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.
(25 votes, average: 4.76 out of 5)
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10 Responses to “When a Generic Isn’t Equal to the Brand Name” (Pingbacks/trackbacks not shown below)
Cathie at 11:26 am on
April 23rd, 2008
Great and timely article. I was a big proponent of generic OTC & RXs - until recently. I had been on bupropion (generic) and was switched - by accident - to Wellbutrin. I started to feel better - depression eased markedly. Then I realized that I had been switched. This was the SR form. There is a difference - and, no pun intended - it’s not all in the head. I agree - time to revise the FDA standardization methods; without delay.
wordmeister at 11:58 am on
April 23rd, 2008
Outstanding article. No … OUTSTANDING article. Thank you, thank you.
Christina A at 1:38 pm on
April 23rd, 2008
Good article… important things to be realized within the research as well.
John M. Grohol, Psy.D. at 6:10 pm on
April 23rd, 2008
And just to be clear, I wish generics were the same as the brand-name drugs, given the price differential. It’s up to the FDA to lay down the law and ensure this is the case.
But given their report last week, they seem unconcerned about the differences between generics and brand-name medications. This doesn’t bode well for change any time soon.
wordmeister at 1:37 pm on
April 24th, 2008
Thanks, Dr. Grohol. I knew for a long time that the tolerance limits set were overly generous, but I was clueless about the significance of formula differences.
I’m not up on the current boundaries for being within tolerance (can you help?), but from memory, the last time I looked, they were 80-125. So we could be taking anywhere from 80 to 125 percent of the medication ordered. Put together with what’s here, it’s a near-terrifying situation for those of us who must use generics.
This is positively shameful misfeasance by an agency that is supposed to protect us. Is there anything that consumers can do to help change this?
Thank you again.
Katherine Stone at 11:34 am on
April 28th, 2008
I had no idea. Thanks for sharing this. I will link to it from Postpartum Progress.
Wanda Durocher at 5:33 pm on
April 28th, 2008
I feel this is a very important issue concerning generics. The FDA is not doing it’s job. Thier job is to protect us. I felt that not All generics were as good, was true before reading this update. Someone that could commit suicide, because of the difference in a generic drug and a Brand name drug is VERY SERIOUS.
David Willman at 9:07 pm on
May 2nd, 2008
A significant and extensive problem. So many of us are not given the choice to say no to generics due to insurance companies’ desires to hold down costs.
The article shows a great deficiency in approvals and oversight of generics by our great governmental agency. So what is the author proposing that might and/or should be done to make much needed improvements/changes?
Adrienne at 8:35 pm on
June 21st, 2008
I have had increasing thought of suicide. My life has gone downhill recently based on external circumstances. I am on the generic of Wellbutrin. I will switch back asap.
Thanks
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Great and timely article. I was a big proponent of generic OTC & RXs - until recently. I had been on bupropion (generic) and was switched - by accident - to Wellbutrin. I started to feel better - depression eased markedly. Then I realized that I had been switched. This was the SR form. There is a difference - and, no pun intended - it’s not all in the head. I agree - time to revise the FDA standardization methods; without delay.
Outstanding article. No … OUTSTANDING article. Thank you, thank you.
Good article… important things to be realized within the research as well.
And just to be clear, I wish generics were the same as the brand-name drugs, given the price differential. It’s up to the FDA to lay down the law and ensure this is the case.
But given their report last week, they seem unconcerned about the differences between generics and brand-name medications. This doesn’t bode well for change any time soon.
Thanks, Dr. Grohol. I knew for a long time that the tolerance limits set were overly generous, but I was clueless about the significance of formula differences.
I’m not up on the current boundaries for being within tolerance (can you help?), but from memory, the last time I looked, they were 80-125. So we could be taking anywhere from 80 to 125 percent of the medication ordered. Put together with what’s here, it’s a near-terrifying situation for those of us who must use generics.
This is positively shameful misfeasance by an agency that is supposed to protect us. Is there anything that consumers can do to help change this?
Thank you again.
I had no idea. Thanks for sharing this. I will link to it from Postpartum Progress.
I feel this is a very important issue concerning generics. The FDA is not doing it’s job. Thier job is to protect us. I felt that not All generics were as good, was true before reading this update. Someone that could commit suicide, because of the difference in a generic drug and a Brand name drug is VERY SERIOUS.
A significant and extensive problem. So many of us are not given the choice to say no to generics due to insurance companies’ desires to hold down costs.
The article shows a great deficiency in approvals and oversight of generics by our great governmental agency. So what is the author proposing that might and/or should be done to make much needed improvements/changes?
I have had increasing thought of suicide. My life has gone downhill recently based on external circumstances. I am on the generic of Wellbutrin. I will switch back asap.
Thanks
