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They’re in biotech company labs and most hospitals. Biobanks store appendixes, ovaries, skin, sphincters, testicles, fat, even foreskins from most circumcisions. They also
house blood samples taken from most infants born in the United States since the late sixties, w...
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the Genographic Project began doing the same to map human migration patterns, as did the NIH to track disease genes. And for several years the public has been sending samples by the millions to personalized DNA testing companies like 23andMe, which only provide customers with their personal medical or genealogical information if they first sign a form granting permission for their samples to be stored for future research.
Scientists use these samples to develop everything from flu vaccines to penis-enlargement products. They put cells in culture dishes and expose them to radiation, drugs, cosmetics, viruses, household chemicals, and biological weapons, and then study their responses. Without those tissues, we would have no tests for diseases like hepatitis and HIV; no vaccines for rabies, smallpox, measles; none of the promising new drugs for leukemia, breast cancer, colon cancer.
scientists are stealing your arm or some vital organ. They’re using tissue scraps you parted with voluntarily. Still, that often involves someone taking part of you. And people often have a strong sense of ownership when it comes to their bodies. Even tiny scraps of them. Especially when they hear that someone else might be making money off those scraps, or using them to uncover potentially damaging information about their genes and medical histories. But a feeling of ownership doesn’t hold up in court. And at this point no case law has fully clarified whether you own or have the right to
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There are, essentially, two issues to deal with: consent and money. For most people, knowing if and how their tissues are being used in research is a far bigger issue than profiting from them. Yet when this book went to press, storing blood and tissues for research did not legally require informed consent, because the law governing such things doesn’t generally apply to tissue research.
Today, if doctors want to gather tissues from patients strictly for research purposes—as in Henrietta’s case—they are required to get informed consent.
They also believe it’s important for donors to be able to control who has access to their tissues, because they worry that information gathered from tissue samples might be used against them.
And in a handful of cases, genetic tests performed on people without their consent have been used to deny workers’ compensation or health insurance claims (something now protected against by the Genetic Information Nondiscrimination Act of 2008).
Because of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, there is now clear federal law in place to prevent the kind of privacy violation that happened to the Lacks family when doctors at Hopkins released Henrietta’s name and her medical records.
‘As of today, when you go to the doctor for health care, your medical records and tissue samples can be used for research and nobody has to ask you’—if the issue were stated that bluntly so people could really understand what’s happening and say they’re okay with it, that would make me more comfortable with what we’re currently doing. Because what’s happening now is not what people think is going on.”
If the issue of consent isn’t addressed, Robert Weir, founder of the biomedical ethics center at the University of Iowa, sees only one outcome: “Patients turn to law as a last resort when they don’t see their participation being acknowledged.” Weir favors fewer lawsuits and more disclosure. “Let’s get these things on the table and come up with legal guidelines we can all live with,” he says. “Because going to court is the only other option.” And court is where these cases often end up, particularly when they involve money.
In fact, several patient groups have created their own tissue banks so they can control the use of their tissues and the patenting of discoveries related to them, and one woman became a patent holder on the disease gene discovered in her children’s
tissues, which lets her determine what research is done on it and how it’s licensed.
The thing is, people can’t “think of doing that on the front end” unless they know their tissues might be valuable to researchers in the first place. The difference between Ted Slavin, John Moore, and Henrietta Lacks was that someone told Slavin his tissues were special and that scientists would want to use them in research, so he was able to control his tissues by establishing his terms before anything left his body. In other words, he was informed, and he gave consent. In the end, the question is how much science should be obligated (ethically and legally) to put people in the position to do
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Though the judge in the John Moore case said patients must be told if their tissues have commercial potential, there was no law enacted to enforce that ruling, so it remains only case law.
After the Moore case, Congress held hearings and commissioned reports that uncovered the millions of dollars being made from human tissue research, and it formed a special committee to assess the situation and recommend how to proceed. Its findings: the use of human cells and tissues in biotechnology holds “great promise” for improving human health, but raises extensive ethical and legal questions that “have not been answered” and to which “no single body of law, policy or ethics applies.” This, they said, must be clarified.
Ted Slavin—a hemophiliac whose doctor told him his cells were valuable. Slavin founded Essential Biologicals, a company that
sold his cells, and later cells from other people so individuals could profit from their own biological materials.
I am a very lucky woman.
from the BBC documentary The Way of All Flesh. I also relied on the journals of Deborah Lacks, medical records, court documents, police records, family photographs, newspaper and magazine reports, community newsletters, wills, deeds, and birth and death certificates.
The character named Hela appeared in many Marvel comic books. See, for example, “The Mighty Thor: The Icy Touch of Death!” Marvel Comics Group 1, no. 189 (June 1971).
