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Oops! FDA Admits Huge Osteoporosis Drug Mistake

fda-osteoporosis-drug-mistake

As you may have probably noticed by now, the FDA tends to backpedal.

They overlook risks and side effects and approve drugs to market. Then, after the drug has done plenty of damage, here comes the FDA again, warning of the drug’s risks.

It’s happened once again with a long-established, rather “fishy” osteoporosis drug.

Thankfully, the Save Our Bones Program is on the cutting edge. From the get-go I’ve been warning about the risks of this “mysterious” drug that even baffles its own maker as to its mechanism of action. When mainstream scientists openly acknowledge that they don’t fully understand how a drug works, you can be pretty sure that it can lead to unpleasant revelations down the road.

And that’s exactly what happened with a well-established osteoporosis drug.

New Announcement: Calcitonin Salmon Doesn’t Work and May Cause Cancer

Calcitonin salmon was approved by the FDA in the mid-1970s because it was thought to increase bone density. But, according to FDA panelist Amy Whitaker “no studies have definitely shown that higher density actually reduces bone fractures,”1 and calcitonin salmon “…has very little evidence of efficacy.”1

The FDA panel has just voted that the risks of calcitonin salmon outweigh any benefits when used to treat osteoporosis. Considering it doesn’t even work, for once, that makes perfect sense!

Now for the really bad news, “…health authorities around the world have been reviewing the drug’s safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. 1

Salmon Isn’t the Only Thing That’s Fishy about Calcitonin

If you’ve never heard of calcitonin salmon, it may sound very strange. And frankly, it is! Calcitonin salmon (Miacalcin and Fortical) is inhaled, taken in pill form, or even injected. Miacalcin and Fortical are synthetic versions of calcitonin salmon, a hormone found in the bodies of mammals, birds, and fish. In its natural form, calcitonin works synergistically with parathyroid hormone to help regulate blood calcium levels.

But the mechanism of action of synthetic calcitonin salmon on bone health is not really known. Novartis, the makers of Miacalcin, admit that they do not really know the mechanisms by which this mysterious drug works…and now the not so surprising consensus is that it doesn’t.

My Prediction Comes True

If you’re on the Save Our Bones Program, and if you’re a regular reader of the Save Our Bones blog, you know that hormone therapy is not something I recommend, ever. If you caught my answer posted on Vivian Answers Day #10 from more than 2 years ago, then you are already aware that I was discussing calcitonin salmon and its risks long before the FDA made its recent “discovery.”

When a reader asked about taking calcitonin salmon (Question & Answer #6), I responded with this:

“…my prediction is that one day, the companies that make these kind of drugs might be in troubled waters. I say this because salmon calcitonin’s role is bone metabolism is not well understood, and that can lead to some unwanted surprises as time goes by.”

In addition to the recently-revealed “unwanted surprises,” calcitonin salmon has always carried a risk of unpleasant side effects, such as nosebleeds; sinus pain; joint and back pain; nasal crusts, redness, and swelling; stiffness; and headache. And these are just the common ones. Less-common side effects include bladder infections, hives, swelling of the tongue, breathing difficulty, hair loss, muscle pain, and sweating. And it looks like we can add cancer to that list of side effects as well.

The FDA Can Ignore Its “Experts”, Protecting Big Pharma’s Interests

You aren’t likely to see calcitonin salmon taken off the market any time soon. The FDA is not required to follow the advice of its panels, so the opinions from this recent panel are not automatically going to curtail prescriptions. In other words, calcitonin salmon is likely to continue being prescribed. Time will tell if Big Pharma prevails…

But more importantly, this is yet another reason why the FDA’s drug approval is irrelevant. A drug may be approved, but then “unpleasant surprises” come up down the road, as dangerous side effects are discovered.

Take Fosamax as an example. Approved by the FDA in 1995, the specter of dangerous side effects casts an ever-growing shadow over this drug. The disfiguring side effect known as osteonecrosis of the jaw (ONJ) is particularly associated with Fosamax.

Indeed, the entire class of FDA-approved drugs known as bisphosphonates is burdened by a growing body of evidence against them. Studies have shown that bisphosphonates double the risk of esophageal cancer, and they also increase the risk of atypical femoral fractures.

No Drug is 100% Safe

The bottom line is this: no osteoporosis drug is ever going to be 100% safe. There is always a risk involved with any osteoporosis drug, FDA-approved or not. The drug companies patent synthetic chemicals that more often than not are proven to be dangerous – after they’ve been on the market and caused untold suffering and sometimes irreversible damage.

Leaving your bone health in the hands of Big Pharma and trusting the FDA can leave you with severely damaged health and greatly decreased wellbeing.

This is why taking control of your own bone health is so crucial. The Save Our Bones Program is designed to give you all the information you need to make your own bone health decisions. If you haven’t yet, you can take your bone health into your own hands without ever having to take chances with drugs. Thousands have done it, and so can you!

Till next time,

References

1 Perrone, Matthew. “FDA panel sees risk in long-used osteoporosis drug.” Associated Press. Google News. March 6, 2013. Web. http://www.google.com/hostednews/ap/article/ALeqM5iLALZYT8s2JFuGRT_URkd_p6OJ0A?docId=9f63b31bdf094dedbf88e7d40593c619

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60 comments. Leave Yours Now →

  1. Carolina martinez October 24, 2014, 9:24 am

    Hello, Vivian I have found your webpage very useful and full of information and I want you to give me an advise my mom is being told that she have high calcium and that the hormone is eating her bone. The doctor gave her two options either she takes a treatment or they make a surgery to remove the hormone that is eating her bone and I want to ask you if that would be a good choice they haven’t diagnosed her with osteoporosis jet but when she goes with the specialist he will tell her what she have and base on that they will recommend one of the two options. And my question here is that if it will be a good to remove the hormone that is eating her bone or not what are the pros and cons of that decision. I will be waiting your response. Thank you

  2. Beverley January 5, 2014, 11:46 am

    I just had a bad break. I am taking Rocaltrol Calcitrol 0.50MCG. Is this related to
    calcitonin salmon. I am a victom of Fosomax and was to be put on Fortin, the needle . Thank God I read your warning and refused it. Have lost my jaw bone and have a hard time getting teeth that fit. The price of progress is very high.

  3. Karen April 10, 2013, 6:51 pm

    Thanks for all your work Vivian. I too have trouble absorbing calcium. I just put in an order or the Laminine.
    Hoping it helps. Appreciate the tip.

  4. nadine sand April 3, 2013, 11:19 pm

    I use olive oil in baking and cooking. A friend suggested coconut oil would be better for me. Comments? Thank you

  5. Gerri D. March 18, 2013, 4:02 am

    Thanks Vivian for all the important information that you make available to us.I cannot believe how misinformed people are about meds,and diet and how to keep healthy in general.They seem to think that the drs word is law.I have tried to help some of my friends to correct their thinking,and to turn them onto your site.Thank you again Vivian for all that you do.

  6. Pegge Taylor March 17, 2013, 7:37 pm

    Vivian Thanks so much for all your help. I look forward to email if its from you, to see what new wisdom or insight you have for us. Is there a reason to chose Algae Cal plus over regular Algae Cal for Calcium pills. I tell people all the time about your book & program but didn’t know the difference. Could you please let me know–Thanks so much :) Pegge

  7. Deneece Squires March 17, 2013, 3:59 pm

    what are you thoughts about Forteao ?

  8. Dick Mann March 17, 2013, 1:30 pm

    I have bone cancer metastasised from prostate cancer. About a month ago, I had a nuclear treatment, i.e.,quadramet. I have a lot of pain in my legs due to the bone cancer. My doctor asked me if I want to renew my zumeta iv. Is this good or is there a better way to strengthen my bones?

  9. Judy Kroetsch March 17, 2013, 9:15 am

    I have been reading about positive results in bone density from taking strontium and/or MBP. Have you any feedback on either of these?

  10. betsy March 17, 2013, 1:28 am

    Have you ever tried candied citrus peal as a snack? I add ginger to it as I make it andIi can hardly leave it alone when I get into it. I hope it is alkalizng.

  11. Valerie March 16, 2013, 12:28 am

    Dear Vivian , Thank you for your eye opening emails,I have been taking Arimidex for 10 months and a friend has told me it can harm my bones I am getting swollen joints in my fingers Advice please

  12. Elizabeth Misa March 15, 2013, 2:20 pm

    Thank you Vivian again for keeping us informed. It is too bad the FDA does not represent and protect the people. Since I have been in your program I no longer have the pain in my right hip. I owe that to your advice. I am eating healthier and the benefits are showing. Thak you and God bless you.

    Liz

  13. Nicole March 15, 2013, 1:07 pm

    Hi Vivian – I have been taking Calcitonin nasal spray for several years with no side effects so far. I had osteoporosis & now I have graduated to osteopenia. I just read your article & am wondering whether the cancer fret you mention applies to the pill form of the drug only or also the nasal spray. Please let me know whether I should tell my doctor I want to stop. Thank you for all your hard work on our behalf. Believe me it’s much appreciated – Nicole

    • Vivian Goldschmidt, MA March 17, 2013, 4:02 pm

      Hi Nicole,
      In the study regarding calcitonin and cancer, pills were used; but the active ingredient is the same. Whether or not to take osteoporosis drugs in any form is entirely your decision. So I encourage you to learn as much as you can and then take your health into your own hands. And you’re already obviously doing your research since you came to this site! :) Best of luck whatever you decide!

  14. sylvia Richars March 14, 2013, 11:36 pm

    Will someone please tell me what they know
    about Forteo ?

  15. Eloisa Vennesi March 14, 2013, 10:06 pm

    Dear Dr. Goldschmidt… My name is Eloisa Vennesi and I was diagnosed with Osteoporosis 3rd degree on my hips and Osteopenia on my spine in January, 2008 in Orlando, FL. My doctor in Orlando prescribed me Fosamax 70 mg once a week plus 1200 mg of Calcium + Vitamin D. I took Fosamax for 2 1/2 years until I saw your add in July 2010 on the internet and decided to stop taking Fosamax on my own and started following your diet through the emails I started receiving from you. Well… 2 1/2 years have gone by and I just had my Dexa Scan done and guess what ? My osteoporosis got reduced to Osteopenia on the hips and I still have Osteopenia on my spine, but I managed to reduce the Osteoporosis on the hips from 3rd degree to Osteopenia. I walk a lot everyday, get some sun, take my 1200 mg of Calcium + Vitamin D and also 600 mg of magnesium chloride plus eat a lot of vegetables, fruit, fish, chicken and turkey. I have been following your advices on my everyday diet and it helped me a lot. I am here today reporting this because I know it can help other people with osteoporosis. Thank you very much Dr. Goldschmidt for all the info you have been posting for all of us… This is the real healing for our problems…. I appreciate every email I receive from you and read them carefully… they are the only thing I really pay attention now… Please, keep on taking care of us as you have been doing all along… Thanks a lot for everything…. Eloisa Vennesi

    • Vivian Goldschmidt, MA March 17, 2013, 3:57 pm

      Eloisa, that’s wonderful news! Thanks so much for sharing your success with the community. May you continue on your path to health and wellness! :)

      • Eloisa Vennesi March 18, 2013, 6:09 pm

        It was my pleasure, Dr. Goldschmidt…. and thank you very much for the warm wishes… Rest assured I will keep on following your advice…. Thank you very much for all you have done for all of us…. :-D

  16. rosa March 14, 2013, 8:56 pm

    Hi Mrs Vivian. my question is about yesterdays information. I have a daughter with major deppression with psycotic features recourrance and severe plus ADHD. and the medecine for depression never worked on her they made her more suicidal so is best for her not take anything. my question is if you know of something natural for ADHD so she can try please

    • Carolyn Cash March 16, 2013, 8:28 pm

      I Have a son (now adult) with adhd and we found that all forms of sugar caused him to be more hyperactive. As an adult he still has to watch his diet to exclude sugar.

    • Vivian Goldschmidt, MA March 15, 2013, 4:47 pm

      Dear Rosa,

      I am sorry to hear that your daughter is experiencing those health struggles! Right now, though, my research is focused on bone health and drug-free options for osteoporosis. I haven’t researched ADHD in depth, but the use of BPA in canned food liners has been linked to ADHD and other symptoms. You can read more about that here if you’d like:

      http://saveourbones.com/canned-food-bone-health/

      Also, I do know that some people have luck with a gluten-free diet in managing ADHD symptoms.

      I wish your daughter health and wellness!

  17. Denise March 14, 2013, 8:00 pm

    Dear Vivian,would you tell me please if organic milk is good for you?

    from a french girl.

  18. rhonda sears March 14, 2013, 7:55 pm

    Do you know if Fosteum is safe and/or effective? My bone density test shows severe osteopenia and my doctor wants me to take something. I told him I did not want to take osteoporosis drugs and he said this is a medical food. What do you know about Fosteum? Thanks

  19. Denise March 14, 2013, 7:51 pm

    Dear Vivian,i have a question for you,is organic milk good for you?

  20. Ellie March 14, 2013, 4:35 pm

    Thank you Vivian, for all the imformation that you have given me and others about about
    Save Our Bones. My MD Doc. as been after me for few years trying to get me
    to take,
    Fosamox,or one of the others. My daughter-in-law got bad news when she went
    to her dentist.
    Thanks
    Ellie

  21. Sharon March 14, 2013, 3:07 pm

    I tried Miacalcin for a short period of time — but had to stop because of nasal crusting. Sounds as if stopping soon after starting was a very good thing!

  22. Maria J.Mckenney March 14, 2013, 2:35 pm

    Thanks Vivian, I never take o ate that kind of salmon, I’m kerful for every thing I take o ate. Maria J. Mckenney

  23. shula March 14, 2013, 12:50 pm

    Very good to know about this Calcitonin drug.

    I have a question about the Organic Calcium. Is it true that when taking this type of calcium – we don’t have to take the full dose of 1500 mg per day, and can take less? If yes – how much we should take?

    Will appreciate your answer
    Thank you so much, Vivian
    Shula

    • Vivian Goldschmidt, MA March 14, 2013, 11:25 pm

      Hi Shula,

      Thanks for writing in!

      The actual dosage of calcium is not nearly as important as the absorbability of the calcium. And when you look at the dosage, be sure to note the amount of elemental calcium. That’s the actual amount of usable calcium you are getting. For example, one calcium supplement may show 1,190 mg from calcium citrate and 1,087 from calcium malate. But the total amount actually breaks down to 500 mg of elemental calcium, which is all your body can absorb at one time anyway.

      So if you’re taking the right kind of calcium, you can take much less than 1500mg!

      • Hilary March 15, 2013, 12:31 am

        Dear Vivian

        I have wondered for some time what “elemental calcium” is, so thankyou!

        Recently I purchased (upon your recommendation)TrueOsteo from NatureCity. Their calcium serving size of 2 tablets is 360mg of “Calcium (from AlgaeCal”. How much elemental calcium would this be please?

        Thankyou!
        Hilary.

  24. Bobbie Dicking March 14, 2013, 12:12 pm

    Thank you. Thank you. Thank you. Your ministry is comforting. All that you have shared has helped me to make wise choices and become responsible in my health care. May God continue to bless you.

    • Vivian Goldschmidt, MA March 15, 2013, 4:51 pm

      Thank you, Bobbie! Your encouragement and appreciation are heart-warming.

  25. Judy March 14, 2013, 11:18 am

    I have recently been having some issues with my hands – trigger finger in one finger of each hand and I can’t ben either of my thumbs. A co-worker has suggested “SieraSil Joint Formula 14″ Has anyone heard of this and is it on the up and up or does it have bad consequences? Help!

  26. Lilly March 14, 2013, 10:45 am

    Dear Vivian:
    Thank you, thank you very much for all you do! I have learned so much from your wonderful e-mails and I send them to my friends so I can pass this knowledge to more people.

  27. Katman March 14, 2013, 10:44 am

    It is NOT experts – it’s the ATTORNEYS, STATE BAR UNION MEMBERS, NIHILISTS, USURPERS, IMPOSTERS, IMPERSONATORS, et.al. that are protecting BIG PHARMA.

    BIG PHARMA & the UNITED STATES are ultra vires corporations that are guilty of Crimes Against Humanity, Peace & G-d.

  28. Wendy Shaw March 14, 2013, 10:04 am

    Thank-you Vivian for all your work and research. I am like you in so many ways and staying away from drugs has always been my belief for good health. I so enjoy reading all your e-mails and learning from them. My bones are getting stronger all the time because of you.

    • Vivian Goldschmidt, MA March 14, 2013, 11:22 pm

      Wendy, that is so good to hear. Thank you for taking the time to share that! I am so glad your bones are strong and healthy, and that the Save Our Bones Program could play a part in that. :)

  29. sandra sullivan March 14, 2013, 8:46 am

    i was told i had osteoparosis and ostopena 4yrs ago but refused drugs ,so my docter gave me d3 to take which if i am not careful when i take them it stops mt thyroid tablets working ,i had thyroid cancer and had my thyroid removed 16yrs ago and its the meds i take that they say are thinning my bones

  30. cathy March 14, 2013, 8:29 am

    Hi there. I am 53 yrs. Old and recently had a bone scan done. They said I had borderline osteopenia. I also have a lot of night sweats. Would you r program help with both? Thanks

  31. Camille Dempsey March 14, 2013, 8:27 am

    Had my first Official Bone Density at 82. Learned of Drug dangers at CURVES. Got your book and have been advertising. My Diagnosis was Osteo Pinea Still don’t spell well at 82!!Thanks for all your valuable information!!!

  32. Susan March 14, 2013, 7:32 am

    I am so confused. My doctor has been wanting me to take drugs for my osteoporisis for years and I have refused. I have dramatically increased my exercise and I eat a healthy diet but I’m still being told my spine is deteriorating. She now is being persistant about me taking a drug – Evista – but I’m concerned about using it with my family’s history of breast cancer. Perhaps I missed it but I didn’t see this drug specifically mentioned on your website. Do you have any information on it?

    • Lynn March 14, 2013, 5:44 pm

      Evista caused me to have leg cramps, so I quit taking it.

    • Glen March 14, 2013, 9:42 am

      I am a 55 year old man with Osteoporosis. I tried taking the various drugs prescribed by my now ex-doctor. (We ended up in quite an argument over this matter), not only because of what I read here but because of how bad they made me feel. I just had another mineral bone density test done and it has gotten a lot worse. It was at -2.1 & is now at -3.1 overall. I suffer from severe lower back pain and currently taking morphine and oxycodone to deal with it. Since my initial diagnosis, I have suffered three compression fractures in my lumbar region, have had an emergency cervical fusion, a total left knee replacement and most recently, right shoulder surgery to remove a huge bone spur that was cutting into my rotator cup. I also suffer with damage to my sciatic nerve. I eat very healthy and take natural supplements rich in calcium and vitamin D but my latest MRI, show continuing bone loss and arthritis in my back. My body does not seem to process calcium properly. Is this what I have to look forward to for the rest of my life? Nobody seems to have the answers for me.
      Glen

      • Darlene March 14, 2013, 12:41 pm

        Glen, you may benefit from Lifepharm’s LAMININE, a natural whole food product that is proving to assist the body to regenerate. Very good information on http://www.eggoflife.com/darlenefoster

    • Rayna March 14, 2013, 9:16 am

      Hi Susan,
      My doctor says I have the same thing that my spine is deteriorating as well. I took Evista for 3 years and it did not help at all. As of matter of fact my spine got worse, so my doctor decided to try Prolia. According to my doctor Evista was to help prevent breast cancer but it increased my night sweats, which was the only side effect I had (so far). When my doctor recommended Prolia and I did the research and got another doctor’s opinion who recommended Reclast. Because they scared me, I took the six month shot Porlia. Not being happy with my decision, I finally found Save our Bones and bougth the program and now I am trying the program. Very educational and encouraging. I am not going to take any more drugs Osteoprosis.

  33. Maryann Ascencao March 14, 2013, 7:22 am

    I have been diagnosed with osteopenia of the femor. The doctor has recommended a new prescription vitamin called, Fosteum, manufactured by, Cornerstone Research and Development, Inc. Do you know anything about this? It is expensive 180 capsules cost $150.

  34. Carolyn March 14, 2013, 6:57 am

    Thank you for your continous credible research and it brings comfort to people like me who have stopped taking Fosamax after reading all about its ineffectivenesss.

  35. Darlene Wood March 14, 2013, 6:51 am

    Vivian: I love to read your articles and info. I have osteoporosis with T-Zones being 3.2..3.4 and this was 2 yrs ago. I stopped Fosamax MANY years go and, the last med. was Prempo that I recall and quit that about 10 yrs ago. I am 62. Within this past year, I fell and broke right humeras (spiral), never healed and 5 mos later had surgery w/plate. My back was really hurting and blamed on sleeping in recliner for 7-8 mos. following breaking my arm. Saw orthopetic Dr…had X-ray and MRI. I have fractures in lower spine and now wearing brace. Has definitely given comfort. Ortho. Dr. said to contact my family Dr. and to get on something for osteoporosis. I have done a lot of research on my own. I say no to biosphansates and the “yearly” intraveous. I think “anabolic” drugs is probably right for me..they increase rate of bone formation is what I need.
    What is your opinion or, someone out there, about “FORTEO”, a daily injection? Would love to hear from someone about this drug ASAP. I have to do something. Thank you.

    • Valerie March 14, 2013, 12:09 pm

      Hi Darlene , I also was on Fosamax for nearly a year and developed jaw problems so I stopped taking it. My Doctor tried to talk me Into taking Forteo shots, it would of cost me over a thousand dollars a month. Not only that when you quit taking the shots you have to go back on Fosamax according to my Doctor. What part of I can’t take that does she not get. I agree with Vivan all drugs have side effects, if you could follow her program I’m sure it would help you. Check out the side effects of Forteo, not worth the risk.

  36. Blanaid March 14, 2013, 6:40 am

    Safe in the arms ( and ‘pen’) of Vivian.

    Thank you a thousandfold

  37. Nanci Edgcomb March 14, 2013, 6:33 am

    Why is it so expensive to buy just the book? What do women do who don’t have that kind of money to spend?

    • Joyce Maxwell March 18, 2013, 7:22 pm

      Try AMAZON for used books at reduced price! Good Luck

    • cath March 16, 2013, 2:25 pm

      Hi Nanci. Some of us have managed to buy these books at a much reduced price, because the books are damaged in some way from comeing off the press, Vivian has reduced them (I think this has happened twice now since I have been following Vivians site). So keep watching it might happen again. Hope this helps. warm regards England

  38. Ghassan Mahir March 14, 2013, 5:48 am

    Thanks Vivian for the continuous input. You should also be praised for the forecast, something which will be the reward for anyone who sincerely and systematically go about investigating the truth about almost anything. Personally, I’ve found that it is almost always, very sadly I should add, that people don’t heed the advice from people like me (no matter how sincere I am or knowledgeable with diplomas and published books, as they well know) because it is the white-coat doctor who is the authority here, so they wait for the doctor to tell them about it, and after long years, when the damage has taken place, they will listen to the doctor when he or she tells them what I’ve been relentlessly telling them for years. Sad. One should be hopeful, however, that in this internet-bound age, people are beginning to hear (at least) the other side of the story, something which should encourage more and more to listen to people like you – who are the real expert here – earlier rather than later. Thanks again.

    • Vivian Goldschmidt, MA March 14, 2013, 11:20 pm

      Ghassan, thank you for your kind words! Yes, I am thankful for the internet for getting information out there. It’s much easier to be well-informed than it used to be!

  39. Hannah March 14, 2013, 3:47 am

    Thanks for this infomation Vivian. You are a life saver for us.
    Could this Calcitronin be a part of Calcitrol? Hannah

  40. Hannah March 14, 2013, 3:46 am

    Thanks for this infomation Vivian. You are a life saver for us.
    Does this Calcitronin be a part of Calcitrol? Hannah

  41. Walter O. Lituan April 1, 2013, 9:37 am

    Dear Sir/Madam, my knee had been giving me pain for quite some time now and I wish to buy what you recommended here New Zealand produce Glocosamin and Chondroitin mixed with DMSO. I would appreciate it very much if you could share with me the email address of the manufacturer of this product. Thank you for sharing your experience. Sincerely yours. Walter

  42. Walter O. Lituan April 1, 2013, 9:31 am

    Dear Sir/Madam, I would like to buy the Glochosamin chondroitin and dmso which you said works like wonder. I wish I could try it as the pain in my knee has been a problem for quite some time. Could you kindly tell me whert to buy this New Zealand product. Thank your for your response. I would really appreciate it. Sincerely yours, Walter O. Lituan

  43. Jane March 19, 2013, 5:36 am

    Try cutting out acidic forming foods (animal products, caffeine, refined foods, alcohol, dairy, sugar etc). I did and my athritis disappeared. Plus I felt much healthier!

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