At the bottom of page A4 of a recent Wall Street Journal is a three inch story about medical research that you haven’t heard about. It appeared on page zero of your local paper and didn’t make any evening news show I know about. The dirty little secret is that few of us have any notion what Congress gets up to every day, let alone the black holes of state and local government. This little squib is a case in point.
All it tells us is that the House has passed a bill “to boost federal funding for medical research and expedite Food and Drug Administration approvals for many new drugs and medical devices.” It calls for an increase in National Institutes of Health funding of $8.75 billion over five years. The money would be targeted at cutting-edge areas like customized treatment based on individual genetics. Action in the Senate is pending.
So this is a good thing, right? Who could be against an effort to discover new cures and get them to patients quickly? Well, we learn in one little sentence in this tiny, buried news story that “the measure drew criticism from researchers and public health advocates.”
How could that possibly be? The bill contains more money for research. Are these people biting the hand that feeds them? Or do they perhaps realize the congressional hand is a lot more interested in feeding other supplicants than NIH researchers. That $8.75 billion may be a sort of bribe or sop intended to win over critics or keep them quiet. It may also have the pleasant effect of doing research on the public dime that the medico-pharma complex will then be able to exploit for gain. Win-win.
In fact, the reason researchers and public health advocates are chary of the bill is because in their view “it would weaken FDA standards.” In short, this is the latest skirmish in a war that has been going on for decades. There are two ways to speed up FDA approvals of new pharmaceuticals and other therapies.
One is to provide sufficient funding to put more investigators on the case, in order to detect dangerous products and drugs before they go to market and kill or injure people. When it comes to medical approvals, speed kills as plenty of previous examples show – Vioxx, Fen-Phen, DES – or the recent news that mother’s little helpers — Paxil and Prozac –are linked to birth defects.
The alternative approach is the one this bill appears to envision, taking the cop off the beat. That is telling FDA to do more with less. This trend has been apparent for years. FDA is regularly tasked with regulating more and more food, devices and drug products without being given corresponding resources to do the job. Demanding that the approval process be speeded up thus amounts to giving big pharma a license to print money, and to let the patients pay the price if the drugs and devices turn out not to have been ready for market.
As long ago as the Clinton administration, the Gingrich revolution drove to deregulate everything, leading in time to reckless lending, dangerous products, lax health and safety enforcement. Gingrich targeted the FDA for special attention, calling for the replacement of FDA with a “council of entrepreneurs” to speed approvals of innovations. Under this plan, the market could take care of any poisonous foods or drugs after the fact, through law suits. Sound familiar? This proved to be too much for legislators to swallow then, but his minions didn’t give up.
I have a long memory of the beginnings of this crusade, starring a freshman congressman in my district Richard Burr who won a seat in the Gingrich sweep. His credentials included playing football for Wake Forest with the jock’s favorite major, communications, followed by a 17-year career as a sales manager for a lawn and garden wholesaler, and knee-jerk, anti-government, Reagan conservatism. He was undoubtedly popular with fellow Rotarians, though at an editorial board audition he seemed unready for prime time. He favored big defense increases, but when asked if anything the Defense Department was presently doing could be cut he got a deer in the headlights look. His party-supplied talking points didn’t cover such complicated details.
No matter, his district was safely Republican so soon he was to be seen following a party script at a committee meeting televised on CSPAN. There he was, raking FDA doctors and administrators over the coals for not approving drugs fast enough. He’s now the senior Senator for the great state of North Carolina, and the script hasn’t changed.
Interestingly, when he ran for Senate in 2004 his net worth was estimated at under $1 million. A decade on a government salary later and his net worth is estimated at nearly $4 million, by one calculation a 421% increase. It may only be a coincidence, but his prospering has coincided with his vigorous opposition to Obamacare and perpetual attempts to minimize oversight by FDA. Of 100 senators, he ranks second in campaign contributions from health insurers and number one in contributions from pharmaceutical companies. Friends help friends.
There is nothing unusual about the Burr case of doing well by doing ill. Congress is filled with small-town pols who arrive in Washington as zealous ideologues unprepared by education or experience to be writing laws, let alone regulating the 25% of all products we use that are covered by FDA protections. Working to rush untested products to market and to make it harder for Americans to get health care may not be good for the people, but it can be very, very good for their elected representatives.