cb.blog

Category: Politics

Pol·i·tics: the art or science of government or governing, especially the governing of a political entity, such as a nation, and the administration and control of its internal and external affairs. Posts in this category pertain to local and national politics.

  • Stanislav Shmulevich Koran Hate Crime Case Beginning to go Viral

    The Stanislav Shmulevich story I discussed yesterday is beginning to go viral.

    LGF updates with a report that Phil Orenstein of Democracy Project is getting involved, and also that many lawyers are lining up to help with the defense.

    The mainline blogosphere is taking notice, as Michelle Malkin, Allah Pundit (who agrees with my legal analysis that the felony charges are baseless), Neal boortz, and others are beginning to weigh in.

    More blog reactions: Infidel Terrorist, Side Effects May Vary, Jihad Watch.

    Why is this case important? Consider that Omar Ahmed, the chairman of the board of CAIR – the group behind the escalation of the valdalism to the level of a hate crime – spoke the following (H/T Halal Pig) [emphasis added]:

    “Those who stay in America should be open to society without melting, keeping Mosques open so anyone can come and learn about Islam. If you choose to live here, you have a responsibility to deliver the message of Islam … Islam isn’t in America to be equal to any other faiths, but to become dominant. The Koran, the Muslim book of scripture, should be the highest authority in America, and Islam the only accepted religion on Earth.“

    This statement represents the true intent of CAIR, MSA student groups at college campuses across the country, and Islam as a whole. Islam is not merely a religion (if it can even be called that); it is a fascist socio-political movement, the goal of which is world domination and subjugation to Islamic law. We must stand together against Islam’s goals of conquest, or we will all fall together – and the Land of the Free will be no longer.

  • Outrageous: Sharia Law in New York

    Completely, utterly, outrageous: Sharia law has now taken precedence in New York.

    LGF reports (and follows up on) the story (with a hat tip to Purple Wombats) of Stanislav Shmulevich, who was arrested on felony counts of aggravated harassment and criminal mischief, for throwing a Koran into a toilet at Pace University. From the wire story:

    A 23-year-old man was arrested Friday on hate-crime charges after he threw a Quran in a toilet at Pace University on two separate occasions, police said.

    Stanislav Shmulevich of Brooklyn was arrested on charges of criminal mischief and aggravated harassment, both hate crimes, police said. It was unclear if he was a student at the school. A message left at the Shmulevich home was not immediately returned.

    …

    The school was accused by Muslim students of not taking the incident seriously enough at first. Pace classified the first desecration of the holy book as an act of vandalism, but university officials later reversed themselves and referred the incident to the New York Police Department’s hate crimes unit.

    Yes, you read that correctly: two felony counts, aggravated harassment and criminal mischief – classified as hate crimes – for throwing a Koran in the toilet.

    According to this story, Stanislav was caught by a security camera as he was leaving a (Muslim) meditation room where the Korans were stored.

    This incident is clearly a First Amendment, free speech and establishment challenge, and reeks of involvement by CAIR.

    As has been pointed out in the LGF comments, burning the American flag, displaying a crucifix in a vat of urine, and displaying a painting of Mary covered in dung are all considered forms of protected religious or political speech. Flushing a Koran, however, is now considered a hate crime.

    Here are the New York Penal code definitions of aggravated harassment (First Degree, Second Degree) and Criminal Mischief (First Degree, Second Degree, Third Degree, Fourth Degree).

    Granted, I’m no lawyer, but the felony escalation of the criminal mischief charge appears to be specious, and the aggravated harassment appears not to apply whatsoever. On the former charge, no explosive was used (first degree, class B felony), the Koran was not worth $1,500 (second degree, class D felony), and the Koran was not worth $250 (third degree, class E felony). At best, Stanislav committed a class A misdemeanor (fourth degree).

    On the latter charge, Stanislav neither communicated with a person via phone or any form of written communication nor physically touched a person (second degree, clauses 1-3, class A misdemeanor), nor did he damage premises used primarily for religious purposes (first degree, class E felony). That no actions (spoken or written communication, or physical contact) were directed at any person, the “hate crime” provision of the first degree charge is irrelevant.

    If you value your freedoms as an American, you had better be absolutely outraged at what is happening here.

    Personally, it makes me want to go buy a Koran, wrap it in bacon, throw it on the glowing charcoal of my Weber, and douse the charred remains in the toilet – and then post a picture so the intolerant, fascist scum at CAIR and elsewhere can choke on it.

    After all, as has been pointed out on various comments threads:

    The Koran is itself a hate crime against Jews and Christians.

    Amen!

    More coverage from Digg, Hot Air, Jawa Report, Texas Hold ‘Em, UrbanGrounds, Deep Thoughts, Pierre Legrand’s Pink Flamingo Bar, Riehl World View, JustOneMinute, Saber Point, Israel Matsav (twice), Relapsed Catholic, Dog Opus, 186K Per Second, Never Ye Melted, Hindu-Jewish-Christian Rightwing Conspiracy.

  • Follow-Up to Matt Franck Anti-Cloning Measure Article

    About a week ago, I wrote about this Post-Dispatch article, written by Matt Franck. I discussed the perceived bias in the article with respect to Amendment 2 and the efforts of supporters of the HJR11 anti-cloning measure the article discussed.

    As I try to do whenever I discuss someone’s writing, I emailed the author to let him know of my blog post, and to allow (and to solicit) a response. To my pleasant surprise, Mr. Franck responded to my email. In the interest of fairness, based upon his response, I would like to re-visit the question of bias in his reporting of the Amendment 2 issue.

    Mr. Franck responds:

    My ability to respond to your email in detail is limited by time. But let me reply in brief. The stated aim of lawmakers who support HJR11 and its Senate counterparts is to essentially negate Amendment 2. Yes, I understand that the proposal doesn’t mention the amendment. But the fact remains, it would make SCNT illegal — something specifically protected under Amendment 2, and a procedure at the heart of the push to pass the ballot measure.

    Here, I agree with Mr. Franck that part of the underlying intent of HJR11 was to overturn parts of Amendment 2; however, the further intent of HJR11 was to expose the intentional deception and hypocrisy of Amendment 2 and that of its supporters and their $30 million propaganda campaign.

    The Coalition for Lifesaving Cures states “Fact #3” on their “Fact Sheet” that “Amendment 2 clearly and strictly bans any attempt to clone a human being.”:

    Amendment 2 bans human cloning and makes any attempt to clone a human being a felony crime. Opponents of stem cell research claim that making stem cells in a lab dish is the same thing as “human cloning.” Medical experts and most other people disagree with that view and understand that “human cloning” means creating a duplicate human being – not making stem cells in a lab dish.

    The truth of the matter – as exposed by Amendment 2 supporters’ objections to HJR11 – is that, currently, (embryonic) stem cells cannot be made “in a lab dish”; they must be harvested from an embryo. To date, stem cells must be harvested from embryos resulting from natural or in vitro conception. The comment about “making stem cells in a lab dish” is in reference to embryos produced via Somatic Cell Nuclear Transfer (SCNT) – or, in other words: cloning.

    The issue centers around the correct identification of the entity produced by SCNT. Biologically and genetically, that entity is an embryo, genetically identical to the donor of the somatic cell from whom the clone was produced. In fact, for the purposes of harvesting stem cells from the entity resulting from SCNT, that entity must prove to be a viable embryo that undergoes self-directed development from the initial single-celled zygote into a 5-7 day-old embryo at the blastocyst stage.

    The Coalition continues to divert this issue by intentionally mis-identifying this entity as a “clump of cells”, a “ball of cells”, or other similar terms. Doing so provides a means to avoid the reality that SCNT produces a cloned embryo. Thus, they are able to ignore the biological and genetic reality, and claim some arbitrary “birth of a cloned human” as the “cloning” that is “strictly” banned.

    The media coverage – for whatever reason – has tended to favor the Coalition’s position with respect to terminology. It is the reason that many of us make a concerted effort to find and correct this misinformation wherever it is propagated in the news media. Thus, in response to Mr. Franck’s article, I wrote in my email to him:

    Second, you state:

    “Opponents of Amendment 2 had wanted lawmakers to send a ballot measure
    to voters in November 2008. The proposed amendment would have asked the
    public to ban all forms of human cloning, including when the research is
    used solely to produce embryonic stem cells. Voters specifically
    protected that form of research by passing Amendment 2 last year.”

    This statement is inaccurate. The result of of human cloning is NEVER
    “solely…embryonic stem cells”. This research – somatic cell nuclear
    transfer – ALWAYS results in the production of a living embryo of the
    same species as that of the gamete and somatic cell from which the
    embryo was produced. Should SCNT of a human egg and somatic cell nucleus
    ever succeed, the result will be a human embryo. Any stem cells
    resulting from this process will and must come from the destruction of
    that embryo. They cannot be produced apart from the embryo using SCNT.

    On that point, Mr. Franck responds in his email:

    On your second point — yes, I know and agree that SCNT produces an embryo [which] is then harvested for stem cells. I think you misread my use of the word solely. I did not mean to imply that all that is produced are stem cells.

    I appreciate Mr. Franck clarifying this point in his response. He goes on to address the question of his personal bias in regard to the Amendment 2 issue:

    There are limits to the territory that I can cover in a 350-word story. In lengthier stories — of which I have written several — I deal with these issues more thoroughly. Even so, I stand by my story.

    …For three years, I have strived to cover this issue with detachment and fairness. And I believe that if you ask around, I have a good track record in this regard.

    While I certainly infer a bias in the end result of the article in question, I want to be fair in asserting the source of that bias. To that end, I did my best to research Mr. Franck’s past articles. He was kind enough to send me the copy of a rather lengthy piece he wrote, and of which I found a copy at the Center for Genetics and Society website. I also found recent Post-Dispatch articles here and here, as well as a copy of an article reposted here.

    After reading this broader sample of Mr. Franck’s writing on the Amendment 2 issue, I believe that he is correct in his assertion that he has made every effort to deal with the issue with detachment and fairness. While I disagree with repeated use of incorrect and/or potentially misleading terminology (such as referring to an embryo as a “ball of cells” or “clump of cells” or “cluster of cells”), an overall reading of his articles lends me to believe that he has attempted to present each side of the issue fairly.

    I believe any overt bias inferred from these articles – and in particular, the article I originally critiqued – results from the limited scope of a shorter article and, more importantly, the editorial bias of the Post-Dispatch.

    Finally, I would like to thank Mr. Franck for taking the time to respond to my email. Not many reporters would take the time to do so – especially to respond to someone being critical of that reporter’s work.

  • Post-Dispatch Misleads on Anti-Cloning Measure

    The St. Louis Post-Dispatch today reported that MO House Bill HJR11 was killed in committee yesterday. Unfortunately, the P-D could not see past its own bias in order to report accurately on the measure. Ironically, in order to spin the truth, the article exposes the hypocrisy and deception of Amendment 2.

    To begin with, take the opening paragraphs of the article:

    A House committee killed legislation Monday designed to largely invalidate a new constitutional amendment protecting stem cell research.

    The 3-4 vote by the House Rules Committee all but ends efforts this legislative session to overturn Amendment 2, which 51 percent of voters approved in November.

    Based on this reporting, one would infer that the measure refers either to Amendment 2 in particular or stem cell research in general. To the contrary, the wording of HJR11 references neither stem cells nor Amendment 2. In fact, the words “stem cell” – or any derivation thereof – do not appear anywhere within the text of the measure:

    Be it resolved by the House of Representatives, the Senate concurring therein:

    That at the next general election to be held in the state of Missouri, on Tuesday next following the first Monday in November, 2008, or at a special election to be called by the governor for that purpose, there is hereby submitted to the qualified voters of this state, for adoption or rejection, the following amendment to article III of the Constitution of the state of Missouri:

    Section A. Article III, Constitution of Missouri, is amended by adding thereto one new section, to be known as section 38(e), to read as follows:

    Section 38(e). 1. The general assembly may enact laws concerning health care research, including controlling taxation, appropriations, and use of public resources for health care research, and regulating research that could pose a risk to human life or health.

    2. It is unlawful to engage in human cloning. For the purposes of this section and section 38(d) of this article, “human cloning” means the creation of a human zygote, human blastocyst, or human embryo by any means other than the fertilization of a human egg by a human sperm.

    3. The provisions of this section supersede any provision of section 38(d) of this article that is inconsistent with this section.

    As you can see, the measure makes no mention of either Amendment 2 or stem cells. How on earth, then, could the author make such a claim? Examine the next paragraph for the answer:

    Opponents of Amendment 2 had wanted lawmakers to send a ballot measure to voters in November 2008. The proposed amendment would have asked the public to ban all forms of human cloning, including when the research is used solely to produce embryonic stem cells. Voters specifically protected that form of research by passing Amendment 2 last year.

    The deception seems to get ever more subtle. To wit [emphasis added]:

    The proposed amendment would have asked the public to ban all forms of human cloning, including when the research is used solely to produce embryonic stem cells.

    Did you catch it? The problem with this statement is that “the research” – that is, human cloning – is never used “solely to produce embryonic stem cells”, since the result of human cloning is – always and by definition – a human embryo, not just embryonic stem cells.

    The problem with this rationalization is the same problem that the proponents of Amendment 2 had during their 30 million dollar campaign of deception: the claim that Amendment 2 would “strictly ban human cloning“. In fact, as both an educated reading of the wording of the amendment as well as the double-speak found in this P-D article reveal, Amendment 2 not only did no such thing, it actually made human cloning constitutionally protected in the state of Missouri.

    This duplicity is further revealed by the actions of the house committee that killed the measure [emphasis added]:

    “I’d say that a third (of House members) will be happy they don’t have to vote on this,” said Shannon Cooper, R-Clinton.

    Cooper, who serves as chairman of the House Rules Committee, said he voted against the measure simply because he supports Amendment 2.

    If Amendment 2 “strictly bans human cloning” – as its supporters claims it to do – why would an Amendment 2 supporter vote against a measure that would allow Missouri voters explicitly to ban all forms of human cloning? Any proponent of Amendment 2 could only oppose such a measure if in fact human cloning were a part of Amendment 2. That supporters of Amendment 2 oppose this measure demonstrates that their claim that Amendment 2 “strictly bans human cloning” was an outright lie.

    Cooper – and those like him – should be ashamed of himself, and is a disgrace to the Missouri Republican party. Duplicity, hypocrisy, lying, and subverting the democratic process have no place in the Republican Party. For one, if his beloved Amendment 2 “strictly bans human cloning” then what does he have to oppose in HJR11? For another, even if he legitimately opposes HJR11, how dare he deny the voters of Missouri the opportunity to exercise our democratic right?

    The truth, which should now be plainly evident to all, is that Amendment 2 constitutionally protected human cloning for the purpose of human-embryo-destructive research, and that the proponents of Amendment 2 knew this truth and intentionally mislead Missouri voters into believing that passing Amendment 2 would “strictly ban human cloning”.

  • My First Hate Mail!

    This evening my humble blog reached an important milestone: a received my very first hate mail.

    Using the pseudonym “Elroy Spankster”, someone undoubtedly from the Party of Tolerance sent the following [expletives edited]:

    For the love of God give it a rest. If he/she wanted you two to be married it would have already happened. Claire McCaskill rocks and your hero Georgy W. sucks Hillary [male reproductive appendage]. …now [perform fellatio on] that you disgraceful republican [male homosexual].

    (I guess I struck a nerve of some sort with ol’ Elroy…)

    Apparently, “Elroy Spankster” wanted this missive to remain anonymous, as the email address given was an obvious fake; however, a simple google search reveals his true email address to be [email protected] (and, for the curious, he is a technician from St. Louis, and his Yahoo ID is spankinelroy).

    I particularly like the “girls rule, boys drool” argumentation method in the Claire McCaskill/George W. Bush reference. And while I’m sure that, to those of his liberal persuasion, “republican” and “disgraceful” are redundant, Elroy should know that using a slang term for a homosexual male in a disparaging manner (in this case, associated with either “disgraceful” or “republican” – my apologies, Log Cabin Republicans) is considered “intolerant”, and unacceptable.

    Overall, as far as hate mail goes, this one is not a particularly good example. It is neither intelligent nor creative, although it does include the obligatory ad hominem and hypocrisy. Maybe it’s the best “Elroy” has to offer, but I consider it a sub-par performance. Better luck next time!

  • The Butcher is Dead

    Saddam Hussein has been executed by hanging. Coverage from Fox News, Michelle Malkin, Pajamas Media, and probably most of the blogosphere.

  • Institutionalized Islam is Neither a Religion Nor Peaceful

    Salim Mansur, a Muslim, writes this article in response to a call for apology from Muslims, by fellow Toronto Sun writer Michael Coren.

    From the earliest years of post-Prophetic Islam, Muslims holding the power of the sword and what constitutes the authoritative meaning of the Koran and the prophet’s traditions, have rigged the boundaries of institutionalized Islam. The wielders of the sword and interpreters of faith have worked in tandem to impose their consensus on all Muslims, and those who have questioned their authority have paid a steep price.

    Yet we must still tolerate the ad nauseum recitations that Islam is a “Religon of Peace” – even amid all of the threats and acts of violence against so much as mere words that the supposedly “peaceful” practicioners of Islam find offensive?

    This institutionalized reality of Islam and its resulting complexity are not well understood by non-Muslims. Institutionalized Islam is represented by Muslim majority states and their political and religious leaders who share a consensus on matters of politics and faith.

    What is to be understood or misunderstood? The reasons why fascists are fascist, and their means of enforcing their fascism, are entirely irrelevant. Only the will and means to defeat them bears any importance. We do not care to understand Muslim fascists; we only care to defeat those who would murder innocents and attempt to impose their will by force on otherwise free society.

    Below institutionalized Islam’s scrutiny exists a vast unaccounted number of Muslims who seek anonymity to escape the coercive notice of authorities in mosques and in presidential or monarchical palaces. Their voices, were they heard, would be rudely dismissed as heretical.

    And it is the embodiment of those voices that must rise up, unite, and overthrow the fascists from within, before your religion will ever have any chance of respect from and peaceful co-existence with the free world.

    From its beginnings, institutionalized Islam’s representatives hollowed out the spiritual content of Islam in the service of political expediency. The inevitable followed — politics dressed in the robes of religion.

    In other words, Islam is nothing more than fascist socio-political ideology disguised as religion. Given that the modus operandi of Islam has not changed since the days of Mohammad, we have no reason to believe that Islam has ever been otherwise.

    The faces of institutionalized Islam — political leaders such as Egypt’s Hosni Mubarak or religious leaders such as Lebanon’s Hasan Nasrallah — are revealing of what politics have done to faith.

    Islam has never been a religion of faith. Righteousness by works is, by definition, in opposition to righteousness by faith. This truth sets Christianity apart as unique from all other religion, in that it is only by the interceding work of God Himself, to take on the sin of the world, in order to redeem mankind to Himself, that man is saved from sin and reconciled into right relationship with God. Nothing man does can save himself, apart from faith in the redemptive work of his Savior God. No component of Islam in any way resembles this doctrine.

    The doctrine of faith is tied immutably with grace, and its adherents are compelled by nothing other than love to spread this doctrine to others. Islam is a doctrine of works, and its adherents are compelled by their desire to accomplish their own righteousness through the conversion of as many as possible. This desire leads naturally to the use of force and jihad as a means to add to one’s “good works”.

    Politics have not perverted Islam; fascist political ideology is the natural progression of the religious ideology itself.

    Within the Arab Sunni world the Egyptian-born Sheikh Qaradawi, 80, of Qatar, is the face of institutionalized Islam. He is the closest to what might pass for a titular head of Muslims akin to the Pope. Qaradawi’s words, now broadcast by television network al-Jazeerah, are taken as authoritative pronouncements of Islam. He is the “spiritual” leader of the Muslim Brotherhood, a movement formed to repudiate freedom and democracy, and a defender of Islam’s war against the West by any means, including suicide bombings.

    If “authoritative pronouncements of Islam” include the repudiation of freedom and democracy, war against opposing culture, and suicide bombings, then Islam has no claim whatsoever as a “religion of peace”.

    For such representatives of institutionalized Islam, all things are political. They are the authoritative guardians of the ideology that in Islam religion and politics are inseparable, and jihad — holy war — is its defining aspect.

    War is the “defining aspect” of the self-proclaimed “religion of peace”?

    Hence, since this institutionalized Islam is at war with the West, for Coren or anyone else to expect an apology from its generals is rather naive.

    Thank you, Salim, for proving the point: Islam is at war with western civilization, and as such it is not a “religion of peace” but rather a fascist political movement under the guise of religion. Islam, as you indicate, does not have “titular religious heads”, but rather, “field generals” bent on the destruction of freedom and democracy – again, by your own admission. Certainly, those bent on our destruction are not wont to apologize for attempting to carry out that end. Therefore, we are fully within reasonable right to hunt down and destroy every arm of this fascist movement.

    Via Lucianne.

  • Gas Prices Drop Below $2.00

    Democrats’ worst post-Labor-Day nightmare, Part I:

    Gas Prices 002

    Gas Prices in the St. Louis area fall below $2.00. Here is the gas station nearest my house.
    Photo © Chip Bennett, all rights reserved.

    Great timing, Claire [emphasis added]:

    “Considering that Jim Talent thinks giving tax breaks to oil companies raking in record profits is the best way to lower gas prices, it’s difficult to see how keeping him in the Senate will result in cheaper prices at the pump,” DSCC spokesman Phil Singer said. “Claire McCaskill thinks it makes more sense to eliminate those tax breaks so that we can invest in alternative energy sources like ethanol. That’s the kind of change that’s needed to deal with the record gas prices.”

  • Plame-Gate: Flame-Out

    I told you so.

    Christopher Hitchens lays it out.

    Plame-Gate, Part I: The Joe Wilson Niger Affair:

    I have now presented thousands of words of evidence and argument to the effect that, yes, the Saddam Hussein regime did send an important Iraqi nuclear diplomat to Niger in early 1999. And I have not so far received any rebuttal from any source on this crucial point of contention.

    Plame-Gate, Part II: The “Outing” of Valerie Plame:

    But there was always another layer to the Joseph Wilson fantasy. Easy enough as it was to prove that he had completely missed the West African evidence that was staring him in the face, there remained the charge that his nonreport on a real threat had led to a government-sponsored vendetta against him and his wife, Valerie Plame.

    In his July 12 column in the Washington Post, Robert Novak had already partly exposed this paranoid myth by stating plainly that nobody had leaked anything, or outed anyone, to him. On the contrary, it was he who approached sources within the administration and the CIA and not the other way around. But now we have the final word on who did disclose the name and occupation of Valerie Plame, and it turns out to be someone whose opposition to the Bush policy in Iraq has—like Robert Novak’s—long been a byword in Washington. It is particularly satisfying that this admission comes from two of the journalists—Michael Isikoff and David Corn—who did the most to get the story wrong in the first place and the most to keep it going long beyond the span of its natural life.

    And the conclusion:

    The answer to that question (of whether the Intelligence Identities Protection Act had been broken), as Patrick Fitzgerald has since determined, is “no.” But there were plenty of senior people who had known that all along. And can one imagine anybody with a stronger motive to change the subject from CIA incompetence and to present a widely discredited agency as, instead, a victim, than Tenet himself? The man who kept the knowledge of the Minnesota flight schools to himself and who was facing every kind of investigation and obloquy finally saw a chance to change the subject. If there is any “irony” in the absurd and expensive and pointless brouhaha that followed, it is that he was abetted in this by so many who consider themselves “radical.”

    Checkmate.

    (Hat tip: Lucianne)

  • More Re-Definition of Terminology

    First, they tried to re-define “embryonic” as “early”. Next, they tried to re-define “cloning” as “implantation”. Now, they’re trying to re-define “cure”.

    Adult stem cells have thus far produced at least 72 human treatments. It appears that one of the latest tactics of the pro-Amendment 2 Coalition is to refute that fact (emphasis added):

    Winship says there have been no proven cures found with embryonic stem cell research and said adult stem cells are a proven – and ethical – alternative.

    “The reality is, it’s still zero” cures “for embryonic stem cells,” she said.

    Farrow said embryonic stem cell opponents would do anything to derail the initiative, including overstating the potency of adult stem cells.

    “You’ll hear our opponents say that there are between 65 to 100 adult stem cell cures. That’s simply not true,” Farrow said.

    “The truth is there are only nine adult stem cell cures, and we believe that research needs to go forward,” she said. “But adult stem cells have been researched for over 50 years. The first earlier embryonic stem cell research didn’t start until 1998. We haven’t even had a full decade of research with embryonic stem cells.”

    What on earth could possibly explain such disparity? Apparently, the Coalition, in an attempt to level the playing field in their favor, have begun applying a “FDA-approved” qualification (emphasis added):

    Dr. William Neaves is with the Stowers Institute Medical Research. “This is a contest between society and disease, not between adult stem cells and early stem cells,” says Neaves.

    Researchers say embryonic stem cells hold infinitely more potential than adult stem cells for curing disease. They say the claim about dozens of treatments already developed from adult stem cells is not true. “At best, only nine of those diseases have, after 50 years of research with adult stems cells, FDA-approved therapies that are available to patients,” says Neaves.

    The Coalition is obviously hedging on the belief that the general public have no real understanding of what FDA approval is, what it means, or how it happens. I will try to give a brief overview.

    FDA is divided into various “centers”. I work for a pharmaceutical company that manufactures, packages, and sells drugs. We are under the direction of FDA’s CDER: the Center for Drug Evaluation and Research. Medical devices – pacemakers or defibrilators, for example – are under the direction of CDRH: the Center for Devices and Radiological Health. Stem cell treatments are under yet another center – CBER: the Center for Biologics Evaluation and Research.

    In order for a drug, device, vaccine, or other treatment (hereafter, treatment) to get FDA approval, a rigorous and intensive process is required. The sponsor (company requesting approval) must complete a submission application including all the data supporting the approval request. For a new treatment, the submission would include data from three phases (Phase I, Phase II, Phase III) of clinical studies. These clinicals are the heart of the company’s justification for requesting approval. Phase I clinicals are very small (less than 100 participants) studies, generally using healthy humans, to determine physiological interaction of a treatment with humans. Phase II clinicals follow successful of Phase I, and are controlled, small-scale (a few hundred participants) studies using people who have the condition for which the treatment is indicated, used to determine preliminary data with respect to the effectiveness of the treatment, and any side effects associated with the treatment. Phase III clinicals follow successful completion of Phase II, and are controlled (or uncontrolled), large-scale (a few hundred to thousands of participants) studies used to determine the effectiveness of the treatment for the general population, and to ascertain the overall risk-benefit relationship of the treatment.

    Based on these data, in addition to other aspects of the submission (stability data for a drug, for example), FDA will approve or reject the application. Once FDA has approved an application, the sponsor can legally market and sell the treatment in the US.

    As with many other treatments, due to the nature of the conditions for which stem cell treatments are intended, such treatments are not always well-suited for typical clinical trials. FDA is aware of and working to reconcile the difficulty of translating stem-cell treatments into clinical trials.

    Note, however, that other mechanisms exist, prior to or in lieu of FDA final approval, for treatments to be used (legally and effectively). Two such mechanisms are the Treatment Investigational New Drug (Treatment IND) approval, in which “FDA will permit an investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population”, and the parallel track policy, in which “patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising.”

    Some treatments – such as prenatal drugs – may never proceed through all clinical phases and final approval, but may be given to patients as investigational treatments for non-approved indications as long as the patient gives informed consent (which is also required for participation in clinical studies). Such is the case for Treatment INDs discussed above.

    The bottom line is this: all treatments administered in the US must have FDA approval, whether in the form of a final New Drug Approval (NDA), or as an Investiational New Drug approval (IND). So, of the more than 72 treatments currently in use, every single one in use in the US has FDA approval of one form or another.

    That said, much stem cell research and advancement takes place outside the borders of the US and outside the control of FDA. Any treatments derived from such research would not be subject to FDA approval; therefore, any implication regarding such approval is

    This argument is not unique to the Missouri Amendment battle. In this 07/06 letter to Science, Do No Harm refutes the argument for the straw man that it is, and also points out that some 1170 clinical trials involving stem cells currently exist, including some 565 trials currently active and seeking participants – while not one single clinical trial is underway for embryonic stem cell treatments. Moreover, the letter points out that there are currently no peer-reviewed references to embryonic stem cell-derived human treatments. The above-referenced list of 72 human treatments derived from adult stem cells, which Do No Harm maintains, includes only those treatments for which peer-reviewed scientific publication of their effectiveness exists.

    Yet again, the Coalition can only offer mistruths and deception.