Big Pharma

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by Silviu “Silview” Costinescu

This damning op ed just came out on the most prestigious British Medical Journal (BMJ) and shocked a lot of people.
But, as I’ll show you, there’s been even more shocking and more based research out there pointing the same direction ages ago, and it’s been largely overlooked. So maybe it’s time to stop the awe and start going after the blind sentinels we’re paying to safeguard our body of knowledge that keeps us alive.

Oh my, oh my!
How do these academic fucktards (don’t excuse my accuracy) expect anything “evidence-based” to fare in a post-truth world where men are pregnant and virus isolation is done “in cultures”?! I mean, evidence was an endangered species on Planet Science even before woke science and the macarenavirus…
What can the price of evidence be in an economy where “a patient cured is a customer lost”?!
How do they discover hot water in 2022 and expect to maintain a prestige?!

Whatever the answers may be, we can use this and the references I’ll add after to awaken any NPC that still exhibits signs of intelligent life trapped inside:

The illusion of evidence based medicine

BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o702 (Published 16 March 2022) Cite this as: BMJ 2022;376:o702

  1. Jon Jureidini, research leader1,  
  2. Leemon B. McHenry, professor emeritus2

Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors

The advent of evidence based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics. The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry sponsored clinical trials are misrepresented.1234 Until this problem is corrected, evidence based medicine will remain an illusion.

The philosophy of critical rationalism, advanced by the philosopher Karl Popper, famously advocated for the integrity of science and its role in an open, democratic society. A science of real integrity would be one in which practitioners are careful not to cling to cherished hypotheses and take seriously the outcome of the most stringent experiments.5 This ideal is, however, threatened by corporations, in which financial interests trump the common good. Medicine is largely dominated by a small number of very large pharmaceutical companies that compete for market share, but are effectively united in their efforts to expanding that market. The short term stimulus to biomedical research because of privatisation has been celebrated by free market champions, but the unintended, long term consequences for medicine have been severe. Scientific progress is thwarted by the ownership of data and knowledge because industry suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.

The pharmaceutical industry’s responsibility to its shareholders means that priority must be given to their hierarchical power structures, product loyalty, and public relations propaganda over scientific integrity. Although universities have always been elite institutions prone to influence through endowments, they have long laid claim to being guardians of truth and the moral conscience of society. But in the face of inadequate government funding, they have adopted a neo-liberal market approach, actively seeking pharmaceutical funding on commercial terms. As a result, university departments become instruments of industry: through company control of the research agenda and ghostwriting of medical journal articles and continuing medical education, academics become agents for the promotion of commercial products.6 When scandals involving industry-academe partnership are exposed in the mainstream media, trust in academic institutions is weakened and the vision of an open society is betrayed.

The corporate university also compromises the concept of academic leadership. Deans who reached their leadership positions by virtue of distinguished contributions to their disciplines have in places been replaced with fundraisers and academic managers, who are forced to demonstrate their profitability or show how they can attract corporate sponsors. In medicine, those who succeed in academia are likely to be key opinion leaders (KOLs in marketing parlance), whose careers can be advanced through the opportunities provided by industry. Potential KOLs are selected based on a complex array of profiling activities carried out by companies, for example, physicians are selected based on their influence on prescribing habits of other physicians.7 KOLs are sought out by industry for this influence and for the prestige that their university affiliation brings to the branding of the company’s products. As well paid members of pharmaceutical advisory boards and speakers’ bureaus, KOLs present results of industry trials at medical conferences and in continuing medical education. Instead of acting as independent, disinterested scientists and critically evaluating a drug’s performance, they become what marketing executives refer to as “product champions.”

Ironically, industry sponsored KOLs appear to enjoy many of the advantages of academic freedom, supported as they are by their universities, the industry, and journal editors for expressing their views, even when those views are incongruent with the real evidence. While universities fail to correct misrepresentations of the science from such collaborations, critics of industry face rejections from journals, legal threats, and the potential destruction of their careers.8 This uneven playing field is exactly what concerned Popper when he wrote about suppression and control of the means of science communication.9 The preservation of institutions designed to further scientific objectivity and impartiality (i.e., public laboratories, independent scientific periodicals and congresses) is entirely at the mercy of political and commercial power; vested interest will always override the rationality of evidence.10

Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence do we have in a system in which drug companies are permitted to “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system? Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue, advertising, and sponsorship revenue.

Our proposals for reforms include: liberation of regulators from drug company funding; taxation imposed on pharmaceutical companies to allow public funding of independent trials; and, perhaps most importantly, anonymised individual patient level trial data posted, along with study protocols, on suitably accessible websites so that third parties, self-nominated or commissioned by health technology agencies, could rigorously evaluate the methodology and trial results. With the necessary changes to trial consent forms, participants could require trialists to make the data freely available. The open and transparent publication of data are in keeping with our moral obligation to trial participants—real people who have been involved in risky treatment and have a right to expect that the results of their participation will be used in keeping with principles of scientific rigour. Industry concerns about privacy and intellectual property rights should not hold sway.

Footnotes

  • Competing interests: McHenry and Jureidini are joint authors of The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research (Adelaide: Wakefield Press, 2020). Both authors have been remunerated by Los Angeles law firm, Baum, Hedlund, Aristei and Goldman for a fraction of the work they have done in analysing and critiquing GlaxoSmithKline’s paroxetine Study 329 and Forest Laboratories citalopram Study CIT-MD-18. They have no other competing interests to declare.
  • Provenance and peer review: Not commissioned, externally peer reviewed

References

  1. ↵
    1. Steinman MA, 
    2. Bero LA, 
    3. Chren MM, 
    4. Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med2006;145:284-93. doi:10.7326/0003-4819-145-4-200608150-00008 pmid:16908919CrossRef PubMed Web of Science Google Scholar
  2. ↵
    1. Mukherjee D, 
    2. Nissen SE, 
    3. Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA2001;286:954-9. doi:10.1001/jama.286.8.954. pmid:11509060 CrossRef PubMed Web of Science Google Scholar
  3. ↵
    1. Doshi P. Pandemrix vaccine: why was the public not told of early warning signs?BMJ2018;362:k3948doi:10.1136/bmj.k3948. FREE Full Text Google Scholar
  4. ↵
    1. Jureidini J, 
    2. McHenry L, 
    3. Mansfield P. Clinical trials and drug promotion: Selective reporting of Study 329. Int J Risk Saf Med2008;20:73-81doi:10.3233/JRS-2008-0426. CrossRef Google Scholar
  5. ↵
    1. Popper K. The Logic of Scientific Discovery.Basic Books, 1959. Google Scholar
  6. ↵
    1. Bok D. Universities in the Marketplace: The Commercialization of Higher Education.Princeton University Press, 2003.Google Scholar
  7. ↵IntraMed. Criteria Used to Develop Influence Score. 2008. https://www.industrydocumentslibrary.ucsf.edu/drug/docs/#id=shbn0225
  8. ↵Schafer A. Biomedical conflicts of interest: A defense of the sequestration thesis—Learning from the cases of Nancy Olivieri and David Healy. Journal of Medical Ethics. 2004;30:8-24.
  9. ↵
    1. Popper K. The Poverty of Historicism. Routledge, 1961: 154-5. Google Scholar
  10. ↵
    1. Howick J. Exploring the asymmetrical relationship between the power of finance bias and evidence. Perspect Biol Med2019;62:159-87. doi:10.1353/pbm.2019.0009 pmid:31031303 CrossRef PubMed Google Scholar

As you can see, their references range mostly from classical to old. Experienced tinfoil hats must already be yawning by now, but they’re not the primary target for this piece.

Here are some really good comments on this from Bret Weinstein:

Now let me provide some more reading recommendations along this line.

The very same BMJ, almost 10 years ago:

Education And Debate

Who pays for the pizza? Redefining the relationships between doctors and drug companies –

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7400.1189 (Published 29 May 2003)

“Twisted together like the snake and the staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous (box). As national drug bills rise at rates that vastly exceed those of inflation (fig 1), this entanglement and the subsequent flows of money and influence are attracting increasing public and academic scrutiny.

Studies from several countries show that 80-95% of doctors regularly see drug company representatives despite evidence that their information is overly positive and prescribing habits are less appropriate as a result.1 2 Many doctors receive multiple gifts from drug companies every year, and most doctors deny their influence despite considerable evidence to the contrary.3 Industry interactions correlate with doctors’ preferences for new products that hold no demonstrated advantage over existing ones, a decrease in the prescribing of generics, and a rise in both prescription expenditures and irrational and incautious prescribing, according to a recent analysis of the ethics of gift giving.4 The number of gifts that doctors receive correlates with beliefs that drug representatives have no impact on prescribing behaviour.3

Accepting meals and expenses for travel or accommodation for sponsored educational meetings is common despite evidence that this is associated with an increase in formulary requests for and prescribing of the sponsor’s drug.2 3 Most doctors attend company sponsored events providing continuing medical education, 2 yet evidence shows that these preferentially high-light the sponsor’s drug.3 Many professional societies rely heavily on industry sponsorship, …”

Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs

Journal of Law, Medicine and Ethics, 2013, Vol. 14, No. 3: 590-610, Posted: 20 Jun 2013 Last revised: 11 Apr 2020

Donald W. Light – Rowan University School of Osteopathic Medicine ; Center for Migration and Development; Institute for Advanced Study

Joel Lexchin – York University

Jonathan J. Darrow = Harvard Medical School

Date Written: June 1, 2013

Abstract

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.

Most scientists ‘can’t replicate studies by their peers’

BBC, 22 February 2017

Test tubes
Image caption,Scientists attempting to repeat findings reported in five landmark cancer studies confirmed only two

Science is facing a “reproducibility crisis” where more than two-thirds of researchers have tried and failed to reproduce another scientist’s experiments, research suggests.

This is frustrating clinicians and drug developers who want solid foundations of pre-clinical research to build upon.

From his lab at the University of Virginia’s Centre for Open Science, immunologist Dr Tim Errington runs The Reproducibility Project, which attempted to repeat the findings reported in five landmark cancer studies.

“The idea here is to take a bunch of experiments and to try and do the exact same thing to see if we can get the same results.”

You could be forgiven for thinking that should be easy. Experiments are supposed to be replicable.

The authors should have done it themselves before publication, and all you have to do is read the methods section in the paper and follow the instructions.

Sadly nothing, it seems, could be further from the truth.

After meticulous research involving painstaking attention to detail over several years (the project was launched in 2011), the team was able to confirm only two of the original studies’ findings.

Two more proved inconclusive and in the fifth, the team completely failed to replicate the result.

“It’s worrying because replication is supposed to be a hallmark of scientific integrity,” says Dr Errington.

Concern over the reliability of the results published in scientific literature has been growing for some time.

According to a survey published in the journal Nature last summer, more than 70% of researchers have tried and failed to reproduce another scientist’s experiments.

Marcus Munafo is one of them. Now professor of biological psychology at Bristol University, he almost gave up on a career in science when, as a PhD student, he failed to reproduce a textbook study on anxiety.

“I had a crisis of confidence. I thought maybe it’s me, maybe I didn’t run my study well, maybe I’m not cut out to be a scientist.”

The problem, it turned out, was not with Marcus Munafo’s science, but with the way the scientific literature had been “tidied up” to present a much clearer, more robust outcome.

“What we see in the published literature is a highly curated version of what’s actually happened,” he says.

“The trouble is that gives you a rose-tinted view of the evidence because the results that get published tend to be the most interesting, the most exciting, novel, eye-catching, unexpected results.

“What I think of as high-risk, high-return results.”

The reproducibility difficulties are not about fraud, according to Dame Ottoline Leyser, director of the Sainsbury Laboratory at the University of Cambridge.

That would be relatively easy to stamp out. Instead, she says: “It’s about a culture that promotes impact over substance, flashy findings over the dull, confirmatory work that most of science is about.”

She says it’s about the funding bodies that want to secure the biggest bang for their bucks, the peer review journals that vie to publish the most exciting breakthroughs, the institutes and universities that measure success in grants won and papers published and the ambition of the researchers themselves.

“Everyone has to take a share of the blame,” she argues. “The way the system is set up encourages less than optimal outcomes.”

Top of a copy of Nature magazine
Image caption,Scientific journals can play a role in helping improve the reliability of reporting

For its part, the journal Nature is taking steps to address the problem.

It’s introduced a reproducibility checklist for submitting authors, designed to improve reliability and rigour.

“Replication is something scientists should be thinking about before they write the paper,” says Ritu Dhand, the editorial director at Nature.

“It is a big problem, but it’s something the journals can’t tackle on their own. It’s going to take a multi-pronged approach involving funders, the institutes, the journals and the researchers.”

But we need to be bolder, according to the Edinburgh neuroscientist Prof Malcolm Macleod.

“The issue of replication goes to the heart of the scientific process.”

Writing in the latest edition of Nature, he outlines a new approach to animal studies that calls for independent, statistically rigorous confirmation of a paper’s central hypothesis before publication.

“Without efforts to reproduce the findings of others, we don’t know if the facts out there actually represent what’s happening in biology or not.”

Without knowing whether the published scientific literature is built on solid foundations or sand, he argues, we’re wasting both time and money.

“It could be that we would be much further forward in terms of developing new cures and treatments. It’s a regrettable situation, but I’m afraid that’s the situation we find ourselves in.”

“UP TO 90% OF THE PUBLISHED MEDICAL INFORMATION IS FLAWED” – PSYCHOLOGY TODAY

“Can any medical research studies be trusted?” – Psychology Today

Why Has the Number of Scientific Retractions Increased?

Abstract

Background

The number of retracted scientific publications has risen sharply, but it is unclear whether this reflects an increase in publication of flawed articles or an increase in the rate at which flawed articles are withdrawn.

Methods and Findings

We examined the interval between publication and retraction for 2,047 retracted articles indexed in PubMed. Time-to-retraction (from publication of article to publication of retraction) averaged 32.91 months. Among 714 retracted articles published in or before 2002, retraction required 49.82 months; among 1,333 retracted articles published after 2002, retraction required 23.82 months (p<0.0001). This suggests that journals are retracting papers more quickly than in the past, although recent articles requiring retraction may not have been recognized yet. To test the hypothesis that time-to-retraction is shorter for articles that receive careful scrutiny, time-to-retraction was correlated with journal impact factor (IF). Time-to-retraction was significantly shorter for high-IF journals, but only ∼1% of the variance in time-to-retraction was explained by increased scrutiny. The first article retracted for plagiarism was published in 1979 and the first for duplicate publication in 1990, showing that articles are now retracted for reasons not cited in the past. The proportional impact of authors with multiple retractions was greater in 1972–1992 than in the current era (p<0.001). From 1972–1992, 46.0% of retracted papers were written by authors with a single retraction; from 1993 to 2012, 63.1% of retracted papers were written by single-retraction authors (p<0.001).

Conclusions

The increase in retracted articles appears to reflect changes in the behavior of both authors and institutions. Lower barriers to publication of flawed articles are seen in the increase in number and proportion of retractions by authors with a single retraction. Lower barriers to retraction are apparent in an increase in retraction for “new” offenses such as plagiarism and a decrease in the time-to-retraction of flawed work.

Misconduct accounts for the majority of retracted scientific publications

Ferric C. Fang, R. Grant Steen, and Arturo Casadevall arturo.casadevall@einstein.yu.edu

October 1, 2012 | 109 (42) 17028-17033 | https://doi.org/10.1073/pnas.1212247109

Abstract

A detailed review of all 2,047 biomedical and life-science research articles indexed by PubMed as retracted on May 3, 2012 revealed that only 21.3% of retractions were attributable to error. In contrast, 67.4% of retractions were attributable to misconduct, including fraud or suspected fraud (43.4%), duplicate publication (14.2%), and plagiarism (9.8%). Incomplete, uninformative or misleading retraction announcements have led to a previous underestimation of the role of fraud in the ongoing retraction epidemic. The percentage of scientific articles retracted because of fraud has increased ∼10-fold since 1975. Retractions exhibit distinctive temporal and geographic patterns that may reveal underlying causes.

The number and frequency of retracted publications are important indicators of the health of the scientific enterprise, because retracted articles represent unequivocal evidence of project failure, irrespective of the cause. Hence, retractions are worthy of rigorous and systematic study. The retraction of flawed publications corrects the scientific literature and also provides insights into the scientific process. However, the rising frequency of retractions has recently elicited concern (1, 2). Studies of selected retracted articles have suggested that error is more common than fraud as a cause of retraction (3–5) and that rates of retraction correlate with journal-impact factor (6). We undertook a comprehensive analysis of all retracted articles indexed by PubMed to ascertain the validity of the earlier findings. Retracted articles were classified according to whether the cause of retraction was documented fraud (data falsification or fabrication), suspected fraud, plagiarism, duplicate publication, error, unknown, or other reasons (e.g., journal error, authorship dispute).

Retracted scientific paper persists in new citations, study finds – Illinois University, JAN 5, 2021

“Pharmaceutical companies often manipulate the word innovation for rhetorical purposes and seldom develop clinically superior drugs, thus corrupting the R&D process. He cited studies indicating that over the past 30 years, on average fewer than 2 major clinical advances and 7-13 superior drugs were developed each year, compared with the 85-90 drugs that are developed with few or no advantages. With 113,000 deaths a year caused by adverse drug reactions just in hospitalized patients and 2.5 million serious reactions, Professor Light believes there is an epidemic of harmful side effects from drugs that often have few offsetting advantages.”

“The Pharmaceutical Industry, Institutional Corruption, and an Epidemic of Harms” – Donald Light Harvard seminar

Conflicts of Interest as a Health Policy Problem: Industry Ties and Bias in Drug Approval – Harvard University 2014

“A staggering 94% of surveyed physicians acknowledged receiving financial compensation of some form from pharmaceutical companies, ranging from small perks such as free gifts and meals to stipendiary speaking invitations and salaried positions as industry consultants.”

Drug Companies and Medicine: What Money Can Buy – Harvard University, 2009

The Haunting of Medical Journals: How Ghostwriting Sold “HRT”

Summary Points

  • Some 1500 documents revealed in litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals.
  • Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HT), and to cast raloxifene and other competing therapies in a negative light.
  • Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.
  • Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.

Introduction

In recent litigation against Wyeth, more than 14,000 plaintiffs brought claims related to the development of breast cancer while taking the menopausal hormone therapy Prempro (conjugated equine estrogens [CEEs] and medroxyprogesterone acetate [MPA]). Some 1500 documents revealed in the litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals. These documents became public when PLoS Medicine and The New York Times intervened in the litigation. Both intervenors successfully argued that ghostwriting undermines public health and that documents proving the practice should be unsealed.

In this Policy Forum article, I use these documents, which are available through PLoS at http://www.plosmedicine.org/static/ghostwriting.action or at the Drug Information Document Archive at http://dida.library.ucsf.edu/documents.jsp to show how industry uses ghostwriters to insert marketing messages into articles published in medical journals. As a paid expert witness, I had access to these documents during the litigation but I have received no payment for researching or writing this Policy Forum.

Hormone Therapy History

In 1942, Premarin (CEE) became the first FDA-approved treatment for hot flashes. Promotional efforts implied that estrogen could preserve youth and health. By the early 1970s, physicians, under the mistaken impression that menopause was an endocrine disease similar to hypothyroidism, were prescribing estrogen to millions of asymptomatic women. In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use, and estrogen sales decreased [1].

After adding a progestin pill to counteract estrogen-induced endometrial cancer, hormone “replacement” therapy (HRT; now properly termed menopausal hormone therapy, or HT) became popular in the 1980s. Through the 1990s, HT was touted to prevent cardiovascular disease, osteoporosis, Alzheimer’s disease, colon cancer, tooth loss, and macular degeneration [1]. Prempro, which combined CEE and the progestin Provera (medroxyprogesterone acetate), was approved in the U.S. in 1995. In 1998, the Heart and Estrogen/progestin Replacement Study (HERS), a randomized controlled trial (RCT) in women with cardiovascular disease, found no benefit of HT for preventing cardiovascular events [2]. In 2002, the Women’s Health Initiative (WHI), a large RCT in healthy women, demonstrated conclusively that HT failed to prevent cardiovascular disease, increased the risk of breast cancer and stroke, and reduced fracture risk [3],[4]. Later analyses revealed that HT increased the risk of dementia [5] and incontinence [6].

Today, despite definitive scientific data to the contrary, many gynecologists still believe that the benefits of HT outweigh the risks in asymptomatic women [1],[7]–[8]. This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.

To be continued?
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! Articles can always be subject of later editing as a way of perfecting them

ORDER

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by Silviu “Silview” Costinescu

I’ll be brief, debunking celebritard pranks is a bit of a low bar for me, but seeing the Pfizer connection…

SOURCE

SOURCE
SOURCE
SOURCE

BONUS

SOURCE
SOURCE

Also:

https://www.biospace.com/article/pfizer-trial-meets-efficacy-endpoint-for-potential-alopecia-areata-therapy/

Thanks Jane Doe1776 !

When I was a young lad, we used to call this BTL – Below The Line advertising. Now excuse me for a little while, I need to use the bathroom.

To be continued?
Our work and existence, as media and people, is funded solely by our most generous supporters. But we’re not really covering our costs so far, and we’re in dire needs to upgrade our equipment, especially for video production.
Help SILVIEW.media survive and grow, please donate here, anything helps. Thank you!

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by Silviu “Silview” Costinescu

Just like your whole government and ruling class

To be continued?
Our work and existence, as media and people, is funded solely by our most generous supporters. But we’re not really covering our costs so far, and we’re in dire needs to upgrade our equipment, especially for video production.
Help SILVIEW.media survive and grow, please donate here, anything helps. Thank you!

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Sometimes my memes are 3D. And you can own them. Or send them to someone.
You can even eat some of them.
CLICK HERE

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by Silviu “Silview” Costinescu

Every time I hear Pharma dispensers like Paul Ofitt or Pharma trolls like Biden accusing non-vaccinated people of murder, this study comes to mind first thing.
This British Medical Journal analysis used to be one of the first shadow-banned links on Facebook, years before the term was even coined. Together with Google, they managed to fade it out from public attention and references, but it’s a staple of medical journalism and criticism.

Medical error—the third leading cause of death in the US

British Medical Journal  03 May 2016

Summary points
-Death certificates in the US, used to compile national statistics, have no facility for acknowledging medical error
-If medical error was a disease, it would rank as the third leading cause of death in the US
-The system for measuring national vital statistics should be revised to facilitate better understanding of deaths due to medical care

Medical error is not included on death certificates or in rankings of cause of death. Martin Makary and Michael Daniel assess its contribution to mortality and call for better reporting

The annual list of the most common causes of death in the United States, compiled by the Centers for Disease Control and Prevention (CDC), informs public awareness and national research priorities each year. The list is created using death certificates filled out by physicians, funeral directors, medical examiners, and coroners. However, a major limitation of the death certificate is that it relies on assigning an International Classification of Disease (ICD) code to the cause of death.1 As a result, causes of death not associated with an ICD code, such as human and system factors, are not captured. The science of safety has matured to describe how communication breakdowns, diagnostic errors, poor judgment, and inadequate skill can directly result in patient harm and death. We analyzed the scientific literature on medical error to identify its contribution to US deaths in relation to causes listed by the CDC.2

Death from medical care itself

Medical error has been defined as an unintended act (either of omission or commission) or one that does not achieve its intended outcome,3 the failure of a planned action to be completed as intended (an error of execution), the use of a wrong plan to achieve an aim (an error of planning),4 or a deviation from the process of care that may or may not cause harm to the patient.5 Patient harm from medical error can occur at the individual or system level. The taxonomy of errors is expanding to better categorize preventable factors and events.6 We focus on preventable lethal events to highlight the scale of potential for improvement.

Case history: role of medical error in patient death
A young woman recovered well after a successful transplant operation. However, she was readmitted for non-specific complaints that were evaluated with extensive tests, some of which were unnecessary, including a pericardiocentesis. She was discharged but came back to the hospital days later with intra-abdominal hemorrhage and cardiopulmonary arrest. An autopsy revealed that the needle inserted during the
pericardiocentesis grazed the liver causing a pseudoaneurysm that resulted in subsequent rupture and death. The death certificate listed the cause of death as cardiovascular.

The role of error can be complex. While many errors are
non-consequential, an error can end the life of someone with a
long life expectancy or accelerate an imminent death. The case
in the box shows how error can contribute to death. Moving
away from a requirement that only reasons for death with an
ICD code can be used on death certificates could better inform
healthcare research and awareness priorities.


How big is the problem?

The most commonly cited estimate of annual deaths from
medical error in the US—a 1999 Institute of Medicine (IOM)
report7—is limited and outdated. The report describes an
incidence of 44 000-98 000 deaths annually.7 This conclusion
was not based on primary research conducted by the institute
but on the 1984 Harvard Medical Practice Study and the 1992
Utah and Colorado Study.8 9 But as early as 1993, Leape, a chief
investigator in the 1984 Harvard study, published an article
arguing that the study’s estimate was too low, contending that
78% rather than 51% of the 180 000 iatrogenic deaths were
preventable (some argue that all iatrogenic deaths are
preventable).10 This higher incidence (about 140 400 deaths due
to error) has been supported by subsequent studies which suggest
that the 1999 IOM report underestimates the magnitude of the
problem.
A 2004 report of inpatient deaths associated with the
Agency for Healthcare Quality and Research Patient Safety
Indicators in the Medicare population estimated that 575 000
deaths were caused by medical error between 2000 and 2002,
which is about 195 000 deaths a year (table 1⇓).11 Similarly, the
US Department of Health and Human Services Office of the
Inspector General examining the health records of hospital
inpatients in 2008, reported 180 000 deaths due to medical error
a year among Medicare beneficiaries alone.12 Using similar
methods, Classen et al described a rate of 1.13%.13 If this rate
is applied to all registered US hospital admissions in 201315 it
translates to over 400 000 deaths a year, more than four times
the IOM estimate.
Similarly, Landrigan et al reported that 0.6% of hospital
admissions in a group of North Carolina hospitals over six years
(2002-07) resulted in lethal adverse events and conservatively
estimated that 63% were due to medical errors.14 Extrapolated
nationally, this would translate into 134 581 inpatient deaths a
year from poor inpatient care. Of note, none of the studies
captured deaths outside inpatient care—those resulting from
errors in care at home or in nursing homes and in outpatient
care such as ambulatory surgery centers.

A literature review by James estimated preventable adverse
events using a weighted analysis and described an incidence
range of 210 000-400 000 deaths a year associated with medical
errors among hospital patients.16 We calculated a mean rate of
death from medical error of 251 454 a year using the studies
reported since the 1999 IOM report and extrapolating to the
total number of US hospital admissions in 2013. We believe
this understates the true incidence of death due to medical error
because the studies cited rely on errors extractable in
documented health records and include only inpatient deaths.
Although the assumptions made in extrapolating study data to
the broader US population may limit the accuracy of our figure,
the absence of national data highlights the need for systematic
measurement of the problem. Comparing our estimate to CDC
rankings suggests that medical error is the third most common
cause of death in the US (fig 1⇓).2

Better data

Human error is inevitable. Although we cannot eliminate human
error, we can better measure the problem to design safersystems
mitigating its frequency, visibility, and consequences. Strategies
to reduce death from medical care should include three steps:
making errors more visible when they occur so their effects can
be intercepted; having remedies at hand to rescue patients 17;
and making errors less frequent by following principles that
take human limitations into account (fig 2⇓). This multitier
approach necessitates guidance from reliable data.
Currently, deaths caused by errors are unmeasured and
discussions about prevention occur in limited and confidential
forums, such as a hospital’s internal root cause analysis
committee or a department’s morbidity and mortality conference.
These forums review only a fraction of detected adverse events
and the lessons learnt are not disseminated beyond the institution
or department.
There are several possible strategies to estimate accurate national
statistics for death due to medical error. Instead of simply
requiring cause of death, death certificates could contain an
extra field asking whether a preventable complication stemming
from the patient’s medical care contributed to the death. An
early experience asking physicians to comment on the potential
preventability of inpatient deaths immediately after they
occurred resulted in an 89% response rate.18 Another strategy
would be for hospitals to carry out a rapid and efficient
independent investigation into deaths to determine the potential
contribution of error. A root cause analysis approach would
enable local learning while using medicolegal protections to
maintain anonymity. Standardized data collection and reporting
processes are needed to build up an accurate national picture of
the problem. Measuring the consequences of medical care on
patient outcomes is an important prerequisite to creating a
culture of learning from our mistakes, thereby advancing the
science of safety and moving us closer towards the Institute of
Medicine’s goal of creating learning health systems. (19)

Health priorities

We have estimated that medical error is the third biggest cause
of death in the US and therefore requires greater attention.
Medical error leading to patient death is under-recognized in
many other countries, including the UK and Canada.20 21
According to WHO, 117 countries code their mortality statistics
using the ICD system as the primary indicator of health status.22
The ICD-10 coding system has limited ability to capture most
types of medical error. At best, there are only a few codes where
the role of error can be inferred, such as the code for
anticoagulation causing adverse effects and the code for
overdose events. When a medical error results in death, both
the physiological cause of the death and the related problem
with delivery of care should be captured.
To achieve more reliable healthcare systems, the science of
improving safety should benefit from sharing data nationally
and internationally, in the same way as clinicians share research
and innovation about coronary artery disease, melanoma, and
influenza. Sound scientific methods, beginning with an
assessment of the problem, are critical to approaching any health
threat to patients. The problem of medical error should not be
exempt from this scientific approach. More appropriate
recognition of the role of medical error in patient death could
heighten awareness and guide both collaborations and capital
investments in research and prevention.
Contributors and sources: MM is the developer of the operating room
checklist, the precursor to the WHO surgery checklist. He is a surgical
oncologist at Johns Hopkins and author of Unaccountable, a book about
transparency in healthcare. MD is the Rodda patient safety research
fellow at Johns Hopkins and is focused on health services research.
This article arose from discussions about the paucity of funding available
to support quality and safety research relative to other causes of death.


1 Moriyama IM, Loy RM, Robb-Smith AHT, et al. History of the statistical classification of
diseases and causes of death. National Center for Health Statistics, 2011.
2 Deaths: final data for 2013. National vital statistics report. http://www.cdc.gov/nchs/fastats/
leading-causes-of-death.htm.
3 Leape LL. Error in medicine. JAMA 1994;272:1851-7. doi:10.1001/jama.1994.
03520230061039 pmid:7503827.
4 Reason J. Human error. Cambridge University Press, 1990. doi:10.1017/
CBO9781139062367.
5 Reason JT. Understanding adverse events: the human factor. In: Vincent C, ed. Clinical
risk management: enhancing patient safety. BMJ, 2001:9-30.
6 Grober ED, Bohnen JM. Defining medical error. Can J Surg 2005;48:39-44.pmid:15757035.
7 Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system.
National Academies Press, 1999.
8 Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in
hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med
1991;324:370-6. doi:10.1056/NEJM199102073240604 pmid:1987460.
9 Thomas EJ, Studdert DM, Newhouse JP, et al. Costs of medical injuries in Utah and
Colorado. Inquiry 1999;36:255-64.pmid:10570659.
10 Leape LL, Lawthers AG, Brennan TA, Johnson WG. Preventing medical injury. Qual Rev
Bull 1993;19:144-9.pmid:8332330.
11 HealthGrades quality study: patient safety in American hospitals. 2004. http://www.
providersedge.com/ehdocs/ehr_articles/Patient_Safety_in_American_Hospitals-2004.pdf.
12 Department of Health and Human Services. Adverse events in hospitals: national incidence
among Medicare beneficiaries. 2010. http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf.
13 Classen D, Resar R, Griffin F, et al. Global “trigger tool” shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff 2011;30:581-9doi:
10.1377/hlthaff.2011.0190.
14 Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal
trends in rates of patient harm resulting from medical care. N Engl J Med
2010;363:2124-34. doi:10.1056/NEJMsa1004404 pmid:21105794.
15 American Hospital Association. Fast facts on US hospitals. 2015.http://www.aha.org/
research/rc/stat-studies/fast-facts.shtml.
16 James JTA. A new, evidence-based estimate of patient harms associated with hospital
care. J Patient Saf 2013;9:122-8. doi:10.1097/PTS.0b013e3182948a69 pmid:23860193.
17 Ghaferi AA, Birkmeyer JD, Dimick JB. Complications, failure to rescue, and mortality with
major inpatient surgery in Medicare patients. Ann Surg 2009;250:1029-34. doi:10.1097/
SLA.0b013e3181bef697 pmid:19953723.
18 Provenzano A, Rohan S, Trevejo E, Burdick E, Lipsitz S, Kachalia A. Evaluating inpatient
mortality: a new electronic review process that gathers information from front-line providers.
BMJ Qual Saf 2015;24:31-7. doi:10.1136/bmjqs-2014-003120 pmid:25332203.
19 Institute of Medicine of the National Academies. Continuous improvement and innovation
in health and health care. Round table on value and science-driven health care. National
Academies Press, 2011.
20 Office for National Statistics’ Death Certification Advisory Group. Guidance for doctors
completing medical certificates of cause of death in England and Wales. 2010.
21 Statistics Canada. Canadian vital statistics, death database and population estimates.
http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/hlth36a-eng.htm.
22 World Health Organization. International classification of diseases.http://www.who.int/
classifications/icd/en/.

To be continued?
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by Silviu “Silview” Costinescu

If you’re a typical millennial, schooled, not educated, and with no historical time perception, you may think this happened ages ago and it’s no longer relevant. But the victims would be younger than my mom today and the affair has been concluded just a few years before my birth. It is conceivable that some of the participants are still working and giving advice on Covid nowadays.

Pharmafia and its faucist lemmings have jumped on an imaginary flying white horse and are pointing fingers at all dissatisfied costumers and skeptics from some imaginary moral heights they fly in their empathy-deficient heads.
They call out racism, egoism and what not in everyone who’s not a Pharma-junkie yet, projecting their own faults all over the place like a garden sprinkler made by Goebbels Industries .
They need bitch-slapped back into reality with some historical facts.
Because if a person had Pharmafia’s criminal record, you’d ask for bodyguards and a restraining order, and the last thing you’d take from them would be health-advice.

THE HIDDEOUS THRUTHS OF TESTING VACCINES ON HUMANS

By Leah Rosenbaum, Forbes, June 12, 2020

Sixty years ago, a monstrous hepatitis experiment was performed on mentally disabled children at Willowbrook State School that raises serious ethical questions about vaccine challenge trials for Covid-19.

Nina Galen was ten years old when she became part of one of the most controversial human experiments in American history. Her mother, Diana McCourt, was looking for an institution that could care for her severely autistic daughter. “I was just desperate,” McCourt says now, more than 50 years later. “I think I was having a breakdown because I was just trying to take care of everything.”

McCourt finally settled on Willowbrook State School, a home for severely developmentally challenged children and adults on Staten Island, New York. In order to get Nina a spot at the overcrowded facility, however, she had to make a Faustian bargain—consenting to allow her daughter to be part of a quest to find a vaccine for hepatitis. “I had no choice,” McCourt says, “I had tried so many different places and so many arrangements, and they didn’t work out, so I went along with it.” 

Nina became one of more than 50 mentally disabled children, ages 5 to 10, under the care of Dr. Saul Krugman, a respected pediatrician from New York who wanted to determine if there were multiple strains of hepatitis, and whether a vaccine could be created to protect against the disease. Krugman and his partner, Dr. Joan Giles, used the Willowbrook residents to test a preliminary vaccine for this disease that had killed millions worldwide. From 1955 to 1970, the children were injected with the virus itself or made to drink chocolate milk mixed with feces from other infected children in order to study their immunity.

For much of human history, hepatitis caused some of the deadliest outbreaks in the world. The symptoms, including fever, liver damage and yellow skin, were written about by Hippocrates in the fifth century B.C.E. While we now know that there are multiple viruses (most famously, hepatitis A, B and C), in the first half of the 20th century researchers only knew of one form of the disease, which was then called epidemic jaundice. 

Finding a vaccine became particularly important for the United States during World War II, when hepatitis outbreaks affected more than 50,000 American troops. To fight this disease and others, the Surgeon General’s office established the Armed Forces Epidemiological Board.

Willowbrook-building
School for Scandal: In addition to conducting hepatitis experiments, Willowbrook’s staff physically abused residents.

In the early 1950s, Dr. Krugman, a former flight surgeon for the U.S. Army Air Corps, went to the Epidemiological Board with a proposition: he wanted to create a vaccine for hepatitis, and knew the perfect place where he could do his research. Willowbrook was overcrowded, already rampant with disease, and at the time it wasn’t uncommon to test vaccines on children.

The idea goes back to the grandfather of vaccines himself, Edward Jenner, who used an 8-year-old boy as the first test subject of his groundbreaking smallpox vaccine in the late 18th century. The Willowbrook hepatitis experiments would be vaccine challenge experiments, so-called because the body is intentionally “challenged” with a direct exposure to the virus to see if a particular treatment prevents someone from getting the disease. 

“He believed he was helping the children at this school deal with the epidemic,” says Dr. Krugman’s son Richard, a pediatrician at the Children’s Hospital Colorado and former head of the U.S. Advisory Board on Child Abuse and Neglect. “He certainly thought he was making a contribution to infectious disease research.”

Although there’s little doubt that Dr. Krugman accelerated the discovery of a hepatitis vaccine, the ethics of his experiment have resurfaced as vaccine challenge trials are being debated for Covid-19. Many politicians, medical ethicists and scientists have come out in favor of the idea, which would include giving healthy volunteers a dose of an unproven vaccine, and then deliberately exposing them to Covid-19 to see if it offers protection against the virus.

While the vaccine challenge trials would be done with healthy adult volunteers, the Covid-19 vaccine challenge trial and the Willowbrook hepatitis experiments beg the same question: Is it really necessary—or right—to risk the health of a few for the benefit of many? 

Saul Krugman arrived at the bucolic Willowbrook campus in 1955. Nestled on almost 400 acres on Staten Island, the large, U-shaped brick buildings were surrounded by a lush green forest. A painted yellow and blue carousel sat at the entrance to the grounds, and first-time visitors described it as enchanting, like a summer camp. Inside, however, Willowbrook was a nightmare. 

Do No Harm: RFK described Willowbrook's conditions as ″less comfortable and cheerful than the cages in which we put animals in a zoo.″
Do No Harm: RFK described Willowbrook’s conditions as “less comfortable and cheerful than the cages in which we put animals in a zoo.” 
But since the kids were mostly white and many of the “caregivers” black, I doubt libtards will get triggered by this

The school opened in 1947 and was built to hold 4,000 residents, but for years that number was over 6,000. Disease and neglect were everywhere, and multiple residents died from untreated illness and abuse. In 1965, Robert F. Kennedy, then a New York Senator, made an unannounced visit to Willowbrook and left appalled. “There are no civil liberties for those put in the cells of Willowbrook,” he later testified before Congress, calling the institution a “snake pit.” 

When Dr. Krugman and Dr. Giles began the Willowbrook hepatitis experiments, they used the conditions of Willowbrook to their advantage for recruiting new families. Despite its well-documented horrors, Willowbrook was still one of the only options for children with severe disabilities, and there was a long waitlist. Dr. Krugman offered several parents, including Nina Galen’s, the ability to jump the line and have their children put in the newer, cleaner research wards with more staff—if they joined the experiments. “I did feel coerced,” McCourt says, “I felt like I was denied help unless I took this [opportunity].” 

Krugman also told parents that since hepatitis was already prevalent at Willowbrook, their children may as well have the chance for a vaccine. McCourt remembers being told her daughter could get an “antidote” to hepatitis if she joined the experiment. When she asked why the hepatitis studies couldn’t be done on primates, she was told that using animals would be “too expensive.”

Despite understanding the optics of infecting mentally disabled children with a potentially deadly disease, Dr. Krugman felt the risk was worth the reward. “The decision to feed hepatitis virus to patients at Willowbrook was not undertaken lightly,” he wrote in a 1958 paper published in the New England Journal of Medicine. He noted that the strain of hepatitis in Willowbrook wasn’t very severe, that many of the children would get infected anyway, and that any knowledge gained from the experiment would in fact help other Willowbrook residents. He also emphasized that the study was sanctioned by the New York State Department of Mental Hygiene, and the Armed Forces Epidemiological Board of the Surgeon General’s Office. 

“I don’t think you’re ever justified to inoculate a child with an infectious virus that might kill them,” says pediatrician Paul Offit. 

Some of Dr. Krugman’s trials built on previous research that giving children antibodies from patients who had recovered from hepatitis could prevent new infections. (A similar concept, using convalescent plasma of recovered Covid-19 patients to treat sick patients, is being explored today.)

The experiments also involved infecting healthy children with the virus through the chocolate milk concoction. The doctors eventually learned how much it took for the children to show symptoms of hepatitis, allowed them to recover, and then gave them the virus all over again. These experiments were done to test if someone who had recovered from hepatitis would remain immune or if they could be reinfected again. 

As each trial concluded, Dr. Krugman published the results in prominent medical journals including the New England Journal of Medicine, the Lancet, and the Journal of the American Medical Association. From the time of the first publication, the experiments were controversial within the medical community. In 1966, renowned medical ethicist Henry K. Beecher published an article titled, “Ethics and Clinical Research,” which listed Willowbrook as an example of an unethical clinical experiment and concluded that “there is no right to risk an injury to one person for the benefit of others.” 

Five years later, the editorial board of the Lancet apologized for publishing Dr. Krugman’s studies without greater skepticism. “The Willowbrook experiments have always carried a hope that hepatitis might one day be prevented,” the editors wrote, “but that could not justify the giving of infected material to children who would not directly benefit.” A year later, Krugman had to ward off protesters at a medical conference in Atlantic City. 

Consent-form_AK-redacted_1958
Bad Form: Willowbrook often accepted children in exchange for parental permission to conduct hepatitis testing. THE COLLEGE OF STATEN ISLAND ARCHIVES AND SPECIAL COLLECTIONS

“I think he got a lot of flak for it from people who didn’t understand the context or the reality of the institution,” Richard Krugman says. “It certainly got caught up in the politics of the day.”

But Dr. Krugman had as many fans as he did detractors. New York State Senator Seymour Thaler, originally a critic of the hepatitis experiments, later said that Krugman had “done a magnificent thing.” Dr. Franz Ingelfinger, a former editor of the New England Journal of Medicine, also supported the research. “How much better to have a patient with hepatitis, accidentally or deliberately acquired, under the guidance of a Krugman than under the care of a zealot,” he wrote. 

In addition to discovering the hepatitis A and B strains, Dr. Krugman “certainly did speed up the development of a hepatitis B vaccine,” says Paul Offit, a pediatrician and director of the Vaccine Education Center at The Children’s Hospital of Philadelphia. But, Offit adds, “I don’t think you’re ever justified to inoculate a child with an infectious virus that might kill them.” 

As members of the medical community protested Krugman’s experiments, a greater force was mobilizing to close down Willowbrook for good. 

In 1972, Geraldo Rivera, then a local television reporter in New York, snuck into the grounds of the school and broadcast the inhumane conditions of Willowbrook. He had been tipped off about the residents’ living conditions by Michael Wilkins, a doctor at the school who was not involved in the hepatitis trials. 

“It’s almost 50 years and speaking about it still makes me cry,” says Rivera, now a roaming correspondent-at-large at Fox News. “The conditions were so horrible.” Rivera remembers seeing children naked, smeared in their own feces and hitting their heads against the wall. “I would imagine that the situation I had was similar to the GIs that freed the concentration camps.”

Geraldo-Rivera-by-Michael-Ochs-Getty-Images
The Last Great Disgrace: As a result of Geraldo Rivera’s 1972 investigation of Willowbrook, a federal law was passed to protect people in institutions. MICHAEL OCHS/ GETTYIMAGES

At roughly the same time, a whistleblower exposed the infamous Tuskegee syphilis study in which researchers deliberately let hundreds of Black men go untreated and several died from the disease, even though there was a known cure. Willowbrook was one in a long line of human experimentations on children, prison inmates, people in mental health facilities, and minority communities, and Tuskegee was the tipping point.

Dr. Krugman, however, was rewarded for his work at Willowbrook. That year, he became president of the American Pediatric Society.

In 1974, the National Research Act was passed in an effort to create regulations that protected subjects in human research trials. One measure it implemented was the creation of an ethics task force, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. “The National Commission might never have come into being were it not for Willowbrook and Tuskegee and several other instances,” says Karen Lebacqz, one of the original members of the commission. 

By 1979 the commission had published the Belmont Report, a comprehensive guideline of basic ethical principles that guide modern clinical trials. The National Research Act also established the practice of Institutional Review Boards (IRBs), independent committees that must take time to review the ethical aspects of human clinical trials to this day. 

Aside from potential ethical dilemmas, today’s coronavirus vaccine challenge trials have something else in common with the Willowbrook hepatitis experiments: they may not even be necessary. While Dr. Krugman is credited for speeding up the development of a hepatitis vaccine, other researchers were not far behind. In the late 1960s, Dr. Baruch Blumberg independently discovered the hepatitis B virus, and together with Dr. Irving Millman submitted the first patent for a hepatitis vaccine in 1969. Blumberg did all his research by taking blood samples and testing the liver functions on children and adults who were already infected, and his work earned Blumberg a Nobel Prize for Medicine.

“Whenever people are desperate,” ethics professor Karen Lebacqz says, “they always want to relax ethical standards.”

Similarly, even if a challenge trial for coronavirus gets approved, there’s no guarantee that it will lead to a faster vaccine development. The U.S. government’s initiative to develop a coronavirus vaccine may be called “Operation Warp Speed,” but Christine Grady, Chief of the Department of Bioethics at the National Institutes of Health Clinical Center, says that a lot of time and thought have to be put into properly designing a trial.

“Whether or not doing a challenge trial would even speed up the trial is a question that is not exactly clear,” says Grady, who is married to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Paul Offit agrees. “You have to have the right dose. And to get the right dose, you have to have these mini-challenge trials,” he says. “I don’t think it’s going to happen.”

Karen Lebacqz, one of the original Belmont Report authors, also has concerns about the accelerated Covid-19 vaccine protocols. “Whenever people are desperate,” she says, “they always want to relax ethical standards.”

Saul Krugman’s controversial experiments at Willowbrook were only the beginning of his illustrious career. He later became the head of pediatrics at New York University School of Medicine, was elected to the National Academy of Sciences, authored a classic textbook of pediatric infectious diseases, received the prestigious Lasker Award, and helped to develop the first rubella and measles vaccines.

He defended the Willowbrook trials his whole life, writing in 1986, “I am as convinced today as I was at that time that our studies were ethical and justifiable.” Krugman passed away in 1995, and his obituary in the New York Times has only a small mention of his experiments at Willowbrook.

To this day, while many modern-day ethicists use the Willowbrook studies as an example of unjust human experimentation, there are always second opinions. “It’s complicated,” Grady says. To her knowledge, “Krugman’s first goal was to understand the disease…but I think there are some things about it that certainly don’t look good and would be hard to get approval today.” 

Mike Wilkins, the Willowbrook doctor who helped organize parents to shut down the institution in 1987, also doesn’t think that the experiments are black-and-white. “I’m not wanting to crucify Krugman,” he says now, “hepatitis B, for God sakes, is an international disease that there’s now a vaccine for. But let’s never ever do that again.”

To be continued?
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by Silviu “Silview” Costinescu

If a person had Pharmafia’s criminal record, you’d instantly ask for a restraining order.

Study: Pfizer, GSK, Eli Lilly Topped Military Industry in Defrauding US Govt (2010)

10

Sanofi-Aventis

DEC 2012

Sanofi-Aventis agreed to pay $109 million to resolve allegations that the company gave doctors free units of Hyalgan (an injection to relieve knee pain) to encourage those doctors to buy their product. Sanofi lowered the effective price by promising these free samples to doctors, but at the same time got inflated prices from government programs by submitting false price reports, alleged the United States. Medicare and other government health care programs “paid millions of dollars in kickback-tainted claims for Hyalgan,” according to the DOJ announcement.

9

Endo

FEB 2014

Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm. As part of the agreement, Endo admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to healthcare providers this way.

8

AstraZeneca

APRIL 2010

AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the antipsychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation.

7

Amgen

DEC 2012

Amgen agreed to pay a $762 million fine to resolve criminal and civil charges that the company illegally introduced and promoted several drugs including Aranesp, a drug to treat anemia. Amgen pleaded guilty to illegally selling Aranesp to be used at doses that the FDA had explicitly rejected, and for an off-label treatment that had never been FDA-approved.

6

Merck

NOV 2011

Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug’s heart safety to increase sales.

5

Eli Lilly

JAN 2009

Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the antipsychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.”

4

Abbott

MAY 2012

Abbott was fined $1.5 billion in connection to the illegal promotion of the antipsychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose.

3

Johnson & Johnson

NOV 2013

Johnson & Johnson agreed to pay a $2.2 billion fine to resolve criminal and civil allegations relating to the prescription drugs Risperdal, Invega and Natrecor. The government alleged that J&J promoted these drugs for uses not approved as safe and effective by the FDA, targeted elderly dementia patients in nursing homes, and paid kickbacks to physicians and to the nation’s largest long-term care pharmacy provider, Omnicare Inc. As part of the agreement, Johnson & Johnson admitted that it promoted Risperdal for treatment of psychotic symptoms in non-schizophrenic patients, although the drug was approved only to treat schizophrenia.

2

Pfizer

SEPT 2009

Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with “the intent to defraud or mislead”, promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the antipsychotic Geodon, an antibiotic Zyvox, and the antiepileptic drug Lyrica.

Also see: CORRUPTION UNLTD. 2: PFIZER IN NIGERIA – DEAD KIDS, DEATH THREATS AND DEADLY DRUGS

Pfizer sent this message to physician early 2021:

1

GlaxoSmithKline

JULY 2012

GlaxoSmithKline agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.

Sources:
US Department of Justice
ProPublica

RECAP:

Also see: CORRUPTION UNLTD: GSK AND “TRUMP’S VACCINE CZAR”. SEX TAPES, DEAD BABIES, BRIBES AND PROSTITUTES

To be continued?
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Sometimes my memes are 3D. And you can own them. Or send them to someone.
You can even eat some of them.
CLICK HERE

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by Silviu “Silview” Costinescu

Much like the Fed, CDC isn’t a government agency, it’s more like a prototype of today’s PPP’s (Private-Public Partnerships) used by the WEF to siphon public wealth into private pockets and subvert the political self-determination of the people.

One way for CDC to attract funds is their Foundation.
And we can’t follow the money if we don’t even know who the sponsors are.
If you had difficulties before in finding them, though I can’t imagine one, now you have no excuse, you just need to CLICK HERE to find out more about the conflict of interests in which Pharmafia thrives like a baby in the amniotic juice.
Removing that womb would terminate this vile genocidal cartel.
There’s more than just that page, but that’s where you start YOUR OWN RESEARCH.

Interestingly, the CDC Foundation self-portrait looks very much like Klaus Schwab:

“The CDC Foundation is an independent nonprofit and the sole entity created by Congress to mobilize philanthropic and private-sector resources to support the Centers for Disease Control and Prevention’s critical health protection work.

We are a catalyst for unleashing the power of collaboration between CDC and philanthropies, private entities and individuals to protect the health, safety and security of America and the world.

The government has unique capacities as well as limitations. The same is true for the private and philanthropic sectors. We believe that people, groups and organizations have greater positive impact and can accomplish more collectively than individually. By aligning diverse interests and resources and leveraging all parties’ strengths, our focused collaborations with private and philanthropic partners help create greater impact than any one entity can alone. Your support saves and improves lives—right now and in the future.

Thanks to our donors, we have launched approximately more than 1,200 health protection programs and raised over $1.2 billion to support CDC’s work over the past two decades. To keep people healthy, safe and secure, we managed hundreds of programs in the United States and in more than 140 countries.” – SOURCE

Now, to make my point, I just need to highlight some of the names found there, for your later references.
These are some of the people who home-detain, muzzle and inject us.
Interestingly, most of them are also partners in the World Economic Forum.

Before fusing humans with technology, the Schwaborg has fused Pharmafia with Big Tech, mainstream media and the Governments. These are not independent voices confirming one another, they’re the same entity, like the Borg (and I’ll prove later that Star Trek’s Borg is not just science-fiction entertainment).


If your nutritionist has a McDonalds badge, you have no nutritionist.
Btw, many US and UK hospitals, maybe in other countries too, host McDonalds restaurants.
Same people.

Some things are not meant to be businesses, public health is one of them.

To be continued?
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by Silviu “Silview” Costinescu

Bill Gates: My ‘best investment’ turned $10 billion into $200 billion worth of economic benefit

PUBLISHED WED, JAN 23 2019, by CNBC

  • Investing in global health organizations aimed at increasing access to vaccines creates a 20-to-1 return, the Microsoft co-founder and philanthropist says.
  • Putting $10 billion into the S&P 500 would have grown only to $17 billion over 18 years, factoring in reinvested dividends, Gates tells CNBC in Davos.

Investing in global health organizations aimed at increasing access to vaccines created a 20-to-1 return in economic benefit, billionaire Microsoft co-founder and philanthropist Bill Gates told CNBC on Wednesday.

Over the past two decades, the Bill and Melinda Gates Foundation has donated “a bit more than $10 billion” into mainly three groups: the Global Alliance for Vaccines and Immunization, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the Global Polio Eradication Initiative.

“We feel there’s been over a 20-to-1 return,” yielding $200 billion over those 20 or so years, Gates told CNBC’s Becky Quick on “Squawk Box” from the World Economic Forum in Davos, Switzerland. “Helping young children live, get the right nutrition, contribute to their countries — that has a payback that goes beyond any typical financial return.“

As a comparison, Gates echoed what he wrote in an essay in The Wall Street Journal last week under the banner “The Best Investment I’ve Ever Made,” saying that same $10 billion put into the would have grown only to $17 billion over 18 years, factoring in reinvested dividends.

On vaccines, Gates also had a message for parents who fear side effects as a reason not to get their kids their shots. “It is wild that just because you get misinformation, thinking you’re protecting your kid, you’re actually putting your kid at risk, as well as all the other kids around them.”

Using measles as an example of a once-dangerous disease that’s easily preventable by a vaccine, Gates warned against complacency.

“As you get a disease down to small numbers, people forget. So they back off. They think, ‘Gosh, I heard from rumor. Maybe I’ll just avoid doing it,’” he said. “As you accumulate more and more people saying that for whatever reason, eventually measles does show up. Kids get sick. And sometimes they die.”

To be continued?
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by Silviu “Silview” Costinescu

I have more memes confirmed than WHO has Covid cases

Pfizer sees Covid-19 as ‘durable’ revenue stream as profits rise

Pfizer CEO Albert Bourla at the Pfizer-BioNtech Covid-19 vaccine factory in Belgium, where capacity is ramping up

John BIERS, Tue, May 4, 2021, AFP via Yahoo News

Pfizer sharply increased its 2021 profit projections on Tuesday, citing much higher Covid-19 vaccine sales which are on track to provide a “durable” revenue stream in the wake of the pandemic.

The drugmaker reported a jump in first-quarter profits based on surging revenues, with nearly one-fourth of sales coming from Covid-19 vaccines.

With German partner BioNTech, the pharma giant is ramping up vaccine production and now estimates 2021 revenues of $26 billion from the vaccine, up from the $15 billion projected in February.

But the surging profits have drawn criticism as governments face pressure to step in to ensure vaccines are provided to underserved countries.

Pfizer, which says it is on the cusp of winning US approval for individuals 12 to 15 years old to receive its vaccine, is holding talks with “basically all governments of the world” about providing booster shots through 2024, Chief Executive Albert Bourla told analysts on a conference call Tuesday.

The company is studying the efficacy of giving the jabs six or more months after the second vaccine dose, and developing doses that could be stored at standard refrigerated temperature for up to 10 weeks.

Bourla expects “durable demand” for Covid-19 vaccines, similar to that of the flu vaccine.

“It is our hope that the Pfizer-BioNTech vaccine will continue to have a global impact by helping to get the devastating pandemic under control and helping economies around the world not only open, but stay open,” Bourla said in prepared remarks.

That would create “a scenario in which Pfizer can continue to be both a leader and a beneficiary,” he said.

Pfizer has won wide praise for its technological prowess in developing a game-changing vaccine in record time. However, critics called the profits troubling given the divide in vaccine availability between rich and poor countries.

World Health Organization chief Tedros Adhanom Ghebreyesus last month decried a “shocking imbalance in the global distribution of vaccines” and called for efforts to fortify the WHO’s Covax programs, which aims to ensure that poorer nations can access the shots.

India and South Africa are leading an effort in the World Trade Organization to waive intellectual property and patent rules, at least temporarily, which would open the door to broader production of vaccines at a time when the virus is causing mass misery in India and some other countries.

President Joe Biden said Tuesday he had not made a decision on whether to support a vaccine waiver, but that the United States was moving “as quickly as we can” to export doses.

Biden also said he was ready to “immediately” begin vaccinations for 12 to 15-year-olds as soon as Pfizer’s Covid shot is approved by regulators for the age group.

Pfizer reported net income of $4.9 billion, up 45 percent from the same period of the prior year.

Revenues also jumped 45 percent to $14.6 billion, including $3.5 billion in Covid-19 vaccine sales.

The results include the lift from Covid-19 vaccines, which generated profit margins of “high-20s,” implying around $900 million in profits in the most recent quarter.

As of May 3, Pfizer and BioNTech have shipped about 430 million doses of the vaccine to 91 countries around the world.

The company has reached an agreement to provide up to 40 million doses for Covax, a globally-pooled coronavirus vaccine procurement effort aimed at providing vaccines to low- and middle-income economies.

However, the company on Tuesday pointed to a series of deals to expand offerings in richer countries, including the United States, the European Union, Canada and Israel.

– Criticism of profits –

Pfizer has defended its approach to vaccine pricing, saying it has moderated pricing through a “pandemic phase” that could last into 2022 at levels “to encourage broad access.”

The company said it is charging $19.50 per vaccine dose in the United States, but has not disclosed its US profit margin.

Zain Rizvi, a law and policy researcher at progressive Public Citizen advocacy group, said Pfizer’s rising profits showed the need for governments to take action to save lives.

“Pfizer is cashing in on the crisis and hoarding technology, even as billions of people around the world go without a vaccine,” Rizvi said in an email to AFP.

“Pfizer’s profiteering shows the urgent need for governments to step-in. Governments should require Pfizer to share technology with manufacturers around the world to help ramp up global production.”

The company is building more capacity and expects to manufacture at least three billion doses in 2022, up from 2.5 billion now expected in 2021. In February, Pfizer said it expected to produce up to two billion doses in 2021.

Pfizer shares rose 0.3 percent to $39.95.

Pfizer sees robust COVID-19 vaccine demand for years, $26 bln in 2021 sales

REUTERS

Pfizer Inc (PFE.N) has just raised its forecast for 2021 COVID-19 vaccine sales by more than 70% to $26 billion and said demand from governments around the world fighting to halt the pandemic could contribute to its growth for years to come.

The company said it expects to file for full U.S. approval of the vaccine in May for people over the age of 16, as it is now only authorized for emergency use. It also expects to hear soon from U.S. regulators on expansion of the vaccine’s emergency use authorization (EUA) for children ages 12-15.

Revenue from the vaccine – developed with German partner BioNTech SE – is expected to account for more than one third of Pfizer’s sales this year.

The forecast is based on contracts to deliver 1.6 billion vaccine doses this year. The company expects to sign more deals for this year and is in supply talks with several countries for 2022 and beyond.

“Based on what we’ve seen, we believe that a durable demand for our COVID-19 vaccine – similar to that of the flu vaccines – is a likely outcome,” Chief Executive Albert Bourla said.

The two-shot vaccine was Pfizer’s top-selling product in the first quarter. Expenses and profit from the vaccine are split 50-50 between Pfizer and BioNTech.

Given persistent infections globally and ongoing discussions with governments, Mizuho analyst Vamil Divan said the 2021 forecast could increase further and spill over to future years.

Daily vaccination rates for adults in the United States are off more than 25% since hitting a peak in mid-April. Authorization in children would expand the vaccine-eligible population by millions of people.

Pfizer said it expects to have safety and efficacy data for children ages 2-to-11 in September, when it plans to ask for further expansion of the EUA for that age group.

The company has also filed new data with U.S. regulators that would allow the vaccine to be stored at standard refrigerator temperatures for up to four weeks, up from five days currently.

Pfizer logo seen outside their building in Manhattan, New York City, New York, U.S., March 2, 2021. REUTERS/Carlo Allegri/File Photo
Pfizer logo seen outside their building in Manhattan, New York City, New York, U.S., March 2, 2021. REUTERS/Carlo Allegri/File Photo

Pfizer and BioNTech aim to produce up to 2.5 billion COVID-19 vaccine doses this year, 900 million of which are not yet included in the New York-based drugmaker’s sales forecast.

If Pfizer sells that number of doses at similar prices, the vaccine’s sales in 2021 could be more than 50% above the projected $26 billion.

Moderna Inc (MRNA.O) has forecast $18.4 billion in 2021 sales of its similar COVID-19 vaccine.

Pfizer expects to profit from the vaccine, while some drugmakers including Johnson & Johnson (JNJ.N) have said their vaccine will be sold on a not-for-profit basis until the end of the pandemic.

Pfizer aims to manufacture at least 3 billion doses of the vaccine next year. It also expects to have safety and immunogenicity data from a third booster dose of the vaccine in July.

Pfizer and BioNTech have published data showing impressive durability for their vaccine at least six months after vaccination. Still, Bourla said he believes regular boosters will be needed to maintain high levels of immunity, and governments around the world have started signing deals for the shots.

The COVID-19 vaccine generated $3.5 billion in revenue in the first quarter, exceeding analysts’ estimates of $3.28 billion, according to Refinitiv data.

Total revenue for the quarter of $14.6 billion, topped analysts’ forecasts of $13.5 billion.

It plans to boost R&D spending to fuel drug discovery using the messenger RNA technology in the COVID-19 vaccine. The company is developing two flu vaccines that are expected to enter clinical trials in the third quarter.

Pfizer shares were down slightly in afternoon trading. – REUTERS

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To be continued?
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