When a Generic Isn’t Equal to the Brand Name
Walmart has made $4 generics the talk of medicine. But are generic medications always as good as their name-brand counterparts? Not always.
The Wall Street Journal yesterday wrote an entry yesterday about how they differ — Inexact Copies: How Generics Differ From Brand Names. The spotlight is shining on generics because of their low cost and increasing reports about how being switched to a generic form of a medication can lead to negative side effects not experienced on the brand-name drug.
By law, generics must demonstrate “bioequivalence,” a scientific term meaning that their chemical composition and uptake by the body should be similar (but not necessarily exactly the same). Given how people can react to even slight medication changes, it shouldn’t be surprising to find that some people don’t tolerate a generic version of a medication in the same way they tolerate a brand-name medication (the opposite can also be true).
Joe and Terry Graedon of The People’s Pharmacy conducted their own investigation into the bioequivalence of a generic form of Wellburtrin XL — bupropion XL — in 2006 and found it wanting. The FDA released its own report on this issue last week and found that while the drugs did exhibit different uptake profiles, they were similar enough to meet the FDA guidelines. The Graedon’s response to the FDA report can be found here:
Although the FDA says Budeprion XL 300 is good enough, its own report regarding the time to maximum blood levels (Tmax) suggests that the 150 mg pill behaves differently in the body: “The bupropion Tmax was faster for Teva’s XL product (2-3 hours) than Wellbutrin XL (5-6 hours).”
In other words, a generic can be formulated differently enough to result in a 100% difference in time to obtain therapeutic levels in your blood, and still be considered “equivalent” to the brand name version.
If this is “good enough” for the FDA, then perhaps it’s time to re-examine the bioequivalence guidelines. Because such a difference has been significant enough to generate numerous reports of generic problems, not only in this one generic medication, but in many others as well. The pressure to prescribe a generic over a brand-name is only going to increase as the cost difference is significant.
When generics aren’t quite the same as their brand-name counterparts, all sorts of problems can occur. According to the FDA reports, most people who were switched to the generic form of Wellbutrin XL lost the antidepressant benefits of the medication. A generic is useless if it doesn’t provide the therapeutic benefit it is supposed to. The FDA looks at a graph on paper and says, “Well, they look close enough!” Meanwhile, a drug that’s supposed to be helping a person with their possibly suicidal thoughts suddenly has stopped working.
This is nobody’s idea of a Good Thing. Cheap medications that don’t work are useless in a doctor’s arsenal.
Let’s ensure generics really are the same, because when they differ, people’s lives can hang in the balance.
Grohol, J. (2008). When a Generic Isn’t Equal to the Brand Name. Psych Central. Retrieved on November 28, 2015, from http://psychcentral.com/blog/archives/2008/04/23/when-a-generic-isnt-equal-to-the-brand-name/