I heard this piece on NPR, the entire time all I could think about is it seems tailor made for the pharm industry.
They never mention a specific instance of impurities found, just a vague "they're made over in India/China!" thing. No details here other than people drinking tap water in India.
I agree that it’s a bad article, but problems with generics aren’t new or shocking.
If you’re on generic hypertension meds and monitor your BP, you’ll find that your pressure will vary when manufacturers change. Usually it’s minor, but I’ve seen cases where there is significant variance.
I have personally noticed large differences in side-effects between various generic brands of SSRIs. That's anecdotal, but now I always pick the same generic brand out of the ~5 I have tried for the same compound.
Same here. I always believed that generics were identical until one time the pharmacy gave me a generic for an SSRI. I was suddenly enveloped in physical pain in my chest and neck, so I called my doctor. She told me it happens, generics can cause different side effects and reactions, so she gave me a new prescription specifying the brand and the pain went away...until much later when there was a shortage of the brand name and I had no choice to go to the generic. And the pain came right back.
I believe there's probably some differences - especially in packaging. Some medications are different between generics or between generics and name brand in bioavailability. The title of the article isn't backed up by the content though in this case.
What I’ve heard anecdotally: The “generic” part of a generic drug is the active ingredient - that should be essentially the same between manufacturers. What differs, however, is the delivery mechanism. So for something that is extended release, the mechanism for releasing over time can vary between manufacturer.
I’m not entirely sure that this is the full story though, I haven’t researched the problem enough.
I guess one of the problems that seems to be cropping up in pro sports that do testing is that traces of other drugs appear in unrelated drugs do to the equipment not be thoroughly cleaned between batches. Seems like an inspector / cheapening of production issue more than a location issue.
Growing up I though of NPR as a bastion of the left but the older I get the more cynical I become. Your take reminds me of the most infuriating story I heard on NPR about Amazon Seasonal workers.
They spotlighted a retiree couple would supplements their income with it in the winter and drives south to gamble in the summer and it just sounded like a profile of a charmed life, somehow I imagine that isn’t the case for most people who work there...
They have monthly fundraising drives where they ask listeners to pay up for fearless journalism but a lot of it sounds like it was written by and for entrenched industries.
I also get the sense it's increased over the years. If you count all fund-raising time (drives plus the at least tens of minutes on ordinary days they push donations or giving them cars), promoting their own podcasts, and the now-seemingly-much-longer sponsorship messages (straight-up ads) I'm not sure it's any better than commercial radio.
I hate to pull politics into this, but their coverage of the 2016 Presidential really opened my eyes to their biases. Bernie Sanders was not treated as a serious candidate through then entire race, but they absolutely fawned over Hillary Clinton. The same is happening now for all 230 candidates v Joe Biden. Any story they air treats most candidates as fringe, but Biden as the only serious contender.
I feel like NPR has gotten worse in the last 10 years. Completely ignoring the topic of bias, (because it's a fruitless minefield) it seems difficult to encounter a story on NPR that isn't primarily about emotions. NPR seems to believe that a story is only accessible if there's a single person (or small group of people) who can directly emote about the wrongness of a situation. A caricature of an NPR story might go something like this "As violent insurgency breaks out in [some country], we bring you no details about the local politics, tribes, or history, but instead 15 minutes of an individual mother telling you just how miserable her life is. And here she is along with some ambient sounds so you can really feel like you're there."
I'm aware that there's a group of folks who believe that personal stories are relatable, while statistics are easily ignored. At best, I feel like this view is shortsighted: not everyone works this way, and sympathy shouldn't be limited to cases with emotional proximity. (ie, rational ethics are possible) At worst, NPR is deciding how you should feel about the story by inserting an emotion-based testimonial.
NPR is as much of a mouthpiece for the elite as any other mainstream media source. Their two top contributors are Lockhead Martin and Walmart, yet you don't hear many ads for them over the air, so how is NPR paying them back for their contributions? That would be maintaining the Overton window and publishing stories that support the military industrial complex and neo-liberal agendas.
I don't really take my comment to be that political. More about corporate control of the power structures. Is there something incorrect about my comment? Shouldn't root cause be discussed when talking about shortcomings? I do believe their emotional story telling is an intentional weakening to avoid hard hitting true journalism that challenges power structures.
Edit: ironic that the original comment was about NPR being too emotional and yet a discussion about factual details is emotionally down voted as "political".
NPR is generally vacuous. Some Public Radio shows do/did have in depth coverage (e.g. Diane Rehm show, but she is now retired). The fact is many people like it at that level...they want the human story and the gist. They do not want a nuanced and detailed understanding of geopolitical and cultural events, etc. For that, I've moved on to other sources...but these tend to be specialized policy blogs.
Nailed it. I haven't been able to put it into words, but you absolutely nailed it.
You get that people are suffering, and even a glimpse into how, but absolutely no reasons why, except 'the Houthi rebels have been fighting for ten years' or some other one line plug.
There's less and less actual news on NPR and more, and more emotions.
Like everyone else they're devoting a lot of time, very early (it's NEXT F*CKING YEAR!) to the US Presidential election, and, as usual, 90% of their time is horse-race crap. How should so-and-so's campaign handle this jab? How're those poll numbers looking? Issues and fact-checking statements and positions are a rare afterthought. It's awful.
Plus my local station spends so much time on ads anymore (sponsor messages, promos for other NPR programs, trying to convince me to give them my car) that it's nigh-intolerable even if the coverage were any good, which it's not.
It depends a lot on the topic. For example, their reporting of Supreme Court decisions is generally factual and straightforward with decent analysis. But there are definitely a lot of stories like you describe. I often get bored with it and switch to something else.
My local station plays BBC News for an hour in the mornings and the contrast is strong. The BBC still does those kind of stories, but a lot less. The most remarkable contrast is interviews. NPR seems to believe that the purpose of interviewing someone is to give them access to an audience so they can say what’s on their mind. The BBC seems to believe that the purpose is to question them and extract information from them.
What irks me is that I either have to agree that they track me or I'm redirected to "text version" of the site, but in the latter case they redirect me to the list of articles, usually even without the one I came for, as if showing that without tracking I'm completely useless for NPR and I could as well go away. This attitude speaks louder than words.
It's oddly enough not consistent. Often enough, it redirects me to the article, but not always. Maybe they don't do it for all parts/categories of the site?
Colloquially, people say "bias" when they want to say "agenda" but scientific-sounding, and that is probably fruitless to discuss.
I think bias is useful to consider in terms of cognition and process.
A journalist has a perspective and there are simply parts of it that he's not consciously aware of, especially missing knowledge.
But the process is also important. A news operation needs to attract readers and their readership's interest is what dictates what is "newsworthy." (They also need sponsors, and this can get bad enough that some trade publications essentially just reprint press releases. But that's less NPR's issue.)
It sounds like NPR is playing to their readership, and this can be a vicious cycle: you can start out with a more diverse audience and more diverse reporting, but by playing to a majority and losing your minority audience over time, you wind up with a monoculture.
So accurate, and perfectly describes the article I complained about in another comment[1]. The best part is, when NPR focuses on personal stories they really get to choose the narrative. Linked article happens to be two retirees who love gambling and working seasonally for Amazon, why them instead of some other family whose forced to work seasonally and can't get health insurance? No clue, but the framing sure makes Amazon look good.
You may be interested in an article by the person being interviewed in the OP, which has a few more details and at least one specific instance of impurities:
Well, it was an interview of a book author; it sounds like the book has a lot of detail in it. And the fact that generics are not actually identical, but reverse-engineered best efforts was a bit scary.
I was a kid in the "generics are identical but cost less" generation. I agree this felt like a piece funded by big pharma, but I also can't help but feel I was probably really naive about what a generic really is.
Be wary of only doubting things when you personally disagree with them. It's good to be careful, but you'll soon surround yourself with like opinions if you're not careful
Exactly; there was a oped w/ similar voice in NYT about a week ago. US Pharm companies are losing the ability to fix prices on their preferred generics, so they're switching to fear PR to promote their 'premium generics.'
Everything in healthcare regulation tends to face intractable tradeoffs between cost, time, quality, and access, but small molecule generics should be an exception to that. The development work has been done, and the cost of goods is so cheap in general that it it seems entirely reasonable to demand more stringency in proving equivalence in manufacturing to the brand name.
An important question is - what's going to happen as we move into biosimilars and other large molecule 'generics?' These are much more complex than these small molecules, and it doesnt bode well for their future if we can't even get small molecule genetics up to par. I do think its doable though, and I'm glad that there's work out there like these articles bringing attention to the issue.
There was a similar issue with Wellbutrin extended, where the active ingredient was theoretically the same, but the bit that was supposed to slowly give it to you would dump it on you instead.
"'In the first two hours of a dissolution test, we found Budeprion released 34 percent of the drug, while Wellbutrin released 8 percent. At four hours, the Teva product released nearly half of its ingredients, while original Wellbutrin released 25 percent. The generic did not act like a once-a-day formula but more like an immediate release formula,' Dr. Todd Cooperman, Consumer Lab's president, stated."
Problem with that is Wellbutrin can cause seizures if you have too much at once, and it synergizes with things like ADHD meds to lower the seizure threshold further. Since Wellbutrin itself is a third-line ADHD medication, that last bit was a real issue--at one point I was prescribed both Wellbutrin XL -and- Concerta, and had to get "only as prescribed" scrips for both to avoid generics. Pulling the Wellbutrin generic with the known-bad delivery mechanism was one of the few cases where the FDA actually stepped in on a previously-approved generic and did something.
In general, I don't worry too much about the active ingredients in generics (though maybe I should) but I worry an awful lot about extended-delivery mechanisms. I don't think testing or standards are sufficient to enforce a bioavailability curve across a dosage lifetime.
Hmm, generic Wellbutrin thinned my hair and made it fall at a worrying rate in only 2 weeks and stopped after discontinuation. Otherwise, it was a fantastic drug for me, unmatched still by any other.
Reading your comment makes me want to try the brand name. Maybe it was an allergic reaction to one of the fillers?
That is the actual substance name. Some generics have their own "brand name" that will usually be a minor variation on the real name. In this case, one of the generics that didn't deliver correctly was from Teva and branded Budeprion.
"Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them."
The whole point of government agencies like the FDA is to perform inspections that consumers lack the ability, time or resources to do on their own.
I get that we're in a complicated interconnected world and you've got to look out for yourself, but that's me. There's about 300 million Americans out there and a good portion of them are busy raising kids and busting their ass working and CAN'T spend hours investigating their prescription meds and inspecting their food.
Also, it's politically incorrect to say this, but a smaller number of consumers aren't intelligent enough to even begin taking care of themselves. They need the FDA more than anyone.
I’ve done my research and I’ve decided that drug x my doctor recommended is possibly right for me. There should be absolutely no more research required.
“The generic is the same thing, just cheaper” is taken as gospel. If it turns out that’s not the case... that’s it, full stop.
I’m all for a lack of regulation, but once the FDA says it’s clear for anyone to make it they still have to check to make sure that’s what they’re making.
Edit: and this is, of course, assuming that any of this is true.
That strikes me as useful as the "security expert" who shows up on TV and tells people to "only download apps you trust".
Who really knows anything about ANY of the apps they download? Nobody has the required knowledge / time to make that determination with any amount of success.
Anyway the FDA situation reminds me of a libertarian blogger who a while back wrote a great blog that went something like "Guys, libertarians aren't supposed to hate the FDA / EPA!"
His point being that libertarians are supposed to get riled up when government gets involved in protecting people from decisions that they should make on their own, such as preventing people from jumping off anything because jumping off a cliff is bad (overly simple example but that's the idea). Situations like telling good medicine from bad where you need huge amounts of testing and industry knowledge, or having someone dump toxic waste next to your house that you can't tell ... you're permanently hurt by the time you figure it out is something libertarians should want a government involved in.
Life is complex, we can't figure everything out ourselves.
I’m sorry , why are you presenting these as if they are the only options? And did you just defer to a common saying to make an assertion about how the world works instead of making a genuine argument?
Pick two, cheap and good. If the FDA is correctly doing their job, it should take some time to process if the generic drugs are effective. And for non-generic drugs, the R&D involved specifies that it doesn't come fast.
At least in the US it appears the costs of drugs is not tied to any real market forces / competition type forces, and I don't think when drug prices were lower the FDA was doing less testing.
There's a free-market answer to the FDA problem, I don't think any real libertarian would argue otherwise (note: I'm not a libertarian).
The solution is having a brand, and building that brand based on trust. Additionally, 3rd parties you subscribe to could verify the claims of brands and their integrity.
This is similar to things like Fair Trade [1] certifications, or Kosher certifications.
I often buy brand-name drugs OTC for QA purposes. I know that for the most part, Tylenol is going to contain 500mg of the primary ingredient when I buy it. Those portions are likely to be of good purity and uniform size. The off brand, might have more or less, of similar or dissimilar quality. I trust that US-based business for the most part actually care about their customers. It's a web of trust. Do I trust non-US business with manufacturing operations overseas? Not really when it comes to medication, no.
> The solution is having a brand, and building that brand based on trust.
You mean like Boeing's 737 MAX8 aircraft? Or Purdue pharma's Oxycotin (aka: that opioid that Purdue Pharma claimed was non-addicting, except it kick-started the entire opioid crisis because spoiler alert: its opium-based and therefore very very addicting?)
1. Big brands make mistakes.
2. Consumers don't know the brands: do you know whether or not your drugs are Purdue Pharma or not?
3. Brands are sold. The original company who made a brand may have cared very much about it. But 10 years or 20 years later, the brand may be owned by entirely new people. Either everyone has retired / moved on, so the company is simply consisting of new people... or maybe the brand was chopped-up and sold to 3 or 4 different companies. Quick: who owns Epipen right now? (That drug brand has been passed around at least 3 times in the past decade)
All of these things go into factoring your individual trust level for a brand.
Do you consider gmail.com as a brand to be more trustworthy than 'totallynothackers-email.com' for hosting your email? Of course you do.
In the case of medicine (or anything else that can kill you for that matter), the brand trust has been (mostly) replaced by regulator trust, or store-based trust. EG, CVS is probably going to source from reputable suppliers. You can also fill prescriptions on sketchymeds.com if you choose, especially if you're outside the US.
Brands being sold and bought are an input to the brand-trust equation. It might mean 3rd parties are the more trusted source of information in a given segment than the brand name itself (of course, you could say the same thing about 3rd parties, ad infinitum).
But even doctors, whose job is literally to keep track of these drug thingies, have gotten things wrong. See the opioid crisis + Oxycontin.
What hope do laypeople have when even the specialists with over 10-years of high-class training get these things wrong on a nationwide level?
Before the Oxycotin news, I thought Purdue was just "that chicken company" at the grocery store (Yeah, I'm ignorant. But that's the fact, at least I know I'm ignorant). I don't have the time to figure out which brand-names to trust or what not to trust.
My doctor gave me a "Tomed mandibular advancement device". I don't even know what a mandibular is. My only hope is to trust the doctor and hope it fixes my problem. I've never heard of "Tomed" before.
How the hell am I, as a customer, supposed to build a relationship with a brand, when I only buy one or two of their products per lifetime? How am I supposed to do market-research, and figure who their competitors are? If I buy a competing product, what assurances do I have that it works as well as the one my doctor gave me?
Look, I trust that the engineers are trying to build devices that improve my life. I trust my doctor is trying to improve my life. I trust my insurance company is trying to save (themselves and me) the most money. But I recognize that there are systemic flaws in the US Healthcare system, and something isn't exactly working right.
In any case, the "brand" system being proposed in this topic is clearly not a solution. Not only is it NOT working right now, I have my doubts that it would ever work under our current system. I'm just too ignorant about the companies who make medical devices and drugs, and I've got the freaking internet in my pocket to research things instantly. That's not the problem, it takes more than 5 minutes, or even an hour, of googling to review peer-reviewed journals and figure out which devices, techniques, or drugs are effective.
Ultimately, I'm going to trust my doctor and insurance company. Its all I got. I'm not going to be trusting my life to brands of which I've never used before. Its incredibly rare for me to buy any form of medical device in general, I simply don't have a relationship to any medical brand what so ever.
> Ultimately, I'm going to trust my doctor and insurance company.
You're already benefiting from the brand-trust type of system. You trust your insurance company (currently because the market is regulated, but if the market wasn't as regulated, you'd probably be choosier about who you shop with). Your insurance company pays the most for in-network doctors. Doctors probably need malpractice insurance and not be complete frauds to be in an insurance network.
I think the airline industry is a good example in the US. I could often save money by going with a smaller carrier, but I choose to spend a little more to go with the bigger carriers, primarily because I know if there are any problems, they're more likely to have extra flights to get me where I'm going.
Another good example is HVAC companies. You can pay someone working out of a truck to install a new A/C system for slightly less than the name-brand (factory authorized dealer) in your area. You're probably going to get what you pay for. Companies want to stand by their name. This is a once-in-a-while transaction that can cost multiples of 10's of 1000's of dollars (depending on size/complexity of the system, obviously).
The actual device is worth 150 EUR from Germany (where Tomed is located). The US-distributer sells it for $500. Somehow, the markup got all the way up to $1000 by the time it got to me.
Clearly, something, somewhere, has gone wrong in the system. This is a 150 EUR mouthguard that is being sold to me for $1000. As in, what I've literally paid for. Why?
You've been making great arguments. I appreciate them. However, why not order the device from Germany yourself? Are there stringent regulations in place that prevent customers from purchasing across state or even country lines?
First, there's no reason for me to buy the device. I already own one (the one my doctor gave me), and I have no need for a 2nd (yet).
So... why did I buy it from my doctor at first? Well, because the doctor said I needed one. I setup an appointment with the nurse, who then gave me the device. A week later, I got a bill for $1000. Shocked at the price of the device, I ended up doing research. $500 is the cheapest I could find it in the USA, and if I include doctor fees + nurse fees, it is "reasonable" that they would mark it up a few hundred dollars above that.
In any case, I already "bought" the device before I realized. So I don't think I really have any choice aside from paying the bill.
I'll try to buy it straight from Germany in the future. But I didn't even know the name of the device until after I got it from the nurse.
I'm kinda new to this whole doctor / taking care of my health thing. But I'm just sharing my experience with everyone, so maybe other people can learn from my mistakes.
My general presumption was that my insurance company would be improving the cost-efficacy of the overall system. Apparently not however. Now, its just a $1000, and now I'm over my yearly deductible, so I've basically got free health-care for the rest of the year because of this. (So I don't consider this a big financial mistake, even if it cost $1000. Its more proof that the insurance company is slacking in its job of efficiently pricing these medical devices I'm using...)
Yeah, there's a multitude of issues with the health insurance-scam system in the US. It's easy to get swindled in the health care industry.
Brand-trust relationship dynamics don't say much about how things should be priced, but it does imply well-known and trusted brands will likely command a premium.
> Clearly, something, somewhere, has gone wrong in the system. This is a 150 EUR mouthguard that is being sold to me for $1000. As in, what I've literally paid for. Why?
There are multiple factors, but a motivator is that US regulators are under pressure from both sides to adopt rules that make healthcare consumers less price sensitive.
On the one hand, the supplier is quite happy to be collecting $1000 rather than $150.
On the other hand, people don't like paying $1000, so they go to the government and ask them to do something about it. The government could then push for more price transparency and make sure that existing regulations aren't impairing competition and driving up prices, but that's exactly the opposite of what the people making $1000 instead of $150 want.
The alternative is to get somebody else to pay for it in enough cases that the remaining cases (i.e. yours) don't have enough political power to actually fix it. So they cause the money to come from insurance premiums or taxpayers in most cases, whose costs are in turn laundered through employer-provided health insurance or general tax revenues.
But the seller can't charge $150 retail and still get $1000 from insurance, so they set high prices and anyone without [sufficient] insurance coverage is relegated to either overpaying or using whatever kind of need-based assistance if any that the seller provides, or figuring out a way to order from overseas.
This type of regulatory corruption is obviously not a cost efficient way to provide healthcare.
And it's much the same reason branding and private certifications are ineffective. If regulators get rid of most of the charlatans then consumers become willing to trust that anything approved by regulators is safe. Then when it isn't (as with the MAX8), there is a single point of failure, both because people are then less wary of things that are potentially dangerous, and because independent private infrastructure to verify quality atrophies when government embeds their own safety standards into law, even if they do a mediocre job of it.
> ...independent private infrastructure to verify quality atrophies when government embeds their own safety standards into law, even if they do a mediocre job of it.
Pretty much the story for every aspect of government.
You can be sure Gmail is harvesting your mails for tracking or profiling purpose while you still have to demonstrate totallynohacker-email do that.
One of my email and cloud storage provider is Zaclys, a little french non-profit organisation which host owncloud/nextcloud instance and an email service for 10€/year...
I can't be sure Zaclys is not harvesting my emails, but the fact I pay them for that service reassure me about their intention. In other hand I know for sure Gmail is not trustworthy regarding my privacy.
Most of the libertarians I know are fine with the FDA doing research and providing information, maybe even requiring specific and true labeling for certain publicly sold goods. What they do not like is the FDA banning the sale of drugs or foods that they do not approve of, even with proper and true labeling. Because that is is just another attempt to take decisions away from people.
Yeah I think that is understandable, it's not all or nothing with the FDA, you certainly can approve of some aspects and be libertarian, and not approve of others and be libertarian and it all still makes sense philosophically.
I would add that its intensely slow process is the epitome of the harmful lumbering bureaucracy that libertarians react strongly against. Factory inspections are understandable, but the approval process takes so much time and effort it's no wonder generics cost far more than they should. The FDA has the power to move more quickly, but they have no incentive to do so
Sibling comments have given examples here, but the one-sentence summary would be that libertarians are in general opposed to licensure, and believe that a free market with certification (which would be provided by trusted private entities) is superior.
In more detail, the argument goes something like "any time you require a license, you are necessarily reducing the choices available in the free market, and more choices are good." See e.g. Milton Friedman, "Capitalism and Freedom".
I think the purist libertarian position on the FDA would be that it should be abolished and replaced with a private certification agency. But if you _must_ fund it with government money, it should be a certification body and not a licensing body.
That is interesting. Usually when people say this, it's from the opposite perspective. I don't often see people casting the idea that there are people who do need extra help as "politically incorrect"; I'd guess the particular political stance that doesn't like this would be a strong individualist, strong personal responsibility, small government stance.
Well, saying "some people are stupid" is definitely politically incorrect (even though factually correct - as happens in most cases where PC is involved). "Some people might need help" is perfectly safe though.
Recently I was switched to a brand-name after a decade+ on generics. The difference was obvious and really surprising to me as I figured the same chemical compound would produce identical results. The facts described in the article would explain the difference. Really sucks for people that need medication to be rolling the dice every month.
How are you rolling the dice? Don't you get the same drug each time? I always do. And why monthly? For high blood pressure I get 98 tablets in a packet, that's fourteen weeks.
The title is misleading. The article claims that drugs manufactured outside the US for sale inside are not held to the same standards as those made in the US. This has rather little to do with their status as generics.
I am/was on a generic version of Proscar (prostate drug and it's also a higher dosage of Propecia-a hair loss drug) called finasteride. From 2006 up to I think 2015 or so, TEVA was the brand of generic I was under and it worked great. At some point the drug stopped working. I thought maybe I built up a tolerance or something.
I remember one day I was standing in the kitchen pissed off that my meds weren't working anymore and looking at my prescription bottle when I noticed it was no longer from TEVA, it was from a company called Aurobindo; the drug was manufactured in India. I immediately called the pharmacy and told them I want to switch. I did some research and found one that is manufactured in the US by Accord pharma. Accord I believe is still HQ out of India, but the drug is made here in the US at least. Fast forward about 6 months, and things are finally returning back to normal - the meds were working! At that point I filed a complaint with the FDA against Aurobindo. Never heard back, but I tell everyone I know to avoid using Aurobindo drugs.
I don't know, I feel like outsourcing the manufacturing of drugs - especially those with a life or death impact - is a mistake.
You should always check that the medication you have received from the chemist is the one you expected to get. If I were handed an unfamiliar drug I would immediately ask the pharmacist what was going on and ask for an explanation of the likely effects.
I read ChinaRX recently, and it included a lot of similar concerns. But it emphasized that a lot of the components and active ingredients are produced in China, and some American companies are not always very vigilant or thorough in checking the purity or quality of their suppliers. So even if a pill is made in America, it could still be at risk as much as a foreign pill.
The book kind of veered off in parts to being a little bit fear-mongery/off topic--a large portion of it was rehash of a Planet Money chicken tax podcast, and then another large block was focused on container ships-- though so I wouldn't really recommend it.
the trouble is that the burden is wrongly on consumers to file complaints with the FDA if they find that their generic medications are not performing in the way that they should.
based on my experience inside the biotech/biopharma industry within several different roles, i think that ideally the FDA would be terrorizing the pharma companies producing generics such that each new manufacturing lot of medications would be tested for bioequivalence in small cohorts of patients before hitting the market.
of course, this will never happen because it would be expensive and time consuming for manufacturers of generics, who rely on volume to make a profit (traditionally -- i know this is changing as they are currently raising prices like wild). so, consumers get the shaft and nothing is done because the perfect solution has the imperfection of reducing revenues.
it's a tough problem, though. i'm fairly certain that doctors know that you get what you pay for with many generics -- but i'm also fairly certain that doctors understand not everyone can afford brand name medication.
It wouldn’t, but they could ensure the generic was effective and manufactured correctly. The problem is that a consumer can easily be ripped off, a nation state buyer will not.
If anything that seems like it would make things worse - someone else, completely disconnected from your care, making decisions about what manufacturer should provide your drugs.
Government sourcing is riddled with plenty of cases of corruption and wrongdoing. Generally the worst case is that they overpay for something. With medicine, the worst case is that someone dies. I’ll pass.
Only able to read the first article (2nd two are verboten for EU users), but all I read is that a private company was implicated, not a national level single buyer (such as the NHS in the UK).
In particular there is a growing amount of evidence that the generic anticonvulsant drugs are not nearly as effective as the original brand-name version, and I don't believe it is known exactly why. Just that the FDA's definition of what makes two drugs equivalent is not sufficient in all cases.
My younger brother died because of this. He got moved off Keppra to a generic equivalent because insurance refused to pay for the real thing, and his seizures immediately began to increase in frequency. One night he suffered a grand mal and never woke up.
Anecdote, but I personally noticed variable effectiveness of epilepsy drugs between different generic manufacturers and the brand name. I was taking Teva brand for a while and it seemed to work fine. Soon I noticed that the drug wasn't working as well (i.e. had seizures) and I saw the brand I was taking changed (I forget what it was). Anyway I had to run around and find a pharmacy that had Teva brand again. I also learned you can ask your pharmacy what generic brand they carry, and you can also ask them to fill your prescription with a particular brand, but you have to give 1-2 days heads up.
Ultimately, I ended up going on the brand name of the drug and it worked much more consistently. Often, if a generic drug isn't working well, doctors will write prescriptions that request the brand name so that insurance approves it. I think they all know that generics can be hit or miss for these types of drugs. Anyway, I don't take generics anymore. Now, almost every time I go to the pharmacy they ask me "You know how expensive this is, right?"... Yep. My insurance is billed for almost $5k every time I go, and I pay $180/mo. Generics would cost me $20/month or so. It must suck for people who can't afford it, or who have crapp(ier) insurance, or who don't even know about the variance between manufacturers.
Somewhat off-topic, but I would like to see regulations around non-opiate drugs changed to the point where I can buy my BP drugs off the shelf. I can see no reason this can't happen. It can't be a safety issue. I can show you hundreds of supplements significantly more dangerous than BP drugs.
I want to be able to stock up on BP meds, so that there is an emergency, I am not 100% dependent on the pharmacy being open and reachable. Currently, I am at greater risk than someone who is addicted to heroin. You can stop heroin without risk of death.
Our anecdote: My fiancee was prescribed generic Exemestane. We 100% believed that “generic is exactly the same compound, just cheaper”. Her joints became stiff and sore. All over. It was debilitating. (It’s a known side-effect of the drug.) Took the generic for two years. Then the supply of generics ran out locally and we had to get brand-name Aromasin. The exact same compound. We had no expectations of different effects or less side effects. Her joint pain mostly cleared up. By like 90%. The difference - once it dawned on us - was shocking.
Yet another anecdote: Several years ago, my wife had her birth control switched to the generic by our pharmacy. The day after she started taking it she became extremely nauseated, it passed later that day. The next day, the same thing. After the third time, we realized that it wasn't a coincidence, she stopped with that pill and the nausea ended.
After some online research, we found the generic was manufactured in India and some people had mentioned a similar issue with the product. It took us switching pharmacies to get back on the name brand.
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[ 2.5 ms ] story [ 155 ms ] threadThey never mention a specific instance of impurities found, just a vague "they're made over in India/China!" thing. No details here other than people drinking tap water in India.
If you’re on generic hypertension meds and monitor your BP, you’ll find that your pressure will vary when manufacturers change. Usually it’s minor, but I’ve seen cases where there is significant variance.
My cardiologist pulled out a sheet with instructions on how to complain to the FDA, so I’m pretty sure it was common for that drug.
I’m not entirely sure that this is the full story though, I haven’t researched the problem enough.
They spotlighted a retiree couple would supplements their income with it in the winter and drives south to gamble in the summer and it just sounded like a profile of a charmed life, somehow I imagine that isn’t the case for most people who work there...
They have monthly fundraising drives where they ask listeners to pay up for fearless journalism but a lot of it sounds like it was written by and for entrenched industries.
https://www.marketplace.org/2017/12/21/business/holiday-seas...
Honestly, I love NPR, but. . .
I'm aware that there's a group of folks who believe that personal stories are relatable, while statistics are easily ignored. At best, I feel like this view is shortsighted: not everyone works this way, and sympathy shouldn't be limited to cases with emotional proximity. (ie, rational ethics are possible) At worst, NPR is deciding how you should feel about the story by inserting an emotion-based testimonial.
Edit: ironic that the original comment was about NPR being too emotional and yet a discussion about factual details is emotionally down voted as "political".
You get that people are suffering, and even a glimpse into how, but absolutely no reasons why, except 'the Houthi rebels have been fighting for ten years' or some other one line plug.
There's less and less actual news on NPR and more, and more emotions.
Plus my local station spends so much time on ads anymore (sponsor messages, promos for other NPR programs, trying to convince me to give them my car) that it's nigh-intolerable even if the coverage were any good, which it's not.
My local station plays BBC News for an hour in the mornings and the contrast is strong. The BBC still does those kind of stories, but a lot less. The most remarkable contrast is interviews. NPR seems to believe that the purpose of interviewing someone is to give them access to an audience so they can say what’s on their mind. The BBC seems to believe that the purpose is to question them and extract information from them.
I thought it was odd at the time.
Now in retrospect, NPR was cheering on the now Terrorists.
Colloquially, people say "bias" when they want to say "agenda" but scientific-sounding, and that is probably fruitless to discuss.
I think bias is useful to consider in terms of cognition and process.
A journalist has a perspective and there are simply parts of it that he's not consciously aware of, especially missing knowledge.
But the process is also important. A news operation needs to attract readers and their readership's interest is what dictates what is "newsworthy." (They also need sponsors, and this can get bad enough that some trade publications essentially just reprint press releases. But that's less NPR's issue.)
It sounds like NPR is playing to their readership, and this can be a vicious cycle: you can start out with a more diverse audience and more diverse reporting, but by playing to a majority and losing your minority audience over time, you wind up with a monoculture.
[1] https://www.marketplace.org/2017/12/21/business/holiday-seas...
https://blogs.sciencemag.org/pipeline/archives/2019/01/04/th...
https://www.nytimes.com/2019/05/11/opinion/sunday/generic-dr...
I was a kid in the "generics are identical but cost less" generation. I agree this felt like a piece funded by big pharma, but I also can't help but feel I was probably really naive about what a generic really is.
https://www.nytimes.com/2015/06/17/business/generic-ritalin-...
Everything in healthcare regulation tends to face intractable tradeoffs between cost, time, quality, and access, but small molecule generics should be an exception to that. The development work has been done, and the cost of goods is so cheap in general that it it seems entirely reasonable to demand more stringency in proving equivalence in manufacturing to the brand name.
An important question is - what's going to happen as we move into biosimilars and other large molecule 'generics?' These are much more complex than these small molecules, and it doesnt bode well for their future if we can't even get small molecule genetics up to par. I do think its doable though, and I'm glad that there's work out there like these articles bringing attention to the issue.
"'In the first two hours of a dissolution test, we found Budeprion released 34 percent of the drug, while Wellbutrin released 8 percent. At four hours, the Teva product released nearly half of its ingredients, while original Wellbutrin released 25 percent. The generic did not act like a once-a-day formula but more like an immediate release formula,' Dr. Todd Cooperman, Consumer Lab's president, stated."
https://abcnews.go.com/Health/fda-finds-generic-antidepressa...
https://www.fda.gov/drugs/postmarket-drug-safety-information...
Problem with that is Wellbutrin can cause seizures if you have too much at once, and it synergizes with things like ADHD meds to lower the seizure threshold further. Since Wellbutrin itself is a third-line ADHD medication, that last bit was a real issue--at one point I was prescribed both Wellbutrin XL -and- Concerta, and had to get "only as prescribed" scrips for both to avoid generics. Pulling the Wellbutrin generic with the known-bad delivery mechanism was one of the few cases where the FDA actually stepped in on a previously-approved generic and did something.
In general, I don't worry too much about the active ingredients in generics (though maybe I should) but I worry an awful lot about extended-delivery mechanisms. I don't think testing or standards are sufficient to enforce a bioavailability curve across a dosage lifetime.
Reading your comment makes me want to try the brand name. Maybe it was an allergic reaction to one of the fillers?
The whole point of government agencies like the FDA is to perform inspections that consumers lack the ability, time or resources to do on their own.
I get that we're in a complicated interconnected world and you've got to look out for yourself, but that's me. There's about 300 million Americans out there and a good portion of them are busy raising kids and busting their ass working and CAN'T spend hours investigating their prescription meds and inspecting their food.
Also, it's politically incorrect to say this, but a smaller number of consumers aren't intelligent enough to even begin taking care of themselves. They need the FDA more than anyone.
I’ve done my research and I’ve decided that drug x my doctor recommended is possibly right for me. There should be absolutely no more research required.
“The generic is the same thing, just cheaper” is taken as gospel. If it turns out that’s not the case... that’s it, full stop.
I’m all for a lack of regulation, but once the FDA says it’s clear for anyone to make it they still have to check to make sure that’s what they’re making.
Edit: and this is, of course, assuming that any of this is true.
Who really knows anything about ANY of the apps they download? Nobody has the required knowledge / time to make that determination with any amount of success.
Anyway the FDA situation reminds me of a libertarian blogger who a while back wrote a great blog that went something like "Guys, libertarians aren't supposed to hate the FDA / EPA!"
His point being that libertarians are supposed to get riled up when government gets involved in protecting people from decisions that they should make on their own, such as preventing people from jumping off anything because jumping off a cliff is bad (overly simple example but that's the idea). Situations like telling good medicine from bad where you need huge amounts of testing and industry knowledge, or having someone dump toxic waste next to your house that you can't tell ... you're permanently hurt by the time you figure it out is something libertarians should want a government involved in.
Life is complex, we can't figure everything out ourselves.
What is better? A situation where the poor sometimes get ineffective drugs, or a situation where the poor get no drugs?
If you picked G.) Other. You don't understand how the world works. It's the "cheap, fast, good", you picked 3 instead of 2.
Edit, would love to hear solutions.
Not Everything is cheap.
Did you want a third option where old people get medicine, but young people pay higher taxes?
Pick your solution, someone loses.
The solution is having a brand, and building that brand based on trust. Additionally, 3rd parties you subscribe to could verify the claims of brands and their integrity.
This is similar to things like Fair Trade [1] certifications, or Kosher certifications.
I often buy brand-name drugs OTC for QA purposes. I know that for the most part, Tylenol is going to contain 500mg of the primary ingredient when I buy it. Those portions are likely to be of good purity and uniform size. The off brand, might have more or less, of similar or dissimilar quality. I trust that US-based business for the most part actually care about their customers. It's a web of trust. Do I trust non-US business with manufacturing operations overseas? Not really when it comes to medication, no.
1: https://www.fairtradecertified.org/
You mean like Boeing's 737 MAX8 aircraft? Or Purdue pharma's Oxycotin (aka: that opioid that Purdue Pharma claimed was non-addicting, except it kick-started the entire opioid crisis because spoiler alert: its opium-based and therefore very very addicting?)
1. Big brands make mistakes.
2. Consumers don't know the brands: do you know whether or not your drugs are Purdue Pharma or not?
3. Brands are sold. The original company who made a brand may have cared very much about it. But 10 years or 20 years later, the brand may be owned by entirely new people. Either everyone has retired / moved on, so the company is simply consisting of new people... or maybe the brand was chopped-up and sold to 3 or 4 different companies. Quick: who owns Epipen right now? (That drug brand has been passed around at least 3 times in the past decade)
Do you consider gmail.com as a brand to be more trustworthy than 'totallynothackers-email.com' for hosting your email? Of course you do.
In the case of medicine (or anything else that can kill you for that matter), the brand trust has been (mostly) replaced by regulator trust, or store-based trust. EG, CVS is probably going to source from reputable suppliers. You can also fill prescriptions on sketchymeds.com if you choose, especially if you're outside the US.
Brands being sold and bought are an input to the brand-trust equation. It might mean 3rd parties are the more trusted source of information in a given segment than the brand name itself (of course, you could say the same thing about 3rd parties, ad infinitum).
What hope do laypeople have when even the specialists with over 10-years of high-class training get these things wrong on a nationwide level?
Before the Oxycotin news, I thought Purdue was just "that chicken company" at the grocery store (Yeah, I'm ignorant. But that's the fact, at least I know I'm ignorant). I don't have the time to figure out which brand-names to trust or what not to trust.
My doctor gave me a "Tomed mandibular advancement device". I don't even know what a mandibular is. My only hope is to trust the doctor and hope it fixes my problem. I've never heard of "Tomed" before.
How the hell am I, as a customer, supposed to build a relationship with a brand, when I only buy one or two of their products per lifetime? How am I supposed to do market-research, and figure who their competitors are? If I buy a competing product, what assurances do I have that it works as well as the one my doctor gave me?
Look, I trust that the engineers are trying to build devices that improve my life. I trust my doctor is trying to improve my life. I trust my insurance company is trying to save (themselves and me) the most money. But I recognize that there are systemic flaws in the US Healthcare system, and something isn't exactly working right.
In any case, the "brand" system being proposed in this topic is clearly not a solution. Not only is it NOT working right now, I have my doubts that it would ever work under our current system. I'm just too ignorant about the companies who make medical devices and drugs, and I've got the freaking internet in my pocket to research things instantly. That's not the problem, it takes more than 5 minutes, or even an hour, of googling to review peer-reviewed journals and figure out which devices, techniques, or drugs are effective.
Ultimately, I'm going to trust my doctor and insurance company. Its all I got. I'm not going to be trusting my life to brands of which I've never used before. Its incredibly rare for me to buy any form of medical device in general, I simply don't have a relationship to any medical brand what so ever.
You're already benefiting from the brand-trust type of system. You trust your insurance company (currently because the market is regulated, but if the market wasn't as regulated, you'd probably be choosier about who you shop with). Your insurance company pays the most for in-network doctors. Doctors probably need malpractice insurance and not be complete frauds to be in an insurance network.
I think the airline industry is a good example in the US. I could often save money by going with a smaller carrier, but I choose to spend a little more to go with the bigger carriers, primarily because I know if there are any problems, they're more likely to have extra flights to get me where I'm going.
Another good example is HVAC companies. You can pay someone working out of a truck to install a new A/C system for slightly less than the name-brand (factory authorized dealer) in your area. You're probably going to get what you pay for. Companies want to stand by their name. This is a once-in-a-while transaction that can cost multiples of 10's of 1000's of dollars (depending on size/complexity of the system, obviously).
The actual device is worth 150 EUR from Germany (where Tomed is located). The US-distributer sells it for $500. Somehow, the markup got all the way up to $1000 by the time it got to me.
Clearly, something, somewhere, has gone wrong in the system. This is a 150 EUR mouthguard that is being sold to me for $1000. As in, what I've literally paid for. Why?
So... why did I buy it from my doctor at first? Well, because the doctor said I needed one. I setup an appointment with the nurse, who then gave me the device. A week later, I got a bill for $1000. Shocked at the price of the device, I ended up doing research. $500 is the cheapest I could find it in the USA, and if I include doctor fees + nurse fees, it is "reasonable" that they would mark it up a few hundred dollars above that.
In any case, I already "bought" the device before I realized. So I don't think I really have any choice aside from paying the bill.
I'll try to buy it straight from Germany in the future. But I didn't even know the name of the device until after I got it from the nurse.
I'm kinda new to this whole doctor / taking care of my health thing. But I'm just sharing my experience with everyone, so maybe other people can learn from my mistakes.
My general presumption was that my insurance company would be improving the cost-efficacy of the overall system. Apparently not however. Now, its just a $1000, and now I'm over my yearly deductible, so I've basically got free health-care for the rest of the year because of this. (So I don't consider this a big financial mistake, even if it cost $1000. Its more proof that the insurance company is slacking in its job of efficiently pricing these medical devices I'm using...)
Brand-trust relationship dynamics don't say much about how things should be priced, but it does imply well-known and trusted brands will likely command a premium.
There are multiple factors, but a motivator is that US regulators are under pressure from both sides to adopt rules that make healthcare consumers less price sensitive.
On the one hand, the supplier is quite happy to be collecting $1000 rather than $150.
On the other hand, people don't like paying $1000, so they go to the government and ask them to do something about it. The government could then push for more price transparency and make sure that existing regulations aren't impairing competition and driving up prices, but that's exactly the opposite of what the people making $1000 instead of $150 want.
The alternative is to get somebody else to pay for it in enough cases that the remaining cases (i.e. yours) don't have enough political power to actually fix it. So they cause the money to come from insurance premiums or taxpayers in most cases, whose costs are in turn laundered through employer-provided health insurance or general tax revenues.
But the seller can't charge $150 retail and still get $1000 from insurance, so they set high prices and anyone without [sufficient] insurance coverage is relegated to either overpaying or using whatever kind of need-based assistance if any that the seller provides, or figuring out a way to order from overseas.
This type of regulatory corruption is obviously not a cost efficient way to provide healthcare.
And it's much the same reason branding and private certifications are ineffective. If regulators get rid of most of the charlatans then consumers become willing to trust that anything approved by regulators is safe. Then when it isn't (as with the MAX8), there is a single point of failure, both because people are then less wary of things that are potentially dangerous, and because independent private infrastructure to verify quality atrophies when government embeds their own safety standards into law, even if they do a mediocre job of it.
Pretty much the story for every aspect of government.
One of my email and cloud storage provider is Zaclys, a little french non-profit organisation which host owncloud/nextcloud instance and an email service for 10€/year...
I can't be sure Zaclys is not harvesting my emails, but the fact I pay them for that service reassure me about their intention. In other hand I know for sure Gmail is not trustworthy regarding my privacy.
Essentially the same problem that turned the FAA into Boeing's lapdog.
In more detail, the argument goes something like "any time you require a license, you are necessarily reducing the choices available in the free market, and more choices are good." See e.g. Milton Friedman, "Capitalism and Freedom".
I think the purist libertarian position on the FDA would be that it should be abolished and replaced with a private certification agency. But if you _must_ fund it with government money, it should be a certification body and not a licensing body.
That is interesting. Usually when people say this, it's from the opposite perspective. I don't often see people casting the idea that there are people who do need extra help as "politically incorrect"; I'd guess the particular political stance that doesn't like this would be a strong individualist, strong personal responsibility, small government stance.
I remember one day I was standing in the kitchen pissed off that my meds weren't working anymore and looking at my prescription bottle when I noticed it was no longer from TEVA, it was from a company called Aurobindo; the drug was manufactured in India. I immediately called the pharmacy and told them I want to switch. I did some research and found one that is manufactured in the US by Accord pharma. Accord I believe is still HQ out of India, but the drug is made here in the US at least. Fast forward about 6 months, and things are finally returning back to normal - the meds were working! At that point I filed a complaint with the FDA against Aurobindo. Never heard back, but I tell everyone I know to avoid using Aurobindo drugs.
I don't know, I feel like outsourcing the manufacturing of drugs - especially those with a life or death impact - is a mistake.
The book kind of veered off in parts to being a little bit fear-mongery/off topic--a large portion of it was rehash of a Planet Money chicken tax podcast, and then another large block was focused on container ships-- though so I wouldn't really recommend it.
https://www.canada.ca/en/health-canada/services/drugs-health...
based on my experience inside the biotech/biopharma industry within several different roles, i think that ideally the FDA would be terrorizing the pharma companies producing generics such that each new manufacturing lot of medications would be tested for bioequivalence in small cohorts of patients before hitting the market.
of course, this will never happen because it would be expensive and time consuming for manufacturers of generics, who rely on volume to make a profit (traditionally -- i know this is changing as they are currently raising prices like wild). so, consumers get the shaft and nothing is done because the perfect solution has the imperfection of reducing revenues.
it's a tough problem, though. i'm fairly certain that doctors know that you get what you pay for with many generics -- but i'm also fairly certain that doctors understand not everyone can afford brand name medication.
Hope that doesn't cause a black market of effective, expensive drugs.
Government sourcing is riddled with plenty of cases of corruption and wrongdoing. Generally the worst case is that they overpay for something. With medicine, the worst case is that someone dies. I’ll pass.
https://www.justice.gov/opa/pr/defense-contractor-and-its-ce...
https://www.sun-sentinel.com/news/fl-xpm-1989-01-07-89010109...
https://www.chicagotribune.com/sns-boeing-scandal-story.html
My younger brother died because of this. He got moved off Keppra to a generic equivalent because insurance refused to pay for the real thing, and his seizures immediately began to increase in frequency. One night he suffered a grand mal and never woke up.
Ultimately, I ended up going on the brand name of the drug and it worked much more consistently. Often, if a generic drug isn't working well, doctors will write prescriptions that request the brand name so that insurance approves it. I think they all know that generics can be hit or miss for these types of drugs. Anyway, I don't take generics anymore. Now, almost every time I go to the pharmacy they ask me "You know how expensive this is, right?"... Yep. My insurance is billed for almost $5k every time I go, and I pay $180/mo. Generics would cost me $20/month or so. It must suck for people who can't afford it, or who have crapp(ier) insurance, or who don't even know about the variance between manufacturers.
I want to be able to stock up on BP meds, so that there is an emergency, I am not 100% dependent on the pharmacy being open and reachable. Currently, I am at greater risk than someone who is addicted to heroin. You can stop heroin without risk of death.
After some online research, we found the generic was manufactured in India and some people had mentioned a similar issue with the product. It took us switching pharmacies to get back on the name brand.