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