A seismic shift has occurred as this is the first time ever in history that human embryonic stem cells will be injected into human subjects. Geron Corporation has enthusiastically announced the FDA’s approval of their Phase 1 clinical trial to begin using human embryonic stem cells in patients with new spinal cord injuries. This news came as no big surprise; Geron’s CEO, Thomas Okarma, has been promising for years that they would be the first in human trials using embryonic stem cells. Geron has poured some $100million into embryonic stem cell research since 1996; they have much at stake as they begin this trial, injecting human embryonic stem cells into patients.

I imagine investors in Geron stock are delighted now as its price soared some 50% with this news, and Geron stock has moved from “hold” to “buy” status. We shall see.

From Geron’s news release:

Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

Geron will recruit patients who have “documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 and agree to have GRNOPC1 injected into their lesion site 7-14 days after their spinal cord injury.” They hope to begin their study as early as this summer.

While the world watches and waits as Geron begins this clinical trial, let me point out a rather significant statistic that most people don’t know. The majority of Phase 1 clinical trials fail, and they fail pretty miserably. Keeping this in mind, the scientific world should be watching even closer as Geron begins recruiting patients and the actual clinical trial unfolds.

How’s this for a statistic:

“In clinical trials, teams of physicians carry out studies designed to determine if the drug is safe in people and is an effective treatment for the disease in question. Of the 250 compounds that enter preclinical testing, only five will make it this far.”

Sources I spoke with tell me that the Phase 1 failure rate is 60%-90% and even as high as 95% with cancer drugs. So, the majority of new drugs in the Phase 1 trial, where safety is the primary focus, fail. If the drug is deemed safe, then it is permitted to move on to Phase 2 of the trial. With this kind of failure rate, you can quickly understand why the FDA takes safety in human clinical trials so seriously and why it is so very expensive to move a new drug or therapy onto the market.

Historically the biotech-cures-all approach to medicine is full of stops and starts, hype and hope, and disastrous results. Therefore those in the scientific community who have pinned everything on embryonic stem cells being the Holy Grail (the gold standard against which all other research will be measured) and holding the secret of cures (remember, that is what this is all about), will be watching and holding their breath, hoping that Geron doesn’t fail. Art Caplan, director of the University of Pennsylvania’s Bioethics Center, said, “It is going to take years to develop therapies” and we shouldn’t give patients false hope.

So very much is at stake for those of us who oppose embryonic stem cell research. While we hope that the patients who enter into this clinical trial are not further harmed, we also hope that embryonic stem cells don’t work because we object to using nascent human life instrumentally, no matter what good can be achieved. If embryonic stem cells are successful in providing benefit to patients, it will be close to impossible to turn back the clock. This is a watershed moment.

Since Phase 1 trials focus primarily on safety, you can be sure that there will be a very strict and stringent protocol that will need to be followed, and at any given moment the trial could be stopped. This, of course, would be the kind of result that would significantly hinder any future studies using human embryonic stem cells in human subjects. The scientific community has placed so much hope in this area of research. But one wrong move and it all comes to an end. That’s reason to be nervous.

Two examples of safety concerns quickly came to mind when I heard of Geron’s news:

1) The failure of Fetal Tissue Transplantation, which came about right after President Clinton took office in 1993, as the cure-all for Parkinson’s disease.

2) The disastrous gene-therapy news of Jesse Gelsinger in 1993.

For all the hope and hype over fetal tissue transplants, the research has provided mixed results at best, and certainly the 15 years of research has not proved to be beneficial to patients. And the sad story of Jesse Gelsinger set gene therapy back decades. Can you say GM foods and Monsanto or e. coli and spinach?

Jennifer Couzin wrote a good article on this topic in Science, “Celebration and Concern Over U.S. Trial of Embryonic Stem Cells.” One chilling quote comes from John Gearhart, one of the leaders who first isolated embryonic stem cells back in 1998. Gearhart said, “We’re still a long way from really understanding a good deal about these cells and how to use them safely.” So with massively high failure rates in clinical trials, the experts in embryonic stem cell research reminding us how little we still know about these cells and their safety and efficacy, the massive breach of the ethical use of human subjects in research (yes, I do believe the human embryo is a human subject) and progress in iPSC and adult stem cell research, we should all pause at this moment in time and ask ourselves: do we want to set ourselves up for such a huge fall?

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Jennifer Lahl is TSR´s Bioethics Contributor.

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This is the name given to the first few months of the Second World War in the Western Front, when France and Britain, which had reluctantly declared war on Germany, failed to attack while the Wehrmacht was busy in Poland. The Royal Navy, under the able leadership of Winston Churchill, was of course an exception and understood from day one that, in General MacArthur´s words, in war there is no substitute for victory. Although the circumstances might be almost completely different, such a period of time comes to mind when looking in retrospect at the last few weeks in Gaza, where the Israeli Defense Forces undertook an operation whose objectives do not seem to have been clearly set out.

Briefly, the situation in Gaza prior to Operation Cast Lead was: 

– An economy completely dominated by foreign aid, unconditionally provided by democratic countries, for the most part.

–A not-too-high standard of living, high enough however to sustain a very high birth rate and to prevent the population from having to concentrate on productive work in order to feed themselves.

–A ruling regime bent on destroying Israel, as made clear on multiple occasions.

–An asymmetrical conflict in which rockets were constantly being launched at Israel without this prompting a military response from the IDF.

–A permeable border with Egypt, traversed by multiple tunnels, employed to supply Hamas with weapons and munitions.

But above all, the situation was marked by an obsession with “negotiating” with “Palestinians”, both Hamas and Fatah, in the vain hope that a deal might be achieved and peace finally secured.  

Is peace possible in the Middle East? Of course it is, however the road leading to it does not go through endless negotiations and does not depend on Israel being more generous here or there. Peace in the Middle East will only come when the Palestinians have been defeated. 

One might be tempted to believe they have, and of course they have gone from defeat to defeat in the battlefield, but it is not such battles that define who wins and who loses a war. After all the Viet Cong suffered horrendous losses in their ill-fated Tet offensive … and went on to win the war.  

Defeat is the loss of the will to fight on, once it has been made clear that further belligerence will only result in meaningless loss of life and bring one not an inch nearer one’s objectives. According to this definition, the Palestinians have not been defeated. 

They have not been defeated because they still believe that by prolonging their half-a-century campaign against Israel, a democratic state which has never allowed its military a free hand in dealing with its enemies, they will destroy its will to resist and end up succumbing to a second Holocaust. They have not been defeated because they still think that Israel’s friends, the community of democratic nations, will desert it in order to appease Jihadists and hope to be eaten last by the crocodile.  And they have not been defeated because they are being fed by a wide assortment of NGOs, international agencies, and governments, who have turned Gaza into a large-scale welfare state experiment.  

Welfare destroys the human soul and the work ethic, which set apart free men from slaves. Welfare allows families to send their sons into battle, knowing that they won’t miss the fruit of their labor. Welfare lets young men spend all their days plotting the destruction of their democratic neighbor. 

Has Israel’s foray into Gaza changed any of this? Unfortunately not. Of course, some hundreds of terrorists have been killed, which is a cause for celebration, but governments, international organizations, and NGOs are already queuing up to “reconstruct” Gaza. There is nothing which leads us to believe that Hamas will suddenly decide to recognize Israel’s right to exist. 

When a country decides to go to war, the gloves must be taken off. Otherwise the ensuing stalemate will only result in prolonged indecision and the need to, after a short period of time, take once again the same steps.  It is precisely this which has taken place in Gaza, where Israelis have not played to win. 

It is therefore time to start looking at other options.

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Alex Calvo is TSR´s International Security and Defense Editor.

A law graduate of London’s School of Oriental and African Studies, Alex spent some time travelling in Asia before embarking on a career in banking. His duties gradually shifted to international law, while his strong interest in international relations made him spend an increasing amount of time studying the subject and following current events. Three years ago, he finally decided to start working for himself as legal consultant an embark on a PhD in strategic studies. A professor at European University’s Barcelona campus, he is spending a semester at the Organization for Security and Co-operation in Europe’s Academy in Bishkek (Kyrgyzstan), and holds a commission as reserve officer.

Alex’s main area of interest is Asia, including Central, South, and East-Asia. He is also a keen student of military history and doctrine, with an emphasis on counter-insurgency operations.

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During the 20 months that Fisher-Price spent developing the innards and software of its latest animatronic Elmo, engineers gave the project the code name Elmo Live. And sure enough, they made him more animate than ever: He moves his mouth in time with the stories he tells, shivers when he gets scared, and has a fit when he sneezes.

When they were finally able to test the doll on children, they were struck by how immediately the kids blocked out all other stimuli in the room and began interacting with Elmo. “It was as if Elmo were part of their family,” says Gina Sirard, Fisher-Price VP of marketing. “To a child, he really is alive.”

So the code name stuck, and over the past few months legions of $60 Elmo Live dolls have joined families everywhere. Some are certainly doomed to join previous Elmos in a new pastime: robotic-toy torture. YouTube is full of videos of idiots dousing Elmo with gas, setting him on fire, and laughing as his red fur turns to charcoal and he writhes in a painful dance.

I’ve seen videos of the incineration of T.M.X. Elmo (short for Tickle Me Extreme); they made me feel vaguely uncomfortable. Part of me wanted to laugh—Elmo giggled absurdly through the whole ordeal—but I also felt sick about what was going on. Why? I hardly shed a tear when the printer in Office Space got smashed to bits. Slamming my refrigerator door never leaves me feeling guilty. Yet give something a couple of eyes and the hint of lifelike abilities and suddenly some ancient region of my brain starts firing off empathy signals. And I don’t even like Elmo. How are kids who grow up with robots as companions going to handle this?

This question is starting to get debated by robot designers and toymakers. With advanced robotics becoming cheaper and more commonplace, the challenge isn’t how we learn to accept robots—but whether we should care when they’re mistreated. And if we start caring about robot ethics, might we then go one insane step further and grant them rights?

First, the science: The brain is hardwired to assign humanlike qualities to anything that somewhat resembles us. A 2003 study found that 12-month-olds would check to see what a football-shaped item was “looking at,” even though the object lacked eyes. All the researcher had to do was move the item as if it were an animal and the infants would follow its “gaze.” Adults? Same reaction.

The perennial concern about the rise of robots has been how to keep them from, well, killing us. Isaac Asimov came down from the mountaintop with his Three Laws of Robotics (to summarize: Robots shouldn’t disobey or hurt humans or themselves). But what are the rules for the humans in this relationship? As technology develops animal-like sophistication, finding the thin metallic line between what’s safe to treat as an object and what’s not will be tricky. “It’s going to be a tougher and tougher argument to say that technology doesn’t deserve the same protection as animals,” says Clifford Nass, a Stanford professor who directs a program called the Communication Between Humans and Interactive Media Lab. “One could say life is special—whatever that means. And so, either we get tougher on technology abuse or it undermines laws about abuse of animals.”

It’s already being considered overseas. In 2007, a South Korean politician declared that his country would be the first to draw up legal guidelines on how to treat robots; the UK has also looked into the area (though nothing substantial has come of it anywhere). “As our products become more aware, there are things you probably shouldn’t do to them,” says John Sosoka, CTO of Ugobe, which makes the eerily lifelike robot dinosaur Pleo (also tortured on Web video). “The point isn’t whether it’s an issue for the creature. It’s what does it do to us.”

We live in an age of anxiety—about the economy, the environment, terrorism. And now even about our toys, which are forcing us to question the boundaries of humanity and compassion. Back on Sesame Street, Elmo Live’s creators have an answer: Keep soul-searching to a minimum and recognize that you’re buying a product, pure and simple. “This is a toy,” Fisher-Price’s Sirard says. “There shouldn’t be any laws about how you use your toys.” Happy grilling, Elmo!

Source: Wired

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A CEASEFIRE WILL ONLY EMBOLDEN TERRORISTS AND PREVENT THE EMERGENCE OF A DEMOCRATIC MIDDLE EAST  

Recent widespread calls for a ceasefire in Gaza, coming from many world leaders, international organizations, and the media, make it imperative to examine whether the Obama administration should support them and lend its support to the negotiation of a truce. In order to do this, we need to examine the nature of non-state actors, such as Hamas, as well as the meaning of Jihad, the holy war they openly wage.  

An advantage of non-state actors is their lack of a population or territory which can be targeted. This prevents states from effectively deterring them and is the main reason why a nuclear device in their hands would be much more worrisome than one in the possession of a state, however hostile. 
 
By gaining control of the Gaza strip, Hamas has effectively ceased to be a non-state actor, having in actual practice joined the ranks of hostile states, no matter what their precise legal status in international law or diplomatic practice.  From a military point of view, this has some advantages and some disadvantages. Hamas has, on the one hand access, to more resources than it did before and more freedom of movement within its area of operations.  On the other hand, it now has a population which can be targeted and which can end up turning against them. However, this is only a weakness if Hamas is treated as a state actor by Israel and her allies. 
 
Should Hamas be allowed to escape the consequences of being responsible for the population of the Gaza strip, it would be able to reap the advantages of statehood without the pitfalls. Any such double standard would only give it a great military advantage and lengthen the conflict indecisively.  In MacArthur’s words, “In war there is no substitute for victory”.  

In addition, we should not forget that Hamas rejects concepts such as “ceasefire”, common in contemporary international law, relying instead on terms belonging to the Islamic law on Jihad. While some secular Arabic newspapers may use the term waqf al-nar, a literal translation of ceasefire, Hamas sees any temporary cessation of hostilities, to which they refer as hudna or tahdiyya, as simply an opportunity to re-arm and prepare for the next fight, the only possible outcome of Jihad being victory over the unbelievers.

It is therefore imperative to reject any calls for an early truce and to avoid any form of aid reaching the civilian population. Gaza’s inhabitants must confront the consequences of being ruled by Hamas and must reject it themselves.  Any other solution will be only a short-term one, resulting in a resumption of hostilities once Hamas has had the time to reorganize and rearm and has been able to portray such activity as a victory.  

Can anyone imagine food being shipped to World War II-era Japan before it realized further resistance was futile and decided to surrender? The seeds of modern-day democratic Japan were sown that day, in the same way that a future democratic Middle East will be born the day the so-called Palestinians realize that they have lost, that they have no hope of military victory, and that the Free World will never surrender.  

Any ceasefires, truces, or deployment of blue helmets would only serve to delay the arrival of such moment and therefore must be avoided at all costs. Furthermore, we should never forget that many dictatorial regimes in the Middle East hide behind Hamas and other terrorist organizations that threaten Israel’s national security.  Once they have been defeated, a major step will have been taken towards their replacement by democracies, the only sure way to finally achieve peace in the region.

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Alex Calvo is TSR´s International Security and Defense Editor.

A law graduate of London’s School of Oriental and African Studies, Alex spent some time travelling in Asia before embarking on a career in banking. His duties gradually shifted to international law, while his strong interest in international relations made him spend an increasing amount of time studying the subject and following current events. Three years ago, he finally decided to start working for himself as legal consultant an embark on a PhD in strategic studies. A professor at European University’s Barcelona campus, he is spending a semester at the Organization for Security and Co-operation in Europe’s Academy in Bishkek (Kyrgyzstan), and holds a commission as reserve officer.

Alex’s main area of interest is Asia, including Central, South, and East-Asia. He is also a keen student of military history and doctrine, with an emphasis on counter-insurgency operations.

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