Wednesday, December 17, 2008

Health Care Rights in India and the U.S.

In yesterday's post on "Drug Marketing in Mumbai" I mentioned that I'm reading ethics literature from India in preparation for a visit I'll be making soon.

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.

* 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.
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.

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.

3 comments:

Dr. Val said...

About the Abigail case... I think they were trying to get access to Erbitux for Abigail, and it was in phase III trials at the time (so there was mounting evidence for its efficacy - their request to purchase it wasn't scientifically unreasonable.)

I have very mixed feelings about the FDA ruling. I understand that we don't want to 1) set a precedent that would lead to insurers having to pay for expensive experimental therapies 2) discourage people from entering clinical trials 3) allow drug makers to profit from "false hopes" in terminal cases. However, couldn't we add enough caveats to make it reasonable to allow patients who have exhausted all other options to purchase (with their own money) drugs that have shown promise but are not yet FDA approved?

What if we said that the drugs had to be in phase III trials, with enough evidence to suggest a plausible benefit for the patient? Terminal patients are rarely good candidates for clinical trials (I don't think we'd be poaching from the CT pool), few can afford to buy monoclonal antibodies (and the like) on their own so if there were trials for terminal patients, they'd still have great incentive to join, and I'm not sure that just because a patient can buy a treatment that insurance will HAVE TO follow suit.

Something about limiting personal choices (for those who have the means to make them) seems un-American to me. There are very low risks of harm in monoclonal antibody treatments (so the argument that the FDA must err on the side of patient safety doesn't really fit the Abigail case). Yes, it's sad for those who can't afford to buy every possible therapy - but why should we deny access for those who can? With the right caveats, I think we could allow people like Abigail to try every remaining option. But of course I agree that phase I drugs are just not far enough along the research pipeline to make educated choices about them.

Jim Sabin said...

Hi Dr. Val -

Just in case readers of this blog haven't visited your website I want to encourage them to do so (http://getbetterhealth.com).

I've copied here the comment I left on your own blog:

"First, congratulations on your (relatively) new excellent site! You've been a real innovator and leader in medical communications! I'm honored that you've visited my blog and engaged with the slightly wonky issues I take up!

I share your view that "limiting personal choices (for those who have the means to make them) seems un-American." The court was split in deciding the Abigail Alliance case. That isn't surprising. I think people of good will and common sense will continue to give different emphasis to the relative importance of protecting the public, protecting the integrity of drug trials and evidence-based medicine, and giving maximum choice to people in last chance situations.

I think the option you imagine - access to drugs in phase III trials with various caveats - is very reasonable. The one position I would hold to is that insurance funds shouldn't be paying for unapproved treatments."

Best

Jim

Dr. Val said...

Thanks for the compliment about my blog, Jim. I moved to DC a couple of years ago so I've become a bit wonky myself - wonk by association? I agree with you that insurance companies should not be required to pay for experimental therapies. In this economy, I doubt that there will be a danger of that. :)