In the contentious debate over insuring Americans' health, the value of generic prescription drugs is a rare point of consensus. Patients, physicians, employers, politicians -- all hail generics as powerful treatment for a swelling healthcare tab. On average, these copycat medicines cost less than a third of the brand-name drugs they mimic. In turn, the competition they provide drives down the cost of those first-to-market drugs.
Officials of the Food and Drug Administration insist this feat of economics comes without any compromise to a medicine's effectiveness. To be marketed in the United States, these low-cost medicines must be approved by the FDA, which ensures they are "bioequivalent" to their brand-name counterparts -- the same dose of the same active ingredient, delivered in the same way, and manufactured according to the same standards of quality.
The Generic Pharmaceutical Assn. touts them with a slightly catchier slogan: "Same Medicine. Same Results." But sometimes, patients and their doctors beg to differ.
A switch from a long-used brand-name drug to its generic equivalent can, on occasion, bring a shifting profile of side effects. In a number of cases documented in medical journals and recounted in interviews with physicians, a generic version of what is often called a "pioneer" drug simply doesn't appear to work as well for many patients.
"Everybody thinks generics are swell: To suggest otherwise is like saying you don't love your mother," said Dr. Peter R. Kowey, chief of cardiovascular diseases at the Philadelphia area's Main Line Health System, who reviewed the issue of generic substitution of certain heart drugs for the American Heart Assn. But between some pioneer drugs and their generic imitators, Kowey said, "we are concerned that the margin of difference is large enough" to risk patients' health.
Last December, the American Epilepsy Society called on the FDA to approve a large clinical trial to determine "once and for all" whether the substitution of brand-name drugs with generics increases the risk of "breakthrough" seizures or toxicity among patients with epilepsy. This type of research would probably take years. But until such a study is completed, the society declared, it would oppose measures by state, federal or private insurance programs that would limit physicians' choices in prescribing anti-seizure medicines.
Last fall, an independent laboratory, prompted by a flurry of consumer complaints, presented evidence that a generic version of the once-a-day antidepressant Wellbutrin XL may be less effective than the original at reducing some patients' depressive symptoms. An agency spokeswoman said the FDA is investigating the matter and will make its findings public when the inquiry is complete.
In a report released today, the New York-based ConsumerLab.com, which conducted the Wellbutrin XL analysis, also urges the FDA to review the performance of a new generic for Toprol XL, a once-a-day version of a high blood pressure drug that is the fifth most-prescribed medicine in the United States. That challenge comes after dozens of patients complained to the People's Pharmacy -- a multimedia source of information about drugs and supplements -- of erratic spikes in blood pressure and side effects after they had switched from Toprol XL to a new generic version of the drug.
Cardiologists, meanwhile, have been growing more vocal in their concern about "generic substitution" for newer, brand-name drugs. They have had long-standing worries about the effect of switching patients whose blood has been thinned with Coumadin to generic versions of the anticoagulant, including warfarin. Many have warned that patients with heart arrhythmias should be switched to generic drugs only when necessary. And many cardiologists view the swelling field of generic blood-pressure and cholesterol drugs with some distrust.
The American Assn. of Clinical Endocrinologists, the Endocrine Society and the American Thyroid Assn. joined voices in 2004 to warn that patients with hypothyroidism could be harmed by switching among the many generics used to treat the condition. And physicians who care for organ transplant recipients have opposed generic substitution of immunosupressant drugs for their patients without a transplant specialist's prior approval. Societies that represent these doctors have been active in seeking state laws that would limit such switches.
Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Assn., dismisses all of these debates as "misinformation campaigns" masterminded by brand-name pharmaceutical companies. As these companies' most profitable medicines face competition from generic upstarts, Jaeger said, they seek to "extend their monopoly" by sowing doubt in the minds of physicians, pharmacists and patients about the quality of the cheaper substitutes.