One of my top priorities is to keep the Save Our Bones community up-to-date with the latest information. Not surprisingly, what I find often shocks me and sometimes amazes me. But one thing remains constant: I always dig deeper into the real meaning of the latest osteoporosis news and I’m always thrilled to share it with you.
This month has seen many interesting new developments in the osteoporosis arena. Recent research reveals an until-now unknown and peculiar pathway that builds bone.
You’ll also read about a recent and truly disturbing FDA drug approval. And we’re going to look (yet again!) at the triumph of Big Pharma over government regulators that may sadly claim many, many innocent lives…
Bone Growth Stimulator Discovered…Get Ready For New Osteoporosis Drugs!
A Washington University School of Medicine research team has delved more deeply into the mechanism of bone growth. Their findings are really interesting, pointing to the role of a certain protein in activating bone formation. Unfortunately, as usual, this breakthrough information will be most likely used to develop new osteoporosis drugs.
“Studying mice, Long (the lead study researcher) focused on a pathway involved in bone formation. The so-called WNT proteins carry messages into cells and regulate embryonic and adult tissue in mammals, including humans. The WNT proteins enter cells from the outside and then can activate multiple pathways inside those cells.
Long and his colleagues studied mice that made either normal levels or an extra amount of WNT proteins. They found that a particular WNT protein, WNT7B, is a potent stimulator of bone formation in mice. Mice engineered to make additional WNT7B manufactured new bone at much higher rates than normal mice.
The researchers also found that the protein created more bone by greatly increasing the number of bone-manufacturing cells in the mice. Our bones are in a constant state of flux as the number of bone-making (osteoblast) cells fluctuates, while the number of bone-degrading (osteoclast) cells also adjusts.
The WNT7B protein had no effect on the total activity of bone-degrading osteoclasts but substantially increased the number of bone-building osteoblast cells. And it did so by stimulating the mTOR pathway.
‘It’s still early, but our finding seems to point out that activating the mTOR pathway may be a good way to stimulate bone growth,” said Long, also a professor of medicine and of developmental biology.” 1
This sounds exciting at first – what’s wrong with stimulating the body’s natural bone-building process using its own protein? There’s actually quite a bit wrong with it. I'll explain.
Stimulating the mTOR pathway had no effect on osteoclasts, the cells that break down bone. As Savers know, losing bone is as important as building new bone in the remodeling cycle, since that is how bone cells renew themselves. This is the first red flag.
The second warning has to do with how medications are patented. While the protein referred to (WNT7B) is “natural,” it will have to have a synthetic chemical added to it to make it a patentable drug. Drug companies know they can’t patent a natural substance.
You see, the Osteoporosis Reversal Program advocates working with the body’s natural bone-building process, but it’s not through artificial stimulation that emphasizes only one aspect of the bone remodeling cycle. Your body knows how to build bone; it doesn’t need to be “told” how with dangerous drugs. The key is giving it the nutrients and terrain it needs to do what it’s designed to do: build strong and healthy bones.
FDA Approves Drug So Dangerously Addictive That Drug Addiction Specialists Are Up In Arms!
This is a very disturbing piece of news.
Today’s “conventional wisdom” supports the concept that the FDA’s approval of a drug is a “safety badge.” In other words, if the FDA approved a prescription drug, it must be safe, right? Wrong.
For one thing, there’s no such thing as a 100% safe drug. More importantly, the FDA’s approval of a particular drug seems to not be related to “safety”… Unfortunately, as you’ll read, there’s more involved in the drug approval process than meets the eye…
“A coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.
The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.
‘In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,’ the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.
‘It's a whopping dose of hydrocodone packed in an easy-to-crush capsule,’ said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. ‘It will kill people as soon as it's released.’” 2
And take a look at this ironic twist, clearly showing how the “concerns” voiced by the FDA are just shallow rhetoric:
“Bigger, stronger opioids — especially those containing hydrocodone — are a concern. Hydrocodone (Zohydro's sole ingredient) is one of the most frequently prescribed — and abused — opioids.
For that reason, in October, the FDA said it intended to shift hydrocodone-containing drugs from Schedulle III to Schedule II. That rescheduling (still pending approval by the Drug Enforcement Administration) would mean much stricter dispensing and prescribing rules for hydrocodone-containing products.
At the time of that recommendation, the FDA posted a statement on its website that it “… has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”
A day after announcing the proposed drug schedule change for hydrocodone, the FDA announced Zohydro's approval. It was a confusing juxtaposition, some say.
“Shocking, outrageous and genuinely frightening,” said Kolodny of the Physicians for Responsible Opioid Prescribing.”” 2
Also, prosecutors from 28 different states are mobilizing to get this approval revoked.
“The letter from 28 states attorneys general asks the FDA to revoke the drug's approval or require manufacturer Zogenix to quickly reformulate the drug so it is more difficult to abuse.” 3
It makes no difference how the drug is “reformulated”; the message is clear: FDA approval means nothing. The same approval process occurs with osteoporosis drugs, and this just goes to show that you can never trust the FDA’s assurances.
European Drug Regulators Surrender to Big Pharma: Protelos Can Be Prescribed, But With A “Warning”
Back in April 2013, the European Medicines Agency (EMA) recommended that the use of Protelos and Osseor (strontium ranelate) be restricted to reduce the risk of heart problems. And the Pharmacovigilance Risk Assessment Committee (PRAC) actually recommended that these drugs no longer be used to treat osteoporosis.
During the months following April 2013, PRAC conducted an in-depth review of the study data that suggested heart problems could be connected to Protelos. After looking closely at the “benefits” and risks of these drugs, they drew the conclusion that the risks are simply too great to balance any benefits.
“The PRAC has now conducted an in-depth review on the benefits and risk of the medicine. It was noted that for every 1,000 patient-years there were 4 more cases of serious heart problems (including heart attacks) and 4 more cases of blood clots or blockages of blood vessels with Protelos and Osseor than with placebo. In addition, Protelos and Osseor are associated with a number of other risks, such as serious skin reactions, disturbances in consciousness, seizures, hepatitis (liver inflammation) and reduced number of blood cells.
With regard to its benefits, Protelos and Osseor have been shown to have a modest effect in osteoporosis, preventing about 5 non-spinal fractures, 15 new spinal fractures and 0,4 hip fractures for every 1,000 patient-years.
The PRAC weighed the benefits of the medicinal products against the known risks and concluded that the balance was no longer favourable and recommended Protelos and Osseor be suspended…” 4
However, the Regulatory Agency has refused to follow the Committee’s advice, in essence caving in to Big Pharma…
“Medicines and Healthcare products Regulatory Agency (MHRA) says it will be issuing updated advice to healthcare professionals that Protelos, used to treat severe osteoporosis in post-menopausal women and men with a high risk of fracture, should only be prescribed to patients who do not have a history of heart problems and if the patient is unable to take other medicines for this condition.
The EMA will be updating the patient information leaflet for Protelos to reflect the prescribing guidelines and small risk of heart problems and blood clots.” 5
Because osteoporosis is not a disease, there’s no need to take any osteoporosis drug. In fact, in the Osteoporosis Reversal Program, I point out that no osteoporosis drug is worth the risk of dangerous side effects, and issue my own warning urging everyone to suspend the use of all osteoporosis drugs.
Till next time,
1 Dryden, Jim. “Discovery may lead to new drugs for osteoporosis.” January 30, 2014. Washington University in St. Louis Newsroom. Web. http://news.wustl.edu/news/Pages/26429.aspx
2 Smith, Stephanie. “New pain pill’s approval: ‘Genuinely frightening.’” February 26, 2014. CNNHealth. Web. http://www.cnn.com/2014/02/26/health/zohydro-approval/index.html?hpt=hp_t2
3 “28 states ask FDA to rethink approval of new painkiller drug Zohydro.” December 12, 2013. NY Daily News. Web. http://www.nydailynews.com/life-style/health/28-states-fda-rethink-approval-new-painkiller-article-1.1545864
4 “PRAC recommends suspending use of Protelos and Osseor (strontium ranelate).” January 13, 2014. HALMED: Agency for Medicinal Products and Medical Devices of Croatia. Web. http://www.almp.hr/?ln=en&w=novosti&d=2014&id=998&p=1
5 Gould, Mark. “Osteoporosis Drug Warning.” February 24, 2014. OnMedica. Web. http://www.onmedica.com/NewsArticle.aspx?id=5e4669e2-3caa-410b-be01-2b2c0c197406