One Judge Puts a Halt to Human Embryonic Stem Cell Research

Posted on by

Jake Meyer by Jake Meyer

Before the cells in your body become skin cells, muscle cells, or nerve cells, they are first stem cells.  Human embryonic stem cells are pluripotent – they can become any of the approximately 200 types of cells in the human body – which makes them particularly valuable for treatment and research.  Human embryonic stem cells could conceivably be used to treat patients, by transplanting them into damaged or diseased tissue.  They can be used to study disease mechanisms that cannot be studied within the body and to develop non-stem cell based therapies for conditions.  Among the many promising developments in stem cell research, researchers have created: dopamine-producing nerve cells that could be a promising treatment for Parkinson's disease, insulin-producing islet cells that control the insulin levels in mice with diabetes, and liver cells that could be used for treatment of liver diseases.  But a recent case decision casts into doubt the legality of all federal funding of stem cell research.

Chief Judge Royce Lamberth of the District Court for the District of Columbia granted a preliminary injunction preventing the National Institutes of Health from implementing federal guidelines that allow for the federal funding of research on human embryonic stem cells.  For researchers like Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital Boston, "[t]his ruling means an immediate disruption of dozens of labs doing this."

Continue reading →

Collaboration Among Alzheimer’s Researchers As A Model For Future Genetics Research

Posted on by

Jake Meyer by Jake Meyer

Researchers studying Alzheimer’s disease have been using an approach to learning about the disease rarely used in the life sciences – cooperation.  In 2003, the Alzheimer’s Disease Neuroimaging Initiative formed as a collaborative effort to find biomarkers that show the progression of Alzheimer’s disease in the brain.  Researchers from the National Institute of Health, Food and Drug Administration, the drug and medical imaging industries, and universities and non-profits have been sharing all of their data and making every finding freely accessible to the public.  The collaboration agreed that no one would either own the data or submit patent applications.  Now in 2010, the collaboration is starting to bear fruit.

The Alzheimer’s collaboration is significant for two reasons. First, the collaboration of Alzheimer’s disease research is yielding promising results for the understanding and treatment of the disease.  This collaborative approach looks to be effective – currently there are over 100 studies being conducted to test drugs that could slow the effects of the disease or cure it.  Second, this type of collaboration in the life sciences is rare, as the practice of allowing patents on the results of basic scientific research (such as human gene sequences and correlations between genetic mutations and disease) in the life sciences fields has created an incentive to not share results, but instead withhold data.  Dr. John Q. Trojanowski, an Alzheimer’s disease researcher at the University of Pennsylvania, describes how uncommon collaboration like this is in the life sciences: "It’s not science the way most of us have practiced it in our careers.  But we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately." 

Continue reading →

European Parliament Takes Cloned Meat and Nanoparticles Off the Menu

Posted on by

Jake Meyer by Jake Meyer

Here in the U.S. we like our food fast, cheap, and in large portions.  Other than that, we don’t particularly care what’s in our food – whether it’s meat from genetically-modified animals, genetically-modified corn which has been found to cause cancer in rats, or nanoparticles.  The European Union is a little more conscious of what their citizens ingest and the European Parliament has called for a ban on meat and milk made from cloned animals and their offspring.  The European Parliament has also called for a moratorium on the use of nano-sized ingredients in food until risk assessments can be made.

European Parliament novel foods rapporteur Kartika Liotard commented on the reasoning behind the ban of meat and milk from cloned animals: “A clear majority in the European Parliament supports ethical objections to the industrial production of cloned meat for food.  Cloned animals suffer disproportionately highly from illnesses, malformations and premature death.”  French Member of European Parliament, Corinne Lepage voiced the concern that these cloning techniques also “raise[] serious issues about animal welfare and reduction of biodiversity, as well as ethical concerns.”

Continue reading →

Free Tibet Based on Cultural Differences, Not Genetic Differences

Posted on by

Jake Meyer by Jake Meyer

A group of scientists at the Beijing Genomics Institute has discovered the quickest example of human evolution to date.  A study revealed that at least 30 genes have undergone evolutionary changes in Tibetans in the timeframe of 3,000-6,000 years.  The discovery is interesting from a purely scientific standpoint, as an example of how quickly the human genome (and therefore, human body) can change and adapt to its environment.  Tibetans, who have long sought to have Tibet to be a sovereign nation, could be tempted to use this discovery to argue that Tibet should be recognized by China, but the characterization of Tibetans as genetically distinct could have unwanted consequences.

These genes are responsible for Tibetans’ ability to live and work at high altitudes.  The Tibetans live at altitudes of over 13,000 feet, where the air contains 40% less oxygen than at sea level, but Tibetans do not suffer from the effects of mountain sickness. The study found 30 gene variants that were rare among the 40 Hans Chinese in the study were much more common in the 50 Tibetans in the study.  A variant of the gene hypoxia-inducible factor 2-alpha (HIF2a) appeared in 87% of Tibetans in the study, and only 9% of Hans Chinese.  Tibetans with this variant of HIF2a had less red blood cells and therefore less hemoglobin in their blood, which would help explain less susceptibility to mountain sickness. 

Continue reading →

Controversial DNA Forensic Technique Catches California Serial Killer

Posted on by

Robert Enneser by Robert Ennesser

On July 7, 2010, Lonnie David Franklin, Jr., was arrested and accused of murdering eleven people between 1985 and 2007.  Franklin had been dubbed the "Grim Sleeper" because he is believed to have taken a 14 year hiatus from killing between 1988 and 2002.  What led to his arrest after 25 years of eluding police? A controversial technique known as a "familial DNA search," in which DNA evidence from Franklin’s victims or crime scenes was closely matched to DNA obtained from his son.  Franklin’s son was convicted of a felony, and DNA collection is a normal procedure after a felony conviction.  Despite the success of the police in catching a serial killer, there is debate as to whether it is fair to use family members’ DNA to track down criminals.

On the national level, DNA information is stored by the FBI in the Combined DNA Index System (CODIS), which contains more than 8 million genetic profiles.  It has assisted in more than 116,000 investigations, including nearly 11,000 in Illinois.  Each CODIS profile contains information from 13 genetic markers composed of short tandem repeats (STRs) – repeated patterns of DNA scattered throughout the genome. Initially, CODIS included only violent felons but subsequently expanded to include all felons and later all felon arrestees.   Individual states have their own databases with differing inclusion requirements.  Some states do not expunge DNA profiles of arrestees later found innocent, other that do often require long, complicated procedures.  The FBI does not use familial DNA searches, but states are free to use the searches if they choose.  As a result, in California and Colorado, DNA of people never convicted of a crime and not under individual suspicion can be compared against DNA found at a crime scene. 

Continue reading →

Health Impact Assessments: A Policy Tool for Health Reform through Prevention and Planning

Posted on by

SarahBlennerBy Sarah Blenner, JD, MPH

Tamar is a sophomore in high school and plays on the school’s water polo team.  Her team practices in the swimming pool after classes are over for the day.  Following practice, when Tamar takes public transportation home, she has to transfer at two different bus stops before making it home.  Formerly, the trip lasted 45 minutes, but with recent reductions in bus service, the trip now lasts an hour and a half, leaving Tamar less time to complete her homework.  Tamar now has to wait longer on street corners at night, where she is increasingly exposed to a variety of negative elements such as extreme weather, cigarette smoke, gang violence, potential sexual assault, and the use of drugs by the people around her.  Longer exposure to these risks may increase her chance of engaging in behaviors that will negatively affect her health.  Had the policy implementing the bus cuts been subject to a formalized planning process that evaluated future impacts on the health and safety of those who use the public transit system, recommendations may have been implemented including maintaining frequent bus routes in critical neighborhoods or when students who participate in after-school activities are leaving school.

There are many factors that contribute to our health, such as individual behavior, societal influences, genetic predisposition, health care, and the physical environment.  In order to improve our health or the health of our communities, we must address these factors.  For one, environmental exposure can occur both through direct and indirect exposure.  Direct exposure occurs when an individual comes into contact with toxins, e.g. chemicals found in paint, the air, or even baby bottles.  Health can also be affected by indirect environmental factors, such as housing, urban development, land use, and transportation.  Tamar, the high school student who took the bus home from school, will be negatively affected by indirect environmental exposures.

The health of Americans is in need of improvement. According to the Center for Disease Control and Prevention (CDC), 34% of adults are considered obese, and another 34% overweight; 10% of adults in the U.S. have either diagnosed or undiagnosed diabetes; and 7.5% of adults in the U.S. have been diagnosed with asthma.  Former Interim President for Partnership for Prevention Corrine Hudson once said “[r]eal health reform must start with prevention.  Without a much stronger emphasis on prevention than now exists, we have little hope of controlling costs without sacrificing health.”  Health Impact Assessments do just this. Health Impact Assessments have been defined by both the World Health Organization (WHO) and the CDC as “a combination of procedures, methods, and tools by which a policy, program or project may be judged as to its potential effects on the health of a population, and the distribution of those effects within the population.”

Continue reading →

GMO Regulatory Practices: Food for Thought

Posted on by

Robert Enneser by Robert Ennesser

Genetically Modified Organisms, or GMOs, are often considered to be a fruit of our achievement in genetic engineering.  Inventors made waves in 2004 with the first GMO pet, Glofish®, fluorescent zebra fish-like pets that literally glow.  The proponents of GMO crops assert that they will help feed people around the globe by producing crops in more areas and larger quantities.  But there are also potential downsides of GMOs.  First, genetically-engineered crops can contaminate conventional crops, such as through seeds spread by wind.  Second, many crops are engineered to be resistant to the common herbicide glyphosate, but there is evidence of an increasing prevalence of weeds resistant to glyphosate.

There is a regulatory agency in place to address concerns raised by GMO crops.  Under the Plant Protection Act (PPA), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) regulates the introduction of genetically engineered plants (which it terms “plant pests”) within the United States.  A manufacturer may petition APHIS if it believes its genetically engineered plant is not a “plant pest” and should be available to be freely sold and planted (deregulated).  The deregulation process requires APHIS to analyze the potential impact of the GMO on the environment pursuant to the National Environmental Policy Act of 1969 (NEPA).  Generally, APHIS files a brief environmental assessment (EA), but if it determines that the seeds could significantly affect the environment, APHIS must complete a detailed environmental impact statement (EIS).

Continue reading →

Bilski v. Kappos: The Supreme Court Tells Us That Methods of Hedging Risk Are Not Patentable And Not Much Else

Posted on by
Reply

Jake Meyer by Jake Meyer

On June 28, 2010, the U.S. Supreme Court issued a decision in Bilski v. Kappos, a case the patent law community had been anxiously awaiting.  The oral argument took place on November 9, 2010 and the Court waited till the last possible moment to release the decision.  The case dealt with the most fundamental question of patent law, the first question a patent examiner asks: what is patentable subject matter?  The case could have had far reaching implications for many types of patents — from business methods, to software, to medical methods.  Instead the Supreme Court issued a narrow decision that largely left the law surrounding what is a patentable process unchanged.  By not setting forth a clear test for patentability of processes, however, the Court opened the door for even more patent challenges.

In In re Bilski, the Court of Appeals for the Federal Circuit, the court that hears the appeals of all patent cases, announced that the proper test to determine whether a process was patentable subject matter under 35 U.S.C. § 101, was the machine-or-transformation test, stating that a “process is surely patent-eligible under 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”  The patent claims in Bilski were directed to a method of hedging risk in commodities trading.  The Federal Circuit found that Bilski’s claims were neither tied to a particular machine nor did they transform a particular article into a different state or thing.  Therefore, the claims in Bilski were not patentable.

On appeal, the Supreme Court affirmed the ruling of the Federal Circuit and found that the claims to hedging risk in commodities trading were not patentable because they were directed to an abstract idea.  But the larger question before the Court was one that the Court sidestepped:  what is the scope of the test for determining whether a process was directed to patentable subject matter.

Continue reading →

BRCA in the Outback: The Australian Gene Patent Challenge

Posted on by
Reply

DamonGuptaby Damon Gupta

The U.S. case challenging the validity of gene patents is moving to the next step in the U.S. legal system.  Myriad Genetics has filed a notice of their intent to appeal the Southern District of New York’s decision invalidating patent claims on the BRCA1 and BRCA2 gene sequences and methods of determining the existence of mutations associated with breast cancer, of which Myriad is the exclusive licensee.  The Court of Appeals for the Federal Circuit will be next in line to hear the case and determine whether to affirm or deny the lower court’s decision.

The validity of gene patents is also being challenged in Australia, and Myriad is a party to the lawsuit.  June 8, 2010, Rebecca Gilsenan, an attorney with the Maurice Blackburn law firm, filed a lawsuit pro-bono on behalf of applicants (plaintiffs), Cancer Voices Australian, an advocacy group for all cancer patients in Australia, and Yvonne D’Arcy, a Brisbane woman diagnosed with breast cancer who could not afford BRCA1 testing by the exclusive licensee of the challenged Australian gene patent.

Continue reading →

The FDA Crashes the Spit Party: Direct-to-Consumer Genetic Testing is Under Investigation

Posted on by
1

Jake Meyer by Jake Meyer

Direct-to-consumer (DTC) genetic tests are genetic tests that are marketed directly to the public, instead of through a physician.  DNA is collected for DTC genetic tests through either saliva kits or cheek swab kits that can be used in the comfort of a person's home and then mailed to the company for analysis.  Customers of the DTC genetic testing company deCODEme use a "buccal DNA collector" to collect DNA for analysis, by gently scraping the inside of his or her cheek.  The DTC genetic testing company, 23andMe sells a kit that includes a saliva collection device, called a Spit Kit.  In fact, 23andMe made headlines by hosting a "spit party" in New York during the New York Fashion Week.  DTC genetic tests offer a wide variety of tests, providing people with information regarding their ancestry; their chances of developing a disease, condition, or trait; their nutritional profile; and their responses to particular drugs.  However, providing this type of genetic information does not come without risks, particularly when the genetic information is not put into context or interpreted by a physician.  There has been little regulation of DTC genetic testing, but now the Food and Drug Administration (FDA) is taking notice.

Concerns about DTC genetic testing were recently raised when Pathway Genetics announced that it was planning to sell saliva collection kits at Walgreens and CVS stores.  After the announcement, the FDA sent a warning letter to Pathway and the U.S. Congress began an investigation of the marketing practices of three DTC genetic testing companies (including 23andMe).  A mix-up at one of the DTC genetic testing companies brought further scrutiny.  On June 4th, 2010, 23andMe announced that up to 96 of its customers "may have received and viewed data that was not their own."  June 10, 2010, the FDA sent letters to five DTC genetic testing companies (23andMe, Navigenics, deCODEme, Illumina, and Knome) stating that the companies must either apply for approval or discuss why certain test claims don’t need the FDA’s approval.  The letters indicated that the FDA considers the DTC genetic testing offered by these companies to be a device "intended for use in the diagnosis of disease or other conditions" under 21 U.S.C. § 321(h) and therefore subject to regulation.

Continue reading →