The sedative thalidomide was provided to patience during the 1960’s to counteract the effects of war (Fintel, Carias & Samaras, 2009). It was first introduced into Germany and then extended worldwide. The medication was given to anyone since the pharmaceutical company stated that it was safe for everyone. They reached this conclusion since no rats died during the trial stage, no matter the dosage given to the rats. Dr. William McBride noticed that this medication stopped morning sickness so he decided to use it for this secondary purpose on all pregnant patients. The problems began when McBride associated the birth defects of his patients to the medication. The mother’s of the deformed children were given the sedative to stop the morning sickness but they were unaware of the cost of taking this medication. Frances Kelsey, who at the time was a FDA inspector, decided to not allow the use of the product in the USA since there was not substantial information on the drug. She followed a rigid decision making process. She did not stray from the finding of the research and made a sound decision due to the lack of information on the side effects of the product on humans (Fintel, Carias & Samaras, 2009). Due to the decision made by Kelsey and McBride, the FDA decided to place rigid standards on medication approval and require rigorous years of investigation before allowing the distribution of them on the market. In addition, all side effects and health warnings must be informed to the patient receiving the medication. I believe both the pharmaceutical company and the doctors made poor choices because they didn’t look deeper into the side effects of the medications. In addition, the doctors took it upon them to use the medication for other reasons without evaluating if it would be a safe choice for their patients. They identified their problem but didn’t consider well their alternatives.
The sedative thalidomide was provided to patience during the 1960’s to counteract the effects of war (Fintel, Carias & Samaras, 2009). It was first introduced into Germany and then extended worldwide. The medication was given to anyone since the pharmaceutical company stated that it was safe for everyone. They reached this conclusion since no rats died during the trial stage, no matter the dosage given to the rats. Dr. William McBride noticed that this medication stopped morning sickness so he decided to use it for this secondary purpose on all pregnant patients. The problems began when McBride associated the birth defects of his patients to the medication. The mother’s of the deformed children were given the sedative to stop the morning sickness but they were unaware of the cost of taking this medication. Frances Kelsey, who at the time was a FDA inspector, decided to not allow the use of the product in the USA since there was not substantial information on the drug. She followed a rigid decision making process. She did not stray from the finding of the research and made a sound decision due to the lack of information on the side effects of the product on humans (Fintel, Carias & Samaras, 2009). Due to the decision made by Kelsey and McBride, the FDA decided to place rigid standards on medication approval and require rigorous years of investigation before allowing the distribution of them on the market. In addition, all side effects and health warnings must be informed to the patient receiving the medication. I believe both the pharmaceutical company and the doctors made poor choices because they didn’t look deeper into the side effects of the medications. In addition, the doctors took it upon them to use the medication for other reasons without evaluating if it would be a safe choice for their patients. They identified their problem but didn’t consider well their alternatives.