Category Archives: Medical Research

Bisphosphonates vs. Nutrition for Osteoporosis? Part III

Here is the wrap-up of the three part series on osteoporosis by Dr. R. Keith McCormick whose Chiropractic practice can be found at 145 Old Amherst Rd. Belchertown, MA  01007 – Telephone # (413) 253-9777.  Enjoy the final installment of what I think is an important issue and should be shared with all of your friends and relatives, especially females who might be taking bisphosphonate drugs.

WHY USE NUTRITIONAL THERAPY BEFORE RESORTING TO DRUGS? Strategic nutritional therapy can reduce a patient’s fracture risk without the risks for adverse effects posed by drug therapy. It therefore makes clinical sense to first use nutritional therapy before resorting to pharmaceuticals. There are, of course, situations where a patient may have already sustained one or more fragility fractures or has been determined to be in imminent fracture risk and may require a combination of drug (such as teriparatide, the 1-34 amino acid segment of parathyroid hormone) and nutritional therapy. But in the clinical setting, there is often a window of time where the use of nutritional therapy can be used as a first choice.

Specific biomarkers shown to be related to bone health can be used to identify metabolic dysfunction that can be improved through nutrition. In addition, because osteoporosis is a catabolic disease with high correlation to diabetes, Alzheimer’s, and cardiovascular disease, improving these indicators may reduce etiopathologic mechanisms of other disease processes. Drug therapy as a first choice does nothing to improve a person’s overall health. It can only reduce fracture risk and that only possibly for a limited time period.

WHAT FACTORS MUST BE CONSIDERED PRIOR TO PRESCRIBING A BISPHOSPHONATE?  All too often, physicians look at improving bone density with a bisphosphonate as being the means to an end, when in fact the bone loss is just one symptom within a system struggling against a catabolic tide of inflammation-induced destructive forces. Before a person is placed on bisphosphonates as a panacea for bone loss, many factors should and must be ruled out. These include vitamins D and K deficiency, hypercalcemia, mineral deficiencies, high oxidative stress, chronic systemic inflammation, chronic low-level metabolic acidosis, malabsorption syndromes such as celiac disease, food allergens leading to chronic systemic inflammation, and heavy-metal toxicity. Artificially increasing bone density with a bisphosphonate while leaving the catabolic fires of destruction to burn on is both shortsighted and irresponsible.

Because there are currently no adequate guidelines available, it is difficult to assess an individual’s true fracture risk. The best we can do is to assess the patient’s lifestyle and superimpose upon this their level of bone mineral density to make a judgment call as to their risk for fracture.  But laboratory tests can also be used to improve our assessment of risk and guide the application of a nutritional treatment program. These lab values include the resorption markers N-telopeptide and deoxypyridinoline, but other indirect markers such as morning urine pH, urine organic acids, chemistry screen, CBC, 24-hour urine calcium, TSH, anti-tissue transglutaminase, antigliadin antibodies, glucose, 25-hydroxyvitamin D, homocysteine, hsCRP, and others can also be used to assess fracture risk and overall health. When biomarkers are abnormal, they may reflect a rise in the patient’s risk for fracture. Prescribing a bisphosphonate before laboratory tests are obtained is not an optimal approach to improving a patient’s bone health.

In summary, when bisphosphonates are used before adequate laboratory evaluation and before appropriate strategic nutrition is used to reduce fracture risk, we have lost not only an important opportunity to normalize bone remodeling but a chance to reduce the catabolic forces of chronic inflammation and further disease.

Bisphosphonates vs. Nutrition for Osteoporosis? Part II

Here is part II of the three part series on Bisphosphonates versus Nutrition in the treatment of osteroporosis by Dr. R. Keith McCormick whose practice can be found in Belchertown, Massachusettes.

MICROFRACTURE RISK FROM LONG-TERM BISPHOSPHONATE USE?  Bisphosphonates interrupt the tightly coupled bone-renewing synchrony of osteoclasts that get rid of the old, worn, microfractured bone and the osteoblasts that form strong renewed bone. This reduction in bone turnover leads to skeletal ageing, and there are concerns that long-term bisphosphonate use (> 3 years) may lead to brittle bones and an increase in microfractures. This brittleness is due to altered mineralization properties such as a rise in mineralization homogeneity, which is not a feature of normal healthy bone.

In addition to altered mineralization from long-term use of bisphosphonates, adverse changes also occur within the bone’s non-mineral organic matrix, specifically within the collagen fibers. The “material properties” of collagen give it its strength, and this, in part, is dependent upon the formation through enzymatic mechanisms of structural cross-linking. These enzymatic cross-links hold the collagen fibers together and give them strength and also impart flexibility and toughness to bone. When cross-links are formed from non-enzymatic sources, such as through advanced glycation end products (AGEs) seen with chronic elevation of blood glucose in diabetes or in chronic oxidative stress, collagen integrity is sacrificed, bone becomes more brittle, and fracture risk increases. Bisphosphonate therapy, with reduced osteoclastic activity and bone turnover, leads to the accumulation of these non-enzymatic cross-links and may be of great concern to patients using bisphosphonates long term, especially those, such as diabetics, who are most susceptible to the formation of AGEs.

The extent to which these property changes, induced by long-term bisphosphonate use, influence fracture risk is, as yet, unresolved. But one can easily foresee that ageing bone, especially in a young individual who started taking bisphosphonates when he or she was 30, 40, or even 50 years old, may not end up as “healthy” bone.

WHAT IS THE MOST SERIOUS POTENTIAL CONSEQUENCE OF BISPHOSPHONATE USE?  Concerns over the side effects from bisphosphonate use are obvious and valid. But serious side effects are relatively rare and they pale in comparison to another potentially devastating drawback from the unscrutinized, premature use of bisphosphonates for the treatment of osteoporosis. That is the failure to therapeutically address the chronic inflammation and metabolic dysfunction that is often not only the major underlying cause of bone loss but may also be a potential contributor to other disease processes not yet manifested. By using bisphosphonates to improve bone density, only one aspect of osteoporosis is being addressed. The underlying inflammation, a consistent contributor to all chronic degenerative disease processes, continues untreated.

Bisphosphonates vs. Nutrition for Osteoporosis? Part I

Dr. R. Keith McCormick, DC of Belchertown, MA, gave an insightful talk at the recent Boulderfest 2007 in which he described the realities of osteoporosis and the problems with the family of drugs being purveyed by the pharmaceutical industry known as bisphosphonates. In part one of a three part series, Dr. McCormick has been gracious enough to explain to my blog readers why bisphosphonates are NOT the right thing to do to prevent or treat osteoporosis.  Here is part 1.

Osteoporosis is a disease process characterized by skeletal weakening from low bone mass and a deterioration in micro-architectural quality. The physical and financial burden of this disease is substantial with over 50 percent of women and 13 percent of men in America destined to sustain an osteoporotic-related fracture within their lifetime. With these high-stakes costs it is important that our method of treatment is not only efficacious but also conducive to the patient’s over-all good health.

Bone health is naturally maintained in a person’s body by a balanced remodeling system that ensures continued replacement of old worn-out bone with strong new bone. During normal bone remodeling, the bone-forming cells (osteoblasts) produce enough new bone to replace that which was resorbed by the osteoclasts. It is when this coupled remodeling process is in balance that bone health is maintained. When the osteoclasts resorb excessive amounts of bone, remodeling becomes uncoupled and there is a net decrease in bone tissue. Drug therapy has therefore concentrated on reducing osteoclastic activity in an attempt to correct this imbalance that leads to bone loss. The antiresorptive agents, bisphosphonates, have become the most commonly used pharmaceuticals for this task. With less osteoclastic activity, remodeling slows and there is less bone loss. Most physicians and millions of patients who have taken bisphosphonates view them as harmless drugs that increase bone mineral density and reduce the risk of fractures. But after decades of use, concerns are now rising over the safety of bisphosphonates.

HOW DO BISPHOSPHONATES WORK?  Bisphosphonates are synthetic analogs of inorganic pyrophosphates (commonly used antiscaling or water-softening chemicals) that bind to the divalent calcium ion (Ca2+) in the hydroxyapaitite crystal of bone. It is here that nitrogen-containing bisphosphonates are able to decrease excessive osteoclast activity. They do so by repressing farnesyl diphosphate synthase, an enzyme important for the synthesis of osteoclast cell regulatory proteins. Without these proteins, osteoclasts can no longer function and bone resorption is substantially reduced. With decreased osteoclastic activity, resorption sites are reduced, which lessens the risk that a minor external mechanical load could impart a breakpoint strain leading to trabecular buckling and catastrophic structural failure. It is from this reduction in resorption sites that bisphosphonates are able to reduce fractures. From a glance, and from statistics showing that bisphosphonates reduce both vertebral and nonvertebral fractures, this seems a very positive therapeutic outcome. But is this mode of therapy improving the actual “health” of bone? And, are there drawbacks to these powerful drugs that must be considered before prescribing their use?

Tune in tomorrow for part II and Wednesday for the completion of this important series.

The Media Lies Continue – Antioxidant’s Do Help Reduce Cardiovascular Disease Risk

As I have pointed out in the past, the media seems to love to lie to the public about the benefits of nutritional supplements. Caleb Hellerman, a stalwart for media distortions with CNN wrote how there was no benefit to the use of supplements in the past, a clear distortion and lack of good reporting. Now the media jumped on one of the worst studies on antioxidants done to date. Their claim as I reported earlier, was that women gained no benefit from the supplementation of antioxidants like vitamin C and E. Turns out, that was a clear distortion of the findings of the study.

My original post showed that the researchers did not look at the lifestyles of the study subjects which distorts the data. Today, I found out more dishonesty about the study which sickened me. Mike Adams points out that they included the data on the benefits of antioxidants from women who DID NOT TAKE the supplements. They showed no benefits to supplementation of vitamins C and E. NO KIDDING!  How can any self-respecting journal publish a piece a garbage like that?  And unless the media purposely distorts the truth, how could they publicize this?  The only reason I can see is the incestuous relationship they have with the advertising dollars from the pharmaceutical industry.  This is just another reason why pharmaceutical advertising must be banned.

Back to the study. What was revealed yet not reported by the media is that those women who actually took the supplements showed a clear benefit and reduction of cardiovascular disease. What did the media report? That there was no benefit despite the evidence that there was one. How dishonest is this? Antioxidants ARE beneficial. The truth is out there, but when money from the pharmaceutical industry clouds minds, the truth is often hidden.

Pharmaceutical Companies are Ruining Our Health Care System

In a well thought out article, Robert Bazell, Chief science and health correspondent for NBC News, writes about the ridiculous and scandalous way drug companies are ripping us off. In this case he uses the example of the drug Nexium, that purple pill and how little of a difference there is between it and Prilosec a drug from the same company but costing 7 times more!

Remarkably, the FDA approved Nexium even though it was only proven to be 3% better than its predecessor which is virtually identical except for a minor difference which allowed it to be patentable. This was purely a money-making ploy and had nothing to do with helping patients. The cost to us?  Since seven million people use Nexium which costs $200 per month and Prilosec costs $30 that comes out to a waste of $1.19 billion a year. That is an out and out theft. Multiply this by 20 drugs and you can see the enormous amount of money being made with little benefit to any of us.

So how did they do it?  By spending up to $16 million a month on advertising. Don’t think advertising works?  In this case, there is clear evidence that pharmaceutical advertising drives physician’s prescription. How else can you explain the use of a far more expensive drug with limited benefits over a cheaper generic?  You can’t and it is an abomination. Congress needs to jump on this and stop pharmaceutical advertising to patients. It is a rip off of unprecedented magnitude. We need to reel in our health care costs and this is one way to do it. The other thing that needs fixing is the approval process in the FDA. Why approve this drug at all when no benefit to human health is seen?  Make them improve the drugs not just change something minor and rip people off again.

Better yet, look into nutritional and alternative means of controlling heartburn and you will save so much more than money. You will avoid all those side-effects from the drugs and needing treatment for them as well.

In another article written by the same author, he seems stunned that Lipitor’s maker Pfizer drags out Dr. Richard Jarvik who in Mr. Bazell’s words asks the question, “Would you buy a heart medication from someone whose own efforts to cure heart disease led to failure?”  Do people realize this man never practiced medicine and his claim to fame, the Jarvik Heart was actually based on work by the famous ventriloquist Paul Winchell. It was considered a barbaric medical device that caused pain and suffering to whomever it was tried on. This is who Pfizer hires to push its drug which by the way losses its patent protection in 2010. Wonder what crap they will roll out to replace it.

Antioxidants and Health – More Headline Nonsense

In the upcoming Archives of Internal Medicine a study was published that seemingly negates the benefits of antioxidant nutrients, especially when it comes to the prevention of cardiovascular disease.  It was a large scale study with over 8,000 women being looked at over a greater than 9 year period and the findings were likely very accurate, that antioxidant supplements do not prevent coronary heart disease.  Problem is, the study has a few fatal flaws that never make it to the headlines. All the headlines focus on is that antioxidants don’t help prevent heart

What the pharmaceutical company funded media fails to highlight is that they researchers did not look at the lifestyles of the individuals taking the supplements. If you have someone who has a very oxidative lifestyle filled with alcohol, poor diet, and no exercise there is no doubt that antioxidant supplements, especially in the low doses they used in the study, will have little effect on coronary heart disease. What the headlines should have said is that we found little benefit to supplements if you don’t give a damn about your health. You can’t use supplements to overcome a bad lifestyle.

The bottom line here is that the headline is deceiving. What it should have said is that supplements may are not helpful to people who don’t care about their health. There are numerous studies to show benefits of antioxidants in human health and this one does little to deny that fact, what it does suggest is that antioxidants alone are not the answer. Total focus on lifestyle issues is the answer. Sorry public, no pills to overcome bad decisions.

Avandia – Isolated Problem or a System Gone Bad

Despite research showing that the drug Avandia causes an increased risk of heart disease in patients with diabetes, the FDA yesterday voted to allow the drug to remain on the market. So how is this protecting the public? Isn’t part of the job of the FDA to protect us from drugs that can harm us? Apparently not. BTW a scientist from the FDA supposedly was taken off the case when he or she found information that suggested that the drug was not safe. Read the article here.

Is this an FDA problem or an issue that goes much deeper. My opinion is the latter. It is a system that no longer holds the pharmaceutical companies accountable in a real world manner. The FDA is shorthanded, under-budgeted and faced with billion dollar lobbyists pressuring them to “fast-track” their next blockbuster drug. This is a huge problem and will likely not get fixed any time soon. People I’ve talked to with an inside knowledge of the FDA tell me that there is a growing frustration level at the agency because they feel like they are being lied to and deceived by some of the pharmaceutical companies when it comes to adverse event reports and followup efficacy research.

What is needed is independent research into drug on the market. My proposal is to create a government agency under the FDA which would give out grants to universities to study the effects of drugs on patients, kind of a Phase IV research program. The research would be funded by the pharmaceutical industry in a pooled manner. You sell 1 billion dollars worth of a drug, you put in 3% into the pool. All the companies are mandated to put the money in depending on the sales figures for their drugs in the U.S. In the case of Avandia, since they sell 3 billion dollars a year of the drug, Glaxo would be forced to fork over 90 million to the project.

From this, we could have a top notch monitoring system to oversee the safety of the drugs being marketed to physicians. The other overhaul would be to severely curtail advertising of drugs to the consumer. The crap from the industry that they are just educating the public is just that, crap. The education, and I mean education not bribery, should be focused strictly on the physicians, with strict guidelines. No trips to the Bahamas to hear a sales pitch, just local lectures and information passed on in a professional manner. One other issue, no more marketing to physicians about off label uses of drugs. The sales rep should be banned from touting a drug for treatment of a disease that has not been approved by the FDA. This is dangerous and unscientific and needs to be prosecuted if found.

This issue is not going away anytime soon as long as the pharmaceutical industry is not run just for profit. Time for a change.

Unnecessary Operations – Alternatives to the Alternatives

In an article on CNN.com, Carl Pesmen from Health Magazine details 5 common surgical procedures that are overused in America. Some of the interesting information he presented includes the surprising fact that over 12,000 Americans die each year from unnecessary operations. Here are the 5 surgeries, Mr. Pesmen’s alternatives and mine.

  1. Hysterectomies – According to the article, of the 617,000, between 468,000 and 524,000 are unnecessary. It is necessary for ovarian cancer but it is mainly used to remove fibroids and stop persistent vaginal bleeding. According to the article, there are a number of alternative. Dr. Tori Hudson, ND has a nice article here, that has can help women before they need this unneeded surgery.
  2. Episiotomy – Cutting the vaginal opening before childbirth is considered by some to be a way of making for a more comfortable birth but with post surgery symptoms like pain, irritation, muscle tears, and incontinence doing the alternative, which is Kegels, I think women would be far better off avoiding this. The unfortunate part is that 73 percent of the women who had the surgery, didn’t have a choice. This means, before going into the hospital, tell your doctor not to do it unless absolutely necessary. Emphasize absolutely as they are typically men and they may not listen.
  3. Angioplasty – One million two hundred thousand operations using angioplasty are done annually and they have not been proven to help with non-emergency patients any better than standard drug treatment. It does make for a nice home and car for the surgeons, but if you want to avoid the knife, this article suggests making sure you stay on the drugs. Better yet, go to Dr. Jeffrey Dach’s website and learn how to naturally avoid heart disease. Take some responsibility and you’ll stay healthier, longer.
  4. Heartburn surgery – Amazingly enough, this surgery often times doesn’t even work. Lifestyle changes and acid reducing drugs are their alternatives. I agree with the first but vehemently oppose the second.  Natural remedies include, Alka Seltzer Gold (yeah it is pretty natural), proteolytic enzymes, probiotics and even hydrochloric acid.
  5. Back surgery – Many people who have the surgery only report a short term relief. Unless there is real damage done to the spine, exercise, weight loss and lifestyle changes are far better long-term solutions. Here I wholeheartedly agree with Mr. Pesmen.

Bottom line on alternatives for all of these surgeries is changing your lifestyle. Get off your butt and get working. You’ll be happy you did.

Vitamin D – When is a good thing too much?

Vitamin D, as many of my regular readers know, is one of my favorite supplements. Research keeps on coming on all the good results scientists keep coming up with.  Here is a small list from recently published articles:

Still, there are times when you can get too much of a good thing.  In the July 19th 2007 issue of the New England Journal of Medicine, a letter to the editor pointed out a case where a women developed a series of life threatening toxic effects from taking Solutions IE Ageless Formula II supplement from Aloe International which contained 186,906 IUs of vitamin D. The symptoms she suffered included nausea, fatigue, constipation, back pain, forgetfulness and vomiting. It is known that long-term daily vitamin D consumption of 40,000 IUs of vitamin D3 can cause hypercalcemia in health patients so the amount this women took was obscenely high.

Of course, this is an isolated instance and not the standard in the nutritional supplement business. This is an example though of why the industry needs to make sure it regularly checks each batch for quality. This is not being done unfortunately and the FDA was forced to step in and create a rule that the manufacturers of nutritional supplements must test their products. Some advocacy groups bristled at the thought of FDA control and rolled out the dreaded term CODEX to scare the public but sad to say, it was a necessary evil to bring some sanity to the nutritional supplement industry. I have personally seen products, like an electrolyte product on the market claiming 136 mgs of magnesium in each serving but when I checked out their label claim through an independent lab, they only had 32 mgs of magnesium. That is only one-third of the label claim. This same company has already been admonished twice by the FDA for other offenses (like selling a product that could cause miscarriages) yet they stay in business.

There are many good companies out there but consumers must be wary. Hopefully, the new regulations will mean better and safer products on the market.

Phthalates in the News….. Again

Data on the negative effects of the common plasticizer phthalates keeps on coming. Last month, it was the relationship between phthalates, insulin-resistance and male waist circumference and this month it is the effect of this toxin on thyroid function in men.  The journal Environmental Health Perspectives has published numerous articles on the subject but the last two issues seem to really bring home the fact that we need to look at phthalates more closely and avoid exposure as much as possible.

The June 2007 article, authored by Stahlhut, et al, shows a link between levels of urinary excretion of phthalates and insulin resistance as well as obesity in males. The gist of the article found here, is that phthalates may be anti-androgenic, meaning it blocks the production of testosterone. We know that by depressing testosterone you see an increase in cholesterol and a decrease in the ability to regulate blood sugar.

This month, researchers Meeker, Calafat and Hauser report on a study they did which looked at 408 men and measured their urine output of two forms of phthalates. There conclusion was that there may be an association between phthalate concentrations and altered free T4 and/or total T3 levels. This is the first time that human studies were conducted on this relationship and it seems to back up the limited animal research that showed this same correlation.

To find out where your levels are, have your doctor call Lab Interpretation LLC at 775-851-3336 and ask about the Environmental Pollutants Panel and you can check not only your phthalate level, but a number of other petrochemical solvents (benzene, toluene, xylene, parabens, trimethylbenzene and styrene), Phthalates are commonly found in drinking water as well as cosmetics, shampoos, perfumes and other skin and hair care products. Go to the Environmental Working Groups website (click the link) and go to their Skin Deep database. There you will find out where your exposures may be from.