Safer Medicines - putting patient safety first

Putting patient safety first

Frequently Asked Questions




  1. GAO/PEMD-90-15 FDA Drug Review: Postapproval Risks 1976-1985.
  2. Dollery, C. in Risk-Benefit Analysis in Drug Research, ed. Cavalla, 1981, p87.
  3. Handbook of Laboratory Animal Science ,Volume II: Animal ModelsSvendensen and Hau (Eds.) CRC Press 1994 p6.
  4. A Clinical Guide to Reproductive and Development Toxicology. CRC Press, Ann Arbor, Michigan, 1992.
  5. Schardein, p2-3.
  6. as quoted in Bitter Pills by Stephen Fried, Bantam Pub., 1998, p274.
  7. Schardein, J. L., Chemically Induced Birth Defects, Marcel Dekker 1985.
  8. Hawkins, D. F., Drugs and Pregnancy: Human Teratogenesis and Related Problems, Churchill Livingstone, p41-49, 1983.
  9. Develop Biol Standard1980:45:163-173.
  10. Sabin, Albert, in JAMA1965;194(8):872-876.
  11. Parish H.J., Victory with Vaccines, E.&.S Livingston, LTD, 1968.
  12. Sabin, Albert, MD statement before the subcommittee on Hospitals and Health Care, Committee on Veterans Affairs, House of Representatives, April 26, 1984 serial no. 98-48.
  13. Science 199, vol. 109: p85-87
  14. Roberts, F., in BMJ1922, p1194.
  15. Brochure passed out by ACT UP San Francisco at Emory University, April 26, 1997.
  16. NEJM 1994;332:259-260.
  17. Scientific American, Sep. 1997.
  18. Committee on the Use of Animals in Research. Science, Medicine, and Animals. National Academy Press, Washington DC, 1991.
  19. Institute of Medicine. Mobilizing Against AIDS. Washington D.C., National Academy Press, 1986.
  20. AIDS Etiology, Diagnosis, Treatment, and Prevention. 3rd edition. Philadelphia, J.B Lippincott, 1992.
  21. AIDS Research and Human Retroviruses1992;8:349-356.
  22. Presidential Commission: Report of the Presidential Commission on the human immunodeficiency virus epidemic. Washington D.C., Government Printing Office, 1988, p39-47.
  23. DiCarlo DrugMet Rev,15; p409-131984.
  24. Mutagenesis1987;2:73-78.
  25. Handbook of Laboratory Animal Science, Volume II Animal Models Svendensen and Hau (Eds.) CRC Press 1994 p4.
  26. as quoted in L.A. Times, Wednesday, May 6, 1998.
  27. Yasargil, M.G., ed. Microsurgery Applied to NeurosurgeryGeorge Thieme Verlag 1969. Donaghy, R.M.P and Yasargil, M.G. Eds. Microvascular Surgery, Mosby, 1967.
  28. Lancet, 1, p13-2, 1983.
  29. Lancet, 1, no. 8480, p17-9, March 8, 1996.
  30. Journal of the American Medical Association, June 30th 1962. Roald Hoffman, The same And Not The Same, Columbia University Press 1995 p136; Nature2001; 410: 411-12
  31. E.g. Perel, P and colleagues. British Medical Journal (2007) 27: 197–200; Hackam, DG and Redelmeier DA. Journal of the American Medical Association(2006) 296: 1731–1732; Bailey, J. Biogenic Amines, vol.19, N° 2, pp 97-146, May 2005.
  32. Pirmohamed, M. British Medical Journal 2004;329:15-19.
  33. Lazarou, J and colleagues. Journal of the American Medical Association (1998) 279: 1200-5.
  34. Vioxx caused approximately 320,000 heart attacks and strokes worldwide, as calculated from Merck's own estimated 20 million 'at-risk' patient exposures and 16 excess adverse cardiac events/1,000 exposures, calculated by Topol et al, New England Journal of Medicine 2004;351:1707-9. Approximately 120,000-140,000 of these events were fatal.
  35. Coghlan, A. New Scientist, 31st August 1996.
  36. US Food and Drug Administration (2004) Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products.


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