Finding The Risks of Drugs
Pharmaceutical companies are required by law in all countries to perform clinical trials, testing new drugs on people before they are made generally available. The manufacturers or their agents usually select a representative sample of patients for whom the drug is designed – at most a few thousand – along with a comparable control group. The control group may receive a placebo and/or another drug that is already marketed for the disease.
The purpose of clinical trials is to discover:
- if a drug works and how well
- if it has any harmful effects, and
- its benefit-harm-risk profile - does it do more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?
Clinical trials do, in general, tell us a good deal about how well a drug works and what potential harm it may cause. They provide information that should be reliable for larger populations with the same characteristics as the trial group - age, gender, state of health, ethnic origin, and so on.
The variables in a clinical trial are specified and controlled and the results relate only to the population of which the trial group is a representative sample. A clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, nothing could tell you the whole story, but a clinical trial must tell you enough; "enough" being determined by legislation and by contemporary judgements about the acceptable balance of benefit and harm.
Read more about this topic: Pharmacovigilance
Famous quotes containing the words finding, risks and/or drugs:
“The thing that’s between us is fascination, and the fascination resides in our being alike. Whether you’re a man or a woman, the fascination resides in finding out that we’re alike.”
—Marguerite Duras (b. 1914)
“The amount of it is, if a man is alive, there is always danger that he may die, though the danger must be allowed to be less in proportion as he is dead-and-alive to begin with. A man sits as many risks as he runs.”
—Henry David Thoreau (1817–1862)
“There is not much sense in suffering, since drugs can be given for pain, itching, and other discomforts. The belief has long died that suffering here on earth will be rewarded in heaven. Suffering has lost its meaning.”
—Elisabeth Kübler-Ross (b. 1926)