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effects such as feedback and the compounding of individual effects are dif cult to comprehend, let alone predict, intuitively. It is necessary to take a systems perspective of the project and what happened, and systems modelling can help to demonstrate such effects. We need to learn not only the easy lessons ( we neglected con guration control and that got us into a mess, costing $x to resolve ) but also the lessons that derive from the more complex non-intuitive behaviours of our projects, discussed over the last few chapters ( we doubled our workforce on this project but it only yielded 5% extra output ).



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want a first crack at what could be a promising new cure for their patients And hospitals and universities want the prestige that comes from being seen as a place that does pioneering work In the words of Dr Victor Hatcher, director of the office of clinical trials at New York City s Montefiore Medical Center, It s part of the mission of a medical center like Montefiore When oncology patients come, they expect that you ought to have clinical trials They want to be offered the chance But there s growing controversy over whether the test sites have given drug companies too much control over the conduct of the trials and the publication of research, as discussed in 15] Page 86: Doctors don t want to know [Peter Jaret, She Turns Her Pen on Drug Makers, Los Angeles Times, August 9, 2004, F1.





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In total there are 33 000 human genes as against approximately 30 000 nematode genes and a few thousand in most bacteria Given the fact that there is relatively little difference between the human genome and the nematode genome in terms of overall gene number, then the old adage must apply, that is it is not how many you have but how you use them In other words, the high level of expression control (both temporal and cellular) during human development as compared to the situation in nematode development must be the presiding reason that humans are many times more complex as organisms than nematodes Transcription factors are central to this process of expression control although not the complete reason.

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] Page 86: Still, the FDA and Temple held firmly [In August 2004 the FDA added an even more controversial twist to the debate when it approved a stent made by Guidant Corp a device that supposedly would prop open the carotid artery in the neck in order to prevent a stroke after a trial without any control group at all Instead, all 581 patients in the trial got the stent The control was that Guidant compared their rates of stroke, death, and heart attacks with the historic rates among patients who had undergone the traditional treatment, surgery] Page 87: In 1989 it published guidelines [In the fall of 2003, the agency also announced that it wanted to create a database that would show how men and women react differently to drugs and track and encourage the inclusion of women in clinical studies.

It contracted with seven universities to gather data on how women respond to certain treatments] Page 88: Congress had to pass a special [Testing on children raised so many ethical issues that, soon after the dispute over antidepressants, the FDA created a special Pediatric Ethics advisory subcommittee] Page 89: Dr Henry I Miller, a former FDA official [Henry I Miller, To America s Health, Hoover Institution Press, 2000, pp 65 66] Page 91: Novartis had to change the name [Daniel Vasella, Magic Cancer Bullet, HarperBusiness, 2003, pp 151 153] Page 92: On an offhand suggestion [This information comes largely from my interviews with Irwin Martin but also from Ron Winslow, The Birth of a Blockbuster: Lipitor s Route out of the Lab, Wall Street Journal, January 24, 2000].

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