Saturday, January 24, 2009

UPDATE: Those Wonderful Stem Cells Will Save Us

Gee guys I was only trying to be a smart ass this week, but just days after the MIC came on board, we see the first FDA approval of a phase-I clinical trial using actual human embryonic stem cells. Interesting timing by the Agency (only days after the MIC was sworn in; same week as the annual Right-to-Life march on DC, etc.). Simple coincidence? I think not. Five years from now, especially if they are proven to be safe and effective, I can guarantee you the MIC and other libtards will be claiming this as their own invention . Interesting how this new therapeutic was developed during the dreaded dark-age of the Bush years. So Ms Blumner, is this your idea of American science being in "suspended animation" and the Bush administration's "lack of interest in pushing America toward innovation"? Sounds like good old American ingenuity and free-market Pharma R&D to me. This is how American science works best; basic stem cell and development technology arising from Academia (Wisconsin and California in this case), and the IP being licensed by industry who then do the heavy lifting and run with it to market.

The company involved is Geron Corporation and the first indication is traumatic spinal cord injury. You can read the full press release here. GRNOPC1 is the therapeutic candidate and this cell product is a partially differentiated oligodendrocyte progenitor line arising from the human embryonic master cell stock H1 that was derived previous to August 9, 2001 and thus not subject to the Bush ban (although the company is quick to point out that no Federal funding was used in its derivation). These cells have "demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury". Thus they will be tested in trauma victims by direct injection at the cord lesion site 7-14 days post injury. The primary end-point will be safety with a secondary endpoint of restored neurological function. So technically this is a phase-I/II clinical trial.

My big question from January 19 was whether anyone could show me the specs for a cGMP batch of stem cells. Apparently Geron could do that if we could get a peek at their 21,000 page IND application. Here is their abbreviated CMC description from the press release:

"GRNOPC1 is produced using current Good Manufacturing Practices (cGMP) in Geron's manufacturing facilities. Geron's GRNOPC1 production process and clean-room suites have been inspected and licensed by the state of California. The cells are derived from the H1 human embryonic stem cell line, which was created before August 9, 2001. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial. Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin. Production of GRNOPC1 from undifferentiated hESCs in the master cell bank uses qualified reagents and a standardized protocol developed at Geron over the past three years. Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. GRNOPC1 product that has passed all such specifications and has been released is available for the approved clinical trial. The current production scale can supply product needs through pivotal clinical trials. The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years. "

Pretty damn impressive. Now the big question will be safety and efficacy. Apparently this product is effective in animal models of spinal cord injury. How that will equate to human outcomes is the subject of the trial. Safety will be the primary issue. Stem cells are rapidly growing progenitor cells and thus possess a certain degree of cancer risk since they could potentially differentiate to a rogue cell type and form a tumor. That is how they were discovered in the first place as a cell type in teratomas. All indications in animals is that GRNOPC1 is low risk for this potential. But just as we have seen with conventional small-molecule therapeutics, issues of toxicity (or in this case tumor potential) may not become apparent until well after thousands of patients have been treated and followed up (classic post-market surveillance).

The other issue is rejection. These cells are allogeneic meaning that they came from a donor unrelated genetically to the recipient. As the press release points out, GRNOPC1 cells are not overly reactive immunologically but the clinical protocol does specify using "a limited course of low-dose immunosuppression". So they are not completely silent as far as the immune system is concerned. Whether long-term immunosupression will be required is unknown. Also, I have to wonder, what if there are long term immunological issues with these patients, will we see MS-type effects as demyelination progresses? Only time will tell.

And of course the big moral issue with this therapy surrounds the human embryo that was sacrificed for derivation of the original H1 cell line. Who was that? Who could they have been? Were they male or female (Geron knows this from the karyotype). The libtards will counter that it was just a small mass of cells (most likely a blastocyst phase embryo). The pro-lifers will tell you that it was human and sacred. Such things are best discussed with your God. I hear He is patient, but for those involved, I would have your speech rehearsed well in advance just in case.

Tuesday, January 20, 2009

Hail to the Mulatto-In-Chief

I normally would not stoop to the level of a street urchin and ACTUALLY call our new president a "mulatto-in-chief" but what the hell. Biologically it is a correct definition and in the spirit of hyphenated Americanism (assuming african-American and mulatto-American are synonymous?) and in the spirit of the street antics of the great unwashed demonstrated today as our exiting President reached the inaugural stage, it seems fitting that "mulatto-in-chief" (MIC) be forever synonymous with "Obamessiah" in all future postings of Social Detritus. But then that's what we are all about here; social "detritus".

The Rott hits it right on the head today and I can't help but reprint this tidbit. Go there and read the whole thing:

......"We survived wars because the enemy was not of us, but from foreign roots. This time, the scenario is deceitful, as the enemy is our own countrymen that have decided that life can be easier if we chose to delegate and rescind our individual responsibilities, suborning them to a faceless collectivism of socialist government. “Hope and Change” is not the battle cry of a nation, but the whimper of a society, that has grown decadent, lazy and complacent and only wishes “Bread and Circuses” and satellite TV. In a few hours from now, we will have our “Bread and Circuses”, to our own demise as free individuals. America, you have chosen to follow the path of the Roman Empire, totally ignorant of the circumstances of it’s demise. Our only hope is to stand together against the tyranny of the ignorant masses, and carry on what we ALL know is the vision of the founders, who selflessly gave their lives, their fortunes and their sacred honor to ensure those unalienable rights, G-d given, would not and could not be taken away from America."........


Our Nation Is Ready To Be Smart Again ????

Will someone PLEASE just shoot me now and get it over with ? I really can't stand another Bush Derangement Syndrome (BDS) article from some libtard moonbat. Today's installment comes to us from one Robyn (cute spelling) Blumner over at the St. Petersburg (no not that one; Florida) Times. It appeared in my local rag this morning under a completely different title which to me seems a bit odd by itself but then again this is the MSM. Let's see; you are a hard-working columnist and you go to all of the trouble to write an article. It then goes out on the wire and any rag in the nation can pick it up and add whatever title is useful (in this case to once again bash the President) for their local purposes. Sort of like writing a book with a blank cover and letting your local Borders add the title. It appears that her original title is: "Our nation is ready to be smart again". Such eloquence !

Basically it looks like "Ms ?" Blumner is a bit taken aback by Bush's recent farewell interviews. Seems to her that he is trying to boastfully re-write history a bit to make his administration look better than it really was. I for one will leave that to history to decide although I must agree that he could have done a lot more talking and explaining during his time in office. However, anyone with only a passing interest would realize (assuming they took the time to listen to his other interviews and speeches) that government by focus group (read Clintonian) just wasn't his style. We saw this in the elder Bush too but his communications staff was a bit more on the ball overall.

Once Blumner gets over her BDS rant (taking nearly half the article by the way), she gets to her point that Bush's policies have put us into a state of "suspended animation" and "lack of interest in pushing America toward innovation". Wow, if that is the case, then I wonder how things could be so bad that we can afford to spend $170 Million on the Obamessiah's inauguration ? This is classic socialist world-view. Does the word "capitalism" and "free-market economy" mean anything to you Ms Blumner? Just taking the Pharma industry for example, I haven't seen any signs of lack of innovation.

The real whopper of a laugh comes almost at the end of the article when she quotes that great congressional intellect Nancy Pelosi:

"So when House Speaker Nancy Pelosi tells NPR that the coming economic stimulus plan can be described in four words — "science, science, science and science" — she is expressing a great pent-up demand for America to start being smart again and energetic and start fixing problems rather than creating them, with government as a partner. "

Yes, right Ms Blumner, lets look to Capitol Hill for answers. The same nitwits that legislated us into the sub-prime mortgage mess in the first place. At least President Bush can take comfort knowing that there are still enough citizens out there with the good sense to give Congress the approval rating they deserve which consistently have been lower than his own.

And if we as a Nation are so smart, one has to wonder just how we would go and elect one of the most inexperienced presidents to office in one of the most turbulent and dangerous times in our history. Is it really that hard getting over the 2000 election?

Monday, January 19, 2009

Those Wonderful Stem Cells Will Save Us

Well folks it is now one Earth day and counting here in the land of the STUPID before the O-man is sworn in as president. Look for major medical advances and new cures to be announced tomorrow (1/20/2009) as the Bush Stem Cell ban will most likely be overturned and recipients of Federal grants and contracts will be free to once again work with human embryos purely for the purpose of deriving embryonic stem cell lines. If you have followed the MSM over the last eight years you would be led to believe that the evil Bush-Cheney machine has been keeping all of that technology suppressed for Halliburton or something.

Never mind the fact that private industry was never under any restrictions assuming they were not using Federal funds, and if an academic researcher suddenly had some major discovery or technical advance to report in the field they could easily be contracted by industry to carry on with private money or better yet join the ranks of Pharma R&D workers where the rewards are great but the job security isn't. As we all know, Academia has such a wonderful track record of bringing new therapies to market.

So........with the Pharma regulatory environment getting more difficult all the time can anyone show me the specs or guidances for a cGMP batch of human embryonic stem cells?

The Bush Vaccine Initiatives

Geez.... and I thought the Bush Administration was so anti-science, anti-research; have a look at this article describing the upcoming deflation of the vaccine sector:

"Coordinated by the Office of Biomedical Advanced Research & Development Authority (BARDA) within the Department of Health & Human Services, this influx of money during the Bush years has re-energized the flu vaccine business and brought in large new players where there previously there had been a slow exodus of firms. Three major companies and one significant independent vaccine business have taken advantage of the flu funding to join the US market: GlaxoSmithKline (through imports and the purchase of ID Biomedical in Canada), Novartis (through Chiron), AstraZeneca (through Medimmune) and CSL (joining the US market from Australia). Are the manufacturing and commercial development subsidies that the vaccine companies learned to count on from the Bush Administration likely to continue? Probably not; but they may be replaced by a different, and more timely, form of incentive – enhanced government-stimulated markets for vaccine products." Cole Werble, RPM First Take, January 19, 2009.

So instead of continuing R&D and infrastructure development to make vaccines more financially palatable to the Pharma industry, the Obamanoid will expand accessibility to the target populations for conventional vaccines. Interesting, but wasn't that the exact market that led to the mass Pharma exits pre-9/11?

The Gupta Nomination

Last week's Friday Digest of the Patriot Post has an interesting analysis of the Gupta nomination for Surgeon General among other things:

"Predictably, one cabinet appointment that makes sense is coming under fire. Dr. Sanjay Gupta is a well respected and world-renowned neurosurgeon whose commentaries on health and well-being are broadcast far and wide in print and in the media. Yet his nomination is meeting resistance because liberals claim that Dr. Gupta has said some pretty nasty things (read: accurate things) about the concept of universal health care. Rep. John Conyers (D-MI), head of the House Judiciary Committee, wants to quash Gupta's nomination because he says Gupta "lacks the requisite experience needed to oversee the federal agency that provides crucial health care assistance to some of the poorest and most underserved communities in America." That's Conyers' story and he's sticking to it."

Not unexpected since Dr. Gupta is one of the few not pulled from the Clinton cess-pool.

Sunday, January 11, 2009

Coulter on Obamamania

I've been amused by the free-ride the drive-by-media gave to the Obamessiah. But who could be surprised by any of this nitwittery. Just look at how Scientific American tried to put Al Gore in the same league as Niels Bohr, Francis Crick, and Stephen Hawkin back in 1998.

Here is an excerpt from Ann Coulter on the media free-pass of the Anointed One:

"When the Obama family materialized, the media was seized by a mass psychosis that hadn't been witnessed since Beatlemania. OK! magazine raved that the Obamas "are such an all-American family that they almost make the Brady Bunch look dysfunctional." Yes, who can forget the madcap episode when the Bradys' wacky preacher tells them the government created AIDS to kill blacks! Still gushing, OK! magazine's crack journalists reported: "Mom goes to bake sales, dad balances the checkbook, and the girls love Harry Potter" -- and then the whole family goes to a racist huckster who shouts, "God damn America!" Months before network anchors were interrogating vice presidential candidate Sarah Palin on the intricacies of foreign policy, here is how NBC's Brian Williams mercilessly grilled presidential candidate Barack Obama: "What was it like for you last night, the part we couldn't see, the flight to St. Paul with your wife, knowing what was awaiting?" Twisting the knife he had just plunged into Obama, Williams followed up with what has come to be known as a "gotcha" question: "And you had to be thinking of your mother and your father." Sarah Palin was memorizing the last six kings of Swaziland for her media interviews, but Obama only needed to say something nice about his parents to be considered presidential material. " Ann; 1/7/2009.

It would be completely hilarious if only it were not so serious. Never mind the fact that I'll probably be working until I am 85. My real concern now is for my children and the twisted society they will inherit.