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Home arrow newsitems arrow Virus Drug: BaseLess EUCom Conditional OK for Costly Remdesivir as French HCQ, Russian Avifavir Wait

Virus Drug: BaseLess EUCom Conditional OK for Costly Remdesivir as French HCQ, Russian Avifavir Wait

Pisac ACM
04. 07. 2020.
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*Strasbourg/Angelo Marcopolo/- While the Pandemic Spreads, Twice-Failed, (initialy for "Hepatitis", Later for "Ebola"), and Now for "COVID-19" Virus, too Costly "Remdesivir" IntraVenous Drug, Patented by US MultiNational Corporation "Gilead", surprisingly got a "Conditional" OK from EU Commission, Limited to 1 Year, and Subject to Answer on Still Open Questions on its alleged "Efficiency" and "Side Effects", (that USA's "FDA" has Recently Asked to Show to the Public in a Long List at a "Note"),

Curiously withOut any New, Nor Decisive Trials' Study, except from an Old and UnReliable Paper (See Facts Infra), Funded by Controversial Dr. Fauci's NIAID, (a Technocrat who did Propaganda for "Remdesivir" Already Since ...February/March, and Again Exploited a White House visit to make unsolicited Publicity for the Same, also on April, See: http://www.eurofora.net/newsflashes/news/misleadingclaimsonvirusdrug.html),

WithOut Even Daring Claim that "Remdesivir" might, Perhaps, Reduce Mortality at all (sic !),

and, therefore, WithOut any Explanation for Brussels' Sudden Hurry to serve USA's "Remdesivir",

But, on the Contrary, Cheap, Simple, apparently More Performant, and Claiming to Save Human Lives, European Drugs, as mainly French "HCQ+" (including Recent Publications), mainly British "DexaMethaSone" (for Grave Cases, Awaiting to be Published, for the 1st Time), and mainly Russian "AviFavir", etc. are still Waiting...

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- The EU Commission's astonishingly Exceptional Laxism on USA's "Remdesivir" came with an "Accelerated" Procedure of  just ONE (1) Week After EMA's Consultation, Instead of ...almost TEN (10) Weeks, "Normally", an Official Press Release Boasted.

>>> But, such a Hurry, for a MultiNational Private Company's Expensive, UnCertain, and Controversial (See Infra) Merchandise, Surprisingly Contrasts greatly with the Scandalous DELAY for EU Commission to Push Measures to Protect European Citizens from being Massively Infected by that Deadly Virus coming from China, and, even More, from North-Western Italy since February, Until it Became Too Late, since the EU had been, Meanwhile, Transformed in ..."EpiCenter" of a World's "PanDemic", as the "WHO" notoriously Announced on March, (See: ... + ... + ... + ..., etc)

- EU Commissioner for Health and Food Safety, Stella Kyriakides reportedly Claimed that the Fact that such a Conditional Authorisation was Granted ..."Less than 1 Month After (Gilead's) Application was Submited", would "Show... clearly the EU (Commission)'s Determination to Respond Quickly, Whenever New Treatments Become Available".        

=> Why, then, Nothing Similar WasN't yet done by EUCom., Neither for "HCQ+", mainly Supported by Chinese, French and recently USA Trial Studies, particularly by Professor Didier Raoult, Ford Foundation, etc., Nor for the more Recent Russian "AviFavir" Drug, (which has been Already Officialy Authorized by Moscow's Government) ? Perhaps, also "DexaMethaSone", Backed by the UK Government and the WHO for Grave Cases, at Respirators/Oxygen intake, (with a 1st Publication reportedly Imminent)..

It's Not a Secret that, Both Kyriakides and EU Commission's current President, Von der Leyen, are Notoriously Known for being Personaly Linked to Big "Bio-Medical Tech" Lobbies, since a Long Time Ago. But, most People, naively thought that these would be, mainly, European...  But, in "Remdesivir"'s case, "Gilead" Company's Interests are Obviously North American !   

>>> However, according to Recent Global Data, "HCQ+" is currently Tested in almost as Many as 400 Trials around the World, while "Remdesivir" Only in about 20 (sic !)...

+ DexaMethaSone" (DMS) has Recently been "Aproved" by the UK Government, and Included in the "Standard" Treatment in Hospitals of the National Health Service. Even if it is Dangerous for the Immune System, a UK Scientific study is reportedly Imminent, for Patients in Grave situation, with Life-Saving promisses.

++ And "AviFavir" has Already been Distributed for Large Use in Russia, Belarus, and Kazakstan, and is currently "Ready for Exports", while "5O Other Countries" accross the World have reportedly Expressed their interest to be Provided with...          

- "Gilead" reportedly Claimed that there were "Also" some Other Countries which would be "Using" "Remdesivir" accross the World, including  f.ex. the "United Arab Emirates", which, Nevertheless, have More than the ...DOUBLE Number of Deaths from the Virus, than their Equivalent and Neighbouring Qatar, (even with Only the ...HALF Number of Infections Compared to it)...

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 As for the Rest of EU's Bio-Tech. vis a vis the Virus, it seems that it Risks to be a Mess :  Apparently, Far Away from f.ex. French President Macron's Dream about European Scientists' alleged Potential to Discover the precious "Antidote" to that Deadly Virus, on the Contrary, Recent Press Reports show that the Biggest French and German Companies are Not really United, in some Great EU Projects for Cures or Vaccines, But, UnFortunately, Walk ... Separately, Each one Associated to a Different ...USA Company !                    

Moreover, Recently, all the "3 Biggest" EU Countries, (Germany, France, and Italy, etc), apparently went to ...Post-BREXIT UK, in order to Pass Command for a Brittish expected Vaccine...

*** Here, probably, the Incoming EU President-in-office, German Chancellor Angie Merkel, as well as French Economy Minister Bruno Le Maire, etc, are Right to Criticise some EU Buraucracy's OutDated, and/or UnFit for Nowadays' World, so-called "Competition" Restrictive Rules, which practicallly and Excessively Hinder the Necessary Creation of Big "European Champion" Companies, Able to Struggle and Win against even Huge Competitors in the Global Arena ! (We saw various Similar unacceptable Problems, mutatis-mutandis, on Cars, even on BioTech, on High-Speed Trains, etc).

However, Sometimes it Risks to be more Pernicious : - What Happened with that "Promissing" EU Bio-Tech Company, previously Tooted by US President Trump, which had, Earlier, an American CEO, and Risked to be Bought by the USA, reportedly "Saved" by EU Commission's "Fast" Move to immediately Give ... 400 Millions €, in order to Keep it inside the EU, particularly during the Fight against the Virus ? In Fact, Today, After Too Many Months withOut any Important News coming from that Affair, Most People ...do Not even Remember Whether its Project was about a Drug or a Vaccine, and even Less What was this Company's Name... As for the Name of its Supposed Product/Project, perhaps, it might be Only ...the Accountant having Send that Voucher, who could Remember precisely ! Some, Recently, only said that it would Plan to ..."Start" (sic !) some "Tests" from ...July, withOut Any Clear Indications about When it Might, Eventually, Conclude...  

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>>> But, Meanwhile, for USA's "Gilead" Multinational Company, Business is Business... The COST for its "Remdesivir" is Huge : According to "Wall Street Journal", it intends to Charge 520 $ per Vial Dose, i.e. about 3.120 $ for a Typical 5 Days' Treatment of One Patient, (with 2 Vials the First Day), and, in consequence, up to... 6.240 $ for a Possible 10 Days Cure !

=> On the Contrary, "HCQ+" would reportedly cost Only ...about 7,3 $ in the USA, (according to "Wikipedia", which does Not Clarify the precise Dose), or  "10 $" (according to a Group of Doctors), perhaps up to 18 € for 5 Days, and 36 € for 10 Days, (with 500 mg per Day, according to Dr. Raoult's formula). I.e., Comparatively, almost "Nothing"...

+ "DexaMethaSone" is, also, "Comparatively Low Priced, and Available Worldwide", according to the Brittish Government. It might Cost just about 1 or 3 € each Daily Dose, (depending on the Quantity purchased : f.ex. per 120 or 30), approximatively. I.e. an Average around 7,5 or 15 €, for 5 or 10 Days...

++ As for "AviFavir", Russia reportedly Left it "Free" inside its National Health System. However, even in "Export" it shouldn't cost much more than "HCQ+", Because Both are No more "Patented" (i.e. Subject to "Authorisation" by a Patent-Owner) Nowadays, but "Generic" (i.e. Free to be Produced by Any Company which Wishes to do so) Drugs, ("HCQ+" since Decades, "AviFavir" since 2019).

On the Contrary, "Remdesivir" is a Patented Drug, with "Gilead" Company Holding (and Exploiting) an Exclusive Patent...

=> In Consequence, the Difference is ..."Explosively" Huge, Both for Individual Patients, and for a Collective, National Health Protection System ! The Same, also, for Risks of Public Officials' eventual "Corruption", which Obviously are Very Big...

_____________________________

*** But, at Least, Does "Remdesivir" really "Worth" it ? Is it Really so "Efficient" for Health, that Anything should be done in order to Use it ?

>>> FACTS are Crystal-Clear : NO ! NO ! and NO ! That's the Biggest SCANDAL : Apparently, "Remdesivir" is NONE of That...

+ On the Contrary, Many Concrete Data, Even show that "Remdesivir" seems INFERIOR to, and/or MORE DANGEROUS than Both "HCQ+" and "AviFavir" !

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* FIRST of all, "Remdesivir" is a ... RECIDIVIST LOSER !

- It was, reportedly, Created, Initialy, during Former POTUS Barack Hussein Obama (a "Socialist"/Liberal), Back on 2009, in an Attempt to Face HYPATITE C. But, it FAILED... + Later, (Always during Obama's era), Back since 2015, it was  send to Africa to Face "EBOLA" Virus, (and Supported with a Lot of Public, Federal Money, Even from the PENTAGON, particularly of the US Navy Force)...

But, Again it FAILED, (the Last African "Guinea Pig" Tested Patient, reportedly ...Escaping by Running Out, Probably because of "Remdesivir"'s Heavy "Side-Effects" - See Infra- and the Congolese Government sent a Letter confirming that, at least 2 Other Drugs were much Better, than that) !

- Nowadays, the "Socialist"/Liberal Former POTUS Jimmy Carter - Appointed, Long-Time CEO of USA's "NIAID" Network, Dr. Anthony FAUCI, (a Member of the National Team of Experts who Advise the "White House" on the Virus, and Notorious "Pal" of the Most Fanatic Anti-Trump Medias of the "Socialist"/Liberal Establishment : CNN, WAPO, NYT, etc, Because he Often Contradicts him openly), has been Pushing "Remdesivir" in order to be used against COVID-19 Virus, this time, Already since  ...February/March 2020. + Fauci Recidivated, anew, Later on April 2020, when he Exploited a random Visit to the "White House" in order to, Suddenly, ...make Publicity for "Remdesivir" to the Press ! (See: http://www.eurofora.net/newsflashes/news/misleadingclaimsonvirusdrug.html, etc). ++Moreover, it is, again ... Fauci's "NIAID" that Funded the Only Trial "Study" which Claims that "Remdesivir" Might, eventually, have, at least Some "Positive" Effects, (Even if this does Not Concern the Continuing Mass Killing of Innocent Human Lives, ...on the Contrary !), which reportedly was What gave the Main Pretext to EU Commission to take that Controversial Decision Today. But, Facts show that this is Due to Fail, Here Again, (See Infra).

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- On the Contrary, "HCQ+" has been, Notoriously, Continuously Used, very Successfully, During Many Decades in the Past, Until Now, (and Still does, Nowadays), in order to Efficiently Fight Against several Serious Illnesses, such as Malaria, Lupus, ArtheroSclerose, etc, almost Since the 2nd World War  !

+ And, even "AviFavir", is a Variation which stems from a Japanese Drug, Previously used Frequently, Since 2014, against certain Forms of "Serious" Flu, with Succesful Results...

(For "DexaMethaSone", a UK Publication is, reportedly, due asap, particularly on its alleged Immune System suppressing effects, which might be OutWeighted in Grave Cases of this Deasly Virus only, with due attention).

=> So that Both these last 2 Drugs, ("HCQ+" and "AviFavir"), are, Already, Well Known, and, their Eventual "Side Effects" have been Found, Studied, Publicized, Largely Tested, and Neutralized, since Many Years Ago, so that they can Easily be considered, Nowadays, as "SAFE" Drugs, Whenever the Established Precautions are taken.

(F.ex. on "HCQ+" and Patients with some Heart Conditions, and on "AviFavir" about Pregnant Women and Foetus/Young Children, etc).

- On the Contrary, "Remdesivir", due to its Repeated "Failures" (Comp. Supra), had Not Yet, until Now, Any Real Opportunity to be Sufficiently Tested and/or Widely Used, in order to Clearly Know All its Eventual "Security" Problems, and/or Negative "Side Effects", as well as How Exactly to Prevent or Neutralize them....

=> That's, by the way, Why, EU Commission issued Now Only a "CONDITIONAL" Approval, for "EXCEPTIONAL" Use, Just in "Serious" Cases f.ex. of "Pneumonia" and/or "Oxygen Need" Problems with the Virus, Adding that this Could Not be Extended for More than 1 Year, Unless the Current UnCertainties on "SAFETY" and/or "SIDE EVENTS" are Lifted Earlier. (AME Even, initially, had Asked for a "Side-Effects" Input "on August" 2020)...

+USA's FDA on REMDESIVIR's NEGATIVE SIDE-EFFECTS :

    + Just a Few Days Earlier, on Mid-June 2020, in Addition, USA's "FDA" Reminded the Fact that Failed former Hypatitis/Ebola Drug "REMDESIVIR, which has Not Yet been FDA Approved+0, has got Just "an Emergency Use Authorization (EUA) in May 2020, allowing for Remdesivir ... to be administered IntraVenously, By health care Providers, as Appropriate, to treat ...COVID-19 in ...patients Hospitalized, with Severe Disease" Only. On the Contrary, Eventual "Safety and Efficacy of Remdesivir for ...COVID-19" in general,  Still "Continue to Be Evaluated".

=> In Consequence, (and given Recent Critical Studies, f.ex. from China, etc), "the EUA Requires that Fact-Sheets about using <<Remdesivir>> in treating COVID-19, be made available to Health care Providers and to Patients and Caregivers" :

+ >>> I.e., "Including information on POSSIBLE "SIDE-EFFECTS", such as: increased levels of Liver enzymes, (which may be a sign of Inflammation or Damage to cells in the liver); and Allergic reactions, which may include low Blood Pressure, high" or "low Heart Rate, Shortness of Breath, Wheezing, angio-Edema (f.ex, lip or tongue Swelling), Difficulty Swallowing, Rash, Nausea, Vomiting, Sweating, Shivering, and Respiratory Distress."

- What a Long List... => Enjoy !

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+ Concerning Health "Safety", in Addition, "Remdesivir" has Also a Problem by the mere Fact that, this Obama's Era Controversial, Twice Failed Drug (Comp. Supra), is Also BASED on ...GENETIC MANIPULATIONS, (Contrary to "HCQ+" and "AviFavir" : See Infra) :

- F.ex., its alleged Target is to Penetrate Human Cells and DISRUPT the RNA/DNA Process (and/or Protein) which ensures the Virus' Replication. I.e., - "It Enters Inside [a Cell] and Acts Directly on its Genes", as notes French Newspaper "La Croix", too.

=> But, such Moves Might, Eventually, Provoke, also, Various Other, still UnKnown and/or UnDesirable Changes inside the Human Genome, perhaps Resulting in Several Health Problems, including, f.ex. Cancer, and/or Many Other Dangerous Consequences, (as, f.ex., it was Already seen in the case of "Clonning", since 1998+, and more Recently, during Controversial "Gene Editing" Techniques, After 2016-2017+, not to speak about the Monstruous Risks of "Heritable" Gene-Editing, Automatically Transmissible to all Future Generations, since a 1st known Incident on October 2018, that CoE's PanEuropean Convention on Bio-Ethics OutLaws, and Many Critics Want, Nowadays, to clearly "Ban" also at a Global Level : See, f.ex., ... + ..., +..., etc).

- On the Contrary, "HCQ+" has been Already Used Since a Long Time BEFORE the Discovery of the DNA, Back on 1953,  (and is Rather, Supposed to Boost the Natural Human Immunity System), while even "the Mechanism" of "AviFavir" is mainly Based on "Bio-Chemical" effects, "does Not Inhibit RNA or DNA Synthesis in ...Cells", "and is Not Toxic to them", (according to "Wikipedia", speaking of that Drug's "Ancestor" : the Japanese "Favipiravir" [of 2014 : Comp. Supra], from which it Stems).

=> In Consequence, they DoN't seem to have, at all, Similar "Safety" and other Problems as those of "Remdesivir", which were Mentioned Supra, mainly Due to its Risks of Abuse of Genetic Manipulations...

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    + Moreover, "Remdesivir" currently is an "INTRA-VENOUS" Infusion - administered Drug, which Needs to be Used "in a Hospital", and under "Close Monitoring".

    => From this Fact, already Result several "Limitations", in real Practice, as 2 Scientists Recently Observed at a Critical Article in "NEJM" Review...

    Proposals and/or Promises to, Eventualy, try to Make it Also Usable, perhaps, "by Aerosol", have surfaced Recently, (f.ex. by some MEPs and/or even "Gilead" Company itself, But, they Need Previous Tests, which would Only "Start" from August (sic !), and, at any case, it Also seems Difficult to Use Human Respiration as a Gate-Way for Patients who, precisely, are considered to have Serious Problems to Breath ! (Comp. Supra)...

    - On the Contrary, Both "HCQ+" and "AviFavir" can Easily be taken through Simple Pils, (while "DexaMethaSone" reportedly allows Various Ways of InTake).

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    >>> Remains, Now, the MOST IMPORTANT of all : WHAT Might those Drugs do to SAVE HUMAN HEALTH and LIVES ?

- Astonishingly, "Remdesivir"s Alleged Potential (Despite its Expensive Price : Comp. Supra), is Both subject to CONTROVERSY, i.e., in Fact, UnCertain Yet, (See Infra), and, at Any Case, EXTREMELY LIMITED and quite UnReliable !

=> First of all, Even the Most Favorable "Studies" on "Remdesivir", and some of its Bigger Supporters (as USA's Dr. Fauci : Comp. Supra), do NOT DARE, Nowadays, CLAIM that it Might SAVE Human LIVES : NO, there is NOT (yet ?) ANY Serious STUDY Claiming that !... (See : http://www.eurofora.net/newsflashes/news/misleadingclaimsonvirusdrug.html, etc)

    + On the Contrary, there is, Even, a Chinese Trial STUDY (Initialy Mentioned by the WHO, and Published earlier at the "LANCET"), which Found that, a Group of Patients who had Taken "Remdesivir" faced ...MORE DEATHS, than those who had Not !  Indeed, its Results Noted about ...+1,2% MORE DEATHS with Remdesivir, than withOut !

(But the Size of that Difference, in Percentage, was estimated to be Not Statisticaly Significant, because reportedly Small).

------------------------------------

+=> Moreover, in General, the Overall Final Conclusion of that 1st Study, made in China, in a Crystal-Clear way, Denounced the Fact that "Remdesivir was NOT associated with ...Clinical Benefits", and "has NOT been proven EFFECTIVE for treatment of patients with severe coronavirus disease 2019 (COVID-19)" at all.

    Even the 2nd Study, on which is Mainly Based the present Controversial EU Commission's Decision, (and its Fan, Dr. Fauci), Admits that Remdesivi "has NOT reached Statistical SIGNIFICANCE" on Death or Life matters...

     + Moreover, Astonishingly, that Controversial Study Reveals that its Authors are  Even..., Still "aWAITING FINAL ...DATA (etc), ...AFTER which an UPDATE of the RESULTS WILL be provided" (sic !)

    => In other words, its NOT even KNOWN Nowadays IF the FINAL RESULT might, Eventually, be, Perhaps, ...MORE DEATHS with Remdesivir, than withOut ! (Comp. Supra).

    >>> That's the Reason, for which, EU's Experts at EMA had ASKED from "Gilead' to provide "FINAL DATA on MORTALITY", at the LATEST "on AUGUST 2020"...

    (For the CAUSE of such a Strange Phenomenon, See Infra).

-----------------------------------

    + Even WORSE concerning Health : Remdesivir seems to have Many Serious "ADVERSE" Negative "EFFECTS", to the Detriment of several Petients who Suffer from them :

    - Indeed, Already, Earlier, that 1st, Critical Study in China, Published by THE LANCET, (Comp. Supra), found that ...+6,5% More Patients treated with Remdesivir, than those who took only a Placebo,  faced "ADVERSE EVENTS" which made them ..."STOP Early" these Tests, and Go Away...

Among the "Most common" such Adverse Effects" of Remdesivir, it's mainly "Nausea and ACUTE RESPIRATORY FAILURE" (sic !), which were Cited by "Gilead" itself.

    + Moreover, Even that 2nd Study, on which was Mainly Based EU Commission, Pubished by NEMJ, ADMITS that, Inter Alia,  "the most Common ADVERSE events in the Remdesivir group were ... + acute KIDNEY INJURY, decreased estimated glomerular filtration rate or creatinine clearance, or increased BLOOD Creatinine (40 events [7.4%], as Compared with 38 [7.3%]) [for the Placebo Group]; PYREXIA (27 events [5.0%], as compared with 17 [3.3%]); HYPER-GLYCEMIA or increased Blood GLYCOSE level (22 events [4.1%], as compared with 17 [3.3%])" (in Placebo Group)...

     ++ Even Worse : => In Consequence,, at the USA, the Powerful "FDA", Recently pointed out that "the EUA Requires that FACT-SHEETS about using <<Remdesivir>> in treating COVID-19 be made available to Health care Providers and to Patients and Caregivers". "Including information on ¨Possible SIDE-EFFECTS, such as:"

    >>>" increased levels of Liver enzymes, which may be a sign of Inflammation or Damage to cells in the liver; and Allergic reactions, which may include low Blood Pressure, high" or "low Heart Rate, Shortness of Breath, Wheezing, angio-Edema (f.ex, lip or tongue Swelling), Difficulty Swallowing, Rash, Nausea, Vomiting, Sweating, Shivering, and Respiratory Distress."

- What a Long List !  "Enjoy"...

    => All this Fits with, and might Explain, Moreover, the Wider Fact that, apparently, People doN't run to Test Remdesivir at all, but, rather, prefer to Go Away : F.ex., +2 Other Tests, previously Scheduled in China, were, Finally ...Abandoned, because almost Nobody was found Willing to Participate as Guinea Pig to them !

Such Facts inevitably Remind, Also, a Previous "Flop" that Remdesivir notoriously Faced Already in the Past, when, after having been Initially Presented as a Drug against African "EBOLA", it was Finally Rejected by Congo as "significantly LESS Effective than (Other) Treatments"; while, among the (Only) 2 Last Patients reportedly still remaining at a Congo Hospital for Remdesivir Trials, at least 1 (i.e. ...50%), suddenly RUN AWAY...

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    - So that, the ONLY main CLAIM made by that Controversial Srudy in favor of this Drug is that, reportedly, "Patients in the remdesivir group had a Shorter Time to Recovery than patients in the placebo group (median, 11 days, as compared with 15 days)", i.e. an Allehed Difference of about 4 Days.

    But, something Similar had Already been Noted by the Previous, Chinese Study (Comp. Supra), which had Found a Difference between 21, instead of 23 Days, i.e. Only -2 Days Earlier". An alleged Small Distance of Only 2 Days, which had been Dismissed as "Statistically NON Significant"... So that it had, Finally,  Concluded that Remdesivir was "Unable to demonstrate Any Statistically Significant clinical Benefits" at all...

    On the Contrary, by Claiming anOther +2 Days Earlier, that 2nd Study, Funded by Dr. Fauci-related Sources, immediately Argued that this would be a reportedly "Important" thing, Basing all its Revendications on that... To the point that its sponsor, "Gilead" Company even ...Abused of that Claim as an Excuse for the Excessively Heavy Price that it Asked to be Paid for Remdesivir's alleged Higher "Cost" (Comp. Supra), arguying that Hospitals would Save some Cure's Money !

    But, at least, has this been really "Proven" Beyond Any Legitimate Doubt ?

    >>> The Answer, as things stand until now, cannot be but a crystal-clear "NO !"...

    Simply Because the "DATA" Presented by that pro-Remdesivir Study are, in Fact, Too UNRELIABLE to hold Such Claims, and this, for MANY REASONS !

    Indeed, Among (Many) Others Failures and Misgivings :

--------------

 - (1) -

First of all, that Study had been, in Fact, Published, Already Since ...MAY, But, Curiously, those EU Commission's "Experts" Presented it, about ...2 Months Later, on JULY, As If it would have been, rather, a kind of "New" Development..., which would, Allegedly, Show that, some in Brussels, at last, Started to "Move Fast" (sic !) on Health Issues... I.e., an Obviously Excessive, or even UnSubstantiated Claim.

------------------------------

   - (2)-

This Shaky and Obviously InSufficient "Study", (Signed, at First, by a Simple "Medical Doctor", Mr "Beigel", a.o.) was Pubished at Nowadays "NEJM", i.e., a Notoriously ...Fanatic "Anti-HCQ" Paper, Recently taken over by a Controversial Chief Editor, (See Facts already Published by "Eurofora", also at : http://www.eurofora.net/newsflashes/news/msmediagogagaonhcq.html, etc)...

    + In Addition, it has been FUNDED Mainly by "NIAID" and "NIH" Sources, which, in Fact, Depend from the Most Vociferous Propagandist of "Remdesivir", the Controversial "Dr. FAUCI" HimSelf, who had, Already, Singled out and Praised "Remdesivir" as a "Promising" Drug, as Early as ...Since Three (3) Months Ago, from the very Beginning of March !

    He Later Abused of an UnRelated Opportunity at a POTUS Trump's meeting with some Journalists at the White House, (where he's one among the Members of its "Experts"' Team on the Virus), in order to Loudly Claim that this Controversial "Gilead" Company's 2nd Study would have ..."Proven" (sic !) that Remedesivir "can Block (re-sic !!) this Virus", so that " We Now Have the Capability of Treating (re-re-sic !!!)" it, as he Boasted...

    Controversial Dr Fauci, (Notorious for having Repeatedly Criticized US President Trump and others, always Against the popular HCQ Anti-Virus Treatment, a cheap Competitor to expensive Remedesivir), had been Initially Hired at USA's Federal Administration during Former "Socialist/Liberal" Dems' Party POTUS Jimmy Carter's era, (while being also reportedly Familiar with controversial Millionaire Soros, Bill Gates Sr., and the Bilderberg circle).  Since then, he has been reportedly continuing Research for a "Vaccine" against HIV, withOut Finding Any, since the 1980ies :  i.e. During about "40 Years"  !

    Fauci's latest "Prognosis" for an eventual Vaccine against the CoronaVirus, currently is, at the Best, around 1,5 Years... But, Meanwhile, too Many innocent People are Dying, throughout the Whole Planet, by that Deadly Virus, Every Day...

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+ After the "LANCET-Gate" Scandal, also anOther "MEHTA" on the HCQ - Remdesivir Row ?

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cclib_virus_stephanopoulos_pub_for_mehta_b_on_remdesivir.._gma_video__eurofora_screenshot_400 

     +Last, but Not Least, by an Extraordinary "Coincidence", among the Leading Authors of that Controversial "Study" for Remdesivir, figures Aneesh Kumar MEHTA : A MD with the Same Family Name (and Same Origin, Job, etc) as the Number 1 Leading Author of the Notorious "Fake" Study abused Against the "HCQ" Cure supporters, (Biggest Competitor to Remdesivir), which resulted to a Unique in History "LANCET-GATE" World-wide SCANDAL, and was Retrieved, After it was Proven that it was Based on UnVerifiable and Falsified "Data", Following a 1st comprehensive Denonciation, by "Eurofora", Dated 23 May 2020, which Revealed a "Bogus Study" with "11 Big Flaws", (See: http://www.eurofora.net/newsflashes/news/bogusmoveagainsthcqdrugvvirus.html, etc). Obviously, Both "Mehtas"' Controversial "Studies", objectively Serve the Same Interests, (Against HCQ, but For Remdesivir, as Virus' Cure)...

 

another_mehta_in_2nd_bogus_paper_for_gileads_remdesivir_flop_gma_video__eurofora_screenshot_400 

  Aneesh Kumar MEHTA (MD) studied Medicine at Emory (private) University, Georgia, (BS, and MD at Oklahoma), where he was, Suddenly propulsed as Appointed "Assistant Professor" on 2009, (withOut any PhD and Not Even any Master), i.e. "Socialist/Liberal" Former POTUS Barack Hussein OBAMA's 1st Year in Office, (when he Allowed Federal Funding for Genetic Manipulations on Human Embryos [Previously Forbidden], as novel Deadly Virus H1N1 Pandemic Started). On 2012 Emory University "apologized" for having "Intentionally MisReported Data" on its "Students' ...Scores and Class Rankings, between 2000 and 2012". Its Students' Absolute Majority is "Non-White" 58% versus 42%, anf Former "Socialist/Liberal" POTUS Jimmy CARTER was among them, (Wikipedia).  Mehta has Specialized particularly on Organ Transplantation-related issues, (Against Natural Immune System's Barriers), and on "Ebola" Virus, (etc). By the 1st, he is Related also to that Other "Mehta", of the Anti-HCQ Scandal. While, by the 2nd, he is Related even to "Gilead"'s Remdesivir Drug. Bill GATES' Foundation is Funding several activities at Emory, where NIH Funds, among Many Others, also  a Project to Link "Vaccines" with "Genetic Engineering and BioTech" in India, (in fact, Both Aneesh Kumar Mehta, and Mandip Mehta's names stem from a Pakistan-Neighbouring Indian Region, Largely Islamized : Comp. http://www.eurofora.net/newsflashes/news/bogusmoveagainsthcqdrugvvirus.html, etc).

-----------------------------------------

    -(3)-

    Even More Grave : That Key pro-Remdesivir Controversial "Study", (where EU Commission and Others just Based Exceptional Decisions : Comp. Supra), is Only a ..."PRELIMINARY Report", which Merely "Summarizes the Preliminary results from this OnGoing Trial", as is own Text Acknowledges...

    - Indeed, "Even Though the Trial was (Still) Ongoing" and UnFinished, InComplete, Nevertheless, its Authors Moved to "UnBlind the ("Preliminary") Results to the Trial Team Members from the NIAID (Linked to Dr. FAUCI: Comp. Supra), Who, subsequently, Decided to make the (Preliminary) Results Public" (By Dr. FAUCI Himself : Comp. Supra), just because They Believed, themselves, that "these Findings were Deemed to be of Immediate importance", (in reality, in order To Back "Gilead" Big Pharma Company's Demand for a FDA partial and provisional Approval..), that Text Admits !

    - in Fact, that Controversial "Study" is Limited Only to ...the 1st HALF of its Planned Work, covering just about 14 or 15 Days, Instead of ...29 or 30 Days, which were its Official Aim... (See Infra).

    - That's Why, f.ex., the FDA Noted, on this occasion, that this Controversial Remdesivir "Study"'s real Results, Still "CONTINUE to Be Evaluated". And EU's Experts at EMA, Asked "Gilead" Company to Present its "FINAL RESULTS", particularly "on Mortality", (i.e. the Most Important matter), "at the Latest, on AUGUST".

=> As a Consequence, that Controversial "Study" Itself, clearly WARNS that "Additional analyses of Outcomes ... Will be conducted, After the Full cohort has Completed 28 days of follow-up, and May provide Additional Insight", (still UnKnown Nowadays).

    - "We are aWAITING FINAL visits, DATA entry, Monitoring, and data lock, for the Last of the 1063 Patients enrolled, After which an UPDATE of the Results WILL be provided", Promish that Controversial "Study"s Authors.

    >>> In particular, Not Even "the ...Estimates of Mortality (the Crucial Point) by 28 Days, are Not reported in this Preliminary analysis, given the Large Number of Patients that Had Yet to Complete Day 29 visits",... (Comp. Supra)

    In other words, Nobody still Knows, (at least, Not Officially), Whether Remdesivir might, perhaps, Limit somewhat the Number of Dead, (Even if its Fans do Not Claim such a thing : Comp. Supra), or Leave it practically Equal to Placebo Group, (as this "Study" sees, (Comp. Supra), or, may be, Even Worse, it MIGHT ... AGGRAVATE the Situation, by Resulting at a BIGGER NUMBER OF DEAD, THAN what had been the case BEFORE, (as, already, a Previous Chinese Study had Found : Comp. Supra) !

__________________________________________

    -(4)-

++ In Fact, there was Even 2 Exceptional "CHANGES to the (Overall) Trial DESIGN", on which, "the NIAID (i.e., ultimately Dr. FAUCI : Comp. Supra) Made all Decisions", as that Controversial "Study" Acknowledges :

=> Indeed, First of all, "INITIALLY", the "Primary Outcome", "When the Trial was Designed", Back "in February", had been  "Defined as the ...Clinical Status .. at DAY 15", Since the Beginning of that Trial. But, Later-on, a "CHANGE was proposed on March" and "Finalized on April 2", "in response to Evolving Information, ...indicating that Covid-19, May have a MORE PROTRACTED course, Than Previously Estimated", (as that Controversial "Study" Claims). So, the Trial's overall Duration was EXTENDED, "FROM a Comparison ...on DAY 15, TO a Comparison ..up to DATE 29", i.e. almost the DOUBLE of what had been "Initially" Scheduled !

+ Moreover, in Addition, a "Review ...ORIGINALY PLANNED (Only) as an INTERIM Analysis, ...WHILE Follow-up was STILL ON-GOING", i.e. "Based on DATA CUT-OFF DATE of APRIL 22", Nevertheless, was "Provided to...(the) NIAID", (i.e. pacticaly to Dr. FAUCI), and "Subsequently MADE PUBLIC" so Early... (Comp. Supra).

BUT, on the Contrary, it's ALONE "The treating Physician (who) could Request to be made AWARE of the Treatment ...of Patients who had not COMPLETED DAY 29", and that, Only "IF Clinically REQUIRED"...

=> As a Consequence, Practically, THE PUBLIC (including even the EU itself) Still IGNORES what happened during the 2nd STAGE of that Trial, i.e. Between 15 and 29/30 Days (Comp. Supra) ! So that, Even if, f.ex., Mortality and/or Adverse side-Effects, might, perhaps, have had a Worse FINAL RESULT with Remdesivir at the End, than with Placebo, (as, f.ex., the Earlier Chinese Study had Found : Comp. Supra), nevertheless, such a Crucial Fact would remain CONCEALED to the Public, until now !

    At any case, the Period Between the "Data CutOff Date of April 22", for that "Preliminary Report" on this Trial, and EU Commission's Decision of Today (July 3), i.e. about ...2,5 MONTHS (sic !), Obviously is TOO LONG, so that the present DELAY of the Full, Real FINAL RESULTS seems Doubtful and UnJustified...As for EU Experts' EMA's above-mentioned Demand for Gilead to show is Final Results at the Latest ON AUGUST" 2020, (i.e. ...More than 4 MONTHS Afterwards !), it's Blatantly EXCESSIVE.

-----------------------------------------------

    -(5)-

    Finally, probably the Most Grave FLAW of this Controversial "Study" is that its DATA appear Very UNRELIABLE, and that, from Many Points of View !

--------

- (a) TOO MUCH DISPERSION

    First of all, that Trial reportedly included "1.063 PATIENTS", SEPARATED, around Various Hospitals, at  "73 SITES" (sic !), and, in Addition, DISPERSED throughout ... TEN (10) Different COUNTRIES accross the World !  (From USA and the UK, up to Germany, Denmark, Spain and Greece, as well as Japan, Korea, and Singapore, even Mexico)...

    => So that, Obviously, it becomes Too Hard, or even quasi-IMPOSSIBLE, in real Practice, to Ensure (among Others) EQUIVALENT Conditions between the Remdesivir and Placebo Groups, all along some 30 Days !      

    How could the Organizers of such a Trial Seriously CONTROL, be well INFORMED of, DECIDE, and VERIFY, in a really Unified Way, the Manifold Concrete Aspects and Developments of such a Delicate and Complex "Study", Despite an Obviously Excessive Dispersion ? (See also Infra).

---------------------------------------------------

- (b) + Even ... "REMOTE MONITORING" !!!???...

    Particularly During a Global Crisis as the current Deadly Pandemic, such a Dispersion (Comp. Supra), Provoked a lot of Exceptional and Serious Problems for Such a Trial :

    - Indeed, "Numerous Challenges were Encountered during This Trial", its Organizers Admit. Inter alia, f.ex., it "was implemented during a Time of Restricted Travel (among 10 Countries in 3 Continents of the World), and Hospitals (among 73 Different Sites) Restricted (even) the Entrance of (so-called) Non-Essential Personnel", as they found in practice...

    => Consequently, among various others, f.ex., "Training, Site Initiation Visits, and (Even) MONITORING visits, OFTEN were performed REMOTELY" (sic !), they Reveal.

    But, is it Serious to Pretend really CONTROL All the Delicate and Complex, often Unforeseen and/or Life-Threatening Medical Developments in the Health Situations of More than a Thousand of Patients, Dispersed accross 73 Different Hospitals, throughout 10 Countries at 3 separate Continents with Various Time-Frames, During 24 Hours Each Day throughout a Whole Month, (Comp. Supra), ...Merely BY PHONE Calls, and/or EMAILS, or VIDEO-CONFERENCES, just Sitting at your Office, during US Working-Hours ?...

    Obviously Not.

--------------------------------------------

- (c) + Too Big DIFFERENCES Between Various + Many HOSPITALS

    + Moreover, the InEqualities between 73 Hospitals in 10 Countries, inevitably, proved to be Too Serious, in real Practice, as the Authors of that Controversial "Study" Recognized themselves :

    - Indeed, inter alia, f.ex., "Research Staff were Often assigned Other clinical Duties, and staff illnesses Strained research Resources", as they bitterly found...

    ++ In Addition, "Many (sic !) Sites did Not have adequate supplies of personal Protective Equipment, and (Not Even) Trial-related Supplies, such as swabs" !

    => In Such Circumstances, it's Obviously Impossible to Guarantee really "Equivalent Conditions" for Serious "Comparison" Between all Remdesivir or Placebo Groups of 1.063 Patients.

-------------------------------------------------------------

 - (d) +"OTHER THERAPIES" in VARIOUS HOSPITALS ?!...

    Perhaps the Most Decisive FLAW, which, Normaly, should be Enough in order to Definitively DISCREDIT this, already Controversial, "Study", is that of a so-called ..."Adaptive-Design Platform" (sic !), as they nick-named it, which, in Plain English, Scandalously means that ...ANY among 73 HOSPITALS COULD GIVE to those 1.063 Patients, practically, ANY TREATMENT THEY LIKED !

    - Such an UnBelievable SCANDAL was, Indeed, Revealed, by a Note in that Controvesial "Study", where its Authors Confess the Incredible Fact that They had "Allowed participants to receive (Also) OTHER THERAPIES for Covid-19, that were PERMITTED BY THEIR Home INSTITUTIONS", (i.e. 73 Hospitals, in 10 Countries and 3 Continents)...

     - "IF (NDLR : i.e. They DoN't Even Know, and, apparently, doN't give a damn, about Who, What, Whether and When Might, Eventually, Do Any Such thing !) A HOSPITAL had a written POLICY or Guideline For use of OTHER TREATMENTS for Covid-19, (then) Patients COULD RECEIVE those (perhaps Absolutely DIFFERENT) Treatments", that incredible Text acknowledges !

    => - Naturally, "It WILL (i.e. at an UnIdentified Future...) be Important to IDENTIFY these CO-THERAPIES and Any EFFECTS they Might have on the Results", Obviously, they were Obliged to add, briefly, (in Catimini)...

    >>> In Other Words, to Put it Plainly, in a Nutshell, EVEN IF, f.ex., A HOSPITAL USED ..."HCQ+Az+Zinc" (and/or Any Other Drug, f.ex. the Russian "AVIFAVIR", etc), in order to Obtain the RECOVERY of Patients Considered to be IN a "REMDESIVIR" GROUP, the Authors of that Controversial "Study", in fact, DIDN'T MIND so much !

    => In front of a so BIG SCANDAL, (largely UNHEARD of, in Other Trials), it's NOT ONLY the (Still "Expected" : Comp. Supra) "FINAL Results" of this Controversial "Study", BUT EVEN the current "PRELIMINARY Report" (Comp. Supra), which Should, Normally, be Straightly REJECTED, and Thrown to a Waste-Basket,

     (Unless, perhaps, it might be Preciously kept as a ..."Collectors' Item" of an Historic Record-Breaking "BOGUS" Fake-"Study", Even More Ridiculous than that, co-Signed by just anOther "Dr. Mehta", which Notoriously Provoked Recently the World-wide "LANCET-GATE" Scandal Against "HCQ+" : Comp. Supra, and ..., etc)...

-----------------------------------------------------------------------

AVIFAVIR :

On the Contrary, the much Cheaper, Simple, and apparently Safe Russian Drug "Avifavir" (Comp. Supra), reportedly COULD SAVE some HUMAN LIVES, since a Recent Trial found that it was paticularly "RAPID":

    - In Just "5 Days", it had Already "Eliminated" the Virus "in 77,5% of Patients", while, "Also" at "14 Days" there was "a Significant Difference" between that "Avifavir" Group of Patients and anOther Group receiving "Standard ...Therapy".

+ More Recent Trials (UPDATED) found that, in Just "4 Days", the "Virus Disappeared in approximately 62,5% of Patients, While this occured in Only 30% of cases in the Control Group" (receiving Standard Drugs). And "by the 10th Day", there were No more Virus' Traces "in 90%" cases, Compared to "80% in a Placebo Group".

----------------------------------------------

HCQ+

Concerning HydroxyChloroQuine, (with Azythromycine, and Zinc), the Latest Published study of Dr. Didier Raoult, revendicates an Astonishing, Record-High, 99,5% SURVIVAL, if it's taken at an Early Stage, (After Only 0,9% of Cessations of Treatment for Adverse Effects, Mainly Gastro-Enterologic), Based on a Retrospective Analysis of the Results of Treatments on 3.747 Patients (separated in Various Groups), at Marseille (France), Only a Small Number of whom had been Oriented to Standard Treatments for Safety reasons, according to a Publication at the current edition of TMID Review (Elsevier).  See also : http://www.eurofora.net/newsflashes/news/hcqazrtopsurvivalcontravirus.html, etc).

--------------------------------

DEXAMETHASONE

This UK-sponsored, Cheap and Simple, but Partly Delicate, Substance was Credited, at a Seriously Advanced State of the Virus' Infection, to, reportedly, REDUCE MORTALITY by about 1/3 for Patients on Ventilators, and about 1/5 for those requiring Only Oxygen, according also to the WHO.

Thus, it seems that it might, eventualy, serve as Complementary, mainly to "HCQ+", (which acts at Early Stages and much More Widely), but, perhaps, also to "Avifavir", (Comp. Supra),

------------------------------------------------

=> Taking into account, also, those apparently Serious "European" Competitors, (Comp. Supra), and Hoping that even more might soon emerge, Nowaday's EU Commission's Hurry towards USA Compagny Gilead's controversial Remdesivir, ill-based on what really seems to be just another ..."Bogus" Fake-"Study", as "Eurofora"s Critical Analysis just Proved, (Comp. Supra), appears very Strange, and, at any case, UnSustainable.
 

the_muse_unsustainable_youtybe_video__eurofora_screenshot_400 

https://www.youtube.com/watch?v=EF_xdvn52As


(../..)

 

("Draft-News")

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