This month's Bulletin covers two major developments related to the pharmaceutical industry. One story is about the ongoing litigation over the horrific effects that the osteoporosis drug Fosamax has had on some consumers.
The second story marks the first inklings of a new drug in development. Sadly, odds are that this groundbreaking research will be used by Big Pharma to develop new osteoporosis drugs.
And lastly, we'll look at a study that cross-examined the dietary habits of people around the world to uncover a deadly pandemic.
Supreme Court Blocks Suit Against Merck
The Supreme Court has blocked a large multi-party lawsuit against pharmaceutical giant Merck. The lawsuit intended to hold Merck accountable for the atypical femoral fractures caused by their osteoporosis drug Fosamax.
More than 500 Fosamax users from 45 states contend the company failed to warn them or their doctors of the danger, despite early evidence suggesting the increased potential for spontaneous bone breaks without any previous stress.
Merck, which does not dispute the risk and has included a warning with prescriptions since 2010, argued it cannot be held liable for damages in state courts because the Food and Drug Administration in 2009 rejected a proposed warning to patients.
“When the FDA exercises this authority, it makes careful judgments about what warnings should appear on a drug's label for the safety of consumers,” Justice Stephen Breyer wrote in the court's opinion.
“For that reason, we have previously held that ‘clear evidence' that the FDA would not have approved a change to the drug's label preempts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug,” he wrote.
The case was returned to a lower court for further proceedings.1
The judge ruled that because the FDA analyzed the data and decided no warning was necessary, Merck shouldn't be held legally responsible, even though they knew the drug would cause atypical fractures. The plaintiffs cannot sue the FDA directly because it is shielded by the federal government.
The judge didn't dispute the fact that the drug poses a significant risk, nor that it caused the fractures. All parties are in agreement that important risk information was denied to the people who suffered atypical fractures.
Bisphosphonates like Fosamax (alendronate) tamper with the bone remodeling process. Fosamax increases bone mass by preventing osteoclasts (specialized cells that make room for new bone) from removing old, damaged bone. The micro-fractures that develop in old bone under pressure of new bone can lead to atypical femur fractures.
The Supreme Court's decision to protect the corporate interests of Merck over the lives and well-being of American citizens further emphasizes the importance of reversing osteoporosis without Big Pharma's drugs. Not only do the pharmaceutical companies themselves have a history of deceiving consumers to sell their dangerous and ineffective drugs, but it seems that the federal government is willing to protect them through the FDA and the judicial system.
The Supreme Court has ruled that Fosamax users cannot sue Merck for failing to inform consumers that Fosamax causes atypical fractures. The judges decided that Merck is not legally responsible for withholding information about the fracture risk because the FDA knew about the risk and didn't require them to label the drug with a warning.
Japanese Scientists Uncover Gene That Activates Bone Formation
Scientists at Kumamoto University in Japan have discovered that the gene SIRT7 is important for bone formation. The researchers found that the expression of this gene decreases with age, contributing to the bone loss that typically accompanies aging.
Through experimentation on laboratory-cultured osteoblasts, the researchers found that SIRT7 activates osteoblasts via a protein called SP7/Osterix.
Recent experiments performed by a research group led by scientists from Kumamoto University, Japan showed that mice lacking the SIRT7 gene had reduced bone mass. A bone morphometry analysis showed that bone formation and the number of osteoblasts (bone-building cells) had been reduced. Furthermore, the researchers obtained similar results using osteoblast-specific SIRT7 deficient mice, thereby showing that (osteoblast-specific) SIRT7 is important for bone formation.
Reduced bone formation is common in people with osteoporosis, and the mechanism for this reduction is not well known. To clarify the mechanism, the researchers compared sirtuin (SIRT1, 6, and 7) expression in the skeletal tissue of young and old mice, and found that SIRT7 decreased with age. They then considered that this decrease in SIRT7 in the older specimens may be associated with decreased osteogenesis, and may even be a cause of osteoporosis.
“In situations where SIRT7 does not work sufficiently, such as in an older individual, osteoblast formation is impaired due to low SP7/Osterix transcriptional activity. We believe that this decreased osteogenesis is associated with osteoporosis,” said study leader Dr. Tatsuya Yoshizawa of Kumamoto University. “Our results, show that the regulatory pathway of SIRT7 — SP7 / Osterix is a promising target for new therapeutic agents to treat decreased osteogenesis and osteoporosis.”2
Unfortunately, this increased knowledge will be funneled into creating new drugs to artificially tamper with the delicate natural process of bone remodeling.
There's already a proven way to reverse osteoporosis without chemically altering your gene expression using drugs. Diet and exercise are time-tested tools for building bone and improving overall health.
Researchers in Japan have discovered a gene that regulates osteogenesis and may be a contributing factor for osteoporosis.
Poor Diet Is #1 Killer Worldwide
A new study examined the eating habits of people from 195 countries to measure the relationship between diet and mortality.3
The researchers found that 11 million people die each year because of poor eating habits– more than from any other single cause.
Globally, consumption of nearly all healthy foods and nutrients was suboptimal in 2017. The largest gaps between current and optimal intake were observed for nuts and seeds, milk, and whole grains, with mean consumption at 12% (95% UI 12–13; 3 g [2–3] of nuts and seeds per day), 16% (16–17; 71 g [70–72] of milk per day), and 23% (23–23; 29 g [29–29] of whole grains per day) of the optimal levels (percentages calculated on the basis of data before rounding). In parallel with suboptimal healthy food consumption, daily intake of all unhealthy foods and nutrients exceeded the optimal level globally . The consumption of sugar-sweetened beverages (49 g per day) was far higher than the optimal intake. Similarly, global consumption of processed meat (4 g [4–4] per day, 90% greater than the optimal amount) and sodium (6 g [5–6] per day, 86% greater than the optimal amount) were far above the optimal levels. The global intake of red meat (27 g [26–28] per day) was 18% greater than the optimal intake…
…Globally, in 2017, dietary risks were responsible for 11 million [95% UI 10–12] deaths (22% [95% UI 21–24] of all deaths among adults) and 255 million (234–274) DALYs (15% [14–17] of all DALYs among adults…
…Our findings show that suboptimal diet is responsible for more deaths than any other risks globally, including tobacco smoking, highlighting the urgent need for improving human diet across nations. Although sodium, sugar, and fat have been the main focus of diet policy debate in the past two decades, our assessment shows that the leading dietary risk factors for mortality are diets high in sodium, low in whole grains, low in fruit, low in nuts and seeds, low in vegetables, and low in omega-3 fatty acids; each accounting for more than 2% of global deaths.3
Fortunately for Savers, consuming a bone-healthy pH-balanced diet ensures that you're getting all the nutrients you need to live a long and healthy life.
Study finds that unhealthy diets cause more deaths each year than any other cause.
Smart Eating And Full Living
Data about the deadly effects of a poor diet underscores the power of food in our lives and on our bodies. You can use food to grow strong, healthy bones and live a full and robust life. Conversely, failing to take advantage of that ability can cause frailty, disease, and death.
A healthy diet is more effective at maintaining health and increasing longevity than any drug the Medical Establishment prescribes. It's also safer, since the only side effect of a pH-balanced, osteoporosis-reversing diet is an increase in overall wellness and enjoyment of life.
Eat Your Way to Stronger Bones!
Discover over 200 mouth-watering bone healthy recipes for breakfast, smoothies, appetizers, soups, salads, vegetarian dishes, fish, and plenty of main courses and even desserts!
Comments on this article are closed.
I am 69, have had 2 fractures in my back which healed, problems with lumbar, have fibromyalgia, arthritis and stomach issues. My Endocrinologist said if I didn’t take Forteo/tymos if I fell and broke my leg, I would be dead within a year. I took reclast for 5 years and quit in 2015. I see the terrible side affects of these 2 drugs, and dont want to take them. My endocrinologists really put the pressure on. I don’t know what to do. I was extremely physically active my whole life until 2002 when I found out I had severe osteoporosis and fractures. I have been a vegetarian most of my life. I do not know what road to take, any ideas out there?
Vivian, At 83, my Endocronologist is recommending Prolia. What is your opinion on this 2x/yr injection.
How can I get a hard copy (not digital) of your cookbook
How does osteoarthritis, for instance in a hip joint, relate to osteoporosis? I am just beginning to look into this issue, so apologize if question seems elementary.
I was told I had the worst osteoporosis that my doctor had ever seen…. and was promptly asked which drug I would like I said I’m following your Save our Bones plan as well as doing Pilates reformers 3x a week for exercise.
One year later…. no osteoporosis. 👍. I tell everyone to skip the drugs and follow your plan. And I’m a believer in Pilates reformers too
Bones take years to improve significantly. I find it hard to believe that someone can go from “worst bones ever seen” to “no osteoporosis”. I’d like to see the T-score comparison. My orthopedic Dr. as well as endocrinologist said it takes years to set improvement, that is why they don’t do DEXA scans too frequently. I am not in favor of bone drugs, but I do doubt such a fast major reversal is possible thru diet and exercise only.
What is your opinion of using the Power Plate?
Can we purchase the actual books rather than the digital download?
Thank you Vivian for keeping us informed on cororate greed that results in harm to female bodies!
Vivian, thank you for the “heads up” about The court’s decision on Merck. I’m incensed that they’re, apparently, not going to be held liable for the horrible drug they foisted on unsuspecting victims. My mother was one of them. Both of her femurs fractured spontaneously while walking across her living room in 2009. The next two years of her life were a nightmare of surgeries, etc. Unbelievably, the docs wanted to put her back on Fosamax after the first surgery. I told them absolutely not.
Sadly, as hard as we tried, she never fully recovered from the horrors that drug visited on her and died from a massive stroke brought on by yet another pharmaceutical, pradaxa. (I caution everyone about that drug, also.)
I discovered your website at the time of my mother’s first surgery for the breaks and have followed it ever since. Ten years! Amazing. I’m thankful that you’re here to support sensible, natural approaches to bone and general health. Thank you. Your work is a gift to the world.
Thank you Vivian. Have you heard of the ‘plant Paradox ‘ eating plan of Dr Steven Gundry? A way of healing the gut and preventing autoimmunity through the elimination of lectins from the diet. Would love your opinion.
Hi I am 63 years old I’ve probably had osteoporosis for at least the last 10 years I’ve never taken any medication for it except for calcium I recently was told by my doctor that it is extremely advised that I takes medication for it I have lost 2 in of my height and suffer from repeated compression fractures in my back I’m extremely frightened to take any Pharmaceuticals I am trying to do this to help myself naturally any help would be greatly appreciated. My doctor also found out I am very low on vitaminD. She has put me on 500,000 unit once a week for the next 6 months.