The Profit Motive

Bias may affect a drug company s overall analysis of the patterns of adverse reports from the clinical trials. In my forensic experience, the methodology of the analyses may deviate drastically from the scientific process. In addition, if the conclusions seem to threaten the future of the drug, the conclusions may be modified or kept secret (see chapter 14). In general, drug companies have learned to employ many of what Scott (2006) called tricks of the trade to make clinical trials produce exaggeratedly good results. 

By 1969, the FDA developed a systematic approach to collecting and maintaining adverse drug reactions after marketing. For many years, it was called the SRS. The regulations were updated in 1985, and the system has been renamed MedWatch (for the basic regulations, see Johnson 

Unlike in England, in America, there is no formal requirement or readily available mechanism for health professionals to make these postmarketing reports. Nies (1996) estimated that over 40% of doctors do not even know that they can report adverse effects directly to the FDA. 

In addition to the larger numbers of patients involved and the longer treatment periods, the postmarketing SRS has a number of advantages over the premarketing clinical trials. 

First of all, most of the pharmacists and physicians making the reports from the field, unlike those conducting the clinical trials, are not being directly paid by the drug companies. They are likely to have much less vested interest in retaining the drug company s goodwill. 

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To save shipping space, the Ministry of Agriculture directed farmers to concentrate on the production of grain, and guaranteed markets and prices. Agriculture showed that the profit motive and state direction could be successfully combined to create a more efficient sector. 

Schieppati, A., G. Remuzzi, and S. Garattini. 2001. Modulating the Profit Motive to Meet Needs of the Less-Developed World. Lancet 3S8 1638-1641. 

The goal of the university researcher will be to acquire new knowledge, obtain funding for laboratory research and secure material for publication. The profit motive and the development and acquisition of exclusive rights in new products and processes are usually the objectives of an industrial research sponsor or licensor. 

One is almost apologetic about approaching such an important subject in such an unsophisticated manner, but it is most important to get at the heart of the matter without delay. Profits are very important to all of us, for without the profit motive, free enterprise is dead. 

The pharmaceutical industry, once a rather specialized hybrid between the chemical industry and the clinical research laboratory, has also taken on a new dimension - also exploiting the remarkable advances in both molecular genetics and cell biology. It is not the case that the rise of biotechnology has brought about an unprecedented clash between corporate and scholarly values. First, while there is clearly a conceptual distinction between the profit motive and the search for the truth, these values etre not, in any significant way, in conflict. Second, the academic-corporate connection has existed for many years in many areas. It is novel only to certain areas of biological research. 

Some Issues Frequently Raised (y. Much of the available literature about these university-industry arrangements deals with the controversies and conflicts which have been raised by the Issues involved. Although a discussion of these Issues is beyond the scope of the inventory presented here, it would seem useful at least to touch on a few of these points. For instance, with regard to the many new biotechnology companies which have recently been formed, it was pointed out that quite a few have principals who also serve on another company s board or whose primary employment is with a university. Concerns have been expressed regarding conflicts of Interest, complications on safety fronts, patent and royalty areas, and communications. Some scientists fear that biologists will become reluctant to publish their findings once the profit motive is at work. Further, it was noted that the majority... 

The profit motive ensures legitimate research in a reasonable time frame and with little waste. In spite of the negative connotation the word "profit" has picked up in recent years, the profit motive, in a competitive economy, still provides for consumers the best possible products at prices in line with the free market. 

Dennis Chamot drew a parallel to health care. Reed agreed, and said that a recent book suggests that 20 years ago, health care costs for administration were about 10 percent. After privatization, they are now about 17 percent. So the profit motive adds to the cost of health care and doesn t... 

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