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Are Egypt's Poor Falling Victim to Unethical Medical Trials?

19 October, 2016
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The Egyptian Initiative for Personal Rights (EIPR) has just released a report documenting violations of the international pharmaceutical companies during clinical trials on Egyptian patients. The EIPR had its door open yesterday for journalists, doctors and pharmacists to discuss and know more about their investigation.

Moderated by Alaa Ghannam, the researchers, Ayman Sabae and Niveen Mahmoud explained the report's aim and the methodology they used to the attendees gathered at EIPR's headquarters located in Garden City, Cairo. "We are not against clinical trials; this report's aim is to adjust these technical matters to prevent future violations during clinical trials," Sabae clearly stated several times throughout the press conference.

The report answers four pivotal questions: Is Egypt still a drug-industry magnet despite the current political instability? Are there immoral practices performed during clinical trials in Egypt? Are the drugs tested during these clinical trials in Egypt available at prices that the Egyptian public can afford? Is there a need for more ethical control by European countries in the case of clinical trials conducted on Egyptians, by European or Swiss companies for their market licensing?

Egypt is second only to South Africa as the go-to state in the continent for pharmaceutical companies conducting clinical trials. "That is mainly because patients in Egypt are both impoverished and medically naïve – [many] have never been treated before. Moreover, the Egyptian market is very cheap in terms of labor and patient compensation."

The report illustrates how patients are not fully aware of what they signed up for; they don't know the logistics of withdrawing or their right to continue with the treatment even after the trials are through.

Indirectly backed by the current law in Egypt, Sabae pointed out that nothing requires the companies to be fully licensed to conduct such trials before phase 1 and 2; phase 1 is where researchers test the drug in a small group (ranging from 20 to 100) of healthy people for the first time to evaluate its safety, determine a safe dosage range, and identify the side effects. Phase 2 is where are tests are performed on larger groups (ranging from 100 to 300) and are designed to assess how well the drug works; toxicity and failure of the drug are usually discovered in this phase.

The main reason behind this is the healthcare problem Egyptian underprivileged patients have been suffering from. They are unable to afford the treatment expenses, especially cancer patients, so they hang on to the clinical tests for dear life, as it is often the only option. 

The Secretary General of the Arab Doctors' Union, and a representative from the Doctors' Syndicate, Dr Osama Abdel-Hay explained that a patriarchal relationship between doctors and their patients is another reason why patients agree to conduct clinical trials blindly.

"It is socially acknowledged that a PhD holder would have higher understanding capabilities than anyone else, which is definitely not true. I was once in a pre-trial session with a patient, explaining to him the process of a clinical trial and giving him information about his rights and the informed consent, the patient's escort  spontaneously asked us: 'do you really think he’ll understand any better than you guys do?'" Abdel-Hay said.

On the other hand, even Abdel-Hay's colleagues in the Syndicate among the Egyptian public in general are also not very convinced, thinking that these patients are poor and they won't understand like the richer more educated patient. "This is a very critical issue; the poor patient can understand like the rich, educated patient all the same. The level of education has got nothing to do with the social intelligence and the patient's right to understand," he argues.

Niveen Mahmoud went on to explain their research methodology, and the results of whether the drugs being tested are available at affordable prices in the Egyptian market or not. They specified 24 internationally-developed drugs from a total of around 50 that have been tested during clinical trials between the years of 2005 and 2010 in Egypt. They looked into three aspects; the licensing, the inclusion of the drug in Egypt's healthcare, and its affordability.

The Egyptian Drug Authority (EDA) website shows that nine out of the 24 drugs specified didn't have any instructions about their licensing, and five licensing dates out of the remaining 15 had expired. Moreover, two out of these, for treatment of blood pressure and diabetes, were still available in the market on an expired licence. Mahmoud, acknowledging that the website may not be up to date, said they had reached out to the EDA and the drug companies for and update, but had not yet heard a response.

To assess pricing, they looked across large- and small-scale pharmacies as well as an online retailer. "We found out that most of the drugs weren't available at non-chain pharmacies, and were sold at a very high price – especially drugs that treated cancer; they would reach EGP 25,000 to 26,000 per month which is around 20 times the minimum wage in Egypt," said Mahmoud.

Only six medicines were included in the national healthcare treatment program, however the bureaucratic procedures often makes access difficult.

The panel also revealed the paucity of the compensation for patients taking clinical trials: a bed in public hospitals to get treatment after the trial is over, "Which is already their right,” Sabae reminded us.

Otherwise, they offer their patients an opportunity to be granted a trial extension. 

In conclusion, the researchers made a number of proposals help guarantee the welfare and rights of the patients taking part in clinical trials. "We suggest that a united legislative framework be established to organize, watch over, clarify the post-trial treatment process to the patients," Sabae said.

"The Ministry of Health must provide an up to date, transparent database of clinical trials," he added.

Sabae also highlighted that it is very important to commit to the ethical guidelines and measures acknowledged worldwide, as well as having the legislation require the companies to train their nurses and laborers conducting the trials on the patients.

"We also need to involve all this in academic curricula in schools of pharmacy and medicine, as to reform the culture and protect the patients' right and therefore wellbeing," he suggested. 

Last but not least, in critique to the report, professors and doctors argued that "clinical trials are very convenient methods to treat patients, so this report suggests that patients don't get treated;" the researchers recommend that the medical society deem those trials as part of scientific research, not as a charity to treat underprivileged patients at no cost. 

Image: Leena ElDeeb

Tags MENA Because Egypt clinical trials medical ethics