Generic drugs--cheaper forms of name-brand medicines--account for most of the pills dispensed by pharmacies in the U.S. Using these alternatives saved American consumers $121 billion last year, according to Generic Pharmaceutical Association, a trade group.
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Yet many people doubt that the less expensive pills are as effective as the brand-name drugs they replace. Thirty percent of 1,000 adults polled in May by Prescription Solutions, a pharmacy benefit manager, either didn't believe generics were as good as their brand-name counterparts or were unsure. People tend to associate cost with quality, says Jacqueline B. Kosecoff, Prescription Solutions' chief executive. "Generic often connotes something different."
That's one reason some consumers hesitate to trust generic drugs. They also read about patients' accounts of their troubling experiences online and even occasionally hear about drug manufacturing companies that violate standards and are forced to issue product recalls.
Yet Gary J. Buehler, director of the office of generic drugs in the Food and Drug Administrations' Center for Drug Evaluation and Research, sees little cause for concern. The FDA, he says, is confident that generics perform as well as brand-name medicines. The agency says rigorous quality and safety measures show that generics are of identical strength, purity and quality as the original brand-name drug.
"I don't think consumers should be worried," he says. "There's a lot of anecdotes out there, but we haven't seen any real scientific evidence."
Why the Concern?
While there is no evidence to support the claim that generics are inferior, patients often cite their own experiences as proof--and the Internet is home to countless testimonials.
Joe Graedon, a pharmacologist who runs People's Pharmacy, a Web site clearinghouse for drug-based medical advice, says he has received "hundreds and hundreds" of patient complaints about dozens of drugs. One of the most frequently discussed drugs has been the generic antidepressant Bupropion (brand names Wellbutrin and Zyban). Patients have cited a lack of efficacy or intolerable side effects such as severe depression and fatigue.
The FDA is investigating these claims, and while Buehler cannot comment on the case, he does note that "hundreds of thousands of people take this drug successfully."
Dr. Harry Lever, a cardiologist at the Cleveland Clinic, shares Graedon's concerns about the number of patient complaints. In particular, in the past he has been puzzled by occasional reports from patients that they fared better on the brand-name beta-blocker Toprol XL--which is used to treat cardiac conditions such as high blood pressure--than they did when taking the generic version. Since the time-release formula of the generic Toprol is not identical to the brand name, he says, it may not be as effective.
His suspicion was heightened earlier this year after two companies, Sandoz and Ethex, a subsidiary of KV Pharmaceutical Company, stopped producing the generic version. FDA inspections found that both companies weren't following manufacturing guidelines.
Buehler says the FDA is meticulous in studying the effect of different time-release formulas. If clinicians observe a significant difference between the two, they will not permit pharmacists to substitute the generic for the brand-name drug. Patients on Coumadin, for example, are not advised to alternate between the brand-name blood thinner and the generic warfarin. Torprol XL does not fall into this category.
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Image: Generics vs. Brand Name