When Your Car Spies on You

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By Lori Andrews

Cars are getting smarter.  Some can show you a video of what is behind you to help you park in a tight spot.  Others can automatically apply the brakes if you are about to run into the car in front of you.

Now cars have a new power.  They can snitch to an insurance company about your driving.   A tracking device can be installed in your car to monitor how and when and how far you drive.  Progressive and other insurers offer discounts on car insurance to drivers based on data from such devices.

Do you accelerate sharply, corner too closely, travel at night or drive great distances?   Those traits can be used against you and prevent you from getting a discount.  But many of those factors are beyond your control.  If your job requires you to work in the evening, why should you be penalized by your insurer?

Most insurers’ devices are installed in the data port of car, under the drivers’ side of the dashboard, which limits their use to cars sold after 1998.  But the Canadian insurer Desjardins uses a mobile phone app, Ajusto, that doesn’t even need to be installed in the car.  But phone apps raise additional issues.  Nothing prevents an insurer from matching data from the phone driving app with other information.  Nearly two-thirds of smartphone owners look up health information on their devices.  What if you’ve done a Google search for the side effects of an allergy medication?  The insurer might take that to mean you are using the medication while driving, despite the drug’s warnings about drowsiness.

Who else will ultimately get the driving information?   Will the police want to know who is driving faster than the speed limit?   As a phone app, Ajusto can tap into location information.  Will spouses and employers want to know where the driver has been?  Already, information from toll passes has been used as evidence in criminal cases and divorce cases.  If you get into an accident while using Progressive’s Snapshot device, Progressive will turn over their information about your driving style and history to the court.

These programs to reward safe drivers might actually lead to more accidents.  A friend who used the Progressive device heard a series of beeps from his car if he braked too quickly.  The only way to avoid the beeps was to stay four car lengths behind the car in front of him, but that meant other cars were constantly swerving in front of him.  It also greatly increased the chance of his being rear-ended.

The tracking devices for cars are touted as a way to save you money.  But the data they collect can be used against you.  Progressive announced that it will start charging higher rates to drivers who volunteer to use its Snapshot device, but whose driving does not measure up.  Courts can order that you turn over your driving information to someone who sues you.   Tracking devices have real risks. What you might save in premiums, you’ll lose in privacy.

A White House Invitation to Launch Precision Medicine

By Lori Andrews

President Obama at the launch of the Initiative

Last Friday, I was a guest at the White House for President Obama’s launch of the Precision Medicine Initiative.  The goal of the Initiative is to sequence people’s genomes and read the nuances of their genes to determine how to prevent disease or more precisely treat it. The President illustrated how this would work by introducing Bill Elder, a 27 year old with cystic fibrosis. Bill has a rare mutation in his cystic fibrosis gene and a drug was fast-tracked at the FDA to target that mutation.  “And one night in 2012, Bill tried it for the first time,” explained President Obama. “Just a few hours later he woke up, knowing something was different, and finally he realized what it was:  He had never been able to breathe out of his nose before.  Think about that.”

When Bill was born, continued the President, “27 was the median age of survival for a cystic fibrosis patient.  Today, Bill is in his third year of medical school.”  Bill expects to live to see his grandchildren.

The Precision Medicine Initiative will involve sequencing the genomes of a million Americans.  Such a project would have been unimaginable if we hadn’t won the Supreme Court case challenging gene patents.  Prior to that victory, genetic sequencing cost up to $2,000 per gene due to patent royalties.  Now it will cost less than ten cents per gene.

Bill Elder at the White House event

The people who volunteer as research subjects for the project may expect cures for their own diseases.  But, even when genetic mutations are discovered, cures are a long way off.   “Medical breakthroughs take time, and this area of precision medicine will be no different,” said President Obama. And despite the fanfare surrounding genetics, researchers often find that environmental factors play a huge role in illness. At the same time the White House was preparing for the launch of the Precision Medicine Initiative, Stanford researchers and their colleagues across the globe were publishing a study in the January 15 issue of the prestigious journal Cell challenging the value of sequencing research.  Their study, “Variation in the Human Immune System is Largely Driven by Non-Heritable Influences,” tested sets of twins’ immune system markers.  The result: Nearly 60% of the immune system differences were based on the environment rather than genes.

Capturing environmental information about the million volunteers will involve invasions of their privacy as their health and behavior is categorized and quantified from every perspective.  Their genetic data will be combined with medical record data, environmental and lifestyle data, and personal device and sensor data.  If not handled properly, this data could be used to stigmatize the research participants or discriminate against them.  Will they be properly informed of the risks in advance?  Will sufficient protections be in place for their device and sensor data, which is often not covered by medical privacy laws such as HIPAA?

At the White House last Friday, President Obama said, “We’re going to make sure that protecting patient privacy is built into our efforts from day one. It’s not going to be an afterthought.” He promised that patient rights advocates “will help us design this initiative from the ground up, making sure that we harness new technologies and opportunities in a responsible way.”

Professor Andrews with Henrietta Lacks’ descendants at the White House

President Obama underscored that commitment by inviting members of Henrietta Lacks’ family to last Friday’s event. In 1951, Henrietta Lacks was dying of cervical cancer.  A researcher at Johns Hopkins University undertook research on her cells without her knowledge or consent (or that of her family).  Her immortalized human cell lines provided the basis for generations of research in the biological sciences, as well as research by commercial companies.  When her husband learned about it years later, he said, “As far as them selling my wife’s cells without my knowledge and making a profit—I don’t like it at all.”

A former Constitutional Law professor, President Obama is aware of the importance of people’s rights.  Let’s hope that his aspiration of an Initiative that guards research subjects’ autonomy and privacy will be honored by the scientists who will actually operationalize the $215 million project.

Why Reporters Need to Learn Cryptography

Lori Head Shot 2014 v.2 smallBy Lori Andrews, JD

Julian Assange, Feb 27th The Media Consortium conference, Chicago, IL

Julian Assange Skyped into the TMC conference to discuss “The Use and Abuse of Whistleblowers” with Juan Gonzales, Democracy Now!; Gavin MacFadyen, Centre for Investigative Journalism; and Bea Edwards, Government Accountability Project.

They use burner phones as they cross borders.  They buy old Lenovo computers because there are fewer backdoors into those computers that allow surveillance.

They are not spies or criminals.  They are investigative reporters trying to get on-the-ground stories to help us understand and sometimes change our world.

Last week, The Media Consortium and IIT Chicago-Kent College of Law joined forces to describe the challenges that reporters face in an era when intelligence agencies such as the National Security Agency and corporations such as Google spy on what each of us is doing on our digital devices.  At the joint workshop, Josh Stearns of Free Press and the Freedom of the Press Foundation reported on how many journalists had been killed and jailed in last year.  And it’s not just a problem abroad.  According to the World Press Freedom Index, the United States has slipped to number 46 in a ranking of countries on how much freedom it gives its reporters, well below even countries such as Ghana and Uruguay.  amalia deloney of the Center for Media Justice described how surveillance in general disproportionately affects people of color.  She showed a slide of a police tower that one might have guessed was situated in Guatemala or another oppressive nation.  Instead, it was in a primarily African-American neighborhood in Charlotte, North Carolina.

What information is the NSA collecting about activists, reporters and you?  The NSA gathers the phone numbers, locations, and length of virtually all phone calls in the United States.  It collects records of nearly everything you do online, including your browsing history and the contents of your emails and instant messages.  It can create detailed graphs of your network of personal connections.  It can create phony wireless connections in order to access your computer directly.  It can intercept the delivery of an electronic device and add an “implant” allowing the agency to access it remotely. Continue reading

California’s Revenge Porn Statute: A Start but not a Solution

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By Lori Andrews

Susan, a professional woman in her 30s, met a man she thought she’d ultimately marry.  Their relationship was sufficiently intimate that she sent him a naked photo of herself.  When she caught him cheating, she broke up with him.  He took revenge by posting that selfie on a revenge porn website, along with her name, the name of her town, and her social media contact information.  She received messages from complete strangers asking for more naked photos.  As she went about her daily life, she was afraid that one of those men would stalk her.  She worried that her co-workers might have come across the photo.  She knew that if she applied for a new job, that nude photo would come up in a Google search of her name.  She’d been branded with a modern Scarlet Letter.

Across the Web, thousands of people attack their exes by posting disgusting comments about them, warnings not to date them, or nude photos of them.  On October 1, California Governor Jerry Brown signed into law a bill criminalizing what has become known as revenge porn.  The law assesses a thousand dollar fine in a narrow situation.  It is a misdemeanor for a person to photograph “the intimate body part or parts of another identifiable person, under circumstances where the parties agree or understand that the image shall remain private, and the person subsequently distributes the image taken, with the intent to cause serious emotional distress, and the depicted person suffers serious emotional distress.” Continue reading

U.S. Supreme Court Liberates Breast Cancer Gene

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By Lori Andrews

Today the U.S. Supreme Court held in Association for Molecular Pathology v. Myriad Genetics, Inc., that human genes were not patentable since they are products of nature and not inventions.  This decision is great news for patients, doctors, and scientific researchers.  Some biotechnology companies might grumble about the decision, but the decision will actually stimulate innovation by pharmaceutical companies and the new generation of biotech companies.

The case involved Myriad’s patents on the human breast cancer genes known as BRCA1 and BRCA2.  Those patents made your genes Myriad’s property once they were removed from your body.  Consequently, the company could control all uses of the genes, including any diagnostic testing or research.  The U.S. Supreme Court saw the absurdity of letting a company own your breast cancer genes.  Continue reading

NSA SPYING VIOLATES FIRST AND FOURTH AMENDMENTS

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By Lori Andrews and Jake Meyer

The United States Foreign Intelligence Surveillance Court in Washington, D.C. in a top secret court order ordered Verizon to produce to the National Security Agency (NSA) “all call detail records or ‘telephony metadata’ created by Verizon for communications (i) between the United States and abroad; or (ii) wholly within the United States, including local telephone calls.”

Since we’re Verizon users, this order means that the NSA knows who we called, where we called them from, and for how long.  The NSA even knows that we’ve talked to each other. Continue reading

Supreme Court to Hear Challenge to Patents on Human Genes

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By Lori Andrews

On April 15, the U.S. Supreme Court will hear the case Association of Molecular Pathology v. Myriad.  The question before the court is:  Are human genes patentable?

For 150 years, the Supreme Court has said that abstract ideas, laws of nature and products of nature are not patentable.  Such patents would run afoul of the progress clause of the Constitution and section 101 of the Patent Act.

In 1980, the Supreme Court in Diamond v. Chakrabarty held that genetically modified living organisms are patentable if they are markedly different than what occurs in nature.  That case reiterated that laws of nature like E = mc2 are not patentable, nor are products of nature such as plants from the wild or minerals from the ground.

Three decades after the Chakrabarty decision, the Supreme Court revisited the exception by taking a trilogy of cases.  In the first one, Bilski v. Kappos, the Court held that an abstract idea–hedging in trading energy futures–could not be patented.  In Mayo v. Prometheus, the Court held 9-0 that a law of nature–how the body responded to the administration of a drug–was not patentable.

In the Myriad case, the Court will be addressing the third part of the exception, dealing with products of nature.  It will address whether an “isolated” breast cancer gene is an unpatentable product of nature.  The patents at issue cover two isolated genes related to breast cancer, BRCA1 and BRCA2.  The patents define the isolated gene to include a gene sequence “removed from its naturally occurring environment.”  This claim gives Myriad the ability to control all uses of anyone’s breast cancer genes once they are removed from the body, giving Myriad the right to exert a monopoly over all BRCA1 and BRCA2 breast cancer gene testing and research.

What is a gene sequence?  It’s a series of chemical letters known as nucleic acid bases–designated by A, T, C, and G.  It is important because a single change in the letter–a typo in the sequence–can lead to a genetic disease.  To diagnose a genetic disease, a physician or laboratory compares the patient’s genetic sequence to a normal gene sequence to see if there are differences that predispose the patient to breast cancer.

The question the Supreme Court will ask, under the Chakrabarty case, is whether what Myriad patented is “markedly different” from the breast cancer genes in the body.  Myriad asserts that the isolated gene is a product of human ingenuity.  Myriad argues that it “successfully isolated the ‘BRCA’ molecules and disclosed their creation to the world. This momentous advancement required significant skill, insight, and invention on the part of Myriad’s inventors.”

Myriad also argues that isolation of the gene “depended on an enormous amount of human judgment, including how to define the beginning and end of what came to be called the BRCA1 and BRCA2 genes, and then creating isolated DNA molecules corresponding to those particular defined genes.”  Myriad also argues that by isolating the gene, it gave the gene new uses since genes in the body cannot be used for diagnosis.  It also created copies of the gene in the lab.

In contrast, the petitioners in the case argue that what Myriad patented is not markedly different from nature.  For Myriad’s gene sequence to work as a diagnostic tool, it must have the identical sequence to that of a breast cancer gene in nature.  The petitioners argue that once the unpatentable product of nature, the gene sequence, was discovered, Myriad used routine means to create copies of it and to undertake diagnostic comparisons to patients’ genes.  The Court is likely to look to a 1948 Supreme Court case, Funk Brothers Seed Co. v. Kalo Inoculant Co., in which the patent applicant combined six types of bacteria and the claimed invention was found to be an unpatentable product of nature because the bacteria “served the ends nature originally provided.”  The petitioners argue that here the isolated gene sequence merely serves the ends nature intended.

In addition to extensive briefing about whether there is sufficient human ingenuity involved to consider an isolated human gene to be a patentable invention, the affidavits and amicus briefs in the case gathered all existing data on whether gene patents encourage or discourage innovation.  Over 90 affidavits were filed, including those from Nobel Laureates.  Briefs from over 102 amicus groups were filed, including briefs from medical organizations such as the American Medical Association and patient advocacy groups such as the March of Dimes arguing for the invalidation of gene patents, and briefs from industry organizations such as the Biotechnology Industry Organization and intellectual property associations such as the American Intellectual Property Law Association arguing that gene patents are valid.  Also weighing in were prominent scientists, various companies and numerous law professors.

I filed an amicus brief in the case on behalf of medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, and American Society of Human Genetics, providing evidence that patents on genetic sequences interfere with health care and research.

Medical organizations are concerned because gene patents increase the cost of the diagnosis and treatment of genetic diseases.  For 20 years, a gene patent holder controls any use of “its” gene. The patent holder can charge whatever it wants for any test analyzing the patented gene–even if that test uses a technology that was not invented by the patent holder.  Myriad, which holds the patent on the BRCA1 and BRCA2 genes, charges over $3,000 for its genetic test for breast cancer.  One in four laboratories has stopped performing certain genetic tests because of patent restrictions or excessive royalty costs.

The ability of a patent holder to prevent health care providers from using a patented genetic sequence denies people crucial medical information.  Most drugs only work on a percentage of patients who use them.  An asthma inhaler might only work on seven of ten people to whom it is prescribed, causing the other three to suffer symptoms of asthma and pay for an inappropriate drug until the right medication can be found.  Genetic testing can help to distinguish those people for whom a drug will work from those people for whom it will not work, but, if the same entity holds the patents on the drugs and the gene sequences, it may prevent use of the gene sequence because the identification of people for whom the drug will not work will limit the market for the drug.

One company has filed for patent protection on a genetic sequence that could be tested to determine the effectiveness of its asthma drug in a prospective patient.  The company, however, has said that it will not develop the test–or let anyone else develop the test.  While such a test would be crucial to doctors in determining which patients would benefit from the use of the asthma inhaler and which patients would benefit from a different drug or treatment, it would also diminish the market for the drug because a trial use of the asthma inhaler would no longer be needed to know if it would be an effective treatment.

For more information, listen to my interview with Minnesota Public Radio on the subject or view the video of an interview with me on the OYEZ website.

Big Brothers—Mitt and Barack—Are Watching

Lori Andrews by Lori Andrews

Facebook and other social networks are transforming huge swaths of our lives–how we work, shop, and stay in touch with the people we love. They are also changing the political process itself. When John F. Kennedy and Richard Nixon debated on television, concerns were raised that politics would deteriorate into a contest where the most telegenic candidate won. But TV debates took place out in the open–anyone could tune in. And the Federal Communications Commission adopted regulations so that opposing candidates were granted equal time to present their views.

With social networks, it’s not the most telegenic candidate who wins, but the one with the best data crunchers. Barack Obama was swept into office largely because of his presence on the Web. His social network campaign was managed by one of the founders of Facebook, twenty-four-year-old Chris Hughes, who took a leave from the company to propel Obama into office.

Continue reading

Justice Ruth Bader Ginsburg and the Case that Got Away

Lori Andrews by Lori Andrews

Last weekend at Yale, a panel of law professors told mesmerizing stories of Ruth Bader Ginsburg’s work as an advocate and as a Justice. The five speakers gave detailed analyses of various briefs and opinions she’d written and how those materials had created a legal foundation for gender equality. But there was a surprising guest in the audience.  Sitting in the first row was the Justice herself.  And after each of the speeches, Justice Ginsburg stood and told the law professors what they gotten right or wrong, or provided some backstory to the cases they’d discussed. It was like that scene with Marshall McLuhan in Annie Hall!

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From Nude Photos to Naked Genomes: Berkeley Gets Poor Marks on Frosh Gene Tests

Lori Andrews by Lori Andrews

What do George W. Bush, Hilary Clinton, Meryl Streep and Wendy Wasserstein have in common?  As incoming freshman to Ivy League universities, they were required to pose nude for photographs.  The goal of the project was to correct students’ posture—and to correlate posture with later life achievement.  From the Ivy League, the practice spread across the country until a female freshman at the University of Washington in Seattle challenged it.  In 1968, the program was abandoned, under criticism it was eugenic.

I attended Yale after the demise of the notorious photo program.  But when I read about U. Cal Berkeley’s recent plans for its incoming freshman, I realized Berkeley officials hadn’t learned the lesson of the posture program.  Rather than requiring nude photos of their students, Berkeley officials were planning to peer at students’ DNA.  Indeed, they were opening the door for sensitive genetic information to be made available about our future leaders–their current students.

The Scope of the Berkeley Program

Last summer, 5,000 incoming students at University of California, Berkeley received a surprise along with the packet of information about their freshman year.  Their admissions packet contained an item that looked like a Q tip and an invitation to swab the inside of their cheeks for genetic testing.  The targeted genes were involved in breaking down lactose, metabolizing alcohol and absorbing folic acid.

The program came under criticism from lawmakers, bioethicists and even the California Department of Public Health.  Now Berkeley has significantly cut back the program.  What lessons should Berkeley officials learn from this experience? 

Lessons to be Learned

1.    In the quest to be avant garde, don’t forget the basics

Berkeley officials seem to have been caught up in the novelty of the program.  “Science is moving so fast right now,” said Alix Schwartz, director of academic planning for the college’s undergraduate division. “If we assigned them a book, it would be out-of-date by the time they read it.”

Think hard about that comment.  Parents are spending up to $40,000 a year to send their children to Berkeley.  In most of their courses, students will be assigned books to read.  It would not be unreasonable for parents to ask, is it really worth $160,000 for my child to get an obsolete education?  Why don’t I just get a quickie genetic profile done on my child an put him or her in a job best on the genotype?

2.    Take responsibility for the well-being of your students

Years ago, psychology professors routinely required their students to be subjects in experiments as part of their course requirements.  Now the Code of Ethics for psychologists forbids this sort of coercion of students.  But Berkeley’s “offer” to students, although presented as voluntary, was itself coercive.  “The consent form for the project is pure marketing,” Jeremy Gruber, the president of the Council for Responsible Genetics told California lawmakers at the August 2010 hearing on the program.  The form listed speculative, unproven benefits of the testing, but none of the risks.

The genetic testing program was replacing the “one book” program to give students a common experience to discuss.  A student entering Berkeley might feel compelled to swab rather than risk ridicule by others or marginalization by not participating.  Or worse yet, by saying “My parents wouldn’t let me send in my DNA.”

And what happens when the students started discussing the results of their tests?  Would those who were poor metabolizers of alcohol be left behind when others went to the local bar?  And, as Boston University public health professor George Annas asked, would those who had genes related to alcohol tolerance feel they could drink to excess? 

3.    Look closely at conflicts of interest

According to the consent form for the project, the students DNA sample would “become the property of the University” until its destruction and the university would “save the data for future teaching purposes and for possible publication of the aggregated data and its analysis.”  Such an approach makes one wonder if the project is being undertaken for the students’ benefit or for that of university researchers.  Indeed, the professor behind the program had formed his own genetic testing company last year.

There was also to be a writing contest where the winning students would have a chance to win further genetic testing from 23andMe, a private company that offers DNA profiling.  But should a public university be endorsing a private company?  “The FDA and Congress are currently investigating this type of testing, described as ‘snake oil’ by a member of the House Energy and Commerce Committee at a recent hearing, also described as ‘not ready for prime time’ by the Centers for Disease Control,” Gruber said at the California hearings.

4.     Check the legality of what you are doing

Berkeley planned to do the genetic testing in one of its university labs and provide the individual results to the students.  But its labs had not complied with state and federal requirements, such as the Clinical Laboratory Improvement Act, which cover any lab that provides a medical result back to a consumer.  These laws are designed to ensure the accuracy of the test results.  The university argued that it was not providing medical information and thus was not covered by the laws.  But that argument was just not credible, given the university’s position that this information could be useful to students in planning preventive measures.

Ultimately, Berkeley backed off of its program when the California Department of Public Health warned that the plan to have students’ DNA samples analyzed at an uncertified lab would violate state law.  Now, instead of offering individual test results to students, it will only post aggregate results.

Berkeley’s Poor Marks

The Berkeley administration deserves poor marks on how they handled the program.  In fact, they seemed to have flunked psychology (with a coercive program), law (not complying with statutes), biology (by not acknowledging the limits of predict
ive value in the tests they were offering), ethics (creating a potential conflict of interest) and history (not applying what had been learned from posture photos debacle).   Perhaps now they’ve learned the lesson that the use of genetic tests needs to be analyzed and contextualized–which, after all, are the hallmarks of any great college education.