FDA and pharmaceuticals after supplements again

Discussion in 'Fibromyalgia Main Forum' started by grace54, Jul 21, 2008.

  1. grace54

    grace54 New Member

    From the American Association for Health Freedom newsletter-
    Abuse of FDA Citizen Petitions
    Did you know that:

    A drug company petitioned the FDA to ban a B vitamin in order to protect its own drug product?

    Or that the second largest drug company in the world is using the FDA’s citizen petition process in order to try to prevent any dietary supplement product from making weight loss claims. The company wants weight loss claims to be re-classified as disease claims!

    If you’ve been reading our efforts to stop Wyeth from working with the FDA to ban bio-identical estriol, then you’re probably not surprised that the FDA is being used to try to ban natural products.

    But did you also know that you can help keep natural, safe products on the market by simply writing Congress and the FDA and telling them you’re supportive of Vitamin B6 and that you don’t want the FDA restricting free speech?

    Act now!

    It is important that as many messages as possible be sent to the FDA opposing these petitions. Since the FDA has made it more difficult for citizens to contact them, we will be personally hand-delivering the messages. It is also important that members of Congress hear from their constituents on this important issue as well. In order to send the message to the FDA and your congressional representatives, Go to AAHF site to sign petition-www.healthfreedom.net Don’t forget to personalize your letter.

    THE DETAILS

    Medicure Pharma’s attempt to ban the natural, bioactive form of vitamin B6

    On November 30, 2007, Medicure Pharma submitted a citizen’s petition to the FDA asserting that that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) should be banned. Despite the fact that P5P most important, bioactive, natural form of vitamin B6, Medicure wants to see the product banned from sale by the US dietary supplement industry because its marketing of P5P-containing supplements undermines the company’s incentive to continue developing its drug product (MC-1).

    Dr Robert Verkerk, Executive Director of our affiliate, the Alliance for Natural Health says, “This is an astonishing development that shows just how easily pharma companies are willing to show their hand. Well I’m sorry, natural got there first! You can’t just decide to have a natural form of a product banned because it interferes with your drug patents. We’ve found two patents secured by Medicure for P5P to be used in cases of heart disease. It seems they’ve come to the same realization as millions around the world—vitamins and other natural products can be used to help protect you from chronic diseases, including heart disease.”

    A recent, large scale Japanese study, for instance, published in the Journal of the American College of Nutrition (2008 Feb;27(1): 127-36), concluded "Dietary intake of vitamin B6 was associated with a reduced risk of coronary heart disease among middle-aged non-multivitamin supplement users. Dietary folate and vitamin B12 were also suggested to be protective factors for coronary heart disease."

    Glaxosmithkline’s attempt to shut down competition from the natural products industry in the weight loss field

    On April 17, 2008, the world’s second largest drug company, GSK, along with the American Dietetic Association and the Obesity Society—both regarded by many as fronts for some drug companies — petitioned the FDA to try to prevent any dietary supplement product from making weight loss claims. The company wants weight loss claims to be re-classified as disease claims, therefore making them the sole domain of treatments with licensed pharmaceuticals. GSK’s Alli product directly competes with the wide range of dietary supplements that help support weight loss—and Alli has become the third top-selling obesity drug less than a year after its launch, despite serious side effects.

    Commenting on the GSK petition, Verkerk added, “Obesity control is a growth area for Big Food which contributes so greatly to the problem. GSK —which works in cahoots with Big Food—now wants a slice of the action and it wants to eliminate the main source of competition—the natural products industry. Consumers must engage with these petitions and have their say. The time for sitting on the sidelines is over.”

    These Latest FDA Petitions Follow the Recent Ban on Bio-Identical Estriol

    Wyeth pharmaceuticals petitioned the FDA to ban bio-identical estriol, even though bio-identical estriol is a critical ingredient in bio-identical hormone therapies, and no adverse event had ever been associated with its use. AAHF, along with our congressional allies, are currently attempting to reverse this ban. (Read more about this attack and our efforts.) Please do not let these new petitions to the FDA succeed.

    Take action today!


    [This Message was Edited on 07/21/2008]
  2. gapsych

    gapsych New Member


    I really wonder if this is a big pharma issue or making natural health remedies more accountable.

    If "natural" remedies are to be taken seriously, they need to be accountable just as in prescription drugs.

    Many people who advocate Alternative medications want the accountability.

    For example many of the natural medications that say they are for weight loss, do not help and may even be harmful to ones health.

    I take CQ110, Folic Acid, fish oil and iron. These were all recommended by my doctor. But even then, I want something to be in place that will guarantee that what I am taking is really what it says on the bottle.

    Thanks for the article.

    GA
  3. slevah

    slevah New Member

    I picked up on this about a month ago.... this is what I sent to my senators. If any of you want to use what I said, please do:

    "I request that the FDA disapprove Medicure Pharma Inc's attempt to ban P5P (MC1 or Vitamin B6). This is yet another attempt of a pharmaceutical company trying to commit widespread biopiracy, stealing all the good medicine from nature, claiming patent protection on the useful molecules, and trying to get the FDA to outlaw virtually all of the natural substances from which those medicines were first derived.

    I, as a citizen, demand that my freedom to have access to natural supplements not be taken away from me. It is time the FDA starts representing the PEOPLE, not the pharmaceutical companies. This has got to stop!

    And, yes, in a situation such as this (B6) and estriol -- it's big pharma, not a quality control issue! [This Message was Edited on 07/21/2008]
  4. tansy

    tansy New Member

    I take P5P so have a vested interest even though I live in the UK. I personally do not want to rely upon doctors, who do not have sufficient background knowledge, to understand when supplements, including the more bioavailable forms, are needed. If P5P becomes patented it will push the price up considerably.

    There have been other occassions when pharmaceutical companies have attempted to patent alternatives; fortunately they were prevented from doing so. I sincerely hope this will be the case with P5P.

    There's been an active campaign in the UK to Save our Supps; medical professionals, researchers, and politicians have been actively involved.

    tc, Tansy
    [This Message was Edited on 08/09/2008]
  5. tansy

    tansy New Member

    Hi Jam

    I am taking P5P (the converted form of B6), methyl B12, and B1 to help with nerve regeneration. I have some peripheral neuropathies and last summer experienced a 100% loss (motor and sensory) in one of my neural pathways. After doing extensive research I went back to taking P5P.

    B6, as I'm sure you know already, is necessary for many metabolic pathways; some of these pathways also require adequate Mg levels.

    tc, Tansy
  6. dragon06

    dragon06 New Member

    I agree with gapsych. There needs to be accountability in the natural and supplements world. Right now there is no way of even knowing what they print on the outside of the bottle is actually what is in the bottle. Too much room for scamming as far as I am concerned. There needs to be accountability for these natural supplements...even if that means having to get and RX for them...besides if we did get an RX for them at least then they would be covered by insurance.
  7. grace54

    grace54 New Member

    That was good Andrew.

    One point about safety in prescription medicine and supplements. We know that most drugs and supplements are made on the world market and there is no way safety can be guaranteed. Remember the lead from China issues and who knows what else in these products that have not been discovered. Does anyone think the FDA is testing these drugs for you?

    The reputable supplement companies have an incentive to keep their products as safe as possible and many of them are inspected by independent companies.They know big pharma is watching them as well to put them out of business if they can. Getting the FDA involved will mean absolutely nothing but higher prices and more control.

    Making a supplement into a prescription would mean billions of dollars in research and patents so pharma can charge you hundreds of dollars for a vitamin. Not all of us have prescription coverage so many of us could not get what we need to actually help cure us. If one is really concerned about safety just do some research on how many have died due to the particular supplement you are looking at. Then do the same research for lets say your favorite NSAID and discover how many have bled to death or died of heart attacks etc. Again who is watching out for your safety? No need to depend on anyone for safety figures as the proof is already out there.

    While chatting with my Dr. recently I told him how well and fast anti-inflammatories work but I was concerned about the nasty side effects being reported even with my occasional use. He said I too am very concerned and don't like them at all, but seldom does a patient ask about them. I had asked him if he had ever prescribed Limbrel ,the patented prescription food product anti-inflamatory that is made from plant materials and he said he never heard of it and in his little palm pilot there was no reference to it.

    So even my Dr. is not looking out for me. He is a good man and I like him,but he is in between a rock and a hard place as he knows he must prescribe the drugs even though he knows the reported harm being done on a daily basis.Most of his patients demand them and few question their safety.When a patient like myself asks for something safer, the poor Dr. has nothing to give me. Such is the doctoring of modern times.And some want these scientists to have more control, no thank you.
  8. Iam1ShadyLady

    Iam1ShadyLady New Member

    There is a product called Cumarin that does this but it's main ingredient Cumaricin (Spelling?) can be bought seperately alot cheaper. It boosts the body's natural anti-inflammatory defenses. It really works. Hubby has rhuematiod arthritis and it is the only thing that totally took away the pain and gave him range of motion.


    SHELL
  9. gapsych

    gapsych New Member


    I just want to warn you that there was someone kicked off the board because of a picture that was similar to the one you posted.

    I would hate for you to get into trouble.

    The picture is very inappropriate. I am puzzled that you would think it is funny.

    GA