FDA Sued to Force Mercury Out of Medicine
From an organization announcement
The Coalition for Mercury-free Drugs (CoMeD) filed an amended
complaint in U.S. Federal Court, disputing the FDA response it received on
September 26, 2006, defending the use of mercury in medicine.
CoMeD is asking the court to compel the FDA to: comply with the law,
follow existing regulations, and provide proof of the safety and efficacy of
mercury in drugs.
This lawsuit was originally filed in August 2006 because the FDA had
failed to answer the issues raised in a CoMeD citizen petition (FDA Docket:
2004P-0349), filed on Wednesday, August 4, 2004, by representatives from
Of concern is that mercury, which is second only to plutonium in
toxicity, remains in at least 45 different prescribed and over-the-counter
drugs (according to the FDA), including various eye ointments, ear
solutions, nasal sprays, vaccines, biologics, and perhaps most importantly,
in flu vaccines currently being administered to millions of pregnant women,
children, and the elderly.
Mercury is toxic to all human systems. Infants and children are
especially susceptible to mercury poisoning. Mercury has been implicated in
a long list of human chronic disorders including Alzheimer's disease,
asthma, attention-deficit disorder, autism, diabetes, and multiple
sclerosis, among many others.
In a letter sent to the CoMeD and made public on September 27th, Dr.
Jeffrey Shuren, the FDA Acting Assistant Commissioner for Policy, denied the
CoMeD petition, but his admission that the FDA had no substantive evidence
confirming the safety of mercury in medicine was stunning.
FDA also acknowledged that mercury in drugs could easily be
Plaintiffs' lead attorney, Clifford Shoemaker stated, "In its
response, the FDA refused to address the merits of the complaint. It is not
the responsibility of consumers to prove drugs 'unsafe'; it is the FDA's
duty to prove drugs are safe. The FDA has ignored a mountain of scientific
evidence and its responsibility to the public, specifically to protect our
children. . It has failed to follow its own statutes and regulations. . Just
as we witnessed with Vioxx, the FDA has turned a blind eye to the danger of
mercury in medicine. To the detriment of multiple generations, industry
influence over the FDA has again compromised drug safety."
In a 1999 internal email, obtained under a Freedom of Information Act
(FOIA) request, an FDA official admitted that the agency's failure to
evaluate the cumulative amount of mercury in medicine, "...will raise
questions about FDA being 'asleep at the switch' for decades by allowing a
potentially hazardous compound to remain.and not forcing manufacturers to
exclude it from new products."
In a second email, the same FDA official wrote, ". the greatest point
of vulnerability on this issue is that the systematic review .by the FDA
could have been done years ago and on an ongoing basis."
In May of 2003, the U.S. House of Representatives, Government Reform
Committee released a report, "Mercury in Medicine - Taking Unnecessary
Risks" following a three-year investigation into mercury. The report found,
"Mercury is hazardous to humans. Its use in medicinal products is
undesirable, unnecessary and should be minimized or eliminated
entirely...The FDA has never required manufacturers to conduct adequate
safety testing on thimerosal and ethylmercury compounds.Studies and papers
documenting the hyperallergenicity and toxicity of thimerosal (ethylmercury)
have existed for decades." Furthermore, it concluded, ".the Committee.did
find evidence that thimerosal did pose a risk.Thimerosal used as a
preservative in vaccines in [sic; is] likely related to the autism
epidemic...Our public health agencies' failure to act is indicative of
institutional malfeasance for self-protection and misplaced protectionism of
the pharmaceutical industry." (For the published Congressional report, See:
In February, 2004 the California Environmental Protection Agency
Office of Environmental Health Hazard Assessment found "the scientific
evidence that PMA (phenylmercuric acetate) and thimerosal cause reproductive
toxicity is clear and voluminous.The evidence for its reproductive toxicity
includes severe mental retardation or malformations in human offspring who
were poisoned when their mothers were exposed to ethyl mercury or thimerosal
while pregnant, studies in animals demonstrating developmental toxicity
after exposure to either ethyl mercury or thimerosal, and data showing
interconversion to other forms of mercury that also clearly cause
reproductive toxicity". (See page 3 of:
To view CoMeD's petition to remove mercury from medicine, and all the
subsequent documents, including the FDA responses:
To view CBS News Report on CoMeD's delivery of the petition to the