Heckuva Job

Via xan:

What would happen if terrorists managed to detonate a nuclear device in a major U.S. city? Hundreds of thousands of people would suffer from acute radiation exposure. They would be at long-term risk of developing cancer, but most deaths would be from damage to the bone marrow, infections and internal bleeding.

Pentagon scientists discovered a possible treatment for radiation sickness after testing a drug made by Hollis-Eden, a small biotech company in San Diego.

"In the summer of 2001, the military came and visited us and they said, 'You know we’ve been testing your drug and we’ve been looking for a drug like this for 40 years,' " says Bob Marsella, the company’s vice president.

Was the military interested in the drug for troops?

"Yes," says Marsella. "Two weeks after 9/11, they came and visited us again and said, 'We’d like to develop this now, not only for troops but for civilians.' "

Hollis-Eden’s drug, Neumune, was not FDA-approved, but the Pentagon had been testing it on mice, dogs and monkeys, where it stopped the lethal bleeding and infections caused by radiation exposure.

The Pentagon decided the drug was in a class by itself and stated in a letter to 60 Minutes: “NEUMUNE … seems to be the most efficacious, least toxic and most comprehensive in its effects.”

"And then we started to look at the impact a nuclear bomb would have on a city and how many people would be exposed and potentially use this product," Marsella says. "And we started looking at the numbers. They were staggering. They were in the millions of doses, so we thought to ourselves, this could potentially be a very big market."

Marsella and his boss, Richard Hollis, knew it was a market with only one initial buyer: the U.S. government. They had to convince potential investors that Washington would spend hundreds of millions of dollars to buy their drug.

"We started circulating in Washington, and there was a lot of support for a medical countermeasure that could save human lives in the event there’s a nuclear 9/11," says Hollis.

"But we couldn’t get it funded," he says. "So we were here in Washington trying to figure out how we were going to get it done and, coincidentally, we were here for the State of the Union when the president addressed it."

"I ask you tonight to add to our future security with a major research and production effort to guard our people against bio-terrorism called Project Bioshield," President Bush said during his 2003 speech.

"Project Bioshield" provided nearly $6 billion to create a biodefense industry. The program gave drug companies a powerful incentive to come up with new drugs to be used in the event of terrorist attacks. For the first time, there would be a guaranteed market for drugs if they tested successfully. It was the assurance Hollis-Eden had been waiting for.

"So you have a partner in the Pentagon?" Bradley says.

"Yes," Hollis says...

Over the next three years, Hollis-Eden spent more than $100 million, with the expectation that the government would buy millions of doses.

Finally, last September, the Department of Health & Human Services surprised everyone by announcing that it would commit to purchase a radiation drug from whichever company had the best product, but only 100,000 doses.

No one expected the order to be that small.

"Our stock plummeted. We went to $5 a share. And we were shocked and surprised because we just couldn’t see how they could come to that decision," Marsella says.

No one knows where a terrorist strike might take place, but there are dozens of U.S. cities with populations large enough to be plausible targets.

Drugs would need to be stockpiled in every city, according to Lee Hamilton, Vice Chairman of the 9/11 Commission.

"A hundred thousand doses is not nearly enough," he says. "If you really had a major attack you probably would need much more than that. One estimate we made was that we’d need 10 million doses."

Who made the decision to buy 100,000 doses instead of 10 million? It was Stewart Simonson, the man who oversees Project Bioshield. Simonson is a Republican political appointee who, before running Project Bioshield, was a lawyer for Amtrak. Republicans as well as Democrats have criticized his management of the program...

Why did the government decide to buy only 100,000 does to treat acute radiation syndrome?

"Well this is the place to start and we don’t see 100,000 as the end, we see 100,000 as the beginning," says Raub.

"So, if you order 100,000 and there’s a nuclear explosion … when do you get the rest of them?" asks Bradley.

"Again, we take this a step at a time. First off, we need agents that we can be sure will work," Raub replies.

"If we were told four years ago, Ed, that they were only going to buy 100,000 doses, we would have never developed this drug," says Marsella.

But HHS said the initial 100,000-dose order was just a starting point.

"They’re supposed to create a market, not a starting point," says Marsella. "If they were going to buy tanks for the military would they just buy one tank, or would they buy 100 tanks? And I think that the contractor would have a hard time spending all the money and research and not have a guarantee that they’re going to buy more than one tank."

"But they’re not saying, 'We’re only going to buy 100,000 doses.' They’re saying, 'This is where we’re going to start,'" Bradley says.

"How much more are they going to buy, Ed? Do we know that?" says Marsella. "Are they going to say they’re going to buy millions more? See, they won’t commit to that."

"The thing that must be understood here is the urgency of the problem," says Lee Hamilton. "We don’t have an unlimited amount of time here. We know that it is possible to have a nuclear attack very soon, and we must not go about business as usual."

Somebody seems to have a pre 9/11 mentality.

Xan goes into more detail about Simonson, who is doubtless way out of his depth- that being only a few inches doubtless- but let's think a bit more about this compound.

Specifically, Neumune protects our infection-fighting bone marrow, known to be particularly hard hit in a dirty bomb or nuclear attack, he tells WebMD.

Speaking here at the annual meeting of the American Society for Therapeutic Radiology and Oncology, Stickney notes that researchers in a recent scientific article in the BMJ predict that if a small and crude nuclear device were detonated in New York City, approximately 50,000 people would die from the initial blast. But another 200,000 would die shortly thereafter from severe bone marrow damage, and an additional 700,000 would be at risk because of radiation sickness resulting from bone marrow damage.

"The primary cause of death from radiation is a severe depletion of bone marrow cells," Stickney says.

Enter Neumune -- a close relative of performance-enhancing DHEA, or dehyroepiandrosterone. It is a hormone naturally made by the adrenal glands.

In studies in monkeys, Neumune protected all three elements of the bone marrow: the white blood cells that fight infection, the platelets that help blood to clot, and the red blood cells that transport oxygen throughout the body, Stickney reports. "No other single compound has ever done that before."

In the studies, 30 primates were exposed to potentially fatal doses of radiation. "The doses we gave were such that you would expect 50% of the animals to die," Stickney says, "a good simulation of what would happen [to humans] in a terrorist nuclear explosion."

Ten of the animals received no treatment, while 10 received placebo and 10 received injections of Neumune beginning several hours after radiation exposure. The study showed that 90% of the Neumune-treated macaques survived, compared with only 55% of those that received either placebo or no treatment...

The evidence seems clear. As a steroid analog, it's quite stable chemically and easy to store for the long term. The toxicity issue seems minimal: a one time dose might cause some pituitary suppression, but that may be part of the mechanism aiding survival.

Apparently Simonson is also responsible for the muddle of a response our government's had to the H5N1 influenza. Like our susceptibility to nuclear attack, we've been fortunate to avoid tragedy with this security issue too. Perhaps for not much longer.

I wonder if the reluctance to buy more has been because Darth Rumsfeld's pet drug company, Gilead Biosciences, hasn't been involved?