On the Edges of Science and Law

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. 

The Eyes Have It: Tighter FDA Regulation of LASIK Surgery

By Lori Andrews

What has Tiger Woods got that you don't have?  Ads for LASIK surgery capitalize on his golf swing, his charisma, his fortune--with the subtle implication that you, too, could be a Tiger if only you underwent surgery for nearsightedness.

Over a million people a year undergo LASIK.  But not everyone who submits to the procedure enjoys Tiger's success.  The surgery, laser-assisted in-situ keratomileusis, can pose risks. Some patients who have undergone LASIK complain of double vision, blurriness, and depression.  Last year, the FDA held hearings on the risks, including a report of suicide by a man who had an unsuccessful procedure.

Should Inmates Have Access to DNA Testing? Some Prosecutors Say No

By Tim Welch

For prison inmates who are languishing in cells serving sentences for violent crimes they did not commit, a DNA test can be a harbinger of freedom.  That is, if they can get one.  State legislatures have begun to recognize the potential that DNA testing has for exonerating wrongfully-convicted prisoners.  Forty-six states now have laws that enable convicted prison inmates to request a DNA test on evidence related to the crimes they were convicted of in court.  But what sounds like an easy and effective way to reduce the number of wrongfully-convicted prisoners in the United States is meeting significant resistance from prosecutors.

Even though they are increasingly willing to allow DNA testing of an inmate, prosecutors are delaying these tests in some cases by years due to the scope of the applicable state laws.  In reality, DNA tests have exonerated hundreds of wrongfully-convicted people in the United States.  But many of the 46 state laws allowing this type of testing stipulate that the results must be able to prove the prisoners innocence.  Prosecutors will argue that for many types of crimes, simply not finding a DNA match to the inmate is not enough to establish innocence.  For example, in the event of a murder, the fact the blood collected from the scene does not match the perpetrator is not sufficient to prove that the perpetrator did not commit or aid in committing the murder.  This is especially true when a jury had already convicted the perpetrator on the basis of testimony and identification.

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."

Association for Molecular Pathology v. United States Patent and Trademark Office: Meet the Plaintiffs

By Jake Meyer

Earlier this week, a lawsuit organized by the American Civil Liberties Union was filed challenging the validity and constitutionality of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad Genetics.  The plaintiffs in this case include: women who wish to have testing for the BRCA1 and BRCA2 genes; researchers who have the capabilities to offer testing for these genes but are unable to because of Myriad's patents on the BRCA1 and BRCA2 genes; medical organizations; and women's health organizations.

The presence of the certain mutations in the BRCA1 or BRCA2 genes is associated with a predisposition to breast or ovarian cancer.  Women who have these mutations are much more likely to develop these cancers and men who have the mutation can pass the mutation to their daughter.  Women who learn they have these mutations will often opt for drastic surgeries, such as a mastectomy or oopherectomy (removal of the ovaries) to avoid a battle with breast or ovarian cancer.  However, Myriad Genetics owns patents that cover both the BRCA1 and BRCA2 gene sequences and mutations of the genes, which grant Myriad a monopoly over the gene sequences (for an example of one of Myriad's patents click here). Myriad is the only company that offers genetic testing for BRCA1 and BRCA2 in the U.S. and therefore women cannot get second opinions before making decisions about major surgery.  Also, since Myriad has a monopoly on testing, it can charge whatever it wishes for the testing – currently the test costs over $3,000.  Many insurance plans don't cover this testing and many people can't afford the out of pocket cost of the test – so testing isn't available to them.  Further, according to a 2006 study, Myriad's test can miss certain mutations that help cause the disease.

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

GUEST BLOGGER Sarah Blenner

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."

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

 By 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.

Nanobots!

By Jake Meyer

Nanotechnology is a vague term that encompasses a wide range of technologies.  Some of the technologies may be as mundane as a material used to strengthen a tennis racket, such as the carbon nanotubes used in the Babolat NS Drive Tennis Racket.  But the term nanotechnology is also used to include inventions that appear to be science fiction.  One possible use of nanotechnology is to create tiny robots that can be introduced into the human body to a number of medical procedures such as: deliver drugs, clean arteries of cholesterol, or to transport oxygen in the blood stream.  Although it may be many years before we have tiny robots coursing through our veins, advances in science and technology are bringing medical nanorobots closer to reality. 

An article in published in Nature last week, titled "Miniature Devices: Voyage of the Microrobots," describes how scientists at the Institute of Robotics and Intelligent Systems in Zurich, Switzerland may have overcome three obstacles in the way of realizing a future filled with medical nanorobots – "how to make, power, and steer them."  To propel the robot, the scientists created an artificial flagellum – a biological propeller that allows bacterium to swim.  The artificial flagellum is attached to a magnetic "head," and when the robot is placed in an oscillating magnetic field, the flagellum spins, propelling the robot through liquids at a blazing speed of 1-2 micrometers per second.  The magnetic field that provides the power for the robot also provides a method for controlling the robot.  By changing the direction of the magnetic field, the direction of the movement of the robot is changed. 

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

By 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.