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The price we pay for physician gullibility on generics

Pharmaceutical companies fight tooth and nail to keep physicians (and patients) from switching to generic versions of their brand-name drugs after the patents for their drugs expire.

After all, billions of dollars are at stake.

One way the pharmaceutical companies wage this battle is to persuade physicians that the generic drug (whose bioavailability must be 80 percent to 125 percent of that of the original drug) is not only inferior, but potentially harmful.

The strategy works beautifully, even when the data behind the brand-name-drugs-are-superior claims are, at best, very weak — and can be traced to, um, not exactly neutral, nonbiased sources.

A case in point: generic antiepileptic drugs. 

Two articles (extracts here and here) in the November issue of the Archives of Neurology debate whether brand-name antiepileptic drugs offer enough of an advantage to outweigh their huge additional cost — particularly since that cost causes some people (those for whom the drugs aren’t covered by health insurance — where have we heard this story before?) to stop taking them, or to take them only intermittently.

In a rather pointed editorial that accompanies the articles, pediatric neurologist Steve Roach, MD, charges physicians with being gullible.

“When the price of eggs rose to unprecedented levels in 1966, President Lyndon B. Johnson ordered his surgeon general to decrease demand by warning his fellow Americans of the health hazards of egg consumption,” Roach writes. “The evidence against the lowly egg was at best shaky, and recent studies suggest that the health risks from eggs, if any, were greatly exaggerated. Nevertheless, millions of health-conscious Americans dutifully altered their diets, secure in their belief that eggs must be bad for one’s health. Are we physicians so gullible and easily manipulated that we could possibly fall for such an arrogant ploy? Evidently, because most physicians of the day accepted the marginal idea that eggs are worse than other foods with the same lack of skepticism that many neurologists today display toward the notion that generic antiepileptic drugs (AEDs) pose a frequent patient risk.”

“The data supporting an increased seizure risk after conversion to generic AEDs are weak,” he continues. “Carefully designed comparison studies of the caliber required by the FDA to initially establish a drug’s safety and efficacy do not exist.”

Why, then, do physicians continue to believe that the generic anti-epileptics are inferior?

“It is important to recognize potential sources of bias and conflict of interest when analyzing the suitability of generic drugs,” writes Roach. “The cost of developing and marketing a new drug is huge, so it is easy to understand the desire to continue selling an expensive brand-name drug after its patent has expired. The fact that many of the articles promoting brand-name AEDs over generic drugs have been written by individuals who are employed by AED manufacturers or those receiving personal financial and research support from these companies does little to promote confidence. What is difficult to explain, however, is how usually questioning physicians could accept such weak arguments without even a trace of skepticism or a demand for more evidence.”

One more reason medical costs have gone through the roof.

Comments (3)

  1. Submitted by Alicia DeMatteo on 11/11/2009 - 12:46 pm.

    I had heard the stat before about the bioavailability of generics being 80 to 125 percent of the orignal, name brand drug. I asked my doctor about it a few years ago because it concerned me that I may not be getting as much (or too much) of an important ingredient in any given generic.

    I’m not a chemist or biologist or anything, but doesn’t it stand to reason that this difference COULD really make a difference in the effectiveness of a prescription drug?

    Also, is there a logical reason why generic drug makers wouldn’t want to make their drug as close as possible to the name-brand version?

  2. Submitted by Susan Perry on 11/12/2009 - 01:00 pm.

    Taylor: Of course, theoretically, it could make a difference–and that’s certainly what a drug company with an expiring patent wants you and your doctor to worry about.

    But most knowledgeable non-biased experts aren’t concerned. Here, for example, is what Consumer Reports said about this issue earlier this year:

    [O]ur 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.

    (You can read the entire Consumer Reports piece at:

  3. Submitted by Alicia DeMatteo on 11/13/2009 - 11:47 am.

    Thanks, Susan! I appreciate the follow-up.

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