Biotech Versus Bioterror
GOTTLIEB, SCOTT
Biotech Versus Bioterror How to get the antidotes we need for anthrax, smallpox, and other killer bugs. BY SCOTT GOTTLIEB EBOLA VIRUS KILLS QUICKLY. It hails from a family of hemorrhagic fevers...
...Doctors from the World Health organization put the broader theory to work in the summer of 1995, when 300 cases of Ebola surfaced in Zaire...
...our modern war footing is riding on the success of efforts like this...
...But Chimerix has had a hard time attracting capital to fund its endeavor...
...With that end in mind, the National institutes of Health, the U.S...
...The anthrax toxin causes its victims to suffer widespread inflammation and organ damage...
...The best new drugs come out of entrepreneurial companies looking for profits...
...Part of the idea came from a group of Russian virologists who had worked for years on even more malignant strains of the virus...
...Antidotes to deadly bugs lack all the qualities that make a suitable market— among them a large and growing patient population that can be readily estimated and freedom to price...
...The drug is believed to be an effective treatment for smallpox, and a pill form would be a valuable addition to national biodefense stockpiles...
...Right now serious money from private investors wants no part of bioterrorism...
...But nobody should expect this approach to be a cookie-cutter solution to all our biodefense needs...
...The grants Abgenix got from the Army are small potatoes compared with the ventures the company pursues with its private partners...
...The Bush administration's solution has been a series of crash programs managed by the Health and Human Services department and aimed at the most pressing needs...
...The government funding may leave us with some interesting scientific ideas, but it is woefully insufficient for producing and stockpiling drugs that can be deployed in the event of an attack...
...Seven years ago, during an outbreak in Africa, doctors stumbled on a possible cure...
...To combat a wide-scale attack, doctors need a drug that could neutralize the toxin while it courses through a victim's blood...
...Virologists isolated the immune particles from the blood of survivors and infused them into dying victims...
...These antibodies are being engineered to bind the anthrax toxin and could presumably be used for pre- and post-exposure—as prophylactic remedies or as treatments for active infection...
...Now a California biotechnology company, Abgenix, is working with a branch of the U.S...
...This creates a definable market...
...They were searching for the perfect biological weapon when they realized that the reason some people survived Ebola was the ability of their immune systems to generate antibodies to the bug...
...Right now, drugs aimed solely at bioterrorism don't come close to meeting this commercial justification...
...EluSys, for instance, recently received a grant for $2.8 million from the Army to accelerate the development of its antibody technology against anthrax toxin...
...The expanded list includes about three dozen bugs...
...Army Medical Research Institute of infectious Diseases, and the Defense Advanced Research Projects Agency have been sprinkling grants on researchers with relevant technology...
...There's no guarantee that companies will be able to sell successful products to the government, or that they'll be permitted to charge a fair price...
...The sooner we get serious about funding them, the better...
...Maybe not, but the political choice here is stark—either work with the pharmaceutical industry or leave Americans unprepared for a bioterror attack...
...There's only one alternative: Doctors need stockpiles of off-the-shelf antidotes...
...When you work on bioterrorism, you're put in a different box...
...But most of these are earmarked for basic research aimed at proving concepts rather than producing antidotes and vaccines...
...It hails from a family of hemorrhagic fevers that trigger massive internal bleeding...
...It leaves you in limbo and puts your investors at risk," Painter says...
...But by most industry estimates, taking a complicated drug through preclinical development and getting it to the point where it can be tested in people can take $50 to $100 million...
...Ebola is on the short list of bioa-gents believed to be the preferred weapons of would-be terrorists, along with such deadly germs as smallpox, anthrax, and botulism...
...It will be difficult, if not impossible, to vaccinate Scott Gottlieb, an internist, is a resident fellow at the American Enterprise Institute and author of the Gilder Biotech Report...
...This includes smallpox vaccines, where HHS dangled a sizable grant before vaccine makers until Acam-bis stepped up to take the bid...
...even front-line troops against all these potential weapons...
...The private capital that's comfortable funding these long-term ventures isn't interested in companies working on bioterror-ism...
...Nobody wants to be caught in the room discussing incentives with drug companies," said one Democratic staffer...
...Typically, drug development requires cycles of five or more years...
...Seven of the eight people who received the cocktail survived...
...Venture capitalists don't count that as a commercial opportunity" says George Painter, president and chief executive officer of Chimerix, a San Diego-based biotechnology start-up that is developing an oral formulation of an intravenous drug called Cidofovir...
...It only works where the technology is already in Right now, serious money from private investors wants no part of bioterrorism...
...In this case, the profits will have to come from federal procurement programs...
...Most biotechnology executives estimate that it takes a potential market of at least $500 million to coax investors into sinking money into a particular line of research...
...the later stages of development and it's just a matter of ramping up production...
...This is something that the New Jersey-based biotechnology company EluSys Therapeutics has also learned as it develops antibodies that could neutralize the deadly toxin that anthrax infection produces...
...Senator Joseph Lieberman has offered legislation that would change some of these incentives...
...Army to fabricate these antibodies on a large scale in the hopes of mass-producing a cure...
...During the mail attacks last year, five of the eleven victims who reached the late stages of anthrax infection died despite the fact that they were treated with the antibiotic Cipro...
...By all measures, the program is a suc-cess—and now it's being duplicated to develop a safer and more effective recombinant anthrax vaccine...
...The one high-profile project the Defense Department has tried to manage on its own—the production of an anthrax vaccine—has been plagued with setbacks...
...It also provides tax incentives for companies conducting research into bioterror antidotes, and a guaranteed market for the products by compelling the government to stipulate in advance what it wants, what companies would be paid for a successful drug, and how much the government would stockpile...
...There's no guarantee that companies will be able to sell successful products to the government, or that they'll be permitted to charge a fair price...
...The federal grants going directly to private biotechnology companies are also allocated for just one- or two-year increments...
...But Lieberman's bill will require the consideration of at least three congressional committees and sprinkles incentives on the drug industry at a time when pharmaceutical companies are in political limbo...
...Right now, the best drug companies are loath to become federal contractors, leaving many government grants to be picked over by a collection of second-tier outfits...
...The bill extends patent protection on drugs developed to thwart bioweapons and would shield drug makers from liability if side effects emerged after drugs were used to mitigate an attack...
...None of these drugs will be available in the event Iraq unleashes bioweapons on American troops, and at current funding levels, none will be ready even in the next few years...
...The provisions are similar in spirit to the successful inducements offered to makers of orphan drugs that target rare diseases, where the potential payoffs are too small for companies to justify without special inducements...
...We need a private-sector industrial base to deal with all the other threats...
...There's also the possibility that companies will toil for five years to develop a countermeasure to one threat, while federal agencies will have already moved on to other worries...
...The bacteria had already released an ample load of toxin...
Vol. 8 • October 2002 • No. 7
