Two weeks ago, a study in The Lancet found no benefit from the use of hydroxychloroquine (HCQ) to treat sick COVID-19 patients.
Today, that study stands retracted.
As it had relied on a huge dataset of about 96,000 patients sourced from 671 hospitals insix continents, the World Health Organization, citing a ‘do no harm’ principle, suspended drug trials pending a safety review.
This led to some countries in Europe withdrawing the drug from their own trials.
Another study involving some of the same authors and relying on the same data published in The New England Journal of Medicine, which sought to answer questions on the associations between cardiovascular disease, COVID-19 and drugsthat target the enzymes that play a role in facilitating the virus in attacking a host, has also been retracted.
The Lancet study triggered a backlash from scientists who found problems with the methodology and, more importantly, the dataset.
It emerged that mortality attributed to the disease in Australia did not match with the country’s own estimates.
There was no way to tally patient records and the hospitals they were sourced from.
There were problems with the statisticsdeployed and the conclusions about the potential risk from the drug.
The bigger concern was that the data was supplied by Surgisphere Corporation, which had a handful of employees with limited scientific expertise, and claimed to have aggregated its numbers by compiling electronic health records in less than two months.
Experienced clinical trial specialists said this was a labour-intensive process.
Moreover, when aspersions about the data started to swirl, the company, citing client confidentiality, said it was unable to share its data sources for independent assessment.
In their retractions, the journals have blamed Surgisphere for being opaque with its primary data.
The averagepeer-reviewtakesweeks and the clinical trial process months, but now the expectation is that science delivers its results like magic.
For years now, questions have been raised on the effectiveness of the traditional, time-consumingpeer-review process and this has launched a welcome culture of papers being uploaded as preprints for review.
In the present instance of the HCQimbroglio, it is the independent effort by external scientists that brought the blight to light.
The key lesson is that it is a mistake to assume the scientific process as one divorced from the influence of power, privilege, finance and politics.
The means and methods to a scientific result matter more than results — only achieved through global scrutiny.
Openness, more than blame game, is what the post-COVID world needs now.
Improving India’s Covid Testing Rate
The number of tests for Covid-19 are not rising in India as fast as would be desirable.
Constraints on the supply of kits.
A deliberate design on the part of several state governments to restrict the number of tests, so as to keep their tally of acknowledged Covid cases down.
Some states are tailoring their testing norms to present a picture of competent handling as opposed to taking measures that would actually make a difference.
Should the Centreset up an organisation to monitor testing and data, drawing on the experience of one of the world’s success stories on tackling HIVAIDS, the National AIDS Control Organisation (Naco)?
Should it then take over testing and reporting, while leaving treatment of those testing positive to the state governments?
While the Indian Council of Medical Research (ICMR) is a regulatory body, which can well supervise the working of such a testing agency, call it the National Covid Control Organisation, or Nacco, can Nacco coordinate, expand and secure the integrity of the testing infrastructure?
Such an agency would also ensure that there is uniformityof testing protocols across states.
This means not abandoning the system of contact tracing, and to expand the ambit of testing as set out by the ICMR.
Over the past few months, ICMR has validated a large number of testing kits that have been developed.
This should mean a plentiful supply of testing kits available for use.
There is no reason why a Covid test should not be available for the asking, on par with a test for typhoid.
ICMR should also provide data on when applications were submitted for validation of testing kits and when these were disposed of.
If there is a bottleneck in production, say, availability of reagents, it must be identified and removed.
In the meantime, ICMR could advise the populace on effective immunity-boosting methods.
Ease regulations to make India a drone hub
As the sale of cigarettes and alcohol during the Covid-19 lockdown shows, any form of restrictions on usage has always been detrimental to industry, consumers as well as the State exchequer.
The only party it benefits is the seller, who resorts to black-marketing, selling it at marked-up prices.
The market for non-militaryunmanned aerial systems (UAS) — drones — in India has been marred by restrictive policy, which can stagnate this industry in its infancy.
The Indian UAS market is expected to touch $885.7 million, making it about 4% of the nearly $21.47 billion global market.
At the same time, it accounts for 20% of global imports of UAS, making it the fifth-largest importer of drones.
This indicates the presence of demand beyond the military.
Usage of UAS in the power and utilityindustries, agriculture, highways, mining and railways.
India is a laggard, compared to non-military UAS manufacturing countries, especially China and the US.
This can be attributed to the absence of adequate demand for commercial UAS in domestic markets because of drone regulations that are too obtrusive.
Intelligence agencies: there are over six lakh unregulated drones of various capacities and sizes.
Detrimental for both the consumer and governmentrevenue.
Civil Aviation Ministry, 2019: ‘No Permission, No Take-off’ (NPNT) clause, the only one of its kind globally.
All drone manufacturers need to have an NPNT software add-on on their drones. Without it, no drone manufacturer can sell its drones in India.
These regulations heavily rely on the functioning of a ‘digital sky’ platform, which is supposed to be the only platform that can grant automated permission to own and operate drones.
However, the platform is still non-operational. Thus, there is no other way for drone operators to seek permissions to operate UAS legally.
Apart from permit-orientedrestrictions imposed, there are the hardware specifications that have to be met to be regulatory-compliant.
The regulator also lacks facilities to test and certify UAS for airworthiness.
Drones can reduce costs of compliance, provide high-qualityinformation (including areas difficult to extract data from, such as hilly terrain) and enable real-time monitoring.
UAS industries in China and the US have matured to levels where their markets have seen a lot of capital invested in these systems, and are driving innovation.
Merely addressing domestic demand issues will not suffice.
Phased manufacturing plans can be a tool to encourage international drone manufacturers to ‘Make in India’.
Initially, tariffs can encourage manufacturers to assemble semi-knocked-down drone units in India.
Thereafter, assembling of completely knocked-down units should be incentivised.
And, finally, regulatory and fiscal incentives should be aligned to ensure that all drone components are manufactured in India.
Regulation should not stifle.
A right time to shift pharma gears
Could the rules and practices organising health care around the world have been better suited to this COVID-19 outbreak?
Medicines are among humanity’sgreatestachievements.
The global market for pharmaceuticals is currently worth ₹110 lakh crore annually, 1.7% of the gross world product.
Roughly, 55% of this global pharmaceutical spending, ₹60 lakh crore, is for brand-nameproducts, which are typically under patent.
Commercial pharmaceutical research and development (R&D) efforts are encouraged and rewarded through the earnings that innovators derive from sales of their branded products.
These earnings largely depend on the 20-year product patents they are entitled to obtain in World Trade Organization member states.
Such patents give them a temporary monopoly, enabling them to sell their new products without competition at a price far above manufacture and distribution costs, while still maintaining a substantial sales volume.
In the United States, thousand-fold (100000%) markups over production costs are not atypical.
In India, the profit-maximisingmonopoly price of a new medicine is much lower, but similarly unaffordable for most citizens.
To be sure, before such huge markups can yield any profits, commercial pharmaceutical innovators must first cover their large R&D costs, currently ₹14 lakh crore a year, including the cost of clinical trials needed to demonstrate safety and efficacy, the cost of capital tied up during the long development process, and the cost of any research efforts that fail somewhere along the way.
While we should evidently continue funding pharmaceutical R&D, it is worth asking whether our current way of doing so is optimal.
First, innovators motivated by the prospect of large markups tend to neglect diseases suffered mainly by poor people, who cannot afford expensive medicines.
The 20 World Health Organization-listed neglected tropical diseases together afflict over one billion people but attract only 0.35% of the pharmaceutical industry’s R&D.
Merely 0.12% of this R&D spending is devoted to tuberculosis and malaria, which kill1.7 lakh people each year.
Thanks to a large number of affluent or well-insured patients, the profit-maximisingprice of a new medicine tends to be quite high.
Consequently, most people cannot afford advancedmedicines that are still under patent.
This is especially vexing because manufacturing costs are generally quite low.
Firms earn billions by developing duplicative drugs that add little to our pharmaceutical toolbox — and billions more by cleverly marketing their drugs for patients who will not benefit.
Health Impact Fund: an alternative track on which pharmaceutical innovators may choose to be rewarded.
Any new medicine registered with the Fund would have to be sold at or below the cost of manufacture and distribution, but would earn ten annual reward payments based on the health gains achieved with it.
India, China hold talks, agree to resolve differences peacefully
India and China on Friday held talks between their Foreign Ministries and agreed to follow a consensus that differences should be handled peacefully and should not become disputes, in the highest-level diplomatic engagement since tensions along the Line of Actual Control (LAC) erupted in May.
States to decide on reopening of schools
HRD Ministry ready with guidelines
The State governments will each make their own decisions on when to reopen schools, School Education Secretary Anita Karwal said on Friday, emphasising that the Centre would not intervene in the issue.
CM declares ₹100 crore relief for Raigad district
Uddhav assures additional manpower for restoration work
Mr. Thackeray, who visited the district by boat from Bhaucha Dhakka to Alibaug, also said the actual relief package would be announced after an assessment of the damage.
He was accompanied by ministers Aaditya Thackeray and Aslam Shaikh, additional chief secretary A.K. Singh, and other senior officials.
He also said while clearing the trees, there is a possibility of having some animal beneath, and hence, one should be careful.
5 held for raping Kerala woman, abusing her son
In an incident that triggered mass outrage, five men have been arrested for the alleged gang-rape of the wife of one of the accused in the presence of the couple’s son in Kadinamkulam on the outskirts of Thiruvananthapuram late on Thursday.
The Thiruvananthapuram rural police have intensified the probe to ascertain the possibility of the case being linked to a sex trade racket.
Besides the victim’s husband, four others, identified as Rajan, Mansoor, Akbar and Arshad, all from the same locality, were arrested by the police.
Can private hospitals treat all at Ayushman Bharat rate, asks SC
The Supreme Court on Friday asked the government to respond to whether COVID-19 patients, who are not beneficiaries under the Ayushman Bharat scheme, can be treated in private hospitals at the same subsidised rates offered under the scheme.
A Bench led by Chief Justice of India (CJI) Sharad A. Bobde heard petitioner-advocate Sachin Jain argue that COVID-19 treatment costs only ₹4000 for an Ayushman Bharat beneficiary in a private hospital, while others have to shell out a minimum of ₹50,000 for treatment in the same hospital.
Prevention of Human and Animal Mortality on Highways.
Road, Transport and Highways Minister Nitin Gadkari has launched national awareness campaign on Prevention of Human and Animal Mortality on Highways.
Launching the campaign through Video Conference yesterday, Mr Gadkari underlined the need for generating awareness and education for the masses at large towards reducing or eliminating mortality on the roads.
He said, ecology and sustainability are most important for human life.
The Minister informed that the country witnesses nearly five lakh road accidents every year, in which about 1.5 lakh lives are lost.
Mr Gadkari said, he is endeavoring to bring down these figures by 20 to 25 per cent by March next year.
Over five thousand black spots have been identified, and the process for their rectification including temporary and permanent measures is being carried out on urgent basis.
He requested NGOs and social organisations to locate black spots for animals on the roads, and inform his ministry, so that necessary corrective action may be taken.