Save Our Bones Bulletin: Brain Power Peaks In Autumn, Amgen/UCB Resubmit Osteoporosis Drug For Approval, Tax Dollars Fund Stem-Cell Osteoporosis Drug Research

This month’s Save Our Bones Bulletin contains a remarkable revelation about the relationship between cognitive function and the four seasons.

We also bring you an update on Big Pharma’s latest attempt at a quick-fix drug for osteoporosis. This new drug’s dubious ascent through the approval process seems to be marching forward, raising red flags left and right.

To round things off, you’ll learn about a stem-cell-based osteoporosis drug created by a private biotech start-up and its unexpected funding source: tax dollars.

Brain Power Peaks In Autumn

A study published this month in PLoS Medicine has shown that cognitive processing power shifts from season to season. People who live in the Northern Hemisphere experience their highest brain function in late summer and early fall, while signs of cognitive decline are at their worst in winter and spring.

The researchers analyzed data from 3,353 participants enrolled in separate cohort studies in the U.S., Canada, and France. Each participant underwent neuropsychological testing, and for some, information about factors associated with Alzheimer’s disease was available.

Relevant Excerpt

”The authors found that average cognitive functioning was higher in the summer and fall than the winter and spring, equivalent in cognitive effect to 4.8 years difference in age-related decline. Besides, the odds of meeting the diagnostic criteria for mild cognitive impairment or dementia were higher in the winter and spring (odds ratio 1.31, 95% CI: 1.10-1.57) than summer or fall. The association between season and cognitive function remained significant even when the data were controlled for potential confounders, including depression, sleep, physical activity, and thyroid status.

Finally, an association with seasonality was also seen in levels of Alzheimer’s-related proteins and genes in cerebrospinal fluid and the brain.”1

The authors of the study suggest increasing dementia-related clinical resources in the winter and early spring since symptoms are likely to be most severe at those times. Their findings also shed light on how much the environment and behavior impact our brains.2

The study wasn’t meant to identify which elements of seasonal shifts cause changes in mental function, but they could include changes in sun exposure (as with Seasonal Affective Disorder), seasonal illnesses, or seasonal behavioral shifts.

Synopsis

A study found that cognitive decline is most pronounced in the winter and spring and that conversely, brain function is at its peak in summer and fall.

Amgen And UCB Resubmit Rejected Drug For FDA Approval

Pharmaceutical giants Amgen and UCB partnered in 2004 with the goal of creating a new osteoporosis drug. This year, they submitted Evenity (romosozumab) to the FDA for approval– for the second time. Their first attempt failed, and for a good reason.

Relevant Excerpt:

“The FDA rejected the original BLA (Biologics License Application) in July 2017, requesting more data related to adverse cardiovascular events. Evenity is a monoclonal antibody being developed to treat osteoporosis in postmenopausal women. When the companies announced topline data from the Phase III ARCH trial, which compared Evenity to Merck’s Fosamax (alendronate sodium) in May 2017, there was a higher risk of serious cardiovascular events with Evenity than Fosamax.

Evenity works by inhibiting the activity of sclerostin. This results in increased bone formation and reduced bone resorption.”3

Fosamax is ineffective and dangerous- as evidenced by the years of lawsuits brought against Merck for failing to disclose the drug’s devastating side effects. If the FDA- which regularly fails to protect citizens from harmful or deadly drugs- found Evenity to be worse than Fosamax, then we know it’s a disaster waiting to happen.

In spite of that, these powerful pharmaceutical corporations are working to push the drug through the FDA’s approval system. Given how many osteoporosis drugs the FDA has allowed onto the market, it won’t be surprising if the additional studies that Amgen/UCB submitted for review convince the agency to gloss over the clear and present danger of Evenity.

The Save Institute will be keeping an eye on this story, and as it develops, we’ll make sure to keep you up to date.

Synopsis

Amgen and UCB have resubmitted their newest osteoporosis drug Evenity (romosozumab) to the FDA for approval after it was rejected last year due to its dangerous cardiovascular side effects.

California State Program Funds Osteoporosis Drug Development

A government program in California dedicated to supporting the development of stem-cell-based treatments has awarded more than 1.5 million dollars to a pharmaceutical company so that they can pursue trials of a new osteoporosis drug.

The state program is called The California Institute for Regenerative Medicine (CIRM), and their primary focus is the support of medical research and drug development that involves stem cells. They awarded the grant to a privately owned biotech firm called MAX BioPharma Inc. of Santa Monica.

Relevant Excerpt:

“The California Institute for Regenerative Medicine announced May 24 that it had awarded the pre-clinical biotech firm a $1,689,855 grant.

The funds will enable the six-year-old firm to test a therapy that targets stem cells in a skeleton, creating new bone forming cells and blocking the destruction of bone cells caused by osteoporosis. The disease is especially prevalent in Latinos.

“We’re very happy with this very important support from CIRM,” said Farhad Parhami, founder and chief executive of MAX BioPharma. “It will allow us to finally take some very important steps forward filing with the FDA to begin testing our osteoporosis drug on humans.”4

CIRM’s website states that part of its mission is to provide support where there is “an unmet medical need.”5 There are many untreatable illnesses and conditions which stem cell research could help cure or manage, but osteoporosis does not fall into the category of unmet medical needs.

As Savers know, there are many drug-free, natural ways to strengthen bones. Eating a pH-balanced diet, supplementingwith bone-essential vitamins and minerals, and engaging in weight-bearing exercise are all scientifically tested and proven ways to increase bone density and reduce fracture risk. Better still, they improve overall health without causing any adverse side effects.

Clearly, the almost 1.7 million dollars would have been better spent educating the public about safe and natural ways to reverse osteoporosis.

Synopsis

A state program in California awarded 1.7 million dollars a biotech firm to support trials of a new stem-cell-based osteoporosis drug.

Osteoporosis Drugs Are Not The Answer

Every osteoporosis drug causes terrible side effects in exchange for (at best) mediocre and temporary results that are greatly surpassed by a holistic and natural approach. And Savers know that we already have the tools we need to reduce fracture risk and take care of our bones.

References

1 PLOS. “Dementia symptoms peak in winter and spring, study finds.” ScienceDaily. ScienceDaily, 4 September 2018. Web. https://www.sciencedaily.com/releases/2018/09/180904140617.htm

2 Andrew S. P. Lim, et al. “Seasonal plasticity of cognition and related biological measures in adults with and without Alzheimer disease: Analysis of multiple cohorts.” PLOS Medicine, 2018; 15 (9):e1002647. Web. https://www.researchgate.net/publication/327428337_Seasonal_plasticity_of_cognition_and_related_biological_measures_in_adults_with_and_without_Alzheimer_disease_Analysis_of_multiple_cohorts

3 Mark Terry. “Amgen and UCB Take Another Shot at Osteoporosis Drug” BioSpace. July 13, 2018. Web. https://www.biospace.com/article/amgen-and-ucb-take-another-shot-at-osteoporosis-drug/

4 Dana Bartholomew. ?MAX BioPharma Awarded $1.7 Million to Fight Osteoporosis.” LA Business Journal. May 24, 2018. Web. http://labusinessjournal.com/news/2018/may/24/max-biopharma-awarded-17-million-fight-osteoporosi/

5 https://www.cirm.ca.gov/about-cirm/our-mission

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26 comments. Leave Yours Now →
  1. Shirley Bell October 13, 2018, 11:10 am

    I am pleased to have found this wonderful site again. I always looked forward to my regular emails from Save Our Bones with Vivian for many years. I did wonder what had happened as the emails suddenly stopped.
    Great find today!
    Best wishes
    ShirleyAnn

  2. Desley Strik October 5, 2018, 5:01 am

    Dear Vivian.
    Thank you for all the wonderful information & recipes etc over the years on Osteoporosis which has been a great help.
    Do you know anything that may be helpful for cholesterol as my Doctor is pushing the statins. My cholesterol is quite high.
    Warm Regards
    Desley

  3. Martha October 3, 2018, 12:47 am

    I am very happy to find you, I bout all your books and I love your recipes.Judy like to know if any food remedy for lowering cholesterol. I lowered my cholesterol 40 points with food.
    I used 1 measuring cup of chop up cactus leaves, the same amount chop up fresh pineapple and the same amount water . Put in the blander and keep in a glass jar in refrigerator and every day for 5 weeks first think in the morning drink 8 oz.
    It is delicious and effective only if you drink first think in the morning and wait 15 minutes to eat breakfast .

  4. Jackie September 29, 2018, 11:27 am

    Some time ago you advertised a machine to detox drinking water. Can you please send me some info on that machine. For the past few years l’ve been buying and drinking distilled water. Have been following your program for a few years. My osteoporosis has not improved but has not worsened. Stopped taking the drugs seven years ago.

  5. Betsy Goldtrap September 28, 2018, 1:03 pm

    Does Synthyroid cause bone loss of it is the correct dosage?

  6. Laura Winn September 27, 2018, 8:09 pm

    I was recently diagnosed with osteoporosis and my doctor prescribed Fosamax. I hesitately agreed but I do not want to be on this med. From what I have read, the side effects are horrible. I am 66 y/o and would much rather be more holistic. I eat all organic foods, no red meat, and take Bone Up supplements. I would appreciate any advice on what to do instead of taking this horrible big Pharmacy scam medicine. Thank you.

    • Laura Winn September 27, 2018, 8:12 pm

      Also, any links to pertinent articles I can forward to my doctor to back up my argument to get off Fosamax. Thanks!

      • Suzy September 28, 2018, 6:28 pm

        Laura, this entire site is FILLED with articles for you to share with your doctor. I told my doctors I wasn’t going to take *any* of the osteoporosis drugs, and I have followed this program for quite a few years now. I slipped on some wet leaves last fall, but didn’t break a bone! I know this program works! People have improved DEXA scores because of this program! Good luck!

        • laura winn September 29, 2018, 3:13 pm

          Thanks Suzy. I’m on board now and am writing my doctor today to say No Thanks to Fosamax. I knew I should never have agreed and this website gives me so much hope… and knowledge.

  7. verajean thedell September 27, 2018, 5:23 pm

    I have been taking Levothyroxin for many years. Now Synthyroid. But I am now
    reading that these medications can cause Osteoprosis. Which I have. Do you
    know how long between taking the medication (in the AM), and eating breakfast,
    I should wait. ? Or is there a better medication for Thyroid that does not cause
    Osteoporosis ?

    • Tamara September 28, 2018, 3:50 pm

      it is good question to find it out about thyroid medication. I have been taking Levothyroxin since 2006. I am just wondering if is this medication cause Osteoporosis?
      But I have been eating quite a lot of nuts, some cheese, yogurt, sunflower seeds, pumpkins something like that to keep going for strong bones. I am sure it will help balance to eat calcium such as almond, nuts etc and medication as well. if they are not eating enough calcium more likely cause more osteoporosis. it is kind difficult if they are eating too little calcium or too much calcium.
      I need help.
      Thank you, Tamara

  8. Denis Corrin September 27, 2018, 2:07 pm

    Dear Vivian; Like you, I found Fosomax taken orally too toxic for my body so that led me to your Savers program. This was all as the result of my “falling from a standing position onto a flat stone sidewalk and breaking my (left) hip.” (3 plus years ago). Now our local ‘Healthy Bones Clinic’ is promoting Prolea. I’m concerned about current findings from research and experiences.
    Regards
    Denis

  9. Jean September 27, 2018, 11:06 am

    Thank you Vivian for all your info. I have been following you for a few years now. I still have regular dexa scans and my last one was good. I am now classed as low risk!!!!. So glad I found you.x

    • Vivian Goldschmidt, MA September 27, 2018, 1:14 pm

      Great news, Jean! Thanks for sharing!

  10. Judy September 27, 2018, 10:47 am

    I have been following the program for a few years now, ever since my doctor told me I was borderline. So I have been following the diet, exercising, and taking TrueOsteo. In doing so, my numbers have remained the same – not better but not worse – so I put the brakes on the decline! My question is: Does the supplement count as the 20 in the 80/20 ration or are supplements not acidifying? Also, can cholesterol be managed with diet alone?

    • Save Institute Customer Support September 27, 2018, 1:12 pm

      Hi Judy,

      Please check your inbox for a message from our Customer Support team.

  11. Ita September 27, 2018, 10:25 am

    Thank you, Ita.

    • Vivian Goldschmidt, MA September 27, 2018, 1:14 pm

      You’re welcome, Ita!

  12. kitty foster September 27, 2018, 9:59 am

    Hello, I have been seeing & reading information about Algeacal.com calcium products. What is your update on this. Thanks for all your great newsletters. I love them.
    a gratful reader…Kit-T

    • Save Institute Customer Support September 27, 2018, 1:10 pm

      Kitty, please check your inbox for a message from Customer Support.

  13. mona September 27, 2018, 9:09 am

    Should we be surprised that cognitive function peaks before and after summer solstice which are the longest days of the year for northern hemisphere, and people get the longest amount of sunlight each day. And cognitive decline is the worst around winter solstice when days are the shortest. Maybe instead of providing “dementia related resources” (drugs?), we need indoor full-spectrum lights.

    • Vivian Goldschmidt, MA September 27, 2018, 9:14 am

      Thank you for sharing those insights, Mona. Full-spectrum lighting is an excellent idea, and far healthier than any drug therapy the researchers might propose!

  14. Jean Whitaker September 27, 2018, 8:37 am

    I was diagnosed at age 52 with osteoporosis (T-scores of -2.7 range). I am thin, worked inside 12+ hours a day, Vit D level below 20, ate packaged dinners and rarely ate breakfast or lunch, and had 5 years in my mid-twenties in which I had monthly periods only during summer months because of stress related to my teaching job. I took Fosomax for 2 years, then the generic for another several years. I had some improvement in my DEXA the first year, but none afterwords. I developed high blood pressure and migraine headaches. I stopped meds despite doctors continually saying I should take Prolia. Fastforward to age 65. For the last 3 years I have been retired, eat 3 healthy meals a day, take 6000 units of Vit D daily plus 400 of VitK2 and do 30 minutes of low impact aerobics plus 35 minutes of treadmill at 3 miles per hour speed every day. My DEXA last month finally improved enough to put me in the osteopenia range and the report said “no medication recommended.” You can get better without medications!!

    • Vivian Goldschmidt, MA September 27, 2018, 9:17 am

      I’m so glad you shared your inspiring story with the Saver community, Jean! Keep up the excellent work, and keep encouraging others.

  15. Robyn September 27, 2018, 8:20 am

    Dear Vivien,
    Thankyou for your informative and researched email. I was interested in both subjects. I do have ospeoporosis and was offered fosamax and another drug to treat the conditions. However I had researched the drugs and was not happy with side affects and also the way that the drugs strengthened the old bone but prevented new bone from being made which is contrary to how the amazing body works. I opted for Vitamin D3, calcium citrate powder as I am dairy intollerant and also the calcium citrate helps significantly with my intolerance to oxalates as the calcium binds the oxalates. Also I added in Methionne 7 vit K2 and a fresh produce diet no chemicals, meats and chicken from a very reliable company who are so proud of their products as chemical free, antibiotic free, hormone free and at my last scan there had been no change, no deterioration. My Doctor at the time who was very good and caring was really pushing for the osteoporosis drugs and tried to frighten me with the scanario that her fear was that one day I would fracture my hip. However I did not let this information change my mind in fact it made my decission to say “No thank you” more resolved and have no regrets. I do appreciate all your information and everyone’s research that you have been able to help people make informed decissions. I am concerned re dementia as my mother had Alzheimers for 12 years and I do have some scerlosis of the brain as had an MRI. I reseach Alzheimers very thoroughly for my mother and also spoke with a Dr Ruth Cilento who had written to wonderful books on aging. I had so much respect for thhis family as all Dr’s and her mother’s books were in my library and I had gleaned pearls of wisdom from them when our children were born and applied many of her natural remedies. The only sibling in the family was Dianne Cilento who was a very good actress at one time married to Sean Connery. going back to Dr Ruth Cilento who was wonderful talking with me on the phone and was very interested in my mother and I mention Mum was on one of the Miracle! drugs and her advice was to take Mum of the drug asap as it was very toxic and gave me very sound advice on diet, exercise and socialising all of which Mum was following and found a wonderful Dr who was very holistic and helpful and Mum’s Alzheimers was very slow and Mum had many years of quality of life and made sure Mum was playing cards, socialising with friends, taking her on holidays and exercise and her decline was only in the last few years with her overall health and we made her journey one of joy and Mum was so gracious and always smiling, enjoying music which we found a wonderful connection that we all shared and I purchased every old musical and every week we would go to the movies and I would take chocolates and we would enjoy the experience. I didtake her to the cinema until I realise that the dialogue was problematic which the musicals filled in beautifully. Heartfelt thanks Robyn from thevworld down under.

    • Vivian Goldschmidt, MA September 27, 2018, 9:19 am

      Robyn, that’s amazing! Like Jean above, I thank you for sharing this encouraging and exciting part of your (and you mum’s) health journey with the Saver community. It really is inspiring to read testimonies like yours!

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