McBride published a letter in The Lancet, in December 1961, noting a large number of birth defects in children of patients who were prescribed thalidomide, after a midwife called Sister Pat Sparrow first suspected the drug was causing birth defects in the babies of patients under his care at Crown Street Women's Hospital in Sydney. McBride was awarded a medal and prize money by the prestigious L'Institut de la Vie, a French institute, in connection with his discovery, in 1971. Using the prize money, he established Foundation 41, a Sydney-based medical research foundation concerned with the causes of birth defects. Working with P H Huang, he proposed that thalidomide caused malformations by interacting with the DNA of the dividing embryonic cells. This finding stimulated their experimentation, which showed that thalidomide may inhibit cell division in rapidly dividing cells of malignant tumors. This work was published in the journal "Pharmacology and Toxicology" in 1999 and has been rated in the top ten of the most important Australian medical discoveries.
McBride's involvement in the Debendox case is less illustrious. In 1981 he published a paper indicating that the drug Debendox caused birth defects. His co-authors noted that the published paper contained manipulated data and protested but their voices went unheard. Multiple lawsuits followed by patients and McBride was a willing witness for the claimants. Eventually, the case was investigated and, as a result, McBride was struck off the Australian medical register in 1993 for deliberately falsifying data. An inquiry determined "we are forced to conclude that McBride did publish statements which he either knew were untrue or which he did not genuinely believe to be true, and in that respect was guilty of scientific fraud." He was reinstated to the medical register in 1998. The Bendectin case, and the subsequent removal of the drug from the US market, has had a number of consequences. Firstly, there was an immediate increase in the rates of hospitalization for nausea and vomiting in pregnancy. Secondly, it created a treatment void in terms of having a safe medication that could be used for alleviating morning sickness in US pregnant women, a condition which, in the most severe form, called hyperemesis gravidarum, could be both life-threatening and cause women to terminate their pregnancy. The lack of availability of a safe and effective drug for the treatment of nausea and vomiting of pregnancy resulted in the use of other, less studied drugs in pregnancy. Thirdly, it has been claimed that subsequent to the Bendectin experience, drug companies stayed away from developing medications for pregnant patients. As a result, only a few medications were approved by the FDA for obstetrical indications in the past several decades. Lastly, the perception that all medications are teratogenic increased among pregnant women and healthcare professionals. The unfounded fear of using medications during pregnancy has precluded many women from receiving the treatment they require. Leaving medical conditions untreated during pregnancy can result in adverse pregnancy outcomes or significant morbidity for both the mother and baby. Ongoing education of physicians and the general public has resulted in improvements in the perception of medication use in pregnancy; however, further advances are required to overcome the devastating effects of the Bendectin saga.
