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Generics Just As Good As Brand Name

Posted Dec 02 2008 10:08pm
MSNBC has picked up on a study that has otherwise not generated a great deal of media attention, but that I think is rather important. The study, published in today's issue of JAMA was systematic review (look for all possible studies) and meta-analysis (analyzes data from multiple studies) that compared generic to brand name medications for common heart conditions such as high blood pressure and high cholesterol. They essentially found no difference in both the efficacy and safety of generic medicines compared to the same brand name medications.

This study is very important because there still exists a common misconception that generics are just not as good as the real thing. This misconception is held by both physicians and patients. In fact, in their analysis, the authors of the JAMA study looked at the conclusions of the individual studies which similarly suggest (despite the data showing otherwise) that generics might not be a great substitute. The authors suggest that one possible reason could be potential conflicts of interest from the individual investigators, and about half the studies analyzed did not disclose any conflicts of interest.

As health care cost continue to rise and the economy seems to get worse by the day, patients are becoming more used to taking generic medications, especially when many are available at Walmart for $4. However, the belief that generics do not work as well likely still persists. As I mentioned in an earlier post regarding the nocebo effect, if a patient doesn't think a medications is going to work, there is at least a 30% chance that it won't. In addition, patients who value their health care and believe generics to be inferior, may needlessly waste their out of pocket health care dollars paying expensive co-pays.

When a new medication is approved by the FDA, the drug company must prove that it is both safe and effective. When the drug company loses exclusivity on their patent, generic manufactures can duplicate the drug. Unlike the original brand drug, all the generic manufacturer has to prove to the FDA is that the blood levels of the drug are virtually equivalent to the original branded product, which is much easier to do. This is why generics are so cheap: the generic companies have virtually no investment in research, and they have very little in expenses to get their drug approved by the FDA (and they also don't spend a lot of money on marketing to physicians).

This study confirms that there is really no difference between generic pills and branded pills when it comes to safety and efficacy. Since the pills are not exactly the same, rarely patients might have an adverse event when switching such as an allergic reaction to a dye in the pill. However, this is very rare. The only time a difference really matters is when a pill has a narrow therapeutic window, which means a tiny change in dose can have a big effect. Common drugs with narrow therapeutic windows are hormones (like thyroid replacement medications), blood thinners (coumadin/warfarin), and pills whose levels need to be monitored (like tegretol). However, in the JAMA study even warfarin/coumadin performed similarly. Thus, even these switches are safe, though more careful monitoring is needed.

This does not necessarily mean that you should always use generics. Some branded products which are not yet available in generic form, are often needed to achieve the desired effect where a generic would likely fail. A good example is cholesterol lowering medications. The generic statins, simvistatin in particular, will get you close to a 40% reduction in bad cholesterol at the maxium dose, but for those patients who need much greater lowering of their cholesterol, drugs like Lipitor (which goes generic in 2011) or Crestor will be needed.

Bottom Line: If a generic will do the trick for your particular disease, then you should take the generic confidently. Though the study did not specifically address this, the same principle applies to over the counter medications. Doesn't make sense to spend $8.99 on extra strength Tylenol, when you can get the CVS brand for $6.99.
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