A blast from the past

The Beeb in the 1970’s:

BBC TRANSCRIPT TO BE USED IN WAKE OF NUCLEAR ATTACK

This is the Wartime Broadcasting Service. This country has been attacked with nuclear weapons. Communications have been severely disrupted, and the number of casualties and the extent of the damage are not yet known. We shall bring you further information as soon as possible. Meanwhile, stay tuned to this wavelength, stay calm and stay in your own homes.

Remember there is nothing to be gained by trying to get away. By leaving your homes you could be exposing yourselves to greater danger.

If you leave, you may find yourself without food, without water, without accommodation and without protection. Radioactive fall-out, which follows a nuclear explosion, is many times more dangerous if you are directly exposed to it in the open. Roofs and walls offer substantial protection. The safest place is indoors.

Make sure gas and other fuel supplies are turned off and that all fires are extinguished. If mains water is available, this can be used for fire-fighting.

You should also refill all your containers for drinking water after the fires have been put out, because the mains water supply may not be available for very long.

Water must not be used for flushing lavatories: until you are told that lavatories may be used again, other toilet arrangements must be made. Use your water only for essential drinking and cooking purposes. Water means life. Don't waste it.

Make your food stocks last: ration your supply, because it may have to last for 14 days or more. If you have fresh food in the house, use this first to avoid wasting it: food in tins will keep.

If you live in an area where a fall-out warning has been given, stay in your fall-out room until you are told it is safe to come out. When the immediate danger has passed the sirens will sound a steady note. The "all clear" message will also be given on this wavelength. If you leave the fall-out room to go to the lavatory or replenish food or water supplies, do not remain outside the room for a minute longer than is necessary.

Do not, in any circumstances, go outside the house. Radioactive fall-out can kill. You cannot see it or feel it, but it is there. If you go outside, you will bring danger to your family and you may die. Stay in your fall-out room until you are told it is safe to come out or you hear the "all clear" on the sirens.

Here are the main points again:

Stay in your own homes, and if you live in an area where a fall-out warning has been given stay in your fall-out room, until you are told it is safe to come out. The message that the immediate danger has passed will be given by the sirens and repeated on this wavelength. Make sure that the gas and all fuel supplies are turned off and that all fires are extinguished.

Water must be rationed, and used only for essential drinking and cooking purposes. It must not be used for flushing lavatories. Ration your food supply: it may have to last for 14 days or more.

We shall repeat this broadcast in two hours' time. Stay tuned to this wavelength, but switch your radios off now to save your batteries until we come on the air again. That is the end of this broadcast.

So is he the brawler, the boozer or the cheater?

 

“I converted very quickly from a first generation city-bred Australian into a characterisation out of that classic Australian movie Sunday Too Far Away.” {‘Steve’ Gulaptis MP in his maiden speech on 21^st February 2012}

Japanese whalers receive setback in U.S. Court

FRESNOBEE7: AP - In this photo taken on Sunday, Feb. 12, 2012 and released by Sea Shepherd Conservation Society, the Japanese whaling vessel Yushin Maru No. 2 shoots its water cannons at the Sea Shepherd crew on a inflatable boat during an encounter by the whalers and anti-whaling activists in the Antarctic Sea. (AP Photo/Sea Shepherd, Billy Danger

JOINT MEDIA RELEASE

The Institute of Cetacean Research / Kyodo Senpaku Kaisha

17 February 2012

Joint Statement on Court ruling by the U.S. District Court

The Institute of Cetacean Research and Kyodo Senpaku Kaisha Ltd. are disappointed that the Court did not award a Preliminary Injunction that would prevent Sea Shepherd from physically attacking their vessels during the current research season.

The Institute of Cetacean Research and Kyodo Senpaku Kaisha Ltd. will study the details of the ruling once it is issued. The court has not yet issued a ruling on Sea Shepherd’s motion to have the case dismissed.

The Institute of Cetacean Research and Kyodo Senpaku Kaisha Ltd. are now evaluating their options to ensure safety at sea in the future.

For more information contact: Gavin Carter, Washington, DC: +1-571-243-6030

2010 flu vaccine concerns are raised again

On the 16^th February 2012 The Australian newspaper reported that; A FLU vaccine banned for children and found to trigger the most side-effects in adults has again been selected for the nation's flu immunisation program, on the grounds an Australian-made product would guarantee supply.  Taxpayers will spend $117 million on a contract  for Australian pharmaceutical giant CSL to supply the nation's seasonal and pandemic flu vaccines until 2016…The federal Health Department's Therapeutic Goods Administration, which has yet to determine the cause of the fits in children, has released new data revealing Fluvax was four times more likely to trigger side-effects in adults than two rival vaccines.

Having grown up during an era when polio was rife and children still died from what are now preventable diseases I am a great supporter of public vaccination programs and realise that most vaccines have some degree of side effects - even if its just skin irritation where the jab was given.

But even I have to wonder if the Australian Therapeutic Goods Administration has fully addressed CSL manufacturing problems after it was conveniently found that the concerns expressed in the Untitled Letter by U.S. authorities only applied to vaccine supplied to America.

CSL Biotherapies Untitled Letter

Brian McNamee
Chief Executive Officer (CEO)
CSL Biotherapies
45 Poplar Road
Parkville, Victoria 3052
Australia

Dear Mr. McNamee:

The Food and Drug Administration (FDA) conducted an inspection of CSL Biotherapies, located at 45 Poplar Road, Parkville, Victoria 3052, Australia, between April 19 and April 28, 2010. During the inspection, FDA investigators documented deviations from current good manufacturing practice (CGMP) requirements in the manufacture of licensed biological vaccine products and monovalent influenza bulks. These products include Afluria and Influenza A (H1N1) Monovalent Vaccine. Deviations from CGMP include the applicable requirements of Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act), Section 351(a) of the Public Health Service Act (PHS Act), and Title 21, Code of Federal Regulations (21 CFR) Parts 210, 211, and 600-680.

At the close of the inspection, FDA issued a Form FDA 483, Inspectional Observations that described a number of significant objectionable conditions relating to your facility’s compliance with CGMP. Significant deviations observed during the inspection include, but were not limited to, the following:

1) You failed to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, and failed to extend the investigation to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy [21 CFR 211.192]. Specifically, your investigation dated April 16, 2010 (initiated January 5, 2010) into the formation of dark particles in Afluria Multi Dose Vials (MDV’s) is inadequate. For example:

• The investigation was conducted under procedure -(b)(4)--4161 entitled “Corrective and Preventative Actions.” This procedure was not followed in that the investigation did not “document such that there is traceability of the corrective and preventative actions from the identification of problems to implementation of solutions and the follow up to evaluate effectiveness.”
• During the investigation, a Mercury/-(b)(4)- interaction between product and vial and/or stopper was identified as a potential root cause of the particle formation. This interaction has not been evaluated so as to rule it out as a potential root cause, even though notification was received of this potential interaction on December 17, 2009 by the stopper supplier.
• Retention samples from all commercial lots have not been evaluated for the presence of black particles. Stability samples were examined for one commercial lot (Afluria lot ----(b)(4)---) and retention samples were evaluated for three commercial lots (non-USA Panvax H1N1 lots ----------------------(b)(4)--------------------) but the investigation does not document the rationale for limiting the investigation to these lots only.

2) You failed to assure that drug product containers or closures are not reactive and additive so as to alter the safety, identity strength, quality and purity of the drug beyond the official or established requirements [21 CFR 211.94(a)]. For example:

• Your firm was notified by its stopper supplier on December 17, 2009, that ----(b)(4)--- rubber --(b)(4)-- stoppers may react with thimerosal and therefore are not recommended for use with thimerosal containing products. To date your firm still utilizes these stoppers for MDV’s of vaccine containing thimerosal.
• Extractable/leachable studies representative of product and use conditions have not been conducted for the --(b)(4)-- rubber --(b)(4)-- stoppers and 5mL tubular glass -(b)(4)- vials used for thimerosal containing Afluria and H1N1 MDV products. These stopper/vial components were used to manufacture 23 lots of Afluria vaccine and 6 lots of H1N1 vaccine which were distributed to the United States.
• Extractable/leachable studies have also not been conducted for the -------(b)(4)-------- ------------------------ stoppers and ----------------(b)(4)----------- glass syringes that are used for Afluria and H1N1 single dose vaccine products. These stopper/vial components were used to manufacture 79 lots of Afluria vaccine and 46 lots of H1N1 vaccine which were distributed to the United States.

3) You failed to assure that reserve samples from representative sample lots or batches are examined at least once a year for evidence of deterioration [21 CFR 211.170(b)]. Specifically, procedure -(b)(4)--3735, entitled “Identity Testing and Visual Examination,” is inadequate in that it does not require a periodic examination of samples representative of all presentation types. Influenza MDV’s containing thimerosal have been manufactured since 2007, however, retention sample inspections for influenza vaccine conducted for 2008 through 2010 only evaluated thimerosal-free syringe presentations. Retention samples for MDV’s containing thimerosal have not been evaluated under the periodic review of retention samples.

Additionally, significant deviations in the manufacture of your monovalent influenza bulks were observed during the inspection. These deviations violate Section 501(a)(2)(B) of the FD&C Act and Section 351(a) of the PHS Act. Specific areas of concern include, but are not limited to:

Control of Components

1. You failed to establish testing procedures designed to assure components conform to appropriate standards of identity strength, quality, and purity. For example:

• There are no data to support the expiration date for thimerosal solution, stored at -(b)(4)- for -(b)(4)- months, used in the manufacture of Afluria and HlNl vaccines.
• There are no data to support the -(b)(4)- expiation date of thimerosal raw material under your actual use and storage conditions. The raw material is stored in the -----(b)(4)----- container at ------(b)(4)-------- and is opened and closed multiple times for dispensing in a Class -(b)(4)- area.

We acknowledge receipt of your written response dated May 14, 2010, which addresses the inspectional observations on the Form FDA 483 issued at the close of the inspection. We also acknowledge your commitments made in your response to address the items listed on the Form FDA 483.
We have reviewed your responses and have the following specific comments. The items are numbered to correspond to the observations listed on the Form FDA 483.

Observation 5b

Please provide a summary of your action plan to address the medium risk assigned to the -(b)(4)------- fittings by your firm for review. Include within this summary a copy of the extractables study conducted under worst case conditions and your decision/justification in the determination of the requirement for a leachable study based on the results of the extractable study as described in your response.
Neither the above deviations, nor the observations listed on the Form FDA 483 presented to your firm at the conclusion of the inspection, are intended to be an all-inclusive list of deviations at your establishment. It is your responsibility to ensure compliance with all requirements of the laws and regulations administered by FDA.

We would like to meet with you and other senior management at CSL Biotherapies to further discuss the issues cited in this letter and how you will address them going forward.. Given the potential contributions of safe, pure, and potent vaccines to the public health, we encourage frequent interactions between your technical staff and FDA in an effort to help CSL Biotherapies move forward with corrective actions as rapidly as possible.

Your reply should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200N, Rockville, Maryland 20852-1448. To schedule a meeting at your earliest convenience, please contact Robert McElwain, Consumer Safety Officer, in the Division of Case management at (301) 827-6196.

Sincerely,

/signature/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

I always wondered why so few charity collectors knocked on my front door

I’m a POYSN! A poison person living in one of those "poor, old, young, stupid and non-english speaking" households.

So it’s been other people’s bigotry which has kept me safe from unwanted solicitations via phone or doorstep.
A big thankyou to the Legacy Marketing Team, David, Chris and Amanda!
Ain’t life grand?

Mart

Lismore

* GuestSpeak is a feature of North Coast Voices allowing Northern Rivers residents to make satirical or serious comment on issues that concern them. Posts of 250-300 words or less can be submitted to ncvguestspeak AT gmail.com.au for consideration.

Today the Clarence Valley Mayor seeks support for LGA moratorium on coal seam gas mining

Clarence Valley Council Ordinary Council Meeting

Tuesday 21 February 2012

Mayoral Minute 10.001/12 Coal Seam Gas (CSG) Operations

REPORT SUMMARY

As Councillors are aware, Coal Seam Gas (CSG) operations in NSW and on the North Coast are coming under community scrutiny and there are great community concerns regarding the affects CSG activities will have on the environment and on prime agriculture land. The following recommendation proposes to give Council a general policy position on the matter.

RECOMMENDATION

Whilst Clarence Valley Council acknowledges their statutory responsibilities in relation to planning development applications and assessment, Council as a matter of social responsibility and in the long term sustainability interests of the environment and the community which they represent, does not support or endorse Coal Seam Gas activities within the Clarence Valley area and will not alter this position until such time as;

1.There are clear land use legislation and policies enacted by the NSW Government to responsibly guide and regulate the Coal Seam Gas industry in relation to their activities and in particular with the impact on and/or loss of prime agriculture land and other environmentally sensitive issues; and

2. It is scientifically proven and demonstrated that the impacts of the Coal Seam Gas industry will not result in any significant and detrimental environment outcomes particularly in relation to aquifer water quality;

3. The General Manager be directed to report to Council for their consideration any development application made to Clarence Valley Council which involves proposed activities associated with the Coal Seam Gas industry on Council land.

4. The State and Federal Governments be informed of Clarence Valley Council position.

BACKGROUND

Council will also be aware that Kyogle and Lismore City Councils late last year passed motions which have imposed moratoriums on Council owned lands. These motions are now coming under legal scrutiny. On this point, the NOROC meeting held on 3 February 2012 unanimously resolved the following;

“That NOROC seek legal advice on behalf of member councils in relation to the implications of imposing moratoriums on seismic testing, exploration and other coal seam gas activities on roadside reserves and council-controlled land.”

Given that further legal advice is being sought on behalf of NOROC regarding the validity of the motions that have been carried by Lismore and Kyogle and the fact that Clarence Valley Council is not in receipt of any applications for activities on Council owned land, I am not proposing a similar moratorium at this stage, however, should the Council be in the receipt of an application for consideration and/or once the legal advice is received, this position could change. It is noted that no applications have been lodged with Clarence Valley Council to-date.

I have also asked the General Manager to report any applications to the Council for seismic testing or exploration activities on Council land. This will allow the Council can make a decision based on the merit of the application.

I also represented Council at the “A Division Conference” of the NSW Shires Association. The division also passed the following

That "A" Division call on the NSW State Government to release the terms and conditions controlling the issue of licences for coal seam gas mining within the Northern Rivers area immediately.”

I also consider it important for Councillors and the community to realise that Council cannot abrogate their statutory decision making responsibilities and obligations in relation to development applications and associated planning matters and as such the recommendation as stated above is prepared in the context of Council’s social and community responsibility.

I believe that leadership on the issue by the State Government is required to identify what the parameters are for the coal seam gas industry.

Cr Richie Williamson

MAYOR

UPDATE:

The Mayor's office confirms that this Minute was unanimously supported by Clarence Valley councillors attending the Ordinary Monthly Meeting of 21 February 2012.

Psst! Do you swap family pics with Al Qaeda?

Who needs stand-up comics and old knock-knock jokes when we all have the US legislature within mouse click reach. I kid you not this is US Committee on Homeland Security’s Subcommittee on Counterterrorism and Intelligence Chairman Pat Meehan seeing Twitter, Facebook and Blogger villains everywhere last week:

“However, use of social media isn’t confined to terrorists. It is also a criminal issue and represents an entirely new operating space, both for individuals sharing pictures with friends and family and terrorists, criminals, and other bad actors.”

* Mad bomber lighting up on Google Images

The Abbott-Hockey Economic Theory of Small Government

With so many conflicting explanations of how a Tony Abbott-led federal government (with Joe Hockey as Treasurer) would manage Australia's economy, I went in search of the theoretical basis of various Coalition claims about small government, lower taxes, budget costings and wandering surpluses.

This is where I think it all starts for these maestros of mathematics.................

(a + b) (a - b) = a² - b²  + 1

Graphic from io9.com

'Steve' Gulaptis MP - Wannabe Koala Killer

When I first heard on the grapevine that Nats MP for Clarence Chris Gulaptis was going to honour one particular so-called promise of that notorious speedster and disgraced former Clarence MP Steve Cansdell I was gobsmacked.

Last Saturday The Daily Examiner confirmed the gossip – Gulaptis is asking NSW Roads and Maritime Services “to review the speed limit on Iluka Road within the next two months, with a view to returning the limit to 100kmh from its present 80kmh”.

For the sake of cutting 2-3 minutes off a journey into or out of the sleepy little coastal village of Iluka, former land developer Gulaptis wants to risk local wildlife – including the increasing rare coastal emu and koala populations.

I’m betting fellow Nat and Roads and Ports Minister Duncan Gay is probably endorsing this move. He doesn’t have a clue about this local road or how the Lower Clarence feels about its wildlife and I'm sure Gulaptis will be careful to keep it that way.

Grandpa Koala's response to this irresponsible political vandal:

ABC Radio NSW Sound & Reference Library - Koala - grunting and growling Powered by abmp3 search engine

70th Anniversary of the Bombing of Darwin 1942 - revisionism run wild

Let’s get real folks – all these glowing media reports on the 70^th anniversary of the first Japanese bombing of Darwin are so distorted that they bear little relation to the 1942 reality.

Yes, there was an attempt to defend this northern city and some of it could be described as ranging from brave to heroic. Yes, the entire subject was censored at the time and not all eyewitness records are in the same place.

BUT. The was also widespread NT Government, civilian, Australian and American defence forces panic, with a good many fleeing without authorisation to the Adelaide River (some servicemen getting as far as southern cities) in a rout wryly described at the time as The Adelaide River Stakes.

There was looting by civilians and servicemen and in at least one case a cruelly racist response to Aboriginal casualties.

So let’s be adult about this and truly Aussie on the first national day of observance – reject the historical revisionism currently doing the rounds in the meeja.
You can start with Charlie Lowe's March 1942 first report in the official investigation and go on from there.

Pic from ABC News