Sunday, September 26, 2004

Boston Globe on EmCell's stem cell work

A recent article in the Boston Globe on EmCell, a company in the Ukraine engaged in research on embryonic stem cells, was skeptical of the work by EmCell. While not judging the accuracy of the evaluation of EmCell, I noticed several misstatements in the Globe article.

Text from Boston Globe:

A patent, moreover, is no indication that a technique actually works, said Janis Fraser, who reviewed EmCell's patents for the Globe and is a principal in the Boston office of the law firm Fish & Richardson. A patent is a claim of invention, and the patent office's main function is to verify that an invention is original. It does not test effectiveness. In the United States, the FDA is charged with evaluating whether a treatment is safe and effective. An FDA spokesperson said that the agency has no information on EmCell.

[Comment by LBE: It is true that the Patent Office does not experimentally test inventions. However, it is not true that the "main" function of the PTO is to check originality. The PTO is charged with evaluating patentability, which includes utility, novelty, nonobviousness, written description and enablement. Of enablement, the PTO does check to see that the disclosure enables the invention for practice by one of ordinary skill. Albert Einstein did the same thing in the Swiss patent office a hundred years ago. The FDA does check whether a treatment for a particular purpose is safe; however, a medical doctor is legally allowed to prescribe an approved drug for a purpose OTHER THAN evaluated by the FDA.]

The EmCell website contains numerous scientific reports, which it calls "publications." But none have been published in a journal reviewed by other scientists, meaning that they hold no more weight than an advertisement. Smikodub said that he would like to publish his results in peer-reviewed research journals. He said he submitted one report, on his AIDS therapy, to a journal, but it was rejected without explanation.

[LBE comment: The term "publication" refers to something that has been published (made publicly available.) What "weight" the publication has is determined by whether it is accurate and reproducible. Publications in the Proceedings of the National Academy of Sciences (PNAS) can be communicated (not reviewed) but still have more weight than an advertisement. Further, the publications of Jan-Hendrik Schon were peer reviewed by referees for journals such as Science and Nature, and yet turned out to be fraudulent, not accurate and not reproducible. The absence of peer review does not prove lack of value and the presence of peer review does not prove value.]


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