Devens firm joins push to get decontamination lotion to first responders

First in a series
By Don Eriksson

DEVENS -- In an effort to break what appears to be a bureaucratic logjam, the local manufacturer of a key ingredient of an antidote to chemical warfare agents has joined an effort to get the product into the hands of civilian first responders. The product was approved by the Food and Drug Administration (FDA) last year

Edward Price, president of Devens-based Polycarbon Industries, said the company has joined two corporate partners, E-Z-Em of Lake Success, N.Y., and O'Dell Engineering of Ontario, in an effort to push for a wide release of the antidote by gaining the support of legislators.

Polycarbon produces Dekon, an active ingredient in Reactive Skin Decontamination Lotion (RSDL), in its Leominster facility. RSDL is produced by E-Z-Em, and O'Dell Engineering holds the license.

RSDL is a complete personal decontamination system in the form of a sponge saturated with the decontaminating lotion that is sealed in a special, easy-open pouch designed for use by soldiers in full chemical warfare field gear. The Army pushed RSDL through the FDA approval process in March 2003 when the Iraq war heated up, Price said.

The Army is currently field testing it on a schedule that ends in 2006. According to Price, Randall Sweeney, director of government contracting for O'Dell, and Nayla Feghali, product manager for NBC Protection Technologies of Quebec, the Army holds the FDA license and is not releasing the well-known product to the civilian market.

Price said RSDL has been extensively tested since the mid-1990s and has proven highly effective for decontamination against Sarin, VX, T-2 toxin, blistering chemicals and other nerve and germ warfare agents. Unlike the antidote currently used by the military, RSDL can be applied directly over open wounds.

In an effort to release RSDL from the Army's grasp, the manufacturing companies lobbied legislators last month for support. They spoke with the congressional staffs of Reps. John Sweeney (R-NY), Joe Hoeffel (D-PA), John Olver (D-MA), Marty Meehan (D-MA), Ed Markey (D-MA) and Sen. Rick Santorum (R-PA).

They have been in contact with the Massachusetts delegation, including legislative assistant Matt Washington from Olver's office and staff members of Congressmen Marty Meehan, Edward Markey, and John Tierney, and of Sen. Edward Kennedy. Price said he has received limited response from Kennedy, and Washington is circulating a letter for signatures.

"I'm a little surprised, given the Massachusetts delegation's activism in the past, that they aren't immediately taking the lead on this," he said.

Price, Sweeney and Feghali said the Army's current personal decontamination system is a 1960s carbon-based powder technology known as M291 that is no longer produced because of a lack of key raw materials. The last batch was made three years ago, and the Army, which is the single sourcing manager for chemical weapons protection, has been extending the shelf life of the remaining supply.

"M291 is irritating to the eyes and nose and can't be used on open wounds," Price said. "RSDL is a lotion that chemically neutralizes the agent and decontaminates open wounds as well."

All three manufacturing representatives said that RSDL has been used by Canadian troops and in other countries for years. The product came to the U.S. through foreign comparative testing and was in the top three as a choice for use by all branches of the U.S. military.

"Special forces are using this new product. The White House and high ranking officials had it for the [former President Ronald] Reagan funeral, which was considered a top security event," Price said.

Sweeney said RSDL has been in production long enough to become an industrialized product. "We have enough ingredients for 500,000 doses, which the Army doesn't appear too concerned about," he said. "It appears that due to their lack of approval for first responders, [the Army] doesn't want us administering RSDL, and we're at a loss to understand [why]."

The Army's role differs from anyone else's, Sweeney said, but "the bottom line is, if you have victims, you'd want people with something other than soap and water and Windex there. The last I knew, it is the Army's job to protect the public. It should transfer [FDA] approval to the Department of Homeland Security."

Price said the Army is testing RSDL's compatibility with concentrated oxidizers (similar to a strong bleach) that it uses to decontaminate vehicles. RSDL is also being tested with fuels, oils and other military equipment. The packaging, designed to be carried in a pocket and withstand pounding and scraping, is also being tested.

"That's fine," Price said, but the [Army] oxidizers are so strong that a first responder would never use them. And," he added, "the pouches would be safely stowed in ambulances."

Feghali said longevity tests that began two and a half years ago have proved positive. The anticipated shelf life of RSDL is at least five years.

"There's no question we have a vested economic interest," Price said, "but the fact is, what's currently being used is 1960s vintage."

Sweeney said O'Dell must turn down customers every day. "We receive phone calls and e-mails from the first responder community on a daily basis," he said.