Why Some Generic Drugs Do Not Work
A Rare Interview with Joe and Teresa Graedon of The People’s Pharmacy.
Pharmacologist Joe Graedon and medical anthropologist Teresa Graedon are the authors of dozens of books and of the nationally syndicated People's Pharmacy newspaper column. Their People's Pharmacy radio show has won numerous awards and is carried by more than 500 radio stations. The Graedons are highly respected for their award-winning work in consumer health communications. Their website, www.peoplespharmacy.com, is an excellent resource for people experiencing side effects with medications.
Because of the Graedons' current work on the ineffectiveness of some generic drugs, Dr. Cohen asked the Graedons for an interview. They kindly accepted.
Dr. Cohen: How did you become aware of the problem with generic drugs?
Joe and Teresa: We were getting a large number of complaints from consumers that their generic drugs were not as effective as the brand name formulations they had taken previously. We have received hundreds, perhaps thousands of messages over the last several years regarding generic drug problems.
Dr. Cohen: People with what kind of conditions have been affected?
J and T: Several conditions are represented. Depression, chronic pain, high blood pressure and heartburn are among the most common.
Dr. Cohen: Can you give us a few examples?
Joe andTeresa: Here are two letters from consumers taking antidepressant medications.
I am so glad I found this site! I tried the generic version of Wellbutrin and thought I must just be very sensitive to it. I had done super well on the brand Wellbutrin XL but felt like I was going to lose my mind on the generic! I ended up flushing it all down the toilet. It was horrible stuff! It makes me so mad when I remember the pharmacist snapping at me when I told him that the generic was not working like the brand Wellbutrin!! He said that it couldn't be true!
I have been taking Prozac since 1990 and have had excellent results. My insurance company INSISTED I change to the generic of Prozac. After about 3?]4 weeks my family started to notice a difference in my behavior and asked if I had stopped taking my medicine. I had noticed I was feeling "down" more often and it was a fight to bring myself back "up" and get everyday things accomplished. I also found I began to have serious thoughts of just "ending it all," something I hadn't thought about for years. I thought it was just a tough period I was going through. I never thought my body was not responding to the generic drug. I spoke with my doctor and she suggested I try the brand name Prozac for a few weeks to a month and see how I felt. After about 2 weeks I noticed a remarkable difference in my outlook and my family said they noticed that I was more like my "normal" self again. Although I have heard from many people that generics are exactly the same as the brand name drugs ?] in this case for me the generic was like taking nothing at all. I DO take generics whenever possible but Prozac is one medication I refuse to ever change again. Life with chronic depression is no fun and life threatening for me.
Dr. Cohen: Have you been able to identify the basis of the generic drug problem?
Joe & Teresa: We don't have any testing facilities ourselves, so we asked Dr. Tod Cooperman of ConsumerLab.com to do some testing. Dr. Cooperman did two separate tests on a generic form of Wellbutrin XL 300. This is a long?]acting antidepressant that is taken once a day. The generic is called Budeprion XL 300 and is supposed to be identical to the brand name product. Dr. Cooperman's tests demonstrated that the two pills dissolve in very different ways.
Dr. Cohen: If I understand this correctly, the U.S. Food and Drug Administration (FDA) is aware of the differences between Wellbutrin XL and the generic. Yet, the FDA does not believe the problem is important enough to warn doctors and patients. Is there any way the FDA could prevent the problem?
Joe & Teresa: The FDA could be more transparent about its testing procedures. The label of prescription medicine could reveal where the active ingredients come from. If shirts and shoes have to have country of origin labeling, why not prescription drugs? The FDA should actually monitor and test drugs from pharmacy shelves, but this will require a much bigger budget and more manpower than the agency currently commands.
Dr. Cohen: I might add that many doctors and pharmacists are not aware of the many limitations of the FDA's testing of generic drugs. The FDA allows different drug formulations and different rates of release and absorption. The FDA accepts generic drugs that are 20% weaker or 25% stronger than the brand name medication. These problems explain why generics are ineffective for some patients, and why generics are too strong and cause drug side effects in others. Joe and Teresa, what can people do if their generic medication is not as effective as a brand name drug they used previously?
Joe & Teresa: The first thing to do is to report the problem to your doctor. A sympathetic doctor can write "Dispense as Written" to prevent automatic substitution with generics by pharmacies or insurers. It is equally important for consumers to report generic drug problems directly to the FDA through MedWatch. The URL is: http://www.fda.gov/medwatch/.
Dr. Cohen: When did you establish The People's Pharmacy? (If I recall correctly, I read your book in the 1970s.) What was your goal in writing about medications?
Joe & Teresa: Good memory Jay! The first edition of the first People's Pharmacy book was published in 1976. For the last 30 years we have been striving to provide consumers with objective and useful information about pharmaceuticals, vitamins and other dietary supplements.
Dr. Cohen: When did you establish the website (www.peoplespharmacy.com), and has it been in helpful in collecting reports of adverse effects to medications and other substances?
Joe & Teresa: Our Web site got off to a slow start in 1996. We started in conjunction with another health website. In 2005, we finally took the bull by the horns and built an independent Web site. It has become a beacon for consumers to report adverse drug events and share home remedies. The FDA and the World Health Organization (WHO) are interested in the reports that are being generated by visitors to www.peoplespharmacy.com.
Dr. Cohen: Can anyone send a report about a side effect to you?
Joe & Teresa: Absolutely! We welcome such reports. When something totally unexpected shows up we will report it directly to people at the FDA who can investigate further and help make labeling changes. That happened with the stop?]smoking drug Chantix and reports of depression and suicidal ideation.
Dr. Cohen: Is there anything else you want to tell us about your work and how people can use your information?
Joe & Teresa: Consumers must become knowledgeable about risks and benefits of any treatment they receive, whether it is an herbal approach or a new prescription drug they see advertised on television. Far too many people are harmed when they do not realize what symptoms may be danger signs of drug toxicity.
Dr. Cohen: Thank you for explaining the problems with generic drugs. I have been an admirer of your work for more than 30 years.
NOTE TO READERS: The purpose of this E-Letter is solely informational and educational. The information herein should not be considered to be a substitute for the direct medical advice of your doctor, nor is it meant to encourage the diagnosis or treatment of any illness, disease, or other medical problem by laypersons. If you are under a physician's care for any condition, he or she can advise you whether the information in this E-Letter is suitable for you. Readers should not make any changes in drugs, doses, or any other aspects of their medical treatment unless specifically directed to do so by their own doctors.
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