The manufacturer of a new anti-radiation drug that promises to save lives in the event of a nuclear attack on U.S. soil says the federal government is dragging its feet on a program meant to provide billions of dollars in help with WMD-related medications, while most Americans sit defenseless in the event of a terrorist nuke strike officials say is inevitable.
The federal government in July 2004 set aside $5.6 billion for “Project Bioshield” – an incentive program for industry to produce drugs to treat Americans after chemical, biological, radiological or nuclear attacks – but biotech and pharmaceutical companies say they cannot continue research and development without financial commitments from the federal government, commitments that have been slow in coming over the last 13 months.
Developed by Hollis-Eden Pharmaceuticals of San Diego, Calif., the nuke-attack drug, dubbed Neumune, is a treatment for Acute Radiation Syndrome, or ARS, a life-threatening condition resulting from exposure to high levels of radiation. ARS is also known as radiation sickness.
The company’s website explains the condition:
“In ARS, radiation damages production of major blood elements produced by the bone marrow – neutrophils, or white blood cells that protect against opportunistic infections, and platelets, key clotting elements that protect against bleeding episodes. Severe depletion of these blood elements can lead to conditions known as neutropenia (low neutrophil counts) and thrombocytopenia (low platelet counts). Either of these conditions can lead to death in the first 30 to 60 days following radiation exposure. If an individual can survive this initial period of insult, the bone marrow will generally return to normal production of these critical blood cell components.”
If a drug were stockpiled that could lessen the impact of ARS after a nuclear or dirty-bomb attack in the U.S., the lives of countless Americans possibly could be saved. Just half of those stricken with ARS survive untreated, but Hollis-Eden says its new drug would increase that level to 90 percent.
After a nuke attack, explained Scott Rieger, Hollis-Eden director of corporate communications, “you have to get people through that first 30 or 60 days before you begin to worry about longer-term effects. … We’re focused on the immediate period when hundreds of thousands of people could be vulnerable to dying of infection and hemorrhaging.”
Though a nuclear terrorist attack on U.S. soil has been characterized by officials as high up as Vice President Cheney as a matter of “when” and not “if,” there exists few government measures to protect Americans from the effects of radiation after a nuke is detonated.
As WND has reported, for more than 10 years, al-Qaida chief Osama bin Laden has planned to use nuclear weapons in a terrorist attack on the U.S. The plan is dubbed “American Hiroshima.” In fact, as first reported in Joseph Farah’s G2 Bulletin, captured al-Qaida operatives and documents suggest the weapons have already been smuggled into the country.
Intelligence analysts and sources disagree on the details of the way bin Laden’s “American Hiroshima” plan unfolds. Some G2 Bulletin sources emphasize bin Laden’s commitment to re-enacting the 1945 attack on Japan with one nuclear detonation, followed by another days later.
Paul Williams in his upcoming book, “The Al Qaeda Connection,” however, sees a much more devastating, coordinated, all-out, surprise attack coming.
Don Boys, the author of “Islam: America’s Trojan Horse” and a former Indiana congressman, says U.S. officials should get serious about nuclear terrorism by urging Americans to prepare for disaster by stockpiling food, water, building shelters and planning evacuation routes.
Even if residents struck by a nuclear attack survive the initial impact and have access to food and water, however, ARS, if left untreated, can kill them within weeks.
Bob Marsella, Hollis-Eden’s senior vice president, pointed to a government estimate that 190,000 would die of ARS in Washington, D.C., should a nuclear attack occur in the city.
“The government knows the number of people who are going to die from radiation sickness,” Marsella told WND. “And today we have nothing to give those people.”
Marsella explained Neumune would be handed out to victims as they are evacuated or decontaminated after an attack. The treatment consists of five doses, one a day for five days, and would cost between $50 and $100.
“The majority of people who died in Hiroshima and Nagasaki was from radiation sickness, not the blasts themselves,” Marsella noted.
Hollis-Eden says it is co-developing Neumune with the Armed Forces Radiobiology Research Institute, or AFRRI, an agency within the U.S. Department of Defense and “a leader in studying the short- and long-term effects of radiation injury.”
States the drug’s promotional material: “After screening thousands of compounds in an effort to find a radioprotectant suitable for widespread use, AFRRI selected Neumune as its leading candidate for radioprotection based in part on its striking efficacy in earlier preclinical models conducted in mice. These studies showed that up to 100 percent of animals treated with Neumune prior to being exposed to radiation survived, versus up to 100 percent mortality in the animal group receiving placebo.”
Although AFRRI has worked with Hollis-Eden on the drug, the firm says it has provided the funding.
The drug has proven effective on tests using over 200 non-human primates, the company reports.
While Hollis-Eden says the approval process with the Food and Drug Administration has gone fairly smoothly, with the next step being human-safety studies, it is the Project Bioshield program’s slowness that could prevent widespread distribution of the radiation medication in time to save lives after a domestic terror attack.
Under the Bioshield legislation, the Department of Homeland Security can enter into advanced-purchase contracts with companies guaranteeing payment upon delivery once a drug is FDA-approved. Once contracts are in place, companies have the incentive to develop drugs and go through the approval process. No taxpayers funds are expended until approval is granted.
Rieger says DHS has postponed the issuance of a federal “request for proposal” for an ARS drug to September 30.
In the meantime, Hollis-Eden submitted its own unsolicited proposal to provide its new medication.
“We’re trying to do their work for them, to make the process easier,” Marsella told Investor’s Business Daily. “It’s extremely disturbing to have bureaucratic delays without good reason.”
Rieger says those in the Department of Homeland Security administering Project Bioshield have issued requests for proposals on just four potential WMD “material threats” – anthrax, small pox, radiation/nuclear and botulism – even though there are over 100 pathogens the program is suppose to address.
The process of defining these material threats employed by DHS is “opaque” and “highly bureaucraticized,” Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland, testified before Congress last month.
Noted Greenberger: “DHS’s lassitude in supervising the making of material threat findings is mystifying.”
The department has let just one contract to date, an award for an anthrax medication that would treat 25 million people.
“Industry, to a large extent, is not too enthusiastic because the government has not defined the market,” Rieger told WND. “It hasn’t put the Bioshield mechanism in play” to encourage drug development and approval.
Rieger says Hollis-Eden could produce, with its suppliers, millions of doses of Neumune, which is a steroidal hormone, once it is approved.
While potassium iodide is a traditional treatment for radiation exposure, it helps prevent the long-term risk of thyroid cancer, not the immediate risk of ARS. Potassium iodide could be used in conjunction with a drug like Neumune, Rieger said.
Marsella says he hopes to get final approval for the drug by the end of 2006.
A message forwarded to WND from the Department of Homeland Security is attributed to spokesman Donald Tighe: “[Project Bioshield] is complicated and very important work, and we are making significant progress.”
A more specific response to allegations of foot-dragging was promised for a later time.