The high cost of prescription drugs has everyone looking for ways to save. Hospitals, HMOs and insurance plans are as upset about their pharmacy bills as individual patients are.
One popular solution is to buy generic drugs . Doctors are encouraged to prescribe generic equivalents when possible. Patients may be penalized if they insist on a brand name. The co-pay for branded medications is often double or triple that for generics. People without insurance often can’t afford anything other than generic medicine. How good are these substitutes?
For 30 years we have defended generic drugs. The FDA assured us that their rigorous standards ensured quality. A few years ago, however, we started to get reports from readers about generic drug failures.
Some parents claimed that when a child with ADHD was shifted from Ritalin to generic methylphenidate, his behavior and attention deteriorated. Patients whose epilepsy was well controlled on the anticonvulsant Dilantin reported seizures when switched to generic phenytoin.
An article in the journal Neurology (Oct. 2004) confirmed that some generic phenytoin did not perform up to standards. The neurologists reported breakthrough seizures in patients under good control for years. We also heard from people who had problems with irregular heartbeats, hypertension, acid reflux or pain when they were switched. Many found the generic version of their medication seemed less effective than the original.
We were puzzled by this spate of reported problems with generic medicines, so we contacted the FDA to find out how the agency monitors the quality of drugs after they are approved. We were not reassured by what we learned.
As far as we can tell, the pharmaceutical marketplace in the U.S. works on the honor system. The FDA relies on drug companies to be honest. For such a profitable industry, there is remarkably little oversight. Airplanes, elevators and even restaurants are inspected on a regular basis. But more than three billion bottles of pills are dispensed in the U.S. each year and only a relative handful are actually tested. The FDA says it pulls about 300 pill bottles off shelves to test for content and dosage strength. This amounts to 1 in 10,000,000.
Where do ingredients for generic drugs come from? More and more often, countries like China and India are getting into the game. The competitive nature of the generic drug market makes low-cost source materials very attractive. Without constant quality surveillance, we worry that U.S. consumers may not always be getting what they expect.
We have examined the controversy over generic drugs in much greater depth in our new book, Best Choices From The People’s Pharmacy (Rodale Books). It offers guidelines for using generic drugs safely. Some include:
- Record numbers (blood pressure, blood sugar, etc) that show if the drug is working.
- Monitor lab results (cholesterol, thyroid, INR).
- Observe your subjective response to antidepressants, pain medicine or sleeping pills.
With care, you can use generic drugs safely. If you suspect your medicine is not working properly, notify your doctor immediately. Switching back to the brand name might cost more, but it could save your health.
