Sunday, July 23, 2006

Adult Stem Cells NOT Treating Parkinson's and 36 Other Diseases on Brownback's List

Here is a comment that was made by "bmmg39" on my Michael Fumento letter; it is followed by my response:

"Anonymous, no one has claimed that ASCs are "curing" Parkinson's and other diseases. They are successfully TREATING people with those diseases, something ESCs have yet to do for even one human patient. By the way, Anuket, HUMAN ESCs were only isolated in 1998, but non-human ones have been studied and experimented on for decades. You can't complain about a so-called head start."

Oh my goodness, bmmg39, they are NOT successfully or in any other capacity treating Parkinson’s with ASCs. Call The Michael J Fox Foundation, Parkinson’s Disease Foundation, National Parkinson Foundation, American Parkinson’s Disease Foundation – call one, call ‘em all – check their websites – I guarantee you, you will find nothing – there is one person on this planet who has received an autolgous stem cell transplant for Parkinson’s, and that was over five years ago. So, if ASCs are being used to treat (as in FDA-approved treatment, not one person in a clinical trial) people with Parkinson’s, someone is doing a very good job of hiding it from us. If you are in on the secret, please have mercy on us and tell us where to go to get this treatment.

As far as all of the other diseases allegedly being treated or cured with ASCs, I have done the footwork – have you? Have you looked up each and every disease/condition on, for example, Senator Brownback’s list? Well, neither have I, because I got sick of it, but I did look up 62 out of 69 of them, and ASCs are not listed by NIH as a treatment for 36 out of 62 of the diseases on Brownback’s list. No doubt ASCs are being studied in relation to some of the 36, but something that is in clinical trials is by definition not yet a treatment.

Of the 26 diseases/conditions actually being treated with ASCs, I can only see one (testicular cancer) that isn’t a disease of the blood – and those have been being treated for the last 40 years with bone marrow transplants – nothing new there.

And regarding the headstart – if you are going to count ECS animal experiments, I’m afraid you have to count them for ASCs, too. When do you think they started? The first listing I find in PubMed that references the species on which the experiment was performed was in 1955 – guinea pig (PMID: 13344491). The very first bone marrow transplant (BMT) study in PubMed is dated 1950 (PMID: 15442952). That far back, all that is provided is the title of the study, and this one does not reveal the species, but you can be sure that if someone was working on guinea pigs in 1955, no one was working with humans in 1950.

The first animal ESCs, however, were not isolated until 1981 (see this month's Nature). So even if we take 1950 as the beginning of ASC animal studies (they undoubtedly started earlier) there is a minimum of a 30-year gap. I consider that a bit of a head start, don’t you?

It would be helpful if more people did just a little more footwork rather than just blindly believing words because they want them to be true.

Monday, March 27, 2006

Open Letter to Michael Fumento

Michael Fumento wants his readers to think adult stem cell research (ASCR) is the underdog soooooo badly, it is almost cute. He needs ASCR to be the underdog, of course, to create the illusion that those of us who support embryonic stem cell research (ESCR) are the enemies of ASCR - then he can paint us as trying to hide ASCR successes and steal government funding for ASCR - you know, it is that whole "don't have an enemy? need one? what are you waiting for? create one!"

The reality, of course, is that supporters of ESCR are neither stealing government funding away fron ASCR, nor are we hiding ASCRs successes - many of us would stand to benefit from any ASCR gains - does he think we are nuts? No, of course he doesn't. He just wants the rest of the world to think we are.

However, as I once heard someone say, read it and weep, Mr. Fumento. You know the answers to the questions below as well as I do, so step up to the truth, if you dare. [answers provided by anuket 7/29/06]
-------------------------------------
Hi Michael,

My name is Anuket, and I have some questions about the stem cell issue that I wonder if you would answer publicly so that others can be enlightened, as well. I guess I will just list them.

  1. How much funding has adult stem cell research (ASCR) received from the federal government since 2003, and how much is it budgeted to receive by the end of 2007?

    2003 to 2005 actual: $593M
    2006 to 2007 budgeted: $400M

    TOTAL PROJECTED 2003 to 2007: $993M

  2. How much funding has embryonic stem cell research (ESCR) received from the federal government since 2003, and how much is it budgeted to receive by the end of 2007?

    2003 to 2005 actual: $84M
    2006 to 2007 budgeted: $77M

    TOTAL PROJECTED 2003 to 2007: $161M

    Numbers taken from the NIH table of Disease Funding Levels

  3. What did Clinton do about ESCR? Did he fund any? Did he do anything?

    On August 25, 2000, the Clinton Administration's NIH Guidelines for Research Using Human Pluripotent Stem Cells were printed in the Federal Register [Page 51975], lifting the moratorium on research using human pluripotent stem cells derived from human embryos and fetal tissue put in place by the Director, NIH, in January, 1999. These guidelines authorized federal funding for research utilizing ESCs that were derived from embryos donated by people undergoing IVF. The actual derivation of the ESCs would have to be done using private funding, but once the cell line was created, researchers could obtain NIH funding to work with them.

    The first meeting of the NIH committee charge with reviewing grant applications for ESC research was scheduled for April, 2001. Bush took office in January of 2001 and ordered that the Clinton policy be reviewed - the April meeting was cancelled.

    In August of 2001, Bush announced the current policy.

  4. How long has human ASCR been going on?

    The first studies utilizing human ASCs listed in Pubmed are in the early to mid-60s, depending on the search term used (stem cells, adult stem cells, bone marrow transplant), so human ASCR has been underway for a minimum of 40 years.

  5. How long has human ESCR been going on?

    Human embryonic stem cells were first isolated in 1998, so human ESCR has been underway for about seven years.

  6. On the list of diseases being treated with ASCs that you link to:

    • How many of these diseases are diseases of the blood, or the immune system, or metabolic disorders?

    • How many of these treatments consist of bone marrow transplants?

    • Would you define "treat" for me? Do you mean an ASC therapy was tried in a clinical trial and seemed to have a positive outcome, but the therapy is not yet approved by the FDA and available to us, or do you mean a therapy that has been approved by the FDA and is readily available to us?

    • How many of the diseases listed are neurological in nature?

    • How many types of adult stem cells are currently being used in therapies that have been approved by the FDA and are available to patients today?

    • My random sampling of 7 disease turned up 2 that, according to NIH, are not being treated with ASCs - how many of these diseases are actually not being treated with ASCs?


  7. How long do you estimate it takes, on average, with a new idea for a therapy, to get from the lab, through animal trials, to the first human clinical trial?

  8. The embryos in question - the ones that we are talking about when we say ESCR - who donates them to research?

    People undergoing IVF donate them to research.

  9. Should the people who donate them to research have the right to do that?

  10. Do you oppose IVF?

Thank you for your time and I look forward to reading your response, and I hope you will post the answers to these questions on your site.

(I am calling this an open letter but am not sure it really is one, since I already sent these questions to Mr. Fumento privately, asking him to answer them publicly. He declined to answer them at all.)

Sunday, February 05, 2006

DoNoHarm: Is It Lies or Is It..... um, Lies...

I sent the following letter to five of the seven esteemed founders of the site DoNoHarm today. The founders are:

Kevin FitzGerald, SJ, PhD
C. Christopher Hook, MD
Ralph Miech, MD, PhD
Robert D. Orr, MD
David A. Prentice, PhD
Frank E. Young, MD, PhD
Joseph Zanga, MD, FAAP

Click here to see the "fact" sheet in question, and click here to see the studies cited to support the whacked out assertion that adult stem cells are being used to treat Parkinson's.

Dear Sirs,

I am writing to make you aware of gross inaccuracies in the Parkinson’s “fact” sheet on the DoNoHarm site and to request that Parkinson's be removed from the site's list of disease being treated with adult stem cells, as it is not being treated with adult stem cells.

The ESC (embryonic stem cell) research section is actually not bad. The five studies cited a) were actually published, b) had a suitable number of subjects, c) actually used ESCs, and d) resulted in improvement, benefit, and alleviation of symptoms to some degree in each and every instance. There are always obstacles that need to be resolved when an area of medical research is in its infancy, as ESC research is, and it is actually quite encouraging that tumors only developed in two of the five studies listed.

However, the ASCs (adult stem cell) section is all wrong, and I mean that quite literally. Of the seven items listed, four do not utilize ASCs at all, one cannot be said to be a study, never mind a treatment, and one cannot be verified at all as it is not clear it has been published. The seventh item actually is a published study, and it actually used ASCs, but being a study cannot be put forth as supporting a claim of “”treatment,” not to mention the fact that the study concludes that more study is necessary.

I will be more specific.

The 2003 study by Gill examined the effect of a neurotrophic factor - GDNF, to be exact - on people with Parkinson’s. The 2005 pathology follow-up to the Gill study by S. Love revealed that the brain treated with GDNF showed signs of neuronal sprouting. GDNF is not ASCs. Likewise, the 2000 Fallon study utilized a “growth protein,” not ASCs.

Further, the 2002 Akerud study did not use ASCs, either. As it says in the study, “To stably deliver PSP in vivo we engineered a c17.2 NSC line,” and the C17.2 NSC (neuronal stem cell) line was derived from “neonatal mouse cerebellar external germinal zone cells.” (jvi.asm.org) Now, technically, the neuronal stem cells are not embryonic, but somehow I don’t think any of you would condone the use of neonatal human cerebellar external germinal zone cells, either - would you? [It is with great embarrassment that I add, after the fact, that this was an animal study, to boot.]

These studies should be removed from the “fact” sheet first of all because they do not even evaluate ASCs for their therapeutic potential, never mind constituting ASC-based "treatments" for Parkinson's.

The inclusion of Dr. Levesque’s work is problematic on several levels. First, to date, Dr. Levesque has merely presented his work at a conference - he has not published his completed study results in a peer-reviewed journal. Secondly, the results he presented to the conference (his only known results) were based on observations of a single subject - as all of you are well aware, one subject is not a meaningful data source. Moreover, because there was only one subject, the study could not have been double blind, placebo (or sham surgery) controlled. Each of these concerns taken on its own is cause for removing this information from the ”fact” sheet.

Taken together, the inclusion this information as a “treatment” in the “fact” sheet is baffling. This information should be removed.

I am unable to confirm the information said to have been presented to the Japan Neurological Society by Okayama University in 2001, as the only corroboration provided is a newspaper article, as opposed to, say, a study published in a peer-reviewed journal. This information should be removed.

Thus, the 2004 Mari Dezawa study is the only item that actually used ASCs on a meaningful number of subjects and was published in a peer-reviewed journal. However, given that it was a study, and especially given that it concluded that “further studies are needed...to ensure the long-term safety and efficacy of manipulated MSCs,” to call it evidence of ASCs “treating” Parkinson’s disease is grossly premature. [Again, it is with great embarrassment that I add, after the fact, that this, too, was an animal study.]

The fact of the matter is that there are no treatments for Parkinson’s utilizing ASCs. I wish there were. But until there are, if credibility is at all important to you, you will make sure that all the DoNoHarm's claims to that effect are removed from the site.

Saturday, October 08, 2005

IVF, Embryos & Giant Pink Elephants

If I didn't know better I would probably think that any embryos used in research had been collectively plucked from a future of bibs, baby food and spit up by the ruthless and immoral supporters of ESCR, when in reality, any embryo used in research was slated to die before it was donated to research.

Further, those who argue against permitting the use of excess in vitro fertilization (IVF) embryos in research, if you follow their reasoning to its logical conclusion, must also argue for the abolition of IVF as it is currently undertaken.

Increasingly, couples having trouble conceiving are turning to assisted reproductive technologies (ART) in their quest to have children. The most common type of ART is in vitro fertilization (IVF), which involves extracting a woman's eggs, fertilizing them outside of the body in a Petri dish (in vitro means “in glass”) and then transferring the resulting embryos into the woman's uterus with the hope that one of them will implant.

In most cases, however, more embryos are created than are used in the pursuit of implantation - and the right to determine the destinies of those embryos currently rests with couples who produced them. Ultimately, there are three options from which to choose: donate the embryos to another couple, donate them to research, or have them discarded by clinic personnel. There are those who would count leaving them in storage as an option, but storage is just an interim state; all of the frozen embryos will face one of those three aforementioned options eventually. And just so that we are clear, I will say that both donating an embryo to research and simply discarding it result in the destruction of the embryo.

If one believes that it is wrong to destroy an embryo in the course of research, then one must believe that it is wrong to destroy an embryo, period - whether it is in the course of research, or in the course of a day at the IVF clinic. From that it follows that if IVF were to be allowed to continue in an acceptable form, of the current three options available to couples - donate to another couple, donate to research, or simply destroy - the latter two would have to be eliminated, leaving only one option: donating to another couple.

However, that model, even if it were legally defensible, would only be acceptable if no other embryos were harmed in the IVF process - but other embryos are harmed. One IVF clinic describes in detail how the staff sifts through the embryos formed in one IVF procedure and decides which ones are viable for implantation - the others are discarded. And then there is the problem of freezing itself. There is a baseline attrition rate of anywhere from 10-25% when embryos are frozen and thawed. The attrition rate can be lowered by discarding embryos that may be viable under normal circumstances but are judged to be less likely to survive freezing. (Genetics & IVF Institute, Georgia Reproductive Specialists)

So, any way you slice it, if one argues that it is wrong to destroy an embryo in the course of research, one must ultimately argue for the abolition of IVF as it is currently undertaken.

Monday, August 08, 2005

Hurlbut, Bioethics, and Hypocrisy

Dr. William Hurlbut, a bioethicist, is a member of the President’s Council on Bioethics (PCBE) and is staunchly pro-life, (as is Leon Kass, the head of the PCBE.) Some time ago, Dr. Hurlbut had an idea he hopes will provide a way around the controversy regarding embryonic stem cell research (ESCR.) If his idea works, it will be possible to obtain embryonic stem cells (ESCs) without harming embryos.* In and of itself, there is nothing fishy about his having such an idea.

However, when you look at it a little more closely, questions arise. One of the first that comes to mind is, why have I heard about this? Let’s face it – this is only an idea, nothing more. Indeed, in the words of the PCBE itself, in its May 2005 White Paper: Alternative Sources of Pluripotent Stem Cells, Dr. Hurlbut’s idea is “as yet untested experimentally (even in animals.)” Ordinarily, we don’t hear about research until it is finished, subjected to rigorous peer review and published in a respected scientific journal. Then it hits the papers. Can you imagine what life would be like if we were informed of every idea that was born in the scientific community? There would be no room for any other news.

So the fact that Hurlbut’s idea (along with one other) was announced to the country last winter with significant coverage in at least two major papers – the Boston Globe (11/21/04) and the Washington Post (12/3/04) – and was covered again in June of this year in Wired, not to mention the 184 hits a search on “Dr. William Hurlbut” +alternative yields on Google, begs the question - why? Let’s not forget, not only has zero research actually been done on these ideas, but Dr. Hurlbut is not even a scientist. How on earth could a non-scientist with a mere idea get the kind of coverage generally reserved for huge scientific discoveries in two major media outlets?

And there is more. Since November, Hurlbut has been traipsing around the country looking for support for his idea from religious leaders and others. But…why? Ordinarily, when a scientist has an idea for a research project, she or he writes a grant, secures funding, and does the study. It couldn’t be a question of whether such an experiment would be eligible for federal funding because it would have to be done in animals, first – there is plenty of federal funding available for research on animals. So why doesn’t Hurlbut find an actual scientist to undertake his experiment, secure funding, and get to work?

The only explanation I can come up with is that Hurlbut’s goal is not, as he says, to get this research undertaken – his goal is to publicize the idea and get it onto the internet and into newspapers all over the country; plant a seed in the minds of those who are only listening with half an ear that there is an alternative, that ESCR is really unnecessary, and thereby increase the misinformed base of support for the marginalization or elimination of ESCR.

That would be one goal of Hurlbut's crusade, but it was and is also intended to lay the groundwork for a more overarching goal: to derail the votes in the House and the Senate on HR 810, a bill that would expand federal funding for ESCR. It could not possibly be a coincidence that the PCBE published its White Paper, which announced four ideas, including Hurlbut's, theorizing alternative methods for obtaining ESCs, in the very same month House Majority Leader Tom DeLay finally allowed HR 810 to come to a vote. And because of Hurlbut's crusade, the White Paper has received plenty of advance press, all over the country. This is just the next step in a long series of political moves using inaccurate and misleading information (plenty of information on that subject on my blog) to convince the public that ESCR is unnecessary in an effort to create an atmosphere that would be amenable to retaining, or even expanding, restrictions on it.

The irony is that in choosing to promote research ideas, hypotheses, as its next step, the right is fixing the searchlight full force on the hypocrisy of its own anti-ESCR soundbites, which have been repeated like mantras since 2001.

One of those mantras is “false hopes.” All those irresponsible people, goes the mantra, who are “hyping” ESCR are giving those poor sick folk false hopes by leading them to believe that cures and treatments are right around the corner

But what about Hurlbut, et. al.? When it comes to these totally hypothetical ideas, they can’t be about anything BUT hope. Hope, quite literally, is all there is, because right now there is no research at all to support these hypotheses.

Another, particularly inane, mantra is "there are no guarantees that ESCR will ever yield anything,” First of all, does it even bear saying that there are never any guarantees that any medical research will yield results? And, secondly, Hurlbut and friends' experiments would be no different from any other – i.e., no guarantees – but that is not stopping the right from shouting the “news” from the rooftops. Suddenly, who needs guarantees?

Likewise with “even if ESCR does someday yield results, it won’t be for years and years.” With Hurlbut and company's completely untested ideas, there is virtually no mention of the fact that these hypotheses are even further from fruition (if they ever come to fruition) than your average ESCR.

I don’t see myself as particularly adept at reading between the lines, but, quite honestly, such a talent would be wasted here. Hurlbut’s crusade fairly screams “propaganda,” and the PCBE’s and the right’s support of it puts their hypocrisy on parade.

Fortunately, for whatever reason, Senate Majority Leader Bill Frist recently broke with President Bush and announced his support for expanded federal funding for ESCR. If enough senators follow their career compasses or their consciences now (it matters not to me which it is) we just might end up with a federal policy on ESCR that actually reflects the will of the people.

If not, the right will go on stealing hope, time, and potentially much more, from those who need them most.

This post is also available at Blogger News Network.

*please see below for a short description of Dr. Hurlbut's idea.

Dr. William Hurlbut and Altered Nuclear Transfer

This entry is sort of an appendix to the entry entitled "Hurlbut, Bioethics and Hypocrisy." If you are unfamiliar with somatic cell nuclear transfer (SCNT), you might want to read SCNT 101 (below) before you read this.

Dr. Hurlbut’s idea would use a slightly modified version of SCNT (which they give a different name, altered nuclear transfer, or ANT) to create what the PCBE calls a “biological artifact.”

Hurlbut theorizes that it might be possible to make genetic alterations in the somatic cell before it is transferred into the egg such that the resulting entity would not have the ability to form past a certain point, and therefore would never have had the potential to become a fully formed human being. For example, “the altered nucleus might be engineered to lack a gene or genes that are crucial for the cell-to-cell signaling and integrated organization essential for (normal) embryogenesis” PCBE White Paper, May 2005.

The resulting “biological artifact” would never have been a living organism, says the PCBE, and therefore its destruction by the extraction of stem cells would be perfectly acceptable. The genetic alteration would then have to be reversed in the extracted cells, but after that, they would be normal, pluripotent stem cells – or so says Hurlbut’s hypothesis.

For a full description of this idea, along with three others, along with analysis of the ethical questions surrounding each idea, please read the PCBE’s May 2005 White Paper entitled Alternative Sources of Pluripotent Stem Cells.

DNA Cloning and Somatic Cell Nuclear Transfer – a.k.a. SCNT 101

It might be surprising to some to learn that there is more than one kind of cloning. That is why it is important to differentiate between them by referring to them by their actual names rather than the umbrella term “cloning.”

DNA cloning, recombinant DNA, gene cloning – these all refer the “the production of many identical copies of a specific DNA fragment.” merckmedicus.com

However, when the word “clone” in any of its forms is used these days, what is being referred to is another kind of cloning called somatic cell nuclear transfer, or SCNT.

All of the cells in the body, with the exception of one type of cell, contain two strands of DNA – one from each parent – they are thus known as diploid (they are also known as somatic.) The exceptions are gametes, also known as germ cells, i.e., egg and sperm cells. They are haploid, i.e., they only have one strand of DNA, so that one day, when the egg and sperm merge, they will form a single cell, known as a zygote, with precisely the desired number of strands of DNA - two.

With SCNT, there is no sperm involved. Instead, the haploid nucleus of an egg is removed and replaced with a diploid nucleus taken from any other cell in the body, resulting in an unfertilized egg that nonetheless has diploid DNA. If, then, a little bit of electricity is applied to the unfertilized, diploid egg, that somehow jumpstarts the same chemical reactions that are triggered by the completion of the union of egg and sperm, and the egg begins to divide like an embryo would.

Barring any unforeseen difficulties, this entity will continue to divide like an embryo, and on the fourth or fifth day, it will be possible to extract stem cells from it, as would also be possible with an embryo. At this point in time, it is not possible to perform the extraction without destroying the entity or embryo. Alternatively, as with an embryo, in the absence of any interference, and with the provision of a suitable environment, the entity could go on dividing and potentially grow into a fully formed adult. SCNT has been used to produce many animals, including Dolly the sheep and Snuppy the dog. However, at this time, the failure rate on producing animals via SCNT is extremely high – for example, Snuppy was the only success out of 1,000 implantations.

That is a summary of SCNT in my words. NIH says it much more succinctly:

Somatic cell nuclear transfer
—The transfer of a cell nucleus from a somatic cell into an egg from which the nucleus has been removed.