In 2007, The People’s Pharmacy, a newspaper drug advice column by Joe and Terry Graedon, noted on their website that they started getting reports from people taking a generic form of Wellbutrin called Budeprion XL 300 mg. These reports discussed how patients taking the generic version of this antidepressant weren’t experiencing the same beneficial effects of the medication as when they were taking the name-brand version. And the side effects were often worse.
The Graedons became so concerned that they commissioned an independent lab analysis of the generic version of Wellbutrin manufactured by Impax Lab and Teva Pharmaceuticals in 2007. This report found that the generic version of Wellbutrin simply wasn’t equivalent to the brand-name version.
In April 2008, the FDA reviewed their existing studies, and concluded they were the same. The FDA did not review the independent analysis, or any actual data on the 300 mg version of the product (you know, the one people were actually complaining about).
Here it is more than four years later, and the U.S. Food and Drug Administration (FDA) finally agrees with the independent analysis, the Graedons, and the hundreds of people who’ve complained about the efficacy of Budeprion XL.
How many thousands of people took generic Wellbutrin with little positive antidepressant effects over the past 5 years only to be hornswaggled, not only by pharmaceutical companies, but by the very government agency empowered to police them?
To show you how screwed up the FDA process is in regards to this dangerous situation, read this paragraph from the FDA news release:
The Impax/Teva product, Budeprion XL 300 mg, was approved in December 2006. Soon after, FDA began to receive reports that patients who were switched from Wellbutrin XL 300 mg to its generic counterparts were experiencing reduced efficacy. FDA analyzed those reports and concluded that the complaints appeared to be linked to the Impax/Teva product.
FDA therefore asked Impax/Teva to conduct a study directly on its 300 mg extended-release product to compare its bioequivalence to Wellbutrin XL 300 mg. FDA asked that the study include patients who had reported lack of efficacy after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg. Impax/Teva began the study, but terminated it in late 2011, reporting that, despite efforts to enroll patients, Impax/Teva was unable to recruit a significant number of affected patients to generate the necessary data.
So way back in 2006 — six years ago! — the FDA had reports that something was amiss with this drug. It wasn’t working. Patients weren’t getting better on it.
They waited. And waited. And waited some more while the drug company was tasked with conducting one, single, simple study. Five years after the FDA told the company to do the study, the company said, “Nah, we can’t do it. It’s too hard.”
In 2008, the FDA — in an effort to cover its own ass — simply reiterated how it tests generic drugs. At the time, they didn’t require drug manufacturers to test higher doses independently, so they were just going off of the generic data for the 150 mg version of these drugs. They apparently failed to even take a look at the independent analysis commissioned by the Graedons and conducted by ConsuemrLab.com. Doh!
Apparently being deaf, dumb and blind, the FDA decided instead to commission its own study in 2010 (three years after already having the data showing these drugs were not bio-equivalent). Why? Because the patient reports kept coming in despite the FDA’s and Teva’s reassurances that these drugs were the same. (I imagine them saying, “Dumb patients! What do they know?”)
In 2010, in light of the public health interest in obtaining bioequivalence data, FDA decided to sponsor a bioequivalence study comparing Budeprion XL 300 mg to Wellbutrin XL 300 mg. This study was conducted in 24 healthy adult volunteers and was designed to measure both the rate and the extent of release of bupropion into the blood. The results of this study became available in August 2012, and show that Budeprion XL 300 mg tablets fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg.
An astounding amount of time passes once again. I’m not sure why it takes nearly 2 years to run a small study of only 24 patients, but hey, I guess since we’re only talking about people’s lives here, no hurry. Thanks FDA!
Five years ago, the FDA knew these drugs were not bio-equivalent, despite its cursory ass-covering 2008 review. During those 5 years, Teva was allowed to continue marketing and selling Budeprion XL 300. How many people died1 while taking an ineffective antidepressant during those 5 years? Why it took 5 additional years — making thousands of U.S. citizens suffer — isn’t answered in the news release.
And I suspect it never will be.
Read the blog entry over at the People’s Pharmacy: Patients Vindicated! Generic Wellbutrin (Budeprion XL 300) Withdrawn