Wed, Sep

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.

  • "This advance will, in the future, help save thousands of lives that would have had a fatal outcome in the past."



    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).

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