Op/Ed: Patients are not the problem

By Joanne Doroshow and Laurie Beacham
The news could hardly have been worse: untold numbers of patients unnecessarily becoming sick or dying from Vioxx, and a recalcitrant drug company, Merck, deciding it was worth continuing to risk killing and injuring Americans rather than pull the profit-making drug off the market.

But, it turns out, it was worse. The very federal agency set up to protect us from unsafe drugs helped facilitate this public health disaster. An FDA drug safety reviewer indicated that his superiors delayed publication of a study that connected Vioxx to heart problems. Reports suggested an atmosphere at the FDA that discouraged criticism of high-profile drugs.

"All the FDA must consider is that their only client is the American public, not the pharmaceutical companies," said Sen. Charles Grassley.

We shouldn't be surprised by this. Since the 1980s, business lobbyists, their congressional allies and the White House have succeeded in weakening health-and-safety laws and ensuring that regulatory agencies fail to do their jobs by staffing them with individuals tied to the very industries they are supposed to regulate.

When Merck finally pulled Vioxx off the market on Sept. 30, 2004, evidence had been accumulating for several years that the drug doubled the risk of heart attack or stroke. Internal emails at Merck suggest that the company kept this information to itself and sued a researcher who wrote about it.

Most Americans would agree that corporations that disregard their responsibilities as corporate citizens, like Merck, should not be rewarded. Yet that is exactly what might happen. Not satisfied with just weakening safety laws, corporate lobbyists are swarming Congress, asking for special treatment in the courts. A bill expected to be taken up by Congress in its new session provides just that -- minimizing drug companies' legal responsibility to those they've injured.

With regulatory oversight of corporate practices virtually ground to a halt, "immunity" or so-called "tort reform" is not the direction in which we should be going. Proponents claim limiting legal exposure will lower insurance rates and help the economy. Untrue. All such laws do is protect corporate wrongdoers and criminals while stripping citizens' rights. In fact, California demonstrates that the only way to control insurance rates is by regulating insurers. Proposition 103, passed by voter initiative in 1988 and the most stringent insurance regulation in the country, knocked premiums way down. Damage caps passed before Proposition 103 failed to control rates.

America's civil jury system is the last line of defense against corporate misconduct. Time and again, history has shown that lawsuits deter culpable manufacturers, polluters, hospitals, drug companies and others from repeating their misconduct and provide the necessary economic incentive they need to become safer and more responsible. With no legal process, reckless corporations can prolong misconduct and suppress information about dangerous products and practices.

The threat of liability no doubt contributed to Merck's decision to voluntarily withdraw the drug when it did, knowing it could no longer hide the truth. Imagine the signal that would be sent to other drug companies if the threat of financial liability were suddenly eliminated. The potential outcome is frightening: an environment in which unsafe products would proliferate, resulting in soaring rates of consumer deaths and injuries, and little chance of ever finding out why.

At a time when reports of corporate misconduct seem almost routine and the government does little about it, eroding the last line of defense -- the civil justice system -- seems ludicrous. It would be especially tragic given the growing dominance of corporate America in our lives.

Joanne Doroshow is executive director and Laurie Beacham is communications director of the Center for Justice and Democracy.