December 02, 2008

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By Patrick Sauer
TUESDAY, Dec. 2, 2008 (Health.com) — People who are taking a generic drug to lower blood pressure or ward off stroke and heart troubles can rest easy. Those low-cost alternatives are just as good as more expensive, brand-name drugs, according to Harvard researchers who published a large new analysis of the available data in the Journal of the American Medical Association.

"We found no evidence that brand-name drugs are superior to generic drugs in terms of the clinical outcomes," says the review's lead author, Aaron S. Kesselheim, MD, of Brigham and Women's Hospital and Harvard Medical School. "Doctors should consider generic drugs where appropriate for their patients with cardiovascular disease."

The researchers looked at 47 studies—with 9 different types of cardiovascular-disease drugs—conducted between 1984–2008. The majority of the studies, which included more than 800 patients, looked at four drug types: beta-blockers, which treat high blood pressure and heart arrhythmias; calcium channel blockers, which also lower blood pressure; diuretics, which reduce strain on the heart by boosting fluid output; and warfarin, which prevents clots. When the results were combined, they found no evidence that brand-name drugs were superior to generic versions.

The researchers looked at data from 1984 through the present. In '84, the Hatch-Waxman Act authorized the U.S. Food and Drug Administration to approve generic drugs that are the "bioequivalent" of the brand-name counterparts.

Although that was almost 25 years ago, the perception still exists that generic drugs are inferior to the brand-name version, the authors say. It's a costly assumption, particularly for cardiovascular drugs. As a group, they make up the largest chunk of money spent on outpatient prescriptions.

As prescription-drug costs rise and incomes decline in a weak economy, generic drugs are an increasingly important way to keep costs down—and keep patients taking their medications.

"There is clear evidence that when we treat patients with less expensive medicines that they can afford, they better adhere to them and that's what we want," says coauthor William Shrank, MD, of Brigham and Women's Hospital and Harvard Medical School. "We want patients to take the medications we prescribe."

People should feel comfortable taking a generic drug, says Steven Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic. He always prescribes the generic equivalent and points out that many states have laws that mandate the same approach.

"In this economy, there's a lot of people out of work, but what are you going to do if you have hypertension and can't afford expensive drugs?" says Dr. Nissen. "I can now give out at least three classes of cheap drugs that are generically available that you can get at Wal-Mart for a few dollars a month. That is a fantastic thing for making sure people who most need medicines can get them."

Dr. Nissen, who has been an outspoken critic of the pharmaceutical industry, notes that on rare occasions, generic drugs have had quality-control problems. He advises patients to get the generic versions, but to be vigilant and talk to your doctor if there is any reason to believe that the drug is not relieving your symptoms.

Generics are more widely available than ever before, but it can be hard to convince both doctors and patients to use them, particularly if there's a perception that "more expensive" equals "better." For example, volunteers in a 2008 study reported more pain relief after taking a $2.50-priced placebo pill compared to a 10-cent placebo pill, even though both were equally ineffective.

"[The news] is certainly reassuring, but only if you allow yourself to be reassured. That's the challenge here," says Jeffrey Goldberger, MD, director of cardio electrophysiology at Northwestern Memorial Hospital in Chicago. "Patients have strong biases and it can be difficult to reverse them."

Dr. Kesselheim says that the review's basic findings weren't unexpected, but the authors were surprised that roughly half of the 47 studies' accompanying editorials and commentaries (which are written by experts) had a negative view of generic substitutions. "The evidence doesn't support that level of caution," he says.


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