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