| According to the Journal of the American
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| | its culture that belittles safety in the
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| Medical Association (JAMA), "Adverse drug
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| | drug companies' interest.If the FDA were
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| reactions are the fourth leading cause of
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| | to pull a drug due to safety issues, it
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| death in America. Reactions to
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| | would hurt the marketing of the drug. It
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| prescription and over-the-counter
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| | might also call into question why they
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| medications kill far more people annually
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| | approved the drug in the first place.
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| than all illegal drug use
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| | Therefore, you get this culture of
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| combined."Annually, drug companies spend
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| | cover-up, this culture of suppression,
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| billions on TV commercials and print
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| | this culture of denial and this culture
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| media. They spend over $12 billion a year
| |
| | that demonstrates above all else that
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| handing out drug samples and employing
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| | industry is the client and not the
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| sales forces to influence doctors to
| |
| | American people.Loudon: Have your peers
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| promote specifically branded drugs. The
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| | turned against you?Dr. Graham: No. I've
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| drug industry employs over 1,200
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| | been very fortunate. Tom Devine at GAP
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| lobbyists, including 40 former members of
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| | has told me that the experience of a
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| Congress. Drug companies have spent close
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| | typical whistleblower is that they'll
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| to a billion dollars since 1998 on
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| | have the support of their peers but the
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| lobbying. In 2004, drug companies and
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| | peers will be so afraid of retaliation
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| their officials contributed at least $17
| |
| | that they won't express that support in
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| million to federal election campaigns.To
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| | public.I've had a very different
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| get a full diagnosis of this provocative
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| | experience. I've been basically embraced
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| story, highly acclaimed health guru Gary
| |
| | by my peers as someone who has said what
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| Null sent his lead investigator and
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| | they want to say and what they wished
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| Director of Operations, Manette Loudon,
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| | they had been able to say and that they
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| to Washington, D.C. to interview FDA
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| | recognize as the truth. They're really
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| employee and Vioxx whistleblower Dr.
| |
| | proud of the fact that I've said it and
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| David Graham. What you are about to read
| |
| | they're not afraid to be seen with me.
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| may leave you questioning the safety of
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| | They're not afraid to work with me. I've
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| all drugs, but it is a story that must be
| |
| | been pretty fortunate in that way.Now
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| told. Unless Congress steps up to the
| |
| | with management it's been another story.
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| plate and changes policy at the FDA,
| |
| | Upper management avoids me and doesn't
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| millions more will become unwitting
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| | talk to me. I could be walking down the
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| victims of adverse drug reactions from
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| | hall and I'll say hello, and they'll act
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| unsafe drugs.Manette Loudon: All of these
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| | like I'm not there. They don't give me
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| attacks backfired on them. Tell us a
| |
| | interesting work assignments. They don't
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| little bit about that. Dr. Graham: Well,
| |
| | call me in to consult on things that I
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| Sen. (Charles) Grassley (R-Iowa) and his
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| | should be consulted on even though I am
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| staff quickly realized that what they
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| | the senior epidemiologist in the Office
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| were saying about me was fabricated. The
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| | of Drug Safety with more experience than
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| editor of The Lancet also realized that
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| | any of the other people there. I'm looked
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| what the high level FDA officials were
| |
| | up to by the scientific staff because of
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| saying to him was a pack of lies. He sent
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| | that expertise.Basically, I feel like I'm
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| e-mails to them saying it looked to him
| |
| | in the Gulag.Loudon: How do you cope with
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| as if they were trying to interfere with
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| | that going to work each day?Dr. Graham:
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| his editorial process. He was very savvy
| |
| | It's difficult. It's a mind game. They're
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| to what these people were doing.Tom
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| | hoping that I'll just become very
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| Devine, as he said publicly, was very
| |
| | frustrated and disillusioned and leave or
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| interested in doing the right thing. He
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| | that I'll slip up in some way so that
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| said, "We don't want to protect somebody
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| | they can take some sort of action against
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| who's a lawbreaker and who really isn't
| |
| | me. As Tom Devine at GAP has said, I have
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| representing the truth so produce your
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| | to be "Saint David." I can't afford to
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| evidence." They had no evidence because
| |
| | make any mistakes.That's very difficult
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| there is no evidence. But I produced my
| |
| | and it is a little bit discouraging. But
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| evidence. I showed him all the
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| | I've been a target of retaliation in the
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| documentation, all the emails, and the
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| | past. You take 10 drugs off the market
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| reports that I've written. They flunked
| |
| | well, no good deed goes unpunished at the
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| every test and I passed every test.In all
| |
| | FDA. I've experienced retaliation with
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| of the criticism I have received relating
| |
| | many of those other episodes but not as
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| to Vioxx and drug safety, they've never
| |
| | severe as what I've experienced with
|
| attacked the work or the science that
| |
| | Vioxx.This is the first time that my job
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| I've done or the results that I've come
| |
| | was actually in jeopardy and where the
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| to. What they've done is call me names.
| |
| | FDA actually intended to fire me. That
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| The ad hominem attack is the last refuge
| |
| | was stopped only because Sen. Grassley
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| of the indefensible. They don't have an
| |
| | intervened. He put the heat on the FDA
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| argument that's substantial.They know
| |
| | and told them, "Lay off. This guy has
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| that they're vulnerable. They know that
| |
| | told the truth. He's helped America.
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| they've disserved the American people.
| |
| | Whose side are you on?"Crusadorwould like
|
| The FDA is responsible for 140,000 heart
| |
| | to thank Manette Loudon and Pam Klebs for
|
| attacks and 60,000 dead Americans. That's
| |
| | their help in putting this interview with
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| as many people as were killed in the
| |
| | Dr. David Graham together.Crusadoris a
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| Vietnam War.Yet the FDA points the finger
| |
| | hard-hitting, in-depth health publication
|
| at me and says, "Well, this guy's a rat,
| |
| | that cuts through the health lies that
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| you can't trust him," but nobody is
| |
| | are so prevalent in our world
|
| calling them to account. Congress isn't
| |
| | today.Crusador is published every two
|
| calling them to account. For the American
| |
| | months. To obtain a free sample or to
|
| people, it's dropped off the radar
| |
| | subscribe to this one-of-a-kind
|
| screen. They should be screaming because
| |
| | publication, visit their Web site. >
|
| this can happen again.Loudon: On CNN with
| |
| | Dr. Mercola's Comment: Dr. David Graham
|
| Lou Dobbs you said that there was a
| |
| | has also helped write new legislation
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| certain "culture" that exists at the FDA.
| |
| | called the Grassley Dodd Bill that is
|
| Can you explain what you meant by
| |
| | currently held up in committee. It is a
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| that?Dr. Graham: The FDA has a very
| |
| | radical bill that should help transform
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| peculiar culture. It runs like the army
| |
| | the FDA back to its roots and really
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| so it's very hierarchal. You have to go
| |
| | protect the public safety. It would set
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| through the chain of command and if
| |
| | up a new independent Center inside the
|
| somebody up above you says that they want
| |
| | Food and Drug Administration (FDA) to
|
| things done in a particular way well,
| |
| | review drugs and biological products once
|
| they want it done in a particular way.
| |
| | they are on the market. The bill
|
| The culture also views industry as the
| |
| | addresses the fact that the Office of New
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| client.They're serving industry rather
| |
| | Drugs carries too much sway over the
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| than the public. In fact, when a former
| |
| | FDA's drug-safety apparatus. Today, drug
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| office director for the Office of Drug
| |
| | makers have the ability to negotiate with
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| Safety criticized me and tried to get me
| |
| | the FDA officials who approved their
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| to change a report I'd written on another
| |
| | drugs to begin with when the FDA
|
| drug -- Arava -- he said to me and to a
| |
| | considers corrective action. By creating
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| colleague who was a coauthor on this
| |
| | a Center for post-market review, this
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| report that "industry is our client."I
| |
| | legislation puts you, the American
|
| begged to differ with him. I said, "No,
| |
| | consumers, where you belong at the FDA,
|
| industry is not the client, it's the
| |
| | and that's front and center.I don't ask
|
| American people, the people who pay our
| |
| | you to write your congressman frequently,
|
| taxes. That's who we're here to serve."
| |
| | but this one is worth it. You can help
|
| He said, "No! Industry is our client." I
| |
| | save some lives by helping to increase
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| ended the conversation by saying, "Well,
| |
| | pressure to change the way the FDA is
|
| industry may be your client, but it will
| |
| | run. The drug companies do NOT want this
|
| never be my client."Another aspect to the
| |
| | bill passed and they have the largest
|
| culture at the FDA is that it overvalues
| |
| | lobby in Congress so we really need all
|
| the benefits of drugs and undervalues the
| |
| | the help we can get.You can find out how
|
| risks of drugs. And so the FDA will
| |
| | to contact your Congressman by going to
|
| always say to you, "Well, we're leaving
| |
| | the following URL: All you need to do is
|
| this drug on the market because the
| |
| | write a simple short note telling them
|
| benefits exceed the risks." Well, the FDA
| |
| | how you feel the FDA is critically broken
|
| has never assessed the benefit of any
| |
| | and you believe that the new proposed
|
| drug that it's ever approved.It works on
| |
| | legislation would really help improve
|
| what's called efficacy. Does the drug
| |
| | that.If you want to review the entire
|
| work or not? Does it lower your blood
| |
| | bill, it is up on the site. Related
|
| pressure or does it lower your blood
| |
| | Articles: The FDA "Foxes" Keep Guarding
|
| sugar? Not, does it prolong your life?
| |
| | the Drug Safety "Henhouse"Testimony of
|
| Does it prevent you from having a heart
| |
| | David J. Graham, MD, MPHVioxx Reapproved
|
| attack?Those are benefits. All they focus
| |
| | by FDA Panel Members With Ties to Drug
|
| on is efficacy.For example, ask the FDA
| |
| | CompaniesDr. Mercola is the founder of
|
| why on earth they didn't ban high dose
| |
| | Mercola.com, one of the world's most
|
| Vioxx after the VIGOR Study showed in
| |
| | visited and trusted health websites, and
|
| early 2000 that it increased the risk of
| |
| | publisher of the free e-newsletter -- the
|
| heart attack by 500 percent? High-dose
| |
| | #1 dietary health and wellness newsletter
|
| Vioxx was approved for the short-term
| |
| | on the Web with over 500,000 subscribers.
|
| treatment of acute pain. What earthly
| |
| | Dr. Mercola, a physician for over two
|
| benefit was there that exceeds a 500
| |
| | decades, is also a New York Times
|
| percent increase in heart attack risk?
| |
| | bestselling author whose latest book,
|
| Ask the FDA to produce its benefit
| |
| | "Dr. Mercola's Total Health Program,"
|
| analysis that shows that the benefits
| |
| | presents his entire renowned dietary
|
| exceed the risks. It doesn't exist.The
| |
| | health program and has sold over 150,000
|
| FDA has never looked at benefit. The FDA
| |
| | copies. He is routinely interviewed by
|
| just says to the American people, "The
| |
| | the media for his expert insights,
|
| benefits exceed the risks. Trust me.
| |
| | including CNN and ABC World News Tonight.
|
| Believe me." If you held the FDA to its
| |
| | His passion is to change the fatally
|
| proof the American people would see how
| |
| | flawed conventional medical system to one
|
| badly served they've been by the FDA and
| |
| | focused on real prevention and cure.
|