Ensuring Safe, Effective And Necessary
Vaccines For Children

by Michael Horwin

This article originally appeared in the Spring 2001 edition of the California Western Law Review, Volume 37, Number 2. The copyright of this article is owned by the California Western Law Review. All rights are reserved and it may not be reproduced or transmitted without written consent of the California Western Law Review. It is presented here because the author obtained special permission.

(The following is the introductory section of the article without the original footnotes;
to read the entire article with footnotes, download this Word document.)

On August 22, 1984 Sean Leary, a healthy nine-month old baby, was administered his third DTP vaccine. Later that afternoon, Sean began to vomit. The next day, he stopped eating. He stayed alert but was no longer active. That night he cried out every fifteen to thirty minutes. The following day his mother took him to the pediatrician’s office as soon as it opened. The doctor immediately noted the “obvious circulation collapse.” There at the pediatrician’s office, “Sean’s eyes rolled back in his head and he stopped breathing.” He was rushed to an emergency room. Resuscitative efforts failed and Sean was pronounced dead at 1:44 p.m. Sean’s parents filed a claim under the National Vaccine Injury Compensation Program and the defendant hired an expert witness named Dr. Jerome Klein. Dr. Klein testified that the relationship between the vaccination on August 22, and Sean’s death on August 24, was “merely coincidental.”

In addition to testifying on behalf of vaccine manufacturers, Dr. Klein is also the chief editor of “pneumo.com” a vaccine website paid for by Wyeth-Lederle. Wyeth-Lederle is the largest supplier of DTP in the country and also manufactures eight other vaccines. Besides having a relationship with this major vaccine manufacturer, Dr. Klein holds a position on the National Vaccine Advisory Committee. This committee helps the federal government decide what vaccines will be recommended for all children in the United States.

One of Dr. Klein’s colleagues is James Cherry, M.D. Dr. Cherry has been called “the leading defense expert witness in vaccine litigation.” By 1988, Cherry had testified in over eighty cases in which parents sued because their children were allegedly injured or killed by vaccines. Cherry has written that it is a “myth” that pertussis vaccination can cause encephalopathy (brain inflammation) , even though a manufacturer lists it under adverse reactions. Furthermore, Cherry has financial relationships with at least four major vaccine manufacturers. One manufacturer, Wyeth-Lederle, has paid his department at UCLA Medical Center $450,000 in unrestricted funds labeled as “gifts.” But most importantly, Cherry has been a member of the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). This committee plays a key role in determining U.S. vaccination policy by making vaccine recommendations to the Director of the Centers for Disease Control and Prevention (CDC).

Our legal system entitles pharmaceutical companies to hire expert witnesses to defend their products in court. But a growing number of people who are concerned with the safety of vaccines are fearful that these relationships are jeopardizing the integrity of vaccine policymaking. They ascribe their concern to the fact that many of the doctors who enjoy financial connections with vaccine manufacturers are the same individuals who sit on federal advisory committees and make vaccine policy for the country.

Sean Leary is not alone. Since 1986 there have been over 5,000 claims alleging serious childhood vaccine injury including death, paralysis, seizure disorders, and epilepsy. And these claims may represent just a fraction of the total number of injuries. New vaccines are also bringing new injuries. In March 1999, a vaccine was approved that was designed to prevent diarrhea. Within four months it had killed at least one child and critically injured nearly a hundred more by causing intussusception, a previously rare disease. Three months later it was withdrawn from the market.

The House of Representatives Government Reform Committee conducted an investigation into the background of the doctors who participated in the pivotal FDA and CDC vaccine advisory committees that allowed this vaccine to be approved. The investigation culminated in a committee report released on August 21, 2000. According to the report, “The Committee’s investigation has determined that conflict of interest rules employed by the FDA and CDC have been weak, enforcement has been lax, and committee members with substantial ties to the pharmaceutical companies have been given waivers to participate in committee meetings.”

Vaccines are the only medical intervention mandated for healthy children. Although some exemptions are possible, children may not be permitted to attend public school and their parents can be charged with neglect or child abuse, if the child is not vaccinated. Parents must therefore rely upon the integrity of federal vaccine policymaking. Their children’s lives depend on the exercise of careful and prudent decision making devoid of self-interest. The increasing numbers of vaccine injuries and the revelations of the Congressional Investigation raise an important question—how can the law provide children with safe, effective and necessary vaccines when the current system cannot adequately police conflicts of interest and children are obligated to get their shots?

Every child in this country is vulnerable to a system that places financial ties before human life. This note will argue that the pharmaceutical companies play a key role in determining what will be injected into healthy children. It will suggest that this involvement has resulted in the expenditure of millions of dollars for vaccines that may be unnecessary or unsafe. Various solutions will be presented, each designed to protect children’s lives.

Section I discusses the fact that children are now getting more vaccines at a younger age than ever before. It highlights the concerns of physicians, scientists, and parents, and presents information from federal databases and the medical literature. Section II examines the conflicts of interests uncovered in vaccine policymaking. It provides a brief review of the findings of a recent congressional investigation on the most influential vaccine commit-tees: the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). It also highlights the conflicts of interest associated with the two newest childhood vaccines, RotaShield and Prevnar. Section III will examine various solutions to reestablish integrity in vaccine policymaking, and how children can be protected from abuses. Two different categories of solutions will be offered. The first focuses on strategies to eliminate, reduce, or compensate for conflicts of interest in vaccine policymaking. Various approaches will be discussed, including closing the loopholes in the current law, instituting a more stringent code of ethics, retooling the committees, and adding an oversight or ombudsman role. The second category of solutions takes a remedial perspective and focuses both on protecting children and punishing those who abuse the system. These approaches include utilizing taxpayer derivative actions to induce state agencies to scrutinize federal vaccine recommendations and using Qui Tam litigation under the False Claims Act to encourage manufacturers to reform their vaccine manufacturing and marketing strategies. Section IV will seek to redefine the problem by taking a preventive law approach. Here, the current paradigm, a vaccine for every ill, will be challenged. Finally, Section V will provide some concluding thoughts on the steps required to facilitate positive change.



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