Hint: It was over a golf game.
After our recent blog on the secret legacy of thalidomide, more questions arose. Such is the nature of a story about a drug shrouded in deception.
Our original piece focused on: the widespread use of sedatives by women in America in the 1950s; the introduction of thalidomide in the 1960s through "clinical trials"; the impact thalidomide had on the lives of two women born with missing limbs, including the blog's co-author, Eileen Cronin, who happened to be born in Cincinnati, where Richardson-Merrell, the American drug company that distributed the drug in the United States, was headquartered; and the bombastic response after babies were born with missing limbs.
We revealed flaws in a system with a growing dependence on sedatives and proposed a broader perspective on thalidomide, a drug manufactured in Germany by The Grunenthal Group.
In part one of our follow-up series on thalidomide, we focus on the pseudo "clinical trials" and gross negligence of Richardson-Merrell, which distributed thalidomide to 1,267 U.S. physicians. In part two, we address faulty data resulting in the underestimate of infants affected by and the number of pregnant women included in the U.S. drug trials.
Unregulated "Drug Trials" -- First "Safe Sleeping Pill for Pregnant Women"
The "clinical trials" of thalidomide reveal an ugly truth about the early days of drug research in the United States.
The FDA never approved thalidomide for use in the U.S. While that is certainly true, it is equally true that more than 20,000 Americans were given thalidomide under so-called clinical trials.
In fact, the FDA did not monitor clinical trials for the most part prior to thalidomide. Richardson-Merrell, filing for FDA approval, knew that, and recklessly used the lax policy to put a toxic sedative into the hands of physicians. According to Dr. Rock Brynner, Ph.D., and Trent Stephens, co-authors of Dark Remedy: "There were hardly any FDA guidelines for collecting data during trials, so Richardson-Merrell sought none."
A Redundant Theme: No Records
We previously detailed that the most comprehensive history of thalidomide is the book published in 1979 by a task force from the London Sunday Times titled Suffer the Children: The Story of Thalidomide, authored by Phillip Knightley, Sir Harold Evans, Elaine Potter and Marjorie Wallace. They wrote: "It is generally assumed by people outside the pharmaceutical industry that the Food and Drug Administration protected Americans from taking a drug until it had been proved both effective and safe. This was not necessarily so."
The Times writers described patients involved in the "clinical trials" of thalidomide as "guinea pigs" because they were not informed that the drug was in a trial phase or that they, as patients on a routine office visit, were subjects in a study. This practice already had been found to be a "violation of the Nuremburg Medical Code." Worse, the study began after Richardson-Merrell researchers found thalidomide was lethal to animals in strong enough doses, according to both The Times and Dark Remedy. Those animal studies were buried.
While U.S. media have widely reported that the FDA did not approve thalidomide, they have failed to question our government's inability to shut down its "clinical trials." Tragically, the FDA rejections were themselves the cause for a greater dispensation of the drug under the so-called clinical trials. In both the Times and Dark Remedy accounts, at least 1,267 U.S. physicians were told A) the drug was being safely used in Germany; B) 20,000 patients had been taking it in the U.S. safely and C) follow-up was not needed.
The Times reporters elaborated on Richardson-Merrell's attempts to get past the FDA: "In fact, one of the reasons for the trial programme [sic] involving 20,000 or more patients was, it was said, to gather evidence of the drug's effects to present to the FDA." Ironically, it is because of the denials and the requests for more data that there were increasingly reckless administrations of the drug to women in the U.S., under a flawed system that allowed drug studies to go unmonitored.
A Forged Medical Paper Composed During a Golf Match
Most egregious was Richardson-Merrell's naked aggression of getting thalidomide into the hands of obstetricians by forging a paper under the name of an obstetrician from Cincinnati, Dr. Ray Nulsen.
The nature of Dr. Nulsen's compliance goes back to his relationship with Don Merrell, an executive of Richardson-Merrell and a family member of one its owners. Nulsen and Merrell had been in a college fraternity together. The ghosted paper, referenced by both The Times and Dark Remedy, was reportedly published in the American Journal of Obstetrics and Gynecology in June of 1961. The "data" used in this study consisted of notes that Dr. Nulsen's secretary jotted down. In sworn testimony, Dr. Nulsen later stated the "paper" was drafted during conversations over golf with Dr. Pogge, a Richardson-Merrell executive, who allegedly wrote the paper with assistance from his secretary, but signed Nulsen's name to it.
In our last piece, we mentioned that one Cincinnati-based doctor failed to report his delivery of thalidomide-injured babies, two of whom he delivered as stillborns. He called those "flukes." That doctor was Dr. Nulsen. He delivered at least three more infants with multiple defects, according to Dark Remedy and Suffer the Children. He also said that he gave pre-marketing samples of thalidomide to 80 pregnant women in his practice. He lied in depositions, then ultimately claimed he had maintained no records. According to The Times authors, Nulsen was given 109,000 tablets -- a number documented in Richardson-Merrell's records -- and "whenever he ran out, his secretary called the company, and it delivered a new supply."
As for Dr. Nulsen's practices in the "clinical trials," The Times reporters explained that his method of dispensation often involved his secretary leaving tablets of thalidomide in envelopes in a mailbox outside of his office. As Dr. Nulsen was an obstetrician, all his patients were women, and, during the Baby Boom, mostly pregnant women.