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The FDA Owns Your Stem Cells

Mar 25, 2012 | Politics, Sci-Tech

Writes Scientist Keith Lockitch on FDA Versus Stem Cell Therapies:
Who owns your cells? The FDA seems to think it does, given its lawsuit against Regenerative Sciences, a company that treats orthopedic injuries by extracting, culturing and reinjecting adult stem cells derived from a patient’s bone marrow.

The case is precedent-setting in that FDA is claiming authority to regulate a patient’s own cells as though they were chemical drugs. As one researcher describes it:
If you start to look at this product as being the patient’s own stem cell, how can the FDA claim Regenerative is manufacturing [cells] – they’re culturing them. . . . They seem to have lost perspective on using autologous stem cells. There’s just no way you could apply manufacturing standards. . . . 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 FDA “coming into a stem cell clinic” is that this could have a significantly chilling effect on this whole field of medical research. Under the burden of FDA’s regulatory intervention, the costs of developing adult stem cell treatments would explode and treatments that might have otherwise been profitable might never even make it to market—as has happened with drug development in the U.S. And while stem cell therapies are under FDA review, patients will be denied government permission to use treatments derived from their own cells. [FDA Versus Stem Cell Therapies]

Read the full post at VOICES for REASON.


Physics Today: Logic Leap Reviewed

Dec 1, 2010 | Sci-Tech

“The Logical Leap” — a Review:
That scientists should employ the inductive method is not the main theme of The Logical Leap; rather, the book makes the stronger claim and demonstrates that scientists must use this method in order to make progress. And many scientists are indeed making progress, even now, particularly in the applied fields. But what happens when the inductive method is misapplied, or worse, abandoned? String theory is a case in point: Some physicists accept it because it is “beautiful”, not because it was induced from observational evidence. That sort of evidence has caused many fundamental theories of contemporary physics to stagnate for more than a generation. Indeed, Harriman quotes the late Harvard University chemist E. Bright Wilson, who said, “It is very unsatisfactory that no generally acceptable theory of scientific inference has yet been put forward. Mistakes are often made which would presumably not have been made if a consistent and satisfactory basic philosophy had been followed.”

Defining the Climate Debate

Oct 29, 2010 | Sci-Tech

Another great one by Warren Meyer:

Alarmists like to call climate skeptics “deniers,” usually in an attempt to equate climate skeptics with holocaust deniers. But skeptics do not deny that temperatures have warmed over the last century, or even that man (through CO2 as well as land use and other factors) has played some part in that warming. What skeptics deny, though, is the catastrophe. And even more, what skeptics deny is the need to drastically reduce fossil fuel use – a step that will likely be an expensive exercise in the developed west but an unmitigated disaster for the poor of Asia and Africa. These developing nations, who are just recently emerging from millennia of poverty, need to burn every hydrocarbon they can find to develop their economies. [Denying the Catastrophe: The Science of the Climate Skeptic’s Position – Forbes]

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