The Real FDA Scandal

So Members of Congress and the press are working up another panic about the state of the Food and Drug Administration. The place is a mess all right, but as usual the most alarming news is receiving almost no attention. Washington is responding to a series of investigations concluding that the FDA cannot "adequately" monitor America's food supply and medical products. One of the FDA's outside advisory panels, the Science Board, reports that the agency is in "a precarious position," in part because it is chronically underfunded. The Government Accountability Office chimes in that, at the FDA's current pace, it would take 13 years to inspect every foreign drug plant exporting to the U.S. and 1,900 years to inspect every overseas food factory.

That last factoid may be true, or not, but it does raise the question of whether such a crackdown is possible, never mind desirable. Monitoring 100% of foreign imports -- or 10%, or whatever -- would be so onerous that it might as well be a ban. Yet lapses like adulterated Chinese toothpaste are exceedingly rare, mainly because companies have every incentive to police themselves. (Ask Mattel about its toy import nightmare.)

Still, it's generally agreed that the FDA could use more cash, and the White House's 2009 budget requests a 5.7% increase. But what no one reports is that the Science Board says these shortfalls crop up because Congress hasn't increased FDA funding in proportion to its burgeoning regulatory demands. Over the last two decades, Congress has expanded the FDA's reach more than 127 times; it now oversees about 25 cents of every dollar spent in the U.S.

The Science Board's most important, and distressing, finding is that the FDA bureaucracy "cannot even keep up with the advances in science" -- and not solely due to a lack of funding. While "the world of drug discovery and development has undergone revolutionary change," the authors write, the FDA's "evaluation methods have remained largely unchanged over the last half-century." Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.

The observation comes on page three, which leads us to suspect that Congress's hand-wringers haven't even read the study. Here's a refresher: "The mission of getting safe and effective drugs to patients in a timely manner is currently threatened by inadequate expertise and capabilities," the Science Board notes. Particularly in complex and specialized fields like genomics and biotechnology medicine, the FDA lacks the basic competence "to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced" and "to support innovation in the industries and markets that it regulates."

The Science Board authors propose that the FDA "modernize current regulatory pathways," especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.

The FDA uses rigid statistical techniques to evaluate developmental drugs, even when the lives of terminally ill patients are at stake. Many advanced immunotherapies for cancer, for instance, are held hostage to the FDA's old models, which still insist on crude mortality rates and the large average effects detected in clinical trials. Better metrics would include improving the quality of life or slowing the progression of tumors, or focusing on targeted populations. The Science Board says that "there is an urgent need for developing . . . new statistical methods that are most appropriate for the data generated by new areas of science."

Take Junovan, a medicine for a rare pediatric bone cancer. Junovan's successes in a clinical trial were "only" demonstrated with a 94% level of statistical certainty, instead of the FDA-mandated 95%. Avastin, a revolutionary biologic currently used against lung and colorectal cancers, also looks like it will get a thumbs-down as a treatment for metastatic breast cancer. While the evidence shows that patients lived longer before their symptoms got worse, they didn't live longer on average. Refusing to consider "progression-free survival" as a drug benefit is not only unscientific, but morally hideous.

The real scandal is that these policies are the product of the FDA's institutional culture, which puts political incentives and bureaucratic procedure above patient results. Congress and the press could do some good if they investigated that problem, but it's so much easier to say, "spend more money." Perhaps that's why the Science Board ends on a mordant, but all too accurate, note: "Finding: Recommendations of excellent FDA reviews are seldom followed."

Source





NHS reforms 'in full retreat’

Reform of the National Health Service is stalling as Britain continues to fall behind comparable countries in Europe, a report from the influential Reform think-tank concludes. While the Government claims that the overhaul of the NHS continues, it is in denial about what is happening on the ground, according to Professor Nick Bosanquet and his co-authors, Andrew Haldenby and Helen Rainbow.

The reform programmes remain “embryonic, and in some cases in full retreat”, the report says. As a result, the NHS is facing “a perfect storm” created by the combination of an ageing population, expensive new technology and a more informed society. Without successful reform, the report says, the NHS will decline, providing substandard quality and access. An outflow of talented staff would increase the difficulties.

Mr Haldenby, the director of Reform, said: “In his major speech on the NHS in January, the Prime Minister said that reform was all but in place . . . In fact, reform has barely left the starting gate.”

Andrew Lansley, the Shadow Health Secretary, said: “This report highlights Gordon Brown’s mismanagement of our NHS. He has spent a lot but achieved too little.”

Source