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This really is the key point. In graduate school I worked along side many individuals with close ties to the pharmaceutical industry, and many had very similar stories to tell... Getting a drug approved is an interesting process. Not only do you have to prove your drug is not harmful, not only do you have to prove that it does what it's supposed to, you also have to prove that it works better than all the available alternatives. I heard numerous stories where a drug would go to trial, and for some subset of the trial population it would be a miracle cure. However, the way the current approval process runs, those miracles have to be averaged out with the rest of the population, and often the end result would be "it's not better than existing drugs: denied!" Of course, scientists being the curious type quickly figured out that what they were seeing was the consequence of genetics. Have a certain variant of gene X? Then this is a miracle cure. But only 10% of the population has gene X, so on the whole this drug doesn't appear to be better than the alternatives. The problem is, the FDA doesn't know how to approve drugs that only work for people with a specific variant of gene X. Mostly, it's a chicken and egg problem: most drug trials don't include genetic profiling, because it would be wasted money since the FDA doesn't consider genetic profiling, because most drug trials don't include genetic profiling. If sequencing becomes cheap enough that it can be included as part of the standard drug trial process, this could all change. Personalized medicine is the future. Edit: Interestingly, though the name escapes me at the moment, I did hear of one drug that was approved for a specific gene variant. However, this was only because that gene variant was particularly prevalent in African American men, and demographic data is collected during the trial process. I recall there were a lot of upset scientists regarding this outcome, though, because conflating race with genetics is dangerous and irresponsible. There might be an 80% correlation (and even that might be on the high side), but that implies that there are non-African American males who could benefit but won't get the drug, and African American males that will get the drug even though it has no beneficial effect... Edit, post-Google: Well, that was rather easy to find -- http://www.nytimes.com/2005/06/24/health/24drugs.html |
Source: Kahn J (2005) From disparity to difference: How race-specific medicines may undermine policies to address inequalities in health care. South Calif Interdiscip Law J 15: 105–130.
http://128.125.42.47/why/students/orgs/ilj/assets/docs/15-1%...