Looking back on last fall's bioterrorist attacks, in which five people died from exposure to anthrax bacteria delivered through the mail, most bioterrorism experts agree that the nation got off easy. Had the perpetrator tweaked the design and delivery of the assault, making it more deadly or more widespread, our public health infrastructure might have failed us. The ghastly potential for a biological or chemical attack to kill and sicken thousands lies not so much in the scope of the attack itself, but in the inability of government health agencies and hospitals to deal with it.
The government's response to the anthrax attacks shined a red-hot light on the under- prepared, ill-equipped and inexperienced public health apparatus and the structures that support it. Congress slashed funding for the approval of new technologies that could prevent bioterrorism throughout the 1990s. From 1993 to 2000, Congress reduced the budget for the Food and Drug Administration office that approves new medical devices by more than $35 million.
Many also question whether the health system's brain trust is even capable of responding to a large bioterrorist event. As Pulitzer Prize winning journalist Laurie Garrett reported in December's Vanity Fair, there are probably less than half a dozen people at the Centers for Disease Control and Prevention who have ever worked through an acute epidemic in the United States.
Predictably, the Bush administration has responded to these shortcomings by throwing money at them, not in the hopes of attracting more qualified scientists and other professionals to careers in public health, but so that private industry will step forward and build the tools to defend against future bioterrorist threats. Those firms, many of them technology manufacturers, will lead the charge toward better health security…just as soon as they can undo the red tape around their wrists.
The FDA's approval process for new medical technologies-a product list that includes everything from electronic brain scanners to the special bifurcated needles needed to administer smallpox vaccine-is supposed to last 180 days. However, devices now languish for more than 400 days before getting a green light, according to the Advanced Medical Technology Association (AdvaMed), a nonprofit organization in Washington whose member companies manufacture more than 90 percent of the medical technologies used today.
Jim Benson, who served as acting FDA commissioner in 1990 and is now AdvaMed's executive vice president for technical and regulatory affairs, said that in some cases patients have been denied new opportunities for treatment and some companies have nearly been driven into bankruptcy waiting on the feds to give new products the nod.
If you have any doubts about how seriously the administration takes this issue, you probably won't resolve them by looking at the president's budget request for next year. It calls for nearly $6 billion in bioterrorism response funding at the Health and Human Services Department (which houses theFDA), and sets aside more than one-third of that money to pay for research and development of new biodefense technologies like disease testing kits. That's great news for industry. But at the same time, the FDA center to approve those new devices is budgeted for only a $4 million increase for counter-terrorism initiatives.
Compounding the problem, medical technology is evolving faster than ever before, Benson said. Unless the FDA can hire enough staff with expertise in the subject areas they review, the agency risks being overtaken by the very innovations it's trying to support, he added.
The bioterrorist attacks have led public health experts worldwide to agree that now is the time to clear away unnecessary market barriers, yet nearly six months after the events, high-profile technologies are still being held up. Take Roche Diagnostics.In November, the company agreed to manufacture a rapid testing kit for anthrax designed by the Mayo Clinic that can yield results in less than an hour. However, the kit has yet to be approved.
In a perfect world, Benson said the market for home testing kits and other products that let patients take control of their own health might see a market upsurge. "Maybe that's wishful thinking…[but] I'd like to see that," he said.
The stakes for medical technology firms were huge well before the anthrax attacks. The annual U. S. market for medical devices is $78 billion, according to AdvaMed. Manufacturers spend nearly 13 percent of their revenue on research and development of new products, four times the average for all manufacturers. But since the average life cycle of a medical device is 18 months to two years, many products are obsolete by the time they're sold. With the federal government now one of the industry's most important customers, it's clear to Benson and others that the approval process has to be sped up.
The government might take a lesson from the information technology acquisition and procurement reforms of the mid-1990s that freed agencies from drawn-out purchasing cycles that put them well behind the technology curve. Not surprisingly, some agencies are now taking advantage of the new rules to implement biodefense software, which doesn't require FDA approval.
The Air Force Surgeon General's Office, in conjunction with four technology firms, including Oracle Consulting, has developed a disease-monitoring and tracking system that scours the Web and health databases for signs of a covert bioterrorist attack to warn hospitals, public health agencies and emergency response units of impending danger. The program is in now being pilot-tested.
Also, e-business software manufacturer Integic of Chantilly, Va., has created a mobile, battlefield version of its patient records tracking software. The program is now used in some military hospitals to help doctors make diagnoses and to record treatments and symptoms. That kind of historical information could be vital in spotting outbreaks before they occur, noted Larry Albert, senior vice president of the company's health care practice. Albert said that after Operation Desert Storm, military and health officials were frustrated by a lack of battlefield medical information when soldiers began to complain of the symptoms researchers now suspect could be linked to Gulf War Syndrome.
Government has always called upon private industry to help solve its problems-now it's pleading on bended knee. If the rules can be changed to allow information technology companies greater access to the federal market, many ask the question, why can't the regulatory process be adjusted so that medical technology companies can sell their products to governments and public health facilities more quickly? Benson points out that the FDA has made improvements in the past five years, but there is still much to be done. And now more than ever, doing it is a matter of life and death.