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+ - Ex-FDA Branch Chief over LASIK device approval cal-> 2

Submitted by kkruecke
kkruecke (540019) writes "LASIK technology is supposed to be improving, but if it's improved so much, what was it when it was approved in the first place? In April of 2008 people were testifying to the FDA about risk of suicide following Lasik (go to youtube and search "lasik hearing").

Now on 1/6/2011, Morris Waxler, PhD, former Chief of the FDA branch responsible for reviewing LASIK clinical trials, filed a petition with the FDA calling for immediate withdrawal of LASIK
devices and asking for a LASIK public health advisory. Check out http://www.thepetitionsite.com/1/support-petition-to-withdraw-lasik-approval/

What's more, Waxler says that the FDA was under tremendous pressure from the LASIK industry to approve the technology. When you read his petition, he says that (direct quote) "the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814. In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies cherry-picked, withheld, and hid data from FDA thatclearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law
and regulation. I will submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal Investigation."

  The language that Waxler uses is very alarming, and he uses a lot of scientific research. He talks about an "epidemic of permanent eye injury" from the "medically-unnecessary" surgical procedure. The research shows that (a) the LASIK flap never heals and may be accidentally dislodged for the rest of a patient's lifetime, (b) that the cornea is permanently weakened and may develop ectasia weeks, months, or years later, leading to vision loss, (c) that corneal nerves which stimulate tear production are severed and destroyed during LASIK, and that these nerves never fully recover — potentially leading to permanent dry eye disease, (d) that having LASIK causes problems in the future for glaucoma screening and cataract surgery, (e) persistent decrease in corneal cells (keratocytes) — it is unknown how this decrease affects long-term viability of the cornea, and (f) that visual quality at night is permanently reduced after LASIK, even when the patient has 20/20 or better daytime vision.

It sounds like "most people do well" is marketing spin."

Link to Original Source

Comment: Re:Sounds Like Drupal (Score 1) 98

by kkruecke (#34962626) Attached to: Foundation Drupal 7

Drupal is uneven, missing features that you would expect from a full CMS and enabling functionality via contrib modules that I have spent months coding in the past. Features show up that are clearly not ready for prime time and are slowly developed into useful modules that become a core part of the Drupal developer's toolkit. It really seems like the archetypal open source/agile project in that way. Unfortunately, that style doesn't work well in a dead tree format. It will be interesting to see if a second edition hits the shelves that fixes some of the glaring problems.

What opensource CMS's are good?

Image

Foundation Drupal 7 98

Posted by samzenpus
from the read-all-about-it dept.
Michael J. Ross writes "Of all the better-known content management systems, Drupal is oftentimes criticized for having the steepest learning curve. Yet that would only be a valid charge as a result of Drupal's great power and flexibility — particularly in the hands of a knowledgeable Drupal developer. But how can the interested programmer begin gaining those skills, as quickly as possible? One approach is to read and work through the examples of an introductory book, such as Foundation Drupal 7, written by Robert J. Townsend (except for a chapter contributed by Stephanie Pakrul)." Read on for the rest of Michael's review.
Image

Scientists Find Tears Are the Anti-Viagra 207

Posted by samzenpus
from the blood-hound-gang-is-wrong dept.
An anonymous reader writes "The male test subjects didn't know what they were smelling, they were just given little vials of clear liquid and told to sniff. But when those vials contained a woman's tears (collected while she watched a sad movie), the men rated pictures of women's faces as less sexually attractive, and their saliva contained less testosterone. Is this proof that humans make and respond to pheromones? The researcher behind the study doesn't use that controversial word, but he says his findings do prove that tears contain meaningful chemical messages."
Security

Detailing the Security Risks In PDF Standard 136

Posted by Soulskill
from the many-and-varied dept.
crabel writes with this quote from the H Online: "At the 27th Chaos Communication Congress in Berlin security researcher Julia Wolf pointed out numerous, previously hardly known security problems in connection with Adobe's PDF standard. For instance, a PDF can reportedly contain a database scanner that becomes active and scans a network when the document is printed on a network printer. Wolf said that the document format is also full of other surprises. For example, it is reportedly possible to write PDFs which display different content in different operating systems, browsers or PDF readers — or even depending on a computer's language settings."
Microsoft

Microsoft Research Takes On Go 175

Posted by Soulskill
from the narrowing-the-possibilities dept.
mikejuk writes "Microsoft Research has used F# and AI to implement a consumer-quality game of Go — arguably the most difficult two-person game to implement. They have used an interesting approach to the problem of playing the game, which is a pragmatic cross between tree search with pruning and machine learning to spot moves with a 'good shape.' The whole lot has been packaged into an XNA-based game with a story."
Facebook

How Zynga's CityVille Drew 70 Million Players In Less Than a Month 101

Posted by Soulskill
from the none-of-us-are-as-dumb-as-all-of-us dept.
An article at Gamasutra takes an in-depth look at how Zynga's new browser-based social game CityVille managed to accumulate tens of millions of players in the relatively short time since its launch early this month. Quoting: "The Facebook interface induces a high degree of user blindness. It does not do a great job of exposing new games and applications, and lacks a directory or a 'Featured in the App Store' style of editorial (as Apple does for the iPhone), which means that for most developers there are huge problems in getting their games in front of users' eyeballs. With all of the free advertising channels on the platform now constrained or dead, this has meant that the Facebook economy has been acquiring an increasingly Darwinian shape. Where it used to be an egalitarian environment in which any developer could strike it big, over the last year it has become top-heavy with larger developers accruing exponential success, and cutting off oxygen to smaller companies by default."
X

Ubuntu Dumps X For Unity On Wayland 640

Posted by Soulskill
from the no-longer-marks-the-spot dept.
An anonymous reader writes "Canonical and Ubuntu founder Mark Shuttleworth has announced that Ubuntu will move away from the traditional X.org display environment to Wayland — a more modern alternative. The move means there is now little reason for GNOME developers to recommend Ubuntu as an operating system. Shuttleworth said, 'We're confident we’ll be able to retain the ability to run X applications in a compatibility mode, so this is not a transition that needs to reset the world of desktop free software. Nor is it a transition everyone needs to make at the same time: for the same reason we'll keep investing in the 2D experience on Ubuntu despite also believing that Unity, with all its GL dependencies, is the best interface for the desktop. We'll help GNOME and KDE with the transition, there's no reason for them not to be there on day one either.'"
KDE

KDE 4.5 Released 302

Posted by Soulskill
from the newer-and-shinier dept.
An anonymous reader writes "KDE 4.5.0 has been released to the world. See the release announcement for details. Highlights include a Webkit browser rendering option for Konqueror, a new caching mechanism for a faster experience and a re-worked notification system. Another new feature is Perl bindings, in addition to Python, Ruby and JavaScript support. The Phonon multimedia library now integrates with PulseAudio. See this interview with KDE developer and spokesperson Sebastian Kugler on how KDE can continue to be innovative in the KDE4 age. Packages should be available for most Linux distributions in the coming days. More than 16000 bug fixes were committed since 4.4."

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