Clinigen's recent acquisition of South African giant Link Healthcare for over 100 million pounds reflects the recent rise in popularity of South Africa as a clinical trial site of choice. According to the online registry ClinicalTrials.gov, in February 2013, over 1,600 clinical trials had been registered in South Africa with the national clinical trial business being valued in the region of 250 million Euros, and growing each year. The main reason? South Africa hosts a large pool of potential patients with little current competition from other sponsors. Similar to Eastern Europe, China and India, South Africa has thrived as a site of quick patient enrolment. However this may hide another truth relating to the treatment of the patients within the country. This article will focus on evidence that pharmaceutical companies are exploiting the poorer South African population through the use of placebo-controlled studies and limited post-trial access to treatment.
Placebo Controlled Trials
There are a number of factors which makes South Africa an ideal melting pot for clinical trials. Whilst not as cheap as India, the population is more genetically diverse, with a wide range of patient types. Added to this, sponsors do not have to rival other large clinical trials for patients in the country. The largest reason, however, is down to the availability of patients for studies. Enrolment rates can be so rapid that it is often seen as an area to rescue recruitment for struggling studies elsewhere. Unfortunately, it is the inequality which is still present in the country that drives this rapid enrollment. Sub-standard healthcare for most of the non-white population in South Africa has resulted in the poorer population having limited access to healthcare drugs as the country's world class private health sector is still only accessible to around 18 per cent of the population. Many patients see the clinical trials as a way to get much needed treatment for free. However these studies often use placebos and essentially mean the patients are missing out on potential treatment. Although South African Good Clinical Practice Guidelines specifically state a placebo should only be used when 'there is no known effective preventive cure', a number of recent studies show this has not always been adhered to.
Case Studies – Large Scale Placebo Comparator Studies in South Africa
One recent clinical study in South Africa with questionable ethics involved a study run for those with asthma. A Swedish pharmaceutical giant chose South Africa, alongside other nations, to enroll children between the ages of 6 -12 years of age with mild asthma. Importantly, this was to be a placebo-run trial, which would potentially leave some asthma sufferers without the aid of their proven asthma treatment. The company defended their activity, noting that the FDA had approved the trial, since their regulations for trials outside of Europe were relaxed in 2008. The sponsor company argued they acted within guidelines, working to improve asthma treating medication. However, there are strong reasons to suggest this is a prime example of South African patients being exploited.
The first factor which points to poor compliance was the fact the drug company completely outsourced their trial to a service provider. This immediately reduced any knowledge they had of how the trials were being run on the ground, and gave them less control and understanding of the compliance of their trials. Secondly, although asthma is a relatively mild respiratory disease, it still has the potential to kill. In turn, there was a period where young patients receiving the placebo drug were being taken off their normal medication and therefore at risk without their normal medicine.
However, the most compelling point to prove unethical practice in South Africa was the fact the sponsor was not running the clinical trial to uncover a new treatment that didn't already exist. Leading medical professionals agree that normal asthma treatments work well, so there was no serious need for new, large scale studies to be set up to uncover new treatments. The reality was the sponsor's existing patent for their asthma medicine was close to expiring. This would have meant the company would no longer have held exclusive rights to their medicine, which would have paved the way for other pharmaceutical companies to produce the same treatment at a lower price, forcing the sponsor out of the market. Essentially their new global study in asthma was hoping to produce a new asthma treating drug which could then be patented, marketed and sold as the most effective treatment for asthma. In turn, the use of patients placed them at an unnecessary risk, which (some experts say) proved deeply unethical and was arguably done with the sole intention of personal profit.
Other evidence also exists to show South Africa has become exploited by Western pharma companies. A similar study looking into finding an improved candidate for schizophrenia run by an American sponsor company was also criticized for using placebos. Schizophrenia has the potential to kill the sufferer if they are not on the necessary medicine, however two separate studies carried out by the sponsor both used non-active placebos for one group of patients. Whatsmore, the endpoint of the trials was chosen as the 'point of relapse' in the patient, at which point they would be placed back on their normal medication. Such a study has been widely criticized as careless by the industry, and further proved the exploitation of patients for the benefit of western pharmaceutical giants. Notably, South Africa was not the only nation to be used as a clinical site with an under equipped health system. Trials also took place in Romania, Mexico and the Ukraine, indicating that South Africa may not be alone in its patient exploitation.
Lack of Post Trial Care
Clinical trials, if successful, serve to benefit patients globally. However a wealth of evidence exists to show many patients enrolled in clinical studies in South Africa lose any medical support once the trial has been completed. A healthcare infrastructure weighted against the poor appears the largest reason for this. Although a popular clinical site destination, unlike European countries such as Germany, pharmaceutical drugs in South Africa often take years to become affordable in clinics and hospitals to the poorer population. In turn, patients enrolled in original trials often relapse. Worryingly Wemos, a leading non-profit patient advocacy group based in Holland, has revealed the scale of clinical operations taking place in South Africa that neglect patients after their cooperation in trials. A previous lack of transparent information regarding clinical activity taking place in South Africa sparked a number of investigations after 2013. These investigations discovered that hundreds of clinical trials were actively being carried out for conditions such as asthma, schizophrenia, HIV/AIDS and rheumatoid arthritis within South Africa off the record. What is also surprising was the apparent lack of local Non-Governmental Organisations (NGOs) or activists focusing on the monitoring of these clinical trials or patient rights. Such groups can often prove vital in ensuring patients receive continued support after they have been through a trial, and suggests that thousands within South Africa are being unfairly exploited for Western profit. The patients are going through clinical trials and getting no long term benefits afterwards, which is a clear breach of existing Helsinki regulations and an unethical use of patients.
South Africa has the potential to be a fantastic site for clinical trials, which could benefit pharmaceutical studies as well as the poor and sick population. However, unethical procedures and exploitation means these aims are being sorely missed. Comparator trials run for pre-existing treatments are placing South African patients at unnecessary risk, whilst offering little potential benefit. Whatsmore, a lack of post-trial support for many patients enrolled leaves poor South Africans without any lasting benefits from a trial. New medicines will still remain expensive, and unattainable, despite patient subjects having a hand in their development. Proposed solutions are varied, but the overarching aim is to make sure sponsor companies are complying with ethical global regulations such as the Helsinki Regulations. A main method of doing so is to ensure larger sponsor companies remain fully aware of how their trials are being conducted. This stems from the fact it appears to be easy for pharmaceutical companies to hide behind their acting CROs when failed regulations are exposed. In turn, many believe sponsor companies outsourcing their activities to remote areas should pay to have official regulatory bodies ensure their trials are running within ethical guidelines. Measures like these which put sponsor companies in direct liability for their activities may be the only way trials can be ethically run in a country where much of the population is crying out for medical aid.
http://www.reuters.com/article/2015/09/22/us-linkhealthcare-m-a-clinigen-idUSKCN0RM0JF20150922 http://www.kznhealth.gov.za/research/guideline2.pdf http://www.reuters.com/article/2015/09/22/us-linkhealthcare-m-a-clinigen-idUSKCN0RM0JF20150922 http://www.wemos.nl/files/Documenten%20Informatief/Bestanden%20voor%20'Medicijnen'/Clinical_Trials_Industry_South_Africa_2013_v3.pdf
*PHOTO CREDIT: Nicolas Raymond