Dr. Akl Abu Qara writes: The consumer is caught between the vortex of drug efficacy and safety – Alzheimer’s disease for example!

In an important and perhaps historic precedent, the United States Food and Drug Administration, which is considered one of the most important specialized agencies in the world, approved a specific drug to treat Alzheimer’s disease, this which in itself is considered a historic breakthrough, in light of numerous attempts to find a drug for Alzheimer’s disease in different forms. This has been done in the past by giant pharmaceutical companies who have spent hundreds of millions of dollars on this, and in light of the huge increase in the number of people with Alzheimer’s disease, especially in people under the age of sixty or seventy, as these ages make up the majority of people with Alzheimer’s disease, and in The enormous expense incurred by health services and insurance companies around the world to deal with this disease have increased.

Alzheimer’s disease is one of the diseases that develop gradually, that is, over time, and it is scientifically accepted or almost accepted that the cause of this disease is the formation of a protein and slowly under the form of a cloud that shades cells or memory cell locations in the brain, and that this protein is formed by the action of enzymatic stimulation, Without going into details or the exact mechanisms of enzyme formation or proteins, any factors that interfere to inhibit, slow, or reduce the formation of enzymes and proteins will limit the formation of clouds around cells in the brain, and thus limit progression, slow down, or even freeze development sort of Alzheimer’s disease. Severe and possibly fatal, and that’s what the new drug that has been registered by the US agency is working, despite the controversy that accompanied the development and registration process, which still rages on.

Through my experience in drug development and working with international pharmaceutical companies, the reason for the controversy is mainly due to the spiral or the extent of the balance of two important factors for the discovery, development or the registration of any drug, to know the effectiveness and safety. or the extent of the negative effects of drug abuse, and these two factors have limited or halted the development of important drugs for many past and present difficult diseases, such as cancer, heart disease, depression and neurological conditions, including Alzheimer’s disease.

Where important drugs for Alzheimer’s disease were stopped in their final stages because their negative effects outweighed their effectiveness in fighting the disease, including a drug that was being developed for the disease Alzheimer’s disease many years ago, which is in the form of a semi-natural biologic drug that reaches the brain and treats Alzheimer’s disease and reduces it, but at the same time Time has shown that a large number of patients who took it and participated in the final stages of the trials had problems moving their limbs, and it was therefore stopped by the specialized health agencies, with great material, scientific and health repercussions.

In general, it is known that the issue of “food and drug safety” that reaches the consumer or the patient concerns all the inhabitants of our country, as it is the case in other countries of the world, large and small , women and men , because everyone, in one way or another, consumes their own food and their own medicines, and therefore everyone has the right, or their right, to have the correct information reach them on this that penetrates inside the bodies, especially nowadays or in this period, with the continuous escalation of the percentage and type of chronic or non-communicable diseases that are spreading in our country and in the countries around us, and with ambiguity or The reasons or factors for this are unclear.

The question of the safety, efficacy or validity of drugs for human use is a very important question, especially for a patient who is consuming drugs, and sometimes if the intended benefit is not achieved, the repercussions of their use can be serious and life-threatening especially when these drugs are taken for serious illnesses and for long periods of time. Therefore, the patient has the right to know two important issues related to the drug being consumed, namely the safety and the ‘efficiency.

In addition to the importance of correct information reaching the Palestinian patient or consumer in an organized manner about the safety and efficacy of the drug being consumed, we occasionally receive information about seizure or confiscation, or about the presence of invalid drugs and pharmaceutical preparations, expired or unlicensed, or of unknown origin in the Palestinian markets, where the danger lies in the fact that these preparations, and perhaps also because of their cheap price, can easily end up in the hands of consumers and therefore in the body, and their effects and repercussions, which can be immediate in the form of intoxication or pathological symptoms, or long-term in the form of serious illnesses that appear in the after some time, without or with difficulty explaining or the time has passed to treat them.

As it is well known that the pharmaceutical companies, before putting the new medicine on the market, carry out safety tests for many years on the active substance and other inactive substances which are included in the formula of the medicine, and before that the new drug is not examined or tested on patients before it is put on the market Safety studies are carried out on laboratory animals or on healthy human volunteers Therefore, the contamination of the drug and then the absence of confirmation of the stability of the chemicals it contains is an indication of the drug’s safety. Symptoms of a dangerous drug may appear on the Palestinian patient immediately or after a long time. And in case this happens, the patient or the doctor is unable to find an explanation for this, as we know that according to the laws applied in any country, the medicine must bear the expiry date of the medicine, as well as the environmental conditions in which the drug is stored, and the expiry date depends on several factors, including the type of drug, the form of the drug, whether liquid or solid, the manner in which it is administered to the patient, and the nature of the chemical substances present in the drug, in particular the active chemical substance, in terms of the duration of its stability in its original form and its non-dissolution in other chemicals for a certain period of time. A specific period of time, as well as the conditions under which the drug is supposed to be present in terms of temperature, humidity and light. Therefore, the presence of expired drugs on the market should be treated immediately as unusable, especially if these drugs are given for sensitive diseases.

ومن أجل مكافحة هذه الظاهرة وبفعالية، وبالإضافة الى الدور الرقابي الدوري الذي من المفترض أن تقوم به الجهات الرسمية متمثلة في وزارة الصحة وغيرها من الدوائر، من المفترض أجراء الفحوصات الدورية التي يتم تطبيقها على الادوية قبل تسجيلها او قبل تسويقها، وكذلك يجب اعادة اجراء الفحوصات المخبرية في حال الشك بفعالية او بسلامة الدواء، واذا كان هناك خلل بناء على نتيجة الفحوصات، يجب اتخاذ الاجراءات المطلوبة ومنها الاجراءات القضائية، وانه يجب تطبيق القوانين الفلسطينية وبحزم وخاصة على الجهاتالتي تسوق الادوية والمستحضرات الفاسدة أو غير الصالحة ، وكذلك المستحضرات الكيميائية الاخرى من مواد تجميل ومنظفات Etc.

Although drug efficacy and safety factors focus on drug development, these two factors should not be overlooked after the drug is brought to market and then in the consumer. In case of abnormal complications, they should be reported immediately to the responsible authorities. , or by observing the form of the medicine, the color, the hardness of the tablet, the taste, and of course by looking at the expiry date and the storage conditions before taking the medicine, and that in the event of the appearance of health complications or not feeling the benefit of the drug, he is supposed to stop consuming it and contact the relevant authorities to avoid repercussions that may aggravate the disease or harm the health.