Once again we have a company that is lying as they desperately fend off competition the old fashioned way:
buying political support to punish your competitors. This company in South Carolina bleeds horseshoe crabs to get a compound which is used extensively in the medical industry to detect contamination. This has been a great approach for decades. Now a better synthetic mouse trap has been built and is the gold standard in Europe and Asia but here in the U.S. it's being blocked. The largest harvester of horseshoe crab blood has tried to create a synthetic but has had poor results. At this point it's just likely fighting for time to succeed. Welcome to America.
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Representatives from Charles River have said that more than 80 million LAL tests are performed annually at a value of over $500 million, and that the company makes the most in the industry.
“We were fifth in a field of five when we started, and now we’re the number one provider of this technology,” said John Dubczak, an executive director for Charles River based in South Carolina.
Though the company has tried to make its own synthetic equivalent to LAL, Charles River has been unsuccessful at manufacturing something that works as well as its blue blooded product, Dubczak indicated.
That’s part of the reason why the company has become one of the main antagonists to the synthetic innovation, believes Dr. Lawrence Niles, a wildlife biologist who co-leads the national Horseshoe Crab Recovery Coalition from New Jersey and has been involved with animal conservation projects for more than 40 years.
“They have a lot to lose from switching over to rFC,” Niles said.
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Charles River’s statements about the synthetic — a technology first invented over 20 years ago in Singapore and already approved in Europe, Japan and China as an equivalent to LAL — have indicated the company believes it doesn’t provide for a test as effective as the natural one, and more research is needed to prove it does.
“Our position is that this is very exciting, but it requires more development,” Dubczak said.
Last year, the company hired a lobbyist based in Washington D.C. to pressure the government about its opinions on the topic.
“Speedy adoption should not be viewed more favorably than certainty of patient safety,” Charles River urged the U.S. Pharmacopoeia in its 2019 letter.
The efforts seem to have paid off. Half a year after it received Charles River’s letter, the U.S. Pharmacopoeia announced it was canceling a proposal expected to eventually grant the synthetic equivalent status to LAL in America. The decision was “based on stakeholder comments and in accordance with USP’s public process for standards development.”
The group has clarified it is supportive of investigating the use of rFC and may publish a chapter about it later, but that it is taking time to consider the synthetic since “tests using rFC do not benefit from the same level of real-world evidence as LAL.” A committee is expected to vote on a related issue in March.
Some scientists said the information Charles River provided to regulators was misleading.
“When they present data, there is always a spin,” said Dr. Jessica Ponder, a toxicologist at Physicians Committee for Responsible Medicine, a nonprofit based in Washington, D.C. “They want to establish a paradigm where LAL is the gold standard purely on precedent, which is not scientific. The oldest method is not the best method in most of science.”
The pandemic has heightened the urgency to approve the synthetic as an equivalent to LAL, Ponder believes, since there’s a growing demand for vaccines and antibody drugs that have to be tested for contamination.
“I don’t feel safe counting on a limited resource for all of our response to COVID when anything could happen to it,” she said.
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Just kidding. It probably happened before the Bucs won the playoffs.
