Generic drugs rock! (Except when they don't)

Jan 30 2009 Published by under Medicine

A patient broke the news to me. There is a massive recall of generic drugs made by a single company, Ethex Corp, a subsidiary of KV Pharmaceuticals. The company makes many of the popular generic drugs that I prescribe every day, such as generic extended-release metoprolol.
This is a really big deal, and I'm pretty angry that I had to rely on a patient to tell me. Generic medications have revolutionized the affordability of essential care, and are usually a good thing. Also, insurance companies push them, and hard, offering incentives for their use, and penalties for using branded drugs. Because the U.S. has a pretty good quality-control system, this is usually not a problem. After all, we don't live in China where some guy can open a little factory and start cranking out bogus pills. Of course, KV and Ethex can have their factories anywhere they wish, and who knows what happens there?
A news search on the web brings up mostly hits from law firms looking to file dubious suits on behalf of "victims", but they've got it wrong. Patients aren't victims because they have headaches and tummy cramps---none of these symptoms are likely to have anything to do with these poorly manufactured drugs. We are all victims of a lousy system that allows crappy drugs to sneak into an otherwise very good supply of generic medications. We are victims because of the inconvenience caused. Thankfully, there isn't likely to much in the way of injury, but who knows?
And that's the problem. If I have to wait for a patient to give me the information, we have a big, huge, horrible problem here. Who knows what's going on with our drug quality control? Not me, and I'm a doctor.

10 responses so far

  • DuWayne says:

    Wow, I won't feel so stupid about double posted comments in the future.
    I really cringe reading this. While I don't tend to look at my doctor as an object worthy of blind faith, I do look at him the way I expect my handywork clients to look at me; As the expert who understands and knows his shit better than I do. Doesn't mean I won't pay attention and look into a diagnosis and the recommended therapy, but I do assume that I am merely making sure that I didn't stumble into wooville, rather than second guessing the pro.
    I understand that doctors aren't omnipotent and that accidents happen. But this is fucking scary. Especially given what I am going to see my doctor for on Monday. I am really having a hell of a time keeping it all together right now. Give me a belly ache, instead of actually reducing my stress and anxiety and I'm likely to end up curled in the corner hacking up blood.

  • CyberLizard says:

    So how do we know if we've gotten pills from the recall? I see a drug I take on the list and I always get generic, but I also know there are at least two different generic manufacturers of it. How do I know which one I've got?

  • CyberLizard says:

    Never mind. has a pill finder with pictures. The brand I take is made by Barr Laboratories. Whew!

  • anon says:

    How the heck did they screw up so many different medications, is what I wonder. I mean one or two, sure, but seriously. And I would expect them to be explicit about what, exactly, they screwed up. I'd sort of like to know how much medication I've been taking.

  • Oh, thank goodness, neither of my generics is made by Ethex (a phoneme for "ethics"? How ironic!) Thanks for the drugfinder, Cyberlizard!
    Scary stuff! How many people have to die before our drug quality assurance is given proper priority?

  • Doc and readers, and The People's Pharmacy by med journalists, Joe & Terry Graedon, have been investigating generic drug quality since we've been increasingly relying on them.
    The problem appears to lie in the unbelievably small number of FDA staff following generic mfrs. Seems that initial quality inspections are great but resources are not plentiful for follow-up investigations.

  • The variance in quality of generic drugs is especially important for people who rely on Lamictal. Whenever I call in a prescription refill for my daughter, I have to remind the physician to mark the scrip as "Dispense as written." Generic psychotropics can vary (according to our original pharmacologist when my daughter was diagnosed with seizure disorder) by as much as 25% in terms of the active ingredient. That's not so good when lamotrigine has a narrow effective range, and a high concentration leads to serious skin rashes.
    I have had a few battles with dispensing pharmacies who tried to fill with generics.

  • Dan says:

    The Benefits of Generic Medications
    Often when one goes to seek medical attention from a health care provider, that provider usually writes a prescription for that patient for medication to either treat the symptoms of the disease that may be present, cure the disease, as with the case regarding antibiotics, or the provider may prescribe medications to delay the progression of a disease that may exist with their patient.
    The actual cost of that medication the patient receives from a pharmacy can vary greatly, and here is why:
    More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate. Health care providers are aware that generic drugs are less expensive than branded drugs that are equivalent to the generic drug prescribed as far as safety and efficacy are concerned. Nearly two thirds of all medications prescribed to patients in the United States are now for generic medications.
    Generic medications are copies of branded medications that previously existed, yet no longer have a patent on these medications, which allows generic drug companies to produce these formally expensive drugs and a much lower cost
    Why aren’t generic medications prescribed all the time, then? The branded drugs have representatives who leave samples of these branded medications with the health care provider, with the intention and belief that this provider will select this branded drug as a result. Generic medications, while much less expensive than branded medications, do not have samples of these drugs to be left with health care providers.
    Around 4 billion prescriptions filled every year, so cost savings is rather important. Generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market. However, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs.
    With branded medications, about 75 percent of these newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market, so there is no benefit with many of these expensive branded drugs. Finally, about half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course, as it relates to safety for the patient taking the drug.
    Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients from branded medications they may be taking to generic medications, if possible. This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements to health care providers to select their promoted medications. Both financial inducements that occur are remarkably legal, overall. Yet I find financial inducements in health care inappropriate and unethical when a health care provider treats a patient with prescribing medications for them.
    Not long ago, generic drugs were not prescribed that often, or produced to a great degree, because of the cost of bringing such a med to the market, which at the time required the same clinical trial protocols as branded meds.
    Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA. This reduced cost of generic manufacturing and approval allowed for more of these meds to saturate the pharmaceutical market, and doctors started prescribing more generic meds as a result.
    Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds through such tactics as reformulation or combining their branded medication with another generic drug to create a new combination medication, which is called evergreening, of their meds, which allows for them to continue the patent lifespan of their branded medication.
    Additional branded drug company tactics include frivolous patent infringement lawsuits, which delays generic availability for a longer period because of these lawsuits. Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication.
    The pharmacies that fill the prescriptions for the patients written by the health care providers support generic use, as pharmacies make more money off of generic prescriptions they fill for others compared with branded drugs. So delays will not prevent the utilization of generics, overall, or for a long period of time.
    Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics, or have acquired generic pharmaceutical companies entirely because of the progressive impact generic drugs are having on the business of branded drug companies.
    Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has now been replicated by the generic medication.
    Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- as safety of these new drugs have not been overall established. This is concerning to several different health care providers. The familiarity of the generic drug accessible to them after the patent expiration of possibly the branded drug the health care provider had prescribed in the past assures the provider often that there will not be any safety or efficacy concerns by selecting such a generic drug.
    Many clinical studies have proven that generics are as effective compared with branded medications for particular disease states. The ALLHAT trial showed this, with generic diuretics showed equivalence if not superiority over the branded medications it was compared with during this 4 year trial funded mostly by the NIH. Drugs utilized in this trial were cardiovascular drugs, and the examination of these both branded and generic drugs showed that the least expensive drugs, the generic drugs, provided the most benefit for the patients studied in this trial.
    Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers directly. Both mechanisms for obtaining samples of generic drugs by a health care provider remain quite rare, however.
    Then there are some health care providers who insist that you get what you pay for, so they are convinced that branded drugs are always more efficacious and tolerable than generic medications. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. However, there may be some truth to decreased efficacy of generic drugs over their previously branded equivalents, yet not to a the point where it is a clinical concern.
    In the U.S. Health Care System, cost is a rather large concern for members of the public health, and those who attempt to restore their health as it needs to be at times. Generic medications provide financial relief for patients in need of drugs to improve their health. And both the health care provider as well as the patient can be assured that a generic drug prescribed to, and taken by, a patient will provide the efficacy needed to address the medical problems of the patient. More importantly, the patient saves money, without compromising their safety,
    Dan Abshear

  • Samuel Barns says:

    It would seem that the generic drug company from which you obtained your drugs would have informed you of the recall. At the very least, the drug rep from which you purchased the generic drugs should have done a better job of supporting his customer base by informing them when recalls such as this happen.

  • Lin says:

    I'm an RN and fairly drug knowlegeagble so I was taken by complete surprise when after I had taken hydrocodone that helped me with no side effects from one pharmacy and then I took the same drug (?) hydrocodone from Walgreens and had a huge problem. Enough of a problem to make me go to an ER. It was still not identified as the problem, but then every time I tried to take it again, the same issues began again.
    If anyone can verify generic issues from Walgreens and any such similiar problem please let me know. thanks