“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.
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