By Randall Osborne
Saddled with a mass of disputed votes from the presidential election, ballot counters in Florida last week forged ahead with their task of figuratively "high-throughput screening" the ballots.
State Supreme Court justices, having scrutinized arguments from lawyers as closely as the FDA would inspect the pivotal data in any new drug application, ruled that recounted votes can be used to decide the tight race which came down to Florida's 25 electoral votes. Democrat Al Gore was hoping the manual recounts of 1.7 million Florida ballots would flip Republican George Bush's 930-vote lead in the state. The Bush camp, for its part, made rumblings about challenging the high court's decision that allowed considering them.
As the nation waited, news clips of both candidates showed them wearing nervously optimistic faces faces with expressions that are familiar to all in biotech, from other contexts. Theirs were the resolute yet cheerful fronts of the losing companies in failed collaborations. Theirs were the brave, troubled visages of corporate spokesmen, facing media and investors with bad Phase III results.
If Bush and Gore felt worried behind their masks as the days wore on, they were not the only ones. Biotech has a stake in the outcome, too. The industry's standing with the government never has been altogether solid, and its growth for many years was an uphill fight. New science brought genetic engineering approaches so novel that CEOs fumbled to explain their intricacies, referring complex queries to lab experts. Investors often were left befuddled.
Such previously unheard-of abilities brought freshly daunting moral and social issues, arousing fearful suspicion in politicians whose main concern, as ever, seemed to lie in mollifying a populace just as fearful and suspicious, if not more.
Some confusion and fear persist. Biotech boosters complain that to harvest stem cells for research, for example, has become to some citizens almost a demonic act. People are terrified of taco shells.
But Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization (BIO), said the main hurdles now, and in the post-election months and years ahead, have less to do with public perception of biotech as an enterprise than with specific matters such as Medicare and FDA reform, and prescription drug user fees.
"The bottom line is, we have our work very clearly cut out for us, no matter who gets elected," Feldbaum said. The fates of biotech issues "may not come down from the signal of whether it's Bush or Gore," he said.
"I'm hearing members express complacency if Bush is declared the winner, and a few others have voiced dismay at Gore [winning]," Feldbaum said. "But I would tend not to agree with people expressing the extreme viewpoint that Bush would be a godsend and Gore would be the devil of the piece. It's not that simple, and it never was."
Gore, Feldbaum acknowledged, "took some real shots at the pharmaceutical industry, and we're going to be vigilant, even wary."
When he researched Gore's position on biotech, however, Feldbaum found "only one mention, in an Oct. 30 speech he gave in Green Bay, Wis., where he made a highly positive reference to biotech."
Not that it seemed likely to mean much, Feldbaum added.
"I think it's a moot point," he said last week.
Much of what BIO expects to happen "will get on the agenda no matter who's elected president," Feldbaum said. "Given the current state of Congress, how split it is down the middle, we're going to need broad bipartisan support for anything. We may have some advantage on tax matters from a Republican administration and Congress, but the Democratic side of the Senate has moved to the left."
Better clues to what will befall the industry appear on the low- or mid-range levels, Feldbaum said.
"We have to keep a very close watch on the transition teams," he said. "Who will be the next head of [the Department of] Health and Human Services, or possibly the FDA, if there's a change there? It's possible there will be, and it's more likely if Bush is elected."
Ultimately, Feldbaum said, "what's challenging is the sheer number of issues likely to come up in the next Congress. There's a convergence, not of weather systems but of issues, to create the perfect storm."
The Prescription Drug User Fee Act (PDUFA) was "a major element of our legislative and regulatory work from 1994 to 1997, when it finally passed. People think the user fees themselves should continue. They're very popular, and I don't expect them to cease. What's more complicated is whether or not we should revisit the FDA Modernization Act [FDAMA], and I believe we should."
Whoever is president, the most significant issues are likely to become those related to Medicare reimbursement, Feldbaum said. "We're nailing them down," he said. "If tax issues and patent issues have five corners, we may have nailed down four of them. The Medicare debate is about to enter an important phase, and we're positioned well, despite the campaign rhetoric."
Thanks to voters making their wishes known at levels lower than the presidential, whatever happens in Medicare, or the PDUFA/FDAMA debate, biotech's advancement in the lab is likely to be less threatened than in the past by alarmist conservatives, Feldbaum said.
"When you take a look at the complexion of Congress, and the relative moderation you're going to see, particularly on the right, the Moral Majority will not hold sway over research issues," he said. "There's a strong bipartisan center that will hold."
Investors have wised up, and that's a good thing. "It's a better-informed group than we've ever had," Feldbaum said, noting there have been "a couple of phases" of biotech interest that were largely reflexive, not reflective. "In 1993 and 1994, anything negative that happened, even if it was about sepsis" which was, for a long time, an elusive target for biotech research "the whole market would go down. One bit of bad news and 'kerplop.' One bit of good news, and [stocks] go up."
By 1997 and 1998, "the dot.com people started coming our way, and they couldn't even spell genomics," Feldbaum said. "They were, again, an unsophisticated group."
With a more studious, rational and patient crowd of biotech investors, the industry should be able to hold its own, whatever is brought by political landscape changes, or social debates over scientific efforts.
"Anything can happen, and there's going to be the bioethics issue du jour, or at least once a year," Feldbaum said. "It will take a pretty good swipe at us, and then we'll straighten things out, like with gene therapy last year." A patient in gene therapy studies by the University of Pennsylvania died in September 1999, casting a pall over such research for many months afterward. In March, the FDA issued a warning letter to a researcher at the university.
Episodes like that will keep the biotech market volatile to some degree, but investors overall are sober enough to evaluate them intelligently, Feldbaum said. "We've got an influx of day traders, and I'm still concerned about those people," he said.
Predicting a Bush win in the election, Feldbaum said the Republican is "more likely to appeal, having gone this far. There will be a feeling he was robbed if he doesn't get it." But Gore also has not promised to accept the recount decision without further legal action if it doesn't go his way.
Feldbaum said he didn't want to sound blindly optimistic, or to suggest it doesn't matter whether a Republican or Democrat gets the big chair. But, he said, the battles to be fought by biotech will be fought individually, and biotech has reached a steady state that can endure them.
"The industry is doing well, and I don't see politics affecting that," he said. *