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]



Medical Murder? Mass Woman Medically Kidnapped from Home Dies After Being Denied Medical Intervention

by Health Impact News/MedicalKidnap.com Staff

Lawyers and guardians denied Beverley Finnegan the life-saving treatment her sister wanted her to have. The guardianship cost her life. Photo source.


As the icy blast of the historic “bomb cyclone” chilled the heart of Boston and flooded her streets, an even more chilling battle was taking place over the life of 69 year old Beverley Finnegan.

The fight to get court-appointed guardians and attorneys to allow her to receive life-saving medical treatment has ended with her death just before noon on Friday, January 5, 2018.

See Beverley’s story here:


Her tragic death follows the one day that her sister and advocate Janet Pidge were not able to be by her side at Framington Union Hospital. The brutal snowstorm kept Janet, as well as many other residents in the greater Boston area, home and off the streets on Thursday.

“A Turn for the Worse” – During a Crippling Snowstorm

Beverley’s condition was largely unchanged during the last several weeks, so the Friday morning phone call came as a shock.

Gary Zalkin, attorney for Framington Union Hospital, left a voicemail at 8:30 a.m. saying that that she had taken “a turn for the worse” and would likely pass within the next hour or so.

Janet was already en route to the hospital to be by her sister’s side. Advocate and journalist David Arnold told Health Impact News that he joined Janet in Beverley’s hospital room. He reports that her heart stopped several times, while doctors kept saying that her brain had shut down. Finally, her heart stopped beating for the last time, and she was pronounced dead at 11:48 a.m.

Janet’s attorney Lisa Belanger calls it “euthanasia” – the hastening of Beverley Finnegan’s death. Belanger attempted to file a criminal complaint on Saturday, since euthanasia is illegal in Massachusetts. However, the police denied her request, telling her to file medical malpractice instead. She told Health Impact News:

This is worse than the Twilight Zone.

Kidnapped and Denied Civil Rights over Medical Disagreement

For months, Beverley Finnegan and her sister Janet Pidge have been battling the state of Massachusetts to bring her home. The sisters owned a condo together, and they relied on each other. Several years ago Ms. Finnegan named her sister as her proxy if ever she needed someone to make decisions for her. Her wishes were completely ignored.

A doctor diagnosed her with an illness that, in hindsight, she may never have had. Dr. Anne McKinley said that she had a lung infection called Mycobacterium kansasii and that she would die without treatment. When Ms. Finnegan chose not to go back to that particular doctor, Dr. McKinley filed a protective order with the courts.

Police and social workers broke into the condo and seized her. Because she fought against her kidnappers, she was deemed mentally ill and violent. She was bodily seized and forced against her will into a nursing home and forced onto psychotropic drugs.

The door frame was broken during Beverley Finnegan’s state-sanctioned abduction, yet she was labeled “paranoid.” Photo source: Boston Broadside.

For months, she begged and pleaded to go home, saying that they were going to kill her. The presumably imaginary infection that was used as a pretense to deprive her of her liberty was never addressed – not once.

Stranger Named as Her Guardian, While Sister Fights Back

Lawyers petitioned for, and won, the ability to override Ms. Finnegan’s wishes, and a judge appointed a guardian with Jewish Family and Children’s Services. Under a draconian legal construct known as “guardianship,” Marissa Levenson was granted the authority to make life-altering decisions for a woman she had never before met.

Marissa Levenson, guardian with Jewish Family and Children’s Services, was given authority to place Ms. Finnegan into a nursing home against her will. Photo source: Boston Broadside>.

According to Lonnie Brennan of the Boston Broadside, who met with Janet Pidge and has attended some of the court hearings:

Beverly’s sister, Janet, is hysterically desperate: she’s fighting daily to get anyone to help. Janet can’t stop talking about her sister, non-stop. She’s anxious, desperate, and determined to get someone to listen. She’s spent her savings, she’s knocked on seemingly every door of every lawyer or politician she could find.

She’s been lied to along the way in the same way her sister was lied to. She is called delusional and paranoid for not believing the state.

She can’t stop. She fights on. She’s determined and gets into rants about the shock of the taking of her sister, long-term problems at her condo with certain neighbors, and the tragic history of her family (for which a movie should be set).

Her money is gone and she’s stuck asking for rides daily or help to pay for the trains to take her from Newton to Framingham each day where she prays at her sister’s side. 


Life-Saving Medical Measures Denied

Lisa Belanger says that the decline in Ms. Finnegan’s health was directly related to fact that the state placed her under guardianship. Under that guardianship, she was forced into a nursing home that did not properly care for her. Due to their alleged neglect and possibly actively harmful practices, Ms. Finnegan wound up in a coma on November 30, and doctors have neglected basic medical care that could have saved her life.

On December 18 and again on December 22, Belanger went head to head in court with a gaggle of attorneys and guardians who were determined to pull the plug and end Beverley Finnegan’s life, against the adamant wishes of her sister.

On one side were the guardian and attorneys for Framington Union Hospital, Jewish Family and Children’s Services, and Springwell – a non-profit organization utilized by the state of Massachusetts to implement Adult Protective Services policies.

They all argued that it would be more compassionate to pull the plug than allow her to live life under the current circumstances.

Lisa Belanger argued for Ms. Finnegan’s basic Constitutional right to life. She presented an affidavit from renowned medical expert Dr. Paul Byrne dated December 22, in which he stated that she did “not fulfill any set of ‘brain death’ criteria.”

Dr. Byrne laid out specific medical protocols that should have been taken already but hadn’t. He said that if they would initiate such treatment immediately, Beverley’s health should improve.

Since that time, Lisa Belanger engaged in a life and death struggle to get the hospital to do the basic medical treatments that could have saved Ms. Finnegan’s life. She sent numerous requests to the newly appointed Guardian ad Litem Joanne Moses and to the various attorneys involved, including the hospital’s attorney Gary Zalkin.

Her every attempt was rebuffed.

Counsel for Framington Union Hospital, Gary Zalkin. Photo source.

Even though Beverley’s sister and her attorney were clear that they wanted such measures being taken, Zalkin reportedly said that they would have to wait until the new Guardian ad Litem approved of the tracheostomy and they were all able to go before the judge again for approval.

Lisa Belanger countered with:

EVERY SECOND THAT GOES BY YOU AND YOUR CLIENT ARE OVERTLY DEPRIVING MY CLIENT’S SISTER OF WHATEVER RECOVERY IS POSSIBLE.

To confirm, Judge Monks expressly stated that Metro West HAS AUTHORITY to perform emergency necessitated procedures–that such procedures do not require a court order.  Again, the emergency procedures are laid out by Dr. Byrne in his provided affidavits that you have received.

As already substantiated from the documentation I provided you, you and your client’s FAILURE TO ACT continues to be knowingly and deliberately causing overt harm to my client’s sister, Beverley Finnegan.

None of the life-saving procedures were initiated. On the day that Beverley’s sister could not be with her at the hospital due to the massive snowstorm, her health suddenly declined. By the time Janet Pidge and Lisa Belanger got word of her demise, all of the government offices to which they could have turned were closed due to the storm.

They were completely helpless to stop what they see as Ms. Finnegan’s needless death. Because of the guardianship, Beverley’s trusted loved one was powerless to intervene to save her life.

This woman who was functional, in full control of her mind, and able to walk and care for herself on her own just a few months ago is gone – another victim of guardianship.

David Arnold has written several articles on the dangers of guardianship. He told Health Impact News:

Guardianship is a form of slavery, but it is actually far worse than slavery. It needs to be abolished.

With guardianship, they want to rob them and kill them.

Conflicts of Interest: Psychotherapist, Jewish Family and Child Services All Complicit in Death

Even though the sisters lived in a large metropolitan area, the small group of players involved in their case have worked together in a number of similar guardianship cases, according to public records.

Jewish Family and Child Services seems to be a major player in the region. They played a significant role in the decisions leading to the rapid decline of Beverley Finnegan’s health.

Attorneys Gary Zalkin, Lawrence K. Glick, and Wendy K. Crenshaw each appear on the dockets of many guardianship cases in various roles – alternately as counsel for the ward, counsel for the petitioner for guardianship, the petitioner, or guardian.

There are cases where the same attorney’s name shows up in the record in more than one role. In a case from 2016, Case #BR16P0649GD, Gary Zalkin is listed as the attorney for the ward, the petitioner on behalf of the facility wanting to place the ward under guardianship, and as the guardian himself. That is three conflicting roles – all represented by the same attorney.

Zalkin practiced for 14 years as a psychotherapist (Source) before attending law school. He has lectured and written on the practice of guardianship, and has apparently found his niche. According to his website:

Attorney Gary Zalkin wrote the chapter in the Mental Health volume of the Massachusetts Practice Series that explains the new guardianship and conservatorship laws. He has additionally pioneered the affirmation of health care proxies for mental health issues in Massachusetts. He has served as chair of the Riverside Community Care Human Rights Committee and as president of the Board of the National Alliance for the Mentally Ill of Massachusetts, MetroWest affiliate.

In 2005 Attorney Zalkin was honored by Massachusetts Lawyers Weekly as one of fifteen “rising stars – Massachusetts lawyers who have been members of the bar 10 years or less, but who have already distinguished themselves in some manner and appear poised for even greater things.”

Attorney Gary Zalkin received his B.A. in psychology from Brandeis University in 1989 and his M.S.W. from Simmons College School of Social Work in 1992.

Gary Zalkin is also “a member of the Harvard Medical School’s Program in Psychiatry and the Law.” (Source).

Cover-up of Medical Malpractice?

How is it that a person can lose every Constitutional and human right, including the rights to make personal and medical decisions, refuse medical treatment, live in her own home, be autonomous, and choose to live – based on a letter from a doctor not backed up with evidence?

Framington Union Hospital. Photo taken by an advocate, name withheld by request.

What really happened to Beverley Finnegan – both in the nursing home before her hospitalization and in the hospital during the snowstorm, during the time that her sister could not watch over her and try to protect her?

Is there a cover-up happening of medical malpractice?

What kind of benefit is there to those parties networked together? Why are there so many entities and individuals working to take away the basic human rights of senior citizens?

How can citizens protect themselves from the tyrannical overreach of people operating under the color of law to take all their worldly goods as well as their very liberty? Is anyone safe?

Beverley Finnegan’s voice has been silenced. Will her death go unnoticed, or will it mean something? Who will speak out for justice for her and for countless others whose lives are being stolen?


Other Adult Guardianship Stories We Have Covered:

Medical Kidnapping of Seniors: A $273 BILLION Industry

Obamacare: America’s Elder Medical Kidnapping Epidemic is Leaving Seniors Homeless







Deadly Medicine Creating the Master Race

by John Carlos Cantu           


U-M Taubman Health Sciences Library exhibit presents a chilling look at Nazi ideology.

The 1938 words of Dr. Joseph Goebbels, Nazi minister of propaganda, stand above the display panels of what is undoubtedly the most somber exhibit Ann Arbor has seen at the University of Michigan Taubman Health Sciences Library.  Goebbel’s quote runs as follows: “Our starting point is not the individual, and we do not subscribe to the view that one should feed the hungry, give drink to the thirsty, or clothe the naked…. Our objectives are entirely different: We must have a healthy people in order to prevail in the world.” 

These words are chilling and they’re more than an adequate rationale for this heart-rending investigation into a politics that sought to implement one of the most perverse policies in history. 

As Mary Beth Reilly, writer for the U-M’s Center for the History of Medicine, says in the display’s gallery statement, “The Nazi regime was founded upon the conviction that ‘inferior races’ and individuals had to be eliminated from German society so that the fittest ‘Aryans’ could thrive. 

“By the end of World War II, six million Jews and millions of others—among them Roma and Sinti (Gypsies), people with disabilities, homosexuals, and others belonging to ethnic groups deemed inferior—had been persecuted and murdered.”  And as Alexandra Minna Stern, Zina Pitcher Collegiate Professor of the History of Medicine and Associate Director of the Center for the History of Medicine at the U-M Medical School, adds, “The exhibition is a visually powerful experience for viewers that shows how the doctrine of racial hygiene was taken to its most heinous extremes.” 

Indeed. And as the exhibit pointedly illustrates, there’s more than enough blame to go around. For the exhibit begins with a panel illustrating the various programs from countries around the world (including the United States) advocating various eugenic schemes at the turn of the 20th century whose “racial hygiene” included programs in population policy, public health education, and government-funded research whose ends (even if they weren’t remotely the same) clearly showed an undeniable bias.  

The rediscovery of Austrian botanist Gregor Mendel’s genetics experiments in 1900 coupled with the increasingly fashionable “Social Darwinism” of British philosopher cum sociologist Herbert Spencer, whose catchphrase “survival of the fittest” was being bandied about, led to increasing public prestige in the efforts to stabilize public policy issues that emerged with increasing industrialization and urbanization. This was, in retrospect, a philosophical and political slippery slope that was in part absorbed in the ideology and practice of the newly emergent Nazi party of the 1920s. 

From the early 1930s through the balance of the Nazi regime, there were repeated campaigns to rid German society of what they viewed as biological threats. As “Deadly Medicine” clearly shows, this policy absorbed the efforts and energies of many of the nation’s most talented doctors, psychiatrists, anthropologists, and medically trained geneticists, as well as social planners and party functionaries at every level.  [And soon to be repeated in the form of Obamacare - ED] 

What started as a secret campaign to eliminate the weak and infirm disguised as medical assistance metastasized into a full-fledge program of eradication under the pressure of World War II. Ultimately, this so-called “sanitary campaign” finally took form as a genocide that we now know as the Holocaust, resulting in the near total annihilation of Europe’s Jewish population. 

To its credit, “Deadly Medicine” doesn’t pull any punches. Its juxtaposition of scientific certitude and racial hatred are handled as responsibly as the topics deserve. 

By naming names, dates, and events—as well as providing significant visual evidence—the exhibit takes the full measure of this circumstance where those in charge of healing and sustenance distorted their responsibilities until their lifework turned into a horror whose pain continues to this day.  

It’s certainly enough pain for Professor Stern to remind us that the example of this massive failure of science, technology, tolerance, and ultimately compassion, “raises weighty questions about the potential benefits and harms of genetic and reproductive technologies today.” And it’s on this cautionary note that the solemn exhibit rightfully concludes.

 

 




“It’s certainly enough pain for Professor Stern to remind us that the example of this massive failure of science, technology, tolerance, and ultimately compassion, “raises weighty questions about the potential benefits and harms of genetic and reproductive technologies today.” And it’s on this cautionary note that the solemn exhibit rightfully concludes.”  The article first appeared here. - DNI