Hacker News Reader

Comment by SamoyedFurFluff | Hacker News Reader

This is comparing to generic drugs from one specific company, based on the notion that the specific company is capable of providing a cheaper generic drug in a situation most favorable to the drug maker (a bulk purchase). It doesn’t actually go into if the generic will actually be a suitable replacement for each patient. For people with complex health needs, like the over 65+ folks on Medicare, it makes total sense to be on precise, non-generic drugs. I’ve known plenty of people with complex health needs that cannot take the generic, for whatever reason. Hell, I know people with needs like ADHD (a single diagnosis, not a complex health case) that cannot take a generic version.

View on HN

Yeah no.

Generics -are- equivalent and regulated to be as such. [1] If you are hearing anything different it's just BS.

[1] https://www.fda.gov/drugs/questions-answers/generic-drugs-qu...

Yes but no. Generics are not 1-1 substitutes because the FDA allows some (a lot) of wiggle room when it comes to bioequivalence.

A really good example where this fails miserably is Adderall for ADHD. The generics are absolutely miserable. And if you actually find a generic you tolerate you can never switch pharmacies because they’ll be different.

I’m no pharmacological expert but when I asked my pharmacist they explained it to me they said it was because Adderall is a mix of two drugs and it’s expensive to refine them into a balanced ratio but the FDA doesn’t care so generics don’t bother.

I believe it's therapeutic equivalence that the FDA is lax on, not bioequivalence. Bioequivalence is just "does it deliver the same amount of the active ingredient," theraputic equivalence is "does it deliver the active ingredient in the same manner." The active ingredient is the same, the inactive ones are where the difference lies. Usually, they're similar enough that it doesn't really matter, but some drugs really do benefit from buying the name brand.

A good example is with methylphenidate generics - you get the same amount of methylphenidate, but the name-brand extended release is far more effective than the generic extended release because it spreads the same amount of active ingredient over a longer period (the delivery mechanism created by the inactive ingredients in some generics is subpar).

Occasionally, you'll get non-bioequivalent generics that slip through FDA approval, which happened to some methylphenidate generics [0][1]. I remember getting switched to the name brand when this came out, as the supplier for all the pharmacies near me used a non-bioequivalent manufacturer. (Authorized generics don't have this problem since it's literally the name brand with generic labels slapped onto it, but the one the nearby pharmacies could get through their suppliers was not the authorized generic.)

[0]: https://www.fda.gov/drugs/drug-safety-and-availability/quest...

[1]: https://www.reddit.com/r/ADHD/comments/3af86d/fda_rules_2_fo...

ADHD medication is an excellent example illustrating the potential "wiggle room" differences between generics and brand drugs. The composition is similar enough to meet FDA generic drug standards, but the rate at which the generic drug mechanisms distribute the drug differs and potentially decreases treatment efficacy for many patients.

Though, I do wonder if Vyvanse becoming a generic brand will help solve this dilemma, because the release mechanism is tied closer to the individuals metabolism via hydrolysis of an amino acid rather than relying on release rates set by minor manufacturing differences.

The rules aren't strict enough IMO but the observed variation is very low in practice. Australia allows very similar amounts of wriggle room in theory [1].

Most people I know in Australia with ADHD are treated with generics (very common among my friend group for some reason) and none that I am aware of have noticed any substantial differences between generics and brand name equivalents but I couldn't quickly find any studies that have investigated this.

I wonder if that is due to variation in balance of the included amphetamines (as most of these are multiple active ingredients) though as I doubt that the inactive ingredients would play a significant part.

[1] https://www.nps.org.au/assets/fc20fd821a02cf80-8d2289edb5e3-...

They aren't perfectly equivalent, but see my sibling comment.

Coke and Pepsi and RC Cola are equivalent but they are not the same. People can react differently to equivalent medication.

There's certainly nobody that can't take a generic medication, barring unusual ingredient allergies. What is actually happening is that people "dialed in" the dose they need on a different formulation of a drug, so they'd need to go through the process of figuring out the correct individualized dose for them if they switch to a different version. It would probably have made more sense for them to have started with a generic version so they don't have to go through this process more than once.

Wait what? This analysis is very much a broken window fallacy (fallacy of the seen vs the unseen); there are also very likely individuals "who can only take the generic version" because maybe the dosing schedules/bioavailability are slightly tweaked by the fillers or delivery additive, etc.

Sure, this is a valid point. But this is not true for the majority of Medicare patients and, importantly, not why this is the case. This is happening because of existing deals and non-competitive drug purchasing.

Generics are literally identical to the original drug.

Anecodtally, my wife had significantly different experiences with two different manufacturers of a generic prescription pain management medication that came in patch form. The medication might've been the same, but the amount that made it into her system seemed to vary enormously based on which company’s patches she received. Same dosage, same delivery method.

There’s more than just the raw chemical in play in a lot of meds.

Bioequivalent as judged by the FDA does not at all mean identical.

ETA: The fact that generics are not “literally identical” is probably the most important scientific, policy, and commercial consideration in that industry. FDA has to determine whether the benefits of lower costs justify the potentially lower efficacy, and set bounds for how different a generic can be and still count as “bioequivalent.”

Reply on news.ycombinator.com