This week’s news involves some interesting insights into Big Pharma. In spite of recognizing that a pH imbalance caused by the wrong dietary choices leads to bone loss, the International Osteoporosis Foundation is still pushing toxic prescription drugs as the only way to manage osteoporosis.

Also, once again Big Pharma is selectively choosing data that falsely depicts their osteoporosis drugs as safe. But as pharmaceutical companies continue to develop highly profitable new osteoporosis drugs, they are starting to lose in court.

No doubt, it’s been an interesting week in osteoporosis news! So let’s get started…

The International Osteoporosis Foundation Admits That an Acid pH Causes Bone Loss, But Still Recommends Dangerous Osteoporosis Drugs

The latest report from the International Osteoporosis Foundation is full of scary statistics about the prevalence of osteoporosis worldwide. In fact, the IOF labels osteoporosis as a “growing public health problem”. What’s their proposed solution? Not surprisingly, more drugs. And while they briefly explain the damaging effects on bone density of diet-induced metabolic acidosis, they ignore it as a solution, and continue to unabashedly support Big Pharma by pushing osteoporosis drugs.

News Excerpt:

“Osteoporosis is the most common bone disease and is manifest in the form of fragility fractures, also referred to as low or minimal trauma fractures. … Worldwide, during the year 2000, there were an estimated 9 million new fragility fractures, of which 1.6 million were at the hip, 1.7 million at the wrist, 0.7 million at the humerus and 1.4 million symptomatic vertebral fractures18. Overall, 61% of fractures occurred in women, including 70% of hip fractures.

“…it is essential that preventive measures be taken at menopause to optimize bone health. This includes specific recommendations for calcium and vitamin D supplementation, other supplements, exercise, need for bone density measurements, fracture risk assessment, and potential need for pharmacologic intervention and follow-up. Good nutrition and an active lifestyle are essential to optimizing health in general, and musculoskeletal health in particular. They are the key foundations for osteoporosis prevention strategies in both genders…”¹

For the first time ever, the IOF fully supports the information in the Osteoporosis Reversal Program, as it briefly mentions the value of maintaining the pH balance to preserve bone density:

“The impact of acid-base balance on bone is a comparatively new area of research. Investigation of the effect of aging on blood acid-base composition suggests that reduced renal function in older people diminishes the kidney’s ability to excrete hydrogen ions in response to changes in blood pH. Accordingly, healthy adults manifest a low-grade diet-dependent metabolic acidosis which increases with age. Diet can contribute to acidosis when alkali-producing fruits and vegetables are consumed in insufficient amounts to balance the intake of acid-producing foods such as cereal grains and protein. The organic acids in fruits and vegetables are metabolized to alkaline bicarbonate; cereal grains contribute phytic and other acids and protein adds acid in proportion to its content of sulphur-containing amino acids (which are metabolized to sulphuric acid). An acidic environment has negative effects on preservation of bone in that it can impair bone forming cells.” ¹

When you’re reading the above paragraph you could think you’re reading a summary of Chapter 7 in the Osteoporosis Reversal Program. Of course, the predictable difference is that the IOF bypasses this valuable information and continues to recommend osteoporosis drugs as the ultimate solution to bone loss.

Fear Mongering Disguised as Information

The IOF further supports Big Pharma's agenda by describing osteoporosis as a “bone disease”. Fortunately, Savers are well aware that osteoporosis is not a disease. Osteoporosis is simply the body’s way of manifesting an imbalance in the system.

You see, our nutritional and lifestyle needs change as we age. The simple solution is, make the necessary changes to bring your body into balance. That’s exactly what the Osteoporosis Reversal Program is designed to do.

It’s interesting that the “preventative measures” are described as “essential” in the report, such as vitamin and mineral supplementation, exercise, and good nutrition. But the IOF’s report goes on to discuss, in detail, the World Health Organization’s (WHO) fracture risk tests and guidelines…and what to do if you fall into the “at risk for fractures” category: “Consider initiating pharmacologic treatment.”¹

This same advice is repeated over and over at the end of the report, as numbers are crunched and data is presented. Every segment ends or begins with the recommendation to “consider pharmacologic treatment” (in other words, drugs) if you score low on the WHO’s test.

Drug Companies Protect Their Products…and Profits

Tarsa Therapeutics, Inc. is boasting a meta-analysis attempting to prove that their drug, salmon calcitonin, does not increase the risk of cancer. And Amgen is proud to present various “selected” abstracts showing how Prolia (denosumab) increases bone density, while they prepare to release a new drug, Romosozumab.

News Excerpt:

“Tarsa Therapeutics Inc. announced that it presented a new meta-analysis showing that salmon calcitonin does not appear to be associated with an increased risk of cancer in postmenopausal women. The meta-analysis was conducted using data derived from approximately 11,000 women in 24 randomized, controlled calcitonin trials that included reporting of adverse events. The meta-analysis yielded an odds ratio close to unity with a narrow bound on the error of estimation, suggesting that calcitonin does not appear to be associated with an increased risk of cancer. 

The data were presented in a plenary poster session at the 2013 ASBMR Annual Meeting. Tarsa is developing an oral calcitonin tablet for the treatment and prevention of post-menopausal osteoporosis.” ²

Conveniently, Tarsa is ignoring all the data showing that salmon calcitonin does not even work. Instead, it has selected to focus mainly on the recently revealed cancer scare while ignoring other alarming side effects of salmon calcitonin (or calcitonin salmon – even the name vacillates). These side effects range from unpleasant (headaches, sinus pain, joint pain, and nasal crusts) to debilitating (bladder infections, swollen tongue, difficulty breathing, and muscle pain).

Although this “fishy” drug has been around since the 1970s, it was in March of 2013 that the FDA admitted its big mistake regarding calcitonin salmon. You see, the FDA approved this drug decades ago, but when the FDA panel met in 2013, they changed their minds and declared that the risks outweigh the benefits.

The fact is, there are no benefits to taking this drug! It was shown to be ineffective at increasing bone density, and the potential cancer risk as well as the side effects simply render this drug useless at best and harmful at worst.

Now On to the Latest Drug From Amgen…

The pharmaceutical giant has just presented some “abstracts of interest” (i.e., carefully selected data) on its drug Prolia (Denosumab) at the American Society for Bone and Mineral Research (ASBMR) annual conference. Amgen also announced a new drug, Romosozumab.

News Excerpt:

“Romosozumab data include results from the Phase 2 study that demonstrate significant increases in volumetric bone mineral density. Romosozumab is being developed in collaboration with UCB. Prolia data include 19 abstracts, featuring several on long-term safety and efficacy data from the open-label extension study of the pivotal Phase 3 fracture trial for up to eight years.

…

Romosozumab is a bone-forming agent that inhibits sclerostin. It is currently being studied for its potential to reduce fracture risk in an extensive global Phase 3 program. This program includes two pivotal studies evaluating romosozumab against both placebo and active comparator in more than 10,000 women with postmenopausal osteoporosis. Romosozumab is being developed in collaboration with UCB.”³

Amgen is talking out of both sides of its corporate mouth here. If Prolia is so “wonderful,” then why are they developing a new drug? If you’re a regular reader, you’ll know that Prolia is anything but wonderful.

Romosozumab apparently inhibits sclerostin, a protein with which Savers are familiar. Sclerostin is produced by cells in mature bone, and is essential in the bone remodeling process. Among other roles, sclerostin stops new bone formation when the body deems it necessary, such as when it’s time for old bone cells to be shed before new ones can be formed.

Ironically, drugs like Reclast act as sclerostin stimulators, thereby preventing the formation of new bone. This latest drug by Amgen does just the opposite by inhibiting sclerostin. To call it a “bone-forming agent” is simply wrong.

The delicate interplay between minerals, vitamins, hormones, proteins, antioxidants, and host of other substances simply cannot be replicated by the artificial stop-start effect of drugs. When it’s nourished with proper exercise and nutrients, your body does just fine stopping and starting bone formation on its own.

The bottom line is, no drug can do what your body does.

Novartis to Pay Over One Million Dollars to Zometa Lawsuit Winner

For the second time this year, a victim of osteoporosis drugs receives justice…but sadly, there’s no way to undo the damage the drugs have done. After 4 years on Zometa (the same drug as Reclast), Nancy Guenther lost her jaw bone.

News Excerpt:

“A Florida woman who took Zometa to prevent the risk of osteoporosis has won a $1.3 million jury award against drug maker Novartis for causing destruction of her jawbone.

Nancy Guenther was diagnosed with breast cancer in 1999. When her doctors discovered that the cancer had metastasized to her bones, they prescribed Zometa to reduce her risk of bone fractures. Guenther received 46 injections of the drug over four years between 2002 and 2006.
During that time, she claimed she developed a condition in which the jawbone dies, called biphosphonate-related osteonecrosis of the jaw.

…

Guenther had to have her jaw bone removed and replaced with a metal chain, according to her attorneys…

Jurors found that the drug company was negligent in failing to warn by not providing an adequate warning about the risks of Zometa.”⁴

My heart aches for this woman, who is only 61 years old. While the Florida jury awarded her $300,000 for medical bills and $1 million for “physical and emotional pain and anguish,” she is still facing life with a metal chain in place of her jaw bone.

Osteonecrosis of the jaw, or ONJ, is a once-rare disorder that has resurfaced with the widespread use of bisphosphonates. In fact, the above news excerpt notes that “bisphosphonate-related osteonecrosis of the jaw” is recognized as a specific form of this disease.

This is not the first lawsuit involving ONJ. Rhoda Scheinberg sued Merck, the makers of Fosamax, when a tooth extraction developed into ONJ after 6 years on the drug. Once again, the jury ruled that Merck did not provide adequate warning.

Let’s hope this trend of legal victories continues. How many tragedies, lawsuits, and “wins” on the part of victims will it take for Big Pharma to stop marketing these toxic drugs? Unfortunately, the wins don’t make a dent in Big Pharma’s huge profits. Perhaps, if there are enough lawsuits, the drug companies will actually “feel the pain” in their collective wallet. Sadly, that’s the only language they might understand.

The really good news is that there’s just no need to take the kind of risks that could land you in the Emergency Room or court room. As I pointed out above, if you give your body what it needs, your bones know just what to do to replenish themselves.

The Osteoporosis Reversal Program, with its comprehensive lifestyle, nutrition, and exercise guidelines, will show you how you can achieve strong, healthy bones without ever taking dangerous drugs.

I always like to end on a good note, and I’ve found…

The Perfect Halloween Video

This video features a Halloween light display set to the music of the classic holiday favorite Monster Mash. Enjoy the show and smile, because you won't get spooked by your electric bill this month (but the house owners probably will!)

Till next time,

References

¹ International Osteoporosis Foundation. “Bone Care for the PostMenopausal Woman.” 2013. PDF. https://share.iofbonehealth.org/WOD/2013/thematic-report/WOD13-Report.pdf
² “Tarsa Study Debunks Calcitonin, Cancer Link.” Drug Discovery & Development. October 7, 2013. Web. https://www.dddmag.com/news/2013/10/tarsa-study-debunks-calcitonin-cancer-link
³ “Amgen Presents Nearly Two Dozen Avstracts From Romosozumab And Prolia ® (Denosumab) At ASBMR.” The Wall Street Journal. October 4, 2013. Web. https://online.wsj.com/article/PR-CO-20131004-904851.html
⁴ Hsieh, Sylvia. “Jawbone Death from Osteoporosis Drug Costs Novartis $1.3M.” Lawyers.com. October 4, 2013. Web. https://blogs.lawyers.com/2013/10/novartis-pays-1m-for-bone-death/