If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies (...) increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies (...) increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

The practice of nonphysician ethicist-consultants giving ethics advice concerning the appropriate medical treatment of patients in hospitals is a relatively recent development. Although only a minority of hospitals make substantial use of any formal ethics consulting service, the number is growing and apparently will continue to do so. Indeed, at least among urban teaching hospitals, some sort of ethics consulting service is increasingly commonplace.

In the past twelve to eighteen months, another perceived threat to the safety of America's blood supply has arisen. The fear is that Creutzfeldt-Jakob disease will join hepatitis, HW and AIDS in the public and medical consciousness as the 1990s next infectious disease epidemic. A particular kind of ethical dilemma has arisen causing much debate and consternation for hospitals, regulators, and blood suppliers, and has elicited a remarkably varied response.CJD is a rare but uniformly fatal neurological disease: it affects the (...) brain and the rest of the central nervous system. Its incidence in the population of the developed world is about one per million per year, although some geographic anomalies exist. CJD manifests itself in two broad ways. First, the disease is associated with symptoms of mental deterioration and dementia, including memory loss, anxiety, and cognitive impairment. Second, CJD is also associated with a range of neurological symptoms, including muscle rigidity, seizures, tremors, muscle twitching, and spasticity, as well as problems with muscle coordination and unsteady gait, sometimes resulting in total disability. (shrink)

In the past twelve to eighteen months, another perceived threat to the safety of America's blood supply has arisen. The fear is that Creutzfeldt-Jakob disease will join hepatitis, HW and AIDS in the public and medical consciousness as the 1990s next infectious disease epidemic. A particular kind of ethical dilemma has arisen causing much debate and consternation for hospitals, regulators, and blood suppliers, and has elicited a remarkably varied response.CJD is a rare but uniformly fatal neurological disease: it affects the (...) brain and the rest of the central nervous system. Its incidence in the population of the developed world is about one per million per year, although some geographic anomalies exist. CJD manifests itself in two broad ways. First, the disease is associated with symptoms of mental deterioration and dementia, including memory loss, anxiety, and cognitive impairment. Second, CJD is also associated with a range of neurological symptoms, including muscle rigidity, seizures, tremors, muscle twitching, and spasticity, as well as problems with muscle coordination and unsteady gait, sometimes resulting in total disability. (shrink)