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Medicine United States

Generic Drugs May Not Be As Safe Or Effective As You Think (npr.org) 200

Posted by BeauHD from the you-get-what-you-pay-for dept.
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.
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Generic Drugs May Not Be As Safe Or Effective As You Think More

Generic Drugs May Not Be As Safe Or Effective As You Think

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  • So these concerns.... (Score:4, Insightful)

    by Anonymous Coward on Monday May 20, 2019 @11:40PM (#58627696)

    Do they apply ONLY to manufacturers of generic drugs? Are all name-brand drugs manufactured in USA?

    • Re:So these concerns.... (Score:5, Insightful)

      by Mr. Dollar Ton ( 5495648 ) on Tuesday May 21, 2019 @01:11AM (#58628004)

      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)

        by Type44Q ( 1233630 ) on Tuesday May 21, 2019 @05:35AM (#58628688)

        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, Insightful)

      by arglebargle_xiv ( 2212710 ) on Tuesday May 21, 2019 @01:15AM (#58628018)

      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)

        by ShanghaiBill ( 739463 ) on Tuesday May 21, 2019 @03:01AM (#58628250)

        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.

    • From what I can gather from US news (only news feed in the world that is also entertaining :) ) your domestic producers prefer to buy politicians, they do not care about low level government employees much. Just yesterday I saw a parliamentary committee member literally crying over farma profits' reduction possibility. We have corruption all over the planet but US is really the World Leader (tm).

      • ...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.

        • :D
          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.
        • I can't say I have, but the bimbos they have on the US news are plenty shallow for me already. Maybe the problem is that I don't look to the news for entertainment. Silly me. Maybe one day I'll get my head in Twitter-land with the rest of the populace. Until then I'll continue gripping the paper they drop off at my office in the morning.

    • Re: (Score:2)

      by mcmonkey ( 96054 )

      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.

  • Fabricating *data*? (Score:5, Insightful)

    by Krishnoid ( 984597 ) on Monday May 20, 2019 @11:40PM (#58627702) Journal

    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)

      by Anonymous Coward on Monday May 20, 2019 @11:47PM (#58627742)

      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.

      • Re: (Score:2, Informative)

        by Anonymous Coward

        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.

    • The problem is the patents surrounding drug manufacturing. The generic manufacturers have to find alternative untested pathways to produce the drugs. Solution: Expire the patents along with the manufacturing rights.

      • Re: Fabricating *data*? (Score:4, Informative)

        by sconeu ( 64226 ) on Tuesday May 21, 2019 @12:52AM (#58627948) Homepage Journal

        They don't go generic until the patent expires.

        • Re: (Score:2)

          by jrumney ( 197329 )
          Except in very limited circumstances - under WTO rules, countries are allowed to compel the patent holders to license the patents to a generic manufacturer at a reasonable price (normally they let the companies negotiate first, and step in to set a price if they cannot come to an agreement). It has happened with HIV, cancer and hepatitis treatments in India and elsewhere in Asia.

          • Yes, but that is still NOT a generic drug per TFA. You misunderstood the word 'generic' (expired patents) and 'original' (active patents) drug.

            • Re: (Score:2)

              by jrumney ( 197329 )
              It is you that is misunderstanding. Original refers to the original manufacturer's trademarked and patented product, which in some cases they may license another manufacturer to produce "under license", for production capacity or tax treatment (local manufacturing) reasons. Generic refers to another manufacturer producing their own medicine with the same active ingredients, regardless of whether the patents have expired or are under a compulsory license or voluntary licensing arrangement.

        • 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)

        by greatpatton ( 1242300 ) on Tuesday May 21, 2019 @03:03AM (#58628254)
        As a chemist, this is pure bollocks! Only drugs produced through GMO yeast/bacteria/etc. can face an issue, as you have to make your own, but as the final product can be easily tested for equivalence (in structure, purity, etc.). For the rest, this is only organic chemistry, and industrial process optimization. FDA can also easily make their own test on final product imported in the US, to see if they match with the specification of the batch.

    • Re: (Score:1)

      by Anonymous Coward

      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

    • 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

      • 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

    • 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 is that it still hasn't solved the primary difficulty, that we all die.

    The secondary problem is that if you are sick, or need a doctor or medicine, you are already in a bad situation.

    • Re: (Score:2)

      by Megol ( 3135005 )

      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)

    by Applehu Akbar ( 2968043 ) on Monday May 20, 2019 @11:47PM (#58627736)

    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)

      by pilaftank ( 1096645 ) on Tuesday May 21, 2019 @12:07AM (#58627836) Homepage

      ... Switzerland (which is legally not European)

      Switzerland is European. It's just not in the EU.

      • 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)

      by Anonymous Coward

      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.

    • Re: (Score:2)

      by dgatwood ( 11270 )

      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.

      Maybe that's the lab rat you're smelling?

    • Yeah, to be sold in the US and EU these guys are going to have to be GMP. I've never sat throught a GMP audit, but I've been through plenty of GLP audits and those FDA inspectors are going to figure out if you fudged things pretty fast. If your paper records "look old" that's just going to raise more questions about your archival standards. They're also going to evaluate your quality processes, and that'd be almost more effort to fake than to just go ahead and do...

    • 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.

    • 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.

  • Somebody may be on the take here... (Score:5, Insightful)

    by gweihir ( 88907 ) on Monday May 20, 2019 @11:47PM (#58627740)

    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.

  • Products - reputable source in reputable contries (Score:2, Interesting)

    by Anonymous Coward

    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

    • 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)

    by WindowsStar ( 4692767 ) on Tuesday May 21, 2019 @12:04AM (#58627826)
    Seems conveniently timed that they would say this; with the law suit filed against the drug companies raising the prices of generics in some cases 3000%.

  • if this were the case (Score:5, Insightful)

    by schematix ( 533634 ) on Tuesday May 21, 2019 @12:18AM (#58627864) Homepage
    The pharma companies peddling the name brand drugs would test them and LOUDLY TELL EVERYONE (INCLUDING THE FDA) - SEE IT'S NOT THE SAME! But they don't. Would be trivial for them to test.

    • Re: (Score:3)

      by gweihir ( 88907 )

      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)

    by seoras ( 147590 ) on Tuesday May 21, 2019 @01:30AM (#58628054)

    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.

    • 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.

      • Re: (Score:2)

        by seoras ( 147590 )

        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

      • That is a really cool device. It's unfortunate that it costs $2000

        Just wait for the patent to expire!

    • 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

      • Re: (Score:2)

        by seoras ( 147590 )

        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.

    • Can it also test for potency? There used to be fake malaria medicine sold in Africa. Then the fraud became detectable. So the manufacturers of counterfeits would mix just a bit of the real thing in to fool the test. And this resulted in resistant microbes.
    • Every few years I hear about some project using NIR spectroscopy, and they never pan out. Meanwhile, I'm still using my old fashioned FTIR. [wikipedia.org] It's the size of a refrigerator, has to be filled with liquid nitrogen everyday, and cost about a million dollars. But if you want data you can trust, accept nothing else.

      • Re: (Score:2)

        by seoras ( 147590 )

        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)

    by oh2 ( 520684 ) on Tuesday May 21, 2019 @01:54AM (#58628102) Homepage Journal
    So, if this is such a problem, just do spot checks at the border and in pharmacies. The article sounds more like justification for artificially high pricing. Wasnt Trump going to fix this, along with mexican financing for that wall of his ?

  • And as a cynical person in todays world ... (Score:4, Informative)

    by CptJeanLuc ( 1889586 ) on Tuesday May 21, 2019 @02:47AM (#58628210)

    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.

    • Re: (Score:1)

      by Anonymous Coward

      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

      • Re: (Score:3, Informative)

        by Anonymous Coward

        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)

    by havana9 ( 101033 ) on Tuesday May 21, 2019 @03:11AM (#58628268)
    Looks to me this is only a problem in USA where all are worshippers of the God money, and government is bad. There is a problem of fake pharmaceuticals, especially if bought using unofficial channels.
    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)

    by thegarbz ( 1787294 ) on Tuesday May 21, 2019 @03:23AM (#58628322)

    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?

  • "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.

    • Most of them are, you only know ahead of time if it is part of an external ongoing audit that tracked back to you and they just want you to pull the records for them ahead of time.
  • Quote from Fortune: "The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same." (http://fortune.com/2013/01/10/are-generics-really-the-same-as-branded-drugs/)

    An issue I first noticed after being dispensed

  • it's not only the literal "drug" that matters (Score:5, Interesting)

    by _randy_64 ( 457225 ) on Tuesday May 21, 2019 @08:18AM (#58629114)

    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.

    • This seems to be problematic for two reasons. Many makers of name-brand drugs will first file a patent for the drug and then, later, file a patent for the release mechanism thus effectively extending their monopoly on the drug. So generic manufacturers may be able to make a generic of the drug but very well may have to use a different extended release mechanism. Bad that the manufacturers try to game the system, worse that the FDA allows it, and worst that the consumers have no recourse.

  • 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.

  • 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

    • Sometimes the patent on the active ingredient expires before the patent on the delivery matrix, so the generic drug may be the same but may not survive the digestive system the same way, or may release more/less quickly, and so on.

    • Re: (Score:3)

      by mcmonkey ( 96054 )

      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.

  • and they are cheaper (smells like a FUD campaign to me :P)

  • Follow the money (Score:4)

    by HeckRuler ( 1369601 ) on Tuesday May 21, 2019 @02:37PM (#58631542)

    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.

  • "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."

    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)

    by dcw3 ( 649211 )

    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.

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