The generic drug myth

By Naomi Wax
www.baltimoresun.com/news/opinion/oped/bal-op.generics20dec20,0,7067826.story

December 20, 2007

It's a drag when you suffer from depression. And it's really a drag when the medication you've been treating your depression with effectively for years suddenly leaves you feeling anxious, nauseated or even suicidal.

Even more of a drag? When you realize those symptoms began when you switched from your brand-name antidepressant to its generic version. But it's downright depressing when your doctor, pharmacist and health insurance provider insist that these side effects you're experiencing must be in your head.

Yet the true insanity lies in the way many medical professionals, convinced by the Food and Drug Administration, keep pushing the myth that generic drugs are identical to their brand-name counterparts. Assurances of total sameness "in dosage form, safety, strength, route of administration, quality, performance and intended use" pop up all over the FDA's Web site and are dutifully reprinted on the sites of health insurers, drug makers, pharmacies and others whose interests it serves.

Insurers, for instance, save so much on generics that a number of them offer incentives to doctors and pharmacists to switch their patients off brand-name drugs. Even more widespread is insurers' practice of charging lower co-pays for generics. Many insurers won't cover brand-name drugs at all if there's a generic available.

To be sure, consumers benefit financially as well. But how advantageous is it to save $70 a month if taking a generic makes you feel lousy?

I wrestled with this question a few months ago when my doctor prescribed sertraline, a Zoloft generic, to treat my depression. I'd done well on Zoloft in the past and had seemed to do all right when I was switched to a generic, but I'd taken it for only a few months before I went off the medication entirely. This time, after a month, sertraline hadn't made a dent in my symptoms. My generics-happy insurer wouldn't cover Zoloft, so I contemplated paying the additional cost myself. And I did some research.

It turns out that hundreds of former Wellbutrin XL 300 users were facing a similar dilemma. The FDA-approved generic, Budeprion XL 300, had arrived on the market last December, and in the weeks and months that followed, complaints began to appear all over Internet health boards. Users who had been successfully treated with Wellbutrin for years said that they had been switched to Budeprion by their doctor or pharmacist, often without being informed, and had suffered such consequences as a return of depression, suicidal thoughts, panic attacks, mood swings, anxiety, nausea and insomnia. Those who then went back on the brand-name medication reported that their symptoms disappeared.

Veteran syndicated health columnists Joe and Terry Graedon were so alarmed by the unprecedented volume of reader response on their Web site, PeoplesPharmacy.com, that they notified the FDA. In October, the FDA confirmed that it was investigating, but it has yet to issue a comment or findings.

The Graedons also contacted ConsumerLab.com, an independent testing organization. It discovered that "generic bupropion XL released its ingredient at a very different rate than Wellbutrin XL." The generic pill released 34 percent of its ingredients in the first two hours, compared with the brand name's 8 percent. Although both pills started out with equal amounts of active ingredient (bupropion), according to the ConsumerLab report, the large upfront dose from the generic could account for the anxiety, irritability and nausea - all known side effects of too high a dose of bupropion.

The FDA finds it acceptable for generics to use different time-release technology than their brand-name counterparts. Although the rate and extent of absorption must be similar enough to be deemed "medically insignificant," lab data and/or test results from a small group (typically 24 to 36 people) of healthy volunteers (typically male) - provided by the manufacturer - are considered sufficient to demonstrate this. Clinical testing is not required for generics.

Although generics must have the same active ingredients as the brand-name product, they can include any number of different inactive ingredients (colorings, flavorings, binders, diluents, fillers, etc.) that can cause differences in how well a particular patient absorbs and tolerates a particular medication - especially patients with allergies, sensitivities or gastrointestinal disease.

Formulas also vary from one generic manufacturer to the next. So someone who has success with, say, Company X's Zoloft generic may have trouble if his or her pharmacist refills a prescription with Company Y's version. Which is what happened to me. Once I'd made the rounds of neighborhood pharmacies and found one that carried my old generic brand, my symptoms improved.

For the majority of generic drugs, the abbreviated approval process and FDA-sanctioned differences don't present a significant problem. But the success of those generics doesn't justify the FDA's loud and persistent denial of problems with others, including generic versions of Ambien, Klonopin, Ritalin, OxyContin, Vicodin, Valium, Toprol, Synthroid and Dilantin, to name a handful.

At the moment, this appears to be a situation that's about to get worse before it gets better. In fiscal year 2007, the FDA approved a record 682 generic drug products, 30 percent more than in 2006. And in October, it launched an initiative that aims to boost approvals further.

The solution, however, isn't to do away with generics, or to make their approval process as rigorous as that of innovator drugs; that would only drive up costs and defeat the purpose of having generic drugs. The FDA should simply 'fess up about the differences that can exist between generics and brand-name drugs and acknowledge the potential repercussions. The agency should educate physicians and pharmacists about the differences. And then it's up to doctors and pharmacists to spend an extra 68 seconds with their patients to explain that there are, in fact, differences between brand-name and generics, and between generics and generics.

Finally, the FDA would do well to be a bit less dismissive of consumer complaints. After all, just because people who rely on antidepressants may have a mental illness doesn't mean we're crazy.

Naomi Wax is a New York-based journalist and the editor of PillGirlReport.com. This article originally appeared in the Los Angeles Times.

http://www.peoplespharmacy.com/archi...e_syndrome.php

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