In the most recent issue of the Indian Journal of Medical Ethics, Dr. Helen Sheehan from the South Asia Studies Department at the University of Pennsylvania has a fascinating article on "Cancer, access to investigational drugs, and patient rights in the USA and India."
Dr. Sheehan tells a story from the U.S. (the Abigail Alliance case, which I discussed in "Access to Experimental Drugs - the Supreme Court Gets it Right") and a story from India (a cancer drug trial carried out at the Regional Cancer Center in Thiruvanathapuram in Kerala).
What's most striking in the story is that the rights at stake are polar opposites. Interestingly, both situations involve Johns Hopkins.
The Abigail Alliance case was brought on behalf of Abigail Burroughs, a young woman who contracted a rare head and neck cancer that did not respond to standard treatment. Her Johns Hopkins physician wanted to give her an experimental medication, not yet approved by the FDA. The legal action claimed a right for dying patients to have access to experimental drugs. The drug was not made available. Abigail died in 2001. The drug was subsequently approved by the FDA.
The posthumous appeal claimed a constitutional right to the drug, based on the fifth amendment guarantee that no person shall “be deprived of life, liberty, or property, without due process of law.” Patients in “last chance” situations, when standard treatment offers no hope – are facing death. The Abagail Alliance argued that by not facilitating access to drugs that have passed through Phase 1 trials, the FDA is depriving them of the right to opt for a potentially life-saving intervention. The District of Columbia Circuit Court ruled against the Alliance.
The situation at the Regional Cancer Center in Kerala involved trial of an experimental drug on 27 oral cancer patients from November 1999 to April 2000. The agent had only been tested in mice. Without approval from any IRB, a scientist from Johns Hopkins contracted with the Regional Cancer Center and brought the drug to India. In July 2001 a physician at the Regional Cancer Center blew the whistle on the study, claiming that no approval had been given and that the informed consent process was a sham. Johns Hopkins conducted its own investigation and concluded:
* The scientist was negligent for failing to submit a proposal for the clinical trial to a Johns Hopkins University institutional review board. Under university policy and federally mandated procedures, faculty experiments involving human subjects must have prior IRB approval, whether conducted in the United States or abroad.In the U.S., the Abigail Alliance claimed (unsuccessfully) that the FDA regulations were too strict and abrogated Abigail's rights by preventing her and her physicians from protecting her against avoidable death. In India critics concluded that the Regional Cancer Center was too lax in its oversight of research, and that the drug trial abrogated participants' rights to adequate protection.
* The trial did not meet Johns Hopkins standards for research with human subjects. For example, the committee found there was inadequate safety testing of the drugs in animals before they were injected into human patients. The committee also said that consent forms used to recruit patients for the study were inadequate.
* The scientist carried drugs used in the study to India without either an "investigative new drug" approval from the Food and Drug Administration or explicit FDA export permission.
* The scientist, without authority, signed several versions of a document committing the university to collaboration with the RCC.
It isn't surprising that a country with strict research regulations (the U.S.) pushes drug research to sites where the regulation is more lax (such as India).
A New England Journal article discusses the risks to India as "A New Colonialism."
I hope we are in the process of seeing a global re-equilibration with regard to "rights" in health care. In the U.S. our expectations are excessive - as evidenced by our belief that we have a right to anything we or our doctors hope might provide benefit. In India, at least as seen by an outsider, expectations for what each individual deserves are too low, as evidenced by the way poor patients at the Regional Cancer Center were herded into a study. The disputed drug trial in India reflects the dark side of both countries - U.S. entitlement to join in the exploiting of poor citizens in India.
We owe thanks to the whistleblowers and journalists who give both countries opportunity to look in the mirror and see our failings.