Another Stem Cell Debacle

Once again, a major advance in stem cell science has been tainted by allegations of fraud. A leading research centre in Japan, the RIKEN Institute, has apologised for “research misconduct” by a young scientist who published a paper in Nature in January which described an exciting new method for producing pluripotent stem cells.

The ease of the method astonished stem cell biologists, but no one was able to replicate the results and careful scrutiny of the paper soon revealed some troubling problems. It revived painful memories of the notorious Hwang Woo-suk and the fraudulent stem cell papers he published in 2005 in the journal Science.

Haruko Obokata now stands accused of misusing images to support the creation of what she and her colleagues termed “stimulus-triggered activation of pluripotency” (STAP) cells. She admits that there were mistakes in her paper, but denies the charges of misconduct. She also insists that the method does work.

A six-member committee set up by the RIKEN Institute was asked to investigate six errors in the paper. Four were found to be innocent mistakes, but two were branded “misconduct”. “Dr Obokata’s actions and sloppy data management lead us to the conclusion that she sorely lacks, not only a sense of research ethics, but also integrity and humility as a scientific researcher,” was their brutal conclusion. Nature is conducting its own investigation.

The president of RIKEN, Nobel laureate Ryoji Noyori, issued an apology both for Obokata’s alleged misconduct and for the carelessness of her co-authors. If the misconduct is confirmed after the appeals process, he said that the paper should be retracted and that the authors would be disciplined.

Harvard researcher Dr Charles A. Vacanti was also a co-author. He maintains that his version of the STAP process works. “While the investigation determined there were errors and poor judgment in the development of the manuscript, I do not believe that these errors affect the scientific content or the conclusions,” he told the Boston Globe.

The method could still be vindicated or at least it could give insights into pluripotency. A Hong Kong researcher even said earlier this week that Vacanti’s protocol seemed to work. RIKEN is going to conduct a “rigorous scientific re-evaluation” of STAP which will take about a year to complete. But, as MIT expert Rudolf Jaenisch told the Globe, “It’s embarrassing; it’s not good for the field.”

Source: BioEdge

USA: Absence of Stem Cell Donors Consent

After President Obama reversed his predecessor's stand on embryo research in 2009 shortly after his inauguration, the battles seemed over. The main ethical consideration was ensuring that the donors of embryos and gametes gave their informed consent to research.

However, a review of human embryonic stem cell lines in the US has raised concerns about informed consent amongst gamete donors. Some of the stem cell lines, though approved by the National Institutes of Health, may have involved gametes from donors who had not consented. The review, conducted by academics from Rockfeller University and The Hastings Center, a bioethics think tank, identified 30 lines of approved stem cells with unknown provenance. These cells may very well have come from non-consenting gamete donors. In addition to this, the providers of 19 lines did not respond to requests for consent information.

The authors of the review criticised American IVF clinics, from which many of the embryos were sourced, for failing to obtain consent from gamete donors: "just 30% of oocyte donor consent forms in surveyed US IVF clinics mention the possibility that resultant embryos might be donated to research, and only 8% mention donation to hESC research specifically" the authors of the review stated in a letter to Cell Stem Cell.

They also stressed that "information about the provenance of the hESC lines should be public and readily available", particularly for the hESC research community. They conclude:

"With such rapid advances occurring in stem cell research, it is critical that consent forms for donation of gametes to IVF refer not just to the possibility of future research use, but also to derivation of hESCs specifically. Also, information about the provenance of the hESC lines should be public and readily available. The hESC research community will be best served if their essential research materials--gametes and embryos --are donated by individuals who knowingly and willingly agree to the use of those materials in hESC research."


Related reading:  Absence of Gamete Donor Consent; Some Stem Cell Lines Off Limits; Whistleblower Exposes Soo Kyung's Stem cell Research; Mouse Stem Cells for Retina Repair

Whistleblower Exposes Soo-kyung's Stem Cell Research

Korean scientists will need more than a stiff drink to recover their joie de vivre after stem cell researcher at Seoul National University admitted that she manipulated data for articles published in an international journal.

Veterinary researcher Kang Soo-kyung was pinged by an anonymous whistleblower who sent the editors of ten journals a 70-slide Powerpoint report on her irregularities. On May 19 Antioxidants & Redox Signaling announced that four of her papers were being retracted, including two in the latest issue. Kang ‘fessed up immediately. “In response to allegations brought forth by a reader of this Journal, I take full responsibility as corresponding author and accept that some of the data presented is not accurate. I retract the publication in its entirety from scientific literature,” she said in a statement.

However, she also insinuated that the whistleblower was driven by malice. “About 80 percent of the evidence used against me is false,” she said. There could be more unsettling revelations, as the whistleblower claims that Kang has been cheating since 2006. “If we don’t stop this author now, no one can prove fabrication later on,” he wrote. A cloud now hangs over more than a dozen of her studies.

Poor oversight may have contributed to the problem. Kang was hauled before a university committee two years ago after “mistakes” surfaced in a paper for the International Journal of Cancer. Some Korean scientists blame intense pressure and competition. “The school and the government demand their scholars show visible progress in their projects on yearly basis. They are all stressed. What she did is unacceptable but I can see where her deeds came from,” one scientist commented on a Korean university blog.

The latest incident is a painful reminder that one of the worst scientific frauds of the past century happened in the same field at the same university by another veterinary researcher. In 2005, after being feted as a national treasure for being the first in the world to clone human embryos and create embryonic stem cells, Hwang Woo Suk turned out to be a fraud. The incident severely tarnished Korea’s scientific reputation. This new imbroglio will do nothing to shine it up. ~ Korea Times, May 29; Korean Herald, May 31

Related reading:  South Korea Ramps Up Stem Cell Research

Media Misses the Point on Stem Cell Therapy

Dr. Peter Saunders advises Brits not to bother to read the BBC on stem cell therapy.  Here's what he has to say:

Reading the reports about the new embryonic stem cell trial for spinal cord injury that have been all over the BBC and the British papers today I am struggling to know what all the fuss is about and why in fact it is even news at all.

I’ve come to the conclusion that it is causing such excitement for five main reasons:

1.Our media are obsessed with any story involving embryonic stem cells despite the fact that these entities have not yet provided any treatments for any human disease after more than ten years of hype (By contrast adult and umbilical stem cells have already provided treatments for over 80 diseases – see my Triple Helix review)

2.Because there is ethical controversy in their use (as harvesting them involves the destruction of human embryos) it provides an opportunity for the media to revive the myth that religious zealots are trying to hold back scientific advance and stop millions of people being cured from terrible diseases.

3.The science correspondents writing for our national newspapers seem not to read medical journals any more but simply regurgitate press releases produced by commercial companies (like Geron) who wish to promote their products and improve their public image.

4.Geron have lots of money (they have already spent $170m developing this ‘treatment’) and a very good PR machine.

5.British scientists are worried about research funding in the current economic climate and so are trying to attract public and media attention in the hope of attracting grants so they are trying to pull the wool over the eyes of gullible politicians and members of the public with exaggerated claims.

If you go to the National Institutes of Health (NIH) website which logs current clinical trials you will find there are 3,124 listings of trials involving adult stem cells and 141 involving umbilical stem cells. These therapies are increasingly well established and pose no ethical problems (and so are of little interest to the British media).

By contrast today’s story is of the first clinical trial involving embryonic stem cells after over a decade of breath-holding.

There are no results yet and no scientific papers yet published in any peer-reviewed journals.

Read it all here.

Wisdom Teeth Pulp and Stem Cell Research

Everyone may be carrying a personal stem-cell bank in their wisdom teeth. Until now, most induced pluripotent stem cells have started from skin cells. But even though these are easy to procure, they are very low in reprogramming efficiency.

Researchers at Japan's National Institute of Advanced Industrial Science and Technology have found that wisdom teeth contain a soft pulp with mesenchymal stromal cells. These are similar to bone marrow cells, a common source for stem cells. But tooth pulp is obtained far more easily than bone marrow.

The researchers collected tooth samples from three donors and successfully generated a series of iPS cell lines by activating three key genes. One feature of the new technique was that they did not have to activate the c-MYC gene which can lead to the cells becoming cancerous.

This could have many therapeutic applications. The removal of wisdom teeth is very common in developed countries and provides a perfect opportunity for removing biological material in a sterilised setting - and the teeth can be frozen and stored for many years. ~ Journal of Biological Medicine, Sept 17

Induced Pluripotent Stem Cells

Research in stem cells and the origin and treatment of disease is definitely moving away from destructive embryonic stem cell research toward induced pluripotent stem cells (iPS).

A fantastic review that connects Japan's Dr. Yamanaka, San Francisco's Srivastava, the University of Texas Southwestern Medical Center in Dallas, and the Burnetts of Sulphur Springs, Texas, is published in the Japan Times. (Written by Rob Waters for Bloomberg news.)

Yamanaka, a professor at Kyoto University, developed a technology that may make the argument moot. Yamanaka, who has two daughters, started his effort 10 years ago, after peering at a tiny embryo through a microscope and reflecting that it might form a child if it wasn't used to make stem cells, he said in an interview.

"That's the moment I thought about this project," he said. "I saw that if we could make pluripotent stem cells without using human embryos, that would be ideal."

In 2006, he scored his first success. Using a virus to insert four genes into the skin cells of mice, he started a process that returned the cells to a primordial state able to form any other cell in the body. Yamanaka named them induced pluripotent stem, or iPS, cells. The next year, he repeated the feat with human cells.

Yamanaka and researchers elsewhere are now racing to find better ways to achieve the same effect. They would like to get rid of the virus, which can cause the genes to lodge permanently in the structure of the cell and may trigger the growth of tumors.

Yamanaka's technique exploits a basic fact of human biology — that every cell in a person contains the genetic instructions that set that person's traits, from hair color to inherited disease. By taking skin cells from a person with a disease and turning them into cells in the heart, brain or pancreas that are affected by a genetic disease, researchers can experiment with disorders at their earliest stages, Harvard's Melton said.

Labs are now creating iPS cells because making them is far simpler than getting cells from embryos, said Jeanne Loring, founding director of the Center for Regenerative Medicine, part of the Scripps Research Institute in La Jolla, Calif.

"Every stem-cell researcher I know has made about a dozen," Loring said.

She estimates that researchers have made 300 different so-called lines of iPS cells, a number that may double this year. Each line is a colony of cells descended from the first ones made. Scientists keep them alive in culture and the cells keep replicating.

Read it all here.

Parting on Stem Cell Research

May 11, 2009 When Barack Obama removed George W. Bush's ban on federal funding for new embryonic stem cell research in March, the president cast his decision as part of a larger effort to remove politics from science. No longer would research, Obama said, be shackled by a "false choice between sound science and moral values."

It turns out the president cannot separate politics and science so easily. No sooner had Obama issued his order than conservative lawmakers in state legislatures began proposing new restrictions on embryonic stem cell research, ranging from criminal penalties to bans on state-level funding. In fact, Obama's decision has emboldened conservatives to increasingly link stem cell research to abortion. Far from conceding the issue, they are in it for the long haul.

But the stem cell battle is not just a high-profile clash of values. The dispute provides a sharp focus on how science may help reshape America. Several states have set aside billions of dollars to support stem cell research, and the new federal money Obama is promising will generally flow to those areas. That means states supporting stem cell research will experience an economic windfall while attracting highly educated technology workers who tend to vote Democratic. The more conservative states restricting stem cell research will attract fewer funds and fewer socially liberal voters. In short, a state's stem cell policy will influence electoral results and help determine whether a state turns red or blue.

Read it all here.

Obama's Disturbing Attitude Toward Life

Yesterday President Barack Obama issued an executive order that authorizes expanded federal funding for research using stem cells produced by destroying human embryos. The announcement was classic Obama: advancing radical policies while seeming calm and moderate, and preaching the gospel of civility while accusing those who disagree with the policies of being "divisive" and even "politicizing science."

Mr. Obama's executive order overturned an attempt by President George W. Bush in 2001 to do justice to both the promise of stem-cell science and the demands of ethics. The Bush policy was to allow the government to fund research on existing embryonic stem-cell lines, where the embryos in question had already been destroyed. But it would not fund, or in any way incentivize, the ongoing destruction of human embryos.

For years, this policy was attacked by advocates of embryo-destructive research. Mr. Bush and the "religious right" were depicted as antiscience villains and embryonic stem-cell scientists and their allies were seen as the beleaguered saviors of the sick. In reality, Mr. Bush's policy was one of moderation. It did not ban new embryo-destructive research (the president had no power to do that), and it did not fund new embryo-destructive research.
"Moderate" Mr. Obama's policy is not. It will promote a whole new industry of embryo creation and destruction, including the creation of human embryos by cloning for research in which they are destroyed. It forces American taxpayers, including those who see the deliberate taking of human life in the embryonic stage as profoundly unjust, to be complicit in this practice.

Mr. Obama made a big point in his speech of claiming to bring integrity back to science policy, and his desire to remove the previous administration's ideological agenda from scientific decision-making. This claim of taking science out of politics is false and misguided on two counts.

First, the Obama policy is itself blatantly political. It is red meat to his Bush-hating base, yet pays no more than lip service to recent scientific breakthroughs that make possible the production of cells that are biologically equivalent to embryonic stem cells without the need to create or kill human embryos. Inexplicably -- apart from political motivations -- Mr. Obama revoked not only the Bush restrictions on embryo destructive research funding, but also the 2007 executive order that encourages the National Institutes of Health to explore non-embryo-destructive sources of stem cells.

Second and more fundamentally, the claim about taking politics out of science is in the deepest sense antidemocratic. The question of whether to destroy human embryos for research purposes is not fundamentally a scientific question; it is a moral and civic question about the proper uses, ambitions and limits of science. It is a question about how we will treat members of the human family at the very dawn of life; about our willingness to seek alternative paths to medical progress that respect human dignity.

For those who believe in the highest ideals of deliberative democracy, and those who believe we mistreat the most vulnerable human lives at our own moral peril, Mr. Obama's claim of "taking politics out of science" should be lamented, not celebrated.

In the years ahead, the stem-cell debate will surely continue -- raising as it does big questions about the meaning of human equality at the edges of human life, about the relationship between science and politics, and about how we govern ourselves when it comes to morally charged issues of public policy on which reasonable people happen to disagree. We can only hope, in the years ahead, that scientific creativity will make embryo destruction unnecessary and that as a society we will not pave the way to the brave new world with the best medical intentions.

Read it here.

Mr. George is professor of Jurisprudence at Princeton and co-author of "Embryo: A Defense of Human Life" (Doubleday, 2008). Mr. Cohen is editor-at-large of The New Atlantis and author of "In the Shadow of Progress: Being Human in the Age of Technology" (Encounter, 2008).

First to Recieve Tissue-Engineered Organ

Claudia Castillo's body part was grown using her own stem cells harvested from bone marrow.

Professor Anthony Hollander, part of the team behind the breakthrough, described it as an example of "stem cell science becoming stem cell medicine".

Using Ms Castillo's stem cells to create a new airway for her means there are none of the tissue-rejection problems that are a major issue for transplant surgery and which usually mean recipients have to take powerful drugs for the rest of their lives.

Researchers from the UK, Italy and Spain worked together in the extraordinarily complex procedure to grow tissue from the 30-year-old mother of two to fashion a new bronchus – a branch of the windpipe – and carry out the transplant operation.

Scientists believe the same approach will be used in years to come to create engineered replacements for other damaged organs. In five years, they hope to begin clinical trials in which laboratory-made voice boxes are implanted into patients with cancer of the larynx.

Professor Martin Birchall, a member of the team from the University of Bristol, said: "What we're seeing today is just the beginning. This is the first time a tissue-engineered whole organ has been transplanted into a patient.

Read it all here.

A Catholic Bishop Holds the Line

My Brothers and Sisters in Christ,

In the months preceding Election Day, we have witnessed several elected officials who are Catholics publicly address the Church’s teaching on the grave matters of conscience formation, the inviolability of innocent human life and voting. Several of these Catholic politicians have cited the document of our United States Conference of Catholic Bishops, entitled “Forming Consciences for Faithful Citizenship” in a way that misrepresents the intent of the document and the authentic teaching of our Catholic Church – misrepresentations that warrant clarification.

For many people in our increasingly secularized culture, conscience is erroneously reduced to a collection of personal preferences that are thoroughly subjective and relative. In this wrong understanding of conscience, every individual opinion is assigned moral correctness and the existence of objective truth is denied. Yet, the very mission of the Church as a teacher of right and wrong rests on the existence of objective truth and the conviction that this truth can be known by us.

In our Catholic moral tradition, conscience is not an inclination inside of us that allows us to justify doing whatever we want. It is not a mere feeling about what we should or should not do. Conscience is the voice of God in the human heart, revealing the truth to us and calling us to do what is good while shunning what is evil.

Before following our conscience, we are obliged to form our conscience. A well-formed conscience requires that we have a sincere openness to embrace goodness and truth. We must be students and learners, shaped and challenged by the Word of God and the teachings of the Church, rather than embracing a partisan position and then stretching for ways to justify it.

Conscience formation requires that we examine the facts and the background information on issues. Conscience formation requires that we evaluate each candidate’s past record on issues and the general direction each candidate would give to the issues. In forming our conscience then it is critical that we see beyond party affiliation, analyze campaign rhetoric carefully and choose according to moral principles rather than self-interest.

Finally, since a well-formed conscience seeks always and everywhere to discern the will of God in some matter, prayerful reflection is essential.

In summary, rigorous study, moral reflection and prayerful consideration are the primary elements in forming one’s conscience. When our Church takes a position on some moral issue, you can absolutely trust that these three elements have been vigorously involved.

Catholic moral teaching is not a hodge-podge of competing and equally valid opinions.

Granted that there are many and complex issues that are in our hearts and on our minds as we go to the polls on November 4th. For that matter, Catholics and all people of good will can arrive at different opinions and various solutions for such issues as the delivery of health care, the revitalization of the economy, the use of military force, taxation policies, and the many other issues that face voters in the upcoming election.

However, we must be aware that not all political issues carry the same moral weight and that there is a serious moral obligation on all of us to oppose in conscience and in action those issues that are intrinsically evil. We are not free to choose whether or not we shall oppose those things which in and of themselves are always and everywhere morally evil.

From this, it is clear that the defense of the sacredness of human life from the very moment of conception to natural death is THE paramount issue of our time. Abortion, euthanasia, human cloning and embryonic stem cell research are intrinsic evils – actions that are always and everywhere wrong and no circumstance can justify their use. Each is a direct attack on innocent human life. The fact is that since the 1973 Roe v. Wade Supreme Court decision, every medical and genetic discovery has underscored the human personhood of the unborn from conception.

We have all heard fellow Catholics say that “I can not be a single issue voter.” Fair enough – there are many issues on all of our minds. But consider this. If someone were to break into your home – your place of security and well-being – and hold a scalpel to your throat with the intent to kill you, I suspect that you would in that moment become a single issue person. In that instant, everything would focus on the one question: What must I do to survive?” Everything else immediately becomes secondary. Many of the unborn are precisely in that situation. They cannot act in their own defense. You and I must.

Throughout the United States Catholic parishes have been praying The Novena for the Election, seeking God’s direction for our nation as Election Day approaches. In these final hours study, read, pray. As a faithful citizen, cast your vote. May the Holy Spirit guide all of us to act on consciences conformed to the will of God.

Sincerely yours in Christ,

Most Reverend Ronald W. Gainer
Bishop of Lexington
Kentucky

Testicular Stem Cells

WASHINGTON - Cells taken from men’s testicles seem as versatile as the stem cells derived from embryos, researchers reported Wednesday.

The new cells could be useful for growing replacement tissues, according to a study in Thursday’s issue of the journal Nature. But because of their source, their highest promise would apply to only half the world’s population: men.

Embryonic stem cells can give rise to virtually any tissue in the body and scientists believe they may offer treatments for diseases like Parkinson’s and diabetes and for spinal cord injuries.

The testicular cells avoid the ethical dilemma of embryonic stem cells, which are harvested in a process that destroys the embryos. For that reason, many people, including President Bush, oppose their use.

Avoiding the ethical problem“The advantage these cells have in comparison to embryonic stem cells is that there is no ethical problem with these cells and that they are natural,” said study lead author Thomas Skutella, a professor at the Center for Regenerative Biology and Medicine in Tuebingen, Germany.

Using testicular cells isn’t the only promising method that avoids embryos; recent studies also show promise for reprogramming ordinary body cells by slipping certain genes into them.

Read it all here.