Human Guinea Pigs

The very concept of medical and scientific experimentation on human beings is troubling, even frightening. Of course, legitimate research­ - carried out in an ethical manner on informed and consenting subjects - has led to many developments of significant benefit.

Despite the introduction of codes to govern ethical research conduct and public bodies to enforce them, recent decades have witnessed a troubling number of documented cases in which human subjects have participated in experiments without their full knowledge or consent.

In addition, two well-known public health controversies&one whose long-term results are now being recognized and another that is developing without reliable scientific data&offer stark evidence of situations in which governments and health authorities have “enrolled” large groups of people in experiments, effectively turning them into “human guinea pigs.”

Ethics and Experiments

Human experimentation dates back hundreds of years. But after the 20th century’s two world wars accelerated the development of substances for killing and maiming, including chemical or biological warfare agents, one positive outcome was the Nuremberg Code, developed out of post-Second World War tribunals. This group of principles is intended to guide medical experimentation on humans, outlining the moral, ethical, and legal aspects of using human subjects.

The Nuremberg Code has since been expanded in the Helsinki Report, and these policies have, in turn, been revised by various national regulatory agencies that oversee legitimate medical and other types of research or experimentation involving human beings.

In Canada, the Canadian Institutes of Health Research sponsors several ethical and moral initiatives regarding the conduct of human experiments. These initiatives promote research that meets the highest ethical standards and include monitoring and evaluating ethical issues pertaining to health and health research.

In the United States, the National Institutes of Health and the Food and Drug Administration (FDA) publish and enforce policies and regulations regarding human research subjects and their protection. In addition, guidelines established by the US Department of Health and Human Services allow for Institutional Review Boards to approve and oversee the handling and protection of human test subjects and clinical trials.

Legitimate human research serves a beneficial humanitarian purpose when it is conducted safely, when the need for the data exists, and when the human subjects have been fully educated about the research and have given their informed consent. However, regulatory agencies governing human test subjects may not always adhere to written policies on human experimentation in actual practice.

An article in the Atlanta Journal-Constitution (“FDA Ignored Memo’s Warning? Aug.18, 1994) reported the FDA failed to act on information that indicated that women participating in tests of the breast cancer drug Tamoxifen (Nolvadex) weren’t told of cancer deaths that occurred during previous trials of the drug.

The newspaper also reported that Paul Goebel, an FDA investigator, had warned the FDA of the high incidence of endometrial cancer and uterine sarcoma among users of Tamoxifen but that test subjects were not informed of these dangers.

Uninformed or Unwitting Consent

Outside the realm of regulated medical research, human experimentation takes place where it may not be tightly regulated. This can happen when new products are introduced before their health or environmental impacts are fully researched or understood.

Military personnel and prisoners are often used as human guinea pigs. This is testing made easy because soldiers and prisoners are expected to obey orders. In many documented cases, no information was given to the subjects about the tests being conducted on them or about the risk of adverse or dangerous reactions and side-effects.

In a recent news article, Timothy W. Maier reported that President Clinton, in 1999, ordered military personnel to receive experimental vaccines, which were not approved by the FDA. This executive order denied a soldier the right to refuse the experimental vaccines. The order essentially assured that the US Department of Defense could implement any experimental program it wants, without repercussions.

Fluoride and Public Health

The history of the fluoridation of public water supplies in North America and other industrialized nations offers a clear example of a public health experiment in which millions of human beings have participated, with the encouragement of government authorities, but without full awareness of the long-term effects of the chemical on their bodies.

The US Environmental Protection Agency and other government agencies have steadfastly maintained that fluoridation promotes dental health, even though a growing body of scientific data indicates that this assumption is essentially false.

The level of fluoridation in water is considered optimal at 0.0000007 mg/kg per day (approximately one part per million). Fluoridated water supplies contain more than this recommended amount. By drinking fluoridated water, the public can potentially ingest more than 0.01mg/kg per day, which is 100 times the recommended dose.

The result of this fluoride poisoning is dental fluorosis, a mottling, discoloration, or loss of the teeth. This is also indicative of unseen skeletal bone damage. Studies show that fluoride also interferes with thyroid hormone formation, leading to secondary pathologies.

Despite such significant evidence of its hazards, the fluoride “experiment” continues on millions of “human guinea pigs” daily.

The Case of GM Foods

The introduction of genetically modified foods represents another significant ongoing experiment in which human subjects have been recruited without their knowledge. The use of artificial substances - recombinant DNA or genetically modified ingredients&has created a whole new category of unknown substances intended for human consumption.

Yet there is often little scientific information available to the public about the long-term consequences of the development of these substances, or their effects upon the human population and native biological organisms.

In her report, “Blinded by Science,” Dr. Judy Carman, an epidemiologist and biochemist with Flinders University, South Australia, points out the potential dangers of genetically modified food, noting the lack of significant safety testing on humans or animals to date.

For example, Carman critiqued Monsanto’s testing of “Roundup Ready” soybeans, citing a lack of sufficient testing of the modified soy products not only on farm animal subjects, but also in human health trials.

Carman found that while Monsanto claimed:

As people cook soybeans before consumption, this would deactivate the enzyme [the], ...raw soybeans will be fed to cattle. Steak is often served medium rare to rare. Therefore, there is a possibility that people will consume this new still-functional enzyme in their diet.

As this does not seem to have been considered by [Monsanto], there seem to have been no studies measuring quantities of this enzyme in cattle tissue, the ability of the enzyme to persist during moderate cooking, or the effect that the enzyme would have on animals including humans.

It is clear that legitimate medical and scientific research, conducted in an ethical manner on subjects who are fully informed about the trials and the risks they may involve, has its place in the promotion of human health.

But it is equally clear that when experimentation takes place outside this tightly regulated realm - possibly without our consent or with an incomplete picture of the risks and long-term effects - our determined skepticism can be downright healthy.