The media has reported many recent incidences of abuse of persons with psychiatric disabilities during experimentations with psychiatric drugs. While this experimental testing has been going on for years, it appears as if the public is now beginning to pay attention due to several exposes in the media. Greater awareness of this problem is necessary so that the proper authorities can institute procedures that will eliminate the mistreatment of disabled patients.

A dramatic example of this abuse is the case of Joseph Santana. Mr. Santana was a patient at Bronx Psychiatric Center. He died after his experimental medication had been changed. The medical examiner ruled that Santana, 36, died of a combination of experimental drug M.100907, the anti psychotic drug Olanzapine and the muscle relaxer Ativan, given to him at the Bronx, NY, Psychiatric Center. It turns out the maker of M.100907, Hoechst Marion Roussel, a company based in Frankfurt, Germany, paid the state to conduct an experiment on people like Santana, its spokesperson Lori Kraut said (New York Post, January 17, 1999).

"I’m just so angry because all I keep seeing is my brother calling for help," his sister Maria Santana said as her voice quivered and tears streamed down her face. Joseph Santana screamed for help, and no one heard him because they thought he was a delusional mental patient.( New York Post, January 17, 1999).

Pharmaceutical research has become a $5 Billion industry in the U.S. With this much money at stake, it is no wonder that there have been many violations of ethics. A group of leading bioethicists concluded in a report published last month in the Journal of the American Medical Association that these highly profitable arrangements breed conflicts of interest (Boston Globe, February 9, 1999 at A08). A public investigation of this situation should be conducted so that we can see and realize how delicate, dangerous, painful and unfortunately necessary human research is in this society.

Another problem with this type of research is that many experiments are conducted on people who are incapable of consent. Therefore, those who may not understand the risks or benefits are taking part in an experiment. Furthermore, required disclosures have not always properly described the risks involved in these experiments.

The death of Joseph Santana was not an isolated incident. The National Institutes of Health discovered a host of serious violations in risky experiments on schizophrenics by Mount Sinai and the affiliated Bronx Veterans Affairs Hospital. Violations included failing to fully inform patients of the risks and intentionally inducing psychotic behavior in patients who had been well. Researchers gave them L-dopa which results in a psychosis in the mentally ill. One of the patients grew violent and hit a doctor, while another experienced suicidal thoughts. ( New York Post, February 11, 1999). Additionally, the federal government shut down experiments being conducted at Duke University Medical Center and the Veterans Hospital in Los Angeles in recent months.

In New York State, a task force was convened by the Health Department to address the issue of drug testing on mentally disabled people. The task force was composed of thirteen people consisting of psychiatrists, ethicists, researchers and others. No consumers were on this task force. The task force recommendations included a proposal which would allow experiments that pose a slight risk to be performed on mentally ill and severely disabled adults who are not capable of giving their consent. These experiments could be conducted even if they offer no benefit to the patient. (The New York Post, March 21, 1999).

This report was roundly criticized by the disability community. In recent months, many advocates have put pressure on the current administration to impose greater safeguards for people who are unable to consent to this research. It is still uncertain, what, if any new guidelines the state Health Department will adopt in this area. This lack of commitment demonstrates the importance of legislation that will protect vulnerable persons from abuse during drug testing.

There are currently two areas in which the government is working to prevent abuses of mentally disabled individuals involved in medical experimentation. Consumers should be aware of these efforts and contact the proper authorities in order to voice their support of greater protections.

First, the federal government is considering more restrictive requirements in research that it sponsors. In 1995, President Clinton created the National Bioethics Advisory Commission to provide advice and make recommendations to appropriate government entities regarding the appropriateness of departmental, agency or other governmental programs, policies, assignments, missions, guidelines, and regulations, as they relate to bioethical issues arising from research on human biology and behavior. In December 1998, this Commission made recommendations for stronger protections (see Insert). The Clinton Administration has yet to give final approval of these guidelines so that they can be implemented.

Secondly, the state legislature is considering legislation that would create tighter restrictions on medical research that is conducted on those who are unable to consent. There is currently a bill before the state senate on this issue. This bill requires greater protections for the individual who is unable to consent. Additionally, in January, the state assembly began an investigation on human experimentation that could lead to hearings and legislation, ( New York Post January 19, 1999). As yet, no legislation has been introduced in the Assembly. Consumers and advocates should contact their state representatives and voice support for legislation that will create greater protections to mentally disabled individuals.

In conclusion, using human subjects for drug testing will continue so long as cures for illnesses remain elusive. It is also inevitable that drug testing on those who are incapable of consent will continue. Therefore, it is imperative that those who are the most vulnerable have laws which will protect them from abuse.

Examples of Recommendations from the National Bioethics Advisory Commission from a Report on Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity. The report was issued in December 1998. The Commission made twenty-one recommendations in all.

Objection to Participation in Research Recommendation 7.

Any potential or actual subject’s objection to enrollment or to continued participation in a research protocol must be heeded in all circumstances. An investigator, acting with a level of care and sensitivity that will avoid the possibility or the appearance of coercion, may approach people who previously objected to ascertain whether they have changed their minds.

Even when decision making capacity appears to be severely impaired, respect for persons must prevail over any asserted duty to serve the public good as a research subject. Hence, a potential or actual subject’s objection must be heeded regardless of the level of risk or potential benefit, just as it would in the case of an individual who clearly retains decisional capacity. Respect for persons requires that we avoid forcing an individual to serve as a research subject, even when research offers the possibility of direct medical benefit to the individual, when his or her decisional capacity is in doubt, or when the research poses no more than minimal risk. While objection must always be respected, situations may arise in which the investigator could legitimately return to ascertain whether the previous objection stands.

Recommendation 9. A person who has been determined to lack capacity to consent to participate in a research study must be notified of that determination before permission may be sought from his or her legally authorized representative (LAR)[[[ this phrase not needed jg: to enroll that person in the study]]]. If permission is given to enroll such a person in the study, the potential subject must then be notified. Should the person object to participating, this objection should be heeded.