Months after thousands of people in the eastern U.S. were given back injections tainted with black mold, more than 300 have contracted fungal meningitis and 28 have died, including two in Virginia. As doctors scramble to treat those affected, regulators are trying to unravel what happened at the Massachusetts pharmacy that produced the drug. Whatever the cause, technology that could prevent a similar disaster already exists—and it was developed right here in Charlottesville.
Jim Veale was fresh out of UVA’s graduate physics department when he started Lighthouse Instruments in 1995 with a patent for a high-sensitivity laser. Five years later, he’d developed a revolutionary way to use the technology to check the integrity of sterile pharmaceuticals.
Injectables and other drugs packaged in small vials usually have a cushion of pure air, or “headspace,” sealed in above them. If the gas balance in that space is off—if there’s suddenly too much oxygen, for instance—it’s a clue that there’s a leak, and if air can get in, so can microbes. In Lighthouse’s early days, Veale learned that the standard method of testing headspace was, by necessity, destructive: In order to get a sample, pharmaceutical companies had to break open random vials. If they found a problem with one, they might have to scrap tens of thousands of doses.
“That’s when I had the idea,” Veale said. “Why couldn’t we do that measurement with this laser we have? The end user wouldn’t have to destructively test or open up the vial.” And what’s more, the technology would allow for 100 percent inspection.
Today, said Veale, Lighthouse employs 26 people, and its headspace systems are widely used by pharmaceutical companies around the world. “We have some competition, but we’re really the only ones offering this kind of laser technology,” he said.
And advancements are marching forward. They’re running final tests on new equipment designed to detect big drops in oxygen in vials, which would indicate the presence of microbes or other contaminants sealed in during the manufacturing process.
It’s possible that’s what happened at the New England Compounding Center, the source of the tainted drugs blamed for the meningitis outbreak. Officials have found problems at the plant, including puddles and dirty floor mats near areas that were supposed to be sterile.
Tom Thorpe is CEO of Afton Scientific, a small-batch drug maker. He’s also one of Veale’s best friends, and their companies share office space in Belmont. He knows full well how vigilant manufacturers have to be to avoid contamination. From air filters to fingertips, everything has to be cleaner than clean.
“You have to be constantly afraid of making a mistake,” he said.
But compounding pharmacies like the Massachusetts company are regulated far less strictly by the FDA than pharmaceutical manufacturers, Thorpe said, even though they often make similar products. Unless the government says test, companies won’t test. But the meningitis outbreak—and the arrival of technology that can assure safety while reducing waste—might shift the risk-benefit analysis for everybody in the industry.
“A lot of this technology adoption is driven by regulatory requirements,” said Veale. “Right now, I think everybody’s taking a wait-and-see attitude about how that regulatory environment is going to change.”