Sometimes, There's Just No Right Thing To Do

The New York Times reports a rather sad tale of a lawsuit between the University of Arizona and a small Indian tribe called the Havasupai who lived at the bottom of the Grand Canyon.

Tribe members suffered from an unusually high incidence of diabetes which often led to amputations.  Since it's a three hour climb to the rim of the canyon from the village, having a leg or foot amputated either permanently imprisons tribe members at the bottom of the canyon or forces them to move elsewhere.

A member of the tribe approached a doctor for help in 1989.  Because a genetic cause had been reported for high diabetes rates among Pima Indians, the doctor thought that the Havasupai might have the same problem and referred the matter to the university.

One Professor Markow received a grant to collect blood samples from the tribe and look for genetic causes of diabetes.  Prof. Markow was also interested in schizophrenia and received a grant to research that disease as well.

"I went and told people, if they have their blood taken, it would help them," said Floranda Uqualla, 46, whose parents and grandparents suffered from diabetes. "And we might get a cure so that our people won't have to leave our canyon." Roughly 100 tribe members who gave blood from 1990 to 1994 signed a broad consent that said the research was to "study the causes of behavioral/medical disorders."  [emphasis added]

The consent form was kept simple because of limited English skills among the tribe.  The researchers did not find any genetic links to diabetes, but they found a high degree of inbreeding, which can make any group more vulnerable to disease.  Another paper showed genetic links to Asian groups which suggested that the tribe had crossed the Bering Strait some thousands of years ago.

Unfortunately for the university, not all the tribe members were limited in their English - some tribe members found the resulting research papers and became very upset.  The tribe had taboos against close relatives marrying each other and did not appreciate the suggestion that their norms had been violated so often that it showed in their blood.  Even worse, the Bering Strait link paper contradicted their origin stories which stated that they had been specially created in the bottom of the Grand Canyon to look after it.

The tribe found a lawyer who took their case for no fee.  After spending $1.4 million fighting the case, the university gave $700,000 to the 41 members of the tribe and, no doubt, an undisclosed amount to the lawyer.

Swearing he would ne'er consent, consented?

Schizophrenia is clearly a behavioral or medical disorder and would be covered by the plain meaning of the consent form, but did the members of the tribe understand it?  Given that they did sign the forms, how would you know what exactly they thought they meant?  Legally, should it matter?

Lawyers have a concept called a "meeting of the minds."  If two parties to a contract don't agree on what it means, their minds have not met and the contract is flawed.

Not understanding the contract won't get you out of a deal with a cell phone company, but what about medical research?  If a patient needs a medical degree or a law degree to understand a consent form, can ordinary people sign legally-binding consent forms at all?

When you check the "I agree" box on a Microsoft contract without reading it, have you and Microsoft had a "meeting of the minds?"  That question hasn't been tested in court so nobody knows.

What about using the Havasupai blood samples for tracing the tribe's origins?  That was not a medical condition and the tribes resented being told that the evidence of their blood contradicted their creation beliefs.

This sort of question will become more and more common as genetic research advances.  A large medical company got a patent on some genetic material which was taken from the tumor of a cancer patient.  Should the patient whose genes are being used to cure cancer in others be given a royalty?  Should anyone be able to patent a gene pattern at all?  After all, genes are found in nature.

Then there's the issues involved in the Iceland genetic study.  Iceland has a relatively small population of around 275,000 and has maintained detailed medical records since 1915.

Because the country was never invaded, the written records of who's related to whom go back centuries - most Icelanders can trace their assumed ancestry back about 1,200 years.  Ancestral data have been collected into the Book of Icelanders and made available electronically.

This treasure trove is a paradise for any company who can get enough blood samples from Icelanders.  Knowing how various genes were inherited and what they do might lead to new cures.

In 1998, the Icelandic Parliament granted an exclusive license to a drug company to access their detailed medical records.  Icelanders are supposed to get free access to medicines which are developed using the database, but some of them want royalties when the drugs are sold elsewhere.

A number of questions arise:

• What does "consent" mean?  Consent forms that cover everything cannot be understood by anyone who hasn't graduated from both law school and medical school, but even simple forms seem to have caused confusion.

• Was it reasonable for the University of Arizona to pay $700,000 in damages to the Indian tribe who were upset that their creation stories had been questioned?  What, exactly, were the damages and how could they be quantified?  The tribe members weren't helped by the study since it didn't find a solution for their diabetes problem but they weren't harmed either.

• Does the fact that the Icelandic parliament made medical data available to a drug company mean that every Icelander had given consent?  Does a government have the power to grant blanket consent on your behalf?

• Who owns your medical data?  In Iceland, a citizen can opt out and nothing more about that person will be put in, but nothing that's already there will be taken out.  At the very least, this means that all data collected on underage children will always be included even if they choose to opt out when they grow up.

The arrangement between Iceland and the drug company was canceled in 2004, but in the US, the government has free access to any and all medical data at any time; in effect, the government owns your medical history.  In theory, that will help researchers trove for cures.  In theory, unauthorized persons won't have access, but we know how easily government employees who were angry at Joe the Plumber for criticizing Mr. Obama were able to publish his "private" data all over the Internet.

Maybe we should just accept the statement of Bill Joy of Sun Computers:

You have no privacy.  Get used to it!