While we are waiting for the cotton to grow, a little reading about how bad the tainted drug problem is.
Anna Edney
(Bloomberg) -- Heparin tainted with unauthorized Chinese-
made ingredients may be on the market in the U.S. and the Food
and Drug Administration hasn’t moved swiftly enough to prevent
it, according to a congressional probe nearly a decade after
hundreds of deaths were linked to sullied batches of the blood-
thinning drug.
This possible contamination is different from the earlier
one, when Chinese producers made crude heparin containing a
deadly chemical. They may be using cow and sheep intestines to
produce the raw material for heparin that is supposed to be
derived only from the intestinal membranes of pigs, according to
a letter the House Energy and Commerce Committee sent Tuesday to
the FDA. The agency has known about the risky practice since
2007, around the time it discovered the chemically enhanced
crude heparin, the panel said.
The FDA didn’t react early on “to credible evidence of non-
porcine contamination of the Chinese heparin supply,” according
to the letter, only putting out testing guidelines for
pharmaceutical companies in 2012. Even after the tragedy of the
chemically soiled heparin, the committee said, “loopholes and
exemptions that permit part of the Chinese drug supply chain to
operate outside government scrutiny still remain.”
Christopher Kelly, a spokesman for the FDA, said the agency
would respond to directly to the committee and declined to
comment. The letter was signed by five Republican leaders of the
panel, including Chairman Fred Upton of Michigan. The committee
investigation was based on government and industry documents and
interviews.
The allegations in the letter renew worries over how
potentially dangerous pharmaceuticals, particularly from China,
can reach world markets, as well as authorities’ ability to
police vast global supply chains.
Corrupted Chain
The chemical, oversulfated chondroitin sulfate, was
connected to 246 deaths and sickened hundreds of people who took
the blood-thinning medicine, the FDA said at the time.
Regulators never found at what point in the chain in China that
the drug, sold in the U.S. by Baxter International Inc., was
corrupted. The FDA closed its initial criminal investigation
after it became difficult to obtain evidence in China, though it
has since re-opened a related inquiry, according to the House
committee. Baxter, which recalled its heparin in 2008, hasn’t
sold the anticoagulant since. It said at the time it was alarmed
that the contamination appeared to have been deliberate, but had
no proof of how it happened.
The letter from the House committee said the FDA dropped
the ball on many fronts and may have allowed unsafe blood
thinners to remain on the market longer than necessary.
Regulators didn’t properly or widely enough share information
and didn’t follow up on leads about tainted heparin from other
governments, according to the letter. Agency investigators
failed to inform others about dodgy crude heparin makers, the
panel said. It also said the FDA didn’t follow up on concerns
that heparin with the chemical was recycled after the poison was
removed and may have entered the U.S. market.
Asking Questions
The committee asked the FDA to answer a series of questions
by April 12, including what actions it’s taken to improve
internal communication, whether it takes into account raw
material shortages in its inspection strategy, whether it has
investigated the potential recycling of contaminated heparin and
what it could do to improve its probes of “economically
motivated adulteration.”
The U.S. depends heavily on China for medicine. Along with
India, the country is one of the top two producers of base
ingredients for drugs in the world, according to the National
Academies of Sciences, Engineering, and Medicine. The FDA has
made inspections in China a priority, and has barred more than
40 plants from exporting some or all of their products to the
U.S. In addition, the FDA has banned 34 heparin plants in China
from supplying the U.S. because they either don’t meet
manufacturing standards or refuse to allow the agency to conduct
inspections.
Studies show heparin made from cows rather than pigs works
differently in the body, the letter said. The French National
Agency for Medicines and Health Products Safety called non-pig
blending a “critical” violation in an inspection report released
in February. France cited China’s Dongying Tiandong
Pharmaceutical Co. for making heparin with ruminant DNA, which
includes cows and sheep. Dongying is registered with the FDA as
a manufacturer of active ingredients and isn’t on the agency’s
list of companies banned from importing to the U.S.
Insufficient Pig Supply
China is the major supplier of crude heparin to the U.S.
because of its abundant pig supply, according to the U.S.
Government Accountability Office. Thousands of pig farms extract
and process the intestines that are collected by consolidators
who sell them to manufacturers that refine them. Investigators
with the House committee conducted a statistical analysis and
determined there aren’t enough pigs in China to create all the
heparin material being sold by producers in that country.
“The pig supply in legal slaughterhouses in China would not
be sufficient to support the number of pigs needed to
manufacture the amount of Chinese heparin for export alone, not
even taking into account the amount needed for the Chinese
domestic heparin market,” according to the letter to the FDA.
The panel ran numbers for 2007 and found China was 100 million
pigs short, with analyses for following years showing similar
shortfalls, the letter said.
The agency considers heparin adulterated if it contains
oversulfated chondroitin sulfate or non-pig material, according
to an FDA document for the pharmaceutical industry on monitoring
heparin quality. Material from cows could pose a risk because of
possible contamination with mad cow disease.
