Monday, March 30, 2009
The FDA stirs from its stupor
Steve Huff
Recent columns
From the RoundTable blog
Just when I thought I could completely dismiss the Food and Drug Administration as a faithful guardian of American health, it goes and does this.
For years the FDA looked the other way while Big Pharma gleefully promoted such health disasters as Vioxx and Rezulin. Meanwhile, Big Pharma illegally extended drug patents through kickback deals with generic drug manufacturers. The Bush administration flogged science with politics by delaying and restricting the contraceptive pill called Plan B. Pharmaceutical "drug reps" cheerfully bribed doctors with gifts and favors while consumers footed the bill. Pharmaceutical lobbyists strong-armed lawmakers for favorable legislation. Natural supplement makers foisted unproven and unregulated remedies on Americans in the form of "natural supplements."
Big medicine did these things right under the nose of the FDA, the Congress, the president, you and me. I'd pretty much learned to live with it.
Now, however, stronger warning labels appear on old medications; stout limitations have been drafted for the prescription of narcotics; natural supplements are more aggressively monitored, resulting in, among other things, the discovery of a slew of drug-laced weight-loss products. A circuit judge has exposed and excoriated the Bush administration's political interference with the approval processes of the FDA.
In the lame duck phase of the last administration, drug companies agreed to restrictions drawn up by the Pharmaceutical Research and Manufacturers of America. These restrictions put an end to the trinkets and baubles plastered with drug names that had previously worked their ways into the pockets and subconscious memories of your doctors.
Don't get too warm and fuzzy about it. The changes followed a stream of heckling and battering by conscientious medical organizations and individuals. With the new, sunnier Obama administration waiting in the wings, Big Pharma may have seen the writing on the wall. All of that probably pales in comparison, though, to the desperation of drug companies to achieve damage control from the bloody crash and burn of several ultra-high-profile drugs -- Vioxx, Zetia and Vytorin.
Even the Bush-stacked Supreme Court has jumped on the regulatory bandwagon, ruling in effect that drug companies must update warnings for their drugs, even when the FDA did not originally require it.
All those changes cover only the "drug" part of the Food and Drug Administration. In the wake of salmonella-tainted peppers from Mexico and peanut butter from Georgia and Texas, the push is on to finally fund and staff the regulatory subagencies that monitor such farms and factories.
A group of renegade, front-line FDA scientists has publicly argued that the most complex and perilous medical devices were approved on less-than-scientific grounds at the direction of the Bush administration. Congress is investigating not only the bureaucrats, but also the scientists. Even so, manufacturers of medical devices complain that they are overregulated. Let the accusations fly; let the investigations unfold.
Other unmet challenges: The age limit on pediatric cold medications has increased from 2 years of age to 4. That's fine, but evidence shows no benefit and possible harm from such medications for children under the age of 6, and likely older. Also, television commercials continue to mislead the public on pharmaceutical products that the average person cannot begin to understand. The herbal supplement industry promotes products that lack proof of purity or effectiveness. Drug reps continue to schmooze doctors with comfort food meals at "educational" meetings, as well as with "consultant fees" at "market value."
Tobacco is by far the deadliest drug I know. Congress has yet to authorize the FDA to regulate it.
Keep an eye on this: Drug companies are merging in droves. This month, Merck absorbed Schering-Plough. A couple of months ago, Pfizer devoured Wyeth. While these mergers bring to mind some interesting drug combinations (perhaps a Viagra/Premarin combo to help ditto-heads balance their feminine and masculine sides), they also introduce the dreaded "too big to fail" scenario.
Will future taxpayers have to bail out the companies that bilked them out of billions for drugs that didn't help them in the first place?
For all you hard-line free market ideologues, if you still think government is the disease and deregulation the cure, check your pantries, pill boxes and pacemakers. There's bound to be something in there that has altered your thinking.
Huff, a family physician from Patrick County, is a Roanoke Times columnist.
