A bird flu pandemic that hits the
United States could trigger 40 percent absenteeism rates among the U.S.
workforce and kill 2 million Americans, according to a just-released White House
report. The Bush administration has asked Congress for $2.3 billion this year to
fund the next phase of its pandemic preparedness effort, including a plan to
create the domestic capacity to produce and stockpile pandemic vaccine. Will it
be enough?
Fortunately, we live in a country
that develops up to 70 percent of the world's new medications. The
pharmaceutical industry spends $39 billion a year on research and development --
a sum greater than the entire operating budget of the National Institute of
Health, and 19 times more than the research and development budget of 1980.
But the people we rely on to bring us
the medicines and vaccines that will protect us from emerging global epidemics
are now contending with an even bigger threat to the public health: lawsuits.
The trial lawyers of America have set
their sights on the pharmaceutical industry, and the results could be
catastrophic. In my home state of Michigan, trial lawyers are lobbying to
retroactively overturn a landmark law passed 10 years ago that says FDA approval
of product cannot be overturned by state courts unless the approval was
fraudulently obtained. This law has protected the rights of those who have been
legitimately harmed while discouraging meritless lawsuits based on junk science.
The trial bar's efforts to roll back this law in Michigan are a herald of things
to come nationwide.
It's critical that we uphold laws
like Michigan's, and enact similar tort reforms in other states. Making a new
drug available to the public typically costs $1 billion and takes 15 years. Only
three of every 10 drugs that are approved by the federal government actually pay
for themselves. It takes an enormous amount of capital to keep the
pharmaceutical pipeline flowing -- capital that comes from investors who are
willing to take risks and be patient throughout a lengthy government review
process that measures safety and effectiveness. We can't afford to gum things
up.
Yet the capital to finance this
process of discovery and production is much harder to come by when drug
companies are besieged by an ever-increasing number of mass product liability
suits that force them to withdraw FDA approved drugs from the market, and make
massive payouts to settle liability claims. The lack of capital means that new
drug discoveries lag, promising areas of research are shelved, potential
vaccines go untested, and effective remedies are kept out of the hands of
doctors and patients.
In short, at a time when we need the pharmaceutical industry to be at its most
nimble and creative, it is instead being forced to operate in slow motion.
The trial lawyers would like us to
believe that their efforts are all about keeping us "safe." But in fact, a
recent empirical study by Emory University professor of economics and law Paul
Rubin found that tort reform in the states that reduce incentives for lawyers
and plaintiffs to pursue frivolous lawsuits actually reduced accidental deaths.
Over a 19-year period, legal reform correlated to more than 14,000 fewer
accidental deaths.
The debate over tort reform was
important before the emergence of the global economy and the health threats it
engenders. Today, the debate is urgent. If we allow the trial lawyers to decide
when, how and if potentially life-saving drugs reach the market, we will have
made an already dangerous world even more so. We need to act now to reform our
tort system and curb lawsuit abuse, before it is too late.