re the differences between original and generic drugs - most vets know that diazepam can occasionally cause “fulminant hepatic necrosis” - ie it can seriously cock up the liver - in cats when given orally. This has, apparently, never been shown to be the case with the original “valium” made by Roche - possibly a coincidence, possibly not.
Gotta say… not the best answer I’ve seen Cecil Slang… The question clearly stated that Dave C. wanted to know about over the counter drugs, but the only mention of any over the counter stuff is a small blurb about cough syrup in the final paragraph… You would have at least thought that he would have presented analysis on the three drugs mentioned in the question (Tylenol, Motrin, and Sudafed) vs. their clones…
It was still very interesting though…
Wayfarin (Coumadin) MUST be closely monitored by a health care professional with regular blood tests (similar to a diabetic checking blood sugar levels)- too low and clots can form which can then cause a stroke. Too much and your blood won’t clot for minor or major wounds. Hence, Cecil’s claim on generics is pretty much shot to hell since, for this drug, it’s monitored and doses are adjusted.
Anecdote != evidence. I’m sharing mine anyway. I’ve found that one particular generic brand of my most important prescription drug simply does not work. Research indicated the company uses a different (cheaper) processing method for the main ingredient, and while it technically results in the same percentage of that ingredient it is not released as readily. To get the same results I had to take a larger dose. I now pay extra for the name brand.
Then it gets interesting. I refilled another of my meds, which I’d used a generic brand of for some time, and noticed it wasn’t working well. Checked the brand – same manufacturer as the other stuff that didn’t work. Switched to a different generic and we’re back in business.
My point is that SOME generic drug manufacturers (at least one anyway IMHO) produce a techically similar but functionally different version.
I actually have a problem with one of Cecil’s columns! Never thought that would happen.
The drugs he focused on, Digoxin, Warafin, and phenytoin, are all drugs that the blood levels really matter. They are normally monitored pretty closely until the therapeutic range had been reached… For these drugs, it doesn’t really matter gerneric vs. brand, as much as manufacturer. These are drugs where you don’t want to substitute someone from the manufacturer they started on, be it a generic manufacturer or the brand company.
One thing I will agree with, some generic manufacturers are better then others, and I have seen people being allergic to some of the fillers in one generic, but not another.
I also have a beef with this column. I used to work for a generic drug manufacturing plant in the Montreal area and I’d like to point out that Health Canada’s standards are very strict for generics. I know this column is written by an American for a primarily American audience, but as many Americans travel up here to purchase drugs I wish Cecil had pointed out that (literally) YMMV.
(If anecdotes are allowed, I once sat in on a meeting where it was announced that hundreds of tubes of medicinal skin cream would be destroyed because of a labeling error. All the ingredients were correct, but two non-medicinal (filler) ingredients were listed in the wrong order. Any discrepancy was enough to trigger immediate action.)
I’m pretty sure Cecil emphasized that the only time that generics have been noted to give worse results are with those that pretty much require exact bioavailability to work. The reason that generics of the same dosage will give different availabilities is that the inactive ingredients (fillers) affect the absorption rates. For some medications, the only important thing might be that the drug eventually makes its way into your system; as long as it all gets absorbed by the time it gets through your digestive track, it should be basically identical. Most are probably somewhere in between, and while generics might affect the efficacy, it isn’t something you should worry all too much about.
However, I do empathize with those that were possibly expecting an answer regarding Tylenol vs. CVS brand acetaminophen. While OTC analgesics are not nearly as life critical as blood clotting medication, the bioavailability of the drug can definitely affect its quality as perceived by the user. Of course, there’s probably a lack of studies of this sort of thing because those with the money for them just don’t care enough.
[off topic] What the heck is up with that cartoon accompanying the column?[/ot]
True enough. But… I’ve been explicitly told, “You can get {Brand A Warfarin} or generic Warfarin, but don’t allow your pharmacist to substitute {Brand B Warfarin}; it acts funny.”
Shite column imo, it would have been nice if Cecil had actually addressed the question that was asked. Hopefully Dave C. from Wisconsin will protest!
Is brand name Tylenol any safer or better than Target or WalMart brand? Is the absorption comparable? What kind of binders do they use? Are they really manufactured in the same factories?
It appears to be Dave C. removing the blindfold from his wife, who is upset either that hubby gave her inferior drugs or subjected her to a double-blind test over a headache. I admit that I thought the blindfold was a bra at first, but remembered that Slug’s bras and boobs all look like they could poke an eye out.
A few more points to make about this:
- To say that the 1984 Hatch-Waxman law lowered the bar for generics doesn’t tell the whole story. That law opened the door to generics for drugs approved post-1962. Generics for pre-1962 drugs were previously available, and there was a generic drug industry before 1984. The significance of 1962 is this: in that year the bar was raised for all new drugs, requiring evidence of efficacy before approval. Before 1962 (going back to the first law in 1906), the only requirement was evidence of safety. So, the bar wasn’t really changed for generics, it was raised for brand name drugs.
- As one previous commenter noted, anecdotes don’t equal evidence. There are a few drugs for which claims have been made that generic versions don’t work as well, but there’s a MOUNTAIN of evidence that generics are equivalent. FDA looks carefully at all evidence of inequivalence. Yes, I can hear the cynics scoff about whether FDA can handle the job, but you have to think about where the adverse information about generics comes from. The brand name companies perhaps, who are losing their shirts to generic competition?
- Not all products have generic equivalents. There is a system of classification for therapeutic equivalence, and the narrow therapeutic range drugs like Coumadin are not interchangeable from one manufacturer to another. All pharmacists know this, and are not allowed to make an inappropriate substitution.
- With regard to over-the-counter medications, which is what the question was about, it should be noted that most of these products are NOT individually approved as are the generic prescription drugs. Generic prescription makers have to submit their evidence of bioequivalence, along with manufacturing and testing technical data, to FDA which takes maybe a couple of years to review and approve it. No subsequent change can be made without going through another clearance process. There are requirements to report manufacturing and clinical experience annually, and to report immediately any product defect found in marketed products. Not so for over-the-counter medications. The OTCs have to adhere to FDA standards (called monographs) that establish what the ingredients and disease claims can be, but there are no requirements to show bioequivalence on a product-by-product basis. On the other hand, OTCs are inherently less critical than prescription drugs, and FDA’s monograph standards are based on pretty good safety and effectiveness data. Are house-brand cough-cold drugs as good as the brand name? Probably, but the evidence is nowhere near as good as for prescription generics. Also, there are lots of products in stores, particularly in the health food sections, that are not covered by monographs and for which data of effectiveness is simply unknown.
- To complicate things, some OTC products (like Motrin and Rogaine) started life as prescription products and were later switched to OTC as experience accumulated that self-medication was safe. Generic versions of these drugs may have gone through the same approval process as for prescription drugs; that is, submission of bioequivalence data, etc. to FDA. Others may not. How does a consumer know what has been FDA-approved and what hasn’t? For one thing, federal law prohibits a manufacturer from indicating FDA approval on labels. Go figure. You can also spend a day going through databases on FDA’s web site, but that’s another story.
I will have to agree with most of the comments posted.
Having worked in a Pharmacy for years, I can tell you that the likelihood of getting a branded drug when a generic exists (unless you or your physician asks for it) is basically nil. They cost the Pharmacy too much, insurance providers don’t cover them, etc.
Some people do have problems switching, but this is less of switching from a “good” brand name drug to a “cheap knock-off” generic and more like switching between different manufacturers of the same drug.
You can have the same problems switching from one maker of a generic drug to another maker of the that drug. So the question isn’t really brand-vs.-generics, but of manufacturers, of which the branded drug is just another manufacturer.
So what does this mean to us? Not much actually. Unless there is a shortage or a significant change in pricing scheme, Pharmacies tend to purchase the same makers of the same drug as they had previously done before.
So if you walk in to the Pharmacy with a prescription for a drug, you will get the generic if it exists. The theoretical therapeutic difference between the branded drug and its generic equivalent does not matter as long as you still keep getting the same manufacturer of that med, and the dose can be adjusted to produce the desired outcome. Remember that medicine is more art than science, so it is not always possible to predict the outcome that a particular drug may have.
The advantage of a branded drug is that it represents a known manufacturer. If you get Prinivil branded lisinopril, you know that Merck made that drug, but as a patient, if you get a generic lisinopril, you don’t know whether it was from Teva, or Wyeth, or Abbot, or any number of other generic makers. Just keep getting your meds at the same Pharmacy, and you shouldn’t have to worry about it (your Pharmacist can be more effective for you if you only get your prescriptions filled at one Pharmacy anyways, so this is all around good advice).
This whole article sounded like it was either paid for by Big Pharma, or else that all the sources that were used to research it came from studies by Big Pharma to scare people away from generics. I suppose Cecil, as the world’s smartest human being, doesn’t have to cite sources. Some transparency would have been nice in the article as to where the information came from.
Rack-a-Bones said:
That’s Slug’s rendition of
There is the apocryphal story about a manufacturer who responded to its drug going generic in a creative way. This mfgr found a small “generic” company whom they paid to produce a generic explicitly DESIGNED to be inferior. It then used this as evidence against the quality of generics. Smart, eh?
Well I know personally they can be very different. When I had my wisdom teeth pulled out, the dentist gave me 7.5 mg hydrocodone which I got from CVS. I took 4 of them that night (the limit before acetaminophen hepatoxicity) and they did absolutely nothing. Then when I had knee surgery a few months ago, I was prescribed 10 mg hydrocodone and got them from Walgreens. One of them repeatedly did the job nicely. I decided not to get any more analgesics from CVS.
One reason I do not mention my (occasional) staff reports on my resume is because of Slug’s illustrations of Cecil’s column. I’m used to them and can use them to induce vomiting when needed.* I am more careful of potential employers. :eek:
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- Yes, I know Slug might/will take this as a recommendation. Bro, you being one of the SICKEST cartoonists around (besides, but barely, the scat cartoonists) you have sickened me for decades and can sicken me forever more.
- Yes, I know Slug might/will take this as a recommendation. Bro, you being one of the SICKEST cartoonists around (besides, but barely, the scat cartoonists) you have sickened me for decades and can sicken me forever more.
Your implication that Cecil takes money from or is influenced by “Big Pharma” is both unfortunate and incorrect. I can’t even list the ways in which that is off-base.
Regarding citing sources, sources are not put into the print column, as there is simply no space in an 800-word limit. Selected sources are added to the column online within about 1-2 days after the column runs.
FWIW after a long hiatus due to massive workloads for people, we are back-adding some sources to past columns, at a rate of about 4-5 past weeks per week, give or take. It depends upon how busy we are.
Una Persson:
I’m sure Cecil doesn’t take money from the pharmaceutical industry, but it’s a reasonable question to ask if any of the cites were from articles funded by pharma. A lot of the research out there is funded by them and can be biased.
That being said, there is evidence that some generic drugs differ in action (and adverse events) from their branded counterparts. And it’s not an easy task to get insurance companies to pay for brand name drugs.
I normally get generics, but I thought I had an option to get brand name, if I pay some difference in cost myself.
Like if a generic is $4 and the name brand is $25 for my cost. Does the Insurance company pay more for name brand in that case? Probably, I’m sure the markup on name brand drugs is extraordinary.