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.
According to David Allen in When Office Technology Overwhelms, Get Organized we need “a system that creates space to think, to reflect, to review, to integrate and to connect dots” to put ourselves into “a productive state — the feeling that you’re doing exactly what you should be doing, with a sense of relaxed and focused control?” This allows us to sort out the “chaos of the workplace” and stay “focused on the most important things, as they relate to your goals, direction, values and desired outcomes. You must constantly recalibrate your resources to generate the best results, and to say “not now” to what’s less important.” However points out Allen, we must learn how to do this by following a “sequence of five events to optimize your focus and resources“:
• Capture everything that has your attention, in your work and your personal life, in writing. Maybe it’s your departmental budget, a meeting with the new boss, an overdue vacation, or just the need to buy new tires and a jar of mayonnaise. For the typical professional, it can take one to six hours to “empty the attic” of your head. It may seem daunting, but this exercise invariably leads to greater focus and control.
• Clarify what each item means to you. Decide what results you want and what actions — if any — are required. If you simply make a list and stop there, without putting the items in context, you’ll be stuck in the territory of compulsive list-making, which ultimately won’t relieve the pressure. What’s the next action when it comes to your budget? The next step in arranging your vacation? Applying this simple but rigorous model puts you in the driver’s seat; otherwise, your lists will hold your psyche hostage. And keep in mind that much progress can be made and stress relieved by applying the magic two-minute rule — that any action that can be finished in two minutes should be done in the moment.
• Organize reminders of your resulting to-do lists — for the e-mails you need to send, the phone calls you need to make, the meetings you need to arrange, the at-home tasks you need to complete. Park the inventory of all your projects in a convenient place.
• Regularly review and reflect on the whole inventory of your commitments and interests, and bring it up to date. As your needs change, what can move to the front burner, and what can go further back? Make these decisions while considering your overall principles, goals and accountabilities. Schedule a two-hour, weekly operational review, allowing space to clean up, catch up and do some reflective overseeing of the landscape, for all work and personal goals, commitments and activities.
• Finally, deploy your attention and resources appropriately.
Remarks Allen, “I have never seen anyone apply these practices, with some degree of commitment and application, and not find significant improvement in focus, control and results. The technology, the organizational goals, the quirkiness and turbulence of external realities — these become things to manage, not a hoped-for source of productivity itself.”
Read the full article.
Write Yaron Brook and Don Watkins in The “On Your Own” Economy – Forbes:
Are you bothered by the thought of government embedding itself in every aspect of your life? According to President Obama, the only alternative is “a government that tells the American people, you are on your own. If you get sick, you’re on your own. If you can’t afford college, you’re on your own. . . . That’s not the America I believe in.”
Did people shrink from the twin values of freedom and responsibility? On the contrary, the vast majority of Americans during the 18th and 19th centuries eagerly embraced life’s challenges and flourished under the new system. People didn’t flee from America, they fled to America. They
came here poor, but ambitious—ready to carve out a life for themselves in a country that offered them the only thing they asked for: an open road.
Of course, Americans during this era were not “on their own” in the lone-wolf, asocial sense implied by Obama. Free Americans developed complex webs of association based on voluntary agreement. An unprecedented division of labor—capitalists, businessmen, and workers
coming together to create wealth on an industrial scale—was a product of this new found freedom.
Read the full article at: The “On Your Own” Economy – Forbes]