Inexact Copies: How Generics Differ From Brand Names

[question everything]

The Wall Street Journal

HEALTH JOURNAL
By MELINDA BECK

Inexact Copies: How Generics Differ From Brand Names
April 22, 2008; Page D1

Joe Zealberg, a psychiatrist in Charleston, S.C., prescribed generic drugs to patients for years and rarely had problems -- until last year. A number of patients who had done very well on brand-name medications "crashed and burned" when they switched to generics, he says. One woman "went from being perfectly fine to crying inconsolably 24 hours a day" after she switched from one generic antidepressant to another, Dr. Zealberg says. Another patient was sold a generic version of his attention-deficit drug that contained no identifying markings whatsoever -- a violation of federal rules. Ten of his patients switched to a new generic version of the antidepressant Wellbutrin, but eight of them changed back, saying they felt anxious or shaky or their depression had returned. Several complained that the generic drug had a bad smell, he says.

(snip)

By law, generics must have the same active ingredient and the same action as the brand-name version, which allows them to piggyback on the original safety and efficacy trials. But generics do have different inactive ingredients, which can affect how they are absorbed into the body. Generics can produce blood levels as much as 20% below or 25% above that of the original drug and still be considered "bioequivalent," according to Food and Drug Administration guidelines. Some patients are more sensitive to those differences than others, and people who experience problems with medications are advised to contact their doctors, the drug manufacturer and the FDA's MedWatch. But as an FDA report last week on generic Wellbutrin revealed, consumers who complain may not get much satisfaction.

(snip)

But patients soon started logging complaints about Budeprion at PeoplesPharmacy.com, a Web site that has become a clearinghouse for medication gripes. "We've received hundreds of complaints about generic drugs in general. But with this one drug, all of a sudden -- kaboom -- right after it was approved," says Joe Graedon, a pharmacologist who runs People's Pharmacy with his wife. Readers' postings cite side effects such as tremors, headaches, anxiety and sleep disturbances. Some consumers said their depression had returned, in some cases bringing thoughts of suicide. Many reported that their adverse effects stopped when they returned to the brand-name drug. Mr. Graedon alerted the FDA. He also asked ConsumerLab.com, which normally runs tests for dietary supplement manufacturers, to compare Budeprion and Wellbutrin. Using a test-tube test that some industry experts question, ConsumerLab found that Budeprion dissolves faster, releasing 34% of the drug within the first two hours, compared with 8% for Wellbutrin.

(snip)

The FDA conducted an investigation and reported last week that although there were "small differences" between the two formulations, "they are not outside the established boundaries for equivalence." The generic did reach its maximum blood concentration in two to three hours, compared to five to six hours for Wellbutrin, but the FDA said those differences "were not considered clinically significant." What accounted for the consumer complaints? The FDA cited "the natural history of depression," in which some patients have a recurrence of symptoms even while on medication. Some critics say the FDA, in effect, was saying, "it's all in their heads." But they were more alarmed to read in the report that the FDA relied on tests comparing a lower dose of Wellbutrin and Budeprion -- 150 mg -- when it first approved the 300 mg version in 2006, and didn't have specific bioequivalence data on the 300 mg dose that had generated the complaints.

(snip)

The FDA explained that it didn't want to expose test subjects to the risk of seizures with the 300 mg dose. Bioequivalence tests are conducted on healthy people, not those who need the medication, and each gets just a single dose, so there is no chance to work up to 300 mg slowly, as actual patients are advised to do. Sandy Walsh, an FDA spokeswoman, says this is common procedure for testing antidepressants and antipsychotics.

(snip)


URL for this article:
http://online.wsj.com/article/SB120882069010332969.html (subscription)

[The_Casual_Observer]

1. I hear that some generics are imported from China.

Great.

[question everything]

2. At least, some of the inactive ingredients

I think that this what happened with Heparin.

[Gman]

3. But we're not allowed to purchase medicine from Mexico or Canada

because they want to "protect" us from impure drugs.

LOL!