tag:blogger.com,1999:blog-8550428.post7653698875249685353..comments2024-03-28T13:38:36.788-04:00Comments on Pharma Marketing Blog: BiDil Sales Disappoint: Blame Genes or Marketing?Vladhttp://www.blogger.com/profile/04114063498108633047noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-8550428.post-83870992487703376472007-05-26T09:51:00.000-04:002007-05-26T09:51:00.000-04:00One thing that hasn't been discussed, and that is ...One thing that hasn't been discussed, and that is the idea of medications just for African-Americans and the Tuskegee factor. Ten years ago, as part of the FDA Modernization Act, guidance was introduced: “The Secretary shall, in consultation with the Director of the National Institutes of Health and with<BR/>representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials..." <BR/><BR/>The FDA acknowledges that medications may work differently in women and minorities--and that's a good thing. However, the reality in the market may be quite different when a company tries to say that a medication is for a certain racial group. Will there be trust? The African-American community has a long memory, and it's as if the Tuskegee Syphilis Study happened yesterday. This is quite different from outreach for diabetes and heart disease when the answer involves medication such as insulin or the statins; it may be a factor, for some time to come, with any medication marketed "for African-Americans only."Mikehttps://www.blogger.com/profile/14665398466994067520noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-68094018838783941972007-05-04T16:11:00.000-04:002007-05-04T16:11:00.000-04:00Chris,Thanks for your comments.Too bad about the m...Chris,<BR/><BR/>Thanks for your comments.<BR/><BR/>Too bad about the mtDNA -- it was a good opportunity to interject a connection between a topical story (America's tainted food supply) and class divisions between people of color and whites. Sometimes, facts get in the way of a good story, so I tend to ignore them. Thank God for comments from more knowledgeable people like yourself ;-)<BR/><BR/>JohnPharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-70097571758108197482007-05-04T16:01:00.000-04:002007-05-04T16:01:00.000-04:00IMO, the key BiDil problem is not self-identificat...IMO, the key BiDil problem is not self-identification of being black, as reported on BrandeekNRX, nor is it ineffective marketing, as reported by here(although this is an important factor in all disappointing launches). The key problem is one of strategy. NitroMed conducted a great trial that proved 2 generic drugs, in combination, worked very effectively in black HF patients. They assumed insurers/patients would pay a premium for a re-formulated version of these 2 drugs that was much more convenient to take (less pills and less pill taking events per day). This proved to be dead wrong, and all NitroMed did was increase the sales of these generics (and possibly provide a nice public service).<BR/><BR/>Additionally, I don't think I agree with your comment on mitochondrial DNA. The bacterial origin of mitocondria into eukaryotic cells occured on the order of billions of years ago. Humans do not pick up new mitochondrial DNA from bacterial infections. While clearly distinct from nuclear DNA, mtDNA IS genetic material that codes for proteins in the mitochondria, and is different person to person. mtDNA also has distinct lineage patterns (mother to offspring). Not to say mtDNA might not change over time, in evolutionary terms, but I don't think it is from acquiring new mitochodria from bacterial infection!Chrishttps://www.blogger.com/profile/01800514013935328369noreply@blogger.com