The costs of doing drug business?

6. January 2011 William Davis (28)
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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Comments (28) -

  • Brent

    1/5/2011 11:12:42 PM |

    Is Sloniacin safe to use without a doctors supervision?  (I have low LDL, but it is almost all "B" particles. Triglycerides are pretty close to target range.)  What dose do you usually start patients out at?

  • Anonymous

    1/6/2011 12:01:03 AM |

    Could someone please explain how Abbot and Glaxo Smith Kline obtained patents for Niaspan and Lovaza? And why doctors prescribe these when essentially the same things are available over the counter?

  • Tx CHL Instructor

    1/6/2011 12:27:43 AM |

    I wrote up an article on my blog illustrating my experience with the healthcare industry back when I was trying to earn a living as an insurance peddler. See http://chl-tx.com/2009/09/how-to-get-the-best-deal-on-health-care/

  • Basil

    1/6/2011 12:56:24 AM |

    I hate how the drug companies cry about how much they spend on research.  Most research is funded by government grants with the bill footed by the taxpayer.  Then they make us pay for it again when we purchase the drugs.  What a scam.

  • terrence

    1/6/2011 1:01:59 AM |

    I paid a lot less than $5 for 100 tabs of house brand Niacin at Safeway(aka Vons, Randalls).

    I took 1,500 mg for several months. I got a warm flush for 15 to 20 minutes that was bad at all. My LDL went way down after a few months, and HDL went up a bit.

    Cheap is good, if it works.

  • terrence

    1/6/2011 1:14:30 AM |

    Typos, typos, typos...

    I paid a lot less than $5 for 100 tabs of [500 mg] house brand Niacin at Safeway(aka Vons, Randalls).

    I took 1,500 mg [a day] for several months. I got a warm flush for 15 to 20 minutes that was [NOT] bad at all. My LDL went way down after a few months, and HDL went up a bit.

    Cheap is good, if it works.

  • Travis Culp

    1/6/2011 1:52:42 AM |

    At least she didn't insist on the name-brand like that Lovaza guy.

  • Anonymous

    1/6/2011 2:59:53 AM |

    Be careful with switching.

    Be careful with liver effects.

    http://cholesterol.emedtv.com/niacin/types-of-niacin-p2.html

  • Anonymous

    1/6/2011 3:17:22 AM |

    I was trying niacin supplements, and I started out with 500 mg each morning, which initially caused uncomfortable flushing. The flush got less uncomfortable over the next few weeks, and then I added another 500 mg at bedtime. The flush came back, but gradually got less uncomfortable over the next week, and then BAM!!! I suddenly started getting the worst headaches I have ever had. A couple of ibuprofen would make the headache bearable, and I did not immediately associate the headaches with the niacin, since the onset of the headaches was several days after I upped the dose to a gram a day. The headaches persisted, and after the 3rd day of those horrible headaches, I decided it had to be something I changed recently, and the niacin was the only thing that made sense.

    So I omitted the niacin complete the next day. No headache. Ok, since I had taken 500mg for several weeks without getting headaches, I took 500mg the following day -- BAD HEADACHE. I divided the tablets using a pill-splitter to get a 250mg dose -- BAD HEADACHE. Nuts. I cut it out completely, no headache.

    I get about 50mg of niacin in a multi-B-vitamin tablet without headache, but I wonder if I have somehow sensitized myself to niacin, which would mean that I won't be able to get the cholesterol effects I was after.

    I'm also wondering if maybe there is some interaction between the niacin and some other vitamin or mineral (or food). I haven't taken any of the 500mg pills for over a week (no headaches at all during that time), and I may try 250mg tomorrow morning (and carry a dose of ibuprofen with me just in case). But I'm interested in seeing if anyone else has had a similar experience.

  • Anonymous

    1/6/2011 6:13:12 AM |

    Niacin can do wonders. In the distant past I used it to control and stop knee pain which had troubled me for several years. A true life saver given what NSAIDs were doing to the stomach.
    In time, it apparently caused the heart
    to start skipping beats. In rare persons, it may cause myopathy of the heart muscle; therefore, I stopped it.
    And when higher than 100 mgs per day
    are reintroduced the heart starts to
    skip beats again even years later.
    I am not saying don't use it but it can have side effects so be alert. There are
    alternatives to niacin if it doesn't fill the bill. For example pantethine and fenugreek seed for blood lipids and fish oil, boswellia, and MSM/DMSO2/dimethylsulfone for joint pain.


    Trig

  • Coach Rollie (FX)

    1/6/2011 6:54:28 AM |

    Is there a big difference between big drug companies and street drug dealers.  Hmm.

  • Anonymous

    1/6/2011 1:27:21 PM |

    Be careful of timed release niacin...can cause jaundice.

    I think consumers in the EU recently lost the right to use herbs/supplements (?)...coming to the US soon?

    Very important that we protect drug company profits...since main street is going down the tubes?  Wink

  • Dr. William Davis

    1/6/2011 3:34:14 PM |

    Brent--

    I believe that, ideally, any form of niacin is best taken under supervision.

    That said, it is sad to realize how few healthcare practitioners actually know or care about using niacin. The only reason there is some awareness is because of, of course, drug industry marketing of Niaspan.

  • Kent

    1/6/2011 6:04:20 PM |

    Thanks Doc,

    I am curious as to the release time you have given on Sloniacin. Is that release time you quoted from the manufacturer?  

    From what I gathered there were 3 types of Niacin, imediate release (IR), extended release (ER), and slow release (SR). With Niaspan and Enduracin being in the (ER)camp and Sloniacin being in the (SR) camp, being a bit harsher on the liver.

  • polacekt

    1/6/2011 7:09:04 PM |

    Kent,
    There is no clinical differentiation between SR and ER.

    Kos funded a dissolution study comparing Niaspan and 7 non-prescription niacin products labeled as SR or Timed-Release, including Endur-acin and Slo-Niacin. The results were graphed and compared, and Niaspan was the slowest, with Endur-acin virtually identical.  slo-niacin was a bit quicker.

    Kos and Abbott have gone to great lengths to perpetuate the myth that the Niaspan dissolution is unique, that non-prescription products are longer acting, and therefore more hepatotoxic.  The reality is if you dose them once daily like Niapsan, you have the same kinetics and dynamics. Dosing twice daily makes them easier to tolerate, but means that one must be more careful in determining you max dose before liver enzyme elevation occurs - hence physician monitoring especially during the dose escalation period.  For many ER niacin users dosing twice daily, 1500mg is a total max daily dose.  With respect to results (dynamics) the twice daily regimen increases the LDL response, but lowers the HDL response somewhat as compared to ER once daily.
    So how you take it may also depend on your lipid goals and what else you are taking.  
    I can tell you first-hand, that the majority of the medical community is not aware of this published dissolution data, or the pharmacodynamic differences in dosing regimen.
    Any one who receives push-back from their physician should provide them with the article, "Dissolution Profiles of Extended Release Niacin...." American Journal of Health-System Pharmacy, 2006

  • Anonymous

    1/6/2011 10:46:53 PM |

    Good info. Does anyone know of a doctor in Sioux Falls, SD that is up to date on this and other treatments/tests that Dr. Davis discusses on this blog? My current GP doc has no idea on much of this.

  • polacekt

    1/6/2011 11:01:38 PM |

    your best bet is to find a certified lipidologist.  go to learnyourlipids.com and put your city and zip in.  it will tell you there are several near you.

  • Anonymous

    1/6/2011 11:14:26 PM |

    Here is a start to self education but it is best to Pubmed all of these issues; just enter Niacin and then start reading. Sometimes all you need is to read "conclusion." Very well organized. pubmed.org

    I read it for the fun of it. Is pubmed everything we need to make informed choices? Nope, not at all, but like I said, it is a good solid start.

    Dissolution profiles of nonprescription extended-release niacin and inositol niacinate products.
    Poon IO, Chow DS, Liang D.

    College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX 77004, USA.

    Abstract
    PURPOSE: The dissolution profiles of nonprescription extended-release niacin and inositol niacinate products were studied using the prescription extended-release niacin, Niaspan, as a reference.

    METHODS: Seven nonprescription extended-release and 12 nonprescription inositol niacinate products were collected from community and online pharmacies in the United States. Extended-release Niaspan was used as a reference. Dissolution profiles were examined by the United States Pharmacopoeia dissolution test, using a paddle method. Release samples were removed every 30 minutes for up to 240 minutes. Niacin was quantified by high-performance liquid chromatography.

    RESULTS: Ten out of the 12 inositol niacinate products were capsules and 6 of the 7 extended-release formulations were tablets. During the initial 30-minute dissolution study of inositol niacinate products, free niacin was released to various degrees. One product achieved fast dissolution, with >30% cumulative release of niacin. The cumulative percentage of niacin released at 240 minutes of all inositol niacinate products was statistically different (p < 0.0001). The majority of these products reached a plateau of releasing niacin in one to two hours, which was maintained until the end of the study. Six out of the seven extended-release niacin products had extended-release profiles. Five products showed a statistically higher dissolution rate (p < 0.05) than that of Niaspan.

    CONCLUSION: Significant variations in dissolution profiles were noted among the 7 nonprescription extended-release and 12 nonprescription inositol niacinate products in vitro, and their dissolution rates were not comparable to that of the prescription extended-release niacin. Further studies are warranted to correlate such dissolution data with their in vivo efficacy.

  • Jason A.

    1/7/2011 3:22:52 AM |

    Alot I read online says to use IR niacin to avoid liver toxicity, which can occur with slow release. Any thoughts on the issue? Any brand recommendation for IR niacin? Thank you.

  • Samual

    1/7/2011 5:43:08 AM |

    Its a great Blog. Medical tourism, which is the practice of traveling from one place to another for medical care, is no longer limited to patients seeking conventional treatments and thus leads to Pancreatic cancer treatment India.

  • Anonymous

    1/7/2011 12:49:10 PM |

    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.

  • Anonymous

    1/8/2011 6:32:59 AM |

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

  • polacekt

    1/8/2011 6:53:17 AM |

    Anonymous, Why are you anonymous?

  • Stargazey

    1/8/2011 3:21:48 PM |

    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.

  • Anonymous

    1/8/2011 11:43:20 PM |

    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.

  • Anonymous

    1/9/2011 8:00:56 AM |

    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.

  • Simply Natural FX

    1/10/2011 11:42:29 AM |

    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.

  • Anonymous

    1/27/2011 1:22:28 AM |

    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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