Death of a $7 billion industry

Vitamin D has taken its place as a crucial ingredient for coronary plaque control and control of CT heart scan scores.

Vitamin D replacement is also crucial for bone health, particularly the prevention of osteoporosis. But conversations about vitamin D replacement to true healthy levels is notably absent from the conversation on treatment and prevention of osteoporosis. Yes, you will find a small dose of vitamin D in calcium tablets and in multivitamins. Those of us who check blood levels of 25-OH-vitamin D3 in patients will tell you: They don't work. These are unabsorbable forms of vitamin D and at trivial doses. There was an attempt to give this issue a little cursory attention when a small dose of vitamin D was added to Fosamax (Fosamax D).

There are an estimated 50 million Americans with various degrees of osteoporosis. It's numbers like this that make the drug manufacturers salivate. Osteoporosis treatment is also chronic. This is among the holy grails of the drug industry: developing agents for widespread ailments that require long-term treatment that extends over years. That's a lot more profitable than 10 days of antibiotics that are over and done with in one treament course.

The osteoporosis market now stands at $7 billion per year and is expected to grow 6-7% per year, according to industry analysts. Drugs like Fosamax, Evista, and Actonel will eventually be replaced by Boniva, Eclasta, and bazedoxifene, and later by AMG-172 and balicatib. Monthly costs for these drugs can be $70 or more per month, sometimes several hundred dollars. (Experience has shown that the introduction of new drugs does not necessarily mean that other drugs will drop in price.)

Here's a clinical trial I'd like to see performed: Vitamin D restored to healthy levels of 50-100 ng/ml over an extended period and compared to a group treated with placebo. My prediction is that there will be dramatic differences in bone density. (Small studies have been performed, but no large, long-term trials of the sort that would yield real firepower.) Or, how about vitamin D to true therapeutic levels over 5 years compared head-to-head with one of the drugs. My prediction: little difference.

Vitamin D also provides an enormous panel of health benefits beyond restoration of bone density, like rise in HDL, drop in triglycerides, facilitation of control over CT heart scan scores, drop in fracture risk, drop in blood pressure and C-reactive protein, reduction in risk for colon, prostate, and breast cancer. None of the drugs can hope to provide any of these effects, except a drop in fracture risk.

Vitamin D usually costs around $2 per month. I doubt that such trials will be performed. If I were a manufacturer of osteoporosis drugs and my career success was dependent on the increasing revenues of these drugs, I would be quaking in my shoes, hoping that the public does not learn what a powerful tool good old vitamin D is. But if you are an individual just looking for health tools, vitamin D is, in my view, amongst the most powerful natural, nutritional tools you have available with outsized health benefits.

Comments (8) -

  • Anonymous

    6/28/2007 2:17:00 AM |

    I asked my doctor to include 25-OH-vitamin D3 in my cholesterol blood test. The nurse put down Vitamin D 25-Hydroxy (code 19893E)on the test requisition form without mentioning D3. Is this correct?

  • Anne

    6/28/2007 3:18:00 AM |

    Interesting about CRP and Vit D. Do you have a reference I can take to my doctor? I have had bypass and my hs-CRP has been high for years. I finally got my 25(OH)D up to 47ug/mL last summer but have not been able to get my PCP to recheck either CRP or D.

    Great blog.
    Anne

  • pomeropd

    6/28/2007 4:59:00 AM |

    A news article supports Vitamin D
    June 20, 2007 By Martha Kerr

    NEW YORK (Reuters Health) - A new study shows an association between low vitamin D levels and risk factors for cardiovascular disease "in a nationally representative sample."

    Dr. Keith Norris, at Drew University School of Medicine in Los Angeles, and colleagues analyzed data from the Third National Health and Nutrition Examination Survey (NHANES III), conducted between 1988 and 1994.

    They evaluated blood levels of vitamin D and the risk of heart-related disease in 7,186 men and 7,902 women.

    Average vitamin D levels were lower in women, older individuals, racial and ethnic minorities, obese people and those with hypertension or diabetes, the researcher report in the Archives of Internal Medicine.

    Compared to people with the highest vitamin D levels, those with the lowest levels were more likely to have high blood pressure, diabetes, and obesity -- all risk factors for heart disease.

    Norris said that this evidence of the link between heart disease and vitamin D "reinforces the emerging evidence that suggests higher levels of vitamin D may be helpful to reduce the risk of cardiovascular disease."

    In terms of taking a vitamin D supplement, "present dose recommendations range from 800 IU to 1,200 IU daily," he noted. However, he thinks 2000 IU per day is more likely to achieve adequate blood levels of vitamin D for prevention of cardiovascular disease. "There appears to be good safety at doses of 2000-3000 IU per day."

    He pointed out that it has been known for a long time that vitamin D helps to make strong bones, but there is now "convincing evidence" that it has several beneficial effects on cardiovascular health.

    "The potential implications from a public health and healthcare cost perspective are tremendous, even if vitamin D only impacts 5 percent to10 percent of heart health," Norris concluded.

    SOURCE: Archives of Internal Medicine, June 11, 2007; Reuters Health

  • Dr. Davis

    6/28/2007 12:18:00 PM |

    See the study Circulating MMP9, vitamin D and variation in the TIMP-1 response with VDR genotype: mechanisms for inflammatory damage in chronic disorders? Quarterly J. Medicine 2002 Dec;95(12):787-96, online at http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=12454321&ordinalpos=22&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
    You will note that a dark-skinned population was chosen, simply because they tend to be so severely deficient in vitamin D. But it is a genuine effect. I've witnessed it hundreds of times.

  • Dr. Davis

    6/28/2007 12:19:00 PM |

    I'm not sure about the code, but that's appears to be it.

  • JT

    6/28/2007 5:27:00 PM |

    It truly is amazing how over looked this simple nutrient is to our health.  And the benefits Americans could reap economically from increasing our vitamin D3 are fantastic to see.  Our health care system is reported to be heading for a collapse in the future due to run away hospital costs.  And every little bit to lower those costs would have to help I believe.  

    This argument reminds me of ethanol.  I fill my jeep up with ethanol.  I'm lucky in that there is a station just a few miles from my place.  As manufactured from corn, the fuel is not perfect, I know.  Plenty of smart people have let me know that ethanol is driving up the price of corn, which in turn drives up the price of milk, beef, pork, and in general all live stock prices.  Increased prices in these American staple foods immediately hurt the average American in the wallet.  

    After find out I have heart disease, I do not feel guilty about reports of price raises anymore.  I think how bad would it be if Americans ate less corn, beef, pork, and milk?  If less Americans ate those staple foods and instead made cheaper vegetables a mainstay in their diet, wouldn't we as a nation be healthier?  Wouldn't we see lower medical costs then?  Is it bad to want energy independence and also a healthier America?

  • Anonymous

    4/5/2009 6:30:00 PM |

    I have a friend who is having liver failure.  Has there been any links between eclasta and liver problems.  His liver problems began about 3 months ago and he is on a cancer drug called zolodex.  LIver failure can be a cause of taking the wrong combination of drugs. Any comments will be appreciated.

  • buy jeans

    11/3/2010 6:45:12 PM |

    Vitamin D also provides an enormous panel of health benefits beyond restoration of bone density, like rise in HDL, drop in triglycerides, facilitation of control over CT heart scan scores, drop in fracture risk, drop in blood pressure and C-reactive protein, reduction in risk for colon, prostate, and breast cancer. None of the drugs can hope to provide any of these effects, except a drop in fracture risk.

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