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Secrets of the FDA Revealed by Top Insider Doctor: Part 3

According to the Journal of the American its culture that belittles safety in the
Medical Association (JAMA), "Adverse drug drug companies' interest.If the FDA were
reactions are the fourth leading cause of to pull a drug due to safety issues, it
death in America. Reactions to would hurt the marketing of the drug. It
prescription and over-the-counter might also call into question why they
medications kill far more people annually approved the drug in the first place.
than all illegal drug use Therefore, you get this culture of
combined."Annually, drug companies spend cover-up, this culture of suppression,
billions on TV commercials and print this culture of denial and this culture
media. They spend over $12 billion a year that demonstrates above all else that
handing out drug samples and employing industry is the client and not the
sales forces to influence doctors to American people.Loudon: Have your peers
promote specifically branded drugs. The turned against you?Dr. Graham: No. I've
drug industry employs over 1,200 been very fortunate. Tom Devine at GAP
lobbyists, including 40 former members of has told me that the experience of a
Congress. Drug companies have spent close typical whistleblower is that they'll
to a billion dollars since 1998 on have the support of their peers but the
lobbying. In 2004, drug companies and peers will be so afraid of retaliation
their officials contributed at least $17 that they won't express that support in
million to federal election campaigns.To public.I've had a very different
get a full diagnosis of this provocative experience. I've been basically embraced
story, highly acclaimed health guru Gary by my peers as someone who has said what
Null sent his lead investigator and they want to say and what they wished
Director of Operations, Manette Loudon, they had been able to say and that they
to Washington, D.C. to interview FDA recognize as the truth. They're really
employee and Vioxx whistleblower Dr. proud of the fact that I've said it and
David Graham. What you are about to read they're not afraid to be seen with me.
may leave you questioning the safety of They're not afraid to work with me. I've
all drugs, but it is a story that must be been pretty fortunate in that way.Now
told. Unless Congress steps up to the with management it's been another story.
plate and changes policy at the FDA, Upper management avoids me and doesn't
millions more will become unwitting talk to me. I could be walking down the
victims of adverse drug reactions from hall and I'll say hello, and they'll act
unsafe drugs.Manette Loudon: All of these like I'm not there. They don't give me
attacks backfired on them. Tell us a interesting work assignments. They don't
little bit about that. Dr. Graham: Well, call me in to consult on things that I
Sen. (Charles) Grassley (R-Iowa) and his should be consulted on even though I am
staff quickly realized that what they the senior epidemiologist in the Office
were saying about me was fabricated. The of Drug Safety with more experience than
editor of The Lancet also realized that any of the other people there. I'm looked
what the high level FDA officials were up to by the scientific staff because of
saying to him was a pack of lies. He sent that expertise.Basically, I feel like I'm
e-mails to them saying it looked to him in the Gulag.Loudon: How do you cope with
as if they were trying to interfere with that going to work each day?Dr. Graham:
his editorial process. He was very savvy It's difficult. It's a mind game. They're
to what these people were doing.Tom hoping that I'll just become very
Devine, as he said publicly, was very frustrated and disillusioned and leave or
interested in doing the right thing. He that I'll slip up in some way so that
said, "We don't want to protect somebody they can take some sort of action against
who's a lawbreaker and who really isn't me. As Tom Devine at GAP has said, I have
representing the truth so produce your to be "Saint David." I can't afford to
evidence." They had no evidence because make any mistakes.That's very difficult
there is no evidence. But I produced my and it is a little bit discouraging. But
evidence. I showed him all the I've been a target of retaliation in the
documentation, all the emails, and the past. You take 10 drugs off the market
reports that I've written. They flunked well, no good deed goes unpunished at the
every test and I passed every test.In all FDA. I've experienced retaliation with
of the criticism I have received relating many of those other episodes but not as
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
I've done or the results that I've come was actually in jeopardy and where the
to. What they've done is call me names. FDA actually intended to fire me. That
The ad hominem attack is the last refuge was stopped only because Sen. Grassley
of the indefensible. They don't have an intervened. He put the heat on the FDA
argument that's substantial.They know and told them, "Lay off. This guy has
that they're vulnerable. They know that told the truth. He's helped America.
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
as many people as were killed in the Dr. David Graham together.Crusadoris a
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
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
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
that?Dr. Graham: The FDA has a very radical bill that should help transform
peculiar culture. It runs like the army the FDA back to its roots and really
so it's very hierarchal. You have to go protect the public safety. It would set
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
client.They're serving industry rather Drugs carries too much sway over the
than the public. In fact, when a former FDA's drug-safety apparatus. Today, drug
office director for the Office of Drug makers have the ability to negotiate with
Safety criticized me and tried to get me the FDA officials who approved their
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
colleague who was a coauthor on this a Center for post-market review, this
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
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.




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