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Examples of Information to Which Individuals are Exposed
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The heading on the advertisement on the right (click here for larger view) suggests that some product is being promoted which will relieve pain. The claim is made in the ad that the product Movementum will allow for pain-free movement all day long. Should I quickly run to the store and buy some believing that this product will work for me? Perhaps, before I run out and buy some of this product I should obtain answers to some questions.
1. What evidence is presented in the ad which will lead me to believe that this is a good product for me? There is not any supporting evidence.
2. In the fine print contained in the ad the following statement is made. "These statements have not been evaluated by the Food and Drug Administration (FDA)." What is the Food and Drug Administration?
3. What does it mean for a product to be evaluated by the Food and Drug Administration?
4. What does it mean for a product to be approved by the Food and Drug Administration?
The following information was taken from the FDA Home Page:
The FDA is one of the nation's oldest and most respected consumer protection agencies. Its role is to promote and protect the public's health by helping safe and effective drugs reach the market in an efficient way and monitoring products for continued safety after they are approved. From the time of submission of an innovative new drug for approval, it could take at least six months to obtain approval. "At the heart of all FDA's product evaluation decisions is a judgment about whether a new product's benefits to users outweigh its risks." No regulated product is risk free. The FDA will allow a product to present more of a risk when the potential benefit is great. This is especially true for drugs which are used to treat life threatening diseases such as cancer. In order to obtain approval for a drug the submission group must provide evidence that the drug is effective and that there are minimal side effects. The submitting group must provide the results of laboratory, animal, and human testing to the FDA in order to obtain approval to market the drug. The testing on humans is in the form of a clinical trial to show the effectiveness of the drug relative to the population it is intended to treat and to also show that there are not serious side effects. The FDA requires the submitting group to provide a label for the drug which contains information about dosages and potential side effects. Once the FDA has approved the drug as well as the labeling which contains dosage information as well as potential side effects the drug can then be marketed.
Approval of the product alluded to in the ad by the FDA would be strong supporting evidence. This approval carries with it an indication of the specific use of the product as well as a list of potential side effects.
The drug VIOXX was approved by the FDA. Why then was it recently pulled off the market?
Even though a drug is approved it is continually monitored to determine if there are long term side effects resulting from prolonged use of it. It is not feasible to obtain long term information relative to side effects prior to the drug being approved. This was the case with VIOXX. The data obtained from the long term studies provided information that the side effects of prolonged use of the drug out weighed the efficacy of it so it was pulled off the market.
At a later point in this presentation, information will be provided about clinical trials in general alluded to in the FDA discussion.
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