In January 1966, Beecher published an editorial in the Journal of the American Medical Association (JAMA) entitled “Consent in clinical experimentation: myth and reality.” The clinical experimentation referred to was not therapeutic investigations conducted as part of a hospital stay, in which the welfare of one specific patient was at stake. Instead, the experimentation Beecher discussed concerned non-therapeutic studies designed to benefit the entire human race. In his 1966 article, Beecher debunked four common myths about human experimentation.
Myth #1: Informed Consent is Always Possible to Obtain
The first myth Beecher discussed involved informed consent. Following the Nuremberg Code (1947) and the Declaration of Helsinki (1964), Beecher acknowledged a widespread misconception that adherence to codes and guidelines would “provide some kind of security” against wrongdoing.
In reality, Beecher believed that codes and guidelines could not provide answers for all unforeseen events. As a result, informed consent was “often exceedingly difficult or impossible to obtain in any complete sense.” This attitude is consistent with viewpoints expressed during his lifetime, especially in a 1962 article where Beecher argued that the point was not that consent should not be sought, but rather that it could never be fully attained.
Myth #2: Patients Always Trust Their Doctors
The second myth Beecher exposed was that patients always trust their doctors. As a consequence of blind trust, patients would willingly participate in any experiment proposed by their physicians.
In reality, Beecher claimed that it was ridiculous that patients would “knowingly seriously risk their health or their lives for a scientific experiment.” In this sense, he argued that scientific knowledge and advancement were ideals that average patients would ignore unless the experiment benefited them personally.
Myth #3: An Investigator's Oath Guarantees Informed Consent
A third myth Beecher rejected was that an investigator's word was sufficient to prove that informed consent had been obtained. In reality, the evidence of informed consent is not in the assurance but in reviewing the conditions under which an experiment is conducted.
As Beecher claimed, “It is clear that many published studies never should have been undertaken in the first place.” Furthermore, Beecher acknowledged that even reviewing an experiment may not uncover all wrongdoing. Thus, whether an experiment was ethical depended “on what transpired between investigator and subject before the experimentation was started.”
Myth #4: The Ends Justify the Experimental Means
The final myth Beecher debunked was that scientific ends somehow justified the experimental means used to reach them. In this sense, an otherwise unethical experiment could become morally acceptable if it produced worthwhile data.
To Beecher, this attitude was especially outrageous as it implied that physicians could play God by making martyrs of their patients. Beecher's own work for the CIA, however, in which interrogation subjects died following experimentation with psychotic drugs such as mescaline, makes his moral position here ironic.
Does Patient Security Come From the Investigator?
Unfortunately, Beecher’s solution to all four myths was equally unsatisfactory. According to him, patient security rested with a “responsible investigator who [would] refer difficult decisions to his peers.”
From a modern standpoint, it is difficult to see how peer review would prevent informed consent abuses from occurring. After all, responsibility is not evaluated on a sliding scale. A research study is either ethical or it is not, just as an investigator either conforms to accepted rules, or does not.
Does Unethical Research Continue?
The Nuremberg Code, the Declaration of Helsinki, and the Belmont Report did not put a stop to unethical research. Although those codes and guidelines set forth the proper procedures by which research on humans should be conducted, behavioral suggestions are not the same thing as legal prohibitions.
In 2007, Markman and Markman cited three modern examples of research abuses that occurred between 2001 and 2006:
- A healthy woman took part in an asthma study at Johns Hopkins University, in which all the risks associated with an experimental inhaler were not explained beforehand. The woman died, and all federally-funded research at the university was halted temporarily.
- A young man participated in a gene therapy study. He was injected with an adenoviral vector that had been designed to mimic one of his defective genes. The investigators gave the young man too much virus, however, and he died from the overdose.
- An anti-inflammatory monoclonal antibody (TGN1412) had been tested successfully in rhesus monkeys without side effects. The investigators claimed that TGN1412 was ready for human use, although they failed to consider how differences in metabolic rates between species would cause the antibody to stay in a human body for nearly one full month. Based on repeated assurances of safety without risk, six healthy volunteers joined the study and were injected with TGN1412. All six volunteers became seriously ill from severe side effects.
As Markman and Markman noted, “these events show that some clinical investigators still do not comply with the fundamental requirements for ethical research involving human beings.”
The Cost of Clinical Research
According to Baird (2003), a pharmaceutical company loses $1 million a day for each day that a new drug is delayed getting to market. Thus, the pressure on researchers to succeed, and to succeed quickly, is enormous.
In this sense, the myths behind human experimentation not only need to be eliminated (as Beecher suggested), but also new safeguards have to be put in place to protect human subjects.
References
Baird P. 2003. Getting it right: industry sponsorship and medical research. CMAJ. 168(10):1267-1269.
Beecher HK. 1966. Consent in clinical experimentation: Myth and reality. JAMA. 195:34-35.
Markman JP, Markman M. 2007. Running an ethical trial 60 years after the Nuremberg Code. The Lancet. 8:1139-1146.
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