Wildlife groups pressure Big Pharma to curb crab blood addiction
* Groups urge drugmakers to drop crab blood, adopt synthetic
* U.S. standards group says more data needed on man-made
* Eli Lilly switched to synthetic, urges others to follow
(Adds Eli Lilly comment)
By John Miller
ZURICH, June 1 (Reuters) - Wildlife advocates are pushing
drugmakers to curb the use of horseshoe crab blood by switching
to a synthetic alternative for safety tests, including those
needed before a COVID-19 vaccine can be used on humans.
Fishermen net hundreds of thousands of the creatures off the
U.S. East Coast and Asia every year, draining their prized
milky-blue blood for use in medical safety tests that detect
bacterial contamination in intravenous drugs or implants.
The National Audubon Society, Defenders of Wildlife and
other groups called for greater use of a man-made option, called
recombinant Factor C (rFC), in a statement released on Monday by
umbrella organization the Horseshoe Crab Recovery Coalition.
They say this shift could save 100,000 horseshoe crabs
annually on the U.S. East Coast alone and help threatened
migratory birds that depend on crab eggs for survival.
"It is unfortunate that biomedical research still relies on
the harvesting of a vulnerable wild animal population when there
is a simple, effective, sustainable replacement," said Ryan
Phelan, a campaigner with California-based conservation group
Revive & Restore.
However, the testing industry's impact on the U.S. crab
population is disputed, with varying estimates of how many die
during bleeding or after they are returned to the ocean.
Swiss biotech company Lonza, a leader in the field,
said that good stewardship had led to "stable to increasing"
Regulatory hurdles to rFC also remain, with U.S. standards
group U.S. Pharmacopeia (USP) last week scrapping plans to put
the synthetic test on an equal footing with industry-standard
crab blood trials.
While Europe is moving to recognize the synthetic as
comparable, USP announced on Friday that more data was needed to
support such a move.
Adoption has lagged, in part, because drug regulators have
demanded that rFC endotoxin tests undergo extra validations -
adding time and cost - to prove they match the accuracy of crab
So far, only two drugs, both from Eli Lily, have
been approved after relying on rFC for final endotoxin tests.
Eli Lilly, which has switched 90% of its safety testing to
rFC since 2016, on Monday told Reuters that it supports the
wildlife groups' aims to get more companies to follow suit.
The wildlife groups pledged to target U.S. legislators and
regulators to spur action.
Horseshoe crabs' copper-rich blood has helped the species to
survive for 450 million years - and made it a source of one of
the drug industry's most unusual raw materials because it clots
in the presence of bacterial endotoxins.
Drained from live crabs, the blood has long been the
standard to detect contamination in shots, infusions and medical
Companies including Lonza and Charles River Laboratories
are the biggest crab bleeders, supplying many of the 70
million annual endotoxin tests in a roughly $1 billion market.
More recently, man-made rFC from Lonza, France's bioMerieux
and others has emerged an alternative, and they have
been pushing to gain market share, though Charles River has
opposed recognition, sparking an industry battle.
Eli Lilly on Monday announced that it had begun testing a
COVID-19 antibody in humans with all the safety testing done
with rFC, said Jay Bolden, a Lilly biologist whose hobby as a
birdwatcher spurred him to lead his company's switch to the
There is sufficient scientific evidence, including from more
than 40,000 samples tested by Lilly so far, to support the
synthetic's comparability with crab blood, Bolden added.
"And that data is out there, and it's either not being
looked at or it's being ignored," he told Reuters. "There's no
reason the USP should be asking for more data."
(Reporting by John Miller; Editing by Pravin Char and David
First Published: 2020-06-01 16:11:53
Updated 2020-06-01 20:55:46
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