Texans unknowingly donate children's blood to research

Texans unknowingly donate children's blood to research
Medical privacy advocates, ethicists say parents should be asked for consent before newborns' screening samples are kept.
By Mary Ann RoserAMERICAN-STATESMAN STAFF Sunday, February 22, 2009
For almost seven years, the state has been indefinitely storing blood from nearly all newborns in Texas without their parents' consent for possible use in medical research.
The blood is collected as part of a 44-year-old state-mandated newborn screening program in which hospitals, birthing centers and midwives draw blood from a baby's heel — parental consent isn't required for that, either — so the state can test for a host of birth defects. The state either discarded the blood after six months or, more recently, stored it for three years before destroying it.
But starting in 2002, the state health department began collecting and keeping blood indefinitely for current or future medical research, a practice that has been the subject of a legal challenge in Minnesota.
Five dots of blood are collected on paper for the screening and then stored.
Under the health department's policy, the samples can be used by the medical community for things like cancer research, birth defects studies and calibration of lab equipment, said Doug McBride, spokesman for the Department of State Health Services.
The law doesn't require that parents be told how the blood might be used. But if parents are aware of the blood draws, Texas law lets them opt out only for religious reasons.
Parental consent isn't obtained, McBride said, because "requiring permission might be more costly and could require more time of hospital staff. But our real concern would be for the babies with detectable disorders that weren't detected because their parents declined the screening — babies who had no say in that decision."
The blood spots are stored at Texas A&M University's School of Rural Public Health, and each card bears a code number instead of a name, McBride said. The names matching those codes are kept at the state health department and are not released to researchers without parental consent, McBride said. The state considers the stored samples to be "de-identified."
Since 1965, Texas law has required the screening of newborns for birth defects, and the state now checks for 27 different health conditions — ranging from a gene that can cause severe mental disability to sickle cell anemia.
In 2002, the state health department's Birth Defects Epidemiology and Surveillance Branch asked that the blood be stored for research rather than discarded; the department's leadership agreed.
It contracted with Texas A&M in 2006 to store the samples because the agency did not have room to keep them indefinitely, according to a Nov. 15, 2006, health department memo.
The agency says in the memo that it did not need to change state law to store the blood samples because "the agency's position has been that health-related research that uses these bloodspots is consistent with this agency's overall mission."
The same memo says the department considers the blood samples to be "state records," which state law allows agencies to store indefinitely.
Quinn Godfrey, a 32-year-old father of two from San Antonio, said he had no idea when his daughter was born three years ago that newborn blood was being collected or stored indefinitely.
"My concern is they might not be able to do much with it right now, but 10 years from now? They could do a lot with it the way technology is going," Godfrey said.
When his second child was born Feb. 9, Godfrey said, he objected and asked to have an outside lab do it. But when he was told that wasn't possible, he gave in, he said.
Researchers in Texas said they hope to allay any parental concerns by pointing to the good being done with the blood and the future benefits to society.
"I'm using it to extract genetic variations and causes of certain birth defects: cleft lip and cleft palate and club foot," said Jacqueline Hecht, a professor of pediatrics and vice chairwoman for research at the University of Texas Medical School at Houston.
Hecht gets selected blood samples of children known to have those defects from the state's birth defects registry, but the names are excluded, McBride said.
By knowing the genetic fingerprints of disorders, researchers can suggest ways to prevent birth defects, Hecht and others said.
Without access to the blood samples, Hecht said, "we might miss the opportunity to make huge breakthroughs to help humanity. I'm using them to try and make life better."
Hecht said she considers privacy concerns to be overblown because she and her colleagues have no idea to whom the blood belongs.
"There are a lot of hoops you have to jump through" to use samples, she said, such as getting approval from an institutional review board, which looks out for patients' rights. "I don't see what the issue is."
But if the stored blood is so scientifically beneficial, "why isn't it more publicized?" asked Godfrey, the San Antonio father. "It just seems like they're being awfully sneaky about it."
James Harrington, director of the Texas Civil Rights Project, said that although his three grown children were all born in Texas, he had no idea of the practice and was "stunned by the whole thing."
Harrington said that he has no problems with screening newborns for birth defects but said he opposes storing samples without consent.
"I believe it's a violation ... of unlawful search and seizure," he said. "We're dealing with the most confidential information we have, and (for the government) to say, 'Trust us,' ... I find it impossible to believe."
McBride said, "There is nothing illicit, untoward or threatening going on. The purpose is to save lives, not to steal them." He's heard no complaints from anyone in Texas, he said.
"I would bet most parents aren't aware in Texas," said Twila Brase, a nurse who is president of the Citizens' Council on Health Care in St. Paul, Minn. The nonprofit has advocated patient and physician relationship rights since 1998.
Her group is fighting the practice in Minnesota after learning about it six years ago, she said.
"Our greatest concern is that this blood is being stored unbeknownst to the parents, and genetic research is being conducted without the consent or knowledge of the parents," Brase said. "And it's available for whatever legislators would decide to do with it in the future. When parents here discovered that, they got absolutely steamed."
What surprised Brase and others even more than not requiring parental consent was what they call the "warehousing" of the blood samples. Minnesota has stored more than 815,000 samples in the past 11 years, and as in Texas, no law authorizes that, Brase said.
Texas has stored 4.2 million samples since July 2002 — two per child, McBride said.
In Minnesota, Brase's organization won a ruling from an administrative law judge ordering that the state get informed consent from parents to store the blood, and the group aims to start a national outcry against the policy. Already, Brase said, blood from 52,000 Minnesota children has been used for genetic research without their parents knowing.
What if someday someone's genetic information got out to insurers and employers and was used to discriminate against certain people, Brase asked. "This is my DNA; it's not yours," she said. "Ask me if you want to use me for some project."
McBride said the state is bound by state and federal laws to protect the privacy rights of patients so it would not release the names to researchers or anyone else without parental consent.
Andrew Olshan, chairman of the epidemiology department at the University of North Carolina, said there is strong interest among researchers in creating a national database drawing on research from the samples to help solve the riddles of what causes autism, cancer and various birth defects. He said the potential benefits outweigh privacy concerns.
Art Caplan, a nationally known ethicist who directs the Center for Bioethics at the University of Pennsylvania, said he isn't troubled by the lack of consent or the indefinite storage. He said he sees a "ton of benefits" to having the blood available for research but said Texans should be educated about it and a public commission should control the samples.
But a Texas medical ethicist said parental consent should be obtained at the time the blood is drawn.
"Even if something is a social good, there can be a social harm," said Dr. Howard Brody, director of the Institute for the Medical Humanities at the UT Medical Branch at Galveston. "It's important to have trust in the scientific community ... and the more things that are done without consent, the more trust goes down."
The argument that scientists have a right to the blood because what they are doing with it is good "runs roughshod" over the rights of others, Brody said.
At minimum, the issue deserves more public discussion and transparency, he said.
"This is exactly the kind of issue," Brody said, "that is going to come back and bite us as a scientific community."
maroser@statesman.com; 445-3619