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Promote safety, not profits

By Lou Dobbs
CNN

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Lou Dobbs
Pharmaceuticals
Food and Drug Administration (FDA)

(CNN) -- During the Senate's investigation of the recall of Merck's pain reliever Vioxx, a veteran Food and Drug Administration drug safety scientist said Americans are virtually defenseless under the current system. That's simply unacceptable.

The FDA has failed to protect millions of Americans from the dangers of Vioxx and many other prescription drugs, including antidepressants regularly prescribed to children. Dr. David Graham, the FDA whistleblower who said we're incapable of preventing another occurrence, estimates that Vioxx may have caused 88,000 to 139,000 strokes or heart attacks before any action was taken. And there's no evidence that the system is changing for the better.

Most Americans look upon the FDA as serving us: consumers, patients, those who rely on prescription drugs for better health. The American public, however, is no longer the agency's primary constituent. The FDA, to a large degree, has become the captive of the same industry it was created to regulate.

While taxpayers foot most of the bill for the FDA's budget, the agency also receives hundreds of millions of dollars from the drug companies, which pay huge fees to have new drugs expediently reviewed and approved. Most people agree that relationship is all too comfortable.

"There's only one customer that should be at the table, and that's the American people," says Sen. Chuck Grassley, R-Iowa. "The American people should be the number one and only client of the FDA, and that's purely for safety of drugs."

Changes are absolutely necessary inside the FDA, an overhaul that will provide the public with more transparency into the drugs on which they depend. It's essential that we create an independent drug safety agency, a body free of drug company influence that will monitor drugs once they're on the market.

Grassley is leading that charge for reform. The senator is expected to introduce legislation that would put some distance between the FDA's Office of Drug Safety and its Office of New Drugs. The table of organization within the FDA shows the two agencies are independent bodies, but in reality, they aren't.

Grassley and many leading experts point out that the Office of New Drugs can put overwhelming pressure on the other office.

In addition to creating an independent drug safety board, we must ensure the new agency be given all available resources to keep the public safe from potentially harmful drugs. While there are 800 scientists handling initial drug approvals in the Office of New Drugs, only 14 scientists handle post-approval scrutiny in the Office of Drug Safety, according to the FDA. And two-thirds of FDA medical reviewers said they were less than fully confident that the agency adequately monitors post-market drug safety.

The FDA currently has no power to require a company to conduct trials after a drug has been approved. The FDA can encourage drug makers to perform post-market safety studies, and in fact, it has requested 1,339 post-approval studies. But about 60 percent of those were never even started, according to an FDA statement in 2003.

Never have these post-market studies been more necessary, however. Public Citizen, a nonprofit consumer advocacy organization, recently launched a new drug safety Web site that provides comprehensive data about the 538 prescription drugs. The group warns that 181 of those medicines are unsafe or ineffective.

Larry Sasich, research analyst at Public Citizen's Health Research Group says he thinks Grassley's bill is a step in the right direction. "What is really striking to me," Sasich says, "is that a number of people from different backgrounds and different political bents have come to basically the same conclusion about the situation: There needs to be autonomy for the safety experts. It's really a non-partisan issue, this is an issue of public health and public safety."

It's actually in these companies' best financial interests to monitor drug safety. One estimate says Merck's legal costs in the wake of the Vioxx fallout could reach $12 billion, and the company's liability could total $18 billion, according to Merrill Lynch.

"There is an uphill battle now for the Food and Drug Administration to re-establish itself as the real referee between the safety of the public and the profitability of the drug companies," Grassley says.

Passing a bill may not solve the major drug safety problem we are currently facing. But it's important that Congress confront this issue now in order to guarantee millions of Americans aren't left defenseless against products that pledge to make them better. It's important to promote total safety rather than total profits.


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