Showing posts with label pharmaceutical. Show all posts
Showing posts with label pharmaceutical. Show all posts

Sunday, June 10, 2012

What Did Dr. Oz Leave Out About Strontium?

Let me preface today's blog with a head's up that I spent 5 hours researching this subject before writing the blog. It's a little technical, but I thought the detail was important. 

Although I may have a pretty good handle on the subject, I may also have missed something that wasn't available on the internet. Please feel free to comment if you feel I missed something.

Last Thursday, Dr. Oz told his audience about four supplements, extensively researched by his staff, which he highly touts as anti-aging supplements. The four were resveratrol, vitamin D, fish oil, and strontium. Please see my previous blogs about fish oil (Tuesday, April 10, 2012 titled ‘Et tu fish pills?’) and Vitamin D (Tuesday, March 20, 2012 titled ‘What's The Big Deal About Vitamin D? It turns out quite a bit.’   

At a later date, I'll write about resveratrol. In the interim, please note that one of the leading, if not the number one in the world, resveratrol researcher, Depak Das at the University of Connecticut, was dismissed from his university post because he was found to have repeatedly falsified his resveratrol research data. This has thrown the entire field of resveratrol research into dispute and a major conference that was scheduled in India called Resveratrol 2012 was cancelled late last year as he was one of the top experts expected to present. Enough about resveratrol for now; today, let's have some fun with strontium.

Dr. Oz recommended that women take 680 mg of strontium each day separated from the calcium he also recommends they take.  Of course, he made no reference to recent studies that suggest potential harm from taking calcium (see my blog from Friday, May 25, 2012, 'Calcium Pills Raise Concerns -- Again!'). He mentioned on the show that strontium has been studied in Europe and that the studied form is not available in the U.S. 

Here's what he didn’t share. The form of strontium studied in Europe was strontium ranelate, a synthetic salt that combines strontium with ranelic acid.  The studies done in Europe were good studies and one of the studies was published in the New England Journal of Medicine, a peer reviewed prestigious journal published by the Massachusetts Medical Society and associated with Massachusetts General Hospital, the premiere Harvard affiliated public hospital. See reference below.

The study involved the consumption of 2 grams of strontium ranelate each day for a period just short of five years. The strontium clearly increased bone density on scans and decreased fracture risks in post-menopausal women. It was generally well tolerated except for increased nausea and diarrhea during the first three months of administration.  All study participants also consumed calcium and Vitamin D at different dosages.  As a result of the study, the drug was approved and is only available by doctor prescription for dispensing by a pharmacist to people at high risk of fractures in Europe, and requires strict medical supervision. 

Why strict medical supervision? Strontium competes with calcium and magnesium and displaces them. What that does to your bone health and overall health has not been studied and is unknown.  There are reports that it can cause a condition called osteomalacia, which involves the softening of the bones caused by defective bone mineralization secondary to inadequate amounts of available phosphorus and calcium, or because of overactive resorption of calcium from the bone, often as a result of hyperparathyroidism. In other words, taking strontium may interfere with your normal function of calcium uptake by bones.

A review of comments from users found on the internet included, a doctor “urged caution and told me about the deaths due to 'hypersensitivity syndrome' and a second consultant told me she was still not happy with calculation of DEXA scores.” The reference to the DEXA scores is that when doing the diagnostic DEXA Scan tests for osteoporosis, the test results are apparently skewed by the use of strontium.  There were many comments that indicated no problems.

So why isn’t it available in the U.S.? The answer is because the French company that owns the patent has not pursued FDA approval. The apparent reason for this and the one most often cited is that the FDA would require some homegrown research before approving it and the company doesn’t want to foot the bill. So you can’t get it here.

Of course, some entrepreneurial folks decided that if you can get the synthetic strontium ranelate here, they should cook up some strontium citrate because as it has no synthetic compound involved (ranelic acid is synthetic and citrate is not) and therefore can be sold as a supplement here in the U.S.  How did they come up with the recommended 680 mg dose? Apparently, strontium ranelate contains 680 mg of strontium. How much strontium does strontium citrate contain? I can’t tell you.

Also, what’s the difference between the way citrate and ranelate act in your body? I don’t know and nor does anyone else because it hasn’t been studied. Let’s look at an example of two other different chemical molecules binding together. Sodium when combined with chloride becomes sodium chloride, the salt we eat. When sodium is combined with citrate, it becomes monosodium citrate, a salt used to prevent anticoagulation of stored blood. Different chemicals when combined create different compounds.

So what’s the biggest problem with taking strontium citrate to prevent or treat osteoporosis? Beyond some of the concerns cited above, it’s never been studied and reported on in humans.

There was a study begun in the U.S. at University of California Davis Medical Center a few years ago that was meant to be completed and results reported in 2010, but the study, named the Scope Study, has mysteriously disappeared.  I’m not kidding. There are conspiracy theories all over the internet regarding what happened to this study. Some claim the bisphosphonate companies got to them. Just theories with no evidence whatsoever to support them. My experience is when a research institute goes mum on a study, it’s often due to something going wrong with the study.  Nonetheless, the results never came out. That gives me pause to ever recommend such a drug under such circumstances.  

Furthermore, while strontium ranelate was studied with 680 mg of strontium, studies with far less amounts have never been reported. If it is actually good for you, could less work just as well?

Strontium is present in our food supply. For example, it is available in vegetables such as spinach, lettuce, carrots, peas, beans, potatoes and celery. Wheat, barley and other grains used to make bread also have significant levels of strontium. According to one source I found, flour, grains and breads average 2,150 mg per gram of stable strontium.

So as always, before taking a pill containing a super high dose of a mineral which has not been studied for a prolonged period of time, you should increase your intake of foods containing that mineral that have been used for millions of years.

It is important to remember that high-dose strontium is essentially a bone drug, and, as with all bone drugs, it is only indicated when there is a clear high risk of fracture defined as a 20% likelihood of a major osteoporotic fracture over the next 10 years.

The bottom line is that the long-term safety and efficacy of strontium citrate has not been evaluated on humans in large-scale medical trials.

That’s why once again I say shame on Dr. Oz for recommending it to the general population without good science to support what is available in the U.S. It only serves to make people more anxious and confused that maybe they have misssed something. It is often dangerous to experiment on your own body.

By the way, here are the chemical structures for strontium ranelate and strontium citrate. Do they look similar? If no, it's because they are not. One, ranelate binds with two atoms of strontium, while the other, citrate, only binds with one atom.


Strontium Ranelate 

 
Strontium Citrate
References:
Meunier PJ, Roux C, Seeman E, et al. The effects of Strontium Ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. NEJM 2004 350;459 -68
Reginster JY, Seeman E, DE Vernejoul MC, et al . Tropos Study. J Clin Endocrinol Metab 2004–1774. Strontium ranelate reduces the risk of nonvertebral fractures in post-menopausal women with osteoporosis.

Friday, June 1, 2012

I'm Sorry To Be A Party Pooper, But...

Many people love chocolate for obvious reasons. When they hear it's good for them, that's just frosting on the cake (pun intended). Over the next day or so, you are going to see and hear a tsunami of headlines, yet again, about the heart benefits of eating dark chocolate. The headlines will blare how dark chocolate prevents cardiovascular events.

This breaking news will be the result of a modeling study that predicts that patients with metabolic syndrome who eat dark chocolate every day could have 85 fewer events per a population of 10,000 over 10 years. The study, conducted by Chris Reid, PhD, of Monash University in Melbourne, Australia and colleagues was supported by a grant from a pharmaceutical company.  (For more about metabolic syndrome, please read end of blog).

The researchers used a Markov model to assess health effects and associated costs of daily consumption of plain dark chocolate compared with no chocolate in a population with metabolic syndrome but without diabetes or cardiovascular disease.

That's my first problem with the study.

It wasn't a gold standard randomized double blind controlled study. It wasn't even a good observational study. It was a mathematical calculation, and at that it only showed a benefit of .85 (yes, point eighty five) fewer heart related events per 100 people, and of the heart events, they are predicting .15 fewer events leading to death. That means for every 1000 people who eat the chocolate, there would be 1.5 fewer deaths.

Okay, you say, I get to eat chocolate and maybe I'll be the one guy or gal out of a thousand that benefits from it. So here's my real problem with the study. As a modeling study, it also made assumptions about the type of chocolate that was consumed. The researchers wrote, ""Evidence to date suggests that the chocolate would need to be dark and of at least 60% to 70% cocoa, or formulated to be enriched with polyphenols." There is no reference to the sugar content of the chocolate.

True, dark chocolate in high concentrations (usually over 75% cacao) contains polyphenols, which are healthful antioxidants. However, the sweetness in the dark (or sometimes called bittersweet) chocolate always comes from added sugar of one sort or another. This sugar is usually not healthy and is also fattening.

I know from personal experience that when I added for the purported health benefit (and the taste) one small piece (1/8 of a bar) of dark chocolate a night with 75% cacao (the higher the cacao the more sugar needed to make it enjoyable), my weight started to slightly increase from that one solo change. I stopped the practice.

If you think that this was a study that should make you go out and buy some dark chocolate, here is what the researchers said about their own study.

Reid and colleagues noted that the study was "limited by its reliance on the Framingham algorithm, which may underestimate risk in a high-risk population, and by assumptions about the risk of death following a cardiovascular event." Furthermore, "the study was also limited by the assumption that the benefits of dark chocolate, which have only been observed in short-term trials, extend to 10 years."

By the way, there are many non-processed rich sources of polyphenols in fruits and vegetables such as blueberries, black berries, strawberries, red grapes, eggplant, etc., so you don't need to eat chocolate to get your daily dose.

In conclusion, dark chocolate is better than regular chocolate. The higher the percentage of cacao, the more healthy polyphenols it contains, but watch out for the increase in carbohydrates. Nibble on no more than 1/8 of a bar at any given time. Most importantly, if you want to eat it, do it for the taste, because the heart benefits are still inconclusive.

More on Metabolic syndrome

From PubMed

Insulin resistance syndrome; Syndrome X

Metabolic syndrome is a name for a group of risk factors that occur together and increase the risk for coronary artery disease, stroke and type 2 diabetes .

Causes, incidence, and risk factors

Metabolic syndrome is becoming more and more common in the United States. Some estimate it as affecting 25% of the U.S. population. Researchers are not sure whether the syndrome is due to one single cause, but all of the risks for the syndrome are related to obesity.

The two most important risk factors for metabolic syndrome are:
  • Extra weight around the middle and upper parts of the body (central obesity). The body may be described as "apple-shaped."
  • Insulin resistance, in which the body cannot use insulin effectively. Insulin is needed to help control the amount of sugar in the body. As a result, blood sugar and fat levels rise.
Other risk factors include:
  • Aging
  • Genes that make you more likely to develop this condition
  • Hormone changes
  • Lack of exercise
People who have metabolic syndrome often have two other problems that can either cause the condition or make it worse:
  • Excess blood clotting
  • Low levels of inflammation throughout the body

Symptoms

  • Extra weight around your waist (central or abdominal obesity)

Signs and tests

According to the American Heart Association and the National Heart, Lung, and Blood Institute, metabolic syndrome is present if you have three or more of the following signs:
  • Blood pressure equal to or higher than 130/85 mmHg
  • Fasting blood sugar (glucose) equal to or higher than 100 mg/dL
  • Large waist circumference (length around the waist):
    • Men - 40 inches or more
    • Women - 35 inches or more
  • Low HDL cholesterol:
    • Men - under 40 mg/dL
    • Women - under 50 mg/dL
  • Triglycerides equal to or higher than 150 mg/dL
Tests that may be done to diagnose metabolic syndrome include:
  • Blood pressure measurement
  • Fasting glucose test
  • HDL cholesterol level
  • LDL cholesterol level
  • Total cholesterol level
  • Triglyceride level

Treatment

The goal of treatment is to reduce your risk of heart disease and diabetes. Your doctor will recommend lifestyle changes or medicines to help reduce your blood pressure, LDL cholesterol, and blood sugar.
Recommendations include:
  • Lose weight. The goal is to lose between 7% and 10% of your current weight. You will probably need to eat 500 - 1,000 fewer calories per day.
  • Get 30 minutes of moderate intensity exercise, such as walking, 5 - 7 days per week.
  • Lower your cholesterol using weight loss, exercise, and cholesterol lowering medicines, if needed.
  • Lower your blood pressure using weight loss, exercise, and medicine, if needed.
Some people may need to take daily low-dose aspirin.
People who smoke should quit.

Expectations (prognosis)

People with metabolic syndrome have an increased long-term risk for developing cardiovascular disease and type 2 diabetes.

Complications

  • Atherosclerosis
  • Diabetes
  • Heart attack
  • Kidney disease
  • Nonalcoholic fatty liver disease
  • Peripheral artery disease
  • Stroke

Tuesday, March 13, 2012

Are Drug Companies Inherently Evil?

Recently, I have seen a spate of numerous articles decrying the criminality of pharmaceutical companies. I find this very disturbing. The articles suggest that drug companies routinely withhold information from the FDA and the public about the adverse side effects of their products. That these same companies pay off doctors to prescribe dangerous and unnecessary medications. That profit motives override any humanistic concerns or decency. A careful reading of such diatribes usually reveals that the originators of these anti-prescription, anti-FDA, anti-drug company tirades offer or suggest supplement alternatives to taking prescribed drugs.

Yes folks, these attacks are often generated by members and/or proponents of the supplement industry spewing forth an "our product is better" propaganda. Knock down the drugs and drug companies and the logical alternative becomes a supplement. Sully the FDA and it no longer matters that supplements have no approval or oversight of their own.  It's a brilliant ploy.

I am sad to say that it reminds me of Joseph Goebbels, the Nazi's Propaganda Minister during Hitler's rise to power. Goebbels exploited popular emotion and deployed all means of propaganda to achieve his nefarious ends. He made scapegoats out of Jews and others to rally people to his cause. Let me be clear that I am not calling supplement marketers Nazis.  I am, however, stating that I believe that companies like the Life Extension Foundation (LEF) don't miss a beat in berating the FDA in order to sell more supplements. If you can't trust the government and its regulatory agency, you need to find an alternative.  LEF and countless other supplement marketers offer themselves up as a logical choice. You can tryst them, they would have you believe, because they are fighting the FDA on your behalf.

The saddest part is that many (but thankfully still a small number) doctors looking to spruce up their revenues are jumping on the supplement bandwagon. Armed with more scientific knowledge than the average person, they can be particularly effective in making unsubstantiated arguments. As they say in Latin, caveat emptor or "let the buyer beware" of doctors selling supplements.

I am pretty sure, but I can't be certain, that almost all of these supplement marketers when faced with an acute personal medical illness turn to what they would have you believe are corrupted by drug company doctors to be treated with fraudulently approved and prescribed drugs. As some like to quip, there are no atheists in foxholes.

By the way, this blog is not meant as an impassioned defense of the pharmaceutical industry. The industry has been guilty of some serious crimes and disasters over the years. Drug companies have been found guilty of illegally influencing doctors prescribing habits and new rules were implemented to limit future abuses. In additions, some drugs, despite copious testing will prove long term to be less helpful and more harmful than expected.   On the whole, I think they have introduced many new drugs over the years that have spared countless people from real pain and suffering.

Overall, I still put my trust in the FDA and it's regulatory process, imperfect as it may be, over any unregulated product with spurious health claims. That's not to say, I wouldn't use some proven supplement under the right circumstances. It's just not the first place I look for a solution. That said, I still believe that food is the best source of cure for many maladies and will avoid medicine whenever possible if food offers a viable alternative.

Give me chicken soup first instead of cough medication any time.