"We know that we
need to better under-
stand children's use
of pharmaceuticals,"
says Dr. Goldkind.
"One of my goals is to
do that in the most
ethical manner."

It literally took an act of Congress for Dr. Sara Fay Goldkind to land her dream job—becoming a bioethicist with the Food and Drug Administration in Washington, D.C.

In January 2001, Congress passed the Best Pharmaceuticals for Children Act, and two years later, Dr. Goldkind was named bioethicist of the Office of Pediatric Therapeutics at the Food and Drug Administration. “I felt like this was a dream job,” says Dr. Goldkind, 47, a 1983 graduate. “This job has tremendous importance . . . it has tremendous impact.”

Dr. Goldkind is the only bioethicist at the FDA, the branch of the government that regulates and approves everything from vaccines to pacemakers to ingredients in food. It’s a job most people don’t know exists, but it is a key position. Goldkind’s charge is to protect the interests of children who consume the drugs they require, ingredients in food they eat, as well as medical devices they may use. She makes sure that children used in research studies by the pharmaceutical companies aren’t harmed.

“It is real life stuff,” says Dr. Goldkind, who is also an internist. “For me it is making sure the children who bear the burden of the research are going to in some way reflect the children who reap the benefits.”

Children, she says, need drugs and other products, but they also need to be protected while they are in studies because they can be exposed to too much or too little medicine. “We know that we need to better understand children’s use of pharmaceuticals,” says Dr. Goldkind, who has four children of her own and is married to a physician. “One of my goals is to do that in the most ethical manner. There is still a lot of confusion as to how best to study children. We want to add clarity to the process.”

As a bioethicist, Dr. Goldkind is influenced by philosophy, law, medicine, science and religious studies. If a pharmaceutical company wants to study a product to treat migraine headaches or the safety and effectiveness of additives in infant formula, the company must come to the FDA with a proposal and describe the research. Dr. Goldkind’s job is to consult with the FDA review division to examine the potential impact on children of a new drug or device. So far, she has been involved in about 50 consultations, each having a product associated with them ranging from infant formula to cardiac catheters.

Becoming a doctor was an easy decision for Dr. Goldkind, and her exposure to medicine came at an early age. The oldest of three children, Dr. Goldkind grew up in Washington, D.C. Her mother, interested in pursuing a medical career, was a homemaker while her father, a pharmacist, later became a professor of pharmacology at George Washington University. At times, he took his children to his lab where they could watch how certain chemicals changed colors in a test tube. When she was six, Dr. Goldkind crushed a finger in a collapsible chair requiring reconstructive surgery. By the time she was 11, Dr. Goldkind made up her mind, she wanted to become a doctor.

“I think I was influenced by a real respect for and interest in science, and I think I was influenced by a sort of nurturing, caring component of my personality and also my feeling that I wanted to do something that I felt was personally significant,” Dr. Goldkind says.

After graduating from medical school in 1983, Dr. Goldkind moved to Boston where she completed her residency at Boston City Hospitals, the hospital highlighted in the hit series St. Elsewhere. She and husband, Lawrence, ’80, moved to Florida in 1987, where she worked as an internist. But soon Dr. Goldkind began focusing on bioethics. From 1991 to 1998, she completed course work at Georgetown University’s Kennedy Institute of Ethics, the University of Chicago Clinical Center for Ethics, and she finished a fellowship in clinical consultative ethics at the University of South Florida School of Medicine.

At the University of South Florida, she earned a master’s degree in religious studies with a concentration on religion and public policy and comparative religious ethics. “There were a lot of ethical issues that arose for me as I was going through training that I felt I wanted to address,” Dr. Goldkind says. Some of the issues centered on death and dying and respecting patients’ wishes in their final days of life. During a study she conducted, Dr. Goldkind found that the religious beliefs of health care providers influenced how they reacted to issues of death and dying, assisted suicide and euthanasia. “I thought those topics were very important to better understand,” Dr. Goldkind says.

Dr. Goldkind began focusing on children because the medical community had become so overprotective of them that drugs were manufactured without a clear understanding of how they would affect children. “Kids were being treated with sort of extrapolations . . . from adult data. It became clear that we were actually putting kids in harm’s way in order to protect them.”

Now, drugs and other medical products for children use children in research studies. “Children are classically considered a vulnerable population and need additional protection,” Dr. Goldkind says.

Dr. Goldkind believes she makes a difference in their lives. “I really do feel like I am value added,” she said. “Which is why I think this is a dream job.”