Industry is saying there are all these lifesaving drugs that the FDA is slow to approve and people are dying in the streets because of it. That's my official job. There is nothing lifesaving there. Some of these senior level FDA officials were in my supervisory chain and are people I work for.

DR. GRAHAM: I think that PDUFA funding for the FDA is a mistake. 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. 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." What you have to do is you have to take that responsibility and power away from them and put it with the group who sees their mission as serving the public and protecting the public health from unsafe drugs. Another aspect to the culture at the FDA is that it overvalues the benefits of drugs and undervalues the risks of drugs. It doesn't exist. Basically it's a tax.

The standard that the FDA uses to approve a drug is primarily "does the drug work?" The incentive is to review and approve the drugs as quickly as possible, and not stand in the way of profit-making. I begged to differ with him. David Graham, MD, an epidemiologist is FDA’s Associate Director of  Drug Safety who, throughout his career, has been a thorn for FDA managers by identifying serious hazardous effects of FDA-approved drugs.

I believe this is biology's century. In 1999, his data helped identify the risk of liver damage from Pfizer’s diabetes drug Rezulin — which eventually was withdrawn from the market.

David J. Graham is an American epidemiologist who is the Associate Director of the Food and Drug Administration's Office of Drug Safety. His data helped identify a dangerous medicine, but he only received a letter of reprimand for not having backup slides on acetate. Vioxx's maker, Merck, conducted a big trial to prove the drug caused fewer ulcers than an older medicine did. 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? It's not saying I'm a saint, because I'm not.

David Graham is a senior scientist who works in the Office of Drug Safety within the FDA. He has rarely cried wolf--most of the medicines he flagged were eventually pulled from the market. He just went directly to the Lancet.
Do you believe the FDA can protect the public from dangerous drugs?

The major problem with Acutane® is that it's just so widely overused that it causes an enormous amount of potential harm to pregnancy exposure. When they look at safety it's entirely the opposite.

MANETTE: How do you feel about direct-to-consumer advertising? In blunt candor, Dr. Graham specifically states that the FDA is incapable of protecting Americans from unsafe drugs. I can vouch for that from personal experience. How many people are actually benefiting? The Center for Drug Evaluation!

If you are wondering why some people are hesitant about vaccines, this website will walk you through those reasons in an organized and step by step fashion. The FDA also needs to determine the post-marketing benefits of a drug.

Can you explain what you meant by that? 2019.

The difference is that either the problem isn't as serious in terms of the numbers of people that were injured or that it's a fatal reaction - they're not willing to expose themselves to retaliation by the FDA - and retaliation would surely follow. And how can health. 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. Missing, hidden and destroyed adverse event data. Missing, hidden and destroyed adverse event data. To hear Graham tell it, this is part of a systemic failure to address drug safety on the part of the FDA, a story that reaches back over the entirety of his 20-year career at the agency. They're really proud of the fact that I've said it and they're not afraid to be seen with me. The FDA didn't want patients to have that information so they refused to have signed informed consent. An  in-depth interview with Dr. Graham  was conducted in 2005 by Manette Loudon, the lead investigator for Dr. Gary Null. When industry yanks the chain whose neck is going to get tugged? We're not living in a neutral world where the information we're getting is objective and unbiased. Then at the end the auctioneer gets on and says, "You know this drug could cause…," and they rattle off 25 different things in three seconds. DR. GRAHAM: Currently, the performance evaluations for managers at the FDA are built around the drug review. 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.

All the other SSRI antidepressants are no better than sugar pills. He claims successes in removing from the U.S. market the unsafe drugs Omniflox an antibiotic, Rezulin, a diabetes treatment, Fen-Phen and Redux, weight-loss drugs, and phenylpropanolamine, an over-the-counter decongestant, and in restricting the use of Trovan, an antibiotic, to use in hospitals. My hope is that they will act decisively to reform the FDA and make the American people safer by having strong post-marketing.