GENERIC THREAT?: How do generic versions of drugs differ and does that pose any threat? ©iStockphoto.com
Because of the recession, among other reasons, more people are turning to generic drugs, often manufactured abroad. Is there any cause for concern?
By Molly Webster
As we cope with the economic recession, we’ve all had to make concessions. It’s been “good-bye” to European vacations, organic milk and magazine subscriptions. But there are those things we can’t give up without risking serious illness or death, one of which is prescription medication.
In 2004 the U.S. Centers for Disease Control estimated that at least 47 percent of Americans had a prescription filled each month. Besides ordering brand-name pills, powders and sprays from Canada, some people are trying to cut costs by turning to generic medications. But don’t worry: unlike switching from a real Louis Vuitton purse to a knockoff bought in Chinatown, this isn’t a switch that will leave you aching for the real thing in a few months time.
“In theory, generics are every bit as high quality as brand name,” says William Hubbard, a former associate commissioner of the U.S. Food and Drug Administration (FDA). “I would readily take a generic if it was prescribed to me.”
A generic drug contains the same active ingredient, which provides therapeutic benefit, as does the brand-name version. But having the same medicinal component does not mean the two pharmaceuticals are identical. They may contain different inactive ingredients, including those for pill coatings and color or to bind the constituents into tablet form. They also may vary in bioequivalency, which is the amount of drug that is available in the bloodstream at any point in time. In fact, a 2009 FDA study showed that of 2,070 orally administered generic drug products approved by the agency between 1996 to 2007, generics differ in bioequivalency from brand names, on average, by about 3.5 percent; less than two percent varied by more than 10 percent. For many, these differences are not significant enough to reduce therapeutic benefits or, on the other hand, cause toxicity.
“For the vast majority of patients, switching is not an issue,” says Aaron Kesselheim, a physician and drug policy researcher at Harvard’s Brigham and Women’s Hospital. Kesselheim is author of a 2008 study that showed there are no statistically significant therapeutic differences among generic and brand-name heart medications.
The minority of patients for whom a switch might be problematic are those on narrow-margin therapeutic index drugs, such as anticoagulants and antihypertension meds for which there is a fine line between a dosage that is beneficial and one that is toxic. Even when using pioneer (or brand-name) drugs, doctors monitor patients on these types of medications until they find the precise dose that works with each person’s physiology. Switching medication, especially if there’s even a small bioequivalence variability, can introduce a change that throws off therapy.
“If a person is stable on narrow therapeutic index drug, it makes sense to think two times about changing to a generic or to a new brand-name drug,” Kesselheim says.
Despite convincing scientific evidence that generic drugs are largely equivalent to pioneer meds, there remains an undercurrent of fear toward nonbrand names. In fact, as part of Kesselheim’s 2008 study in JAMA The Journal of the American Medical Association, his team reviewed 43 editorials that had been published in peer-review health care journals between 1975 and 2008 concerning generic substitutions for branded cardiovascular disease pharmaceuticals. The study found that 53 percent expressed a negative view toward generics. There’s myriad sources that could explain the worry, including patient case reports and antigeneric advertising by brand name drug companies. But to be fair, much of the concern is rooted in some scary generic drug scandals, in which toxic substances made it into a medication that was produced overseas, such as occurred with heparin in 2008. Today, more than 40 percent of the active ingredients in generic and over-the-counter pharmaceuticals are produced in India and China—and that number is only expected to increase: In the next few years a number of brand-name pharmaceuticals will be going off patent, with the expectation that within 10 years, 80 percent of the prescriptions Americans take will be generic.
And, although generics have thus far been shown to be as effective and safe as branded drugs, there is a concern that they are more likely than brand-name meds to be the target of adulteration with toxic substances, because some companies might be tempted to cut corners in efforts to keep them as cheap as possible.
“FDA requirements are pretty strict,” Hubbard says, “but foreign firms don’t have the same culture of safety and oversight—and they are interested in the lowest price.”
According to the FDA, the rules that it has set to regulate generic drugs are just as tough as for brand-name meds. But keep in mind that the federal agency was originally formed as a domestic watchdog—overseas expansion and the proliferation of pharmaceutical manufacturers have challenged their infrastructure. The New York Times reported that in 2007, out of 500 Chinese facilities the FDA only got around to checking 13. Acknowledging this situation, the agency is looking to expand overseas staff in an attempt to ramp up on-the-ground regulation of manufacturing facilities. In 2008 the FDA opened three offices in China and two in India, not to mention others in Costa Rica and Belgium. Hubbard further suggests that in the future, all foreign facilities with any role in the U.S. pharmaceutical industry should be required to register with the FDA, providing contact information as well as a list of their product lines.
Plus, the U.S. Pharmacopeia (USP), a standard-setting authority for prescription and over-the-counter meds, has recently changed some of the identification tests that manufacturers are required to run on products destined for the U.S. These newer, more stringent analyses are more sensitive to impurities than prior protocols were. (And, for what it’s worth, the USP is also trying to organize momentum for establishing some tougher food tests—think: melamine.)
Today, however, Hubbard says that prescription-takers “don’t need to panic”: 67 percent of Americans take generic medication, and there are few adverse instances to recount. And studies have shown them to be just as effective as branded meds.
So, with the great recession raging, bring on the generics.
http://www.scientificamerican.com/article.cfm?id=are-generic-drugs-bad-for-you
Photo via the BBC
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