Introduction to biomechanics


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

According to the Journal of the Americanculture that belittles safety in the drug
Medical Association (JAMA), "Adverse drugcompanies' interest.If the FDA were to pull a
reactions are the fourth leading cause ofdrug due to safety issues, it would hurt the
death in America. Reactions to prescriptionmarketing of the drug. It might also call
and over-the-counter medications kill farinto question why they approved the drug in
more people annually than all illegal drugthe first place. Therefore, you get this
use combined."Annually, drug companies spendculture of cover-up, this culture of
billions on TV commercials and print media.suppression, this culture of denial and this
They spend over $12 billion a year handingculture that demonstrates above all else that
out drug samples and employing sales forcesindustry is the client and not the American
to influence doctors to promote specificallypeople.Loudon: Have your peers turned against
branded drugs. The drug industry employs overyou?Dr. Graham: No. I've been very fortunate.
1,200 lobbyists, including 40 former membersTom Devine at GAP has told me that the
of Congress. Drug companies have spent closeexperience of a typical whistleblower is that
to a billion dollars since 1998 on lobbying.they'll have the support of their peers but
In 2004, drug companies and their officialsthe peers will be so afraid of retaliation
contributed at least $17 million to federalthat they won't express that support in
election campaigns.To get a full diagnosis ofpublic.I've had a very different experience.
this provocative story, highly acclaimedI've been basically embraced by my peers as
health guru Gary Null sent his leadsomeone who has said what they want to say
investigator and Director of Operations,and what they wished they had been able to
Manette Loudon, to Washington, D.C. tosay and that they recognize as the truth.
interview FDA employee and VioxxThey're really proud of the fact that I've
whistleblower Dr. David Graham. What you aresaid it and they're not afraid to be seen
about to read may leave you questioning thewith me. They're not afraid to work with me.
safety of all drugs, but it is a story thatI've been pretty fortunate in that way.Now
must be told. Unless Congress steps up to thewith management it's been another story.
plate and changes policy at the FDA, millionsUpper management avoids me and doesn't talk
more will become unwitting victims of adverseto me. I could be walking down the hall and
drug reactions from unsafe drugs.ManetteI'll say hello, and they'll act like I'm not
Loudon: All of these attacks backfired onthere. They don't give me interesting work
them. Tell us a little bit about that. Dr.assignments. They don't call me in to consult
Graham: Well, Sen. (Charles) Grassleyon things that I should be consulted on even
(R-Iowa) and his staff quickly realized thatthough I am the senior epidemiologist in the
what they were saying about me wasOffice of Drug Safety with more experience
fabricated. The editor of The Lancet alsothan any of the other people there. I'm
realized that what the high level FDAlooked up to by the scientific staff because
officials were saying to him was a pack ofof that expertise.Basically, I feel like I'm
lies. He sent e-mails to them saying itin the Gulag.Loudon: How do you cope with
looked to him as if they were trying tothat going to work each day?Dr. Graham: It's
interfere with his editorial process. He wasdifficult. It's a mind game. They're hoping
very savvy to what these people werethat I'll just become very frustrated and
doing.Tom Devine, as he said publicly, wasdisillusioned and leave or that I'll slip up
very interested in doing the right thing. Hein some way so that they can take some sort
said, "We don't want to protect somebodyof action against me. As Tom Devine at GAP
who's a lawbreaker and who really isn'thas said, I have to be "Saint David." I can't
representing the truth so produce yourafford to make any mistakes.That's very
evidence." They had no evidence because theredifficult and it is a little bit
is no evidence. But I produced my evidence. Idiscouraging. But I've been a target of
showed him all the documentation, all theretaliation in the past. You take 10 drugs
emails, and the reports that I've written.off the market well, no good deed goes
They flunked every test and I passed everyunpunished at the FDA. I've experienced
test.In all of the criticism I have receivedretaliation with many of those other episodes
relating to Vioxx and drug safety, they'vebut not as severe as what I've experienced
never attacked the work or the science thatwith Vioxx.This is the first time that my job
I've done or the results that I've come to.was actually in jeopardy and where the FDA
What they've done is call me names. The adactually intended to fire me. That was
hominem attack is the last refuge of thestopped only because Sen. Grassley
indefensible. They don't have an argumentintervened. He put the heat on the FDA and
that's substantial.They know that they'retold them, "Lay off. This guy has told the
vulnerable. They know that they've disservedtruth. He's helped America. Whose side are
the American people. The FDA is responsibleyou on?"Crusadorwould like to thank Manette
for 140,000 heart attacks and 60,000 deadLoudon and Pam Klebs for their help in
Americans. That's as many people as wereputting this interview with Dr. David Graham
killed in the Vietnam War.Yet the FDA pointstogether.Crusadoris a hard-hitting, in-depth
the finger at me and says, "Well, this guy'shealth publication that cuts through the
a rat, you can't trust him," but nobody ishealth lies that are so prevalent in our
calling them to account. Congress isn'tworld today.Crusador is published every two
calling them to account. For the Americanmonths. To obtain a free sample or to
people, it's dropped off the radar screen.subscribe to this one-of-a-kind publication,
They should be screaming because this canvisit their Web site. > Dr. Mercola's
happen again.Loudon: On CNN with Lou DobbsComment: Dr. David Graham has also helped
you said that there was a certain "culture"write new legislation called the Grassley
that exists at the FDA. Can you explain whatDodd Bill that is currently held up in
you meant by that?Dr. Graham: The FDA has acommittee. It is a radical bill that should
very peculiar culture. It runs like the armyhelp transform the FDA back to its roots and
so it's very hierarchal. You have to goreally protect the public safety. It would
through the chain of command and if somebodyset up a new independent Center inside the
up above you says that they want things doneFood and Drug Administration (FDA) to review
in a particular way well, they want it donedrugs and biological products once they are
in a particular way. The culture also viewson the market. The bill addresses the fact
industry as the client.They're servingthat the Office of New Drugs carries too much
industry rather than the public. In fact,sway over the FDA's drug-safety apparatus.
when a former office director for the OfficeToday, drug makers have the ability to
of Drug Safety criticized me and tried to getnegotiate with the FDA officials who approved
me to change a report I'd written on anothertheir drugs to begin with when the FDA
drug -- Arava -- he said to me and to aconsiders corrective action. By creating a
colleague who was a coauthor on this reportCenter for post-market review, this
that "industry is our client."I begged tolegislation puts you, the American consumers,
differ with him. I said, "No, industry is notwhere you belong at the FDA, and that's front
the client, it's the American people, theand center.I don't ask you to write your
people who pay our taxes. That's who we'recongressman frequently, but this one is worth
here to serve." He said, "No! Industry is ourit. You can help save some lives by helping
client." I ended the conversation by saying,to increase pressure to change the way the
"Well, industry may be your client, but itFDA is run. The drug companies do NOT want
will never be my client."Another aspect tothis bill passed and they have the largest
the culture at the FDA is that it overvalueslobby in Congress so we really need all the
the benefits of drugs and undervalues thehelp we can get.You can find out how to
risks of drugs. And so the FDA will alwayscontact your Congressman by going to the
say to you, "Well, we're leaving this drug onfollowing URL: All you need to do is write a
the market because the benefits exceed thesimple short note telling them how you feel
risks." Well, the FDA has never assessed thethe FDA is critically broken and you believe
benefit of any drug that it's everthat the new proposed legislation would
approved.It works on what's called efficacy.really help improve that.If you want to
Does the drug work or not? Does it lower yourreview the entire bill, it is up on the site.
blood pressure or does it lower your bloodRelated Articles: The FDA "Foxes" Keep
sugar? Not, does it prolong your life? DoesGuarding the Drug Safety "Henhouse"Testimony
it prevent you from having a heartof David J. Graham, MD, MPHVioxx Reapproved
attack?Those are benefits. All they focus onby FDA Panel Members With Ties to Drug
is efficacy.For example, ask the FDA why onCompaniesDr. Mercola is the founder of
earth they didn't ban high dose Vioxx afterMercola.com, one of the world's most visited
the VIGOR Study showed in early 2000 that itand trusted health websites, and publisher of
increased the risk of heart attack by 500the free e-newsletter -- the #1 dietary
percent? High-dose Vioxx was approved for thehealth and wellness newsletter on the Web
short-term treatment of acute pain. Whatwith over 500,000 subscribers. Dr. Mercola, a
earthly benefit was there that exceeds a 500physician for over two decades, is also a New
percent increase in heart attack risk? AskYork Times bestselling author whose latest
the FDA to produce its benefit analysis thatbook, "Dr. Mercola's Total Health Program,"
shows that the benefits exceed the risks. Itpresents his entire renowned dietary health
doesn't exist.The FDA has never looked atprogram and has sold over 150,000 copies. He
benefit. The FDA just says to the Americanis routinely interviewed by the media for his
people, "The benefits exceed the risks. Trustexpert insights, including CNN and ABC World
me. Believe me." If you held the FDA to itsNews Tonight. His passion is to change the
proof the American people would see how badlyfatally flawed conventional medical system to
served they've been by the FDA and itsone focused on real prevention and cure.



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