corruption

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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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ORDER

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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.
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by Silviu “Silview” Costinescu

In 2000 the Washington Post published a major exposé accusing Pfizer of testing a dangerous new antibiotic called Trovan on children in Nigeria without receiving proper consent from their parents. The experiment occurred during a 1996 meningitis epidemic in the country. In 2001 Pfizer was sued in U.S. federal court by thirty Nigerian families, who accused the company of using their children as human guinea pigs.

UPDATE NOVEMBER 21, 2021: JUST DUG OUT A GREAT 2010 VIDEO REPORT ON THIS

Democracy Now! did a great job covering this story, they summarize most of the important facets and bring a few more interesting details, their sources being close to mine or the same

The trials led to the deaths of 11 children. Dozens more were left disabled.Pfizer’s Unapproved Clinical Trial The unauthorized trial involved tests on 200 children with Pfizer’s antibiotic Trovan. Source: BBC News

In 2011, Pfizer paid $700,000 to four families who lost children during the Trovan trials.

In addition, the company set up a $35 million fund for those affected by Trovan. Pfizer also agreed to sponsor health projects in Kano, Nigeria.

The question that boggled many analysts: How din Pfizer manage to settle so low, after Kano initially filed for $7BILLION damages?

2006: a panel of Nigerian medical experts concluded that Pfizer had violated international law.

2007: Charges

Source

“After more than a decade of silence, the Nigerian government has decided to sue Pfizer, seeking $7bn (£3.5bn) in damages for the families of children who allegedly died or suffered side-effects in the experiment. Kano State government has also filed separate charges against Pfizer.
But Mr Sani says compensation will not be enough.
“In addition to the compensation, they should be killed like the children they have killed,” he says.
The Pfizer experiment was cited by many as a reason for the mass rejection of polio vaccinations in many parts of northern Nigeria in recent years.
Some local Islamic preachers said there was a western plot to sterilise Muslim women. After several tests were carried out to proving the vaccine’s safety, the programme has now been resumed.
Whether the families ever receive compensation, it will never be enough to bring back Anas’s lost dreams of becoming a soldier.” – BBC

2009: The Nigerian state of Kano settled with Pfizer for $75 million in July 2009. Details of the federal settlement were never reported.

At the end of January 2009, a New York appeal court ruled Mr Etigwe and Mr Altschuler’s case could be heard in the US. The Connecticut attorney says it could still go ahead. “Our case is firmly embedded in the US … so a Nigerian settlement does not foreclose our case. But this is very good news. I’m glad we remained the constant gardener and could see this come to fruition.”

2011:

Eleven of the children died and many more, it is alleged, later suffered serious side-effects ranging from organ failure to brain damage. But with meningitis, cholera and measles still raging and crowds still queueing at the fence of the camp, the Pfizer team packed up after two weeks and left.

That would probably have been an end to the story if it weren’t for Pfizer employee, Juan Walterspiel, the Independent writes in 2014.
” About 18 months after the medical trial he wrote a letter to the then chief executive of the company, William Steere, saying that the trial had “violated ethical rules”. Mr Walterspiel was fired a day later for reasons “unrelated” to the letter, insists Pfizer.

2014: Pfizer to pay only $163.50m after deaths of Nigerian children in drug trial experiment!

Out of court settlement in the case inspired ‘The Constant Gardener” movie.

The company claims only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin. The pharmaceutical giant says it was the meningitis that harmed the children and not their drug trial. But did the parents know that they were offering their children up for an experimental medical trial?

“No,” Nigerian parent Malam Musa Zango said. He claims his son Sumaila, who was then 12 years old, was left deaf and mute after taking part in the trial. But Pfizer has denied this and says consent had been given by the Nigerian state and the families of those treated. It produced a letter of permission from a Kano ethics committee. The letter turned out to have been backdated and the committee set up a year after the original medical trial.

At stake at one point in 2013 was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. “There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano,” Mr Etigwe said. “The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer.”

Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.

It appears that Pfizer has finally ended the public relations nightmare with Friday’s settlement. But the Trovan battle may not be over yet.

2015: Nigerian govt withdraws civil lawsuit in preparation for new case against Pfizer. New case never followed.

Reuters: Nigerian government lawyers have withdrawn a 7 (b) billion US dollar civil lawsuit against US drugmaker Pfizer on Friday in preparation for filing a new case, with new material they believe will strengthen their case. The criminal case, is one of three currently being brought in Nigeria against the company. The government has accused Pfizer, the world’s largest pharmaceutical company, of taking advantage of a 1996 meningitis epidemic to test an experimental drug without authorisation or full understanding of the families involved – allegedly contributing to the deaths of some of the children and making others sick. Pfizer denies wrongdoing. The civil case is in addition to a federal criminal case and separate from civil and criminal cases launched at the state level in the northern state of Kano. All the cases stem from the same mid-1990s drug study. Pfizer treated 100 meningitis-infected children with an experimental antibiotic, Trovan. Another 100 children, who were control patients in the study, received an approved antibiotic, ceftriaxone – but the dose was lower than recommended, the families’ lawyers alleged. Up to 11 children in the study died, while others suffered physical disabilities and brain damage. Pfizer always insisted its records show none of the deaths was linked to Trovan or substandard treatment. Barrister Abdulateff Thomas said that he did not accept any of the company’s excuses that the studies were conducted through a deal with the Nigerian government. “If there was any deal at all it was made by an individual against the interest of the government, against the interest of a nation,” he said. “Could they do that deal in America? Can they do it in the UK? Or in any of the European countries? No,” he added. Speaking before the latest development, he added that he did not believe that Pfizer would suffer any consequences as a result of the – now withdrawn – lawsuit. “Nothing is going to happen to Pfizer, if anyone tells you otherwise. Pfizer is going to remain strong, he said. Authorities in Kano state are blaming the Pfizer controversy for widespread suspicion of government public health policies, particularly the global effort to vaccinate children against polio. Islamic leaders in largely Muslim Kano had seized on the Pfizer controversy as evidence of a US-led conspiracy. Vaccination programmes restarted in Nigeria in 2004, after an 11-month boycott.

So we have over a decade of legal battles in which Pfizer saves about $7billion in penalties. As spectacular as it is mysterious. No one has ever revealed an official explanation that satisfies that kind of success, you would expect some solid steel evidence that crushed the cases and the demands from the plaintiffs, but that is unheard of.

The answer might be hidden is some classified U.S. State Department cables made public in 2010 by Wikileaks, which indicated that Pfizer had hired investigators to dig up dirt on Nigeria’s former attorney general as a way to get leverage in one of the remaining cases. Pfizer had to apologize over the revelation in the cables that it had falsely claimed that the group Doctors Without Borders was also dispensing Trovan during the Nigerian meningitis epidemic. And by doing so, validated the cables.

A Pfizer representative in a phone interview with Washington Post declined to discuss specifics of the cable or Liggeri’s alleged comments. In its written statement last week, Pfizer said it negotiated the confidential settlement with the federal government “in good faith and its conduct in reaching that agreement was proper.” Pfizer said it had agreed to pay the legal fees and expenses incurred by the federal government in the litigation and no payment was made to the federal government of Nigeria itself.

According to the cable, Liggeri also told U.S. officials that the lawsuits were “wholly political in nature,” and that the humanitarian group Doctors Without Borders also gave children Trovan. Officials with the organization said that is not the case, and other records suggest that only Pfizer would have had access to Trovan at the time.

Doctors Without Borders published this response in 2011: “Among the US government diplomatic cables recently published by the Wikileaks website were details of a meeting between an official from the pharmaceutical company, Pfizer, and US Embassy officials in Nigeria in April 2009.

At the time of the meeting, Pfizer was in the midst of a legal battle with Nigerian government officials regarding a medically unethical antibiotic clinical trial in children. The clinical trial took place in Kano State in 1996 during a massive meningitis outbreak.

Pfizer carried out the trial of the oral antibiotic trovafloxacin, branded Trovan, even though there had not been any previous medical evidence that it could be effective against meningitis. The Pfizer researchers conducted the trial in Kano State Hospital, where a Doctors Without Borders/Médecins Sans Frontières (MSF) team was treating children using a preferred and clinically approved antibiotic regimen for bacterial meningitis.

A US$75 million settlement with the State of Kano was reached July 30, 2009. Other cases are still pending before the US courts and the Nigerian federal government continues to pursue legal claims against Pfizer.

It is against this backdrop that Pfizer falsely accused MSF in the US diplomatic cables of using Trovan. Documented evidence has shown that these accusations are patently false. MSF did not, at any time, administer Trovan to patients. Litigation connected to this case and comprehensive investigative reports on the matter suggest that Pfizer’s attempts to rewrite history are intended to deflect responsibility for the company’s actions.

MSF was not working in the same part of the hospital in Kano State as Pfizer clinical researchers, and MSF staff had no connection to Pfizer. When MSF staff became aware of what Pfizer was doing, they were appalled at the practices of the company?s team. MSF personnel on the ground communicated their concerns to both Pfizer and the local authorities.

“It was not a time for a drug trial,” says Jean Hervé Bradol, former president of MSF France, to whom the Kano teams were reporting at the time. “They were panicking in the hospital, overrun by critically ill patients. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell.”

Pfizer officials have made no attempt to clear the record as of yet and retract these unsubstantiated claims against MSF. A handful of internet reports have adopted the version of events proffered by the Pfizer official.

An exhaustive Washington Post investigation, drawing on extensive background information and interviews provided by MSF staff, published on December 17, 2000, makes clear the distinction between Pfizer?s activities and the work of MSF during the meningitis outbreak:

‘Behind a gate besieged by suffering crowds stood two very different clinics. A humanitarian charity, Doctors Without Borders, had erected a treatment center solely in an effort to save lives. Researchers for Pfizer Inc., a huge American drug company, had set up a second center. They were using Nigeria’s meningitis epidemic to conduct experiments on children with what Pfizer believed was a promising new antibiotic?a drug not yet approved in the United States.’

The article later triggered the various legal proceeding taken by the victims and Nigerian authorities against Pfizer.

With proven treatments at hand, Pfizer instead chose to carry out tests for an unproven drug on children whose lives hung in the balance. ‘The situation called for using treatment protocols known to be effective rather than carrying out clinical trials on a new antibiotic, with uncertain results,’ said Dr. Bradol.”


BBC reported it too at the time (2010):

“According to a US cable released by WikiLeaks, Pfizer wanted to “put pressure” on Michael Aondoakaa. He was heading a lawsuit against the company over a 1996 drug trial during a meningitis epidemic.
The trial allegedly led to the deaths of 11 children – charges Pfizer denies.
Pfizer reached a $75m settlement last year with Nigeria’s Kano government over the case, which also allegedly left dozens of children disabled.

In a statement released by Pfizer in response to the leaked diplomatic cable published by the UK’s Guardian newspaper, the pharmaceutical company said it “negotiated the settlement with the federal government of Nigeria in good faith and its conduct in reaching that agreement was proper”.

The cable quoted conversations said to have taken place between US embassy staff and Pfizer’s head in Nigeria, Enrico Liggeri. It referred to a meeting between Mr Liggeri and US officials on 9 April 2009.

“According to Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases,” the cable released by the whistle-blowing website WikiLeaks said. “He said Pfizer’s investigators were passing this information to local media.”

Mr Aondoakaa was removed from the position of justice minister in February this year by Nigerian President Goodluck Jonathan.”

Thing is no one has ever proven a Wikilieaks cable to be fake, definitely not this one.

Another good report on the cables I found in mainstream-media comes from the Atlantic (2010):

“In 2000, following the Post revelations, a cry for justice in the Nigerian media triggered street protests and an investigation by Nigeria’s health ministry, whose report on the incident went missing until 2006, when a leaked version revealed that the health officials had reached more or less the same verdict as the fired Pfizer expert: The experiment was “an illegal trial of an unregistered drug,” a “clear case of exploitation of the ignorant,” and a violation of Nigerian and international law.

These disclosures prompted a raft of civil and criminal lawsuits in Kano State Court on behalf of the families and in Federal High Court on behalf of the nation itself, as it were. But Pfizer kept the suits tangled up in proceedings to postpone any settlement.

A State Department cable dated April 20, 2009 and released by WikiLeaks, however, suggests that Pfizer’s legal strategy was not simply to delay–it was also to blackmail. Written by an economic counselor at the US embassy in Abuja, Nigeria, the cable reports minutes of meetings during which Pfizer representatives informed the U.S. ambassador that the firm had agreed to settle the Kano State suit for $75 million, mere pocket change for the pharma giant. The ambassador was told that Pfizer “was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15 million a year in legal and investigative fees.”

It was how Pfizer deployed these fees that dropped a bombshell:

According to [Pfizer country manager Enrico] Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer’s investigators were passing this information to local media, XXXXXXXXXXXX. A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa’s cronies were pressuring him to drop the suit for fear of further negative articles.

Blessed with immense reserves of oil, Nigeria, like many oil-rich developing nations, has in turn been cursed with extravagant corruption. Aondoakaa was among those caught up in it. The cable does not mention Pfizer’s settlement of the $6 billion federal lawsuit, which was signed in secret by lawyers from Pfizer and the Aondoakaa-led Nigerian ministry of justice in October 2009. With the settlement’s terms under wraps, how much Pfizer paid and to whom remains a mystery.

In February 2010, Aondoakaa was booted from the government over charges of corruption. Pfizer denies the version of events reported by the U.S. Department of State official. “Any notion that the company hired investigators in connection to the former attorney general is simply preposterous,” Christopher Loder, a Pfizer spokesman, told The New York Times.

When I emailed Loder asking for comment about the allegations in the WikiLeaks cables, he repeated his statement to the Times verbatim, adding that the cases had been “resolved in 2009 by mutual agreement” and that Pfizer’s conduct was “proper.”

The 1996 Trovan tragedy has cast a long shadow. In 2003, the parents of Kano State boycotted a U.S.-made polio vaccine, threatening to single-handedly short-circuit the global initiative to eradicate the disease. These parents bore the legacy of the Trovan trial and the ensuing years of failed and foiled litigation. Suspicion and cynicism of Western motives ran so deep that they accepted their local clerics’ warnings that the polio vaccine was a plot by Christians to sterilize their daughters, relenting only when health officials switched to a vaccine manufacturer based in Indonesia, a Muslim nation.

Despite all this, Pfizer apparently perceives itself as the real victim. As detailed in the leaked cable, Liggeri portrayed Pfizer to the ambassador as entirely the injured party, dismissing the lawsuits as “wholly political in nature” and asserting that during the meningitis outbreak in 1996, MSF also administered Trovan to children. (When asked for comment by the Guardian, Jean-Hervé Bradol, former president of MSF France, said, “We have never worked with this family of antibiotic. We don’t use it for meningitis. That is the reason why we were shocked to see this trial in the hospital.”) Liggeri warned darkly that the lawsuit against Pfizer had so chilled the entire pharmaceutical industry that “when another outbreak occurs no company will come to Nigeria’s aid.” Whether or not that’s true, it’s not clear that Nigerians would want Pfizer’s help after all.”

However, it took some real alternative independent media to reveal the gravity of the situation, in 2010, when the Democracy Now! news outlet hosted an Washington Post reporter involved in the case and a Nigerian journalist. Dhe deadliest details came together:

“After our stories, there was an official federal investigation in Nigeria. But it was never made public. It disappeared. And many years later, we finally got a copy of this report. It concluded that Pfizer had violated both Nigerian law and international law and was very critical. It also mentioned that members of the investigative panel had been the target of death threats during their investigation. We were told there were three copies of this report. Attorneys in the U.S. who brought a class action lawsuit said they had spent years trying to find this report that we came up with. One they tracked to a safe. And when they opened the safe, it was not there. Another was supposedly in the possession of a man who died before lawyers got to him.
After we made this report public, there was a new set of public officials in power in Nigeria, and they decided to bring criminal and civil charges against Pfizer, including homicide — both Pfizer and some current and former employees of Pfizer. The state of Kano in the northern Nigeria settled for $75 million. The federal charges, which initially were seeking $7 billion from Pfizer, just sort of evaporated. We never knew what happened to them. And now, this new revelation comes out and raises very serious questions about why those charges just evaporated.” – Joe Stephens is a staff writer for the Washington Post. He was part of the investigative team that broke the story in 2000

Musikilu Mojeed, a Nigerian journalist  who has worked on this story for the NEXT newspaper in Lagos, commented the following: 
“Nigerians are clearly outraged by this revelation that Pfizer hired investigators to smear the attorney general, to blackmail him to drop the federal charges. But not a lot of people are entirely surprised in Nigeria, because before the WikiLeaks cable came out, our newspaper, NEXT, had exposed the mysterious disappearance of the federal charges against Pfizer. You know, suddenly, the case just disappeared. Nobody knew how the case was withdrawn. Nigerians were not told. It was just done in secret. And our newspaper broke this story. That is, a $6 billion federal suit against Pfizer disappeared secretly, that the attorney general simply did — went into a secret deal with Pfizer and a few Nigerian lawyers without anybody knowing about it. In fact, Pfizer may have violated U.S. law, because Pfizer refused to disclose the details of that settlement, even in its filing for the quarter of 2009 to the U.S. government. So, Nigerians are clearly outraged.

And even the attorney general, the former attorney general, himself, is threatening that he might sue Pfizer for blackmailing him. But in any case, the attorney general himself is known to be terribly corrupt. So a lot of people are not surprised, because he’s know to be a corrupt man. He cannot enter the United States, because the U.S. government has barred him, has withdrawn his visa and that of his family, because he’s known to be corrupt. But a lot of people are outraged that Pfizer could go to that extent to hire an investigator to blackmail a Nigerian official.”

Evidences of various forms of wrong-doing on the Pfizer side kept appearing the following years, see this 2011 CBS news piece:

Pfizer Bribed Nigerian Officials in Fatal Drug Trial, Ex-Employee Claims

“A former Pfizer (PFE) employee’s letter to a federal judge alleging that the company put a courier on a KLM flight to Nigeria carrying bribes for local officials is a classic example of how hard it is to get away with corporate skullduggery: The letter cites 40 Pfizer executives, FDA officials and other witnesses who allegedly have inside knowledge of the scandal — not very secret for a secret conspiracy.(…)

The letter was written by Dr. Juan Walterspiel, who in 1996 was a pediatric research physician in Pfizer’s Groton, Conn., facility. He worked on the Trovan trials, but he objected to the testing method being used. Pfizer dismissed him in 1998. His letter claims that:

  • Pfizer paid a bribe to continue the study of Trovan.
  • Pfizer did not get informed consent from parents of children in the test.
  • Pfizer gave fake ethics documents backing the test to the FDA.
  • Corners were cut because “Speed was of the essence and stock options and bonuses at stake.”
    Pfizer ignored Trovan’s poential reaction with antacids, which are often given to patients who have had surgery.
  • The FDA started but mysteriously called off an investigation into the scandal.
  • One patient in the Trovan arm of the experiment died without being taken off Torvan or given medical care. Normally, if patients react badly to experimental drugs researchers take them off the therapy and give them medical care.
  • Pfizer has photographs of the members of its Kano team.

The letter was previously dismissed in a previous ruling in the case as “speculative” and too filled with hearsay to be regarded as evidence. Pfizer told BNET:

Dr. Juan Walterspiel’s employment with Pfizer was terminated in 1998 for legitimate and proper reasons. Dr. Walterspiel did not travel to Nigeria to participate in the 1996 Trovan clinical trial and thus has no direct or first-hand knowledge of the conduct of the clinical trial. Dr. Walterspiel made these similar allegations over 10 years ago, and has repeated them from time to time since then. Pfizer investigated the allegations and found that they were not supported by the facts.”

Walterspiel’s letter was based on an affidavit filed in the case in the early 2000s. At the time, much of the case was under seal and documents were not electronically filed, so Walterspeil’s allegations went largely unnoticed beyond the lawyers who saw them. Walterspiel then wrote to former Pfizer CEO Jeff Kindler in 2007, repeating his claims. He sent a copy of that letter it to Judge William Pauley on Jan. 28, 2011, who entered it onto the record a few days ago.

The letter does not name names. Instead, Walterspeil uses numbers to stand in for the identities of the people he links to the Trovan trial. Three of them knew that Pfizer had sent a cash courier to some Nigerian officials who “needed to be paid off” before the trial could continue.
Pfizer had not obtained the proper ethics committee approvals before the test began, Walterspeigel claims. (Research on human subjects usually requires approval of an independent institutional review board before it can start.) So the paperwork was faked.
The FDA began investigating the Trovan trial but the probe was suddenly ended.
The older ruling supplies some of the names behind the numbers. Local sources also accused corruption between the corporation and the government.”

In addition to blaming Pfizer, many local media commentators also lamented what they saw as a corrupt Nigerian administration that had rubber-stamped the trial without due diligence. “The propensity for corrupt practices on the part of a few venal Nigerians has apparently permitted our people to be used as a laboratory for the unregulated testing of a new drug with obviously bad consequences thereof,” read a Feb. 8 editorial in Lagos’s independent weekly Tempo.

Meanwhile, the residents of Kano have been left with a legacy of fear. The News, a weekly magazine from Lagos, reported on Jan. 29, 2001 that people in the district are refusing new immunizations for CSM, cholera, and measles. “The bature (white men) will kill us again if we allow them to give us…tablets and injections,” they told the magazine.

According to John Murphy’s report for the Baltimore Sun, the Trovan trial may have left some Nigerians distrustful of Western interventions: “Some of Kano’s fears of the vaccine stem from its experience with the U.S. pharmaceutical giant Pfizer Inc.”

“The country’s health authorities say that the Pfizer controversy is partly responsible for many families in northern Nigeria refusing to allow their children to be vaccinated against polio. That in turn has been blamed for an outbreak that spread across parts of Africa. The Kano authorities also refused to distribute the polio vaccine.” – The Guardian 2007

Epilogues:

1

2. Meet Nigerian born Dr Onyeama Ogbuagu, who is allegedly at the core of developing the Pfizer vaccine. He is one of the twin sons of Prof. Chibuzo Ogbuagu. His parents had the twins in New Haven CT when they went for their doctoral programs at Yale. The Ogbuagu’s returned to Nigeria where Onyeama studied medicine and then returned to the US and Yale.

To be continued?
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by Silviu “Silview” Costinescu

Censorship is what happens when people with greater powers than others go from saying “I hate this speech!” to factually suppressing that speech.
Censorship IS hate speech enacted. Institutionally.
Institutional hate that breeds more hate.
And institutions follow an agenda. So there is a hate agenda.


Censorship has never protected anyone from hate. If only hate was just about speech!
Censorship actually exacerbates hate through frustration. Most ideologically motivated mass shooters were deeply frustrated that their message was suppressed, and they killed people as a way to make themselves heard, among others.

In establishment’s propaganda, “hate speech” has become speech hated by the powers that be. Stalin and all communist dictators were branding any opponent “enemy of the people” and any dissenting speech as “subversive”. Replace that with the more contemporary “conspiracy theorist / terrorist” and “hate speech”, see if it reminds you of anyone.

Censorship means we are paying people to take away our speech and our vision. Collectively, censorship doesn’t happen TO us from an entirely external source. Censorship happens usually when a society abandons itself and the fight for freedom because it’s been bought up with more comfort or, more often, with promises of comfort. And, eventually, that comfort always proves to be less preferable than the comfort of liberty.

So censorship doesn’t really protect the people, but, in almost every instance, it has protected powerful and corrupt people from truth. Even the hate that it breeds fits a control agenda, because it’s divisive and it distracts us from lies, corruption and systemic failures. It robs us of messages of love and help from other people, when they go against the censor’s agenda .
It’s just another typical situation of problem sold as a solution to itself. Logical hocus-pocus. That’s why they don’t properly teach logic in schools.

There is no way in which censorship can be beneficial, neither to the censored OR the censor. The latter always ends up suffering a form of strong backlash, because the energies it tries to suppress always find a way through, energy doesn’t disappear, doesn’t stay locked forever, it always transforms and manifests.

There’s no way censorship works for us, but there’s a million ways it can go against us.

Fight censorship simply by not participating in it and not collaborating with censors!



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! My articles can always be subject of later editing as a way of perfecting them