Demonstrated Incompetent With Public Health And Healthcare - CDC Now To Police Racism?

CDC |  Racism is a system pdf icon[224 MB, 16 Pages]external icon—consisting of structures, policies, practices, and norms—that assigns value and determines opportunity based on the way people look or the color of their skin. This results in conditions that unfairly advantage some and disadvantage others throughout society.

Racism—both interpersonal and structuralexternal icon—negatively affects the mental and physical health of millions of people, preventing them from attaining their highest level of health, and consequently, affecting the health of our nation.

A growing body of research shows that centuries of racism in this country has had a profound and negative impact on communities of color. The impact is pervasive and deeply embedded in our society—affecting where one lives, learns, works, worships and plays and creating inequities in access to a range of social and economic benefits—such as housing, education, wealth, and employment. These conditions—often referred to as social determinants of health—are key drivers of health inequities within communities of color, placing those within these populations at greater risk for poor health outcomes.

The data show that racial and ethnic minority groups, throughout the United States, experience higher rates of illness and death across a wide range of health conditions, including diabetes, hypertension, obesity, asthma, and heart disease, when compared to their White counterparts. Additionally, the life expectancy of non-Hispanic/Black Americans is four years lower than that of White Americans. The COVID-19 pandemic, and its disproportionate impact among racial and ethnic minority populations is another stark example of these enduring health disparities.

Racism also deprives our nation and the scientific and medical community of the full breadth of talent, expertise, and perspectives pdf icon[1.5 MB, 208 Pages]external icon needed to best address racial and ethnic health disparities.

To build a healthier America for all, we must confront the systems and policies that have resulted in the generational injustice that has given rise to racial and ethnic health inequities. We at CDC want to lead in this effort—both in the work we do on behalf of the nation’s health and the work we do internally as an organization.

Worse Than Walensky: Dr. Leana Wen Claims "Very Narrow Window To Tie ReOpening Policy To Vaccination Status"

CTH |  There is so much in this soundbite from Dr Leana Wen (Public Health Policy, George Washington University) it is difficult to encapsulate.

When they show you who they are, believe them.  In this soundbite Dr. Wen is apoplectic that people might realize there is no need for a vaccination because everything is open and there is no crisis.   She frets that American people will enjoy their freedoms without vaccination.  Just watch and listen to the priority in her soundbite.

The blind-spot exposure of their ideology is a weakness of the totalitarian mind.  They spend so much time in an echo-chamber they cannot fathom the insanity of what they are espousing.  To them it just seems like the typical conversation they have all the time, because they never face anyone challenging them.

“We have a very narrow window to tie reopening policy to vaccination status because if everything is reopened, then what’s the carrot going to be… How are we going to incentivize people to actually get the vaccine… So that’s why I think the CDC & the Biden  admin need to come out a lot bolder & say “if you’re vaccinated, you can do all these things…here are all the freedoms that you have, because otherwise people are going to go out and enjoy these freedoms ANYWAY.”

The Wholesale Discrediting Of The American Medical Industrial Complex

nakedcapitalism |  Of so many tragedies to come out of the COVID-19 pandemic, one of the saddest to me – and probably the one with the longest-reverberating consequences – has been its wholesale discrediting of our health science institutions.

Here we are, over a year into this pandemic, and we cannot get a straight answer on whether or not this relatively cheap and safe drug (ivermectin) saves human lives from COVID-19 or not. Worse, we can’t even seem to properly investigate it. All questions bring hysterics, or hardly-believable obfuscation, or (informed?) outrage, no matter what authority we turn to. The fallout in my own life from watching all this unfold has been… dramatic.

I don’t trust what the CDC says. I don’t trust what the WHO says. I don’t trust what the FDA says. I don’t trust Pfizer and the rest of the pharmaceutical companies any farther than I can throw them. I look with suspicion on my own scientist acquaintances, wondering if they are really following the data, or if they are clinging to a chosen worldview that science in America still works, oh god it still works, oh god it hasn’t been completely discredited, no it cannot be, my life work must have meant something, it must still work, it must still work….??

None of this means that ivermectin works–or for that matter, that it doesn’t work. It means that I have realized, slowly and then all-of-a-sudden, that I cannot know. Nor can any other layperson. We are alone, our economy is collapsing in slow-motion, and our lives are at stake. Or so we think! If we doubt so much, how much more should we really be doubting? I believe, for what it’s worth, that COVID-19 is real and that these experimental vaccines probably won’t kill us. At least… not that many of us.

But I wonder now, in my darker moments, whether the claim of those who don’t believe such things that refusing the vaccination is a “Darwin’s test – pass it and survive” have grokked something that was beyond me, in my previous worldview. How could it have come to this…? And if I am feeling like this, how must people with less scientific background (I attended a science magnet school) be feeling about it all??

Will my children be safe from measles, etc in the years to come? I have vaccinated them with the whole slate, and feel fine about that choice, but will the fallout from this debacle mean the end of herd immunity in America, as trust in the ‘health experts’ collapses into dust? How can we get it back, then – at gunpoint? With all that would imply… is it even worth such a high price…?

No Corporate Sector Does A Better Job Masking Dysfunction And Profiteering Than Healthcare

charleshughsmith |  Unbeknownst to most Americans, many core systems are already in the first stages of collapse. No corporate sector does a better job of masking dysfunction and profiteering than healthcare, and so the collapse of healthcare systems will surprise everyone who swallowed the sector's glossy PR. 

Though 2020 is widely perceived as "the worst year ever," it was only a snack. The real banquet of consequences will be served in 2021. The reason 2020 was only a snack is that systems didn't break down in 2020. The reason 2021 is the main course is that systems will break down, and once broken, they cannot be restored.  Systems have numerous sources of potential fragility:

1. Systems can be tightly bound to other fragile systems, setting up the potential for a domino-like cascading collapse that starts with one system failure that then brings down every connected, interdependent system.

2. Systems can be hollowed out by self-interested insiders who mistakenly believe the system can survive endless looting.

3. Systems can be weakened by perverse incentives that provide strong incentives to under-invest in core functions and divert revenues to profiteering and extraction (stock buybacks, bonuses to managers, etc.)

4. Systems can appear robust to casual observers because insiders cloak the decay of function, accountability and transparency.

5. The decline of functionality / results can be hidden by bureaucratic obscurity (accounting statements in which all the important information is buried in footnotes starting on page 217, etc.) and by complexity thickets that reduce accountability to near-zero: no one is responsible for the decay of function, accountability and transparency.

6. Process replaces results as the Prime Directive of the system. Devoting resources to following processes rather than to getting results generates an illusion of functionality even as the ability to evolve and adapt is lost.

7. Buffers that enabled effective responses to crisis are stripped to the bone as redundancy and resilience are discounted as "hurting profits" or "needless expenses."

8. Insiders and the public / customers wrongly assume money can solve all of these systemic frailties. But money cannot buy trust, competence, institutional depth, productive incentives or anything else that is essential to robust, anti-fragile systems.

Americans are unprepared for the collapse of core systems. The secular faith holds that corporate ownership of core systems, centralized state control and the relentless pursuit of infinite greed will magically manifest the best of all possible worlds because self-enrichment by any means available is what perfects systems.

Thomas Frank Like Savoir Faire - He's Everywhere - Now On Healthcare...,

lemondediplomatique |  The great underlying political crisis of this plague year, it is often said, is the stubborn refusal of Americans to respect expert authority. There’s an epidemic raging... and just look at those people frolicking in a swimming pool at the Lake of the Ozarks, repeating stupid conspiracy theories, spreading non-peer-reviewed medical advice on social media, running errands without a mask on, setting off roman candles in the street. And just look at their idiot of a president, dismissing the advice of his own medical experts, blaming everyone but himself for the disaster, suggesting we inject ourselves with Clorox because it’s effective on countertops and toilet bowls.

In truth, this grand conflict between the ignorant and the enlightened has been a motif of our politics for years (1). Liberals, we believe, are uniquely attuned to objective reality; they dutifully heed the words of Nobel laureates and Genius Grant winners. But Republicans are different: they live in a world of myth and fable where the truth does not apply.

Ordinarily our punditburo plays this conflict for simple partisan point-scoring. Us: smart! Them: stupid!

But the pandemic has given the conflict an urgency we have not seen before. These days, right-thinking Americans are tearfully declaring their eternal and unswerving faith in science. Democratic leaders are urging our disease-stricken country to heed the findings of medical experts as though they were the word of God.

Our ‘thought leaders’, meanwhile, have developed a theory for understanding the crazy behaviour we see around us: these misguided people are not merely stupid, they are in the grip of a full-blown philosophy of anti-expertise called ‘populism’. These populists are the unlettered who resent the educated and sneer at the learned (2). They believe in hunches instead of scholarship; they flout the advice of the medical profession; they extol the wisdom of the mob. Populism is science’s enemy; it is at war with sound thinking. It is an enabler of disease, if not a disease itself.

So sweetly flattering, so gorgeously attractive is this tidy little syllogism that members of our country’s thinking class return to it again and again. Medical science is so obviously right and populism so obviously wrong that celebrating the one and deploring the other has become for them one of the great literary set pieces of the era, the raw material for endless columns and articles.

And What's Behind the Touting of Remdesivir?

"Love Passionately." Smaller letters advise: take PrEP, (it might say something about financial assistance available)  The PrEP regimen involves Gilead's drug Truveda.   Gilead has donated thousands of the pills to the federal government, but government pays for the required  prescription/ distribution/ monitoring by physicians, and at a cost multiples of times the cost of the pills.

Gilead encourages risky behavior in its advertising for this drug to curb the effects of that behavior, all at taxpayer expense. Fauci's involvement with HIV AIDS was highly controversial. Same Fauci, in league with Gates, is now behind a lockdown forcing not-sick, not-risk-taking persons to abstain from normal life functions, then advising the use of a drug produced by Gilead to cure "the invisible enemy".

A rising public awareness of the lack of integrity of career officials at yet another 3 letter federal agency. In the short term it serves as yet another excuse for draconian state policies that will result in the destruction of the economy and thus the Republic. Meanwhile there is plenty of money to be made:

NIH evaded disclosure of the massive financial links of its members to Gilead Sciences, the manufacturer of a competing drug remdesivir. Among those who failed to disclose such links are 2 out of 3 of its co-chairs." "Nearly 20% of this panel is employed by or has investment interests in Gilead."

My, imagine that. The NIH Panel on COVID-19 Treatment Guidelines is made up of 50 researchers and physicians. This panel will decide treatment recommendations for Remdesivir.

Remember in 2014 when Gilead won FDA approval for the drug Harvoni? The price per patient was $94,500 if you wanted your Hepatitis C cured.  Gilead isn’t a charity.  May 4 - Gilead receives $37.5M grant to develop/test Remdesivir—courtesy of US taxpayers. Taxpayer funded study shows small non-mortality benefit. FDA approves Remdesivir

Patient cost: $1000

Remdesivir manufacture cost: $10

Gilead projected 2020 revenue for Remdesivir: $1,000,000,000

Covid-19 Treatment Protocols FAR From Established Or "Agreed Upon"

wattsupwiththat |  I reviewed the scientific literature on hydroxychloroquine (HCQ), azithromycin (AZ), and their use for COVID-19. My conclusions:

• HCQ-based treatments are effective in treating COVID-19, unless started too late.
• Studies, cited in opposition, have been misinterpreted, invalid, or worse.
• HCQ and AZ are some of the most tested and safest prescription drugs.
• Severe COVID-19 frequently causes cardiac effects, including heart arrhythmia. QTc prolonging drugs might amplify this tendency. Millions of people regularly take drugs having strong QTc prolongation effect, and neither FDA nor CDC bother to warn them. HCQ+AZ combination, probably has a mild QTc prolongation effect. Concerns over its negative effects, however minor, can be addressed by respecting contra-indications.
• Effectiveness of HCQ-based treatment for COVID-19 is hampered by conditions that are presented as precautions, delaying the onset of treatment. For examples, some states require that COVID-19 patients be treated with HCQ exclusively in hospital settings.
• The COVID-19 Treatment Panel of NIH evaded disclosure of the massive financial links of its members to Gilead Sciences, the manufacturer of a competing drug remdesivir. Among those who failed to disclose such links are 2 out of 3 of its co-chairs.
• Despite all the attempts by certain authorities to prevent COVID-19 treatment with HCQ and HCQ+AZ, both components are approved by FDA, and doctors can prescribe them for COVID-19.

Intro

Hydroxychloroquine (HCQ) was accepted as a COVID-19 treatment by the medical community in the US and worldwide by early April. 67% of the US physicians said they would prescribe HCQ or chloroquine CQ for COVID-19 to a family member (Town Hall, 2020-04-08). An international poll of doctors rated HCQ the most effective coronavirus treatment (NY Post, 2020-04-02). On April 6, Peter Navarro told CNN that “Virtually Every COVID-19 Patient In New York Is Given Hydroxychloroquine.” This might explain decrease in COVID-19 deaths in the New York state after April 15. The time lag is because COVID-19 deaths happen on average 14 days after showing symptoms.

But on April 21, several perfectly coordinated events took place, attacking HCQ’s use for COVID-19 patients.

1. The COVID-19 Treatment Guidelines Panel of the National Institute of Health issued recommendations with negative-ambivalent stance regarding the use of HCQ as a COVID-19 treatment.  This surprising stance was taken contrary to the ample evidence of the efficacy and safety of HCQ and despite absence evidence of its harm. The panel also strongly recommended against the use of hydroxychloroquine with azithromycin (AZ), the combination of choice among practitioners.
2. On the same day, a paper (Magagnoli, 2020) was posted on a pre-print server medRxiv, insinuating that HCQ is not only ineffective, but even harmful. This not-yet peer reviewed paper, by unqualified authors with conflicts of interest, received wall-to-wall media coverage, as it if were a cancer cure. It used data from Veterans Administration hospitals, spicing its effects. The paper has shown to be somewhere between junk science and fraud.
3. Rick Bright, a government official who was probably more responsible for the low level of preparedness to the epidemic than most others, and had been re-assigned to a lower position earlier, emerged as a “whistleblower.” He claimed he had been demoted for opposing hydroxychloroquine, the claim to be soon debunked by documents bearing his signature. The media also gave him a wall-to-wall coverage.

On April 24, the FDA struck its own blow, issuing a stern warning against use of HCQ for COVID-19 treatment.

Waaaay Too Long, Well Worth Reading Detailed Technical Account From The Trenches

medium | What to Wear, What to Wear … 

“Do you want PAPRs?” asked the resource nurse.

These are Powered Air-Purifying Respirators: In our case, a white plastic hood with a clear face shield, attached by hose to a motorized fan/filter worn on a belt around the waist. We don these spaceman hoods now for high-risk situations like intubations, the prologue to putting a patient on a vent.

If a patient is failing despite oxygen, then he might need sedated, intubated (i.e., have a plastic breathing tube slipped into his trachea), and put on a ventilator. We do this routinely in emergency medicine. But it involves getting up close with a coughing, struggling airway — perhaps between periods of vigorous bag-mask ventilation — and it turns out this is all high-risk for aerosolizing a coronavirus, so that it floats in the air all around us.

This happens in a negative-pressure room — resource was already tracking the patient in the computer to our main resuscitation bay, which has a sliding glass door and a fan that continuously sucks air in from the hall — so no viral particles can wander the ER. The fans draw the air through filters and outside of the building — hopefully someplace up high and remote, where any few scattered viral or bacterial particles that make it so far will be killed off by sunlight. None of this, however, protects those of us inside the room, hence the question: Should we dress like astronauts to meet the new COVID-19 patient? Or go with standard gear?

Standard included an N 95 mask, which each of us had been wearing all shift, for weeks now. They feel like hard cardboard, with moldable edges. When sealed to the face, supposedly they keep out “95%” of whatever’s floating in the air — as long as that whatever is bigger than 0.3 micrometers (300 nanometers). (This is regulated by the National Institute for Occupational Safety and Health; the N stands for “not resistant to oil,” which means it’s fine for healthcare work but not for some industrial processes.)

If you’re wondering: “Is filtering out 95% enough?” — join the club. Sucking in 5% of the coronavirus that comes my way sounds like a bad deal.

Worse, the coronavirus itself is only 0.125 micrometers (125 nanometers). So … small enough to make it thru the mask?

Nevertheless, we have some clinical evidence that N 95s prevent viral or bacterial infections. And we hypothesize that if say a coronavirus is floating in the air, it’s doing so in a large water droplet. Suddenly, the exact size in micrometers of said droplet is of interest, so there’s a brisk trade in math-heavy papers like this one from the Journal of Fluid Mechanics — with its 1,000-frames-per-second images of sneeze- and cough-expelled saliva sprays. This and other literature suggests virus-filled saliva droplets range from 5 to 15 micrometers (5,000 to 15,000 nanometers)— far too big to make it past the N 95.

Maybe so, but the N 95s are miserable things.

Before COVID-19 they were considered “single-use,” worn to see a patient and then discarded upon leaving the room.

Now, in the setting of an international shortage, at every hospital I work at or know of, they are being used in a completely new way: Worn constantly, sometimes with a surgical mask over top to “keep the N 95 clean,” and then turned in for some sort of deep cleaning. The CDC has offered only the most grudging of guidance blessing this sort of reuse, but what can we do? At least we are past the early days, when we doctors were literally studying the specs on vacuum cleaner bags and air conditioner filters, wondering if we could cut them up and sew them into face masks.

To be clear: At none of the hospitals where I work did we ever run out of protective gear. But at all of them we had reason to worry about it, and if we haven’t run out, it’s in large part because of the ingenuity of the physicians and nurses in suggesting workarounds.

How Private Equity Drives Surprise Billing

Prospect |  Surprise medical billing has quickly become a small but critical flashpoint in health care reform. Because doctors and hospitals negotiate separately with insurance companies over reimbursement rates, it's possible for a patient's insurance to cover hospital charges while failing to cover the fees of some doctors in the hospital who are “out of network.” Patients who visit an emergency room (ER) or are admitted to an in-network hospital by an in-network doctor may find that some of the professionals who treat them are not covered by their insurance. That is because hospitals have outsourced ER, anesthesiology, radiology, or other specialized services to outside physician practices or staffing firms. Patients often find themselves on the hook for thousands, or even tens of thousands of dollars in surprise medical bills.

Twenty-five states have passed laws with limited protection for patients from out-of-network bills, usually for emergency room or urgent-care services; 20 more states are considering legislation. But these laws do not cover self-insured employer plans, which can only be regulated by the federal government. These plans cover an estimated 61 percent of workers who have private insurance, up from 44 percent 20 years ago. That means Congress must step in to protect insured patients from unfair and unexpected medical charges.

And that puts lawmakers up against the powerful and influential private equity industry, which plays a major role in supplying hospitals with physicians. They have aggressively bought up large national staffing firms or “physician practice management” (PPM) companies, as well as emergency providers that hospitals and other health organizations have outsourced, such as ground and air ambulance companies. And they are using the typical tools to protect their investments from a legislative onslaught: lobbying cash, dark-money front groups, and allies in Congress pushing loopholes and half measures.

The Role of Private Equity: Driving Market Concentration

Private equity funds use substantial debt to acquire doctors' practices through leveraged buyouts, and to finance mergers of practices into large staffing firms. Emergency medical and specialist practices are a prime buyout target, because patients who need emergency care cannot haggle over price, and third-party payers guarantee payment. This satisfies the private equity business model of promising “outsized returns” to investors.

Private equity firms buy up small specialty physician practices that have begun to consolidate and “roll them up” into umbrella organizations to gain local, regional, and ultimately national market power. Researchers at the Kellogg School of Management found that most individual acquisitions were below the dollar threshold that would have required the transaction to be reported to antitrust regulators.

Do Healthcare Professional Staffing Firms Specialize In Pimping H1-B Replacement Negroe Physicians?

laprogressive |  About a third of hospital emergency rooms are staffed by doctors on the payrolls of two physician staffing companies—TeamHealth and Envision Health—owned by Wall Street investment firms. Envision Healthcare employs 69,000 healthcare workers nationwide while TeamHealth employs 20,000. Private equity firm Blackstone Group owns TeamHealth, Kravis Kohlberg Roberts (KKR) owns Envision.

Care of the sick is not the mission of these companies; their mission is to make outsized profits for the private equity firms and its investors. Overcharging patients and insurance companies for providing urgent and desperately needed emergency medical care is bad enough. But it is unconscionable to muzzle doctors who speak out to advocate for the health of their patients and co-workers during the global pandemic that is rapidly spreading across the US.

Yet, that is what Blackstone-owned TeamHealth just did. Why would an experienced ER doctor be fired in the middle of a pandemic? One clue may be that Blackstone’s CEO, Stephen A. Schwarzman, is part of President Trump’s inner circle. He may not want to risk that relationship by allowing TeamHealth’s doctors to inform the public about Washington’s mishandling of the allocation of supplies and protective gear. The President might conclude that TeamHealth doctors didn’t appreciate him enough, and where would that leave Schwartzman?

PeaceHealth St. Joseph Medical Center may have the distinction of being the first hospital to have a doctor outsourced from a physician staffing firm unceremoniously fired for telling the public the truth. But it won’t be the last. Hospitals are now telling doctors treating coronavirus patients they will be fired if they speak to the press.

Most People Aren't Aware of the Risk of Systemic Healthcare Failure

Medical Industrial Complex Moved QUICK To Protect Its Interests

WSJ |  The Trump administration is considering using a national disaster program to pay hospitals and doctors for their care of uninsured people infected with the new coronavirus as concerns rise over costs of treating some of the 27 million Americans without health coverage, a person familiar with the conversations said.

In natural disasters such as hurricanes, hospitals and medical facilities can be reimbursed under a federal program that pays them about 110% of Medicare rates for treating patients such as those evacuated from hard-hit areas.

The Centers for Medicare and Medicaid Services has been in discussions about using that program to pay providers who treat uninsured patients with coronavirus, the person said.

Dr. Robert Kadlec, who is the assistant secretary for preparedness and response at the Department of Health and Human Services, said Tuesday at a congressional hearing that discussions are being held about using the National Disaster Medical System reimbursement program.

n 2018, 8.5% of people, or 27.5 million, didn’t have insurance at any point during the year. It was an increase from 2017, when 7.9% of the population, or 25.6 million, were uninsured, according to the U.S. Census Bureau.

Lottery Underway for One Hundred Doses of the Most Expensivist...,

thescientist |  SMA occurs from having two copies of a mutated version of the survival motor neuron 1 (SMN1) gene, which is responsible for the proteins that maintain neurons related to muscle movement. Without proper signals from the brain to move, muscles begin to atrophy and cause a host of related problems, such as decreased mobility and an inability to swallow. Many patients die by age two, and applicants for the lottery must be under two years old. The drug, given intravenously, provides the brain with a functional copy of SMN1 through a viral vector.

Pharmaceutical giant Novartis has begun accepting applications for a lottery-based program to give away 100 doses of a gene therapy for spinal muscular atrophy, a sometimes-deadly muscle-wasting disease that affects about 1 in 10,000 births. The initiative will provide access to children with SMA living in countries where the intervention, Zolgensma, has not yet been approved. But there are far more than 100 patients who could be eligible.

The company has cited production limitations as the reason for high treatment costs and limited doses for the lottery. An independent bioethics committee worked with Novartis to develop the terms of the lottery.

“It’s a difficult situation,” Ricardo Batista, the father of an infant with SMA who lives in Canada, tells The Globe And Mail. “It’s a lottery where we’re leaving children’s lives up to chance. I don’t think it’s a game that any of us want to play.”

Biologics Global Market Opportunities And Strategies To 2021

Shortly before I went on "hiatus" last year, I posted about the Nobel given for "directed evolution" and what I casually referred to as "Mubabs" - you know - all those newfangled biologic medicines that have become pervasive mainstays of broadcast and print advertising. I thought it was amusing just how many oddly named mubabs there were and began collecting the oddly named drugs and what they were prescribed for summer before last.

reportlinker  |  The biologics industry comprises companies manufacturing biological products that are derived from genetically modified proteins and human genes.Biologics products include a wide range of recombinant therapeutic proteins, vaccines, and monoclonal antibodies.

These products are isolated from natural sources such as human, animal, and microorganisms by biotechnological methods and other cutting-edge technologies.

Executive Summary
The global biologics market was worth $221 billion in 2017 and is essentially segmented into monoclonal antibodies, therapeutic proteins and vaccines. Biologics are very large complex molecules manufactured in a living system such as microorganisms, animal cells or plant cells. They are produced using the recombinant DNA technology and are composed of sugars, proteins, nucleic acids or a combination of these substances. In 2017, 12 biologics were approved in the USA, 10 in European Union and 7 in Japan. There are over 1000 biologics under development which will drive the biologics market in the future. Cancer is the therapeutic area with maximum number of biologics under development and Alzheimer’s has the least number.

Of the total biologics market across the globe, Monoclonal antibodies (mAbs) accounted for a share of 43% in 2017 and was worth $94 billion. North America had the highest share in 2017 at $39.2 billion followed by Western Europe with a market value of $26.4 billion. Asia-Pacific was the third largest market with a share of 12% and a market value of $11.4 billion. mAbs are biological drugs that recognize and bind to a specific antigen that causes various chronic health conditions such as arthritis, cancer, multiple sclerosis. mAbs can be further segmented based on the presence of different amounts of murine (mouse or rat origin) sequences in the variable region. The segments consist of murine mAbs, chimeric mAbs, human and humanized mAbs. Of these, humanized mAbs accounted for 43% share in the monoclonal antibody market with a market value of $37.6 billion followed by human mAbs and chimeric mAbs at $32.9 billion and $18.8 billion respectively. Murine mAbs accounted only for 5% of the total mAbs market and was worth $4.7 billion in 2017.

Therapeutic proteins or recombinant proteins are engineered in the laboratory and works by targeting therapeutic process which compensates for the deficiency of an essential protein. Therapeutic proteins include cytokines, peptide hormones and enzymes. The market for therapeutic protein was worth $80 billion in 2017 accounting for a share of 36% of the global biologics market. North American market for therapeutic proteins was worth $33 billion in 2017 followed by Western Europe at $17.3 billion. The market in Asia Pacific was worth $11.3 billion and the markets in South America, Eastern Europe, Middle East and Africa accounted only for 4%, 6%, 9% and 4% respectively. Based on the segmentation of therapeutic proteins into cytokines, peptide hormones and enzymes, peptide hormones accounted for 45% of the market followed by cytokines at 18% and enzymes at 10% share. Other blood factors also had a share of around 27% in the total therapeutic proteins market globally.

The Medical Industrial CONGRESSIONAL Complex

WaPo | Vilified by lawmakers from both parties for months, the health-care industry this year appeared to face an existential threat to its business model.

But this week, pharmaceutical companies, hospitals, insurance companies and medical device manufacturers practically ran the table in Congress, winning hundreds of billions of dollars in tax breaks and other gifts through old-fashioned lobbying, re-exerting their political prowess.

“It’s the ‘no special interest left behind bill’ of 2019. That’s what it feels like this is,” said Andy Slavitt, a former health administrator who served in the Obama administration. “There’s no other explanation.”

Support came from virtually every corner of Congress.

A bipartisan push to curb the practice of surprise medical billing was delayed until next year, with Senate Minority Leader Charles E. Schumer (D-N.Y.) working behind the scenes to raise objections to the package, according to three people familiar with the talks who spoke on the condition of anonymity to share details of private negotiations.

A bipartisan bid to rein in prescription drug prices failed to advance, as Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) blamed Senate Majority Leader Mitch McConnell (R-Ky.) for blocking the effort.

Pharmaceutical firms also won extended protections for select patents, as lawmakers tucked 17 words into Page 1,503 of a bill that critics allege could amount to billions more in profits for the industry.

And through a flurry of letters and targeted meetings with freshman House Democrats, the health-care industry ginned up broad support for repealing taxes that were central to the 2010 Affordable Care Act. Even House Speaker Nancy Pelosi (D-Calif.), one of the law’s architects, agreed to go along.

The success shows how formidable the health-care industry remains, able to overwhelm Democrats with well-honed talking points and splinter Republicans through a concerted push.

A New Era of HealthCare Fraud

khn |  Derek Lewis was working as an electronic health records specialist for the nation’s largest hospital chain when he heard about software defects that might even “kill a patient.”

The doctors at Midwest (City) Regional Medical Center in Oklahoma worried that the software failed to track some drug prescriptions or dosages properly, posing a “huge safety concern,” Lewis said. Lewis cited the alleged safety hazards in a whistleblower lawsuit that he and another former employee of Community Health Systems (CHS) filed against the Tennessee-based hospital chain in 2018.

The suit alleges that the company, which had $14 billion in annual revenue in 2018, obtained millions of dollars in federal subsidies fraudulently by covering up dangerous flaws in these systems at the Oklahoma hospital and more than 120 others it owned or operated at the time.

The whistleblowers also allege that Medhost, the Tennessee firm that developed the software, concealed defects during government-mandated reviews that were supposed to ensure safety.

Both CHS and Medhost have denied the allegations and moved to dismiss the suit. The motions are pending. Last month, Department of Justice lawyers wrote in court filings that they were still investigating the matter and had not yet decided whether to take over the case.

The lawsuit is one of dozens filed by whistleblowers, doctors and hospitals alleging that some electronic health records (EHR) software used in hospitals and medical offices has hidden flaws that may pose a danger to patients — and that a substantial chunk of the $38 billion in federal subsidies went to companies that deceived the government about the quality of their products, an ongoing Fortune-KHN investigation shows. The subsidies were designed to persuade hospitals and doctors’ offices to install software that would track the medical history of every patient and share the information seamlessly with other health care providers.

But the software makers allegedly gamed the system, repeatedly. Three major EHR vendors have made multimillion-dollar settlement deals — totaling $357 million — over Justice Department investigations which include allegations that they rigged or otherwise gamed the government’s certification test. At least two other companies are under investigation.

Beyond those cases, federal officials have paid hundreds of millions of dollars in subsidies to doctors and hospitals that could not show they were even qualified to receive them, according to federal officials. Nearly 28% of doctors and 5% of hospitals who attested to meeting government standards later failed audits. Federal officials told Fortune and KHN that they have clawed back $941 million in improper subsidies.

“We’re entering an entirely new area of health care fraud,” John O’Brien, senior counsel with the Department of Health and Human Services Office of Inspector General, said in a July 2017 video announcing a $155 million False Claims Act settlement with eClinicalWorks, one of the nation’s leading sellers of EHRs for physicians.