Friday, May 10, 2019

Opinion: The Great Divide on Infanticide

(DISCLAIMER: This is an opinion piece and the opinions and views expressed here do not represent ISOGG nor the members of ISOGG).

By Katherine Borges
Most Americans have heard of the infamous case of Scott and Laci Peterson of Modesto, California. On Christmas Eve 2002, Scott Peterson reported his pregnant wife, Laci, as missing after she supposedly took their dog for a walk. Four months later, Laci's body and that of their unborn son, Conner, washed up on the shores in San Francisco Bay. Scott Peterson was convicted of first degree murder in Laci's death and second degree murder in Conner's death. Their deaths led to the passage of the “Unborn Victims of Violence Act of 2004” which recognizes an embryo or fetus in utero as a legal victim; if they are injured or killed during the commission of any of over 60 listed federal crimes of violence. Scott Peterson was sentenced to the death penalty for their killings.

I live in a small town on the border of Modesto. This heinous crime affected everyone who lives here and still haunts us to this day.

Fast forward to March 2019 when 57-year-old Theresa Rose Bentaas is arrested for leaving her baby boy to freeze to death in a ditch beside a South Dakota cornfield 38 years ago. The case was solved combining forensics with genetic genealogy. One of our British genetic genealogy colleagues wrote on social media that the mother was the “victim” and should “not be treated as a criminal.” This sparked a long debate. Especially amongst the Americans who had a differing of opinions about this, and it carried over to the “Family Tree Live” conference held at London's Alexandra Palace 26-27 April 2019.

A panel discussion included American law enforcement's use of ancestral DNA; which I felt was biased because there were no Americans on the panel. Why is it ok to give opinions on American laws with no Americans at the table? Perhaps an International Law attorney would have been apropos to be on the panel since laws vary by state.

Between the panel and additional conversations, I was shocked and nauseated to hear the British POV on infanticide. My environment. My culture. My religion. Are all against infanticide. 

But all of this emotion-filled discussion wasn't for naught. For myself and many other Americans had never heard of the UK infanticide laws. Once it is understood that this is their law and culture, then it's maybe a smidgen less shocking how they can feel that the South Dakota case should have leniency showed. But let me be clear here: I'm saying I understand it, not that I agree with it.

And I also think the British and their like-minded peers in the Commonwealth and Ireland need to incorporate some of the same understanding for America. For example, one of the issues I heard raised was their concern that their DNA could be used to convict someone in America and the person might receive the death penalty. They need to realize they can't paint everyone with the same brush in America. As far as infanticide goes, two recent cases prove that America doesn't always throw the book at and execute baby killers. A Pennsylvania woman will receive no prison time after her 11-week old baby died from ingesting a lethal mix of drugs in breastmilk. Another woman received no prison time after she tried to drown her newborn baby in a McDonald's restaurant toilet.

The biggest take away to impart is this: We have no say in UK et. al. laws and the way they are administered, and they have no say in ours (US). Administration of laws is not at our level so it's pointless to debate. If you're going to engage anyway, just remember that every case is not black and white in how it will turn out.

Tuesday, November 28, 2017

Seventeen years and millions tested ought to count for something Sen. Schumer

Here we go again. A new day. A new person. Another federal entity being called upon to save us from ourselves. 

Sen. Chuck Schumer of New York announced at a press conference on the Sunday before Cyber Monday 2017, plans to investigate the terms of service agreements of ancestral DNA testing companies. In Senator calls for more scrutiny of home DNA test industry, Schumer is quoted, 
"...some of their terms-of-service agreements weren't clear on just what companies could do with your genetic information."
The senator is asking the Federal Trade Commission to:
"...take a serious look at this relatively new kind of service and ensure that these companies can have clear, fair privacy policies."

The direct-to-consumer ancestral DNA testing industry started in the year 2000 so can hardly be called "relatively new". 

With respect to the DNA companies' "clear, fair privacy policies", there's always room for improvement. That said, the DNA companies named in the article have worked very hard and invested quite a bit to insure "clear, fair privacy policies."  AncestryDNA is a prime example. Their privacy policy is clear, concise, and updated on a regular basis with past versions available. AncestryDNA even provides a version for US citizens as well as international.

Launched in 2007, 23andMe has also heavily invested in their Terms of Service (ToS) and Privacy Policy. Both the ToS and privacy policy even contain a glossary. How much more clearer can they be? Schumer additionally said, 
"Here's what many consumers don't realize, that their sensitive information can end up in the hands of unknown third-party companies," he said. "There are no prohibitions, and many companies say that they can still sell your information to other companies."
23andMe explicitly states they DO NOT provide any information to a third party without express permission under "Consent to the Transfer of your Personal Information" under number 2. on their privacy policy:
"We will not sell, lease, or rent your individual-level information (i.e., information about a single individual's genotypes, diseases or other traits/characteristics) to any third-party or to a third-party for research purposes without your explicit consent."
Much of the fault in consumers not realizing what they're consenting to, lies not in ignorance or illiteracy, but in laziness. A 2016 episode on NPR shared that 98% of those who participated in the study missed a clause agreeing to give up their first-born child. Consumers need to be proactive and educate themselves by reading the ToS and privacy policies.Towards the end of the article, Schumer again states the DTC DNA companies are
"...brand new, and they need safeguards."
Ancestry has been in the DNA market since 2006. 23andMe since 2007 and MyHeritage is a reseller of a test from a company founded in 2000. Again, not "brand new". 

Consumers have a right to their genetic information just as much as we have the right to medical information as allowed under HIPAA law. Let Sen. Schumer know. Help educate him. Contact.

Sunday, June 7, 2015

Semper necessitas probandi incumbit ei qui agit

Or translated in English to "the necessity of proof always lies with the person who lays charges". An apropo maxim for Colleen Fitzpatrick's latest attempt to discredit Benjaman Kyle (She was previously interviewed on a news segment). Ms. Fitzpatrick opens by asking in the title of her June 2, 2015 Indentifinders blog post, "Has the Genetic Genealogy community lost its GPS?" with "GPS" referring to "Genealogical Proof Standard". She charges that the genetic genealogy community has a "blatant disregard" for the Genealogical Proof Standard.

After quoting comments made by others in support of Mr. Kyle, Ms. Fitzpatrick accuses those supporters as embracing his "statements as true without review".

Ms. Fitzpatrick then proceeds to diagnose Mr. Kyle with a "mental problem" or "psychological condition": 
"If Mr. Kyle is an amnesiac, he has a mental problem. If he is only pretending to be an amnesiac, he has a psychological condition.
And it should be noted that while Ms. Fitzpatrick lists on LinkedIn that she holds a PhD in physics from Duke University, she is not an MD, nor PhD trained in psychology, nor even a Licensed Clinical Social Worker to make any diagnoses or determination on the state of Mr. Kyle's condition. Even so, she uses her diagnoses as a basis for saying, 
"Why are so many genealogists jumping on Kyle’s bandwagon without questioning what he is saying?"
In what is perhaps, the most dumbfounding part of her diatribe, Ms. Fitzpatrick then writes:
"The wise genealogist should insist Mr. Kyle produce the name of the law firm he alleges I hired. A wise genealogist should also request a copy of the letter I supposedly sent to DNA volunteers to deter them from working on his case.
Kyle has not produced either of these items, nor have any DNA volunteers come forward claiming to have received such a letter."
because the utter folly in mentioning this is that it actually exists and has been produced! Its posted here with the permission of the recipient:

This letter was transcribed and posted to the Indentifinders blog comments section but its been sitting in moderation since June 3, 2015.

The next part of the blog post delves into the denial of service attack and blocked access to Mr. Kyle's DNA accounts. These are things that the DNA companies have records on and can be verified by them for Mr. Kyle, and any involved law enforcement and/or legal representation. 

Ms. Fitzpatrick closes her blog piece by questioning Mr. Kyle's character with "An individual’s DNA does not provide insight into his character" and insinuating that he may have had a nefarious past in the mafia, drug cartel, child molester or dodging child support. And that because people believe what he's saying that genetic genealogists are nothing more than a "...rabid crowd, cannibalized by their starvation for excitement". She closes with,
"What happened to our Genealogical Proof Standards?"
That last line may be the most valid statement made in the article by Ms. Fitzpatrick! What happens when GPS lists "evidence [that] is direct and virtually impregnable" like producing a legal letter? Are there any ramifications if a member of the Association of Professional Genealogists uses a blog to carry out a character assassination on a former client? 

Indeed, what has happened to proof and standards?

Wednesday, December 11, 2013

Bad research vs. the truths behind the 23andMe stories

By Katherine Borges
Director, International Society of Genetic Genealogy

You'd have to be living in a cave to not know about the media storm that's befallen 23andMe over the past several weeks. With one damning media story cranked out after another, its hard to imagine the old adage about "There's no such thing as bad publicity" proving true for 23andMe. Its like the old game of telephone gone horribly awry. In one example, the FDA desist letter was picked up by Swedish and Finnish media outlets with the claim that the 23andMe test will, "...lead women [to] unnecessarily operates off their chest after notification that they have an increased risk of breast cancer."
Another person asked if lungs were "taken away if there was the risk of lung cancer?"

While parts of the stories may be subject to being "lost in translation" overseas, the situation with how much research journalists are conducting on their stories isn't any better in the U.S. The article, "Would you like to share your DNA code today?" by Barbara Shelly of the Kansas City Star is a prime example. Ms. Shelly reused an Associated Press quote from the attorney for a class action law suit filed against 23andMe last week. But if she had thoroughly researched her story instead of just jumping on the latest witchhunt bandwagon, then she would have been the first to conduct REAL journalism by fleshing out the truth in the stories.

For instance, would Ms. Shelly, or even the Associated Press for that matter, still have used the quote from the plaintiff's attorney if they knew that the plaintiff was the wife of one of her attorney's law firm partners?  Or that the plaintiff ordered her test in September and received her results on November 19, just three days before the FDA letter went public? Or that the plaintiff's husband's law firm specializes in class action law suits? Knowing these facts, how much weight does the attorney's quote carry? How much time did the attorney put into researching 23andMe before making the assertion that their database building is "thinly disguised". Frankly, its not disguised at all, the company has been quite open about building a large database.  Would Ms. Shelly and AP still have used the quote if they knew all of this?

Another aspect that Ms. Shelly took the easy way out on is that she makes the assumption that, "...genetic testing company selling one's DNA code the way an online retailer sells email addresses..." and labeled it "creepy."  If Ms. Shelly had done her homework by either ordering a test herself or interviewing someone who had tested, then she'd know that the people who order the test agree to a consent form that rivals iTunes' consent form. She would have also learned that 23andMe customers knowingly fill out health questionnaires for the purpose of advancing medical research via using large datasets of DNA combined with health information. That is, afterall, why the company was founded. Furthermore, adequate research of 23andMe's website would have also revealed that unlike retailers who sell personal and identifying information, 23andMe's consent form explicitly states no information is shared without a person's consent and the information is aggregated and stripped of identifying info.

Ms. Shelly further demonstrates her ignorance of the genetics field with scaremongering statements like, "What if a potential employer learns someone has a high risk of an expensive disease, such as diabetes?" If she knew anything of the field or once again, had researched the topic before making such an outrageous remark, she would know that thanks to a federal law known as the Genetic Information and Non-Discrimination Act signed into law in 2008, that it would be illegal for an employer to use such genetic information against an employee.

As for the rest of her article, at least Ms. Shelly acknowledges that the medical field is already utilizing personalized genetic information. But then she shows her lack of research skills yet again by not citing the contributions that 23andMe has made. She casts those aside with a flippant, "There is a vast gulf between the quickie commercialized service offered by 23andMe and the groundbreaking medicine practiced by Kingsmore." 

Ms. Shelly, you owe 23andMe an apology and a retraction. In the meantime, perhaps the public can "weed out the bad" reporting and the FDA will soon allow 23andMe's "good work to thrive".

Wednesday, September 28, 2011

Glenn Hammonds' speech at the San Francisco FDA Town Hall Meeting

Glenn Hammonds was the only DTC speaker at the FDA Town Hall meeting in San Francisco, California on 22 September 2011. Here is his speech published in its entirety:

Good morning everyone. My name is Glenn Hammonds, I'm a native of Nashville, Tennessee, but I've lived in the San Francisco Bay Area since 1979, and in Oakland since 1987. It is a pleasure to be back in South San Francisco where I spent many years as a scientist at Genentech and Exelixis.

I'd like to thank CDRH Director Shuren and his staff for arranging this meeting, and for giving me the opportunity to speak on the subject of Direct To Consumer Genomics.

I am concerned, as a consumer, as a scientist, and as a citizen, at the prospect of elimination of direct to consumer testing.

As a satisfied customer of 23andMe, I would be appalled to lose access to their services, which I have enjoyed for several years, and which I have recommended to friends and family. I've also used FTDNA, and am satisfied with their testing, although I don't understand why they have to remove perfectly good data from their reports before releasing it to me.

As a scientist who's spent a good deal of time in biotech and pharma, I think it likely that restricting access to these inexpensive and powerful tests could well slow discovery and innovation. I was impressed by the list given by Don Vorhaus of the Genomic Law Report web site detailing why this might happen, including the following factors.

Reduced access to capital.
Fewer new products
Fewer entrants into the field
Increased risk of Litigation.
Reduced access to technology.
Encouraging overseas development.

As you know, students in graduate and medical school today are using DTC genomic data sets, often their own, to learn genomics in a way profoundly different from any previous generation. Some of this work is already available on line, for example the Integrome project from Stanford. Genomics will continue to transform medicine and biology for a long time. These students are the vanguard of a fully genomic aware cadre of scientists and physicians. Don't stunt their growth!

Finally, as a citizen of a nation that values personal freedom and responsibility, I know that a person is not a just a patient, a consumer of medical devices, drugs, and advice. A person's genome is the starting point for all that a person is, and contains information about the whole person. Restricting access to information and advice about that most important part of personhood itself is abhorrent, and cannot stand.

I'd like to close with a selection of opinions from other customers of 23andMe, sent to me after I made a public appeal through the web site.

"It is important that you express the unhappiness - anger if you will - that has arisen among many who feel that any attempt to regulate DTC is unnecessary and unwelcome."

"In my personal experience, I took my 23andMe results to my physician and after I explained them to him he agreed to add them to my medical record."

"The medical profession and individual citizens need education, as much education as we can can help them get, about the coming era of personal genomic medicine. Restricting the information that can be learned from DNA testing from individual consumers does not promote better medical care."

"I don't find the health and trait information on this site compelling and am much more interested in genealogy and ancestry, but I can't support the restriction of information to any user whatever their interest."

"I do NOT want the government to filter my access to information about my own genome."

"The only other way I want the government involved is to ensure that insurance companies cannot use such information to deny me coverage, and that employers can't use it to not hire me"

Monday, September 28, 2009

ANALYSIS - "Direct-to-consumer genetic tests: beyond medical regulation?" D. Magnus, et al.

A "Commentary" paper that leads off with an abstract stating DTC test analysis is "uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak". This assessment is based on only one paper reference.

The introduction of the paper provides a brief description of DTC tests and asks if tests should be regulated. The Discussion section covers the current federal and state regulatory framework for genetic tests already in place including the 2008 California Dept. of Public Health's "cease and desist" letters.

The authors' opinion that the DTC companies arguments for offering tests directly to the public are "weak to indefensible" citing that while "People may indeed have a right to their genetic information, but it does not follow that we should not regulate the process to make sure that information is appropriately provided." They summarize that the second argument for public DTC is that the tests are "not really medical" and the third argument is "that patients deserve direct access to their health information without a physician intermediary." The authors state that "A physician working for a company selling tests is clearly not well situated to look after a patient's best interest".

The authors stretch to support this argument with, "To make matters more confusing, personal genomics could predict risks of very weak genetic associations while leaving out powerful predictive mutations" like in a rare form of breast cancer. But then the straw-man is revealed in their caveat, "But these are not tests offered through personal genomics services."

The authors then postulate that "California and New York states are right to create standards to protect their citizens from the risks of medical testing" which first of all, California did not create a "standard"; the California Dept. of Public Health arbitrarily sent "cease and desist" letters based on anonymous "letters of complaint". New York's law dates from 1996, and can hardly be suggested as standards created for the DTC-era since the law pre-dates it.

The authors acknowledge that physicians will need training. What the authors do not mention is what kind of impact such training will have upon the industry such as: will all physicians require training? Who will pay for the training? How long will such training take and will the DTC companies still be allowed to sell tests during this time frame? These and many more questions need answering before any legislation or standards are imposed.

Tuesday, September 8, 2009

UK - The Human Genetics Commission Principles and Consultation Questions

The Human Genetics Commission released today "A Common Framework of Principles for direct-to-consumer genetic testing services: Principles and Consultation Questions". A copy can be downloaded here.

The purpose of the document:
"promote high standards and consistency in the provision of direct-to-consumer genetic tests amongst commercial providers at an international level in order to protect the interests of people seeking genetic tests and their families. They will identify where individual companies and or national jurisdictions should have defined measures in place and the nature of those measures. " - pg 1
"The HGC is not a regulatory body. It hopes that these Principles will lead to the development of codes of practice that take account of existing regulatory structures where the need for additional regulation or legislation is revealed to be necessary."
Excerpt that references ancestry testing:
"Other tests can also provoke anxieties, such as ancestry tests that offer fundamental information about identity and ethnicity."