|As Reporters Uncover Bartering for Infant Blood Samples
TCRP Testifies for Opt-In Consent
|State Holds Hearing on Infant Blood Samples
TCRP Testifies for Opt-In Consent
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
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.
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