Death of a $7 billion industry

28. June 2007 William Davis (8)
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.
Tags :

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.

Add comment

Loading
"Make big money fast with CT scans"

"Make big money fast with CT scans"

31. May 2008 William Davis (6)
Rather than the headline New Study Could Change Heart Disease Diagnosis And Treatment being run in Utah TV and newspapers, instead it should read:


Make big money fast with CT scans!

Is your bottom line shrinking? Have you fallen on hard economic times? Is competition from other hospitals and providers threatening your financial health?

Then we have a solution: Do a CT coronary angiogram on everybody! Look for disease in people with no symptoms, scare the heck out of them, and voila! Instant need for bypass surgery!

Ka-ching!! That'll be $100,000, please.

Do it again, and again, and again, and your hospital will be quickly in the black in no time!

And, for the savvy marketer, tell the newspapers that you're going to conduct a study to see if this approach works--even before the study gets started! Even if the study pans, you'll come out a winner because you did it in the name of "research"!



Apparently a group of cardiologists at the Intermountain Medical Center and LDS Hospital in Salt Lake City, with the financial assistance of Siemens, a manufacturer of CT scanners, is funding a 1000-patient study of diabetics, all without symptoms of heart disease, half of whom will undergo "screening" CT coronary angiograms (not heart scans) followed by bypass surgery, if "needed". The other half will receive conventional, "aggressive" medical therapy. "Aggressive" means cholesterol treatment, blood pressure control, and blood sugar control (no kidding).

The outcomes of the two groups will be compared after two years.

To understand the absurdity of this study, note that they are proposing what amounts to "prophylactic" bypass surgery, since the participants are without symptoms. Since there are no stress tests, a measurement of flow or functional capacity (exercise tolerance) cannot be factored in. Decisions will be made on the basis of severity of "blockages" in asymptomatic people, a hazardous notion that has never been shown to provide benefit. No doubt: Some diabetics with extensive disease may obtain benefit from screening, but many more will undergo what amounts to unnecessary bypass that provides no benefit. We already know from studies dating back over 20 years to the days of the original CASS (Coronary Artery Surgery Study) that putting asymptomatic people through bypass surgery willy-nilly does not reduce mortality.

Of course, the "aggressive" preventive treatment they propose is more like the least common denominator level of treatment. In fact, I would characterize the "aggressive" preventive treatment as ridiculous. Doing less would be malpractice. Much more could be done, but doing a lot more would pose a real challenge to the bypass arm of the trial.

But the smell of money drives such efforts: More CT angiograms, more hospitalization for bypass surgery. The payoff to the hospitals from this effort is likely to exceed $5 to $10 million, all money that they might not have otherwise seen. The ill-informed people in the local media gush with enthusiasm, the hospital acts like they are at the cutting edge of medical technology, the doctors pose as saviors.

All this time, real preventive efforts go unmentioned. No fish oil (28% reduction in heart attack, 45% reduction in sudden death from heart attack), no genuine diet efforts (i.e., not the diabetes-promoting American Diabetes Association diet), no effort to identify sources of coronary risk beyond LDL cholesterol (low HDL,small LDL,and postprandial or after-eating abnormalities, for instance, are prominent sources of risk in diabetics), no vitamin D. In my view, the preventive arm of the study amounts to doing virtually nothing beyond prescribing statin drugs.

Don't fall for it.
Tags :

Comments (6) -

  • Anonymous

    5/31/2008 2:02:00 PM |

    Good timing for my father on this blog post.  It isn't heart disease but next week my father is driving to Chicago to have his head examined with an MRI to learn the potential of having an aneurysm. (I think I said that right, aneurysm)  I asked him why and he told me the exam is "free".  I don't much about how hospitals are run but from my experience every time I've been to one nothing was free.  If anything everything bought was 10 times normal price.  I've warned my father not to fall for scams - nothing is free dad.  My guess is this is a way for the hospital to drum up $100,000 business from the unsuspecting sucker.

  • Jenny

    5/31/2008 2:14:00 PM |

    Even more important is the danger from the high levels of radioactivity exposure caused by those scans. There was a study published that looked at the CT scan exposure of ER patients and found that the cumulative level was far over the level known to cause cancer.

    Science News report.

    CT scans should be used only when justified by a very real and present danger. And even then often X-rays would be a better choice.

  • Anonymous

    5/31/2008 3:41:00 PM |

    Just when I thought the profession could not sink lower!  This seems to be another example of the current philosophy - "sick until proven healthy."  Unfortunately, this type of doctor doesn't recognize anyone as healthy. Oy....

  • Jessica

    5/31/2008 4:53:00 PM |

    Great analysis.

    We hosted a health care forum on 14 May and during the Forum, one of the doctors said, "we're wasting money trying to prove that healthy people are healthy."

    So true.

    Asymptomatic and they're being entered into a study which includes invasive "bypass" as a clinical intervention?

    Brain dead.

  • PJ

    5/31/2008 11:36:00 PM |

    You know, that's actually terrifying.

  • jpatti

    6/4/2008 3:40:00 PM |

    I really can't *imagine* anyone signing up for this study.

    After a week of heartburn, I spent the night screaming and vomiting before an unsuccessful emergency angio.  And after all that, while on narcotics and IV heparin, I had to be "talked into" a bypass.

    I can't imagine doing it for the sake of science.

Add comment

Loading