On the Edges of Science and Law

Judge Sotomayor

By Julie Burger

The headline of a recent Time Magazine story about President Obama's U.S. Supreme Court nominee asked, Sotomayor's Diabetes:  Will it Be a Handicap?

The authors seem to be asking whether Judge Sotomayor's type 1 diabetes will be an impediment to her confirmation.  Although many news stories about Judge Sotomayor mention that she was diagnosed with the disease at age 8, most commentators and experts believe that the disease will not negatively impact her ability to be a justice on the Supreme Court.  The disease is serious, raising the risk of heart disease, blindness, amputation, and kidney problems.  And yet, if well-controlled, people with diabetes can live long and productive lives.  There is no reason Judge Sotomayor's diabetes should prevent her from being qualified to sit on the Supreme Court.

Dyslexia Gene eneG aixelsyD

By Jake Meyer

The other day I while doing some patent law related research, I stumbled across a patent in the U.S. Patent and Trademark's patent database on a gene linked to dyslexia—U.S. Patent No. 7,355,022.  Dyslexia has been defined as a learning disability.  It can manifest itself in many different ways, but usually appears as some type of difficulty with reading and/or writing. 

After I found the patent on a dyslexia gene, I started to think about the types of inventions a company licensing this patent might be.  After a gene is "discovered," lab tests for the gene can be developed.  These genetic tests could be used to determine if someone has this dyslexia gene and therefore a predisposition to dyslexia.  Tests could also be used to preselect embryos to help ensure a child might be born without dyslexia.  Or perhaps in the future genetic therapies or a cure to dyslexia could be found. 

Should Infant DNA Later Be Used in Forensics?

By Lori Andrews

Since the 1960s, public health departments around the globe have tested hospitalized newborn babies for serious genetic disorders, generally without the parents' knowledge or consent.  Many departments save that DNA, tiny spots of blood on paper.  Now questions have arisen about whether law enforcement officials should have access to those samples.  In other words, should babies have a right not to self-incriminate themselves?

In the United States, an Institute of Medicine committee recommended that DNA banks created for medical and research purposes (such as newborn screening banks) not be used for forensic purposes.  But, in other countries, courts have handled fascinating cases on route to setting policies.

Do Inmates Have a Constitutional Right to DNA Testing? U.S. Supreme Court Says No.

By Tim Welch

Last month, I wrote an entry about the current trend of prosecutors blocking convicted prison inmates from accessing DNA testing on old pieces of evidence stored in police files.  Despite inmate advocacy groups' claims that DNA tests have exonerated hundreds from false imprisonment, prosecutors are denying the tests to inmates, citing insufficient scope of state laws.  William Osborne, a man currently serving a 26-year sentence for a 1994 rape conviction in Alaska, brought his case all the way to the Supreme Court.  Osborne is seeking a DNA test under 42 U.S.C. § 1983 on police evidence collected during his 1994 rape trial.  But yesterday, the Supreme Court dealt a major blow to the wrongfully-convicted of America's prisons.

On June 18, 2009, the Supreme Court ruled 5-4 against Osborne, deciding that convicted prison inmates do not have a constitutional right to obtain DNA tests on old evidence.  As a result, the decision of whether or not to grant inmates access to DNA testing will remain in the hands of state courts and legislatures.  While according to the Chicago Tribune, 47 states have already enacted laws that allow inmates to receive DNA testing in some post-conviction instances, Alaska is not one of them.  Osborne, who won in the U.S. Court of Appeals for the 9th Circuit, may now face an impossible task in obtaining what he believes to be justice.

"Generic" Versions of Expensive Biologic Drugs Would Benefit Consumers

GUEST BLOGGER Pat Bickley

Competition from generic drugs has substantially reduced the prices of many prescription drugs.  However, under current law, the FDA can only apply the expedited testing of a generic designation to certain classes of drugs, generally those that are chemically synthesized, small-molecule products.  Larger and more complex drugs, such as biologics, are not allowed to receive generic designations. Biologics are protein-based and produced in living cells.  They also tend to be much more expensive.  Annual costs can be as high as $48,000 for the breast cancer drug Herceptin and $20,000 for the rheumatoid arthritis drug Remicade.  Manufacturers of biologics, such as Amgen and Genentech, justify these costs as necessary to recoup their substantial investments in developing and gaining approval for the drug.

"Cheese Please, and No More Exercise Wheels"

By Jake Meyer

We've all talked to animals before, but never have the animals talked back.  Recent research makes the possibility of a day when the family dog calls your name, and tells you to sit and shake hands a little more probable.  Researchers at the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany have placed a human language gene in a strain of mice.

Although there are undoubtedly numerous genes that enable human speech, the replacement of the mice's FOXP2 gene with a human version of the gene had some surprising effects.  The mice with the human FOXP2 gene grew nerve cells with a more complex structure in the basal ganglia--a region of the brain used in language in humans.  The mice also had a new "voice."  When baby mice are separated from their mothers they make ultrasonic whistles.  But in the mice with the human gene, the whistle was a lower pitch.

Sperm Donors, Products Liability, and the Rights of Children

By Lori Andrews

When I first started working in the infertility field 25 years ago, the AIDS crisis had emerged, but doctors still were not screening sperm donors for the virus.  One doctor actually said to me, "I didn't screen my wife before I had children with her, why should I screen a sperm donor?"

The infertile couples didn't see it that way.  There might be lots of reasons to have a child with your spouse, but when couples go to infertility clinics, they are specifically trying to have a healthy baby.  Yet, due to lack of screening, children created through sperm donation have been born with AIDS, hepatitis, cytomegalovirus, and a variety of genetic diseases.  No mechanism exists for sperm banks to learn of the children's problems and stop using the donor for future pregnancies.

Resources for European Laws on Patient Rights

By Tim Welch

Patient rights continues to be an issue of global concern due to the rapidly expanding field of biotechnology.  As genetics become more involved in the treatment of disease and electronic medical records raise challenges for privacy, the law must evolve to ensure patient protection.

A webpage run by the Center for Biomedical Ethics and Law at the Catholic University of Leuven (Belgium) provides a substantial resource for information about European laws related to patient rights.  The webpage, located at http://www.europatientrights.eu, includes information about the status of the European Convention on Human Rights and Biomedicine (Biomedicine Convention) in each EU Member State, as well as individual countries' laws regarding patients' rights to informed consent, information about health, access to medical files, privacy, and use of genetic services.

Another One Bites the Dust--Second Conspirator Found Guilty in Sale of Body Parts from UCLA

By Julie Burger

On May 14, 2009, a jury convicted Ernest Nelson of conspiring to commit grand theft, embezzlement and tax evasion for selling body parts that had been donated to UCLA's medical school to private medical research companies and pharmaceutical companies.  Nelson's alleged co-conspirator in the case, Henry Reid, the former director of UCLA's willed-body program, is currently serving four years after pleading guilty to conspiring to commit the theft. 

According to allegations, Reid provided portions of cadavers to Nelson who then sold them to companies for research.  But it wasn't the mere exchange of money for body parts that was the problem.  Prosecutors stated in 2009 that the defendants' plan unraveled because they had failed to properly fill out paperwork showing that the bodily tissue had been tested and was disease free, raising the suspicions of a state health investigator.  They stated that the companies that provided $1.5 million for the body parts over the course of four years had "legally paid" for the tissue.  Nelson's defense was that UCLA had authorized the sales, but that Henry Reid, the director, had not forwarded the money to the university.