Citat:
Ursprungligen postat av
severustheemperor
Ouch... Du menar att din kompetens på området är högre än Indiens, som har godkänt och börjat använda det.
Gå tillbaka ett par sidor i tråden så har du ett stort antal referenser
Du hittar ju bara på en massa skit utan en enda referens el. länk.
Du trammsar ju förbi all vett och reson.
För det första
ljuger du direkt ut: Indien rekommenderar INTE ivermectin i sin nationella behandlingspolicy för covid-19 (så kallad treatment policy).
https://www.newindianexpress.com/nation/2020/oct/23/change-in-covid-19-treatment-protocolivermectin-drug-not-to-be-usedicmr-issues-advisory-on-felud-221 4115.html
https://health.economictimes.indiatimes.com/news/pharma/anti-parasitic-drug-ivermectin-not-to-be-included-for-covid-19-treatment-protocol-health-ministry/78819616
"The national Covid management guidelines do not advise the drug’s use."
Och dessutom OM din jävla lögn hade varit sann: Indien??
När samtliga 42 länder i västvärlden INTE rekommenderar det än? Då ska vi lyssna på världens mest korrupta land?
Alltså igen : Indien??
Som har lanserat en mängd olika mediciner för att de tjänar pengar på det såsom favipiravir, itolizumab, remdesivir och hydroxychloroquine som alla visat sig gå åt helvete?
https://www.statnews.com/2020/12/11/drug-regulator-india-failed-pandemic-stress/
The itolizumab approval
Itolizumab (Alzumab) is an anti-CD6 monoclonal antibody that was originally developed by Biocon, one of India’s largest pharmaceutical companies, to treat psoriasis. The company was hopeful that the drug could be repurposed to treat the cytokine storm that can occur in severe cases of Covid-19.
But instead of testing this hypothesis in a well-designed clinical trial, the drug was tested on a small cohort of 30 patients. On the basis of data generated from this poorly designed study, CDSCO granted the company an emergency use authorization (EUA) so itolizumab could be used treat cytokine release syndrome in patients with moderate-to-severe Covid-19 and acute respiratory distress syndrome on the recommendation of a “subject expert committee.”
The approval was granted subject to the company conducting a Phase 4 study, which involves post-marketing surveillance. In effect, CDSCO waived a typical, rigorously designed Phase 3 clinical trial, like those had been carried out in the U.S. and Europe to evaluate the efficacy of remdesivir and dexamethasone.
The CDSCO’s actions soon came under withering criticism for a number of reasons including a poorly designed trial, lack of rigor, lack of transparency about the membership of the subject expert committee, and confusion about the provision in Indian law that allowed for emergency use authorization.
The National Taskforce of the Government of India that was set up to determine treatment protocols for Covid-19 declined to include itolizumab in the national treatment protocol,
exposing how even government bodies had little faith in the regulatory process that was used to approve the drug for treating Covid-19 patients.
The favipiravir approval
The second dodgy approval granted during this pandemic by the CDSCO is for favipiravir (sold as FabiFlu in India), an antiretroviral drug developed by Japan’s Fujifilm Group to treat influenza that it licensed to Mumbai-based Glenmark Pharmaceuticals.
In June 2020, director Somani, on behalf of CDSCO, granted Glenmark “emergency use” approval to market favipiravir as a treatment for mild and moderate cases of Covid-19. Experts have raised serious questions about the efficacy of this drug in treating patients with Covid-19. A review of the literature on favipiravir in June by a trio of Indian researchers concluded that there was no convincing evidence for the efficacy of the drug in treating Covid-19. At the time,
there were serious questions being raised about the medical basis of the approval granted to Glenmark, since the DCGI was simply not disclosing any information that Glenmark had provided upon which the CDSCO based its approval.
Glenmark recently announced the results of a Phase 3 trial it conducted in India on the efficacy of favipiravir for Covid-19. It claimed the drug was more effective than the standard of care for treating mild and moderate cases of Covid-19. Critics have questioned the company’s claim, asking why the trial was open label and why the outcome regarding the primary endpoint, which was viral clearance, was not statistically significant.
The company has been accused of cherry picking from the trial’s secondary endpoints to launch a media campaign claiming the drug is effective for treating Covid-19.
