In the first of its #LockedUpInLockdown series, Shawview Consulting interviewed Sunayana Shah, global regulatory, scientific and medical expert based in London live via webcast on 26 March 2020. Here is the edited transcript of that interview.
1. How are you coping in the current lockdown?
Although we were anticipating a lock down a lot earlier, I do not think anyone was really prepared when it was eventually announced. The tsunami of information can become overwhelming as new data flashes up on the tv or mobile. But then the quintessential ‘keep calm and carry on’ message kicks in and one just gets on with the task at hand…like perfecting the ‘art of handwashing’....and let’s face it how many of us really washed hands properly using the correct technique before Covid-19 global public health messaging? If Italy’s experience shows anything, isolating affected areas and limiting movement of people needs to be taken early, and put in place with absolute clarity and then strictly enforced. As of Tuesday this week (24/3), United Kingdom has been declared under lockdown.
2. How are things going in your country with Covid-19?
We have the most unprecedented and comprehensive lockdown of British society in living memory. It is a police enforced lockdown and we are all ‘enlisted’ by the PM to stay at home and are only allowed out for very limited purposes such as occasionally shopping for necessities, once a day to exercise, medical need or providing care, travelling to and from work (if you cannot work from home). Only a few weeks ago restaurants and pubs were open but now we are in the lockdown phase which means ‘Stay at home, Protect National Health Service, Save lives.’
3. The UK has had an ‘interesting’ initial approach to the outbreak, which was subsequently publicly queried by the WHO. What’s your take on it?
The epidemiologists at Imperial College published their research which shaped some of the earlier thinking. Their model predicted that the virus could infect 80% of the population in 3-4 months if left to spread without intervention from the Government and population. It was predicted that the demand for intensive care beds could rise up to ‘30 times the number available’ and up to ‘half a million people’ could perish by summer. With such a grim outlook, tough measures have been put in place to delay the spread of the virus by lock down in the UK.
Inevitably, this has direct economic costs which are colossal.
Some say UK entered this crisis with an underfunded healthcare service already close to breaking point, a fragile welfare state and a labour market where millions of jobs are said to be insecure and workers only a pay packet away from penury. The Chancellor of Exchequer has set aside billions in an unprecedented fiscal stimulus package to protect jobs and income which has gone down well with businesses, with further announcements for the self-employed yet to come.
This is a global emergency, and as such could be misconstrued by some in society as a failure of capitalism with the markets failing.
There is jaw dropping economic data from China shows GDP may have declined as much as 10% year on year in the Q1 of 2020. The last time China reported such an economic contraction was more than 40 years ago at the end of the Cultural Revolution. China is turning a corner and is due to lift its lockdown in Wuhan, Hubei on April 8.
4. As an expert in pharmacy, pharmacovigilance and safety, what’s your assessment of the virus itself and how we are treating it?
Let’s talk about how contagious is the Severe Acute Respiratory Syndrome virus called SARS CoV 2 also known as Covid-19. Covid-19 is is 1000x more infective than the previous SARS virus.
In the age of robotics and cell and gene therapy and tissue engineering, it is all the more wondrous that washing with soap and water for at least 20 seconds remains one of our most valuable medical interventions with alcohol based sanitiser a good back up when soap and water are not available.
Artificial Intelligence (AI) could play a critical role in expediting the development of treatments and vaccines during this and future outbreaks, such as using AI to predict protein structures which could speed up the development of vaccines. More than 20 COVID-19 vaccine candidates are under investigation and many are partnering to speed up the development of vaccines and treatments. Then there is the task of scaling up manufacturing capabilities to meet substantial global needs.
In practical terms, the protection of front line staff in pharmacies is vital as they are the first port of call. Managing the influx of people all wanting their medicines whilst they wait is challenging and a perimeter has to be set up or even a system where they can let one person in at a time. Patient information posters are prominently displayed on the outside of the stores with relevant information so unnecessary interaction can be avoided.
As the GP practices have effectively moved to an online service, all the advice/queries/ reassurance needed has moved to Community Pharmacy. Pharmacy teams have seen an unprecedented increase in demand for prescriptions as patients panic. We have a "toilet roll" situation with medicines both OTC and prescribed. Practically the issue is getting the deliveries to the housebound and managing the demand of prescriptions. This, on top of own staff needing to isolate, if affected, is pushing Community Pharmacy to the brink of imminent collapse. Community Pharmacy has more people contact than anyone else in the health service and there is a general feeling amongst the pharmacists in this moment in time is that they have been left vulnerable and exposed.
To help out, retired pharmacists or those have recently left the register can temporarily return to practice. Pharmacists, amongst others, will need to remind the general public on the dangers of buying fake medicines and devices from unauthorised websites, unregistered online pharmacies and other vendors aiming to exploit fears and concerns and misunderstandings during the ongoing pandemic.
A couple self medicated on Chloroquine phosphate with dire consequences after they heard its connection to COVID19 during President Trump’s news conference. Unfortunately the couple did not take professional advice and ended up taking a non -pharmaceutical version intended for use in killing parasites in home aquariums with unfortunate consequences. There is real education need to warn people that self medicating with inappropriate drugs can lead to risk of harm.
Presently, there are no proven therapies except supportive care. In China, Italy. France and Spain, a number of patients have received off label drugs such as chloroquine, hydroxychloroquine, azithromycin, lopinavir-ritonavir (Kaletra), favipiravir, remdesivir, ribavirin, interferon, convalescent plasma, steroids, and anti-IL-6 inhibitors based on their in vitro antiviral or anti-inflammatory properties. These therapies have been mostly given without controls, except for a few randomized trials started in China and more recently in US.
Although many drugs have in vitro activity against different coronaviruses, currently, no clinical evidence supports the efficacy and safety of any drug against any coronavirus in humans including SARS-Cov-2. The administration of any unproven drug as a last resort wrongly assumes that benefit will be more likely than harm.
There have been reports of overdose effects with chloroquine. CQ/HCQ , azithromycin, and lopinavir-ritonavir could potentially increase the risk of cardiac death and as most patients who have died of Covid-19 were elderly and had CV comorbidities. Additionally, hepatitis, and neutropenia are clinical manifestations of Covid -19 and both hepatic and bone marrow dysfunction could be exacerbated by the off label use of these drugs. Therefore it would be impossible to differentiate the drug related adverse effects from the disease manifestations in the absence of a control group. Use of i/v steroids has been associated with delayed Covid19 clearance in both lungs and blood with MERS and SARS -Cov and increased risk of secondary infections in patients with the flu.
This brings me to the issue of AMR and the hidden threat lurking behind Covid19. Global catastrophes like climate crisis and spread of antibiotic resistant superbugs have been happening over years not just days and global leaders need to take concerted actions to slow down these looming disasters. Without a control group it is not possible to accurately determine the adverse effects of any experimental drug. Compared with RCTs, the administration of old or new drugs may be less safe.
The NIH sponsored adaptive trial with unprecedented speed from concept to implementation in just a few weeks, in the middle of a pandemic, is remarkable.
WHO has launched a global megatrial called Solidarity of the 4 most promising treatments.:
o Remdesivir - an experimental antiviral compound
o CQ/HCQ - antimalarials
o Lopinavir/ritonavir (Kaletra) - HIV drugs
o Kaletra + interferon beta - an immune system messenger that affects viruses.
It has been reported, that early results from 2 clinical trials in China were said to be disappointing. Having an honest discussion around emerging clinical data would help the progress and more information on how long after showing the symptoms, were the patients dosed, as well as the baseline viral loads across the trial arms. Parsing through emerging data for these important drivers of success can help define what an effective treatment window and optimal candidate looks like.
5. How are the case numbers playing out and how is the NHS in England handling it so far, given traditionally it’s found a bad flu season difficult to cope with?
As of Tuesday the total cases were approx 8000, with new UK cases approx 1400 and those recovered were 135 with a total of approx 433 deaths. Shielding the most vulnerable for 12 weeks or longer, PM’s Lockdown is clear: Stay home Protect the NHS, and Save lives. GOV.UK has launched a Coronavirus Information Service on Whatsapp this automated ‘chatbot’ will allow you to get answers to the most common questions from the trusted source. There is an App launched from researchers at Kings College to self report daily to help slow the outbreaks and identify those at risk sooner (https://covid.joinzoe.com/).
Currently, 250000 NHS Volunteers are required with a new scheme set up to help the elderly and vulnerable. Around 35,000 more staff willbe recruited into NHS and 3.5 million test kits are on the way to the NHS. The antibody test will allow people to see whether they have had the virus and are immune to it and can go back to work. In the UK mass coronavirus home testing is to be made available next week. It is vital to figure out how many people have already had Covid19 or are immune.
6. What’s happened to Brexit now?
Full Brexit talks are on hold amid this global crisis. the EU has drafted a post Brexit deal proposal on areas of security foreign policy and fisheries. There is no mention of delaying the Brexit transition period at present
7. Finally, what’s your tip for people stuck at home, locked up and social distancing? What’s your tip or survival tactic?
As you go into lockdown, there will be no set routine and the sleep cycle will most likely be distorted due to anxiety, and ‘infodemic’ which affects physical and mental health. It is best to develop a set routine and maintain a minimum of 8 hours sleep cycle. Keep washing your hands frequently for at least 20 seconds and don't cough or sneeze without catching it in a tissue and disposing it immediately and keep a two metre distance between people. Keep things clean as we do not know how long the virus survives on surfaces so wipe clean the groceries before putting them away.
Be kind, show your compassion and humanity, interact with family and friends and colleagues via a technology that suits and does not cause added stress, keep a short window for looking at new information. Don’t hoard stuff and go and buy only things you really need and, by the way, do let me know if you locate a loo roll anywhere!
Cook well balanced meals and keep immunity up, Do not dehydrate! Exercising, such as dancing like no one is watching you - HIIT. Meditation and breathing exercises for full oxygenation of lungs. Make a list of activities that you can tick off that you have been putting off for a while like rearranging the wardrobe. Try the ‘Marie Kondo’ technique of decluttering. Learn a new language, or try calligraphy, read or write a book, write a diary of how you are actually feeling, watch concerts/ballets/operas streamed from the opera house.
Take time to appreciate the trees when allowed out once a day for exercise- top tip - read the Hidden Life of Trees by Peter Wohlleben and as far as I know it is still safe to hug a tree!
And if you are having trouble sleeping…try listening to the Shipping forecast on the BBC ---dogger…fisher…german bite…zzzzzz!!!