Jamie Thomson, the father of embryonic research since he isolated the first line of embryonic stem cells in 1998, recently brilliantly discovered, along with a Japanese associate, a method of creating faux-embryonic stem cells from adult skin cells, as announced in November 2007.
Virtually all of the stem cell writers in America declared the stem cell therapy, wars were over. “We can make embryonic stem cells from skin, so there are no moral issues!” they exclaimed. As is normal for embryonic publicists, they were years premature. We are no closer to real cures for real humans than we were before the new miracle. Embryonic cures cannot sail, this decade or next.
On the day after the big press release, I wrote that the Thomson announcement was a non-event; only that the embryonic movement needed its “miracle press release of the month,” and Thomson gave them one, inadvertently I am sure, since Thomson has never been anything but an honest man of science. His level-headed statement on the so-called miracle is refreshing when compared to the cheerleaders: “I believe these new results, while they do not eliminate that controversy, is probably the beginning of the end of that controversy,” Thompson said. ”Even though we have this nice new source of cells, it doesn’t solve all the downstream problems of getting them into the body in useful form.” A bit of an understatement, perhaps, but coming from THE man, I’ll warmly embrace it.
Let us take a look from the real world of science rather than the science fiction world of the embryonic cheerleaders.
The majority of these cheerleaders in America do not know that embryonic cells come from cancer cells and those cancer cells come along with every embryonic stem cell in every lab in the world. The reason they don’t know it is that the word “cancer” has been prohibited from being mentioned in association with “embryonic” in virtually every newspaper and medical journal in the land.
But the movement’s censors could not keep the word “cancer” out of the Thomson promotion, since Thomson put it in himself, as did his colleague Dr.Yamanaka and other quoted serious researchers. The same thing happened in 2006 when an honest embryonic researcher at the University of Rochester, after his team virtually cured his lab animals of Parkinson’s, was forced to watch as those doomed animals all developed tumors. “Cancer” appeared in the reporting medical journal and the spin doctors were forced to use it in the newspapers. The researcher was brutally honest about the events, which is why the Washington Post refused to print his most damning quotes and why the censors are still doing their best to keep “cancer” and “embryonic” out of the same newspaper articles
That, and Thomson’s efforts to keep the truth in view (not an easy task in America, even for him) was the clue that convinced me this whole “miracle” was virtually meaningless as to the only thing that matters: “Where are the embryonic cures for human beings, or even animals, for that matter?” The answer is “further away than they seemed to be in October—and that was real far away.” Over the intervening weeks, serious embryonic people started to realize the truth. Some said things like “We are five years away, probably more.” Five years? No way, Jose’. Fifteen, maybe.
As a comparison, let us look at the largest USA phase2 adult (non-cancerous) stem cell clinical trial for chronic heart disease. Baxter is sponsoring that one, and they got FDA approval in 2004. They hope to finish phase two before the end of 2009, installing one of America’s leading stem cell heart, researchers, Dr. Douglas Losordo, to run it. If they stay lucky (with Losordo in charge, I’m betting “yes”) they will get FDA approval in 2010 for phase3, much more difficult than phase2. IF Baxter decides to spend the considerable money, and it may not, four years would be a minimum to complete it. Again, if their luck holds up, they could get final approval by 2014, ten years after their 2004 phase1 approval.
Add to the calculation the fact that adult stem cells do not carry cancer and also that Baxter’s stem cells come from the individual patient so there is zero risk of rejection by the patient’s immune system. That makes Dr. Losordo’s job “easy.” Easy = 10 years of FDA trials!
Now let’s look at “not-so-easy,” in fact at something so complicated, no one yet knows what all the traps down the road may bring. In a word, let’s take a closer look at EMBRYONICS than you will ever get in any American medical journal, nor in the giants of pro-embryonic liberal print media in NY, WashDC and LA.
FIRST, Thomson and friends must confirm their findings, meaning that some other research group must duplicate them elsewhere; and the consensus seems to be two years, perhaps less. Merely SOP in science, no argument there.
SECOND, researchers must conquer the cancer issue if they even dream of the FDA considering an embryonic stem cell trial. Conquering that embryonic cancer cell has proved impossible to overcome during the decade since Thomson’s initial discovery and no one is even claiming serious progress. They like to blame their failings on Bush, but this ignores thousands of researchers working around-the-clock around the world, mostly in countries with government funding and NO government restrictions. The manipulations of the pro-embryonic media proves how desperate they are to keep that information from their readers, the majority of whom are “true-believers.” Their readers, overwhelming pro-embryonic, have no idea that cancer is even a problem, let alone that nobody, not even Thomson, has yet come up with a way to avoid it.
THIRD, they must conquer the rejection problem, a problem “solved” by transplant cardiologists who have no choice but to permanently compromise the dying heart patient’s immune system to prevent rejection of the new healthy heart. “Permanently Compromising” the patient’s immune system is NOT an option for embryonic researchers.
FOURTH. The requirements for embryos, very expensively obtained embryos, in their research, is enormous. Some researchers say that only 1%-2% of donated embryos are biologically fit for research. This means that they need 50 to100 embryos to get one worthy of researching. That is one more mountain to climb. I do not envy them. Thomson & Yamanaka have done what they can to solve this issue, but, as you will soon see, those mountains just grew higher.
FIFTH, and this will come as a shock to those that follow the movement, is that the only bragging point of embryonics (all others have been shown dozens of times to be either scientifically false or irrelevant) is that their cells are “pluripotent,” which means they can presumably become any cell in the human body, and therefore help any part of the body get better. Some are beginning to realize what I said in 2006: “Pluripotentcy is a two edged-sword.”
The best researchers in the world, on five continents, all know that science cannot begin to control the embryonic stem cell’s ability and desire to become whatever it darn well pleases. Good embryonic researchers can train their cells to significantly help patients with many different diseases, but once the cells are finished doing that, off they go, wherever and whenever and however they wish, and that “however” too often results in tumors. In two words, as of the beginning of 2008, embryonic stem cells are unstable and unpredictable. The Curse of the Pleuripotent!
Put it all together.
2010: They confirm Thomson’s skin cell miracle.
2012: They conquer the cancer and the rejection problems. I don’t really believe just two years. However, I want to give them a best-case scenario, so I will also ignore the instability factor.
2013: FDA approves the first embryonic clinical trial.
2023: Ten years to get through three phases of clinical trials is the minimum under today’s rules….using long-proven safe and stable adult stem cells. I doubt that ten years is possible for embryonics, given their instability and unpredictability, but let’s use it.
In my previous writings I have estimated 2018, but too many snippets are coming out of the real world of science to allow such an easy path to human treatment. The strange thing is that the leading embryonic scientists in America, but not the media giants, are actually pulling in their horns. If I didn’t know better, I’d think they are concerned.
First thing I noticed was the fear of “reprogramming” that Dr. Yamanaka used to revert the skin cells all the way back to embryonic cells. Embryonic stem cells are already unpredictable, and Yamanaka’s method figures to raise the level of unpredictability. That makes them impossible to use on humans. That is not Don Margolis talking, that is Dr. George Q. Daley, a stem cell researcher at Children’s Hospital Boston, who concludes:
“But for the ultimate goal of getting cells into a patient, it’s a lot less clear. These cells may never be useful for direct therapy.” Amen, Dr. Daley! For a guy who earns his living in embryonics, your honesty is refreshing!
Across town there is another embryonic research leader who is even more adamant than Dr. Daley. From Boston.com:
In what is even more of a lurking threat, the process uses retroviruses to carry the genes into cells. These viruses can disrupt the normal function of DNA and also can spur the birth of cancer cells.
Some proponents of reprogramming argue that problems from genetic modification and use of viruses are purely technical and easily surmountable. But other stem cell researchers are skeptical that reprogrammed cells or specialized cells produced from them will ever win approval for use in humans. “It will never be approved [by the FDA] to put these cells in a patient,” said biologist Douglas A. Melton, codirector of the Harvard Stem Cell Institute. “The retrovirus can be a Trojan horse that can carry all sorts of problems.” (Thanks to Boston.com)
What is astonishing about these quotes is that they both come from Boston, the hotbed of embryonic exaggeration and adult stem cell denigration. FYI, there is no bigger embryonic research center in the USA, and probably the world, than Harvard, and the only difference of opinion between CoDirector Melton and myself is that he believes that real embryonic cells can someday safely be put into a human being, and I do not. I repeat, only an opinion, on both our parts.
I am excited about the advances in embryonic stem cell research and the promise it holds for the distant future. However, as you can see, those involved with the research understand and freely admit that there are still significant practical hurdles to overcome. In the meantime, adult stem cells offer a safe, proven alternative with the power to save and improve lives now, lives that are being needlessly pushed to the grave rather than to what works now.
Don Margolis started the world’s first commercial company to actually treat and improve the lives of dying heart patients using adult stem cells, with about 200 successes to date. He is not a doctor, but a charter member of the American Academy of Actuaries. He is neutral on the issue of embryonic stem cell morality. He never mentions the subject and will not discuss it, believing that the debate itself does nothing but take the public’s attention away from the only thing that matters; i.e. thousands of Americans are dying unnecessarily each month because of the senseless debate. His one and only mission is to “S.A.I.L. NOW” (Save And Improve Lives NOW) with long-proven-safe adult stem cells, rather than in 2023, if then, using embryonic stem cells.