October 26, 2006

Government Rejects Vaccine Petition

AP: Government Rejects Vaccine Petition
Oct 24, 7:10 PM (ET)

WASHINGTON (AP) - Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.

A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.

"Only a small number of licensed and approved products still contain thimerosal, and the available evidence supports FDA's conclusion that all currently licensed vaccines and other pharmaceutical drug products containing thimerosal are safe," Dr. Jeffrey Shuren, the FDA's assistant commissioner for policy, wrote in denying the petition.

"We're not accepting that answer," said Dr. Mark Geier, one of the petitioners. The group now plans to seek a court order that would force the FDA to withdraw thimerosal from all vaccines and medicines unless the agency can show the preservative is safe, Geier said.

Thimerosal, about 50 percent mercury by weight, has been used since the 1930s to kill microbes in vaccines. There have been suspicions that thimerosal causes autism. However, studies that tracked thousands of children consistently have found no association between the brain disorder and the mercury-based preservative. Critics contend the studies are flawed.

Since 2001, all vaccines given to children 6 and younger have been either thimerosal-free or contained only trace amounts of the preservative. Thimerosal has been phased out of some, but not all, adult vaccines as well.

Most doses of the flu vaccine still contain thimerosal, though manufacturers produce versions free of the preservative for use in children. The FDA said it was in discussions with those manufacturers to increase the supply of thimerosal-free flu vaccine.

There also are minute amounts of mercury, as thimerosal or phenylmercuric acetate, in roughly 45 eye ointments, nasal sprays and nasal solutions, the FDA said. Various antivenoms for black widow and snake bites also contain thimerosal.

UPDATE: Coalition for Mercury-free Drugs Response

Today CoMeD responded by filing a petition to stay the FDA's decision
because the FDA & HHS failed to:

A. Address the key issues raised in the CoMeD citizen petition or
B. Provide publisdhed peer-reviewed science (or references thereto)
to support most of the assertions they made, and
C. Did NOT address issues associated with their failure to:
1. Comply with, among other things, the 1987 statute mandating they reduce the adverse reactions in childhood vaccines,
2. Enforce the legally binding 1973 regulation requiring manufacturers of biological products, including vaccines, to prove that any compound the used was "sufficiently nontoxic" before using it or continuing to use it in a product formulation for the compound Thimerosal, and
3. Act in a manner that complied with a unanimous 1988 Supreme Court case that mandated that drugs, including vaccines must meet all legally
binding requirements (clearly set forth in official policies, laws (including binding regulations), and statutes BEFORE the government may use its administrative discretion in deciding to license/approve a drug or its labeling.

In a day or two, the CoMeD petition for a stay should be listed in the dockets as they acknowledged, by email, having received it and, when the full response is linked electronically, I will post the specific link to this filing.

Factually, the FDA did NOT address the key petition issues and the reporter seemed to have only read the FDA's response to CoMeD and NOT the 2004 petition BECAUSE, as the 2004 petition noted, Congress and NOT CoMeD raised the issue about the probable link between Thimerosal and "autism" in the Houses' 2003 "Mercury in Medicine" report.

Factually, the 2004 CoMeD petition (Docket: 2004P-0349) focused on the failure of the government and the drug manufacturers to:
a) prove Thimerosal was safe so that it was "sufficiently nontoxic" in appropriate toxicology studies as required by law since 1973, b) the government's ongoing failure to comply with a 1987 statutory mandate to reduce adverse events in childhood vaccines, and c) the government's failure to comply with a unanimous 1988 US Supreme Court case (Berkovitz, a polio vaccine case) limiting the government's administrative discretion to decisions made AFTER the requirements of all applicable policies, laws and statutes have been proven to have been met.

Hopefully, faced with this response and other actions, the FDA and the HHS will address the issues raised by CoMeD in its original petition as requested -- in a manner that fully complies with all applicable binding policies, laws (including regulations) and statutes governing the FDA's actions and the permissible conduct of drug manufacturers including vaccines.


Dr. King,
CoMeD Science Advisor

PS: When the petition documents are linked, CoMeD will post this new filing under 21 CFR 10.35 in:


along with the documents list with pointers to the articles that have already been posted in the CoMeD website's documents page as Appendices "A" and "B" as well as posting Appendix "C" to the site's documents page.

No comments: