(FORTUNE Magazine) – Dr. David Graham, Boy Scout leader, devout Christian, and 20-year veteran of the Food and Drug Administration, has become the agency's most outspoken critic in the aftermath of Merck's Sept. 30 Vioxx withdrawal. Graham first gained notoriety for his estimate that Merck's COX-2 pain medication may have caused some 28,000 heart attacks. Then, in November, he criticized the FDA's drug-safety oversight in explosive Senate testimony. But all the while, the Johns Hopkins-- and Yale-trained physician has managed to keep his day job as associate director for science at the FDA's Office of Drug Safety. This January, Dr. Graham, 50, will publish a controversial paper in the medical journal The Lancet upping his estimate of Vioxx-induced heart attacks to roughly 100,000. (He claims that the FDA initially tried to suppress his report.) Graham talked to FORTUNE's John Simons about the FDA, Vioxx, and the future of drug safety.

Why do you believe the FDA tried to prevent a public airing of your conclusions?

I'm hitting too close to home. Vioxx illustrates quite graphically how defenseless the U.S. is against unsafe drugs.

Has this ever happened before?

Yes, there have been efforts to suppress and intimidate. I've been instrumental in getting ten drugs off the market, but the FDA's pushback on Vioxx was more intense than I've experienced with other drugs.

Why did you wait to go public?

The issue wasn't serious enough to attract the attention of Congress. The Senate Finance Committee initiated an investigation. They called me to testify. Since then, what compelled me was my conscience. It's the FDA that's basically responsible for 100,000 people having heart attacks and as many as 55,000 people dying of those heart attacks. The FDA alone had the power to prevent that from happening.

But what about Merck, Pfizer, and others that sold--and still sell--COX-2 medicines?

That's a fair question. I've avoided answering that because I don't know what the industry knew and when they knew it. There were always theoretical concerns about COX-2 inhibitors. And if what we heard in Senate testimony is correct--that Merck tried to design some of its studies to obscure, lessen, or hide the cardiovascular risk of their drug--to me, that's a concern. But the organization that has a public obligation and responsibility to deal with that is the FDA. In my view, the FDA should not have approved Vioxx. The FDA really let the public down.

So you believe the FDA sides with industry rather than consumers?

The people at the FDA's Center for Drug Evaluation and Research invest a lot of themselves and their time helping a company get a drug approved. There's a big sense of ownership in the drug for them. It's like their child. If someone comes along and says little Johnny did something bad, their response is, "Little Johnny would never do that." There's a conflict of interest there. The people who approve a drug cannot be relied upon to regulate it once it's on the market. It's just asking too much of human nature.

In light of all that, what's your recommendation for FDA reform?

The culture of the FDA is so focused on the approval of products that its safety function needs to be removed. A separate agency of product safety should be created.

Do you still have a future at the FDA?

It's been the roughest six months of my career, and among the roughest times in my life. The feeling I get is that I don't have a future at the FDA. The sense I get from management is that I'm an enemy, a traitor, a pariah.

What kind of guidance do you give family members on drugs to avoid?

There's something I was taught in medical school: Don't be the first to take a new drug, because the testing that's done before a product is marketed is inadequate to identify what the safety problems really are.