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Osteoporosis News: FDA Regulators Look Out for Merck, Pharmaceutical Giant Loses Lawsuit, and the FDA Makes You the Guinea Pig

osteoporosis-news

It seems there’s always news in the osteoporosis community. And it’s going to stay that way for quite some time, courtesy of Big Pharma. Today, the spotlight is (yet again) on Merck and its popular osteoporosis drug, Fosamax.

“Dear Merck: Please make a safer drug than Fosamax! – signed, the FDA”

While that’s a fictional quote, it sums up what’s going on between pharmaceutical giant Merck and the FDA. Documents from a recent legal battle have revealed that the FDA has asked Merck repeatedly for a safer osteoporosis drug than Fosamax.

Of course, Save Our Bones readers (a.k.a “Savers”) are already aware of the harmful side effects of this bisphosphonate, particularly the link between Fosamax and osteonecrosis of the jaw.

And notice the disturbingly cozy relationship between the regulators and Merck. Instead of stopping the sales of Merck’s blockbuster drug, the FDA was actually pleading with Merck to discover a “safer” drug that would replace Fosamax. The inevitable question is, who’s really in control of drug “safety”?

So watch out – now that Fosamax’s patent has expired, Merck is finally “making good” on the FDA’s request with odanacatib, which belongs to a new class of drugs known as “cathespin-K inhibitors.”

News Excerpt

“Merck has stated that odancatib will present fewer long-term safety issues than the bisphosphonate drugs due to the drug’s unique mechanism of action on bone turnover, which is slightly different than Fosamax’s mechanism.

In an April 2012 earning conference call, when asked about the commercial viability of odancatib in an already-crowded osteoporosis drug market, Merck Chairman and CEO Kenneth C. Frazier noted that there exists ‘declining use of bisphosphonate [drugs] due to some concerns that have been raised around long term safety’.  Merck expected to file for odancatib’s approval in 2013, however, Merck recently disclosed that it will delay filing the formal application for odancatib marketing approval until 2014.  At its peak, Fosamax generated $3.5 billion per year in annual sales for Merck.  In the United States, Merck has already stopped selling the 35 mg dose of Fosamax.  It is anticipated that Merck will discontinue marketing Fosamax in the United States once it receives marketing approval for odancatib.” 1

Win Some, Lose Some: Merck’s in Trouble

Over 4,000 state and federal lawsuits have been brought against this massive pharmaceutical corporation. Seven of these cases have gone to trial, and incredibly, Merck has won five of them. But Merck has recently lost two cases, and the most recent one – Scheinberg vs. Merck – puts Merck on the hot seat.

Scheinberg is a resident of New York who contends that Fosamax caused her immense suffering in the form of bone disease in her jaw following a tooth extraction. The jury ruled that Merck failed to give proper warning of the risks of Fosamax.

News Excerpt

“Lawyers for Scheinberg, a 69-year-old New York resident, contended Fosamax caused her to suffer delayed healing and a bone disease of the jaw after a tooth extraction. The jury found that Merck’s failure to warn of the drug’s risks was a cause of her injury.
‘With this victory, this litigation has a renewed purpose and a renewed focus,’ Tim O’Brien, a lawyer for Scheinberg who also represents other plaintiffs in Fosamax lawsuits, said in a statement.

The lawsuit, filed in 2008, was one of 975 pending before U.S. District Judge John Keenan in New York after a judicial panel consolidated Fosamax cases alleging jaw-related injuries.

Another 842 lawsuits alleging femur injuries are pending in the U.S. District Court in New Jersey. Other lawsuits are pending in state courts.

The only other Fosamax case that Merck has lost at trial resulted in a $8 million verdict by a federal jury in Manhattan in June 2010 for Shirley Boles, a Florida woman who alleged she developed osteonecrosis of the jaw after taking the drug.”2

Conflict of interest? Big Pharma Bankrolling Almost Half of FDA’s Annual Budget

Back in 1992, Congress gave in to the pressure the drug companies were putting on the FDA for faster approval times, and passed the Prescription Drug User Fee Act. As part of the deal, the pharmaceutical industry agreed to pay additional user fees, effectively becoming a major contributor to the FDA’s ever-growing budget.

News Excerpt

“In the 1990s, industry dollars began rolling in to the world’s pharmaceutical companies, nicknamed “Big Pharma.” Drug companies, in turn, discovered they were able to take money to influence doctors as they peddled new drugs and devices to patients.
As promised, FDA approved drugs much more quickly. And in 1997, the Food and Drug Administration Modernization Act directed the FDA to create a “Fast Track” mechanism whereby important new drugs could get to patients even sooner.

The same year, user Big Pharma fees added $87.5 million to the FDA’s annual $1.0 billion budget. To wit:

  • In 2009, the agency’s budget request was just under $2.4 billion, with $628 million of that total coming from the Big Pharma.
  • By 2012, user fees amounted to $1.33 billion, and they are projected to grow to $1.97 billion in 2013.

That means that by 2012, if approved by Congress, 44 percent of the FDA’s $2.5 billion allocation will come from Big Pharma, the very companies whose products the FDA is charged with regulating.” 3

Why let Big Pharma toy with your health and wellbeing?

You don’t have to be Big Pharma’s guinea pig, because you have a choice. With the Save Our Bones Program by your side, you have full control of your bone health without having to worry about dangerous side-effects; there’s only a healthy change for the better!

Till next time,

References

1 Cousins, Farron. “FDA To Merck: Make a Safer Osteoporosis Medication Than Fosamax.” Ring of Fire. February 11, 2013. Web. http://www.ringoffireradio.com/2013/02/11/fda-to-merck-make-a-safer-osteoporosis-medication-than-fosamax/
2 Raymond, Nate. “Merck hit with $285,000 verdict in Fosamax trial.” Reuters. February 5, 2013. Web. http://www.reuters.com/article/2013/02/05/us-merck-fosamax-idUSBRE91416H20130205
3 “FDA Fast-Track Programs for Drugs and Medical Devices.” Drugwatch. February 27, 2013. Web. http://www.drugwatch.com/fda/

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36 comments. Leave Yours Now →

  1. Ann Greenway March 18, 2013, 9:19 am

    After 11 years on Fosamax,3 wrist fx,2femur fx(2 fixators,2 titanium rods,) I fell last week while walking & have both wrists fx & a rib fx! My last fxs two years ago, i immediately stoppped Fosamax. Return visit to the Dr. this Wed. to consider rx(2 casts or maybe one cast &one fixator) The Dr. is already waving pamphlets about Forteo & Prolia at me. No,they aren’t bisphosphonates but side effects & no track record just the same. My bone density tests “aren’t so bad” they keep saying BUTmy bones are BRITTLE. HELP, any comments? Thanks, Ann

    • Vivian Goldschmidt, MA March 18, 2013, 5:10 pm

      Ann, you might benefit from doing a search of this site – just type in “Forteo” and “Prolia” in the search box at the top of the page. Then you can see every article I’ve written about these particular drugs. Then you’ll be armed with information!

  2. Valerie Saenz March 13, 2013, 11:21 am

    In my most recent visit to my doctor my T-score of my left hip went down form -2.7 to -2.9. It was recommended that i would do an infusion of Boniva followed by a once a year inyection of Reclast. Almost five years ago i underwent surgery as a consequence of renocell carcinoma, so of course i am concern about any medicines i take.

    I have started taking Ezorb in powder form a little over a month ago since those calcium pills did not agree with my stomach. I also purchased your book and try my best to incorporate fruits and vegetables in my diet. I also go the gym and do yoga.

    I would like to get your opinion on Ezorb.
    Thank you.

    Valerie

  3. Patricia Hendrick March 6, 2013, 6:59 pm

    I’ve been taking Calcium for the last year and a half. CAL-MAG 1:1 infused with mineral drops boron, vitamin C & D.and specially selected botanicals. I’ll be having a DXA scan in August. I’ve been doing most of the things you suggested, Drinking distilled water, taking vitamin D, more exercises, calcium enriched food etc. The thing that I’ve noticed is that I started to have ache in one toe and now on the other foot (same thing) hands also and left shoulder, . It’s like what I’d imagine arthritis to be. I think it’s from the calcium. I’ve ordered the TRUOSTEO that you recommended and I’m hoping this solves the problem.

  4. MS. L. March 6, 2013, 4:30 pm

    Hi Again! Vivian,

    I Just Tried To Send You Something On Alka Seltzer Plus Severe Allergy Sinus Congestion And Headache, But Was Told I Had Sent It In Before.
    I Might Have, But I Never Got An Answer To It. I Just Want To Make Sure It’s Not Hurting My Bones!

    LOVE, LESLIE (MS. L.)

  5. MS. L. CARMEL (LESLIE) March 6, 2013, 4:23 pm

    Hi! Vivian,

    Is Alka Seltzer Plus Severe Allergy Sinus Congestion And Headache Liquid Gels Bad For You? Because It Does Seem To Help Those Allergy And Sinus Symptoms!

    LOVE, LESLIE ( MS L. CARMEL)

  6. MS. L. CARMEL (LESLIE) March 6, 2013, 4:22 pm

    Hi! Vivian,

    Is Alka Seltzer Plus Severe Allergy Sinus Congestion And Headache Liquid Gels Bad For You? Because It Does Seem To Help Those Allergy And Sinus Symptoms!

    LOVE, LESLIE ( MS L. CARMEL)

  7. Carol Moore March 6, 2013, 1:48 pm

    After taking Fosamax for 2 years and a bit, 2 years ago I heard all kinds of awful things so stopped taking it after researching and found Save Our Bones. I increased my calcium, vitamin D and I was exercising at Curves 3 days a week so increased it to 5 days. When I told the Dr. I was off of it she sent me for another bone density test and it came back “Low Risk”. I was so thankful and that was after only 6 months. Thanks Vivien…..Carol

  8. Carol Moore March 6, 2013, 1:48 pm

    After taking Fosamax for 2 years and a bit, 2 years ago I heard all kinds of awful things so stopped taking it after researching and found Save Our Bones. I increased my calcium, vitamin D and I was exercising at Curves 3 days a week so increased it to 5 days. When I told the Dr. I was off of it she sent me for another bone density test and it came back “Low Risk”. I was so thankful and that was after only 6 months. Thanks Vivien…..Carol

  9. Carol Moore March 6, 2013, 1:47 pm

    After taking Fosamax for 2 years and a bit, 2 years ago I heard all kinds of awful things so stopped taking it after researching and found Save Our Bones. I increased my calcium, vitamin D and I was exercising at Curves 3 days a week so increased it to 5 days. When I told the Dr. I was off of it she sent me for another bone density test and it came back “Low Risk”. I was so thankful and that was after only 6 months. Thanks Vivien…..Carol

  10. Faye Clarkson March 5, 2013, 8:01 pm

    Tell me about it. I am due for Bone Mineral Densimositry test in May. Now the specialist appears to be looking at Calcium and Vitamin D, exercise and so on. I am way ahead of them thanks to people like you, the Vitamin D council, health books. I have refused medication before, this is one time I will definetely say no to med’s. I think my GP is very tuned in to me as a patient and acts promptly to assist me. I was aware of some problems with Fosomax, but chose to take it anyway. I was hoping it would increase my bone density and reverese osteoporosis as they stated. I think I am on the right track, Thank to God, as well as helpful people who belive in natural remeies.

  11. patty d March 4, 2013, 9:46 pm

    Is grow bone, by Garden of Life ok to take.? supposed to build bone. it has strontium in it, and my doctor told me not to take it.

  12. mary March 4, 2013, 7:01 pm

    I would like to know what drug company makes acceptable Organic Calcium? Also what multiple vitamin and mineral has adequate levels to support bone activity, that Vivian recommends?

  13. LynnCS March 4, 2013, 5:28 pm

    Since I have been improving my diet by following most of the recommendations in the Save Our Bones Program, I have been noticing my skin is better. My muscles are building better. I haven’t checked my bone density again, but am sure it’s better. Even my hair is a nicer color.

    Since I am eating a hearty, healthy diet filled with lots of plant foods, I have been able to get off all my medicines except a single dose Armour Thyroid.

    I hope everyone can get on the healthy food; make food their medicine and get off the chemical fix its. Many medical doctors and other advocates are joining in to reverse illnesses that we always thought couldn’t be reversed. You can too!

    Thanks, Vivian for bringing us all this information. You and people like you make is easier to make these changes. I’m glad I am doing it. Even being a person who can be in denial and often resistant, I’m enjoying an improved life. Lynn

    • Vivian Goldschmidt, MA March 4, 2013, 6:24 pm

      That’s so good to hear, Lynn. When you have a healthy diet and lifestyle, your whole body responds!

  14. Ben March 4, 2013, 4:36 pm

    I took Forteo for 1 year, resulting in a whopping 2% (..yes, I said 2%)improvement. The side-effects were negligible, save for an alarming increase in weight, on the order of 38 lbs. Needless to say, Forteo is no longer on the menu and my weight is now stable at 155 lbs. The doctor who saw me through a 10 hour surgery said, and I quote, ” Fosamax, my god, I wouldn’t take Fosamax !!” Needless to say, I did not take the filthy crap. She saved what was left of my bones and tht was 4 years ago. Bottom line, when 3 doctors tell you to swallow Fosamax, immediately show them the nearest door and send them through said door at high-speed. DO Your HOMEWORK!

  15. Feona March 4, 2013, 4:02 pm

    Today I had a DEXA scan and saw my consultant and for the first time in 2 years. In that 2 years I’ve been trying (more or less!) to follow your advice and now I have seen the results – for the first time in 20 years I’ve had good news.My bone density has increased at my hip and is stable at my lumbar spine. The consultant was talking about new drugs, as she knows I won’t take bisphosphonates. For each drug she named (including strontium ranelate and raloxifene) I named the side effects. ‘You’re right,’ she said. ‘The more sophisticated the drug, the worse the side-effects. I wouldn’t take them! Keep taking Vitamin D and keep on with your diet and lifestyle as you are.’ It seems some consultants are finally realizing the truth – the drug companies care only about making money, not about the terrible effect of their drugs on people.

    • Vivian Goldschmidt, MA March 4, 2013, 6:37 pm

      Feona, how wonderful that you have such a knowledgeable consultant. Let’s hope others follow suit!

  16. Rosa March 4, 2013, 1:14 pm

    I bought your book. — My sister’s recent bone scan was PLUS FOUR! She takes 100,000 units of Vitamin D2 a week, and has taken this prescription vitamin for over TEN Years. Her bone scan results increase with each test. Since I bought your book almost 2 years ago, “Save Our Bones Program”, I turned to the index TO CHECK OUT YOUR COMMENTS ON Vitamin D2. I thought that the INDEX would be at the back of the book, but i cn’t find it. All I see is some blank pages with the words NOTES at the top. Your comments on page 119 state, “Another important point is that the Vitamin D used to supplement foods is D2 (ergocalciferol) a closely related plate-derived molecule and the high dosage prescription vitamin D with 50,000 IU contains ergocalciferol as well. Some studies show that D2 does not raise blood levels as well as D3 does. …(skip a paragraph) Studies have shown yet another bonus of sunlight exposure, which is the reduction of stress, anxiety, and depression. ..Instead of a Recommended Adily Allowance, Vitamin D has an AI (Adequate Intake) guideline of 400 I.U. for both men and women aged 51 to 70 years old, and 600 IU of older than 70. In both cases, these recommendations apply regardless of sun exposure, but keep in mind that because this is fat-soluble, supplemental dosages do accumulate in the body.” page 120, Save our Bones Program. In this book, there is NO MENTION of Vitamin D2’s role in building bones, or raising Bone Scan Results. Although it mentions studies, these studies do not seem to be related to Bone density or Bone Density scores/results. Neither is there any way for me to read these articles at the local Medical School Library, since there is No footnote documentation. As mentioned in a previous email, my sister (now in her sixties) is in excellent health, works many hours a week, and babysits for her grandchildren. I am surprised that so little is said about the positive benefits of taking Vitamin D2.

    • susan March 5, 2013, 12:39 pm

      Hi Rosa I to have been taking vitamin D3 400 IU for nearly 4 yrs now I still have trouble with my back due to a fall when I went to the G P he wanted to put me on some more rubbish but I refused he wasn’t too happy about that and said takinking my D3 was not enough but I will carry on and hope for the besr Susan

  17. Rosa March 4, 2013, 12:48 pm

    PLUS FOUR, YES, My Sister’s latest bone scan was PLUS FOUR. Over ten years ago my sister had a bad fall and broke some bones. Now for ten years she had taken VITAMIN D2, — 100,000 units per week in two 50,000 capsules. It’s a prescription, not over the counter. Since then her bone scans have gone from minus something to PLUS FOUR. She says that her bone scan results increase with each test because of the vitamins. She says she knows lots of other people in her area who take the Vitamin D2 treatment. She is in her sixties, has excellent health and energy, and has started a new career working many hours a week. Are there studies about D2? Why don’t we hear more about D2? I think that many of your readers wish they had a bone density score of PLUS FOUR. Although I read your website column frequently, I haven’t heard much about taking high levels of Vitamin D2 . I have read several times that D2 was bad for you and you should take only Vitamin D3. I hope that you will comment on this vitamin.

    • Marlene March 5, 2013, 7:31 pm

      I was amazed to read your comments on vitamin D and your sisters results since being on 100,000 units per week. I am seriously considering asking my doctor for a prescription. You mentioned that other women that you know are also taking that much. Have you heard what their results are. Also, do you know of any side effects.

      Would love to hear your comments.

    • Vivian Goldschmidt, MA March 4, 2013, 6:36 pm

      Hello Rosa,
      That’s excellent news about your sister!

      In the Save Our Bones program, I touched on vitamin D2 – here’s what I wrote in the section on Foundation Supplements:

      “Another important point is that the Vitamin D used to supplement foods is D2 (ergocalciferol), a closely related plant-derived molecule and the high dosage prescription vitamin D with 50,000 IU contains ergocalciferol as well. Some studies show that D2 does not raise blood levels as well as D3 does.”

      You might enjoy this blog post on vitamin D as well:

      http://saveourbones.com/the-latest-news-on-vitamin-d/

      Have a great week!

    • Nancy Hadley March 4, 2013, 2:46 pm

      I too have become interested in vitaminD2and vitamin3 from what I read vitaminD3 goes a step farther and protects the colon. I’m trying vitamin K2 too to stop calcification of the arteries.

  18. polly haaf March 4, 2013, 12:41 pm

    I have your program….have u heard any bad news re Ezorb? Sure hope not…

  19. Karen Michael March 4, 2013, 11:57 am

    Dear Vivian: I took Actonel for 3 years after 2 different orthopedists told me I had the worst osteoperosis they had seen. Then, in a week moment I took an infusion of Reclast (even after my primary care Doc said not to because it stays in your system for about 3 years). Since then (3 years ago) I have lost 30 pounds. I had all kinds of tests done when I first started losing weight and all the test doctors told me they were sorry but couldn’t find out what was wrong. Have any of your other readers had a similar outcome? I have been eating correctly now for quite a while, green shakes and vegs, protein shakes and chicken and fish. Thanks!

  20. Crete Sham March 4, 2013, 11:13 am

    Dear Vivian, I was taking Fosamax for six years, and I could actually feel it damaging my body, especially my oesophogos – I had great duffiiculty swallowing it, and dreaded the day of the week when I had t take it! But I carried on out of fear of broken bones- One day. I just. Decided to stop, much to my doctor’s disapproval
    I was so happy to be off it, and I still feel the irreversible damage to my throat and digestive system, not that anyone would believe me!
    Soon after that I came a cross your emails, and even though I can’t afford to buy your program, I avidly await all your suggestions, and I feel eternally grateful
    God blless you
    Love
    Crete (South Africa)

    • Customer Support March 4, 2013, 12:04 pm

      Crete, may I suggest that you drop us an e-mail at customer support – just click on the smiley face icon at the top of the page. :)

  21. Terry March 4, 2013, 10:57 am

    Thanks for the update Vivian. I wonder what “side effects” will be found on the new wonder drug. It really amazes me that they are going to stop producing fosamax after this “odanacatib”comes on the market. Makes me think the have no confidence in it, or maybe confidence they can get doctors to prescribe it with its record(money). Anyway, thanks for the food for thought. You feed us well both ways. Hugs from Tenn.

  22. Jan Diamond March 4, 2013, 9:53 am

    How does Evista rank with all these Osteoporosis med’s. Is it safe? I recently was put on this medicine after years of taking a bisphosphonate……..
    Jan Diamond

  23. Lynda Brunais March 4, 2013, 8:28 am

    Dear Sue Parker,

    This drug Atelvia is just like actonel, Boniva, and Fosamax. This mediation works by slowing bone loss, but with BAD SIDE EFFECTS. It is a twin to all the others I mention. You will have severe muscle and joint pain. They call it Risedronate. The mediation belongs to the others I mention. Just another drug doing the same harmful stuff to your body. I WOULD do more research before on what you could do or take for your problem. Doctors are people like you and me. They do what the manuals direct them to do. BE PROACTIVE in your life. Research what you should do, whats best for your problem your having. The natural way is always the better way for me. Good Luck….

    • Terry March 4, 2013, 11:00 am

      Same here Sue, I took two weeks on Atelvia and totally was so sore. Every time I reached for something it was like I overextended my muscles. So glad I’m on board with Vivian’s program. I have a fighting chance!!

  24. Joy Sue Parker March 4, 2013, 7:00 am

    I have a pill waiting to be taken called Atelvia which my Doctor gawe me (sample) two weeks ago. I am going back to the Doctor tomorrow, plase try to answer before I go if possible. I was told to take it last week and haven’t as I am nervous about this kind of drug. I am having a lot of trouble and have been told if I were to fall I cold break everything. I broke my right hip 12 years ago…

    Please advise and thank you. Joy Sue Parker

    • Vivian Goldschmidt, MA March 4, 2013, 12:02 pm

      Joy Sue, I understand your concerns. Remember, your health is in your hands – it’s not your doctor who will suffer any ill effects from the medication he or she wants you to take! You’re the one who has to deal with the consequences. So I encourage you to be diplomatic and polite, but please don’t be afraid to tell your doctor something like this from the Save Our Bones program’s Doctor Dialogues:

      “Thanks for your advice, doctor. I am also quite worried about Osteoporosis/Osteopenia, and appreciate all your recommendations to help me combat this condition. But I’m also very worried about the possible side effects of the drug you are prescribing. What I’d like to do is to cautiously weigh the pros and cons, and then make my own decision. By the way, I know about a nutritional and drug-free way to conquer Osteoporosis/Osteopenia that has no side-effects whatsoever. One less thing to worry about, doctor…don’t you think?”

      I hope your appointment goes well! Be confident in your bones and in yourself! :)

  25. susan March 4, 2013, 6:50 am

    I would just like to say how lucky I have been I was on FOXAMAX for 11yrs till my cousin in RALIEGH N/C told me to get off them right away which I did, when I told my G P he was not to happy with me but I still refuesd to take them and thank the lord I did I now take herbla medicene and I am not too bad till I slipped and injurned my back and that has set me back a little but girls be careful what you take Sussan

    • Vivian Goldschmidt, MA March 4, 2013, 11:59 am

      Yes, Susan – it’s always a good idea to be careful what you take…and eat! :) Good for you for making your own decision regarding your osteoporosis treatment.

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