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Beware of Drug Providers! FDA, WHO, Big Pharma’ and COVID vaccine

9 December 2020 03:14 am - 0     - {{hitsCtrl.values.hits}}

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The drug Mafia in operation compels poor patients not only to pay a high price for a poor quality superfluous product, but also bear the risk of exposing their physical organs to a heap of chemicals with numerous side-effects 

 

The ‘medical mafia’ of developing nations are off-shoots of the huge invasive Transnational Pharmaceutical conglomerates branded as ‘Big Pharma’ by the Western medical journalist. They operate individually and collectively in every third-world nation brining unspeakable misery to the poor patients, by simultaneously producing a cheap drug [with severe aftereffects and flood the market], for the costly remedy to follow. They buy over some of the politicians, health authorities, medical consultants through local agents, especially in developing countries. The world’s big pharma companies, Johnson & Johnson, Pfizer, GlaxoSmithKline and Sanofi considered many options to assault COVID-19, beginning tests on existing action, while their vaccine units began studying the virus and creating strategic partnerships to share science, resources and expertise. They say, an encouraging outcome from phase 3 trials will lead to a request for regulatory sanction in the first half of 2021. 

 Let me quote from my premiere contribution to the Daily Mirror six years ago, entitled, ‘Shocking  revelations by world’s top medical Authors’   -  [ http://www.dailymirror.lk/53335/pharma-mafia-sabotages-national-medicinal-drugs-policy#sthash.6i4OtcW0.dpuf ]


‘Medical journalists, Dr Marcia Angell, and Jerome P Kasirir, both former chief editors, New England Journal of Medicine, and Ms Alison Bass, an award-winning investigative journalist, who covers Medicine for prestigious international media have published volumes of bestsellers, including, ‘The Truth about Drug Companies, How they deceive Us’ by Dr Angell: [Random- 2004. ISBN 9780375508462.] and ‘Side Effects’, by Bass; they deal with the ‘crimes’ committed by Pharmaceuticals Mafia in US and Europe. Dr Marcia in her decades of involvement with the industry observes how the ‘Big Pharma’ shifted from their honourable duty of discovering and developing useful drugs, to disgraceful marketing methods.  She reveals their strategies in gaining  influence over medical research, education and doctors prescribing habits; and all myths related to so-called high spending on research and on their strategy for using  publicly financed institutions for their ‘research’ and  more, the grievous rigging on clinical trials to make their drugs look better.  She provides details about bribing legal authorities for obtaining  specially extended patent rights for a product, and depriving a competitor from ‘spoiling’ his lucrative market. She covers several areas of corruption and cheating of doctors, saying, “With profits soaring, the giants brazenly use their funds to push their agenda through US Congress, the FDA (Food and Drugs Authority US, the controlling arm), and academic medical centres”.’

FDA’s role in COVID19 Vaccine

The FDA officers are physicians and career scientists who have globally known experts in  vaccine development and in assessment of safety and effectiveness of vaccines proposed to thwart infections.  They are committed to make decisions based on technically determined valuations of data. They are the people who make these important public health decisions, not only for US, but to the entire third world. FDA is expected to maintain and control the process of creating a high standards vaccine of quality, safety and effectiveness. FDA is supposed to provide technical and regulatory counseling to vaccine developers and carry out a meticulous evaluation of clinical trials, a process that continues on a vaccine that has been authorised for emergency use by them. 

COVID Vaccines developed so quickly?

In emergencies, like in a pandemic, the process is atypical. The American Government has coalesced with agencies, academia, international organisations, NGOs and pharma giants to develop a combined plan for speeding development of the vaccines. Have they compromised on the review process, scientific quality standards, reliability of the vaccine by hurrying through to speed development of it?  FDA and the World Health Organization, through its Department of Essential Medicines and Health Products (EMP) have entered into a pact agreeing to divulge information to each other for the purpose of continuing discussions in order to facilitate and coordinate activities of WHO/EMP for the identification of pharmaceutical material and ingredients. They also have agreed to maintain confidentiality of certain information relating to its activities which they consider non-public? 
The New York Review of Books & magazine-2009, carried Dr Angell’s article where she wrote under, “Drug Companies & Doctors: A Story of Corruption”, “...Similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.” 


And Commenting on the Prescription Drug User Fee Act -1992  which allowed the FDA to collect fees from multinationals to fund the new drug approval process, Angell has stated,
“It’s time to take FDA back from the drug companies...In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.”--In 1997, Time magazine named Marcia Angell one of the 25 most influential Americans for that year.


Are they conducting clinical trials according to the rigorous principles? Clinical trials for evaluation of COVID-19 vaccines need thousands of participants to create the data and miscellaneous  information needed to determine safety and effectiveness. To gain information about how effective the vaccine, initially, the vaccine is given to a small number of healthy people. Its safety is assessed by increasing the dose.  Transparency and dialogue, as per FDA Commissioner Stephen M. Hahn, MD, are critical for the public to have confidence in COVID-19 vaccines.  A debate about the safety and effectiveness of BioN Tech and Pfizer’s vaccine was made up of public health experts from around the country to ensure public understanding about whether to approve a vaccine for emergency use for the prevention of COVID-19. 

"The British medical authorities re-examined or conducted trials to assess efficacy of the drug and revealed that it had been deceptively offered. The drug ‘Paxil’ in reality was not affective, on the contrary it made the youth worse to the extent that it dragged them to near suicidal point of depression and in fact some of them did commit suicide!"

Americans in general see the FDA as blundering and inefficient, public-interest groups, Congressional committees, newspaper editorials, have targeted this ‘authority’ for repeated attack.  They call it a foot-dragging bureaucracy that took three decades to impose regulations for over-the-counter [OTC] drugs and for food coloring additives and still impose them in an irregular manner. A private investigator once told a Baltimore jury that three generic drug manufacturers were getting quick approval for their drugs in exchange for ‘santhosams’ (Benefits) to FDA staff, a scandal that received headline attention in the media. The smart Big Pharma ensured not only speeded authorisation of their drugs, but also a delay for the competitor. The supervisory chemist in the Generic Drugs Division, employed two meticulous accomplices who took their time in handling applications, and another one who could manage many approvals a year. So, it was a ‘Rabbit vs Tortoise’ race at FDA. Chang, A Chinese who headed the department later confessed that he accepted illegal contributions.


Many FDA employees have been prosecuted of accepting bribes, and a few Big Pharma  firms and quite a few  mafia executives have pleaded responsible to fraud, and a number of other firms are currently under investigation. Addressing the WHO sponsored Annual Conference themed ‘Partnership for Safe Medicine’ and held on December 10, 2013, Ms Margret Hamburg – the former Commissioner of FDA said, “It is sad that we live in a world in which some ‘criminals’ are willing to maximise profits by placing poison in infant formula, and medically necessary drugs. It is a reality we must face. And more importantly it is a reality that we must become more proactive in dealing with.”  


FDA approved the Bjork-Shiley Valve [heart implant] with a long history of cracking from its early clinical trials. Shiley was then acquired by the giant Pfizer. Regardless of this malfunction, the valve reached the open market in April 1979 for problems to surface within the next three years, the item had to be removed from the shelves because of its failure, but later it continued with ‘improvements’. Pfizer and Shiley finally, after selling tens of thousands of units had to withdraw the product from the market in 1986. The FDA did NOT think that they should notify valve users that a defective gadget had been fixed in their hearts. The company did sent letters warning surgeons of the risks connected with the valves, but patients remained ignorant of the fact.

Commit suicide

 The Economist a few years ago- carried a report titled ‘For my next trick’ revealed in a shocking way how giant pharmaceutical companies conducted medical trials. They swap their findings halfway with a different set of findings which leads to dishonesty and hoodwink the medical and health authorities concerned. It quoted an example where a drug named Paxil, an apparent highly successful anti-depressant. In a stunning exposure, in the first decade of 2000, the drug added US$2 billion annually to the company’s coffers. Used mainly by under 20, the drug meant for teenagers was administered to beat depression. The British medical authorities re-examined or conducted trials to assess efficacy of the drug and revealed that it had been deceptively offered. The drug ‘Paxil’ in reality was not affective, on the contrary it made the youth worse to the extent that it dragged them to near suicidal point of depression and in fact some of them did commit suicide!
Quote from our premiere [30/09/14] article….
Corrupt practices by ‘Big Pharma’


“…The unique feature of pharmaceutical marketing is that the ultimate consumer or the ‘customer’ for a product, is not the patient who pays for it, but the medical practitioner who prescribes it.  They, in most instances are either misguided, ill-advised or tricked by the trader. Half of the practitioners fall into this category, while the other ‘mischievous’ sect is lured into it by the unscrupulous marketer, who doles out lucrative ‘santhosams’, ranging from five-star family holidays, local or foreign, sponsorships of medical studies for their children, handsome monthly remuneration packages running into hundreds of thousands and many more in return for ‘prescription-habits’ spelled out by them. This process compels the poor patients not only to pay a high price for a poor quality superfluous product, but also bear the risk of exposing their physical organs to a heap of chemicals with numerous side-effects.”


  ‘Outcome switching’, according to the Economist, emerges as a good example of the different ways in which science could go wrong. It is reportedly a hot topic currently, especially due to what is known as a ‘replication crises’ in fields ranging from psychology to cancer research in which the results published are evaporated in the process of duplication. The remedy to this hazardous development which was said to be infallible has been planned by a team of experts from Oxford Centre for Evidence Based Medicine. A project named COMPARE to counteract the tendency to employ an ‘Outcome Switching’, a label attached to swapping information on 
clinical trials.


 Pfizer had to pay 2.3 billion US Dollars to resolve allegations that the company unlawfully promoted uses of four of its products, including Bextra, the painkiller, along with Geodon, the anti-psychotic, Zyvox, the antibiotic, and Lyrica, the anti-epileptic. Federal prosecutors permitted Pfizer to avoid being sentenced for colossal fraud and dishonesty by letting them form another company to obtain the fall. So Pharmacia & Upjohn bore the conviction, whose only function was to plead guilty despite it had never sold drugs. Pfizer got off scot-free, except for $ 2.3 billion fine, just one-fourth of their annual profits. 


The Mafia conspired cleverly, spending millions of dollars through the agents to get the top ranking men attached to WHO and FDA and bring them under their realm. But they failed in handling the late Professor Senaka Bibile, who was on a mission introducing medical drug policy in third-world countries. They did not give up, they had other ideas; the ‘threat’ to the powerful Trans-nationals caused by him had some bearing on his mysterious death in 1977 while working in Guyana under a UN project introducing his formula. It’s a well known ‘secret’ that Prof Bibile was assassinated by inducing artificial cardiac arrest using a drug.  


WHO and our political authority on Pharma are under reliable hands. However, It’s just Big Pharma at its devious best, continuing to swindle the world billions of dollars, and causing danger to the lives of millions, beware!

Writer can be reached at -  kksperera1@gmail.com

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