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  1. #1901
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    Re: Healthcare going forward

    Quote Originally Posted by opinterph View Post
    What you are describing is known as “product hopping.” It is a scheme in which minor changes to the original (patented) product, such as dosage per capsule, tablet, etcetera renders the reformulated product not-equivalent to the original and therefore not subject to generic substitution. By combining introduction of the reformulated product with a switch in the market (convincing physicians to prescribe the reformulated drug), pharmaceutical companies can effectively prevent generic substitution for their products and thereby thwart consumers’ access to a lower-priced generic alternatives.

    We should also note that there is a price disconnect in the pharmaceutical market, because the consumer of the drug does not choose which product to purchase. The doctor makes that decision and then the consumer (or insurer) pays for the product. By preventing or limiting choices (gaming the system), the pharmaceutical companies remove competition from the marketplace; which increases their profits, reduces options for consumers, and unfairly maintains higher prices.
    This is correct.

    In some cases, the pharmaceutical company creates a new drug that is slightly altered- a new delivery method, a slight change in chemical structure or a combination of two existing drugs. The drug company has the option of then discontinuing production of the original drug which forces patients to take the new brand name version. It's also no coincidence that many of the physicians who prescribe the brand name are also on that CMS list of physicians who have been paid consulting fees by the drug company that makes the brand name drug.

    Because patents are granted for a particular molecular structure, this creates all sorts of opportunities for drug companies to create new versions of very similar molecules that they can then obtain a second patent on.

    You might have seen some ads that Vanda runs on US television for "Non 24 disorder". In some blind people, they do have issues with maintaining a 24 hour day- something that is actually called "circadian rhythm sleep disorder" (CRSD). In 2000, researchers discovered that people with CRSD, melatonin may be effective in helping normalize the 24 hour sleep-wake cycle. You can buy 100 melatonin pills for about $7 retail.

    Vanda had developed a molecule that was similar to melatonin around the same time, however researchers found that the new melatonin-like molecule wasn't as effective as short-acting benzodiazepines like Ambien. Vanda decided to market their drug- now called Hetlioz- for "Non-24" and they started running television ads showing blind people. The drug company did not do studies comparing Hetlioz to melatonin- saying that they had trouble finding enough blind people with Non-24 to do a study. Other research has shown that the drug is probably not effective but the commercials continue to run on most US stations.

    Hetlioz- because it is a brand name drug- costs about $5,000 per month or about $4,993 more than melatonin.
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  2. #1902
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    Re: Healthcare going forward

    Quote Originally Posted by KaraBulut View Post
    Hetlioz- because it is a brand name drug- costs about $5,000 per month or about $4,993 more than melatonin.
    I wonder how much of that goes to R&D and advertising? I also wonder how it can be justified?
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  3. #1903
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    Re: Healthcare going forward

    Quote Originally Posted by gsdx View Post
    I wonder how much of that goes to R&D and advertising? I also wonder how it can be justified?
    The Hetlioz story is a fucking trainwreck. The studies that they submitted for FDA approval involved only 52 subjects (because Vanda said they couldn't find enough people with the disorder to do a more robust study). The studies were cery flawed and it was difficult to ascertain whether the drug even worked on those 52 subjects.

    While this lowered the "R&D" costs, it begs the question, "If you can't find enough people with the disorder for your study, is the drug really needed?".

    The FDA panel almost didn't approve the drug but when they did approve it, they made a big mistake on the approval. The drug was supposed to be for blind people who have no light perception (i.e. they cannot see ANY light). The drug was accidentally approved for all blind people- including people who have light perception.

    Further reading:
    https://seekingalpha.com/article/184...emain-relevant
    https://www.citizen.org/sites/default/files/2265.pdf

    Given the number of commercials they run, there's little doubt that the advertising cost is substantial for this drug:


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  4. #1904
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    Re: Healthcare going forward

    ^ I've seen a commercial, but not any of those above.

    Still, the story you just told makes it much easier to understand why there are so many lawsuits over FDA-approved drugs. No wonder it takes so much time for those drugs to become available up here. This is from the Government of Canada website:

    How are drugs reviewed in Canada?

    Drugs are authorized for sale in Canada once they have successfully gone through the drug review process. This process is the means by which a drug application is reviewed by scientists in the Health Products and Food Branch (HPFB) of Health Canada, and on occasion, outside experts, to assess the safety, efficacy and quality of a drug.

    Throughout the process, the safety and well-being of Canadians is the paramount concern.

    What is the Health Products and Food Branch?

    Health Canada's HPFB is the national authority that regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians. These products include drugs, medical devices, disinfectants and sanitizers with disinfectant claims.
    https://www.canada.ca/en/health-cana...ed-canada.html

    EDIT: By the way, there have been instances wherein drug companies are involved in class-action suits before the drugs are approved for sale up here.
    Last edited by gsdx; October 19th, 2017 at 03:52 PM.
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  5. #1905
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    Re: Healthcare going forward

    Quote Originally Posted by gsdx View Post
    ...EDIT: By the way, there have been instances wherein drug companies are involved in class-action suits before the drugs are approved for sale up here.
    There's a lot of attention on pharmaceutical lawsuits but we probably should be as concerned with medical device lawsuits.

    In the US, the FDA approves medical devices before they are mass-marketed. This includes things like IV pumps, pacemakers, orthopedic implants like hip joints, surgical implants like breast implant or blood clot filters, etc.

    There's a loophole in the law called a 501K exception that says if a new device is similar to a device that has already been approved, then it doesn't require the same level of review. So, for example, if I were to say that my hip implant product that is made of cobalt is similar to a titanium hip implant on the market, I could ask for expedited approval for my cobalt implant.

    If later my cobalt implant is discovered to be defective and it results in cobalt shrapnel escaping into your pelvis, then you would have to sue someone to get the money to a) have the bad implant removed, b) install a safer implant, c) pay for any cleanup required to get the cobalt shrapnel out of your body and d) pay for any lost wages, pain/suffering or other costs that were incurred as a result of my bad implant.

    This is just one reason why there's so many lawsuits on medical devices in the US.
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    Re: Healthcare going forward

    ^ Wow. I did not know that.
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    Re: Healthcare going forward

    At one of our inservice meetings, an "implant rep" displayed and described various "items" wrapping each offering with an estimate on "price points." KaraBulut is on the money. tried and true does not apply to new "items." The results can be crushing.
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