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Unethical Medical Experiments Still a Possibility, Experts Say

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Sixty-five not so short years ago, the U.S. Public Health Service intentionally infected 1,500 involuntary human subjects in Guatemala with syphilis to determine if penicillin could prevent sexually transmitted diseases.

The experiment was led by U.S. physician Dr. John Cutler, who was also involved in the Tuskegee Experiment, in which hundreds of African-American men with late-stage syphilis were observed from 1932 to 1972, while all treatment was withheld.

When a Wellesley College professor chanced upon the archived, never published Guatemalan study last year, it was an eye-opener for President Barack Obama.

The revelation prompted Secretary Hillary Rodham Clinton to issue a joint apology with Secretary of Health and Human Services Kathleen Sebelius.

Obama charged his Presidential Commission for the Study of Bioethical Issues to investigate whether such a study could ever happen again, with assurances that today’s rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

That’s not what the Commission found.

The 14-member international panel of experts convened in Washington Feb. 28-March 1 to study the question. In the final round table Commission chair Dr. Amy Gutmann probed her panel as to what steps had been taken to prevent that kind of experimentation from happening again.

Despite the more than 1,000 rules and regulations enacted over the last several decades to protect Americans, they are not consistent among federal agencies, the bioethicists and researchers said. And the rules only apply to studies done by federal scientists, funded by federal agencies or testing substances that require federal approval.

If no federal funding or review is involved, unethical, immoral and even cruel experiments can still be done on humans and hid behind a veil of secrecy.

Dr. Susan Lederer, Professor of History of Medicine and Bioethics at the University of Wisconsin School of Medicine and Public Health testified to the unethical, immoral, unjust medical practices and research of the past, and said there are more atrocities not yet discovered. Even more alarming, ethicist Eric Meslin, director of the Indiana University Center for Bioethics said it could happen in the United States today. “We have a leaky system,” he said.

Dr. Robert Califf, Duke University’s vice chancellor for clinical research, agreed there’s no 100 percent guarantee. “There still will be bad things that will happen,” he said.

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The public testimony included stunning assertions that non-consensual, unethical medical and brain experimentation is happening today. “All of the horrific experiments [the Commission] mentioned; Willowbrook, MKULTRA, radiation experiments mostly were done without informed consent,” testified Dr. John R. Hall, a medical doctor from Texas. “They were funded by the Department of Defense, and intelligence agencies where I’m not so sure you would know if there is an Institutional Review Board much less if IRB is looking at informed consent.”

Hall said the Common Rule, legislation meant to protect human subjects would better protect treating someone with frostbite by burning it then it would from unethical experimentation. “As far as ongoing experimentation, we in the medical community are seeing alarming increases in patients claiming to be experimented on with electromagnetic technologies,” he said.

Native American scholar Dr. Andrea Smith, in her analysis ‘Conquest: Sexual Violence and American Indian Genocide’ describes pharmaceutical companies using Native Americans as guinea pigs to test new drugs and nuclear tests on or near Indian reservations as proof that American Indians are still considered expendable by government policies.

In the 1990s, Smith said, “Researchers reported that Alaska Native populations were ideal laboratories because they were geographically isolated, and no scandals would come out because no one knew what was going on there.” Native children elsewhere were used in medical experiments and various vaccine programs in the 1970s, “because the BIA asserted they were their parents,” she said.

The hormonal contraceptive Depo Prevara was also tested on Native Americans, Smith said. A researcher from the National Cancer Institute told Smith she supported drug experiments on Native children as being their only access to some of those drugs not available through the Indian Health Service.

“While we have heard about alleged concerns from the past, we currently have policies and procedures in place now that would prevent these types of activities from occurring,” said Dr. Yvette Roubideaux, director of the IHS. “Any proposed research involving IHS-operated facilities now must undergo intensive Institutional Review Board and tribal reviews and must involve patient consent.”

Smith said some other countries hold the same view of indigenous peoples as expendable, and who have been subjects in medical experiments and new drug testing without informed consent.

Commission members referred to foreign studies as “offshoring.” The U.S. Department of Health and Human Services reported in 2008 that 40 percent to 65 percent of federally regulated clinical trials were done in other countries, and that U.S. regulators inspected fewer than one percent of foreign clinical trial sites.

Two modern foreign studies caused public outrage. In Uganda, U.S.-funded doctors withheld the AIDS drug AZT to all of that country’s HIV-infected women, leaving their newborns unprotected. Health officials in the U.S. said they sought to answer questions about AZT’s use in developing countries.

In the other case, Pfizer representatives traveled to Nigeria to test drugs on 200 children during a 1996 meningitis epidemic without their parents consent; 11 died while others suffered mental retardation. When Nigeria’s attorney general pressed charges, Pfizer hired investigators to dig up any evidence of corruption against him to pressure him to drop the case, according to U.S. cables leaked in 2010.

The Commission’s next meeting is in May. Their final report is expected in October.