The Avastin Decision

Did the FDA do the right thing?

The Wall Street Journal, and others, have denounced the FDA’s move as “a chillingly blunt assertion of regulatory power.” But my Manhattan Institute colleague Paul Howard is the guy who gets it right, in a blog post for Medical Progress Today:

If you think (as I do) that the FDA should be expanding the accelerated approval pathway and allow more drugs to get to market based on promising early studies. rather than waiting for large Phase III clinical trials that can take years to complete, you can argue that this outcome actually strengthens AA. Critics have charged that AA is sop to industry, and that companies never do the follow up studies to support AA. Avastin proves them wrong.

This is exactly the point. If you want the FDA to approve more innovative, new drugs based on promising but early clinical results, you have to give the FDA a way to revoke those approvals later on, should larger trials prove that those drugs aren’t as safe or effective as they first seemed. This is why the FDA should be congratulated for the way it has handled the Avastin breast cancer saga, and why I hope we will see the FDA handle more cases like this one, not less.

Yes, this is better than the way they’ve done it in the past, but this argument presumes that the FDA should have such regulatory power in the first place. It’s one thing to provide data on efficacy. It’s another to prevent people from making their own decisions about what drugs to use for which ailments.

Don’t Believe The News

This is unintentionally hilarious:

Kerrick also spoke about the current status of the NASA Space Shuttle Program and its official retirement on Aug. 31. The media has caused a lot of worry and uncertainty about the future of NASA’s role in galactic travel, she said.

“Don’t believe the news,” she said. “Through this whole process, I learned not to trust the news.”

Although it is true that the program is gone, Kerrick said, NASA will be around until at least 2020. She also said Orbital, a private company based in Virginia, and SpaceX, a company based in California, are the primary sources of funding to continue the development of shuttles capable of going beyond low-Earth orbit.

It’s unclear whether she really said this stuff, or if the reporter just garbled whatever she actually did say, but there are at least four problems with that last paragraph.

[Via Jeff Foust]

A Tantalyzing Space Press Release

I just got this from Shafer Corporation:

Schafer Corporation Signs Licensing Agreement with MoonDust Technologies LLC

PRESS RELEASE

FOR IMMEDIATE RELEASE

November 21, 2011

Schafer Corporation Licenses Space Commercialization Technology to MoonDust Technologies, LLC

Albuquerque, NM – The Schafer Corporation, a scientific and engineering company, has signed a Licensing and Development Agreement with MoonDust Technologies, LLC (MDT) of Tucson, AZ to give them exclusive, worldwide production and marketing rights for a unique line of products resulting from the use of Schafer’s Proprietary microgravity production technology. Although well known for their defense-related space capabilities, Schafer has been developing and evaluating technologies for commercial space applications since 2008.

The Agreement grants MDT the exclusive right to produce and sell these products worldwide and provides Schafer with royalties on the sales. As part of the agreement, Schafer will provide MDT with technical and engineering support focused on the design and development of space hardware. “We’re excited about this opportunity,” said Schafer Corporation President Tony Frederickson. “For over 40 years, visions of space-based commercial ventures have been driven by the advantages of microgravity fabrication for a range of high-value products. We’re pleased that Schafer technology will play a part as this dream at last nears reality.”

“We were blown away,” said MoonDust Technologies CEO Rick Gibson. “When we saw what they had developed it was a no brainer; form the company and let’s do this. The impact will be stunning – we’re looking at a broad range of transformational products involving medical, information, and DOD applications.”

MoonDust Technologies, LLC was created as an affiliate of the Medusa Group of companies in Tucson, AZ. Dan Hodges, CEO and President of Medusa said “Notably, Schafer’s micro-gravity technology allows us to solve some extremely difficult technical issues and create solutions and products that are desperately needed, but simply couldn’t be solved with earth-bound processes before. This approach is the only way to go.” MDT expects to have sample products available for industry review next summer, 2012.

About Schafer Corporation

Schafer Corporation, formed in 1972, is a leading-edge technology company providing high quality products and professional services to government and industry customers. Schafer’s legacy is rooted in space, optical, and directed energy programs. Today, our knowledge and experience supports all branches of the military, the Department of Defense, Department of Homeland Security and NASA. In addition to our legacy competencies, we support these customers over a broad set of disciplines including system engineering, technology management, missile defense, commercial space, net-centric systems and communications, nano-fabrication, modeling and simulation and agile software development.

For more information, please visit: www.schafercorp.com

Contact: Rhonda Peyton P: 505-338-2856

About MoonDust Technologies, LLC

MoonDust Technologies, LLC (MDT) was created in 2011 by Rick Gibson with its headquarters located in Tucson, AZ. MDT is an OEM product company that specializes in the production of unique materials that can only be manufactured in microgravity environments. MDT owns exclusive rights to Proprietary technology that has been developed by leading edge defense and advanced aerospace companies.

For more information, please visit: www.MoonDustLLC.com
rpeyton@schaferalb.com
MoonDust Media Relations: Rick Gibson
p: 520-661-6797

About Medusa

Medusa comprises a group of five affiliated companies specializing in electromagnetic, ultrasound and aeronautical research, development and operations. With broad operational expertise, MRO and laboratory facilities, the Company has unique large corporation capabilities with the attention to detail and customer needs which emanate from a small company atmosphere.

For more information, please visit: www.medusa.com

Medusa Media Relations: Darrin Holman p: 520-512-5299

Via Rich Glover at Shafer, who says that “…if successful, this is a game changer.”

Penn State In Michigan?

Well, this is interesting, I guess, but as commenters note, usually there’s not just one witness in cases like this. Hard to know what’s cause and what’s effect in terms of the guy’s mental condition (that is, is he mentally ill because of real abuse, or is he making up stories about abuse because he’s mentally ill?). Though apparently the mother was aware, and they did have contact.

For whatever it’s worth, when I was growing up, I lived around the corner from Congressman Kildee, and delivered his morning paper. When I collected from him, he never invited me in.

[Update a while later]

Given that he’s retiring this year, I wonder what effect, if any, these revelations will have on the race to replace him? Might make it tougher for nephew Dan.

[Late evening update]

Welcome, Instapundit readers. I have to say that it’s certainly possible that he just wasn’t that into me. Certainly true of a lot of women that I’ve met over the decades…

What Occupy Harvard

…should tell their elite liberal parents on Thanksgiving:

The man you think is a “sucker” because he votes for Republican candidates who don’t seem to give a hoot about him will vote for them every time. He looks at you, the crowd of The-Fix-Is-Always-In, and he casts his lot with the crowd of wealth and initiative.

You see, Mom and Dad, they don’t lie about his prospects. They tell him that he has to sink or swim. They don’t disrespect his willpower by promising that government will make life easier for him. They tell him that they respect his individuality. They tell him straight out what you, the liberal elite, know to be true but will never say. They tell him that life in America is winner-take-all, and that they are the people who will let him keep what he has. They tell him that his religion, his wife’s capacity to reproduce, his children—whether they are “successful” or not—are his treasure. They tell him that they don’t care if he is a person of modest ambition, little sophistication, and humble means. What they value is his capacity to change his own life.

What you tell him is that he should put his life in your hands. Yet you scorn his religion. You mock his faith in the sacredness of conception. You deride his belief in family. You tell him that his love for hunting makes him a murderer, and that his terror at being economically displaced makes him a xenophobe and a racist. Then you emasculate his hope for the future by telling him that if his ship comes in—that dream of a ship that makes the grinding disappointment of daily life worth living through—you’ll help yourself to a big slice of it. And you expect him to believe your rhetoric about fairness and equality when, all the while, you are accusing him of gullibility in his politics and bad faith toward the least fortunate of his fellow citizens. When, all the while, you are living untouched by your own policies. When you are cushioned against life’s hardness, not by government, but by simply knowing other people in your class. You expect him to buy your talk about equitable distribution of wealth when you are sailing through tax loopholes off into the sunset. For this man, his emotions make all the rational sense in the world.

Indeed.

Biting Commentary about Infinity…and Beyond!