Recently I was informed that the average time for US Government approval for use of a new medical procedure/product is 14 years.

As a career engineering development person, my first thought was how can any medical procedure/product remain cutting edge when new technology is constantly appearing while these candidate methods are winding their way through the maze of government approval gateways?
Now I see that the clinical hold on the GRNOPC1 will not be lifted until the “third quarter of 2010″ … almost a year away.

Why is that, if, as you say:
“These cysts are non-proliferative, confined to the injury site, smaller than the injury cavity, and were not associated with adverse effects on the animals.”

My concern is for the nerve-damaged people now hoping for a possible successful intervention that may return them to normal, or nearer normal function.
Clearly, any procedure/product must be shown to be a net benefit to the population of sufferers, and that involves complex judgements by those charged with approving them.
But “14 years” sounds like a vastly over done level of caution, and one that inevitably results in continued suffering by some who would, given a choice, accept some increased level of risk if it can shorten their recovery time.

Primum Non Nocere—Above All, Do No Harm, indeed, but there are at least two ways harm can result:

1. By hurried implementation/use of methods and remedies that turn out to cause unacceptable outcomes for the patient.
2. Continued suffering and possibly death of patients who could have been spared by a reasonable sense of urgency on the part of the approving authorities.

It has been my experience in long years of dealing with Federal Bureaucracies on new developments that they are driven by great reluctance to approve anything.
Approval always involves risk to the civil servant, because there is the chance of a negative result that will reflect badly on the approving authority.
Disapproval and delay (and there are always available excuses for delay) involve little or no risk for the civil servant.
Of course, any attempt to plead for faster resolution usually results in the opposite outcome, and an even more cautious and hesitant response by the civil servants involved.
Thalidomide still hovers in the background, and in the mind of many people.

It boils down to human judgement, but I submit that “14 years” must surely be “erring on the side of caution” to a degree that has and is causing significant suffering and death that could be avoided by a cautious but more reasonable balance of risks.

Very Sincerely,
William E. Haynes

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GERON AND FDA REACH AGREEMENT ON CLINICAL HOLD

Company and Regulatory Agency Define Path to Re-Initiate Human Trials for Spinal Cord Injury

MENLO PARK, Calif., October 30, 2009 – Geron Corporation (Nasdaq: GERN) today announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based product, GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with complete thoracic spinal cord injury and to support future expansion of the trial to patients with cervical injuries.

Geron has been performing a series of preclinical studies to expand the clinical program for spinal cord injury beyond patients with complete thoracic injuries. The company’s goal is to test the safety and utility of GRNOPC1 in patients with complete and incomplete (less severe) injuries in both thoracic and cervical regions.

As announced previously, in one preclinical study, a higher frequency of animals developed cysts in the injury site than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1. These cysts are non-proliferative, confined to the injury site, smaller than the injury cavity, and were not associated with adverse effects on the animals. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, the company developed new candidate markers and assays. Data from studies using the new markers, were submitted to the FDA. The IND for spinal cord injury was placed on clinical hold pending FDA review of the data.

Geron will complete a confirmatory preclinical study using GRNOPC1 that has been characterized by the new markers and assays, as agreed upon in discussions with the FDA. As part of the ongoing plan to advance clinical development to cervical patients, Geron had already initiated this preclinical study in an animal model of cervical injury.

In discussions with the company, the FDA has advised that it concurs with Geron that positive data from this study can be used to support both release of the clinical hold and expansion to cervical patients. Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010! (emphasis is Bill Haynes’)

The company is initially developing GRNOPC1 for spinal cord injury, but is also exploring application for other neurological diseases, including multiple sclerosis, stroke and Alzheimer disease.

About Geron

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials in different cancers. For more information, visit www.geron.com.

Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
info@geron.com

I think you missed the point.
Bankrupted the USA:  Done
Nationalized Banks:   Done
Nationalized domestic auto companies:  Done
Czars appointed mostly without Congressional vetting or approval:  32 Czars in office
Controlled all but one News Channel: Done
Appointed known Mao sympathizers to admin. jobs on his staff:  Done
Appointed avowed Socialists to dominate FCC and invoke “Fairness Doctrine” by decree, bi-passing Congress. Done
Directed US Chamber of Commerce to cease opposing his Health Care Plan. Done
Violated security laws with impunity by giving UAW priority over long term bond holders in GM Bond liquidation. Done
Expanded arbitrary limitation of executive compensation to companies that did NOT receive bail out funds.  Done
Should I go on?

Bill

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What can I say…? The record speaks for itself…!

ACHIEVEMENTS…!

Reference the images viewed recently (first image), in which I commented on the apparent disorientation of the solar panels and radiators on the ISS.

Here’s a couple of earlier images that show the panels in what I consider a more properly rigged condition.
I believe the contrast is clear.

Note the two docked Soyuz space vehicles in the second image.

Bill

PS: NASA is now discussing terminating ISS in about five years!
The Shuttles have operated since 1981, but we are shutting down the ISS just a few years after it is completed?
There’s also the looming issue of how they will go about shutting it down? By allowing it to re-enter out of control like Skylab (NASA has since admitted that they did not have control)?
Or, as makes a lot more sense to me, by boosting it up to an altitude where it will have a much longer un-reboosted life and storing all that expensive mass for future salvage.
These issues cry out for discussion by the Congress and the Space Community. BH