If it were up to Public Citizen, we should not be taking any new drugs until they were on the market for at least seven years:
Nearly lost in the controversy over Glaxo’s Avandia is a strongly worded statement issued the other day by Public Citizen, the advocacy group, about Merck’s relatively new diabetes pill, which was approved last fall by the FDA. On its web site, the group cautions that Januvia shouldn’t be used for another seven years, because the drug’s long-term safety is still unknown.
Related posts:
- Will Januvia take out Byetta?
- 2007 Diabetes Year in Review
- Januvia and Stevens-Johnson
- Insulin in vogue again
- PointofLaw.com takes apart Public Citizen’s critique of tort reform
- Is the FDA killing research?
- The controversy of no-consent studies
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{ 5 comments }
If no one uses Januvia for the next 7 years, then we still won’t know its safety after the 7 year period.
Dr. Rack,
Thank goodness someone gets that! I have never understood how people think there’s no illogic in basically saying “No one should take drug X because we don’t know its long term effects, and we’ll never know its long term effects because no one should try it.” The scary thing is when even doctors think this! The only thing I can figure out is that most people think that trying new drugs is something that should be done by other people, so they can then benefit from the information. A sort of “I’m too special to risk trying experimental drugs, but other people should.” Of course, they still want the very best in cutting edge medicine. They just want it tested on someone else.
I’m sure when Zimulti comes out, though, overweight people will be CLAMORING FOR IT!!!
Guess it justs depends on what disease you’re treating. Weight loss/baldness/bigger erection – check!
Diabetes, hypertension, heart failure – no thanks.
Americans are blessed and too special for these drugs, i.e. those for diabetes, hypertension, heart failure, AIDS, etc. – conditions that can come about with wrong day-to-day choices, yet not part of a fabulous, carefree lifestyle.
Trials for these medicines could be done in the 3rd world countries…where they have no recourse to courts and life’s “fair” deals.
But for drugs enhancing a fabulous, carefree/careless lifestyle…Americans say, bring them on, yesterday!!!
Ordinarilly in the practice of medicine (and I exclude guideline monkeys and consensus hounds), doctors discuss risk and benefits and patients accept or decline their recommendations. With new drugs the “unknown” category of risk is somewhat larger. Some patients, in accord with their own circumstances, faith in science, and risk tolerance will take the drug early. The less pressed or more skeptical will wait. The former acts as a long-term test group for the latter.
Freedom works!
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