Drug testing on people - Facts and warnings

Peace be upon you and the mercy of Allah.

Introduction to Clinical Trials

Dear brothers, a few days ago, approval was issued by one of the Arab countries for a clinical trial of drugs for the disease Covid-19 caused by the coronavirus, and the news was published by the World Health Organization. Some people started circulating this news in a condemnatory manner, asking: Are we a testing ground? Yesterday, people circulated a video of French researchers talking about testing drugs on Africans.

These two events open the file of human drug trials, what is called in the countries of the third world testing drugs on the inhabitants of what is called the countries of the third world, most of which are Muslim countries, of course. It is an old file and did not start with the trial of Covid-19 drugs nor with this French video.

Therefore, I see it as my responsibility as a doctor in the field of pharmacy, then as an academic who studies the subject of clinical trials, I see it as my responsibility to clarify some facts briefly, then to hold the workers in this field responsible for investigating more and fulfilling their duty in preventing the violation of people's rights, and at the same time to ensure that the interest of conducting these trials is in accordance with the appropriate approved principles.

Stages of Clinical Drug Trials

Now, dear ones, any new substance proposed to be a beneficial drug for a disease is tested on animals. If it is proven to be effective and non-toxic, it is then tested on humans through several stages: the first, second, third, and fourth stages.

So, we have human clinical or clinical trials:

• First Stage: Ensure the safety of this substance proposed to be a successful drug. Ensure its safety, meaning it does not lead to serious side effects.
• Second Stage: Ensure its effectiveness and the necessary doses and the number of times it should be given per day, etc.
• Third Stage: It is tested on a larger number of people, meaning several thousand.
• Fourth Stage: This stage is post-marketing studies, meaning the substance has become a drug available in the markets, then the producing company follows up with doctors if any new side effects have appeared that did not appear in the earlier stages.

Importance of Clinical Trials and Their Controls

Clinical trials, by this definition, are indispensable and important. Our objection is not to their conduct in principle, but the most important thing is the conditions and controls that are set to ensure the patient's right according to the principles announced by the World Health Organization.

The patient must know that this is a trial for a new drug, that he should not pay a material fee, that he should know what the side effects that may affect him are, that all measures should be taken to reduce the likelihood of him being exposed to any risks, that the side effects should be treated if they appear, and that he should continue to benefit from the treatment or medical procedure that has been proven to be beneficial according to the study even after the study is completed. That is, the treatment or procedure should be provided to him after that, not "we tested it on you, now goodbye." No, the drug is beneficial, so take this drug after the trial.

All of this should be explained to the patient in clear language that he understands, and we should ensure that he has understood it. Then the patient signs a statement that he has understood the subject and agrees to participate in the trial.

Questions About Applying Controls in Poor Countries

The question being strongly raised here is: Is all of this being followed in poor countries? Where people's health and lives are taken into consideration as you know? I will present some facts to you, gentlemen, and then leave it to the concerned parties to investigate.

There is a global charter called the "Helsinki Declaration" by the World Medical Associations, from which a committee or organization was formed to follow up on the ethics of medical practice. This organization published that one of the clearest examples of the difference between dealing with patients in the poorest countries and patients in the richest countries is Egyptian cancer patients.

Then, if the effectiveness and safety of the drug were proven, the supervising company continued the study in richer countries, and the patient did not benefit from the drug in the long term. Meaning, "We tested the drug on you, found that the drug is beneficial, that the drug has no side effects, or perhaps you may have side effects, exclude the drug." Medicines that were not excluded, that proved to be beneficial, fine, may God grant you good health, patient, Muslim, poor, we will continue our studies since we have proven to you that these are safe drugs, we will continue our studies abroad in richer countries.

There is a website that we will put for you in the comments called "Center Watch," which contains the number of human trials in every country, even in its different governorates. Every country and every governorate of this, or every city of this different country, and information about these trials, and in what stage they are: Phase One, Two, Three, or Four in detail, and the addresses of the studies and the goals of the studies. You will find thousands of trials in developed countries there.

Therefore, our problem is not with conducting the trial, but with its conditions and ensuring the patient's rights within it. A country like Egypt, for example, has hundreds of trials. There are documents from DW channel (DW), and of course, it is not a good or reliable channel in everything it presents, but this report contained evidence and interviews about human trials, and it opens eyes to hidden things that must be followed up.

And our methodology, as we have announced before, whether in the Journey of Certainty or in the publications or in life in general, any human being who brings evidence and this evidence can be traced and investigated and its authenticity proven, we take from him. And our testimony with his words does not mean that we agree with his general methodology and general direction at all.

There is an important scientific research conducted by a team led by Dr. Sherif Muhammad Shahata from Tanta University. This research contains very valuable information, talking about the reality of human studies globally, especially in the poorest countries, and how some patient approvals are forged, meaning they forge that the patient agreed while he is poor, has no home, and knows nothing. Sometimes patients do not know what is in it, sometimes the side effects that occur with them are hidden, sometimes the trials are not conducted on animals first but directly on humans. Why do we not test on animals first? We test on humans directly. This is completely contrary to the official global protocols.

We will also put for you a study titled "Preventive Measures in Human Trials in Low- and Middle-Income Countries Need Strengthening, Not Weakening," a study published in an international journal. What does this title mean? This study shows that even regulation itself has become less concerned with the patient's interest. Meaning, people are not applying the laws, health organizations, go back to the modern versions of these laws and reduce the conditions and controls?

We said, gentlemen, the clinical trial standards state that the patient must benefit after the study from the treatments or tests or procedures that the study has shown to be beneficial to him. Nevertheless, in a study that investigated the trials conducted between 2004-2007 on tuberculosis, malaria, and AIDS, it was found that only 1.3 percent, meaning about one percent of these trials mentioned following up on the patient after the study. Of course, what is the benefit if you are conducting a trial on the patient and it is proven that there is an effective drug, then "may God grant you good health, the patient is done, thank you, we mean we will market the drug to others." Is he not the most deserving to benefit according to the announced protocols? He is the most deserving to benefit. No, only about one percent of these studies mentioned what happens after the results in terms of follow-up for patients.

Awareness and Supervision of Clinical Trials

So, does all of this mean that people should refrain from clinical trials, human trials? It means that we should raise awareness and supervision of these studies. The situation, gentlemen, is unfortunately difficult. And many people are forced to enter these, but with all of this, we must raise awareness to save people as much as possible.

Do not think, gentlemen, that if the World Health Organization announces a human study or if international organizations supervise it, this necessarily means that these studies are conducted according to the principles. Some think that when we quote statistics or health directives from the World Health Organization, this means that we trust it. No, gentlemen, we do not trust these international organizations, but when Muslims do not have alternative organizations for statistics and information and these pieces of information are unfortunately the first to be mentioned, we are sometimes forced to mention the words of the World Health Organization, there is no alternative to it.

Otherwise, if one of you followed the episode "Science Fraud, Homosexuality as an Example," he would see an example of the politicization of the World Health Organization even in health, yes even in health. How did this organization issue regulations regarding the fight against sexual deviance, and these regulations were similar to counter-terrorism regulations, terrorist regulations in the true sense of the word. And how it encouraged the spread of a culture of accepting deviance and preventing it from being considered a psychological deviation in one way or another, and reporting those who oppose sexual deviance, which they of course call homosexuality.

Important Questions Before Participating in Trials

Here, gentlemen, I will conclude by raising a set of important questions before anyone participates in these studies, before someone says I am for or against a clinical study. As I told you, these studies are indispensable, and with the bitter reality and the lack of many countries taking responsibility for caring for the people present in them, unfortunately, many will be forced to participate in these studies. But we raise awareness by asking the following questions: ten questions.

1. Study Phase

The first question: What phase is this study in? Phase 1, 2, 3, or 4? So that they test the drug on us and you bear the responsibility of giving me a drug for my illness. Is it Phase 1? Did you inform me that it is Phase 1 so that I can agree if you were forced to agree?

2. Nature of the Tested Drug

Secondly: Are all the tested drugs known drugs for other uses with nothing new in them? Meaning, there is a way of treatment that there are drugs that exist and are used but have not been tested for this particular disease. So is this drug that you will test on me a drug that is originally given for other diseases and its safety has been proven to some extent, or is it a new drug? Not known for its good or bad as they say.

3. Exaggerating the Disease to Accept Experiments

Thirdly: Is the COVID-19 infection being exaggerated for a patient to accept experiments? Are we making the coronavirus a big issue? Undoubtedly, it is a serious and important matter, which I have repeatedly warned about and spoken about in detail. I have said not to take it lightly, and I have mentioned the preventive measures and treatment procedures, as well as the treatments in detail. However, is the infection being exaggerated for a patient to accept any kind of experiment?

4. The Patient's Need for Treatment

Fourthly: Does the experiment only include those who need treatment? What do you mean? I mentioned to you, esteemed audience, in the article "Five Facts About Corona" that we published about seventy days ago, that a percentage of patients do not need treatment at all according to European, Chinese, and Korean treatment protocols. The majority of patients do not need treatment even if they are infected with corona. There are guidelines that we mentioned in detail for treatment, meaning treatment with drugs specific to the virus. So, does the patient actually need treatment?

5. Experimenting Vaccines on Non-Patients

Fifthly: Can the study be conducted on people who are not patients? What do you mean they are not patients? The renowned global magazine Science published an article four days ago in the form of a question, meaning with a question mark: "Should we speed up the production of a corona vaccine by deliberately causing the disease in volunteers?" What do you mean? The article in the global Science website says that vaccine production requires a long time, and the World Health Organization will find very few volunteers worldwide. The tragedy is if people's needs and poverty are exploited, and the issue is exaggerated for them so that such experiments are conducted on them. So, are they actually patients or not? The issue is about a vaccine or an immunization, not treatment. I also differentiated between treatment and immunization in the article "Five Facts About Corona."

6. Justification for Testing New Drugs with Effective Drugs Available

Now, the sixth question: Is there a reason to test a drug other than the known effective ones, such as Hydroxychloroquine and Chloroquine, and antiviral drugs, known virus medications? On the same day we announced that clinical trials would begin in Egypt on drugs for corona, the U.S. Food and Drug Administration announced its approval of Chloroquine and Hydroxychloroquine for the treatment of COVID-19. The question that arises is: If these two drugs are effective, why are other drugs being tested?

It may be said, and this is already being discussed, that these two drugs are not for all cases, and even the antivirals available are not for all cases. Some cases may be refractory, and there may be contraindications in some patients that prevent us from using the drugs we said are effective. Okay, fine. Does the patient know that? Is the patient informed and clearly understood that it is possible to treat you with an approved and effective drug, but we want to try another one on you for the service of humanity and for those who cannot take this drug to take the alternative drug? Does the patient understand this?

Of course, are the necessary tests done for the patient before testing any drug? As it may be dangerous for him, especially if he has another disease. For example, Hydroxychloroquine and Chloroquine are dangerous for people who have a condition called QTc prolongation, or a certain condition in heart rhythm disturbances, predisposing them to heart rhythm disturbances. This is also a legitimate question.

7. Guarantees of Compensation and Follow-up

The seventh question, which is the most important of all: Are there guarantees to compensate the patient if they are affected by side effects from the tested drugs? Will they be followed up after the experiment? After the experiment is over and the patient goes home, will they be followed up? Is there a mechanism for their follow-up? Will they benefit from the drug if its efficacy is proven later?

8. Application of the Basics of Clinical Trials

Eighthly: Will the basics of clinical trials be applied? Are those who supervise them trustworthy?

9. Equality of Rights Among Patients

The ninth question: Will a resident of a poor country, a person in a poor country, enjoy the same benefits as an American or European on whom the experiments are conducted?

10. Eligibility of Relaxed Countries to Supervise Experiments

The tenth question: Are the countries that have relaxed travel from infected countries, then concealed the actual number of cases and are still, it appears, concealing, trustworthy for patients and authorized to say yes, we agree to conduct clinical trials and the health of patients will be considered in these experiments?

Conclusion

Finally, esteemed audience, I am not saying that we should think well absolutely of pharmaceutical companies and those who conduct clinical trials, nor am I saying that we should think ill absolutely. However, they are undoubtedly profit-making companies, and many of them in their work have bribery and turnover for doctors under the name of pharmaceutical advertising as you know. Therefore, let the Muslim be cautious, wise, attentive, and vigilant.

And this time again, I will not prolong the discussion on this file, not because it is not important, it is very important, but my brothers, there is a kind of branching, and I would like to return to some important topics that we started with series. Therefore, I leave it as a trust in the necks of my brothers, the doctors, pharmacists, academics, researchers, and anyone who has the ability to monitor these experiments and their progress, and prevent bribery and turnover in them, and to fear Allah with the people, for he is responsible for them. Peace be upon you and the mercy of Allah.