Monthly Archives: July 2014

Mining Your Genetic Data for Profit: The Dark Side of Biobanking

Most people are now familiar with big data and how it’s used to target advertising or suggest love matches based on the data we drop as we move through life in the digital age. In exchange for tech freebies, data space in the cloud, or that new dating app, we do a quick cost-benefit analysis, we click “agree” on user licenses, and dive in. We share our preferences, our locations, our wish lists, tastes, and moods.

But would you do the same with your blood?

In a recent Investigative Fund story for Pacific Standard, I shared the story of a town where more than 10,000 people have contributed their blood, urine, and medical records in exchange for $10 gift cards to Walmart. Their hope is to help their town’s economy and the health of future generations.

The words of one participant haunted me: she said she would never want her samples used to make a profit by a private company in a way that could possibly create pricey drugs or unaffordable treatments. And it turns out that’s exactly what could happen: a portion of every contribution is marked for a commercial enterprise to create genetic tests for the market.

In fact, I traced the line of that woman’s blood, given in a small church in the South and entrusted to university researchers, to a warehouse on the edge of town where her vials are deep-frozen in perpetuity alongside thousands of others, a portion of them flagged for a company to make for-profit products. No law acknowledges the identifying link between her and her body’s most personal code—the DNA contained in her samples—and no national legal or regulatory framework is set up to protect the anonymity she is promised, much less the spirit of altruism she has vested in her gift.

Her blood, like that of hundreds of thousands of others who consent to biobanks on open-ended terms, could enter the world of de-identified samples—genetic materials not subject to any consent or health information privacy laws—but that might not be so de-identifiable after all.

Her story raises deep questions about the stark limits of current controls in a nascent industry at the very edge of the frontier of humans and technology: biobanking. Drawing on contributions from tens to hundreds of thousands of people, biobanks aggregate raw biological materials—blood, urine, and tissue, often alongside other medical, environmental, and health data about the donors. These banks are powering a quest to mine genetic and medical data for links between genes and disease.

One key U.S. law that should guide this research and protect participants, the Common Rule, was modeled on tenets developed after World War II. It requires participants to give “informed consent,” and to agree with full knowledge of the exact nature, duration, and purpose of research. It applies to all federally funded research involving humans, and to a much larger swath of activities that span everything from drug testing to behavioral research, as well as to biobanking.

How it all plays out in practice is a different matter.

linked from 18 pieces of personal health information deemed “protected” under federal law, including names, race, zip codes, addresses, facial images, phone numbers, or fingerprints. This is called “de-identification.” Once this process is complete, there are no laws to monitor or regulate these samples. They can be transferred outside of the research body to which they were donated; in the worst-case scenarios, those samples and data could be used for research purposes that might offend participants or, in the wrong hands, be used to discriminate against them or their families.

The biobanking industry shares its samples widely, and operates on the premise that de-identified samples don’t represent a risk to participants. They also say it is not feasible to contact donors each time samples are researched or shared. Having unlimited access to use and trade samples is key to how the business works, in part because samples grow more and more valuable to researchers over time. As new people join the biobank and the amount of data on each individual contributor grows, the information in biobank gains computational power.

But this highly dynamic situation is also what makes biobanking so fraught with questions. One of the biggest asks whether it is possible to give truly “informed” consent to a future with a lot of unknowns.

There is also evidence that even officially “de-identified” biological samples and data, using other publicly available information diffused across the electronic sphere, can be used to identify individuals—their names, their families, and addresses. Last year, for example, the New York Times featured a story on researchers who were able to zero in on specific people using DNA and one or two other pieces of information, or DNA alone, drawn at random from databases.

“Nowadays with DNA and the technology we have to analyze DNA and the databases out there with DNA that is connected to people’s names, the idea that something can be completely de-identified or not re-identified is very dubious,” says Dr. Stephanie Solomon, assistant professor of Health Care Ethics at the Albert Gnaegi Center for Health Care Ethics of Saint Louis University. “It is like once people say the magic word ‘de-identified,’ everything can relax—the donors can relax, the researchers can relax, the regulations can relax, and that scares me.”

Federal rule-makers are acutely aware of the problems in the biobanking model. A 2011 document from the Department of Health and Human Services (HHS) emphasizes that no current laws for protecting participants or their information were “written with an eye toward the advances that have come in genetic and information technologies that make complete de-identification of biospecimens impossible and re-identification of sensitive health data easier.” And a group of prominent computer scientists and data scholars sent a letter to HHS calling current privacy protections for human biological data “outdated” and “too narrow to address even today’s range of data privacy problems.”

But the process of updating those protections is at a standstill. A spokesperson for HHS said that although “relevant agencies within HHS are currently very much engaged in working out the details of moving forward with that proposal,” there is no timeline.

In the meantime, participants in biobanks must weigh the risks and benefits of an unknown future, not only for themselves but for anyone who shares their genes.

Meanwhile, the technology to use samples in myriad unforeseen ways is developing rapidly. “The whole history of research ethics is something horrible happens and everyone scurries around to stop it from happening again, and some of these things could have been anticipated and prevented,” Solomon says. She says she believes in the advances that can come out of biobanking are important, but false promises to participants could hinder biobanking. “If we say that the future is that all of this stuff is going to be identifiable, how do we best respect and protect people and also do the research we want to do? That is a much more appropriate way to go into the future.”

Amanda Wilson, Pacific Standard

In Search for Killer, DNA Sweep Exposes Intimate Family Secrets in Italy

The body of Yara Gambirasio, a 13-year-old student, was found on a chilly day in a quiet northern city in Lombardy in February 2011, three months after she was reported missing following a gymnastics practice. The autopsy showed she had been beaten but not sexually abused, stabbed several times and left to die in a field less than 10 miles from her home.

The autopsy also revealed stains on the young girl’s frayed clothing: a liquid that contained the DNA of a person whom investigators called “Unknown Male No. 1.”

In the absence of other evidence, investigators embarked on the country’s largest DNA dragnet, taking genetic samples from nearly 22,000 people.

Finally, last month, they said they had found their suspect, Massimo Giuseppe Bossetti, a 43-year-old father of three from Lombardy.

But what some praised as a triumph of modern science and 21st century sleuthing, has also set off a debate about the risks of privacy violations and the darkened corners of the past they can expose after the DNA testing also revealed something unknown even to the suspect’s family: that he was the illegitimate son of a man who had died in 1999.

Geneticists arrived at this conclusion after narrowing the DNA search to one local family and a long-dead bus driver whose known sons did not match the genetic sample found on the slain girl’s body. The dead man’s DNA was first lifted from a stamp he had licked. Later, he was exhumed to carry out further tests.

When a match was made last month, and Mr. Bossetti was arrested, the ensuing media frenzy was set off in part by the details of what one newspaper described as a “genetic soap opera.”

Recent confidences on the part of the residents of small towns in Lombardy about a long-ago — and until now secret — affair eventually led investigators to the mother of “Unknown Male No. 1,” who presumably cuckolded her husband with a local acquaintance in the late 1960s.

Italy’s privacy watchdog eventually berated the media for leaking news of the alleged affair and for pursuing comment from its unsuspecting protagonists, notably the cuckolded husband and the wife, and the suspect’s known and newly discovered siblings.

A sharply worded statement by Italy’s privacy authority called on media outlets to use “maximum respect” in reporting personal details incidental to the case of the murdered girl. “Not even the public interest legitimizes the media frenzy over intimate personal details such as to create irreparable damage to family life and personal relations,” Antonello Soro, the chief of Italy’s Data Protection agency, said in a statement.

Investigators had initially concentrated their efforts on tracking down people whose mobile phones had been used near where the girl was abducted and killed. The families of classmates were tested, as were regulars at a nearby discothèque and the members of the sports center where Ms. Gambirasio had taken gym classes.

Investigators said they could have eventually tested all 120,000 phone owners intercepted in the area that night. “But I don’t know if we would have gotten them all,” said Letizia Ruggeri, the lead prosecutor in the case. “Luckily we didn’t have to.”

Despite the sheer number of people tracked down for DNA testing, the investigation raised few eyebrows in Italy. A court order can be issued in case someone refuses to be tested, “but I never needed one because everyone submitted to the test voluntarily,” Ms. Ruggeri said. She acknowledged the extraordinary scale of the case, both in costs and in manpower, noting that it had been a one-of-a-kind situation. “But there was no legal obstacle to our doing it,” Ms. Ruggeri said.

The previously unknown familial ties and their public exposure are the unfortunate “collateral effects” of a complicated case, said Carlo Previderé, a forensic geneticist at the University of Pavia, where hundreds of DNA samples — including swabs from some 500 women identified as potential birth mothers of the suspect — were tested. The women included former classmates, colleagues, shopkeepers, neighbors and clients who would have known the deceased bus driver in the late 1960s. The testing eventually identified the birth mother.

Professor Previderé’s lab positively identified Mr. Bossetti after testing DNA material taken during a breath analyzer test staged by investigators, who pretended to stop him by chance.

“The important fact is that this man’s DNA is the same as the DNA found on Yara,” he said, noting that the odds of anyone else sharing the same genetic profile was “one person out of two billion of billions of billions” or practically nonexistent.

For investigators and the national media, the positive DNA match immediately emerged as the smoking gun in a case that had floundered for months and had resulted in one wrongful arrest.

By most media accounts, the case is effectively closed. Mr. Bossetti’s casual Facebook musings have been deconstructed to glean diabolical intent; personal habits — including a very Italian propensity to frequent tanning salons — have been reread by commentators in a dark, narcissistic key. Even the suspect’s reputation as a family man who attended church has been recast as a modern-day version of the classic wolf in sheep’s clothing.

“There’s the desire to punish, to dole out an exemplary punishment — the trial is as good as done because of the media effect,” said Roberta Barbieri, a lawyer who defended a Moroccan man arrested — and released — a few days after Yara’s disappearance.

Valerio Spigarelli, president of the national criminal lawyer’s body, is among those who have challenged the public dissemination of genetic information gathered through such vast DNA screening.

“When something leads to very personal rights, like paternity or maternity, perhaps the results could have been guarded a little more jealously,” he said.

Prosecutors say that while the DNA match is “very revealing,” other evidence consolidates their case, including the suspect’s presence in the area on the night of the murder. Furthermore, the suspect’s genetic material was found on the young girl’s underwear and leggings, “a sensitive spot, next to a cut” and its presence in that spot would be difficult to explain otherwise, said Ms. Ruggeri the prosecutor.

“DNA doesn’t fly,” said Luciano Garofano, the retired commander of the military police’s leading forensic department, based in Parma.

Mr. Bossetti insists he does not know how his DNA got onto Yara’s body. He spoke to prosecutors this month, “answering all the questions put to him, and explaining some elements,” one of his lawyers, Claudio Salvagni, said.

Yet even geneticists certain of the DNA match balk when it comes to definitively pinning the murder on the “Unknown Male No. 1.”

There is no doubt, said Giuseppe Novelli, an acclaimed geneticist and chancellor of the University of Rome Tor Vergata, whose department worked on the case, that the DNA traces found on the young girl belongs to the match. There is no doubt, either, “that he is the illegitimate son of a dead man,” he said.

“But whether he is the murderer, I don’t know,” Professor Novelli said. “Now we have to decide how it got on Yara’s body.”

Elisabetta Povoledo, NY Times

Who’s Keeping Your Data Safe in DNA Banks?

Thinner than average, with serious, shadowed eyes, Kevin Anderson, 36, has worked as a filmmaker for over 10 years. He’s traveled throughout Europe and the Americas producing web and sports videos, news packages and documentary shorts. In his infancy, he was diagnosed with a rare genetic disease, phenylketonuria (commonly referred to as PKU), where the body cannot properly break down protein. Throughout his life, he has taken medicine and followed a special low-protein diet, but other than these restrictions he enjoys a healthy life.

Recently, though, he “stumbled across this video that showed people with undiagnosed PKU.” While he had often heard stories about what would happen if he had never treated his condition, “I’d never seen pictures of it, I’d never encountered it myself, so it just wasn’t quite real to me,” he says. “And when I watched that video.… ” He trails off, choking up, pausing until the heartbreak passes. “It just captured me. I had the sudden realization I would have become mentally retarded; I would have been in an institution if it hadn’t been for newborn screening.”

Every year, approximately 4 million newborns in the U.S. are screened for congenital disorders, and about 12,500 of these infants are diagnosed with an inherited condition. Many of these disorders (like PKU) can be effectively treated when caught early, allowing an infant to grow and develop normally. By every account, newborn screening is one of modernity’s biggest medical success stories—yet most of us are not familiar with this compelling tale or even know that we most likely have been screened.

That’s the good news. The bad news is that we also may not be aware that many states have created biobanks funded by genetic material left over from our screening tests, and, even more surprising, our specimens may be used for purposes we do not fully understand or for which we have not granted informed consent.

Blood Spots

Massachusetts began the original newborn screening program back in 1963 with a test for PKU. Though few babies were found to have the condition, the benefit of an early diagnosis was so great that other states soon instituted screening programs. Once they’d adopted the practice, states expanded their scope and began testing for more conditions. Ten years ago, 46 states were screening for just six conditions; now all 50 states and the District of Columbia routinely screen newborns for at least 30 genetic conditions, with some states testing for nearly twice that number.

Though each state runs its own program, they all begin by collecting a blood spot from the heel of a newborn infant. The sample is analyzed; results are returned. Commonly, the screening program is first mentioned when a mother has checked into the hospital for delivery, and, generally, the programs are mandatory under state law.

That this information comes so late in the game is a “long-standing issue and a controversy to a certain extent in the newborn screening field,” says Dr. Jeffrey Botkin of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, which advises the Department of Health and Human Services on newborn screening. In the 1960s when the program was first developed, “the feeling was, the advantages for newborn screening were so compelling, it was appropriate or acceptable to have states simply mandate screening,” he says. Now 43 states allow parents to decline the screening process based on religious beliefs or philosophical reasons. Rarely, though, is that option exercised. Some believe the reason is that most parents only hear about the program in the hectic period after a mother in labor enters the hospital.

“These newborn screening DNA databases make a complete mockery of informed consent,” Jeremy Gruber, president of the Council for Responsible Genetics, tells Newsweek. “What people also don’t know…is that this is the one test that is not done by the hospital or a third party on behalf of the hospital.… It is done by the state department of public health.”

In most states, blood spots are transferred to long-term-storage banks run by state departments of health, where they are retained for at least a couple of years. But in 12 states, samples are kept in a biobank for 21 years or longer. That’s because, increasingly, health departments are using—and sharing—the genetic information for research and analysis. This practice has accelerated since 2009, when the National Institutes of Health (NIH) awarded a contract to the American College of Medical Genetics and Genomics (ACMG) to establish a Newborn Screening Translational Network and develop a national repository of newborn DNA “stored by state newborn screening programs and other resources.” Meanwhile California, Iowa, Michigan and New York already participate in a virtual repository, which allows researchers to access data—and in some cases the stored infant blood spots themselves—for their investigations.

This expansion of the newborn screening programs will continue to create new opportunities for big research ventures. As DNA sequencing becomes cheaper and more accessible, many predict whole genome sequencing will replace the current blood spot tests. According to ACMG Executive Director Michael S. Watson, the NIH has already awarded research grants to explore the feasibility of integrating whole genome sequencing into newborn screening.

Monetizing the Human Genome

It has been more than a decade since the human genome was first sequenced, and every week, it seems, there’s new research identifying a mutation to predict some dread disease. It is now understood, for example, that variations of the APoE gene may increase the risk of Alzheimer’s disease and that the BRCA gene mutation may double the risk of breast cancer.

In many cases, though, it’s still unclear how one genetic mutation might affect a person’s health. Scientists will need lots and lots of DNA samples to translate the wealth of information found in any one genome—it is only by comparison that they can understand how, when and which genes matter, separate from the environment. Current efforts at genetic analysis are plagued by a lot of noise and uncertainty.

For instance, 23andMe, a consumer genetics company, will sequence your DNA and provide you with ancestry-related reports and raw data. Previously, 23andMe’s reports included odds ratios for certain medical conditions. But in December 2013, the Food and Drug Administration (FDA) prohibited the company from continuing to sell health reports, as they could not be “analytically or clinically validated.” (The FDA’s approval process for these reports is ongoing.)

In reality, a health report may just be the most enticing carrot 23andMe was able to dream up in order to get your DNA in its computers. As noted by the authors of an article in The New England Journal of Medicine, “23andMe has…suggested that its longer-range goal is to collect a massive biobank of genetic information that can be used and sold for medical research and could also lead to patentable discoveries.” This characterization is not denied by 23andMe, which tells Newsweek, “The primary mission of our company is to accelerate genetic discovery.”

The real money, then, isn’t selling you a health analysis; it’s in using and selling your data for biomedical research.

It’s not much different from how Google, Yahoo and Facebook give us search engines, email and social networking for free, only to sell all the information they gather to anyone wishing to market products to us. 23andMe has already conducted research funded by the NIH and collaborated with academic and industry partners. The company offers customers who buy personal genetic reports the option to participate in its wider research program. Currently, 23andMe stores data from more than 700,000 genotyped customers, and of these, more than 80 percent have not only opted into the research program but have also actively answered survey questions.

“The way information becomes really valuable is when we can start to look at genetic information and also understand phenotypic data,” explains a company representative. Research looks something like this: After first isolating all their customers who have stated on a survey that they have a particular allergy—say, a cat allergy—a researcher might run a query to see if these customers share some genetic mutation, and with further analysis find out where those variants are located in the DNA. “Those are the things we want to explore,” 23andMe says. “But we can only do that if you answer questions.” Participation in biomedical research, then, really has two parts: consenting to use of your genetic data and providing your personal information to enhance the value of that data.

The company’s privacy policy states it cannot share individual-level data with third parties without a customer’s explicit permission. Consent only enables company researchers “to look at the de-identified genetic data in the aggregate,” 23andMe says.

The Illusion of Anonymous Information

The state screening programs and the Newborn Screening Translational Research Network also de-identify newborn baby blood spots before loaning them out to researchers, but so far truly anonymizing DNA has proved impossible.

“Right now we don’t know a way to guarantee anonymity from the technical aspect,” says Yaniv Ehrlich, a computational biologist at the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology. Famously, Ehrlich and his colleagues published a paper showing how they discovered the (supposedly hidden) identities of participants in genetic research studies by cross-referencing their data with publicly available information. A clever academic stunt, sure, but one that also revealed an uncomfortable truth and made many people question the possibility of privacy in the genomic era.

Some protections regarding genetic privacy do exist. The Genetic Information Nondiscrimination Act (GINA), which became law in 2008, prohibits health insurance companies from using genetic information to make eligibility, coverage or premium-setting decisions. The law also prevents employers from including genetic data in their decisions about hiring, firing and promotions. However, GINA has gaps. For instance, the law does not apply to companies with fewer than 15 employees or the U.S. military. And it also does not cover long-term care insurance, life insurance or disability insurance; for instance, having discovered you have the BRCA gene that raises your risk for breast cancer, a company can legally deny you a life insurance policy.

Botkin argues “there’s no motivation” for anyone to re-identify DNA and cross-reference it with public sources. “Why would anyone want to take the time and effort?” he says, adding, that so far “there are no examples of cases in which bio-specimens have been used in an unethical manner leading to individual harm.”

Watson offers a different perspective on the matter. “It just amazes me what people will put into social network and media about themselves and then be worried about the privacy of the exact same information in another context,” he says. “They don’t appreciate how easy it is to link across these things.” He and his colleagues have built barriers into the Newborn Screening Translational Research Network to prevent anyone from doing “this type of linkage” across databases.

Nevertheless, your DNA is a treasure trove of personal information, including your eye and hair color, paternity and health. Gruber likens it to a file cabinet containing your most secret documents, except with DNA it’s more as if you are walking around with these documents and “anyone with the proper tools can now open your filing cabinet and find out about you,” he says. The fact is, you shed DNA daily, in countless public places, and though you probably instinctively feel your DNA and sequenced genome is yours, you have no real ownership rights—especially once your DNA has been entered into a biobank.

Who Owns Your DNA?

Science magazine drew a very pointed analogy between genetic data banks and money banks in an article published earlier this year. As a bank account holder, you get a receipt when you deposit money. Later, you can access your account, and even terminate your relationship with the bank if you choose. “When we make a deposit to a data bank or biorepository, in contrast, putting our data or specimen into the hands of researchers or clinicians, we lose track of it,” the authors write, further noting how “a deposit to a research or clinical repository is a one-way transaction in which we give up most of our agency and control.”

Currently, the legal right to retain and use dried blood spots is determined by each state. While Oklahoma prohibits the use of dried blood spots for public health purposes, including research, without express parental consent, four other states declare the spots state property. Though rules are clear, Pediatrics reported, some states “may be acting outside the scope of their legal authority.”

Arguably, this was the case in 2008, when five families sued both the Texas Department of State Health Services (DSHS) and Texas A&M University for using stored blood spots for undisclosed research purposes without parental permission. Previously, Texas had destroyed samples soon after newborn screening, but the state changed its rules in 2002 without notifying parents and began donating stored samples to researchers. In the lawsuit, the Texas Civil Rights Project claimed using blood spots in this way went beyond the purposes of the newborn screening program and violated parents’ rights under the Fourth Amendment, which protects against “unreasonable searches and seizures” by the government. (Texas A&M declined to comment.) The case was settled out of court, with the DSHS required, as part of the agreement, to list on its website all the research projects to which blood spots had been sent.

It came out, then, that the DSHS had loaned blood spots to (and been “appropriately reimbursed” by) pharmaceutical companies, while also lending 800 blood spots to a lab run by the U.S. Armed Forces Institute of Pathology to help get its new forensic database up and running. The 800 spots were used to establish general reference points of variation among different ethnic groups. A representative explained that the DSHS provided de-identified blood spots “because we believed it was an important research project, and the information we agreed to provide in no way could be linked to a particular person.”

Nevertheless, once again the Texas Civil Rights Project filed a lawsuit, this time claiming the DSHS acted unlawfully and with deception when it sold, traded and distributed infant blood samples collected without consent between 2003 and 2009. The judge dismissed the case when none of the families named in the lawsuit were found to have unknowingly contributed to the pathology lab, says James Harrington, the lawyer who represented the families.

However, as a consequence of all the publicity, Texas destroyed millions of samples still stored in its biobank and enacted a new law in 2012 for its newborn screening program. “Now they ask people if they want to opt in, and they have to disclose if they’re giving it to someone else, a pharmaceutical company, whatever,” Harrington says.

Other states may soon be grappling with some of these same issues. Recently, Indiana learned how its Department of Health has stored blood samples from babies born since 1991 for possible use in medical research, all without parental permission.

Botkin says that people are “generally stunned” to learn the states are saving infant blood spots left over from the screen tests. And yet, when explanations are offered, the use of the blood spots clarified, the research oversight mechanisms explained, people are reassured, and the “vast majority” are supportive of state programs retaining and using specimens.

But maybe they shouldn’t be. Currently, there are private commercial data banks, including those run by health care companies; biobanks under the auspices of the NIH, academic and private research institutions; and the FBI’s Combined DNA Index System, routinely used for law enforcement purposes. Gruber says as genetic biobanks “become more widespread and the uses for DNA become more common…we’re going to start to see more and more bleed-over of these databases.” Your child’s DNA, then, might easily move out of the state newborn databases and into research programs where it might be used for purposes you never intended, or even imagined.

Susan Scutti, Newsweek

Revealed: SECRET DNA TEST SCANDAL at UN IP agency

Allegations of bizarre and potentially illegal conduct within the World Intellectual Property Organisation have raised serious questions, after The Register obtained access to an internal report indicating reasonable grounds to suspect serious misconduct within the UN agency.

The report, published exclusively by The Register today, outlines serious allegations against WIPO chief Francis Gurry. The organisation’s staff council has also demanded a prompt and independent investigation.

Gurry was re-elected director-general of WIPO last month despite questions over the alleged illegal DNA testing of staff, the shipping of computer equipment deemed useful for military purposes to Iran and North Korea and the award of a large IT contract to a company run by an acquaintance of the WIPO chief.

The internal Report of Misconduct , which includes 54 pages of exhibits, begins:

“I write to report what I believe is serious misconduct by WIPO Director General Francis Gurry. Specifically, I draw your attention to (1) the taking of DNA from senior WIPO staff members without their knowledge or consent, in violation of international human rights, as well as efforts to suppress evidence and investigation of the incident; and (2) evidence of the corruption of a recent procurement that was redirected and awarded to an Australian company led by an acquaintance of Mr Gurry, even though that company had not been selected in the competitive process.”

It is alleged that Gurry ordered the illegal collection of staff DNA in order to find out who sent anonymous letters of complaint to him and other directors.

The US State Department and South Korean officials have both asked for an independent investigation into the allegations, but instead WIPO appointed its own committee to decide if further action was required. This committee was allegedly implicated in the original, secret DNA testing of senior staff.

In May this year WIPO’s “Independent Advisory and Oversight Committee” (IAOC) considered whether there was a conflict of interest in handing the investigation to the organisation’s own Internal Audit and Oversight Division (IAOD).

In early May, WIPO’s legal counsel advised:

“The director of the IAOD deemed himself to have a conflict of interest, due to the fact that the Report refers to him (together with a number of other WIPO officials) in the DNA allegations. For this reason he recused himself from considering the report.”

But by the end of May, the IAOD, and its director Thierry Rajaobelina, apparently decided it was quite capable of carrying out a preliminary investigation without any fear of a conflict of interest.

WIPO’s staff council reacted angrily. It said in an internal email sent 15 May:

“The Staff Council strongly supports the call for an external, independent and professional investigation into the taking of staff DNA and the suppression of the facts.

“The Council’s primary concern is the welfare of WIPO staff. The theft of DNA from staff is a violation of their human rights. The evidence available, in the form of a report from the Hôpitaux Universitaires de Genève, shows conclusively that DNA was taken from staff without their knowledge or consent.

“Previous attempts to address this situation with the WIPO Administration have been unsuccessful, and to this day no explanation has been provided to staff as to why their DNA was taken secretly and without lifting of immunity.”

In a further email sent 11 June, the WIPO staff council said:

“The Staff council cannot comprehend how any new internal process investigating an issue of such gravity can possibly be fair and free of conflict.”

The email ends:

“The Staff Council further respectfully calls on the Secretary General of the United Nations in defense of the reputational interest of the UN and its core values and ethics, to intervene at this juncture to ensure that the investigation proceeds fairly and promptly.”

The DNA testing was begun in 2008 after Gurry received several anonymous, typed letters, seen by the Register. The letters, signed by the “Watchdog for International Civil Servants” and “Watchdog for International Civil Service” accused Gurry of financial impropriety and sexual harassment. Gurry took the letters to Swiss police, who found fingerprints and DNA from a man and a woman on the notes.

After the complaint was made, WIPO security staff secretly took cigarettes, lipstick, dental floss and sweet packets from staff offices in order to obtain DNA samples. These items were handed to Swiss police which gave them to the forensics department of the Hôpitaux Universitaires de Genève (HUG) for DNA analysis.

The complaint questions the legal basis of this testing because the staff, who were later fingerprinted and DNA tested by Swiss police, were never asked for their DNA and at the time were immune from prosecution because they were diplomats. Their immunity was not lifted until two months after the items were taken.

Eventually none of the staff were found to have DNA matching that found on the envelopes.

Gurry is also accused of improperly influencing the award of a WIPO contract to consultancy Argo Pacific, run by Dr Paul Twomey, a long-time acquaintance of Mr Gurry and former CEO of ICANN.

Despite claims that nothing links them except being born in Australia, a letter from Twomey to Gurry dating back to 2004 is available online  – and show Twomey inserting a handwritten “Francis” in front of “Mr Gurry” in the salutation.

The IT contract bid

Gurry has said his next six-year term will focus on adapting WIPO’s mission to better provide for the digital age. WIPO’s procurement process for the new IT contract began in summer of 2013. A bid package and terms of reference were written and sent out.

The report alleges that Gurry had subsequently complained that the bid package had not been sent to Argo Pacific, so it was recalled. An amended package was sent out in or around September 2013 to various companies including Argo Pacific.

The procurement committee followed WIPO rules by creating a formula for judging the various bids, allocating points to different aspects such as cost and technical competence.

The report alleges that Argo Pacific’s bid was 40 to 50 per cent higher than the next highest bid. When Gurry heard this, he allegedly told the committee to reduce the weighting or importance of price. It is alleged in the report that when this proved impossible under WIPO rules, he simply cancelled the procurement process and awarded the contract directly to Argo Pacific – a procedure only allowed in an emergency situation.

The report does not suggest that Argo or those running it acted improperly.

Contacted for comment on the matter this week, a WIPO spokeswoman told The Register:

“The Director General has already stated publicly that the allegations are without foundation and that he has no further comment.”

An insider at WIPO told the Register:

“Gurry is known as a smart guy and he’s had some success in reforming the organisation. But his competence as a leader and manager, his lack of impulse control and the lack of proper governance structure within WIPO mean he must now be suspended while the investigation is carried out.”

John Oates, The Register

 

DNA and Privacy in Vermont

The intersection of technology and law has been the scene of numerous collisions in recent years, and often it has been unclear which had the better claim to the right of way. A sharply divided Vermont Supreme Court decided just such a case last week, ruling that the routine collection of DNA samples from defendants charged with felonies is unconstitutional. We think the outcome is right, although not all the relevant issues have been addressed.

A little background is in order here. Vermont began collecting DNA samples in 1998 from those convicted of violent crimes. Seven years later, the law was expanded to include those convicted of any felony or attempted felony. Then in 2009, the Legislature extended the mandate to provide DNA samples to those arraigned on a felony charge for which a judge has found probable cause — that is, those who have been formally charged, but not yet convicted.

It was this iteration of the law that the justices last week ruled to be in violation of the Vermont Constitution’s provisions governing searches and seizures. It’s worth noting that these guarantees are more stringent than those contained in the Fourth Amendment of the U.S. Constitution. This is an important distinction because the U.S. Supreme Court has upheld a statute similar to Vermont’s that was challenged on Fourth Amendment grounds.

In a 3-2 ruling, the majority of the Vermont court basically held that the privacy interests of defendants who have not yet been convicted outweighed the state’s interest in collecting the samples and analyzing them. The justices noted that if the accused are eventually convicted, they would have to provide the sample anyway. And if not, the law requires that the sample and the analytic record drawn from it be destroyed — a recognition by the Legislature of the “limited weight of the State’s interest” in collecting the samples.

That seems about right to us. There are only two possible reasons to take samples from those charged and awaiting trial. One is to confirm that defendants are who they say they are, and the second is to compare their DNA profile with those taken from the scenes of crimes not yet solved or that are committed in the period between arraignment and trial. More conventional means of establishing identity have been used for years — fingerprints and photographs — and have proven effective. And the presumption of innocence requires that defendants who have not been convicted of any crime not be subjected to what amounts to a warrantless search when they are not suspected of committing any specific crime other than the one they are charged with.

One key issue not addressed in the decision — and which is a question to be sorted out another day by the courts or the Legislature — is the manner and duration of storage of DNA information. Vermont’s statutory program creates a DNA databank, containing DNA samples, and a DNA database, which contains profiles derived from the samples. These profiles are shared with a national database maintained by the FBI. The profiles are derived from analyzing the samples at 13 standard locations within the subject’s chromosomes, a process that yields highly specific individual identification without having any known association with disease or other personal medical information.

But as the court’s majority noted, DNA samples themselves contain a “massive amount of unique, private information ” that goes beyond identification. This could include health status; risk for developing certain diseases; and perhaps sexual orientation and even propensity for certain kinds of conduct. Prohibitions exist in Vermont’s law against misuse of this information. Nonetheless, it is cause for concern when government collects, and has the ability to analyze, vast amounts of personal information about individuals and potentially about their family members. It is a legitimate question what purpose is served by retaining the original DNA samples once the profile — the identification tool — has been derived. It seems to us that DNA analysis is such a powerful tool that it presents a strong temptation to misuse it, a temptation that could be removed without impinging on legitimate law enforcement needs.

Valley News editorial

Evanston Seeks To Stay Out Of Suit Over Posted DNA Results

Evanston Insurance Co. sued Gene By Gene Ltd. in Texas federal court Wednesday, challenging coverage for a proposed class action accusing the genetic testing services company of automatically publishing results on its website without getting permission from customers. 

   
The Illinois-based insurer urged the federal court to apply an exclusion in its policy for claims based on violations of any statute that limits the transmission of information or other material.

Evanston contests a duty to defend or indemnify for the underlying suit, which alleges violations of Alaska’s Genetic Privacy Act, under two general and professional liability policies as well as two excess policies.

“All of the Evanston policies contain a similar exclusion that exclude from coverage all claims asserted against Gene By Gene in the underlying lawsuit,” the insurer said in its complaint.

The insurance dispute stems from a proposed class action that accuses Gene By Gene of automatically posting full results of its customers’ DNA tests on its “publically[sic] available website” without getting its customers’ blessing.

The underlying plaintiff, Michael Cole, brought the putative class action on May 13 in Alaska federal court.

Cole claimed that Gene By Gene, also known as Family Tree, markets and sells DNA tests to consumers to help them research or identify their ancestry.

Family Tree offers customers who have received a DNA analysis the chance to research their origins, after which it automatically publishes their test results to its website, according to the suit.

Cole asks the Alaska federal court to require Family Tree to stop the alleged misconduct and to award actual damages as well as statutory damages of at least $5,000. Cole argues that Family Tree should pay $100,000 in statutory damages because its alleged violations of the Genetic Privacy Act allowed the company to reel in profits.

Evanston says it does not owe a duty to defend or indemnify Gene by Gene and seeks a ruling from the court saying as much.

A representative for Gene By Gene and an attorney representing Evanston were not immediately available to comment Wednesday.

The exclusion that Evanston raises in the dispute also applies to actions brought under the Telephone Consumer Protection Act and the CAN-SPAM Act, or any other similar statutes.

In a published opinion, the Eleventh Circuit recently applied a broad version of the TCPA exclusion, which applied to personal and advertising injuries tied to violations of “any statute” addressing the sending of “any material” by “any means whatsoever.”

Evanston’s exclusion applies to any “statute, law, rule, ordinance or regulation that prohibits or limits the sending, transmitting, communication or distribution of information or other material.”

Evanston is represented by Marc Wojciechowski of Wojciechowski & Associates PC.

Counsel information for Gene By Gene was not immediately available.

The case is Evanston Insurance Co. v. Gene By Gene Ltd., case number 4:14-cv-01842, in the U.S. District Court for the Southern District of Texas.

–Editing by Patricia K. Cole. , Law360

Indiana storing blood & DNA of 2 million children without parents’ consent

As word of an Eyewitness News investigation spreads through Holliday Park, parents admit they are surprised.
“You’re kidding, right? I had no idea,” said Ramon Moore, playing catch with his 7-year-old son, Xavier.
“I didn’t know that at all,” agreed Holly Ruth, holding her 3-month old son, Lincoln.
“Nobody ever told me,” echoed Mallory Ervin, chasing her 4-year-old son, Theo, on the playground.

Xavier, Lincoln, Theo and millions of other Indiana children all have something in common: the state of Indiana is storing their blood and DNA in an undisclosed state warehouse.

“I’m curious why they didn’t share that,” said Ervin. “It now makes me think ‘what are they hiding?’ As a parent, I’d absolutely like to know.”

13 Investigates has discovered the Indiana State Department of Health is holding the blood samples of more than 2.25 million Hoosier children – without their parents’ permission. If your children were born in Indiana since 1991, chances are their blood and DNA is among the state’s massive collection. 

Following WTHR’s investigation, state health officials are now seeking input on what to do with the blood samples after admitting they don’t have the consent needed to use them for anything.  

How Indiana got your kids’ DNA

Indiana, like most other states, conducts a newborn screening test on every baby born within its borders. As required by state law, a nurse or midwife takes a few drops of blood from the heel of each newborn. (There is a limited exemption for families citing religious objections.) 

The blood is collected on a special card and sent to the state’s Newborn Screening Lab in downtown Indianapolis. That’s where researchers quickly test the blood to look for more than 50 medical disorders that could be dangerous – and even deadly – if not detected early. Parents and physicians are notified of the results.

“It’s really to prevent bad outcomes for these children so they can reach their full potential,” said Bob Bowman, director of ISDH’s Genomics and Newborn Screening Program. “We can prevent severe mental retardation and even death.”

By nearly all accounts, the program is considered a public health success story. Each year, it identifies about 200 children who have serious metabolic, genetic or endocrine conditions. Newborn screenings help detect genetic heart defects in another 45 Indiana babies annually, and newborn hearing loss is identified in about 200 more babies, thanks to Indiana’s Newborn Screening Program.

Very few parents object to the state collecting their baby’s blood for the purpose of detecting health problems.

But there’s another part of the program most parents were never told about. For decades, ISDH has been keeping the leftover blood samples for possible use in medical research. And the health department admits it never asked parents’ permission to do that.

“No, we did nothing to notify parents,” said Bowman. “That’s why we are struggling right now to try to figure out what is the best and most appropriate thing to do.”

Warehouse full of blood

State health officials say its collection of dried blood and DNA is currently stored in 666 bankers boxes in a large warehouse in Indianapolis. ISDH agreed to provide 13 Investigates with a photo that shows rows of boxes stacked on shelves inside the warehouse, but it would not allow WTHR to visit the warehouse or say where the warehouse is located.

“Right now we have samples dating back to 1991, so there are approximately 2.25 to 2.5 million samples currently being held,” said Bowman. “We do have a lot.”

Because the boxes contain blood sample cards for almost all children born in Indiana over the past 23 years, they contain the DNA of native Hoosiers who are toddlers, adolescents, teenagers – even recent college graduates.

According to Bowman, the blood samples have been detached from personal identifying information, which is maintained separately in a state computer database.

Health officials have been storing all of the leftover blood in case it is requested for medical research. ISDH has received several requests but, so far, has not agreed to release the blood samples, realizing it did not obtain proper consent to do so.

Ethical dilemma

“In medical research, you do need to get formal permission. You need to tell someone what you are planning to do. That was not happening,” said Dr. Eric Meslin, director of the IU School of Medicine’s Center for Bioethics. Even though the samples have not been used for research, he says collecting blood for one purpose and then warehousing it for another is not good public policy.

“I think it’s very legitimate for people to be concerned and wonder ‘What happened?’ I think it’s a natural human reaction [to say] ‘You’ve got something of mine and I don’t know about it?’ In a situation like this, you need to ask permission,” he said.

Sidney Blake, whose three young children were all born in Indiana, says the lack of consent is troubling.

“As a parent, if something is going to be done with my child’s blood, I definitely would like to know that,” Blake said. “I just think it’s the type of of thing you should disclose up front.”

Other parents say the state’s failure to disclose its intentions undermines what might otherwise be an acceptable concept.

“I’m all for research, but I want to know about it,” said Ervin. “I think because they didn’t obtain the proper consent, I’d ask the state to destroy what they have without my permission.”
    
“That is the risk,” explained Meslin. “The tragedy would be people misinterpreting silence as some kind of devious plan when, in fact, it was just people forgetting to ask. To be ethically smart, legally smart, scientifically smart, you just have to ask.”

New state policy

Asking is exactly what the state health department is now doing. Last year it changed its notification policy for newborn screening tests. Parents are now asked up front whether they will allow their newborn baby’s blood to be used for research. And if they say no, their child’s blood sample is no longer kept for decades. 

“Those are stored in the lab for six months, after which time we destroy them,” said lab director Barb Lesko.

But that new policy applies only to newborn screenings conducted within the past twelve months. What about all the blood samples collected before that — the more than 2 million blood samples now stored away in boxes in a state warehouse?

“We don’t have consent for those samples to do additional testing, so right now they are just sitting there, waiting for determination on what to do with them next,” Lesko explained.

Both ISDH and the screening lab insist newborn blood will NOT be released for research without parental permission — permission the state does not have. 

And even if the state did have proper consent, 13 Investigates has discovered the state’s massive collection of blood might be unfit for research.  

Indiana now stores its newer blood samples in locked freezers maintained at sub-zero temperatures. That helps preserve and protect the blood’s DNA. But older samples have been kept for decades in a warehouse with no temperature or humidity controls. The state admits that could be a significant problem.

“At this particular point in time we don’t even know how many of the older samples could be used for research,” said Bowman. Asked if the state’s more than 2 million stored blood samples might be useless, Bowman responded: “It’s possible, yes.”

So the state is holding onto millions of baby blood samples for research even though the blood might no longer be scientifically viable. And even if it is, the state doesn’t have your permission to use the blood for research anyway.
     
It begs the question: Why is the blood still being kept at all?

“Again, it’s something we’re struggling with,” Bowman replied with a deep sigh. “It is a complex issue.”

You get to decide

In response to WTHR’s investigation, the state health department has decided to allow you to decide what happens to your children’s blood samples.

Do you want them kept for research or do you want the state to destroy them?

The choice is now yours.

“We are eager to hear what parents have to say,” Bowman said. “We know there are some parents who would definitely like those samples destroyed. There are some parents who would like those samples kept. Determining how to exactly figure out which parents would want those samples kept and which ones would want them destroyed is presenting a challenge for us.”

Consider your options carefully

Some privacy advocates argue states should have strict limits placed on the blood samples they collect from newborn babies.

“It’s one thing for newborn blood samples to be tested for a specific set of newborn genetic conditions; it’s entirely another for the government to grant itself the right…to use them for genetic research without parental knowledge or consent,” wrote Twila Brase, president of Citizen’s Council for Health Freedom a national organization dedicated to protecting patient and privacy rights.

Her organization believes state and federal efforts to expand newborn screening programs can be a “back-door effort to bypass parental rights, collect and store newborn DNA and expand government access to the genetic code of Americans.”

Those who agree may be inclined to ask the state to destroy their children’s blood samples, which the state health department has stored without consent for possible research projects.

Kristine McCormick hopes parents will make a different choice: give the state permission to use your children’s stored blood for future research.

McCormick lost her 5-day-old daughter, Cora, to a congenital heart defect one year before Indiana included congenital heart defect testing as part of its newborn screening program. At the time, researchers were still developing the test that may have saved Cora’s life.

“I know it’s scary to think that your daughter’s blood is stored somewhere. But I think it’s a lot scarier to attend your daughter’s funeral,” she said. “Research wasn’t in time to save my child’s life, but the research that could be done on the blood spots that are stored … who knows where this research could lead. It could save a lot of babies.”

Meslin believes the state’s collection of dried newborn blood could prove to be valuable for future studies on a variety of topics such as autism, and he says discarding the blood would be “a terrible waste.”

“We are in the midst of a genetic revolution,” the ethicist said. “We have the ability to learn more and more from little bits of blood and biopsy material. If we throw all that away, it means any scientific value is lost – lost forever. That’s not in the public interest.”

Lesko says regardless of a parent’s decision, the state’s Newborn Screening Lab will comply.

“As a parent, you want to have control over what’s done with part of your child,” said Lesko. “It’s important for us to be as transparent as we can be, and we want parents to make the final decision.” 

 Bob Segall, WTHR 13

Vermont court rules no DNA collection until conviction

The Vermont Supreme Court has ruled in favor of more than 100 alleged offenders. The case dealt with the collection of their DNA and a suspect’s right to keep their genetic material private prior to conviction.

The ruling won’t overturn any convictions because the practice of collecting a suspect’s DNA has been on hold since the court challenges began, but there’s no way to know how many unsolved cases will remain that way due to the decision.

In a 3-2 decision issued Friday, the Vermont Supreme Court struck down a 2009 law allowing investigators to collect DNA from all felony suspects after being charged.

The law has been on hold since the state’s defender general brought multiple suits which represented more than 100 alleged offenders.

Without the ruling, law enforcement could collect samples and compare a suspect’s genetic material to that recovered from the scenes of unsolved crimes.

“And what the court made clear is that there’s no ability to do that without a warrant, so in other words, the court needs a good legal reason to collect someone’s DNA,” said Dan Barrett of the American Civil Liberties Union of Vermont.

Barrett called the ruling a great decision. He says though the method could solve crimes or potentially clear wrongfully convicted individuals, it’s too invasive for Vermont’s constitutional privacy protections.

“The important distinction for us is when one has been accused of a crime, but not convicted. As everybody knows from watching ‘Law and Order,’ one is presumed innocent until proven guilty, so that has to mean something under our Constitution,” said Barrett.

Barrett says a different Vermont law will still allow those who say they didn’t do it to request a test of an alternate suspect.

“I think there’s a greater likelihood of having people who have committed a crime not being found out,” said Jerry O’Neil, a former federal prosecutor.

O’Neill says there’s no way of knowing to what extent that may be the case though. He also points out that the court’s justices hinted they could sign off on similar but slightly different version of the law.

“Certainly the Legislature could change the statute in such a way that it will be possible to go ahead and get those samples anyway,” said O’Neill.

A key proponent of the law, Sen. Dick Sears, D-Bennington County, says he hasn’t read the decision yet, but will consider bringing forward a new proposal next year if re-elected.

The law did require it to be expunged if prosecutors could not prove their guilt however; the time necessary for a trial may have given investigators the opportunity to tie the suspect to a different crime.

Kyle Midura, WCAX

Canada Agency Clashes With Insurers on Genetic Testing

A Canadian agency is pushing life and health insurers to stop asking applicants for access to genetic test results, drawing resistance from an industry that says the data help companies properly price policies.

The request today from the Office of the Privacy Commissioner of Canada asks insurers to go beyond their voluntary moratorium on asking clients to undergo tests. Without the assurance of permanent privacy, some people would be discouraged from undergoing exams because the results could eventually be used against them, the office said.

“It is not clear that the collection and use of genetic test results by insurance companies is demonstrably necessary, effective, proportionate or the least intrusive means of achieving the industry’s objectives,” according to the statement.

The tests may show a vulnerability to cancer or other disease. In the U.S., a law prohibits genetic discrimination by employers and health insurers. The Genetic Information Nondiscrimination Act of 2008 doesn’t apply to life insurance or long-term care coverage, according to the U.S. National Institutes of Health. Some states have additional laws.

“They say these tests aren’t necessary, we think they are,” said Frank Zinatelli, vice president and general counsel for the Canadian Life and Health Insurance Association, the industry group representing 99 percent of the industry in the country. “This would be significant if we were not permitted to collect information that’s relevant to assess risk properly.”

Katia Dmitrieva , Bloomberg

David Cameron in talks with EU leaders over international DNA database

David Cameron has been involved in talks which could increase cooperation over policing in Europe, documents show.

Ministers have told EU leaders that they will make a decision on whether to take part in a Europe-wide DNA database by 1 December next year and have promised to compensate Brussels if Britain decides to pull out.

Britain insisted on the right to opt out of 133 EU-wide policing measures when it signed the Lisbon treaty in 2007. It has until December this year to decide which exactly it wants to implement.

A document leaked to the Times states: “The UK government has also indicated that in a number of other cases it will set in motion a process towards the subsequent opting in to certain other instruments of particular importance.”

The development will add to the discontent among some Eurosceptic Conservative backbenchers who remain mistrustful of Cameron and concerned by the rise of Ukip. It follows a grandstanding performance by Cameron last week as he criticised the planned appointment of Jean-Claude Juncker as commission president.

Jacob Rees-Mogg, a leading Eurosceptic, told the Times that Cameron faced a serious battle: “As the prime minister has made it clear that he wishes to bring back powers in relation to justice and home affairs, it is surprising that the foreign office is paving the way for a further surrender of power to Brussels.

“It is troubling that more information is coming from leaked commission documents and press releases than from statements to the House of Commons. This lessens the ability of the British people to scrutinise the activities of the government and is characteristic of the back-room deals that led to Mr Juncker’s appointment.”

Rajeev Syal , The Guardian