FDA Sued to Force Mercury Out

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 CoMeD.

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 eliminated.

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…”

To view the complete article, visit www.putchildrenfirst.org/media/1.6.pdf

The Other Secret Bush Court?
David Kirby, excerpted — read it in its entirety at http://www.huffingtonpost.com/david-kirby/

Next year, a “Special Master” in an obscure Federal court known only to a few Americans will preside over a highly sensitive judicial matter of urgent national importance. The Bush Administration wants to hold the hearings in a sealed courtroom, off limits to the press and public, with stiff “sanctions” for any outsider who attempts to gain unauthorized access to the secretive proceedings within.

You may not know it, but there is an official federal “vaccine court," where some 4,750 autism-related cases have been pending for years.  Claimants believe the mercury-based vaccine preservative, thimerosal, and/or the MMR vaccine, contributed to their children’s autism, and they are seeking compensation from a special vaccine injury fund administered by the federal government.

The long-awaited autism vaccine trial will commence on June 11 in the courtroom of Special Master George Hastings. The plaintiffs and their attorneys have asked for complete transparency in every aspect of the tribunal, including public disclosure of all evidence and unhindered media access to the hearings. The few autism families whose medical records will be scrutinized as legal examples are waiving their right to privacy and confidentiality, so that their stories may finally be told in an open court of law.

But the DOJ (technically, the “defense”) has other plans. On November 3, the Department wrote to Hastings saying it “would oppose public access to the courtroom and public broadcast of the trial,” because such an arrangement “would pose security and privacy concerns” for those in attendance.        

If the DOJ has its way, only claimants and their attorneys will be allowed to sit in the courtroom, or receive password-enabled access to a live audio webcast of the trial. The media will be barred, and so will everyone else. And though there will be an official written transcript, such documents are sometimes redacted, or even sealed, after the trial.

As a journalist, I will be subject to “sanctions” if I sit in on a webcast without authorization from the court. In fact, unauthorized access to the proceedings, according to the DOJ proposal, might lead to “termination of the webcast and closing of the courtroom."    

I think it’s safe to say that the Bush Administration does not want this trial publicized. That seems curious to me. The entire thimerosal question will likely be left up to just one man: Special Master Hastings. Whether he decides for the parents, or for the DOJ, his ruling will forever be considered within a vacuum, subject to intense criticism from either side, unless he agrees that all thimerosal evidence should at long last be made public. I hope he rules that his courtroom is not Guantanamo. These parents, and the public at large, deserve no less.