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
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 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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You’ve likely heard of IG Farben, bud have you ever heard of American IG and the follow up story?
Imagine that the brutal experiments at Auschwitz were better concealed and the prisoners were drugged and brainwashed to believe that’s the best world out there for them. Then find out that the management has never stopped winning, expanding and perfecting their business model, up to today’s Great Reset.
good stuff that i had to leave out the video documentary:
Founded in Binghamton, New York, in 1901, Ansco was a manufacturer of photographic products and film. Ansco was originally founded through the merger of E. Anthony & Company and Scovill Manufacturing. In 1928, Ansco merged with Agfa to form Agfa-Ansco. The new corporation was a division of General Aniline and Film (GAF) Corporation, which was controlled by the German chemical cartel IG Farben. After Germany declared war on the United States in 1941, the United States Government seized the assets of GAF, including Agfa-Ansco. In 1943, the company removed “Agfa” from its name, once again becoming Ansco. The United States Justice Department oversaw Ansco’s operation until 1965, when government-held stock in GAF was sold to the public. In 1977, GAF eliminated its line of consumer photography products, including those manufactured by Ansco at the Binghamton facility. GAF also sold the Ansco trademark to Haking Enterprises. GAF continued to manufacture film at the Binghamton plant for industrial and medical use until 1981, when it sold the plant to Anitec Image Corporation. Over the next two decades, the former Ansco facility was sold several times, and in 2000, it was demolished.
Prior to the late 1970s, dozens of asbestos-containing materials were utilized in the construction and maintenance of buildings at Ansco’s Binghamton facility, including fireproof insulation, pipe covering and insulating cement. Inhaling dust from the application and removal of asbestos-containing materials placed workers at risk for developing an asbestos-related disease, such as mesothelioma or lung cancer.
Fireproof insulation was applied to structural steel during the construction of buildings at Ansco. Fireproofing materials were manufactured as a dry mixture of asbestos, linen and cement, packaged in fifty-pound paper bags. The dry mixture was mixed with water and sprayed onto the structural steel using a hose. Pouring, mixing and spraying fireproof insulation created clouds of asbestos-containing dust. After the fireproofing material was applied, it was typical for tradesmen, such as electricians or pipefitters, to scrape the fireproofing material from structural steel in order to install pipes and conduits. When the fireproof insulation was disturbed, asbestos fibers and dust became airborne.
Workers applied asbestos-containing pipe covering to pipes at the Binghamton Ansco facility. Pipe covering was applied to numerous piping systems in order to maintain stable internal temperatures and to protect pipes from damage. When pipe covering was applied, asbestos fibers were emitted. Insulating cement was also applied to pumps, valves and other equipment. It was manufactured as a powder and mixed with water to prepare it for application. Mixing insulating cement caused asbestos-containing dust to become airborne.
What’s Bayer been up to lately? We find out from their website:
The Bio Revolution is redefining innovation in the life sciences. How this might be a game changer.
The life sciences have made great advances in the past years. Biology, life sciences and the megatrend of digitization are growing closer together, enabling new inventions that impact our daily lives in a scope that we speak of a Bio Revolution. This revolution is reinforced by rapid increases in computing power and the emergence of new capabilities in AI, automation, and data analytics. These trends are further accelerating the pace of innovation and the potential for higher R&D productivity in the life sciences.
All this has led to new ways to understand and explore biology. The range of life forms on earth is incredibly complex and diverse. However, the methods to analyze them can be remarkably similar. Technologies and methods are transcending disciplinary boundaries even faster.
The implications across the life sciences can be enormous:
For human health, for example, a deeper understanding of the relationship between genetics and disease has led to the emergence of precision medicine, which can potentially be more effective than the one-size-fits-all therapies of the past. In the future, new technologies could help the healthcare industry not only treat, but cure or even prevent diseases. New gene and cell therapies, for example, aim to cure genetic diseases, potentially enabling sustainable organ replacement or reversing autoimmune diseases.
The Bio Revolution has the potential to help address some of the most critical global challenges, from climate change to pandemics, chronic diseases, and worldwide food security. Experts estimate that a significant portion of the economic impact of biological applications will be in health care, agriculture, and consumer products.3 Already today, the Bio Revolution with its convergence of science and technology has created an explosion of research projects in science and business. Each year, the amount of Intellectual Property related to the Bio Revolution is increasing.4 This can be seen, for example, by the number of patents in CrispR or plant biotech. In short: the revolution is gaining momentum and holds a great promise for health and food alike.
Total number of CRISPR patent applications worldwide per year from 1984 to 2018.
Fueled by digitalization, growing connectivity, and falling costs, important advances in biotechnology are intertwined with more systemic shift in how bio-innovation is undertaken and who is involved. Microbiome technologies, advanced genomics, gene editing and synthetic biology are among key enabling technologies that have the potential to change the face of bio-innovation. This broader redefinition of bio-innovation creates new prospects to help address important nutrition, environmental and development needs.
World Economic Forum, Bio-Innovation Dialogue Initiative
As a leading life science company, Bayer is aligned with the long-term market trends in health and nutrition and offers innovative and sustainable solutions to tackle some of the key challenges for humanity. Bayer brings to the table an extensive knowledge of human and plant science, supported by its expertise in regulatory processes and an impressive global footprint to ultimately bring innovations from labs to market. https://www.youtube-nocookie.com/embed/EYE1gya7XiM?autoplay=1&start=0&rel=0
The Bio Revolution marks the beginning of a new era: Innovations enabled by the convergence of biology and technology have the potential to significantly improve our lives, our nutrition, and our health.
Did you know that Bayer is at the forefront of the wave of innovation coming from the Bio Revolution?
The Bio Revolution is expected to transform healthcare and agriculture over the next decades – but the revolution is already happening now. With its newly established cell and gene therapy platform in Pharmaceuticals and innovative gene-editing tools such as CRISPR, Bayer operates at the core of the Bio Revolution and has tremendous opportunities to improve health and nutrition.
In Pharma, Bayer’s new Cell & Gene Therapy (CGT) platform steers our strategy in the area and orchestrates our activities along the value chain providing an innovation ecosystem for the companies – including BlueRock Therapeutics and Asklepios BioPharmaceutical (AskBio), which are fully owned by Bayer but operate autonomously. These therapies hold the potential to significantly impact patients’ lives by moving from treating symptoms to potentially curative approaches.
Bayer’s development portfolio of cell and gene therapies already comprises eight advanced assets in different stages of clinical development. These are applicable in multiple therapeutic areas with high unmet need, such as neurodegenerative, neuromuscular and cardiovascular indications, with programs in Pompe disease, Parkinson’s disease, hemophilia A, and congestive heart failure. With over 15 preclinical assets in the cell and gene therapy field, the pipeline is expected to grow steadily year by year.
Yet Bayer is not only using biotechnology to advance health – the promise for agriculture is just as inspiring. In the Crop Science Division, for example, tools like CRISPR can make changes to plant DNA with more precision than ever before and make plants more weather- or disease-resistant, enabling farmers to grow more or better-quality products under changing conditions.
Advancing genetic solutions for a sustainable future (1)PreviousNext
Did you know that Leaps by Bayer invests into potentially disruptive technologies to tackle some of the largest, unsolved challenges in the life sciences?
With Leaps by Bayer – our impact investment approach utilizing venture capital – we are constantly scanning for additional potential breakthroughs that hold promise to either cure or treat people from diseases or help feed a growing population with less impact on the environment.
Since 2015, Leaps by Bayer has invested over $1 billion in ventures that tackle fundamental breakthroughs and shift core paradigms in our industries.
Leaps by Bayer has an investment focus on potentially disruptive solutions in the fields of healthcare and agriculture. The Leaps investment approach is remarkable: It aims to invest into or build up new innovative companies. Bayer supports those companies by enabling the exchange of proprietary assets, which can include sharing own patents or providing access to the Bayer network’s technical capabilities and 150 years of expertise. The companies remain autonomous with respect to decision making, while Leaps facilitates and supports them in a so-called active incubation process. Experienced team members actively engage in the young companies’ development by providing resources and helping them to steer the initial strategic direction. Today, the investment portfolio includes more than 35 companies advancing potential breakthrough technologies.
Leaps is our way of thinking big.
Werner Baumann, CEO of Bayer AG
Many Leaps ventures have made significant progress towards unlocking the potential of new technology platforms with a promising and transformative potential. BlueRock Therapeutics, for example, started as a Leaps investment and is now an integral part of Bayer’s CGT platform and just received clearance to proceed with a phase I trial in Parkinson’s disease.
Other companies, like the biopharmaceutical player Triumvira, are specialized on next generation immuno-oncology treatments. Triumvira focuses on novel T-cell therapies that aim to be safer and more efficacious than current cell therapy cancer treatments. Treating, curing and preventing cancer is one of the focus areas of Leaps by Bayer, since this group of diseases still represents one of today’s biggest health challenges with limited curative or preventative therapies available.
We face a huge disease burden, and the way we produce food isn’t sustainable for the planet. I believe the Bio Revolution can help us overcome these issues.
Jürgen Eckhardt, Head of Leaps by Bayer
Leaps is also investing in the development of sustainable biotechnological solutions in the field of agriculture. One of the ventures in this field is Joyn Bio, a company that aims to significantly reduce the environmental impact of synthetic nitrogen fertilizers through a technology that fixes nitrogen into the soil. Nitrogen is one of the most important nutrients essential for every plant to grow, however, its use and production as a fertilizer is estimated to contribute 3-5% to all global greenhouse gas emissions. Joyn Bio is working on an engineered microbe that enables cereal crops like corn, wheat, and rice to convert nitrogen from the air into a form they can use to grow. This technology may have the potential to help farmers use nitrogen in new ways, and as a result, reduce agriculture’s environmental footprint.
The Leaps by Bayer investment portfolio includes more than 35 companies.
At least that’s what Bayer says. All I know is that they’re still running the show.
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The former CDC director Robert Redfield has just said on CNN that the WHO narrative on the pandemic inception makes no sense, the virus most likely escaped much earlier from an Wuhan biolab, not a meat market. “It’s not unusual for viruses to escape labs”, he said, and, boy, doesn’t he know about it! I’ve seen no evidence of SARS-COV-2, but it’s spectacular to keep watching every day some “authoritative sources” arguing themselves and each other, and unintentionally bringing up stuff that’s been previously swept under various carpets. Keep it up!
The USA TODAY Network’s “Biolabs in Your Backyard” investigation, published since 2015, has revealed hundreds of accidents at corporate, university, government and military labs nationwide. It also has exposed a system of fragmented federal oversight and pervasive secrecy that obscures failings by facilities and regulators.
In January 2015, in an effort to determine the extent of lab accidents at the agency’s facilities, USA TODAY filed a FOIA request seeking copies of all incident reports at CDC labs in Atlanta and Fort Collins during 2013 and 2014. The CDC granted the request “expedited” processing status because USA TODAY demonstrated a compelling public need for the information. But the agency has said it will likely be 2018 before the records are released.
The newly disclosed 2009 incident in the BSL-4 decontamination shower is among about 4,000 pages of records the agency released in late January in response to two FOIA requests USA TODAY filed in June 2012. Those requests sought records about airflow and security door incidents at CDC’s $214 million, 368,000-square-foot Emerging Infectious Diseases Laboratory in Atlanta, commonly referred to by the agency as Building 18.
Most of these released records — which focus on airflow engineering issues in labs — involve a 2012 incident that USA TODAY reported four years ago based on documents obtained from sources. The issue involved air from inside a potentially contaminated lab briefly blowing outward into a “clean” corridor where a group of visitors weren’t wearing any protective gear. Among other incidents revealed in the records:
In 2011, a worker feeding animals in an enhanced biosafety level 3 lab used for studies on dangerous strains of avian flu, was unable to shower out of the lab after a construction contractor mistakenly closed the wrong water valve in a service tunnel. Not knowing when the water would come back on, the worker removed her protective equipment, put on a clean protective suit and left the lab without taking a shower. “I escorted her through the service tunnel to building (redacted) where she signed into our (redacted) select agent laboratory. She disposed of the tyvek suit in a biohazard bag, placed her scrubs in the laundry bin, and took a personal shower.” The CDC told USA TODAY that because the potential for any exposure was considered low risk, a medical evaluation was not required.
In 2008 an unvaccinated repair worker was potentially exposed to an undisclosed pathogen when a door containing contaminated items unexpectedly opened in a malfunctioning device, called an autoclave, that is used to sterilize equipment and other items. The infectious materials inside the device included bedding from infected mice and used laundry. While a report of the incident said that any material that may have escaped through the clean-side door that opened “was likely to be drawn upward toward the exhaust,” the worker was told to shower and his clothes, shoes, wallet, watch and other personal items were disinfected. He was escorted to the clinic for evaluation. The report notes that the autoclave “was installed backwards during building construction” and that as a result, the manual override controls for doors are reversed “which ultimately resulted in the incident.”
Building 18, which opened in 2005 has had a series of significant issues over the years. While the building’s many other high-containment and lower security labs were in operation from the start, its suite of BSL-4 labs did not go “hot” and start working with pathogens until around early 2009. The lab complex made news in 2007 when backup generators didn’t work to keep airflow systems working during a power outage and in 2008 for high-containment lab door that was being sealed with duct tape. The duct tape was applied after a 2007 incident where the building’s ventilation system malfunctioned and pulled potentially contaminated air out of the lab and into a “clean” hallway. Nine CDC workers were tested for potential exposure to Q fever bacteria. None were infected.
Read all the records released by CDC in response to USA TODAY’s 2012 Freedom of Information Act requests here and here.
The full coverage of USA TODAY’s investigation used to be hosted on its own separate website, biolabs.usatoday.com , but they deleted it, unsurprisingly.
As we’ve shown in our video too, a wide range of mainstream media outlets have reflected the situation over the years, not just USA Today, being quite critical of it, but with almost no impact on the general population. Ah, well…
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Americans are being told that a manufacturing problem in a U.K. pharmaceutical plant has led to the U.S. shortage of flu vaccines. Americans aren’t being told (and we aren’t either) that the real manufacturer at fault is a U.S. government agency, the Centers for Disease Control, along with the World Health Organization and other vaccinate-anything-that-moves ideologues that have fabricated a phony crisis over the flu vaccine.
October 24, 2004
“Epidemics of influenza typically occur during the winter months and are responsible for an average of approximately 20,000 deaths,” the CDC stated in 2002. That number mutated to “36,000 flu-related deaths” in November, 2003, and by December a gathering of public health officials warned that the toll could reach 70,000 this year.
In concert with the ramp-up in death statistics, the government-steered vaccination industry has run an elaborate bureaucracy designed to hype vaccine use, as seen in a slide show presentation last April by Glen Nowak, the CDC’s spokesman for the National Immunization Program, to the American Medical Association. Here is the “Recipe that fosters influenza vaccine interest and demand,” in the truncated language that appears on his slides: “Medical experts and public health authorities [should] publicly (e.g. via media) state concern and alarm (and predict dire outcomes) – and urge influenza vaccination.” This “recipe,” the slide show indicated, would result in “A. Significant media interest and attention [and] B. Framing of the flu season in terms that motivate behaviour (e.g. as ‘very severe,’ ‘more severe than last or past years,’ ‘deadly’).” Other aspects of the CDC’s “Seven-Step Recipe for Generating Interest in, and Demand for, Flu (or any other) Vaccination” includes “Continued reports (e.g., from health officials and media) that influenza is causing severe illness and/or affecting lots of people – helping foster the perception that many people are susceptible to a bad case of influenza.” and “Visible/tangible examples of the seriousness of the illness (e.g., pictures of children, families of those affected coming forward) and people getting vaccinated (the first to motivate, the latter to reinforce).”
This motivational slide show was designed to push the bounds of the vaccinated. Where once only at-risk populations were targeted – chiefly the elderly – the vac-crats now aspire to vaccinate the healthy. In the 2002-2003 flu season, the last for which the CDC has reliable numbers, almost 21 million healthy Americans between the ages of two and 64 were vaccinated. The unabashed goal of the vaccination ideologues is universal vaccination, starting with the universal vaccination of children. Because vaccinations in the United States, as in Canada, are generally a pre-condition of admittance into the school system, children make easy prey for the vaccine totalitarians. The U.S. government, in fact, spends more than US$1-billion a year – 55% of the entire childhood vaccine market – to purchase childhood vaccines for poor and uninsured children.
But doesn’t all this vaccinating save countless lives at virtually no risk? In truth, no one knows, because the studies haven’t been done, even in the case of highly sensitive childhood vaccinations. During the last flu season, for example, the CDC received reports of 152 flu deaths among children. Is this high or is this low?
“The answer to this question is not known,” the CDC stated. “Because the number of influenza deaths in children has not been tracked before, it’s not possible to compare the number of deaths in children this year with previous years.”
As for evidence of the efficacy of flu vaccinations in the general population, again, the CDC is operating in the dark. When asked last year if annual follow-ups were performed to determine if the vaccine was effective, the CDC’s Nancy Cox, chief of its influenza branch, admitted, “There is no systematic follow-up to see, to document whether the general population who receives a flu vaccine is infected by a flu virus, because it’s an impossible task. I mean, we have 80 million doses or 70 million doses given and it would be impossible to follow up.” To add to the futility of even trying, Dr. Cox explained that most cases of flu-like illnesses – about 80% – in fact are caused by “many other pathogens.”
The bottom line on the medical benefit of flu shots for healthy people? No one knows. The benefit is entirely a matter of faith among the true believers in the vaccination bureaucracy. The bottom line on the medical harm caused by flu vaccines? Again, no one knows. Various studies do raise concerns, however. One year ago, the Institute of Medicine of the National Academy of Sciences found weak evidence that the flu vaccine triggers neurological disorders, and the IOM’s immunization safety review committee also found that other studies, based on poor data and poor methodologies, do not give vaccines a clean bill of health. Said the committee’s chairman: “The possibility that neurological disorders might be related to vaccines must be given serious consideration.”
New flu vaccines, such as those made from live viruses, pose new types of risks since the vaccines themselves could become unintended disseminators of the flu. Because some 80% of recipients of this type of vaccine shed it to the environment, doctors are advised to avoid prescribing it to those in close contact with at-risk populations, such as those who have compromised immune systems.
The biggest risk of all from flu vaccines, however, may come from weakening the human body’s natural defences. If children are inoculated against the flu as babies, they will never develop the strong, natural immunities they will need to fend off new strains, making them dependent on the vaccine industry’s ability to stay ahead of ever-mutating viruses. Last year’s experience with the dreaded A/Fujian flu provides a chilling scenario. When a vaccine for this flu proved difficult to mass-produce in time for the annual flu season, the World Health Organization, under pressure to do something, gave labs around the world the go-ahead to produce an alternate vaccine, for a different strain of flu, likely to be of little value. As expected, the vaccine proved to have almost no value, although the countless people around the world who lined up for it didn’t know that at the time. Fortunately, people had natural defenses, which are far more potent and longer-lived than vaccines, to protect them. In future, a population vaccinated from the cradle that had never fought off the flu on its own could be highly vulnerable.
Without the international medical bureaucracy that now controls the vaccine industry and annually whips up public fears, sometimes to the point of public panic, the demand for vaccines would fall to a fraction of current levels. Without other government intervention – everything from industry subsidies to an unhealthy bias in what research government will and will not fund – vaccine safety would be improved, the science would not be dominated by ideologues tilting toward universal vaccination and the demand for flu vaccines would fall further still, to more closely correspond to the real, not hyped, public needs. There would be no crisis.
Lawrence Solomon is research director at Consumer Policy Institute. To contact, e-mail: LawrenceSolomon@nextcity.com.
FAST FORWARD TO 2020
I rest my case
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We just found out that Facebook made this information illegal on its platform and cancelled a whole field of science, while Fauci denied its existence, all knowing the truth is different. Praise Veritas!
UPDATE: LAST MINUTE STUDY CONFIRMS AND DEEPENS THE UNDERSTANDING OF THIS. TO MAINTAIN STRUCTURE, I ADDED IT AT THE END OF THE REPORT
UPDATE #2: I’ve just unearthed a 2017 Ted Talk featuring the current Moderna boss Tal Zaks, where he describes the mRNA technology that was first meant to treat cancer, he calls it “information therapy”, see for yourselves:
Below I copy/pasted the press release that circulated at the time in several top publications:
“Following a new collaboration between UiO and research groups in Nottingham and Oxford, it has now been revealed that RNA has a direct effect on DNA stability, according to Professor Klungland’s research.
He believes the discovery will provide the health service with an important tool, since many studies have shown that the regulation of modifications to RNA is important for the development of cancer.
If genes that are important for the chemical compound 6-methyladenine are completely removed, this results in neurodegeneration in both mice and humans.
Where and how
In areas of DNA where RNA binds to one of the DNA threads in such a way that the complementary DNA thread becomes the sole thread (R-loop structures), the DNA stability will change if RNA is chemically modified by m6A.
“Several research groups are now working together to study what effect this can have on the DNA molecule. We already know that R-loop areas are associated with sequences of DNA containing active genes and that this can lead to chromosomal breakage and the loss of genetic information”
Prof. Arne Klungland
New field of research
Normally, epigenetic gene regulation is studied by examining dynamic modifications of DNA and proteins—so-called epigenetic modifications. The modifications can turn genes on or off without changing the underlying genetic code.
Less than 10 years ago, it was discovered that dynamic modifications also exist in RNA and that these have an important role to play in gene regulation
The most common modification is on mRNA is 6-metyladenin (m6A). It has now been shown that this modification is essential for the survival of cells and model (non-human) organisms.
Over the last five years, there has been an enormous increase in the amount of research into RNA modifications—a field called epitranscriptomics.
One of the first studies in this field of research was the result of a collaboration between research groups in Chicago, Beijing and Oslo (Zheng, Dahl et al., Molecular Cell, 2012, 49, 18-29).
End of article citation. I bolded a few paragraphs to make sure you see what I saw: RNA modification not only can alter DNA, but it’s been already envisioned as a tool for DNA editing. This argues against the whole BS official narrative that the RNA vaccine technology is inoffensive for the DNA
One of the most remarkable findings of this study is that depletion of YTHDF2 and METTL3 (the writer that deposits m6A) increases levels of γH2AX, a marker of DNA double-strand breaks, thus suggesting that pathological R-loop accumulation in the absence of the m6A RNA-methylation pathway challenges genome integrity. This result is in line with findings from many studies that clearly suggest the potential of R-loops to induce DNA double-strand breaks2. Moreover, dysregulation of R-loops is emerging as a critical factor driving genome instability in a large variety of pathological contexts, including after oncogenic stress12, in cells infected with Kaposi’s sarcoma–associated herpesvirus, in neurological disorders associated with trinucleotide-repeat expansion (such as Huntington’s disease and fragile X syndrome) and in multiple other inherited ataxias (for example, ataxia with oculomotor apraxia 2)2. The use of existing drugs targeting the m6A pathway (for example, inhibitors of FTO) could therefore be considered as a new therapeutic approach to treat R-loop-related diseases13. Beyond genome stability, the finding that m6A methylation controls R-loop levels across the genome considerably expands the biological functions of the m6A-modification pathway to potentially all R-loop-related functions, including DNA topology (because R-loops have recently been proposed to relieve superhelical stress), immunoglobulin class-switch recombination (and therefore the immune response), replication initiation and transcription1,2,14. Additionally, m6A accumulates at sites of ultraviolet-induced DNA damage6, thus raising the interesting possibility that this modification may also regulate R-loops during DNA repair and thus affect the frequency of chromosomal translocations15. In summary, the results presented by Abakir et al. unveil an unexpected interplay between RNA modifications (the epitranscriptome) and the maintenance of genome integrity. Re-analysis of the pathological contexts implicating dysregulation of the m6A RNA pathway through the prism of genome instability therefore warrants further investigation (Fig. 1).
It’s not every day that a biotech investor stumbles across an entirely new field of science. And frankly, Carlo Rizzuto wasn’t even looking for such a thing. When Rizzuto, a partner at the venture capital firm Versant Ventures, embarked on a scouting trip to New York City in 2014, he was simply hoping to discover academic research that was ripe enough to form the basis of a biotech company.
Rizzuto had an appointment with Samie Jaffrey, an RNA scientist at Weill Cornell Medicine. RNA is often described as a cousin to DNA—the stuff that our genes are made of. One kind of RNA, called messenger RNA, acts as the intermediary code that cells use to transfer information stored in DNA into a set of instructions that cells can easily read for making proteins.
After Rizzuto rejected several of his projects, Jaffrey mentioned a relatively young line of work focused on studying chemical modifications to RNA. In 2012, his lab invented a method to map the location of methyl groups that, for some reason, cells were adding to their mRNA. It was reminiscent of another field, called epigenetics, or the study of chemical modifications made to DNA to turn genes on or off. The entirety of RNA in a cell is called the transcriptome, so Jaffrey dubbed the new field “epitranscriptomics.”
Rizzuto perked up. “This is something that we would be very interested in,” he said.Credit: Gotham TherapeuticsSamie Jaffrey, a professor of pharmacology at Weill Cornell Medicine and cofounder of Gotham Therapeutics, explains the m6A modification on RNA. Jaffrey’s lab invented a technique to map the location of m6A on RNA.
Jaffrey was hesitant. “We’re just doing basic stuff now,” he recalls explaining. His lab, and others, was still trying to figure out how this RNA modification system worked. They were building evidence suggesting that enzymes added and removed these methyl marks to control the fate of mRNA, and thus protein production, but many questions remained. Jaffrey implored: “Carlo, what disease would we be curing if we started a company around epitranscriptomics?”
“It doesn’t matter,” Rizzuto replied. “This is so central to molecular biology; it has to be related to fundamental disease processes.”
Then reality kicked in. Venture capital firms like Rizzuto’s aren’t in the business of funding years of basic research just to see if something like epitranscriptomics is involved in disease. “We were looking at a new paradigm for gene-expression regulation,” Rizzuto recalls, but it was too early to start a company. He and Jaffrey agreed to stay in touch.
Rizzuto’s enthusiasm in 2014 has since percolated among scientists and investors learning about epitranscriptomics. Several groups, including Jaffrey’s, have shown that the epitranscriptomic code—the number and location of chemical modifications across a cell’s RNA—is seriously out of whack in some cancers. And with basic tools in hand to read this previously hidden layer of information in cells, biotech companies are now out to alter it. Three start-ups, including one that Jaffrey and Rizzuto helped found, called Gotham Therapeutics, have launched with more than $110 million in total dedicated to epitranscriptomics drug discovery.
There was a similar reaction to epigenetics more than a decade ago, when it became clear that chemical modifications regulating genes are frequently out of whack in cancer. Companies rushed to develop drugs against proteins responsible for making, removing, and recognizing chemical modifications on genes—often referred to as the writer, eraser, and reader proteins. With the discovery of parallel writer, eraser, and reader proteins working on RNA, epitranscriptomics is looking like a promising, untapped area for drug discovery.
But there’s another parallel to epigenetics that’s less optimistic: thus far, epigenetic drugs have been a disappointment. “Epigenetics turned out to be a lot more complicated than the community originally thought,” says Chuan He, a professor of chemistry at the University of Chicago.
He, a scientific founder of the epitranscriptomics company Accent Therapeutics, has been at the forefront of developing the new study of RNA modifications and their role in disease. He, Jaffrey, and many others are confident that understanding and controlling RNA modifications will provide completely new avenues for treating disease. “What this really offers is a totally new biology,” He says. “And whenever there is a new biology emerging there are always opportunities for therapies.”
A series of discoveries and technical advancements over the past decade has spawned a new field called epitranscriptomics, the study of chemical modifications to RNA, and the proteins that write, erase, and read these modifications. In recent years, studies implicating epitranscriptomic proteins in cancer have led to the launch of three biotech companies dedicated to drugging these proteins.
May 2008: Rupert Fray shows that a methyl-adding enzyme is essential for plant development. The study inspires others to look at RNA modifications.
November 2010: Chuan He proposes new field of RNA epigenetics, suggesting that methyl modifications on RNA can be removed.
October 2011: Chuan He’s lab proves that an enzyme called FTO erases methyl modifications on RNA.
April and May 2012: The labs of Gideon Rechavi (April) and Samie Jaffrey (May) publish the first maps of RNA methyl modifications. Jaffrey coins the word “epitranscriptomics.”
October 2014: Howard Chang’s lab shows that METTL3, which adds methyl groups to RNA, is critical for embryonic stem cell development and differentiation.
June 2016: Storm Therapeutics, founded by University of Cambridge scientists Tony Kouzarides and Eric Miska, raises $16 million to drug proteins that make RNA modifications.
September and November 2017: Independent studies from Samie Jaffrey and colleagues (September) and Tony Kouzarides and colleagues (November) show that METTL3 is elevated in acute myeloid leukemia and that suppressing the enzyme forces the cancer cells to become noncancerous.
May 2018: Accent Therapeutics, cofounded by Chuan He, Howard Chang, and Robert Copeland, raises $40 million.
October 2018: Gotham Therapeutics, cofounded by Samie Jaffrey, launches with $54 million.
February 2019: Evidence builds that epitranscriptomics may be important for cancer immunotherapy. Chuan He shows that deleting a reader protein boosts the efficacy of checkpoint inhibitors in mice.
MAKING A MAP
A series of events beginning in 2008 laid the foundation for epitranscriptomics. That year, while He was studying epigenetic enzymes that remove methyl modifications from DNA, he and University of Chicago biologist Tao Pan began doubting that all these enzymes were really working on DNA as others assumed. The evidence was particularly shaky for one enzyme, called fat mass and obesity-associated protein, or FTO.
But a study coming out of the lab of plant biologist Rupert Fray at the University of Nottingham reinforced He and Pan’s suspicions that RNA modifications were underappreciated. Fray showed that plants missing a methyl-adding enzyme—similar to an enzyme called METTL3 in humans—stopped growing at a specific early stage in their development.
Scientists knew that METTL3 placed a methyl on a specific nitrogen in adenosine, one of the four building blocks of RNA. This modified building block is called N6-methyladenosine, or m6A for short. Beyond m6A, chemists had cataloged some 150 different chemical modifications to RNA in bacteria, plants, and animals. If He could find an enzyme that removed the methyl groups, it would suggest that there was an undiscovered RNA control system in cells, analogous to epigenetic controls in DNA.
METTL3 and FTO are both enzymes, which means they should be pretty straightforward to inhibit with small-molecule drugs. That notion would later be frequently cited by the new epitranscriptomics companies, although it would be several years still before these enzymes were connected to disease.
At first, the significance of these enzymes was lost on many researchers. At Weill Cornell, however, Jaffrey immediately recognized that He’s study was part of a new field that was about to explode. His lab had been working on a method to detect and map m6A across a cell’s mRNA. Jaffrey had also seen Fray’s work on m6A in plants and thought that if the modifications existed in humans, they must be doing something important in us too.
At the time, methods for studying m6A were rudimentary. Researchers could detect the presence of m6A in ground-up globs of mRNA run through common chemistry lab techniques like chromatography or mass spectrometry. “But you had no idea which mRNAs were being modified,” Jaffrey says. No one knew if all mRNA had some m6A or if the methyl modifications were found on only certain transcripts, he adds. “And frankly, it wasn’t even terribly clear that m6A levels changed.”This is so central to molecular biology; it has to be related to fundamental disease processes.Carlo Rizzuto, partner, Versant Ventures
So Jaffrey and Kate Meyer, a postdoc in his lab, developed a technique to figure out which mRNAs contained these modifications. They used commercially available antibodies that attach to m6A to fish out fragments of human mRNA for sequencing (Cell 2012, DOI: 10.1016/j.cell.2012.05.003).
That technique allowed the creation of the first map of m6A. The results were stunning. “We thought that m6A was going to be all over the place, kind of random,” Jaffrey says. Instead, the researchers saw that methyl marks tended to cluster near an area called the stop codon, and only on certain mRNA transcripts. “It was so specific, it just knocked our socks off.”
An even closer inspection revealed that many of the mRNAs containing m6A were linked to differentiation and development, the same functions that were affected in Fray’s stunted plant embryos. “We were amazed,” Jaffrey says.
In April 2012, while Jaffrey and Meyer were waiting for their m6A paper to publish, another group, led by Gideon Rechavi at Tel Aviv University, published its own paper on the use of antibodies to map m6A in mouse and human cells (Nature 2012, DOI: 10.1038/nature11112). “It was met with a lot of skepticism,” says Dan Dominissini, the PhD student in Rechavi’s lab who led the project. “People didn’t get why it was important. It took a year to publish.”
The problem was researchers still hadn’t established a clear link between these RNA modifications and disease, or even basic human biology. Moreover, the field wouldn’t have its name of epitranscriptomics for another three weeks, when Jaffrey and Meyer’s paper describing their m6A-mapping technique was published online in May 2012. Although Jaffrey had been scooped, the back-to-back publications put epitranscriptomics on the radar. The field was poised to explode.
Editing the epitranscriptomic code
The most common RNA modification is N6-methyladenosine (m6A), which is made when a protein complex containing the “writer” enzyme METTL3 adds a methyl group to adenosine. Two different “eraser” enzymes, called ALKBH5 and FTO, can remove a methyl group to turn m6A back into adenosine.Credit: ALKBH5, FTO, and METTL3-METTL14 protein images created with the Protein Data Bank, NGL Viewer
SEARCHING FOR DISEASE
In Chicago, He was positioning his lab as the forefront of epitranscriptomics research. His group discovered that an enzyme called ALKBH5, like FTO, erased methyl marks on RNA, turning m6A back into adenosine. Yet even by 2014, two years after the m6A-mapping methods were published, epitranscriptomics wasn’t getting the recognition, or funding, that He thought it deserved. “People thought it was cute,” He says. “But biologists were not convinced of its significance.”
Epitranscriptomics was now a hot topic. As studies began bubbling up exploring the role of RNA modifications, particularly m6A, in a variety of cells and species, investors started putting money into the field. In June 2016, a British start-up called Storm Therapeutics raised $16 million and became the first company dedicated to tackling the new RNA epigenetics.
Although Storm was several years in the making, it wasn’t clear what diseases the company would be curing. Two University of Cambridge scientists, Tony Kouzarides and Eric Miska, began discussing the idea for the company back in 2012, when they had published work on obscure enzymes that chemically modify microRNAs, which regulate the function of other RNAs.
Although the enzymes were linked to cancer, at least in cells growing in a dish, the microRNA studies went largely unnoticed. Kouzarides and Miska thought more undiscovered links between RNA modifications and cancer must exist, but it took a few years to find investors willing to bet on their hypothesis. “I don’t think that there was a huge amount of actual data; it was just the belief that there must be,” Storm’s CEO, Keith Blundy, says. “The idea that all of these chemical modifications on RNA weren’t dysregulated or mutated or changed in cancer was almost unthinkable.”
That belief, which echoes the sentiment that Versant Ventures’ Rizzuto expressed in Jaffrey’s office in 2014, was about to be validated. In the second half of 2016, studies began linking reader and writer proteins to cancer. Jaffrey saw the evidence firsthand in an ongoing study he was conducting in blood cancer. The implications for drug discovery were becoming clear. He reached out to Rizzuto. It was time to move forward.
ANNOTATIONS IN THE BLOOD
The common thread running through epitranscriptomics research was its link to cell differentiation and development. Chang’s and Rechavi’s stem cell studies on m6A gave several research labs—including He’s, Jaffrey’s, and Kouzarides’s—the idea to look at the role of these RNA modifications in a deadly blood cancer called acute myeloid leukemia.
Leukemia is essentially a disease of dysfunctional differentiation. Healthy people’s bones are filled with hematopoietic stem cells that produce white blood cells. In leukemia, these stem cells go haywire. They proliferate and displace other blood cells because they can’t differentiate, or mature, into normal white blood cells.
In December 2016, He’s lab, together with several collaborators, showed that tissue samples taken from people with certain kinds of acute myeloid leukemia displayed high levels of the enzyme FTO—which, five years earlier, He had discovered is an m6A eraser (Cancer Cell 2016, DOI: 10.1016/j.ccell.2016.11.017). A few months later, with a different set of collaborators, He showed that levels of the methyl-removing enzyme ALKBH5 were elevated in glioblastoma stem cells (Cancer Cell 2017, DOI: 10.1016/j.ccell.2017.02.013).Credit: Journal of the American Chemical SocietyA surface (mesh) structure of an RNA duplex (sticks) with the methyl modification of m6A (balls).
At the beginning of 2017, Lasky, the Column Group investor, reached out to He. Now that epitranscriptomic enzymes were tied to cancer, Lasky’s firm wanted to start a drug company to control RNA modifications. With the new cancer data in hand, He felt that the time was right.
The investors also knew about a publication in the works from Jaffrey and leukemia expert Michael Kharas at Memorial Sloan Kettering Cancer Center. The Column Group and Versant Ventures worked together for a time to begin forming a single epitranscriptomics company with several of the academic leaders. During the summer of 2017 however, the different players split into two camps. The Column Group brought on He and Chang as academic cofounders of Accent Therapeutics. Versant Ventures named Jaffrey the academic founder of Gotham Therapeutics.
While Accent and Gotham were still in stealth mode, Jaffrey published a study showing that genetic mutations led to fixed, elevated levels of METTL3 in acute myeloid leukemia, keeping white blood cells from forming. By reducing METTL3 levels, leukemia cells could be coaxed into undergoing differentiation to become noncancerous cells that eventually die (Nat. Med. 2017, DOI: 10.1038/nm.4416). “It was remarkable because we didn’t even need complete inhibition of METTL3,” Jaffrey says.
Two months later, Kouzarides’s lab at the University of Cambridge published similar results, with additional details on what METTL3 was doing in these cells (Nature 2017, DOI: 10.1038/nature24678). In leukemia, elevated METTL3 encouraged the production of proteins linked to cancer. “It is feeding the cell the very proteins that are driving tumorigenesis,” Gotham CEO Lee Babiss says.
Epitranscriptomics now had drug targets, diseases, and high-profile studies. After recruiting additional investors, Accent launched with $40 million in May 2018, and Gotham launched with $54 million in October. Storm Therapeutics is in the process of raising approximately $65 million for its second round of cash from investors. Although none of these companies will name their targets or first diseases they will attempt to treat, conversations with the companies’ CEOs suggest that developing inhibitors of METTL3 is a goal for all three.
Drug designers have a lot of experience inhibiting enzymes, making METTL3 an attractive first target. But its activity may not be straightforward, says Yunsun Nam, a biophysicist at the University of Texas Southwestern Medical Center. METTL3 grabs the methyl group it adds to RNA from S-adenosylmethionine (SAM), a molecule used by several other enzymes. Companies’ compounds will need to avoid inhibiting these other enzymes as well, she explains.
Nam thinks a workaround could be targeting a protein called METTL14, which is attached to METTL3 as part of a larger m6A-writing complex. “METTL3 and METTL14 are very dependent on each other for stability,” she says.
Even if the companies can develop selective METTL3 inhibitors, it’s unclear how many people would benefit from them. While the leukemia studies by Jaffrey and Kouzarides showed that m6A levels are too high, He’s leukemia and glioblastoma studies showed the opposite, that m6A levels are too low. Other studies have suggested more contradictory results—including that m6A levels may be too high in glioblastoma. In other words, when developing therapies, it will be crucial to know the epitranscriptomic state of one’s cancer cells. Otherwise, giving the wrong person a METTL3 inhibitor might make things worse.
“That’s a possibility,” Robert Copeland, the president and chief scientific officer of Accent, acknowledges. The challenge for Accent and other companies will be to figure out which subset of people with leukemia would benefit from a METTL3 inhibitor, to lower m6A levels, and which would benefit from an FTO inhibitor, to raise m6A levels, Copeland explains. “If the pendulum swings too much one way or too much the other way, you can cause disease.”Credit: Accent TherapeuticsRobert Copeland, president and chief scientific officer of Accent Therapeutics
Although the leaders of Accent, Gotham, and Storm are being secretive about their strategies, they all hint that the potential scope of epitranscriptomics drug discovery is much bigger than just targeting METTL3.
In addition to the m6A erasers, a growing body of work is uncovering the importance of the m6A readers. Earlier this month, He’s lab showed that an m6A reader protein called YTHDF1 is an important control switch in the immune system and that inhibiting it might dramatically boost the efficacy of existing checkpoint inhibitors, a popular class of cancer immunotherapy (Nature 2019, DOI: 10.1038/s41586-019-0916-x). “I think a lot of immunotherapy companies will jump into epitranscriptomics once they read the paper,” He says.
And this isn’t the first known link between epitranscriptomics and immunotherapy, Accent’s Copeland says. His firm has been studying an enzyme called ADAR1—which stands for adenosine deaminase acting on RNA—that modifies adenosine bases in RNA. Studies from academic labs show that some tumors depend on ADAR1 in ways that normal cells do not. One study suggests that blocking ADAR1 could make certain drug-resistant cancers vulnerable to checkpoint inhibitors (Nature 2018, DOI: 10.1038/s41586-018-0768-9).
Other labs entering the fray are uncovering new proteins that read, write, and erase RNA modifications, with links to additional types of cancer and other diseases. The scope of epitranscriptomics could be enormous. “That’s what excites us about the field,” says Blundy, Storm’s CEO. “There are many, many RNA pathways that are regulated through modifications.”
The discoveries aren’t all coming smoothly, however. For example, Jaffrey claims that the main target of the eraser enzyme FTO isn’t actually m6A but a slightly different modification, called m6Am. Others disagree. “There is still some debate, but that is the normal trajectory for a field, especially in the early days,” Jaffrey says.
The field also still has technical hurdles. “Right now the methods to map and detect m6A are crude,” Jaffrey admits. Existing methods require large sample sizes and are ineffective at quantifying how m6A levels change over time on particular mRNA transcripts. His lab is now working on ways to better quantify m6A to diagnose or predict diseases in the clinic. Such tools will be critical for recruiting the right people into clinical studies testing inhibitors of epitranscriptomic proteins.
Another issue is the lack of publicly available small-molecule inhibitors for studying epitranscriptomic proteins. “We don’t even have an inhibitor for research,” says Dominissini, who has also developed new RNA-modification-mapping techniques and now runs his own epitranscriptomics lab at Tel Aviv University. Right now, researchers have to use genetic techniques to remove or block production of writer, eraser, and reader proteins, but what the field really needs are simple small molecules to test the hypotheses that these proteins will make good drug targets, he says. Of course, that’s what the companies are working on.
A similar lack of compounds stalled epigenetics drug discovery more than a decade ago. Pioneers in the epitranscriptomics field are unfazed by these parallels. “I don’t think there is a relationship between the success or failure of an epigenetics drug to an epitranscriptomics drug,” Jaffrey says.
The scientists and companies in the field are running full speed ahead. Hundreds of labs have cited papers from Dominissini, He, and Jaffrey, and all can point to several ongoing studies investigating the role of RNA modifications in other diseases. “It reflects how fast people jumped into the field,” He says. “Epitranscriptomics is booming.”
RNA AS A PATHWAY TO THE BRAIN
A 2018 study from the Scripps Research laboratory of Sathyanarayanan Puthanveettil, PhD, peers deep within the nucleus of developing brain cells and finds that long noncoding RNAs play an important role in the healthy functioning and maintenance of synapses, the communication points between nerve cells in the brain.
“Long noncoding RNAs are often described as ‘the dark matter of the genome.’ So, systematic interrogation of their function will illuminate molecular mechanisms of brain development, storage of long-term memories and degradation of memory during aging and dementia,” Puthanveettil says.
RNA are the master regulators of the cell, tiny chains of nucleotides that read, transcribe and regulate expression of DNA, and build proteins. While scientists have gained great insights recently into the genetics underpinning how brain cells reach out and communicate with each other, the role of noncoding RNA is poorly understood. Research suggests that the longest of these noncoding RNA, those over 200 nucleotides long, help determine which genes are activated and operating in brain cells at various times. But which ones?
Writing in the journal Proceedings of the National Academy of Sciences, Puthanveettil and his colleagues on Scripps Research’s Florida campus report that a specific long non-coding RNA, GM12371, controls expression of multiple genes involved in nervous system development and functioning. Furthermore, it affects the developing neurons’ shape and ability to signal.
In mouse hippocampal cells, learning-related signaling upregulates GM12371, while its reduction produces inactive neurons, ones with sparse branches.
Together, the results suggest that healthy growth and development of brain cells and brain circuits depends not just upon specific proteins but also upon specific long noncoding RNAs, which scientists are now beginning to explore.
What role GM12371 dysfunction may play in diseases of the brain and nervous system demands further study, Puthanveettil says.
“Both coding and noncoding RNAs are increasingly viewed as druggable targets. Identifying their specific roles in the fundamental biology of functioning of neural circuits might eventually open new ways of treating neuropsychiatric disorders, such as autism and Alzheimer’s disease,” Puthanveettil says.
A Chinese team of researchers furthers these findings one year later:
“In the emerging field of epitranscriptomic mechanisms, mRNA m6A modification has potential role in learning and memory. It regulates physiological and stress-induced behavior in the adult mammalian brain, and augments the strength of weak memories. As a newly identified element in the region-specific gene regulatory network in the mouse brain, mRNA m6A modification plays a vital role in the death of dopaminergic neuron. Mettl3-mediated RNA m6A modification has the direct effect on regulating hippocampal-dependent long-term memory formation. The decrease of Mettl3 in the mice hippocampus may reduce its memory consolidation, and adequate training or restoration would restore the ability of learn and memory.”
From the same Chinese study quoted above: “Epitranscriptomics, also known as “RNA epigenetics”, is a chemical modification for RNA regulation . According to its function, RNA can be divided into two broad categories, including encoding protein mRNA and non-coding RNA. With the deep research of epitranscriptomics, the researchers found methylation modification on mRNA, which is involved in the regulation of eukaryotic gene expression [2,3,4]. The mRNA is a type of RNA with genetic information synthesized by DNA transcription, which acts as a template in protein synthesis and determines the amino acid sequence of the peptide chain . It is an important RNA in the human body. The methylation is the process of catalytically transferring a methyl group from an active methyl compound such as S-adenosylmethionine (SAM) to another compound, which can chemically modify certain proteins or nucleic acids to form a methylated product . In biological systems, methylation influences heavy metal modification, regulation of gene expression, regulation of protein function, RNA processing, etc. . At the early 1970s, scientists discovered the presence of the methylation modification in mRNA [8, 9]. The mRNA methylation modification mainly located in the nitrogen atom of the base group to form m6A, which is enriched in long exons and overrepresented in transcripts with alternative splicing variants . The mRNA methylation modifications also include 5-methylcytosine (m5C), N1-methyladenosine (m1A), 5-hydroxymethylcytosine (5hmC), N6, 2′-O-dimethyladenosine (m6Am), 7-methylguanine (m7G) (Fig. 1). These modifications can affect regulation of various biological processes, such as RNA stability and mRNA translation, and abnormal mRNA methylation is linked to many diseases“.
Another US study from 2018 deals with “Role of RNA modifications in brain and behavior” and reveals that: “Much progress in our understanding of RNA metabolism has been made since the first RNA nucleoside modification was identified in 1957. Many of these modifications are found in noncoding RNAs but recent interest has focused on coding RNAs. Here, we summarize current knowledge of cellular consequences of RNA modifications, with a special emphasis on neuropsychiatric disorders. We present evidence for the existence of an “RNA code,” similar to the histone code, that fine-tunes gene expression in the nervous system by using combinations of different RNA modifications. Unlike the relatively stable genetic code, this combinatorial RNA epigenetic code, or epitranscriptome, may be dynamically reprogrammed as a cause or consequence of psychiatric disorders. We discuss potential mechanisms linking disregulation of the epitranscriptome with brain disorders and identify potential new avenues of research”.
But the most important take out from this latter study, for me, is the final conclusion that stresses the need for larger data-bases to advance the research. I find it important because data bases need samples. And samples are often collected with swabs, like those used for Covid testing.
“With the development of more and better epitranscriptome sequencing technologies there will be a need to analyze large sequencing datasets. New bioinformatic tools are needed to supplement the current data analysis pipelines which were initially designed to analyze chromatin immunoprecipitation sequencing (ChIP seq) data. These new tools will need to take into account the complications caused by differential splicing, and amplification bias induced during reverse transcription as well as integrate multiple RNA modifications within the same molecule of RNA, across the entire transcriptome. A comprehensive database for curating and sharing epitranscriptomic data should be established to standardize the experimental and computational procedures that are used in different studies.123 We envision that in the not so distant future many new molecular and bioinformatic tools will become available to facilitate rapid advancements in the field of epitranscriptomics.”
Actually China and US have been collaborating for quite a while in getting ahead of the curve in RNA therapies. In 2017, a mixed research team from the two countries noted in a study:
“Over 100 types of chemical modifications have been identified in cellular RNAs. While the 5′ cap modification and the poly(A) tail of eukaryotic mRNA play key roles in regulation, internal modifications are gaining attention for their roles in mRNA metabolism. The most abundant internal mRNA modification is N⁶-methyladenosine (m⁶A), and identification of proteins that install, recognize, and remove this and other marks have revealed roles for mRNA modification in nearly every aspect of the mRNA life cycle, as well as in various cellular, developmental, and disease processes. Abundant noncoding RNAs such as tRNAs, rRNAs, and spliceosomal RNAs are also heavily modified and depend on the modifications for their biogenesis and function. Our understanding of the biological contributions of these different chemical modifications is beginning to take shape, but it’s clear that in both coding and noncoding RNAs, dynamic modifications represent a new layer of control of genetic information.”
It’s obvious we’re dealing with an already vast scientific domain that can expand far and wide and has serious positive and negative potential for the human species. And that’s a completely different story than what the establishment is giving you on the RNA vaccines and technologies.
Last minute paper from RNA Biology confirms a scientific reality that can be simplified as: RNA can be used not only as a backdoor to your DNA, but also to your brain, with the potential to make you and your future generations dumb without anyone ever suspecting it. We don’t know if this is being currently done, but we have the tools, the motives and the psychopaths to do it.
“For more than forty years we have known that like DNA, RNA is chemically modified, with evidence of RNA modifications identified from viruses to Arabidopsis, mouse and man. Characterisation of highly abundant modified tRNA and rRNA first informed us of the plethora of structural and functional roles for modified RNA. “
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.
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?
Timeline of the legal case
2006: a panel of Nigerian medical experts concluded that Pfizer had violated international law.
“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
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.”
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.
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, toldThe 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.
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
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.
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! Articles can always be subject of later editing as a way of perfecting them