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.
Loudon: Do you think we should have any confidence in the FDA and, if so, can you elaborate on what they do that you feel benefits the American people?
Dr. Graham: In terms of confidence in what the FDA does, there are two things that the FDA determines when it looks at a drug: It determines whether or not a drug is safe and it determines whether or not it's effective.
Regarding the determination of drug effectiveness, I think the FDA does a pretty good job. If the FDA says that the drug will have a particular effect, probably for many of the patients who take the drug it will actually have that effect. If the FDA says a given drug will lower blood pressure and you're somebody who has high blood pressure, there's a good chance that the drug will have an effect that lowers your blood pressure. That has to do with the rigor with which they force the drug companies to establish that the drug actually has an effect.
On the safety side, I think that the American public can't be very confident. They can have some confidence because it turns out that most drugs are remarkably safe.
But, when there are unsafe drugs, the FDA is very likely to err on the side of industry. Rarely will they keep a drug from being marketed or pull a drug off the market. A lot of this has to do with the standards that the FDA uses for safety. When they look at efficacy, they assume that the drug doesn't work and the company has to prove that the drug does work.
When they look at safety it's entirely the opposite. The FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe. Well, that's a no-brainer. What company on earth is going to try to prove that the drug isn't safe?
There's no incentive for the companies to do things right. The clinical trials that are done are too small, and as a result it's very unusual to find a serious safety problem in these clinical trials. Safety flaws are discovered after the drug gets on the market.
Loudon: I read somewhere that a drug only has to be better than a sugar pill
Dr. Graham: Right. The standard that the FDA uses to approve a drug is primarily "does the drug work?" That's what they call efficacy.
Most often, they'll compare the drug against something called a placebo or a sugar pill. It's basically something that doesn't have a medical effect. The assumption is that the drug will be no different than the sugar pill. The FDA puts the onus on the drug company to conduct a clinical trial to show that the drug is different from a sugar pill. The way the FDA's approval standards are, the drug does not necessarily have to have a very great effect in order to be approved. The drug might lower your blood pressure by just a few millimeters of mercury, but the FDA will say we can approve it because it does lower your blood pressure.
Now, would that be a benefit or are there other drugs out there -- many other drugs -- that patients could take instead that would lower their blood pressure by 10 or 15 or 20 millimeters? The FDA doesn't really care about that.
What happens is the drug gets marketed. You've got two drugs that are out there -- one drug that effectively lowers your blood pressure a substantial degree and another drug that barely lowers your blood pressure at all. The company that has that second drug markets it like it's this breakthrough medicine. It lowers your blood pressure and they have all these glitzy ads, direct-to-consumer advertising. Lots of patients and lots of doctors will use that medication.
What happens in the process is these patients are actually in a sense being denied a more effective treatment because the FDA doesn't require that drugs that come on to market be at least equivalent to, or better than, the drugs that are already there.
All they have to do is be better than a sugar pill.
Loudon: When you consider the financial impact your whistle blowing has had on the pharmaceutical industry do you have any fears that your life may be in jeopardy?
Dr. Graham: I have tried not to think about that. In the work that I've done, I've never really thought about what the financial impact would be on any particular company. I put that out of my mind because my primary concern is whether or not the drug is safe. If it's not safe, how unsafe is it and how many people are being hurt by it?
In terms of when I identify an unsafe drug, to me it doesn't really matter what drug company it is. I've helped to get 10 different drugs off the market, and they're from 10 different drug companies. It's not a vendetta against any particular drug company. I have to hope that the drug companies don't take it personally. I'm just a scientist doing my job, and I have to leave the rest to God to protect me.
Loudon: Has anyone tried to silence you and stop you from becoming a whistleblower?
Dr. Graham: Prior to my Senate testimony in mid-November of 2004, there was an orchestrated campaign by senior level FDA managers to intimidate me so that I would not testify before Congress.
This intimidation took several forms. One attack came from our acting center director who contacted the editor of the Lancet, the prestigious medical journal in the United Kingdom, and intimated to the editor that I had committed scientific misconduct and that they shouldn't publish a paper that I had written showing that Vioxx increases the risks of heart attack. This high-level FDA official never talked to me about this allegation. He just went directly to the Lancet.
The second attack was from other high level FDA officials who contacted Sen. (Charles) Grassley's (R-Iowa) office and attempted to prevent Sen. Grassley and his staff from supporting me and calling me as a witness. They knew that if they could disarm Sen. Grassley that would neutralize me.
The third attack came from senior FDA officials who contacted Tom Devine, my attorney at the Government Accountability Project, and attempted to convince him that he should not represent me because I was guilty of scientific misconduct; I was a bully; a demigod; and a terrible person that couldn't be trusted.
These people were posing as whistleblowers themselves ratting on another whistleblower. Some of these senior level FDA officials were in my supervisory chain and are people I work for. They were involved in a coordinated attempt to discredit me and to smear my name and to prevent me from giving testimony.
There's one other thing that happened the week before I testified. The Acting Commissioner of the FDA invited me to his office and offered me a job in the commissioner's office to oversee the revitalization of drug safety for the FDA if I would just leave the Office of Drug Safety and come to the Commissioner's Office. Obviously, he had been tipped off by people in the Senate Finance Committee who are sympathetic to the FDA's status quo that I was going to be called as a witness.
To preempt that, he offers me this job, which basically would have been exile to a fancy title with no real ability to have an impact. This was a conspiracy and it was coordinated and there was collaboration among senior level FDA officials.
What a mess!
Crusador would like to thank Manette Loudon and Pam Klebs for their help in putting this interview with Dr. David Graham together.
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:
All you need to do is write a simple short note telling them how you feel the FDA is critically broken and you believe that the new proposed legislation would really help improve that.
If you want to review the entire bill, it is up on the site.