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With the news of availability of generic Lipitor, a cholesterol lowering drug, sales of the prescription brand have plummeted, as expected. Is generic Lipitor really the same as prescription Lipitor? Consider this:
"Generic drugs are identical to brand name drugs." True or False?
We know that generic drugs cost less than their brand name equivalents, offering a savings of 50% or more. But are they "identical"?
Behind every pill is a story. US patents grant the inventor a 20 year property right; only the inventor can manufacture and sell the medicine. When the patent expires, anyone can produce and sell it. The Food and Drug Administration arguably has the most rigorous regulatory oversight in the world for both generic and brand name prescriptions, to ensure that the drugs are safe and effective.
But the devil is in the details. Yes, any company can manufacture a generic drug after patent expiration and must prove to the FDA that it is "bioequivalent" to the brand name pill. Are "bioequivalent" pills "identical"? Consider this. In order to produce it, the generic manufacturer must know how to make the active ingredient, on a multi-ton scale, how to add the inert, inactive components, and how to coat the pill. Each of these steps is critical for the final product to be as safe and effective as the brand name drug.
How do they know how to do this? The generic manufacturer refers to the original patents, along with other scientific articles. But here's the rub. These patents are crafted so that just enough information is revealed to convince the US Patent and Trademark Office that the invention is novel and "non-obvious", while maintaining "trade secrets" including details about large-scale manufacturing.
So each aspiring manufacturer of a generic drug needs to figure out how to mimic the original brand name process for each step. Not surprisingly, different companies can accomplish this using various methods, whether to synthesize the active ingredient, formulate the inactive ingredients or coat the pill.
Why should you care? Because there is mounting evidence that variation from generic to generic produced in the US, and more importantly, those produced worldwide, can determine the safety and effectiveness of a medication. For example, generic forms of the antidepressant Wellbutrin XL 300 were found to release the active drug at different rates compared to the brand name, measured by an independent testing laboratory. In a survey of twenty foreign sources of generic simvastatin, a cholesterol-lowering drug, researchers found that a 20 mg dose actually ranged from 29.7 to 40.1 mg. These medicines can often be purchased over the internet without a prescription. More than doubling the prescribed dosage could result in more adverse side effects. The effectiveness of these medications can also be reduced by differences in "clumping" of the active ingredients and the pill coating - this changes how long it takes for the pill to dissolve and release the drug.
So buyer beware. Generic drugs can be safe and effective, particularly for those produced in the US, but an informed patient working together with their physician will ensure the best outcome. Online social networking for patients and healthcare workers is one of the best ways to make this happen, such as PatientsLikeMe. If you are fortunate enough to have a good health insurance plan, choosing the brand name prescription will ensure uniformity and reliability of the medicine. However, if you and your doctor choose a generic equivalent, be sure to communicate with your health care providers about any potential adverse side effects. To make sure that the medicine is working, be sure that you follow up with your doctor for any required tests. Keep a record of any changes you note in your reaction to the medicine - see "Tips on Generics". And please check with your pharmacist - be sure that their source of any generic is consistent, as there is no requirement to notify you if they do choose another manufacturer.
A generic drug produced in the US, while "bioequivalent" to the brand name drug, may or may not be "identical".
A version of this article was published at NJ Voices.
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Caution should be taken...
As I began to read this article I started to think about the case of Wellbutrin XL, and sure enough you included this example. I think antidepressants and other psychotropic drugs are especially prone to different experiences when compared to a generic formulation. Of course these patients as a whole are probably more likely to suffer "perceived" differences but do not account for all reports, imo.
Yes, a patient might prefer a polished generic tablet over an unpolished brand name tablet even though this would improve their care. The most important question is "Are there clinically significant differences between medications?" The drug manufacturer and the FDA are responsible for ensuring this does not happen. If clinically significant differences exist,there was a problem with the FDA approval process.
I picked up my first prescription of generic Lipitor (atorvastatin)today, December 29th. The generic is made by Pfizer and will be the only one available for several months until other generics are available according to my pharmacist. My insurance plan is getting hit because I'm paying $7.00 per prescription for the generic but they are paying for a slightly discounted Lipitor from Pfizer until the real generics become available.
A disclosure of conflicts of interest, if any, would be appropriate here.
The author does not state how much variability was found in the content of branded simvastatin, i.e. Zocor. What? No one checked that? How about the inter-patient and intra-patient variability of timed release branded Wellbutrin? Was there any measurable difference in therapeutic effect, or just anecdotal reports touted by Pharma? Also unstated is the fact that doubling the dose of most statin drugs yields only about a 6% difference in therapeutic effect. The variability of measured cholesterol levels is about 10% on any given day. In that context, the difference between branded products, for about $5-8 per day and generics, for about $0.04-$0.20 looks a lot different.
Now, any conflict of interest to disclose?
We live in a world where one drug fits all. That single pill one patient might take will be absorbed differently in different patients based on their diet and metabolism, and one pill might have different effects on, for example, a 90 pound Asian woman than on a 250 pound Italian man. We dont worry too much about this sort of variability, but this author wants us to freak out about the insignificant differences between generic and brand-name Lipitor? That is ridiculous. Fda already has a designated class of drugs, call Narrow Therapeutic Index drugs, where very small degrees of variability do make a difference. Cholesterol-lowering statins are NOT in that category. So please, if your doctor writes you a prescription for Lipitor, insist on the generic. It will work just as well as the brand-name on 99.99999 percent of patients and sav them a ton of money.
There is also the US Pharmacopia which has much additional information as well as the Phase I II and III records
I was switched from lipitor to the generic 8 months ago when the generic was available. The worst side effects ever. dizziness, depression, memory loss none of which I had on the brand name. I switched back 3 days ago and pray these horribly side effects go away
I was given lepitor for the past 11 years no problem switched to generic 2 months ago and immediately started having palpitation fatigue by which I did not get up from bed for 2 months been to all kinds of doctors catskan x rays etc. Cardiologist asked me to stop"lepitor" I forgot I was taking the generic and he did not know I was taking the generic. The next day after stopping it I was able to do my house hold chores for the first time in 2 months of my lost life.
I just had to refill my script for the next 90 days. Per my script plan my share was over $400.00 for Lipotor whereas the generic is $10.00 for 90 Days. Who can afford this??