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nyway, many in the industry acknowledge that there really is no choice. The FDA has to be tough, said Taylor Burtis of Antigenics, because people do cut corners. They also manipulate, exaggerate, push the exemptions to the limit, and lie. Sometimes the mistakes are unintentional: Small, new biotechs may not know how to put together a drug application. They have good people, but they have never done it before. The NDAs are written terribly, or they don t have good data, Leigh Thompson pointed out. And sometimes there is downright fraud. Ann Campbell, an Alabama research scientist who had worked on a clinical trial of an antibiotic for what was then Aventis Pharma, Inc., pleaded guilty in October 2003 to providing false data on the number of people participating in the trial. Tom Garvey, who is now an industry consultant, told me he actually has to warn his clients not to try to hide problems like the number of people who had side effects. No wonder CDER spends over $45 million a year on drug safety (including post-market studies).

The wrapper pattern was first introduced as the adaptor pattern in the Gang of Four book on Design Patterns [GHJV95]. As a security component, the wrapper shown in Figure 4.2 enhances an interface presented by a server by adding information or by augmenting the incoming message and the outgoing response. Thus, wrappers impact all requests, even those not modified in any manner by the wrapper. The client must conform to the wrapper s interface instead of the interface of the underlying object. The use of a single security wrapper around a collection of diverse objects can potentially

Figure 12.18: Viterbi algorithm bit error rate performance as a function of quantizer threshold spacing.

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long-term slip rates derived from geologic data. In some settings, these comparisons show that the continuum approach to estimating velocity elds explains most of the observed displacements. For example, Savage et al. (2004a) showed that a uniform velocity eld involving distributed right lateral shear within a 120-km-wide zone in the Coast Ranges (Fig. 8.18) matches the vector sum of all the average slip rates determined independently for all major faults across the zone. Their approx-

As the Phase II trial results came in amazingly strong, the FDA agreed to let the drug skip Phase III and go straight on the market, slashing years off the normal process AIDS finally had its first treatment So why were AIDS activists angry at the FDA For one thing, by then it was already 1987, and people had been dying for six years They had felt ignored by the government and stigmatized by society As well, the AIDS community blamed the FDA for what was really the fault of the drug companies Still, there is plenty of criticism to lay on the FDA itself The agency could have used its bully pulpit to urge the pharmaceutical industry to delve into research It was slow to screen the blood supply, which allowed AIDS to spread more quickly into the wider community and infect celebrities like tennis star Arthur Ashe.

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Mark Novitch, who was either the deputy or acting commissioner in the early years, exemplified the FDA s hands-off approach when he recalled the first time he heard of this odd disease Some people from the Centers for Disease Control had come to tell him about an unusual number of cases of pneumonia clustered in Los Angeles His response was not: What can the FDA do It was: There was little we could do until the NIH and CDC and researchers could present something that would be ready for FDA action It was a research issue Moreover, before and after AZT, the FDA was slow in approving other AIDS drugs In his 1994 book The FDA Follies, Herbert Burkholz describes one example ganciclovir, a drug for an inflammation of the retina known as Cytomegalovirus retinitis (CMV), which is caused by a herpes virus and can lead to blindness.

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mod* the Fork monitor such that after a waitof 1second, the call to get times out and returns the result false."he Philosophe r should release the other fork, if it holds it, and try again. Observe the behavior of the resulting system. 6.4 It is possible for the following system to deadlock. Explain how this deadlock occurs and relate it to one of the four necessary and sufficient conditions for deadlock to occur.

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