The use of hydroxyurea in African children with sickle cell disease is resulting in a number of very positive, noteworthy benefits. Amongst them are significantly reduced pain crises and reduced risk of malaria infection, the reason for the latter being largely unknown.
The advantages of the drug also include:
- It is inexpensive, easy to ingest in pill form and may be able to be made more cheaply if millions of doses are ordered for use in Africa
- The drug can be stored at room temperature
- Children are less likely to die, need blood transfusions, or attract infections
- Increased mortality can be achieved even in areas with limited resources
- Thus far, because the study used moderate daily dosages, very few children required lower dosages of hydroxyurea to prevent their white blood cell and platelet counts from dipping dangerously low
The disease is far more common in Africa than in Western countries. It is caused by a genetic mutation believed to have originated in Africa. Of the 300,000 babies that are born with it each year, about 75 percent of them are in Africa and only 1 percent in the United States. The disease also affects African descendants in the Caribbean and the Americas who were brought there by the African slave trade. Nevertheless, a small percentage of all cases are also found in Europe, the Middle East and India.
Despite the high proportion of cases in Africa, there is reportedly no current treatment there and many children experience agonizing pain and die before age five (5). For this reason, use of the drug can alleviate much pain and suffering as well as increase the mortality rate in these areas. It is said that in America, relief from intense pain can only be derived from opioids. Furthermore, treatments may include blood transfusions or bone marrow transplants which, though they offer hope of a cure, include a risk of death.
Other effects of the disease include anemia and frequent infections. The pain crises previously mentioned are a result of clumped blood cells that jam the capillaries in the brain, lungs, kidneys and other organs. Descriptions of the resulting suffering, particularly for young children, are nothing short of devastating.
There were some reported limitations of the large study thus it has been said that more research will be needed. That being said, it is somewhat refreshing to hear that oversight boards in the four test countries, deemed it unethical to withhold the drug from African children when it is known to work in other locations. The test countries were: Angola, Uganda, Kenya and Democratic Republic of Congo.
Hydroxyurea has been used in the U.S. and Europe for decades. However, early studies caused concern that its use may cause African children to be more susceptible to malaria and other local infections.
Trials which concluded it was safe in American children finished in 2016. Interestingly, it said that the 2017 F.D.A. (U.S. Food and Drug Administration) approval of hydroxyurea for pediatric use opened the way for a trial in children in Africa. It would be helpful to clarify why American approval is needed in order to start a trial in Africa. What political, economic and/or scientific factors influenced the “need” for this approval given the vast majority of cases of sickle cell disease occur in Africa. In other words, why is the F.D.A. the decision-maker for what takes place in Africa? Is hydroxyurea manufactured in America and can only be manufactured there? Apparently, the World Health Organization already has hydroxyurea on its essential medicines list. Was hydroxyurea placed on that list before or after the F.D.A approved it for pediatric use?
A slight mistrust is partially the source of these questions. It exists along side the hesitation of many black American sickle cell disease suffers to enroll themselves or their children in drug trials. For many, their hesitation is due to America’s horrendous history of undisclosed, involuntary medical experimentation on black patients.
Side effects of the drug reportedly include:
- Lower men’s sperm counts
- Hair breakage in women
- Darkened finger nails
The drug is often withheld from pregnant women as a safety precaution although they may suffer severe pain crises.
Interestingly, African men were willing to try the drug when it was explained that the decreased sperm count was generally insignificant and would be restored upon the drug being withdrawn. Thus, despite having a genetic disease, these men still had a concern and/or desire to procreate. The explanation still leads to these types of questions: Once the drug is discontinued in a patient, will they be prone to the symptoms of the disease that they experienced before taking it? How long must it be taken and is there any permanence to this solution?
Dr. Osunkwo demonstrated wisdom and an attitude of patient empowerment when she allowed patients to help design the trials which, in turn, led to increased willingness to participate. However, her reported statement to patients that ‘Being dead is worse than having dark nails’ is only as ethical as the quality of disclosure that patients receive. In other words, each patient should still receive full disclosure of all possible known side effects and the chances of occurrence. They may even need to be advised of what is not yet known about the drug or at least be reminded that perhaps not everything is known.
It was apparently easy to enroll 600 children in the trial because Africans with sickle cell disease had visited Europe where they heard that hydroxyurea worked. It emphasizes the importance of shared information, especially in a climate of mistrust and hesitation to participate in the trial. It is paramount that people be empowered to make educated and/or informed decisions. In this case and many others, shared information inspires hope which, when actioned, can result in great benefit to humanity.
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