January 19, 2006
"Osama bin Laden is a ruthless murderer and the U.S. must not rest until he is either captured or killed. This tape doesn't change that. It merely proves, yet again, that the Bush administration's preoccupation with Iraq has diverted our attention from what it claims is our primary focus, namely to combat terrorist threats to the US."

The White House and Congress should have no higher priority than protecting the American people from a bioterrorism attack or infectious disease outbreak, including a pandemic flu. Any good biodefense plan must have two fundamental components. First, it must encourage companies to develop and make effective medicines to counteract a disease or flu. Second, it must encourage patients to take those medicines.

Unfortunately, President Bush and the Republican leadership in Congress are now proposing a plan that contains neither of these essential components. On the contrary, their plan will protect companies that make ineffective or harmful medicines. And it will discourage rather than encourage patients to take medicine to counter a biological attack or disease outbreak.

If such a counter-productive policy sounds far-fetched, consider this: three years ago, the Bush administration bungled the program to inoculate millions of first responders against smallpox because it ignored the advice of its own public-health experts and refused to provide compensation for those who might be injured by the vaccine.

Doctors, nurses, firefighters and other first responders who would be on the front lines in the event of a smallpox attack by terrorists were bravely willing to put themselves in danger by receiving a risky vaccine. But they were not willing to roll the dice and risk the future of their families without compensation for their losses if they were injured, disabled or even killed by its side effects. Many refused to participate. The administration's failure to listen to the advice of experts turned a critical biodefense program into a failure.

On Nov. 9 of this year, while testifying before the Senate Foreign Relations Committee, Dr. Julie Gerberding, the director of the Centers for Disease Control and Prevention, was asked about the expected success of a biodefense plan that does not include fair compensation to people injured by the medicines they thought would help them. She responded: "Well, I certainly feel that from the standpoint of the smallpox vaccination program, that the absence of a compensation program that was acceptable to the people we were hoping to vaccinate was a major barrier -- and I think we've learned some lessons from that."

There are tried-and-true solutions that would encourage the production of vaccines and drugs without leaving patients destitute if they are maimed by a given medication. Under these alternatives, the reputable and responsible manufacturers of needed medicines -- and the doctors, nurses and hospitals who administer them in good faith -- would be protected from frivolous lawsuits that might deter them from making and administering a needed medicine. But those injured by these medicines would be justly compensated for their injuries.

This solution has been adopted successfully by Congress in the past for childhood vaccines, swine flu and smallpox, and that's exactly the model the Biotechnology Industry Organization urged Congress to adopt.

We were involved with the creation of the Vaccine Injury Compensation Program, which has successfully created incentives for the manufacturers of recommended childhood vaccines, encouraged families to have their children vaccinated and compensated those who are injured.

When thousands of Americans developed neurological problems after being vaccinated against swine flu in the 1970s, Congress protected the manufacturers of the vaccine from lawsuits, but established procedures for injured patients to receive compensation from the federal government. In the case of smallpox, Congress rejected the inadequate compensation program belatedly proposed by the administration and enacted a fair compensation program that paid medical costs and lost wages and provided a financial settlement for incurred disabilities.

But apparently, despite what Dr. Gerberding says, administration officials and leaders in Congress have not learned from their mistakes, because their current plan repeats them. It provides no guarantee that medicines will be made as safely as possible, and contains no compensation for injured victims. That approach failed for smallpox, and it is likely to fail again.

Knowing that this plan cannot survive public scrutiny, the Republican congressional leadership is considering inserting it into a massive appropriations bill as the current session of Congress ends.

Similar "midnight amendments" are often withdrawn if they are exposed to daylight before they become part of the bill. Denying victims the right to compensation for effects suffered from a medicine made with disregard for safety should be debated in the open, not slipped by stealth into a bill with the hope that no one will notice.

In a public debate, we are optimistic that Congress would reject any proposal that protects irresponsible or reckless companies rather than encourages reputable ones, and denies any compensation to health-care providers, children and others harmed by drugs that the government suggested or even required them to take. By working in a bipartisan manner, we can craft a solution that protects Americans from the risk of biological harm.