A New attitude should cure ailments at FDA

[JKaiser]

The United States Supreme Court decided last week that a drug company is not protected from personal injury lawsuits because the Food and Drug Administration had approved its products and its labeling. In a 6-3 decision, the judgment went against Wyeth Pharmaceuticals and awarded a Vermont woman more than $6 million for the faulty labeling of an anti-nausea drug.

The woman, a musician, lost her arm as a result of an inadequate warning. The ruling is expected to dramatically affect other business court decisions of its kind. Wyeth v. Levine reminds us of the extraordinary connection between the FDA and pharmaceutical companies.

While it's nice to see a drug company be held accountable for its products, the ruling lets the Food and Drug Administration off the hook.

FDA scientists are begging for reform at the agency after the Bush years. They say that the managers have intimidated scientists to manipulate data in efforts to approve drugs. Employees assert that they cannot act with scientific honesty for fear of reprisal. They contend that they have complained to Commissioner Andrew von Eschenbach and others. Complaints were ignored. It is suggested that the management charged with oversight of the agency is too close to the regulated industries. The incoming head of the Health and Human Services, Kathleen Sebelius, must revamp the agency so that safety is its main concern.

Drug companies and the FDA have enjoyed a cozy union at consumers' expense. Former President Bush allowed drug corporations' profits to go before the well-being of American citizens. It is easy to surmise that many partially tested drugs have passed through the government agency. And there should be repercussions. There should be many thorough investigations. Unscrupulous managers should be immediately removed from authority.

They should be fired. Every effort should be made to sift through false data and slack oversight policies. The products approved during the Bush administration need extra scrutiny. The task would be monumental, but I suspect that scores of drugs were deemed wrongly safe from 2001 to 2008. If need be, if there is sufficient evidence of shoddy laboratory methods, these drugs and also devices should be recalled for the benefit of the people.

In China, a man who knowingly sold tainted milk was executed. There, accountability is extreme and questionably just. While we do not approve of such harsh punishments, but people are still liable. Individual regulators should be held responsible in civil if not criminal courts for approving and selling harmful drugs. Companies' executives also should not be given impunity. Citizens should be encouraged to seek damages for injuries and illness due to drug profiteers. Oh, one might say that I am promoting rampant litigation. Yet how do we stop immoral and greedy people from knowingly passing harmful food and drugs?

President Obama has promised an era of change. Hopefully, that means that ordinary Americans will be the focus of government action. We must reform the Food and Drug Administration and cut the ties between regulators and industries.

One does not send a lumber company to manage the national forests. Likewise, drug companies do not assure the safety of their own products. There is a rush to make money. New drugs are easily on the market. FDA scientists must be allowed to be forthright about data and must not be subject to internal agency reprisal.

When it comes to drug safety, real science must guide regulators and those people charged with oversight of the pharmaceutical industry. All players must be subject to redress, to just remedy. The Bush years are over, and enough is enough.