Friday, October 12, 2007

Generics not the same? Oh dear me..

Any sort of even minor groundswell against generics could lead to a catastrophic disintegration of the global healthcare system. Generics are cheaper, not just a little, but A LOT cheaper, like 90% or more than the branded versions, and their existence lies at the very core of the modern capitalist-patent innovation system.

We (society) agree not to copy a pharmaceutical company's innovations for a specified period of time (the length of a patent), as long as the details of said invention are published and made openly available after the end of the patent. In the meantime, the innovator enjoys a monopoly on his/her invention and can therefore price and market it at will, thus enabling the innovator to recoup their capital, and society to enjoy the innovation's benefits during the length of the patent. Obviously a key element of generics, once the expiry of the patent, is to exactly copy the original drug. Specifications are of course provided in the original patent, in addition to the fact that most small-molecule drugs can rather easily be reverse-engineered.

Well, this smoothly running deal between society and innovators that underpins the entire innovation paradigm of modern healthcare, while providing the obvious answer to future concerns over skyrocketing drug costs, is being called into question. Apparently, generic versions of GSK's Wellbutrin (bupropion, see label here) have been called into question.

New test findings by that were released to showed that one of a few generic versions of Wellbutrin XL 300 mg, sold as Budeprion XL 300 mg, didn't perform the same as the brand-name pill in the lab...

...For the testing, purchased both the original Wellbutrin XL
300 mg sold by GlaxoSmithKline and the generic version sold by Teva, the same
one that Douglas took and that many other readers complained about, and had six
samples of each drug analyzed. While both drugs contained the stated amount of
the active ingredient, bupropion, "dissolution testing" showed that the generic
drug, which has a different time-release mechanism, released the active
ingredient into a solution at a quicker rate. "The Teva product released
nearly half of its ingredients in the first four hours," says Cooperman. "The
original Wellbutrin released 25 percent." Within the first two hours, 8
percent of the original Wellbutrin had dissolved, compared with 34 percent of
the Teva product, according to Cooperman. By 16 hours, both drugs had released
all the medicine.

WOW. A few quick-hit thoughts:

1. Teva isn't just some fly-by-night sketchy generics operator, it's one of the world's premier generics manufacturers (in fact, it even has one or two of its own branded drugs, like the oral MS drug Copaxone).

2. The MSNBC article, and none of the other articles I've seen, make any mention of the potentially enormous economic and social ramifications of loss of patient faith in generic drugs.

3. While the article notes it briefly, the test done by is highly suspect, in that it was an in vitro test ('in glass' i.e. in a test tube) and thus is not as rigorous as FDA testing. The FDA tests 'bioequivalence' which measures the actual drug biology in healthy volunteers, and is thus far more realistic than some test tube. Nonetheless, the words of this pharmacist stick in my head:
"the combination of anecdotal evidence and the conclusions of the in vitro study
would lead one to believe that patients might receive a different therapeutic
outcome from the two medications."