Is It Time to Regulate Fetal Tissue Donations?
Donated tissue can be used for things like cosmetics research, and women might not be aware.
Abortion providers, including Planned Parenthood, have only a limited ability to specify how donated fetal tissue will be used.
The consent form patients at Planned Parenthood sign if they choose to donate fetal tissue after an abortion explains that such tissue has been used in research on diabetes, Parkinson’s disease, Alzheimer’s disease, cancer and AIDS. Women are asked to initial several parts of the form, including a line that reads: “I agree to give my blood and/or the tissue from the abortion as a gift to be used for education, research or treatment.”
The reality, however, is that Planned Parenthood – or any abortion provider – has only a limited ability to specify the purpose for which fetal tissue will ultimately be used. Even Planned Parenthood seems to tacitly acknowledge this in its form, another section of which requires women to initial a line that reads: “I understand I have no control over who will get the donated blood and/or tissue or what it will be used for.”
In fact, nothing prevents fetal tissue from being used for purposes that would not be considered medical, such as research to develop cosmetics. And even though such practices aren’t illegal, it is unclear that women understand the possibilities when they sign the donation consent forms.
The topic of fetal tissue donation has come to light amid a series of videos released by the Center for Medical Progress, an anti-abortion group that accused Planned Parenthood of selling fetal tissue for profit and of altering the way it performs abortions in order to gather more intact specimens.
The women’s health care provider has denied any wrongdoing and commissioned a study that showed the videos are heavily edited and manipulated. The issue has become a talking point for Republican presidential candidates and is likely to fuel arguments over federal funding for Planned Parenthood.
But less attention has been paid to the regulation of third-party companies that collect the tissue and blood from abortion providers and process and sell the materials to researchers.
“I’ve certainly seen things on the tapes that have given me pause, but is it enough to close Planned Parenthood? No,” says Arthur Caplan, founding director of the division of medical ethics at New York University’s Langone Medical Center’s Department of Population Health. “Could Congress improve the ways we get fetal tissue in this country? Yes.” He points to the fact that there is no information on whether fetal tissue can be imported from other countries, and to the lack of guidance as to the purposes for which tissue can be used.
Because the Food and Drug Administration does not require cosmetic companies to list ingredients, it is difficult to quantify whether, or how often, fetal tissue is used to develop them. In 2009, Neocutis Inc., a skincare company, openly admitted that it had used cells derived from an aborted fetus in Switzerland to make its products, which the company says go toward helping patients with severe wounds and burns, but also to fight skin aging. Company spokespeople said the tissue was collected ethically in Switzerland, following all of the country’s organ donation laws. The abortion, they wrote, was deemed medically necessary by doctors because the fetus would not survive to term, and the parents opted to donate the tissue.
The Uniform Anatomic Gift Act makes it a federal crime to buy or sell fetal tissue, but companies are allowed to collect fees related to the handling and processing of the tissue. Specifically, the National Institutes of Health Revitalization Act, signed in 1993, allows for "reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue."
But the law doesn't define "reasonable payments" or limit how much can be charged, so violations can be difficult to determine or to prove.
R. Alta Charo, professor of law and bioethics at the University of Wisconsin-Madison’s law, medicine and public health schools, says she was struck as to why people are appalled that money would be involved in the procurement of tissue and organs, whether fetal or otherwise.
“It’s been going on for 50 or 60 years; it’s ordinary practice,” she says. “There is good reason for it – we want to help the people who are living or may be living in the future.”
So far, no evidence has emerged that indicates Planned Parenthood has sold tissue for profit, and the organization says it has gone above and beyond requirements in obtaining the tissue, including asking women whether they want to donate tissue only after they have chosen a surgical abortion and not altering how they perform the procedure. Under law, these steps are only required when fetal tissue is used in research funded by the federal government, and it’s a requirement aimed at researchers, not at clinics, but Planned Parenthood is voluntarily following the protocol.
Planned Parenthood also insists it is careful about which companies it works with. The organization has pointed out that the Center for Medical Progress pretended to be a tissue-procurement company in the videos, but that Planned Parenthood refused to work with the supposed company in part because the questions raised by the people posing as its representatives involved things that are illegal.
Most Planned Parenthood clinics do not have tissue-donation programs. One affiliate in California works with a tissue-procurement organization but also has a separate relationship with the University of California. A second affiliate has a direct relationship with the University of Washington. Before the Center for Medical Progress released its videos, four additional affiliates in California were involved with fetal tissue research, but aren’t anymore. Two had their contracts with a tissue-procurement organization canceled because of the fallout from the Center for Medical Progress videos.
“The perception was that [Planned Parenthood] was collecting fetal tissue because it helps with their finances,” Charo says. “At best it’s neutral, but at minimum it’s a hassle. There is no incentive for doing it except for wanting to help medical research generally.”
Asked about its stance on having tissue used only for the purpose of medical research, the organization reiterated its commitment to giving women access to abortion and reproductive health care.
“In their fervor for fighting women’s access to abortion at all costs, those behind these videos are putting an entire field of scientific research at stake,” says Eric Ferrero, vice president of communications at Planned Parenthood Federation of America, adding that the research has advanced vaccines, treatments for life-threatening diseases, and gone toward finding cures for specific maternal and infant health conditions.
StemExpress, a tissue procurement company based in California, says it receives calls from clients every other month specifically requesting fetal tissue – a subset that makes up less than 1 percent of the company’s business, according to a spokesman. Its clients for various services include leading universities such as Stanford, Harvard, Duke and the University of Pennsylvania, as well as companies like Pfizer, Genentech and Quest Diagnostics. It also works with the FDA.
“They are the world’s best known medical researchers,” a spokesman for StemExpress says.
The standards for choosing companies and the purpose of tissue donation, however, are self-imposed and not required by law. Caplan says Planned Parenthood is doing all it can, but government oversight is lacking.
“You can say whatever you want, but is anybody going to do an audit?” he asks. “The question is whether anyone has come and looked at things like shipping records, checks and where it is coming from.”
There were some signs in 2000 that reforms could be on the horizon. The ABC News program “20/20” investigated the sale of fetal tissue, but one of the sources of the investigation was discredited amid revelations that he accepted payments from an anti-abortion group.
A subject of the report, Dr. Miles Jones, a Missouri pathologist, was recorded discussing prices for fetal tissue, and a price sheet was revealed. It showed the prices of various orders, charging $999 for a brain eight weeks and older, $600 for an intact embryonic cadaver older than eight weeks and $550 for reproductive organs.
But a U.S. attorney found the fetal tissue salesman, who is now deceased, not guilty of violating any federal laws. This is largely because it is legal for companies or nonprofits to charge for handling and processing of tissue, and for the personnel time involved, Caplan says.
“Prosecution becomes hard unless you do a careful audit and ask people to justify their costs,” he says.
Fetal tissue procurement companies say significant costs are associated with keeping the tissue and with processing it. A StemExpress spokesman says cells must be purified for researchers, a process that can take months and has a high failure rate.
“You have to manage the tissue in ways that are extraordinarily careful,” Charo says. The tissue has to be kept at a specific temperature and its care is documented, she says, and sometimes it is shipped overseas or across a border.
As a result of the ABC News investigation, the lower House of the Kansas legislature in 2000 passed a bill that would have required tissue to be sold at no more than $25, including the cost of packing and shipping. The bill also required those transferring fetal tissue to provide the government with detailed information, including the names of those shipping and receiving and the method of shipment.
The state Senate passed its version of fetal tissue legislation, which largely restated the federal law, and then the furor around the topic simply died down.
“People basically saw it as a political hot potato that they didn’t want to get near,” Caplan says. “It might have stayed that way except for the ‘sting’ operation forces [of the Center for Medical Progress].”
There should be a commitment to a fixed price or fee schedule, he adds. “Do they follow good standards?” he asks of tissue procurement organizations. “They’re not really watched carefully.”
To be sure, research is conducted on fetal tissue that contributes to life-saving treatments and cures, and their use has led to vaccines such as those that prevent polio and rubella.
According to the Associated Press, 97 research institutions – mostly universities and hospitals – received a total of $280 million in federal grants for fetal tissue research from the National Institutes of Health from 2011 to 2014.
But it is possible, as well, that some tissue is thrown away, or sits in storage and is never used.
“It’s not necessarily the case that every piece of tissue in a bank will be requested,” Charo says of tissue donation in general. “It depends on the state of it and what it's being used for.”
Charo says she doesn’t know of cases where fetal tissue is used non-medically, and that it isn’t used casually.
But a look at organs and tissue from adult donations may offer some clues into what else could occur legally.
Tissue can be turned into medical products – ground-up human bone can used for dental implants or can made into screws that doctors can use to fix a broken bone. Adult tissue can go to penile implants or to cosmetic concoctions that plump lips or reduce wrinkles.
Fetal tissue, however, is not as widely available as tissue from adults, Charo points out. She says she doesn’t think more regulation is needed.
“This happens in every area of tissue donation,” she says.
Others are calling for reform. Scott Gottlieb from the American Enterprise Institute, in an op-ed published last week in the Wall Street Journal, wrote that Congress should limit the use of fetal tissue to valid science that involves the study of the human body’s function or treatment of human disease.
Even Planned Parenthood has called for the National Institutes of Health to hold a blue-ribbon panel on fetal tissue research, which would enlist an independent group to review research that has involved its use and examine practices in the field. Planned Parenthood points out that the last time this occurred was during the Reagan administration in 1988.
Some calls for change are also occurring at the state level. A lawmaker in Ohio introduced a bill that expands a ban on using aborted fetal tissue for experimentation to include any use for diagnosing, treating or preventing disease, and would bar the exchange of money for obtaining and transporting fetal tissue. In Wisconsin, a bill has been introduced to make it a felony to provide or use aborted fetal tissue or cells for experimentation.
In New Jersey, Republican Sen. Joe Pennacchio introduced a bill to ban reimbursement for the cost of removal, disposal, storage and other procurement of fetal tissue. It also would ban the use of fetal tissue in cosmetic research.
Pennacchio said when he introduced the bill that he wanted to close any loopholes that would allow organizations to profit from fetal tissue research.
“It’s not as altruistic as people would like you to believe,” Pennacchio says. “Some could be for nefarious reasons.”
Corrected on Sept. 4, 2015: This story has been corrected to include information about 2000 legislation passed in Kansas.
