Glenmark’s stock rises, standards for repurposed drugs must as well

The money matters first. 
 
Indian pharma company Glenmark saw its share price trade at a new 52-week high on Monday, closing 27% higher. The rally was obviously on the back of the news it broke on Saturday that it had obtained “restricted use approval” for a drug called Favipiravir, to be used in mild to moderate cases of Covid-19. 
 
The drug has been in use in a few countries since 2014 for treating influenza. It is one of many other drugs that are being repurposed and studied for Covid-19 treatment. 
 
Glenmark said:
“Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement. Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.”
The markets were ecstatic but medical practitioners, particularly a handful articulate ones, were not. The regulatory approval is not backed by strong data. 
“We don’t have a randomised trial which shows a clinically meaningful benefit with the drug. The results of the 150-patient study Glenmark has done in India is not published, and data is not available. I am not comfortable prescribing to our patients now. I hope there is data that gets published soon that will make me change my mind,” Dr CS Pramesh, a director at Tata Memorial Hospital in Mumbai, told me yesterday. 
 
While the Indian drug regulator hasn’t issued any statements or accompanying documents, Glenmark did cite some references in its release but they don’t inspire much confidence. 
 
Like a few Covid-19 vaccine makers in the US, Glenmark has rushed to disclose early read-outs from its ongoing trial with 150 people which will conclude in 3-4 weeks. Given that 80% of mild to moderate cases recover by symptomatic treatment, why did the company and the regulator not wait for the trial to conclude? 
 
Who was more desperate—Glenmark or the Indian regulator? Especially because a government-funded Favipiravir study is also underway. 
 
The larger issue here goes beyond this particular drug. It concerns all repurposed drugs. If a quick, small study is done to get early data and push the drug in the market, will the same company or medical group come back at the end of the infection peak to do a larger study? COVID-19 is expected to be active permanently, and several seasons of disease peaks are likely before herd immunity is established.
“The key issue with any of these potential treatments is to balance the oppositional needs of making treatment decisions for individual patients during epidemic peaks on the basis of clinical studies that involve small numbers of patients with ensuring that well-designed, randomized clinical trials are carried out rapidly to provide proof that they are safe and efficacious. 
 
The difficulty is to coordinate rapid hypothesis-generating studies during this first peak to justify a smaller number of well-controlled large trials to be executed in later peaks to provide the data needed for approval of drugs for COVID-19. Researchers, ethics boards, and regulators are accustomed to developing trial plans over months, not weeks—a time frame that is not afforded during this emergent situation. It is necessary for all involved to work faster and more efficiently and then position the well-justified drugs for registration-enabling trials during the next peak.” Rapid repurposing of drugs for Covid-19, Science
What may seem efficacious in 150 people, may not be efficacious in a large group of 500 or 5,000. (Remember the early days of coronavirus testing? The Indian Council of Medical Research and the National Institute of Virology were only approving kits with 100% sensitivity and 100% specificity. That was because those kits were tested over a few samples; once scaled to a sample size of thousands, both sensitivity and specificity declined. Which is why no mature regulator sets the benchmark as 100% for approving a diagnostic kit. Sample size matters. A lot.) 
 
India rushed to prescribe hydroxychloroquine (HCQ) as a prophylaxis, only to roll it back. Have we not learnt our lessons?  
 
“No, we haven’t learnt the lessons from HCQ,” says Dr Pramesh.
Cyberattacks already the first line of attack
Shreedhar   “World War III will be waged online,” goes the feeling. It may not count as a world war, but cyberattacks seem to be mushrooming.   In India, the Computer Emergency Response Team, an office within the Ministry of Electronics and Information Technology, released an advisory warning against impending large-scale phishing attacks.
Malicious actors are planning a large-scale phishing attack campaign against Indian individuals and businesses (small, medium, and large enterprises).   The phishing campaign is expected to use malicious emails under the pretext of local authorities in charge of dispensing government-funded Covid-19 support initiatives. Such emails are designed to drive recipients towards fake websites where they are deceived into downloading malicious files or entering personal and financial information.   The phishing campaign is expected to be designed to impersonate government agencies, departments, and trade associations who have been tasked to oversee the disbursement of the government fiscal aid. The malicious actors are claiming to have 2 million individual / citizen email IDs and are planning to send emails with the subject: free COVID-19 testing for all residents of Delhi, Mumbai, Hyderabad, Chennai and Ahmedabad, inciting them to provide personal information. COVID 19-related Phishing Attack Campaign by Malicious Actors, CERT-in
India isn’t alone here. Last week, the Australian prime minister said the country has been under a cyber attack by a “malicious” and “sophisticated” state-based actor. He did not say more, but China has been the natural suspect.
Relations between Beijing and Canberra have cratered in recent months. Australia led the call for an international investigation into the origins of the coronavirus pandemic, and was damning in its criticism of China’s initial handling of the outbreak. Beijing then imposed tariffs against Australian beef and barley, and Chinese officials have threatened a consumer boycott if relations continue to worsen.   China has long been accused by foreign powers of orchestrating large-scale cyber attacks against other governments. Most recently, Washington in May warned that China was likely behind efforts to steal coronavirus vaccine research from US research institutions and pharmaceutical companies. Australia says it has been targeted by a ‘sophisticated’ state-based cyber attack, CNN
While the Indian government hasn’t said who they think is targeting India, two things are happening. One, India’s northern border with China has been tense—20 Indian soldiers have been reported killed in a clash with Chinese troops. Two, Indians are clamouring for a war on the economic front with China.   We know who cyberattack buck is most likely to be passed on to… 
Indonesia’s personal data protection time bomb
Nadine   Data privacy isn’t a mainstream topic in Indonesia. But recently, several high profile data breaches and the fact that digital services are taking up more and more space in our lives, is forcing the debate to the forefront.   On Detik.com, one of Indonesia’s busiest news sites, a 1,200-word opinion piece by Teguh Arifiyadi and Satriyo Wibowo, two cyber law experts, lays out why Indonesia’s non-existent personal data protection regulation is a ticking time bomb in the time of Covid.   Using digital services is no longer an option, it became a quasi-necessity to get basic needs met during lockdowns. Citizens are handing over private details like address, bank account, ID numbers, phone numbers, and emails to private companies and government agencies—without a lot of protection.    Even companies as big as Indonesia’s largest e-commerce marketplace Tokopedia aren’t immune to cyberattacks. A large data breach occurred just a few weeks ago. The problem with existing laws is that they don’t come with clear sanctions. So that in the case of the Tokopedia breach, the matter was settled with just an apology. As customers, they felt let down, the authors of the article wrote.   Indonesia has had a data privacy regulation in the works since 2014, but the fast-paced development of the sector meant it’s gone through several iterations and delays. Why, Arifiyadi and Wibowo ask?
“Maybe because from the perspective of investment and business, personal data protection isn’t sexy. It contains only obligations and sanctions, extra costs and legal risk without direct benefit.” Without personal data protection, new normal is a time bomb, Detik (link in Indonesian)
Contentious skin products finally face shade   Jon   We live in a world that’s truly connected. One in which America’s Black Lives Matter protests ushered in a new era for Asia’s most controversial beauty trend: skin lightening.   Skin lightening—also known by its more-PR friendly term ‘skin brightening’—is a multi-billion dollar industry worldwide. Still, pharmaceutical giant Johnson & Johnson announced plans to stop producing skin lightening products in response to complaints that they imply white skin is more desirable and representative of fairness.
Source: Jon Russell
“This was never our intention—healthy skin is beautiful skin,” the company said in a statement. Products already on shelves won’t be pulled, but it will no longer produce the products or sell them worldwide, Johnson & Johnson said.

Evidence suggests that it’s high time corporations like Johnson & Johnson took action on an industry that is dogged by health warnings.
The Local Government Association in the UK has described skin lightening products as “the biological equivalent of paint stripper” due to the presence of chemicals such as hydroquinone, steroids or mercury. Products containing mercury, for example, are banned in the UK, US and other countries, but they are still sold in Asia and Africa despite efforts from the UN and WHO to raise awareness. In a tacit admission of the dangers, India implemented a ban on skin lightening product ads. The products themselves remain legal though—the Indian market for them is estimated at $500 million annually. 
These concerns aren’t a revelation by any stretch of the imagination but it has taken Black Lives Matter for Johnson & Johnson to react. The social movement is putting other products from Asia under the microscope, too.
Colgate-Palmolive, for one, is reviewing its ‘Darlie’ brand, which includes top-selling’ toothpaste products. Marketed in China and Southeast Asia, the toothpaste is fronted by “a racially ambiguous man in a top hat.” Its Chinese brand name translates to “Black people toothpaste,” NBC News reports
“We are currently working with our partner to review and further evolve all aspects of the brand, including the brand name,” said a Colgate-Palmolive spokesperson.
Build a better particletrap, and the world will beat a path to your door
Rohin   Given the sheer demand for face masks globally, one would assume that many companies have managed to differentiate themselves by building a better…particletrap. Instead, barring niche products, face masks have stubbornly remained a commodity, even as their prices rocketed up.
Japan’s Uniqlo begs to disagree.
The much anticipated Friday release of Uniqlo’s AIRism face masks met with massive demand online and off, as would-be customers overwhelmed servers and stood in long lines as rain poured down outside of stores, prompting a flood of social media photos.
“There is currently a problem with the connection to our online store due to a large number of accesses from customers,” Uniqlo says on its website. “We apologize for any inconvenience. Please wait a while and try to access the website later.”
The servers remained down past midday. Uniqlo says it is working hard to restore the site.
At Uniqlo’s physical stores, customers were pictured standing in lines while hoisting umbrellas and waiting for stores to open. One photo showed dozens of customers in several lines inside a shopping mall. Uniqlo flooded with customers for its ‘cool and dry’ masks, Nikkei Asian Review​
Here’s a picture of customers queuing up to buy Uniqlo masks.
It’s interesting though that the simple and unassuming Uniqlo (which despises being called a “fast-fashion” brand) and not rival Zara seems to have created a desirable face mask. Could it be because one of Uniqlo’s philosophies is to make timeless “essentials”?
The masks are made of the same material used for the brand’s AIRism underwear. The material is marketed as being cool and fast drying. The masks are made of three layers, one of which is a filter to block bacteria and pollen. Another layer blocks ultraviolet rays.
With summer’s first big hit product on its hands, Fast Retailing is again hoping to demonstrate its ability to design products customers feel they need. Uniqlo flooded with customers for its ‘cool and dry’ masks, Nikkei Asian Review​
Penny-foolish, UPI-wise
Savio   First, the US cash registers couldn’t stop ringing as Americans hoarded toilet paper, water and other essentials. Now, the problem is the cash register is running out… of nickels, dimes, quarters, and even pennies. First, the US Mint cut back production, like all businesses, and then ran into distribution problems, again like all businesses. It’s not only that, NPR reports.
During the lockdown, many automatic coin-sorting machines that people typically use to cash in loose change were off-limits. And with many businesses closed, unused coins piled up in darkened cash drawers, in pants pockets and on nightstands, even as banks went begging. The Latest Pandemic Shortage: Coins Are The New Toilet Paper, NPR
But it’s just loose change, right? Wrong.
The congressman warned that if businesses are unable to make exact change, they’ll be forced to round up or round down, “in a time when pennies are the difference between profitability and loss.” The Latest Pandemic Shortage: Coins Are The New Toilet Paper, NPR
Can. You. Imagine. The. Volume. Of. Unaccounted. Funds? 

Maybe the US Federal Reserve will now seriously consider Google’s recommendation that the Fed replicate India’s Unified Payments Interface (UPI) digital payments model.

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