ebola medicine

Written By Kwame Asiedu - I have over the past few weeks, since an experimental drug was used for the treatment of two United States aid workers (who contracted Ebola) been enjoying the commentary regarding why this drug had never been used. The innuendos, conspiracy theories and blame game that followed, have been to me, of comic value.

The reality is those drugs could never have been used in West Africa thanks to the inaction of governments and public health leaders across the sub region. As far back as 2010 the United States Defence Department had patents for certain strains of Ebola isolated from the outbreak in East and Central Africa. Most people have argued that this was because of some sinister motive, unfortunately a careful understanding of how drug discovery and regulation works will point to a very different view.

In sum, to treat any infection similar to Ebola one will require triggering the body’s natural defence mechanism to fight the intruder; this is the basis for most vaccines in use today. To do this one has to first isolate the actually offending organism and grow it in a laboratory environment, a process termed culturing.

Any scientist or institution for that matter worth its salt would always patent its medical isolates especially if there are no known cures available for the diseases. These isolates then form the basis for vaccines or medicines that may cure the disease.

It is thus not surprising that having isolated strains of the Ebola virus the United States scientist applied for a patent with the United States Food and Drugs Administration.

These isolates are then used in animal trials in a controlled laboratory environment to develop treatments if possible or vaccines.

Unfortunately the nature of diseases like Ebola or many blood-letting (haemorrhagic) fevers is such that human trials are not often possible. The reasons being that from a clinical and statistical stand point the numbers required for clinical trials are difficult to obtain. The mortality rate is too high, making it inhumane to attempt any form of clinical trials.

Currently the disease has killed over 900 people across the sub region, 900 too many I would say but the sad reality is in terms of sample size this is not significant; secondly from a pharmaceutical research stand point there is no incentive for multinational companies as profitability is non-existent. The populations that get infected with such diseases are poor and can’t afford the cost of any potential viable treatment.

This lack of profits for scientific research into certain diseases is what has accounted for what is termed the Global drug gap; this is the gap between the costs of funding research into diseases that are common to the developed world compared with the developing world.

According to Michael R. Reich “Global inequities in access to pharmaceutical products exist between rich and poor countries because of market and government failures as well as huge income differences. Multiple policies are required to address this global drug gap for three categories of pharmaceutical products: essential drugs, new drugs, and yet-to-be-developed drugs. . Policies should combine “push” approaches of financial subsidies to support targeted drug development and “pull” approaches of financial incentives such as market guarantees and “process” approaches aimed to improve institutional capacity.”

This is where we failed as a sub region, in the last financial year for every $1 put into sub Saharan Africa as health related donor support; governments in the sub region took out $1.14 from their own budget allocations to fund non healthcare related expenditure.

Thus the health budgets in the sub region were short changed by $0.14 for every $1 donor support, is it any surprise that the sub regional countries public health infrastructure failed so woefully when Ebola struck? In our world new drug research is not an item on the health agenda.

Secondly for diseases that are poorly funded from a pharmaceutical research stand point, there is an option available to get help quickly in a crisis through what is termed the international orphan drug programme. To do this however, governments in countries where the crisis has occurred must waive certain World Health Organisation (WHO) regulations for the movement of pharmaceutical products in international commerce; this amongst other things allows unlicensed or unregistered medicines to be used to combat the crisis.

My understanding is that none of the countries in the sub region where the pandemic is causing serious problems opted to go down this route until the WHO declared Ebola an international crisis, taking the decision making regarding orphan drugs out of the hands of regional health officials.

I am aware that today the WHO is holding a meeting to explore the orphan drug route that will allow experimental medicines to be used for the first time in the fight against Ebola.

The question is for how long will we as Africans allow leadership to fail us so badly? For how long will we continue to use conspiracy theories and innuendos to explain away our failure of leadership? Let’s always remember once a life is lost it cannot be returned.

Yes, America knew the complexity of transporting drugs across countries without market authorization and yes exploited the orphan drug route by repatriating their kinsmen and using the Unite States Food and Drugs Board orphan drug route; thankfully their citizens are recovering and we are still dying. That is what good leadership looks like.

I hope Ebola never gets to Ghana but should it do, I hope our public health leaders will not continue in this debacle that other countries in the sub region have engaged in.

I would end by saying “don’t blame the gods, for the gods are not to blame, don’t blame America, for America is not to blame.” Let’s put the blame of this pandemic squarely at the door step of our regional leaders, they have let us all down.

Kwame Asiedu|myghanalinks - “Be sceptical, ask questions, and demand proof. Demand evidence. Don't take anything for granted. But here's the thing: When you get proof, you need to accept the proof and we're not that good at doing that.” Michael Specter

Ever since the Ebola pandemic ravaged some countries in West Africa, many have questioned the commitment of the international community and pharmaceutical multinationals, as far as research and development were concerned. There have been many conspiracy theorist and other speculators who have opined at various times that these countries could even have a hand in the pandemic. These arguments were given credence when at the height of the outbreak, it was discovered that countries like the United States, Canada and Great Britain had stocks of experimental vaccines. The disparity in mortality rate amongst blacks and white (up to 90% in blacks and less than 5% in whites) patients was also ceased upon.

Some of us had argued on the contrary, that there was no incentive or scope to attract investment into orphan disease drug research and that governments in the sub region ought to do more to incentivise research. We further criticised the sub regional government for the poor supportive care infrastructure. Last week it emerged that clinical trials of a potential Ebola vaccine were going to be carried out in Hohoe. I have been rather amazed at the negative press that this has received. In all honesty, I have a feeling this bad press is due to a lack of understanding.

Like Noël Coward said in Blithe Spirit “It's discouraging to think how many people are shocked by honesty and how few by deceit.” Truth is clinical trials are an important aspect of pharmaceutical research, without which many important medicines will never had seen the light of day. Few trials have historically happened in Sub Saharan Africa even for diseases that are locally prevalent. Hence it is very common to find new medicines with Summary of Product Characteristics (SPC) making little reference to potential untoward effects in black populations. In effect the first black patients prescribed these new medicines become the guinea pigs. Information abounds regarding the bottlenecks that limit clinical trials in black subjects. There is considerable evidence that blacks are generally recruited for clinical trials at a lower rate. Cultural beliefs or myths about specific diseases or illnesses also cause black communities to generally frown on these experiments. Our society is one that has traditionally frowned on abstract thinking and preferred to deal with the tangible or mystique.

Clinical trials are normally divided into four phases, but often preceded by a targeted trial where your doctor may ask if you are interested in experimenting on a new unregistered drug. This is termed a Phase zero studies. Phase zero studies usually only involve a small number of people and they only have a very small dose of a drug.

Phase one trials aim to test the safety of a new medicine. A small number of people, who may be healthy volunteers, are given the medicine. Researchers test for side effects and calculate what the right dose might be to use in treatment (known as dose-ranging studies). This will usually be the first time the medicine has been tried on humans, so there's an unavoidable element of risk. To minimise the risk, researchers start with small doses and only increase the dose if the volunteers don't experience any side effects, or if they only experience minor side effects.

Phase two trials test the new medicine on a larger group of people who are ill. This is to get a better idea of its effects in the short term and to ascertain whether treatment success is high.

Phase three trials are only for medicines that have already passed phases one and two. They test medicines in larger groups of people who are ill, and compare new medicine against any existing treatment if there are or a placebo to see if it's comparatively better in practice and if it has important side effects. Phase three trials often last a year or more and involve several thousand patients.

Phase four trials take place once new medicines have passed all the previous stages and have been given marketing licences. A marketing licence means the medicine can be made available on prescription. In phase four trials, the safety, side effects and effectiveness of the medicine continue to be studied while it's being used in practice. Phase four trials are not required for every medicine.

From the above it is clear these processes are well thought through and have the requisite checks and balances. From all indications the trials in Ghana are Phase One, hence the use of healthy individuals. Much as I can understand the concerns of many well-meaning individuals and interest groups, I must point out that such trials are also subject to medical ethics committee guidelines. Often there will be local and international oversight. As a result clinical trials may last about four years on the average but in situations like Ebola are generally fast tracked. The reasons for fast tracking in my view are obvious; it will be sacrilegious to have another pandemic anywhere in the world without a vaccine in place. To me that will be the height of public health irresponsibility.

Playing the devil’s advocate, I find it intriguing that on one hand we cry for treatments for diseases like Ebola but are not prepared to be experimented upon. As a people we seem to portray that we value or own lives more than any other race. Reading between the lines and protestations, I get the impression that we believe it is alright for these medicines to be tested in other countries but not ours. However should there be another outbreak of Ebola, we are entitled to receive these vaccines to save our lives. Is this not a sense of entitlement gone mad and the height of all hypocrisy?

The argument that the students are being bribed with GH¢200 each and mobile phones is ludicrous to say the least. Worldwide, payments have always been made to participants in clinical trials both in cash and kind. There is also a top up payment for insurance just in case things go wrong. To see this as a bribe is a clear demonstration of a lack of understanding of life in the pharmaceutical research world.

My only concern seems to be the impression that the nursing students being targeted for this trial are not volunteers but co-opted. This may fly in the face of medical ethics and could raise issues at the point of licencing should these trials be successful. I sincerely hope that this is not the case and would be surprised if it was, considering that last I checked; these trials had World Health Organisation backing. Truth is on this occasion I laud the Health Ministry and all involved in bringing this trial to Ghana. We can’t always have our cake and eat it, this is a worthwhile risk and I whole heartedly support it.

Health officials in Congo confirmed another Ebola outbreak in the country’s east on Sunday, the fourth in less than three years. On February 3, a woman died in Butembo town in North Kivu province, Minister of Health Eteni Longondo announced.

After 29 days at an Ebola treatment center in eastern Congo, fighting for their lives, a mother and her young son were discharged Tuesday amid applause and laughter.

Two experimental drugs - an antibody cocktail called REGN-EB3 developed by Regeneron (REGN.O) and a monoclonal antibody called mAb114 - will now be offered to all patients infected with the viral disease in an ongoing outbreak in the Democratic Republic of Congo (DRC).

A patient has tested positive for Ebola in Abidjan, a city of more than 4 million people, marking the first case of the disease in Ivory Coast in more than a quarter century, the World Health Organization said.

Written By Dr. Edward O. Amporful - As I write this piece, the Democratic Republic of Congo (DRC) is reeling from an Ebola crisis with the World Health Organization (WHO) having declared it a global health emergency. It is reported to have killed about 1,800 people so far. The crisis has been worsened by internal conflicts and mobility of people fleeing from the conflicts. I will continue with information gleaned from the BBC and Bloomberg on the Ebola crisis and deployment of vaccines.

Written By Charles Neequaye - At a time the deadly Coronavirus pandemic is at its peak and causing a lot of havoc in the country, news filtering in from neighbouring countries indicate that on the sideline, the deadly Ebola Virus Disease (EVD) is knocking on our doors asking permission to enter.

The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have licensed an Ebola vaccine, just 90 days after World Health Organization (WHO) prequalification. Registration of the vaccine is expected in additional countries in the coming weeks.

Scientists working on developing vaccines against Ebola have found they can "harvest" antibodies from volunteers vaccinated in research trials and use them to make treatments for the deadly viral infection.

Written By Kwame Asiedu - “Since man cannot live without miracles, he will provide himself with miracles of his own making. He will believe in witchcraft and sorcery, even though he may otherwise be a heretic, an atheist, and a rebel.” Fyodor Dostoyevsky, in The Brothers Karamazov.

RECOMMENDED: HUMAN SECURITY AND PUBLIC HEALTH; THE SEARCH FOR AN EBOLA VACCINE

RECOMMENDED: CLINICAL TRIALS; A DATE WITH THE WORLD OF MEDICAL AND PHARMACEUTICAL GAMBLING  

In the past week Pharmaco-medical research announced two important public health breakthroughs. These put together are probably the biggest health contribution to Africa in recent memories. There was initially the announcement of a vaccine for malaria, then the big one from Glaxo Smith Kline about a vaccine for the dreaded Ebola. International media was awash with reviews upon reviews from expert principal investigators and officials of the World Health Organisation. The spotlight was on countries that had made significant contributions to these two feats. Ironically the fanfare that greeted this was not marked in Ghana, the country of my birth for obvious reasons.

Truth is before these announcements we had gone down as a country that sort to hold the world to ransom in its quest to find a vaccine for Ebola. Thanks to some intransigence and rather bizarre statements on the floor of our legislative house, Ghana had put himself on the map as a medical research laughing stock. We had caused so much unnecessary international panic that the WHO dispatched its Deputy Director General, Dr Anarfi Asamoa-Baah (a Ghanaian) to meet His Excellency John Mahama in an effort to try and bring some sanity into the system. Whilst this was going on some who we as voters had queued in the sun from dawn to dusk and elected into parliament were being infantile. Behaving in a manner akin to kids whose prized toys had been taken away, they shouted themselves hoarse claiming a citizen who many of them couldn’t hold a candle to had impugned on their integrity.

Conducting what could best be described as a North Korean style show trial aimed at score settling and ultimate execution, they extracted an apology and patted themselves on the back. Whilst they were making a mockery of their august house, the world was busy passing Ghana by. Yes they were busy putting the final data together under the coordination of the World Health Organisation Vaccine programme chaired by a certain Prof, Alexander Dodoo. On the 31st of July 2015 the ultimate announcement was made a vaccine that gave 100% protection to contacts of infected Ebola patients had been found. A quote from that announcement by Margaret Chan, the Director General of the WHO almost made me cry. It reads “The credit goes to the Guinean government, the people living in the communities and our partners in this project.” Such pride is what any country’s leadership and citizens crave for. Such statements give immense credibility to a country and prove that it can punch well above its weight. Imagine if the country in this quote was Ghana? Imagine the amount of medical research finance and goodwill it would have generated?

Sadly the sycophants we elect were more interested in their supposed bruised egos because ostensibly someone had dared to call them IGNORANT and tell them to SHUT UP!!!! In my short sojourn through this life, it’s only in Ghana that some misguided few hear SHUT UP and think it’s an insult. In the end they managed to derail the start of Phase II trials in Ghana but not to halt the world’s momentum and march towards breakthrough vaccine research.

Some brave men had decided to be the trail blazers they had chosen to be like Antwi Boasiako; putting their lives on the line in an effort to save human kind. Their names are now etched in history. One such person is Mohamed Soumah, 27, the first person to be vaccinated with the new "most effective Ebola vaccine" in the Guinea trials. On the WHO website, he is quoted as saying, “It wasn’t easy, I can’t say I wasn’t afraid, I was afraid. People in the village were saying that the injection was to kill me. I was the first one to be injected, the very first, here in my village on March 23. 44 people were vaccinated. I had fever and I bled after the vaccination, it worried me a bit, but they warned me that would happen and it didn’t last long. I’ve been monitored for three months and I’ve had no problems. The last follow up, 84 days after the vaccination, was all clear”.

Truth is the thought of Ebola scares the hell out of anybody. However in other countries the quest for a vaccine far outweighed the selfish interest of a few. Compare the behaviour of Mohamed Soumah to the actions of some from the Hohoe municipality and the Volta region parliamentarians. Clearly Mohamed was looking at the bigger picture, whilst the Volta parliamentarians were thinking about the next election. It is this sort of stupidity that often drives this country close to the cliff.

As I type this, doctors in Ghana are on strike, it is clear that the risk to the citizenry is close to home. There is a real possibility that people could die and as usual many are trying to appeal to the good conscience of these doctors to return to work. Even under these circumstances, the country is split right through the middle; with some playing the usual politics with a rather delicate issue. However one thing is clear, for fear of death, we all want these doctors back to work. However when it came to deaths that affected others, thanks to Ebola; as a country we flinched. Yes Ebola was too far away for us to be bothered. Some went as far as suggesting people who volunteered for the trial should be banished from their communities.

In one of my many writings on this subjects I suggested that my hope was that should a vaccine be found, we don’t behave as the beggars we are and request for stocks from the WHO and producing companies. My gut feeling is that we would; without any shame we would expect the world to forget about the shenanigans of our parliament and treat Ghana as a special case i.e. the jewel in the crown and provide us with stocks ahead of any other country. It is this high sense of misplaced entitlement and hypocrisy that allows our parliament to approve loans that are tax payers money of other countries, whilst unable to fashion a way towards governments fiscal discipline. WE MUST BE ASHAMED OF OURSELVES.

Like Jim Butcher opines, “Evil isn’t the real threat to the world. Stupidity is just as destructive as Evil, maybe more so, and it’s a hell of a lot more common. What we really need is a crusade against Stupidity. That might actually make a difference.” I must say this crusade must be led from within Ghana’s Parliament and I make no apologies for saying so. With the sort of money we pay them, such failings when information can be gleaned in confidence cannot be allowed.

But don’t be down hearted my fellow Ghanaian, be gladdened by the fact that when the history of Ebola vaccine discovery is written, it would be noted that it was made whilst a certain Prof Alexander Dodoo was chair of the World Health Organisation Vaccine Programme and that he was a Ghanaian. The case of the stone that the idiot builders rejected would have been well and truly written. Hopefully, haven learnt our lesson; in 2016 many waste pipes from across the political divide would be chased out of our parliament. It is only then that the crusade against stupidity would have well and truly began.

Heavily criticised for its response to the 2014-16 Ebola epidemic, the WHO is now on the front line in dealing with the emergence of new cases in DR Congo. It says that it is preparing for the “worst case scenario”.