Have you heard the news — on the federal genetic database and surveillance program?

Two major new pieces of legislation have received virtually no notice by mainstream media, but, incredibly, give the federal government the ability to both collect the DNA on every American and establish a nationalized DNA database and surveillance system, and to legalize the sharing of genetic information without patient consent. The names given the legislation aren’t what they sound.

The Newborn Screening Saves Lives Act of 2007

Last week, President Bush signed into law bill S. 1858, which will see the federal government begin a nationalized program to gather genetic information for screening on all newborn babies in the United States within six months. This Act is the first step towards establishing a national DNA database. [Background information on the scientific efficacy and ethical issues and controversies surrounding newborn screening here.]

The Citizens’ Council on Health Care had urged the President to veto this bill, saying in a public statement that it strips citizens of genetic privacy rights and DNA property rights. Under this bill, “the DNA of all citizens will be housed in government genomic biobanks and considered government property for government research...It does not require consent and there are no requirements to fully inform parents about the warehousing of their child's DNA for the purpose of genetic research.” A critical analysis of this Act [download here] outlined 5 key concerns:

1. It removes parental consent and calls for an expanded list of genetic conditions and secondary conditions that all children are to be tested.

2. It nationalizes newborn screening and creates a federal database and tracking registry with all genetic information; it empowers the HHS to collect and establish a surveillance system for the incidence and prevalence of genetic and heritable disorders.

3. It empowers the federal government to track and assess the health of those identified with a genetic defect or trait and “coordinate ongoing follow-up treatment.” As the CCHC analysis says: “As the list of trackable disorders and “at risk” genes expands—perhaps to include obesity, diabetes, alcoholism, and violence—more children and families will be entered into genetic tracking registries for monitoring and assessment.”

4. It grants the federal government the ability to “identify populations at risk for disorders affecting newborns and to examine and recognize and address relevant environmental, behavioral, socioeconomic, demographic and other relevant risk factors.” It exposes every newborn and his/her family to genetic research without their consent.

5. To compel compliance by state departments of health, it ties millions of dollars in federal appropriations to their cooperation.

According to the text of this Act as just signed into law, the Department of Health and Human Services is authorized to award grants for the screening of newborns for heritable disorders and establish, maintain and operate a system to assess, and coordinate treatment relating to congenital, genetic and metabolic disorders. It expands the power of the Advisory Committee on Heritable Disorders in Newborns and Children to determine the heritable disorders for which all newborns should be screening. It requires the HHS “to establish and maintain a central clearinghouse of current information on newborn screening... including: ensuring that it is available on the Internet and is updated at least quarterly.”

Sections 6 and 7 give the federal government ownership of the DNA material for use in genetic research without consent and to identify people for experimental treatments and interventions. The Act:

Requires the Secretary to establish an Interagency Coordinating Committee on Newborn and Child Screening to make recommendations on: (1) programs to collect, analyze, and make available data on certain heritable disorders; and (2) the establishment of regional centers to conduct applied epidemiological research on effective interventions for preventing poor health outcomes resulting from such disorders and to provide information and education to the public on such effective interventions.

Requires the Secretary, acting through the Director of CDC, to develop a national contingency plan for newborn screening in the event of a public health emergency. Authorizes the Secretary to continue to carry out, coordinate, and expand research in newborn screening (to be known as the Hunter Kelly Newborn Screening Research Program), including...experimental treatments and disease management strategies for conditions that can be detected through newborn screening...

A report called Newborn Screening: Toward a Uniform Panel and System written by the American College of Medical Genetics was already approved by the U.S. Secretary's Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children and shows how widespread and invasive the screening program is that’s already being envisioned. It not only recommended that 29 conditions be mandated for screening, but also an additional 25 conditions be screened for and mandatory reported, conditions that can be “revealed through screening and have potential clinical significance” even though there is no effective treatment for them. It outlined a process for applicants to request other conditions be added to the screening panel. It also recommended the establishment of a federal role in research, standardized nationalized identification and centralized reporting of results, long-term data collection and surveillance, and enhanced oversight of hospital screening activities. Follow-up and care of identified people would be accomplished through “the medical home.”

There were 22 sponsors of the bill [here] and it passed both the Senate and House of Representatives unanimously. However, there was one especially outspoken critic of it, Texas Congressman Ron Paul, who spoke before the U.S. House of Representatives on April 9th [full text here], saying:

[A]s an OB-GYN, I take a back seat to no one when it comes to caring about the health of newborn children. However, as a Representative who has taken an oath to uphold the Constitution, I cannot support legislation, no matter how much I sympathize with the legislation’s stated goals, that exceed the Constitutional limitations on federal power or in any way threatens the liberty of the American people. Since S. 1858 violates the Constitution, and may have untended consequences that will weaken the American health care system and further erode medical privacy, I must oppose it...

[T]he federal government lacks both the constitutional authority and the competence to develop a newborn screening program... no hospital will want to risk losing federal funding because they did not adopt the “federally-approved” plan for newborn screening. Thus, this bill takes another step toward the nationalization of health care.

As the federal government assumes more control over health care, medical privacy has increasingly come under assault. Those of us in the medical profession should be particularly concerned about policies allowing government officials and state-favored interests to access our medical records without our consent. After all, patient confidentiality is the basis of the trust that must underline a positive physician-patient relationship. Yet my review of S. 1858 indicates the drafters of the legislation made no effort to ensure these newborn screening programs do not violate the privacy rights of parents and children. In fact, by directing federal bureaucrats to create a contingency plan for newborn screening in the event of a “public health” disaster, this bill may lead to further erosions of medical privacy...

Genetic Information Nondiscrimination Act of 2008

In a vote of 414 to 1 (the only dissenting vote was cast by Rep. Ron Paul), the House voted last week to approve bill HR 493, which was reported as prohibiting discrimination in employer hiring or insurance companies from denying coverage or charging higher premiums based on the results of genetic tests. The legislation received the support of HHS Secretary Mike Leavitt who told the Boston Globe it was something to be “thrilled about.”

The Senate and House versions had differed and changes in the language were resolved on May 1^st. The bill has now been sent to President Bush for his signature.

Except, as Fox Business reports, Congress inadvertently legalized the sharing of genetic information without patient consent! “While authors of the recently passed Genetic Information Nondiscrimination Act of 2008 (H.R. 493) had good intentions, the bill inadvertently legalizes the sharing of genetic information without patient consent,” says Sue Blevins, president of the Institute for Health Freedom. “It does so by applying HIPAA regulations to genetic data.”

Blevins points out, “HIPAA regulations permit data sharing without patient consent in connection with treatment, payment, and oversight of the health-care system (‘health-care operations’). Thus, by passing a bill that says HIPAA regulations apply to genetic information, Congress unintentionally legalized the sharing of information among many health-care ‘covered entities’ without patient permission.”

Dr. Janis G. Chester, M.D., president of the American Association of Practicing Psychiatrists, wrote in the Baltimore Sun: “A person’s genetic test results, and all of his or her medical data, should not be available to anyone without the patient’s consent. One’s employer should not even know he or she has had testing done, let alone know the results. The sad fact is that the regulations under the Health Insurance Portability and Accountability Act [HIPAA], which were intended to extend patient privacy as we moved from a paper-based system of medical records to a digital system, are a sham. HIPAA allows the routine release of personal health information without patient consent or knowledge, and even over a patient’s objection….”

The Institute for Health Freedom issued an analysis outlining concerns in this legislation [available here] noting that it treats genetic information as health information under HIPAA, which allows its use and permits sharing of it for a multitude of purposes, all without the person’s consent. [Background on the reality of medical record privacy through HIPAA here and here.]

While the legislation forbids insurers from using genetic information to establish insurance rates, they can use it to determine payment amounts.

As the Kaiser Daily Health Policy Report explained: “The legislation would not ban the use of genetic information for long-term care and disability insurance, and it would not prevent insurers from denying coverage to people who have pre-existing health conditions.”

As the Institute for Health Freedom described, the bill outlaws employers from requesting, requiring or purchasing genetic information, but “it then goes on to list six exceptions.” The exceptions would appear to nullify any real genetic privacy protections. One such exemption is that genetic information can be included when any employer “requests or requires family medical history of the employee or family member of the employee.”

Rep. Ron Paul opposed the bill “because of the federal government’s poor record in protecting privacy.” The Institute’s review includes a history of abuses of genetic information by States and in employment and calls on Congress and the President to ensure the unethical use of genetic information by passing a law that clearly states:

• Genetic testing is voluntary.

• Individuals own their genetic information.

• Genetic information may not be shared without the individual’s consent.

The health insurance provisions of the bill would take effect one year after the measure is signed into law, and employment provisions would take effect after 18 months. Judy Aron at Consent of the Governed asked: “Where is the outrage? Where is the protest?...Let’s all do something to get this type of legislation repealed or at least give parents real rights of consent.”