State gives up in fight to store genetic information

You don’t usually see press releases from state agencies as pointed as the one from the Minnesota Department of Health today. The department announced that it’s destroying “blood spots” taken from newborns under the state’s newborn screening program. The Minnesota Supreme Court ruled last November that the department couldn’t hold onto the samples (see the MPR story).

Here’s the full release:

The Minnesota Department of Health has been given permission by Hennepin County District Court Judge Mel Dickstein to begin destroying the blood spot collection cards of approximately 200 infants born each day in Minnesota in order to comply with a recent Minnesota Supreme Court decision. The destruction will include all those specimens received on or after Nov.16, 2011, the date of the Supreme Court decision.

Judge Dickstein ruled after a Jan. 26 hearing that the department may begin the process of destroying the specimens on Jan. 27, the day after a 71-day retention period sought in court filings. Seventy-one days is the amount of time needed to assure confirmation of a positive diagnosis for the 53 heritable or congenital disorders screened for by the Newborn Screening Program.

“For the first time in almost 20 years, we’re going to begin destroying a valuable public health resource, the residual blood spots from about 200 babies born in Minnesota each day,” said Minnesota Health Commissioner Dr. Edward Ehlinger. “While we are aware that destroying newborn screening blood spots after 71 days will compromise our ability to assure the quality and accuracy of the newborn screening program, we believe it is necessary to take this step in order to comply with the Supreme Court’s decision in the Bearder case.”

In the case known as Bearder vs. State of Minn., the Minnesota Supreme Court said the department could retain the blood spots only as long as necessary for “testing the samples for heritable and congenital disorders.” The court concluded that the 2006 Genetic Information Act mandated that any other use, storage, or dissemination of the blood samples required written informed consent from parents or legal guardians.

Due to the court’s restriction on the use of the blood spots without consent, MDH officials said the program will be hampered in its ability to:

Conduct routine quality assurance and quality control tests of existing screening methods

Evaluate improved tests to screen for current disorders

Validate testing procedures or calibrate instruments to run new screening tests

For example, under the limitations of the court ruling and the Genetic Information Act, implementation of a new screening test for Severe Combined Immunodeficiency (SCID) will be delayed. MDH will have to purchase previously consented specimens from another state to test the lab methods and instruments in order to validate the test. A test must be validated before it can be used to provide results to patients. Additionally, specimens from another state will not be representative of the characteristics of Minnesota babies, such as race or ethnicity, so the validation may not be as robust for Minnesota’s population, program officials said.

In addition, storage of the residual dried blood spots provides other benefits to Minnesota families:

>> The baby’s screening tests can be repeated if needed without getting another blood sample from the baby.

>>The baby’s sample is available to parents for other health-related testing (for example, in the case of unexplained deaths such as SIDS*).

>>The baby’s sample is available to parents to help identify a missing or deceased child.

Storage provides a permanent record that MDH completed the screening.

In order to comply with the Supreme Court ruling, the department determined that it needed to destroy the spots. However, two new lawsuits filed against the department, alleging violation of the Genetic Information Act, require that all evidence pertaining to the suits, including blood spots, be retained. Thus, the department concluded that it could not comply with the Supreme Court ruling with regard to babies born since the ruling without being liable for charges of spoliation of evidence in the other cases. So the department sought and was granted an emergency protective order in Hennepin County District Court, where the lawsuits were filed, that gave permission to destroy bloodspot specimens received on or after Nov. 16.

According to the department’s plan, all blood spots will be destroyed after 71 days have elapsed since the specimen was received. The spots will be destroyed on a daily basis using the Public Health Laboratory’s currently approved methods. For those babies who are found to be affected by one of the heritable or congenital newborn screening disorders, newborn screening staff will seek consent from the parents to retain the spots for future use, such as the improvement of current tests. The records of the results from all screens will be kept for two years as required by federal law, and then destroyed.

Currently, every baby born in Minnesota, within 24-48 hours after birth, has drops of blood placed on a specimen collection card. The cards are sent to MDH for analysis of 53 rare but treatable disorders that can only be found before symptoms occur through newborn screening. If left untreated, the disorders lead to illness, physical disability, mental retardation, or death. Medications or changes in diet help prevent most health problems caused by disorders that are identified through newborn screening. Though newborn screening is mandated, parents and legal guardians may choose to refuse screening of their child or to have their child screened, but to have the spots and test results destroyed.

In 2009, nine families filed the Bearder lawsuit in Hennepin County District Court claiming the newborn screening program fell under the Genetic Information statute and blood spots and data were being stored in violation of the statute. MDH argued that the Genetic Information Act did not apply because the newborn screening statutes gave it “express authorization” to run the program. The District and Appeals Courts agreed, but the Supreme Court disagreed, finding that the newborn screening statutes give “express authorization” only for certain components of the program.

Ehlinger said the department will be pursuing legislation this session that aims at fixing problems with existing statutes. “We will be working with our many public health and children’s health partners to seek changes to the newborn screening and genetic information statutes that are needed to maintain the quality program that protects babies and for which Minnesota is recognized nationally,” he said.

The action comes six years after some medical privacy advocates called for an end to the storage of genetic information by the state without consent.

Here is last November’s full Supreme Court ruling.

  • Jim Shapiro

    An abstract right to privacy vs. The opportunity to better or save childrens’ lives.

    Am I missing something here?

    Of course, there’s that ol’ slippery slope argument:

    “The next thing you know, they’ll be trying to save ADULTS’ lives!”

  • Priscilla Flynn

    Perhaps a revision of the Genetic Information statute would be a more appropriate action. This ruling and action to destroy a vital repository is as misguided as book-burnings by over-reactive (and now defunct) societies fearing ‘information’. I am deeply troubled that a few fear mongers can push their agenda to the brink of dismembering a truly excellent program aimed at improving the public’s health.

  • William

    it is a very sad day for what used to be a very progressive state in health care. even the judges seem to have very limited capacity to understand facts, science and medicine. Because of Ms Brace’s teaparty group, called the Citizens Council on Health Care, (CCHC) unfortunately more Minnesota newborns will die, become retarded, or neurologically impaired in the future as a direct result of CCHD’S work. they not only don’t understand the intricacies of DNA and privacy, ms Brace is apparently completely unaware that the stored specimens are the key to all the new genetic tests we have today that can prevent most if not all serious effects , and in some cases like SCID, the kids are actually cured! Remember the bubble boy? well today they all live a normal life in the 10 states that screen for it. the test was developed using these leftover dried blood spots. They are stored anonymously and don’t even have identifying information on the card. This is not about ‘privacy’ and ‘parents rights” at all as they would have you believe, but about SAVING LIVES. I would love to see Ms Brace in a room of parents of children affected by these disorders, whether they were saved by newborn screening, or in the horrible cases where a child was lost because a test to detect their child’s disorder was not developed in time, maybe even because they were unfortunate to live in a state where spots are not stored. These are the true parent heroes, and no one supports retention of the residual spots for research more than they do. And i am sure they could also teach these ‘parent groups” a little something about a type of rights not in the vocabulary of these anti-government groups, called newborns’ rights. who is there to protect the babies from dying or becoming retarded because their parents didn’t bother to educate themselves and read the literature they were given during prenatal visits and birth? I’ll tell you who – the state public health departments, one of those awful government agencies that allegedly sell your baby’s dna, clone them, give them away willy nilly, and create man-human species! oh my!. Please, you have no clue the efforts and layers of protection state health programs undertake to protect your privacy. I used to live in minnesota – i know the people there to be smart, caring, and wanting to the right thing. so let me warn you minnesotans, this group who led this suit in mn and tx is cloaking this right now in the terms of parents rights and stored specimens. But stay alert – it is now clear their eventual goal is to eliminate Newborn Screening altogether or to make it consented. already, MN is the only state to allow parents to refuse testing for any reason. most states only allow refusal for religious reasons and must sign a form taking full responsibility for any harm that comes to the child as a result of their refusal. others allow no exceptions. MN decline rate is now about 15%, highest in the nation. it’s only a matter of time until an unfortunate child dies, becomes retarded, or committed to life in a wheelchair when it could have been prevented. would you want that for your child? would you want that kind of parent that was more concerned about politics than your life? i think not. good luck Minnesota, and keep your eyes wide open. and most of all, make sure your babies are screened!