In a jaw-dropping development, the FDA added the entire class of statin medications to its Watch List for the potential signal of serious risk/new safety information they call "Cognitve Effects."
A drug is added to the Watch List based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS), derived from patient complaints and physician observations. The FDA states that the appearance of a drug on the AERS list does not mean that the agency has determined that the drug actually poses the listed risk. While the FDA evaluates whether there is a casual relationship between a listed drug and a possible risk, it is not suggesting that physicians stop prescribing these drugs, or that patients stop taking them.
That said, the fact that the FDA put statins on their Watch List after they, and the cardiology/Pharma community, have staked their reputations on them, is significant. A large portion of the country already takes statins, and millions more, even young children, would be on them, if possible. As I have documented on numerous occasions, statins come with a laundry list of side effects that keeps getting longer. In early February, the Lancet published a study showing that statins raised the risk of developing diabetes by nine percent. Since statins have been in use (about 20 years), there have been more than 1000 publications discussing their toxicity. That's more than four studies per month!
All this for a class of drugs that do not even improve HDL (good) cholesterol, which some cardiologists believe is more important to address than lowering LDL (bad) cholesterol.
I found these nuggets only because I track research journals and review what drugs end up on the FDA Watch List. It begs the question. Where is the media on this issue?
Note: if you continue with statin medication, please make sure that you supplement with a minimum of 100 mg. high quality Co-EnzymeQ10. In addition, if you are concerned about your statin use, ask your physician if you can try Niaspan (niacinamide), especially if you biggest cholesterol issue is low HDL.
For information on the effects of statins, please visit the website of Dr. Beatrice Golomb, one of the foremost researchers in the field.
I will say that the media has stepped up the pressure on aspirin. Last week, the Wall Street Journal published The Danger of Taking Aspirin Daily. While the contents in this article should not surprise my clients, as we have pounded this issue into submission over the last two decades, it will come as a shock to much of the public who have bought the aspirin theory hook, line, and sinker. For up-to-the-minute data, simply type the word aspirin in the top left of this blog to read what we have compiled on aspirin. In short, fish oil has gone head to head with aspirin in research and has been found to be just as efficacious, if not more, with virtually no side effects.
You may have read last week about a Senate report stating that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. The report also asks the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. A cardiologist's commentary in Forbes concerning the Avandia situation, as well as Big Pharma as a whole, offers a glimmer of hope that the medical community may finally be starting to get it.
Are There Alternatives?
On the opposite end of the safety spectrum, we have diet, exercise, and health professional-recommended dietary supplements. Besides the obvious heart health stalwarts such as diet, exercise, and stress reduction, safe nutrient alternatives should be discussed with your licensed health professional:
According to a study in the journal Maturitas, middle aged and elderly people with high levels of vitamin D could reduce their chances of developing heart disease or diabetes by 43%. A team of researchers carried out a systematic literature review of studies examining vitamin D and cardiometabolic disorders, which include cardiovascular disease, type 2 diabetes mellitus and metabolic syndrome.
Researchers looked at 28 studies including 99,745 participants across a variety of ethnic groups including both men and women. The studies revealed a significant association between high levels of vitamin D and a decreased risk of developing cardiovascular disease (33% compared to low levels of vitamin D), type 2 diabetes (55% reduction) and metabolic syndrome (51% reduction). All studies included were published between 1990 and 2009.
In most cases, I refrain from citing meta-analyses, because there can be such bias and generalization of data. However the reductions in preventing these diseases are so overwhelming, the study is impossible to ignore.
Journal of the American College of Nutrition also reported the crucial role vitamin D plays with diabetes prevention for one simple reason: vitamin D cell function, or lack thereof due to deficiency, leads to glucose intolerance and inhibited insulin secretion inhibited.
With cases of diabetes set to double and spending on the disease to triple by 2034, according to Diabetes Care, would it not be in our best interest to test every Americans vitamin D levels at their annual physical? Not to mention that it is a dirt cheap, preventive health measure.
Note: the medical vitamin D range is 32-100. The optimum range is 40+ in winter months and 50+ in summer (or good sun months).
For the other nutrients on this list, we have consistently documented their benefits over the years (not a complete list, just the most researched).
- Co-Enzyme Q10
- EPA/DHA Omega-3 Fish Oil
- Plant Sterols/Stanols
- Vitamin E
- Niacin (for raising HDL)
The following comments are taken directly from the transcript at a meeting from an expert committee chosen to update the 2010 USDA Dietary Guidelines.
"Looking at the number of patients with heart disease over the next half century. We're currently at about 12.4 million Americans have heart disease, and by 2050 that number will be about 25 million.
The good news is that we're doing a great job in patients who develop heart disease, keeping them alive. Our case fatality rates have fallen by about 75 percent. That's the good news.
The bad news is that we really haven't affected incidence, and as I'll mention, is it the new cases are still appearing? And the consequences of this graph is tremendous levels of disability, health care cost, and it's all preventable.
So the epidemiologic background of all this is that while mortality continues to fall, the incidence of coronary heart disease does not appear to have declined since about 1990 so that the new cases are still filling the reservoir.
Serum cholesterol levels appear to have been stable since 1990. This is actually despite the widespread use of effective cholesterol lowering drugs, which is now certainly an industry in the multiple billions off dollars. So if everything remained the same, one might have expected to have a decline in serum cholesterol.
So this is really the challenge, is where we're going to go from here, particularly in the public health way, not in a pharmacologic way?"
Pretty compelling stuff. I cannot wait to see if they actually actually address this issue in the DGA update. Regardless, the "cat has been let out of the bag."
In summing up the rest of this testimony, here are the main points discussed:
- Total fat and saturated fat consumption has gone unchanged since the mid-1990s. However, saturated fat replacement with carbohydrates, may have reduced LDL cholesterol, but negatively affected HDL and triglycerides.
- Replacing as little as five percent of saturated fat with omega-3 fat reduced cardiovascular heart disease events and type 2 diabetes in middle age to older adults. The committee discussed using this model as opposed to replacing that five percent with carbohydrate.