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Scripps and Novartis both stand to gain in Florida courts. Novartis has a contract that pays Scripps $20 million a year for first rights on any new drug Scripps creates. If Novartis chooses to accept the marketing of a new drug, it can also become a partner in the human testing, making both companies potentially liable if something goes wrong.
According to Lerner, the Florida law that will protect his company from lawsuits is called "sovereign immunity," which harks back to old English decrees meant to protect government agencies and officials from lawsuits.
Scripps could benefit from the law thanks to its deal with Florida, says Victor Schwartz, general counsel with the American Tort Reform Association and part-time Hollywood resident. "By partnering with the state," Schwartz says, "they're less likely to be held liable." When new drugs are brought to market, companies set up what's called an "institutional review board" to monitor the success. With the Florida deal, Scripps could set up a board comprised entirely of state employees, meaning Scripps would escape blame for problems with the testing.
The losers in such an arrangement are the test subjects who could be injured, says Barbara Noah, a University of Florida law school research associate. According to a 2001 study by a University of Maryland biochemist, an estimated 5,000 people a year die during clinical trials and tens of thousands more are injured. "There is inadequate protection of human subjects," Noah says.
While Scripps did not respond to questions on this issue, drug manufacturers and researchers say lawsuits have hampered their ability to bring new cures and treatments to the market. Noah acknowledges that fear of legal action has made some companies leery of testing new drugs, and Florida's protections for Scripps could give it more freedom to introduce new medicines.
Drug testing has become a deadly business because of the way the federal government operates, says Don Farber, a lawyer in San Rafael, California, who has made a career suing pharmaceutical companies. Drug makers need only two successful trials to get government approval to sell a new product. Meanwhile, companies can have dozens of unsuccessful trials, with injuries or deaths resulting, and still get approval, Farber says. Those unsuccessful trials often get buried in the mounds of paperwork drug companies submit to get government approval. "The whole process is dubious," Farber says. "There are often times drug companies filter out the bad information to get drugs to market."
At the temporary Scripps lab at Florida Atlantic, scientists say they're not thinking about human testing or bringing drugs to the market. Their concerns are developing cures, and then others in the company see if they're marketable. Baker, the neuroscientist working on mad cow disease, says Scripps isn't like pharmaceutical companies that often place demands on researchers to come up with new drugs. "Scripps isn't exactly industry, where there's pressure to develop new things, and it's not exactly academic research either," Baker says. "What Scripps wants is to develop new cures, and I think that's the best goal."
Soon, Scripps Florida may be the site of new announcements of treatment and cures for big-name diseases, Baker says. "It could be decades away, but we're hopeful."
If so, such announcements could give supporters of the state's deal credibility. But if the decades pass with no announcements or miracle medicines, critics of Florida's ten-figure pact with Scripps will surely feel that the state has been swindled, and the environment with it.