Consumer Reports has long advocated the use of generic drugs because they are not only as effective and safe as their branded counterparts but cost less too. So when a segment aired last week on the Today Show that warned about the use of generic drugs to treat epilepsy and other disorders, based on a feature story from the June issue of SELF magazine, we took note.
There have been many anecdotal reports of epilepsy patients who noted an increased numbers of seizures after switching to a generic drug from a branded drug (or even from one generic to another). That is not a new story. But anecdotes don’t prove cause and effect. However, this issue has been observed by neurologists for many years, despite the available scientific evidence that finds generic drugs have the same effect in the body as the brand-name drugs. But reports—from both patients and physicians—of problems occurring when switching supposedly identical drugs continue to crop up. Clinical trials could help resolve this issue, but as far as we are aware, no trials have been done or are in the works.
This crux of the problem revolves around a few drugs that have what is called a "narrow-therapeutic index," which means that the drug is effective and safe within a small dosing range. Too little active ingredient and the drug doesn’t work; too much and it becomes toxic. While this may be a real concern, the FDA makes it clear that their criteria for approving generic drugs takes this issue into account and ensures that generic drugs are just as safe and effective for patients as the branded medicines.
One major, recently published systematic review of studies of certain drugs to treat cardiovascular disease—including studies of a few drugs with narrow-therapeutic indices—showed no difference in patient outcomes when patients used a generic or a brand name drug.
What we find interesting is that the subject of generic efficacy and safety rears its head every few years, and especially now as several popular branded drugs to treat epilepsy have been recently scheduled to go off-patent*: Lamictal (lamotrigine), Keppra (levetiracetam) and Depakote (divalproex sodium). Once that happens, generic drug makers can copy the brands and sell them for substantially less. Last year, consumers and their insurance companies spent about $3 billion* on these three drugs alone in retail sales, placing them among the 100 top-selling drugs.
Clearly, drug makers have a huge financial interest in keeping their branded drugs to treat epilepsy on the market and free from competition from low-cost generics.
Besides the issue of drugs to treat epilepsy, the Today Show host also warned viewers that most generic drugs are manufactured overseas. What was not mentioned is that the majority of bulk pharmaceutical ingredients used by manufacturers to produce drugs in the U.S. are also manufactured overseas*, according to the FDA.
Along those same lines, our recent analysis of drug manufacturers found that from 2004 to 2008 generic drug companies actually received fewer FDA warnings about manufacturing problems than did branded manufacturers. That's particularly notable, since there are far more generic than brand-name drugs on the market. Overall, generic drugs appear no more likely than brand-name drugs to pose risks, according to our review of available data and interviews with experts.
Indeed, we agree that the FDA must improve its inspection of overseas drug manufacturing plants. The FDA admits* that at their current pace, it would take 13 years to inspect all drug manufacturers overseas, compared with 2.7 years for domestic plants. So we applaud the FDA’s move to open new international offices to help correct that problem. We also eagerly await any government-funded, head-to-head trials that compare generic drugs to branded drugs, especially drugs to treat epilepsy, or other medicines with narrow therapeutic indices.
We continue to do our part to help consumers make informed choices by offering our Best Buy Drug reports, which are based on a rigorous analysis of the scientific evidence, and often recommend generic versions of older drugs because—in addition to being less costly—they frequently turn out to be safer and just as effective (sometimes more so) than other, newer and expensive brand-name medicines used to treat the same condition.
In the meantime, when your physician prescribes a drug, ask if there is a generic version or a therapeutic substitution that would be just as effective and safe, but less costly. The evidence, to date, should encourage and form the basis for such inquiries. But, bear in mind that some physicians, because of their own or others’ observations may not want to take even a theoretical risk that would not be in the best interests of their patients.
—Consumer Reports Health editors and medical advisors
* Links to PDF
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