Depressing imagery. Agonisingly depressing. Ghastly. Unnervingly ghastly. Palms. Palms pale. Sweaty. Clammy. Nervous. Tremulous. Heart racing. Racing heart. Pounding chest. Anxious you are. Your choice. Their choice. Denied you were. Denied we were. For the Government placed more value. More value on the pulseless. More value on the apneic. More value on mydriasis. More value on the rigor mortis. More value on the mummified. Sugar Industry. Carcass. Macabre. And for this reason. And this reason only. Rolled up sleeves. Roll down defences. Your defences. Our defences. Their shot. Our arms. Shot of hope? Shot of hoax? Oxford-University AstraZeneca. Sinopharm? Covaxin? Life? death? Probability the name. Russian Roulette the game. PPP to blame.
Clinical trials
And this our argument is sophisticatedly elementary. The very argument elucidated in the column, “Trumps disinformation campaign and Covid vaccine.” The very column that asserts clinical trials surveil Pharmaceutical Companies. The very column which postulated that all shortcuts to clinical trials must be terminated. For as a rule, Phase I to Phase III must be followed.
Phase I
Is the first time the medicine is tested in humans hence the numbers are small(<10 volunteers). Objective guides are:
1. Ascertain safety.
2. Ascertain medicine movement and settlement.
3. Gain preliminary evidence of therapeutic or prophylaxis value.
Phase II
Is when the medicine performance is ascertained, with one group of volunteers receiving the medicine and the other placebos. Noteworthily, the placebos which have no active ingredients, are indistinguishable from the medicine. Phase II <100 volunteers guided by the following objectives:
1. Effectiveness in treating and preventing the condition
2. Appropriate dosing levels
Phase III
Is when the real trial begins, involving thousands of volunteers across many demographics. Once completed, the data is analysed by an independent body before regulatory approval is sought. Phase III is defined by the following objectives:
1. Demonstrate safety and efficacy of the new medicine in patient likely to use it.
2. Confirm effective dosing levels.
3. Identify side-effects profile and contraindications.
4. Develop a risk-benefit algorithm.
5. Compare results against any existing treatments.
Curative, symptomatic relief, prophylaxis or palliative.
Medicines can either be curative, symptom relievers, prophylaxis or palliative. Curative is self explanatory. Prophylaxis is doctors’ language for prevention. Palliatives are for terminally-ill patients.
Curative medicines serve to cure the disease eg antibiotics that cure pneumonia. But some serious diseases eg cancers may not have a treatment with death likely without one. In such cases, an experimental medicine can be used to save or prolong life. Justification? Death is inevitable without the experimental medicine, therefore using it can only be of benefit. And only in such limited circumstances are experimental drugs indicated.
On the other hand, prophylaxis eg vaccines which serve to prevent disease are administered to people who are well. And here is the distinction.The patient is well, so there is no need to take undue risks, that cannot be ethically justified, with experimental medicines. Additional, Phase III is the only phase where thousands of volunteers are tested to establish safety and efficacy hence should only be aborted in limited circumstances.Therefore, this I say with zero apologies. No civilised society would have approved, Covaxin or Sinopharm. No society except the two medical rouge states, India and China.
Covaxin
Covaxin is an inactivated Covid-19 virus developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. For the nature of it’s development is far from sophisticated. Kill the virus, give the inactive virus a chemical bath, stick it in a bottle and your vaccine is ready for shipping.
And this is critical. Covaxin clinical trials were aborted at Phase II after <100 volunteers would have been tested. Let me put this in context. The Oxford University AstraZeneca Phase III trial had 11, 636 volunteers and Pfizer had >43,000 volunteers.
Surely this decision to abort Covaxin trial at Phase II after <100 volunteers were tested, is not grounded in science and likely driven by vaccine diplomacy and commercial benefits. For this reason, vaccinating well Guyanese with this experimental vaccine is not only unsafe but potentially a waste of their time since the medical community cannot say with any degree of certainty that the vaccine works.
Sinopharm
Sinopharm, not dissimilar to Covaxin is an inactive virus that was developed by Sinopharm based in China. Unlike Covaxin, Sinopharm claimed to have completed Phase III clinical trials but flatly refused to share their data. Note: No one hides good data for which Guyanese are being told to trust the Chinese. But I would rather take my chances with the devil.
Now because of their secrecy, we are in the dark on the efficacy and safety of Sinopharm. Surely, medical ethics is foreign to Asia. Surely medical ethics is foreign to PPP. For if PPP had one ounce of ethical blood, they would have told the Chinese and Indians, thanks but no thanks.
Planless PPP
As reported by the Village Voice, the Russian trained Dr. Frank Anthony was in a Q&A with Dr. Cummings. For one such ‘Q’ pertained to Dr. Anthony’s Ministry mitigating plan for the impact of the variants on our stash of Covid vaccine efficacy, in context of the variants being worldwide including Brazil, that we share porous borders with. In response, Dr. Anthony stupefyingly stated that he is unsure of any relationship between the variants and the vaccines. The fact is, all of the vaccines in our stash, including the Oxford University AstraZeneca have minimal to no effect against all the known variants. Therefore, it is without question that Dr. Cummings was highlighting this, as she concurrently attempted to established the Ministry’s plans on mitigating this public health emergency eg procuring variant efficacious vaccines and regular genome surveillance.
Further, Dr. Anthony was interrogated on his Ministry’s comprehensive plan for the management of COVID-19 and the locality of such a plan with a view to securing copies. Dr. Anthony’s response was “with the stakeholders who are implementing the plan.” And this is my humble opinion of Dr. Anthony’s response or lack thereof. There is no plan which is evident in our catastrophic numbers of Covid cases and deaths.
The unfortunate reality is that PPP never had a Covid plan. Dr. Anthony said as much. Covid deaths are exponentially increasing and they are without a plan. Covid cases are exponentially increasing and they are without a plan. ITU is overflowing with patients and they are without a plan. Innocent Guyanese are walking the streets unwittingly infecting each other and they are without a plan. PPP begged for 500,000 Covaxin but without a plan on how to establish their safety and efficacy.Their begging bowl has 20,000 SinoPharm vaccines that pose the similar dangers to Covaxin and they are without a plan to establishing that. The painful truth is, those two vaccines are unlikely to provide Guyanese much protection from Covid. And I say this, your chances on V-Day can’t be much worse with injected distilled water.
V-Day
You are nervous. We are nervous. Very nervous. Sleeves up. Defences down. Your defences. Waiting. Waiting with trepidation. Our fate. Your fate. In their hands. Syringe loaded. Unsure. Unsure of the contents. Bullets? Blanks? Life? Death? Probability the name. Russian Roulette the game. PPP to blame.
