not be able to access testing, there is one resource they can purchase at a moment’s notice – a Washington lobbyist. The firms are hiring as fast as they can. As one company ad streamed out this week, we are “uniquely positioned to help our clients navigate these uncharted waters and the uncertainty that abounds.”

The federal relief package just approved includes $100 billion for hospitals. But how and when you get that money remains a mystery. And time is not on the hospitals side with new projections of a pandemic peak still 4 to six weeks away.

If and when these cards come crashing down, it will left to President Trump and Vice President Pence to explain how the vaulted free enterprise system allowed the House of God to become a House of Cards.

Father Greed: Vanishing Ventilators and Free Enterprise Public Health.

Posted on | April 1, 2020 | 2 Comments

Mike Magee

If you wanted to sum up President Trump’s two key messages this week, they would be: 1) A lot of people are going to die, and 2) Thank God for free enterprise public health.

On both counts, he is on thin ground. Numbers of deaths could far exceed the 240,000 he apparently now finds acceptable. And…not unrelated, Father Greed has firm control over America’s Medical Industrial Complex, paralyzing the critical supply chain with deception and profiteering.

Case in point (outlined in detail in a ProPublica March 30th exclusive investigation), the “disappearing Federal ventilator.”

Here are the basic facts:

1. In 2006, HHS established a special office (BARDA – Biomedical Advanced Research and Development Authority) to manage material preparedness for a medical disaster. The agency’s top priority – stockpiling ventilators. By 2008, they set a goal of the large scale purchase of a functional, but not elaborate, ventilator for $2000.
2. They signed a contract with Newport Medical Instruments for $6.4 million in September, 2010. By May, 2012, the machine was still on the drawing board, and the company was purchased by Covidien, an Irish medical device corporation. Covidien began to raise enough foot-dragging issues to bump up the BARDA offer by $2 million.  But before lifting a finger, they were sold to Medtronic which mailed in designs and then said thank you very much, but goodbye in 2015.
3. BARDA picked up the pieces and in 2015 signed a $13.8 million contract with a small Pennsylvania manufacturer, Respironics, a subsidiary of Dutch technology manufacturer, Royal Philips, N.V.
4. In 2019,  they received a green light  to create 10,000 “low-cost, portable, easy-to-use ventilators” at a cost of $3,280 per unit. The machine was called the Trilogy Evo Universal.
5. Instead, the Pennsylvania company geared up their assembly line to produce a high-priced commercial model selling originally at a list price of $12,495, and now for $17,154.

With not a single Respironics ventilator in the federal stockpile, who are buying from the “Make America Great Again” Murrysville, Pennsylvania plant?  The government of Madrid bought 10 for $11,000 each last month. Budapest, Hungary has a few as well.

Two other points of interest:

1. In 2016, Respironics paid a $35 million fine for kickpacks to medical suppliers who bought their equipment.
2. Jared to the Rescue: Respironics is currently negotiating with Jared Kushner to build 43,000 of the more complicated (and expensive) version of the Trilogy Evo Universal.

If successful, look for a Rose Garden appearance of the Philips Respironic CEO at the next afternoon episode of Trump’s Great  American Catastrophe (airs every day , 5:30PM – 7:00PM).

A Health System Disconnected and Conflicted in an Un-united United States.

Posted on | March 31, 2020 | 2 Comments

Mike Magee

Governors like Andrew Cuomo of New York have discovered the price for inefficiency and conflicts of interest in the face of the Covid-19 epidemic. As he said yesterday, “No one hospital has the resources to handle this. There has to be a totally different operating paradigm where all those different hospitals operate as one system.”

Our system is marked by extreme variability, a nation of health care have’s and have-not’s. Yet even when we Americans acknowledge the absurdity of our convoluted system of third-party payers, and the pretzel positions our politicians weave in and out of as they try to justify it, reform it, then un-reform it, many still find solace in telling themselves, “Well, we still have the best health care in the world.” 

This crisis in a matter of weeks has revealed the limitations of a conflicted network built on short-term profiteering and entrepreneurial adventurism. Here are a few early learnings:

1. There is no national system – not for health, not for disaster.
2. The buck stops nowhere. Since there is no plan, and no point of central control, there is no one in charge.
3. “1000 points of light” doesn’t cover the absence of “good government.”
4. There is no national inventory stockpile because there is no national health plan. When Obama (post-Ebola) constructed centralized disaster planning to try to umbrella this weakness, Trump rapidly disbanded it to erase the Obama name and play to conservative partisans.
5. “Just in time inventory management” boosts profit margins, but leaves all vulnerable to shortages during a crisis.
6. Extreme care delivery segmentation – confronting a disaster scenario – fails for all, not just the poor and disadvantaged.
7. There is no tradition nor apparatus for sharing of human or material health resources in America.
8. What is shared and heavily coordinated are the federal government relations lobbying plans and strategies of the national associations that constitute the Medical Industrial Complex in America including insurers, pharmaceuticals, hospitals, and medical organizations.

The United States is un-united when it comes to public health policy and responses to this crisis. For example, only 32 states, 80 counties, 17 cities, the District of Columbia and Puerto Rico are currently being urged to stay home. For the others, their  citizens (and the virus) continue to wander around.

Our President is unrepentant. Yesterday, for the second day in a row, he paraded corporate leaders of “the greatest health system in the world” in front of the cameras on the White House lawn. At the March 29^th conference, Trump proudly introduced middleman pharmaceutical distribution CEO Michael Kaufman of Cardinal Health, for mutual admiration. Without a hint of irony, or acknowledgement of the cloud currently overhanging his company for their central role in creating the opioid epidemic, Kaufman proudly proclaimed, “We have really seen government agencies working with industry like no time before.”

Though many will die, as even the President now admits, we will survive as a nation. But hopefully, with a new leader, the first order of business will be to create a rational and universal health care system capable of protecting and securing the health of all Americans. Because, as we are tragically realizing, there is no “united states” without a safe, secure and reliable health care system.

Is There a Genetic Pre-disposition to die of Covid-19?

Posted on | March 30, 2020 | 3 Comments

Mike Magee

As Donald Trump learned when he was forced finally to declare bankruptcy on his Atlantic City Trump Taj Mahal Casino, and as our second President, John Adams, said: “Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passions, they cannot alter the state of facts and evidence.” Thus, without apology and as wide-eyed with faux-surprise and “Who knew?” bewilderment as ever, Trump was forced to acknowledge that continued denial on his part could result in over two million deaths.

In contrast, a number of brilliant scientists from around the world have been questioning their original assumptions that Covid-19 was primarily a threat to those over 70, immunocompromised or with existing co-morbid conditions. The reason for their uneasiness is the observation that some younger adults (and recently a child under age 1) who appeared healthy in every way, have become very, very sick – and in a significant number of cases, died from the virus. And as scientists do, they asked, “Why?”

As Science magazine reported this week, “COVID-19, caused by the new pandemic coronavirus, is strangely—and tragically—selective….Researchers are now gearing up to scour the patients’ genomes for DNA variations that explain this mystery.”

What are the genetic suspects so far.

1. The cell surface protein angiotensin-converting enzyme 2 (ACE2): A variant of the gene controlling this protein can make it easier for the virus to penetrate respiratory cell walls.

 2. The human leukocyte antigen genes: These genes control the bodies immune response to viruses and bacteria.

The researchers around the world are just getting started, but they aren’t starting from scratch. There are enormous genomic databanks already in existence seeded by volunteer DNA donations, and funded by private institutes and governments around the world. These include:

Geneticist Andrea Ganna of the University of Helsinki’s Institute for Molecular Medicine Finland (FIMM), with funding from U.S. based Broad Institute, which has created the COVID-19 Host Genetics Initiative and is pooling a group of DNA databases worldwide. Their goal is to cross-match those who have become severely ill or died from the disease against the genomes of those who have not, hunting for genetic vulnerabilities.

FinnGen, has collected DNA samples and health data for 5% of the 5 million–person Finnish population

The Icahn School of Medicine at Mount Sinai is contributing its 50,000-participant biobank.

The UK Biobank, with DNA data on 500,000 participants, has announced it is adding COVID-19 health data.

deCODE Genetics, with testing in broad use in Iceland, has genome and health data on half of Iceland’s 364,000 inhabitants, and is now adding new coronavirus results.

Harvard University’s Personal Genome Project, which has recruited people willing to share their full genome for research, received 600 positive responses in 48 hours when they sent questionnaires to participants, asking about their COVID-19 status.

11 Italian hospitals have signaled their intent to give ethics approval to a University of Seina genetics team to collect DNA samples from willing Covid-19 patients.

Pediatrics researcher Jean-Laurent Casanova at the Rockefeller University is tapping into their global network, and collecting DNA samples on Covid-19 pediatric ICU patients. 

Two weeks ago, President Trump declared “I don’t take responsibility at all.” He has spent the last fourteen days shifting blame and setting state governors and his political rivals up for a fall. Fine, we get it.

But it’s important for you to know that he is an outlier. Many, including frontline nurses and doctors and caring professionals are stepping up – and researchers around the world are doing their best as well.

We can’t waste any time and energy right now on this President. Use your prayers and blessings and support for those who really care about our future.

Work, Love, Courage – in Abundance.

Posted on | March 27, 2020 | 2 Comments

Mike Magee

This morning I listened to an interview of the President of Mass. General Hospital, Dr. Peter Slavin, as he outlined the reality of Covid-19 and the challenges faced by his nurses, doctors and health professionals during this crisis. In his words, I found pride in having been part of the caring professions whose lives center around three critical themes: work, love, courage.

Forty-seven years have passed since I received my medical degree, but not one year has passed in which I was not proud to have chosen this life. My biases are strong and well known by now. Covix-19 has only reinforced them

The world is a better place today for having developed and supported strong, enduring patient-caregiver relationships. This is not simply a function of the nuts and bolts of health services that this relationship provides, in full vision and especially under duress. But also for those things it has reliably delivered over many decades around the world, quietly below the radar screen.

The first of these, as a collective, is the management and processing of a population’s fear and worry, which, absent the efforts of nurses, doctors and caring professionals, would accumulate in our society to destabilizing effect.

The second is a subtle and rational reinforcement of important societal bonds. The importance of this second contribution was best highlighted by the great Cardinal Bernardin, who shortly before he died said to several thousand AMA physicians, “There are four words in the English language that have common English roots. They are heal, health, whole and holy. I tell you this today to remind each of you that to heal in a modern world you must provide health; and to provide health you must keep the individual, the family, the community, and society whole. And if you can do all that, why that is a holy thing.”

The third mostly invisible contribution is hopefulness; a quiet confidence that most problems can be managed, most mysteries solved, and that, absent a cure today, there remains hope for a discovery tomorrow aralen. That deep-seated optimism, embodied in individuals whom you trust, have confidence in, and believe in, is transferable, and helps create a reservoir of good will, a belief that life is worth living, that risks are worth taking, that loving and being loved is possible, that dreaming, imagining, purchasing a home, getting married, having children are all worth the effort.

As these caring relationships have become threatened by Covid-19, stable civil societies are noticing the difference. This situation is made worse by predatory leaders, who leverage lies and fear as a currency to control a population in order to reinforce existing and past power silos, and who attempt to segregate us one from another to maintain the status quo. They not only draw down the reservoir of good will locally and globally, but compromise caring professionals medium and long term success.

I am older now, but still have a voice. I am not inside the hospital any longer, but I am inside the hearts and minds of every nurse and doctor and health professional who willingly place themselves in harms way for each of us. They have the courage to rise, the willingness to work, the hearts to love. They are honest and true.

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