We are not a Corona drug testing field … Health Advisor: Two weeks and we’re done

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Dialogue – Ahmad Jumaa:

Photography- Nader Nabil:

Dr. Noha Assem, Advisor to the Minister of Health for Research Affairs, said that the Ministry’s Scientific Research Ethics Committee received 43 research papers related to the Corona crisis, while 4 of them were rejected; Because there are notes about the scientific validity or the danger to the respondents.

Asem added, in an interview with “Masrawy”, that the Ministry of Health is conducting a number of clinical and observational experiments; Among them, the recovering plasma trial, which was conducted on 80 patients out of more than 120 patients who obtained it, is about to announce its final results, as well as to proceed with the experiment using the drug “Ivermectin” to treat people with the virus, and is scheduled to be completed within two weeks.

The Advisor to the Minister of Health for Research rejects what is said about us as “a field of experiments for Corona drugs” at the present time, and stresses that no research idea should be applied without the approval of the Committee on Research Ethics, and obtaining the consent of patients, according to the scientific terms before starting the experiments … and to the text of the dialogue :

• First of all, what is the difference between the tasks of the work of the Ethics Committee for Scientific Research at the Ministry of Health and the scientific committee responsible for managing the Corona crisis in regard to drug trials?

The Scientific Research Ethics Committee that has existed for years in the Ministry of Health and is concerned with reviewing the research presented to it, whether research carried out in the ministry or foreign studies, and is tasked with reviewing the research presented to it and the extent of its conformity with the necessary scientific and ethical controls in the field of research “not to any extent propagated by an idea applied On human beings directly. “

In order for the research idea to be implemented, it is necessary for an independent body to review it and be reassured about the risks and benefits aspects, and that all matters are going on in a scientific manner so that there is no misuse of scientific research.

As for the scientific committee formed by a decision of the Minister of Health, it has two parts in its work. The first is treatment and implementation of therapeutic protocols, the other is research design, and this is a point that should be noted; Because the Corona crisis provided a great opportunity to look at the importance of scientific research, which necessitated the need to study the disease, its methods of transmission, prevention and treatment.

On the ground .. How many studies related to “Corona” are being studied by the Research Ethics Committee?

We are currently provided with 43 papers. But we don’t necessarily have to agree with all of them, as 4 papers have been rejected. Because it has problems with scientific validity or dangerous for the respondents, and then from the beginning it is rejected.

There is also some research that is a good idea. But it needs revision or more details, and we start examining controls to improve research, and a lot of research has been accepted since the first time.

As for the scientific committee, there is more than one research protocol that we are working on. In principle, since the beginning of the crisis, a patient database has been designed. So that all their data is inside an electronic system to follow them, and any time we need them we go back to the data and see the results of the applied therapeutic protocol, as well as counting the problems of patients, whether in certain hospitals or governorates, other than the committee formed to follow up the deaths and whose membership was also supervised, and among its tasks is to study Cases of death, their increase or decrease, and the analysis of their data. These are researches related to the health system.

All this reflects the interest of Dr. Hala Zayed, the Minister of Health, in this matter; Especially since my position is created as a consultant to the Minister for Research.

What are the details of these studies?

For example, we have the experience of treatment with recovered plasma that is about to end, and we are currently in the stage of analyzing the data, and we also have an experiment to use the drug “Ivermectin” in the treatment of Corona patients, and we are in the stage of collecting data of the cases under study, and we also have a trial of treatment with a drug for HIV, In addition to our participation in the solidarity experiment of the World Health Organization, which contains a number of medicines, including Ramesfevir.

These experiments start with the suggestion of a research protocol, and it is necessary for an independent body to review the scientific and ethical aspects of these researches, and therefore this research protocol is submitted to the Research Ethics Committee for review.

When does the Ivermectin research experience end?

The study is based on 150 patients, and patients are still getting the drug in specific doses, and I imagine we have two or three weeks to finish the study.

• What is your vision of the preliminary results of this experiment?

Let’s set a rule: If you asked this question to a researcher while his studies are still ongoing and he did not finish it, and he answered you, this is a “serious mistake”!

It is not permissible for a researcher to talk about the results of his research before it ends. Suppose that there is a better group than a group, statistically this difference is by chance, and in order to say that this difference is practical and statistical, it is necessary to complete the sample and see the difference.

Why choose this property specifically?

Worldwide, there are laboratory studies that are carried out before the clinical trials are carried out, and Ivermectin has given promising laboratory results for its contribution to eliminating virus cells and has activity against corona, and therefore we wanted to see that given its giving to patients and the expected results.

Ivermectin is not a new medicine that is registered in Egypt, and is used for parasites. Therefore, we have not been concerned about the part related to drug safety, and we are currently studying its efficacy in treating coronary patients.

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• Have the tests for treatment with Ramsdevir succeeded?

Al-Ramdisifir holds a license from the “FDA” and the Ministry of Health for emergency use, then produced by the “Eva” pharmaceutical company, and distributed 1,100 packages to isolation hospitals. Each patient takes the drug under certain conditions and is from observational experiences, and upon completion of the cases the results will be announced; Especially since the drug is already in the treatment protocol.

Also, this drug falls within the solidarity experience of the World Health Organization, and we obtained it from the company “Gilead”; In order to enter into that experience and not use outside it.

• What about trying to use a C virus drug as a possible treatment for Corona?

The drug is one of the treatments for the C virus, and we are still in the experiment stage after obtaining the scientific reviews and approvals, but that experiment will take a longer time than “Ivermectin” because we started that study after that.

• The World Health Organization announced the discontinuation of the tests “Hydroxychloroquine” and “Caltera” .. What is our position on that?

What applies to the solidarity experiment is implemented by all countries, and the two properties were excluded from the experience already, but we still use it in the Egyptian protocol as a treatment for patients, because its results are good compared to global results and every country has a model that it is going to follow.

Hydroxychloroquine has contraindications and contraindications, and it must be obtained under the doctor’s observation and for an EKG before taking it. The same thing with the “calatra” of AIDS treatment, it has certain requirements before taking it, and it is still present within the therapeutic protocol.

• The controversy still surrounds the treatment experience of plasma recoverers .. are the results good or otherwise?

We finished the experiment on patients and in the stage of statistical analysis, and we have groups in the experiment: very dangerous, critical, and the results are good in the cases before entering the stage of artificial respiration with obtaining a percentage and a certain number of antibodies.

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When will the results of the recovered plasma study be announced?

In a few days, the final results will be announced.

Why did some cases die after receiving plasma?

Those who are scheduled to have plasma have a somewhat lower chance of recovery, and even if the plasma has contributed to a 30% reduction in mortality, for example, this is a benefit because we have contributed to improving patient survival, and in general there is no 100% effective treatment.

• Do you obtain patients ’consent to participate in clinical trials?

Of course, the study may not take place without the patient’s consent.

So are there “informed consent” for these patients?

Informed consent has scientific and research conditions that any study goes through, and it may be written consent or the guardian in the case of children, and even the child has the right to know his participation in the experiment.

• Are there children who participated in the trials of “Corona” drugs?

No, current experiences over 18 years of age, who we call “vulnerable groups”, should not be at the forefront of experiences, such as children, pregnant women, people with weak immunity, and prisoners, except in the case of specialized research for children.

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• Are we a testing ground for Corona drugs in Egypt?

Do you think so?! I don’t think we are a fully “test field” for any drug. The presence of one or more independent and oversight bodies reviews research; This contributes to controlling these experiences, and no research idea may be applied without the approval of the Research Ethics Committee and conducting it in a research scope.

The fact that research with certain controls is not a cause for concern to the participants or that we have turned to a field of experiments, and most importantly we have the safety and security of the research, and I told you that we rejected 4 research before entering into the experiments, because if the research was weak we would not allow the patient to be exposed to any danger, it must be Convince us of the potential benefit of this drug.

• Who submits research to the Research Ethics Committee: independent researchers or from within the Ministry of Health?

Usually researchers from the Ministry of Health, along with international research carried out by international companies that work in more than one field in Egypt and need to import drugs or export samples, but in the period of “Corona” we saw a wonderful phenomenon that there are clinical research designed by researchers from the ministry or from Egypt in general and we do not wait for a foreign party or a subsidiary of the pharmaceutical industry, but we are waiting for researchers who have the goal of reaching a treatment or vaccine for the virus, and therefore we are provided with research from independent researchers or universities or from within the Ministry of Health.

• There are many experiments that are based on the same or similar hypothesis repeated between more than one researcher, is this positive or lack coordination?

On the contrary, this strengthens the scientific research system, when we find more than one place conducting studies, the highest evidence is that more than one study is gathered and there is analysis for it, and then similar research strengthens scientific research and does not weaken it, and scientific research is not quarantined on anyone.

Where are we from the Corona vaccines?

True hope of the Corona crisis in providing the vaccine, given that it is a viral disease; To prevent cradle injury.

From the latest WHO update, there are 24 studies in the clinical phase; 3 of them entered the third stage.

We in the Ministry of Health are taking proactive steps in view of these entities; In order to have an opportunity to cooperate with it whether to conduct a protocol for participation in research in Egypt, because it needs a large sample subject to experience, as well as participation in manufacturing itself, and this is what happens in the protocol of cooperation with the Chinese company.

What is the closest vaccine yet?

There are 3 vaccines: Oxford, Synovac, and the American Institutes of Health “NIH”, the closest being the “Oxford” vaccine.

Do we have experiences or studies related to producing a Corona vaccine?

I am responsible for the Ministry’s Scientific Research Ethics Committee and we have not received any research on a vaccine, but we have received inquiries regarding the possibility of conducting a specific research in Egypt, and we are eligible to participate in these studies.

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• If we move to the analysis of corona death data … What is your comment on the infection rates?

The proportions are very low and reassuring, and although we have included the idea of ​​home isolation for Corona patients and many cases are in home isolation, but deaths are known and known, and the percentage of serious cases has decreased among the injured.

• What are the most common causes of death related to Corona?

People with chronic diseases are 3 to 4 times more likely to die compared to those without chronic diseases. In men, the injuries are higher because they are more likely to be infected, but the difference is minimal.

• Are there deaths among children?

There is no significant child mortality at all, the mortality rate under 18 years of age was 0.2%, and the largest mortality was for those over 80 years of age; Especially with more than one concomitant disease.

• Have we passed the stage of danger in Corona?

We are in the direction of overtaking; Because we are afraid of the reaction after the Eid al-Adha holiday, especially after what we saw on Eid al-Fitr and the number of injuries increased very significantly after the holiday. Personally, I will only be assured after the incubation period has passed after the Eid leave. That is, about 5 to 14 days of illness.

Are you afraid of a second wave?

The second wave is a possibility, and this is not only specific to Egypt. But in the whole world.

• How many strains of the virus in Egypt?

We have two strains of the virus in Egypt.

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• What is the happiest moment for you in the Corona crisis?

When the death rate decreased, and the problems related to patients’ health crises decreased, we felt we were heading for a better situation. I don’t care how many cases are affected but rather those with major health problems. Corona is an acute disease and not a chronic one.

• What are the benefits?

When you feel you are going in one direction, people are going in another direction; Because we are looking for the latest treatment, drugs and a lot of effort we are doing, but many citizens did not help us and there was a leniency in taking preventive measures at the end of the month of Ramadan and Eid al-Fitr and caused a significant increase in numbers.

In conclusion .. Are you optimistic about the experiments being done to produce an Egyptian medicine to treat corona?

Before the result, I am very proud of the system that we established, for example a plasma study in which 7 majors participated in manufacturing the protocol and implementation on the ground, as well as the system in the rest of the experiments, and we designed a system to confront “Corona” with the utmost confidence in the hospitals of the Ministry of Health, there are special places to conduct Clinical studies within our hospitals, and this is a long-term outcome of Corona and beyond Corona.

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