Should You Trust Drug “Approvals” By Government Agencies?

It takes confidence to go against “doctor’s orders.” But when you have empowering knowledge and truthful information, it’s easier to stand firm in your convictions to go drug-free.

The fact is, despite dozens of costly tests that should bring reassurance of a drug or chemical’s safety, the FDA stamp of approval does not mean the substance is safe.

In today’s post, we’re going to explore why this is so, and how you can arm yourself with “ammunition” against the relentless pressure to take osteoporosis drugs.

Savers Know Osteoporosis Drugs Are Dangerous

Those who embark on the Save Our Bones Program usually do so because they want to improve their bone health and avoid or go off of osteoporosis drugs. But we receive many e-mails and comments from those who need reassurance in the face of their doctor’s persistent pressure to take the drugs.

Let’s start with a look at …

How The FDA Drug Approval Process Works

It takes years to get a drug completely approved. The average time is 12 years from lab to pharmacy, and the cost is around $350,000,000 per drug.

What happens during those 12 years? The company that develops the drug spends between 3 and 4 years testing it in the laboratory on animals and/or in vitro. Then the company can apply to the FDA for permission to perform tests on humans.

The human testing phase is threefold. In the first phase, a handful of volunteers determine if the drug is “safe” (phase 1 only lasts about one year). In the second phase, more volunteers (around 200) assess effectiveness. And finally, several thousand patients are given the drug in doctor’s offices and hospitals, and monitored for adverse reactions.

At this point, the drug company applies for FDA approval, which takes several years.One would think that so much time, money, and effort would yield safe products.

But sadly, many of those tests and trials are skewed in favor of Big Pharma so they can push their drug through to market. In other words, all tests may very well be biased in the drug company’s favor. The truth only comes out when people are harmed or die untimely deaths as a result of taking the drug. And even then, as you will read next, some drugs stay on the market for decades or never get recalled at all.

Drugs Get Pulled From The Market After FDA Approval

It’s nothing short of terrifying to consider the drugs that have been pulled from the market after being approved (sometimes for decades), especially when you discover the reasons. There are 35 drugs that make the “pulled after approval” list; here are a few to give you an idea.

  1. Vioxx (Rofecoxib): NSAID pain reliever approved and on the market from 5/20/99 to 9/30/04 (a little over 5 years). Pulled because of increased heart attack and stroke risk; around 27,785 heart attacks and sudden cardiac deaths attributed to Vioxx. How tragic, considering there are natural, drug-free ways to manage pain.
  2. Propulsid (Cisapride): Prescribed for nighttime heartburn and GERD. On the market from 1993 to 2000 (7 years). Pulled due to 270 cases of cardiac arrhythmias and 70 associated deaths.
  3. DES (Diethylstibestrol): A synthetic form of estrogen prescribed to prevent miscarriage, premature labor, and other problems in pregnancy. On the market from 1940 to 1971 (31 years). Recalled due to cancer of the cervix and vagina, birth defects, and other hormonal disruptions and complications, even among grandchildren of women who took DES. Babies born to mothers who took DES showed an increased risk of breast cancer after 40. How heartbreaking!
  4. Selacryn (Tienilic acid): Prescribed for high blood pressure; on the market from 5/2/79 to 1982 (3 years). Recalled due to liver and kidney damage, including 36 deaths. Sadly, in April, 1972 (prior to the drug going on the market), Selacryn’s developer sent a report to the drug manufacturer, SmithKline, warning of its liver-damaging potential. SmithKline apparently ignored the report and, years later, plead guilty to failing to file reports with Selacryn.
  5. Quaalude (Methaqualone): Sometimes marketed as Optimal, Sopor, Parest, Somnafac, and other names. Quaalude was on the market for a shocking 23 years, from 1962 to 1985, even though it caused mania, seizures, vomiting, convulsions, and death.

The tragedy of all this is, drugs do not cure any of these conditions. They simply mask the symptoms, and the underlying cause or causes of the problem go unchecked. People are literally risking their lives to relieve symptoms, while safe, drug-free methods exist to treat the actual cause.

Dangerous “Approved” Drugs And Substances Are On The Market Today

While 35 deadly and/or dangerous drugs is 35 too many, there are also quite a few drugs that are candidates for recall but are still on the market. An example of this is calcitonin salmon, an osteoporosis drug approved in 1970 (44 years ago!) and still available for prescription…despite an FDA panel’s advice that calcitonin salmon is not effective at increasing bone density or reducing fractures, and may in fact increase cancer risk.

And it’s not just drugs that are approved as “safe” by the FDA for human use. Some chemical additives also undergo the approval process before finding their way into the food, cleaning, and beauty industries.

Then, after years of exposure, the harmful effects are suddenly “noticed.” Clinical trials may show alarming side effects, but the FDA ignores the findings. An excellent example of this travesty is the antibacterial chemical, triclosan.

Triclosan: Approved For More Than 10 Years, But Now Linked To Cancer Growth

Used in antibacterial soaps, cleaners, children’s toys, kitchenware, and Colgate Total toothpaste, triclosan began its journey into the FDA’s approval process in 1972, when Congress passed a law that required the FDA to publish guidelines for antibacterial chemicals.

A lack of scientific testing proving safety didn’t stop the FDA from writing a rough guideline for the use of triclosan in hand soap and other washes in 1978, noting that triclosan was not recognized as safe and effective.

But that didn’t stop manufacturers from using it in their products, which they had already been doing for years.

Decades went by, and the FDA published several other drafts tweaking the guidelines for triclosan use; but nothing was ever finalized. Yet in the midst of all this, the FDA approved triclosan for use in toothpaste when Colgate-Palmolive Co. showed data that triclosan fought gingivitis.

Fast-forward to summer 2012, when the FDA said its review of triclosan would finally be done (40 years after the Congressional requirement!). Guess what? Despite claims that reviewing triclosan would be a “top priority,” it still hasn’t happened.

While the FDA’s website says that triclosan is “not known” to be dangerous to humans, this is just clever wordplay. The issue is whether a substance or drug has been proven safe.

And when it comes to synthetic chemicals, there is no such thing as 100% safe.

Meanwhile, Scientific Studies Show The Harmful Nature Of Triclosan

There is ample scientific evidence that triclosan is a very dangerous chemical. A revealing study shows that triclosan promotes human breast cancer cells in vitro, and it also stimulates breast cancer tumor growth in mice.1

The reason is that triclosan is an EDC, or endocrine-disrupting chemical. EDCs are sadly prevalent in the environment and our bodies, where they act like hormones and, in the case of triclosan, actually disrupt the genetic code of breast cancer cells, causing them to proliferate and become larger and denser.

That’s not all. Another study published by the American Society for Microbiology found that triclosan promotes the growth and colonization of Staphylococcus aureus bacteria in the human nose, setting the stage for stubborn infections.2

Triclosan Causes Cancer And Fibrosis Of The Liver In Mice

Scientists at the University of California, San Diego School of Medicine found that long-term exposure to triclosan can cause some serious health problems. The molecular methods used on the laboratory mice are relevant to humans; study leader Robert H. Tukey, PhD noted that triclosan presents “…a very real risk of liver toxicity for people, as it does in mice.”3

The mice were found to have compromised liver function and disrupted liver integrity after triclosan exposure for 6 months (this would be approximately 18 years in humans). In response to triclosan’s disruption of a key detoxifying protein, the stressed livers produced extra cells that became fibrotic. Eventually cancerous tumors formed.3

A Stressed Liver Is A Serious Matter

When you don’t have any immediate signs and symptoms, it can be hard to appreciate the possible consequences of an overtaxed liver. But the fact is, toxin exposure is just about impossible to avoid, so your liver is working harder than you realize.

This is why I follow OsteoCleanse™, the 7 Day Bone Building Accelerator at least twice a year. Like many Savers, I recognize that even if I am very careful about toxin exposure (thankfully, I’ve never taken osteoporosis drugs!), chemicals are pretty much everywhere and it’s therefore impossible to completely avoid them.

If you’re reading this, chances are you’re searching for bone health options that do not involve drugs. Maybe you want to break free from osteoporosis drugs, or perhaps you are looking for a way to regain your youthful bone health without turning to dangerous medications.

That means you’re inquisitive and doing your own research, for which I applaud you! As you gain knowledge and gather information, you will soon learn whom you can trust: yourself.

You see, that’s part of developing your bone health philosophy: learning to trust your own scientifically-backed, knowledgeable convictions.

If your research and insight lead you to make the decision to ditch the drugs (or remain) drug-free, I encourage you to take a look at OsteoCleanse™. If you’ve taken bisphosphonates or other osteoporosis drugs and would like to stop, this is a perfect time to turn the clock back on your liver (and your bones!).

In just 7 days, OsteoCleanse™ shows you exactly how to cleanse and detoxify your liver, so you can build and heal your bones more efficiently to see quicker results. Plus you’ll feel more energy and you’ll look healthier once you get rid of the harmful toxins.

To learn more, please click here.

Here’s to the empowerment of knowledge!

References

1Lee, Hye-Rim, et al. “Progression of Breast Cancer Cells Was Enhanced by Endocrine-Disrupting Chemicals, Triclosan and Octylphenol, via an Estrogen Receptor-Dependent Signaling Pathway in Cellular and Mouse Xenograft Models.” Chemical Research in Toxicology, 2014; 140408123000001 DOI: 10.1021/tx5000156. Web. http://www.sciencedaily.com/releases/2014/04/140423102756.htm

2 Syed, Adnan K., et al. “Triclosan Promotes Staphylococcus aureus Nasal Colonization.” mBio, 2014; DOI: 10.1128/mBio.01015-13. Web. http://www.sciencedaily.com/releases/2014/04/140408074944.htm

3 Mei-Fei Yueh, Koji Taniguchi, Shujuan Chen, Ronald M. Evans, Bruce D. Hammock, Michael Karin, and Robert H. Tukey. “The commonly used antimicrobial additive triclosan is a liver tumor promoter.” PNAS, November 17, 2014 DOI: 10.1073/pnas.1419119111. Web. http://www.sciencedaily.com/releases/2014/11/141117154612.htm

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15 comments. Leave Yours Now →
  1. Patricia snow July 18, 2016, 2:36 am

    I have used reclapse for 2 years now. I started having severe hip and lower back pain after the second treatment. The pain comes and goes. Sometimes every step I take hurts. I have a prolapsed disc in my lower back but I am sure my pain doesn’t come from that. I will never take another reclapse infusion.

  2. dallas haddox April 20, 2016, 8:14 pm

    Excellent commentary – Just to add my thoughts if you a RI DoT RI-1040 , my secretary saw a sample version here http://goo.gl/XAhx87.

  3. Maxime July 23, 2015, 5:53 am

    I can’t hear antnyihg over the sound of how awesome this article is.

  4. JLynn April 6, 2015, 4:25 pm

    Now things are making sense! Back In 2012 I was diagnosed with severe osteoporosis. I had the bones of a 70 year old, but was only 50.

    In 2014 my organs were beginning to shut down and extreme risky surgery was needed. A 20lb tumor in my liver was removed. Over the years the tumor grew and destroyed the entire large lobe of my liver, which was also removed along with the gallbladder.

    It will be interesting to see if my bone density improves as my body recovers from years of liver trauma.

  5. Leslie (Ms. L. Carmel) December 5, 2014, 10:33 pm

    Good Evening Vivian And Karen,

    It’s Great To Know That The Save Our Bones Program Can Help Your Joints As Well As Your Bones.

    It’s Also Good To Know That The OsteoCleanse Will Cleanse And Detoxify The Liver.

    Thank You All Very Much, In Advance, For Your Help, And Very Good Advice.

    ALL THE BEST TO ALL OF YOU,
    LESLIE (MS. L. CARMEL)

    Thank You Both Very Much For Both Your Help And Your Comments.

  6. Alice Russell December 1, 2014, 6:16 pm

    I agree with Joanne, Dec. 1. I do not like to download books either. There are several on my computer now. It takes lots of ink, including colored ink, and prints every page while there are many I would prefer to skip to save ink and paper. I would rather pay extra to get the printed version in the mail. I’d now be using those that are still sitting on my computer.

  7. diana December 1, 2014, 3:09 pm

    So sorry to change the subject…..But I would like to know about green tea. Is it good or bad for your bones? Read it’s good for maintaining healthy breasts.

  8. Karen December 1, 2014, 2:03 pm

    Is your bone density excercise program good for your joints too? Is there a natural protocol for maintaining heathy joints?

    • Vivian Goldschmidt, MA December 1, 2014, 3:48 pm

      Hi Karen,
      In most cases, arthritis is either caused or aggravated by too much accumulation of acid residue in the joints (mainstream medicine confuses this with “aging”). Reducing acid residue and bringing the proper acid/alkaline balance to the body is precisely what the Save Our Bones Program is designed to do! Interestingly, I’ve found that many in the Save Our Bones community experience relief from arthritis when on the Program, even though it’s specifically for bone health.

  9. Joanne December 1, 2014, 1:21 pm

    I would like to acquire both Osteocleanse and Densercise, but I really don’t like the e-book format for many reasons. Could you please make both of them available in a softcover or hardcover print format? I would then get them in a heartbeat! I know that I am not alone in this matter

    • Sylvia December 2, 2014, 1:17 pm

      My thoughts, exactly!

  10. Linda December 1, 2014, 12:23 pm

    Thank you for the information about Triclosan in Colgate Total toothpaste. One of my family members is currently using it but it will now be replaced. Greatful for the awareness you have brought into my life about this and drugs for bone density. I refuse to take them even though doctors have tried to give them to me. Following your advice has helped and finding the right integrative medicine doctor is also important. Thank you again.

    • Vivian Goldschmidt, MA December 1, 2014, 1:09 pm

      You are most welcome, Linda!

  11. Mariana December 1, 2014, 11:39 am

    Hi Vivian,
    I do not know how to contact you, because I e-mail to saveourbones.com and you did not answer. I’ve paid $65 for Save our Bones program on Nov. 22nd and I did not receive the program as of today. No one answer my e-mail. Please let me know when I’ll receive the program.
    Thank you

    • Customer Support December 1, 2014, 11:54 am

      Mariana, I am sorry you did not receive our e-mail reply to you on this topic on November 24! We will be sure to contact you again – please check your e-mail for a message from us.

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