During the early 60’s, drug companies used to submit more than 700 requests to the Food and Drug Administration (FDA) annually to approve new drugs and obtain a license to market them, and the FDA had to revise all the information and studies regarding the drug in no longer than 60 days, then it provided the license or requested additional information or studies from the manufacturing company.
A few months after Dr. Frances Kelsey joined the FDA, one of the well-known drug companies asked for a license to sell a new medication called “Kevadon” to treat nausea, as it was proved to relieve nausea in pregnant women. It was given to millions of pregnant women in Europe, Asia and Africa and did not result in any dangerous side effects, and then the company made extensive efforts to get a license.
Dr. Kelsey and her team of professionals revised the documents, studies and information. She found it insufficient to prove the safety of the medication on the long run, so she refused to give the license. The manufacturing company submitted multiple applications and each time the doctor and her team revised the information and refused to grant the license.
After 14 months of struggle, the manufacturing company, with all modesty and embarrassment, withdrew the application to allow selling the drug. The drug was Thalidomide, and dangerous side effects and awful malformations started to show in infants with mothers who used the drug during pregnancy. The number of these cases exceeded tens of thousands in Europe, Africa and Asia, but only a few cases were reported in the United States (as the medication was not approved).
The role of the FDA and Dr. Kelsey in the disapproval of that medication protected tens of thousands of infants from malformations, from which thousands of people suffer in Europe and they are in the third decade of their lives now. Dr. Kelsey received a national award for her attitude.
The lesson which we want everybody to know is that there are international boards specialized in the health sector whose main job is accurately studying medications before mass production and marketing, focusing on the medication’s safety and effectiveness, and hundreds of doctors, researchers and experts in all areas work under its authority.
In America, the first question a cautious consumer asks to ensure the effectiveness and safety of the medication in his hands: Is this medication FDA-approved?
In societies where medical awareness is scarce, however, there are many promoters and posers, who might be knowledgeable in different areas but they exceed their authorities and the limitations of their profession.
Some of these individuals might promote treatment methods that were revoked by international health groups after examination. Some even use their natural talents, social status and personal experience to convince those who revolve in their orbit and follow their steps and that might cause dangerous long-term side effects in some people.
One study or few studies couldn’t be enough to prove the safety or effectiveness of a medication, as there are accurate and correct scientific approaches that has to be followed before proving the safety of any medication, and no one can accomplish that better than specialized medical and scientific administrations where hundreds of experts work, who have no personal interests in approving or revoking any medication. Medicine is a responsibility and a mission, and no one other than the experts should claim knowledge, and those who are knowledgeable should not exceed their powers.
It is God’s mercy that He provided us with causes and natural ways, and it is a necessity to study and examine these methods and laws. The ways of world construction and benefiting humanity aren’t complete without following these laws, and medicine is the study of these causes and laws in ourselves. A Muslim is more worthy than anybody else to follow these ways.
Therefore, our examination of God’s laws in ourselves should be thorough and accurate. Limited understanding of these laws from the so-called semi-scientists results in following the wrong methods which might lead to undesirable results, so it harms and does not benefit, and destroys and does not construct.
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