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Bone drugs side effects
Dr. Susan E. Brown

New warning reminds us bone drugs aren’t “magic pills”

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It’s no secret that I encourage each of you to look for life-supporting ways to enhance bone health — using bone drugs only when absolutely necessary. Bone drugs are not the broad solution that advertisements claim and I believe our bodies are capable of building and maintaining adequate bone strength without them. This is a key point of my Better Bones Manifesto which also holds that these medications disrupt the fabric of life and may lead to unwanted and even dangerous side effects.

These truths were recently reaffirmed when a physician friend forwarded a new safety warning sent to doctors by Genentech, USA, the manufacturer of Boniva, a popular bisphosphonate bone drug.

Labeled “IMPORTANT DRUG WARNING” in a large red box, doctors are advised that there have been “…cases of anaphylaxis, including fatal events” as a result of an immediate allergic reaction to the Boniva injection. Doctors are told that, when giving the Boniva injection, they should “…have available appropriate medical support and monitoring measures.” The warning goes on to note that while reactions are rare, physicians should be prepared.

Considering all side effects

While this particular warning concerns a rare case event, it underscores that bone drugs — given as an injection or in pill form — are certainly not wonder drugs. For example, as part of its communication to doctors, Genentech reminds doctors about other adverse reactions, which include atypical femur fractures, osteonecrosis of the jaw (ONJ), abdominal pain, hypertension, dyspepsia, arthralgia, nausea and diarrhea. Quite a list!

From a patient point of view, I believe that women with a history of severe allergy might do well to take note of the Boniva warning and discuss this matter with their physician. In regards to ANY medications, I strongly encourage you to be aware of their potential side effects and discuss them with your physician. Often — especially in the case of bone health — you have natural, life-supporting options. I am committed to helping you find them!

 

 

Bone drug benefits
Dr. Susan E. Brown

How big is the bang from osteoporosis drugs?

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Answering the question “how big is the bang from osteoporosis drugs?” can be quite challenging.

One reason is that the statistical calculations are complex and highly manipulated making them difficult to understand. Another is that the subjects included in the drug studies are generally highly-selected and may not represent “real-world” populations.

Separating hype from reality

Recently scientists took an important step to help us separate hype from reality in regard to the benefits of bone drugs.

Researchers asked if “real-world” patients taking bone drugs received the same fracture-reduction benefits seen in the clinical trials. After analysis of hundreds of studies, they found that highly compliant, “real world” patients on osteoporosis drugs experienced a 21% reduction in all clinical fractures. This compares to the 24% overall clinical fracture reduction experienced by subjects in osteoporosis drug clinical trials.

What a different messages than we often hear — such as how bone drugs reduce your chance of fracture by 50%! Or have you ever been told that the fracture reduction on bone drugs is really more like 21-24%? That is — if you use the drug faithfully.

Now compare this

Now compare this 21-24% fracture-reduction benefit from bone drugs to the studies documenting that those taking vitamin D in any dose (much less a therapeutic dose) experience a 23-26% reduction in fractures. It seems to me that the bang from osteoporosis drugs isn’t quite as big as we’ve been led to believe.

As your bone health advocate, I congratulate these researchers on the enormous effort to analyze and synthesize data from hundreds of studies. I also congratulate the drug company which funded this study for clarifying the real fracture/reduction benefit of today’s bone drugs.

 

References:

Wilkes, et al. 2010. “Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice versus randomized controlled trials.” Osteoporosis International 21:679-688

Bischoff-Ferrari, HA et al. 2005. Fracture prevention with vitamin D supplementation: A meta-analysis of randomized controlled trials. JAMA, 293(18): 2257-2264

 

 

Bone drug response and vitamin D levels
Dr. Susan E. Brown

A common-sense finding: vitamin D levels predict response to bone drugs

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Over the last few weeks, two of my golfing buddies incidentally mentioned to me that their doctors took them off their bisphosphonate bone drugs because the drugs were not helping stabilize bone. No surprise there — if the drugs weren’t working, of course their doctors were right to stop the treatment.

The interesting part was that right after going off the drugs, both of my friends had gained bone density.

What changes did you make?

Of course, my first question to both women was, “What changes did you make that could have helped you to build bone?” As I probably should have expected, both women reported that after being taken off the drugs, each of them had had their vitamin D levels tested for the very first time. Both women were found to be vitamin D deficient and had begun taking supplemental vitamin D on a regular basis… and that’s most likely the reason they built new bone.

It seems to defy common sense that vitamin D testing should come several years aftertreatment with bone drugs, but unfortunately my friends’ experience is typical. And it has a profound impact on how well the drugs work. New research by Carmel et al., released at the 2011 annual ASBMR meeting, reported that “[w]omen whose mean level of serum 25 hydroxy vitamin D (25[OH]D) was at least 33 ng/mL were almost five times more likely to benefit from bisphosphonates than those whose levels fell below that cutoff.” In other words, a sub-adequate level of vitamin D, defined as any level below 33 ng/mL, was directly correlated with failure of the drugs to provide a benefit.

Now, many doctors still consider vitamin D readings in the high 20s or low 30s to be adequate. Even more troubling, recent Institute of Medicine findings declared vitamin D levels of 20 ng/mL or greater to be adequate. But this research shows that at such low levels, bone has little or no ability to renew itself — even in the presence of powerful drugs that put a halt to osteoclast activity.

We all need adequate vitamin D

Ultimately, this study shows that everyone — even those on bone drugs! — needs truly adequate vitamin D — that is, a level greater than 33 ng/mL — in order to absorb calcium and protect bone. It’s frustrating to realize just how long it has taken medical science to recognize this basic fact. Indeed, I would take this further and state that everyone also needs the full complement of all 20 key bone nutrients.

How long it will take researchers to finally grasp the idea that our skeleton needs a full array of nutrients, just as does the entire body?

 

 

References:

Carmel, A., et al. 2011. The 25(OH)D level associated with a favorable response is >33 ng/mL. ASBMR Abstract 1137. Institute of Medicine (IOM) Dietary Reference Intakes for Calcium and Vitamin D. November 20, 2010.

Better Bones Blog
Dr. Susan E. Brown

FDA looking into bisphosphonate safety? Well it’s about time!

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As I was heading to Maine for the weekend last Friday, two advisory panels of the Food and Drug Administration (FDA) were looking at whether or not it’s safe to take bisphosphonates (such as Fosamax) for more than five years.

Just a mere 15 years after the drugs became common.

If you sense more than a little frustration in the statement above, you are right.  Here’s why:

• While I obviously believe it is important for the FDA to tell consumers about the very real dangers of these drugs, I have to ask what took them so long — so long that there are many women who have been taking a drug for more than 10 years without any study of the safety or the risk! In fact, one drug manufacturer is facing more than 1,500 lawsuits regarding jaw damage or unusual femur fractures and other bone injuries.

• What’s more, there’s a lot of confusion around the effectiveness of these drugs. Research data reported by bone specialists such as Dr. Susan M. Ott has shown the benefits of bisphosphonate drugs are far less than people have been told. Gillian Sanson, in her wonderful book The Myth of Osteoporosis, spells out all of the statistics that show how ineffective these drugs really are, but I want to quote her on just one: “If a woman has low bone density (osteopenia), but no previous fractures, her risk for fracture is low. Any treatment is at best going to marginally reduce an already low risk.It is estimated that up to 270 such women would need to be treated for three years to prevent one vertebral fracture in one of them.” (Sanson, 2011, p. 81-2).

• I also have to wonder where we’re going with this.  Does this mean that we’re going to wake the “sleeping monster” of even stronger drugs such as Prolia? Meaning — will doctors and the pharmaceutical industry cast it as a “new, safer drug” and just switch people to a new drug?

Now, there’s also very good news about the FDA investigation.  In particular, I want to celebrate:

• The news is getting out to more people than ever that bone drugs can cause serious side effects and weaken bone. This story is being reported in depth by ABC News, The New York Times, and other major news outlets.  The ABC News coverage, in particular, features stories of real women who have suffered serious consequences — including one who experienced a traumatic leg fracture after simply stepping off a curb.

• I believe the news is going to help women to become more empowered to return to a bone health strategy that makes sense — such as that of the Surgeon General’s “pyramid approach.” This approach says working with nature is the best way to promote bone health, followed by assessing and treating underlying causes affecting bone health. The last option recommended is the use of bone drugs.

I was hoping I would come back from my travels to put up a post that said that the FDA had see the light and was going to recommend limiting the length of time that any individual could take these drugs. But contrary to expectations, they didn’t do so — even though FDA’s own staffers, in a report issued Wednesday, stated that there appeared to be no benefit to continuing the use of bisphosphonates for more than five years.

It’s a shame the FDA finds itself unable to act in the best interests of both doctors and patients alike. What I had hoped was that the FDA would set this limit and help everyone give more serious thought to using bisphosphonates the way they should be used — as a temporary measure in cases of rapid and severe bone loss — and look to natural alternatives for healthy bone as a long-term solution for osteoporosis.

Of course, at the Center for Better Bones, we’ve been talking about the dangers of bone drugs and the better alternatives for years.  You can read more of my thoughts in my article What do I really think of bone drugs, anyway?

 

References:

Sanson, G. 2011. The Myth of Osteoporosis. Santa Barbara, CA: MCD Century Publications, LLC.

Wilson, D. 2011. F.D.A. to review safety of popular bone drugs. The New York Times, September 5, 2011.

Wilson, D. 2011. Stronger cautions backed on bone drugs for women. The New York Times, September 9, 2011.

CDER. 2011. Background Document for Meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. [Downloadable PDF] (Accessed 09.09.2011)

Better Bones Blog
Dr. Susan E. Brown

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

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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.

 

 

Better Bones Blog
Dr. Susan E. Brown

Strange fractures with bisphosphonates

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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.

 

 

Better Bones Blog
Dr. Susan E. Brown

ABC News report: Fosamax can cause needless fractures

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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.

 

Cancer and fosamax
Dr. Susan E. Brown

Fosamax and breast cancer

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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.

 

 

Better Bones Blog
Dr. Susan E. Brown

A chat with National Osteoporosis Foundation (NOF) folks

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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.

 

Better Bones Blog
Dr. Susan E. Brown

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

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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.