Maurice, the FDA only approved Rituxan for the narrow use because that is all the company applied for, because that is what the clinical trial addressed. Companies depend on "off-label use", meaning they do a clinical trial on an indication for whcih there is a measurable endpoint and a "medical need", which simplifies and decreases the cost for the clinical trial. Once ANY indication is approved, and the drug goes on the market, any physician can go ahead and use the drug for treating any condition for which he thinks it will have an OK benefit:side effect ratio. If the drug is interesting, you usually se a flurry of academic docs do their own mini-clinical trials (cheap, easy, fast and not-very-regulated if done by a non-profit), and report the results in J. Amer.Med. Assoc. or New England J. Med. These publications are adored by the drug companies (IF the results come out "right"!), since each one has saved the cost of a $50-100 mill clinical trial. BUT the only indication that can go on the label is the one that the company actually tested out in lengthy, government-scrutinized trials and plodded through the FDA, along with enough paperwork to kill several forests, and provide many statisticians with jobs.
There are actually a number of potential benefits to this system; one relates to Orphan Drug. A company can only get Orphan Drug exclusivity (as weak as it is) for indications which are the subject of regular trials and FDA approval. Therefore, another company may well decide to run another clinical trial and get its similar drug on the market for a different indication, for which it may be able to get Orphan Drug protection itself (for a market of less than 200,000, which includes a lot of diseases.). More drugs is usually better for the patient and may lower prices, and you never know which will work better until they are both on the market and people can compare them. |
