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playwright and AIDS activist Larry Kramer called one FDA official a murderer Drug companies initially were reluctant to shell out tens of millions of dollar in research and development for a condition that was so difficult to treat, that could be so dangerous to handle, and so it seemed that had such a limited and unpopular clientele When Burroughs Wellcome finally agreed to open up its vast inventory of chemicals for testing, scientists at the NIH and Duke University did the actual work, at government expense One of the compounds seemed promising, so in 1985 Burroughs filed to begin clinical trials for azidothymidine, or AZT The FDA set in motion the normal application process, with a couple dozen healthy people to be tested for safety in Phase I, then several hundred AIDS patients in Phase II along with a control group on a placebo.

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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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Medium-energy collimators have characteristics between those of low- and high-energy collimators. They can be used to image photons emitted by 67 Gallium and 111 Indium. The terms high-, medium-, and low-energy are not rigidly de ned, and usage may vary from institution to institution. Slant-hole collimators: These are parallel-hole collimators with holes directed at an angle to the surface of the collimator. The slant-hole collimator provides an oblique view for better visualization of an organ that would otherwise be obscured by an overlying structure while permitting the face of the collimator to remain close to the body surface (Fig. 6-9).

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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The drug s potential seemed so hopeful that the FDA.

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