Truth About Generic V.S. Brand Name Drugs & How They Impact Chronic Kidney Disease Patients' Health

The New York Times called Amgen's drugs for use of increasing red blood cell levels in Anemic Chronic Kidney Disease patients receiving Dialysis, "one of the most lucrative monopolies of all time, yielding the biotechnology company, Amgen, roughly $40 billion in sales over 23 years." This was before a much smaller company, Affymax, created an effective and legal generic alternative medication for Dialysis patients which the Food and Drug Administration (FDA) later approved. "Now it appears to be over," reported the New York Times. 

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Amgen is not alone. In fact most brand name medications have generic counterparts which are often less expensive. According to the FDA, “nearly 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015.” 

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Hence, this frequently causes those with Chronic Kidney Disease and Dialysis to beg the question if generic medication is as safe as brand name drugs? Are there other instances when you should opt for a brand name? Is it dangerous to your health to switch back and forth? Is there a time when one is preferable over the other? Therefore, the following information provides answers to common concerns among Chronic Kidney Disease and Dialysis patients regarding the use of generic medications as opposed to brand name drugs.

Q: Why are brand name drugs for Chronic Kidney Disease patients including those on Dialysis and who have received a transplant so much more expensive than their generic alternatives?

A: According to the Tufts Center for the Study of Drug Development, the cost to develop and win marketing approval for a new drug is $2.6 billion, and Drug Manufacturers also pay for research and development for medications that failed in trials and can’t be brought to market. Hence, the price difference often stems from additional encumbered costs of developing the life saving or enhancing medication with which Generic Manufactures do not have to balance. 

Q: Does generic medication have the same side effects on Chronic Kidney Disease, Dialysis, and Kidney Transplant patients as brand name drugs?

A: Yes, generics are very similar in terms of the active ingredients used. In fact, most people will never notice the difference. Based upon FDA rules, all generic medications must be within 10% above or below the blood concentrations achieved with the brand name, and  "in reality, they only usually vary by 3% to 4% in one direction or another," said Dr. C. Michael White (University of Connecticut). Chronic Kidney Disease, Dialysis, and Kidney Transplant patients should know that they may experience an allergic reaction to an inactive ingredient in one generic and not another.

Q: Will Chronic Kidney Disease, Dialysis and Kidney Transplant patients always achieve the same effect with a generic as with brand name medications?

A: In an article published by the Huffington Post which explored the use of generic versus brand name medications, they noted that researchers cannot "assure that everyone will achieve same blood concentrations" of the generic medications because of "diversity among people." Dr. White noted that some people, "are just very sensitive to small changes in blood concentrations and notice a difference."

Q: Should those with Chronic Kidney Disease, Dialysis or a Kidney Transplant ever choose to take a brand name medication over a generic option?

A: This is a great question. Many with Chronic Kidney Disease including those on Dialysis and with a Kidney Transplant do not know that Narrow Therapeutic Index (NTI) drugs have a very "narrow" margin for error. NTI Medications including those for seizures, heart arrhythmias, thyroid hormone, warfarin (blood thinner), and lithium all require a very specific blood concentration. Hence, even small changes could cause these types of drugs to become ineffective or toxic. Thus, Chronic Kidney Disease patients should talk to their Nephrologists to asses risks between generic and brand name NTI medications. Those who choose a generic drug should be sure to closely monitor how their bodies adjust to it for the first couple weeks. 

Q: Is it dangerous for Chronic Kidney Disease, Dialysis and Kidney Transplant patients to switch between generic and brand name options?

A: Not typically. If you are taking a Narrow Therapeutic Index (NTI) drug, however, talk with your Nephrologists about the risks and rewards of switching which are trickier due to blood concentration requirements. If you are switching between any type of medication and notice any side effects then contact your Nephrologists immediately. Chronic Kidney Disease patients should know that the "FDA has very strict criteria so over-the-counter store brands must achieve very similar blood concentrations as name brands," according to Huffington Post.

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Shah, Yagana. "The Truth About Generic Vs. Brand-Name Medications." The Huffington TheHuffingtonPost

Pollack, Andrew. "F.D.A. Approves New Anemia Drug."Http:// The New York Times