Friday, May 19, 2017

Court strikes down FAA registration rule for model aircraft

John Taylor and one of the drones he custom built
Federal Appeals Court Voids FAA Registration Rule For Model Aircraft 
In a stunning David versus Goliath case, John A. Taylor, a model aircraft enthusiast and insurance lawyer, beat the Federal Aviation Administration and Department of Justice in a case challenging the legality of a December 2015 FAA rule requiring model aircraft to register like manned aircraft.   The Court of Appeals for the District of Columbia ruled that the FAA's registration rule, as it applies to model aircraft, "directly violates [a] clear statutory prohibition."

How a little-known insurance lawyer became a symbol of (drone) liberty - Technical.ly DC 
 
Federal Appeals Court: The FAA's Registration Rule Violates Section 336 

Today, the Federal Appeals Court of the District of Columbia rules that drone and hobby model aircraft registration did violate the FAA Modernization and Reform Act of 2012  (section 336), and rendered it void. This is a huge victory for hobby model aircraft pilots that were forced to comply with FAA regulations or face stiff penalties. Is this the end of this dark chapter in model aviation? One would hope, but given the FAA propensity of fighting hobby model aircraft and their pilots, the Federal Aviation Administration may retaliate in some manner.

SEC. 336. <> SPECIAL RULE FOR MODEL 
                        AIRCRAFT.

    (a) In General.--Notwithstanding any other provision of law relating 
to the incorporation of unmanned aircraft systems into Federal Aviation 
Administration plans and policies, including this subtitle, the 
Administrator of the Federal Aviation Administration may not promulgate 
any rule or regulation regarding a model aircraft, or an aircraft being 
developed as a model aircraft, if--
            (1) the aircraft is flown strictly for hobby or recreational 
        use;
            (2) the aircraft is operated in accordance with a community-
        based set of safety guidelines and within the programming of a 
        nationwide community-based organization;
            (3) the aircraft is limited to not more than 55 pounds 
        unless otherwise certified through a design, construction, 
        inspection, flight test, and operational safety program 
        administered by a community-based organization;
            (4) the aircraft is operated in a manner that does not 
        interfere with and gives way to any manned aircraft; and
            (5) when flown within 5 miles of an airport, the operator of 
        the aircraft provides the airport operator and the airport air 
        traffic control tower (when an air traffic facility is located 
        at the airport) with prior notice of the operation (model 
        aircraft operators flying from a permanent location within 5 
        miles of an airport should establish a mutually-agreed upon 
        operating procedure with the airport operator and the airport 
        air traffic control tower (when an air traffic facility is 
        located at the airport)).

    (b) Statutory Construction.--Nothing in this section shall be 
construed to limit the authority of the Administrator to pursue 
enforcement action against persons operating model aircraft who endanger 
the safety of the national airspace system.
    (c) Model Aircraft Defined.--In this section, the term ``model 
aircraft'' means an unmanned aircraft that is--
            (1) capable of sustained flight in the atmosphere;

[[Page 126 STAT. 78]]

            (2) flown within visual line of sight of the person 
        operating the aircraft; and
            (3) flown for hobby or recreational purposes.



TaylorFAAOpinion.pdf

The FAA’s Registration Rule violates Section 336 of the FAA Modernization and Reform Act. We grant Taylor’s petition for review of the Registration Rule, and we vacate the Registration Rule to the extent it applies to model aircraft. 


Sunday, May 7, 2017

New concepts re Active Surveillance for Prostate Cancer



Summary of April Meeting of IPCSG of San Diego

By Bill Lewis

DVD’s of our meetings are available in our library for $10ea. Refer to the index available in the library. They can also be purchased through our website: http://ipcsg.org Click on the ‘Purchase DVDs” button.

New concepts in the screening and conservative management (Active Surveillance) approaches for Prostate Cancer

Franklin Gaylis MD, FACS
Chief Scientific Officer, Genesis Healthcare Partners
Voluntary Clinical Professor, Department of Urology, UCSD

Background:  Prostate cancer is the second leading cause of cancer-related death.  Although the percentage of men diagnosed with prostate cancer in their lifetime has almost doubled from 9% to 17% since 1990, when the PSA test was widely adopted for screening, the percentage of men that actually die of prostate cancer is now only about 3%.  Due to PSA screening, there are 40% fewer deaths from prostate cancer than before.  Many of the men now diagnosed with prostate cancer each year have "low risk disease," and never would die of it, but still undergo active treatment that is unnecessary.  In May 2012, the U.S. Preventative ServicesTask Force recommended against PSA screening, due to frequent overdiagnosis and overtreatment.  The PIVOT (prostate intervention vs observation trial) suggested that "observation" was as effective as surgery, in July 2012.  But that applied only to low risk PCa, and there was a significant benefit for patients with high risk prostate cancer. 
The Task Force recommendations were widely adopted, resulting in a 50% decline in PSA screening, and in turn resulting in fewer diagnoses of low risk PCa (as is desirable, since such cancers normally don't need to be treated), but an increase in finding high risk PCa.  This suggests that men are not being biopsied as early in their disease progression, due to the reduced frequency of PSA screening, and Dr. Gaylis and colleagues published a letter in the New England Journal of Medicine in February 2016 pointing this out, and warning that doctors may now be missing the window of curability for many men -- as was common in the pre-PSA era. 
Just this month, the Task Force updated their recommendations to indicate that the decision whether or not to test for PSA must be "individualized" for men aged 55 - 69 years (including both men at average risk, as well as those who are at “increased risk,” such as African American men, and those with a family history of prostate cancer).  They still oppose testing of men aged 70 years and older, indicating their opinion that the benefits do not outweigh the harms.  A major factor in the Task Force revision of their guidelines is the fact that whereas in 2012, very few men went on active surveillance, now almost 40% do after diagnosis (thus avoiding the harms of overtreatment).  The American Urologic Association immediately issued a statement in favor of the revised guideline.  Supporting evidence for the value of screening comes from the European Randomized Study of Screening for Prostate Cancer, which issued the prediction that 3 men out of 1000 will avoid metastatic prostate cancer because of screening. 
Dr. Gaylis feels that men at "increased risk" (see above) should start PSA testing much earlier than age 55; as early as age 40.  And he also believes that the age 70 cutoff is artificially rigid, and that each man's situation should be considered individually.  The popular term is "shared decision making."  He has been doing this throughout his career, and notes that our support group helps men to be involved in the decision making.
Active surveillance can be considered to relate to "time of treatment," or "delayed treatment."  The careful follow-up recommended by Genesis Healthcare includes an annual digital rectal exam (because very aggressive cancer may not produce PSA; Dr. Gaylis found a half-inch tumor in the prostate of a man with a PSA of only 0.7), regular PSA testing (useful for the vast majority), genomic testing (such as Oncotype Dx, Prolaris, and Decipher), multiparametric MRI, and biopsies. 
About 33% of men on active surveillance will eventually require active treatment to prevent harm from the disease.  Only 3% of men with favorable-risk PCa who go through active surveillance (with active treatment if and when needed) will die of the cancer within 10 years.  The risk of dying from some other cause was 19 times higher than the risk of dying from PCa!  (Source:  J. Urol. Suppl., 2009,181:606 abstract 1682)
At Genesis Healthcare, for five years now, a "best practice" standard of care involving treatment both of "very low risk" men, as well as more liberal criteria for reasonable exceptions to the most strict criteria has been used and shared with other doctors and groups.  Their data was published, with their guidelines, in the “Gold Journal,” Urology, last year.  Now about 70% of their "low risk" patients go on active surveillance, and more than 85% of "very low risk" patients likewise.  The definition of “very low risk” is as follows:  Stage T1c disease (identified only by needle biopsy; not palpable by DRE nor visible by imaging); Gleason Score = 6 or less; PSA less than 10 ng/ml; three or fewer biopsy cores positive, and less than 50% cancer in any core; PSA “density” less than 0.15 ng/ml/gram (density = PSA score divided by the estimated weight of the whole prostate).  The more liberal criteria amount to the patient’s request to go on active surveillance, with the risk estimated as low and approved by the physician.
Genetic testing discussion:  Note that Genetics examines the function of a single gene, whereas "Genomics" examines groups of genes to identify their combined influence on an organism.  The Oncotype DX prostate cancer assay was discussed as an example of genomic testing.  It is suitable for newly-diagnosed men with very low, low, or low-intermediate risk PCa.  It helps to improve assignment of the degree of risk, particularly to identify patients who may need immediate treatment. 
One part of the Oncotype DX test evaluates the genes that affect the "health" of the interaction of the prostate cells with the surrounding stroma.  Stroma is the scaffold or supporting structure around the cells.  Proliferation genes are used to measure of how rapidly the cells turn over, or multiply.  (Note that the Prolaris test only looks at proliferation.)  Androgen signaling genes provide a measure of the cell's responsiveness to testosterone.  And cellular organization is the fourth group of genes evaluated.  All four groups of genes, 12 genes in all, are compared with 5 reference genes that serve to account for varying RNA quality and quantity in the test sample.  The assay provides an overall "Genomic Prostate Score" on a scale of 100, with higher scores representing more aggressive cancer. 
A study at UCSF showed, that whereas 10% of a group of 288 men were thought to be very low risk using the strict guidelines like Genesis Healthcare uses, after considering the Oncotype DX score, it was found that 26% of the men could be treated as very low risk.  As might be expected, given the uncertainties of biopsy results, some individual men found their GP Score raised their predicted risk, while others found the opposite.  Dr. Gaylis emphasized that these tests provide "additional information" that can be a valuable part of the overall assessment of risk and treatment options for each man.
Dynamic contrast enhanced (DCE) MRI detects the greater blood flow (more blood vessels) in prostate tumors as compared with healthy tissue.  Along with two other parameters measured using MRI, a "PI-RADS" (Prostate Imaging Reporting and Data System) score is generated, on a scale of 1 to 5, with 5 being "highly suspicious of malignancy."
Fusion biopsies (combining prior MRI data with real-time ultrasound to guide the needles during the biopsy procedure) are now gaining acceptance, because they reportedly detect cancer two to three times as often as standard (i.e., "systematic" but blind, often referred to as random) biopsies, and are especially effective in finding cancer when the MRI images show a high level of suspicion.  This new approach provides progress toward targeted, "pinpoint" biopsies.
A study published last year showed that only 5-11% of men on active surveillance after being diagnosed at age 66 or older during the years 2001-2009, received follow-up testing that met the strict guidelines of the prominent PCa research groups at Johns Hopkins and at Sunnybrook (Toronto, Canada), respectively.  Hopefully, our group members are followed more closely!
At Genesis Healthcare, in collaboration with UCSD, three specific measures of the quality of active surveillance activities now are:  adoption (currently, 70% of qualified candidates go on active surveillance), adherence (follow-up PSA testing; DRE annually; and "confirmatory biopsy" within 18 months), and patient satisfaction at their first consultation.

Questions/discussion:  Comments on drugs used for patients on active surveillance, such as Metformin, a statin, and Proscar?  There is provocative info in the literature that says that statins help prevent growth of prostate cancer.  Some doctors are using these drugs.  Xtandi is being used in a trial at Genesis Healthcare, with patients on active surveillance.  Also Casodex is being used by some.  There is no data available yet that proves the benefits of any of these scientifically.
Are there oncologists at Genesis Healthcare?  They have radiation oncologists, but there are “political problems” with adding medical oncologists, so they don't have any.
A comment on economics: In the USA, we have an 18% inflation rate for medical expenses, and those expenses currently total 18% of GDP.  That’s about twice the rate in other 1st world countries. The Task Force did a little good, trying to recommend against unnecessary expenses, but their recommendations also had some bad effects.  The AUA (American Urologic Association) only recommends based on "scientific data," so they offer no recommendations for many issues.
Value of estradiol (an estrogen)?  Estrogen slows prostate cancer, but can cause strokes.
Differences of other genomic tests compared to the Decipher test?  Prolaris predicts 10-year survival, and is based only on “proliferation promoting” gene activity.  The GenomeDX “Decipher” test is useful to predict if radiation would benefit a man who has adverse pathology (disease outside of the prostate and/or PSA rising after prior treatment).  All are RNA based test.  The microarray technology of the Decipher test looks at thousands of genes (others only look at hundreds), but shallowly (low, med, high); it is especially good at predicting recurrence after prostatectomy.
Dr. Gaylis is not in favor of MRI before biopsy, but wants 12-core first, then later a fusion biopsy and (for low risk patients) genomic testing to confirm the original biopsy findings.
A major factor in the Task Force revision of their guidelines is the fact that whereas in 2012, very few men went on active surveillance, now almost 40% do after diagnosis (thus avoiding the harms of overtreatment).
TURP effect on future treatment, for men on active surveillance?  Depends on how aggressive the surgery was.  A new technique is to vaporize the tissue, which he thinks may reduce introduction of cells into the bloodstream.  He has tried green and red light laser, but didn't like them.  Now there is a technology using steam.  Another new technology is the PlasmaButton from ACMI, which coagulates the tissue, and seems worthwhile.

Saturday, May 6, 2017

MQ-4C Triton UAV JAX Training Facility ready

New Triton training facility opens | Jax Air News

Navy's First Operational MQ-4C Triton Squadron Stands Up This Week
Navy stands up Triton drone training facility

Navy pilots and their crews will soon fly missions spanning the globe — all the while sitting at a computer screen at Jacksonville Naval Air Station.

The only training center and first operational squadron, VUP-19, for the Navy’s new MQ-4C Triton unmanned aerial system — or drones — will join the air station that is quickly becoming home to much of the Navy’s most advanced technology.
By: Mark Pomerleau
C4ISRNET
May 5, 2017

The Navy and contractor Northrop Grumman recently cut the ribbon on a new state-of-the-art facility that will be used to train pilots for the upcoming MQ-4C Triton program.

The facility will include the exact operational mission software, interfaces, and other assets for the aircraft. To the end-user or end-operator, they won’t “know if they were operating a live platform or not,” said Doug Shaffer, vice president and program manager for Triton, in an interview with C4ISRNET.

All the hardware and servers in the facility are the actual operational assets, he said, adding that the only thing the mission system trainer facility doesn’t have is the communication links to the satellites to actually command live assets.

Housed at Naval Air Station Jacksonville, which is home to the first Triton squadron, the facility will start training sailors this summer on operating the Triton for the early operational capability for deploying the baseline configuration of Triton in 2018.

Triton came from the Broad Area Maritime Surveillance – Demonstrator, or BAMS-D, which has been operational for the last seven years in the Middle East serving the 5th Fleet, according to Thomas Twomey, senior manager of business development at Northrop Grumman, who spoke to C4ISRNET at the Navy League’s annual Sea-Air-Space Exposition in April.

While the BAMS-D informed a lot of the requirements for the Triton program, its importance means the Navy has been operating an autonomous persistence maritime surveillance asset; Twomey noted that 5th Fleet doesn’t perform carrier transits without that asset flying above.

The Triton program is set to meet early operational capability in 2018, with initial operational capability slated for 2021. The delay in IOC occurred due to the need for a multi-intelligence capability, Twomey said. With the retirement of the EP-3 surveillance aircraft, the Triton will pick up the intelligence and surveillance slack in terms of payload and capability. Triton could meet IOC a year from now, Twomey said, but with the multi-INT capability, it won’t until 2021. The early operational capability does not include the multi-INT function.

The beauty of the new training facility is two-fold: first, given that it is virtual, new software upgrades, sensor payloads, and variants can be plugged into the system allowing operators to train on these changes very quickly. This facility will be used to train sailors on the new payloads once the multi-INT capability is added, Shaffer said.

Second, Shaffer said, the facility combined with the Triton being an autonomous system means that pilots can continuously train without having to put strain on the aircraft itself. With manned platforms, pilots must get actual flying time in the aircraft, which puts wear and tear on the platform, Shaffer said. This makes autonomous aircraft very affordable in the long run from operational and maintenance and support, he added.

“The U.S. Navy is going to get a lot of life out of this facility,” he said.--
Related/Background:--

MQ-9 Reaper UAV operational with GBU-38 JDAM

VIRIN: 170413-F-YX485-001

An MQ-9 Reaper is loaded with a GBU-12 laser-guided bomb on the left and a GBU-38 Joint Direct Attack Munition on the right on April 13, 2017 at Creech AFB. The first two GBU-38s employed in training successfully hit their targets on May 1, 2017 over the Nevada Test and Training Range. (U.S. Air Force photo by Senior Airman Christian Clausen/Released)

MQ-9 Reapers add to arsenal with first GBU-38 drop

By 432nd Wing/432nd Air Expeditionary Wing Public Affairs
May 05, 2017

CREECH AIR FORCE BASE, Nev. — Airmen from the 432nd Wing/432nd Air Expeditionary Wing and the 26th Weapons Squadron, Nellis Air Force Base, Nevada, made history earlier this week, by employing the first GBU-38 Joint Direct Attack Munition (JDAM) from an MQ-9 Reaper.

While the JDAM has been around since the late ’90s, the munition has just recently been validated and now proven for real-world engagements, marking a significant step in the Reapers’ joint warfighter role.

“We had a great opportunity to drop the first live GBU-38s in training,” said Capt. Scott, 26th Weapons Squadron weapons instructor pilot. “The GBU-38 is a weapon we’ve been trying to get on the MQ-9 for several years now and we had the opportunity to be the first to drop during training.”

While waiting for the aircraft to approach the target area, members of the weapons squadron waited anxiously. After the bombs successfully struck their practice targets in a controlled environment, the entire room cheered.

For the past ten years, skilled MQ-9 aircrew have been employing AGM-114 Hellfire missiles and GBU-12 laser-guided bombs, but the JDAM brings new global positioning system capabilities to the warfighters.

“The GBU-38, just like the Hellfire and GBU-12, is a very accurate weapon and the fact that it’s GPS-guided gives us another versatile way to guide the weapon, specifically, through inclement weather onto targets,” Scott said.

The JDAM being added to the arsenal is another step in furthering the attack capabilities of the MQ-9 Reaper force.

“There’s definitely times when I could’ve used the GBU-38 in combat prior to this,” Scott said.

Not only does the GBU-38 perform through poor weather conditions, it also helps the munitions Airmen and the weapons load crew members who load them.

“The GBU-38 has a 20-minute load time compared to the GBU-12, which has a 30-minute load time,” said Senior Airman Curtis, 432nd Aircraft Maintenance Squadron load crew member. “The GBU-38 is a quicker load compared to the GBU-12 and gets the plane in the air quicker.”

Incorporating this new munition into the total strike package will give MQ-9 aircrews additional capabilities. When integrated with the day/night all weather Lynx SAR/GMTI Radar, it will give the Reaper platform flexible attack capability.

“Our job at the weapons school is to train to the highest standard possible,” Scott said. “We’re going to take the GBU-38 and incorporate it into our advanced scenarios, prove the weapon, and integrate with all Air Force assets. What that gives us is the ability to take it downrange and employ in the most demanding circumstances possible.”

The JDAM will add flexibility and efficiency to the targeting process. Aircrews will continue to employ the AGM-114 Hellfires and GBU-12s downrange in addition to the GBU-38 that is now ready for combat. “The overall impact of the GBU-38 is aircrew will have more versatility for the commanders to provide different effects and make a difference for the guys on the ground,” Scott said. “It has a different guidance system and it opens the bridge to more GPS-guided weapons in the future.”
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A larger, high-res version can be viewed or downloaded here:
https://media.defense.gov/2017/May/05/2001743077/-1/-1/0/170413-F-YX485-001.JPG

Related/Background:--

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Wednesday, May 3, 2017

#ProstateCancer News - 2017-05

Prostate Cancer News - 2017-05

General News

About prostate cancer research, cases and public awareness:

Case Management

Planning a campaign against prostate cancer:

Life Choices

can influence the odds in your favor:

Diet

can starve the cancer

Exercise

can give you strength to fight the cancer and treatment side effects

Screening and Diagnosis

early detection is important because symptoms appear too late for treatment:

Biopsies and Pathology 

is it in there, and if so, what kind of cancer is it:

Genomics

Tests

Imaging

Treatment

Active Surveillance AS

Surgery RP

frequently the first choice for localized PCa, robotic assist dominates:

Radiation RT

Hormone ADT

Chemo


Immunotherapy

New Techniques

Side Effects

Advanced/Recurrence