The Short Answer: YES. At the very least, a definite “maybe”… Let me explain.
The Long Answer:
What I’m referring to is the World Medical Association’s Declaration of Helsinki, a list of ethical guidelines for medical human subjects research, itself not international law, but the international ethical standard. The declaration has been codified into national law in many countries, including most of the European Union. In the US, all foreign clinical trials of pharmaceuticals, medical devices, and procedures submitted to the FDA for approval must either abide by FDA standards or the 1989 Declaration of Helsinki (not the most recent draft; more on that here).
The current Declaration of Helsinki (7th revision, from 2008) has a lot of great stuff in it – guidelines about informed consent, the physician’s duty to safeguard the health of the patient (far more important than the success or failure of a clinical trial), a stipulation that negative results must be reported publicly and registered in open-access databases—but what particularly caught my eye when I first read it last week was this:
Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.
(Section B.17 of the 2008 Declaration of Helsinki; emphasis added)
What this means is that whatever the priorities of the population being treated are – those are by default the most important research questions. Scientists/researchers are bound to investigate these stated priorities first. They are more important than, as a totally random example, the needs or priorities of the pharmaceutical companies…
Ok, but is the Declaration of Helsinki law in the United States?
As yet to be 100%, set in stone, decided. However, there are some very interesting case precedents that point in a positive direction…
Kano, Nigeria; 1996: Pfizer conducted a clinical trial of an antibiotic, Trovan, on children suffering from an outbreak of meningitis. 11 of the children who participated died (5 of them taking Trovan), even though an FDA-approved non-experimental treatment regimewas available at the same clinic courtesy of Medicine Without Borders. The parents of these children brought suit against Pfizer, first in Nigeria and later in the United States. Among other things they charged that the experiments were done without informed consent, a violation of both the Nuremburg Code and the Declaration of Helsinki.
The case, Abdullahi vs. Pfizer, Inc., made it to the United States Court of Appeals, Second Circuit (covering New York, Conneticut, and Vermont; one step below the Supreme Court). The court’s ruling was that the Abdullahi case could be tried under the Alien Tort Act because denying informed consent to the study participants (as guaranteed in the Nuremburg Code and Declaration of Helsinki) constituted a violation of “the law of nations” accepted by the “civilized world” as a norm of customary international law. Pfizer appealed the decision to the Supreme Court, where it was it was denied certiorari; therefore the appellate court decision stands.
This ruling is now part of case law—meaning that unless the Supreme Court were to reverse the appellate court’s decision in a future case, the ruling is the law of the land (by US legal custom).
IN A NUTSHELL: a study participant can sue a pharmaceutical company (or other researcher) for not respecting his rights as outlined in the Nuremberg Code and Declaration of Helsinki, which are considered international “laws of nations.”
To the Mental Health Community at large:
DID YOU HEAR THAT?
The Declaration of Helsinki does represent your rights. And it says:
WHAT THE (MENTAL HEALTH) COMMUNITY WANTS INVESTIGATED MUST BE INVESTIGATED.
The priorities and health needs of the community are more important than anyone else’s — mainstream psychiatry, pharmaceutical companies, et al.
So now that you know the value of your opinions, WHAT DO YOU WANT RESEARCHED? What are your priorities? Health needs? Research interests?
Want to know more about Soteria and other social support treatments for schizophrenia? How about the efficacy of peer-to-peer counseling? Biofeedback training? Holistic healing approaches? Natural supplements? Effectiveness of SSRIs, antipsychotics, and mood stabilizers? The sky’s the limit!
Spell out your research interests, and perhaps we can put together a petition or letter informing our lawmakers and congressman of this community’s research priorities and the legal precedent for having those priorities respected.
POWER TO THE PEOPLE!