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Less expensive…and just as effective

Author: Peter Jaret

Just when many of us were beginning to feel especially grateful for generic drugs as a way to stem soaring health care costs, the alarm sounded. Generics, several popular magazines, newspapers, and even some medical journals warned, may not be as effective as the more expensive brand-name drugs. Among those raising doubts is The People’s Pharmacy, a website operated by Joe and Terri Graedon, who are also the authors of a series of books and newspaper columns under the same name. The Graedon’s website has been soliciting responses from people who’ve had bad experiences switching from brand name drugs to their generic counterparts.

As the number of responses posted on their website makes clear, there are a lot of unhappy people out there.

They may have reason to be disgruntled. When ConsumerLab.com, working in collaboration with The People’s Pharmacy, tested one drug that has raised complaints, the antidepressant Wellbutrin XL, against its generic alternative, results showed that the two drugs released their active ingredients at a different rate. That could theoretically influence their effectiveness. (Although generics are required to have the same active chemical ingredient as the brand-name drug, they may be processed differently.) ConsumerLab.com also discovered small differences between the brand-name high blood pressure drug Toprol XL and its generic rival.

But now a new study published in the Journal of the American Medical Association has come to the defense of generics, citing solid evidence that drugs used to treat heart disease appear to be every bit as effective as their more expensive brand-name counterparts.

The researchers gathered 47 studies comparing generics to brand-name drugs used to treat cardiovascular disease. The majority were randomized controlled trials, which are considered the gold standard of evidence.

In category after category, the generics proved equal to their more expensive brand-name counterparts. Beta blockers? Seven out of seven studies showed the generics were just as safe and effective. Statins? Two of two studies found no difference. Anti-clotting drugs? Here, too, all the studies that have been conducted found that generics were the equivalent of brand-name drugs.

Of the ten categories examined, only two showed any difference. One of eleven studies that examined diuretics and two of the seven studies comparing calcium channel blockers detected differences. But even these differences may not be cause for worry. The two calcium channel blocker studies found a slight difference in one measurement on an electrocardiogram, for example; but there were no differences in heart rate or other clinical outcomes.

“The studies in our sample concluded that generic and brand-name cardiovascular drugs are similar in nearly all clinical outcomes,” concluded the research team, which was led by Aaron S. Kesselheim, MD, MPH, a researcher at Harvard Medical School and Brigham and Women’s Hospital in Boston.

Yet despite the overwhelmingly reassuring findings from many studies, many editorials in medical journals have been surprisingly downbeat. According to the researchers, 53 percent of the articles they surveyed expressed a negative view of generics. Only 28 percent endorsed their use.

The authors of the JAMA report speculate that many doctors and editorial writers base their opinion on anecdotal evidence, a “gut sense” from their own clinical practice and the reports of patients. The People’s Pharmacy group specifically solicited anecdotal stories from the public. And many popular articles use such stories to make the case that generics may not work as well as brand-name drugs.

But anecdotal evidence is notoriously unreliable. If people worry that a generic drug may not work as well as the heavily-advertised brand-name version, the placebo effect alone could make the drug seem less effective. Anecdotal evidence may also fall victim to what researchers call selection bias. The People’s Pharmacy website asks, “Have you ever had a problem with a generic drug? Report it here.” Small wonder the responses are overwhelmingly negative. At best, the survey can be used to alert researchers that certain generic drugs may be worth testing. But it proves nothing.

The highest quality evidence comes from randomized controlled trials, which are designed to eliminate bias. And virtually all of them show that generics used for heart disease are just as effective as the name brands.

There may be another, more troubling reason many editorials and even some studies are biased against generics. Much of the research–and many of the researchers doing drug testing–are supported with money from the pharmaceutical industry, which has a vested interest in selling expensive brand-name drugs. Popular health magazines, meanwhile, thrive on sensational headlines, especially those that warn of “hidden” dangers. Too often the dangers are exaggerated.

The campaign against generic drugs is particularly regrettable at a time when many Americans are struggling to keep medical costs from swamping beleaguered household budgets. Yes, it’s important to test these low-cost alternatives against name-brand drugs to make sure they work. When anecdotal reports suggest problems, clinical trials should be conducted. But it’s just as important to reassure consumers that in almost every case they appear to be just as safe and effective—and a whole lot less expensive.


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