A peripatetic pediatrician's journey into pediatric rheumatology: Part II

The beginning of the PRSCG was part of the evolving plan for the future of pediatric rheumatology in the US. I was impressed with the work of Maxwell Finland in Boston in an earlier era when he cobbled together a group of clinicians to effectively study antibiotics. I knew that we had to develop methods to study medicines for children with arthritis in the US. We were trapped in a circular equation. There were many drugs coming to market for adults with arthritis. I believed that many of these new drugs were non-specific for pain relief and would be used to help all types of pain as well as inflammation. Studies were performed in adults with arthritis. No studies were being performed in children because there were thought to be too few children with arthritis. Therefore the pharmaceutical companies could not justify studies in children for economic reasons. Therefore we had no approved drugs to give arthritic children because the efficacy and safety were not studied in children. It was interesting to me to learn that aspirin was grandfathered in as an approved drug when the US Federal Drug Administration (FDA) was first created many years ago.I had previously studied indomethocin and acetaminophen in a blinded study of acute control of high fever in children. I conducted the study at the Ben Taub Hospital in Houston. It was published in Arthritis and Rheumatism in 1968. The study was able to show that indomethocin was superior to acetaminophen in controlling fever. This was a short usage study, but no adverse reactions occurred in the short dosage regimen. This study, however, did not address the problem of obtaining approval for the use of indomethacin in children.Dr. James Gleichart of Abbott Laboratories contacted me concerning an anti-inflammatory drug and a possible study. This was the first interest of a drug company in studying arthritis drugs in children. He informed me that they were two years from studies in adults or children. Nothing came of the contact.