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FDA letters to Teva, Biogen for misleading advertising

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    FDA letters to Teva, Biogen for misleading advertising

    Have any of you seen these two letters from the FDA dated March 14, 2012? These two drug makers are being taken to task for misleading marketing of Copaxone and Avonex, specifically for overstating treatment outcomes and understating dangers. The FDA demands the two companies cease and desist in this or risk injuction, etc. Sorry, I can't recall the exact wording.

    One caveat: I found a link to these on Facebook CCSVI page......not exactly a group who supports the DMDs. Still, I plan to check this out on the FDA website. If these letters are for real, then I can't help thinking there are many of us who are being used as guinea pigs/cash cows by Big Pharma.

    #2
    I found this article, they are talking about Tysabri, but it is the same company.
    http://www.msnewstoday.com/biogen-re...-internet-ads/

    This stuff doesn't surprise me at all. Lets face it, it is all about the cash.

    Comment


      #3
      Thank you

      Thank you so much for that article. I will be taking it with me when I go to the Cleveland Clinic in April. I have been on some of these drugs and I don't want it anymore. I would like to have an MRI to see if what I am doing is working. But, they usually won't give me one unless I am on the drugs.

      We will see.

      Comment


        #4
        MSers are cash cows that can be milked indefinitely.

        The US marketplace for MS drugs exceeds $10 billion annually.

        No one is interested in researching "alternative" treatments which can not be patented.

        Low Dose Naltrexone
        Curcumin/Cinnamon/Saffron
        Vitamin D
        Calcium 2AEP
        Malic Acid / Fumaric Acid / Alpha Lipoic Acid
        N-acetyl Glucosamine / N-acetyl Cysteine.

        A lot of people make a very good living off MS and our friends who walk and bike.

        Mooo

        Comment


          #5
          FDA

          The letters are genuine--they are on the FDA website, Dated March 24th, for both Copaxone and Avonex regarding misleading ads.

          http://www.fda.gov/downloads/Drugs/G.../UCM296204.pdf

          http://www.fda.gov/downloads/Drugs/G.../UCM296666.pdf

          Comment


            #6
            Yes, they are for real! I found them when I was searching for some updated studies on the efficacy of Copaxone.

            I don't subscribe to the "vast conspiracy" theories, but it certainly makes me uneasy. I've always been a rule keeper, not a risk taker, and therefore have followed doctors' orders.

            I've always assumed there was greater risk in NOT taking prescribed treatments. Now I'm scared to take them and scared not to...
            "I don't know what the future holds, but I know Who holds the future."

            Comment


              #7
              Here's an Article from Last Summer

              regarding the cost and effectiveness...

              http://www.webmd.com/multiple-sclero...ss-of-ms-drugs

              Comment


                #8
                They were sent to me on Facebook also from the CCSVI group. I thought it was interesting that you have to actively search out this information and that it wasn't given in say Neurology Now or one of the NMSS magazines.

                I will state I am anti-DMD. But no matter where you stand on these issues you deserve to hear the whole story so that you can make an informed decision. You need to be aware that doctors are just people with a medical education that are fed information that they often don't question. And a lot of that ongoing education is provided by the drug reps. You need to be your own advocate.

                You also need to be aware of how the FDA appoval process works. Study data is self reported from the pharmaceutical companies after an enormous amount of money is paid to the FDA to look at the data and make a decision. A lot of the data on deaths from Gilenya is just now coming out.

                In an ideal world you can trust blindly. In the real world you need to have all the information so that you can make the best decision for yourself in conjunction with a medical professional who really has your best interests at heart and isn't just chasing a paycheck. When I look at the data I see things that trouble me and I decided that medication was not for me. Others may look and see a promising therapy.

                The real decision maker should be your own body. Are you responding well to the medication? Then by all means continue. If not please don't compromise your health further because someone told you to take it. We all need to remember that nothing has proven to be a stand alone solution. You can choose DMD's and still also choose a non-inflammatory diet and gentle excercise in conjunction with it.

                No one has figured MS out that I am aware of, there are a lot of self interests involved so don't take anything as a fact. Be your own self interest.
                I don't fall, the floor attacks me. The corner of the bed is in on it too.

                Comment


                  #9
                  Thanks again, knuckle, for your list of alternative meds. I am using all but Calcium 2AP and Malic acid. I think they will be next. I would also add to that list, D-Mannose for those who have bladder issues.

                  I gave up on DMDs a few years ago after some twelve years on them. I wanted to try LDN. I can honestly say i have felt better without those big drugs. This only reaffirms my decision. It will be interesting to see what comes of these letters from the FDA.

                  Comment


                    #10
                    When I started Avonex..

                    The neurologist told me they didn't know the long term effects of using it. I think he recommended it because it had just been approved for 'probable'. When I had the relapse he offered beta but only if I would use the autoject. I chose to stay with Avonex.
                    techie
                    Another pirated saying:
                    Half of life is if.
                    When today is bad, tomorrow is generally a better day.
                    Dogs Rule!

                    Comment


                      #11
                      Nance - google "calcium 2 AEP multiple sclerosis" and read my posts regarding BG12 and it's connection to Malic/Fumaric Acid.

                      Two important supplements. I was particularly impressed by Calcium 2 AEP which is used in Germany for MS. Here's a link that explains how it works:

                      http://www.nutritionreview.org/library/calcium_aep.php

                      Comment


                        #12
                        calcium 2aep ms

                        Thanks, Knuckle. I was not familiar with that calcium 2aep ms. Will definitely be looking into it.

                        Peggy

                        Comment


                          #13
                          Nance, thank you for posting this.

                          Does anyone know how seriously these warnings will be taken? It sounds as if Biogen can opt not to comply with the request.
                          MEMBER OF MS WORLD SINCE 4/03.

                          SPMS diagnosed 1980. Avonex 2002-2005. Copaxone 6/4/07-5/15/10.

                          Comment


                            #14
                            FDA Warning Letters

                            My father is an M.D. who worked for the FDA for many years in the Scientific Investigations branch of the Bureau of Drugs. I asked him to read the letters regarding Avonex and Copaxone and give us all a response. Here it is:

                            "An FDA Warning Letter might well be called a Macbeth letter; “…full of sound and fury, signifying nothing.”(Note that I did not use the full quote.) Although the bottom line of both the Copaxone and Avonex letters is that the drug subjects of the letters are “misbranded” and may thus be subject to “Further regulatory action”, which in theory might include taking it off the market, the Warning Letters are in truth the final actions. It would be extremely unusual if this were not to be the case.

                            In FDA parlance, a drug’s label is the package insert, the document which the FDA approves when the drug is approved for marketing. Both Warning Letters go into great detail concerning how drug company promotional materials go beyond the label. The Copaxone letter is the tougher of the two. It states that the web pages and meeting exhibits overstate the drug’s efficacy, present unsubstantiated claims, broaden the indication, omit and minimize important risk information, present unsubstantiated superiority claims, and omit material facts. It not only asks that the company stop using the misleading promotional material, but also that it send corrective messages to the targets of that material.

                            The Avonex letter only accuses the company of overstating drug efficacy, omitting material, and making unsubstantiated superiority claims. It asks only that the company stop using the violative promotional material and makes no request for corrective messages to the targets of that material.

                            I would venture that both companies will admit no wrongdoing, but will comply with FDA requests, and that will end the matter."

                            Comment


                              #15
                              jessiesmom, many thanks to you and your father.

                              His letter clears up a lot of questions I had.

                              Even if nothing specific gets done to correct the problem, it's somewhat comforting to know that it isn't just those of us who post on MS boards who have been troubled by the drug companies' promotional claims....
                              MEMBER OF MS WORLD SINCE 4/03.

                              SPMS diagnosed 1980. Avonex 2002-2005. Copaxone 6/4/07-5/15/10.

                              Comment

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