Brand vs. Generic: When It Matters (And What To Do When It Does)
Should generics be subject to more rigorous approval methods?
Posted Mar 26, 2012
After hearing similar complaints about this same drug, I called the FDA and spoke with a physician in the generic drugs division. She was not impressed, and stated that the number of complaints about generic Wellbutrin was too low to justify concern. When I told her there were entire message boards dedicated to people who'd had adverse reactions to the generic Wellbutrin, including suicidality, she informed me all I could do was make an adverse event report.
This was about five years ago, and the number of complaints for generic Wellbutrin was 80. After one report took me two hours to complete, I gave up and tried to make the rest of the reports by phone. However, because most of the cases were children who were being prescribed Wellbutrin for ADHD, they would not take the reports. (Wellbutrin is approved for major depression and ADHD in adults, but only for major depression in children. It's a good non-stimulant treatment for ADHD but does not have an FDA indication: it is an "off label" use.)
Generic drugs are supposed to be deemed "bioequivalent" by the FDA, which means they should have the same amount of active ingredient as their brand counterparts as demonstrated on healthy volunteers. They do not test whether they actually work or not (ie efficacy/effectiveness). A review of studies comparing bioequivalence and therapeutic effectiveness of generic vs. brand psychoactive drugs concluded that bioequivalence and effectiveness are not necessarily the same, and recommended more rigorous testing for toleratibility and efficacy in actual patients--not just healthy volunteers (Borgheini, 2003).
Furthermore, these are psychoactive substances we are concerned with here. How do we know they are crossing the blood-brain barrier? Crossing it at rates equivalent to the brand name? Or that they are not modified when and if they do? Plasma level does not necessarily equal bioavailability in the brain. And, if a generic is manufactured overseas, how do we know that subsequent batches after receiving approval are of the same quality and quanitity?
I recently met a rep from a well-known chemical company (whose name I won't mention) who had traveled to India to visit their generic drugs plant. "Let me tell you something," she said. "Anyone that says that generic drugs are the same as brand name is lying." She went on to tell me how appalling the plant conditions were, and that there were major safety and contamination concerns.
This reminded me of a weight-loss drug study that was conducted at three centers, one of which was in India. While the two other sites showed a robust response, the India site showed the drug was no more effective than placebo. Confused by this, the researchers eventually found out that the extreme hot temperatures that occur regularly in India had affected the drug's stability, rendering it inactive.
Just because a drug company is headquartered somewhere does not mean the drugs are manufactured there. They may be outsourced to more than one location, and oversight may be poor.
Generic drugs have different fillers and binders that many people point to as the culprit when a generic doesn't work as well. Experts speculate that these chemicals may interfere with absorption, or cause adverse allergic-type reactions that increase inflammation in the nervous system.
What action to take:
First, if you feel your generic is working fine, don't try to switch back to brand; we all have a responsibility to keep health costs down. However, if you feel the generic is indeed inferior, a dosage adjustment may do the trick. In my experience, stimulants, some anti-depressants, and some sleep agents may need a slightly higher dose (but not always.)
Other times, like with Wellbutrin noted above and some mood stabilizers like Depakote and Lamictal, there seems to be a qualitative difference as well, for some people. In these cases I ask for brand name.
If your insurance (or the pharmacist) tells you "it's not covered" even after your doctor has checked the "dispense as written" box, find out if brand name can be approved with a "prior authorization", or "PA". Many times a pharmacy will insist something is not covered but unless they call the insurance (ie not just input into the computer) you don't know for sure. If the pharmacist won't call, you can call yourself or look it up online. You can also download prior authorization forms from your insurance company's website. It's very cumbersome for the doctor's office to do this, so patients need to assist in the leg work. (Some psychiatrists refuse to do it, period.) By filling out the patient and pharmacy information on the PA form ahead of time BEFORE your doctor receives it, things will go much more quickly and smoothly.
One other tip: when a pharmacist insists they've faxed doctor's office "all the information" for a prior authorization, often times they've only send a copy of the rejection notice--not a PA form. Ask to look at what they sent, and get the PA form yourself if needed.
The PA form will have a "medical indication" area to make an argument why brand is needed. Legitimate reasons include intolerance of the generic, that the generic was ineffective, or that the patient had stabilized only on brand-name. There is a human being reading this form, so the better argument the doctor makes (in legible writing!) the more likely the approval will go through.
And finally, report your reaction to the FDA. And yes, consumers can report as well.
Do you have a story about being switched to a generic psychoactive drug? Please share!