MIT Scientist on Harvard's Cloning

Harvard alumnus James L. Sherley, M.D., Ph.D., a professor in the Biological Engineering department at Massachusetts Institute of Technology, has "come out" with his opposition to cloning and destructive embryonic stem cell research. In particular, Professor Sherley, a Pew scholar credited with research on the "assymetrical" division of adult stem cells, is quoted in Australia's MercatorNet,

When the errant biological properties of human embryonic stem cells are considered, it is difficult to foresee them ever being used directly as cures in children or adults. This promise was the earliest misleading misinformation from proponents of human embryo research. Because many factors that guide the normal development of embryonic cells are absent in mature tissues, embryonic stem cells placed in adult tissues produce malformed tissues that are cancerous. So, figuring out how to use human embryonic stem cells directly by transplantation into patients is tantamount to solving the cancer problem.

Human embryonic stem cell scientists, who lacked sufficient knowledge of the cell biology of mature tissues, naively promised to develop new therapies with mature cells produced from embryonic stem cells. These scientists overlooked the fact that mature cells, which lack the renewal capability of stem cells, cannot be used for long-term treatment in mature tissues, which require continuous renewal.

There is one strategy by which embryonic stem cells might be used to develop therapies for the tissues of adults and children. If embryonic stem cells could be used to produce tissue-specific adult stem cells, the adult stem cells could be tried for mature tissue therapies. However, since natural adult stem cells are available from informed consenting adult donors, this possible embryonic stem cell-dependent strategy is not absolute, as has been suggested by proponents of human embryo cloning.

Moreover, if derivation of specific adult stem cell types from embryonic stem cells is found to be possible, the derivation process will take longer than using natural adult stem cells and may still produce defective and possibly tumour-forming adult stem cells. However, more to the point, why pursue this uncertain path that requires destruction and exploitation of human embryos, when adult stem cells can be used instead?

Dr. Sherley wrote an editorial early in June, 2006 calling for Harvard to "revoke" plans to clone human embryos in the Boston Globe and is quoted extensively in another excellent review article, written by James P. Kelly, in the Seoul Times.

Considering the regulation of the use of human research subjects and the human embryo's protection under these regulations:

Human embryo scientists have tacitly agreed that cloned embryos should not be matured beyond an arbitrary early stage of embryo development. (This agreement highlights the deception of their feigned uncertainty on the question of whether human embryos are living human beings.)

However, it is very likely that diseases of adult life, if they show any manifestation in embryos at all, will do so well after this arbitrary stage of maturation. The public can be sure that Harvard's and other scientists, like camels in a tent, will keep inching this boundary forward with newly-crafted, misleading excuses for doing so.

MercatorNet: You seem pretty convinced that human embryos are human beings. Can you explain briefly why?

Sherley: My answer is, "What else could they be -- aliens?" Scientists who want to conduct experiments with human embryos are quick to say what human embryos are not. I challenge them to tell the public what human embryos are. There is only one answer to this question, "living human beings."

"Corrupted" Cells or Ethics?

The New Scientist is reporting the announcement (available by subscription here and the full, free version is here) by Pharmafrontiers (which is officially "Opexa Therapeutics.") that the company has successfully de-differentiated human blood cells into stem cells that are usually thought to be from other cell lineages. In other words, Pharmafrontiers,

"claims to have refined a way to produce stem cells from white blood cells called monocytes and develop them into many different tissue types including, crucially, insulin-producing cells."

This is exciting news. Pharmafrontiers is presenting a report at a scientific conference, where their research and results will presumably be subject to peer-review. The corporation is submitting a paper to a peer-reviewed journal and is applying for a patent on the technology to grow insulin-producing beta-islet cells from each patient's own white blood cells. The article notes several other labs in other parts of the world which have reported similar findings in peer-reviewed journals.

However, the bioethics story is the negative way in which The New Scientist has chosen to report the possibility that adult stem cells may provide therapies for diabetes and other diseases. There is an especially spurious comment about the amount of blood that would be needed from each patient - see the end of this post for more on that.


From the article:

Most mainstream stem cell researchers are sceptical, however, because the idea that specialised cells like monocytes can be "de-differentiated" back to more primitive stem cells remains heretical. "Let's see first how they perform functionally," says Stephen Minger of King's College London.

Pharmafrontiers, is to present its latest results at the end of this month in Toronto at the International Society for Stem Cell Research meeting. Deriving "stem cells" from monocytes was originally reported in 2003 in Proceedings of the National Academy of Sciences (vol 100, p 2426) by a team at Argonne National Laboratory in Illinois, but Pharmafrontiers bought up and refined the technology.

The company says it can de-differentiate monocytes into "multipotent" stem cells by exposing them to certain nutrients and growth factors. Such stem cells can give rise to many but not all tissue types like "pluripotent" embryonic stem cells (ESCs). Different combinations of growth factors can then turn the stem cells into a range of cell types.

Moreover, Pharmafrontiers says it is about to submit a patent application on a brew that turns the monocytes into pancreatic islet-like cells that produce insulin in response to high levels of glucose. "We now want to transplant these cultures into a diabetic mouse model," says Winnier, adding their results are being prepared for publication in a peer-reviewed journal.

Alan Colman of ES International, a company developing insulin-producing cells from human ESCs in Singapore, is also sceptical. He says it would take huge amounts of blood to produce enough islet cells for individual patients.

Chris Major of University College London says most stem cell researchers have neglected the idea of de-differentiating adult cells in favour of using embryonic stem cells. However, he warned there could be problems with using adult cells, because they have suffered years of genetic damage. "With embryonic cells, they're fresh, and not corrupted," he says.

Other teams are also experimenting with stem cells from blood. A team led by Bernat Soria of the Institute of Bioengineering at Miguel Hernández University in Alicante, Spain, last year reported reversing a mouse form of diabetes with insulin-producing cells developed from blood cells (Gastroenterology, vol 128, p 1774). And researchers at the University of Kiel in Germany led by Fred Fandrich report producing liver cells.

(emphases are mine)

The bug-a-boo about the volume of cells that would be necessary to treat any one patient is one of the arguments against the possiblity of using (destructive) embryonic stem cells. In the case of adult stem cells, however, we know the objection is falsified by the currently accepted procedure for collecting stem cells for complete bone marrow transplants. The donor is given a stimulating factor to cause him or her to produce larger than normal amounts of bone marrow-producing stem cells which are released into the circulating blood. The donor then undergoes a procedure called apheresis to collect the stem cells without loss of red blood cells, plasma, or platelets. Apheresis is a technique that allows the removal of specific cells or proteins from the patient's whole blood, with immediate return of most of the blood to the circulation. We've collected platelets and removed harmful antibodies from patients with this technology for decades. Here's a pdf from the University of Utah, explaining the procedure in more detail.

Perhaps The New Scientist should look at its own editorial staff to see whether they belong to the religion that "neglects" research on adult stem cells as "heretical." And why.

Bioethics, politics and projection

The National Review Online (please note today's DBD cartoon) features correspondence between Eric Cohen, Jonathan Moreno, and Sam Berger, concerning Mr. Cohen's article from May on the Castle-DeGette bill and the loosening the funding restrictions on destructive embryonic research.

I am surprised that Moreno/Berger warn,

". . . politicized discussions of scientific issues are likely to end in hyperbole."

Moreno and Berger are associated with the Center for American Progress. In fact, Moreno is Director of the Progressive Bioethics Initiative, a sort of subsidiary of the CAP, founded to counter the Progressive's perception that current bioethics centers are dominated by conservatives. I disagree with that notion, since most of the University bioethics departments are in no way conservative.

Nevertheless, the point of the original argument was to answer political questions by opponents of the President's embryonic stem cell research policy. We are discussing Federal research funds. I have never seen a tax-funded program that was not influenced by and subject to political agendas.

If it's true that politics contaminates science, then its all the more reason to keep government money out of scientific research!

A Right to Life Movie

"Just Like Heaven," a romantic comedy starring Reese Witherspoon and Mark Ruffalo, did not get the attention that I think it should have received, last year. The movie is out on DVD (for more information, see Amazon.com and Netflix)

Warning: the following may contain "spoilers," and give away the surprises in the movie.

Talk about a timely movie! For most of the movie, the heroine is a disembodied spirit who is actually in a "persistent coma." We learn that she has filled out paperwork to the effect that she does not wish to be kept alive on machinery, and named her sister as her agent in the event that she cannot make health decisions for herself.

At one point in the movie, Elizabeth's spirit attempts to communicate with her sister and the doctor who is recommending withdrawal of life support. She argues that she has changed her mind about her wish to be on a ventilator. Unfortunately, only our hero can hear her.

Elizabeth, the hard working surgery "Senior Resident" in the story has sacrificed most of her life for her career. And she almost loses that life in an auto accident on the way to a blind date.

On the way to her sister's house, Elizabeth is driving while sleep-deprived in a hard rain in San Francisco, and has a head on crash after looking down to adjust her radio.

The movie is a romantic fantasy, with the spirit of a woman "haunting" her apartment, mediums and exorcists, as well as the notion that fate or some other force contrives to bring certain people together. With the implication that some of us are not real except with the one we love and a Sleeping Beauty/Cinderella ending.


There's not much science or medicine in the movie (the pneumothorax diagnosis is preposterous, for instance), but it does address the subjects of a balanced life, grief, the ethics of Advance Directives, prolonged life support, and the pressures on those named to make decisions for us. There's even an opportunity in the movie for parents to discuss sexual morality with their children (our hero turns down the overt seduction by a neighbor).

Why worry about science education?

This month's New Oxford Review contains a book review on From Darwin to Hitler: Evolutionary Ethics, Eugenics and Racism in Germany, which addresses the philosophical and religious changes that led to the eugenic crimes of doctors in Nazi Germany.

From the review:

Even so, Weikart concedes that these intellectuals who "built their worldview on science" may not have realized that at the foundation of their edifice were certain "philosophical presuppositions" that did not come "from empirical science and about which science could not arbitrate." In other words, as brilliant as they were, these German scholars and scientists could not quite manage to draw the line between the science of Darwin and Darwinian moral philosophy.

But, what have Darwin and a few rogue doctors in the history of Germany got to do with post-Holocaust Americans?

The review (as well as another available only to subscribers to the Journal of the American Medical Association on the book, Nazi Medicine and the Nuremberg Trials: From Medical War Crimes to Informed Consentby Paul Julian Weindling) reminded me of an earlier article "The Evolution of Genocide," by Rebecca Messall, in the Winter 1999 issue of the Human Life Review. Ms. Messall became interested in the evolution controversy played out over the last decade in Kansas, State-mandated "National Science Education Standards," and her discovery that "a Huxleyan eugenic vision forms the theoretical model of the National Science Education Standards."

According to the 1959 president of the American Eugenics Society, Harry L. Shapiro, three essentials of eugenics are Darwin's natural selection, Malthus' idea of scarcity, and Mendel's analysis of heredity. These are the elements of eugenics, whether or not it is re-named "unified concepts" or "evolutionary biology," or "synthesis." In fact the themes reinforced by the NSES' thirteen year long curriculum are population genetics, natural selection and Malthusian scarcity.

Ms. Messall lays out the connection between the sponsors and authors of Kansas' science standards and various "mainstream" (and government funded) science associations, academies and societies:

The leaders of the effort to "unify" biology and other sciences around natural selection were in fact, as revealed by (Kathryn) O'Keefe's research, some of the century's leading eugenicists.

and,

. . . Despite such a glaring historical lapse in a Harvard-published book purporting to be a history of biology, "Science as a Way of Knowing" is incorporated by reference into the NSES, at least twice for further reading, and the phrase is used and highlighted in the NSES text.
I was alarmed that the NSES relied heavily on Moore's book as a reference and even incorporated its title throughout the text. But it concerned me more that, on its dust jacket, his 1993 book bears official endorsements by, among others, the highest-ranking men in the groups overseeing the national standards and two other men with decidedly bio-philosophical points of view:
=>the President of the National Academy of Sciences, Bruce Alberts
=>F. James Rutherford, head of the AAAS Project 2061 education initiative
=>an elderly Harvard evolutionist, Ernst Mayr, who was a central figure in founding a post-war group to promote the idea of a "unity of the sciences," called the Society for the Study of Evolution (SSE) and its journal, Evolution
=>Paul Ehrlich, original population control advocate/author.

Out of seven endorsers listed on Moore's book cover, four are contributors to the NSES. Moore and at least four endorsers appear to have been colleagues in Huxley and Mayr's Society for the Study of Evolution, a group for which Moore is himself a past-president.

According to documentation in Smocovitis' Unifying Biology, it was Huxley and his contemporary, Ernst Mayr who formed the Society for the Study of Evolution as part of their move to "synthesize" or "unify" (some might say contaminate) all concepts of science with Darwin's doctrine of natural selection.

The book, Science as a Way of Knowing is excerpted at Amazon.com
Be sure and read the part about animism on page 13 - and the dismissive quote about souls and barbarians.

Prostitution is sex abuse and trafficking

Whatever we can think of, someone, somewhere has done it - or is doing it. Christianity Today reports that Germany has legalized prostitution and is setting up "sex huts" around stadiums during its World Cup (soccer or football) series.

Supposedly the sports fans cannot control themselves for a period of time, so the German government is providing a "relief valve."

There is no excuse for a Nation to subsidize and legalize the use of women's bodies for sex - whether for pay or not. No one in this day of hundreds of varieties of Sexually Transmitted Diseases, including HIV/AIDS and the long-overdue recognition that 99%+ of cervical cancer is caused by a "venereal disease," would consider prostitution a "victimless crime."


Countering claims that it is the woman's body and her "choice," the CT editorial cites these statistics:

Prostitution is anything but glamorous. The U.S. State Department's office to monitor and combat trafficking in persons points to prostitution's core problem: The "routine abuse and violence that form the prostitution experience and brutally victimize those caught in its netherworld. Prostitution leaves women and children physically, mentally, emotionally, and spiritually devastated."

The statistics are sickening. "Field research in nine countries concluded that 60 to 75 percent of women in prostitution were raped, 70 to 95 percent were physically assaulted, and 68 percent met the criteria for post-traumatic stress disorder in the same range as treatment-seeking combat veterans and victims of state-organized torture," the office reports. "Beyond this shocking abuse, the public health implications of prostitution are devastating and include a myriad of serious and fatal diseases, including HIV/AIDS." The study found that 89 percent of respondents wanted to leave prostitution.

Speaking of the "underground railroad."

I pointed out the irony of using this term for destructive embryonic stem cell research in my last post.

And I was reminded again, in Nat Henthoff's latest column, "The Devaluing of Life," in which he quotes Jesse Jackson:

The boy's spontaneous insistence on the primacy of life also reminded me of a powerful pro-life speaker and writer who, many years ago, helped me become a pro-lifer. He was a preacher, a black preacher. He said: "There are those who argue that the right to privacy is of a higher order than the right to life.

"That," he continued, "was the premise of slavery. You could not protest the existence or treatment of slaves on the plantation because that was private and therefore out of your right to be concerned." This passionate reverend used to warn: "Don't let the pro-choicers convince you that a fetus isn't a human being. That's how the whites dehumanized us... The first step was to distort the image of us as human beings in order to justify what they wanted to do and not even feel they'd done anything wrong."

Please, read Mr. Henthoff's column on the devaluing of human life crossing lines of politics and stages of life and the wisdom of children and a consistent life ethic.

Creating more embryos to kill

Several medical centers, including Harvard,the University of California at Irvine, and the University of Texas at Houston are bragging in the press that they are not stymied at all by the Bush Administration policy on funding embryonic stem cell research. Why there's even an "underground railroad" for stem cell research funded by two moms in New York. (How's that for irony - the act of rescuing those who weren't considered human enough to be protected 200 years ago is now compared to the deliberate, planned and technological destruction of humans not human enough, today.)

Harvard has been the site of the destruction of new embryos in the search for embryonic stem cells. However, Douglas Melton,Steven Hyman and Kevin Eggan aren't, unlike George Daley, are no longer satisfied with thawing and nurturing hundreds of "left over" embryos in order to derive new stem cell lines. (After all, that technique was inefficient and required 278 embryos to produce 17 cell lines. )

These researchers have moved on and are now attempting to get their hands on "fresh" oocytes in the quest to clone human embryos - after all, Korea's Hwang Wu Suk only had 2000 to 3000 or so oocytes to work with.

Of course, they aren't simply blindly following in the footsteps of the lying embezzling veterinarian's footsteps. If they manage to convince women to donate their oocytes, they hope to produce "disease specific," rather than "patient specific" embryonic stem cells.

"Doctors don't kill patients."

Len Doyal, Emeritus Professor of Medical Ethics, Barts and The London School of Medicine and Dentistry, is the British non-physician "ethicist" who claims that doctors should have the legal right to intentionally and purposefully act to kill their patients, even without consent. The paper, titled "Dignity in dying should include the legalization of non-voluntary euthanasia," was published as a "Guest Editorial" in the second issue of the Royal Society of Medicine's Clinical Ethics. It is available for free in pdf form, at the link "PDF" at the bottom of this page.

Doyal claims that the act of injecting a drug that is meant to kill is the same thing as withdrawing or withholding medical interventions. Unfortunately, many other people, both pro-life and not, believe the same thing.

However, the doctrine of double effect is a time honored way of determining whether or not a procedure that carries a risk of leading to death is ethical. There is, indeed, a difference between withholding the placement of an IV into a vein for artificial feedings while continuing to give ice chips and fluids as tolerated by mouth and using that IV to administer drugs that are intended to cause death. The latter is never a medical treatment and is always unethical. The former should only be done with consent or with the knowledge that the treatment will cause more harm than good.

Under the heading, "The Ethics of Euthanasia," the Times Guardian has published an excellent rebuttal by Professor Jeffrey Tobias,
Professor of cancer medicine, University College London Hospitals, to the UK "ethicist" who has called for legalized euthanasia - with or without consent - of patients by their doctors.

" To argue that there is no real distinction between "the disease that does the dirty work" and the clinician's active decision to terminate life by euthanasia is to profoundly miss the point.


"Doctors don't kill patients. It is exceptionally unusual for life to continue in an extended and distressing way once a medical decision has been made to discontinue support - a decision always taken with the patient's or family's consent. I would go further and argue that this is precisely the reason why clinicians become so irritated with so-called ethicists like Professor Doyal who, by and large, have no medical qualification and no direct experience of the burdens, challenges and privileges of clinical responsibility, but none the less adopt the moral high ground. Of course the euthanasia debate will continue, but to suggest that there are occasions where this could be done without consent speaks of breathtaking arrogance."

Bravo, Professor Tobias!

Informed consent waived for in vitro testing in emergencies.

The FDA has published a new rule which would allow investigational testing on samples "left over" from the usual testing in the event of a public health emergency, such as a terrorist attack.

The Seattle Post-Intelligencer is reporting the new rule as though it is controversial. I do not believe that there is any ethical difficulty - the samples are "left over," consent was already obtained to collect the samples and perform the usual tests. The new rule only concerns tests on these samples, using devices that are considered "investigational" or experimental.

The rule became effective June 7th and is published in the Federal Register:
"Guidance for Industry, Institutional Review Boards Clinical Investigators and Food and Drug Administration; Guidance on Informed Consent for In Vitro Diagnostic Device Studies using leftover Human Specimens;Availability."

SUMMARY: The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical,
biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.

******

Consider the following possible scenario in which a terrorist event
is not suspected until a public health laboratory cultures an unusual or rare organism. When a patient presents to a health care facility with symptoms suggesting a systemic microbial infection, blood and other specimens are typically collected to determine the identity of the causative organism. The clinical laboratory would determine that the specimens contain an unusual organism that cannot be identified by the tests available in that laboratory. Because many clinical laboratories do not have the capability or resources to identify unusual organisms or those to which humans are rarely exposed naturally, the organism (culture isolate) or collected specimen would be referred to a public health laboratory. The public health laboratory would use in vitro diagnostic devices, including those that are investigational, to try to identify the cultured organism or detect its presence directly in the specimen.

In this scenario, the referring laboratory would not have obtained informed consent when the specimen was collected because the person directing that the specimen be collected would not have known at the time that the infecting organism could be reliably identified only by using an investigational device.

A way to end vacation

I'm back and happy to report that there was sun and sand left over. And that walking in the surf and sand is good for a broken toe.

But, what should I write about on my first post back? Art Caplan and the editors at blogbioethics.net were kind enough to help me out by publishing a plea for allowing gay men to donate blood!

HIV is a virus that attacks the immune system. There's not a "dormant" or true gestational period for the infection itself. Almost immediately on infection, the virus begins replicating itself. However, there is a period of up to 6 months when the virus can not be detected by any of the tests used by the blood banking system.

Caplan is wrong about the treatment of heterosexual donors and this statement of myth:

We don’t worry about heterosexuals who engage in risky behavior and might acquire HIV because we know the strict testing of today will screen out their blood if it is infected with the virus.

For at least the last two years, when I donate in South Texas, I am asked not only about IV drug abuse and sleeping with men who have sex with men, I'm asked whether I have sex with people who inject drugs and/or in exchange for money or drugs, or whether I have sex with people who have sex with other people in exchange for money or drugs. I am asked where I've traveled for the last 5 years. A friend was refused the opportunity to donate for 6 months because she traveled in Mexico where malaria is endemic.

I have taken care of patients who received false positive syphillus tests from the blood bank. I've cared for several who were turned away because they had high liver function tests, although the did not test positive for any known virus, including known hepatitis.

I also had one patient who received false positive results on HIV testing during an annual insurance physical at another doctor's office. The false results were confirmed by the back up antigen tests. But labs drawn a second time (and another day) in that doctor's office and a third time in my office were negative. We finally decided - in consultation with the other office and the testing lab - that someone in either the other office or the laboratory had mixed up the tubes of blood. So not only did my patient get a false positive, but someone some where received a false NEGATIVE.

It is vital that the blood supply for sick and traumatized patients - those who need blood transfusions and blood products - is screened as vigorously as possible.