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ALERT: Odanacatib Drug Trial Ended Early. What Could Possibly Go Wrong?

alert

Meet Odanacatib; Merck’s soon-to-be released osteoporosis drug (although it is sure to have a catchier name once it hits the market). Naturally, after taking a big financial hit when its patent for Fosamax expired in 2008, Merck is gearing up for another profitable and, most importantly, patentable osteoporosis drug.

But it gets “better”… This past week, the independent Data Monitoring Committee has halted Phase III trial early due to “a favorable benefit-risk profile”, even though “safety issues remain in certain selected areas.”1 Nobody knows as of yet what those “safety issues” are, but I’m pretty confident that I can predict at least some of them. Here’s why.

Same Old, Same Old…

Odanacatib blocks the enzyme cathepsin K, found in osteoclasts and involved in bone resorption. In other words, cathepsin K breaks down bone tissue. If you have the Save Our Bones Program, you already know the conditions necessary for normal bone remodeling to maintain and increase bone density. The absence of those important processes results in stalled bone resorption, leading to old, brittle bones, which are therefore more prone to fracture.

Bisphosphonates such as alendronate, the generic of Merck’s Fosamax and drugs such as Boniva, Actonel and Reclast also stop bone resorption. Prolia (denosumab) de-activates osteoclasts, resulting in – you guessed it – stalled bone resorption.

Reading the Tea Leaves

Based on Odanacatib’s mechanism of action, it’s easy to predict that the “safety issues” may be the same – or perhaps even worse – than those of bisphosphonates. But of course, this will most likely not be brought to light until much later, as it happened with bisphosphonates.

Alendronate trials were at first of relatively short duration. US and International Phase III trials against placebo were conducted for only three years.2 And during the Fracture Intervention Trials (FIT), study subjects were treated with alendronate for three and four and a half years.2 The Fracture Intervention Trials were followed by the Long-term Extension (FLEX) trials, where it was shown that:

“…for many women, discontinuation of alendronate for up to 5 years does not appear to significantly increase fracture risk.”3

Other long-term studies followed the FLEX trial, including the Phase III 10-year extension study, none of which observed unusual side effects.2 Fosamax was approved in 1996. Bear in mind that since that year, millions of osteoporosis patients were taking the drug, unknowingly acting as guinea pigs. Meanwhile, Fosamax sales for the year 2007 had reached around three billion dollars.4

In September 2011 safety concerns about bisphosphonates were officially announced, linking the drugs to osteonecrosis of the jaw and atypical femur fractures. This, one month after the newly discovered increased risk of esophageal cancer.

To Make a Long Story Short…

It is obvious that the initial drug trials are short for a reason: the big pharmaceutical companies, along with the accommodating regulatory bodies, collude to allow for maximum profits before the very undesirable side effects are discovered. Once approved, doctors will inevitably prescribe the drug to patients, effectively triggering a flood of huge profits which are sure to dwarf the damages they may need to shell out to injured patients in the future.

Indeed, the future looks pretty bright for Odanacatib. As published in Forbes magazine, JP Morgan is very optimistic about the new drug, forecasting

“… a 2014 launch for Odanacatib with sales reaching roughly $1bn by 2017.”1

Unfortunately, a bleak future awaits those who will be the next victims of yet one more of Big Pharma’s deceptions.

Till next time,

References

1 http://www.forbes.com/sites/matthewherper/2012/07/11/has-merck-found-the-heir-to-fosamax/
2 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM270960.pdf
3 Black DM et al. “ Effects of Continuing or Stopping Alendronate After 5 Years of TreatmentThe Fracture Intervention Trial Long-term Extension (FLEX): A Randomized Trial.” JAMA. 2006;296(24):2927-2938.
4 http://www.fiercepharma.com/story/merck-expects-1-8b-hit-fosamax/2007-12-04

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43 comments. Leave Yours Now →

  1. Shaun T May 6, 2013, 8:00 pm

    Considering that 1 in 4 people will die from a hip fracture due to osteoporosis another 2 out of the four will be permanently bed bound, I have a feeling that Fosamax has saved more lives than the 80 or so ONJ cases that arose (predominantly in patients being given intravenous high doses for cancer treatment mind you). From what I understand Fosamax had the single highest fracture prevention data for reducing hip fractures (RRD 53%) according to Cochrane, I encourage the writer of this article to look at the whole picture of health, maybe do a course in epidemiology, or a medical degree even, like those of us who prescribe these drugs and actually see the difference they make to our patients.

  2. Leslie (Ms. L.) July 29, 2012, 9:57 pm

    Hi! Vivian,
    Thank You VERY MUCH, For This VERY INFORMATIVE Article! It Sounds Like VERY GOOD ADVICE! Keep Up The WONDERFUL WORK YOU ARE DOING TO HELP PEOPLE
    LIKE ME SAVE MY BONES!

    LOVE, MS. L. (LESLIE)

  3. Aurora Stephens July 28, 2012, 11:36 am

    Thank you Vivian.
    r

  4. Aurora Stephens July 28, 2012, 11:35 am

    Thank you Vivian. I look forward to your informative emails!

  5. myrtlebarker@shaw.ca July 26, 2012, 4:17 pm

    THANK YOU FOR EVERYTHING VIVIAN.

    I DID ENJOY YOUR ALLEN DRONATE JOKE.

    LOOK FORWARD TO YOUR E-MAILS.

  6. Jean July 26, 2012, 10:55 am

    I’m in the process of reading “Wheat Belly” by Dr William Davis, a preventive cardiologist. Not an easy read, but well written and fascinating. He seems to feel that our cultural addiction to wheat, as we now know it, is the basis of many diseases, including osteoporosis. I wonder what the Save Our Bones community thinks of this. I’m not quite ready to abandon wheat, but I think I might like to try.

    • Marianne July 29, 2012, 7:32 pm

      Two years ago, I gave up wheat and all gluten products and it helped immediately. I lost 40 pounds without effort. Last week, I found Dr. Peter Osborne and the GlutenFreeSociety who has lots of useful info on gluten. Good luck! I think gluten causes inflammation in people who are allergic to it.

  7. Oliver McWilliams July 26, 2012, 8:47 am

    My Mother suffers from Osteoporious as well as many other ailments, which is why I looked you up in the first place.

    Im an Ironman Triathlete so keeping my body in top condition to cope with the massive demands I place on it is vital to me and I must say im finding your information very helpful.

    Have you any thought on taking Omega 3 suppliments and multivitamins

  8. Leonard Green July 24, 2012, 9:09 pm

    Thank you Vivian a lot,
    I am looking for some new medications or alternative treatment for osteoporosis/osteopenia around the world. But I do not have knowledge to understand all that stuff. Could you please help? Could we have any hope that something good would come out in the future? Can Chinese Medicine or other help us? Any hope? How about Germany, Israel and other countries?
    That questions is very important for everybody

  9. Isabel July 24, 2012, 4:22 pm

    Vivian, I thank God for putting you in my life Thank you so much for all your information.

    • Vivian Goldschmidt, MA July 24, 2012, 6:21 pm

      You’re so very welcome!

  10. Sharon July 24, 2012, 4:18 pm

    Once again, thank you for some valuable information!

  11. isabelle butcher July 24, 2012, 3:29 pm

    I want to thank you for all this great information. What is the best thing to do for people with lupus? Thank ISABELLE.

    • Marianne July 24, 2012, 4:20 pm

      Isabelle, I just completed a Cerificate in Plant-Based Nutrition from Cornell University and the T. Colin Campbell Foundation, and I have done a lot of reading. A whole food plant-based diet has been found to be extremely helpful for autoimmmune conditions, as well as cancer, heart disease, diabetes etc. Animal-based foods are more likely to cause inflammation. I would also look into food allergies and/or sensitivities and possibly do an elimination diet for a few weeks. Eliminating all sources of gluten has been helpful for many people. Gluten can cause major inflammation. A wonderful resource is The China Study by Dr. T. Colin Campbell. Good luck!

  12. isabelle butcher July 24, 2012, 3:07 pm

    I have lupus and i would like to know if there is anything for this condition. thank you,Isabelle.

  13. Carolyn July 24, 2012, 1:47 pm

    All I can say is a big thank you for all of your pertinent research. I am doing my best to follow the natural approach in Save Our Bones. I refer to your research on a regular basis, and it is so wonderful to have it all in one place, and to know that it is reliable.

    • Vivian Goldschmidt, MA July 24, 2012, 4:01 pm

      Hurray for truth in science!

  14. Aaron July 24, 2012, 1:17 pm

    Hi Vivian, and other viewers of this post,
    I became interested in Dr. G’s website and blog because of personal bone issues AND because of my wife’s osteoporosis. We are both in our mid-60s and in pretty decent health, but are concerned about how that is going to hold up (for my wife), especially after she surrenders to the drug treatments being offered for osteoporosis. My wife seems OK with them.

    But I feel I am in a dilemma now, since I am torn between: Providing full emotional support for my wife’s trust of her physician (who has already played an important role in assuring the successful outcome of her post surgical treatment for bone fusion – 10-hour surgery – lumbar area) Or telling her, “No!No! There are too many risks!”

    She has responded very well, so far, to all her treatments. It seems just amazing to us that she has done so well (happy, pain free, can do all usual daily activities), so it is hard to now go against the advice of her physician. She had a very competent surgeon who stabilized her lower spine and also removed a terribly impacting cyst that had been causing her severe sciatica pain for a long time. The danger now seems to be that she has to be very careful not to over-exert (i.e., no heavy lifting) the regions of her spine above the fusion.

    Her physician prescribed a one-time transfusion of ReClast, to be given tomorrow (Wednesday July 25). She wants me to be there, the main reason to be of help if she has any side reactions.

    I do not feel as confident as she does about this new transfusion treatment, and I imagine so wouldn’t many of you. I guess this is sort of a desperate last minute plea for some more light on this treatment from you and your readers who could give some convincing evidence or testimony – comments that might sway my wife from going through with her scheduled ReClast transfusion. Thanks for reading this.

  15. Vivian Duenow July 24, 2012, 1:11 pm

    why should Odanacatib be the right one when all else has failed, I still don’t think I would take it,

    • Vivian Goldschmidt, MA July 24, 2012, 3:45 pm

      You mean the wrong one, right?

  16. Nancy Syrett July 24, 2012, 11:24 am

    I realized I was a guenia pig when recent news suggested a “vacation” from the drug and also highlighted an increase in broken femurs. When asking my doctor what were the alternatives to Fosamax, she responded, “You will be on it for the rest of your life.” It’s ironic, because I had brought along my copy of “Save Our Bones” and also asked her to check out the website. She flipped through the pages and said,”You have to be careful of information on the web.” (True, but we all know it is a tool to help us be proactive, right?!) Incidentally, I had already been on Fosamax for nine years! My Mom, at 87, broke her femur a year ago, and she has always had favorable density tests, and never taken any bisphosphonates.
    I voluntarily stopped the Fosamax last September, after 10 years. Now I have to do the hard work, diet and exercise!

    • Vivian Goldschmidt, MA July 24, 2012, 3:44 pm

      Guinea pigs with bigger brains! It’s never too late to stop the drugs :)

  17. PC July 24, 2012, 10:42 am

    ODANA? How close can you get to ….. “OBAMA” ??
    I am a retired veteran. Just when you think you’ve seen all the fraud out
    there, you quickly learn that “You ain’t seen nuthin yet!”

    • Deborah Willis July 24, 2012, 11:50 am

      Stop “hating” for no reason. Someone’s color is not a ‘reason”.

      • Mardi July 24, 2012, 1:14 pm

        I doubt PC’s comment had anything at all to do with “color”! Why’d you jump to that conclusion? PC noted the similarity in the spelling of the name we all know. If I misunderstood your comment, I apologize.

  18. nuala bashford July 24, 2012, 10:29 am

    i now have o.n. of jaw

    • Vivian Goldschmidt, MA July 24, 2012, 3:42 pm

      I’m so sorry that you’re yet one more victim of osteoporosis drugs, Nuala! I hope your condition will improve soon.

  19. Benita A. Smith July 24, 2012, 9:51 am

    I have been a member of the Life Extension Foundation for over twenty years. Though their monthly magazine I have read articles based on hard scientific data; the reference pages for which are always at the end of each article. I learned two very important things about osteoporosis. The first is that it is very important to make sure you take a Vitamin K supplement each day along with eating green leafy veggies that contain vitamin K. Vitamin k, along with making a cut finger clot; is necessary to be able to insure that the calcium in our blood goes into our bones and not into the soft tissue of the body like our heart, joints, kidneys, etc. The second and most improtant thing to know about osteoporosis is that consuming too much animal protein at each meal is what is the greatest cause of loseing calcium from our bones. It is not a lack of calcium in our diet that causes Osteoporosis. If consuming calcium rich foods stopped osteoporosis no one in the US would have porous bones. If anything we consume too much dairy products in this country and not enough things like broccoli and other green veggies. The people who have the highest incidents of osteoporosis of any other demographic group are Eskimos. This is due to the fact that their traditional diet is made up mainly of animal fat and protein; and they eat no green leafy vegetables. The only thing that gets strengthened by taking drugs like Fosomax are the bank accounts of the executives working for the drug companies who sell that garbage.

    • Marianne July 24, 2012, 12:37 pm

      Excellent post! What you wrote is very true! The countries with the largest consumption of dairy and animal-based products are the ones with the highest incidence of osteoporosis and other degenerative diseases of affluence like cancer, heart disease, diabetes, autoimmune diseases and obesity. The USA is in that category. Please check out The China Study by Dr. T. Colin Campbell and the movie Forks Over Knives. Milk is good for baby cows not humans! A plant-based diet is the cure for what ails this country. Also buy organic and avoid toxins. In the long run, you will save money.

      Bisphosphonates are poisons that the doctors prescribe because they do not know what is causing loss of bone density in the first place, if it really is a loss of bone density and not just normal aging. Check out The Myth of Osteoporosis by Gillian Sanson and Overdiagnosed by Dr. H. Gilbert Welch.

  20. Carol July 24, 2012, 9:24 am

    Thanks for the info. You sent me info on Chinese acupuncture , but the web site wasn’t listed. I want to get more info on Chinese healing.

  21. Avis Mawson July 24, 2012, 9:13 am

    I found this article very interesting but unfortunately I couldn’t get the “click” to work to tell me more about Traditional Chinese Medicine.

    As for the new drug just introducted – from the experience I had with the other drugs I wouldn’t touch it with a “ten foot pole” Keep up the good work Vivian – we depend on your information to keep us from committing “drug suicide”

  22. R Mackay July 24, 2012, 8:37 am

    Just wanted to add my thanks to you for your invaluable work.

    • Vivian Goldschmidt, MA July 24, 2012, 3:41 pm

      You’re very welcome!

  23. Celestina Marie July 24, 2012, 7:58 am

    Thank you once again Vivian for the info to keep us informed. The only advance and improvement that comes from these drugs is to line the pockets of the drug companies at the expense of our health. No thank you!

  24. Larry Moore July 24, 2012, 7:36 am

    Hi Vivian

    Is this program just geared for women or is it for both men and women?

  25. Ita July 24, 2012, 5:23 am

    Thank you,Ita.

    • Tee Justice July 24, 2012, 7:08 am

      Thank you for updating us on Merck’s soon-to-be released osteoporosis drug. I believe another important issue for Merck is to have a drug READY for the baby boomers, who are beginning, and will continue, to “flood” their market. Ladies, we gotta keep moving – exercise that body – stop eating those sweets – and pray that we never have to subject ourselves ever again to these poisons. I took Boniva for 1 year and my bone density had worsened. I’m trying to keep the pH up, eat fruits and veggies, and exercise!

      • Vivian Goldschmidt, MA July 24, 2012, 3:40 pm

        Amen!

      • Marianne July 24, 2012, 8:28 am

        Tee, I highly recommend that you and everyone else read The China Study by Dr. T. Colin Campbell. A whole food plant-based diet is the answer to avoiding osteoporosis and the other diseases of affluence, cancer, heart disease, diabetes, and all of the autoimmune disorders. The Standard American Diet is hurting us and the global environment. It is bankrupting our citizens and our nation. I love what Vivian is doing for us! Thank you Vivian! The drug companies and Big Ag need to be stopped. :-)We do not need to be sick! Also check out Forks Over Knives, the movie.

        • Sue July 24, 2012, 12:56 pm

          “Forks Over Knives” is in book form too. Your library should have it. A must see/read!

  26. Feona July 24, 2012, 4:27 am

    Same old same old, then. It’s not the good it can do, it’s the profits it will generate. No thanks.

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