On the Edges of Science and Law

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. 

Biobanks: Let's Regulate At Least One Banking Industry

By Jake Meyer

Large repositories of biological samples (biobanks) are being collected for medical and scientific research.  Some biobanks are publicly funded, like the UK Biobank, a government plan to create a database of DNA samples of 500,000 volunteers aged 40-69 in order to improve prevention, diagnosis, and treatment of life-threatening illnesses.  Some biobanks are held by private companies, like Genizon Biosciences which contains samples from 47,000 patients who are direct descendants of the original French founders of Quebec (a relatively homogenous population useful for genetics research).  Other biobanks are public-private partnerships, such as the biobank operated by deCODE Genetics, in which the government of Iceland granted deCODE an exclusive license to Iceland's genealogical and medical records.

Scientists think that significant advances in medicine science might be achieved through the study of normal genomic variations across whole populations.  These studies must analyze the whole genome, in contrast to using traditional methods to analyze a single gene.  In order to perform studies of normal genomic variations, large-scale collections of samples are required.  One way to get the large number of samples required for this type of research on the whole human genome is through international collaboration and networking among biobanks.  Commentators Barth Maria Knoppers, Ma'n H. Abdul-Rahman, and Karine Bédard, have suggested that achieving international collaboration and networking among biobanks will require the establishment of international frameworks, standards, and norms. 

Wheels of Justice Grind Slowly for Havasupai Tribe

By Julie Burger

In a remote section of the Grand Canyon about 450 members of the Havasupai Tribe live on tribal lands where they have lived for hundreds of years.  Another 200 members of the Tribe live away from Supai, the village area.  In March of 1990, researchers from Arizona State University ("ASU") (Drs. Theresa Markow and John Martin) presented the Havasupai Tribal Council with a proposed diabetes study, saying that they would like to collect and use tribe members' blood for diabetes studies.  The researchers met several times with the Tribal Council, but according to allegations, never revealed they intended to perform research other than diabetes research.  With the Council's approval, blood samples were collected from members of the Tribe, including children and vulnerable people.  Researchers additionally took handprints from members.  English is not the tribal members' primary language and many members do not even speak English as a second language.

The researchers did not stop at diabetes research.  They also performed additional research on the samples for schizophrenia, inbreeding, and population migration, and shared the samples with researchers at other institutions.  After discovering the additional research, the Havasupai filed state court complaints on behalf of individual Tribal members and on behalf of the Tribe against ASU and the researchers in 2004.  The Havasupai maintain that the schizophrenia and inbreeding research was stigmatizing and that they would not have consented to the migration research because it conflicts with their religious origin theory.  A member of the Tribe points out that "[the researchers] challenged our identity and our origins with our own blood and without telling us what they were doing."

Sen. Grassley Investigates Payment to Harvard Researchers by Drug Companies

By 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.

Embryo Stem Cell Research--Politics and Science are Still Entangled

By Lori Andrews

On Monday, President Obama gave the green light for federal funding of embryo stem cell research. Stem cell research provides potential new treatments. Embryonic cells can develop into all the types of cells in the body. In the future, doctors might be able to repair damaged hearts by inserting new heart cells or help people walk with the use of embryonically-derived nerve cells.

Prior to Obama's actions, the existing Bush position reflected a pro-life religious belief that an eight-cell embryo is a person and stem cell research, which of necessity destroys the embryo, is murder. In August 2001, Bush addressed the nation and said that he would only allow federal funding for research on existing embryonic cell lines. Bush did not want to be a party to the termination of any further embryos, but he would allow research on cell lines where the embryos had been terminated in the past.

Coerced Korean Egg Donor Loses Case

By Julie Burger

Debate over embryonic stem cells heats up once again, between proponents claiming the technology will be a panacea to cure the world's ills and opponents contesting the hype and raising ethical and legal issues.  One such issue hit the Korean courts on February 18—the coercion of egg donors.  The saga began when Hwang Woo-Suk, a South Korean researcher, was hailed for his groundbreaking research after he reported in Science in 2004 that he had successfully cultivated human embryonic stem cells from cloned embryos.  One year later, he reported the creation of patient-specific stem cells.  Both articles were retracted after reports surfaced that much of Hwang's work had been fabricated.  As the story unraveled, more ethical and scientific violations were revealed.

Hwang submitted duplicative photographic images of cells to Science which he falsely claimed supported his creation of different cell lines in 2005.  He also manipulated the DNA testing of the cell lines to support his desired results.  Allegations abound that Hwang switched samples to cover up the falsification of data and potentially embezzled research funds.

Enhanced Privacy, Improved Health through Research: In Today's World, Does the HIPAA Privacy Rule Do Enough to Ensure Both?

By Tim Welch

In February 2009, the Institute of Medicine (IOM) released a report, "Beyond the HIPAA Privacy Rule:  Enhancing Privacy, Improving Health Through Research," which outlines the IOM's evaluation of the effectiveness of the 1996 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in the context of today's electronically-intertwined world.  The report, by the IOM's Committee on Health Research and the Privacy of Health Information, assessed the impact of the HIPAA Privacy Rule on health research in the United States and made recommendations to encourage health research while preserving and improving the privacy protection of personally identifiable health information.

Every American doctor's office contains endless rows of file cabinets which house the confidential medical records of the office's patients.  Modern technology offers us the time- and space-saving convenience of storing, organizing, accessing, and transmitting these records electronically.  However, such a free flow of information—in a less-tangible and more easily-shared form than classic paper records—raises privacy and security concerns.  Medical records often contain personally identifiable information that could be damaging to a patient's dignity and lead to discrimination in other aspects of a patient's life.

Testing Children for "Sports Genes"

By Lori Andrews

While some of us might be heading to the gym as we start the new year, certain parents are making another sort of resolution.  They are dialing up Atlas Sports Genetics and plunking down their credit cards to have their infants and toddlers tested for genes supposedly related to sports ability.  One woman who was considering such a test told The New York Times, “What if my son could be a pro football player and I don’t know it?”

As the denizen of a city famous for sports highs (Michael Jordan’s Bulls) and lows (the Chicago Cubs’ near misses), I am cautious about making predictions about a current team, let alone betting my hopes that a three year old will grow up to be the next Tom Brady or Peyton Manning.  And caution in this field should be the word of the day.  The proposed test raises both scientific and social issues.

NIH Pulls Genetic Information from Internet after Research Shows Info Can Be Linked to Individuals

  By Julie Burger

For years, scientists have raced to unlock the mysteries hidden in the human genome. Relatively recent research methodologies, used in genome wide association studies (GWAS), are allowing scientists to much more rapidly uncover genes that may be linked to diseases. In GWAS, genetic and health information from thousands of people is compared to locate mutations or gene variants for diseases like breast cancer, diabetes and heart disease.  (For a scientific viewpoint as to why this research theory might not be successful, click here.)  Because this type of research calls for genetic and other information from thousands, or even tens of thousands of people, researchers are increasingly trying to tap into existing bodily tissue samples and private medical data from blood or biopsy samples taken at a physician’s office or hospital.  Researchers are also asking to share information from other researchers’ studies.  What many people don’t realize is that information about them and their genes could be taken and shared among researchers or even posted on the internet.

Researchers’ quest to correlate genes with disease has encouraged government agencies to implement policies to increase the sharing of genetic samples and genetic and health information even where the individual has not explicitly consented to the secondary use. The National Institutes of Health (NIH) has implemented a plan to increase access to genetic and associated health information. Starting in January 2008, researchers who received government funding for GWAS were required at the end of the study to submit the genetic profile and associated information about the health of the people whose tissue was used. The health information might be blood pressure or weight, or it might be information about drug use, mental health, and it could include information about family relationships.

Millionaire MD Consultants? - Big Pharma Promises Better Disclosure

  By Julie Burger

University medical centers are cutting down on relationships with drug and device manufacturers.  Less free pizza, less free pens.  That’s great, since studies show that even nominal gifts can influence prescribing and practice habits.  But it turns out that cold hard cash rather than trinkets might be the real culprit.

Conflict of interest and government grant funding rules say that investigators on federally funded studies must report whether they receive $10,000 or more a year from, for example, the drug company which makes the drug being studied.  A Congressional investigation spearheaded by Sen. Charles Grassley (R, IA) has highlighted several troublesome alleged undisclosed conflicts of interest incidents: psychiatrist Dr. Charles B. Nemeroff of Emory University reportedly failed to disclose $1.2 million in outside income from drug makers (including money from GlaxoSmithKline) while running a $3.9 million taxpayer-funded study to test GlaxoSmithKline drugs; Drs. Joseph Biederman and Timothy Wilens of Harvard each earned at least $1.6 million in consulting fees from drug makers but reportedly stated they earned only several hundred thousand dollars; Dr. Melissa DelBello of Univ. of Cincinnati allegedly reported around $100,000 from 8 drug companies over two years, while one alone had paid her $238,000.

I don’t know about you, but I would sure notice an extra million dollars in my bank account.  Even a cool hundred K would make a noticeable impact.