In this month’s Bulletin we cover two pieces of news about the flu vaccine. One looks to the future of flu shots and the other examines the low rates of vaccination in the United States.

Then we resume the saga of Evenity (romosozumab), the new osteoporosis drug that Amgen and UCB have been developing and testing for several years. With this new turn of events, it is closer than it has ever been to receiving FDA approval, but not without controversy.

Universal Flu Vaccine In Development

Researchers have identified immune cells called killer T cells that they hope will allow them to create the first ever universal, one-shot flu vaccine. The discovery was made by University of Melbourne Ph.D. student Marios Koutsakos of the Doherty Institute.

The existing method of developing influenza vaccines is consistently ineffective, usually because the most common strains of the virus each year do not match the strains for which the vaccine was created. Researchers believe that a universal vaccine would solve this by protecting against any strain of flu.

Relevant Excerpt

“Influenza viruses continuously mutate to evade recognition by our immune system, and they are vastly diverse, making it nearly impossible to predict and vaccinate against the strain that will cause the next influenza pandemic,” Mr. Koutsakos said.

“We have identified the parts of the virus that are shared across all flu strains, and sub-strains capable of infecting humans, and then investigated if we could find robust responses to those viral parts in healthy humans, and influenza-infected adults and children.”

University of Melbourne Professor Katherine Kedzierska, study leader and laboratory head at the Doherty Institute, said this was an exciting discovery that clearly revealed killer T cells provide unprecedented immunity across all flu viruses, a key component of a potential universal vaccine.

“Influenza B immunology particularly has remained largely understudied because it doesn’t have pandemic potential. However, it is a serious virus that can lead to death and severe illness, mostly in children, and was one of the missing pieces of the universal flu protection puzzle,” Professor Kedzierska said.

The team now has a patent on the discoveries, which will enable them to develop a universal influenza vaccine approach to reduce the impact of pandemic and seasonal influenza around the world.”1

As that development process continues, more studies and information will emerge about just how effective this new approach might be, and what the potential side-effects will be for such a vaccine.

Synopsis

Researchers have identified a type of immune cell capable of fighting all influenza viruses, paving the way for the development of a universal flu vaccine.

More Than 40% Of Americans Reject Flu Vaccine

A survey conducted by the National Opinion Research Center at the University of Chicago in November of 2018 found that 41% of Americans had not gotten the flu vaccine and had no intention of getting vaccinated.

Relevant Excerpt

”People under the age of 45 were the least likely to report being vaccinated. The top three reasons why they didn’t want the shot were: bad side effects; thinking they’ll get the flu from the shot; or thinking it doesn’t work.

Some think the side effects are worse than the flu itself, but that’s just a myth. Usually the only side effect is a sore arm.

It’s also a myth that getting the vaccine gives you the flu. The flu vaccine is inactive and cannot cause the infection. If you do get sick after getting the vaccine, it’s just a coincidence.

And while it is true that the vaccine doesn’t work 100 percent of the time, the benefit is that it lessens the severity. If you do still get the flu you’re 60 percent less likely to need treatment.”2

Aside from their toxicity and treacherous potential side effects, flu vaccines, like all drugs, are acidifying. To counteract acidification and restore pH-balance, the body pulls alkalizing minerals from bone, decreasing bone mineral density. There are many natural, bone-healthy ways to boost your immunity and protect yourself from the flu. The Save Institute recommends against getting a flu shot and instead encourages an immune-boosting diet and regular exercise.

Synopsis

A survey conducted in November of 2018 found that 41% of Americans had no intention of getting a flu shot, citing concerns over side effects and efficacy.

FDA Panel Recommends Approval Of Evenity (Romosozumab), Despite Serious Cardiovascular (And Many Other) Risks

An FDA advisory committee has recommended Evenity (romosozumab) for approval in an 18-1 vote, concluding that the drug’s benefits outweigh its risks for treating osteoporosis in postmenopausal women at high risk for fracture.

This comes after the FDA rejected the drug’s initial application, submitted by developer Amgen in partnership with UCB in 2017 after concerns about cardiovascular (CV) risks. The current application was resubmitted a year later and has a proposal to include a boxed warning that will list potential CV safety risks. The developer also agreed to complete a post-approval observational study assessing the effects of those risks.

Relevant Excerpt

Evenity could have been on the market last year but the FDA rejected it because of an unexpected cardiac safety signal in one of the phase 3 studies in Amgen’s dossier.

Amgen, which developed the drug in partnership with Belgium’s UCB, has come back with new data, and a request for approval in a narrower indication of women with osteoporosis at high risk of fracture, instead of in the population of all postmenopausal women.

This could limit its commercial prospects, and there is no guarantee that the FDA will approve Evenity (romosozumab) as decisions of its advisory committees are not binding.

Nevertheless 18 out of 19 of the experts from the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted in favour of approval.

The BRUDAC reviewed data from the phase 3 FRAME study, testing the drug in 7,180 postmenopausal women at risk for fracture, and ARCH, an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture.

They also reviewed data from STRUCTURE, an active comparator-controlled study with 436 postmenopausal women with osteoporosis.
It was the ARCH study that threw up the unexpected cardiovascular safety signal that has caused the problems.

But things seem to be turning in Amgen’s favour now – the Japanese regulator approved it last week and UCB has filed it in Europe, where it is also under review.

Pascal Richetta, head of bone and executive vice president at UCB, said: “Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis. This is why new treatment options, like Evenity, are so important.”

Evenity works by inhibiting the activity of sclerostin, which enables the body to increase bone formation and reduce bone resorption simultaneously.

Amgen sees Evenity as a successor to its older osteoporosis drug, Prolia (denosumab), which is nearing the end of its patent life and could face competition from cheaper biosimilars.3

Given the 18-1 vote in favor of approval, Evenity (romosozumab) may finally be about to make it to the market, Nothing about this drug has changed between the first and second application to the FDA. The risks now are just as dire as they were then.

Evenity (romosozumab) caused terrible side-effects in addition to stroke and other cardiovascular events. Trial participants experienced atypical fractures and osteonecrosis of the jaw4 but still, the advisory panel disregarded them, and recommended the drug for approval.

Like the rest of the osteoporosis drugs, Evenity (romosozumab) sclerostin alters the natural bone remodeling process, instead of supporting it naturally.

Synopsis

An FDA advisory committee has recommended that the agency approve the new osteoporosis drug Evenity (romosozumab), in spite of its serious medical risks.

Natural Solutions

Fortunately, Savers know that there’s no need to risk dangerous side effects caused by ineffective drugs to reverse osteoporosis and osteopenia. A natural course of action, including a pH-balanced diet and regular weight-bearing exercise, can not only increase your bone strength and resilience, but it can also improve your health and your quality of life.

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.

Learn More Now →

References

1 Doherty Institute. “‘Killer’ immune cells provide solution to elusive universal flu vaccine.” Press Release. 19 February 2019. Web. https://www.doherty.edu.au/news-events/news/killer-immune-cells-provide-solution-to-elusive-universal-flu-vaccine

2 “Over 40 percent of Americans say no to flu vaccinations.” Fox5. 11 December 2018. Web. http://www.fox5ny.com/news/over-40-percent-of-americans-say-no-to-flu-vaccinations

3 PharmaPhorum. “FDA Advisers Back Amgen/UCB’s Osteoporosis Drug Evenity.” January 17, 2019. Web. https://pharmaphorum.com/news/fda-advisers-back-amgen-ucbs-osteoporosis-drug-evenity/

4 Kolata, 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

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21 comments. Leave Yours Now →
  1. Priscilla March 2, 2019, 8:54 am

    I’m a 67 female I was on Fosamax and Actenol over 6 yrs. I quit taking them because of the danger. I was starting to get little fractures more with these drugs. I was excercising and eating right. I just had a DEXA. my score is very low -1. The Dr wants to put me on Prolia. I am fearful of the expense (even with my Medicare complete}, and fearful of the side effects especially. Help I don’t want these drugs……

  2. Donna Moore March 2, 2019, 6:47 am

    After 2 Prolia injections (I was bullied into them but have stopped), I developed “bladder retention” and will be on catheters for the rest of my life. I never attributed it to Prolia until I discovered that a friend of a friend has taken 4 Prolia shots and developed severe bladder issues. My doctor says there is no research to show that either issue was from Prolia. Any others out there with new bladder issues after taking this poison? I feel like the medical community is lying about the severity of these side effects.

  3. Evelyn March 1, 2019, 6:48 pm

    Having PKD and after 3 years of dialysis, and finally a kidney transplant, I am very suspicious of all drugs. Yes I was on fosamax for awhile. Did it help? No!!
    It is depressing to find doctors who seem to be more interested in prescribing more drugs all the time.
    Your articles help me in my refusal of flu vaccines plus googling all prescribed drugs. Was on oxyneo for back pain, having osteo porous , osteo arthritis , 2 herniated lower discs, and a compression. Fracture. After being on this education for three years , told byy doctor would never hurt me, my memory was affected. One day at a function that’s great grand children were at. I couldn’t remember their names. Couldn’t remember a membership number at a grocery store. Right then I knew I had to get off this drug. I did it within 9 days. No my doctor didn’t suggest another pain killer.
    When prescribed a drug one has to be their own advocate. Google the drug. Ask your pharmacist.

    Your help Vivian encourages. Us to look into things in depth. Thank you.

  4. joanna February 28, 2019, 10:45 pm

    I love your site. I love your comments about the flu shots and Fosamax. I myself saved my mom from complications that caused a lot of harm to my aunt. Great job!!!
    Thank you for great materials that you share.
    Joanna

  5. Marilyn Roskell February 28, 2019, 10:05 pm

    Thank you so much Vivian for all your input. I have been following you for some time now. It happened many years ago ,following a dental appointment and being told that they could not work on my teeth because I was taking ACTONEL. I came home and Googled the reasons behind it, after I had a short conferring with the Dentist. To my shock and horror I read up on the side affects and then purchased your book on The Bone Revolution. Extremely eye opening I have to say! I obviously came off the medication which I had been on for approximately 12mths. I eat healthy and I exercise . When I was diagnosed with Osteoporosis about 15 years ago I was told I had the bones of a 75year old…. I was then 53years old. I now take a natural calcium powder which is derived from a marine sea vegetable. I have not broken any bones for about 15 years and the only reason I see I had broken them before I think was due to very bad accidents which I guess any human being would have encountered. I have told so many people about your book and am so thankful that I came across it……so again thankyou Vivian. Kind regards, Marilyn Roskell

    • Vivian Goldschmidt, MA February 28, 2019, 10:20 pm

      What an inspirational story, Marilyn! Thanks for sharing it with us.

  6. Joan February 28, 2019, 2:37 pm

    I’ve never got flu injection I take lemon; ginger,@ garlic every morning.The garlic is great @ I heard if u put some parsley in with it take away the smell of it so that goes in as well

  7. Ita February 28, 2019, 12:47 pm

    Thank you ,Ita.

    • Vivian Goldschmidt, MA February 28, 2019, 1:28 pm

      Ita, you’re very welcome!

  8. shulamit sendowski February 28, 2019, 12:21 pm

    Thank you for the interesting research news.

    • Vivian Goldschmidt, MA February 28, 2019, 1:28 pm

      You’re more than welcome, Shulamit!

  9. Jill February 28, 2019, 9:10 am

    I appreciate your articles very much. What is your position on the necessary levels of Vitamins D2 and D3? There is controversy in the medical field but I have low levels by any standard. Plus, I have some allergic reaction to prescription and over-the-counter products. I eat eggs and avocado and try to get sun – in the north. I’ve been debating about getting a Sperti UV lamp ($400+) but my doctor says one has to have D in the skin in order to generate more D. Online there are studies that indicate UV lamps do work. Thank you.

    • Vivian Goldschmidt, MA February 28, 2019, 10:19 am

      Jill, you’ve got a bit of a challenge with maintaining desirable Vitamin D levels because you’re allergic to supplements and you live up North and can’t get enough sun on a regular basis. At the Save Institute we recommend taking 2000 IU daily of oral Vitamin D3, especially during the winter months, when there’s little opportunity to get out in the sun. Before you get the lamp (and we haven’t researched that option in depth as of yet), you could try a liquid plant-based Vitamin D3 supplement. Please check with the health care provider that’s managing your allergy prior to trying the supplement.

      If you need further assistance with this, please contact our customer support agents at support@saveinstitute.com.

  10. Kelsey Fickling February 28, 2019, 8:46 am

    Thanks for the research you do on our behalf Vivian. I’m so glad I found your site more than 10 years ago – you saved me from Fosamax !! Since then I’ve seen the damage it has done – I’m now 87 years old and my health is very good. I have made sure I follow your advice – I do some exercise – walk each day – take care that I eat well too. Blessings, Kelsey.

    • Vivian Goldschmidt, MA February 28, 2019, 8:59 am

      And we thank you for joining the Saver community and sharing your story with us, Kelsey!

  11. Brenton Wight February 28, 2019, 6:01 am

    The Flu shot still contains mercury, aluminum and other nasty things that increase stillbirth risk 8 times, Alzheimer’s and more, without making much difference in the flu infection or recovery. A glass of lemon juice every day is more effective than the flu shot. 10 years ago I changed my diet to alkaline-forming and quit sugar, fizzy drinks etc, and since then – no colds, no flu, not even a headache in 10 years, now aged 72 and stronger and healthier than I was at 22. And no shots of flu or anything else!

    • Vivian Goldschmidt, MA February 28, 2019, 8:58 am

      Well said, Brenton! Keep up with your healthy lifestyle 🙂

  12. Amy Lanset February 28, 2019, 4:56 am

    I am surprised that you take this anti-vaccine stance. People die from the flu. Remember that it was called Infuenza, and it was – and is – a serious global health threat? It is not a sound byte to sell vitamins. Hundreds of thousands of people were wiped out in major flu outbreaks. Measles are making a come-back, and I expect polio will be next, or bubonic plague. This is fear mongering. You have pointed out that people think they will GET the flu from the shot. Please, encourage science and truth. It is a killed vaccine, it will not infect you.

    • Amy Lanset March 6, 2019, 5:51 pm

      People like me are vaccinated. Each person has to weigh the risks for any medical intervention. When we have eradicated diseases in countries where vaccines are available, and they persist where vaccines are not, that should tell you something. The example you site about India (and Pakistan, by the way), is way more complicated,involving Muslims refusing the real vaccine because they (rightly) distrust it. Maybe not an appropriate topic here, and a huge tragedy and failing of the US. There is a lot more to it if you want to drill down into the subject. But, I do not believe the government or big pharma is trying to poison us with vaccinations. My grandfather and aunt died of TB, so it’s not been that long that this was a common way to lose your loved ones. So, please, let’s not bring trump jargon into a conversation. He and his followers are trying to end civil conversation. It is increasingly hard to get to the truth with so much web information out there. We don’t stand against each other in just having an exchange of ideas.

    • Arlene February 28, 2019, 7:18 pm

      I agree with Vivian 100%. People like you, Amy, should do some research rather than listen to all the fake news from the Pharmaceutical companies. Deaths are grossly exaggerated to scare people into purchasing their products. A couple of cases of measles is not an epidemic. 9 cases of polio in India increased to 46,000 cases AFTER a mass immunization project. The Bubonic plague was germ warfare. People have died or been crippled by the flu vaccine. All this information is on the Internet and will be until Google decides to take it away from us.

    • Vivian Goldschmidt, MA February 28, 2019, 8:57 am

      It is not fear-mongering, Amy. Please read these articles that explain how the flu shot actually weakens the immune system, and how most years, the incorrect strains are selected for the vaccines, making them virtually useless:

      https://saveourbones.com/save-our-bones-bulletin-flu-season-worst-in-years-study-confirms-flu-vaccine-weakens-immune-response-new-bone-formation-pathways-discovered-and-more/

      https://saveourbones.com/save-our-bones-bulletin-cdc-admits-2014-2015-flu-vaccine-is-useless-coca-cola-introduces-new-bone-destroying-drink-radical-doctor-dies-at-age-98-and-more/

      And this link will give you access to all our articles on the flu shot:

      https://saveourbones.com/?s=flu

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