"I remember wheeling down this long, narrow corridor into my office, just a confused, scared mess, but I had to confront him." Phil Vardy was a . The man he had to confront was his boss, one of Australia's most prominent doctors, William McBride.
He had just seensuggesting an ingredient in the drug Bendectin caused birth defects - with fabricated defects and experimental pregnant rabbits .Vardy's confrontation with McBride , and "small battles led to bigger ones which led to bigger ones." It would cost Vardy his job and his marriage. After a decade of media storms and public enquiries establishing fraud, McBride .I was a maternity consumer advocate in Australia then, and watching what happened to Bendectin and the women who needed it was a long slow revelation. This month, the FDA added a hopeful chapter to the saga. But that's jumping too far ahead. Let's go back first.McBride's part began in 1961 when he sent a letter to The Lancet reporting limb malformations . The pendulum swung overnight from under-awareness and inadequate protection to hyper-vigilance, emotion and hype about drug safety in pregnancy.In the wake of Thalidomide, Bendectin inevitably came in the firing line. In some countries up to a third of all pregnant women had taken the drug - over 30 million .That number of women would be expected to give birth to over a million babies with some kind of birth defect - . So the potential for people to point the finger of blame at this drug was sky-high.The National Enquirer and other media . The Public Citizen's Health Research Group (unsuccessfully) petitioned the FDA in 1980 and 1982 to . Bendectin, they argued, didn't work and was "unsafe for human use."Bendectin did work and was never proven to , but it caused a lot of litigation. McBride - his fraud not yet revealed - was a .The case against the drug was made up of flimsy science and selective choices of studies. Even without junk and fraud, it's , rather thanof all strong evidence. Litigation over Bendectin led the Supreme Court to set a .But the drug was off the market by 1983 purely for commercial reasons. Defending it was just too expensive.shows what Bendectin was up against: "Hundreds of thousands of pregnant women and their unborn children will be spared the risk of exposure to this questionably effective and unsafe drug."With Bendectin gone, the . The ratio of hospitalization of pregnant women for nausea and vomiting almost doubled in the US (from about 7 per thousand to 13). There aren't very effective , so many women used .This month, 30 years after the end of Bendectin,was approved by the FDA for the treatment of . It's a new formulation of Bendectin's key ingredients. But we still have a far larger problem.Weof the effects of drugs women need to use when they're pregnant. We seem to be more concerned about protecting people from the risks of research than the .Animal studies can't resolve the problem. Some drugs cause birth defects only in humans, or only in some animals and . Surveillance only gets us so far. Such as finding out too late that a particular type of hypertensive drug in pregnancy was .The problem leaked out to partially affect all women. Women of childbearing age or even all women have often been excluded from drug research - just in case. Yet differences in body weight, metabolism and more between men and women can affect drug response and .Children are another group with extensive additional safeguards for research. By the late 1990s, children were described as "therapeutic orphans", because there were so few safety and efficacy studies in children. And legislative efforts to try .It's theof clinical trials. For too long we have been trying to protect women and children from the risks of untested drugs...by not testing their drugs adequately. Here's hoping the arrival of Diclegis is a sign of wider progress. Followon Twitterand .Visitfor the latest in science, health and technology news. 2013 . All rights reserved.http://hermelindauve.orbs.com/a+psychological+counter-current+in+r
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