The race for new osteoporosis treatments is on, as Big Pharma is desperately trying to find new patentable drugs. And, as further confirmation of the disastrous failure of current treatments, a popular osteoporosis drug touted as the “safest” of all is on its way out, as I predicted from the get-go.
So let’s get started!
Desperate Search for New Osteoporosis Drugs as Existing Drugs Fail
The Foundation for the National Institutes of Health has recently announced the launch of a 3-year study to look more closely at osteoporosis. The intent of the study is to develop “more effective treatments” for osteoporosis.
“The study, which utilizes data from existing academic and clinical trials, is designed to establish the validity of specific imaging and biochemical markers for bone health.
Approximately 9 million adults in the United States suffer from osteoporosis … with our aging population, the numbers continue to rise. Over the last twenty years, progress has been made in both the diagnosis and treatment of osteoporosis. Substantial challenges remain, however, including … efficacy of a given treatment beyond the duration of most clinical trials. Recent concerns have prompted regulatory agencies to review the safety of antiresorptive drugs for osteoporosis, while these same concerns among patients and physicians are decreasing the use of this particular class of drugs.
“ ‘There is an imperative need for continued development of new osteoporosis drugs and for determining rational clinical strategies for their use,’ says Dr. Janet Woodcock from the Food and Drug Administration (FDA). ‘We applaud the FNIH for spearheading this important work.’” 1
I find it fascinating that the Medical Establishment and the media continue to tout “progress” in treating osteoporosis, yet in the same breath they talk about how the number of osteoporosis cases continues to rise.
Think about this for a moment: if current treatments would be successful, there would be no need to develop new drugs… So in essence, the Medical Establishment is recognizing their failure.
Also when faced with concerns about the dangers of current osteoporosis drugs, the medical and pharmaceutical answer is to develop more drugs.
Here at Save Our Bones, we draw a different conclusion: concerns about osteoporosis drug safety should be taken seriously, and valid, effective, drug-free solutions like those described in the Program are the safest and best option.
Amgen’s “Positive” Romosozumab Study Shows a Clear Conflict of Interest
Amgen is announcing the results of a recent study that shows its new drug, romosozumab, increases bone mineral density (BMD) in postmenopausal women, especially when compared to Fosamax and Forteo.
“Romosozumab is an investigational medicine in phase III clinical development for the treatment of osteoporosis in postmenopausal women and is not currently approved by any regulatory authority. Romosozumab is being co-developed by Amgen and UCB.
In this phase II trial, each of the five romosozumab dose regimens significantly increased BMD compared with pooled placebo groups at the lumbar spine, total hip and femoral neck regions (all p<0.001). The largest increases were observed with the romosozumab 210 mg once-monthly dose, with mean increases compared with baseline of 11.3 per cent at the lumbar spine, 4.1 per cent at the total hip and 3.7 per cent at the femoral neck. Additionally, in exploratory analyses, BMD gains were significantly greater than active comparators at month 12, with romosozumab treatment achieving a mean increase of 11.3 per cent at the lumbar spine compared to increases of 4.1 per cent and 7.1 per cent at the same region achieved with FOSAMAX and FORTEO, respectively. At the total hip, romosozumab treatment increased BMD 4.1 per cent, while observed gains with FOSAMAX were 1.9 per cent and with FORTEO were 1.3 per cent (all <0.001).1.” 2
Interestingly, several of the study’s authors revealed financial ties to Amgen and UCB Pharma. In addition, the study itself was funded by these drug companies. So the researchers had a strong financial interest in presenting romosozumab in a positive light.
As Savers know, romosozumab’s mechanism of action is the suppression of a protein called sclerostin. Sclerostin’s role in bone remodeling is to regulate the formation of new bone; it temporarily stops the formation of new bone so old bone can be shed.
Like many osteoporosis drugs, romosozumab may indeed increase bone mineral density; but the problem is, this is achieved artificially by suppressing the body’s natural remodeling process. The bone then becomes hard and brittle, and more prone to breakage. Romosozumab is no exception to this bone-damaging rule.
The study also reported adverse side effects in the participants, including upper respiratory tract infections, back and joint pain, and headaches. “These reactions did not lead to study drug discontinuation or study withdrawal; the safety of romosozumab will be further addressed in subsequent larger studies,”2 the authors note.
In other words, the safety of this new drug has not even been tested yet…which leads us to our next news story about the vacillation between “safe” and “risky” labels on osteoporosis drugs.
Safety of Protelos Called into Question
The European agency PRAC (Pharmacovigilance Risk Assessment Committee), which is the equivalent of the FDA in the United States, has recommended stopping the use of Protelos (also marketed as Osseor, Bivalos, Ossum, Protos, Protaxos) for treating osteoporosis. This follows on PRAC’s recommendation to restrict the drug’s use back in April 2013.
“…the PRAC risk assessment committee of the European Medicines Agency (EMA) said the risks of serious heart problems, including heart attacks, blood clots and blocked arteries, were just too great.
For every 1,000 treated patients, there were four additional cases of serious heart problems and four of clotting among people using Protelos/Osseor compared to those given a placebo or dummy treatment.
Other risks include seizures and liver inflammation.” 3
According to PRAC, any “benefits” of Protelos are outweighed by the known risks. Of course, these risks were known long before by those on the Osteoporosis Reversal Program.
I warn of the dangers of Protelos in the Osteoporosis Reversal Program:
“Protelos has its own list of side effects. During clinical trials, the most common side effects were nausea, diarrhea, headaches and skin irritation. Other quite dangerous but fortunately less commonly reported side-effects were blood clots, fainting, memory troubles and, in rare cases, seizures.”
Protelos is composed of the mineral strontium combined with the synthetic chemical ranelate. It was initially considered a “safer” drug because of its basis in a natural mineral, but as mentioned earlier, it’s most certainly not so.
Strontium ranelate competes with calcium and is a bone thickener rather than a bone strengthener. In fact, as mentioned in the Osteoporosis Reversal Program, studies have confirmed that only the outer cortical bone becomes thicker, thus compromising tensile strength.
Instead, bones can be strengthened naturally via diet and exercise as described in the Osteoporosis Reversal Program. It just doesn’t make sense to risk the dangerous side-effects of osteoporosis drugs.
Till next time,
1 “Foundation for the NIH Launches Bone Quality Project.” PR Newswire. December 5, 2013. Web. http://www.prnewswire.com/news-releases/foundation-for-the-nih-launches-bone-quality-project-234586531.html
2 “Amgen, UCB announce phase II trial of romosozumab in postmenopausal women with low bone mineral density.” Pharmabiz.com. January 3, 2014. Web. http://www.pharmabiz.com/NewsDetails.aspx?aid=79605&sid=2
3 “Europe watchdog advises suspending ‘risky’ osteoporosis drug.” TheNews.com. January 11, 2014. Web. http://www.thenews.com.pk/article-133773-Europe-watchdog-advises-suspending-risky-osteoporosis-drug