Save Our Bones Bulletin: Bisphosphonate Boom In The UK, FDA Rejects Romosozumab, Soda Consumption Down In The U.S.
In this month’s Bulletin we bring you the latest updates on osteoporosis drugs in the UK and the US. The British National Institute for Care and Health Excellence (NICE) has recently expanded the bisphosphonate prescription guidelines, and as a result, these drugs will be prescribed more than ever.
In the United States, the FDA encountered data about the risks of the new osteoporosis drug Romosozumab, that forced it to reject Amgen’s application for approval. The problems go far deeper than the cardiovascular risks that accompany this chemical concoction, but that won’t stop pharmaceutical giant Amgen from continuing to try and force it through the approval process by other means.
We’ll wrap up with some good news on positive dietary habit changes among Americans. It seems that more and more people are taking the time to learn about their health, and the impact of nutrition. Let’s dig in!
UK Institute Recommends Prescribing More Bisphosphonates
The United Kingdom’s National Institute for Care and Health Excellence (NICE) issues guidelines and recommendations for certain medical technologies, practices and treatments after performing cost-benefit assessments. NICE has updated its guidelines on assessing the risk of fragility fracture, and what the risk threshold should be for prescribing bisphosphonates.1
Savers know that bisphosphonates actually cause more harm than good, and that evidence-backed data provides ample evidence that changes in diet, exercise and lifestyle are more effective at preventing fracture. However, the Medical Establishment has not caught up with the times, or prefers to prop up the pharmaceutical industry, and the UK is no exception.
NICE has recommended that oral bisphosphonates be prescribed if the patient is eligible for risk assessment and if the ten-year risk assessment for osteoporotic fracture is at least 1%. NICE considers a patient as eligible for risk assessment if she’s a woman aged 65 or older, or a man aged 75 or older.2
Younger patients can be considered eligible for assessment if they have the following risk factors:2
- previous fragility fracture
- current use or frequent recent use of oral or systemic glucocorticoids
- history of falls
- family history of hip fracture
- other causes of secondary osteoporosis
- low body mass index (BMI) (less than 18.5 kg/m2)
- alcohol intake of more than 14 units per week for women and more than 21 units per week for men.
The eligibility for assessment is so wide, that few older patients will avoid it. And once they are assessed, unless they have a less than 1% chance of fragility fracture over the next 10 years, NICE recommends considering bisphosphonates. This is absurd.
After a certain age, everyone has some risk of fracture due to the natural processes of aging. That doesn’t mean you have a disease, and it doesn’t warrant the prescription of a drug with dangerous side-effects. A 1% ten year risk threshold will result in a manyfold increase of prescriptions.
This clear attempt to get as many people as possible on these drugs is reprehensible and irresponsible. And it’s not just oral bisphosphonates.
“Drug recommendations in the technology appraisal will apply to both women and men for the first time. It also states that IV bisphosphonates should only be given without trying oral bisphosphonates first if the 10 year risk is 10% or greater.”1
If you’re wondering why an institute allegedly dedicated to setting guidelines for the good of the public health would make such an outrageous (and unprecedented proposal), there’s a familiar answer: money.
“Dr Sally Hope, a GP and a hospital clinical assistant in osteoporosis, said: ‘So what has really changed since the initial NICE guidelines is the generic cost of bisphosphonates. They are now very cheap drugs, so it is cost effective to treat lots more people to reduce fracture risk.’”1
Dr. Hope identifies the true culprit. Anyone with a basic understanding of economics can point out what’s happening here. Because the cost of these drugs has been greatly reduced, the only way for the companies making and selling them to make enormous profits is to sell more. The price may have been forced down, but if the volume goes way up, they’ll still come out ahead.
Regardless of NICE’s intentions in reducing the threshold, they have made a recommendation that serves Big Pharma at the expense of the patient’s health. That’s a true shame, especially when the most cost effective treatment for osteoporosis is also completely safe: leading a bone healthy life.
Whether it’s because the Medical Establishment is too set in its ways, or because they’re dedicated to funneling huge profits into the pockets of pharmaceutical company CEOs and stockholders, the result is the same: more people in the UK will walk out of a doctor’s office with an osteoporosis drug prescription.
The FDA Rejects Romosozumab
The FDA has historically done a poor job at protecting people from dangerous and sometimes deadly pharmaceutical products. Only the most obviously damaging drugs get rejected. Companies that jockey to get their products through the process year after year, subtly shifting the terms of their application to improve their odds, are not to be trusted.
One such situation is playing out currently with the long-in-development osteoporosis drug romosozumab by the pharmaceutical company Amgen.
Romosozumab is a new approach to the same mistake: trying to “fix” osteoporosis by chemically altering part of the bone building process, throwing it off balance in such a way that your body produces more new bone, or removes less old bone. This drug inhibits the production of sclerostin, which is a protein produced by osteocytes, cells that are found in mature bone, that’s essential in the bone remodeling process.
Romosozumab was submitted for approval, but one of the study results showed the drug increased patients’ risk of “cardiovascular adverse events.”4 The admission that this drug– meant to artificially ramp up bone formation — increased the risk heart disease is the reason for the FDA to reject their application.
It’s a shame that the romosozumab trial patient whose thigh bone suddenly shattered with no warning, or the two test subjects whose jawbones began to rot from the inside out (osteonecrosis of the jaw) were not reason enough to reject this drug.3 The FDA believes that because not many people experience those dire results, the benefits outweigh the costs. So instead, it’s the more common cardiovascular problems that it cited in rejecting romosozumab.
Unfortunately, that’s not the end of the story. Amgen is expecting a new set of trial data to be published soon, and by reapplying for approval under a different set of terms they may still be able to get the drug on the market.
“The FDA has rejected Amgen’s application for approval of osteoporosis candidate romosozumab. Officials knocked back the filing after phase 3 data linked the sclerostin-targeting antibody to an increased risk of cardiovascular adverse events…
…Having tested romosozumab in more than 13,000 patients and delivered a clean cardiovascular safety profile in the largest trial, Amgen potentially has the data to allay the FDA’s concerns. That gives it a shot at quickly resubmitting and winning approval in the next financial year. But the safety concerns could limit the label of romosozumab and in doing so dent its blockbuster ambitions.
‘Ultimately based on a label that fits the right risk/benefit population and based on conversations with Amgen, we still think the drug could be a $500M+ franchise,’ Jefferies analyst Michael Yee wrote in a note to investors.
The situation makes romosozumab part of an emerging clutch of Amgen drugs that have run into trouble—or look likely to do so—when trying to transition from promising clinical prospects to commercial successes.”4
The profit-driven world of Big Pharma is toxic, both quite literally to the health of its consumers, and figuratively to our health culture, creating a medical field that is more interested in “blockbuster drugs” and “commercial successes” than in helping people to stay healthy. Now more than ever, it’s important to do your own research, question the Medical Establishment, and seek health professionals who value natural solutions and holistic approaches.
Good News: American Soda Consumption At 31-Year Low
Let’s end today’s Bulletin on a high note. If the power and influence of multi-billion dollar corporations starts to feel like an insurmountable challenge, remember that even the smallest choices you make can have impact both on your personal health, and on wider trends. Apparently, many Americans are reclaiming the power of choice in the drink aisle by turning down soda in favor of healthier options.
Industry journal Beverage-Digest reports that soda consumption in the US has reached a 31-year low in 2016.5 In their place, low-calorie products like sparkling or flavored waters, bottled water, coffee and tea are on the rise.
“Bottled-water consumption in the United States reached 39.3 gallons per capita last year, while carbonated soft drinks slipped to 38.5 gallons, Beverage Marketing Corp said.
In contrast, per capita soda consumption regularly exceeded 50 gallons in the late 1990s and early 2000s, according to the report.
Total bottled water volume rose about 9 percent to 12.8 billion gallons in 2016, compared with a year earlier.
“When Perrier first entered the country in the 1970s, few would have predicted the heights to which bottled water would eventually climb,” said Michael Bellas, chairman and chief executive, Beverage Marketing Corp.”5
This is great news for the health of Americans. Soda is a killer, no two ways about it. Studies have shown it can cause gout,6 increase the odds of a heart attack by 20%,7 and increases the risk of Type 2 diabetes by 26%,8 problems related in part to the weight gain it causes.
The acid in colas is powerful enough to clean your car batteries, and melt your bones.
Thankfully, with the quickening spread of information in the digital age, more people are learning the truth about soda, and choosing to develop healthier life habits.
Any one such change might feel small, and unlikely to make a dent in a problem like osteoporosis, but it’s the collected mass of small changes that create a big shift. Yes, it requires more time and energy than resigning yourself to taking a drug, but the path to improved bone health layed out for you by the Save Our Bones Program offers real results that have been experienced by thousands of Savers.
Stop Worrying About Your Bone Loss
Join thousands of Savers from around the world who have reversed or prevented their bone loss naturally and scientifically with the Save Our Bones Program.
If you haven’t already started the process of building a lifestyle that centers the health of your bones (and whole being), then I have exciting news: reading this article was the start of your process, and you’re already on your way. Keep learning and keep making changes that allow you to build stronger bones, and a healthier, more vibrant life.
Till next time,
1Isobel Sims. “Many more eligible for bisphosphonates after NICE lowers threshold to 1%.” PULSE. 11 July 2017. Web: http://www.pulsetoday.co.uk/clinical/more-clinical-areas/musculoskeletal/nice-lowers-threshold-for-prescribing-bisphosphonates/20034787.article
2National Institue for Health and Care Excellence. Osteoporosis: assessing the risk of fragility fracture. Clinical guideline [CG146] Published date: August 2012, Last updated: February 2017. Web: https://www.nice.org.uk/guidance/cg146/chapter/1-Guidance
3Kolata, Gina. “Fearing Drugs’ Rare Side Effects, Millions Take Their Chances With Osteoporosis.” The New York Times. June 1, 2016. Web. http://www.nytimes.com/2016/06/02/health/osteoporosis-drugs-bones.html?_r=0
4Nick Paul Taylor. “Safety scare prompts FDA to reject Amgen’s romosozumab.” FierceBiotech. Jul 17, 2017. Web: http://www.fiercebiotech.com/biotech/safety-scare-prompts-fda-to-reject-amgen-s-romosozumab
5“Americans drank more bottled water than soda in 2016.” Reuters. 10 March 2017. Web: https://www.cnbc.com/2017/03/10/americans-drank-more-bottled-water-than-soda-in-2016.html
6Choi HK, Willett W, Curhan G. “Fructose-rich beverages and risk of gout in women.“ JAMA. 2010 Nov 24;304(20):2270-8. doi: 10.1001/jama.2010.1638. Epub 2010 Nov 10. Web: https://www.ncbi.nlm.nih.gov/pubmed/18244959
7de Koning L, Malik VS, Kellogg MD, Rimm EB, Willett WC, Hu FB. “Sweetened beverage consumption, incident coronary heart disease, and biomarkers of risk in men.” Circulation. 2012 Apr 10;125(14):1735-41, S1. Web: https://www.ncbi.nlm.nih.gov/pubmed/22412070
8Malik VS, Popkin BM, Bray GA, Després JP, Willett WC, Hu FB. “Sugar-sweetened beverages and risk of metabolic syndrome and type 2 diabetes: a meta-analysis.” Diabetes Care. 2010 Nov;33(11):2477-83. Web: https://www.ncbi.nlm.nih.gov/pubmed/20693348