The herbal medicine movement lost an esteemed colleague and true friend with the passing of Floyd Edwin Leaders, Jr, PhD, at age 74. Following a lengthy illness, he died February 26 in Columbia, Maryland.1
"Floyd was a monumental figure in the research and drug development of botanical products in the United States. He was a mentor and a colleague, and most importantly—a friend," said Freddie Ann Hoffman, MD, a former Food and Drug Administration (FDA) official and consultant on botanical drug approvals.
Dr. Leaders was born in Denison, Iowa, in 1931.1 He graduated from Drake University in 1955 with a Bachelor of Science in Pharmacy and attended Iowa State University where he received his Master of Science in Pharmacology in 1960 and his Doctorate in Pharmacology in 1962.2
Dr. Leaders became an assistant professor of pharmacology at the University of Kansas Medical School, but "in 1967, he left academia to join Alcon Laboratories in Fort Worth, Texas, and continued to move up through the ranks of the pharmaceutical industry, serving as Director of Research Service at Schering-Plough, and then Director of R & D at Pennwalt Corporation," Dr. Hoffman said.
In 1977, Dr. Leaders founded Technical Evaluation and Management Services, Inc. Based in Dallas, the contract research organization was "one of the first to run clinical trials for the pharmaceutical industry to meet the FDA's regulatory standards," according to Dr. Hoffman.
"Dr. Leaders was particularly interested in improving the prospects for companies interested in pursuing the drug approval avenues for botanicals, and he mentored numerous clients in this direction, including large pharmaceutical companies as well as small-venture startups," said Mark Blumenthal, Founder and Executive Director of the American Botanical Council (ABC).
By 1992, Dr. Leaders founded Leaders Group, Inc., and he served as consultant for the former Office of Alternative Medicine (OAM) at the National Institutes of Health (NIH), now called the National Center for Complementary and Alternative Medicine.1
After the passage of the Dietary Supplement Health and Education Act in 1994, Dr. Leaders was one of the principle people to motivate OAM to sponsor and organize a two-day conference on botanical medicine, the first conference of its kind sponsored by the US government, a watershed moment in the history of the botanical medicine movement.
Dr. Leaders became a catalyst to increase communication and cooperation among various segments of the botanical medicine industry, researchers, and the federal government.
"In this role, he assisted researchers, clinical investigators, federal agencies, and the industry to understand not only the need for carefully designed studies and data management, but also the rigorous requirements for US [FDA] development and approval," Dr. Hoffman said. "Through his patience and powerful negotiation skills, Dr. Leaders was successful in assisting sponsors in filing Investigational New Drug applications for heterogeneous [i.e., chemically complex] botanical products with the FDA Center for Drug Evaluation Research."
He served as co-chair of botanical drug development workshops sponsored by the Drug Information Association, the FDA, and the NIH. His work also contributed to the "scientific underpinnings" for the FDA Center for Drug Evaluation Research Guidance Document on Botanical Drugs.2
In 1997, Dr. Leaders formed Botanical Enterprises in Rockville, Maryland, and as Chairman and CEO, he worked to make commercial agreements with companies interested in developing botanical drug products.2
"Dr. Leaders was instrumental in helping create a significant bridge of communication and understanding between the herb industry and botanical researchers, on the one hand, and many scientists and policy makers at the FDA on the other, especially at a pivotal time in the development of the herb movement," Blumenthal said.
ABC Board of Trustees Chairperson Peggy Brevoort was close to Dr. Leaders for many years. "Floyd was a visionary and doer," she wrote. "He opened doors for me to new worlds and ideas and concepts that changed how I dealt with our business [East Earth Herbs, now A.M. Todd Botanicals] and its vision. He encouraged some of the most creative thinking I have ever done. He was one of the first persons to understand how our fledgling herb industry could work with rather than against a complicated, established health care system. And he dedicated his energies and business sense to building those bridges." [P. Brevoort e-mail to M. Blumenthal, February 26, 2006.]
Dr. Leaders is survived by his wife of 30 years, Madeline Van Hoose of Montgomery Village, Maryland; his daughter, Terra Leaders Singletary of Midland, Texas; and his grandson.1
1. Floyd Edwin Leaders, Jr, Medical Firm Founder. Washington Post. March 11, 2006: B6.
2. Botanical drug advocate Dr. Floyd Leaders, Jr dies after long illness [press release]. Austin, TX: American Botanical Council; February 26, 2006.