Early New Year’s prediction: drug companies move into muscles

You’ve probably heard me say it before. Muscle and bone work as one single unit —when we build muscle, we build bone. When we lose muscle, we lose bone — and, more importantly, losing muscle and bone means a higher fracture risk. As we age, we naturally lose muscle, lots of it, right along with bone. But here at the Center for Better Bones we’ve had great success encouraging the maintenance and building of muscle strength the old fashioned way: through exercise and an alkaline diet.

I recently heard a major researcher declare that, “Muscle strength was the most important determinant of hip strength.” It’s great to hear that word is getting out about the muscle and bone link, but I have a prediction to make. My early 2011 prediction is that those like us who promote a natural approach to building muscle are going to have competition. Big Pharma may muscle in on us.

The major pharmaceutical companies have been busy developing drugs to interfere with the mechanisms of bone loss, but now may turn their efforts toward developing drugs to interfere with muscle loss. And what makes me think this? Well, I have to credit my insight to a couple of things I learned at the annual ASBMR (American Seminar for Bone and Mineral Research) meeting:

1. It appears that certain academic strength researchers may be moving to work directly for the pharmaceutical industry.

2. An ASBMR lecture I attended mentioned genetic manipulation of a muscle growth inhibitor pathway (myostatin) as one possible avenue for drug intervention.

Why exercise to maintain muscle and bone mass when you can just take a drug? I think most of you already know the answer to that. No drug could ever replicate the whole-body benefits of regular exercise. Aside from bone and muscle strengthening, exercise reduces stress, improves cardiovascular health, boosts brain function, and reduces cancer risk — just to name a few. People of the world stand up, bulk-up, pump that iron, don a weighted vest, and walk. We naturalists are not going to take this challenge sitting down!

For tips to get you started or keep you going, read my article on exercising for bone health.

 

 

Strange fractures with bisphosphonates

In a few weeks, I’ll be heading off to Toronto for the annual meeting of the American Society of Bone and Mineral Research (ASBMR). And this October, we’ll have a lot to talk about. ASBMR recently convened an expert task force to investigate atypical femur fractures among patients taking bisphosphonates. Their results — published this September — confirm the link between long term use of the popular bisphosphonate drugs and atypical fractures of the thigh.

In 94% of the 310 cases studied by the task force, the individuals had been using bisphosphonate drugs, and most of them had been on the drug for more than five years.

While many of these serious fractures occurred without warning, more than half of the people studied reported groin or thigh pain for a period of weeks or months before the fracture occurred. And to top it off, one quarter of patients who experienced such an atypical femur fracture in one leg experienced a fracture in the other leg as well.  Even though this fractures represent only 1% of all hip fractures, the task force found the issue serious enough to warrant rather strong recommendations.

The ASBMR task force recommends the following:

  • That the FDA require bisphosphonate drugs be labeled to inform people about the possibility of serious atypical femur fractures and the associated warning signs
  • That health professionals should reserve bisphosphonates for patients with certain cancers, Paget’s disease of bone, and patients with osteoporosis who are high risk of fracture

Bisphosphonate drugs include: Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid and Zometa.

For more on bisphosphonates and natural alternatives, read my article on drug therapy for osteoporosis.

Read the full text of the ASBMR task force report.

 

 

What do I really think of bone drugs, anyway?

Those of you who read this blog and my articles regularly might think I’m against bone drugs altogether. That’s not truly the case. There are certainly people who have such catastrophic bone loss that it’s appropriate for them to use medications to slow or halt it — but these are usually people who have a serious health crisis going on. Cancer treatment, Paget’s disease of bone, those on long-term high dose prednisone treatment, and similar situations where bone is eroding rapidly are clearly circumstances where these strong medications can be beneficial. But my natural approach to support bones and overall health would be helpful in these patients as well.

Where I take issue with bone drugs is when they’re used to address low bone density without any effort to identify the reason for the bone loss — and that happens all too often. As most of my clients and some of my blog readers can attest, it’s not uncommon for physicians to simply hand out a script when they see a bone scan that indicates osteoporosis (or even osteopenia) without taking any steps to determine why bone is being lost, or even if bone is being lost!

Unfortunately, most physicians regard bone loss itself as a disease, when the vast majority of the time it’s really a symptom of some other, underlying health issue.

Treating the symptom with a drug doesn’t cure the disease — it simply masks the problem.  The “problem masking” in turn often brings with it significant life-damaging side-effects. And most physicians’ don’t mention that these are very powerful medications with a profound impact on the body’s most fundamental processes.

• Bisphosphonates put a halt first to osteoclast activity and over time to osteoblast activity as well.

• Teriparatide (Forteo) stimulates osteoblasts to work overtime in building new bone, but it has worrisome long-term risks that we discuss elsewhere.

• Denosumab (Prolia), a drug slated for FDA approval this summer, goes even farther, interfering with immune factors to prevent the natural process of bone breakdown and renewal.

What it boils down to is this: if your doctor finds your bone health situation so serious that she wants you to take these very powerful drugs — medications that affect not just bones, but other systems in the body too, then your situation is serious enough to warrant a full osteoporosis medical work-up looking for the causes of bone loss.  The case for bone drugs cannot be made on the basis of just one or even two DEXAs. The simple fact that a person is losing bone isn’t, in my opinion, reason enough to start someone on a drug as a knee-jerk reflex. If there is an identifiable underlying condition that is causing an individual to lose a lot of bone, rapidly, this should be uncovered and addressed. 

When a comprehensive natural approach to halting excessive bone loss fails, then can you make the case for bone drugs.  And when there isn’t an identifiable underlying health issue or an identifiable cause of bone loss, it still stands to reason that working to support bones by improving nutrient intake, getting more exercise, dealing with stress, and improving the body’s pH through an alkaline diet are much more sensible first steps than hauling out the “big guns”!

Postscript

Thank you all so much for telling your stories and adding your comments below. When I wrote this post, I did so out of concern that people who had significant health issues that resulted in bone loss would misunderstand my position on bone drugs and believe that I thought bone drugs serve no purpose. Your comments have shown me just how important it was to clarify that position! Many of you have exactly the kinds of health issues that cause rapid, catastrophic bone loss/weakening, so you fall into the category of people that I believe should consider medical therapies under a physician’s care and guidance. I don’t want anyone to feel that taking bone drugs to address this sort of bone loss is somehow wrong or incorrect, and certainly your physician is the first person to whom you should address any questions about medical treatment for bone loss — for the most part, it would not be proper for me to offer advice on whether someone should or shouldn’t use particular treatments, as I’m not familiar with your specific cases. At the same time, though, the alkaline diet and nutritional support that I recommend to all my clients is something that I encourage all of you to consider, as the more support you provide your system, the better it will respond to your treatment regimen. In my work with clients at the Center for Better Bones, I’ve found that these methods are a great support even to those patients who must use bone drugs to halt bone loss related to a medical issue. Best wishes to all of you, and thanks for reading my blog!

 

ABC News report: Fosamax can cause needless fractures

I hate to say “I told you so,” but for years here at the Center for Better Bones, I’ve said that Fosamax and similar drugs had the potential to actually make bones weaker. This is because these strong bisphosphonate medications dramatically reduce both bone breakdown and bone formation, and thus can lead to the creation of “static” or “adynamic” bone — bone that is not capable of healing and renewing itself. I’ve seen cases of this myself. One was my client Carol, who had been using Fosamax for several years. One day, she simply twisted around, lost her balance, and fell to the floor. From this simple fall, Carol shattered her upper leg bone.

Now enough cases of such needless fractures related to long-term bone medication use have been collected that they’ve gotten the attention of the national news media. If you missed it, here’s a link to Diane Sawyer’s report on ABC News describing the risk of fractures associated with long-term bisphosphonate use.

There is a better way. A natural approach to bone health that works with and not against the body’s healing abilities can not only rebuild weak bones into bones that are stronger and more flexible, it can also support total health. If you or someone you care about is considering or already taking Fosamax or similar medications, please take the time to review our section on Rethinking Osteoporosis to learn more about supporting your bones with nutrition and healthful living.

 

Fosamax and breast cancer

Last December, many news outlets were reporting the latest finding to come from the 2002 Women’s Health Initiative in articles that trumpeted the finding that women who were taking Fosamax and other bisphosphonates for their bones had 32% fewer breast cancers than women who weren’t. At first blush, the idea that you could prevent two of the most frightening conditions that affect post-menopausal women — osteoporosis and breast cancer — with a single medication would seem to be a breakthrough of tremendous importance. I wanted to know more. So I looked at what little information is available about the study — there’s not very much, just an abstract from the meeting where the study was presented and various news reports — and consulted with Dr. Dixie Mills, Medical Director of the Dr. Susan Love Research Foundation, to make sure I understood clearly what the findings meant.

My findings only confirmed my initial suspicions that popular media outlets were blowing the significance of this study out of proportion. I’d like to caution women not to take the headlines at face value. Why? For four reasons:

1. First, bisphosphonates like Fosamax, Actonel, and Boniva stop the activity of bone-building osteoblasts, which I feel (and science supports) could, over time, make bone brittle and more prone to fracture. Unless you’re at very high risk for breast cancer, trading lower risk of breast cancer for the risk of hip fracture would just not be helpful.

2. The information in the study wasn’t part of a clinical trial — it was drawn from the Women’s Health Initiative, which was never intended to study whether osteoporosis drugs affect breast cancer rates. “Observational” data like this is never as meaningful as data from a well-designed double-blind, randomized clinical trial because there is no way to make sure you’re comparing people and circumstances that are fundamentally alike. It’s as though you’re talking about “citrus fruit” without being able to say whether you’re looking at oranges, grapefruits, lemons, or limes!

3. Even if it’s true that these drugs have the happy side effect of limiting breast cancer it doesn’t change the fact that they also have many other unhappy side effects that make them very difficult, if not impossible, for women to tolerate. These side effects include serious digestive disorders and the increased risk of esophageal cancer.

4. The finding reported in the news consisted of “relative risk” data — that is, they compared the risk statistic of women on the drugs who got cancer to the risk of women not taking drugs who got cancer. This approach obscures the fact that in absolute terms, if you treated 100 women for 10 years with these drugs, you’d prevent only 1 incidence of breast cancer — and statistically speaking, that’s a lot of cost to women’s health, both physical AND financial, for a very small benefit!

5. Finally, as Dr. Mills pointed out, along with the decrease in invasive cancer that was so broadly discussed in the media was a less widely reported increase in the incidence of ductal carcinoma in situ (DCIS), a non-invasive, milder form of cancer that is nevertheless an important health concern for women.

All of these factors mean that this study’s findings really are very weak, so until someone undertakes a large, well-designed clinical trial that shows the same results, I think the hoopla is a bit premature.

I know there are better ways — natural ways — that women can both improve bone health and lower their risk of cancer of any kind (not just breast cancer) than using bisphosphonates. Here are four areas you can explore if you want to know more:

• Look into getting your Vitamin D status checked. Vitamin D plays a multitude of roles in our health, including helping us maintain strong bones and cancer prevention.

• Learn more about chronic inflammation, which has been implicated in a wide range of health problems — including some forms of cancer.

• Eat an alkaline diet rich in vegetables and fruits, which offer a range of cancer-fighting and –preventing antioxidants.

• Obtain all the 20 key bone building nutrients in adequate doses. All of these nutrients also help build and maintain immune strength.

 

References:

Bankhead C. SABCS: More evidence that bisphosphonates prevent breast cancer.Medpage Today, December 10, 2009.

Chlebowski RT, Chen Z, Cauley JA, et al. 2009. Oral bisphosphonate and breast cancer: Prospective results from the Women’s Health Initiative (WHI) (abstract). Paper presented at the San Antonio Breast Cancer Symposium, December 10, 2009, San Antonio, TX.

 

 

Bone density measurements were never meant to be treatment guidelines

For years we have known that bone density does not itself predict fracture, yet how many men and women have been told, and continue to be told, that they should take osteoporosis drugs based on their bone density? So I was delighted to hear noted osteoporosis researcher Dr. Steven Cummings declare that bone density testing was never intended to serve as a guide to treatment. He made this statement on September 11, 2009 at the annual meeting of the American Society of Bone Mineral Research in Denver.

As Dr. Cummings detailed, the T score definitions of osteoporosis (defined as -2.5 T or more) and osteopenia (defined as -1 T or more) were developed by World Health Organization Committee in the face of expanding bone mineral density testing. Researchers felt the need to define what was “normal” bone density, so they developed the “T scores” rating system distinguish how similar one’s bone density was to that of a young person of the same sex. These definitions were supposed to be guidelines for establishing normal ranges, not signals of a need for treatment with bone drugs.

Dr. Cummings went on to suggest, as I have suggested before, that treatment guidelines should be based on an individual evaluation of multiple risk factors as is offered in the WHO’s FRAX tool, or better yet, in a more comprehensive fracture risk assessment like the one available on this site.

He also reminded his colleagues that another valuable way to assess risk of future fracture is by detection of previous fractures. While you well know if you have had a hip or wrist fracture, you may not know if you have a deformity, or fracture, of a vertebral body in the spine. An important new tool for detection of vertebral fractures is the “Vertebral Fracture Assessment” also known as a “Vertebral Deformity Assessment.” These tests, using either a spinal x-ray or a special picture from the bone density test can reveal of you have “hidden” vertebral fractures. If no deformities are found, no treatment is needed, but if such hidden fractures are found, taking action to strengthen bone is necessary. Existing fracture is the ultimate proof of bone weakness, and having such a fracture puts you at higher risk for further fractures.

Here at the Center for Better Bones, we try to give clients a realistic understanding of their fracture risk so that they know whether they need to take steps to improve their bone health. And we have a complete program that we tailor to their individual needs to help them do exactly that, without resorting to expensive bone drugs with unpleasant and unhealthy side effects. You can learn more about our ideas regarding natural bone health by reading the articles on betterbones.com.

 

Reference:

Cumming, Steven, “Identifying People Who Should be Treated to Reduce Fractures”. Presented at the “Osteoporosis: Focus on Fracture Prevention” Symposium, ASBMR Annual Meeting, Denver, 9-11-09.

 

A chat with National Osteoporosis Foundation (NOF) folks

At the 2009 annual meeting of the American Society for Bone Mineral Research, I had the opportunity to chat with an NOF health educator and was pleased to hear that this powerful organization is coming the recognize the importance of acid-alkaline balance for bone health. As you know, our research suggests that pH balance and chronic, low-grade metabolic acidosis is a major cause of bone loss. Even though the NOF does not officially endorse the idea of metabolic acidosis as a preventable cause of bone loss, they strongly recommend increased intake of alkalizing vegetables and fruits and reduced use of acid-forming caffeine and alcohol. Also, if you are interested in simple, safe exercise suggestions for frail individuals, you might look into the NOF publication Boning Up on Osteoporosis. The booklet offers simple, safe exercises that are helpful for the frail in clear risk of fracture. You can purchase it for $6.50 from the NOF website’s store.

 

Forteo follow-up: Three reports of osteosarcoma using this drug

If you saw my earlier blog on the osteoporosis drug Forteo™, you will recall that the drug was found to cause a rare, serious bone cancer (osteosarcoma) in rodents, but drug proponents suggested such cancers would not occur in humans. But this week I found that there have already been three reported cases of this rare bone cancer developing in people on Forteo.

The most recent case was detailed in an abstract (# SU0345) presented at the annual meeting of the American Society for Bone Mineral Research in Denver, from which I just returned. This is the third case in the recent literature. The first case of osteosarcoma associated with Forteo use was published in the Journal of Bone Mineral Research in 2007 (JBMR vol. 22, p. 334), and a second case was published on-line in Osteoporosis International on the 14th of July, 2009.

These unfortunate findings really drew my attention, as I had been wondering just how long it would take to find that this drug could indeed cause bone cancer in humans, just as it did in animals. Hopefully the rate of such a serious adverse events will be smaller than it was in rodents. It just makes me want to reiterate my slogan “Better Bones, Better Body” — if at all possible, everything we do for bone should be good for our entire body. There is a better way to bone health than through using drugs with such dreadful potential side effects, and I am committed to helping you develop an effective and life-supporting approach to bone health.

 

One woman’s ordeal with osteoporosis medications: there’s a better way!

If you’re thinking about starting a medication for osteoporosis or are unhappy with your current drug regimen, there’s a story I want you to hear. A woman in her 50s with osteoporosis, Joan, recently came to my office looking for help with her bone health. Listening to her story is enough to send you scrambling for a natural, life-supporting approach to strong bones.

At age 48 Joan entered menopause, and three years later her nurse practitioner suggested a bone mineral density test (DEXA). From this DEXA she was diagnosed with osteopenia of both the spine and hip and told to take the osteoporosis nasal spray calcitonin (Miacalcin®). She diligently took this drug only to find at her next DEXA test 2 years later that the bone loss had worsened and was nearing the dreaded “osteoporosis” level.

Then 5 years into menopause her doctor stopped the nasal spray medication and began Fosamax®. This bisphosphonate drug caused serious reflux and the need for acid-blocking medications, which she still takes to this day (ironically, given that long-term use of acid-blocking medications significantly increases fracture risk). Joan then stopped the Fosamax and was put back on the Miacalcin, which had already proven useless for her. Her next bone density test 2 years later showed osteoporosis of the spine and significant worsening of hip bone loss. Now the doctor put her on another bisphosphonate drug, Boniva®, which she used for more than a year even though it gave her leg cramps and heel pain. The next bone density test showed continued bone loss on this second bisphosphonate.

Given the failure of these 3 osteoporosis drugs, Joan was then given the once-a-year IV injection of the bisphosphonate Reclast®. Shortly after receiving this injection she developed a serious and very scary case of iritis (inflammation of the eye iris — a known adverse effect of Reclast) necessitating the use of corticosteroid eye drops (and yes, corticosteroids also cause bone loss). After a year on Reclast® she was found to have continued hip density loss.

At this point, given her adverse reactions to Fosamax, Boniva and Reclast — and their limited usefulness — Joan’s doctor recommend she try the new osteoporosis drug Forteo®, and this was the point at which Joan lost her “compliant patient” status. She went home, studied the Forteo video the doctor had given her, did her own internet search, and decided she would “no way José” use Forteo given its long list of potential risks and side effects. At that point she contacted me at the Center for Better Bones looking for a better way.

The thing that impressed me most about Joan’s case is this: During the many years of failed drug treatment for osteoporosis, Joan never had a medical work-up to identify the causes of her bone loss. No one asked, “Why are you losing bone?” Everyone only asked, “What drug can we give you to halt bone loss?”

Fortunately, Joan has not yet experienced a fracture. But she has lost two teeth due to bone loss in the jaw, and her dentist says she is about to lose two more. Not until she was in my office did someone tell her that her tooth loss was related to her osteoporosis, nor that it could be prevented with the proper bone support.

The good news is, now that she’s starting her Better Bones program, Joan’s prognosis is good. We immediately identified several opportunities for her to reduce the bone-depleting factors in her life, and increased her nutritional support. Her tests showed a significant vitamin D deficiency, which she’s remedying with vitamin D3 supplements.

I’m confident that with proper testing we’ll identify the remaining causes of Joan’s bone loss and get her on the path to better bones. It’s a shame that she had to endure years of medications that did her more harm than good, but fortunately there’s a better way, and at last she’s found it!

 

Is Forteo™ a new bone wonder drug? Not really!

Forteo™ is promoted as a rising star on the osteoporosis scene, a bone drug that actually builds new bone, rather than just halting bone loss. By various mechanisms, Forteo “tricks” the body into building substantial new bone mass and short-term studies show Forteo actually reduces fracture more than other bone drugs. Sure, it is very expensive and has to be given by daily self-administered injections, but still, the large bone density increases and unprecedented reduction of both spinal and hip fractures are impressive.

While all this sounds great, when we look more carefully, we see Forteo has a variety of serious drawbacks and side effects. First, it is experimental and poorly tested. It also brings with it a series of potential adverse effects. These adverse effects include the development of bone cancer in animals, the potential to cause excessive new bone formation, high blood calcium, nausea, immunologic responses, leg cramps, hypotension, depression, and dizziness. For these reasons (not to mention its expense), I do not think Forteo is a worthwhile option for the treatment of osteoporosis in the majority of patients.

To read my full analysis of the Forteo drug, see my article Forteo™ – is this bone drug too good to be true?.