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Patients subject to ethical violations in industry-sponsored clinical trials: EIPR - Daily News Egypt

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Patients subject to ethical violations in industry-sponsored clinical trials: EIPR

Egyptians volunteer because they cannot access medical treatment, say researcher


The Egyptian Initiative for Personal Rights (EIPR) released a new study Tuesday tackling ethical and health issues related to transitional pharmaceutical companies (TNC)-sponsored clinical trials in Egypt.

According to the NGO, Egypt is the second largest nation in Africa, following South Africa, to host clinical trials on patients. There are several reasons for this phenomenon including the fast population growth and widespread ignorance in the field of medical treatment.

The report titled “Industry-sponsored clinical tests in Egypt: Ethical questions in a challenging context” was first released in June in the Netherlands and Switzerland, and was translated into Arabic to be presented by the EIPR in a press conference at its headquarters on Tuesday.

EIPR researcher Ayman Sabae explained during the conference that Egypt is an attractive spot for clinical tests owing its large number of hospitals, especially university hospitals for research purposes, as well as its number of scientific experts.

Other factors that make it attractive for clinical test were the various illnesses within the population that would need treatment or preventative medicines, and the advantage of treating naive patients, many of whom have not been treated previously, thus improving test results.

“Moreover, the labour is less costly than Europe and the United States, and financial compensation for patients is cheaper,” Sabae said in a press conference held Tuesday at the NGO’s headquarters.

The report raised several questions related to medical practices in Egypt, also focusing on the reasons why many Egyptians patients are encouraged, or influenced, to undergo trial medication and procedures as an alternative to paying the high cost of acquiring the medicines they need. “Not because they are hoping to find new cures for chronic diseases,” Sabae stated.

The EIPR stated that half of the Egyptian population does not benefit from a medical insurance system and that medical treatment here represents 72% of a person’s health expenses.

Also tackled in the report was the effectiveness of medicines tried on patients, their right to post-trial access, and availability and affordability of both the trial and medications. “We aim at issuing recommendations to medical companies in order to fulfil an ethical and social responsible attitude towards patients,” he added. “Our goal is to enhance and develop medical research without violating patients’ rights,” he further stated.

The EIPR prepared the research in cooperation with more than 30 Egyptian doctors, professors and medical experts, in addition to three international experts. The organisation was also assisted by several NGOs including Shamseya , Public Eye (formerly called the Berne Declaration), the Centre for Research on Multinational Corporations (SOMO), and Wemos Foundation.

Indicated in the report was the need to protect patients’ rights in the future. It said that no legislation currently exist in Egypt to define and guarantee such rights. “This means that there is no mechanism to monitor companies’ practices,” the report stated.

Multinational companies must abide by international standards such as the World Medical Association’s (WMA) Declaration of Helsinki. The researchers gave particular attention to post-trial access to services and medicines.

“When a company outsources its clinical tests to another country, then it must be among its goals to use the tested medicine in the host country, once proven successful,” said Sabae.

However, the research selected 24 medicines registered with the United States National Institutes of Health (US NIH) that were tested through clinical trials in Egypt between 2005 and 2015, to check if they were licensed to be sold in Egyptian markets, how much they cost, whether they are supported in the insurance system.

It discovered that several medications used during tests had no records of being registered in Egypt.

Only a few of the medications were subsidised by the government. More importantly, the prices of some of those medicines in pharmacies cost as much as 20 times the estimated minimum wage of EGP 1,200—though this is hardly what both prices and wages would be if applied today.

Three cancer treatments were shown to have cost between EGP 9,300 and EGP 26,000 and were not subsidised by the government. Meanwhile, a medicine for Non-Hodgkin’s Lymphoma costs EGP 24,600 and is partly subsidised by the government for doses of 600 mg.

Nevin El-Nadi from Shamseya also said during the conference that patients are not necessarily given post-treatment access or health insurance, and in general did not appear to be fully aware of their rights.

Researchers said they could not obtain statistics on the number of patients who participated in clinical trials or those whom suffered because of them, opting for a qualitative documentation by presenting specific cases in their report.

One of the stories was about a 60-year-old woman who found out she had contracted Hepatitis C. The woman, named Neamat, was able to receive medication for free as announced by the government. She acquired both Olysio and Sovaldi medicines.

Being old and unable to keep up with the many errands required to obtain the necessary documents, medical tests results, and visit doctors, most of the bureaucratic legwork was managed by her son who told EIPR that despite the difficulty he faced no objections whatsoever from doctors in obtaining the medicine which helped his mother significantly.

The son, however, did not know his mother was participating in clinical trials. The doctors kept him and her family uninformed. Since the family had no other method of treating the elderly Neamat, they had to comply with the doctors’ practices.

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https://wwww.dailynewssegypt.com/2016/10/18/patients-subject-ethical-violations-industry-sponsored-clinical-trials-eipr/
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