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Comment by soangry | Hacker News Reader

I'm so angry right now. I did a deep dive into this at one point after being prescribed some generic Vyvanse through Sun via Dillons/Kroger. The pills smell like fish and seem like they didn't work at all. I checked some records from the FDA and Sun wasn't listed. I brought it up to my doctor and they just brushed it off.

I really hope another class action lawsuit is brought against Sun.

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The "fishy odor" is a classic hallmark of amine-containing compounds [1], of which Vyvanse has three [2], including a terminal amine, which is so infamous (at least in the di-amine form) for being smelly that they have delightful names like "Cadaverine" [3].

I don't know if the completely purified drug officially has an odor, but usually you get some free amines that come along for the ride. More likely, some got outside of the gelatin capsule during shipping.

[1] https://www.science.org/content/blog-post/amines-and-landsca...

[2] https://en.wikipedia.org/wiki/Lisdexamfetamine#/media/File:L...

[3] https://en.wikipedia.org/wiki/Cadaverine

I pursonally took Vyvance brand name for over 1.5 years by opening the capsule and mixing it in a bottle of water. Never did it have a smell or taste. Even if Vyvance is manufactured with compounds that often have a smell or taste associated with them, the fact that this generic smelled almost certainly speaks to lower quality controls than the brand name based on my experience. At the very least it would speak to them choosing a component that smells over one that does not.

> Even if Vyvance is manufactured with compounds that often have a smell or taste associated with them

Just to be clear: it's not "associated" -- the drug itself probably smells, and you just didn't notice it. It's very, very common with drugs containing amines.

Metformin, for instance, has a distinctly fishy odor (but it also has a couple more amines):

https://en.wikipedia.org/wiki/Metformin#/media/File:Metformi...

from my experience washing some mediocre amphetamine cooks,

the fishy smell is not characteristic of pure amphetamine, but leftover methylamines from synthesis.

vyvanse adds a lysine but none of these amines are free. it’s odorless as well, but any lysine esthers leftover will stank.

it was shit product

Yes, that could be true, it even likely is. The point I was making is that if I can take apart the capsule and drink the contents mixed with water without noticing a smell or taste, there is a significant difference between brand name Vyvance I aquired during that time and what the other commenter acquired. Given the odor is undesirable, I would say the meds they acquired were much lower quality than the brand name ones I had (which of course I am just assuming are reletively representative).

Good info. Thank you. Only one batch had that very distinct fish odor. Was right after the Vyvanse patent lapsed and went generic.

I have nothing but respect for physicians but my experience is that each acts as a more narrow filter than the last and, beyond their direct expertise they have very little expertise in billing, pharmacy or anything outside of their direct domain, nor do they have the bandwidth for it. Add to that the advertising phenomenon of 'ask your doctor about X' and I suspect that anything beyond the immediate care you're receiving has very little chance of receiving thought/cogent answers.

I respect doctors (and people in general), but I don’t give the medical profession a passing grade. To speak in generalities (there are exceptions), their training is somewhat insane: long hours, sleep deprivation, knowledge cramming, and more. Their daily practice leaves little time or incentive for keeping up with studies. Most were not adequately taught statistics in the first place. To vent a bit more, I don’t think it is unfair to say the system is crap. If we could redesign it from scratch, understanding human nature, how people learn, and the need for ongoing learning, and evidence-based medicine, it would not be this. None of this is meant to assign blame to individuals.

>Their daily practice leaves little time or incentive for keeping up with studies.

Their certification requires it, at least to some extent.

Two responses. First, CME is criticized as being largely influenced by industry rather than primarily intended to advance medical learning. [1]

Second, assuming medical continuing education is something like 20 to 40 hours depending on the region [2], this feels meager and insufficient. In contrast, think of how much learning a software developer does during a year -- perhaps close to 5+ hours per week on average! [3] Very different contexts, very different incentives.

[1]: https://www.chronicle.com/article/lessons-from-a-professors-...

[2]: Based on very quick research: could be off -- corrections are welcome

[3]: There are many differences, of course. Just to pick one example: to what degree does a software developer's continuing exploration into an area (such as a specific business process that their application needs to understand) help their craft? Does it improve their skill level? Does it result in transferable skills? Does it improve the quality of their work?

A software developer is not required to do any continuing education at all.

Ok, but you are moving the goalposts relative to my original quote: “Their daily practice leaves little time or incentive for keeping up with studies.” My first point is that software developers (generally, more often than not) have the time and incentive to learn on an ongoing basis.

Second point: if continuing education has to be mandated, it is likely a symptom of a system that lacks proper incentives.

On the positive side, as more patients educate themselves and press doctors for statistical understanding and synthesis across studies, “Dr. Expert’s” stale knowledge will no longer fly.

Mandated continuing education isn't a sign of missing incentives, it is the incentive. Being required to do something to keep working in the field seems like a pretty strong incentive to me.

But I certainly won't dispute that doctors in most systems in the US are overworked starting at least in residency.

We both know there is a difference between intrinsic and extrinsic incentives. This difference underlies so many things, including: (i) justification for regulatory frameworks; (ii) individual motivation; and (iii) likelihood of follow-up / compliance.

> if continuing education has to be mandated, it is likely a symptom of a system that lacks proper incentives

I’m a pilot and work in finance. They both have continuing-education requirements. The ones in the former are practical and helpful. The ones in the latter are mostly performative. (In some cases, arguably counterproductive.) The existence of continuing-education mandates per se tells you almost nothing about the system as a whole.

Point taken. Interesting example. Do you have some theories about why continuing education requirements are so different in aviation compared with finance? Some factors might include: individual skin in the game, observability, feasibility, and the temporal and causal distance from action to consequences.

> Do you have some theories about why continuing education requirements are so different in aviation compared with finance?

Culture of professionalism. That’s kind of a bullshit answer, but it’s the closest phrase I can come to that encapsulates pilots taking the rules seriously, both because they’re there for a good reason and the FAA isn’t afraid to yank your wings, but also because the FAA isn’t usually making rules to seem tough on pilots or otherwise infantilise them, it’s following an evidence-based approach that’s explicitly endorsed by pilots. (After a crash, you aren’t trying to find who to blame. You’re trying to prevent the next crash.)

Software developer doesn't hold a certification from a trade group that has a government violence backed monopoly on deciding who can make a buck performing said craft.

Yes, they're missing a pretty strong incentive.

It is a rubber stamp cert. I’ve been to a continuing medical education talk. It is your bog standard visiting scholar giving a 45 min talk of their research. Lecture hall is sleepy aside from the usual suspects. Sheet pizza from the cheapest place in town is being served. People are nodding off in the back. About the only way you can tell this is a continuing medical education event is the clipboard and pen being passed around for MDs to sign their name along with a signature.

It is a far cry from actual class. Learning isn’t required only saying you were there.

I have plenty of criticisms for the physicians lobby in the US, but kind of agree this is one area where I'm not sure the problems lie in physicians (outside of some very general sense that they tend to be in key positions of influence in healthcare systems in government and elsewhere).

I do think it's a good example of why pharmacists should maybe have more power in the drug prescription process, and also wonder why insurance companies or pharmacies don't ban drugs from certain places and/or sue them themselves more often.

Oh boy. I've had quite the experience with my own ADHD medication (dextroamphetamine in my case, which is essentially the stuff Vyvanse metabolizes into), and when they substituted for a different brand, that brand was completely different and so totally not compatible with this body. So now I have a Brand Medically Necessary because when they tried to switch it on me I went into hypertensive crisis :)

The drug you mentioned had a reputation for these sorts of problems.

I had the same exact issues on generic Vyvanse, which also causes me intense palpitations compared to the brand-name, I legit thought I was going to have a heart attack several times a day. So much so, that I quit it altogether—I couldn’t stand the side effects or the constant unavailability of the brand-name.

How did you find out what factory the Vyvanse was made at?

You can figure out the generic manufacturer by matching the active ingredient with the pill shape, color, and imprints on a pill identification website. Finding the exact factory of that manufacturer is much harder though.

If you're going to a pill identification website to find out the manufacturer of a prescription drug, you're working too hard. The manufacturer printed is on the prescription label.

Isn't the new direction of capitalism in America Freedom from Regulation?

Yes. This is a clear example of why that's bad and why these agencies need funding and competent staffing.

these agencies had funding and competent staffing. they correctly identified that the factories were producing dangerous products.

The funding comes in because they didn't have the funds to test the drugs. That's something I'd hope was happening with all drugs.

The competence comes in because they put availability above safety. That's an incompetent trade-off.

the real irony is that price and availability cannot be a consideration in approving indications for new drugs

How did you arrive at that conclusion? All of the evidence provided in the article is prior to the “freedom of regulation” as you call it.

To me, it’s indicative of a rotting regulatory institution that lost its way. FDA is about safety, not low cost drugs. I don’t know how that mandate became mission critical for them but it happened before the current administration.

Almost certainly happened because of Clinton and the FDAMA. It's a law that "cut red tape" IE removed safety protocols and standards.

These agencies are rotting primarily because they've been reworked to be business friendly over the last 40 years

The US is long past the point where we need to stop talking about medical regulation generically. Some regulation and enforcement needs to be increased, and others need to be decreased or eliminated, at least in my opinion.

To me this sort of thing is fraud, and I feel like the FDA needs more resources and oversight to fight it. But with other things I think the FDA needs to back off completely, where it's overstepped its useful mission. I personally would like to see the FDA stop telling people what they can purchase or receive from whom, but spend more time guaranteeing that whatever is on the label is what it says it is and nothing else.

To continue making a follow on point, also needing nuance - pharmaceutical manufacturing is exactly the type of industry that can and should be brought back to the US. First, through outright subsidies [0] to get the plants built. And then when domestic supply is high enough, through regulations prohibiting healthcare management plans from buying imported drugs.

[0] spending some of the surplus from having a reserve currency on deliberate policies rather than it being blindly given to asset holders

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