Vsi, ki se ukvarjamo z znanostjo, zelo dobro vemo, da obstaja pozitivna pristranskost (positive bias) in negativna pristranskost (negative bias) pri objavljanju znanstvenih člankov v posameznih akademskih revijah. Vedeti morate, da v uredniških odborih sedijo posamezniki, ki so tudi sami znanstveniki in raziskovalci na istem področju in ki imajo svoje raziskave in svoje poglede na določeno področje znotraj discipline. Poleg tega ponavadi vsaka velika univerza “kontrolira” “svojo” (eno ali več) akademsko revijo. Ko združite oboje skupaj, dobite rezultat, da v določenih revijah lahko objavljate samo raziskave, ki so v skladu s sprejetimi normami, metodologijo in obstoječimi ugotovitvami določene “šole” oziroma “veje” na področju, ki jo zastopa revija, in ki se skladajo s pogledi urednikov revije. To je pozitivna pristranskost. Na drugi strani je močna negativna pristranskost, saj je v tej reviji praktično nemogoče objaviti članke, ki se ne skladajo s trenutno prevladujočimi ugotovitvami, objavljenimi v tej reviji, in s pogledi urednikov. Takšne raziskave so bodisi “desk rejected” bodisi se jim določi recenzente, za katere se ve, da bodo določen članek zavrnili zaradi tako ali drugače argumentiranih “resnih napak in pomanjkljivosti“.

Tako pač deluje akademski svet in ta pristranskost gre nazaj že najmanj do Isaaca Newtona (in njegovega znamenitega spora z Leibnizem), do Charlesa Darwina (čeprav sam ni bil nič kriv), Maxa Plancka itd. Zato tudi pravimo, da “znanost napreduje z vsakim pogrebom“. O tem sem pisal pred leti v Napredek v znanosti: po en pogreb naenkrat?, kjer sem predstavljal analizo, kako se spremenijo znanstvene objave, ko umre vodilni znanstvenik na svojem področju. Drugače rečeno, napredek v neki vedi je možen le, ko “pokopljejo protežiranca” in ko postane okolje “manj sovražno” do novih idej.

No, in to se danes očitno dogaja v bitki glede zdravila proti Covid-19. Velika farmacevtska podjetja se borijo za to, da bo njihovo zdravilo dobilo potrditev ali priporočilo uradnih inštitucij. Trenutno zmagujejo cepiva, ker so pač bila podprta z milijardnimi državnimi pomočmi in finančnimi spodbudami zasebnih fundacij. Če stane ena doza cepiva v povprečju 10 evrov in želimo dvakrat cepiti polovico sveta, je v igri 70 milijard evrov. Že obstoječa zdravila na trgu za farmacevtske korporacije niso privlačna, ker so zanje patenti že potekli in jih v nerazvitih državah generiki proizvajajo za nekaj centov in prodajajo za drobiž.

In v tej igri sodeluje tudi akademska sfera in njena infrastruktura. Z njeno pomočjo so so v tej igri “ubili” nekaj pretendentov, denimo hidroklorokin, oziroma jim onemogočajo pošten boj. Še vedno odmeva sramotni umor hidroklorokina, zdravila proti malariji, v prestižni medicinski reviji Lancet, kjer so objavili raziskavo z morilskimi rezultati, češ da zdravljenje Covid-19 pacientov s klorokinom ali hidroklorokinom vodi v “decreased in-hospital survival and an increased frequency of ventricular arrhythmias“. Mesec dni kasneje so zaradi odkritja, da raziskava temelji na nerazkritih (izmišljenih) podatkih, objavljeni članek morali umakniti. Toda škoda je bila narejena in hidroklorokina se je prijel sloves, da je nevaren, nacionalne agencije in WHO pa ga niso priporočile za zdravljenje Covid-19. Čeprav ogromno študij potrjuje njegove pozitivne učinke pri zdravljenju Covid-19 bolnikov, pa obstaja velika negativna pristranost v ZDA glede objave teh rezultatov:

After analyzing 180 studies on hydroxychloroquine, the @CovidAnalysis website concluded: “Studies from North America are 3.8 times more likely to report negative results than studies from the rest of the world combined.” This is not random but choice.

Še več, še vedno odmeva kriminalna afera, da naj bi v dveh državah (Brazilija in V. Britanija) v ‘SOLIDARITY’ in ‘RECOVERY’ kliničnih testih pod okriljem WHO namerno predozirali Covid paciente s hidroklorokinom, rezultat česar je bil, da so številni bolniki zaradi tega umrli.

Nekatere objavljene raziskave pa so smešne s svojimi prozornimi manipulacijami s podatki. Denimo decembrska objava raziskave (v taisti prestižni reviji Lancet), ki jo je financirala fundacija Billa in Melinde Gates. Avtorja randomiziranega kliničnega testa glede zdravljenja Covid bolnikov s hidroklorokinom (HCQ) v ali brez kombinacije z azitromicinom (AZ) sta ugotovila, da tretma s HCQ zmanjša čas hospitalizacije iz 8 na 5 dni. Kljub temu pa v interpretaciji rezultatov objave zapišeta, da “Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-1“. Poglejte spodaj in ne spreglejte, kdo je financiral raziskavo:

Findings: Between 15^th April and 27^th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Incident LRTI occurred in six participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in nine (four control, two HCQ, three HCQ/AZ). There were no deaths. Median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. HCQ but not HCQ/AZ had faster time to viral clearance (HR=1.62, 95% CI=1.01-2.60, p=0.047 & HR=1.25, 95% CI=0.75-2.07, p=0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group.

Interpretation: Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.

Funding: The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator.

Na drugi strani so nacionalne agencije za zdravila in WHO močno protežirali novo razvito zdravilo remdesivir, ki stane 3,000 dolarjev za terapijo, čeprav se je hitro izkazalo, da ni učinkovit pri zdravljenju Covid-19 bolnikov. Novembra 2020 je nato WHO objavil priporočilo proti uporabi remdesivira, kar pa ni zmotilo ameriške agencije za zdravila FDA, da ga ne bi odobrila.

No, z ivermektinom je težko predozirati bolnike, saj je na trgu že dolga desetletja in ima znane, mile stranske učinke. Kljub temu pa je prejšnji teden farmacevtska korporacija Merck, ki je imela patent za ivermektin (ki je potekel) in je z njim v nekaj desetletjih zaslužila milijarde, objavila zaskrbljenost glede varnosti uporabe ivermektina za zdravljenje Covid bolnikov:

US pharmaceutical company Merck – one of the manufacturers of patent-free Ivermectin – has just published a statement simply claiming, without evidence, that their (unpublished) “analysis” had identified “no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease; and a concerning lack of safety data in the majority of studies.”

An NIH operative quickly retweeted the Merck statement, adding: “Merck’s statement on ivermectin is the leadership and commitment to quality translational science that we need to see from pharma/biotech.” In reality, Merck’s claim is completely baseless and also ironic: after having safely sold ivermectin for several decades, Merck now suddenly questions its safety.

Bi v Mercku naredili enako, če bi patentna zaščita nad ivermektinom še vedno obstajala?

V glavnem, kot lahko vidite, je v tej “znanosti” v podporo uradnim zdravstvenim politikam veliko gnilega. Povsod imamo opravka s pozitivno ali negativno pristranostjo, kakor pač ustreza velikim farmacevtskim podjetjem. Z ivermektinom pač ne morejo veliko zaslužiti, s cepivi in astronomsko dragimi novimi zdravili pa lahko.

V nadaljevanju je nekaj moje pozitivne pristranosti glede ivermektina. Vendar za razliko od drugih raziskovalcev in akademskih revij jaz tukaj nimam nobenega konflikta interesov. Želim le, da se Covid-19 epidemija konča čimprej in s čim manjšimi človeškimi, družbenimi in ekonomskimi izgubami. Zato si želim, da se preuči učinkovitost vseh zdravil, ki so že na trgu, v boju proti virusu in ne glede na to, kdo bo s tem zaslužil. Želim si, da se ivermektinu da poštena priložnost, da se v kliničnih testih izkaže ali je ali ni tako učinkovit. In če je, naj ga WHO in nacionalne agencije za zdravila priporočijo ter s tem skrajšajo to epidemijo in zmanjšajo njene ogromne negativne človeške, ekonomske in družbene učinke.

Ivermectin, the most promising COVID treatment to date, won its developers the Nobel Prize in Medicine in 2015 and a place on the World Health Organization’s Model List of Essential Medicines. Since the 1980s, with billions of doses given, the drug has cured crippling tropical diseases that had devastated African countries, while curbing scabies and lice and protecting livestock and dogs from parasites.

Spurred by pre-COVID studies showing ivermectin killed Zika and other viruses, Australian researchers last spring tested the drug in a petri dish, where it obliterated the coronavirus in 48 hours. Since then, more than three dozen studies have shown good results in preventing and treating COVID-19.

To be sure, some of the results sound too good to be true or are based on small patient samples. Others are available only in online drafts that have not been officially published. But 16 studies have been peer-reviewed, and 11 are randomized control trials that compared patients who did and did not get the drug.

Statistical analyses show universal benefit, albeit to varying degrees, to using ivermectin for COVID. It’s time Americans knew this.

A nursing home in France had a scabies outbreak in March and treated residents with ivermectin. The home had far fewer COVID cases than others there: just seven of 69 residents – average age 90 — became infected, and none were hospitalized or died. Other such reports have come from Cali, Columbia, Toronto and Lajeado, Brazil, where 28 doctors signed a letter urging adoption of ivermectin as a COVID treatment.

In Argentina, 788 healthcare workers took one pill a week for three months and none got COVID; meanwhile 58 percent of 407 untreated workers became infected. In studies from Egypt, India and Bangladesh, likewise, far fewer high-risk people contracted COVID after taking ivermectin. An Indian state that gave free packets of ivermectin, doxycycline and vitamins C and D saw steep drops in COVID cases and deaths soon after.

This research suggests the drug acts both as a prophylactic – for which data is strongest — as well as an early anti-viral and later anti-inflammatory. In a controlled trial of 400 patients in Bangladesh, no treated patients died compared to three in the untreated group, while 100 patients in a separate study got well within three days. A Florida study, published in the journal Chest, reported a 40 percent decline in deaths when ivermectin was added to other treatments in later-stage hospitalized patients.

‘Purposefully alarmist’

A group of American doctors called Frontline Covid Critical Care Alliance knows that many of these studies are imperfect and that more are needed.  But the group, including doctors who have seen the drug work in patients, maintains there is enough to justify use of ivermectin in today’s fierce medical emergency.

“All the ivermectin studies are lining up,” FLCCC co-founder Dr. Paul Marik told me. “If the trials all line up, it means the findings are reproducible and real. Reproducibility is critical in the evaluation of scientific studies.”

In a 2011 article, the scientist who discovered ivermectin in 1975 in a patch of Japanese soil, Satoshi Ōmura, called it “astonishingly safe” and a “wonder drug,” akin to penicillin and aspirin. “After more than 25 years of use,” a review in the Journal of Drugs in Dermatology concluded, “ivermectin continues to provide a high margin of safety.”

But the U.S. Food and Drug Administration seems bent on ignoring both safety and efficacy findings. In a Q&A on ivermectin, the agency lists side effects from nausea and swelling to neurological events and liver injury. FLCCC President Dr. Pierre Kory described the list for me as “purposefully alarmist.”

Indeed, despite more than 40 positive studies on ivermectin for COVID, the FDA seems stuck in a time warp. Its web site calls the Australian study from eight months ago “recently released” while still declaring, without acknowledging newer studies, that “additional testing is needed.” That’s fine, if only there was support. Just three studies on ivermectin are proceeding in the United States – and none is funded by the National Institutes of Health or any other U.S. agency.

Late last April, US COVID Czar Anthony Fauci decreed remdesivir the “standard of care” before even the first study was published. Failures aside, it is still the only FDA-approved treatment, suggesting a rather arbitrary yardstick for judging the adequacy of COVID drugs.

For 25 years, ivermectin has been distributed free in 19 African countries to control parasites. Is it a coincidence that those countries had 28 percent fewer COVID deaths and 8 percent fewer cases than 35 other African nations? Is it a coincidence that the 240-million-resident Indian state of Uttar Pradesh, which distributes free ivermectin, has a COVID death rate that is one-sixtieth that of the United States’? 

Vir: Mary Beth Pfeiffer, TrialSiteNews