Medical Experiments Can Be Done Without Patient’s Consent
ROB STEIN, WASHINGTON POST - The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting the patients’ permission. The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.
The three studies, organizers say, offer an unprecedented opportunity to find better ways to resuscitate people whose hearts suddenly stop, to stabilize patients who go into shock and to minimize damage from head injuries. Because such patients are usually unconscious at a time when every minute counts, it is often impossible to get consent from them or their families, the organizers say. . .
Some bioethicists say the new research is more ethical than some of the earlier studies in several ways, including that patients are not being denied highly effective therapies. Most patients who receive the current treatments do not survive. . . But others say that the studies could be done by finding patients or family members who are in a position to provide consent, even though that might make such studies more difficult.
“This just seems like lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible,” said George Annas, a Boston University bioethicist. . . Annas was particularly disturbed that children as young as 15 might be included in the research. “Suppose a 15-year-old child is in the back of a car that is in a terrible accident,” Annas said. “The EMTs arrive and say: ‘We are doing an experiment with two techniques. We think they are about equal. Is it okay if we flip a coin to see how we treat your son? Or would you rather we just give him the treatment we think is best?’ Unless you think all parents would have the EMTs flip a coin, consent here is necessary.”
Others are concerned patients may be getting experimental therapies that could turn out to be inferior to standard treatments.
ECHOES FROM THE PAST
GINA KOLATA, NY TIMES, 1996 - For the first time in a half century, new Federal regulations allow investigators to enroll patients in some medical research studies without their consent. The Food and Drug Administration regulations, . . . apply only in carefully circumscribed situations. The patients must have a life-threatening condition, like a severe head injury, and must be unable to say whether they want to be part of a study. They would be selected only if it was not feasible to obtain consent from a relative. Furthermore, the community in which the research is done must be notified about the study, and the research design must have been reviewed and approved by the Food and Drug Administration.
Even the most ardent supporters of the new regulations say they understand the seriousness of what they have done. They have repealed a principle that dates back to the Nuremberg trials of Nazi doctors after World War II, when American judges were agonizing over rules that might prevent doctors from ever again using human subjects in horrendous experiments. The judges wrote a code of ethics, the Nuremberg Code, whose first principle was that no one should ever be forced to take part in a medical experiment. “The voluntary consent of the human subject is essential,” they wrote. . .
“It’s a fateful step,” Jay Katz, an ethicist and lawyer at Yale University, said in a telephone interview from Germany, where he was at a conference marking the 50th anniversary of the Nuremberg doctors’ trials. “The first sentence of the first principle of the Nuremberg Code,” he said, stated that nothing should be done to human beings without their consent. And now, he said, “here we are making exceptions.”
US HOLOCAUST MUSEUM - During World War II, a number of German physicians conducted painful and often deadly experiments on thousands of concentration camp prisoners without their consent. Unethical medical experimentation carried out during the Third Reich may be divided into three categories. The first category consists of experiments aimed at facilitating the survival of Axis military personnel. In Dachau, physicians from the German air force and from the German Experimental Institution for Aviation conducted high-altitude experiments, using a low-pressure chamber, to determine the maximum altitude from which crews of damaged aircraft could parachute to safety. Scientists there carried out so-called freezing experiments using prisoners to find an effective treatment for hypothermia. They also used prisoners to test various methods of making seawater potable.
The second category of experimentation aimed at developing and testing pharmaceuticals and treatment methods for injuries and illnesses which German military and occupation personnel encountered in the field. . . The third category of medical experimentation sought to advance the racial and ideological tenets of the Nazi worldview. The most infamous were the experiments of Josef Mengele at Auschwitz. Mengele conducted medical experiments on twins. He also directed serological experiments on Roma (Gypsies), as did Werner Fischer at Sachsenhausen, in order to determine how different “races” withstood various contagious diseases. The research of August Hirt at Strasbourg University also intended to establish “Jewish racial inferiority.”
LANCET, 2005 - Patients the world over need adequate protection from overreaching physicians who use patients to test experimental drugs and procedures without their informed consent. Jacques Michel, a retired director of Hadassah Hospital in Jerusalem who also heads the hospital ethics committee, triggered an investigation of 39 hospitals by Israel’s State comptroller, the government watchdog.
The findings of non-consensual experiments conducted primarily on children, the elderly and psychiatric patients, shocked Israelis. . . The violations were found to be worst in geriatric, rehabilitation, and psychiatric hospitals, where some children had their eardrums deliberately pierced so that a drug could be applied. In another painful procedure, a needle was used to draw urine from the bladder for testing without health ministry approval.”. . . “Anyone who performs a medical experiment on someone who doesn’t or is unable to give his informed consent should be tried for physical assault.”
WIKIPEDIA - The Tuskegee Study of Untreated Syphilis in the Negro Male. . . became notorious because it was conducted without due care to its subjects, and led to major changes in how patients are protected in clinical studies. Individuals enrolled in the Tuskegee Syphilis Study did not give informed consent and were not informed of their diagnosis; instead they were told they had “bad blood” and could receive free medical treatment, rides to the clinic, meals and burial insurance in case of death in return for participating.
In 1932, when the study started, standard treatments for syphilis were toxic, dangerous, and of questionable effectiveness. Part of the original goal of the study was to determine if patients were better off not being treated with these toxic remedies.
By 1947, penicillin had become the standard treatment for syphilis. Prior to this discovery, syphilis frequently led to a chronic, painful and fatal multisystem disease. Rather than treat all syphilitic subjects with penicillin and close the study, or split off a control group for testing penicillin; the Tuskegee scientists withheld penicillin and information about penicillin, purely to continue to study how the disease spreads and kills. Participants were also prevented from accessing syphilis treatment programs that were available to other people in the area. The study continued until 1972, when a leak to the press resulted in its termination.
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This entry was posted on Wednesday, May 30th, 2007 at 4:58 am and is filed under Human Rights . You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
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