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.
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When a Generic Isn’t Equal to the Brand Name | Equals More (4/23/2008)
16 Comments to
“When a Generic Isn’t Equal to the Brand Name”
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
Wonderful article. I would like some more in depth information. I am on Soma, generic is carisoprodol. I went to generic because of insurance reasons, but now it is down to my pharmacy deciding which generic company to use. They recently switched to a new generice company and the new generic doesn’t work at all! I wonder what else is the deciding factor to cut costs at each level. By the time it gets to the consumer, we are lucky if we get a placebo! Great article.
I switched from Welbutrin XL 150 to the generic to appease my insurance company. I had a total meltdown at work and gained weight. I did not make the connection until now. I lost my job, though.
Thank you for this article as generics are constantly being touted by the medical community as the same as the name brand. If the drugs don’t benefit you they are not even worth the 4.00 you pay for them at discount pricing.
I had thought my body had “gotten used to” the Wellbutrin and it wasn’t going to work for me any more. I only recently made the connection that I was switched to generic when I started to get worse. Alas, now I can’t afford the “real” stuff or the generic. I hope something is done about this soon. Is there anything the average person can do to push for change? Thanks for the article.
Bunk. I disagree entirely with this article. If Tmax was shorter for the generic, it shows quicker absorption. Regardless of absorption time, if the same masses of the same active chemicals are present, the determining factor is HOW FAST the drug is being removed from the blood stream.
For a short acting drug that has a half life of four hours, Tmax for generic and branded medications need to be similar.
For a longer acting - specifically for antidepressants - drug, Tmax is less critical, and the longer the half-life of the drug, the more variance is acceptable.
Bunk???? I used Wellbutrin years ago with outstanding results, it worked for me after so many others had failed. I stopped taking it to have a child. I recently felt the need to start it again. I did not understand why it was not working and why I had such terrible side effects - headaches, actually feeling more depressed. I don’t think it’s simply the quick release, there is something else very different about the budeprion - it is ineffective. It’s ridiculous that our insurance companies don’t have to cover the brand name when the generic is obviously not working. How many people have to write in about it? How many people have to suffer needlessly? Wellbutrin is in a class all its own. It works, budeprion does not.
I started taking Wellbutrin 11/05 and within about two months I felt wonderful. I even lost about 15 lbs within six months. Then on 7/08 my life took a turn for the worst. I called my doctor to have my Wellbutrin refilled, and when he called it in he forgot to say “brand name only”. When I went to pick it up at the pharmacy, I discovered I was given the generic. At that time, I ASSUMED it was the same thing and just decided to go with the flow.
WRONG!! It took me a little over a year to finally piece things together and conclude that it was the generic causing me the depression, irritability, hopelessness, and weight gain (especially around my middle). I thought because I had just turned forty that my body was changing and Wellbutrin just wasn’t working for me anymore. I felt desperate because I know from experience that all of the SSRI’s turned me into a fat, drunken zombie, and I did not want to go back on them.
Anyways I called my doctor four months ago, and requested brand name only, and when I saw him last week, I told him about my horrible experience. I also told him that he should be telling his patients about generic Wellbutrin or at least be aware of the symptoms (six months into the generic, I saw my doctor because I felt lethargic, had no sex drive, and was gaining weight). He suggested that it was hormonal and had me have blood work done…everything came back normal), so I felt even crazier and even more hopeless.
Four months back on Wellbutrin XL and I feel wonderful again, although I haven’t lost any of the weight I gained on the generic. I’m now wondering if it did permanent damage to my metabolism. I swear it was like within a few weeks of starting the generic that I gradually began gaining weight on my stomach, sides, and lower back. I never had this problem before, and I have read a few stories from people who have experienced the same thing. UGHHH!! My diet and exercise routine never changed, although I did crave carbs more on the generic. I am now back to low carb and praying that I can once again get back my slender figure. This muffin top business is causing me to hate getting dressed, wearing tight shirts, being hugged, or having my picture taken. Thanks a lot generic!!!!
I feel as if I have lost a year of my life because of of budeprion and I am angry that the FDA allows these inferior generics as cheaper substitutes. I am very grateful that my insurance, right now, will allow me to have the brand name with a higher copay, but IT’S WORTH IT!!!! I feel sorry for the people that are forced to take the generic because of their insurance. IT IS NOT THE SAME!! I repeat, IT IS NOT THE SAME!!! How many testimonies of horrible experiences is it going to take until the FDA does something about this??!!! This is atrocious!!!
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Last reviewed: By John M. Grohol, Psy.D. on 23 Apr 2008
