Monthly Archives: March 2014

Privacy activists decry bill to restore newborn blood sample storage

The Minnesota Department of Health would regain broad authority to test and store blood samples from newborn babies under legislation that has pitted medical privacy activists against advocates of public health and medical research.

The bill, which has passed key committees in the House and Senate, would reverse the direction of recent court rulings, allowing the Health Department to retain blood samples for medical research unless parents specifically say no.

Physicians and state health officials say the tiny blood spots, typically drawn about 24 hours after a baby is born, allow early detection and treatment of dozens of hereditary illnesses, and then, once stored, help scientists study pediatric diseases.

“Minnesota was always the model across the nation for newborn screening, and we have fallen a long way in the last couple years off that,” said Rep. Kim Norton, DFL-Rochester, chief author of the House bill. “And we can return to that and still allow people to opt out.”

Twila Brase, president of the Citizens’ Council for Health Freedom, who has emerged as an influential voice on medical privacy, said the bill would give the state unsettling power to store and use babies’ genetic information.

“Anything having to do with newborn screening has to do with looking into the genetics, into the DNA, of the child,” she said. The bill, she said, would allow “a vast array of research that is going to be done without consent.”

At issue in the legislation is whether parents must “opt out” of having their newborns’ blood sampled and stored, or “opt in.”

A 2011 Minnesota Supreme Court order requires the Health Department to destroy blood samples that test negative after 71 days and samples that test positive after two years, unless parents “opt in” and give written consent that it can keep them.

Bill proponents say that approach decreases the number of babies tested and samples retained because, in the stressful atmosphere of a hospital after birth, many parents would fail to fill out the consent paperwork, even if they wouldn’t otherwise object to the pediatric research.

The bill would allow the department to keep the samples, regardless of the test results, unless the parents fill out a form saying they want them destroyed. Parents or guardians could opt out of testing altogether or out of just storing the spots after testing.

The bill also says the Health Department can use the blood samples for calibrating machines to prevent false positives and to develop future tests that could find more diseases than those screened for now. Any researchers who want to use the blood samples would still have to contact the families and get consent first.

Allowing parents to “opt out” would respect parents’ rights while maintaining a large archive of blood samples, according to Sen. John Marty, DFL-Roseville, chief author of the Senate bill.

“It’s such a lifesaving thing, I think the default ought to be that we’re trying to take interest in the kid’s well-being,” Marty said. “If you have strong moral objections, then you do have the authority as a parent to opt out, but the default should be to protect the interest of the kid.”

Marty said using stored samples is crucial to developing tests for more diseases. When his children were born, in the 1980s, the test could identify about a dozen conditions. Now, Minnesota tests for 54 different diseases and disorders, from cystic fibrosis to hearing loss.

Brase said she thinks passing the bill would result in fewer families participating in the test, because they don’t trust the state to handle their babies’ genetic data responsibly. Having an opt-in model would ensure that parents know what the state will do with their babies’ data, Brase said, because they’ll have filled out a form saying they understand.

In addition to the “opt out” provisions, the bill would require the Health Department to educate more families about the newborn screening program before they get to the hospital, such as through Lamaze classes.

But the bill text says education materials only have to include the “benefits” of newborn screening. Brase said if it were a true education component, it would also include the risks.

 

Rebecca Harrington , Star Tribune.

Google invites geneticists to upload DNA data to cloud

Googling a person is about to take on a completely new meaning.

The Mountain View search giant recently invited geneticists to upload information to the company’s cloud infrastructure. Google also provided scientists with instructions on how to import, process, store and, of course, search DNA data that could unlock clues to curing diseases.

Google’s foray into genomics could open big markets for a company that has already made substantial investments in health care.

“This whole area, by the way of genome analysis, is really in general a hot area,” said George Geis, an adjunct professor who specializes in technology mergers and acquisitions at UCLA’s Anderson School of Management.

A MarketsandMarkets report valued the global genomics market at $11 billion in 2013 and predicted it will reach $19 billion by 2018. The North American health care cloud-computing market is also expected to grow fast in that time, up 30 percent to $6.5 billion.

Enormous databases

Sequencing the human genome can reveal deadly mutations as well as pathways for life-saving drugs. Since one individual’s genome can add up to about 100 gigabytes of data, researchers must perform rigorous analysis to pry insights out of enormous databases.

At the same time, scientists and companies must answer questions about where to store the information, who should have access and how to protect privacy.

To help address those concerns, Google recently joined the Global Alliance for Genomics and Health, a coalition of health care providers, research universities, life science firms and others. The group, which met for the first time this month, is trying to encourage the industry to pool resources and establish standards on how to manage the data.

Expanding into health

For now, Google is providing the genetics community with Web services for free. But “it could very well be something that provides a top-line revenue for them going forward,” Geis said.

The company is quickly expanding into health and medicine. Google owns Calico, a biotech company developing technologies to extend human life. In January, Google unveiled a prototype contact lens designed to help diabetics monitor their blood glucose. It also uses aggregated search data to estimate flu activity in more than 25 countries, and once operated a personal health-record service that let users create profiles for their health conditions, medications, allergies and lab results.

Someday, Google could use genetic data to make its own medical discoveries, Geis said.

“It could very well transform Google into another type of company – it partners with a pharmaceutical company or licenses its discoveries and patents its discoveries,” he said.

But Google faces competition from companies large and small already in the genomics-analysis field.

For two years, Amazon’s cloud service has hosted the 1,000 Genomes Project, the world’s largest database of human genetics. Although the data are public and free, Amazon does charge researchers to use its high-powered computing resources to run data calculations.

‘Lots of room’

“Generally speaking, the cloud space is still in its infancy and there’s lots of room, certainly, for industrial players to try to apply their particular implementation of cloud technologies to new areas,” said Ramon Felciano, co-founder of Ingenuity Systems. The Redwood City company, which was recently acquired by Qiagen, makes software for analyzing biological data.

DNANexus in Mountain View also provides cloud storage for genetic data. Chief Cloud Officer Omar Serang said the company joined the Global Alliance for Genomics and Health because scientists and companies can’t advance research without a common format.

“Information is incredibly siloed,” Felciano said.

The sensitive nature of genetic data prevents easy collaboration due to patients’ privacy concerns.

“The whole field of genetic research, especially genetic research based off large data sets or well-sequenced genomes, is ripe with privacy and ethical issues,” said Lee Tien, a senior staff attorney at the Electronic Frontier Foundation in San Francisco.

Privacy standards

While hospitals and academic institutions must adhere to patient privacy rules, private companies do not necessarily follow those standards, Tien said.

Members of the Global Alliance for Genomics and Health are working to develop common policies that govern ethics, data storage and security. For its part, Google says genomic data stored in its cloud is secure.

“Private data remains private, public data is available to the community anywhere,” the company said on its website.

Tien remans cautious.

“It may all go well,” he said. “But in other cases there will be surprises – and you don’t really want surprises with genetic data.”

Stephanie M. Lee, SF Chronicle

Facing up to the limits of DNA-based forensics

IT’S being dubbed “molecular photofitting”: producing an image of a suspect’s face from DNA left at the crime scene. New research suggests that such reconstructions may soon be possible, giving police another investigative tool.

Until now, DNA has been used to predict only a few physical characteristics, such as certain shades of hair colour, and to draw broad conclusions about genetic ancestry. Concerns have been raised about these predictions being used for crude profiling, potentially racially tinged, which have led Germany and several US states to bar their use by police.

The new technique considers individual variation in facial structure, and thus promises greater refinement. But it could still be used in unsettling ways.

DNA-based forensics carry huge weight in the criminal justice system, and computer-generated images can be seductive. It is easy to see how a judge might accept sophisticated-looking 3D images computed from DNA as “probable cause” to issue a search warrant. Imagine being hauled off for questioning by the police, or having your home turned over by investigators, just because you resemble a photofit assembled from crime-scene DNA.

A conventional DNA test should put innocents in the clear – but only after unsettling scrutiny. That’s why it is crucial for the accuracy of this approach to be validated independently before it comes into widespread use.

DNA-based analysis holds enormous power to convict and to exonerate. But as a two-part New Scientist investigation showed in 2010, its conclusions can be biased both by the statistical methods used and by subjective judgments.

The new tool wouldn’t be used to convict, but wrongful arrests and unjustified searches are still violations of civil liberties. We shouldn’t be blinded by awe at its power: justice won’t always be done just because the face fits.

New Scientist

 

 

Court keeps DNA law, but suit still alive

A federal appeals court says California can continue to enforce its voter-approved DNA law, which requires police to take genetic samples of anyone arrested for a felony. But — to the relief of a Bay Area political protester and other opponents of the law — the court says their legal challenge can continue as well.

The law was part of a 2004 ballot measure but didn’t take effect until 2009. It requires officers to swab an inner cheek of all felony arrestees for DNA and enter the information in a national database. The previous state law had required DNA samples only after a felony conviction.

State officials say the law is a valuable crime-solving tool. Civil liberties groups say it’s an invasion of privacy.

The U.S. Supreme Court took its first look at state DNA laws in June and voted 5-4 to uphold a Maryland law that requires genetic samples from anyone who is charged with a serious felony, which includes burglaries and crimes of violence. Based on that ruling, the Ninth U.S. Circuit Court of Appeals in San Francisco denied a request Thursday to block enforcement of the California law.

But in a 10-1 decision, the court said opponents can go back to a federal judge in San Francisco and try to persuade him to block provisions of the California law that are broader than Maryland’s — such as DNA sampling from those arrested for low-grade felonies, like drug possession and repeated shoplifting. The California law also allows samples to be taken earlier, at the time of arrest, and according to the plaintiffs, also makes it hard to get a DNA sample removed from the database even if the person is never convicted of a felony.

The only disagreement came from Judge Milan Smith, who said the Supreme Court had made it clear that a state could require DNA sampling — a “minor intrusion,” as the court described it — from anyone arrested for any felony, major or minor. That means the California law is also constitutional, he said.

The lead plaintiff in the California case is Elizabeth Haskell of Oakland, who was arrested at a March 2009 antiwar rally in San Francisco on suspicion of forcibly trying to free another demonstrator. She gave a DNA sample and was later released without charges.

Attorney Michael Risher of the American Civil Liberties Union, who represents Haskell and others challenging the California law, said Thursday’s order gives them “the opportunity to show that as applied to people who are arrested for less-serious offenses, who are never charged with a crime, who never go before a judge for a probable-cause determination, this law is unconstitutional.”

Bob Egelko , SF Gate

CRG Testifies Against Rollback of Newborn Privacy Protections

March 17, 2014

Chairman John Lesch
House Civil Law Committee Minnesota House of Representatives

RE: HF 2526
Mr. Chairman and Members of the Committee.

Founded in 1983, the Council for Responsible Genetics is the oldest national bioethics organization in the United States. We led successful efforts to enact the federal Genetic Information Nondiscrimination Act and have supported every state and federal genetic privacy initiative in the last thirty years. We are founders of the Genetic Privacy Network and the Forensic Genetics Policy Initiative and have produced many influential books and reports including Genetic Explanations andBiotechnology in our Lives. Our Board of Directors includes leading scientists and public policy professionals.

We stand in strong opposition to HF 2526. We believe this bill is against the interests of parents in making a truly informed choice about whether the state of Minnesota shall permanently retain and use their children’s personal genetic information.

Before they are even a week old, ninety-eight percent of the 4.3 million babies born annually in the United States have a small sample of blood taken from their heels. These newborn bloodspots (NBS) are then screened for a variety of inherited conditions and are often later stored in state-operated databases. Newborn screening itself is an important public health program and some have described these residual sample “biobanks” in equally positive terms. Although there are concrete benefits of newborn testing, there are also troubling consent and privacy issues raised by the screening, storage, and use of the samples.

With respect to sample storage and use, there is little transparency regarding storage procedures or the use of the samples after they have been screened. Indeed, not only do most parents never realize they have “consented” to storage of their children’s biological material, they fail to understand that the actual state government (as opposed to the hospital) is the entity in possession of this sample.

Several studies have shown that the vast majority of parents want the choice as to whether the state should maintain their child’s sample after screening is completed and most oppose the indefinite storage of such samples. Even though parents want informed consent to store and use the samples, many states including Minnesota do not have clearly articulated policies about consent for the storage and use of samples, do not effectively communicate these policies to parents and do not offer parents a truly informed choice about whether to participate in storage procedures.

The concern of parents that states retain their children’s biological information is heightened because storage procedures and security at these state facilities are arcane and we still have few laws that truly protect the privacy of genetic information.

The opt-out model, which is the basis of HF 2526 is not a true model of consent because it does not require any actual form of consent. One problem of the opt-out model is the ambiguity posed by silence. As applied to the case of newborn screening, a parent who does not voice objection to the screening program may still approve of the program and consent to screening and storage even if s/he does not express affirmative consent. On the other hand, that same parent may disapprove of newborn screening and want to opt out of the program, but s/he is either uninformed about or unaware of the program and therefore does not express explicit refusal. In both cases, however, the outcome is the same: the infant will undergo screening and their sample will be stored. Thus, the opt-out model for screening depends upon parents being well informed about the screening programs and their consent options. The reality, however, is that many parents are not well informed about screening programs or consent, due to inopportune methods and timing of information dissemination and the lack of adequate training for medical professionals responsible for communicating the information. Parents, understandably, want to be actively involved in decision making regarding their children’s personal health information.

Finally, affirmative consent for storage is crucial because it promotes greater governmental transparency. Such transparency is especially important because newborn screening and storage is often exempted from state genetic privacy laws. Researchers and administrators working with these samples know very well how alarming newborn blood spot biobanking can sound to most people, which explains why many of these clinicians, researchers and state labs would prefer these projects to keep a low profile. However, public health officials’ desire to avoid controversy must be balanced against parental interest in being informed about the storage and use of their children’s bloodspots.

How many parents, having just had a baby and still in the hospital truly understand what the state may or may not be telling them? Thus, the only way to be sure that someone is truly consenting is to obtain his or her affirmative consent, as required by the opt-in model.

HF 2526 employees a mechanism for storage of newborn bloodspots that stands in direct opposition to recommendations by the Task Force on Genetic Screening, the Newborn Screening Task Force, and the President’s Council on Bioethics. All three organizations propose that the storage of residual bloodspots should be implemented as an opt-in model of consent. Numerous studies have also supported this position. 

 

The absence of clearly articulated and communicated consent policies is particularly problematic because of the mismatch between the promise of maintaining residual sample databases and the actual benefits generated by such storage. As mentioned above, public health officials and patient groups often emphasize the value that these databases represent, but the actual benefits generated are much less dramatic than their statements would suggest. Across the country, state stored blood spots are used almost exclusively for formulating screening tests and ensuring that existing tests meet certain quality standards. While these are beneficial applications of storage, they do not require the scale of current sample storage and can often be done even more effectively in appropriate research facilities. They certainly fall far short of the too often claimed promises of elucidating disease characteristics and generating earlier interventions.

Newborn screening is one of the few forms of genetic testing to which almost everyone is exposed. Yet parental knowledge of newborn screening and storage practices is extremely limited. As the National Institutes of Health (NIH) and other distinguished bodies move toward developing better and more informed consent procedures, HF 2526 would be moving the state of Minnesota in the opposite direction; against historical trends and even more importantly the desires of Minnesota parents.

We strongly encourage you to oppose HF 2526.

 

Testimony Prepared by:

Jeremy Gruber
President
Council for Responsible Genetics
5 Upland Rd, Suite 3
Cambridge, MA 02140 www.councilforresponsiblegenetics.org 

Newborn-screening bill would end genetic privacy

In a recent commentary, five hospital executives tried to frighten Minnesotans into thinking that if a proposed bill isn’t passed in the Legislature, their babies’ lives will be in danger.

The truth is that Senate File 2047 and House File 2526 would not change newborn screening. Rather, this legislation focuses on what would happen after the screening is done. It would repeal a current law that requires parental consent for the government to store and use newborn DNA and babies’ genetic data. Essentially, this legislation ends genetic privacy.

A Minnesota Supreme Court decision in November 2011 ruled in favor of 21 Minnesota families who sued the Minnesota Department of Health (MDH) over its secretly storing their babies’ DNA. MDH, which began storing and using genetic test results and baby DNA in 1986 without legislative authority, had argued that newborn-screening blood spots are not genetic information. But the Supreme Court found it in violation of the state’s genetic privacy law. A settlement earlier this year required MDH to discard the illegally stored DNA of about 1 million babies.

Now, MDH and others who support research without consent are attempting to get around that ruling. The new legislation, which two committees already have approved, will undo the consent requirements now in law because of the Supreme Court decision and put the handling of our children’s private genetic data back in the hands of the government.

MDH and some hospital executives think they should be able to store and conduct research on the genetic blueprint of 70,000 babies born every year in Minnesota — forever. The Citizens’ Council for Health Freedom strongly disagrees.

We believe in newborn screening for the health and safety of our state’s youngest residents. But it is unnecessary to keep their genetic information without parental consent. As current law requires, 71 days after newborn screening is completed, the blood spots used for the tests should be destroyed unless parents give written informed consent. Currently, after 24 months, genetic test results are also destroyed, unless there is parental consent.

This year’s bills replace consent with dissent, meaning parents must first learn about the practice of storing their babies’ genetic data and then apply to the government to leave the storage and research program. Today, the Health Department can’t do anything until the parent signs a consent form — and we think that’s the way it should be. The ACLU, in a May 14, 2010, letter to the federal newborn screening advisory committee, agreed, calling for express informed consent.

Parents also think that’s the way it should be. A study out of the University of Michigan, “Not Without My Permission,” found that three-quarters of parents support parental consent for research. They want to be asked before their child’s DNA is analyzed. If they approve of the research, they’ll likely give their consent.

Permission will become even more important as genomic sequencing advances. Last September, the federal government awarded $25 million to four institutions to develop a genomic-sequencing program for newborn screening. This would detail every part of the child’s genetic code — at birth. Under the proposed Minnesota legislation, the genetic code, along with the child’s DNA, would be held by state government. As cost containment becomes the push of health care reform, where could this lead? What could government officials decide to do when they hold the genetic code of every child — when they know the potential health care conditions of every citizen from birth?

Proponents of the legislation say parents would still have a choice. They could opt out. True enough, but that’s not consent. It’s not even a real choice. The fact is, many parents can’t remember the newborn screening being done. If they remember, they think it is the hospital laboratory doing the test. They have no reason to think that it’s a government program or that the government would store and use the child’s DNA for research without their consent.

Minnesota has had parental consent requirements for two years. If this legislation becomes law, we’ll move from sunshine back to secrecy. This must not happen.

 

Twila Brase, Star Tribune

 

Hacking Your DNA

Keeping track of what we reveal about ourselves each day—through email and text messages, Amazon purchases and Facebook “likes”—is hard enough.

Imagine a future when Big Data has access not only to your shopping habits, but also to your DNA and other deeply personal data collected about our bodies and behavior—and about the inner workings of our proteins and cells. What will the government and others do with that data? And will we be unaware of how it’s being used—or abused—until a future Edward Snowden emerges to tell us?

Consider this scenario: A few years from now the National Security Agency hires a young analyst trained in cyber-genetics. She is assigned to comb through millions of DNA profiles in search of markers that might identify terrorists and spies and other persons of interest. It’s simple enough, since almost every American and billions of other people have deposited their complete genomes—every A, C, T and G in their cells—into one of the huge new digital health networks, the new Googles and Verizons of medical data.

Sequencing a person’s entire DNA profile will be as cheap as getting a car wash. High-end automobiles and hotels are likely to have installed photonic (light) sensors—devices that quickly read small segments of DNA in a customer’s skin cells to confirm their identity—to unlock doors. Banks may offer DNA-secure accounts that can only be accessed by a person with the correct genetic code.

People in this future world will be accustomed to genetics guiding treatments and saving lives, even as they remain uneasy about who exactly has access—Employers? Insurers? The government? Their spouse or lover?

With her top-secret clearance, the NSA’s new analyst discovers that the agency has accessed the genetic records of not only suspected terrorists, but also heads of state and leaders in industry, academia, the arts and the news media. Troubled by what she has learned, the analyst announces that she’s taking a vacation, and flies to a neutral country carrying top-secret cyber-genetic documents stored on an encrypted nanochip. Like Edward Snowden, she gives her data to a reporter, with the hope of rectifying the injustices she has witnessed.

For better or worse, we’re not there yet. In 2014, neither the government nor the public sector are anywhere near having a World Wide Web for genetic and other personal molecular data, or a global wireless network that can access anyone’s genetic data from anywhere. If this were the Internet, the technology would be in about 1985—at the very beginning.

Physicians, however, are already using genomics to predict and diagnose diseases such as breast cancer and macular degeneration. Thousands of parents use prenatal genetic tests to check if their embryo or fetus carries genes for devastating diseases such as Tay-Sachs or Fragile X syndrome. Researchers have discovered genetic markers that can identify mutations in cancerous tumors that allow doctors to target specific chemotherapy drugs to match a patient’s mutations in their own DNA—leading, in some cases, to astonishingly high rates of remission.

In the past two decades, the drug industry and government agencies like the National Institutes of Health have plowed hundreds of billions of dollars into turning genetics from a research project into something real. AT&T, Verizon, IBM and other IT giants are developing digital health networks and products, while thousands of start-ups are in a mini-frenzy to create new digital health networks and apps.

Some companies, including Google-backed 23andme, have begun to provide customers with access to their own genetic data. (23andme actually stopped providing customers with genetic health data after being warned by the FDA that they need approval for some of these tests—the company says that they are working to fix this). Labs and companies are also in the very early stages of developing devices that read short DNA sequences using light waves, or a simple pinprick of blood.

In January, San Diego-based Illumina, a gene-sequencing company, announced that it can now sequence an entire genome for only $1,000. This may sound pricey, but just a decade ago a single human genome cost hundreds of millions of dollars to sequence. “I’m expecting there to be the hundred-dollar genome soon,” said Eric Topol, a cardiologist and geneticist at the Scripps Research Institute, speaking at the FutureMed meeting in San Diego. “Not long after, it will cost just a few cents.”

This year, the number of people having their genomes sequenced could top 50,000, and that number should increase exponentially over the next few years as governments and health-care systems announce projects to sequence hundreds of thousands of people. Last year the U.K. announced plans to sequence 100,000 citizens by 2017. In the U.S., Kaiser Permanente has teamed up with the University of California at San Francisco to sequence 100,000 patients.

Eventually the mountains of data generated by our DNA and digital health records will be linked to Facebook and Twitter pages (or the future equivalent), and to those pink suede shoes you just bought and shared on the latest incarnation of Instagram. We may not like it, but the reality is that we give up this type of information to these companies every day. And if people want to keep getting the services they provide, they’re going to keep trading data for it.

The result in a few years will be staggeringly complex statistical models designed to predict your behavior and to identify personality types, including those prone to violence or terrorism. Congress has passed a law barring health insurers and employers from using DNA to discriminate. Beyond this, however, we have few protections.

Genetic predictions will not be perfect or deterministic. It turns out that DNA is only part of the equation that makes you who you are or will be. Using genetic profiling for identifying terrorists or other personality types will also be imprecise and fraught with errors. Yet the more data amassed about individuals over time, the more accurate the modeling that creates the predictions.

For instance, scientists in a 2008 study associated a variant of the MAOA gene—the so-called “warrior gene”—to a predilection for violent behavior in some people. The statistical strength of this correlation is weak, and even if you have that genetic marker, you may in fact be a full-on pacifist. But let’s say that one afternoon you as a carrier of this gene variant “liked” an essay by a former Palestinian commando-turned-diplomat. An hour later you got curious about Al-Qaeda and did a quick Google search. What if some search algorithm at the NSA then connected your social media data to your DNA? The next thing you know, the Transportation Security Administration is stopping you from boarding your flight home for the holidays.

This is just one hypothetical example. As we rush into an era of bigger and better data being crunched by legions of government and public sector employees, we may have to get used to our health information being hacked and interpreted incorrectly or in ways that might work against us. Of course, it would be better to have an open debate and transparent policies about this type of data now.

Failing that, we may wake up one morning to read that the NSA once again has been spying on us—only this time, it won’t be about who we called or texted, but the secrets buried deep inside our cells that tell us a great deal about who we are and who we might be in the future.

David Ewing Duncan, Newsweek

FDA wins high-profile support in consumer genetics kerfuffle

When the Food & Drug Administration last November ordered the Mountain View, Calif.-based firm 23andMe to stop marketing its health-related genetic test kit to consumers, the ensuing debate took on a “rage against the machine” tenor. Entrepreneurs, patients’ rights advocates and genetics geeks across the country argued that the plodding, risk-averse regulators of the FDA had neither the right nor the expertise to insert themselves between people wishing to own whatever mysteries their genes contained, and a company that promised to deliver such information.

Now, however, a pair of respected experts in the dual fields of genetics and bioethics has weighed in — on the side of the FDA.

“The FDA was right to issue a warning to 23andMe,” write Boston University bioethicist George Annas and Northwestern University’s Dr. Sherman Elias, a professor emeritus of obstetrics and clinical genetics. Writing in the New England Journal of Medicine, Annas and Elias argue that in the rapidly evolving field of clinical and consumer genomics, firms’ peddling of genetic information that is unexplained, incomplete and potentially wrong can endanger patients.

Given the relatively rudimentary state of the testing offered by 23andMe — and of scientists’ understanding of the genetics of most disease risk — a thorough family history is probably at least as telling for most individuals who are now denied the services of 23andMe, the two wrote. The FDA thus is denying consumers nothing that they can’t already get, they added, and is merely insisting that the services being offered by companies like 23andMe are reliable, accurate and work as promised to inform its customers.

“That is traditional consumer protection, and what the public expects from the FDA,” they wrote.

Annas and Elias also recast this debate as a David-and-Goliath story in which the FDA is on the side of consumers against potential predators — not necessarily the genetics-services companies themselves, but perhaps insurance companies or data-marketing firms that might misuse an individual’s genetic information. Commercial considerations, they wrote, must not get out ahead of the making of laws, institutions and clinical practices designed to protect the privacy of this most private information — an individual’s genetic profile.

Finally, they wrote, the societal debate over a person’s right to refuse to know some genetic information has been engaged. But it is far from concluded, and until it has come to some firm conclusions, firms who offer consumers the raw outline of their genomes may be giving them information they would have chosen not to have.

Racing along behind direct-to-consumer companies like 23andMe (and threatening to overtake them) are whole-genome sequencing companies, which soon will be able to provide quickly and at relatively low cost a far more comprehensive analysis of a person’s genetic profile. That, wrote Annas and Elias, makes a pause in genetic-test marketing all the more timely.

The FDA’s imposition of a moratorium on 23andMe’s marketing “provides the opportunity for serious dialogue that could be a basis for setting standards not just for 23andMe, but for the entire industry,” wrote Elias and Annas. That could mean setting norms and standards for the whole-genome sequencing companies as well, which will raise all the same questions — in spades — before long, they added.

Melissa Healy, LA Times

Ontario Police face scrutiny over DNA testing sweep

Ontario’s police watchdog has launched a review of the DNA sampling practices of the Ontario Provincial Police after a complaint alleging racial profiling in the case of 100 migrant workers. The workers were subjected to a testing sweep, even though for many their only similarity to the suspect’s description was skin colour.

It’s the second such systemic review announced in a week’s time, and the third of its kind since the inception of the Office of the Independent Police Review Director in late 2009.

“Allegations that dozens of migrant workers who were asked to submit to DNA tests for a criminal investigation did not match the description of the suspect except for their dark skin colour raises the spectre of racial profiling and Charter rights issues,” Gerry McNeilly, the independent police review director, said in a statement Monday.

At the core of the review is the case from the Tillsonburg, Ont., area where the DNA sweep was conducted in late October 2013 in connection with a police investigation of a violent sexual assault.

Men whose characteristics differed widely from the suspect’s description were asked to submit to a DNA test.

Justicia for Migrant Workers, a group that found and interviewed 44 of the 100 people who voluntarily gave samples, learned that roughly half of those they spoke to were shorter than the specified height of the suspect, and about half were older than 41, when the suspect was said to be in his twenties.

McNeilly told the Toronto Star that systemic reviews have been rare, partly because of the workload his office has faced following complaints about the policing of the G20 summit in Toronto in 2010. The office receives about 3,500 complaints per year and investigates about half of those, mainly related to police conduct, policy and service matters, he said.

This review is “rare in the sense that it’s the third one, but you also have to accept that we’ve only been in operation since late 2009, and then we were hit with the G20. That took an awfully long time because of the magnitude of it,” McNeilly said.

According to the complaint filed by Justicia, a woman in Bayham, Ont., told the OPP she had been sexually assaulted on Oct. 19, 2013, by a muscular black male, between five-foot-ten and six feet tall, with no facial hair and in his mid- to late-20s.

The OPP announced in December that the force arrested 35-year-old Henry Cooper, a migrant worker from Trinidad and Tobago, and charged him with sexual assault with a weapon, forcible confinement and uttering death threats. In a news conference announcing the arrest, the OPP said DNA evidence was key.

Cooper was not among those identified by Justicia as having submitted samples, outreach worker Chris Ramsaroop told the Star. It is not known if the accused man voluntarily provided a sample to police.

DNA sweeps have proven controversial before. A 2011 move by police to test males in connection with the death of Orangeville nurse Sonia Varaschin prompted a complaint from the Canadian Civil Liberties Association to the province’s privacy commissioner.

Ricardo Federico, a criminal lawyer and adjunct professor at Osgoode Hall Law School at York University, noted the complaint focuses on racial profiling, but the practice of DNA sweeps raises many other broad questions.

“How far do we want the dragnet to go? Do we want the science police knocking on everybody’s door, is what I ask,” said Federico. “What happens if you refuse such a request? Do you become a greater suspect? That’s worrisome.”

OPP Commissioner Chris Lewis responded to the complaint after it was filed, saying, “As an organization, we do not permit our employees to engage in racial profiling.”

OPP spokesman Sgt. Pierre Chamberland said the force would cooperate with the review.

“We look forward to the review, and obviously we’re going to cooperate fully. We’re confident of our investigative practices. If there are ways we can enhance our policies going forward, we’ll be glad to take a look at those options,” he said.

McNeilly said he has set a six-month deadline for the review. When completed, the report and recommendations of the watchdog will be made public.

Tim Alamenciak , The Spec

House Rejects Expansion Of Oklahoma’s DNA Database

A plan to require people facing trial for certain crimes to submit DNA samples to law enforcement has been rejected by the Oklahoma House, despite an emotional plea from the bill’s author.

On Wednesday, the House voted 51-35 against the bill by Stillwater Republican Rep. Lee Denney who says the measure would help solve cases and would only target people charged with particularly heinous crimes.

But lawmakers raised concerns, including what happens to DNA profiles in cases where people were acquitted or had charges expunged.

Denney became emotional when discussing the case of Juli Busken, a University of Oklahoma student from Arkansas who was found dead in 1996 after being kidnapped, raped and shot. Her killer was later identified through a DNA match.