COVID-19 Trials in Egypt, Patient Accounts of IC Violations & the Need to Pass Modern Comprehensive Clinical Trials Legislation

COVID-19 Trials in Egypt, Patient Accounts of IC Violations & the Need to Pass Modern Comprehensive Clinical Trials Legislation

Clinical trials targeting COVID-19 commenced in March of this year in Egypt, like many other nations. Thanks to evolving medical research infrastructure, particularly within the academic medical center complex, Egypt increasingly seeks a way to integrate into the critically important global biopharmaceutical industry clinical research ecosystem. The African Continent’s third most populous nation of 101 million people now has a recorded 92,947 SARS-CoV-2 cases with nearly 5,000 deaths.  The country has responded swiftly, supporting at least 100 COVID-19 focused clinical trials. Although TrialSite has reported that Egypt still hasn’t formalized clinical trials laws, mounting pressure will certainly move the political class there to change that situation. But as a consequence of a lack of modernized clinical trials legislation and various structural challenges and impediments to predictable adherence to the Declaration of Helsinkicommon in some low-middle-income nations—reports of ethical violations emerge (again), namely the use of COVID-19 patients as clinical trial subjects without their knowledge or approval. The passage of a clinical trials legislation combined with other research commitments to safety, quality and productivity will only bolster Egypt’s nascent involvement in the critically important biopharmaceutical research and development sector.

A Note on Sources & Media

TrialSite should note that as elsewhere, news media becomes ever more biased, and Egypt is no exception. Some in Egypt, including TrialSite viewers, allege that Al-Monitor has a nefarious agenda to destabilize Egypt and hence is a questionable source. TrialSite implores all viewers to check multiple sources and vet all news critically, including this article.  In this article, we use multiple sources in an attempt to be as unbiased as possible but our research depends often on the work of other publications that one group or another will maintain some bias. 

No Laws Explicitly Governing Clinical Trials

Although there hasn’t been a formal clinical trials legislation approved lawmakers during 2018-2019 were attempting to change this situation reported TrialSite. However, AL-Monitor reports that President Abdel Fattah al-Sisi made a number of remarks for lawmakers to reconsider. AL-Monitor, a news site launched by an Arab American entrepreneur, reported that Salah Hasaballah, a parliamentary spokesperson, was on the record, “The approval of the clinical trial law in Egypt has been delayed because the parliament has yet to examine the president’s remarks and is preoccupied with other laws.” Although the spokesperson did convey that the law would be passed “before the term of the current parliament ends,” no date was specified. 

A patient rights group called Egyptian Center for the Right to Medicine has advocated for the law. Its director, Mahmoud Fouad, recently told AL-Monitor “The Egyptian government has been stalling on approving the clinical trials law, which is sorely needed.”

Unfortunately, what is really an unacceptable situation, one that has implications for research and medical advancement, not to mention economic development, persists.

President Edict on COVID-19 Clinical Trials Participation

By May 18, a presidential spokesperson named Bassam Radi conveyed to the public that the president declared that clinical trials should be expanded to help COVID-19 patients. Hence, via the president, the country announced its intention to support COVID-19-focused clinical trials, “considering the regional and international distinction of the research conducted by Egyptian research centers and universities.”

And Egypt certainly has embraced the president’s directive. At least 100 reported clinical trials now have some involvement with Egypt, according to the U.S.-based Clinicaltrials.gov repository. The country has 1,095 active clinical trials, according to one account

Patients Report Informed Consent Breaches

TrialSite has confirmed president Sisi’s clinical trials COVID-19 declaration from multiple media sources. Trouble has emerged as patients have come forward reporting what are in some cases clear violations of ethical principals under the World Medical Association (WMA) Declaration of Helsinki

Potential Violation #1: Father of Ms. Abdul Rahman

For example, Hasna Abdul Rahman from the Assiut governorate (between Cairo and Luxor) informed AL-Monitor that her father “showed symptoms at the end of May, and he had a fever and dry cough for two days before he decided to consult the doctor at the hospital.” Ms. Rahman’s father was shortly admitted into a special quarantine hospital due to his age and condition. She reported to the media that her and family were “forbidden any contact with him.” She reported to AL-Monitor that “Six days later, we received a call from the hospital administration telling us about his deteriorating situation. He lost consciousness and was put on a ventilator. We had to rush to the hospital to sign a form.” Actually what family members were requested to sign wasn’t revealed. Upon arrival at the hospital, they were asked to sign a waiver of liability form because they were using an experimental drug. Upon objection, the hospital representatives simply threatened to take their father off of the ventilator, which would mean certain death. Hence, Ms. Rahman states, “We relented under pressure.”

Potential Violation #2 Anonymous Young Man

AL-Monitor reported a young man lost his father to COVID-19 and he blamed the Egyptian Ministry of Health for “tricking him and forcing him to sign a form he did not read,” reported the Egyptian media. The young man is afraid of reprisal and persecution and hence sought to remain anonymous.

He, the young teen, reported his father was admitted to the hospital on June 13 with deteriorated condition due to COVID-19. The hospital isolated him after the senior’s oxygen level dropped below 80%. While in intensive care, the son was approached to sign a form because there was an experimental drug that has been introduced to Egypt. They conveyed due to scarcity not all patients had the option to take the drug but he had to sign a “routine form.” He refused at first but then finally under pressure signed. The boy’s father died six days later. Upon confrontation, the doctors told the deceased’s son that he knew it was a clinical trial and the hospital had no liability or responsibility. After all, he knew because he signed the consent form. The boy recounted to the Egyptian media, “But I had no idea these were clinical trials. I feel the doctor duped us to get the agreement. I am very angry because my father died without our knowledge that the treatment was only a trial.” The boy wants to take legal action but doesn’t know where to start and certainly probably doesn’t have the means or wherewithal.

Clinical Research in Egypt on the Rise

Clinical trials has become completely globalized contributing to a robust, rich and critical economic, health and social ecosystem of networks, institutions and individuals with the power for incredible good: the ability for industry, academia, health provider and government, not to mention patient group to engage, collaborate and execute on important research imperative offers the world great hope for cures and advanced treatments for horrific illness, as well as an economic development generator.

Egypt has transformed into an emerging player representing low-to-middle income nations as the relentless globalization imperative among industry sponsors proceeded full throttle over the past couple decades. By 2017, Egyptian medical research scholars from Tanta University reported that the nation had 41 universities and 94 health related medical schools. This included 24 faculties of medicine containing up to 34 departments in each university.  Moreover, in this gateway between multiple worlds—the Mediterranean, Africa and the Middle East—for example, clinical research was placed on the “essential mandate” for earning the Master or Doctorate Degree as well as a prerequisite for faculty promotion.

Moreover, Profession Ethics Regulations were endorsed by the Ministry of Health (MOH) No. 238/2003 and placed into law 71/2009. By 2017, over 56 Institutional Review Board (IRB) were registered. BY 2018, the Egyptian Network of Research Ethics Committees (ENREC) was launched thanks to the work of Professor Azza Saleh

But these authors anticipated growing challenges: “Yet, in the absence of robust legislative constraints, there is no clear way to avoid violations.” The authors shared experiences from Tanta University.

Ethics and Clinical Trials in Egypt

With a lack of clinical trials legislation and the fact that it is one of the most popular clinical trials destinations in Africa and the Middle East region, scholars interested in this topic naturally started to investigate. In 2013, Henry Silverman (University of Maryland) and Amal Matar (American University in Cairo) reported that the “increase in research in the Middle East was associated with the establishment of research ethics committees (REC).” The scholars sought to better understand impediments, if any, to the effective functioning of this critically important function. The authors found after extensive in-depth interviews that “several barriers” must be “considered by appropriate stakeholders to enhance adequate functioning of RECs.” Of course, with no clinical trials legislation and relatively dysfunctional ethics committee processes spells trouble for a culture of quality and ethical accountability.

The SOMO Report

Egypt was the focus of a report on the ethics of industry- sponsored clinical trials in Egypt. Authored by Irene Schipper and sponsored by the Netherlands-based The Centre for Research on Multinational Corporations (SOMO), a comprehensive report was published in 2016. This report didn’t grade Egypt highly for ethical principals associated with industry-sponsored clinical trials. In fact, the NGO summarized that new evidence was found of unethical practices occurring in industry-sponsored clinical trials in Egypt.

The report was based on 30 interviews with Egyptian experts as well as a dozen clinical trials participants as well as an analysis of industry sponsored cancer trials active in the country was generated articulating the rapid expansion of industry-sponsored clinical trials into low-and-middle income counties such as Egypt. The non-governmental organization summarized:

To protect clinical trial participants, and especially to protect vulnerable people, a robust legislative framework with functioning independent control systems is a prerequisite, but this is clearly not present in Egypt. A fundamental flaw in the Egyptian system of clinical trials is the absence of comprehensive unified legislation. This means that there is no clear guidance to those bodies charged with overseeing clinical trials or to those stakeholders involved in executing clinical trials, leaving room for different interpretations and making it more difficult to identify violations and impose sanctions.”

Conclusion

With now over 100 million people, significant health care needs, and a growing young and restless population, Egypt was actually the epicenter of the “Arab Spring” movements several years ago.  Pent up pressures, resentments and hopes for new opportunity can’t be harnessed for the good, positive and productive without vision, strategy and leadership. That research infrastructure, talent, and drive mixed with some vision and leadership can not only lead to short term positive outcomes but transformative futures isn’t out of the question for Egypt. But political, economic and social turbulence, cultural conflicts and a foundational and systematic lack of access to opportunity will certainly help self-sabotage a great opportunity to advance.  

It all starts with the individual and the bond associated with the appropriate levels of trust in society, government and medical institutions. Clinical trials legislation is a good place to start.