5 ms·

As an aside, the evergreening process has taken on frightening new faces in recent years. Drugs have been repatented with the same formula for 'new' purposes. C

by jkimmel 14y ago

As an aside, the evergreening process has taken on frightening new faces in recent years. Drugs have been repatented with the same formula for 'new' purposes. Case in point is BiDil, an active ingredient repatented for race-specific use in African-Americans without alteration to a previously patented drug formula (the case of repatenting is in and of itself an interesting study, many in the field contest the trials that validated the repatenting as well as the concept of a race-specific drug, as there is no drug-relavent biological basis for race.) [1] - http://en.wikipedia.org/wiki/Isosorbide_dinitrate/hydralazine http://en.wikipedia.org/wiki/Isosorbide_dinitrate/hydralazin... (BiDil) [2] - http://www.nejm.org/doi/full/10.1056/NEJMoa042934 http://www.nejm.org/doi/full/10.1056/NEJMoa042934

refurb 14y ago
It's such an outrageous claim that drugs may have different impacts for different races that the FDA had no problem approving it.
- anoncow 14y ago
  Different races, ethnicities and people differ in subtle ways. People metabolize different molecules differently. However that still is no excuse to repatent a drug.
  - malandrew 14y ago
    I agree, but the correct approach is more akin to feature detection in web browsers than user agent detection. i.e. Check for the presence of a disorder like sickle cell anemia than checking the ethnicity and inferring the probability that such a condition exists.
- bconway 14y ago
  Some drugs do have different impacts on different races. Science is rarely politically correct (probably a good thing).
  - ansgri 14y ago
    Or maybe it's just the politics isn't scientifically correct.
sseveran 14y ago
If they paid for the clinical trial then there should be some sort of protection for the person who paid. Otherwise it will be impossible to expand what a drug is used for after the patent expires.
- zosima 14y ago
  Doctors may just use the drug off-label. If the patient responds then they use the drug, otherwise they try something else. A formal trial really helps very little in these cases. If a bunch of clinicians find that the drug is effective against the condition, they can (as has happened so many times) make their own study to popularize the usage. Remember: The safety of the drug is not in question, just the efficiacy.
  - refurb 14y ago
    But how do physicians know it works if trials aren't run? You can't go by anecdotal evidence. Hell, look at the huge niacin trial that Merck ran. Doctors have been prescribing it for 30 years and you know what? It doesn't help. Unless a massive clinical trial was run, you'd never know whether it was worth prescribing.
- jkimmel 14y ago
  This is a valid point. While I won't dive into the qualms that stem from pharma companies funding and subsequently selectively choosing their trials, the case with BiDil is particularly curious [1]. When BiDil was patented, studies were carried out using _only_ African-American subjects, such that the race-specific efficacy was never actually tested. As such, the basis for the entire patent, which hinged on race specificity, has been challenged by some in the field. In my post above there's a link to a paper that came out one of the trials. [1] - If you're interested, Ben Goldacre has a really interesting talk on the subject. http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...
- belorn 14y ago
  FDA already gives a special monopole privilege after clinical trials. FDA want to encourage companies in doing clinical trails, including on drugs which has an expired patent. Evergreening is companies seeking monopole privilege after that original patent protection and the FDA protection has expired. Nothing to do with clinical trials.
fnordfnordfnord 14y ago
>there is no drug-relavent biological basis for race. Try telling that to people with sickle-cell anemia.
- jkimmel 14y ago
  Drug relevant basis here is defined by whether or not the color of one's skin alters the efficacy of a particular drug. Sickle-cell anemia is perpetuated by a trait that appears with strong correlation to the traits that create dark skin pigmentation. IE) Black people are more likely to carry the sickle-cell anemia trait. However, the color of a person's skin does not contribute to the sickle-cell anemia pathology in any way, it is merely correlated to the presence of sickle-cell trait. A light skinned person with sickle-cell anemia responds to treatment in the same manner as a dark skinned person, the dark skinned person is merely more likely to develop the pathology due to genetic correlation. The same logic applies to this case-study, if it were not compounded by various other idiosyncrasies. The color of a person's skin (what we use to empirically determine race) does not change the effectiveness of most drug agents, and therefore is not biologically relavent in a pharmacological context.
  - smackay 14y ago
    Sickle-cell anemia has very little to do with race and everything to do with protection against malaria - http://www.sciencedaily.com/releases/2011/04/110428123931.htm http://www.sciencedaily.com/releases/2011/04/110428123931.ht.... That people with darker skin live in areas where malaria is present is just a coincidence.

by jkimmel 14y ago

refurb 14y ago

It's such an outrageous claim that drugs may have different impacts for different races that the FDA had no problem approving it.

anoncow 14y ago
Different races, ethnicities and people differ in subtle ways. People metabolize different molecules differently. However that still is no excuse to repatent a drug.
- malandrew 14y ago
  I agree, but the correct approach is more akin to feature detection in web browsers than user agent detection. i.e. Check for the presence of a disorder like sickle cell anemia than checking the ethnicity and inferring the probability that such a condition exists.
bconway 14y ago
Some drugs do have different impacts on different races. Science is rarely politically correct (probably a good thing).
- ansgri 14y ago
  Or maybe it's just the politics isn't scientifically correct.

sseveran 14y ago

If they paid for the clinical trial then there should be some sort of protection for the person who paid. Otherwise it will be impossible to expand what a drug is used for after the patent expires.

zosima 14y ago
Doctors may just use the drug off-label. If the patient responds then they use the drug, otherwise they try something else. A formal trial really helps very little in these cases. If a bunch of clinicians find that the drug is effective against the condition, they can (as has happened so many times) make their own study to popularize the usage. Remember: The safety of the drug is not in question, just the efficiacy.
- refurb 14y ago
  But how do physicians know it works if trials aren't run? You can't go by anecdotal evidence. Hell, look at the huge niacin trial that Merck ran. Doctors have been prescribing it for 30 years and you know what? It doesn't help. Unless a massive clinical trial was run, you'd never know whether it was worth prescribing.
jkimmel 14y ago
This is a valid point. While I won't dive into the qualms that stem from pharma companies funding and subsequently selectively choosing their trials, the case with BiDil is particularly curious [1]. When BiDil was patented, studies were carried out using _only_ African-American subjects, such that the race-specific efficacy was never actually tested. As such, the basis for the entire patent, which hinged on race specificity, has been challenged by some in the field. In my post above there's a link to a paper that came out one of the trials. [1] - If you're interested, Ben Goldacre has a really interesting talk on the subject. http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...
belorn 14y ago
FDA already gives a special monopole privilege after clinical trials. FDA want to encourage companies in doing clinical trails, including on drugs which has an expired patent. Evergreening is companies seeking monopole privilege after that original patent protection and the FDA protection has expired. Nothing to do with clinical trials.

fnordfnordfnord 14y ago

>there is no drug-relavent biological basis for race. Try telling that to people with sickle-cell anemia.

jkimmel 14y ago
Drug relevant basis here is defined by whether or not the color of one's skin alters the efficacy of a particular drug. Sickle-cell anemia is perpetuated by a trait that appears with strong correlation to the traits that create dark skin pigmentation. IE) Black people are more likely to carry the sickle-cell anemia trait. However, the color of a person's skin does not contribute to the sickle-cell anemia pathology in any way, it is merely correlated to the presence of sickle-cell trait. A light skinned person with sickle-cell anemia responds to treatment in the same manner as a dark skinned person, the dark skinned person is merely more likely to develop the pathology due to genetic correlation. The same logic applies to this case-study, if it were not compounded by various other idiosyncrasies. The color of a person's skin (what we use to empirically determine race) does not change the effectiveness of most drug agents, and therefore is not biologically relavent in a pharmacological context.
- smackay 14y ago
  Sickle-cell anemia has very little to do with race and everything to do with protection against malaria - http://www.sciencedaily.com/releases/2011/04/110428123931.htm http://www.sciencedaily.com/releases/2011/04/110428123931.ht.... That people with darker skin live in areas where malaria is present is just a coincidence.