Clifford Shoemaker, Esq

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Clifford Shoemaker, Esq

Clifford Shoemaker, Esq. 9711 Meadowlark Road Vienna, VA 22182 Phone: 703-281-6395 Fax: 703-281-5807

John F. McHugh, Esq. 6 Water Street Suite 401 New York, NY 10004 Phone: (212)483-0875 Fax: (212)483-0876 Email: [email protected]

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

THE COALITION FOR MERCURY- | FREE DRUGS (CoMeD, Inc.), a non-profit organi-| zation, Lisa Sykes, Mark R. Geier, M.D., Ph.D., | David A. Geier, B.A. and Paul G. King, PhD, | | Plaintiffs, | | -against- | 1:09-CV 00015 (RBW) | Michael O. Leavitt as Secretary, Department of | Health and Human Services and | Andrew C. von Eschenbach as Commissioner of | The United States Food and Drug Administration, | | Defendants. | |

DECLARATION OF Dr.

Dr.______declares under penalty of perjury pursuant to 28 U.S.C. 1746 that the following information is true to best of my knowledge and belief and that if called to testify in this matter I could testify competently to these facts.

1. I am a pediatrician.

2. On a daily basis I administer vaccinations which are required by law and pursuant to the schedule recommended by my state.

3. I am aware of the controversy surrounding Thimerosal as are numerous parents who, as the result are afraid to have their children vaccinated due to doubts about the safety of vaccines related to the

Secretary’s slow reaction to this issue.

4. Indeed, the ostrich approach of the Secretary and the AMA to parental concerns related to vaccines has destroyed the credibility of the

FDA in the eyes of huge numbers of the parents I must deal with. When I attempt to defend the program, my credibility is placed at risk as the

Department of Health and Human Services has so conspicuously failed to police manufacturers for such a long period of time.

5. I am fully familiar with the history of Thimerosal and its use in vaccines. There have been serious questions about this substance’s value as a preservative since World War II. There have been reports of the damage it can do to cells and to neurons from the early 1930’s to date. Yet the official position of the Department continues to be that this substance is harmless.

All the known toxicology says otherwise.

6. Such dereliction of duty destroys public confidence in the vaccine program and undermines practitioners. We simply cannot be convincing in advocating vaccinations where the FDA’s only answer on Thimerosal has been its safe because it says so. It is time for the FDA to be called to comply with its legal mandate.

7. Where drug is preventive and is injected into a healthy human being to prevent a disease, it must be established to be safe. This has not happened with Thimerosal. Most flu vaccine is still preserved with

Thimerosal and trace amounts of that substance are still tolerated, remnants of the manufacturing process.

8. Other than with vaccines, if a patient has any adverse reaction at all, we do not administer that drug again to that person. The Secretary and the vaccine manufacturers advise that we not follow that rule with vaccines.

That is the type of advice that destroys the credibility of the program.

9. It is well known that as with any adverse reaction to any drug or substance, everyone will not be affected. Only a subset of the population will have a problem but that can be a serious one, such as autism.

Epidemiological studies are not reliable because they cannot detect rare events. Studies must be focused on those groups of individuals who have had an adverse reaction and on toxicology. In the case to Thimerosal, the toxicology to date indicates that it should not be used in any substance injected into or placed on a human body.

8. CoMeD represents my interests as a pediatrician and therefore I urge this Court to require the FDA to do its job.

Wherefore I urge the Court to require the Secretary to produce affirmative toxicological studies proving that this substance is safe for use on susceptible individuals or to take it off the market.

Signed this ______day of ______, 2009 at ______City and State ___ signature ______printed name street address city, state zip code Tel: area code-exchange-number

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