Generic Drugs May Not Be As Safe Or Effective As Thought
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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.
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.
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.
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.
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.
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.
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?
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.
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.
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.
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.
https://www.canada.ca/en/health-canada/services/drugs-health...
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.