Fraud in Drug Research

Corporate Crime in the Pharmaceutical Industry is a book by Dr John Braithwaite where he describes many examples of corporate crime in the pharmaceutical industry. Dr Braithwaite's revealing study is based on extensive international research and includes interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala. "Data fabrication is so widespread", says Dr Braithwaite, "that it is called 'making' in the Japanese pharmaceutical industry, 'graphiting' or 'dry labelling' in the United States." He further states: "Pharmaceutical companies face great temptations to mislead health authorities about the safety of 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 efficacy is data from other countries, particularly the US. 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."

In his book Dr. Braithwaite reports that between 1977 and 1980 the United States Food and Drug Administration discovered 62 doctors who had submitted manipulated or downright falsified clinical data. A separate study conducted by the FDA has revealed that one in five doctors investigated, who carry out field research of new drugs, had invented the data they sent to the drug companies, and pocketed the fees.