Patients or Guinea Pigs?
Egypt`s Experience with Roche |
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Egyptian regulations clearly stated that a drug that had not been approved in the country of its origin could not be used for trials involving humans in Egypt (For Clinical Trial Law in Egypt, Refer to Exhibit I). The regulation was meant to protect Egyptians from being exploited by transnational research sponsors like Roche during their drug trial processes.. |
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| Roche entered Egypt in 1985. In 2016, it came under fire for not demonstrating the effective and exemplary ethical and moral standards expected of organizations of such global repute . Roche’s drug trial methods and procedures raised several questions on the ethics and legality of the process. Several of Roche’s trials had included medicines which were not approved in Europe – its continent of origin – which violated a mandatory legal clause in Egypt. A 2016 report which published a summary of the drug trial practices in Egypt, showed Roche having conducted 4 trials with as many drugs, out of which 3.. |
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| Egyptian regulations around pharma research made it mandatory for pharmaceutical companies to seek approval and registration of the drugs that were to be used in the trials. However, many of Roche’s drugs were used for the trials without approval. For instance, one of its brands, Avastin (bevacizumab), which was used in the trials for cancer cure, did not show any record of the product’s registration in Egypt,.. |
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| Roche’s commitment to PTA suggested that it offered patients who participated in the clinical trials it sponsored continued access to the medicines that they had received during the trials. It read, “There are certain circumstances when, for the well-being of patients participating in a trial, continued access to the Roche investigational medicinal product is necessary.” While everything appeared impressive on paper, in reality, Roche’s practices were unethical. Roche’s PTA provisions in Egypt.. |
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| The design of the study conducted by Roche to interpret the clinical trials of all its drugs was found to have deviated from the expected norms. Describing it as ‘chaotic’, an industry report highlighted the loopholes in the modus operandi of Roche’s study design. Roche had conducted the trials among a number of subgroups from 24 countries, including Egypt. The limited number of participants from a large number of countries raised concerns over the reliability of the observations over the drugs’ behavior... |
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| Rifampin was one of Roche’s drugs for curing tuberculosis. The drug’s phase I clinical trial was conducted in Egypt. It witnessed active participation from patients with many samples being taken. However, Roche did not maintain a clear stand on the risk/benefit ratio that the trials promised. Roche’s unclear stand undermined the importance of the information that the study was likely to produce. .. |
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| It was evident from the course of the clinical trials that the ethical and moral perspectives needed urgent attention from the stakeholders concerned. The Research and Ethics Committee (REC), one of the critical stakeholders, was expected to play the role of a watchdog to ensure Roche’s adherence to ethical standards... |
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| Looking at the overall drug trial scenario in Egypt led by Roche, a broad question that emerged was whether Egyptians were being genuinely approached as drug trial participants or whether economic deprivation, in addition to the cost of healthcare and loose government regulations, .. |
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Exhibit I: Clinical Trial Laws: Egypt
Exhibit II: Pharmaceutical Drug Trial Process
Exhibit III: A Briefing on CIOMS Guidelines
Exhibit IV: Ethical Principles for Medical Research Involving Human Subjects Declaration of Helsinki (Relevant points)
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