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On Monday the House Committee on Public Health held a five hour hearing on the state’s policy regarding blood screenings for newborn babies. The committee must make recommendations for how the state should obtain informed consent from parents for the screenings.

Andrea Beleno was the lead plaintiff in a lawsuit against the state of Texas after she and others found out that since 2002 the state has been taking babies’ blood samples, not just for screening against more than two dozen illnesses, but for research and bartering.

“Parents don’t get the ability or the information to give informed consent. It’s an opt-out program instead of an opt-in which is just not good enough,” says Beleno.

The group won the lawsuit which forced the state to destroy more than 5 million samples. Now the House Committee on Public Health must come up with recommendations for new legislation on the matter.

“We run the gamut of value for research vs. the need for privacy and informed consent, and I think somewhere we’ll have to find that balance,” said Lois Kolkhorst, Public Health Committee Chairwoman.

The issue at hand is how consent forms for parents should be worded and how thorough they should be.

“Are we truly informing parents that the blood of your child can be used in research in the future?” added Kolkhorst.

After blood samples are tested they are sometimes used for research to help maintain the quality of tests administered and new tests.

“To make sure we have better tests and we develop new tests because we have inherited disorders we don’t have test for,” says Dr. David Lakey, DSHS Commissioner.

It was revealed the samples were also being bartered for medical supplies and some samples were given to the Department of Defense for more research.

“We want it to be an opt-in not opt-out program. Right now they’ll take your babies blood and do what they want with it unless you opt-out,” says Wayne Krause, with the Texas Civil Rights Project.

That’s one recommendation made by Wayne Krause with the Texas Civil Rights Project, he addressed the committee on items to keep in mind when drafting a new law.

In the end it will be up to lawmakers to decide how to best inform parents. They will take up during the next legislative session.

Bartering your baby’s blood: State traded blood for goods and services

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AUSTIN (KXAN) – When Andrea Beleno gave birth to her son last year, she knew she’d do whatever it took to protect him. But she never dreamed she’d be taking on the State of Texas to safeguard her son’s most private information.

And now, revelations are surfacing that not only did the state store that blood without parents’ knowledge – but they also actually bartered it for goods and services to for-profit companies, without the knowledge of parents or of state lawmakers.

Beleno and several other Texas families sued the State Department of Health Services after they learned the agency had been storing and using newborn blood samples, or blood spots, that were leftover after testing for the Newborn Screening Program.

The families weren’t suing for money. They were suing for the right to decide what happens to their babies’ blood specimens – and the information contained in them. The suit prompted the Texas Legislature to step in and pass a new law giving parents the right to opt out of allowing the state to keep the samples leftover after screening.

In December 2009, the Texas Department of State Health Services settled the lawsuit with Beleno and the families. As part of the settlement terms , the state agreed to destroy the nearly 5 million blood samples it had retained without consent and disclose how the spots had been used.

The state posted the list of research projects using the blood spots on its website. The list gives a brief description of the 24 research projects that used just over 8,800 blood spots.

However, the number of research projects disclosed on its website didn’t match testimony by a DSHS official before the House Public Health Committee in March 2009.

Chairwoman Lois Kohlkorst asked DSHS lab director Susan Tanksley about the research and whether there had been any breakthroughs. Tanksley said that there hadn’t been many — only 4 projects had been completed.

Texas Rep. John Davis asked whether the spots had been used for any criminal investigation purposes. Tanksley denied any spots were used for that purpose.

But records obtained from DSHS show that’s not true. In 2003 and in 2007, the state provided samples collected under the Newborn Screening Program for a project sponsored by the Department of Justice and conducted by the Armed Forces Institute for Pathology .

The samples were to help expand the DNA database for law enforcement purposes. This was news that stunned parent Andrea Beleno.

“I think it’s a breach of public trust,” said Beleno. Parents were kept in the dark about how the leftover spots were used and so were lawmakers. During extensive hearings about the Newborn Screening Program, there was no mention of how the vast majority of spots were used.

It took several requests, but KXAN finally obtained records that show that the state has been using the spots to barter with for-profit corporations for lab supplies, test kits and maintenance contracts.

Among those deals was a five year agreement in which the State provided 228,000 blood spots in exchange for $456,000 worth of lab supplies and maintenance services.

In another deal, the state provided at least 3600 spots in exchange for HIV test kits. How much to charge and how to handle the billing was a source of internal discussions at DSHS.

We obtained one email sent by Barbara Kelly-King, who works in the Revenue Management Unit of DSHS. In February 2006, Kelly-King responded to staff questions about how to bill for spots being provided to bioMerieux.

She wrote: “Originally this was to be handled through a contract but the Health and Safety Code 12.0122 entitled Sale of Laboratory Services does not allow for a contract. The lab is now asking bioMerieux to issue a $2.00 credit for every dried blood spot sent.”

A month later, on March 6, 2006, Lab Director Susan Tanksley’s email to staff says:

“We do not have a contract with bioMerieux but essentially an understanding that we will provide DBS [Dried Blood Spots] to them and they will in turn provide HIV reagents. Originally, we wanted a contract for $2/specimen, but we cannot provide this ‘laboratory service’ to them as they are a for-profit organization. Our attorney’s opinion was that it was acceptable to receive reagents in return for the DBS.”

By October of 2008, DSHS decided it could skip the bartering and charge a fee for providing spots to for-profit corporations. It charged MP Biomedicals $1,600 for 400 spots. The same week, the State charged Avoiq $2,400 for 600 blood spots.

In another deal, a pending two-year contract with Avioq, DSHS agreed to provide a regular supply of blood spots at $4 each which would bring in $28,800 to the agency.

Carrie Williams, Acting Press Officer for the Texas Department Of State Health Services, said the charges were a nominal handling fee used to recoup taxpayer dollars.

Internal DSHS emails detail the process for billing. One dated August 26, 2008 asks how the income should be allocated: “What I’m looking for is this: which pot of money will it benefit us to book this under.”

In all, the State receives about 800,000 blood cards per year from babies born in Texas. By 2009, the number of stored spots had grown to about 5 million specimens.

When older spots were needed and were pulled from the A & M storage room supply, the university charged $15 for each specimen. All of those spots have since been destroyed as part of the settlement of the lawsuit filed by Andrea Beleno and the other parents.

Beleno said they were open to hearing options for preserving the spots for important research, but the state’s own actions have caused public distrust.

“I think the way they’ve behaved is unethical in the way that they’ve handled the disclosure of what they are actually doing,” said Beleno, “And I think it makes it really difficult for people to trust that they are in fact using those samples for public good rather than to make money.”

Williams says the agency is strengthening its process for reviewing and approving requests to use the spots. “The process will be more defined and will include more layers of review,” said Williams. She said the state was not selling the spots in any way shape or form. “Any benefit received from providing the bloodspots went directly back into the program or to the agency’s overall public health mission,” said Williams.

Jay Root, The Associated Press

AUSTIN — Texas health authorities will destroy more than 5 million blood samples taken from babies without parental consent and stored indefinitely for scientific research.

The Texas Department of State Health Services announced Tuesday it would destroy the samples after settling a federal lawsuit filed by the Texas Civil Rights Project. The project, acting on behalf of five plaintiffs, had sued the Texas Department of State Health Services and the Texas A&M University System.

The lawsuit alleged that the state’s failure to ask parents for permission to store and possibly use the blood — originally collected to screen for birth defects — violated constitutional protections against unlawful search and seizure. The plaintiffs cited fears their children’s private health data could be misused.

Under the settlement overseen by a San Antonio federal court, the blood samples collected without parental consent must be destroyed by early next year. It also requires the department to publish a list of all research projects that used the blood specimens.

State health services spokeswoman Allison Lowery said an estimated 5.3 million samples would be destroyed. About 4 million to 4.5 million are stored at the Texas A&M School of Rural Public Health, she said.

Andrea Beleno, 33, was one of the parents who sued the state. She said she was stunned to learn that blood samples taken from her son, born in Austin in November 2008, were being stored indefinitely for unspecified research projects.

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“You have to give permission for them to give your kid formula in the hospital,” Beleno said. “I don’t understand why you don’t have to give permission for the state to keep your kid’s DNA.”

Texas has been collecting blood samples for decades to screen for at least 27 different birth defects and other disorders. By law the blood could be taken without consent by hospitals, birthing centers and midwives.

The Department of State Health Services established a policy in 2002 in which it began setting aside the blood “spots” after the screenings are done and allowing some of it to be used for research. Before that, the blood was discarded after a certain interval.

This year the Texas Legislature tightened up the procedures, providing opt-out policies for parents, extending privacy guarantees and implementing controls over any scientific research that uses the samples. At issue in the lawsuit settlement are the millions of samples collected and stored before the law took effect in May.

“As a result of this settlement, DSHS will destroy all bloodspot cards received by the department before May 27, 2009,” the health services agency said in a written statement. “We will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”

Under current law, the department can still use the blood samples for quality control and disease research as long as parents don’t object. The department screens about 800,000 newborn blood specimens each year.

State agrees to destroy more than 5 million stored blood samples from newborns

By Mary Ann Roser, AMERICAN-STATESMAN STAFF

To settle a lawsuit, the state has agreed to destroy more than 5 million blood samples from newborns that it had stored indefinitely for possible research without parents’ consent, the two sides said Tuesday.

The Texas Civil Rights Project filed the lawsuit in U.S. District Court in San Antonio in March on behalf of four parents and a pregnant woman who dropped out later. It claimed that the state’s collection and storage of the samples amounted to “an unlawful search and seizure” and violated the privacy rights of the parents and their children. Under the settlement, the state will destroy 5.3 million samples it has collected between 2002, when the Department of State Health Services began storing the blood, and May 27, when a new state law restricting the practice was signed.

Federal Judge Fred Biery approved the settlement agreement Dec. 14 and gave the state 120 days — until April 13 — to finish destroying the samples, which are stored at Texas A&M University’s School of Rural Public Health.

This year, when stories in the American-Statesman brought the practice to light, the state health department and some medical researchers defended it, saying that collecting the blood spots on paper — done when newborns are screened for various health disorders — might one day provide valuable clues about childhood cancer and other diseases. They said that because the samples were coded and did not identify the babies by name, privacy rights were protected.

But the Texas Legislature approved a law in May requiring medical professionals to inform parents or guardians that the blood spots would be collected and stored indefinitely and could be used for research. Parents who objected could send a statement to the state health department, and their child’s samples would have to be destroyed within 60 days. If the parents didn’t do that, the child could upon reaching adulthood.

Between the time the law passed and Nov. 2, about 6,900 Texans have signed forms asking that the state destroy their child’s samples, out of 240,000 children born in that period, department spokeswoman Allison Lowery said. The department is getting 500 to 600 requests a week to destroy samples, she said.

A statement from the state health department said it “believes settling this lawsuit is in the best interest of this program’s core mission to screen all newborn babies in Texas for life-threatening disorders. Newborn screening saves children’s lives, and settling this lawsuit allows us to continue operating this critical program.”

Jim Harrington , director of the nonprofit civil rights group in Austin, said his organization was “very pleased with the way it worked out.”

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Harrington said there were only two options to end the lawsuit: destroy the samples or try and go back to 2002 and get consent from all parents. About 400,000 babies a year are born in Texas.

Among the parents who sued was Austin lawyer Andrea Beleno, Harrington’s daughter-in-law. Her son Joaquin Harrington was born in November 2008, and Beleno said she had no idea “in the haze after giving birth” that any blood had been drawn and stored.

“To me, this whole thing was about consent,” she said. “If they had asked me … I probably would have consented. The fact that it was a secret program really made me so suspicious of the true motives, there’s no way I would consent now.”

Harrington said he will work with a legislative committee before the next regular session in 2011 to refine the new law.

He wants the state to divulge what research it is using the samples for and whether anyone is making money from it. He also wants to see how well the “opt out” provision is working.

Many other states do what Texas had been doing, and a consumer group in Minnesota has been fighting the practice there for several years.

“The State of Texas has taken first steps to restoring the genetic privacy rights of Texas children. This is a wonderful Christmas present for Texas citizens,” Twila Brase, president of the Citizens’ Council on Health Care in St. Paul/Minneapolis, said in a statement.

State to destroy 4 million newborn blood samples

By PEGGY FIKAC, Austin Bureau

AUSTIN — The state will destroy an estimated 5.3 million blood samples legally collected from newborns but kept without parental consent under a federal lawsuit settlement announced Tuesday.

The number of newborns involved is unclear because multiple samples are received from each by the Texas Department of State Health Services, department spokeswoman Allison Lowery said.

Typically, two samples are taken from each child, but there could be more, she said. The disputed samples cover a period of about seven years starting in 2002. The state conducts newborn screening to detect disorders or illnesses.

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“This is about consent,” said lawyer Jim Harrington of the Texas Civil Rights Project. The group, after discovering the agency had been keeping the samples without permission, sued on behalf of parents in federal district court in San Antonio.

The Health Department said in a statement it would destroy the samples — retained as blood spot cards — that it received and stored before legislation took effect last May allowing their retention. The legislation allows parents, guardians or managing conservators to opt out of having the blood retained.

Lowery said the agency is seeking permission from fewer than 400 parents to preserve their babies’ samples because the children tested positive for rare disorders.

Collected before lawsuit

She said samples have been securely stored at the Texas A&M Health Science Center School of Rural Public Health.

That institution said in a statement that all the blood spots at the center were collected before the lawsuit and are subject to a joint resolution between the center and the agency to destroy them.

Andrea Beleno, an Austin mother who was one of the plaintiffs in the lawsuit, said she was pleased with the settlement.

“There’s no financial gain for any of the plaintiffs,” Beleno said. “Basically, what we wanted to do was to make sure that our children’s privacy was being protected and that the state is respecting our rights, because if we don’t stand up and make the government do that, nobody’s going to do it for us.”

Parents from San Antonio and Houston also were part of the lawsuit, which was filed against Commissioner David Lakey of the Department of State Health Services and Dr. Nancy Dickey, president of the Texas A&M Health Science Center and vice chancellor for health affairs of the Texas A&M System.

“The Texas A&M Health Science Center is glad that we have reached agreement in order to settle the lawsuit,” Dickey’s office said in a statement. “We are saddened, however, that a superb database has been lost. This database could have continued to shed light on causes of congenital birth defects and potentially led to preventive measures saving thousands of infants and their families the distress these defects cause.”

The parents’ lawsuit said there was no legal authority to keep the blood indefinitely without consent.

Harrington said his group became aware the blood samples were being stored after being called by a reporter from the Austin American-Statesman. Beleno said she first read about it in the newspaper.

Detailed conditions

Under the settlement, Harrington said, all blood specimens must be destroyed unless the state gets written permission to retain and use them. The destruction must occur within 120 days of the lawsuit being dismissed with the settlement, which occurred Dec. 14.

The agency also must post information on its newborn screening Web site, including a list of all research projects for which it has provided newborn-screening blood specimens.

In addition, the agency must inform the parents who sued how their children’s blood was used and any financial transactions involving the specimens, Harrington said.

Pledges compliance

The Texas Department of Health said in its statement that it is complying with the new law and “will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”

“If parents don’t object, the department saves the samples for uses allowed under the new legislation — primarily quality assurance and control purposes to ensure accuracy in lab testing and because the samples could provide an invaluable resource in researching new or more effective ways to prevent, diagnose and treat serious medical conditions that affect Texas children, including leukemia and birth defects,” the agency said in its statement.

Press Release

The federal lawsuit filed in March by the Texas Civil Rights Project on behalf of five parents has resulted in new state legislation to protect the state’s access to people’s genetic information. The legislature sent the law to the governor this week for signature.

The lawsuit sought to end the practice of the Texas Department of State Health Services from collecting and indefinitely storing blood samples from the blood screening done at childbirth without parental consent or disclosure to the parent – a secretive practice the health department has engaged in since 2002. Currently, about 4 million samples are stored at Texas A&M, taken from every person born since 2002.

The new law, which TCRP helped negotiate, requires the department to present a detailed written disclosure form at time of birth, giving the parent the opportunity to opt out of the program, either at that time or within 60 days thereafter.

The new law also permits any adults to withdraw consent and have their sample destroyed, even if the parent had given consent. Nor may the department make any use of information or data taken from the sample, if destruction of the sample is requested.

The law puts into place rigorous privacy and confidentiality standards and assures that testing and research will be done consistent with accepted professional medical research methodologies.

Finally, it sets up an interim House of Representatives committee to study the application of the new law and make recommendations to the next session of the Legislature in 2011.

Jim Harrington, TCRP Director and attorney who represents the plaintiffs, called the new law “a great step that helps both scientific research but respects the privacy of people who do not wish to participate. It strikes an acceptable balance between medical science and individual liberty, and we are very pleased that the legislature responded so positively and so quickly to our lawsuit.”

According to Harrington, the only issue remaining in the lawsuit is what do with the 4 million blood samples collected without consent, which the plaintiffs claim violates the constitutional right to be free from unlawful search and seizure and fundamental privacy rights. Harrington said the plaintiffs are negotiating with the department at this time, but expects that the federal judge in the case ultimately will have to make the decision.

Suit Raises Concerns about Collecting Genetic and DNA Data

Five parents this week filed a federal lawsuit in San Antonio U.S. District Court against the Texas Department of State Health Services (TDSHS), Commissioner David Lakey, M.D., Texas A&M, and Texas A&M Vice Chancellor for Health Affairs Nancy Dickey, M.D., claiming they have unlawfully and deceptively collected blood samples from their children at time of birth and stored those samples indefinitely for undisclosed research purposes, without plaintiffs’ knowledge or consent.

The plaintiffs are Geoffrey Courtney of San Antonio, Andrea Beleno and Maryann Overath of Austin, and Keith Taylor of Houston. Also joining the suit is Nancy Pacheco of Austin, who is expecting a child in August.

Plaintiff Andrea Beleno and her son

The suit alleges that the agencies’ activities constitute unlawful search and seizure and violate fundamental privacy rights, contrary to federal and state law, because at the time newborn children have a blood test to screen them for disease or disorders, TDSHS secretly collects and stores their blood indefinitely for other purposes without telling parents what it is doing or why it is doing it. Law requires newborn screening, but there is no legal authority to “seize” the blood and keep it indefinitely, without consent.

The suit also claims that the agencies violate standard, mandatory medical research protocols of obtaining informed consent from subjects before they are studied, using a method that clearly explains to them all the privacy ramifications.

U.S. Department of Health and Human Services regulations set out protocols with regard to minor children and include providing: (1) a description of the research’s purpose and procedure; (2) disclosure of privacy implications of the research; (3) whom to call if questions arise about the research; (4) parental consent; and, (5) a statement of no reprisals for declining to participate in the research. The state agencies do not abide by a single one of these protocols.

Nor have the agency officials disclosed what financial interests or transactions are involved, such as taxpayer expense or whether the samples are sold.

Since 2002, agency officials have routinely collected blood samples from all babies in Texas at time of birth and stored those samples or “spots” indefinitely at the Texas A&M Health Science Center School of Rural Public Health for purposes of undisclosed research unrelated to the purposes for which the infants’ blood was originally drawn, without the knowledge or consent of the infants’ parents. And they continue to do so. So far, they have collected about 4.2 million samples, and collect about 375,000 each year.

The lawsuit asks the court to destroy all blood samples and spots, which defendants have gathered and stored indefinitely without informed parental consent, or obtain consent, within a period set by the judge.

Plaintiffs also want the judge to order the officials to advise them for what purposes the agencies have used the blood samples and spots of the children and disclose all financial transactions involved with the use of such samples and blood. And they want the agencies to stop collecting blood samples and spots from newborn infants and keeping them indefinitely without informed parental consent.

The Plaintiffs also seek to have the court establish a procedure by which the agencies re-acquire informed consent from those children whose parents give consent, when such child reaches the age of 18 and becomes an adult, or otherwise destroy such blood samples and spots.

The Plaintiffs do not object to the state’s mandated newborn screening program so long as safeguards are in place to destroy an infant’s samples within a reasonable period.

TCRP Director Jim Harrington, who is representing the parents, called the agencies’ actions “an amazingly brazen deception by the state and a stunning overreaching into the private lives of Texans.

“They draw blood for a good reason–newborn screening, but then they secretly collect and keep it indefinitely for their own purposes without telling anyone what they are doing or why they are doing it.

“The government can’t just go around collecting people’s blood with all its confidential genetic information and use it for its own purposes without consent or legal authority. In this case, there is neither. This violates our core, fundamental constitutional principles.

“And for what purposes are these agencies storing blood indefinitely, and why do they need to collect and store blood from every person in Texas? They claim they are doing some kind of ‘research,’ but to do research you don’t need to have the blood and genetic material from everyone in society. This raises the specter of a DNA data bank, which can too easily be matched with other personal information the government collects, such as social security numbers and fingerprints.

“There is something utterly incompetent about this – or utterly sinister – or both. This is ‘Big Brother’ in one of its worst incarnations.”

*****

State sued over babies’ blood:
Parents say storing samples without consent is illegal

By Mary Ann Roser
AMERICAN-STATESMAN STAFF

Four parents and a pregnant woman sued the state health department Thursday, claiming that its policy of storing infants’ blood indefinitely for possible medical research is unconstitutional.

The nonprofit Texas Civil Rights Project in Austin filed the suit on the parents’ behalf in U.S. District Court in San Antonio. The suit also names Texas A&M University, which stores the blood for the Department of State Health Services.

The suit claims the state is violating constitutional protections against unlawful searches and seizures as well as state privacy laws. It seeks to stop storage of blood samples without parental consent and asks that samples be destroyed unless the state gets parents’ consent.

Since 1965, the state health department has been tasked with screening newborns for birth defects and other disorders under a law that does not require parental consent. In 2002, the health department decided to store the blood samples, so they could be used for possible research and other purposes, such as calibrating lab equipment, department spokesman Doug McBride said.

The state has since amassed 4.2 million samples at the A&M School of Rural Public Health in Bryan.

After the American-Statesman wrote about the practice Feb. 22, some parents said they were angry that their child’s blood was now state property without their consent and wanted it returned or destroyed. They feared the blood spots might be used someday to discriminate against their child.

“The screening (for disorders) is fine,” said James Harrington, director of the Texas Civil Rights Project. “It’s what they’re doing afterwards.”

The state health department has said the samples could one day help scientists find causes or cures for diseases, adding that infant’s identities are not on the paper cards holding the blood spots.

Earlier this month, it said it would consider destroying samples from parents who sent letters, provided it could find a legal way to do so. Harrington called the response inadequate.

“If you want to talk about Big Brother, this is one of its worst incarnations,” Harrington said at a news conference while flanked by three of the plaintiffs.

McBride declined to comment on the suit, and officials at Texas A&M could not be reached for comment — although the school was experiencing power outages Thursday, according to a message on one official’s voice mail.

Andrea Beleno, 33, of Austin said when her son was born Nov. 4 at Seton Medical Center, she had no idea that blood was drawn, much less stored.

“I think the screening program is good. They test for things that can make babies really sick initially,” she said, holding her son.

“And if they’d asked me if I would consent for this blood to be used for specific medical research, … I would have probably said yes.”

But Beleno said she would have said no to storing his blood indefinitely, just as she would refuse to let her own be stored “forever and ever.”