WASHINGTON _ New York Jet's quarterback Boomer Esiason tookhis effort to save his son from cystic fibrosis to Capitol Hill Thursday,where he urged senators to protect the biotechnology industry frompotentially adverse side effects of health reform.Flanked by the president of the Cystic Fibrosis Foundation and thedirector of the University of Pennsylvania's Institute for Gene Therapy,Esiason expressed his fear that "any change to the current lawsgoverning the development and sale of new drugs" would hinderresearch into a treatment that might save the life of Gunnar, his three-year-old son.Speaking at a hearing of the Senate Committee on Small Business,Esiason said his son already has benefited from biotechnologyresearch, through the use of a newly developed, airway-clearing drugcalled Pulmozyme."The day they gave us Gunnar's diagnosis, they told us there was anew drug coming out in six months. That drug was Pulmozyme,"Esiason said. "Lo and behold, six months later we had a Pulmozymeparty at our house, complete with cakes and balloons."U.S. Sen. Joe Lieberman (R-Conn.), who chaired the sparsely attendedhearing on research by entrepreneurs on childhood diseases, said hebelieves that Congress will indeed revamp the nation's troubled health-care system. "But," he cautioned, "We must take care to do so in a waythat doesn't snuff the life out of the biotechnology business.""It is a fact that new medical technology _ new drugs, new medicaldevices and new medical equipment _ cost a lot," Lieberman said."And some companies have charged too much for their products. Somehealth care proposals attempt to control these costs by imposing costcontrols. I think that would be a mistake for several reasons, not theleast of which involves the future of biotechnology and the fate of thechildren biotech advances will affect."Robert Beall, president and CEO of the Cystic Fibrosis Foundation, ofBethesda, Md., said "some of the proposed bills now swarming beforeCongress could be quite damaging to the scientific community and theCF community. In fact, these legislative changes could dry up theimportant pipeline of new treatment strategies for CF."Beall said proposals to set prices for breakthrough drugs and to enablethe Secretary of Health and Human Services to "blacklist" expensivenew Medicare drugs would be impediments to investment that "wouldstifle new medical advances."Another potentially chilling proposal, he said, would require theNational Institutes of Health, and possibly its grant recipients, toinclude a "reasonable pricing clause" in all licensing agreements."Even the mere mention of these proposals has already scared offinvestment capital, needed up front, by many biotech and drugcompanies," Beall said. "Investors see such regulation as a disincentiveto put their money toward the development of new drugs, especially fororphan diseases."A decline in breakthrough drug investment means, frankly, that liveswill be lost."Brian H. Dovey, a member of the National Venture CapitalAssociation, said investors have poured nearly $806 million intobiotech firms with approximately 270 therapeutics or vaccines indevelopment. Each one of those products costs approximately $259million to research, develop and navigate through the regulatorysystem."Given these numbers," he said, "it is clear that investing in thisindustry is very risky."James M. Wilson, director of the Institute for Human Gene Therapy atthe University of Pennsylvania in Philadelphia, said that biotechnologyhas dramatically accelerated the pace of medical research."In six months, we can discover a new gene and begin to use that inclinical therapy," Wilson said. "Before it would have taken us 10 yearsto begin using a new advance in clinical therapy." He added thatacademia and government could not sustain this pace without theprivate investments necessary to bring new therapeutics to market."We're talking about issues that cannot be taken care of by academia,"he said. "We're talking about manufacturing, we're talking about large-scale clinical trials and we're talking about distributing [newtreatments] to the population.""We need investments from the private sector to accomplish this,"Wilson said.But Sen. John Kerry (D-Mass.), echoed consumer concerns over theprices some companies have charged for new drugs. "Can you makeany suggestions as to how we deal with the inflation side of health care,particularly with regard to drug pricing?" he asked.Beall responded by noting that a high-priced drug may still serve tolower the overall cost of medical care. For instance, he said, South SanFrancisco-based Genentech Inc.'s Pulmozyme costs families like theEsiasons $10,000 a year, but it can reduce the number of neededhospital admissions, which cost an average of $14,000 each."If we can cure disease so that people would not have to go into thehospital, there would be tremendous cost savings let alone an enormousimpact on human suffering, Beall said. Esiason said he would do whatever he could to dissuade theadministration from taking steps that might hinder progress againstcystic fibrosis."If you need us to bring Gunnar to the White House," he said, "just letus know."

-- By Steve Sternberg Special To BioWorld Today

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