Phase 3 participants
As per the methodology of Phase-3 trial of a vaccine, volunteers belonging to both the experimental and control groups are exposed to the same environment of natural infection of the novel coronavirus. We already know that the ‘elderly group’ has a higher case fatality rate when they get infected. That is why during the pandemic, the health sector advocates ‘reverse quarantine’ or ‘cocooning’. So if we enrol the elderly as participants for the study, as suggested by Dr. M.S. Seshadri and Dr. T. Jacob John (Editorial page, “The participants we need in Phase 3 trials”, August 28), we are knowingly allowing fatal complications to occur among them. This is unethical and irrational when other options such as using youth and healthy working volunteers can be explored. The elderly and patients with co-morbidities are definitely not priority groups in a vaccine trial. But they are a priority when it comes to service delivery of a trial finished, legally certified, safe and effective vaccine. Approval from the Ethics Committee will not agree to the inclusion of the elderly for a Phase 3 trial.
Dr. K.R. Antony,
Kochi
Response: Dr. K.R. Antony highlights a practical difficulty in including special groups of vulnerable persons in a Phase 3 vaccine trial because the traditional design will have to be modified to accommodate them. The vaccine would have been found safe in the Phase 1 and 2 trials and it is quite alarmist to suggest that a vaccine will cause fatal complications in senior citizens. What we need is documented objective evidence of safety in seniors so that there is a vaccine roll-out to them on a priority basis immediately after vaccine registration, without further delay in conducting a bridging study after the Phase 3 is over. If seniors were excluded from the Phase 3 trial, time will be lost.
Because seniors will have very low risk of exposure to infection on account of ‘cocooning’, they will not be suitable to assess protective efficacy. Protective efficacy will be measured in all other study subjects, including health-care workers. Because of the need for a special trial design, we recommended that all the stakeholders should quickly consult among themselves to create a suitable ethically sound design.
Dr. M.S. Seshadri,
Dr. T. Jacob John
Tamil Nadu
Bridging the GST gap
When the Goods and Services Tax (GST) was introduced with much fanfare, amidst stiff opposition from States, it was contended that this measure was a panacea for all economic ills and would bring to an end the conflicts between States and the Centre. Now, the States have been forced to seek and retrieve their legitimate share of GST. Apportioning their shares to itself, the Centre is also asking them to seek ‘loans’ from the Reserve Bank of India for the amount, contending funds shortage (Page 1, “Borrow from RBI to bridge GST gap, Centre tells States”, August 28). This is when the Centre has taken ₹4.50 lakh crore between 2015 and 2020 as “dividend” from the RBI . When technology has improved and the government gets taxes transferred in no time, it is intriguing why the shares of the States from GST collected are not immediately transferred to their accounts. This dispensation will affect federalism as well. Had their shares been transferred immediately, much of the woes the States face now would have been automatically addressed.
A. Shreevas,
Chennai
It is strange that when the 101st Constitutional Amendment“clearly” stated that Parliament shall, by law, on the recommendation of the GST Council, ‘provide’ for compensation to all States for loss of revenue arising on account of ‘implementation’ of the GST for a period of five years, stranger things seem to be happening now. The Finance Minister’s advice to States to share the “burden” by way of borrowing from the RBI is absolutely ‘wrong’ on federal and economic grounds.
S.R. Murdeshwar,
Pune
The central government implemented the GST system so that it would be the most efficient collector and distributor of the GST in a non-political manner, to all the States. However, Ms. Sitharaman’s statement that individual States apply to the RBI for aid shows total abdication of the Finance Ministry’s national responsibility. During this crisis of epic proportions, it is the central government’s duty to plan and come together as one nation to address the crisis. Her statement denotes only indifference, instead of empathy and unity of purpose.
G. Parameswaran,
Coimbatore
Pages and pages
The report, “NIA files charge sheet in Pulwama attack case” (August 26), says the charge sheet, of over 13,000 pages, has been filed in court by the investigating agency. The preparation of such a voluminous document itself has taken more than a year. The accused in turn could take a stand that given the size of the document, they may need time, which could take months together. I feel the judicial process needs to be revisited to ensure that the charge sheet filed is crisp and to the point. Any supporting points, records, etc. can be produced or submitted at the time of a detailed hearing.
For that matter, I presume that much of the charge sheet may be in the form of annexures — as the documents supporting each charge.
In the pronouncements of judgments in various cases, the learned judges do make references to previous cases of similar nature and cite passages from these judgments which had a bearing in reaching a final decision. I feel all such judgments can be made part of the judgment as annexures. In today’s world, reading a judgment becomes a very boring experience for an ordinary mortal. I hope the judiciary considers steps to make the entire process simple and ‘light’.
B.C. Unnikrishnan Nair,
Kuthiathodu, Alappuzha, Kerala