People's Pharmacy - Take care with generic drugs
One popular way to lower the cost of prescription
drugs is to purchase generics. Physicians are encouraged
to prescribe generic equivalents when possible, and
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. But how good are these
substitutes?
For 30 years we have defended generic drugs. The
Food and Drug Administration assured us that its 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 attention
deficit-hyperactivity disorder 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. 26, 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.
We were puzzled by the spike in reported problems,
so we contacted the FDA to find out how the agency
monitors the quality of drugs. We were not reassured
by what we learned.
As far as we can tell, the pharmaceutical marketplace
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 3
billion bottles of pills are dispensed in the nation
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 one in 10 million.
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
enticing. Without constant quality surveillance, we
worry that U.S. consumers may not always be getting
what they expect.
Here are some guidelines for using generic drugs:
--Record the numbers (blood pressure, blood sugar,
etc.) that will tell you whether the drug is working.
--Monitor lab results (cholesterol, thyroid, etc.).
--Observe your subjective response to antidepressants,
pain medicine or sleeping pills.
With care, you can use generics 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 preserve your health.