Category Archives: Ethics

Texas Families Bring Suit Challenging State Newborn Screening Program

Posted on by
4

Tim WelchBy Tim Welch

Another state’s newborn screening program has come under fire recently, highlighting growing concerns about the protection and proper use of human tissue and genetic information.

On March 12, 2009, five parents filed a lawsuit in the United States District Court for the Western District of Texas in San Antonio against the Texas Department of State Health Services (TDSHS), Texas A&M University, and various Texas A&M University officials (Beleno v. Texas Dept. of State Health Serv.).  The plaintiffs claim that TDSHS violated federal and state law when, as part of the legally-mandated Texas newborn screening program, TDSHS collected blood samples from the plaintiffs’ newborn babies, stored the samples indefinitely, and allegedly used the samples for unidentified research purposes, all without the plaintiffs’ knowledge or consent.

The Beleno plaintiffs allege that TDSHS has violated their right to be free from unlawful search and seizure, as guaranteed by the Fourth Amendment to the U.S. Constitution and Article I, Section 9 of the Texas Constitution.  The plaintiffs also claim that TDSHS has deprived them of their liberty and privacy interests, as guaranteed by the Fourteenth Amendment to the U.S. Constitution, the Texas Constitution, and Texas common law.

Continue reading →

Should Infant DNA Later Be Used in Forensics?

Posted on by
17

Lori Andrews 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.

Continue reading →

Sperm Donors, Products Liability, and the Rights of Children

Posted on by
Reply

<Lori Andrews 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.

Continue reading →

Resources for European Laws on Patient Rights

Posted on by
Reply

Tim WelchBy 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.

Continue reading →

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

Posted on by
Reply

JulieBergerBy 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. 

Continue reading →

Chicago Takes A Stand: City Council Committee Unanimously Votes in Support of the BPA-Free Kids Ordinance

Posted on by
2

SarahBlennerBy Sarah Blenner, JD, MPH

Bisphenol A (BPA), the controversial, toxic chemical found in many plastic food containers, is once again making headlines.  BPA is an estrogen-mimicking chemical that is used to make polycarbonate plastics.  Hundreds of studies have linked BPA to a variety of adverse health conditions, such as diabetes, insulin dependency, obesity, breast cancer, prostate cancer, hyperactivity, ADHD, autism, early onset of puberty, cardiovascular disease and liver enzyme abnormalities.

In January, Julie Burger argued that “the time to act is now.”  Leading scientists state that the potential health risks of BPA are too significant and the FDA’s determination that BPA is “safe” is simply the chemical industry’s creation of “manufactured doubt.”  With hundreds of studies linking BPA to adverse health conditions, the FDA relied solely on a limited number of studies funded by the chemical industry that showed “no harm.”

Continue reading →

Big Brother Is Watching–FBI, States Expanding Forensic DNA Databases by Millions

Posted on by
Reply

Tim WelchBy Tim Welch

Last month, the FBI drastically changed its policy on whose DNA will be entered into and stored in the largest forensic DNA database in the world.  Previously, the FBI only collected DNA samples from convicts, i.e., people who have been declared guilty by a judge.  The FBI now plans to join 15 states in collecting DNA samples from people who have only been arrested or detained.  Law enforcement officials claim that including people in forensic DNA databases who have either been released without charges or declared not guilty in court will ultimately put more criminals in jail.  But the federal government's decision raises privacy issues as well.

Forensic DNA databases exist at the local, state, and federal level.  When a person is convicted of a crime, his or her DNA code is entered into a computer system, such as the Combined DNA Index System (CODIS), which allows investigators to compare biological specimens collected at crime scenes to DNA profiles of convicted criminals already stored in the database.  Even if no match is found, investigators can cross-check anonymous samples from different crime scenes to hopefully shed light upon unsolved crimes.  Law enforcement officials claim that their forensic DNA databases have helped convict thousands of criminals and have exonerated hundreds of innocent people who were wrongfully convicted.

Continue reading →

Access to Easy Abortions Skew Sex Ratio in China–Leads to Nearly 33 Million More Males than Females Under Age 20

Posted on by
2

JulieBergerBy Julie Burger

A study examining China's 2005 census report estimates that there are 33 million more males than females under the age of 20 in China.  The sex ratio started skewing sharply in the late 1980's with the introduction of low cost and portable ultrasounds which would be followed by abortions if the fetus were female.  Then the couple would try, try again until a penis was finally observed on the machine's screen.  Now, the birth sex ratio stands at 124 boys for every 100 girls.  (Worldwide the ratio is 100 girls to 103-107 males.)  While the Chinese government's policy may be that couples cannot be told the sex of their baby before it is born, until the government comes up with a better way to enforce this policy, it is going to get population control from a method it didn't expect–-fewer women left to have babies and generations of men who cannot find spouses.  In addition, rural areas in China have reported increases in crime and instability–thought to be the result of the growing population of unmarried men.

Teaching Law Through Fiction

Posted on by
Reply

Lori Andrews by Lori Andrews

Last weekend, the Association for the Study of Law, Culture, and the Humanities met in Boston.  Along with panels on constitutional theory, human rights, criminal law, and same sex marriage, there were panels on novels and movies–Billy Budd, Twelve Angry Men, Notes from the Underground, even Harry Potter.

Since I was speaking at the session on "Law and Contemporary Fiction," I prepared by reading the novels written by my co-panelists Alafair Burke (Hofstra University School of Law), Kermit Roosevelt (University of Pennsylvania Law School), and Marianne Wesson (University of Colorado Law School).  They were all law professors by day, mystery writers by night.  But unlike CSI or the usual thriller, their books tried to stay true both to the law and the emotions of being a lawyer.   It struck me that their novels could be used to teach subjects as wide-ranging as First Amendment Law, Criminal Procedure, Corporate Law, and Professional Responsibility.  But their books involved more than just a clever use of a legal construct.  They'd captured the ethical challenges that lawyers face, the insane hours, and the feeling in the pit of one's stomach when a life, a business, or a principle of value is on the line. 

Continue reading →

Sen. Grassley Investigates Payment to Harvard Researchers by Drug Companies

Posted on by
Reply

JulieBergerBy Julie Burger

When allegations were made public that academic researchers who conduct clinical trials were failing to report funding they received from industry (including the drug companies which produced the drug being tested), I suggested some ways medical centers or the government could assure the disclosure of these relationships.  U.S. Sen. Charles Grassley (R, IA) has launched an investigation into whether researchers are failing to disclose payments from pharmaceutical companies.  He found evidence that prominent physicians at prestigious universities failed to disclose payments from drug companies–some payments were even received while the doctor was conducting trials on a drug made by the company paying the physician.  Now the U.S. Attorney for the District of Massachusetts and the Inspector General of the Department of Health and Human Services have issued a subpoena to a law firm that represents States in their claims of Medicaid fraud against manufacturers of antipsychotic drugs.  The subpoena asks for information about researchers and their connections with the drug companies.

Continue reading →