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