Generic Drugs May Not Be As Safe Or Effective As You Think (npr.org) 200
An anonymous reader quotes a report from NPR: As the cost of prescription medication soars, consumers are increasingly taking generic drugs: low-cost alternatives to brand-name medicines. Often health insurance plans require patients to switch to generics as a way of controlling costs. But journalist Katherine Eban warns that some of these medications might not be as safe, or effective, as we think. Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results.
"These plants know that [the FDA inspectors are] coming," Eban says. "I discovered [some overseas drug companies] would actually ... alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old." As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as "overwhelmed and underresourced" in its efforts to ensure the safety of overseas drug production. Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives, because of cost. In a statement to NPR, the FDA said that Americans "can be confident in the quality of the products the FDA approves" and notes it has "conducted a number of unannounced inspections" at foreign plants over the past several years.
"These plants know that [the FDA inspectors are] coming," Eban says. "I discovered [some overseas drug companies] would actually ... alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old." As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as "overwhelmed and underresourced" in its efforts to ensure the safety of overseas drug production. Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives, because of cost. In a statement to NPR, the FDA said that Americans "can be confident in the quality of the products the FDA approves" and notes it has "conducted a number of unannounced inspections" at foreign plants over the past several years.
So these concerns.... (Score:4, Insightful)
Do they apply ONLY to manufacturers of generic drugs? Are all name-brand drugs manufactured in USA?
Re:So these concerns.... (Score:5, Insightful)
Yes, scaremongering is a time-tested and solid business tactic, which has the advantage of being very, very cheap. What is more affordable, lowering the costs of your manufacturing or hiring someone to write a scary story?
Re: So these concerns.... (Score:5, Insightful)
lowering the costs of your manufacturing
The costs of manufacturing have fuck-all to do with the final selling price.
Re: So these concerns.... (Score:5, Informative)
True enough.
For medical drugs, development costs are the overwhelmingly important drivers for price. When you have to spend billions to get a drug developed and certified for use on humans, and 90%+ of your work doesn't get final approval (for good reasons - side-effects, effectiveness, whatever), you'll either have to charge an arm and a leg for the stuff, of you'll go bankrupt....
[emphasis mine]
Yeah... I'm gonna call bullshit. Random example, TEVA (Albuterol maker), spends 3.5x more on marketing than they do on research. I admittedly suck at reading financial statements, so I'd be happy to be corrected. But in this example, research accounts for around 15% of their budget. https://finance.yahoo.com/quot... [yahoo.com]
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The comparator was between the manufacture and the development, not other business.
In the US, developing a new drug requires generating hundreds of thousands of pages of documentation for the FDA to review. The whole process costs over $300M. Many drugs fail early--anything that just doesn't work on rats or is obviously-toxic won't go forward--and the ones that don't often fail late. That means you have humans test the drugs and complain about intolerable side-effects (gastric upset, headaches, mood sw
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If you look at the company [wikipedia.org] on WikiPedia, you should see that the company is specialized in "generic" drug. Also, the number on the stock link in you post is not detail enough. In other words, the marketing money can go in different areas for different drugs. And according to WikiPedia, the money might have gone to promoting generic drugs more than their own development. Thus, I am not so sure that you should use the stock page to determine what you are trying to do.
Re:So these concerns.... (Score:5, Insightful)
Generic Drugs May Not Be As Safe Or Effective As You Think [*]
[*] Study commissioned and paid for by PhRMA, the Pharmaceutical Research and Manufacturers of America. You're welcome.
Re:So these concerns.... (Score:5, Informative)
Generic Drugs May Not Be As Safe Or Effective As You Think [*]
[*] Study commissioned and paid for by PhRMA, the Pharmaceutical Research and Manufacturers of America. You're welcome.
There was no "study". The person making these allegations is a journalist, not a researcher. So no data, no analysis, no peer review, no academic ethics. Just a book to promote.
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Re: So these concerns.... (Score:2)
...only news feed in the world that is also entertaining
Either you've never seen a female Latin American newscaster or your idea of 'entertainment' revolves around tubesteak-smothered-in-underwear.
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It is very unfortunate that when I was growing up, Jerry Lewis and Bob Hope were the pinnacle of entertainment. So my past indoctrination and current expectations for entertainment are focused on utter and complete idiotic take on life and serious incompetence. If Latin American newscasters (especially ladies as you put it) have such features better than US ones, I am willing to learn Spanish and Portuguese any time.
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Do they apply ONLY to manufacturers of generic drugs? Are all name-brand drugs manufactured in USA?
There's nothing in TFA--from gaming inspections to the patent process to overseas manufacture--that is specific to generic drugs and not an issue with brand names as well.
This is not reporting NPR, it's actually an interview with an author, but it appears to be a very poorly done/softball interview.
Re:VENTOLIN ASTHMA INHALERS (Score:5, Informative)
Retail for Ventolin inhaler in Huntsville, AL, US is about US$100. Retail for THE SAME INHALER in Bangkok, Thailand runs between (equivalent in Thai baht) US$6 and about US$9, depending on which pharmacy I go to. If I go to the standalone pharmacy on Sukhumvit Road, north side, just west of Sukhumvit Soi 15, I pay 160 baht, about US$6 at current exchange rate. If I go to the pharmacy in the Food Land on Suk Soi 5, I pay about US$7.50 equivalent. The little pharmacy in the Am' Plaza, just outside the Ambassador Hotel, gets US$9. I don't recall offhand what Boots in Gateway Mall at Ekkamai was getting, but it was in this ballpark. I went there because I'd been swamped, hadn't had a chance to hit the main pharmacy, and I needed the inhaler NOW: the one in my pocket had just gone dry.
SAME MANUFACTURER, SAME FACTORY, SAME PRODUCTION LOT NUMBERS.
Symbicort 160/4.5 costs around US$400 in Huntsville. The equivalent, same manufacturer, same brand name, but a dry powder Turbuhaler (tm) instead of a gas-propelled measured-dose inhaler, cost around US$60 at the pharmacy at Suk Soi 15. The Turbuhaler is actually a much better delivery system than the gas-driven MDI, but it is not yet FDA-approved for Symbicort, and the cost of the approval process makes it unlikely to be approved any time soon. (Note: Pulmicort is approved as a Turbuhaler in the US.)
Spiriva Respimat costs about $400-500 in the US. It costs me $100 in Bangkok. EXACT same drug, EXACT same delivery mechanism, EXACT same factory and production lot numbers.
I've heard the comments about not knowing what you're getting if you buy overseas. I'll agree that you shouldn't be buying from street vendor stands, but these are pharmacies that have been in business for a long time. (I've been going to the pharmacy at Suk Soi 15 for well over ten years now, with never a problem.)
Re:VENTOLIN ASTHMA INHALERS (Score:5, Informative)
2.5 USD in Romania :)
https://www.minifarmonline.ro/... [minifarmonline.ro]
And it IS good, my older child needed it for a while, worked wonders.
Now about TFS and TFA: they're BULLSHIT. It's paid scaremongering article so that big pharma could sell their ridiculously overpriced shit.
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I checked out that site. Amazing prices. They don't ship internationally though, huh? Romania seems to have very low prices for drugs. Among the lowest prices I've ever seen.
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What I don't understand is why pharmacies like that don't sell worldwide. I'd like to buy massive amounts of drugs from that site and resell it all over the world at a slight markup. It would still be cheaper even than alldaychemist. It's pretty annoying.
Re:VENTOLIN ASTHMA INHALERS (Score:4, Insightful)
Because if they did, they would get cut off from the manufacturer. Big Pharma is not stupid. They sell for the max profit they can in each country and use scare mongering and legal methods to enforce it. Canada has already said exporting drugs en mass to the US is a non starter because they do not have sufficient supply. Only stuff like opiods in WV have unlimited supply:)
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I have a similar experience although the prices are not quite as inflated in the UK. I still save money buying online from a generics retailer in Malaysia. I also save a ton of time: my asthma has remained consistent in its severity since I finished puberty, yet I'm required to see a nurse for a checkup every 6 months (which involves waiting 45 mins then talking to a nurse for 5 mins), and the pharmacy will only give a 1 month supply so I also have to visit a pharmacy every month. Alternatively I can ord
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Retail for Ventolin inhaler in Huntsville, AL, US is about US$100. Retail for THE SAME INHALER in Bangkok,
I find that hard to believe! The same inhaler in Australia costs us$5 (A$7.50 for Ventolin at my chemist, generic slightly cheaper).
https://www.chemistwarehouse.c... [chemistwarehouse.com.au]
Other developed countries are similar.
It contains Salbutamol, aka albuterol, and that price is without prescription or subsidies.
It was patented in the 1960s, so WTF is going on???
The US healthcare system is seriously corrupt.
https://undark.org/article/ast... [undark.org]
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The US healthcare system is seriously corrupt.
I would like to present you with the "Captain Obvious" award.
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They got new patents in the US when they switched propellants, even though the active ingredient didn't change. Because all the inhalers in the US were contributing to global warming or something. So all of the generics that were $5 in the late 90s went back to name-brand only in the early 2000s. We just got the generic Levalbuterol over here, and luckily that one is affordable now with most insurances, assuming that albuterol variant woks for you.
The propellant was a CFC and the EPA banned it. The new propellant is CO2 which is actually the GHG. You are correct about the rest though. They had to go through safety trials and re-certify with new patents. It's all weapons grade bullshit. They were retailing for $20 with the CFC propellant and now it's $100 with no change in active ingredients.
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The propellant was a CFC and the EPA banned it. The new propellant is CO2 which is actually the GHG. You are correct about the rest though. They had to go through safety trials and re-certify with new patents. It's all weapons grade bullshit. They were retailing for $20 with the CFC propellant and now it's $100 with no change in active ingredients.
No, the new propellant is Suva (R-134a) (1,1,1,2-tetrafluoroethane).
lawsuits (Score:2)
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for the price of a co-pay on Medicare (the common drugs are likely $5-30 per month, IME)
I think you're missing the mark on this conversation. Just because YOU are only paying $5-30/month co-pay, SOMEONE is paying the remaining amount. It doesn't matter if it's Medicare or Private Insurance we are all paying for this ridiculous system.
Re:VENTOLIN ASTHMA INHALERS (Score:4, Interesting)
The insurance companies are still sorting this one out.
My Proventil (tm) (albuterol/salbutamol MDI) is written to allow generic substitution, so the pharmacy attempted the substitution. Because the generic is not yet on my company's formulary, the insurance company tried to stick me with a $75 copay for it. The pharmacy caught it, said "That's not right", and switched it back to the brand-name, for which I pay $15 or $20 copay.
Fabricating *data*? (Score:5, Insightful)
These plants know that [the FDA inspectors are] coming," Eban says. "I discovered [some overseas drug companies] would actually ... alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old.
So they can't buy pills on the open market and randomly assay them? Or if they ask for samples off the line when visiting, a plant that can properly manufacture a pharmaceutical two weeks out of the year can't do it the rest of the year because they have to ration, I dunno, the extra-special fairy dust that goes into the real stuff?
I bet the problem is that it's too expensive to hire real potions masters, so they only bother to do it when they get an FDA notice. That's probably it.
Re:Fabricating *data*? (Score:5, Insightful)
Word, you don't see people dropping dead from generics in countries that enforce pricing and also buy such generics. Canada or the UK or Germany would be pretty upset if that was happening.
This sounds like a USA Pharma FUD piece to me.
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Word, you don't see people dropping dead from generics in countries that enforce pricing and also buy such generics. Canada or the UK or Germany would be pretty upset if that was happening. This sounds like a USA Pharma FUD piece to me.
You might want to read the article before calling it FUD. They say:
So they will take their biggest shortcuts, their biggest swaps of high-quality to low-quality ingredients, in markets with very poor regulation: sub-Saharan Africa, Southeast Asia, areas of South America.
Which is consistent with your opinion.
Re: Fabricating *data*? (Score:1, Informative)
Re: Fabricating *data*? (Score:4, Informative)
They don't go generic until the patent expires.
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Yes, but that is still NOT a generic drug per TFA. You misunderstood the word 'generic' (expired patents) and 'original' (active patents) drug.
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Which is why the patent holding company has more patents in the wings that build upon the existing patent when it nears expiration. They are withholding improvements and advances in drugs to maintain some exclusivity for longer periods of time.
For example, it could be as simple as some new coating or physical design of the pill. However, a more typical case is a "controlled release" or "continuous release" (CR) composition of the drug. So what happens is before the original patent expires on the chemical
Re: Fabricating *data*? (Score:5, Informative)
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Isn't testing drugs in the distribution channel at least a "canary in the coal mine" kind of test that would suggest more intensive manufacturing plant testing is necessary?
It might be useful to prioritize which plants/manufacturers to test, too, especially if you see different drugs from the same manufacturer with problems.
Plus its a useful cross-reference if plant inspections are showing clean tests but the actual drugs in distribution have problems. I would imagine a real potential problem is manufactur
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Doing random batch tests makes sense, but by then the drugs are already in the distribution channel.
From my understanding, the testing should occur BEFORE the distribution. I don't see why would they do the test after a drug has already gone to distribution channel because it doesn't make sense...
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I think the assertion is more about quality control, like that Japanese steel. And quality control does matter, but you'd think that would be detectable if random, country wide pulls of generics were tested regularly.
Or maybe it's a bit like that restaurant, not kept clean, with a rodent problem and food kept on the floor -- instead of on shelves in walk-in coolers like they're supposed to. EG, health issues not directly related to the medicine, but its preparation. Imagine botulism in your meds!
But I ag
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So they can't buy pills on the open market and randomly assay them?
The problem isn't "can't". Given enough man power and money, the FDA could systematically test enough pills to ensure that there were no problems. Otherwise it is a needle-in-the-haystack search considering the millions of pills that are produced every day.
Or if they ask for samples off the line when visiting, a plant that can properly manufacture a pharmaceutical two weeks out of the year can't do it the rest of the year because they have to ration, I dunno, the extra-special fairy dust that goes into the real stuff?
And how would that approach work? The company would selectively give the FDA samples they know are good. Plus see the first problem of money and man power.
I bet the problem is that it's too expensive to hire real potions masters, so they only bother to do it when they get an FDA notice. That's probably it.
No the real problem is that assaying the pills may not uncover any problems. Unlike what you see on
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Given enough man power and money, the FDA could systematically test enough pills to ensure that there were no problems. Otherwise it is a needle-in-the-haystack search considering the millions of pills that are produced every day.
The drugs are produced in large batches, and retooling and changing things after making small batches of "good" drugs is hard. This also doesn't make sense when you don't know which drugs to test and, besides, it's a lot of volume movement: if the distributors have to assay and report on X pills in the first batches they get and then 1/X for a certain volume, it's not only completely-random, but it scales at equivalent cost per pill (e.g. testing one for every 10,000 pills collected based on inventory co
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So they can't buy pills on the open market and randomly assay them?
This is basically what I had described in a grey-market bill I wanted to push, which was to allow importation of any drug from any manufacturer by pharmacies and pharmaceutical distributors provided they overstocked enough to make or contract frequent assays of individual pills taken from random batches and report the data to the FDA for central correlation. Sometimes the one made in India costs 1/10 as much.
The problem with healthcare (Score:2)
The secondary problem is that if you are sick, or need a doctor or medicine, you are already in a bad situation.
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Most people don't want to do what is known to be beneficial - they want the quick cure over the long term effort. Eat right, exercise, brush and floss, never tan, don't take poisons as entertainment, do regular health-checks, and have the right genes.
Healthcare as it's defined now doesn't concern itself with aging and IMHO that's a good thing ATM. That may change.
I smell a lab rat (Score:5, Insightful)
Generic drugs trade on a worldwide market. If the quality problem were as widespread as this author claims, testing authorities in Japan, the EU, and Switzerland (which is legally not European) would catch any fragrant and long-term corner cutting in generic manufacture.
Is this book pharma lobby FUD?
Re:I smell a lab rat (Score:5, Informative)
... Switzerland (which is legally not European)
Switzerland is European. It's just not in the EU.
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Switzerland is European. It's just not in the EU.
I emphasize separate status because Switzerland has a massive pharma industry all its own, with a correspondingly important inspection system.
Of course it's FUD (Score:1)
Generic drugs trade on a worldwide market. If the quality problem were as widespread as this author claims, testing authorities in Japan, the EU, and Switzerland (which is legally not European) would catch any fragrant and long-term corner cutting in generic manufacture.
Is this book pharma lobby FUD?
Yes.
Maybe there are legit criticisms, but if they were legit they wouldn't just be of generics, they would be of FDA testing generally, etc...
Which means this is FUD, likely slipped to us by Pharma without a paper trail they expect anyone to notice or look into.
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Maybe that's the lab rat you're smelling?
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Maybe that's the lab rat you're smelling?
What you're smelling is my tablet's autocorrect.
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Either way, it stinks. :-)
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Is this book pharma lobby FUD?
Well, yeah, it's NPR - the deep state's propaganda mouthpiece. Look into Kevin Klose's background, or the founding of the organization.
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Generic drugs trade on a worldwide market. If the quality problem were as widespread as this author claims, testing authorities in Japan, the EU, and Switzerland (which is legally not European) would catch any fragrant and long-term corner cutting in generic manufacture.
Yes but not all generic drugs go to all countries. Regulations on dosage, labeling, form, etc means that drug companies set up specific lines for specific markets. And not all lines may be subject to the same standards. For example, EU regulators might do more thorough inspections of plants/lines that only produce EU drugs. And drug companies might be more compliant/diligent in those lines/plants.
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Aurobindo has a list of FDA warnings, findings and violations going back years.
Which means precisely that the FDA is doing its job, not letting everything slide as this book claims.
Somebody may be on the take here... (Score:5, Insightful)
The only reason to write such things is to funnel more business to more expensive manufacturers. No other reason. Of course, medication made abroad to reasonable standards has exactly the same effects and safety as medication made domestically to reasonable standards.
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Please stop posting as AC, so I may insult you in person.
Products - reputable source in reputable contries (Score:2, Interesting)
Simply limit medicines both prescription and over the counter to be manufactured in reputable countries from certified manufacturing companies in the Western EU, NZ, Australia, Canada, US and Japan.
I'm from a large third world country and we would buy if at all possible only medicine imported from those countries. Locally produced medicine may or may not have the active ingredient and may or may not be tainted with unknown chemicals.
There are products which are only allowed to be imported from certain coun
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Simply limit medicines both prescription and over the counter to be manufactured in reputable countries from certified manufacturing companies in the Western EU, NZ, Australia, Canada, US and Japan.
Won't help. Western EU does hardly produce any pharmaceuticals on their own. They buy the active ingridient from a vendor and press it into pills. Considering the low number of fake or dangerous products being sold over here, quality does not seem to be a problem.
But when there is one, it shows some shocking facts: Remember the Valsartan recall? The base pharmaceutical was contaminated at the chemical plant producing it. (NOT the pharma industry who buys that powser and presses it into pills.) For the sake
Timing, timing, timing (Score:5, Interesting)
if this were the case (Score:5, Insightful)
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Indeed. They have the lab, the skills and the motivation. Of course, if they are caught in a lie, that could get extremely expensive, but if they had a legitimate case, they would not hold back. They do not have such a case, so they employ a mud-slinger instead.
There's an App for that. (Score:5, Interesting)
I developed an App for a company that uses machine learning on near infra red spectral analysis. [youtube.com]
It has many applications [sagitto.com] but one of the most successful, and ignored, is the identification of authentic pharmaceuticals.
Not only can the App, in conjunction with a pocket sized NIR spectrometer, identify genuine from fake tablets but it can also tell you if they are past their best before date.
Is the pharmaceutical industry interested? Nope.
It is like there's something else going on in that industry that just doesn't want any solution for verifying their products.
Beer hop growers just can't get enough of it. It works brilliantly at measuring alpha and betas in hops and is a huge success in Australia and NZ.
So it's not the software or product as other industries are loving it.
I keep seeing article after article about the problem with fake pills and pharmaceutical malpractices.
They have a problem, they just don't want a solution.
Re: There's an App for that. (Score:2)
That is a really cool device. It's unfortunate that it costs $2000 and only works on iOS.
I hope in the future you guys can get the price down to a consumer level. If I could buy one of those pocket spectrometers for a couple hundred bucks, and connect it to an Android phone... rather than write this comment I would have just bought one. Looks like an awesome tool.
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At some point in the next 5 to 10 years I believe this tech will be just another camera lens on the back of your average smart phone.
Your smart phone will then be able to scan and diagnose anything you can think of, a bit like the star trek tricorder.
Imagine ordering a meal and checking if for traces of nuts with your smart phone before eating it.
At $2k a pop today it's less than 1/20 of the cost of laboratory spectrum analysers and it fits in your pocket.
Cheap enough for a drug store to buy and use for the
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That is a really cool device. It's unfortunate that it costs $2000
Just wait for the patent to expire!
Measuring IR absorption of surfaces (Score:2)
What's the reliability of this device regarding:
- measuring mostly the IR spectrum on the surface of an object? (you might be measuring the sugar coating around the pill, not the content of the pill - the former might not contain the active compound that the second is supposed to)
- trying to measure the IR spectrum of a complex mixture?
(It's not like the lab practicals I used to give to student at some point in time, where they analyzed the IR spectra of pure substances. Or like the LC-MSMS spectra we did a
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I'm just the App developer so if you are interested in finding out more speak to Sagitto.
What's the reliability of this device regarding:
- measuring mostly the IR spectrum on the surface of an object? (you might be measuring the sugar coating around the pill, not the content of the pill - the former might not contain the active compound that the second is supposed to)
Grind it up in a Mortar and pestle. Pour into a little "baggy" and place the baggy on the analyser.
You need to take a calibration reading for the plastic bag first so it can be base lined.
The sugar and other coatings will appear on the graph but the peaks of interest for the drug shouldn't be obscured.
- trying to measure the IR spectrum of a complex mixture?
(It's not like the lab practicals I used to give to student at some point in time, where they analyzed the IR spectra of pure substances. Or like the LC-MSMS spectra we did analyze in one startup where the different components are automatically separated and analyzed one by one)
a pill would contain (by order of abundance) sugar/other excipient (mostly), food coloring, food preservative, and active compounds. I guess you aren't actually measuring the content of each molecule, only guessing the object based on comparing an over IR spectrum against a library of known spectra ?
This is machine learning not lab people. There are AI models built which are taught what to look for by data scientists.
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Can it also test for potency?
Yes, I believe it can.
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There has been numerous attempts especially in the new fast growing cannabis business.
Cannabis is very like beer hops and this application works just as well at identifying levels of THC and CBDs as it does alpha and betas.
It helps that the NIR is now pocket sized but the real game changer is the machine learning advancements.
Spot checks? (Score:4, Insightful)
And as a cynical person in todays world ... (Score:4, Informative)
My immediate two thoughts on this topics are that (a) the "brand" drugs are probably just the same drugs with a nicer label printed on the box with exactly the same manufacturing processes, and (b) this is probably a sponsored stunt by big pharma to scare people off generics.
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Not all generic drugs are "AB-rated" equivalents, and not all "AB-rated" equivalents are literally identical to the branded version.
Specific examples:
generic for Wellbutrin XL. A couple of years ago, several manufacturers of the alleged generic equivalent to "Wellbutrin XR" were caught selling a version that wasn't even remotely bioequivalent to the brand-name version. Basically, the generic version contained the same amount of the active ingredient, but released it all at once instead of properly titrating
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References:
https://www.fda.gov/drugs/drug... [fda.gov]
https://www.fda.gov/drugs/drug... [fda.gov]
https://www.empr.com/home/news... [empr.com]
Additional note: apparently, the situation with "Adderall XR" vs "Amphetamine Mixed Salts, Extended-Release" is even muddier. Depending upon whom you ask, it appears that most of the generic "Amphetamine Mixed Salts, Extended-Release" capsules available are NOT AB-rated Orange-book equivalents for Adderall XR. It appears that sometime around 2009, the manufacturer of Adderall XR ITSELF changed the e
USA problem caused by no single payer system (Score:4)
You could have a military trained group of cops that inspecs at random pharmacies and warehouses and also have IRS control imported goods and check the balances of medicine factories for instance.
Having also a single payer system and control what kind of generics are subsidized could be useful to stop questionable sources.
You can check this yourself (Score:5, Interesting)
Just read a newspaper backwards. It starts with a section called obituaries. If generic drugs were such an unsafe problem you would read about it in there.
This is a FUD piece. Generic drugs are used the world over and there are no actual end user effects so to speak. Which makes me wonder, if all the documents for the FDA are being falsified, then what is the purpose of the paperwork?
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Indeed. Pharmacies and major companies which produce generics tend to want to not make people sick. It ruins repeat business opportunities.
Zero is a number (Score:2)
"In a statement to NPR, the FDA said that Americans "can be confident in the quality of the products the FDA approves" and notes it has "conducted a number of unannounced inspections" at foreign plants over the past several years."
The above claim would be true if zero unannounced inspections were conducted.
They should all be unannounced.
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Another, more surprising, issue with generics (Score:2)
An issue I first noticed after being dispensed
it's not only the literal "drug" that matters (Score:5, Interesting)
My daughter was taking Pristiq, an extended-release, once a day pill. Once the generic for it became available, of course that's what the insurance wanted to pay for. No problem, I've always been of the opinion that drugs are drugs, and that the generic is exactly the same as the name brand.
But for this specific generic anyway, whatever they used to control the release of the drug didn't seem to work the same way. Instead of a nice steady 24 hour dose of the drug, it released very quickly, so within an hour she was extremely tired (a known side-effect, though she never experienced it with the name brand), and several hours later she would be angry/agitated/anxious/sad, all the things that the drug was supposed to help with. So it seemed like she got a big dose all at once, and then it wore off and didn't help the rest of the day.
Her doctor agreed and said that he had heard of that happening with other generics. So while the drug may be exactly the same, the "packaging" may not be, and that can have some very adverse effects. Fortunately we were able to get her back on the name brand drug, without the weird effect of the generic.
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Yes I did check (still have it downstairs, so I really did). Thanks for the suggestion. I've never had any problem with any generics, so I never thought something like that would be a concern. Glad that what you're doing is helping you.
Improving efficacy (Score:2)
That's why I keep an empty box of Viagra around and dip my Sildenafil prescription in blue food coloring before I stick it in the empty box. The blue colour and the branding make a lot of difference.
This has been my experience (Score:2)
When I broke my collar bone I was prescribed "Tylenol with Codeine" (generic Vicodin) for the pain. Didn't do shit. I went back to the doctor and requested brand name Vicodin. It worked much better.
As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as "overwhelmed and underresourced" in its efforts to ensure the safety of overseas drug production.
This is what happens when so many people are convinced that taxes are always bad, and government is always the problem. Turns out that some government agencies and functions are really beneficial and should be funded so that they are effective. I think a lot of people don't really understand and appreciate h
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When I broke my collar bone I was prescribed "Tylenol with Codeine" (generic Vicodin) for the pain. Didn't do shit. I went back to the doctor and requested brand name Vicodin. It worked much better.
Vicodin does not contain codeine. Vicodin is hydrocodone. Tylenol is a brand name. It is not generic. I do not doubt that one worked for you while the other did not. (Yeah, I got Tylenol with Codeine when I broke my hand. I think I took a couple and threw the rest out. Useless.)
But your doctor switched one drug for another, not a brand name for a generic.
It's not true (Score:2)
Follow the money (Score:4)
Considering just how much money is involved with that headline being published, regardless of how true it is, just how much money and effort did the drug companies expend to make it happen?
Remember the placebo effect. Real drugs with real known benefits ALSO benefit from the placebo effect. They work better if you believe they work. FUD in this case is literally reducing the effectiveness of their competitors, and doing real harm. If the drug company's PR division can make people doubt generics, it's worth billions to trillions.
the end effect (Score:2)
No question about it, American-based industry is far too sophisticated to game the FDA by such crude methods.
But how much different is the end effect?
FUD (Score:2)
FUD from the pharmaceutical industry. Show us evidence of any drug that's not chemically the same as the OEMs, and then we can talk.
Writing from a country with less government (Score:2)
corruption.
We have a choice of generics, which the doctor can overrule only with an explanation and the pharmacist must fulfill.
The government is doing adequate job of enforcing quality controls, so we don't often hear of problems with generic medicines, unless it is some sort of import for private use.
I spend some time in places that are quite corrupt - I was born in one of these. There you're likely to get not only bad generics, but counterfeit 'branded' medicine.
So, the situation depends very much on the
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Generic doesn't mean "fake". If your country has a problem with that, you should tighten tests and do not have different quality standards for brand and generic drugs. And maybe regulate prices so that there is less incentive to sell counterfeit drugs.
Re: Total FUD (Score:2, Interesting)
AOC is like Bernie - a convenient distraction for the socialist wing of the party. But be sure, just like Bernie, the Corporate Progressive nazis who control the Democrat Party will never allow her to run for President. Even if she "wins" the primary.
Re: but, but, globalsism is GOOD and nationalism. (Score:3)
"No one took them from you, you abandoned them"
Our traitorous ruling class sold out the masses of working people, for short term private profits. Thus they lost for themselves the mandate of heaven. They will be replaced. The only question is whether their replacement will be effected by the American people, or by the Chinese army.
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