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Thank you Dr. Lockitch and the Daily Caller.

The Daily Caller
By Dr. Keith Lockitch
8/10/12
Fellow, Ayn Rand Center for Individual Rights


Are you free to use your own body’s cells to treat your medical condition? Under the rule of the FDA, apparently not. A U.S. District Court has sided with the FDA in its lawsuit against Regenerative Sciences, stopping the company from treating orthopedic injuries by culturing and re-injecting a patient’s own stem cells.

Adult stem cell therapies are relatively new; their promise is only starting to be realized, as in a recent study, which saw the safe regrowth of damaged heart tissue in 17 heart attack patients. Yet just as these first successful treatments are emerging, the FDA is flexing its regulatory muscle.

The lawsuit against Regenerative is precedent-setting, because the FDA is, in effect, applying drug manufacturing standards to the use of your own bodily cells. As one researcher put it, “The FDA does not come into a cardiology practice and tell doctors how to do their surgeries or how to do heart replacements. And yet they feel they can come into a stem cell clinic.”

The problem with the FDA “coming into a stem cell clinic” is that it could have a chilling effect on this whole field of medical research. What, for instance, might happen to the costs of developing adult stem cell treatments under the burden of the FDA’s regulatory intervention? The history of drug development over the past few decades offers a hint.

According to the Tufts Center for the Study of Drug Development, the cost of getting a new drug developed and approved 30 years ago was around $138 million (adjusted for inflation). Today, it’s around $1 billion. Another study finds that only 2 out of 10 drugs ever earn enough to cover the R&D costs for the manufacturer — and that’s after they make it to market. How many potentially lifesaving drugs never even make it out of the lab, being too expensive to pursue under FDA control?

How many promising avenues of adult stem cell research will be cut off by the same regulatory oversight? And how many of us who could benefit from new treatments will instead be forced to endure pain and debilitating disease?

Christopher Centeno, the director of Regenerative Sciences, sees his company’s lawsuit as “a 21st-century civil rights issue that will define what control you have about the use of your own cells and tissue. If a loved one is dying in intensive care and a well-done study shows that the patient’s own cells can be used to help, does the patient get to decide to use those cells, or is that a decision for the FDA? Will the patient still be alive while we wait on Washington to issue this decision?”

Unfortunately, the prospect of patients dying waiting for the FDA to act is all too real — as suggested, again, by its regulation of drugs and medical devices.

Because the agency has the power to keep drugs and devices off the market while its regulators plod through their labyrinthine review process, we and our doctors are forbidden by law from using treatments that lack the FDA’s stamp of approval, even with informed consent. In cases where the patient has little time left and no other options, this leads to tragic outcomes.

Consider a recently approved device designed to replace a brittle aortic valve. During a four-year period of FDA review, the device was used safely in Europe while being forbidden in America. According to one commentator, “More than 15,000 patients worldwide will receive the device by the time it’s slated for approval in the U.S. Some Americans healthy enough to fly have sought the procedure in Europe. Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery, have died during the intervening four years.”

The tragedy of dying patients denied the right to use drugs under FDA review is one that has occurred again and again — as in the case of the cancer drug interleukin-2, or beta blockers, which reduce the risk of secondary heart attacks. Estimates put the death toll from the FDA’s withholding of these drugs in the tens of thousands. Do we really want to see the same tragic toll occur in the context of stem cell therapies?

There is no question that the government must spare no effort in defining and prosecuting real cases of medical fraud, malpractice and criminal negligence — and there is no question that such cases exist in the stem cell market. But instead of serving as our protector against charlatans who prey on the sick and desperate, the FDA has itself become an agent of coercion, forcibly denying us the freedom to use treatments that could save our lives.

Regenerative Sciences plans to appeal the decision. It would be a tragedy if we allow the FDA’s regulatory tentacles to extend into adult stem cell research and choke off this promising area of medicine in its infancy.

Dr. Keith Lockitch is a fellow focusing on science and environmentalism at the Ayn Rand Center for Individual Rights. The Ayn Rand Center is a division of the Ayn Rand Institute and promotes the philosophy of Ayn Rand, author of “Atlas Shrugged” and “The Fountainhead.”



Read more: http://dailycaller.com/2012/08/10/wi...#ixzz23CYKMT9m

[opergolon]

No conflict of interest? Here are the patent applications held by the current and past 5 presidents of ISSCR.

-2008 President-George Daley-Children’s Hospital-
Creating Embryonic Stem Cells for Mass production-PCT/US2007/019935
Method for Enhancing Proliferation of Stem Cells-PCT/US03/29185
Proprietary Kit to see if an iPS Cell is Correctly Manufactured-PCT/US09/57849
Method to Create iPSC’s (artificial stem cells)-PCT/US08/12532

-2010 President-Irving L. Weissman-Stanford University
Method for Isolating a Stem cell Type-Issued Patent-US7592174
Regenerating a Liver with a certain Stem Cell Type-US 2001/0049139 A1
Method for Culturing Embryonic Stem Cells-US 2006/0172414 A1
A Method for Concentrating Stem Cells of the same Type-Patent Number US 5087570
A Device for Isolating Stem Cells-US 2004/0038316 A1
Methods to Isolate and Culture Certain Blood Stem Cells-US 2009/0191164 A1

-2011 President-Elaine Fuchs-Rockefeller University
A Method for Changing Skin Stem Cells-US 2012/0034616 A1
A Method for Isolating a new Stem Cell Type-US Patent 7829336
A Method for Modulating Hair Growth-US 2009/0203574 A1
A Method for Isolating Hair Stem Cells-US 2008/0213882 A1

-2012 President-Fred Gage-Salk Institute for Biological Studies
A Method and Device for Extracting Stem Cells-US 2007/0190649 A1
A Method to turn Stem Cells into Nerves-US 2010/0166710 A1
A Stem Cell Therapy to treat Brain Diseases-US Patent number: 6451306
A Method for Culturing Stem Cells from Deceased Patients-US 2002/0098584 A1
A Method to use a Centrifuge to Isolate Nerve Stem Cells-US Patent number: 6767738
A Method to use IGF-1 to turns Stem cells into Certain Nerve Cells-US 2005/0148069 A1
A Patent on using a Molecular Switch to turn Stem Cells to nerve Cells-US 2006/0234378 A1

-2013 President-Shinya Yamanaka- Center for IPS Cell Research & Application
A Method for Producing Induced Pluripotent Stem Cells-US 2011/0250692 A1
Another Method for Producing Induced Pluripotent Stem Cells-US 2009/0227032 A1
A Method for Improving the Efficiency of Induced Pluripotent Stem Cells-US 2011/0039338 A1
Reprogramming Factors to create iPS Cells-US Patent number: 8058065
Yet Another Method for Producing Induced Pluripotent Stem Cells-US 2011/0003365 A1
A Method to create Nerve Cells from Stem Cells-US 2011/0183350 A1
A Method of treating Nerve Problems with Stem cells-US 2009/0208465 A1
Another Method for reprogramming Cells to Stem cells-US 2010/0279404 A1
A Method to create Platelets from iPS Cells-US 2011/0053267 A1
A Method to find Substances that will Reprogram Cells to iPS Cells-US 2008/0274914 A1
A Gene only expressed in Embryonic Stem Cells-US 2008/0299548 A1



Read more: http://dailycaller.com/2012/08/10/wi...#ixzz23Gtb2klz

[Roker]

Excellent research!!

These ISSCR people are so invested in embryonic stem cells they refuse to credit adult stem cells for anything.