The rising number of Covid deaths these last two weeks has brought to the forefront the quality of treatment and management of the patients who have contracted the virus. Voices were raised in criticism of the care offered and the drugs administered. We talk to Sarita Pulton, former principal pharmacist, who was responsible for the procurement of pharmaceuticals and former registrar of the Pharmacy Board, whose responsibility was to ensure the procurement and distribution of drugs and the evaluation of pharmaceuticals. She offers her views about the practice in our public hospitals and the criticism it is drawing.
The newspapers are replete with articles about the current Covid situation with the increasing number of deaths and there is a lot of criticism of the management and treatment of Covid patients in our hospitals. As a former principal pharmacist and registrar of the Pharmacy Board, what do you think we are getting wrong?
Like for many other countries in the world, there has been a lot of ad-libbing in what was a novel situation. We did quite well in the beginning, mind you! Those were the days when we saw Mauritians rising as one nation to face a common enemy. They sacrificed their freedom for the wellbeing of their fellow citizens. The confinement was an economic trauma for both the country and its citizens.
There was no treatment at that time and no vaccine…
Yes, there was no vaccine and no known or available treatment, except the one championed by the prominent and controversial Dr D. Raoult, which was based on hydrochloroquine, an anti-malarial. Studies later found that hydroxychloroquine does not work against the coronavirus.
Then a string of vaccines appeared, didn’t it?
Yes, and with them, hopes of prophylaxis.
Members of government do not tire of congratulating themselves for the success of their vaccination campaign. Are congratulations in order?
When it comes to vaccination, we just took what was available. So, Mauritians were vaccinated with different types of vaccines: Covaxin and Sinopharm classified as inactivated virus vaccines, the ones from Astra Zenecca, Sputnik and Janssens, known as viral vector vaccines and then recently that of Pfizer, an mRNA vaccine. The immunity conferred is different from one vaccine to the other, which leads me to say that, although vaccinated, we were not given equal chances as far as immunity is concerned. People administered a vaccine should have been warned on its effectiveness, instead of being told not to eat meat or eggs for two days, a precaution, I must say, I could not find in any of the vaccines’ patient information leaflets!
«The worst and saddest thing about poor conditions of tender is that the good manufacturers in India and elsewhere slowly stop responding to our tenders because they are not interested to compete with the bas-de gamme. And here we are, with a budget of more than Rs1 billion, procuring drugs without the best firewall and falling frequently out of stock.»
If we did fairly well in the first phase, where did we go wrong this time?
Well complacency crept in and we were taken off guard by the Delta variant!
Several reports coming out of hospitals talk about negligence. Do you think they are being exaggerated or based on facts?
Well, if we mean well, any report whether exaggerated or not, should be looked into if not, fully investigated. That’s what monitoring and evaluation are all about.
You will concede, however, that there must be hundreds of patients receiving the right treatment and going home quietly, leaving the space free for the dissatisfied ones, won’t you?
You must also concede that there’s also the 101st patient in his 40s, father of three who will head for Bigara leaving behind a desperate family. And what do you tell the surviving wife and children: he was too fat, he consumed too much sugar and had diabetes as if these conditions would have prevented him from going on living. It seems nowadays that there’s no situation so awful that you can’t add some guilt to it and make it even worse. And what about the ones dying in their homes when on confinement? There is a need to analyse the excess mortality rate with objectivity because there is an excess mortality! Denial won’t help and denial has never been a scientific method for finding causes and taking remedial action. The stories we hear are mostly about breach of trust.
The trust people had in the capacity of public hospitals to offer adequate care also seems to be waning. Would you say that that is normal, considering the Covid situation that has taken everyone by storm?
No, I do not think it’s normal at all. We had been taken by storms several times in the past. There has been the Dengue epidemic, and the AH1 N1 pandemic. For Dengue, there was no vaccine and only symptomatic treatment was available.
But we knew the vector, didn’t we?
Yes, mosquitoes and so, we went on a mosquito eradication spree. With AH1 N1, we were lucky: there was an antiviral available, Oseltamivir or Tamiflu, which had been developed by Roche. When I was the pharmacist responsible for procurement, I remember purchasing some from Roche but also, more affordable ones from generic manufacturers licensed by Roche in India. We stockpiled both the finished product and the raw material. So, when AH1N1 hit, we were ready.
Are you saying the criticism the public health service is being subjected to is warranted?
People have always criticised the health service in Mauritius but I’ve never seen such a lack of trust in 30 years of service. Words are important, you know. When people start calling the ENT ‘l’abbatoir’ [the slaughter house – Ed], the government should heed these messages. We are in health to serve the people and it starts by listening to the cries of the people. Some thinking should be done on where things are going wrong, how this perception was earned and what must now be done to develop trust again.
Some of the breach of trust is related to the quality of medicines being dispensed in hospitals these days. Has anything changed in the procedures for the procurement of medication to be given to patients flocking to public hospitals?
You see, the world of pharmacy is roughly divided in two: countries where the laws and regulatory authorities are strong and stringent, mostly grouped under the Pharmaceutical Inspection Co-operation Scheme, and the rest. China and India, although they are big generic manufacturers, are not part of the scheme. Our biggest supplier in terms of volume has always been India, where there are more than 20,000 manufacturers scattered in the different states, each with its own regulatory authority. At the top of them all, there is the Central Drugs Standard Control Organisation (CDSCO) based in Delhi. To cut a long story short, there are world renowned manufacturers in India but also very bad ones. The challenge is how to get the good ones to answer your tenders when you are a little speck on the world market!
How did you manage to do that when you were in charge of buying our drugs?
I took advise from the then Drug Controller of India and from him, I learned a lot. For example, how to distinguish between the different manufacturing licences. Then, you simply cannot purchase such an important good as drugs without first inspecting the sites of manufacture. We do not have the capacity for inspections in Mauritius but the drug regulatory authorities of the European Union do and their inspection results are recorded on a database called EUDRA, which is freely available. There are 1,058 sites in India which have obtained a Good Manufacturing Certificate (GMP) from the EUDRA, which says that they have the capacity to manufacture drugs according to European standards. It’s quite a lot and it does allow fair competition. Put in simple words, a GMP tells us who has a good kitchen with the right equipment, the right operating procedures and the right cooks. We also insisted that drugs should be prepared according to standards contained either in the British Pharmacopeia, the European Pharmacopeia or the US Pharmacopeia. And for new drugs which are not yet added in any of these three pharmacopoeias we put other conditions. We only accepted those firms who could produce an Eudra GMP as I made it a condition in the tender documents.
«When I left the service, these conditions in the tender documents were maintained. However, other insidious conditions were added like (a) registration with the cdsco which now allows all the 20,000 manufacturers from india to participate.»
Are these conditions still in place?
I must say that when I left the service, these conditions in the tender documents were maintained. However, other insidious conditions were added like (a) registration with the CDSCO which now allows all the 20,000 manufacturers from India to participate and (b) the Indian Pharmacopeia which allows anyone from Mauritius to procure from wholesalers on the Indian market, while before we only dealt directly with the manufacturers or their accredited agent in Mauritius. So much for traceability!
But this is shocking. If I understand properly, this means in fact is that there is no control of the medicines entering our hospitals, is there?
Let’s put it this way: my personal view is thatwe do not have optimum conditions upstream to allow us the best chances to obtain quality drugs. The worst and saddest thing about poor conditions of tender is that the good manufacturers in India and elsewhere slowly stop responding to our tenders because they are not interested to compete with the bas-de gamme. And here we are, with a budget of more than Rs1 billion, procuring drugs without the best firewall and falling frequently out of stock. Also, bas-de gamme pharmaceutical firms rarely have a big production capacity. They do not have the best performing equipment. So not only do they very often produce lesser quality drugs but they are also late on supplies.
Have you been keeping abreast with the drugs being used abroad to mitigate the effects of Covid?Any information you wanted to share with us in that respect?
First of all, I have to say that when someone catches Covid, they may also develop what is called superinfections caused by bacteria and other agents as the disease progresses. If untreated, these superinfections in an already weakened body are too often the real cause of death. To fight superinfections in the severely ill, you need to admin- ister intravenous antibiotics and antifungals. I understand that Meropenem, Vancomycin and Ceftriaxone are on the protocol for treatment. These were always classified as extremely critical drugs and were grouped under what we called ‘the last resort antibiotics’ as they were restricted to use in patients with severe infections. These were among the drugs for which I had put the most stringent conditions of tender and, most of the time, we only procured the innovator’s drug. With the current conditions of tender, I wonder what they have been able to procure in terms of quality! I’m also given to understand that nowadays critical drugs are being purchased through emergency procurement more often than not.
Do you mean that there is even less quality assurance in emergency procedures?
Definitely, that’s what emergency procurement is all about. It’s often done at hospital level and a few times centrally. What should have been a rare feature is a common one now! You only have to invite three companies to quote and the conditions for quoting are even looser. And too often, drugs are supplied at indecently high prices and generics from India are being supplied at higher prices than the innovator’s drug.
Are there any drugs currently being used for Covid specifically?
There is Favipiravir (or Fabiflu) on our Covid treatment protocol. It’s an antiviral drug developed in Japan to fight emerging influenza.Favipiravir had not been approved for marketing in any country other than Japan until March 2020, when China approved it for the treatment of COVID-19. In June 2020, India approved it under the brand name Fabiflu manufactured by Glenmark. As of today, Favipiravir remains unapproved in Europe and the USA. In May this year, the EUNETHTA [European network for Health Technology Assessment – Ed] stated in its scientific conclu- sion that the current evidence base is not sufficient to support the use of Favipiravir as monotherapy or combination therapy for Covid-19.
And this is the drug being given to patients here?
Yes, it is available in the hospitals and on the private market.
But some newer drugs seem to be coming fast on the market. Are they ‘game changers’?
There are two new antiviral drugs that I think will be game changers: Molnupiravir and Paxlovid. They are important new treatment options for people with Covid, especially for those at high risk in the early stages of infection. These are the first effective oral treatments for Covid to help keep people out of the hospital. The ability to treat Covid with a pill rather than an injection or infusion means more people can be treated faster.
How much research has been done into these drugs?
Molnupiravir began as a possible therapy for Venezuelan equine encephalitis virus in Atlanta then in 2015, they started testing against Corona viruses and saw that it worked. It got the approval for use in the UK. Countries like the UK, USA, Australia and Singapore have already made advance purchase agreements with Merk. Paxlovid is a drug candidate which has just finished phase 3 trial. Despite not being fully approved yet in either country, the UK and Australia have already placed pre-orders.
How do these medicines work?
Molnupiravir was developed by Merck. It creates what we call an “error catastrophe” in the virus, forcing it into making mistakes until it can no longer function. Paxlovid was developed by Pfizer and it works by blocking an important enzyme of the virus, thereby preventing the virus from completing its life cycle. They are both very expensive but the good news is that several Indian drug makers with whom we have worked in the past are due to be licensed by Merck and Pfizer to produce these antivirals. So, there is hope of getting good quality antivirals at cheaper prices as we did for Oseltamivir. We need to negotiate fast and well with the Indian manufacturers.
Do you really believe these will be the silver bullet we have been waiting for?
Antivirals are curative treatments and if we play our cards right, and obtain supplies fast, many lives may be saved. There are three barbaric names worth remembering: Molnupiravir, Paxlovid and Ronapreve. Ronapreve is already in use in the EU, UK, Japan, US …etc.
We will soon be producing our own medicines, including Covid vaccines, according to the government plan. What are your thoughts about that?
A beautiful dream which with some hope, may come true during my evanescent life span. Who knows!
Realistically, what exactly is missing to fight this nasty virus?
In Health, if you want to do the right things whether in time of crisis or not, you need the right people around you, who can tell whether a measure is technically sound, ethical and effective. This is the only way for advancement and the only way I know to build trust. Nowadays, the politically correct seems to have superseded all the other considerations.