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Thread: Warning for Users of Spireva and Avandia

  1. #1

    Default Warning for Users of Spireva and Avandia

    Thank you to Dr. Feinerman from Stem Cell Regen Med for this information.


    YOU MIGHT WANT TO POST A WARNING ON YOUR WEBSITE REGARDING LONG TERM USE OF AVANDIA AND SPIREVA THAT NOW RECOMMEND ONLY SHORT TERM USE OF THESE AGENTS. ALSO THE USE OF AVANDIA IN DIABETICS HAS SHOWN TO LEAD TO A SIGNIFICANT INCIDENCE OF HEART FAILURE. THIS WAS ON PAGE ONE OF THE NEW YORK TIMES.
    First treatment in 2007. Pioneering ever since.

    Barbara

  2. #2
    Join Date
    Jan 2010
    Location
    Texas U S A
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    158

    Default Spiriva dangers

    What ae the dangers that Dr., Feinerman refers? I haven't gotten anything from Dr. Syed yet.

  3. #3

    Default

    The Avandia story is here:

    http://www.nytimes.com/2010/02/20/he...tml?ref=health

    I could not find anything on Spireva such as Dr. Feinerman mentions. I will ask him where the article can be located. This is the latest information I was able to find, but it's a month old, so with the FDA and drugs, it all could have changed in a month!


    FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler

    The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, ...

    Source: Food and Drug Administration
    Thursday, January 14, 2010
    First treatment in 2007. Pioneering ever since.

    Barbara

  4. #4
    Join Date
    Jan 2010
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    Texas U S A
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    Default Jan.14th report

    I had foound that report so I don't know what Dr. Feinerman found.

  5. #5

    Default Another interesting article on the Avandia situation

    ealth Freedom News From Byron J. Richards
    Avandia is Killing Americans, FDA Negligence Comes Front and Center
    Monday, February 22, 2010 - Byron J. Richards, CCN


    It appears the new FDA leadership is not much different than the last administration, as the diabetes drug Avandia killed 304 people in the third quarter of 2009 while the FDA dragged its feet. The scandal is hitting a fever pitch as the New York Times and Washington Post feature stories on a bipartisan Senate investigatory report released over the weekend. It criticizes GlaxoSmithKline for failing to warn patients years earlier that Avandia was potentially deadly. ?Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,? concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

    In reality, the FDA is sitting on several dozen of these big-selling-drug time bombs. FDA management refuses to take action in a timely manner to protect Americans. The logical conclusion as to why the FDA behaves this way is to protect the drug company, in this case GlaxoSmithKline, from a flood of lawsuits. A second reason is that the FDA management knowingly approved a dangerous drug in the first place and now looks inept (which they are) taking it off the market. Back in 2006 the FDA management (headed by cancer biotech kingpin Andrew von Eschenbach) forced their own safety expert to retract the black box warning she wanted to place on Avandia for congestive heart failure. She was then stripped of her power to make such warnings and removed from supervision of the safety of Avandia.

    The new FDA commissioner, Margaret Hamburg, doesn?t seem to have a clue. On Friday evening she said she was going to wait several more months until a new advisory committee (typically industry friendly) offered a new opinion on the issue, adding ?Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.? Is Dr. Hamburg willing to be personally responsible for all the needless deaths that occur in the meantime?

    The Senate investigation showed that FDA safety scientists conducted a report on Avandia and concluded that it should be removed from the market. Their report was ignored by FDA management, as FDA commissioner Hamburg continues to do. It is pretty obvious that GlaxoSmithKline aggressively marketed Avandia knowing that it injured and killed, reaching peak sales in 2007 of 3.2 billion. When cardiovascular concerns began coming to public light worldwide profits fell, and were just over a billion last year.

    The Senators think this problem of drug safety can be solved by placing the safety scientists in their own FDA entity, rather than having their findings overruled by managers who approved the drugs in the first place. While such a change may help, the FDA resists making such a move. I don?t think it would solve the problem.

    The only way this problem is going to get solved is if criminal penalties are given to management at Big Pharma companies who knowingly withhold safety data and then Americans die. If they were tried for involuntary manslaughter, as they should be, then this nonsense would stop. FDA managers who overrule safety findings which then result in deaths of Americans should face the same penalty ? and then the FDA management, often in a revolving door with the industry it is supposed to be regulating, would stop acting like the best friend of Big Pharma.

    Avandia is the tip of the iceberg as far as FDA-approved blockbuster drugs that are injuring and killing Americans. If not for a few Senators trying to look out for the public this information would not see the light of day. The FDA is utterly incompetent at doing the job it is supposed to be doing. It does not need more money to do its job. It needs a legal and ethics overhaul. The next question the FDA should be forced to answer is, ?How many other drugs have your safety scientists warned should not be on the market?? And what about the poisoning of our food supply with GMOs - didn?t your scientists warn they were unsafe to eat?
    First treatment in 2007. Pioneering ever since.

    Barbara

  6. #6
    Join Date
    Jan 2010
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    Texas U S A
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    Default Dr. Hamburg-FDA

    My God what a mess.
    Anything else on Spiriva? I hope not. How would we go about contacting patients that are taking Avandia? I am going to call a relative in Houston to be sure he isn't taking it. I guess one way is word-of-mouth. That is so slow. I am going to talk to my pharmacist friends to give them a headsup on it.

  7. #7
    Join Date
    Jan 2010
    Location
    Texas U S A
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    158

    Default Avandia warning

    I can't believe that I am posting this-
    I just saw on TV- an ad from a law firm stating if you or anyone you know have been given ------and suffered-------from it call-------. You may be entitled to compensation etc.
    Maybe we need to contact the law firms and give them a heads up on the dangers of Avandia. Can the people involved with the decision making in the
    FDA be sued because they didn't see to it that a warning is given out with meds and their dangers and potential side effects? If they could maybe they wouldn't be so lacksidazical about taking care of business.

  8. #8

    Default

    Everett - I think you can be assured that the lawyers are already swimming around like sharks waiting to file suits for those injured or killed by Avandia.
    First treatment in 2007. Pioneering ever since.

    Barbara

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