The costs of doing drug business?

Here’s a telling situation.

Liz had been on prescription niacin, Niaspan, 1500 mg per day (3 x 500 mg tablets) for several years to treat her severe small LDL pattern and familial hypertriglyceridemia (triglycerides 500-1000 mg/dl). Because her health insurance had been paying for the “drug,” she insisted on taking the prescription form.

A change in insurance, however, meant that the Niaspan was no longer covered. Her pharmacy wanted to charge $227 per month.

Liz came to the office in tears, worried that she was going to have to choke up $227 per month. I reminded her that, as I had told her several years ago, she could easily replace the Niaspan with over-the-counter Sloniacin or Enduracin. Both release niacin over approximately 6 hours, just like Niaspan.

Here are the prices I’ve seen with Sloniacin, 100 tablets of 500 mg:

Walgreens: $15.99
Walmart: $12.99
Costco: $8.99

So the most expensive source, Walgreens, would cost Liz just under $15.99 per month to take 1500 mg per day.

$15.99 versus $227.00 per month for preparations that are highly similar. Hmmmmmm.

I wonder what the $211.01 extra per month goes towards? Admittedly, Abbott Labs, the current company selling Niaspan (after Abbott acquired Kos), has invested in a few clinical trials, such as ARBITER-HALTS6. But does supporting research justify this much difference, a difference that amounts to $2532 over a year? If just 100,000 patients are prescribed Niaspan at this dose (a typical dose), this generates $253 million.

Is the cost of developing and marketing a supplement-turned-drug that great? Is this justifiable? Is it any wonder that our health insurance premiums continue to balloon?

I use Sloniacin and Enduracin almost exclusively.



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28 Responses to The costs of doing drug business?

  1. Anonymous says:

    I bought a bottle of 1,000 tabs of 500 mg IR Niacin, Rugby brand, for about $29, shipped. I'm at 2 a day with modest and very manageable flushing most of the time. I've only been at the full dose for about two months so I don't yet know the results but I'm due for preliminary bloodwork soon. IR niacin is supposed to be the least hepatotoxic and most effective for most lipid parameters (LDL excepted). It is certainly the cheapest.

    For those going this route, don't jump in with 500 mg a day right off. Get a bottle of 100 mg and work up slowly. I started with 50 mg and went up 50 mg every two weeks.

    If it turns out I need 1,500 a day and the flushing becomes unmanageable I might go to Slo-Niacin.

  2. Anonymous says:

    Dr. Davis, can you please explain how the money for insurance premiums goes to drug companies?

  3. polacekt says:

    Anonymous, Why are you anonymous?

  4. Stargazey says:

    Is the cost of developing and marketing a supplement-turned-drug that great?

    Yes. Have you ever performed a drug trial? The paperwork is mind-boggling. It costs millions to create a protocol, get it approved, recruit sites, recruit patients, monitor sites, collect data, follow up adverse reactions, compile the data and resolve queries about how the data was entered.

    And if the FDA has significant objections or questions about what you've done, you get to do another trial to resolve those issues.

    All of that has to happen before the first ad goes on paper. I'm not saying the FDA's procedure is wrong, but it costs mega-millions to do it.

  5. Anonymous says:

    Great post, Dr. Davis. My doctor strongly advised me to take Niaspan to lower my triglyceride levels which were 240. I asked her about Slo Niacin because it was so much less expensive, and she recommended against it b/c it's not regulated and you don't know how much of the medicine you are really getting in OTC form. So I took the Niaspan and 6300 mg fish oil for 3 months and it did lower my triglycerides to 112. I also cut out bread and most other bad carbs – pizza, potatoes, sweets other than dark chocolate.

  6. Anonymous says:

    There's a kernel of truth to the concern that OTC/supplement products are not as well regulated as pharmaceuticals, but it's a concern that's WAY overblown by the medical profession and the drug companies who train most of them these days.

    For one thing, the pharm drugs are not as well regulated as many assume. There's not an FDA inspector running or overseeing tests on every batch that goes in a bottle. Plenty of problems come to light still despite staggering fines levied by the FDA.

    Second, the supplement industry is no longer run by hippies stuffing capsules in a garage in Northern California. It is a big-money industry with plenty of good chemists and equipment and manufacturing standards both voluntary and regulatory. It can take a bit of research, but there are plenty of good products out there. For many things like Niacin, the OTC versions are available from generic drug producers with very long track records of quality.

    Lastly, for most applications like lipids, the proof is in the numbers. If we're talking about digoxin, yes, it makes a huge difference if delivery isn't controlled down to the microgram. With niacin, honestly, what difference does it make if you get 520 mg one day and 485 the next? None. If the product is fairly tight, you'll get consistent results with your lipid numbers.

  7. Simply Natural FX says:

    I was taught that for the best results you take the full spectrum of vitamin B's, never separate them. If you take only one you create an imbalance that causes problems with the levels of the remaining B's.
    My question is why the obsession with lipids, target ranges and having good numbers? The only true test is in how you are doing. Why the extra strain, is this to be healthy or avoid getting sick? There is a difference. What is the true goal here?
    The whole cholesterol thing was never a proven problem, but an assumption that has been used to make billions of dollars trying to get the levels down, with no evidence that doing so is in any way helpful, but the means to lowering the count has proven harmful. I see worrying about reaching certain levels, as unneeded stress, which is bad in and of itself.
    If it's toxic to take too much, why strive for higher levels when getting the flush is a sign you've got enough in your system already?
    Cost aside, getting the right kind of vitamin is more important, the natural vs the artificial, the best absorption rate.

    Life is balance, the body strives for it, knows how to get it, just needs the materials to do it best for you.

  8. Anonymous says:

    It's an absolute shame that the FDA is going after Sloniacin for speaking the truth.
    http://bit.ly/eebWnM

    Sloniacin has to remove all references to cholesterol, lipids, statins etc. from their website, brochures and product label. Sloniacin has already shut down their website.

    I don't need this product, but I feel for the folks on fixed incomes who won't know about this cheap alternative to Niaspan.

    I want to scream.

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