Saturday, March 24, 2007

What is the timetable for cures through human embryonic stem cells?

One year ago, in March 2006, LBE published a paper on the fraud of Hwang Woo-Suk which included the text:

Hwang's 2005 paper begins with the text: "Many human injuries and diseases result from defects in a single cell type. If defective cells could be replaced with appropriate stem cells, progenitor cells, or cells differentiated in vitro, and if immune rejection of transplanted cells could be avoided, it might be possible to treat disease and injury at the cellular level in the clinic. By generating hESCs [human embryonic stem cells] from human blastocysts, in which the somatic cell nucleus comes from the individual patient -- a situation where the nuclear [though not mitochondrial DNA (mtDNA)] genome is identical to that of the NT donor -- the possibility of immune rejection might be eliminated if these cells were to be used for human treatment." n46 [See 88 JPTOS 239, 248 (2006)]

The reviewers of Science accepted the truth of this statement back in March 2005, when the second paper of Hwang in Science was submitted. Two years later, in March 2007, the statement is still true. It is quite relevant to any realization of cures or treatment through human embryonic stem cells.

In response to a post by Christopher Thomas Scott on californiastemcellreport, LBE made the following comment:

The post above is directed as a response to one issue in what is a multi-issue problem.

Of the assertion about --the business of discovery, treatments and cures--utilizing embryonic stem cells, one notes that there is an important point about treatments and cures from embryonic stem cells that wasn't mentioned. As disclosed in the first few paragraphs of the second paper in Science by Hwang Woo-Suk, and not disputed by the reviewers of the paper (then or now), to really make embyronic stem cells into an effective cure, one has to have an viable method of human SCNT. The charm of Hwang's paper was the assertion that one could create patient-specific stem cell lines. As we know now, the evidence for this in the second paper was fraudulent. Less discussed, but of great relevance to any assertion of "cures" coming from embryonic stem cells, is the fact that NO LAB IN THE WORLD (with or without U.S. federal funding) has achieved what Hwang claimed in his second, or even his first, paper in Science. The only thing close to what Hwang claimed in the first paper was a report by the group in Newcastle, but no followup on that work was ever reported.

Rather than discuss "rhetorical sideshows," it would perhaps be more informative to discuss where we are NOW in human SCNT, and where we are likely to be, and the timeline for cures based on that reality.

Of the Newcastle work, page 248 of the 2006 JPTOS article noted:

In about June 2005, work from Newcastle in Britain suggested some success with creation of human SCNT blasto-cysts. n52

Footnote 52 stated: M. Stojkovic, et al., "Derivation of a human blastocyst after heterologous nuclear transfer to donated oocytes," For the abstract, see Full paper published August 2005. Roger Highfield, "Red tape has driven me out, says clone pioneer," The Daily Telegraph, p. 6 (Oct. 11, 2005). Speaking of the author of the work (M. Stojkovic), the article notes: Funding is so scarce and competition so fierce that a grant application can be sabotaged by an unsympathetic "referee" from a rival group. Alison Murdoch was a co-author on the paper.

In the time since March 2006, there have been no further reports on the Newcastle work. The article 88 JPTOS 239 has been cited one time since March 2006, in an article 88 JPTOS 743, which discussed the issue of a different false publication in the journal Science. The paper at 88 JPTOS 743 included two footnotes of relevance:

footnote 8: At some level, the use of the word "continuation" to mean more than one thing reminds one of Raffles v. Wichelhaus, 2 H.&C. 906, 159 Eng. Rep. 375 (Ex. 1864), wherein there was one contract mentioning the ship Peerless but two different ships called Peerless. Note MARVIN A. CHIRELSTEIN, CONCEPTS AND CASE ANALYSIS IN THE LAW OF CONTRACTS 87 (4th ed. 2001)[observing that Raffles "highlights the fallibility or variability of language itself and the possibility that the parties to a contract may use the same words to express quite different aims and expectations"]. However, there is no excuse for Science to use the same word to refer to different concepts in the same paragraph.

footnote 11: The present author (LBE) tried to submit a 'letter to the editor" of Science to address the points outlined in the present article in JPTOS. The present author was told that Science stood by the accuracy of the July 28 article. The inability to address (incorrect) matters in prestigious, flagship journals such as Science reminds one of issues in the publications in Science of Hwang Woo-Suk (see 88 JPTOS 239 (2006)).


On a not-unrelated theme, pertaining to the IPBiz post -- More on bad acts by K.Y. Cha in publishing science, related to CIRM's grant to CHA-RMI--, the plagiarism victim in that case (JeongHwan Kim) emailed LBE, including text As you might know, there is also a patent issue in this case. Currently, SH Lee has been indicted for infringement of IP only (criminal case)

The initial article in the Los Angeles Times did mention the presence of both patent and copyright issues in the matter involving Cha, Lee, and Kim. As mentioned in several posts on IPBiz, copyright and plagiarism are DISTINCT matters.

Separately, the poster Faye on californiastemcellreport emailed me about a post I made on californiastemcellreport about funding by the state of New Jersey in embryonic stem cell research. It included the text:

Is NJ headed primarily in the direction of umbilical cord blood stem cell research and other ASCR? How much will actually be going to hESCR?

I am concerned.

From your comment on California Stem Cell Report I couldn't make out if you share this concern, or if you were trying to rebut my concern.

LBE notes that, consistent with the comments earlier in this post, LBE is concerned that the timetable for cures or treatments based on embryonic stem cell research may be much farther into the future than many people think it is. Treatments based on adult stem cells may be capable of an earlier realization. The proper choices are up to our elected representatives. Those decisions should be based on truthful evidence. LBE was, and is, concerned that untruthful statements (e.g., about projected patent royalties) have entered the dialog.

From the final paragraph of 88 JPTOS 239 (2006):

States wishing to fund research in the area of embyronic cell transfer, or in any area of cutting-edge research, will be well advised to note the difficulty in assessing the validity of work at early stages. Further, states should also note that the probability of securing money from patent royalties from patents on early stage work is not high. Further, in the area of work regulated by the FDA, the broad scope of protection from patent infringement offered by 35 USC 271(e)(1) may render early patents in a developing area of low economic value.

That statement was true in March 2006 and it is still true in March 2007.


Blogger bob said...

In regards to your reply on stem cell funding in NJ: First Thanks to the poster Faye for pointing this out. It says alot. Was there always a hidden agenda in NJ to promote other forms of research than human esc? One must think that it would have been hard to mobilize a state government to fund adult stem cells as they are already funded by the federal government. If so, using the issue that hESC are not funded gave justification in the blue state of New Jersey, but the way the legislation was authored left a loophole to fund mostly ASC research. I do believe a key author of the NJ bill is a cord blood researcher. Whether you are for or against research using hesc is not the issue, what is may be that the people of New Jersey expected one thing and got another.A new round of funding in New Jersey is in the works, hopefully they will get back on track.

7:30 AM  

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