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July 2007 Posts
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Minnesota Gene Pool Blog

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July 30, 2007

Does the End Justify the Genes

Craig Westover is a writer and columnist for the St. Paul Pioneer Press. During our third week of the public health gneomics classes at the 2007 Public Health Institute at the University of Minnesota, he provided the libertarian / free market perspective in a discussion with Anne Berry, former Commissioner of Health and current Deputy Commissioner of the Department of Health and Human Services.

In this column, Mr. Westover reflects on the role of government in genetic testing, the recent issues related to the storage and use of newborn screening bloodspots for program quality assurance and new test development. Here, in its entirety, is his article published on July 26, 2007 in the St. Paul Pioneer Press.

Does the end justify the genes?

CRAIG WESTOVER

Article Last Updated: 07/26/2007 09:44:49 PM CDT

Of all our natural rights, none is guarded more zealously than the right of personal privacy, especially when it involves private matters of personal health. Yet, as medical technology advances and public health costs demand action, the boundary between privacy rights and the "common good" is increasingly strained.

Genomics - the study of genes and their roles in disease - offers enormous potential for bettering public health and reducing health care costs. Those are worthy ends. But they require genetically screening a significant number of individuals for predisposition to disease. Using the coercive power of government to enforce genetic screening and research runs smack dab against the unalienable right of personal privacy.

That's the crux of an argument between the free-market health care advocacy group Citizens Council on Health Care (CCHC) and the Minnesota Health Department over rules governing genetic screening of newborns. The dispute crystallizes the conflict of individual rights versus the common good.

At stake is more than a theoretical "slippery slope" argument about the dangers of government collection of personal data. It's a classic case of the seen versus the unseen. The visible results of genetic testing are measured in children's lives. The unseen, unintended consequences are individual psychological, social and financial risks including social stigma, insurance and employment discrimination. Given individual concerns, detailed counseling,

informed consent and confidentiality should be key elements of any genetic testing program.
The CCHC has long criticized the Health Department's rules on infant genetic screening, arguing that they didn't provide well enough for parental consent, gave the department long-term ownership of children's DNA and allowed the department to use infant DNA for genetic research without parental consent - all in violation of Minnesota's Genetic Privacy Act. In March, an administrative law judge, while approving many of the health department's rules, agreed and instructed the health department to make corrections.

The health department appealed the judge's decision prohibiting it from keeping and using genetic material without parental consent, arguing that genetic material is necessary to create and improve tests required by law. Parents may request that blood samples and records be destroyed within 24 months of testing; however, the department argued, if parents do not exercise that option, the department may retain samples.

The chief administrative law judge denied the department's appeal. CCHC president Twila Brase then upped the ante by sending a letter to health commissioner Dianne Mandernach calling on her department to destroy all newborn blood samples obtained without parental consent and to recall and destroy all blood samples distributed for research purposes. In a second faxed letter, Brase requested that Gov. Tim Pawlenty require the MDH to destroy all newborn blood samples by Aug. 14.

What we have here is a failure to communicate.

Brase's tenacity in defense of the principle of privacy rights is something we need more of - especially from politicians who would too often raise the votes of the many over the rights of the few. In a free society struggling to remain so, enhancing individual rights and independent choice must be the starting point of any policy discussion.

That said, infant genetic screening is not some Moreauian experiment involving jungle animals. The Minnesota Department of Health is charged with developing screening tests for genetic abnormalities that have serious health consequences. It has done so with positive results.

Minnesota's public health laboratory tests for 53 congenital disorders. The health department claims genetic screening improves or saves more than 140 children's lives each year. It attributes this achievement in part to its access to collected and retained genetic material, the infant blood samples Brase wants destroyed.

So, does the end justify the genes?

Individual privacy versus the common good: Which takes precedence? The question is not that simplistic. Individual privacy ought to be our first concern as we consider government's role in genetic screening - the first, the foremost, but not the only consideration. Public health can trump individual rights, but the burden is on the state to meet a standard of necessity to do so.

A reasonable person will recognize that genetic screening of newborns has huge potential benefits for individuals and society.

A reasonable person (in a free society) should also question whether the state ought to be the agent that collects and stores individual DNA and whether it ought to be allowed to do so without meaningful informed consent.

The Minnesota Health Department makes a strong case for the benefits of genetic screening, but this is a larger debate; it is ultimately about defining the difference between those things government can do (virtually unlimited) and those (limited) things government should do. The MDH has not yet made the case for the necessity of the state performing infant genetic screening.

Craig Westover, a writer who lives in Afton, blogs at craigwestover.blogspot.com. His e-mail address is westover4@yahoo.com.


Genomics and Spirituality: Can they co-exist?

Dr. Francis Collins is the Director of the National Human Genome Research Institute of the National Institutes of Health. Dr. Collins is a physician and a scientist who led the publicly funded initiative to map and sequence the human genome and the genomes of several model organisms. In addition to being one of the most famous scientists currently working, he is also is an ambassador for genomic science to various communities. He is known for his abaility to communicate effectively and is very in tune with the concerns and interests of his many audiences.

Lately, he has turned his attention to the relationship between evolution and genetic science and religion. Dr. Collins is a Christian and he has written a book called The Language of God. In a recent interview with Beliefnet, he talked about his work as a scientist, evolution as the foundation of modern biology, and how genetics and genomics are providing overwhelming evidence to support the theory of evolutiion. He emphatically maintains that this knowledge of genetics and evolution need not and--most importantly--does not interfere with his faith in God. In fact, he suggests that the wonder of the natural world and the interrelatedness of all life strengthens his belief in God.

We need more discussions of how the developing knowledge that is flowing from biology, physics, astrophysics and other rapidly advancing areas of scientific inquiry can be integrated with the spiriutal experiences and beliefs that have developed over the millennia and have served us so well in the past and the present. I, for one, look forward to this process as a way of growing both in knowledge and faith.


WHO releases a new report on children's environmental health

27 JULY 2007 | GENEVA -- The World Health Organization (WHO) is today releasing the first ever report highlighting children's special susceptibility to harmful chemical exposures at different periods of their growth. This new volume of the Environmental Health Criteria series, Principles for Evaluating Health Risks in Children Associated with Exposure to Chemicals, is the most comprehensive work yet undertaken on the scientific principles to be considered in assessing health risks in children. It highlights the fact that in children, the stage in their development when exposure occurs may be just as important as the magnitude of the exposure.

The scientific principles proposed in the document for evaluating environmental health risks in children will help the health sector, researchers and policy makers to protect children of all ages through improved risk assessments, appropriate interventions and focused research to become healthy adults.

To continue reading this press release and to access to the principles for evaluating health risks in children exposed to chemicals, check out the WHO website.


Francis Collins is coming to Minnesota

Francis Collins will be visiting Minnesota on October 12, 2007 to give the keynote address for a five-state Community Forum on Genomics. The meeting will be held at the Minnesota Department of Health in the Orville Freeman Building at 625 Robert Street North in St. Paul. We are very excited to welcome Dr. Collins to our state and to meet with him about issues of interest and concern related to genomics.

For more information, check out the GenoCommunity website


July 16, 2007

Citizens Council for Health Care wants to destroy NBS bloodspot archive

Newborn screening blood spots are collected on virtually all newborn babies to test for rare and hidden diseases. These diseases need to be identified and treated prior to the onset of symptoms to avoid lifelong disability or death. The Newborn Screening Program has been ongoing in Minnesota since 1965 and has saved hundreds of individuals and their families from the worst effects of these diseases. Newborn screening samples are also useful for research and quality control to improve the program. They also are a close mirror of the population since they are collected on virtually all newborn babies. This is potentially very bad news for all of us who live here because it would be a significantly hamper the NBS program in their work to develop new tests for newborns and to assure that the program maintains its high quality of testing. This also means that we may lose a population-based repository of biological samples which are needed to determine the frequency and health outcomes associated with subtle genomic changes. That is the bad news.

The good news is that this may force Minnesota to develop a system of informed consent that will result in a public that is much better informed about newborn screening, in specific, and genomics, in general, including the need for research and the implications of genomic information and technologies for health. We need to have a basic understanding and support from the citizenry if we are to move this forward.

This feels a little like losing a battle to win the war. We will be following this very closely. The story from the Pioneer Press is below in its entirety.

From the Pioneer Press, July 12, 2007:

Minnesota Health / Activists: Destroy blood samples State wants infants' blood kept for study, but two judges say no

BY JEREMY OLSON
Pioneer Press
TwinCities.com-Pioneer Press
Article Last Updated:07/12/2007 09:50:12 PM CDT

Emboldened by two favorable judicial rulings, a Twin Cities privacy advocate is demanding that the Minnesota Department of Health destroy thousands of newborns' blood samples that it kept indefinitely without explicit permission from parents.

The demand by the Citizens' Council on Health Care follows a July 3 ruling in which Minnesota's chief administrative law judge, Raymond Krause, said the Health Department lacked legal authority to keep the samples, even if it did so to improve public health.

The department was operating under the assumption it could keep blood samples indefinitely when parents didn't specifically request that the samples be destroyed within 24 months. Krause ruled that the department legally needed more than an assumption to do that.

Twila Brase of the citizens council wants Health Commissioner Dianne Mandernach to promise that all samples will be destroyed by early August: "There should be no delay. The commissioner has already appealed the judge's decision and lost."

A state health spokesman said the department is still determining whether it has any legal or legislative options that could overturn the decision.
Without screening, 135 babies in Minnesota would have died or suffered serious harm last year, the spokesman said.

By law, blood samples are collected (unless parents refuse) to determine whether newborns are at risk for certain metabolic or genetic disorders, including the PKU defect that can result in mental retardation if not detected early. The department has amassed 670,000 samples for use in research of these serious but rare disorders.
Ironically, these legal challenges started when the Health Department sought to increase the privacy protections of its newborn screening program.

Brase and others seized the opportunity to complain during the required public hearings for such rule changes.
An initial March ruling by Administrative Law Judge Barbara Neilson upheld existing state health rules requiring parents to sign documents opting out of screening tests for their newborns. Neilson ruled against the state's collection of blood samples, though, prompting an appeal by the Health Department.

Brase has been a vocal critic of several state efforts to collect personal health data and use it for research and the creation of standards of medical care.

Jeremy Olson can be reached at jolson@pioneerpress.com or 651-228-5583.


July 9, 2007

Reflections from PH7200: pharmacogenomics and health disparities

Guest blogger Colleen Kingsbury reflects on pharmacogenomics and health disparities.

Of the many areas of genomics research, one area in particular is backed by tremendous financial resources. The money is behind pharmacogenomics, the application of genomics to understand variations in drug response. And the big money comes from big pharma.

The potential of this research and development is significant both in terms of benefits to individuals and margins on return for investors. Successful pharmacogenomics products may lead to reductions in the number of adverse drug reactions, creating a benefit to society. In the Public Health Genomics courses at the University of Minnesota in May 2007, Lisa Peterson of the University’s Cancer Center stated that adverse drug reactions are the fourth leading cause of death with an estimated cost of $136 billion per year in the United States.

Peterson also shared statistics on the costs of drug development. In 2001, annual worldwide expenditures on pharmaceuticals were more than $300 billion. For manufacturers, drug development is time consuming, requires significant investment and there is no guarantee that a new drug will be profitable.

Case in point: BiDil. “The Food and Drug Administration (FDA) approved BiDil, a drug for the treatment of heart failure in self-identified black patients, representing a step toward the promise of personalized medicine,? heralded the 2005 press release from the FDA. However, according to a 2006 New York Times article announcing the resignation of two top executives who brought the drug to the market, BiDil’s approval “came amid criticism that the government was embracing the idea that blacks were somehow biologically different from others, which some said could promote racial stereotyping.?

Dr. Carmen Paniagua-Ramirez, of the University of Arkansas for Medical Sciences, spoke briefly about BiDil in a lecture at the Public Health Genomics course at the University of Minnesota in June 2007 (see pod cast for June 5). One of her deepest concerns about BiDil is that the FDA accepted the use of race as a biomarker. “It is not about race,? she said, “it is about a genetic variant.?

The Wall Street Journal reported in a July 2007 news item about BiDil, “The drug has been selling poorly — in part because insurers have pushed for use of the cheaper generic drugs rather than the more expensive combination pill.? Will the next mass-market pharmacogenomic offering be different? Stay tuned…