In August Newsweek ran a piece on the drug industry’s suppression of unfavorable research – meaning outcomes showing that the drugs are ineffective and/or possibly harmful. The drug industry apparently is cherry-picking which of its clinical trials to publish, and disappearing those that fail to show that a new drug is effective.
But the piece didn’t ask let alone answer the money question: the connections between the medical establishment, Big Pharma and the Food and Drug Administration. There’s lots of stuff out there on the topic, but I didn’t see media pick-up from this particular piece, so I thought I would do it and embroider the theme into a hyperbolic design just this side of absurdity. What follows is my mental interview with Palmer Buckley, a founding member of the BEB Council on Scientific Social and Pharmaceutical Compliance, and one of the Food and Drug Administration’s ultra-top decision makers. I’ve taken great liberties.
JJ: Hello, Palmer. It’s nice to finally meet you.
PB: Thank you. Glad I can be of some help.
JJ: For starters, a quick question.
PB: You betcha.
JJ: I understand that in the drug review process, members of an FDA Advisory Committee are asked to meet with FDA officials to evaluate an FDA issue. Is that correct?
PB: That’s right. This is America.
JJ: And that the committees do a lot of research on new drugs: should they be approved to go on the market, should they be withdrawn from the market, should there be new labeling and restrictions and so on. How am I doing?
PB: Your nose is up.
JJ: The impression is given that it’s the advisory committees that make the decisions and it’s kind of swept under the rug that they aren’t. So who are the folks at the FDA who make the decisions?
PB: We are Tier 1 within the FDA. It doesn’t get any higher – that means responsible and good and correct. I’m not authorized to say any more because I’m not at liberty to say any more.
JJ: And maybe but. How can I put this delicately? There are disturbing indications that the FDA has commercial and financial ties to the drug companies. That there are big bucks connections between the drug business and the business – the FDA- that regulates it. I hope I’m not being crass, but what’s up with that?
PB: Don’t shortchange yourself. I thought you put that very delicately.
JJ: Sorry, I didn’t get that.
PB: I certainly receive your stimulating question. The fact that clinical trials are required is an indication of regulatory success. Drug companies are subject to oversight on an ongoing basis. The idea that a one-shot effort is a substitute for insufficient supervision is spurious – means wrong.
JJ: What would you do to have the Advisory Committees take part in the decisions about approving or disapproving a drug for sale? Right now they have no part, if I understand correctly.
PB: Absolutely. They have no part in the final decision. Only we do.
JJ: What can be done to give the Advisory Committees a part in the decision- making process?
JJ: If a company that wants to sell a new regulated drug withholds information from the clinical trials, the FDA may make the wrong decision and allow a drug to be marketed because it doesn’t have all the data.
PB: First it goes to the appropriate advisory committee, and then it goes to an ultra advisory committee. See, we’ve got redundancy built into the system up the kazoo. It’s deep. It’s embedded.
JJ: And they decide?
JJ: Your advisory committee.
PB: Are you trying to trap me? I already told you. We decide. Only we.
JJ: Who is “we?”
PB: Sorry. I’m not authorized to tell you that because I’m not at liberty to tell you that. This is America.
When we parted, Smith called over his shoulder, “Cut your grass so it’s two inches high and leave your clippings in the lawn.”
No one could have been kinder or more helpful.