# Any truth to what my pharmacist is saying? **URL:** \ **Category:** Factual Questions\ **Created:** [February 15, 2014, 7:42pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438 "2014-02-15T19:42:03Z")\ **Posts on this page:** 20\ **Page:** 2
**Author:** ![mandala](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/mandala/32/95_2.png) [@mandala](https://boards.straightdope.com/u/mandala)\ **Post date:** [February 16, 2014, 5:35am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/21 "2014-02-16T05:35:26Z")
> [@watchwolf49](#): > > To the OP, are you allergic to Penicillin? Did your doctor mention taking a Vitamin C supplement and a serving of protein four times a day along with the medications? > > Does your doctor own shares of Alkem Inc? No I am not, and he did not; but he might have received fancy stuff from the visiting medical reps. In India, doctors are allowed to receive small gifts along with medical literature from visiting med-reps. ---
**Author:** ![mandala](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/mandala/32/95_2.png) [@mandala](https://boards.straightdope.com/u/mandala)\ **Post date:** [February 16, 2014, 5:38am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/22 "2014-02-16T05:38:07Z")
> [@j666](#): > > Depends. Who makes the generic? > > The pharmacist may have meant the manufacturer of the generic has recently found to have fabricated data, or some other problem. Cefuroxime is a common antibiotic and is made by several companies. One (brand Zocef) is very expensive while some others are much less so. Most of them are fairly well-known and none are known to be disreputable. ---
**Author:** ![mandala](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/mandala/32/95_2.png) [@mandala](https://boards.straightdope.com/u/mandala)\ **Post date:** [February 16, 2014, 5:52am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/23 "2014-02-16T05:52:30Z")
> [@ftg](#): > > It really varies. In some cases they are essentially the same. In others the generic is crap. There was a big scandal a few years ago with thyroid hormones where some generics were found to be really poor. (Despite this, many health insurance companies refused to add the name brand to their approved list. You want _real_ medicine? Pay for it yourself.) > > The pharmacist has a vested interest in upselling you. Get a less biased opinion on your particular drug. Can anyone explain why bioavailability would be different, or potency would be different, across multiple generics/brands that have the same molecule and dose strength? ---
**Author:** ![Nava](https://avatars.discourse-cdn.com/v4/letter/n/da6949/32.png) [@Nava](https://boards.straightdope.com/u/Nava)\ **Post date:** [February 16, 2014, 10:04am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/24 "2014-02-16T10:04:24Z")
> [@mandala](#): > > Can anyone explain why bioavailability would be different, or potency would be different, across multiple generics/brands that have the same molecule and dose strength? Because of the excipients/delivery method. It’s easy to understand that the same amount of the same substance, delivered with food or delivered via injection will act differently, right? The first one will take longer to be absorbed and will be subject to situations which are more chemically agressive. The “non-pill” parts of a pill are there to make delivery easy and more effective in different ways: for example, if you need to take 10mg of anything, the pure crystal would be just too damn tiny to grab easily. The coatings and other excipients are intended to protect the active ingredients through part of the digestive tract, then dissolve, in a specific location and at specific speeds. And same as it happens with pill vs. injection, different excipients will do this job in different ways. Which one is best will depend on the results desired. Also, sometimes the excipient itself may be Not A Good Idea. Story told before, a very popular cold syrup used to have as its excipient an aqueous solution… 70% ethanol! That was enough to send my mother’s transaminases result through the roof; for a patient with liver insufficiency it could have been much worse. ---
**Author:** ![Andy](https://avatars.discourse-cdn.com/v4/letter/a/aeb1de/32.png) [@Andy](https://boards.straightdope.com/u/Andy)\ **Post date:** [February 16, 2014, 10:38am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/25 "2014-02-16T10:38:18Z")
Assuming all suppliers are adhering to the FDA guidelines! there should be no difference in bioavailability between brands, generic or otherwise. Whether through formulation of a different salt of the active compound, a more rapidly absorbed species is produced, this should not affect the therapeutic effect. For example Nurofen is just Ibuprofen, but variously marketed as the acid, the sodium salt and the lysine salt among others. As far as potency is concerned, meaning amount of the active ingredient in each, this should not differ. ---
**Author:** ![j666](https://avatars.discourse-cdn.com/v4/letter/j/9de0a6/32.png) [@j666](https://boards.straightdope.com/u/j666)\ **Post date:** [February 16, 2014, 1:55pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/26 "2014-02-16T13:55:31Z")
> [@Andy](#): > > Assuming all suppliers are adhering to the FDA guidelines! there should be no difference in bioavailability between brands, generic or otherwise. That assumption might be incorrect, for both manufacturers of name brands and generics. Or for manufacturers of both name brands and generics. ---
**Author:** ![DSeid](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/dseid/32/20194_2.png) [@DSeid](https://boards.straightdope.com/u/DSeid)\ **Post date:** [February 16, 2014, 1:56pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/27 "2014-02-16T13:56:01Z")
> [@mandala](#): > > No I am not, and he did not; but he might have received fancy stuff from the visiting medical reps. In India, doctors are allowed to receive small gifts along with medical literature from visiting med-reps. > [@mandala](#): > > Can anyone explain why bioavailability would be different, or potency would be different, across multiple generics/brands that have the same molecule and dose strength? Apparently you are in India. In that case [this article](http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?hpw&rref=world&_r=1) may be part of what your pharmacist is thinking of and the answer to the second question. > [@](#): > > … The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of New Delhi pharmacies found that 12 percent of sampled drugs were spurious. > > In one recent example, counterfeit medicines at a pediatric hospital in Kashmir are now suspected of playing a role in hundreds of infant deaths there in recent years. > > One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed. > > More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants. > > “Some of the fake tablets were used by pregnant women in the post-surgical prevention of infections,” said Dr. M. Ishaq Geer, senior assistant professor of pharmacology at the University of Kashmir. “That’s very serious.” > > Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare. … ---
**Author:** ![ftg](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/ftg/32/2801_2.png) [@ftg](https://boards.straightdope.com/u/ftg)\ **Post date:** [February 16, 2014, 2:12pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/28 "2014-02-16T14:12:57Z")
> [@mandala](#): > > Can anyone explain why bioavailability would be different, or potency would be different, across multiple generics/brands that have the same molecule and dose strength? You do understand that not all drug companies have strong ethics, extensive testing and such, right? These are businesses. They cut corners. The ones in the low end of the business, which generics makers typically are, cut a _lot_ of corners. The FDA doesn’t have a tiny fraction of the resources to verify the claimed purity, potency or effectiveness of all the drugs put on the market. In fact, drug companies lobby Congress to cut the FDA’s monitoring budget, and succeed. Just because there is a law mandating something, doesn’t mean it actually happens. Especially when big corporate profits are at stake. ---
**Author:** ![jtur88](https://avatars.discourse-cdn.com/v4/letter/j/e9c0ed/32.png) [@jtur88](https://boards.straightdope.com/u/jtur88)\ **Post date:** [February 16, 2014, 2:32pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/29 "2014-02-16T14:32:23Z")
Rx drugs are just like corn flakes – the quality of the product can depend (among other things) on how rigorous the quality control is during production, and how the produce is handled before shipment. Generics might be made in plants in which the quality control process is more slack, and storage conditions (especially temperature) for drugs is very important. Your pharmacist is telling you that he trusts name brands to have been made and handled more carefull6y before they get into his own hands. And therefore, more likely to render full efficacy when you take them. ---
**Author:** ![D18](https://avatars.discourse-cdn.com/v4/letter/d/c57346/32.png) [@D18](https://boards.straightdope.com/u/D18)\ **Post date:** [February 16, 2014, 2:35pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/30 "2014-02-16T14:35:35Z")
The term “bioequivalence” has been used a few times upthread. There is actually quite a lot of wiggle room for meeting the standard - the 90% CI of two parameters of the generic to the brand have to fall within 80% to 125%. I don’t know how often that can make a therapeutic difference, but thought I’d point it out FWIW. ---
**Author:** ![Aji\_de\_Gallina](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/aji_de_gallina/32/260_2.png) [@Aji\_de\_Gallina](https://boards.straightdope.com/u/Aji_de_Gallina)\ **Post date:** [February 16, 2014, 3:29pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/31 "2014-02-16T15:29:26Z")
My wife’s an MD and most of her friends are. They always recommend “original” if you can buy them, and none have shares and few even work for Scary Pharma. My youngest kid takes Risperidone. Our pediatrician, who’s also our personal friend told us to get Risperdal (original) but since it’s 10 to 20 times the price of generics he told us to buy from to specific labs. His own experience (he works in free clinics,so he always tries to use the cheapes) is that other generics were not as good. ---
**Author:** ![WhyNot](https://avatars.discourse-cdn.com/v4/letter/w/c77e96/32.png) [@WhyNot](https://boards.straightdope.com/u/WhyNot)\ **Post date:** [February 16, 2014, 3:50pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/32 "2014-02-16T15:50:04Z")
> [@mandala](#): > > No I am not, and he did not; but he might have received fancy stuff from the visiting medical reps. In India, doctors are allowed to receive small gifts along with medical literature from visiting med-reps. If you are buying these in India, then I have no idea what the regulatory bodies or quality control or import restrictions are. That would definitely change my initial answer. Now you get an oracular answer: “If you trust your pharmacist in other matters, there is no reason to distrust him in this.” ---
**Author:** ![twhitt](https://avatars.discourse-cdn.com/v4/letter/t/87869e/32.png) [@twhitt](https://boards.straightdope.com/u/twhitt)\ **Post date:** [February 16, 2014, 5:34pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/33 "2014-02-16T17:34:00Z")
Per the [FDA](http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm), > [@](#): > > FACT: FDA does not allow a 45 percent difference in the effectiveness of the generic drug product. > > FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was 3.5 percent[2]. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name drug. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison. > Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product. I do not see the requirement listed on their site, but pharmacists I have worked for and trust tell me that the requirement was greater than 95% similarity, or a maximum of 5% difference. The tested result of 3.5% average difference the FDA cites falls within this range. Also per the [FDA](http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm), > [@](#): > > One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the pioneer drug. There should not be a substantial difference in the rate of absorption for time release products and their generics. This is tested primarily by checking drug concentration in patients over time. Also, any time release mechanism should be substantially similar; a slow dissolving matrix is not the same as a coating, and would not be allowed. Finally, dissimilarities do happen. These differences are generally rare, and well documented in the healthcare industry and the media. In 2006, a generic medication called bupropion XL 300mg was found to work differently from the brand name drug, Wellbutrin XL 300mg. A [detailed account is here](http://pipeline.corante.com/archives/2012/10/18/the_generic_wellbutrin_problem_whose_fault_is_it.php), but the short version is that after a thorough review, the problematic drug was pulled from the market. When there is a proven difference between products marketed as generic, the problem is solved or the drug is pulled. I’ve found no documented problem with Zocef. No matter the problems with the drug industry, your pharmacist should be a knowledgeable and caring professional who is not working on commission, and who has no incentive to do anything other than provide the best possible care. If you feel like he or she isn’t meeting that standard, I would recommend you switch to another pharmacy. If you have a local pharmacy that’s not connected to a large chain drugstore then in my opinion you’re even more likely to get personal attention. ---
**Author:** ![Jackmannii](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jackmannii/32/311_2.png) [@Jackmannii](https://boards.straightdope.com/u/Jackmannii)\ **Post date:** [February 16, 2014, 8:36pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/34 "2014-02-16T20:36:57Z")
Whatever problems exist with American drug companies cutting corners, there’s reason to think far worse is occurring in foreign pharmaceutical plants (i.e. [those in India](http://www.aei.org/article/cheap-indian-generic-drugs-not-such-good-value-after-all/) and China). The FDA is stepping up inspections abroad, but their budget is still insufficient to protect American consumers from substandard products. There will likely be more incidents like the 2008 heparin scandal, when 81 deaths and hundreds of allergic reactions occurred in the U.S. due to contaminated heparin imported from China. The OP’s pharmacist’s concern over the quality of generic antibiotics in India could be well-founded. ---
**Author:** ![staili](https://avatars.discourse-cdn.com/v4/letter/s/c57346/32.png) [@staili](https://boards.straightdope.com/u/staili)\ **Post date:** [February 17, 2014, 12:03am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/35 "2014-02-17T00:03:54Z")
If the 80 to 125% bioavailability number is accurate, I’m not sure why the FDA is saying they don’t allow a 45% variability in bioavailability. ---
**Author:** ![TheBori](https://avatars.discourse-cdn.com/v4/letter/t/ee7513/32.png) [@TheBori](https://boards.straightdope.com/u/TheBori)\ **Post date:** [February 17, 2014, 2:40am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/36 "2014-02-17T02:40:27Z")
> [@ftg](#): > > You do understand that not all drug companies have strong ethics, extensive testing and such, right? These are businesses. They cut corners. The ones in the low end of the business, which generics makers typically are, cut a _lot_ of corners. > > The FDA doesn’t have a tiny fraction of the resources to verify the claimed purity, potency or effectiveness of all the drugs put on the market. In fact, drug companies lobby Congress to cut the FDA’s monitoring budget, and succeed. > > Just because there is a law mandating something, doesn’t mean it actually happens. Especially when big corporate profits are at stake. I worked in “Big Pharma” for 12 years. The amount of data, documentation and auditing required to manufacture pharmaceuticals in this country would literally make you take a step back. I supported a parenteral plant where sterile injectables were manufactured. We owned our own incinerator to burn any lots of product that “might” have been compromised during the process. I say might…like if an operator did not sign and date one of the steps in the manufacturing ticket. The potential downside of a fatality and/or recall (in both money and loss of credibility and reputation) far outweighs the $3-5 million you lose when you burn the lot, much less what you would save cutting a corner. It costs upwards of $1 billion to identify, develop and test a drug BEFORE it ever gets to market. And only 1 drug in ~2000 makes it to the pharmacy. There’s your high cost of brand drugs. You have to pay for the losers. Generic manufacturers have no such up-front costs. They wait for the patent to expire (that clock started ticking 8 years before the drug ever made it to production) or sue the manufacturer in an attempt to invalidate the patent, copy the formula and make it. The cost is not in the product, but in the research and development. Generic manufacturers don’t develop anything. Thank your lucky stars for big pharma. Oh, and by the way, Bio-equivalence does not mean that the pharmacokinetcs are the same. Ask Dr India for the data.oh, that’s right… ---
**Author:** ![dropzone](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/dropzone/32/7515_2.png) [@dropzone](https://boards.straightdope.com/u/dropzone)\ **Post date:** [February 17, 2014, 4:11am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/37 "2014-02-17T04:11:46Z")
> [@twhitt](#): > > In 2006, a generic medication called bupropion XL 300mg was found to work differently from the brand name drug, Wellbutrin XL 300mg. A [detailed account is here](http://pipeline.corante.com/archives/2012/10/18/the_generic_wellbutrin_problem_whose_fault_is_it.php), but the short version is that after a thorough review, the problematic drug was pulled from the market. “Worked differently?” As in “did nothing whatsoever?” Yeah, I think I had some of them. ---
**Author:** ![twhitt](https://avatars.discourse-cdn.com/v4/letter/t/87869e/32.png) [@twhitt](https://boards.straightdope.com/u/twhitt)\ **Post date:** [February 17, 2014, 6:42am UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/38 "2014-02-17T06:42:32Z")
> [@dropzone](#): > > “Worked differently?” As in “did nothing whatsoever?” Yeah, I think I had some of them. Sure. Many people did. Do you remember what happened as a result? For my patients, we were able to work with them, their doctors and their insurance to find a solution that worked. This wasn’t always the same; sometimes we were able to give the patient the brand name, sometimes they switched to Wellbutrin SR, some were switched to other medications entirely. Things sometimes slip through the cracks, but the FDA does not work for the drug companies, and your pharmacist doesn’t either. When there’s a problem, you should feel that they’re working for you to provide you the best possible care. You’re empowered to take your business elsewhere, and you should if you need to. [QUOTE=staili] If the 80 to 125% bioavailability number is accurate, I’m not sure why the FDA is saying they don’t allow a 45% variability in bioavailability. [/QUOTE] Why is this 80% to 125% thing floating around? It smacks of urban legend to me, and we’re in GQ. Anyone have a cite for this? ---
**Author:** ![D18](https://avatars.discourse-cdn.com/v4/letter/d/c57346/32.png) [@D18](https://boards.straightdope.com/u/D18)\ **Post date:** [February 17, 2014, 7:31pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/39 "2014-02-17T19:31:05Z")
It’s that the 90% confidence intervals have to fall 80% to 125% of the brand. So say they find that the bioavailabity of the generic was 95% that of the brand. Because of the small sample, there will be wide-ish statistical error. So even though the lab test may find a bioavailability of 95%, in reality, that could be quite a bit lower or higher. So as long as they are 90% sure that the bioavailability is 80% to 125%, then the generic can be produced. Now, let’s say a generic formulation was really bad. They’d do the test and find, say, that it was 82% of the brand. Even though that’s above 80%, it still won’t be good enough. Because of the wide confidence interval, that could be much lower. So it wouldn’t be approved. ---
**Author:** ![VinylTurnip](https://avatars.discourse-cdn.com/v4/letter/v/b2d939/32.png) [@VinylTurnip](https://boards.straightdope.com/u/VinylTurnip)\ **Post date:** [February 17, 2014, 8:41pm UTC](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438/40 "2014-02-17T20:41:24Z")
> [@twhitt](#): > > Finally, dissimilarities do happen. These differences are generally rare, and well documented in the healthcare industry and the media. In 2006, a generic medication called bupropion XL 300mg was found to work differently from the brand name drug, Wellbutrin XL 300mg. A [detailed account is here](http://pipeline.corante.com/archives/2012/10/18/the_generic_wellbutrin_problem_whose_fault_is_it.php), but the short version is that after a thorough review, the problematic drug was pulled from the market. Which, I was surprised to discover, just happened [yet again](http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm), this time with the Watson generic bupropion XL 300mg. It’s down to three manufacturers now, not counting the brand name Wellbutrin. [Previous page](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438.md?page=1) [Next page](https://boards.straightdope.com/t/any-truth-to-what-my-pharmacist-is-saying/681438.md?page=3)