Twin DNA Foil Investigators Again

by Dr. Hsien-Hsien Lei
Posted March 21, 2009 in DNA and the Law

Two years ago, identical twin brothers Raymon and Richard Miller both had sex with the same woman who became pregnant. The court decided Raymon was the legal father although the DNA paternity test couldn’t provide definitive proof.

In February, millions of dollars worth of jewelry was stolen in Berlin. Two of the suspects are identical (monozygotic) twins, Hassan and Abbas O. DNA analysis showed that one or both of them were probably at the scene of the crime but it’s impossible to tell. If only one of the brothers is guilty, investigators can’t tell for sure which one it is.

In reality, identical twins do not have perfectly identical DNA due to epigenomic chemical modifications and DNA copy number variations. But until more sophisticated DNA analyses become more widely available or other evidence comes to light, Hassan and Abbas are free and have not been charged. (Spiegel Online via Boing Boing)

Identical twins be forewarned. You may be able to get away with it now, but your time is coming.

NB: In Malaysia, investigators were unable to figure out which one of a pair of identical twins trafficked 166 kilograms of cannabis and 1.7 kilograms of opium. A judge dismissed the case and both twins were set free. (Telegraph)

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State Laws Governing Genetic Discrimination

by Dr. Hsien-Hsien Lei
Posted January 7, 2009 in DNA and the Law

Following the signing into law of the Genetic Information Nondiscrimination Act (GINA) in May 2008, Illinois lawmakers also want to make it illegal for businesses to discriminate against their employees based on DNA test results.

Why do states need to pass their own laws when a national law already exists? According to the National Human Genome Research Institute’s Genetic Discrimination Fact Sheet:

Before the federal law was passed, many states had passed laws against genetic discrimination. The degree of protection from these laws varies widely among the different states. The federal law sets a minimum standard of protection that must be met in all states. It does not weaken the protections provided by any state law.

According to a table compiled by the National Conference of State Legislatures (NCSL) of current state laws regarding the use of genetic information in determining health insurance, Illinois already prohibits insurance companies from:

• Using genetic information to establish rules for eligibility
• Requiring genetic tests/genetic information
• Using genetic information for risk selection or risk classification purposes
• Disclosing information without informed consent

States that so far have no laws in place against the use of genetic information in health insurance include:

• Mississippi
• North Dakota
• Pennsylvania
• Washington

NCSL also has information on other state genetics laws including those pertaining to employment, frozen embryos, and genetic privacy. Their Genetics Legislation Database also has searchable information on genetics bills considered in state legislatures from 2004 to present.

If you live in the U.S., how does your state fare on genetic nondiscrimination legislation?

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How Many Ways Can A Physician Be Sued (Over Genetic Tests)?

by Dr. Hsien-Hsien Lei
Posted November 4, 2008 in DNA Testing, DNA and the Law

…American Medical News counts the ways in Judging genetic risks: Physicians often caught between what patients want and what science offers.

1. Wrongful Birth/Life - Patients may sue physicians for not providing enough genetic testing or giving false negative test results.
2. Pharmacogenomics - Patients may sue doctors for not ordering genetic testing before prescribing certain medications, such as Coumadin (warfarin)
3. Negligent Medical Advice - Patients may sue a doctor who does not warn them of shared familial genetic risk of disease. Judges in a 2004 Minnesota Supreme Court case ruled that physicians had a duty to both patients and their biological family members to inform of them of genetic testing and diagnosis.
4. Personal Beliefs Over Patient Rights - Physicians may not be able to claim “right-of-conscience” when it comes to denying patients genetic testing on the grounds of religious or moral beliefs.

Patients should also keep in mind that their physician may not be well-versed in genetics and is most probably not up-to-speed on the latest available genetic tests. Considering the complexity of genetics, can we expect busy doctors to keep abreast of the field? Perhaps one solution is to increase the number of genetic counselors available and making their services affordable and commonplace. On second thought, isn’t that what some direct-to-consumer genetic testing companies are aiming to do?

*Yes, I am affiliated with DNA Direct that offers pre- and post-test education and expert consultation on genetic tests.

Photo credit: Joe Gratz

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DNA for Terrorism

by Dr. Hsien-Hsien Lei
Posted September 15, 2008 in DNA and the Law, Genetic Engineering

New Scientist reports that the Industry Association of Synthetic Biology (IASB) will begin issuing a seal of approval for members to post on their websites which will show that the companies screen their orders for potentially dangerous DNA sequences. The US National Science Advisory Board had been concerned about the potential for terrorists to purchase synthetic DNA to create deadly viruses.

In order to reduce the the chances of bioterrorism using commercially available genetic engineering, IASB committed to:

1. An anonymized survey of industrially produced and delivered genes
2. A sequence database accessible for all companies involved in gene synthesis that will help to identify orders requiring closer scrutiny

In related news, New York City Mayor Michael Bloomberg said last week the city ranks only 21st out of 54 eligible states and cities in the amount of funding for bioterrorism prevention despite the city being the number one target for terrorists. The mayor said funding is allocated irrespective of the risk for terrorist attack.

Because of the anthrax episodes in 2001, New York is one of only a handful of places in the nation that’s ever experienced a bio-terror attack. Yet in Fiscal Year 2008, we received $2.72 per capita, putting us an incredible 21st out of 54 eligible states and cities.

For more about bioterrorism, see previous Eye on DNA posts - Beware of Genetic Bioviolence and Could Altering DNA in Bacteria Post a Terrorist Threat?

Photo credit: Wellcome Library, 1927 Anthrax poster

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Is genetic testing useful?

by Dr. Hsien-Hsien Lei
Posted August 31, 2008 in DNA Around the World, DNA Testing, DNA and the Law

In The Malaysia Star today, Dr. Teo Soo Hwang explores genetic testing as it applies to the BRCA gene for breast and ovarian cancer - Can genetic testing be useful? The paper is printing “a series of four articles by the Cancer Research Initiatives Foundation (CARIF) that explores how genes are linked to diseases, the relationship between genes and cancer, and what is genetic testing and counselling.”

By the way, Malaysia’s government is currently considering a DNA Identification Bill that would require people charged with a crime to submit DNA samples. While this type of law is nothing new in other countries, such as the UK, the introduction of this bill in Malaysia at this time is part of a political brouhaha involving opposition figure Anwar Ibrahim who has been accused of sexual misconduct. His supporters fear that if he were forced to give a DNA sample, it would be tampered with and falsely incriminating results would be submitted to the courts.

Om Prakash says at malaysiakini.com:

The onus must be on those who want to freely give their DNA sample to prove their innocence. Let us not be threatened with another draconian law like the ISA for political and law- enforcement expediency.

We are not ready to just trust anybody yet.

Conclusion: Genetic testing is useful to some and not so useful for others.

Other DNA articles of interest in The Malaysia Star:

• Your genes, your health (1st in the series)
• Let’s do a CSI

Photo credit: Eye on Malaysia, Lukman Kusuma

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Gene Patents and Genetic Testing

by Dr. Hsien-Hsien Lei
Posted April 29, 2008 in DNA Testing, DNA and the Law

The European Society of Human Genetics (ESHG) has published recommendations on gene patents as applied to genetic testing in the European Journal of Human Genetics. The chair of the working group, Professor Gert Matthijs of the Catholic University of Leuven, said:

This new proposal aims to reconcile what until now have appeared to be conflicting interests patent owners, commercial companies, health authorities, policy makers, geneticists with the ultimate goal of ensuring that patients retain access to the latest technological advances.

Key points include:

1. Patents benefit society through innovation and promoting progress.

2. The definition of “invention” vs. “discovery” with the identification of genes, mutations, links between genetic defect and disease are deemed to be discoveries by some and thus would be unethical to patent.
3. Patenting novel technical tools for genetic testing is a good way to promote investment and allow for invention.
4. Genetic tests that examine a panel of genes will be impacted negatively by gene patents.
5. Genetic tests combined with protein or metabolite measurements will also have to consider multiple patents.
6. Patent applications do not take into account clinical validity and utility.
7. There are international differences in patent systems which affect the availability of genetic services worldwide.
8. Gene patents are overly broad and include not just the sequence but also protein and antibodies, etc.

Access to genetic testing can be impeded every step of the way from the discovery of new genes and mutations all the way up to availability of genetic tests. Right now, most of us concentrate on who has the right to have a genetic test and how. Another consideration clearly has to be who will develop the genetic tests and what intellectual property rights they have over their work.

As Michael Crichton said in a New York Times op-ed against gene patents:

Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000.

Should we prohibit the patenting of genes? Take the poll in this previous Eye on DNA post.

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Genetic Information Nondiscrimination Act (GINA) Nears Unanimous Consent Passage in U.S. Senate

by Dr. Hsien-Hsien Lei
Posted April 23, 2008 in DNA and the Law

About an hour ago, Sharon Terry of Genetic Alliance sent out an email regarding the Genetic Information Nondiscrimination Act (GINA). Here’s an excerpt:

OK all – unbelievable as it is, GINA is all set for UC [unanimous consent] passage in the Senate!!!

There is not time today to do the roll call vote, so the big day is tomorrow. The Senate convenes at 10 AM, but we do not know what time the Bill will come up.

GINA was first proposed in 1995 by Louise Slaughter, a House Democrat from western New York. According to the New York Times, if the bill is brought to the Senate floor tomorrow, debate would be limited to two hours with one amendment to address the possibility of employers being sued.

Under GINA:

• It would be illegal for insurance companies to raise premiums or deny coverage based on genetic information (see Genetic Testing and Health Insurance in the New York Times)
• Employers are prohibited from using genetic information to hire, fire, promote, or assign jobs (see Want a job? Submit your DNA)

Life and long-term care insurance coverages, however, are not part of GINA.

For more information, visit Coalition for Genetic Fairness.

Update (24 April 2008): GINA passed the Senate by unanimous consent of 95-0. Now it will be sent to President Bush so that he can sign the measure into law.

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Eye on DNA Headlines for 22 April 2008

by Dr. Hsien-Hsien Lei
Posted April 22, 2008 in DNA Around the World, DNA Testing, DNA and the Law

• Rick at My Biotech Life hosts Gene Genie : the better late than never personal genomics special edition.
• Please welcome Pamela Ronald at Tomorrow’s Table to The DNA Network. She’s our 53rd member!
• Congratulations to Trisha on the relaunch of the Ideas for Women blog.
• Molecular biologists are in the movies. Peggy at Biology in Science Fiction looks at Splice starring Adrien Brody and Sarah Polley scheduled for release in 2009.
• Auckland University professor Andrew Shelling says personal genomics companies are offering “health horoscopes.” On the other hand, he admits that access to genetic testing in New Zealand is very limited.

  “New Zealand is doing an appalling job of providing adequate genetic testing. We’re well behind Australia and the rest of the world.”
  
  So what’s an info-seeking person to do?

• Here’s a genetic genealogy quagmire. DNA testing of children from the polygamist religious group in West Texas to sort our* out family relationships has commenced. Problem is, many of the children are closely related and have parents who are genetically related as well.

  Because of the group’s isolation, Dr. Einum said he thought it was likely that the parents of any given child were related by a common ancestor, and that any man examined as a possible father could share genetic traits with many other men in the group.

*No, I’m not affiliated with the FLDS.

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Personal Genomics Takes a Bashing on Physician Oversight, Financial Backing, and Privacy

by Dr. Hsien-Hsien Lei
Posted April 21, 2008 in Business of DNA, DNA Testing, DNA and the Law

Direct-to-consumer genetic testing just can’t catch a break lately. We can expect blogs to be snarky but who knew Forbes and BusinessWeek could invoke a similar tone when writing about personal genomics?

First up, Forbes reveals that New York State’s Department of Health has sent letters to a number of personalized genetic testing companies threatening fines and jail time if they’ve been offering their services without a doctor’s involvement. The concern is that customers may not be able to understand their results and be potentially misled as to their risk of disease.

Both 23andMe and DeCode, which has not received a warning letter from New York so far, argue that the lab testing laws don’t apply because their products are not medical tests. “23andMe’s services are not medical … they are educational,” argues 23andMe spokesman Paul Kranhold.

That argument doesn’t mean spit to the New York regulators, who are concerned about the reliability of the online tests and their potential to send people rushing to their doctor demanding a cure for a fatal disease they may never get. [emphasis added]

BusinessWeek focuses on the financial aspect of the big players in personal genomics–23andMe and Navigenics–pointing out that both companies have received funding from Google. The company’s spokesman, Andrew Pederson, says that Google is “interested in supporting companies and making investments in companies that [bolster] our mission statement, which is organizing the world’s information and making it universally accessible and useful.” The difference between the offerings of 23andMe and Navigenics is portrayed as being interesting, broad-based information vs. valuable, medical-based information.

[Navigenics co-founder David] Agus, director of the Spielberg Family Center for Applied Proteomics at Cedars-Sinai Medical Center in Los Angeles, treats Hollywood celebrities, Saudi royalty, and others with deep pockets, but he conceived the company as a way to avert costly diseases.

Neither article mentions concerns over genetic discrimination and privacy which underlie discussions about regulation and access to genetic data. Two comments to the BusinessWeek article debate the issue.

Nicholas Bolibruch:

To all the naysayers, if you want nothing to do with this, just don’t use the service. Google cannot become big brother unless you voluntarily offer genetic material and make accounts on their system. The benefits of preventative health far outweigh the potential privacy violation. If you don’t like it, don’t use it, simple as that. I’m sure the person who gets genetic screening done and finds out they have a predisposition to some form of disease will be happier knowing they maybe able to prevent the problem in advance. When this saves someone’s life, all the naysayers will certainly have egg on their face.

Gerald:

You cannot say “if you don’t want it, don’t use it.” This creates a negative discrimination for non-users, making them suspicious to insurance companies, employers, etc. It’s the same reasoning totalitarian governments all over the world have always been using: “If you have no reason to hide, let yourself get registered by the authorities.” This opens all the door to neo-facist social structures and as a German for sure I will do all what I can to see history repeating itself, although with different names and forces of a globalised company now behind the same scheme of domination of personal liberties.

But perhaps privacy, confidentiality and consent for research will be moot in the future according to the proposal for an open-consent framework put forth by Lunshof et al. in Nature Reviews Genetics. More from DNA Network members:

• A new model for genetic privacy: you don’t have any at Genetic Future
• Private parts at Genomeboy
• Piracy or Privacy? Some Thoughts. at Gene Sherpas

If anyone ever organizes a biosciences startup school, they need to put regulatory affairs, investment choices, and privacy concerns on the syllabus!

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How to Fake a DNA Test

by Dr. Hsien-Hsien Lei
Posted April 13, 2008 in DNA and the Law

Most people who buy DNA test want to know the truth but there are others who want to evade it.

In 1992, Dr. John Schneeberger implanted a plastic tube in his arm filled with someone else’s blood. He had been charged with two counts of sexual assault in Saskatchewan, Canada. When ordered to provide a blood sample, Schneeberger drew the blood himself from the plastic tube instead of his vein. He was eventually deported and sent back to South Africa.

In March 2007, four Massachusetts men were charged with attempting to tamper with DNA testing. They apparently tried to trade ID bracelets when having their blood drawn but was caught when their fingerprints didn’t match the samples. I’m not sure what became of them but they faced a sentence of up to five years in jail.

And in a paper published in the Journal of Forensic Sciences, Dr. Jose Antonio Lorente Acosta at the Laboratory of Genetic Identification of the University of Granada found evidence of fraud in a paternity test case. The suspect had applied another person’s saliva to the inside of his mouth prior to having DNA samples taken with a cotton swab.

And what about accurate DNA analyses that are reported INaccurately? I’m sure there are unscrupulous DNA testing services worldwide that will give people any results they want for whatever purposes they need it for, e.g., immigration. Not to mention people like Simon Mullane, a British businessman who made-up paternity test results rather than actually doing the testing. Makes you think twice about the accuracy and validity of DNA testing, doesn’t it?

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