Monday, May 21, 2007
America can't afford much more drug industry charity
Steve Huff
Recent columns
From the RoundTable blog
In a rare display of unity, the Food and Drug Administration, the pharmaceutical industry, and the public all wanted the same thing -- to get drugs approved. It was the early 1990s and HIV ran rampant through the veins and imaginations of Americans. Promising medications, however, flowed through the FDA approval pipeline like sludge.
Drug companies and AIDS patients champed at the bit. There were millions of lives to be saved, and billions of dollars to be made.
The problem at the FDA was underfunding. In the "read my lips" era of George the First, money had to come from somewhere other than taxes.
Enter the pharmaceutical industry, on a shining white steed named User Fee.
User fees -- payments from drug companies to the FDA for the privilege of submitting new drugs -- were intended to defray the costs of approval and speed drugs to market.
They worked.
Approval times dropped from 33 months to under 12. Lots of people got well. They spent a lot of money on their medications.
Then again, a lot of people spent money on their medications and died. As new drugs burst onto the market, they surprised investigators with their side effect rates. Rezulin, Baycol and finally Vioxx were removed from the shelves. Doctors, medical societies and patient advocacy groups were quick to ask what was going on. It took the administration considerably longer.
A big red flag popped up over user fees. The FDA, starved for funding, came to rely less on the Treasury and more on these fees. Today, 42 percent of the salaries of those who approve new drugs are paid by the makers of those drugs.
What's more, the original 1992 law prevented the FDA from using drug company dollars to monitor medications after they were approved. It took 10 years to loosen that restriction. Even today, only 5 percent of user fees go to surveillance.
Let's ponder that.
When millions of people use a new drug, new problems arise. That's OK. That's why we track things like side effects and deaths.
Alas, the FDA is weak. It lacks both money and authority to do the tracking. User fees speed drugs onto the market but do next to nothing to get them off.
Vioxx flew out of pharmacies for five years before data revealed a near doubling of heart attacks and strokes. Some say the signs were visible before the drug was approved. Others point out that if the FDA had been able to do its job, the deaths could have been picked up within months rather than years. Dr. David Graham, the whistleblower from the FDA, testified to Congress that there was a massive cover-up.
Knowing that the FDA lacks the means to pursue its goals, what keeps drug companies from dragging their feet?
In the case of Vioxx, Americans paid dearly. We were buying $2.5 billion of the stuff the year it was pulled from the market. It likely killed 50,000 people and injured 140,000 more. Emotional tragedy aside, medical and legal costs to individuals, businesses and government will be astronomical.
Merck will pay legal fees too, but don't fret for them. Year in and year out pharmaceutical companies find themselves among the Wall Street elite. Double-digit profit margins are the rule. Problems like Vioxx are mere potholes on the superhighway to success.
Congress has made sure it will stay that way. The same folks who brought you the Medicare "doughnut hole" also made sure that drug prices will remain higher in America than anywhere else. Medicare is legally forbidden to use its massive clout to negotiate lower prices.
Last week the Senate shot down a bill to allow importation of cheaper drugs. Louisiana Republican David Vitter said, "Once again the big drug companies have proved that they are the most powerful and best financed lobby in Washington."
It's gotten to the point where drug companies casually shrug off penalties in the hundreds of millions of dollars. Why obey the rules when it's cheaper to pay the fines?
In their defense, drug companies save taxpayers millions by funding the FDA. They fork out an average of $10,000 per year to each doctor in America for free lunches, "educational" discussions and other reimbursements. They shower patients with "free" medication samples. They bestow tens of thousands upon legislators for travel and campaign expenses.
I hate to look a gift horse in the mouth, but I don't know how much more charity America can afford.
Huff, a family physician from Patrick County, is a Roanoke Times columnist.
