The April 2012 edition of The Health Gazette Ezine will be published as scheduled on April 1st.
This month’s edition continues a brief series on aging. In part three we consider a prescription for anti-aging. Most people are looking for a “magic bullet” approach that ideally comes as something like a daily pill or potion. Many companies would love to supply just such a product but the reality is that no such thing exists or ever will. While people wait in futility for such a pipe dream they could actually implement proven approaches that work. Why don’t they? Well, to be fair, some do and they reap the benefits but most don’t simply because it requires effort. What about you?
Subscribers will find the ezine in their mailbox on publication. It will be posted in the subscribers’ archive around the same time.
Tags: Anti-aging, Health Gazette Ezine
The following article is from the Vitamin D Council Newsletter, by Dr John Cannell.
More than 60 years ago, based on the science of the time (science that has stagnated for 60 years), Dr. E. Orbermer of Italy wrote the following:
“Until further experimental evidence, adequate and incontrovertible, is made available, I submit that we should play for safety. In a climate like that of England every pregnant woman should be given a supplement of vitamin D in doses of not less than 10,000 IU per day in the first 7 months, and 20,000 IU (per day) during the 8th and 9th months.”
OBERMER E. Vitamin-D requirements in pregnancy. Br Med J. 1947 Dec 6;2(4535):927.
The “adequate and incontrovertible evidence” that Dr. Orbermer wanted, to a certain extent, is finally here, 60 years later. As it has to do with developing human beings, it could not be more important. The study is the highest standard of proof, a randomized controlled trial, conducted by Professor Bruce Hollis and colleagues at the Medical University of South Carolina. They took 350 pregnant women, gave 1/3 of them 600 IU/day, 1/3 of them 2,000 IU/day, and 1/3 4,000 IU/day. Then they waited to see, among many things, which group would produce infants with at least 20 ng/ml of vitamin D in their blood, the lowest limit the 2010 Food and Nutrition Board (FNB) says is needed for good fetal health.
Surprise surprise, only the 4,000 IU/day pregnant women group even approached the minimal safety level of 20 ng/ml in their infants. Furthermore, the 2010 FNB recommendations of vitamin D in prenatal vitamins would have left 50% of the White women and 80% of the Black women with fetuses below 20 ng/ml.
However, Professor Hollis found something else, something potentially much more important. He found that the average fetus in the USA is starved for enough building blocks for his or her mother to make adequate activated vitamin D to ship to the baby; activated vitamin D that is probably used for microscopic organ development, such as in the brain.
Activated vitamin D in pregnancy is mysterious. It appears the mother makes it in her kidney (maybe some in her placenta) at levels up to 3 to 4 times normal (without maternal hypercalcemia) and ships it across to the fetus. This only happens if the mother has enough of this vital steroid hormone in her body to ship to the fetus and most mothers do not. If she can’t make it, she can’t ship it maximally, and the 38 fetal organs depending on activated vitamin D to fully develop must do the best they can do with inadequate amounts of this steroid. Of course, none of this applies to mothers who frequently sunbathe, or who take 5,000 IU/day while they are pregnant.
To quote Professor Hollis: “These findings suggest that the current vitamin D (requirements for pregnancy, currently 600 IU/day) issued in 2010 by the Food and Nutrition Board should be raised to 4,000 IU of vitamin D per day so that all women, regardless of race, can attain optimal nutritional and hormonal vitamin D status throughout pregnancy.”
The Vitamin D Council agrees and considers this an important study in support of why adults and pregnant women need at least 4,000 IU/day to elevate blood levels and improve fetal health and birth outcomes. Although there are no trials that support taking more, the Vitamin D Council believes 5,000 IU/day is equally safe and would be more effective at maintaining adequate fetal blood levels of vitamin D.
The MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The “Summary Page” available via the link below provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection
- Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets
- Angeliq (drospirenone and estradiol) tablets
- Aptivus (tipranavir) Capsules and Oral Solution
- Avalide (irbesartan/hydrochlorothiazide) tablets
- Benicar (olmesartan medoxomil) Tablets
- Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
- Cardiogen-82 (Rubidium Rb 82 Generator)
- Crestor (rosuvastatin calcium) Tablets
- Crixivan (indinavir sulfate) Capsules
- Diovan HCT (valsartan/hydrochlorothiazide) Tablets
- EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and
- PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets
- Elestrin (estradiol gel)
- Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
- Famvir (famciclovir) Tablets
- Hepsera (adefovir dipivoxil) tablets
- Invirase (saquinavir mesylate) Capsules and Tablets
- Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
- Lescol (fluvastatin sodium) Capsules
- Lescol XL (fluvastatin sodium) Extended-Release Tablets
- Letairis (ambrisentan) Tablets
- Lexiva (fosamprenavir calcium) tablets and oral suspension
- Lipitor (atorvastatin calcium) Tablets
- Livalo (pitavastatin) tablets
- Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets
- Mevacor (lovastatin) Tablets
- Natazia (estradiol valerate and estradiol valerate/dienogest) tablets
- Norvir (ritonavir) oral solution and tablets
- Orencia (abatacept) for injection
- Ozurdex (dexamethasone intravitreal) implant
- Patanase (olopatadine hydrochloride) Nasal Spray
- Phendimetrazine tartrate SR 105 mg capsules
- Pravachol (pravastatin sodium) Tablets
- Premarin (conjugated estrogens) Vaginal Cream
- Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
- Prezista (darunavir), Oral suspension
- Reyataz (atazanavir sulfate) Capsules
- Rituxan (rituximab) Intravenous Injection
- Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
- Simcor (niacin ER/simvastatin) Tablets
- Tekamlo (aliskiren/amlodipine) tablets
- Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
- Valturna (aliskiren/valsartan) tablets
- Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
- Vasotec (enalapril maleate) Tablets
- Viracept (nelfinavir mesylate) Oral Powder
- Vytorin (ezetimibe/simvastatin) Tablets
- Xalkori (crizotinib) Capsules
- Yasmin (drospirenone/ethinyl estradiol) tablets
- Zocor (simvastatin) Tablets
- Zyvox (linezoid) Tablets and Oral Suspension
Language is interesting. The FDA calls them “Safety Labels” which inspires trust. The truth is, they would much more aptly be called “Danger Labels” and you would do well to regard them as such. Remember, all drugs are dangerous. Consume only what you absolutely must and then do so with the utmost care.
From the Vitamin D Newsletter by Dr John Cannell, Vitamin D Council.
Although the Vitamin D Council and I believe that vitamin D ought to be taken daily to mimic daily sun exposure, I understand the power and reasoning why some doctors prefer to write prescriptions at weekly, fortnightly or monthly directions. For one, it lets the patient know the importance in the recommendation. In turn, the patient is more likely to take vitamin D. And two, the placebo effect in writing a prescription is much more powerful than recommending an over-the-counter vitamin.
Many doctors in the USA prescribe vitamin D, with instructions to take one capsule every week, or every two weeks, or even one capsule per month. Up until that last few years, only one vitamin D — vitamin D2, the less potent and less efficacious type of vitamin D — has been available for prescription. I am glad to say that this is no longer true. 50,000 IU capsules of vitamin D3 are now available by prescription.
Bio-Tech Pharmacal has partnered with distributors to make 50,000 IU D3 available for thousand of US drug stores. That means unless your doctor writes “Drisdol, do not substitute,” then your pharmacist can give you human vitamin D, not plant vitamin D.
If you’re a medical professional, contact your local pharmacy to request they stock the product. If you’re a pharmacist, order the product and begin substituting Drisdol prescriptions now. If you’re a patient, print this story and take it to your pharmacy today and make sure you start taking D3, not D2. The list of distributors — the information they need to know — is below.
If they want to know why they should switch, the following reasons make it clear:
- Vitamin D3 is the type of vitamin D the human body produces in response to sun exposure. Vitamin D2 supplements are produced by irradiating fungus.
- Research has shown that the body prefers vitamin D3 over D2 when both forms are readily available in the body (Heaney 2011)
- Research has shown that vitamin D3 is more efficacious in reducing mortality risk than D2 (Bjelakovic 2011). Research has also shown than vitamin D3 is more efficacious in reducing the risk of fractures and falls than D2 (Bischoff-Ferrari 2009).
I must recommend, however, that if 50,000 IU is going to be prescribed, they ought to prescribe it to take weekly, which equates to 7,000 IU/day. Once every two weeks might do the trick (equivalent to 3,500 IU/day). Once a month is not enough in my opinion (equivalent to 1670 IU/day).
Bio-Tech D-3-50 (50,000IU)
NDC# 53191036201
Domestic Distributors
- McKesson Drug Company
- Cardinal Health
- Emerson Ecologics
- Dakota Drug
- HD Smith Wholesale Drug Company
- Gulf South Medical Supply
- Smith Drug Company
- National Drug Source
International Distributors
- Pharmaceutical Trade Services-US based distributor serving Europe, the Middle East, Asia, Australia/Oceania, Africa and South America
- Symbion Pty- Australia
- Al-AHD Drug Store- Jordan
- Al-Omair International Trading- Kuwait
- Biotech Pharma Services- UAE
- Trans Arabia Drug Store- UAE
- Riyadh International Corporation- Saudi Arabia
- Taiba Pharma LLC- Sultanate of Oman
Tags: Prescription Vitamin D
From Vitamin D Newsletter by Dr John Cannell, Vitamin D Council, 28 February 2012.
Heart failure is a condition where the body can’t pump enough blood to meet the needs of its body. When we think of heart failure, we think of older persons whose heart has worn out, not 4-month-old infants. However, chronic congestive heart failure is a real and existing problem for infants all over the world. That is why we should laud Professor Soad Shedeed in Egypt, who conducted the first randomized controlled trial (the highest standard of proof in medical science) using vitamin D in infants with heart failure. These infants usually either die or get a heart transplant.
In about 60% of his 80 cases, the infants simply had heart muscles that did not work for an unknown reason, called idiopathic cardiomyopathy. The other 40% were born with holes in their hearts, causing heart failure and were hopefully waiting for surgery. All 80 infants had severe heart failure with ejection fractions in the 30th percentile (how much blood you can empty out of the heart with each beat). Normal fraction percentage is about 55-60%.
After randomly assigning the children to one of two groups, he gave 40 of the 80 infants 1,000 IU/day of vitamin D and the other 40 infants placebo, being careful to keep using standard heart failure treatment for all the infants. He also measured three kinds of inflammatory molecules, before and after the treatment in both groups of kids. His findings were nothing short of miraculous.
In the vitamin D group, the ejection fractions became normal, effectively treating (in conjunction with standard treatment) heart failure in some of the infants by definition. These findings were statistically significant compared to the placebo group. The average ejection fraction went from 36% to 52 % after only three months on vitamin D, clinically and statistically significant compared to placebo plus standard treatment, which increased fraction from 37% to 43%.
In the vitamin D infants, vitamin D levels went from 13 ng/ml to 33 ng/ml, and the authors commented that they probably should have given more than 1,000 IU/day. In addition, the inflammatory molecules did what you’d expect; the vitamin D quelled the inflammation.
So we have a relatively large randomized controlled trial (80 infants is a lot for an infantile heart failure study), published in an excellent journal with serious results. I can’t overstate the importance of this study. This is the kind of study that needs to influence clinical practice. This is the kind of study that doctors all over the world ought to be aware of. This is the kind of study that the press needs to know about.