FDA Ethicists Undisclosed Conflicts Of Interest in Prenatal Dex Case

by Alice Dreger and Ellen K. Feder


[A 2014 article that details the questionable practices of modern medicine which both involves fraud and an overt application of eugenics rather than health care.  It is offered as a public service information source along with the caveat to beware of scientific studies which are usually wrong. . [Emphasis - DNI] - ED]

Newly available documents show conflicts of interest for the FDA ethicist who investigated a fetal drug experiment.  

Pediatric endocrinologist Maria New, now at Mount Sinai School of Medicine in New York, is an internationally-recognized specialist in congenital adrenal hyperplasia, a genetic condition that can cause female fetuses to develop intersex (in-between male and female) genitals. For over a decade, Dr. New has encouraged pregnant women at risk of having a child with congenital adrenal hyperplasia to take the steroid dexamethasone starting as early as 3 weeks of pregnancy to try to prevent intersex development.

Dr. New has consistently described this extremely controversial off-label (i.e., not government-approved) use as safe and effective. In truth, there has never been a placebo-controlled trial of this use, and the only long-term prospective trial ever conducted resulted in so many “severe” adverse events that, in 2010, that study’s research team (a Swedish group) went to their ethics board to say they were halting the use altogether.

Dr. New’s aggressive “safe and effective” promotion of this fetal intervention—an intervention designed to cross the placenta and change fetal development—would be shocking enough. But we were shaken in late 2009 when we discovered that, even while she was direct-to-consumer advertising the intervention as having been “found safe for mother and child,” she was taking NIH grant money to study retrospectively whether it was safe and effective.

 In February of 2010, we along with thirty colleagues in bioethics and allied fields sent letters of concern to the U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) asking them to investigate the actions of Dr. New. At the FDA, the investigation was assigned to Robert “Skip” Nelson, a pediatric ethicist. Documents obtained through a Freedom of Information request suggest that Nelson proposed to OHRP that he handle the main part of the prenatal dexamethasone investigation for that agency as well. Ultimately the OHRP findings relied largely on a memo provided to them by Nelson as an FDA official.

While the federal investigation was ongoing, in May of 2010 the American Journal of Bioethics (AJOB) circulated a manuscript (in advance of publication, inviting open peer commentaries) attacking our letters of concern, saying they represented an instance of “unethical transgressive bioethics.”

At the time, we were not aware of conflicts of interest in the federal investigation or the AJOB article, because none were disclosed. Here is what we now know, including from material obtained just this week through the Freedom of Information Act:

First, neither the original AJOB manuscript (May 2010) nor the final published article (September 2010) included a conflict of interest statement from the authors. The lead author, Larry McCullough, failed to disclose that he held paid positions with the two medical schools implicated in the investigation (Mount Sinai and Cornell). The second author, Frank Chervenak, failed specifically to disclose that he was (and still is) Chair of Obstetrics and head of the Maternal-Fetal Medicine unit at the medical school where New “treated” over 600 pregnancies with prenatal dex.  Chervenak also failed to disclose that he served as “key personnel” on New’s NIH grant.

Responses to our Freedom of Information requests show that Larry McCullough gave the AJOB original manuscript to the federal investigators at OHRP prior to publication, in an attempt to undermine the claims in our complaints. No conflict of interest disclosures were attached to the manuscript. This suggests that OHRP personnel would have seen the McCullough and Chervenak criticisms of our request for an investigation, but would not have known of the authors’ conflicts of interest.

Second, it appears that Nelson did not disclose to his FDA or OHRP colleagues that he was a member of the editorial board of AJOB – the journal in which the criticisms were published. One might feel less concerned about this particular undisclosed conflict were it not for the fact that, like the AJOB target article, Nelson’s official FDA findings on prenatal dex misrepresented key facts, including whether the FDA had previously reviewed New’s use of this steroid on first-trimester fetuses.

Third, this week we have obtained additional material through our Freedom of Information request showing that Nelson was, in fact, developing an even deeper relationship with AJOB while he was conducting the prenatal dex investigation. At the very time Nelson was investigating our complaints, he was also negotiating to become editor-in-chief of a new AJOB journal, AJOB Primary Research (since renamed AJOB Empirical Bioethics).

A May 2010 email conversation between Nelson and others at the FDA shows that Nelson was to be compensated by AJOB not only with the editor-in-chief title, but also with $10,000 per year, for editorial assistance. In the email conversation about the new position with AJOB, Nelson never disclosed that the journal was being used to aggressively (dare we say “transgressively”?) undermine complaints he was investigating.

Curiously, Nelson’s FDA memo and the associated OHRP findings on prenatal dex were released on virtually the same day in September 2010 that AJOB published the McCullough and Chervenak “target article” and responses to it. The timing of this “coincidence” was openly celebrated by Glenn McGee, then editor-in-chief of AJOB: “With the release of the September issue of the Journal, both the FDA and OHRP have released letters responding to the complaints that are the subject of the Target Article…”

What might once have been thought fortuitous timing must now be examined through the lens of conflicts of interest, as we now know that, by September 2010, Nelson was working in titled and compensated positions for both the FDA and AJOB.

Fourth, in December 2010, AJOB published a “vindication” by Dr. New that consisted mostly of a long quote from Nelson’s FDA response to our letter. Consistent with the established pattern of non-disclosure, nowhere in conjunction with New’s “vindication” does one find disclosure of Nelson’s dual role as FDA investigator and key member of the AJOB editorial team.

We have repeatedly appealed to the editorial board of AJOB to add disclosures to all the dex-related publications. That has gotten us nowhere, except to force disclosure of who is on the AJOB conflict-of-interest committee. The committee includes Larry McCullough, specifically representing AJOB Empirical Bioethics, the journal given to Skip Nelson.






Alice Dreger and Ellen K. Feder 

Alice Dreger, PhD, is Professor of Clinical Medical Humanities and Bioethics at Northwestern University Feinberg School of Medicine. @alicedreger

Ellen K. Feder is Associate Professor of Philosophy and Religion at American University, and author of Making Sense of Intersex: Changing Ethical Perspectives in Biomedicine, just issued by Indiana University Press.


[Note:  Might wander through the typical profiles of the “bioethicists” identified in the following article: The article originally appeared here 

Larry McCullough, one of the founders of “bioethics”, pop control, research using children, pro-human embryonic stem cell research, etc.:  https://www.google.com/#q=%22Larry+McCullough%22+%22bioethics%22

Frank Chervenak, M.D., ObGyn specialist in maternal and fetal medicine, pro-abortion and woman’s rights, anti-personhood for the unborn, pro-euthanasia, etc.: https://www.google.com/#q=%22Frank+Chervenak%22+%22bioethics%22+%22controversy%22

Glenn McGee, partner with bioethics founder Art Caplan, pro-“designer babies” and human cloning, implicated in conflict of interest in the Celltex corruption case, etc.:  https://www.google.com/#q=%22Glenn+McGee%22+%22bioethics%22

Skip Nelson, Senior Pediatric Ethicist at FDA, promotes research using children, etc.:  https://www.google.com/#q=%22Skip+Nelson%22+%22bioethics%22&start=10

See also “Charges of editorial misconduct at American Journal of Bioethics (AJOB), at: 

http://www.healthnewsreview.org/2011/06/charges-of-editorial-misconduct-at-american-journal-of-bioethics/.

For an extensive analysis and critique of “bioethics”, with extensive references, see my article, "What is 'bioethics'?" (June 3, 2000), UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X:  Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.:  University Faculty For Life, 2002), pp. 1-84, at:

http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html.  As a First Generationer in this “bioethics”, I hold one of the few Ph.D. concentrations in bioethics the field from the KIE and Dept. of Philosophy, Georgetown University (1991).

--  DNI]




Welcome to the Dark Age of Designer Babies

by Carly Andrews


[A sobering 2014 article on alteration of the human gene pool which will have unknown consequences for the human race.  Once invoked, how can this be undone? Is this really what we want genetic science to be? ED]


As FDA holds hearing on new controversial fertility technique, Aleteia expert insists it’s a moral no-go.

The FDA (Food and Drug Administration) is holding a hearing this week in the US to consider a controversial new IFV technology that would involve the creation of test-tube babies, using the DNA from 3 separate people.  The procedure aims at preventing potentially fatal mitochondrial diseases. [emphasis - DNI]
 
Troublesome cells

Mitochondria are organelles (or tiny power stations) found in every cell of the body except for red blood cells, generating energy for the cell. They are passed from mother to child through her egg.
 
There are around 5,000 children in the US suffering from the illness.  Mitochondrial diseases are often caused by mutations – inherited or acquired – in mitochondrial DNA.  The effects can include cerebral developmental delays, muscle weakness, seizures, strokes, dementia, diabetes, blindness, deafness, short stature, respiratory problems and in the worst cases, death.
 
This latest IVF research has discovered that exchanging the defective mitochondria of the parent egg/embryo with mitochondria from a healthy donor egg/embryo, avoids passing on the disease to the infant. 
 
There are two different methods for mitochondrial repair:
 
First – intervention by embryo: 
1. The sperm fertilises two eggs; one embryo is created using the egg of the parent, and another with the egg of the donor. 
2. The nucleus (containing the genetic information) from the donor embryo is removed and destroyed.
3. The nucleus from the parent embryo (which has the unhealthy mitochondria) are removed and the remains destroyed.
4. The parents’ nucleus is inserted into the donor embryo to create a healthy embryo.
 
Second - intervention by egg:
1. A healthy donor egg and the mother’s egg with defective mitochondria are collected. 
2. The donor’s nucleus (containing most of the genetic information) is removed and destroyed.
3. The nucleus from the mother’s egg is removed and the remains destroyed. 
4. The mother's nucleus is inserted into the donor’s healthy egg, and it may now be fertilised by sperm.

The consequences of either of the above procedures mean that the child would have around 20,000 genes from their parents and about 37 mitochondrial genes from a third-party donor. The genetic inheritance of the infant would be irreversibly moderated. 
 
Moral dilemma
 
Antonio G. Spagnolo, Director of the Institute of Bioethics, Faculty of Medicine, at the Università Cattolica del S. Cuore, Rome, has spoken to Aleteia about the moral implications of this highly controversial procedure. 
 
“Undoubtedly the efforts of the researchers in attempting to eliminate pathologies of this type are commendable” he says. “Unfortunately the manner in which they proceed to resolve illnesses is very problematic and numerous moral questions must be confronted."
 
“First of all, at the heart of the matter is the unavoidable problem - which is morally negative in itself - of IVF which is what actually enables the realisation of this new procedure.”
 
The Church is very clear on the moral depravity of IVF practices, in which many human embryos are experimented on and disposed of.
 
“Respect for the dignity of the human being excludes all experimental manipulation or exploitation of the human embryo." [Congregation for the Doctrine of Faith]
 
Besides the many risks involved for both the mother and infant, the big moral problem is that the human embryo is treated as mere disposable biological material, instead of a human person.

The Church explains that the human person is a unified whole, which is “at the same time corporal and spiritual. By virtue of its substantial union with a spiritual soul, the human body cannot be considered as a mere complex of tissues, organs and functions...” 
 
Therefore “the fruit of human generation, from the first moment of its existence...from the moment the zygote has formed, demands the unconditional respect that is morally due to the human being in his bodily and spiritual totality.”
 
If the human embryo must be treated as a human person, then it is “not in conformity with the moral law deliberately to expose to death human embryos obtained 'in vitro'.”
 
But then, wouldn’t the second form of IVF be morally permissible, since it only modifies the egg and not the embryo? 

Professor Spagnolo answers that “the procedure cannot be morally permissible.”
 
Consequences unknown
 
Firstly, in addition to the foundational problem of IVF in itself being morally wrong, Spagnolo emphasises the problem of consequences.
 
“Even for those who retain that in vitro fertilisation does not have any moral problems” he explains that “they still could not help but recognise that this new procedure is, in itself, loaded with unknown elements with regards to its results."
 
Indeed there is no way to tell, from supposed initial ‘success’ in experimentation, what the long-ranging consequences of this procedure could be for the child and what physiological or psychological problems it may cause further down the line. 
 
Gene therapy
 
Secondly, Professor Spagnolo considers the risks involved with understanding the procedure in terms of “gene therapy.” 
 
He explains that the scientific community has “always considered gene therapy on germ cells in the negative sense.” 
 
The practice “deals with inserting correct genes into a germ cell before IVF” he says. “Germ gene therapy is loaded with risks since any possible harm transmitted would be done not only to the embryo in question, but also to the descendants of the embryo.”
 
Here Spagnolo brings our attention once again to the teachings of the Church. 
 
“The Catholic Magisterium reminds us: ‘because the risks connected to any genetic manipulation are considerable and as yet not fully controllable, in the present state of research, it is not morally permissible to act in a way that may cause possible harm to the resulting progeny. ...For these reasons, therefore, it must be stated that, in its current state, germ line cell therapy in all its forms is morally illicit.’” [Dignitas Personae, 26]
 
So basically, 3-person IFV treatment is a moral no-go.

"It is not enough merely to discipline by law the ways in which it is brought about" Spagnolo asserts, "since its fundamental meaning remains the same."



[Note:  Better analysis than most.  Yes, both the end/goal and the means used to reach it must be ethical.  The ends do not justify the means.

(1)  He identifies one of the major scientific consequences that seems the media wants to ignore:  the genetic engineering does not just affect the child born, but because those “foreign” genes become integrated into her germ cells (female oocytes) then those foreign genes will ALSO be passed down through the child’s future generations -- genetically altering not just the child’s genome but all her descendants and the human gene pool as well.  Thus not just one child’s problems are the issue, but also the cloning of those foreign genes down through the generations. 

(2)  I might also add that the fact that mitochondria have fewer genes than the nucleus does not therefore mean that they are “incidental” -- as demonstrated by the various mitochondrial diseases themselves. 

(3)  Approving this research -- much less clinical trials with human patients -- would thereby also approve killing the normal living human embryos used as the source of the healthy mitochondria.

(4)  How can patients in clinical trials give ethically or legally valid “informed consent” when the researchers don’t know the critical “information” they need to inform their patients -- e.g., the scientific facts, the risks and benefits, etc.?

(5)  Scientifically they don’t have a clue as to what genes are causing the problems in mitochondrial diseases.  (a)  As there are many different kinds of mitochondrial diseases, there are probably many different genetic mutations causing them.  (b)  By what genetic criteria will they determine the guilty genes when scientists still don’t know any more that 50% or less of the coding of THE Human Genome Project (which used only nuclear genes, and derived them from samples from people around the world and pooled them all together!).  Answer:  They don’t know, and can’t know.  Thus they are incapable of anticipating any dangerous consequences to the child or her descendants -- or explaining them scientifically.

(6)  A lot of research by many different scientists have shown that the normal “communication” between the nuclear genes and the mitochondrial genes is badly damaged when “foreign” mitochondrial genes are substituted for the natural mitochondrial genes -- and that causes serious damage to the organism.

(7)  And what appears to be a “beneficent” technique can also be used for maleficent purposes as well.  What if they use the same technique to inject non-human animal mitochondrial thus forming a chimera?  Or inject foreign genes desired by researchers into the donor mitochondria before injecting them into the human oocyte/embryo?  Same technique, different foreign genes.  Opens the door to all sorts of genetic engineering of human beings and their descendents.

(8)  My only pause was when he used the term “zygote”.  According to the Carnegie Stages of Early Human Embryonic Development (instituted in 1942 and updated continuously since then to the present), the formation of the human “zygote” is not when the new human being begins to exist.  The “zygote” is Stage 1c;  the embryo already exists before that point at Stages 1a and 1b.  That is, the new sexually reproduced human being begins to exist at the beginning of the process of fertilization, when the sperm penetrates and fuses with the oocyte -- not at the end of the process.  If the “zygote” is claimed to be when the human being begins to exist, that would justify using (and killing) the already existing embryo at Stages 1a and b -- which is when a great deal of human genetic engineering is performed!  Well, at least he didn’t say “conception”. The article first appeared here.  -- DNI




The Perfect 46: A “Science Factual” Film about our Near Future

by Jessica Cussins

 

Sitting down to watch the science fiction film The Perfect 46, I had the strange sensation of walking through a hall of mirrors. Intriguingly meta-conscious, and perceptibly close to reality, this film highlights the world of direct-to-consumer (DTC) genetics and makes it clear that this technology, now at our real-world doorsteps, could drastically shape our very near future.  [Emphasis - DNI]

The story centers on the aptly named company ThePerfect46, which starts off with a seemingly innocuous mission. Taking advantage of the fact that most Californians have had their genomes sequenced by this undefined point in time, it simply offers to analyze a couple’s genomes alongside each other to determine their ability to have a disease-free child.  

But founder and CEO Jesse Darden isn’t content to stop there. In a move that sparks internal controversy and leads to one staff person abandoning the project, he rolls out version 2.0, which allows the company to search through giant databases and match random people together based solely on their ability to create genetically “ideal” children. The film cuts back and forth between a tense situation unfolding for Darden, flashbacks of his life, and a documentary film made about his rise and fall. 

While The Perfect 46 is a fictional film, it is being promoted by a real-life website purporting to actually sell ThePerfect46 product (kudos for the smart marketing ploy!). 

Darden, played quite well by Whit Hertford, is the star of The Perfect 46. He is a Steve Jobs-esque anti-hero: the disliked techie genius, the man behind the company that aims to improve humanity but ends up causing great harm. Darden comes across as “a tortured genius… a character that can be lauded and loathed in equal measure.” He is romanticized as smart and entrepreneurial, but his considerable personal and inter-personal flaws are never out of view. 

Perhaps by now both Darden and ThePerfect46 sound strangely familiar. If so, it’s probably because the similarities to companies and products that actually exist right now are jarring. This is a kind of science fiction that is only just barely fictional.

In fact, writer and director Brett Ryan Bonowicz calls The Perfect 46 science factual.” He invited a number of researchers to be consultants on the film and strove to show “a respect for science.” The scientific community has applauded his use of “authentic science” and raved about how the film is “a refreshing change of pace” because it doesn’t dissolve into a dystopian nightmare.  Here Bonowicz elaborates on why he pursued this approach,

By making the film as factually accurate as possible, the conversation that the film creates should, I think, spark something that a more futuristic, fantastic treatment perhaps cannot. The topics we cover in the film – genetics, eugenics, the moral and ethical implications of a consumer genetics service, and the role of government vs. a DTC model – are discussions that deserve to be out in the public. This is a film of the moment.

 In fact, you may find reality to be even more bizarre than this particular fiction. Just last year, the infamous DTC genetics company 23andMe received a patent for "gamete donor selection based on genetic calculations." The premise of the technology was that it could allow people to choose a sperm or egg provider based on probabilities of having a child with the kinds of characteristics they desired including “height, eye color, gender, personality characteristics and risk of developing certain types of cancer.” In response to backlash from the media about its “designer baby patent” with drop-down menus of characteristics, 23andMe assured everyone that it no longer had any plans to pursue the full range of possibilities described.

Another company, GenePeeks, has remained undaunted. GenePeeks launched just months ago, founded by molecular biologist Lee Silver, who writes broadly about how positive eugenics is both laudable and inevitable, and Anne Morriss, the mother of a sperm donor-conceived son who inherited the rare recessive disease MCADD.

GenePeeks’ “Matchright” is remarkably similar to the product offered by ThePerfect46For $1995, “GenePeeks digitally combines your DNA and the DNA of potential donor matches to create a preview of thousands of personal genomes that your child could inherit, focusing on a panel of genes involved in childhood health and disease.” Based on this information, you can then preview your personal “catalog” of donors and further weed them out based on your preference for such characteristics as height, eye color, hair color, education level, and ethnicity. 

What GenePeeks hasn’t marketed yet is its ability to test for much more than “health and disease.” But the patent it was awarded in January explicitly lists many non-medical traits: aggression, weight, breast size/shape, drinking behavior, drug abuse, eating behavior, ejaculation function, emotional affect, eye color/shape, hair color, height, learning/memory, mating patterns, sex, skin color/texture, and social intelligence, among others. It is thought to be possible to screen for just some of these traits, but all are covered by the patent.

Furthermore, GenePeeks doesn’t intend to limit its availability to sperm banks. It plans to expand soon and become available for “anyone planning a pregnancy in advance.” Of course, there is at least one fundamental flaw in the methodology of all these schemes: two people can have an infinite number of children with a full range of characteristics. Choosing a “preferred” donor can’t possibly absolve all risk

In fact [spoiler alert], in The Perfect 46, a bug in the company’s algorithm results in the birth of 24 children with a severe genetic disorder. The horrific mistake causes the company to close its doors and forces Darden into solitude, where he continues to develop his work and reflect on what went wrong. What is perhaps most remarkable about the scenario is that no one is ever found to be at fault, even when some of the children die, and at least one suicide results. While Darden is depicted as a broken man, devastated by the fault in a system he designed, he is relatively unmoved by personal stories, including one about a loving couple that divorced after hearing they were “incompatible.” In his mind, “Just because I created something doesn’t mean I’m responsible for how people use it.”

Is this the kind of language that will be used around technologies governing life and death in our market-driven culture? The film probes many such important questions. How quickly does the right to know become the responsibility, or even the requirement, to know? What will people do with this information? And what happens, and who is accountable, when it is wrong? 

(If 23andMe is anything to go by, some information will be wrong.)

Furthermore, can changing the kinds of people who are born really be considered “preventative medicine?” When recommendations about who is “fit” to be born are made by a commercial entity, does the absence of state involvement make the actions less eugenic? Is “perfection” what we ought to strive for? If so, what do we make of the founder – who is anxious, anti-social, awkward, not good-looking, and in the end, in “an irony that was lost on no one,” infertile?

The desire to know and control more, even when the meaning of the knowledge and our ability to control it is imperfect, can be powerful. But while it makes marketing sense for drug and genetic testing companies to pathologize more and more conditions, it probably doesn’t make sense for us. As these technologies become increasingly present in our lives, that point risks getting lost.

GenePeeks has just received $3 million in financing. The concept of adding genetic profiles to dating sites seems to be gaining steam. These trends suggest that this film could well be “more of a glimpse of the future than simply a hypothetical conversation about ethics and genetics.” 

But if The Perfect 46 is “a sort of prequel to Gattaca,” hopefully we will find a way to stop short of that future. 

You can find upcoming screenings of this thought-provoking film here, and check out CGS’s personal genomics news page here. Can you make it through the hall of mirrors, discerning the difference between fiction and reality?



[Note:  The burning question remains:  Can they really decode anyone’s genome?  Answer:  No.

Remember that the “human genome” is defined as the total DNA in both the nucleus and the mitochondria outside the nucleus of a cell.  Aside from the fact that only about 15% of  “THE” Human Genome has still only been decoded (along with problems like individual genomes are unique;  the sample consisted of mixing multiple samples from people around the world;  only the nuclear genes, and only their extrons, were addressed, etc. (see:  http://web.ornl.gov/sci/techresources/Human_Genome/project/index.shtml), what about that part of an individual’s genome provided by the person’s mitochondria?  And what about the 85% of the nuclear genes in an individual’s cells that was called “junk DNA” in the “introns” of those nuclear genes until lately?  Are these “kits” even capable of determining the mitochondria and the “junk DNA” in those “introns”?  See, e.g.: 

--  “DNA is actually not well understood. 97% of human DNA is called ³junk² because scientists do not know its function. The workings of a single cell are so complex, no one knows the whole of it. Yet the biotech companies have already planted millions of acres with genetically engineered crops, and they intend to engineer every crop in the world.”

Genetic Engineering and “Junk” DNA, Genetic Engineering, at:  http://www.authorstream.com/Presentation/ramyasekaran-1541143-genetic-engineering/

--  The Astonishing Powers of "Junk" DNA

http://www.khouse.org/enews_article/2012/1982/

--  Most of What you Read was Wrong: How Press Releases Rewrote Scientific History, Center for Genetics and Society, at: 

http://www.geneticsandsociety.org/article.php?id=6390

--  Never-Seen-Before Secret DNA Code And An 'Unusual Meaning'-Scientists Find, at:  http://www.designntrend.com/articles/9627/20131214/never-seen-before-secret-dna-code-unusual-meaning-scientists-find.htm 

-- Junk DNA — Not So Useless After All

“Researchers report on a new revelation about the human genome: it’s full of active, functioning DNA, and it's a lot more complex than we ever thought, at:  http://healthland.time.com/2012/09/06/junk-dna-not-so-useless-after-all/

--  What Junk DNA? It’s an Operating System;  Their report adds to growing experimental support for the idea that all that extra stuff in the human genes, once referred to as “junk DNA,” is more than functionless, space-filling material that happens to make up nearly 98% of the genomehttp://www.genengnews.com/insight-and-intelligenceand153/what-junk-dna-it-s-an-operating-system/77899872/ 

Given that their claims don’t even mention those DNA’s gives an indication that they don’t.  So what does an individual who buys such “kits” really end of knowing about their genome -- and how can any medical or eugenic decisions be based on such “information”?  Indeed, how can any supposed “ideal child” be genetically designed at all?  Is so-called “positive eugenics” a bunch of nonsense?  Perhaps the above, too, is a “discussion that deserves to be out in the public”!  In fact, much of what passes as "genetics research" and the "kits" described below would seem to border on scientific fraud -- and someone should be held legally accountable. The article first appeared here.

Caveat emptor!  --  DNI]