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The sordid! behaViour. of today's iPharmacel1tic~1 cOlJXlrat.ions I has been further demonstrated by Dr John BrmthwlUte; now a Trade Practices Commissioner, in his devastltting eJlpo.se, Corporate Crime in the Pharmaceutical Industry 1(1984). International bribery and corruption, fraud in the testing of drugs, criminal negligence in the unsafe manufacture of drugs- the pharmaceutical industry has a worse record of law-breaking than any other industry. Dest-Tibing many examples of corporate crime, which shows' the depth and seriousness of the crime problem in the pharmaceutical industry, Dr Braithwaite's revealing study is based on extensive international research, including interviews of 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala. The book shows how pharmaceutical m..ultipationals defy the intent of laws regulating safety of drugs by bribery, false advertis ing, fraud in the safety testing of drugs, unsafe manufacturing processes, smuggling and international law evasion strategies. At the t.ime of researching the subject, Braithwaite was a research criminologi"st at the Australian Institute of Criminology and a Fulbright IFellow affiliated to the University of California, Itvine, and the United Nations Center on Transnational Corporations. Fraud in Drug Testing "Data fabrication is so widespread," s'ays Dr Braithwaite, "that it is called 'making' in the Japanese pharmaceutical industry, 'g",phit ing' or 'dry labelling' in the United States." He further S.tates: Pharmaceutical companies face great temptati.ons to mislead health authorities about the safety 01 their products. It is a make or break industry-many companies get VIrtually all their profits from just two or three therapeutic winners. Most of the data that the Australian Drug Evaluation Committee relies upon in deciding questions of safety and effi cacy is data from other countries, particularly the !.,.IS. Inquiries into scientific fraud in the US have shown there is a substantial problem of fraud in safety testing of drugs in the US, just as has been documented in Japan. ~Emphasis aaded.p In his book Braithwaite cited forrrrer FDA Commissioner Goddard expressing his concerns over research dishonesty at a Pharmaceutical Manufacturers Association Meeting in 1966: I h'ave been shocked at the materials that come in. In addition to the prpblem of quality, there is the problem of dishones~y in th'e investigational new arug usage. I will admit lthere are grey areas in tile IND situation, but the conscious withholding of unfavou.ra'ble animal clinical data is not a grey matter. The deliberate choice of clinical investigators known to be more concerned about industry friendships than in developing good data is not a grey matter. The planting in journals of articles that begin to commercialize what is stilf an Investigational new drug is not a grey matter area. These a.ctions'run counter to the law and, the efforts governing drug industry [sid] JUNE -JULY i 993 NEXUS·21