Are Generics As Good As Brand-Name Meds?
11 CommentsBy Ed Silverman // March 17th, 2008 // 11:35 am
This is a bit like asking ‘When is bioequivalency not bioequivalency?’ The age-old debate over the use of generics is raised again by The Los Angeles Times, which quotes a variety of docs and cites a few examples in which assumptions about generic substitution are infused with doubt.
For instance, ConsumerLab.com today reported that its investigation of generic versions of Toprol XL may raise blood pressure rather than lower it and cause atypical side-effects, and that certain generic brands contain ingredients not found in the original and don’t necessarily dissolve like Toprol XL. These differences can potentially trigger chemical sensitivities and result in differences in absorption, the site concludes, adding that the findings of this and other studies its conducted suggest a bigger issue of generic “inequivalence” affecting a wide range of generic drugs.
The Times, meanwhile, notes that the American Association of Clinical Endocrinologists, the Endocrine Society and the American Thyroid Association joined voices in 2004 to warn that patients with hypothyroidism could be harmed by switching among the many generics used to treat the condition.
“Everybody thinks generics are swell: To suggest otherwise is like saying you don’t love your mother,” Peter Kowey, chief of cardiovascular diseases at the Philadelphia area’s Main Line Health System, tells the Times. “We are concerned that the margin of difference is large enough” to risk patient health.
Kathleen Jaeger, who heads the Generic Pharmaceutical Association, dismisses the debate as “misinformation campaigns” masterminded by brand-name drugmakers. As their most profitable meds face competition from generics, Jaeger tells the paper, they try to “extend their monopoly” by sowing doubt in the minds of docs, pharmacists and patients about the quality of the cheaper substitutes.
Well, this much is interesting. Two of the three docs who are quoted by the paper as being skeptical of generics both have ties to brand-name drugmakers, although the paper doesn’t point this out. For a November 2006 CME presentation, Kowey disclosed he is a consultant or an adivsory board member for AstraZeneca, Glaxo, Procter & Gamble, Sanofi-Aventis, Solvay and Wyeth. And Gerald Naccarelli, chief of Pennsylvania State medical center’s division of cardiology, has a long list of fees he has accepted from Pfizer, Sanofi-Aventis, Glaxo and Wyeth, among others.
This is a provocative story, so read on. But what do you think?
Are generics just as good as brand-name meds?
- No (52%, 74 Votes)
- Yes (48%, 69 Votes)
Total Voters: 143
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Lisa Van S
I Voted “NO”, and I have no financial ties to Industry. The generic Zithromax didnt work as well as the brand-name did for me.
Jack2
I voted “yes,” despite ties to the industry.
Even so, I just want to point one potential downside to generics by how pharmacies stock generic medications.
A generic is rated as bioequivalent if it delivers the active component of the drug within 80-125% of the brand name drug. When someone takes the brand name drug they always get a drug produced by the same company, and, presumably, always take an identical medication. When they go to generic they get switched to a new formulation from company X. For example, the new formulation might only delivers 80% as much drug as the brand, so the person gets 20% less drug. This may sound like a big difference, but most of the time this is normally not really a big deal. In the unlikely event it was a big deal, for example you’re no longer getting enough effect from your drug, the dose could be adjusted to compensate for this difference.
The thing is any given pharmacy doesn’t always buy the same generic - they just get the one their wholesaler carries - and the wholesaler almost always carries whatever one is cheapest at the time they ordered. So now someone goes back to the pharamacy to refill their prescription, quite satisfied with company X’s generic. But now the pharmacy dispenses a generic from company Y, since the wholesaler swtiched. This formulation delivers 125% of the active ingredient. Had the patient been on the brand, this would only deliver an extra 25% of the drug, but if the patient switched from company X’s generic (s)he increased the amount of drug he took by >50%.
Even so, this change usually doesn’t make much difference. I just point it out because it’s just one small speed bump you face when using generic drugs you don’t face with brand medication. However, from a society perspective, the cost savings compared to the minor and rare downsides of generic medication are enormous.
Justice in Michigan
Tend to agree with Jack 2, although, like Lisa and probably all of us, I have problem generic stories to tell.
Of course, the empirical issue is how many individual clinical experiences add up to a real question, and what do the numbers really show. At this point, although not earlier, generics are presumed innocent by most providers.
I didn’t vote because, even now, I think we still need better data even for the “big picture.”
Nathan
Jack2,
Here’s one thing I’ve never understood about this bioequivalence: Is this determined in an animal model or in humans? I thought that a generic medication did not have to perform ANY tests in humans to demonstrate bioequivalence. Is that correct? If so, what animal species is used? How can we be assured that the results will translate to humans?
david egilman
Must be ok. The bulldogs at the FDA approves them so by definition everything is fine?
No?
Jack2
It’s done in healthy humans.
I believe the studies are normally cross-over studies (brand to generic or vice-versa) and the analyzed parameters are Cmax and AUC. I assume it must be different with highly toxic drugs (oncology), or drugs that aren’t oral but I really don’t know how it differs.
RTW
The only thing in common between a Generic and a Brand name is the active ingredient. Sometimes the same salt form and perhaps the same fillers or buffers. The Brand name often has a lot of very high tech proprietary (IE trade secret) dissolution technology involved in the product.
The patents from which the generic is created by the generic manufacturer almost never come right out and say how these incipient, particle sizes and a myriad other properties are enabled in the final capsule or tablet is made. A considerable amount of technology goes into getting the active ingredient to be absorbed/dissolved in the digestive track. A lot of factors go into the formulation, most of which are not known or can be reversed engineered by a generic manufacturer. Even today with Dilantin off patent for probably 40+ years. No one makes a generic. Its only available as a brand name because no one other than Parke-Davis ever had been able to make a formulation of it that works. Its a Trade secret and people have been jailed for trying to steal it and sell it to other companies.
I have been involved in the past when I worked in the industry on drugs that although active as all get out failed because they couldn’t be formulated. Some we even milled to nanometer particle sizes to help them get dissolved to no avail. Usually ended up excreated before it was absorbed even through they where sub nanomolar active in solvents we could get it disolved in (none of which was human compatible!) I am sure plenty of other people from inside the industry would have similar stories to tell. Just because you have an active compound is only the start of the problem. As much research is done on formulation, dosage form and when to take the drug as creating the active ingredient.
Frank
Making a drug is a lot like making a cake. If I gave 4 people the same ingrediants and the same recipe, I guarentee that the resulting cakes will all taste different. It is what it is! With drugs, however, you are playing with your life. Generic antibiotic - should be fine. Generic blood pressure - I would be cautious. You want the best product in your system working as it was intended to. If I want my mother’s chocolate chip cookies with walnuts, I will ask her to make it and not some guy around the globe.
Generics have their place, just not for me!
RTW
Jack2 yes CMax and AUC would be the measure. And yes Toxic/Oncology drugs are never tested on healthy people. But typically Generic manufacturers don’t have the technology initially to do complex formulation. In the small sample of healthy people they do the comparison on the CMax and AUC may very well be equivalent. But in significant numbers of consumers these generics may not work as effectively.
I have know several people that have been switched to a generic and they have eventually ended up back on the brand name when the generic didn’t work as well. One fellow told me he was having to more than double his dosage of the generic compared to what he was taking of the Brand name to control his illness. Not on his own mind you even the doctor said so. It was not more cost effective at that point.
BTW another thing is the Pharmacies make a lot more money on the margins/markup of a Generic over that of a brand name, so its in their best interest to switch to a generic if the precription doesn’t specify the brand name.
Jack2
Pharmacies do make more money on a generic script than a brand name script. And pharmacies don’t just want to switch someone to a generic - they have to switch someone to a generic if it’s available and the doctor didn’t expressly forbid substituion (the default assumption when the doc writest the script is the pharmacist will substitute).
However, just because everyone may know a guy who knows a guy who had a problem with a generic once doesn’t mean they don’t usually work, don’t save a ton of money, and the difference wasn’t just in the guy’s head.
I’m the first person to roll my eyes when, some guy goes nuts with a rifle and we find out he was/is on some new CNS drug - and then out of the woodwork come 40 people on this site claim they’ve now conclusively proved this CNS drug causes people to go nuts (wouldn’t someone likely to go nuts be on a CNS drug in the first place?). So just because we all know a guy who knows a guy doesn’t mean generics don’t work either.
If the formulation is so precise and difficult that a generic company can’t copy it then fine - they didn’t copy it, and they won’t be able to market it - and that’s a rare case. But if they did duplicate the drug’s PK, then it’s copied.
Jpharma
I make drugs and I can tell you this: generic drugs are bioequivalent as brands but they are not the same in every aspect of their composition. The small differences may sometimes play a role.
A well known and documented case is that some brands of aspirin caused stomach ulcers why others didnt. And they were all bioequivalent.
It was later found out that some had larger particle sizes than others and this was causing it.
Generics are like other products. There are good and bad products from good and less good companies. The FDA can not control every drug in every aspect. A lot is in the hands of the manufacturer. You should know who makes the drug and, idealy, its active ingredient too. And then make your choice. Going for the most expensive or cheapest offer is rarely the best choice.