Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, March 23, 2012

Re-Post from the Wellness Professor "Tim Dennehy" These osteoporosis drugs actually cause fractures

In October 2010 the FDA released a warning stating that Bisphosphanate drugs used for osteoporosis have been linked to atypical fractures of the thigh. These drugs include Fosamax, Boniva, Actonel and Zometa. This new adverse effect is one among many for these drugs.  

As I have talked about with statin drugs a barometer to establish how well a particular drug works is determined by the number needed to treat (NNT). The lower the NNT the more effective the drug.
So a drug with an NNT of one works for everyone. A drug with an NNT of one hundred works for one out of every one hundred people, etc. Let's look at the number needed to treat for these osteoporosis drugs.

A study out of the "Journal of Bone and Mineral Research" estimates that the number needed to treat for Bisphosphonates is anywhere from 100 to up to several thousands. This means that possibly thousands of people need to take the drug for one person to benefit. (1)  

These drugs do not work for the primary prevention of hip fractures (first fracture). They may work for a very small percentage of people with a low bone mineral density and a history of fractures, but are they worth the risks?

In addition to their lack of efficacy, these drugs can increase your risk of jawbone necrosis, kidney damage and esophageal cancer.

The incidence of esophageal cancer for Bisphosphanate users is 1 case per 1,000 people taking the drug (3). If the NNT of these drugs is 1,000 that means for every 1,000 people that take these drugs one fracture will be prevented, but one case of esophageal cancer will occur. Just like with statins, we are trading one disease for another. 

While there is still a great deal to learn about osteoporosis and how to prevent it, these drugs are not the answer. Here are some ways to limit the risk of osteoporosis and bone fractures in the elderly.

1. Osteoporosis prevention should start in childhood. Adequate Vitamin D levels and calcium intake are critical for strong bones. What is the right form of calcium? Here is a quick answer: it is not cow's milk or supplements. I will discuss why and the best ways to get calcium in my next newsletter.

2. Avoid excessive consumption of acidic foods like grains, dairy, meats, coffee, sugar, sodas, and carbonated beverages. The body has to maintain a PH balance. When the PH is too acidic calcium leaches from the bones to correct this. Eat foods that give you an alkaline PH. These include whole fruits and vegetables.

3. Exercise with weights. Weight bearing exercise is critical for bone health and should be done at least 3-4 times per week.

4. This one may sound obvious, but limit your risk of falling. Avoid drugs that increase this risk, particularly in the elderly, such as sleeping pills and anti-anxiety medications that may cause drowsiness and dizziness.

Until next time....

Stay healthy my friends,

The Wellness Professor 

Sources

1. J Bone Miner Res. 2008 September; 23(9): 1435-1441.
Published online 2008 April 21. doi:  10.1359/JBMR.080418



Friday, March 16, 2012

Are You Taking One of the Stain Drugs? Information You Need To Know

From the Wellness Professor: Tim Dannehy

About one out of every four Americans take a statin drug to lower cholesterol.

In February this year, the FDA said that all statins must carry warnings about increased risks of elevated blood sugar and possible transient memory and cognition problems. The label changes apply to Atorvastatin (Lipitor), Fluvastatin (Lescol), Lovastatin (Mevacor), Lovastatin extended-release (Altoprev), Pravastatin (Pravachol), Rosuvastatin (Crestor), and Simvastatin (Zocor).

Despite the additional warnings, the FDA said that it continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.

There is no debate that statins work very well at lowering cholesterol and triglycerides. The debate is whether their risks outweigh the benefits.

My issue with statin drugs is when they are used for the primary prevention of a heart attack, meaning they are prescribed to people with no history of cardiovascular disease, but may have high cholesterol or triglycerides. Statins show some benefit in preventing heart attacks vs. placebo in this population, but do the risks outweigh the benefits?

Take a look at the Lipitor commercial where they boast a 33% reduction in heart attacks when people take their drug. Sounds great, but here is the reality behind the sales pitch. If 100 people take a statin drug, two of them will have a heart attack. If 100 people take placebo, three will have a heart attack. So 100 people need to take Lipitor in order to prevent one heart attack. That means that 99 other people will get zero benefit from taking these drugs. The only thing they get is the possible side effects.

Here is a recent quote from noted cardiologist Dr. Rita Redberg:

"Despite research that has included tens of thousands of people, there is no evidence that taking statins prolongs life, although cholesterol levels do decrease. Using the most optimistic projections, for every 100 healthy people who take statins for five years, one or two will avoid a heart attack. One will develop diabetes. But, on average, there is no evidence that the group taking statins will live any longer than those who don't."

This is essentially trading one disease for another. No heart attack, but now we have one more person with diabetes.  

Statins deplete important CoQ10 levels

One very important side effect of statins not listed by the drug companies is the depletion of Coenzyme Q10 (CoQ10) levels in people taking these drugs. CoQ10 exists in every cell of the body and is responsible for 95% of the energy production in certain cells.
CoQ10 is an extremely important nutrient that supports vital muscle function. Without sufficient levels of CoQ10, the body's ability to repair and regenerate skeletal muscle is greatly compromised.  
 
CoQ10, according to the Mayo Clinic, is produced by the human body and is necessary for the basic functioning of cells. CoQ10 levels are reported to be low in patients with some chronic diseases such as heart conditions, and muscular dystrophies. Some prescription drugs (statins) may also lower CoQ10 levels.

Studies have shown that two-thirds of patients without heart problems who were put on a low dose of a statin medication developed problems with the heart filling up with blood normally.  

According to the cardiologist who conducted this study, Peter H. Langsjoen, this abnormality was caused by CoQ10 depletion. He reasoned that without CoQ10, the cell's mitochondria are inhibited from producing energy, leading to heart muscle weakness. The heart is especially susceptible because it requires more CoQ10 than any other tissue in the body. 

The results of nine other controlled studies examining whether statins were responsible for decreased CoQ10 production concluded that 90% of the participants suffered significant depletion of CoQ10.

Dr. Langsjoen believes that taking CoQ10 should be mandatory for anyone taking statins so that the risks and side effects can be counteracted. Here is a quote from one of his lectures. 

"A deficiency of CoQ10 always effects heart muscle function" If you want to view his 40 minute lecture about CoQ10 click here. 

It is already a requirement in Canada. Health authorities there require that statins must carry a precautionary warning regarding CoQ10 depletion. Doctors are also required to talk to their patients about taking CoQ10 when they prescribe statins.

If you are taking a statin medication, you would be well advised to research their side effects and discuss the risks vs. benefits with your doctor.

If you decide to continue statin therapy, it is imperative that you include a CoQ10 supplement to counteract the depletion caused by statin drugs.

You must take a high quality CoQ10. There are many junk CoQ10 products on the market that do not get absorbed well and are ineffective. Contact me for more CoQ10 information and I can steer you in the right direction.   

Until next time......

Stay healthy my friends,

The Wellness Professor 

Sources: 

Mayo Clinic Staff, "Statins: Are these cholesterol-lowering drugs right for you?
Merck.com, product information for patients
Lipitor.com, "Lipitor side effects"
The Mayo Clinic, "Coenzyme Q10"
Lef.org, "Life Extension Magazine: Innovative Research and Applications for CoQ10"
The Weston A. Price Foundation, "Dangers of Statin Drugs: What You Haven't Been Told About Popular Cholesterol-Lowing Medicines."
Mercola.com, "Cholesterol-Lowering Drugs Will Wreck Your Muscles"
Mercola.com, "Statins Cause Muscle Damage"
thennt.com, "Statin Drugs Given for 5 Years for Heart Disease Prevention (With Known Heart Disease)"

AJ Web Marketing offers a great  CoQ10 supplement from Dr. Sears:   "Primal Force ACCEL"