• By Dartington SRU
  • Posted on Thursday 15th September, 2011

Paul Meier; The life-saver

Anyone who has had successful treatment over the last 50 years for diabetes, cancer, heart disease, HIV/AIDS, or dozens of other less serious medical conditions, may owe their life to a statistician of whom most will never have heard.University of Chicago Professor Emeritus Paul Meier, who died on 7th August at the age of 87, was an outspoken advocate of randomized controlled trials. While their use to test drugs and treatments is standard practice today, in the 1950s it was usual to give new treatments to those patients who were thought most likely to benefit from them. Often these were the patients with the best chances of recovery, whether under existing treatments or the new ones. Consequently, new treatments tended to be thought better than old ones, even when this was not the case.In an interview in 2004, Meier described the incredulity that greeted his call for randomized trials: “When I said ‘randomize’ in breast cancer trials I was looked at with amazement by my clinical colleagues. ‘Randomize? We know this treatment is better than that one,’ they said. I said ‘Not really’.” [1]The fact that drugs are now rigorously tested, and that those tests give unbiased evidence on their effectiveness, is attributable in a very large part to Meier. As Sir Richard Peto, Professor of Medical Statistics and Epidemiology at Oxford University, told The New York Times: “Perhaps more than any other statistician he was the one who influenced US drug regulatory agencies, and hence clinical researchers throughout the US and other countries, to insist upon the central importance of randomized evidence. That strategic decision half a century ago has already saved millions of lives, and those millions should be attributed to Paul.” Over his distinguished career, Meier held appointments at several US universities, including Chicago, Harvard, Stanford, Johns Hopkins and Columbia, as well as appointments at the University of London and Imperial College and Jerusalem’s Hebrew University.In 1954, Meier conducted the largest medical experiment in history, a double-blind placebo control trial of the Salk polio vaccine involving more than a million children. The trial was successful and led to the vaccine being put into widespread use.Meier was, however, cautious about what his trial had ultimately accomplished: “It would be pleasant to report an unblemished record of success for the Salk vaccine, following so expert and successful an appraisal of its effectiveness, but it is more realistic to recognize that such success is but one step in the continuing development of public health science.”Indeed, the vaccine’s release was far from smooth, and the swift eradication of polio that researchers hoped for frustrated: “The Salk vaccine, although a notable triumph in the battle against disease, was relatively crude and, in many ways, not a wholly satisfactory product that was soon replaced with better ones. The report of the field trial was followed by widespread release of the vaccine for general use, and it was discovered very quickly that a few of these lots actually had caused serious cases of polio.“Distribution of the vaccine was then halted while the process was re-evaluated. Distribution was re-initiated a few months later, but the momentum of acceptance had been broken and the prompt disappearance of polio that researchers hoped for did not come about.“Meanwhile, research on a more highly purified killed-virus vaccine, and on several live-virus vaccines, progressed, and within a few years the Salk vaccine was displaced by live-virus vaccines.” [2]Meier also argued strongly that those involved in clinical trials should be given full and proper information about what they were becoming involved in: “The way we handle informed consent is to say: ‘This explanation is too difficult, too much for a patient to absorb: tone it down, change the language, etc’.”Meier believed, moreover, that patients should be required to take their time in deciding whether to give their consent to becoming involved in trials: “What you want to do is to explain things to the patient and then have him take it home. Not accept it [the consent] if he doesn’t take it home so he can read it at leisure. I have been on the IRB [Institutional Review Board] and insisted that they do this.” [3]He also believed in sharing data from trials so that others could interrogate the results: “I don’t want release of the data until a study is done. But after that, I’m in favor of releasing everything and telling people you can look at everything.“You have to expect that if a study says a drug house’s drug is no good, people will criticize that study, with the drug house’s support. But I think we have to publish our data. Otherwise, you’d just publish one thing – it’s significant.” [4] Born on 24th July 1924, Paul Meier was one of two sons of Frank and Clara Meier. His father was a chemist and his mother a school principal.***************************Footnotes: 1. Marks, H. M. (2004) ‘A conversation with Paul Meier’, Clinical Trials 1, 131-138.2. Meier, P. ‘The biggest public health experiment ever: the 1954 field trial of the Salk poliomyelitis vaccine’. http://www.stat.luc.edu/StatisticsfortheSciences/MeierPolio.htm [Accessed 14th September 2011].3. In Marks (2004) op. cit4. In Marks (2004) op. cit

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