10 ms·

Generic Drugs May Not Be As Safe Or Effective As Thought

85 points by kasperset 7y ago

taurath 7y ago
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.
- yazboo 7y ago
  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: https://www.nytimes.com/2019/05/11/opinion/sunday/generic-drugs-safety.html https://www.nytimes.com/2019/05/11/opinion/sunday/generic-dr...
- Spooky23 7y ago
  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.
  - axlee 7y ago
    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.
    - throwaway18558 7y ago
      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.
  - matwood 7y ago
    Do you have a link to a double blind study where this was tested?
    - Spooky23 7y ago
      I don’t. 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.
  - taurath 7y ago
    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.
  - kwhitefoot 7y ago
    Why do you change manufacturers? I always get the same generic when I get my hypertension pills.
    - rconti 7y ago
      The fact that this is even a consideration is scary, and frankly, what the book was apparently about. I always believed generics were identical.
      - larrywright 7y ago
        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.
    - dillonmckay 7y ago
      The pharmacy will change drug distributors, which will change the manufacturer supplying their inventory.
    - Spooky23 7y ago
      I don’t. I get a different manufacturer every few months.
- protomyth 7y ago
  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.
- marricks 7y ago
  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. https://www.marketplace.org/2017/12/21/business/holiday-season-fills-rv-campground-amazon-workers/ https://www.marketplace.org/2017/12/21/business/holiday-seas...
  - java-man 7y ago
    I hear more ads on NPR than before. Has their funding mechanism changed?
    - colordrops 7y ago
      They only get 16% of their funds from public sources.
    - plussed_reader 7y ago
      No, it is still funded from listeners and corporate interests.
    - asark 7y ago
      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.
  - Loughla 7y ago
    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. Honestly, I love NPR, but. . .
- everdrive 7y ago
  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.
  - colordrops 7y ago
    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.
    - everdrive 7y ago
      My attempts to discuss NPR's shortcomings in an apolitical way are off to a terrible start.
      - colordrops 7y ago
        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".
- kurthr 7y ago
  Bad article, but probably related to the series of contamination issues that various generics have had (eg NDMA contamination in Sartan). https://blogs.sciencemag.org/pipeline/archives/2019/01/04/the-sartan-contamination-story https://blogs.sciencemag.org/pipeline/archives/2019/01/04/th...
  - dillonmckay 7y ago
    Remember when Excedrin was unavailable for over a year because of contamination during manufacture circa 2012?
- rconti 7y ago
  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.
- xeromal 7y ago
  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
- snap12789 7y ago
  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.'
vikramkr 7y ago
This reminds me of this case: https://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-not-equivalent-to-the-brand-is-in-use-anyway.html 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.
- geoelectric 7y ago
  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." https://abcnews.go.com/Health/fda-finds-generic-antidepressant-original/story?id=17399399 https://abcnews.go.com/Health/fda-finds-generic-antidepressa... https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/update-bupropion-hydrochloride-extended-release-300-mg-bioequivalence-studies 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.
newswriter99 7y ago
"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.
- chrismeller 7y ago
  I would actually take it a step further. 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.
- duxup 7y ago
  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.
stallmanite 7y ago
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.
- kwhitefoot 7y ago
  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.
  - dillonmckay 7y ago
    Pharmacies will constantly negotiate and change drug distributors that may use a different manufacturer of generics.
kwhitefoot 7y ago
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.
y-c-o-m-b 7y ago
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.
- kwhitefoot 7y ago
  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.
  - dodobirdlord 7y ago
    Same drug, different generic manufacturer.
sct202 7y ago
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.
tensor 7y ago
Related, what it takes to get a generic drug approved in Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/access-to-generic-drugs.html https://www.canada.ca/en/health-canada/services/drugs-health...
cryoshon 7y ago
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.
- dillonmckay 7y ago
  It has been my experience that doctors are not that knowledgeable about specific pharmaceuticals, particularly compared to a pharmacist.
richrichardsson 7y ago
This would be a non-issue if you had a single buyer at the national level sourcing the drugs on behalf of patients.
- Loughla 7y ago
  Maybe I'm dense, but how would that inherently get rid of generics or change any of the existing regulations?
  - richrichardsson 7y ago
    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.
- throwayEngineer 7y ago
  What a simple solution. Hope that doesn't cause a black market of effective, expensive drugs.
- refurb 7y ago
  Why? If the single payer purchased the cheapest drug from one of these manufacturers, you'd still have the same problem.
  - richrichardsson 7y ago
    Of course you wouldn’t, because they would ensure that they are the cheapest and most effective.
- larrywright 7y ago
  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.
rootusrootus 7y ago
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.
sickygnar 7y ago
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 $20/month or so. It must suck for people who can't afford it, or who have crapp(ier) insurance, or who don't even know about the variance between manufacturers.
LinuxBender 7y ago
Somewhat off-topic, but I would like to see regulations around non-opiate drugs changed to the point where I can buy my BP drugs off the shelf. I can see no reason this can't happen. It can't be a safety issue. I can show you hundreds of supplements significantly more dangerous than BP drugs. I want to be able to stock up on BP meds, so that there is an emergency, I am not 100% dependent on the pharmacy being open and reachable. Currently, I am at greater risk than someone who is addicted to heroin. You can stop heroin without risk of death.
- throwayEngineer 7y ago
  How are pharmacists going to make 60$/hr if you don't pay them for every transaction? /S
AnthonBerg 7y ago
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.
asciimov 7y ago
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.
deleted 7y ago
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RandomInteger4 7y ago
While there may be some truth here, I am highly suspicious because this story feels like corporate sponsored FUD 101.

85 points by kasperset 7y ago

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.

yazboo 7y ago
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: https://www.nytimes.com/2019/05/11/opinion/sunday/generic-drugs-safety.html https://www.nytimes.com/2019/05/11/opinion/sunday/generic-dr...
Spooky23 7y ago
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.
- axlee 7y ago
  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.
  - throwaway18558 7y ago
    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.
- matwood 7y ago
  Do you have a link to a double blind study where this was tested?
  - Spooky23 7y ago
    I don’t. 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.
- taurath 7y ago
  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.
- kwhitefoot 7y ago
  Why do you change manufacturers? I always get the same generic when I get my hypertension pills.
  - rconti 7y ago
    The fact that this is even a consideration is scary, and frankly, what the book was apparently about. I always believed generics were identical.
    - larrywright 7y ago
      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.
  - dillonmckay 7y ago
    The pharmacy will change drug distributors, which will change the manufacturer supplying their inventory.
  - Spooky23 7y ago
    I don’t. I get a different manufacturer every few months.
protomyth 7y ago
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.
marricks 7y ago
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. https://www.marketplace.org/2017/12/21/business/holiday-season-fills-rv-campground-amazon-workers/ https://www.marketplace.org/2017/12/21/business/holiday-seas...
- java-man 7y ago
  I hear more ads on NPR than before. Has their funding mechanism changed?
  - colordrops 7y ago
    They only get 16% of their funds from public sources.
  - plussed_reader 7y ago
    No, it is still funded from listeners and corporate interests.
  - asark 7y ago
    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.
- Loughla 7y ago
  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. Honestly, I love NPR, but. . .
everdrive 7y ago
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.
- colordrops 7y ago
  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.
  - everdrive 7y ago
    My attempts to discuss NPR's shortcomings in an apolitical way are off to a terrible start.
    - colordrops 7y ago
      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".
kurthr 7y ago
Bad article, but probably related to the series of contamination issues that various generics have had (eg NDMA contamination in Sartan). https://blogs.sciencemag.org/pipeline/archives/2019/01/04/the-sartan-contamination-story https://blogs.sciencemag.org/pipeline/archives/2019/01/04/th...
- dillonmckay 7y ago
  Remember when Excedrin was unavailable for over a year because of contamination during manufacture circa 2012?
rconti 7y ago
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.
xeromal 7y ago
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
snap12789 7y ago
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.'

vikramkr 7y ago

This reminds me of this case: https://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-not-equivalent-to-the-brand-is-in-use-anyway.html 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.

geoelectric 7y ago
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." https://abcnews.go.com/Health/fda-finds-generic-antidepressant-original/story?id=17399399 https://abcnews.go.com/Health/fda-finds-generic-antidepressa... https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/update-bupropion-hydrochloride-extended-release-300-mg-bioequivalence-studies 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.

newswriter99 7y ago

"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.

chrismeller 7y ago
I would actually take it a step further. 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.
duxup 7y ago
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.

stallmanite 7y ago

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.

kwhitefoot 7y ago
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.
- dillonmckay 7y ago
  Pharmacies will constantly negotiate and change drug distributors that may use a different manufacturer of generics.

kwhitefoot 7y ago

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.

y-c-o-m-b 7y ago

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.

kwhitefoot 7y ago
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.
- dodobirdlord 7y ago
  Same drug, different generic manufacturer.

sct202 7y ago

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.

tensor 7y ago

Related, what it takes to get a generic drug approved in Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/access-to-generic-drugs.html https://www.canada.ca/en/health-canada/services/drugs-health...

cryoshon 7y ago

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.

dillonmckay 7y ago
It has been my experience that doctors are not that knowledgeable about specific pharmaceuticals, particularly compared to a pharmacist.

richrichardsson 7y ago

This would be a non-issue if you had a single buyer at the national level sourcing the drugs on behalf of patients.

Loughla 7y ago
Maybe I'm dense, but how would that inherently get rid of generics or change any of the existing regulations?
- richrichardsson 7y ago
  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.
throwayEngineer 7y ago
What a simple solution. Hope that doesn't cause a black market of effective, expensive drugs.
refurb 7y ago
Why? If the single payer purchased the cheapest drug from one of these manufacturers, you'd still have the same problem.
- richrichardsson 7y ago
  Of course you wouldn’t, because they would ensure that they are the cheapest and most effective.
larrywright 7y ago
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.

rootusrootus 7y ago

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.

sickygnar 7y ago

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.

LinuxBender 7y ago

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.

throwayEngineer 7y ago
How are pharmacists going to make 60$/hr if you don't pay them for every transaction? /S

AnthonBerg 7y ago

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.

asciimov 7y ago

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.

deleted 7y ago

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RandomInteger4 7y ago

While there may be some truth here, I am highly suspicious because this story feels like corporate sponsored FUD 101.