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Will new ESC rules hurt research?

The retroactive nature of the NIH's proposed guidelines on human stem cell research will exclude funding for many existing stem cell lines that were ethically created yet don't meet the stringent criteria of the proposal's technical requirements, according to a new linkurl:report;http://www.cell.com/cell-stem-cell/fulltext/S1934-5909(09)00210-0 published online today (May 14) in __Cell Stem Cell__. The proposed regulations outline nine distinct elements to be documented in written informed cons

By | May 14, 2009

The retroactive nature of the NIH's proposed guidelines on human stem cell research will exclude funding for many existing stem cell lines that were ethically created yet don't meet the stringent criteria of the proposal's technical requirements, according to a new linkurl:report;http://www.cell.com/cell-stem-cell/fulltext/S1934-5909(09)00210-0 published online today (May 14) in __Cell Stem Cell__. The proposed regulations outline nine distinct elements to be documented in written informed consent forms for embryo donors, including prohibiting directed donation, barring financial compensation, and requiring that donors of unused IVF embryos sign at least two separate consent forms, one of which must avoid mention of stem cell research. All these rules apply retroactively.
Image: Patrick Taylor
Ahead of the NIH's linkurl:May 26th deadline;http://nihoerextra.nih.gov/stem_cells/add.htm for comments on the draft guidelines, the paper's author, Patrick Taylor, a lecturer at Harvard Medical School and deputy general counsel at Children's Hospital Boston, who co-chairs the International Society for Stem Cell Research's linkurl:standards committee;http://www.isscr.org/committees/committeeResults.cfm?CommitteeName=COMMITTEE/STANDARDS and has sat on many of its task forces, spoke with __The Scientist__ about why he takes issue with the new NIH rulebook. **__The Scientist__:** Two months ago, President Barack Obama pledged to lift restrictions on funding human embryonic stem cell research. Do you think that the NIH guidelines live up to that promise? **__Patrick Taylor__:** If you go back to the very wonderful Obama executive order, it talked about maximizing funding. In the context of doing that, it retroactively imposes new restrictions. A lot of people who want stem cell research funded would actually be surprised to learn that under the proposed guidelines a lot of existing stem cell lines aren't eligible [for federal funding]. **__TS__:** Like some of the 21 cell lines approved by President Bush? **__PT__:** This goes beyond the [Bush] Presidential lines and includes many, many stem cell lines created as a result of institutional funding. These lines were created under very rigorous IRB [Institutional Review Board] and ESCRO [Embryonic Stem Cell Research Oversight] processes, and under a set of standards that have really evolved through not just scientific self-regulation but very heavy public involvement and engagement. **__TS__:** Beyond the logistical argument, what do you see as the main problem with the NIH guidelines? **__PT__:** The broader, deeper argument is: Should retroactive ethics be permissible? The answer to that is, 'Look, we actually ought to evaluate stem cell lines based on the sound prevailing ethics of the time that led to them.' **__TS__:** But some past informed consent forms don't live up to current best standards, right? Don't we need clear guidelines moving forward? **__PT__:** Of course, it's vitally important that participants be fully informed and one actually know that they are informed. But an informed consent form is not the same thing as an informed consent process. There are a bunch of different ways of showing and establishing good processes for really informed consent [from embryo donors]. **__TS__:** Where do you draw the line? Isn't that a slippery slope to, say, accepting the stem cell lines collected by discredited Korean scientist Hwang Woo-suk, who violated some ethical principles in creating them? **__PT__:** No. There are certain ethically core principles. And there are years of literature and practical human experience for informed consent in the context of respect for people's knowledge and choices. With the Hwang lines, people were actually being paid or being solicited under the authority of the principal investigator, so they couldn't make free choices. If you look at what scientists and ethicists said at the time, universally they recognized that those stem cell lines crossed a very important ethical line. We're not talking about approving the Hwang lines. **__TS__:** So what are we talking about? Can you give me an example of when the NIH guidelines might not make sense? **__PT__:** The NIH guidelines call for two separate IVF consents: one which says you will actually donate for research -- it doesn't say anything about embryonic stem cell research -- and then a second one once someone has decided to donate for research saying, 'would you be interesting in donating for hESC [human embryonic stem cell research]'? At the time, people thought that was a really important idea, but what we find now in real life is that some people already know what they want to happen. They believe so strongly in embryonic stem cell research. They say, 'I know what I want I don't need two consents.' [And they don't sign the first, non-specific consent, which invalidates the line.] In that context -- and that is what has happened for some of these existing cell lines -- why exactly should that line be invalidated? Why shouldn't there be a federal investment in the research that arises out of that line? Do you want to leave that line just to industry funding? **__TS__:** What would be the scientific impact if cell lines like that weren't eligible for federal funding? **__PT__:** Existing stem cell lines are things that have acquired tremendous scientific value as a result of their being the centerpiece of a lot of scientific research. That's all that knowledge lost. It's as if the last eight years of science and ethics and regulation and so on have just vanished -- literally. It's just snap your fingers. It's gone. **__TS__:** On Tuesday (May 12) the linkurl:International Society for Stem Cell Research;http://www.isscr.org/press_releases/NIHletter.html and the linkurl:California Institute for Regenerative Medicine;http://www.cirm.ca.gov/sites/default/files/PDFs/NIH%20Comments%20NIH_guidelines%20v8_accepted_eb_clean.doc%20%5BCompatibility%20Mode%5D.pdf published comments on their Web sites about changes that they'd like to see made to the NIH's proposals. How would you amend the guidelines? **__PT__:** I think there should be specific grandfathering with respect to some of the [Bush] Presidential lines, and also with respect to things that have actually been approved by IRBs and ESCROs as meeting the ethical standards that are core and prevailing. I think there also should be a process of continuous discussion, and there ought to be some openness to establishing the ethical fundamentals in a way other than just the informed consent forms. Real life is more complicated than just a single form traveling through administrative space. **__TS__:** Do these issues go beyond human embryonic stem cell research? **__PT__:** Yes, the issue of retroactivity versus prospectively isn't one that's unique to stem cells. I think that the impact [of the NIH guidelines] is really important, not only for stem cell science but for self-regulation in science generally. How do we make science policy? Do we make it based on new decisions retroactively applied from government or do we take into account -- and in effect recognize -- the role of scientists, the public, and the media in actually creating that policy? I think we have to. That's the best way to achieve public benefit. **__TS__:** Isn't the NIH consulting the scientific community and the greater public right now? **__PT__:** It's great to do notice and comment. But notice and 30 days comment looking forward is no substitute for eight years of close and careful development beforehand. The views of the scientific self-regulation and a lot of public input into the development of guidelines are being discounted. And I think that's a mistake.
**__Related stories:__***NIH, stem cells: IVF ok, not SCNT
[17th April 2009]*linkurl:Obama good for science, experts say;http://www.the-scientist.com/blog/display/55167/
[5th November 2008]*linkurl:The Future of U.S. Science Policy;http://www.the-scientist.com/2008/9/1/30/1/
[September 2008]
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Comments

Avatar of: Ellen Hunt

Ellen Hunt

Posts: 199

May 14, 2009

This business of "bioethics" people justifying their existence by putting idiotic roadblocks in the way of research has to stop! \n\nAt the same time that bioethics "departments" are turning research into a paper chase worse than the IRS, they are ignoring the loss of human life which occurs because of lack of research progress. And they do absolutely nothing about the fact that certain researchers routinely endanger human life to protect a few publications of their careers. The "profession" exists to self-aggrandize. \n\nThis has reached insanity. Nobody is harmed in any way by gathering human biological samples and using them for medical research - regardless of whether or not permission was gotten. \n\nThe USA needs to go to a system much like that of organ donation in Europe. If you don't specifically opt out, then samples taken can be used - period. And if you ask me, if someone opts out, they better have a darn good reason for it. \n\nAll this rubbish from so-called "bioethics" mavens is purified garbage. It exists to feather the nests of bioethics departments with grants that take money from real research, and fat paychecks for the honchos. There is nothing else going on. Nobody is being protected, least of all patients!
Avatar of: anonymous poster

anonymous poster

Posts: 125

May 14, 2009

Countless ESC are discarded, i.e., destroyed, by the private human fertilization clinics in the U.S. to save the expensive storage costs and space, which is legal and not challenged by the ethicists, yet why is it illegal or still controversial to allow a small percentage of those to be used for medical or biological research, instead? It is contradictory, unfair, and makes no sense from the ethical perspective.
Avatar of: Mike Serfas

Mike Serfas

Posts: 35

May 14, 2009

Ellen, I think that there is a strong argument for moving to an opt-out system on organ donation, because there is a shortage of organs that leads to loss of life - that would be a very positive issue to raise, and hopefully we could see real progress.\n\nBut I'm not aware that there is any great shortage of potential donors for the creation of new embryonic stem cell lines. All that is needed is a sound process by which researchers can create new lines under some reasonable conditions, and be able to continue to use them afterward.\n\nThere are situations in which advances in bioethics will continue to be needed and where some retroactivity, at least in the sense of having qualms about new advances, may apply. To give an extreme (and unlikely) situation, consider how we would feel if someone devised a way to use an existing line of multipotent neural crest cells to create an animal with a largely human brain. (see http://www.freerepublic.com/focus/f-news/1394123/posts) What we need is not a lack of ethics, but wise ethics, honest and probing, philosophically sound but practical.\n\nIt is good to see that President Obama is making real change to improve medical research; but with change there is always some degree of error. In general, the administration will not be able to gather and maintain support for making far-reaching changes unless it shows that it can acknowledge and fix defects in the new policies it creates. This will be one such opportunity.\n
Avatar of: anonymous poster

anonymous poster

Posts: 11

May 14, 2009

...because the rest of the world, thankfully, knows how--and is no longer shy about--reining in its Holy Rollers. \n\nWe're the only country left that still lets the Religious (UN-) Right, tell Medical Researchers how to do their jobs. \n\nTo the extent that we permit religious meddling, America will be relegated to being a sideline country, regarding some of the most potent new therapies of our time. And no, adult stem cells are too often, NOT THE ANSWER.\n\nHowever, the enlightened in this world--of necessity-- will simply relegate our once-great medical establishment, to a non-entity. No one will ask our opinion on anything any more--we've just empowered the superstitious and the scientific illiterates among us, to make our major health decisions for us.\n\nThe rest of the world can only--remembering America's former greatness in Medical Science especially--shake its head when it sees how low the once-mighty USA has fallen.\n\nA sad commentary on the nation whose medical establishment cured polio, measles, and a host of other previously unstoppable diseases.\n\nBut in those days, the Holy Rollers were relegated to small churches (instead of the mega-monsters from the Bush administration) and speaking in tongues (that no one but they understood. Church was for Sundays--and healing the sick was for every other day of the week.\n\nIt would have been considered (back in the 60s and 70s) that only mental defectives, would give Radical Evangelicals, any kind of a say in our HealthCare....
Avatar of: Rebecca Taylor

Rebecca Taylor

Posts: 2

May 16, 2009

I am personally tired of people forgetting their Bio 101 and interchanging embryos and embryonic stem cells. Embryos are complete human organisms, albeit young, and ESC are just cells taken from the embryo. \n\nThis is an important distinction to understand, especially for ethical considerations.
Avatar of: C M

C M

Posts: 4

May 18, 2009

Obama has now flip-flopped so many times, that I find myself wondering if their really was an election last year.\n\nKeeping America in the darkness of the Middle Ages seems to be all the cultists want due their incredible fear of being proven totally irrelevant to the 21st century and beyond.\n\n(Pssst! Don't tell them the world is round!)\n\nNo problem though. Fortunately, other far more advanced countries are using stem cells for treatment, even finding that Adult Stem Cells from Cord Blood are more effective and less-dangerous than embryonic stem cells that can just as easily turn cancerous as not, and increasing their economy with American medical tourists trying to save their lives by leaving America to obtain treatment based on actual science.\n\nToo bad about those Americans unable to travel though, guess the cultists just want them to die or exist in pain.\n\nI thought Obama was going to be one of the good guys? Guess the old saying is still relevant: One can't become a Lincoln by reading about Lincoln; one can only become a Lincoln by thinking Lincolnesque thoughts and doing Lincolnesque things.\n\nMaybe next time. See you in 4 years.
Avatar of: Dan Abshear

Dan Abshear

Posts: 8

May 20, 2009

Over 100 years ago, a Russian histologist suggested stem cells be applied for scientific research. \n\nThey are the human body?s equivalent of a generator, as they can renew, regenerate, and replicate under the right conditions. \n\nThe apex of cellular therapy and regenerative/reparative medicine has been reborn after an 8 year moratorium that basically halted federal funding for stem cell research with most states in the U.S. \n\nNow the NIH can award grants to scientists involved with biomedical research involving stem cell therapy through the CMS to each state in the U.S.\n\nWhile never banned, stem cell research had limited funding during this time. And this was unfortunate, because there are several likely uses of stem cells. \n\nThese uses include the replacement of tissues in the human body, as well as repairing cell types that are defective. \n\nAlso, stem cells can deliver genetic therapies that are needed in certain patients.\n\nESCs are totiplotent if obtained from the morula which is a pre-blastocyst stage. Normally, the stem cells are acquired from the blastocyst itself. \n\nFrom this source, the stem cells can be any cell in the human body except for the placenta, and are pluripotent. \n\nEmbryonic stem cells are obtained from a 4 day old embryo called a blastocyst, and are pluripotent from this source. \n\nThe blastocyst contains about 100 cells, and is not suitable at this stage for implantation into the uterine wall. \n\nThe inner core of the blastocyst has about 20 cells, and this is where stem cells are obtained. \n\nThese cells are unspecialized cells that can be developed or morphed into the over 200 cells available in the human body through differentiation, as ESCs are undifferentiated by nature. \n\nAs such, they can become any human cell, as long as they are prevented from clumping or crowding together when explanted into cultures as they are propagated. After stem cells are cultured, they are moved to what are called stem lines. \n\nUntil recently, ESCs were believed to be most beneficial instead of the adult stem cell alternative (ASC), as these stem cells are limited to application to the tissue the stem cells were obtained from only. \n\nHowever ASCs (somatic stem cells) now can be coerced into differentiation through plasticity (trans-differentiation). \n\nThis likely will reduce if not eliminate those opposed to stem cell therapy because of moral and ethical reasons related to the utilization of ESCs.\n\nThanks to molecular biology, four transcription factors control the transfer of genetic information from DNA to RNAS to regulate gene expression. So ASCs can have the same beneficial qualities as ESCs.\n\nIn the past, viral vectors and exotic genes interfered with the purity of ASCs. Now ASCs are re-programmed using plasmids instead of viruses and oncogenes that can become detrimental for the patient treated. \n\nSo now, ASCs can safely become induced pluripotent cells with the same potential as ESCs. As a result, the ASCs are free of genetic artifacts that potentially can interfere with transgene sequences. \n\nThey are capable of, and are able to renew and reproduce with minimal effort, stem cells, under the right laboratory conditions. \n\nHuman blood can be reproduced with stem cells under the right conditions, it has been shown by researchers.\n\nSCT can also be used to investigate disease states for better treatment options.\n\nDisease-specific stem cell lines, which are those cells that are pluripotent and are created with the same genetic errors of certain diseases, are studied for this reason.\n\nSo there clearly is a huge potential for stem cell-based therapies. The first FDA approved clinical trial occurred early in 2009. \n\nThis human trial will involve evaluating primarily the safety of ESCs designed to be used as treatment for spinal cord injury patients. The trial was submitted by Geron Corp.\n\nPfizer, the largest drug company, has implemented stem cell research, as they are an asset to drug discovery by creating within the organization a regenerative medicine unit. \n\nOther large pharma companies are implemented similar research protocols for the same reasons.\n\nGeron Corp. in California is the world?s leading esc developer, and financed researchers at Univ. of Wisconsin, who isolated the first human esc in 1998. \n\nStem cell therapy potentially can cure multiple sclerosis, among other disases and those with damaged human tissue. \n\nThe therapy prevents the advancement of disease, as well as reverses the neurological dysfunctions associated with MS. Patients are injected with their own stem cells obtained from their bone marrow, which are called haemopoietic stem cells. \n\nThese particular stem cells are the origin of all blood cells. Further large clinical trials are needed to support these results. Studies have shown between 70 and 80 percent of MS patients who received stem cell therapy did not relapse afterwards.\n\nAllogenic, or donor transplants, have a risk of graft versus host disease. Autologous, which is the patient?s own stem cells, are preferable and most beneficial. \n\nSimilar results from this autologous bone marrow transplant cellular therapy are seen with Chron?s disease as well.\n\nDuring the procedure, the immune system is reset so it is not in an autoimmune state where it attacks the human body. The process lasts about 2 months, and consists of 6phases:\n\n1. Initial chemo\n2. Release of stem cells\n3. Acquisition of stem cells\n4. Cells are then frozen until ready for transplant\n5. Second chemo to reduce leukocytes\n6. Autologous stem-cell transplant. Immune system is reset.\n\nPositive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently. \n\nThis stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only. As such, this is the practice of regenerative medicine with the implementation of SCT.\n\nSome believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief. \n\nSo stem cell therapy and research may be the most right and ethical thing to do for such patients. Not only is the tremedous suffering relieved with those possessed with devistating diseases, their functional ability is restored for those who receive stem cell therapy. \n\nEmbryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise. \n\nIronically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially. \n\nMost couples with frozen embryos would gladly give them to such research, surveys have concluded.\n\nThese embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning. \n\nTen states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted. \n\nFurthermore, autonomy, which is the patient?s right to determine their health, and justice or fairness remain intact.\n\nStem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to restrictions that exist in the U.S. presently. The United Kingdom is believed to be the leader in stem cell research presently.\n\nDan Abshear\n

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