FDA post-approval clinical trials for pills, policies?
I'm sure it's reported elsewhere, but yesterday's Boston Globe carried a story of House Appropriations Committee approval of an amendment by Rep. Rosa DeLauro (D-CT) to the FY07 agriculture appropriations bill scheduled for House debate next week. DeLauro's amendment would give the US Food and Drug Administration authority to compel drug makers to conduct clinical trials of drugs after they've been made available for consumer use. The amendment stemmed from a recent General Accounting Office report criticizing FDA's post-marketing drug safety efforts.
FDA has requested post-approval trials for 73% of new drugs the Agency approved from 1988-2003, but two-thirds of those trials have not been completed, GAO found. Over the past decade, there have been a number of FDA-approved drugs that have been determined to have unexpected adverse side-effects forcing their approval to be rescinded or to have been found to be ineffective.
While Congressmen can disagree whether FDA has enough authority already, and PHARMA may counsel patience in awaiting the results of these long-term trials, it's pretty much agreed that government health regulators are human and despite their expertise, they cannot always make the right call in recommending approval of a particular pharmacologic intervention. Some system of reconsidering the safety and effectiveness of the approved pills must be done afterwards to make sure they work as intended and improve health outcomes.
If it's true for pills, why not, then, for policies?
Of course, the example is salt. A quarter century ago, FDA led the charge encouraging a non-pharmacologic intervention for every American -- eat less salt. It was a policy, not a pill, but the question remains: was FDA approval of this non-pharmacologic intervention safe and efficacious? What post-approval clinical trials have been done to show that it has worked and improved health outcomes as predicted -- lowering the incidence of heart attacks and reducing cardiovascular mortality? After all, it was deemed so important that no trials could be undertaken at the outset -- "everyone" knew it would work and repeatedly proclaimed "at least it can't hurt anyone."
So, what now, post-approval?
Well, short answer: there's been no controlled trial. There have been 13 observational studies of the health outcomes of those who followed FDA's advice. Funny thing, though, none of them showed the American public to be better off. Heart attacks weren't reduced (some studies say the low-salt group had more heart attacks), mortality for low-salt dieters wasn't reduced (in fact, the latest study says those eating the FDA-approved 2,3000 mg/day of sodium actually died 37% more). Dreadful news for an FDA whose drug approval record is already under attack.
So, if salt reduction were a pill and not a policy, the DeLauro Amendment would compel FDA to come clean and move immediately to withdraw its approval of this intervention until a controlled trial could prove that it works and improves health. So far there's no evidence that such a trial would validate FDA's hoary determination 25 years ago.
