Payment for donors?

Payment for donors?

Sixty years after Henrietta Lacks died of cervical cancer, the
Baltimore County, Md., woman’s cells live on in laboratories around
the globe.
Sixty years after Henrietta Lacks died of cervical cancer, the Baltimore County, Md., woman’s cells live on in laboratories around the globe. Collected by Johns Hopkins researchers as she was being treated, the cells grew incessantly and have since helped scientists make blockbuster medical advances, including cancer treatments and the polio vaccine.

Decades passed before anyone told Lacks’ relatives of her enduring gift to modern science. And while the advances that have come from her cells are worth millions, her family never received a cent.

In the 1950s, tissues were taken routinely from patients and used for research without their approval. But today, Lacks’ story, illuminated in the book, “The Immortal Life of Henrietta Lacks,” by Rebecca Skloot, raises important and unresolved issues about the bioethics of modern tissue research, experts say: consent and money.

Much has changed since Lacks’ cells were harvested. There are now federal informed-consent regulations, and a repeat of a Lacks scenario is unlikely, say experts in bioethics. Nevertheless, debate is brewing in research circles over the gray areas: Are consent rules strong enough? Are people entitled to any compensation if pieces of their bodies turn out to be worthy of a medical advancement?

“If we’re looking at the story of Henrietta Lacks and her family, we can say with confidence that what they experienced would not happen again,” said Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics. “What remains unresolved are the still very big questions about what level of consent and whether and under what circumstances is compensation appropriate. These are all big open questions. There has been big movement forward in the bioethical questions raised from that case, but that’s a long way from saying we’ve got this figured out.”

Today, it would be unethical for a scientist to take samples from people exclusively for research and not ask their permission, Faden said. But tissues can sometimes be used for research without a patient’s knowing it. When people go to the hospital or a doctor’s office for a medical procedure, tissues and blood removed from a patient’s body are often stored for research down the road. Hundreds of millions of samples are collected in the United States alone, said Dr. David Wendler, a staff scientist at the National Institutes of Health Clinical Center and a bioethics expert.

While some institutions give patients consent forms specifying their tissues might be used for research, many don’t, said Skloot. Federal regulations regarding patient consent apply only to federally funded research. There aren’t clear laws requiring informed consent for tissues that are stored, nor is it clear if scientists must tell people if their tissues might be used for profit, she said. The result has been lawsuits and a small but growing group of activists who insist patients should have more control over their bodies.

“There is a lot of argument over this,” said Skloot. And it might only grow louder.

“People have been doing this and banking these things for so long, but it’s becoming bigger because we’re able to learn more and more from cells and DNA,” she said. “As the technology is advancing, the researching on the genetic level is increasing.”

Tissue research is big business for biotech companies and is the future of efforts to make medical advances to personalize medicine, such as drugs tailored to someone’s genetic background, said Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

“We’re talking about a huge international issue – this collection of tissue goes on everywhere,” he said. “People don’t understand that the collection of tissue is an explosive part of biomedical research.”

While some people think consent laws need strengthening, the majority of the public doesn’t know anything about tissue storage, said Caplan. And most who do, don’t care, he said.

“If you go to the hospital, they take out your appendix, they give you a form saying we are removing these tissues, we may use this for research, is that OK with you? And do you renounce any claims to any commercial discoveries we may make?” he said. “Ninety-nine percent of people sign that form without a second thought – they probably don’t read it. Most people don’t really care what happens to their appendix afterward. You’re sick, you’re trying to get treatment, you’re not trying to get into a commercialization fight with your prostate cancer doctor.”

Besides, most people’s tissues aren’t worth much since they don’t yield big medical advances. The only time it really matters to people is in the rare cases where someone’s unusual biology offers scientists new clues to a rare disease, Caplan said.

In a case from the 1990s, families with Canavan disease, a rare genetic disorder, raised money and collected DNA samples to have the condition studied with the hope scientists would find a test to diagnose it and offer it at little cost to them. After a Miami Children’s Hospital researcher found a gene responsible for the disorder, he patented it and began charging royalties on a genetic test to screen for the disease. A huge legal battle ensued. A 2003 settlement allowed the hospital to continue collecting royalties but let doctors and researchers use the patented gene to help find a cure without paying, according to the Canavan Foundation.

But rare diseases aren’t the only ones to trigger ethical and legal fights. Lately, the most common medical research is causing an uproar.

A group of Texas and Minnesota parents sued their states, arguing the mandatory blood samples taken from infants to test for dozens of genetic diseases are stored for research purposes without their permission. In Texas, the state settled the lawsuit in December and is poised to throw away samples from 5 million babies.

“That is huge; that has never happened,” said Skloot. “This could have a really big effect on science if it’s found in many states that you can’t do research on fetal samples without consent. I imagine on the federal level, folks paying attention to this will say, ‘We need to have a bigger discussion on this. We have to figure this out.”‘

While the idea of storing tissues for further research sounds creepy, it’s done to advance science and many discoveries have been the result, said Skloot. On one hand, activists want more control and compensation. But on the other, researchers fear stringent consent and compensation rules would only hinder scientific progress. Many scientists view stored tissues as a treasure-trove, opening the possibility of making discoveries they haven’t even considered.

Scientists who work under federal regulations would argue they are already subject to an enormous amount of review, from funding agencies, the National Institutes of Health and institutional review boards, said Wendler of the NIH.

Still, he thinks many researchers are open to giving subjects credit – they’re just not sure how to do it.

“They wouldn’t object if someone in bioethics could come up with a mechanism that’s feasible,” he said. “I don’t think it’s that they don’t want their subjects to get any credit or any money. It’s trying to figure out how to do that.”

If consent rules were strengthened and compensation was considered routine, the logistical hurdles would be many. How do you contact people years–even decades–after a study was conducted? How do you figure out how much they are owed? Who gets to decide?

“While there should be some consideration for recognition, credit and maybe royalties in practice, it can be incredibly complicated to figure out how to do that,” Wendler said. “In the Lacks case people are still using her cells. If you were going to compensate someone, who would it be? Her nearest living relative? Are they still owed royalties if they are her great-third cousin? The fact that you can keep them in perpetuity makes this practice even harder.”

Nevertheless, how people should be recognized for their contributions to science – and the extent of that recognition – are important ethical questions that need sorting out, he said.

For now, science can learn a lot from Lacks’ story, said Skloot.

“There are human beings behind every sample we rely on in science,” she said.

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