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Me-Too Drugs:
Valuable or Copycat?

(Washington DC, 7/11/02): A new report reveals that 65 percent of drugs approved in the last decade are modified mimics of existing medications, or "me-too" drugs. However, experts warn women against hastily dismissing these copycats as insignificant to their health. After all, studies show that one size does not fit all when it comes to medicine. The effectiveness of a drug and the frequency and intensity of associated adverse reactions have all been shown to vary with gender, race, genetics, age and other factors.

"While some me-too drugs may provide little benefit over their predecessors, others give women much needed choices," said Sherry Marts, PhD, scientific director of the Society for Women's Health Research in Washington, DC.

Some Me-Too Drugs Worth the Wait

Critics caution that "knock-offs" of existing drugs contribute to rising costs and play a role in limiting access to generics by extending patent protection while offering little benefit to patients. Yet these "me-too" drugs differ from their predecessors in a number of important ways. Some are combined with other active ingredients, some offer a different dose, and others differ in their delivery method (i.e. oral, injection and patch). While this tweaking does not constitute a medical breakthrough, it may result in changes in metabolism that can lead to differences in drug effectiveness and side effects that vary from individual to individual.

A new drug, although similar to one already on the market, still may provide some patients with significant clinical benefits. Take, for example, antidepressants. Serotonin reuptake inhibitors (SSRIs) like Prozac are popular with physicians and patients for the treatment of depression. Members of this class of drugs work by increasing levels of serotonin, a chemical messenger in the brain. However, different SSRIs have different effects on mood and important side effects, such as changes in libido or weight gain. An SSRI that works well and with tolerable side effects in one person may cause unpleasant effects or be less effective in another. If there were only one SSRI available, many people with depression would be denied effective, tolerable medication, explained Marts.

Birth control pills also illustrate the importance of incremental improvements in drug development. Today, the active ingredients in oral contraceptives are little different from those introduced four decades ago. Yet evolving doses, types and combinations of hormones in newer birth control pills offer modern women excellent protection against pregnancy with fewer of the risks associated with outdated versions of the drug. Older forms of the pill containing higher doses of hormones are associated with a higher risk of blood clots and stroke compared with new lower dose pills. Furthermore, nausea and other more benign side effects are less frequent with more modern formulations.

"If it weren't for me-too drugs, women would still be taking high-dose birth control pills with their high risk of dangerous and uncomfortable side effects," said Marts.

Similar drugs may provide different levels of effectiveness or different side effects for a number of reasons. Drugs that have the same mechanism of action may, due to differences in their chemistry, be absorbed into the bloodstream or broken down and excreted at different rates. A drug that is absorbed quickly and broken down slowly may be taken less often or at a lower dose. If a me-too drug is effective at a lower dose, it may cause fewer side effects. Different delivery methods can accommodate a range of patient preferences. A choice of similar-acting drugs can allow physicians to prescribe drugs together with less risk of interaction.

Making the Right Choice

The best drug choice will vary from person to person. So what is a woman to do when making a decision about medication?

  • Educate yourself about your medical condition and all available medications.
  • Before taking a new drug, discuss all benefits and risks with your doctor and pharmacist.
  • Ask if there are older, cheaper and equally effective alternatives. For patients who do not respond to the alternatives, potential health benefits of newer versions may outweigh financial costs.
  • Report any and all side effects to your doctor.
  • Discuss with your doctor all other prescription and over-the-counter drugs and supplements you take to minimize the risk of adverse drug interactions.

The Society for Women's Health Research is the nation's only not-for-profit organization whose sole mission is to improve the health of women through research. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the resulting need for more information about conditions affecting women. The Society advocates increased funding for research on women's health, encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of women in medical research studies. Dr. Donnica Moore has been a member of the Society since 1990 and is a past member of its Board of Directors.

For more information on clinical research, click here.

Created: 7/11/2002  -  Donnica Moore, M.D.

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