President Bush is pushing FDA to approve more generic drugs, and to do it faster. The idea is to save money for insurance companies and government programs like Medicaid and the Veterans Administration that spend billions on prescription drugs. It should also benefit consumers without insurance.
Generics are supposed to be identical to their brand name counterparts. Manufacturers must prove only that their “copycat” product is absorbed into the body just like the original brand name drug. Since research costs are significantly lower, generics are generally cheaper, sometimes by 50 percent or more.
Valium prescribed for anxiety costs $30 for 30 pills. The same amount of generic diazepam costs about $9. Prozac costs roughly $100 for a month’s supply, while generic fluoxetine is $35. Not all savings are so dramatic, but for someone taking three or four different prescriptions the savings add up. But are all generic drugs truly equal to their brand name counterparts?
The FDA requires excellent data before approving “knock-off” drugs, but once a generic is on the market a different branch of the agency is supposed to monitor for quality. Some drugs may be falling through the cracks.
We have heard from dozens of readers who have experienced problems with their generic medicine: “I tried to take generic Lopressor with terrible results. My blood pressure shot up within two days on the generic, but dropped 20 points after returning to the brand name.”
Another reader complained, “I was taking Hytrin to treat an enlarged prostate. When using Hytrin I had no problem urinating, but then the pharmacy substituted terazosin.
“Almost immediately I had trouble. I feel an urgent need to urinate, but the flow is almost nonexistent and does not relieve the pressure on my bladder. With Hytrin, I got up once at night to urinate. With terazosin, it is every hour throughout the night.”
Some reactions are extreme. According to one reader, “I had a bad experience with generic Synthroid. My drug provider changed me to the generic thyroid hormone without consulting my doctor. My whole body trembled, my face was flushed and my hands shook until I could hardly write my name.
“I made two trips to the ER and had a CT scan and an MRI. My doctor determined the problem was my thyroid because my lab results were off the charts. After going back on Synthroid, the problem is cured. I feel strongly that pharmacists should not overrule what doctors order simply because of the cost.”
Some health care professionals are convinced that certain generic medications are less effective: “I am a medical assistant for three orthopedic surgeons who do total joint replacements. One of my main duties is to call in refills for pain medication after surgery. Our surgeons specify brand name medicines like Vicodin and Lortab because some generic substitutions don’t relieve patients’ pain.”
The FDA has expressed interest in such experiences. Anyone who would like to report problems with their medicine can contact us with details. Our e-mail is pharmacy(at)mindspring.com or mail to: People’s Pharmacy (Dept Generic), PO Box 52027, Durham, NC 27717-2027. We’ll pass your experience on to the FDA.