January 11, 2012 — Dr John Cannell
In a paper critical of higher levels of vitamin D for allegedly increasing a marker of inflammation, c-reactive protein (CRP), Drs. Muhammad Amer and Rehan Qayyum of the Johns Hopkins School of Medicine, began their paper by saying:
“The cardiovascular protection offered by vitamin D and its analogues is probably mediated by modulation of inflammatory cytokines.”
If you will notice, both physicians know that vitamin D offers “cardiovascular protection.” However, they are concerned 25(OH)D levels higher than 20 ng/ml will increase inflammation as measured by CRP and thus worsen cardiovascular protection. CRP is a protein in the blood which tends to rise in response to inflammation or injury. Its physiologic role is to take part in the “complement system.”
The authors arrived at this conclusion by adjusting their data for up to 9 variables and finding that a 25(OH)D of 20 ng/ml is associated with a CRP (range 0-5) of approximately 1.7 while a 25(OH)D of 50 ng/ml is associated with a CRP of 1.9. Their raw findings contradict their adjusted data in that the raw data showed what we have known for some time and that is that in the lower ranges of 25(OH)D, vitamin D reduces CRP. As with most biomarkers of vitamin D, the big improvement is in people who get their 25(OH)D up from 5 ng/ml up to 20 ng/ml. We know that in most cases, the biggest bang for the buck is in treating severe deficiency in people with such low levels.
So if you have natural levels of vitamin D, say a 25(OH)D of 50 ng/ml, and you want to decrease your CRP by 0.2, then stop your vitamin D and stay out of the sun, get your levels to 20 ng/ml, and see if all the corrections and adjustments the doctors performed were correct. I certainly am not going to do such a silly thing.
Dozens of studies now exist showing supplemental vitamin D3 reduces mortality rates, in part due to its cardiovascular protection. The majority of these studies show that improvement in mortality continues through 30 ng/ml and even up to 40 ng/ml. Not enough people have levels of 50 ng/ml for scientists to see if such levels offer further protection. However, cardiovascular disease is rare in native peoples around the equator where vitamin D levels of 50 ng/ml are not uncommon.
The takeaway message from this paper is that scientists will need to recalculate lots of different “normals,” using vitamin D sufficient subjects. It’s not just that normal CRP may be a bit higher in vitamin D sufficient people, their red blood count and the protein albumin may be a bit lower, for example. The point is that pathologists and epidemiologists will need to redo much of their work. We don’t know the normal range of CRP in 65-year-old men; we know the range of CRP in 65-year-old vitamin D deficient men. Likewise, we don’t know the incidence of heart disease in 65-year-old men; we know the incidence of heart disease in vitamin D deficient 65 year-old men. We have lots of work to do.
Source: Vitamin D Council Newsletter
Tags: CRP and vitamin D, vitamin D
Of course, if there is an accident, then good health depends on good management.
Tags: CDC, field triage guidelines
The MedWatch December 2011 Safety Labeling Changes posting includes 40 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 following link provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm284231.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Multaq (dronedarone hydrochloride) tablets
- Dilantin-125 (phenytoin) Oral Suspension
- Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets
- Relenza (zanamivir) inhalation powder
- Tyzeka (telbivudine) tablets and oral solution
- Capoten (captopril) Tablets
- Danocrine brand of Danazol capsules
- Desferal (deferoxamine mesylate) for injection
- Edarbi (azilsartan medoxomil) Tablets
- Eloxatin (oxaliplatin) for intravenous use
- Heparin Sodium Injection
- Isentress (raltegravir) scored, chewable tablets, film-coated tablet
- Keppra (levetiracetam) Tablets and oral solution
- Onglyza (saxagliptin) tablets
- Ovide (malathion) 0.5% lotion1
- PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
- Plavix (clopidogrel bisulfate) tablets
- Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating
- Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules
While it is good that updates are provided for the above drugs, and all the others that are updated each month, The Health Gazette continues to warn people to only take medication that is really essential and if necessary seek further opinions when drugs are prescribed without sufficient explanation to justify their ‘essential’ status. ALL drugs are dangerous. The above revision approach is simply a demonstration that not enough is known about drugs that become FDA Approved, or for that matter, “approved” in any jurisdiction, and everyone who consumes prescribed drugs becomes little more than a ‘guinea pig’ in a large and poorly controlled drug trial.
Tags: MedWatch
The MedWatch November 2011 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” available via the following link provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm282966.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Cerebyx (fosphenytoin sodium)
- Dilantin (phenytoin sodium, USP)
- Dilantin (phenytoin)
- Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
- Mytelase (ambenonium chloride)
- Onglyza (saxagliptin)
- Amturnide (aliskiren/amlodipine/hydrochlorothiazide)
- Combivir (lamivudine/zidovudine)
- Emtriva (emtricitabine)
- Epivir (lamivudine)
- Epzicom (abacavir sulfate and lamivudine)
- Isentress (raltegravir potassium)
- Lioresal Intrathecal (baclofen injection)
- Methotrexate Sodium for Injection
- Retrovir (zidovudine)
- Tekamlo (aliskiren/amlodipine)
- Toviaz (fesoterodine fumarate)
- Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
- Trizivir (abacavir sulfate, lamivudine, and zidovudine)
- Twynsta (telmisartan/amlodipine)
- VFEND (voriconazole)
- Videx (didanosine)
- Videx EC (didanosine, USP)
- Vimovo (naproxen/esomeprazole magnesium)
- Viread (tenofovir disoproxil fumarate)
- Zerit (stavudine)
- Ziagen (abacavir sulfate)
- Zyflo CR (zileuton)
While it is good that updates are provided for the above drugs, and all the others that are updated each month, The Health Gazette continues to warn people to only take medication that is really essential and if necessary seek further opinions when drugs are prescribed without sufficient explanation to justify their ‘essential’ status. ALL drugs are dangerous. The above revision approach is simply a demonstration that not enough is known about drugs that become FDA Approved and everyone who consumes prescribed drugs becomes little more than a ‘guinea pig’ in a large and poorly controlled drug trial.
Tags: MedWatch
The December edition of The Health Gazette Ezine will be published as scheduled on November 1st.
In December the feature article is titled Healthy Aged? Absolutely!.
Subscribers will find the ezine in their mailbox first and in the archive shortly thereafter.
Tags: Health Gazette Ezine