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