FDA Under the Microscope

Sunday's New York Times has long article about the problems at the US Food and Drug Administration. Although some of the problems mentioned have been reported elsewhere, before -- including this blog -- there are some things I did not know.

For example, I did not know that Newt Gingrich et. al. (part of the Contract on America) once proposed that drug companies be allowed to market their products without FDA approval!

In 1996, Republicans lawmakers led by Newt Gingrich, the house speaker, proposed legislation that would have allowed companies to market their products without agency review, gutting its oversight authority.

Everyone who thought that was a good idea ought to have to take Vioxx until they die. The main point of the article, though, is not that pro-business politicians are misguided. Rather, their main point is that incessant budget cutbacks have had unintended consequences. They point out that the FDA is responsible for oversight of about a quarter of the US economy (food, drugs, and cosmetics), yet it is a small agency by federal government standards: only 10,800 employees, with an annual budget of 1.9 billion dollars.

It turns out that the resources dedicated to monitoring drug safety have declined significantly since 1992. In part, this change resulted from the AIDS pandemic. It became apparent that something had to be done to speed up the drug approval process. Following a mostly-good idea, they decided to collect fees from the pharmaceutical industry, and use that money to speed up the approvals. That's fine, obviously. But the Industry was concerned that the amount of government money that was already going to the process would shrink. Therefore, they lobbied -- successfully -- to have the funding structured such that that could not happen:

The 1992 agreement provided that the F.D.A. could collect fees from industry only if government financing of new drug reviews, adjusted for inflation, never fell below 1992 levels (later revised to 1997 levels). This stipulation was intended by industry to ensure that its money was used to hire new drug reviewers and not simply substitute for government support of those already on staff.

But Congressional financing has lagged the agency's escalating payroll costs. To meet the "trigger" and keep fees flowing, agency officials have been forced to shift dollars from other programs into new drug reviews. This shifting has increased the agency's focus on the reviews even beyond what the drug industry had negotiated.

In 1992, the agency's drug center spent 53 percent of its budget on new drug reviews. The rest went to survey programs, laboratories and other efforts that in part helped ensure that drugs already on the market were safe. In 2003, 79 percent of the agency's drug center budget went to new drug reviews. Everything else has gotten squeezed. [...]

Since the 1992 agreement, agency officials have eliminated half of the scientists in the drug center's laboratories and starved them of new equipment. They have ended many of the agency's collaborations with academic groups that scrutinize the problems of marketed drugs. To pay for a modest in-house effort to catalog some information on drug side effects, a system called the Adverse Event Reporting System, the agency has raided furniture and travel budgets.

The article goes on to review the case of Seldane, a prescription antihistamine that was taken off the market. The FDA did testing that revealed safety problems. Now, the FDA does not have the capacity to do that kind of testing. The FDA also cannot require companies to do testing on drugs that already have been approved. They then turn to the Vioxx story:

Realizing this weakness, Dr. Graham of the agency's office of drug safety collaborated with Kaiser Permanente, a huge health maintenance organization, to check its computer records to see if those taking Vioxx had had more heart attacks. The study took nearly four years to complete. Its results became known in August [2004] and demonstrated Vioxx's dangers.

Dr. David Campen, medical director of Kaiser's pharmacy operations, said the study would have taken half the time if the agency had had the money to pay for drug monitoring programs with Kaiser or other large managed care organizations. Dr. Graham has estimated that the delay in uncovering Vioxx's dangers cost 55,000 Americans their lives, a number top officials at the F.D.A. have labeled as "junk science."

I don't know if it is junk science or not, but even if the actual number was only one-tenth of the 55,000, that would mean over five thousand people died unnecessarily over a two-year period. Now all we have to do is calculate how much of a hit those premature deaths caused to the economy, to see if the budget cutbacks were a good investment. Oh, there I go, thinking like Mr. Gingrich again...

I supposed I should go easy on the Republicans.  After all, their Secretary of Health and Human Services, Tommy Thomson, has stated that he favors the formation of a new agency that would monitor drug safety, independently from the FDA.  Too bad he's leaving.