Who buys, sells and uses fetal tissue acquired from abortion clinics

Videos released by an anti-abortion group during the last two weeks have drawn attention to a little-known practice: the buying, selling and research use of fetal tissue acquired from abortion clinics.

The group behind the tapes accuses Planned Parenthood of selling fetal tissue for profit — which is illegal and which Planned Parenthood denies doing. House Republicans plan to investigate. This may be just one more battle in the nation’s long war over abortion, but the dispute has raised questions about who the buyers and sellers are, what fetal tissue is used for and what the law allows.

 

Scientists at major universities and government labs have quietly been using fetal tissue for decades.

 

They say it is an invaluable tool for certain types of research, including the study of eye diseases, diabetes and muscular dystrophy. Nevertheless, some agree to talk about it only if their names and their universities’ names are withheld, because they have received threats of violence from abortion opponents. Companies that obtain the tissue from clinics and sell it to laboratories exist in a gray zone, legally. Federal law says they cannot profit from the tissue itself, but the law does not specify how much they can charge for processing and shipping.

The National Institutes of Health spent $76 million on research using fetal tissue in 2014 with grants to more than 50 universities, including Columbia, Harvard, the Massachusetts Institute of Technology, Stanford, Yale and the University of California in Berkeley, Irvine, Los Angeles, San Diego and San Francisco. It expects to spend the same amount in 2015 and 2016.

 

Researchers say fetal tissue is a uniquely rich source of the stem cells that give rise to tissues and organs, and that studying how they develop can provide clues about how to grow replacements for parts of the body that have failed.

 

“Think of fetal tissue as a kind of instruction booklet,” said Sheldon Miller, the scientific director of the intramural research program at the National Eye Institute.

Stem cells derived from adult tissue may eventually replace fetal ones, researchers say, but the science is not there yet.

Eye tissue from fetuses has played a crucial role in studies aimed at finding treatments for degenerative diseases of the retina that are a major cause of vision loss in people as they age, according to Miller.

“We couldn’t get this information any other way,” Miller said. He said the eye institute bought fetal tissue from a company, created specialized cultures of retinal tissue from it and sent them to other researchers.

A university researcher who asked not to be identified because he had received threats that led his institution to post a guard outside his laboratory said fetal tissue was extraordinarily useful because “if you want to understand how a tissue or a disease develops, you should go back to the beginning.”

Another researcher, also concerned about threats, said fetal tissue was essential in research to develop treatments for degenerative diseases of muscle, because “to regenerate tissues in a human, you need to understand how human cells work.” Animal tissue can take researchers only so far, they say, because there are critical differences in development.

Fetal tissue can be used only with the consent of the woman having an abortion. Some researchers receive the tissue from abortion clinics at their own institutions, or from tissue banks maintained by some universities. Many buy the tissue from companies that act as middlemen.

 

Those companies pay small fees, usually $100 or less a specimen, to abortion providers like Planned Parenthood, who say they charge only what they need to cover their expenses. The companies then process the tissue and sell it to researchers for higher prices that reflect the processing.

 

The fees, which can run to thousands of dollars for a tiny vial of cells, do not break the law, according to Arthur Caplan, the director of the division of medical ethics at NYU Langone Medical Center.

“It appears to be legal, no matter how much you charge,” Caplan said, adding that there appears to be little or no oversight of the processing fees. “It’s a very gray and musty area as to what you can charge.”

Many researchers buy tissue from two small California companies. StemExpress, a 5-year-old business based in Placerville, Calif., describes itself as “the largest provider of maternal blood and fetal tissue globally.” It also says it offers “special discounts to the academic community.”

Its founder, Cate Dyer, has a bachelor’s degree in sociology from California State University in Sacramento. She started StemExpress with $9,000. An article last November in Sacramento Business Journal said that the company had grown more than 1,300 percent in three years. Its revenue was $2.2 million, according to a report in August 2014 in Inc. magazine.

Dyer said that fetal tissue accounted for about 10 percent of the company’s business. She agreed to be interviewed on the condition that she not be asked about the congressional investigation into her company’s partnership with Planned Parenthood. Her lawyer and a crisis communication expert were present on the telephone interview.

She said the company obtained fetal tissue in accordance with the rules made by ethics boards at the institutions buying it, and the tissue has been used in studies of leukemia, Hodgkin lymphoma and Parkinson’s disease.

It employs 37 people, including scientists, lab technicians and phlebotomists. Most clients come from referrals, and seek hard-to-find cell types, she said.

StemExpress uses procurement technicians to obtain fetal tissue. “We’re collecting biohazardous waste, discarded waste,” Dyer said. “They go to a hospital or to a facility that does terminations and collect tissues from those waste products.”

Back at the company, lab technicians process the tissue to try to isolate the specific cell type a researcher has ordered — for instance, fetal liver stem cells.

“These cells are hard to isolate,” Dyer said. “These are hard processes, expensive processes that take millions of dollars of equipment. Just to attempt to do some of these isolations can cost us thousands of dollars, and it may not even work.”

The effort is reflected in the pricing: a vial containing 5 million frozen fetal liver CD133+ stem cells can cost more than $24,000.

The final products are shipped fresh or frozen. Shipping fees are separate from specimen costs, and an overnight shipment to Germany, for example, can cost thousands of dollars, according to Dyer.

Fetal-tissue sales are not limited to cells in a vial. More than a dozen research papers published since 2012 acknowledge obtaining intact fetal eyes, hearts, livers and kidneys from StemExpress.

The other major supplier of fetal tissue, Advanced Bioscience Resources, or ABR, is a nonprofit that has 12 employees and recent sales of about $1.4 million, according to a Dun and Bradstreet report. A 2013 price sheet listed charges of $300 a specimen for tissue from a second-trimester fetus, and $515 if the fetus was first-trimester.

Linda Tracy, a registered nurse and president of ABR, said in an email that her company’s prices reflect the time, effort and space needed to obtain the fetal tissue. She noted that because funds for academic institutions are limited, her company tries to keep fees at a minimum.

“Planned Parenthood is in no way making a profit from participating in a tissue-donation program,” said Tracy, adding that the $30 to $100 acquisition fees mentioned in the first undercover video sounded “reasonable.”

ABR documents say its products have been used in HIV research by medical researchers at the University of California, Los Angeles and the University of Southern California.

Tissue from the company has also been used at Cincinnati Children’s Hospital and has been involved elsewhere in research on transplants.

A StemExpress brochure uncovered by the organization Center for Medical Progress, which was responsible for the leaked videos, contains an endorsement from a chapter of Planned Parenthood.

It quotes Dr. Dorothy Furgerson of Planned Parenthood Mar Monte saying: “Our partnership with Stem*Express is beneficial in a number of ways.” It goes on to describe contributions to “lifesaving research,” and its confidence that patients’ anonymity is secure.

But critics note several references in the flyer to financial benefits for clinics. By teaming with StemExpress, “you will also be contributing to the fiscal growth of your own clinic,” it says, a statement that some contend suggests clinics may be illegally profiting from providing fetal tissue.

George Annas, a law professor and bioethicist at Boston University, said, “What’s going on now is probably legal, but Congress won’t like it.”

Regarding the companies, Annas said: “They won’t be real happy that this is all out in the public. This threatens their business. Even if what they’re doing is legal, the law can easily be changed.”

 

http://www.seattletimes.com/nation-world/who-buys-sells-and-uses-fetal-tissue-acquired-from-abortion-clinics/

 

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http://www.cnn.com/2015/07/17/health/fetal-tissue-explainer/

 

How exactly fetal tissue is used for medicine

Fetal tissue has been used since the 1930s for vaccine development, and more recently to help advance stem cell research and treatments for degenerative diseases such as Parkinson’s disease. Researchers typically take tissue samples from a fetus that has been aborted (under conditions permitted by law) and grow cells from the tissue in Petri dishes.

Many of the uses of fetal tissue — and much of the debate — are not new. “It’s just that the public is finding out about it,” said Insoo Hyun, associate professor of bioethics at Case Western Reserve University.

In addition, the ways that fetal tissue are allowed to be obtained and used are not new either, Hyun said. The U.S. Department of Health and Human Services released guidelines on the topic in the 1990s.

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Video puts Planned Parenthood on defense 02:35
The federal regulations state that women must decide to have an abortion before clinicians can ask whether they would like to donate fetal tissue. One concern is that women would have more pregnancies or abortions because they want to donate fetal tissue. In addition, clinicians performing the abortions cannot receive payment from researchers who will receive fetal materials, except for reimbursement for costs such as shipping.

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Despite the long history of using fetal tissue in medicine and research, the practice could be on the way out. Even though it has led to important medical advances in the last several decades, “in the future, the need for fetal tissue will go down because of advances in stem cell [technology] that will take over,” Hyun said.

One of the earliest advances with fetal tissue was to use fetal kidney cells to create the first poliovirus vaccines, which are now estimated to save 550,000 lives worldwide every year.

In the early days of making the vaccine, researchers infected fetal kidney cells in Petri dishes to produce a large amount of virus that they could then harvest, purify and use to vaccinate people. (The virus evolves to become less deadly when it infects cells out of the body, and thus could safely be given to people to prime their immune system for the real thing.)

Today manufacturers of the polio vaccine use other types of human cells, which weren’t available in the mid-1900s. They also use monkey cells, which they originally avoided for fear that making the vaccine in animal cells could put people at risk of diseases from other species.

Many of our other common vaccines, such as chicken pox, rubella and shingles, have been produced in tissue derived from fetuses, particularly two electively terminated pregnancies from the 1960s. Advances in how researchers work with cells have allowed them to grow fetal cells indefinitely in Petri dishes, thus not requiring samples from any newly aborted fetuses.

Advances in stem cell therapy, too, could help phase out the practice of collecting cells from fetal tissue. Many researchers can now make stem cells by reprogramming skin cells from an adult into a “blank check” stem cell state. These so-called induced pluripotent stem cells can then go on to develop into neurons or any other cell in the body that researchers can grow in labs and study to better understand diseases such as Alzheimer’s disease.

However, as Hyun explained, research on these stem cells is still in the early stages and scientists need to make sure the neurons or whatever other type of cells they steer the stem cells to become behave like the cells in the body they want them to emulate. So scientists may still grow fetal neuron cells, for example, in a Petri dish alongside stem cell-derived neuron cells as a reference point until they have more confidence in the stem cell technology, said Hyun, who specifically studies the bioethics of stem cell research.

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“The use of fetal tissue may also be supplanted in some cases by cells from umbilical cord blood. Amy Hudson, associate professor of microbiology and molecular genetics at Medical College of Wisconsin, has a grant from the National Institutes of Health to study how herpes viruses cause disease. Because it would be unethical to infect people and study disease in them, she and her colleagues plan to work with lab mice that have an altered immune system that behaves like that of humans. To achieve that, the researchers could transplant into the mice a small amount of liver tissue from fetuses: “a tiny number of cells that you can barely see,” Hudson said.

Yet just the practical challenges of doing this work, and especially the fact that the fetal tissue may not be available at the exact time they need them, are making Hudson and her colleagues think instead about using stem cells from the umbilical cord, which could be easier to obtain. However these cells do not appear to give mice as human-like an immune system. “The fear is we spend time and money on experiments using a halfway-OK [approach] and we get a result that isn’t interpretable,” Hudson said.

There are also a number of clinical research studies that are investigating whether transplanting different types of fetal tissue into patients could help them recover from diseases, similar to the practice of organ donation. One such study is testing fetal eye (retinal) tissue as a possible treatment for retinitis pigmentosa, a disease that can lead to blindness.

A lot of research in the last 10 years has also focused on using fetal neuronal cells for Parkinson’s and another degenerative disease called Huntington’s. Although early research on this approach for Parkinson’s patients was not encouraging, a small subset of patients do appear to benefit from it.

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Nevertheless, clinical research on tissue transplantation as a disease treatment may eventually be able to replace fetal tissue with stem cells, Hyun said. One of the Health and Human Services requirements for using fetal tissue is that no other experimental settings, such as other cell types or lab mice, would be appropriate.

When fetal tissue is used in research, it is often sent from the hospital or clinic that performs the abortion to an affiliated research center, Hyun said. Another safeguard in the Health and Human Services guidelines is that a clinical team that performs the abortion cannot know that the fetus will be donated, to help ensure that they do not change how they perform the abortion, or jeopardize the safety of the woman, Hyun said.

These guidelines have been solidified and become more widespread since the 1990s, Hyun said, adding that, “I believe [all clinicians] are well aware of them now.”

 

 

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