Experimental Drugs on Trial
It takes roughly eight and a half years for a drug to reach the consumer from the time it is first tested to when it appears in pharmacies. This is due to the “gold standard” set by the FDA—a stringent process of testing and retesting drugs to ensure their safety and efficacy. This process is broken up into three phases:
[I] Drug is administered to 20-80 people to test dosage levels and side effects
[II] Several hundred people receive the drug to determine its short-term side effects and efficacy
[III] The effectiveness and safety of the drug are tested on a several thousand people
This extensive scheme was created in an attempt to prevent unexpected side effects from taking a toll on people’s lives. We’ve all heard of cases, however, where this process has failed. Thalidamide, Vioxx, Celebrex, and Laetrile are all examples of drugs that passed the FDA’s requirements and were later recalled due to unforeseen side effects.
Interestingly, patients are now stepping up to shorten this period of extensive testing. Frank Burroughs, for example, founded a group named the Abigail Alliance for Better Access to Developmental Drugs after the death of his daughter. Abigail Burroughs was a terminally ill cancer patient who attempted to enter the pre-trials on drugs like Erbitux and Iressa, but she was denied entry. The argument is essentially summarized by two standpoints: terminally ill patients claim that they should have access to drugs that have not made it through the full testing process while the FDA believes this would endanger the patients by exposing them to untested chemicals. It is, of course, a more complicated matter than it appears. If a patient is out of treatment options and death is eminent, then why not provide some type of treatment, even if the outcome is unsure? For example, it seems that a cancer patient would rather be alive and infertile than to pass away. On the other hand, rushing the testing process could have a negative effect on the entire pharmaceutical industry as many drugs that should not reach market now would.
Where do we draw the line? How sick does a patient have to be in order to receive a drug that is not available to the general public? Speeding up the drug approval process could have potentially life-saving and detrimental effects, and finding a balance between these two extremes will be essential to the credibility of America’s medicinal system.
Benderly, Beryl Lieff. "Experimental Drugs on Trial." Scientific American: October 2007
[I] Drug is administered to 20-80 people to test dosage levels and side effects
[II] Several hundred people receive the drug to determine its short-term side effects and efficacy
[III] The effectiveness and safety of the drug are tested on a several thousand people
This extensive scheme was created in an attempt to prevent unexpected side effects from taking a toll on people’s lives. We’ve all heard of cases, however, where this process has failed. Thalidamide, Vioxx, Celebrex, and Laetrile are all examples of drugs that passed the FDA’s requirements and were later recalled due to unforeseen side effects.
Interestingly, patients are now stepping up to shorten this period of extensive testing. Frank Burroughs, for example, founded a group named the Abigail Alliance for Better Access to Developmental Drugs after the death of his daughter. Abigail Burroughs was a terminally ill cancer patient who attempted to enter the pre-trials on drugs like Erbitux and Iressa, but she was denied entry. The argument is essentially summarized by two standpoints: terminally ill patients claim that they should have access to drugs that have not made it through the full testing process while the FDA believes this would endanger the patients by exposing them to untested chemicals. It is, of course, a more complicated matter than it appears. If a patient is out of treatment options and death is eminent, then why not provide some type of treatment, even if the outcome is unsure? For example, it seems that a cancer patient would rather be alive and infertile than to pass away. On the other hand, rushing the testing process could have a negative effect on the entire pharmaceutical industry as many drugs that should not reach market now would.
Where do we draw the line? How sick does a patient have to be in order to receive a drug that is not available to the general public? Speeding up the drug approval process could have potentially life-saving and detrimental effects, and finding a balance between these two extremes will be essential to the credibility of America’s medicinal system.
Benderly, Beryl Lieff. "Experimental Drugs on Trial." Scientific American: October 2007
posted by Jackie Estes at 12:15 PM
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