Today's Bulletin provides valuable information and breaking news about Big Pharma and the harmful side effects of the drugs they produce.
We'll look at a German study that examined the efficacy of new drugs prescribed by doctors. Unsurprisingly, the results were grim. Then we'll turn to a Canadian study that supports what we already know about the class of common painkillers called NSAIDS: they're bad for your heart. This new information confirms the immediacy of that danger.
Then some positive news- at least for Europe. The European equivalent of the FDA has rejected Amgen's osteoporosis drug Evenity. The FDA has recently approved the drug in the United States- a big red flag that further undermines faith in this regulatory body.
New Drugs Fail To Add Health Benefits
As more and more drugs enter marketplaces around the world, developed and pushed by international pharmaceutical companies, one important question is too rarely examined: are these drugs making anyone healthier?
The German Institute for Quality and Efficiency in Health Care set out to find the answer to that question through a scientific study on the efficacy of new drugs. The result was none too surprising: most drugs don’t provide any health benefits.
Relevant Excerpt:
“According to the study… more than half of the new drugs entering the German healthcare system show absolutely no added benefit.
Between 2011 and 2017, researchers examined 216 drugs that passed regulatory approval and entered the German market. Most of these assessed drugs were also approved by the European Medicines Agency for widespread use throughout greater Europe.
Alarmingly, only a quarter of those drugs showed any significant medical added benefit based on the available evidence. What’s more, 16% showed even a minor added benefit, and a whopping 58% of studied drugs did not show any added benefit over standard patient care.”1
The authors of the study recommended a far more strict drug approval process, and changes to the health care system that will only reward safe and effective drugs- instead of allowing Big Pharma companies to attain dizzying profits off of drugs that are at best having no benefit, and at worst causing serious harm.
Synopsis
A German study found that new drugs entering the market are by and large failing to provide health benefits above those provided by standard patient care. Only a small percentage of drugs showed health benefits.
Over The Counter Painkillers Significantly Increase Heart Attack Risk
A study at McGill University in Canada examined the safety of common painkillers like ibuprofen (Advil), naproxen (Aleve), and other non-steroidal anti-inflammatory drugs (NSAIDs).
The researchers examined the risk of a heart attack while using NSAIDs, and found that taking any dose of NSAIDs for one week, one month or more than a month increased heart attack risk by an incredible 20 to 50 percent.
Relevant Excerpt
“Researchers at McGill University in Canada say that the risk of heart attack while using these painkillers increased with dosage size and was at its highest in the first month of ongoing use.
The research team analyzed several healthcare databases in Canada, Finland, and the United Kingdom, recording results on more than 446,000 people. Of that sample, 61,460 suffered a heart attack.
Previous research found that certain NSAIDs contributed to higher incidents of myocardial infarction (heart attack), but the timing of the risk, the effects of dose level, and treatment duration were not well understood.
Overall, the risk of heart attack increased in patients by between 20 and 50 percent if using NSAIDs versus not using any kind of pain medication.”2
In addition to this and other known risks, it’s relevant to mention here that NSAIDs, like all drugs, are acidifying and therefore damage your bones.
Synopsis
Researchers at McGill University have discovered that taking NSAIDs increases the risk of a heart attack after just one week of use.
European Regulatory Body Rejects Osteoporosis Drug Approved By FDA
Evenity (romosozumab) is an osteoporosis drug developed by pharmaceutical giant Amgen, the manufacturers of another osteoporosis drug, Prolia (denosumab). After the FDA initially rejected the drug in 2017, Eventiy was later approved for use to treat a more narrowly defined high fracture risk population in 2018.
The most glaring danger of romosozumab, and the one that gave the FDA pause, albeit momentary, is the risk of cardiovascular events. These risks, which include stroke, heart attack, and death, lead the European equivalent of the FDA, the Committee for Medicinal Products for Human Use (CHMP), to reject the drug.
Relevant Excerpt
“The marketing authorisation application (MAA) of the drug was based on the findings of a large development programme, which included three phase 3 studies among others, which featured close to 12,000 patients.
CHMP said that its negative opinion was due to results suggesting that patients subjected to the drug had an increased risk of serious effects on the heart or circulatory system, including heart attacks or strokes.
Apart from that, CHMP said that when all the findings of the drug’s clinical development were looked at together, there were more deaths in patients aged more than 75 years who were subjected to the medicine.”3
Romosozumab blocks sclerostin, a protein that inhibits and mediates new bone formation. Over the course of 12 monthly injections, this action results in increased bone mass, but after 12 months it ceases to be effective.
The drug requires a follow-up prescription for a bisphosphonate that will stifle the body's bone remodeling process and preserve the new bone mass. As Savers know, bisphosphonates cause harm to the quality and health of bones by interrupting the body's natural process of building new bone and removing old and weak bone.
These drugs are not safe, and they're not effective.
Synopsis
The CHMP (the European equivalent of the FDA) has rejected Amgen's injectable osteoporosis drug Evenity (romosozumab) because it causes stroke, heart attack, and death in a significant percentage of patients.
Reject Osteoporosis Drugs And Reverse Osteoporosis
Thank goodness there are natural and safe, scientifically proven ways to reverse osteoporosis without relying on the ineffective and dangerous drugs produced by the pharmaceutical industry.
As explained in the Osteoporosis Reversal Program, the right diet and regular targeted exercise, combined with simple lifestyle changes, form a multi-pronged approach to building stronger bones and reducing the risk of fracture.
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 Osteoporosis Reversal Program.
References
2 https://www.studyfinds.org/common-painkillers-heart-attack-ibuprofen/
3 https://www.pharmaceutical-business-review.com/news/chmp-evenity-negative-opinion/
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Save Our Bones Bulletin: Skeletal Stem Cells Control Effects of Aging; Pain Reprocessing Therapy Offers Alternative To Painkillers; New Dangers Of Aspartame UncoveredComments on this article are closed.
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I am an active female who has always done physical activities and healthy eating habits. I am ready to try a product Xyogen has thru clinical studies shown to stop bone density loss. It’s a propriety blend.
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Theresa, can you tell us what the proprietary blend is? I’m doing the exercises but could use some extra help.
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I am confused about the reference to “standard patient care;” specifically, that these new drugs offered no new “added benefit” over “standard patient care.” Does this translate to: “the new drugs are no better than whatever the doctor prescribed earlier?” Or, does “standard patient care” refer to non-drug advice? The wording of the whole article is, to me, confusing. I can’t tell if you are saying “study finds that no drugs are found to be effective,” or “new drugs offer no added benefit over existing ones.”
can you clarify which it is?
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The researchers explain that the drugs they tested don’t improve the health of patients. They conclude the following:
“Combined action at EU and national levels is required to define public health goals and to revise the legal and regulatory framework, including introducing new drug development models, to meet these goals and focus on what should be the main priority in healthcare: the needs of patients.”
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Thank you, Ita.
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You’re welcome!
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Vivian, I love hearing from your program weekly. I have had bone-on-bone for 12 years now and I still try to be active. When the pain gets so I don’t want to get up, I do take an Alleve to get through the day. I keep track and I never have taken more than 12 through the month so it isn’t every day. I am active doing volunteer work & go to gym (not on a regular basis) but I do not want to go through a knee replacement at my age. I am 86 today. Lou Stallard
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Thanks for sharing your story, Lou. You’ll be glad to know that there are natural ways to reduce pain, so you won’t need to take Alleve.
You can read about this topic here:
https://saveourbones.com/fight-pain-naturally-and-increase-opioids-with-these-13-scientifically-backed-tips/https://saveourbones.com/3-natural-ways-to-get-rid-of-chronic-pain/
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I also am taking an aromatase inhibitor for breat cancer and have been warned of its affect on my bones. I’m 1.7 years from completing treatment and decay scans befor and after beginning the letrozole indicate a slight increase in density. I refuse all drugs for my bones and have followed as well as I could your plan but have been hampered by the fatigue of treatment and drug. Perhaps my stamina will get better over time for me to do more of your plan. Regardless, I will stop the AI should my bones deteriorate from it. For me it’s a matter of quality of life and not the few percentage points I MIGHT get from taking the AI. You have a great plan and web site. I especially appreciate the valid citations of your work.
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I recently had breast cancer surgery and am now on a hormone blocking pill to prevent recurrence. It is Aridimex which has the potential to weaken bones. Has anyone had experience with it and still maintained strong, healthy bones?
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That’s an excellent question, Karyl. Since Arimidex is an aromatase inhibitor it decreases circulating estrogen in the blood, which in turn accelerates bone loss. So to prevent and/or mitigate that, it is really essential that you balance your serum pH and exercise on a regular basis. Stay well and healthy!
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Hi Vivian,
I am 64 and dexa indicates -4.8 for L1-L4 T score. Of course the Gyno and Endocrinologist strongly want me to take Forteo . I refuse to take a black box drug or any poisonous osteoporosis drug. I workout at the gym three times per week and started your program. I was told by gynecologist that if I fractured a bone that I would be dead in six months. So unprofessional to predict such a thing. Also, I have read that women with osteoporosis-2.5 or more has only fifteen years left to live. What is all this doom and gloom predictions all about??
I do take magnesium, calcium , d3 and ostinol. I eat mostly an alkaline diet and do not smoke or drink.
Do you have any suggestions ? Thanks for your newsletters and voice.