Chủ Nhật, 1 tháng 10, 2017

News on Youtube Oct 1 2017

(Japanese) お手洗いです。 (This is the restroom area.)

右手通路、 (On the corridor to your right,)

左側の壁に沿って (along the wall on the left side)

多機能が二つ、 (there are two multipurpose [toilets],)

通路右側に男子、 (on the right hand side of the passage are the men's [toilets],)

突き当たり右に (at the end on the right)

女子があります。 (are the womens [toilets].)

(English) This is the restroom area.

There is a corridor on your right.

Two multipurpose toilets

are located on the left hand side of that corridor.

The men's toilets

are located on the right hand side.

The women's toilets

are located at the far end on the right.

(Japanese) お手洗いです。 (This is the restroom area.)

右手通路、 (On the corridor to your right,)

左側の壁に沿って (along the wall on the left side)

多機能が二つ、 (there are two multipurpose [toilets],)

通路右側に男子、 (on the right hand side of the passage are the men's [toilets],)

突き当たり右に (at the end on the right)

女子があります。 (are the womens [toilets].)

(Chinese...)

For more infomation >> Voice Guidance for Public Toilet in Japan (with subtitles) - Duration: 1:17.

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Địa chỉ IP và những điều cần biết|IP Public và IP private address - Duration: 16:34.

For more infomation >> Địa chỉ IP và những điều cần biết|IP Public và IP private address - Duration: 16:34.

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Melania Trump cutting back on shopping and a message to the public without saying a word - Duration: 2:38.

For more infomation >> Melania Trump cutting back on shopping and a message to the public without saying a word - Duration: 2:38.

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Austria's 'burka ban' comes into force, prohibiting face veils in public places - Duration: 2:29.

Austria's 'burka ban' comes into force, prohibiting face veils in public places

For more infomation >> Austria's 'burka ban' comes into force, prohibiting face veils in public places - Duration: 2:29.

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Ludlow discusses child drug abuse issues at public forum - Duration: 1:44.

For more infomation >> Ludlow discusses child drug abuse issues at public forum - Duration: 1:44.

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Voici comment réduire le risque de péter … même en public! - Nouvelles Santé - Duration: 4:53.

For more infomation >> Voici comment réduire le risque de péter … même en public! - Nouvelles Santé - Duration: 4:53.

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PACCARB 7th Public Meeting Day 2, Pt 5: Council Discussion and Vote, Public Comments and Adjourn - Duration: 24:46.

>> Martin Blaser: Before we go on to our council discussion,

I just want to make a thanks to the staff of PACCARB, who have really enabled all this

work.

I want to thank Bruce, who served for a good half of this process before he left the federal

government.

Our -- Jomana Musmar, who has led it since Bruce, and even before.

Laura Gottschalk, MacKenzie Robertson, Tiffany Archuleta -- I well, and others.

So thank you to the staff.

Now it is time for the council to --

[applause]

And now it is time for the council to have public discussion.

Each of you has seen this report in its draft along the way.

You've seen it maybe too many times.

But now is an opportunity to speak in public about your thoughts.

Councilors.

Just so that there is some discussion, I would just like to say that I am in very high agreement

with this report, and we were very -- it was difficult to come up with the top 10, because

there were so many of value.

And I'd like to propose an eleventh.

It will not go into the report as number 11, but just for the purpose of public announcement,

and that has to do with human therapeutics, item 3.2, page 18, sections 3.2 and 3.3.

It's about the development of narrow spectrum antibiotics.

This is a little future oriented.

It's not necessarily for the current round of antibiotic resistant organisms.

But it's an attempt to lower the ecological damage of antibiotics on our microbiomes.

And I'm predicting that the future of antibiotic development will include more and more of

narrow spectrum, once we have adequate diagnostics that will enable us to find these organisms.

And so in our report, we asked for the continued development and refinement of such of these

and to improve the regulatory pathway, and to have further ways to make the development

of narrow spectrum antibiotics more feasible and bring it to the market sooner.

Dr. Laxminarayan.

>> Ramanan Laxminarayan: Thanks, Marty.

So again, I'd like to echo what you said about you know, this having been a long process

but included a lot of people who are not here today, and I think we can be quite happy with

what has emerged from the process.

Just three points.

One is, for those seeing it for the first time, you're probably wondering this looks

like a lot of money.

There's many parts which call for innovation institutes, for, you know, rewards and mechanisms

and so forth, and whether all of this will actually come to pass.

I think that the way to read this would be to sort of see perhaps that there are things

that could happen in the more immediate term, such as for instance, the clinical trials

network, which could lower the cost of drug development.

That could happen very soon.

You know, regulatory pathways that were optimized and, you know, as we've already seen, already

happening to some extent you know, at FDA.

Now these are things that could happen right away without the need for the big bucks, which

will undoubtedly be necessary.

So I don't think, you know, those seeing it for the first time should be worried as, you

know, as this being a very expensive proposition that will never see the light of day.

It does not have to be adopted in its entirety.

It can be adopted in a sequential manner, you know, with starting with the things that

are the most feasible to do.

I think the second point here to make is that I'm not, I mean, I'm aware of these processes

in other countries, and you know we've been involved in this process in the European side

as well with IMI.

This may be the first process that has actually looked at human and animal use simultaneously

anywhere in the world.

So, I think it has a lot of merit from having that cross talk as part of the discussion.

And I think it will be important for us to at this stage, not lose sight of it, and have

these split off into separate allocations.

I think it's as important to get money for vaccines for animals as it is for humans,

and I think the way in which we advocate it will be important.

And I think the third part of it is really in terms of time length, which these obviously

are things which will take a very long period of time, so hopefully our co-chairs will be

advocating for this report very strongly with the powers that be to make sure that it goes

into practice as soon as possible.

Thank you.

>> Martin Blaser: Thank you for your comments.

I'd like to call on Alicia Cole, who is on the phone.

Alisha, can you hear us?

>> Alicia Cole: Yes, I can.

Yes, I can.

Thank you.

>> Martin Blaser: The floor is yours.

>> Alicia Cole: Thank you.

I wanted to commend my fellow committee members for the report, and for all the hard work

that everyone has done.

I just had one comment on -- Angie, there was a section on point number three where

you talked about funding of diagnostic outcome studies.

And I noticed throughout some of our bullet points we call out various federal agencies,

and it's probably just an oversight, but I think we need to also include the V.A.

Especially where we talk about outcome studies, because the V.A. is the largest integrated

health system in the U.S.

They've got 1700 [unintelligible], and so where we're looking at outcomes and other

point of care studies, I think they should be included.

I think they bring a strong voice to the table.

They're having great success, and I think we need to incorporate them in a very specific

called-out way and not just implied.

So I'd like to make that recommendation.

Thank you.

>> Angela Caliendo: So just a question -- clarification, Alisha.

Are you talking about the V.A. funding these studies, or the V.A. being funded for these

studies?

>> Alicia Cole: Being funded for these studies.

>> Angela Caliendo: Okay, so the organizations that we listed

were those that would actually provide the funding.

>> Alicia Cole: Okay.

>> Martin Blaser: And so the V.A. could be a recipient, and

as you point out, is a very good, large scale way to test ideas and products.

>> Alicia Cole: Absolutely.

Thank you for the clarification.

>> Martin Blaser: Thank you.

I call on Dr. Jungman.

>> Elizabeth Jungman: Thank you.

So echoing the thanks for the work, and I know that I in particular had a lot of comments

on many of the drafts, and so I appreciate the really collegial discussion about that

and appreciate that.

I was just kind of picking up on Ramanan's point.

The, you know, full funding of this report is, of these recommendations, is highly unlikely,

and there's a really, you know, a near future fiscal environment.

But even if it was in any circumstance where we are talking about using tax payer dollars

to fund private company activities, that's a big deal.

And accepting that the economic challenges here are really daunting, I think that's something

that, you know, we just have to take really seriously.

And so, you know, we need to really clearly identify what it is we're trying to incentivize,

and our basis for believing that that incentive works, and our rational for believing that

that investment will have more of an impact on spurring development than other options.

And so, you know, this report does that I think at a very high level.

And the next step, you know, for people who are taking this report and moving it forward

will be to, you know, to identify, you know, really some of the details here.

Like what are the specific vaccines that we want to pull out of the incentive structure?

You know, why don't we think that the market is adequate to, you know, reward a diagnostic

to couple with any given antibiotic?

Or you know, how exactly do market entry rewards work?

And so you know, this is, it's already 46 recommendations.

There's only so much you can do in a report, but just to sort of flag the next steps.

And so you know, I think one way to look at this report is it's a fairly high level -- I

mean there's a lot of detail, but still within any of these, for folks who've been involved

with discussions in any of these areas for a long time, it's a fairly high level, you

know, menu of options of things that could spur development.

And it will start I think as a good starting point for the difficult work to come for making

the case for any individual intervention.

So just a -- just adding that layer on.

Thanks.

>> Martin Blaser: And remember, our charge as scientists, as

practitioners in this realm is to come up with the most scientifically sound and feasible

ways to move forward in this idea.

We will rely on our colleagues on Capitol Hill to allocate the funds, and our colleagues

in the federal government to utilize the funds.

I was very pleased by a number of the reports in the last two days where the presenter said,

"Well we, considering PACCARB's recommendations, we have done the following."

So I'm hopeful that we will get a similar response in years to come.

Are there further comments?

So therefore I think it's time, Jomana, for us to take a vote.

>> Jomana Musmar: Sure.

Thank you Dr. Blaser, and thank you to our chairs for working with us on the development

of this report.

It's been a long time coming, and we've come to this day.

So in compliance with the Federal Advisory Committee Act, all deliberations of FACA advisory

committee seeking to reach consensus on advice to be given to the department are to occur

in a public meeting , such as this one, and consensus requires a quorum, which equals

half of the number of voting members plus one.

For the advisory council, for this one, a minimum of eight votes are required for the

passage of this report to the Secretary of Health and Human Services, Tom Pins [sic].

I will call on our voting members for their decision on the current version as it stands

right now on our website.

And for the record, please state either yay or nay when your name is called.

I'll start to my left with our first voting member, Martin Blaser.

>> Martin Blaser: Yay.

>> Jomana Musmar: Mike Apley, are you on the line with us?

>> Mike Apley: I am, and I vote yay.

>> Jomana Musmar: Thank you, Mike.

Helen Boucher?

>> Helen Boucher: Yay.

>> Jomana Musmar: Angie Caliendo?

>> Angela Caliendo: Yay.

>> Jomana Musmar: Alicia Cole, are you with us on the line still?

>> Alicia Cole: Yes, I am.

Yay.

>> Jomana Musmar: Thank you.

Sara Cosgrove?

>> Sara Cosgrove: Yay.

>> Jomana Musmar: Thank you.

Peter Davies?

>> Peter Davies: Yay.

>> Jomana Musmar: Thank you.

Lonnie King?

>> Lonnie King: Yay.

Yay.

>> Jomana Musmar: Thank you.

Kent Kester?

>> Kent Kester: Yay.

>> Jomana Musmar: Ramanan Laxminarayan?

>> Ramanan Laxminarayan: Yay.

>> Jomana Musmar: Thank you.

Aileen Marty?

>> Aileen Marty: Yay.

>> Jomana Musmar: Thank you.

John Rex?

>> John Rex: Yay.

>> Jomana Musmar: >> Tom Shryock?

>> Tom Shryock: Yay.

>> Jomana Musmar: In both senses of the meaning.

[laughter]

Randy Singer?

>> Randall Singer: Yay.

>> Jomana Musmar: And Bob Weinstein?

>> Robert Weinstein: Yay.

>> Jomana Musmar: Thank you.

The report passes through a unanimous vote.

>> Martin Blaser: Thank you, council, for all the work that

has gone into this.

I'm so -- I'd say we're all so indebted to our co-chairs for this process, to Dr. Weinstein

and Dr. Kester, to the co-chairs of the working groups, to all the working groups.

An enormous amount of work.

We have a product that we can bring forward into the realm of consideration.

And that's our job, and shortly we're going to start working on stewardship.

So you can take a deep breath for a few minutes and then we will begin again, but I just want

to thank everybody for a terrific job that's well done, and I'm pleased that we were able

to -- for us all to agree.

Good, good.

So, now it is time in this meeting for our public comment.

And as in the past, we will listen to any public comment.

Priority has been given to members of the public that have registered online.

We ask the commenters to limit their comments to two minutes or less.

As a reminder, this is not a question and answer period, only an opportunity to voice

public opinion.

All members of the public are encouraged to send in their full comments by emailing carb@hhs.gov.

And public comments emailed to the CARB mailbox by the deadline indicated in the federal register

and website are available at the registration desk.

So, I'd like to call on our first commenter today.

We have four people who have registered.

First commenter is Louis Mendelson from AllerQuest LLC.

Mr. Mendelson.

>> Louis Mendelson: Thank you very much to PACCARB for the opportunity

to present my comments.

I have been in the practice of allergy and immunology since 1972.

I've been involved with penicillin allergy research since that time.

I'm also from the same school as many of you, that it's better to put your seat belt on

before the accident, and not after the car accident.

AllerQuest is a small company owned by myself and two other allergists and a biochemist.

We formed this in 2005 when the previous manufacturer of PRE-PEN, the only penicillin skin testing

approved by the FDA, stopped production, and no other company would bring it back to market.

Therefore, no one would be able to test for penicillin allergy again.

Since bringing back PRE-PEN to the market in 2009, we have been working to improve the

product by expanding the panel of penicillin reagents in this test kit to identify even

more people who carry IGE antibodies against what are more penicillin determinatives.

Such tests are critical to antibiotic stewardship, understanding, and stemming antibiotic resistance.

Of course, while 30 million people are labeled as penicillin allergic, 90 percent or more

of these can currently take penicillin without risk of severe reactions.

Without penicillin skin testing, millions of patients are needlessly diverted to broad

spectrum alternatives, such as vancomycin or [unintelligible], which are associated

with a higher degree of infection [unintelligible], as well as a higher risk of clinical complications

along the hospital stage.

Recognizing these costs, the Center for Disease Control in 2016 issued a fact sheet for all

health care providers advising, "The use of broad spectrum antibiotics in patients labeled

as penicillin allergic is associated with higher health care cost, increase of antibiotic

resistance, and sub-optimal antibiotic therapy.

And encourage penicillin skin testing as a reliable and useful method for evaluating

IGE penicillin allergy."

A great number of public health institutions are joining CDC in recognizing the important

role that thorough penicillin evaluation can play in antibiotic stewardship.

The American Academy of Asthma Allergy and Immunology issued its first position statement

in 10 years to address the topic, strongly encouraging, when indicated, indicated from

the history, more widespread and routine performance of penicillin skin testing to reduce cost

of care, enhance patient safety --

>> Martin Blaser: Your time is just about up.

>> Louis Mendelson: Okay.

And improve outcome of care.

Penicillin allergy evaluation has been supported by the American Board of Internal Medicine,

the Infectious Disease Society, the Working College of Allergy and Immunology, and the

Society of Healthcare and Immunology.

We hope this analysis will provide awareness to healthcare providers that penicillin allergy

testing has potential impact on stemming antibiotic resistance.

I thank you very much for allowing me to say this.

>> Martin Blaser: Thank you.

I'd now like to call on Steven Roach from Food Animal Concerns Trust.

Mr. Roach.

>> Steven Roach: Yeah, I'd like to take us back to this morning's

discussion about prevention control.

So and again, as always I talk about animal agriculture.

So infection prevention in animal agriculture from our perspective is primarily related

to farm management practices that lead to the -- to disease.

In both cattle and swine production, co-mingling animals from different sources is still a

problem that is often addressed with routine antibiotics.

Most feedlot cattle receive macrolide antibiotics to address health problems created by inappropriate

diets.

We need practices that are associated with illnesses in both cattle and swine.

The poultry industry has made some changes by cleaning up their hatcheries, which has

resulted in them no longer needing to reuse antibiotics in the hatchery cases.

In many cases, economics drive these choices.

And many of these practices are based on access to inexpensive antibiotics to address consequences.

So when we talk about prevention, we also have to think about -- highly about economics

and animal agriculture.

In terms of federal agencies, there are several issues that I would like the council to take

into consideration.

First, there is no federal authority for on-farm food safety for meat and poultry.

FDA has authority over feed and drugs, but there is no authority for addressing human

pathogens on farms, either resistant or not.

So even if we have a multi-drug resistant outbreaks associated with animal products

traced back to the farm, is dependent on farms voluntarily allowing public health officials

access.

And there is no authority to require farms to take steps to control risks.

And the other thing that's a related issue is that we have no system in place to collect

actionable data on antibiotic use or resistant bacteria on farm.

Several council members are funded by FDA to develop systems to collect antibiotic use

data, but it is unclear whether these efforts will be sustained over the long run.

So these are short term grants.

USDA has some data collection programs, but I ask the council to explore whether the quality

of data collected by these USDA programs is adequate to identify problems and solutions.

Dr. Craig at CDC described CDC's efforts to create a system to detect, respond, prevent,

and innovate in human medicine.

I would say in animal agriculture, detection is rudimentary and the other three are nonexistent.

And a final comment is that Dr. Flynn mentioned lack of resources for some of these programs

within the FDA, but the agency has not requested the new -- in its budget request these new

resources.

So we do have a problem where, I'm kind of disturbed to see agencies saying we don't

have the resources, but if they're not requested, it's much harder to get Congress to actually

provide the resources.

So we really need the agencies to ask.

Thank you.

>> Martin Blaser: Thank you for your comment.

I now call on Amanda Jessick [spelled phonetically] from the Infectious Disease Society of America.

She does not seem to be here.

So I now call on Kevin Kavanagh, Health Watch USA.

Mr. Kavanagh, Dr. Kavanagh.

>> Kevin Kavanagh: Well, thank you very much.

As a recipient of bone morphogenetic protein to my neck, I feel the FDA's embracing of

an effort to increase the speed of approval for device drug hybrids raises significant

safety concerns.

In addition, I was concerned regarding AHRQ's presentation on chlorohexidine, especially

in light of the integrity issues which have been raised regarding the reduced MRSA study.

This was also a subject of a recent Reuter's investigative report by Deborah Nelson, which

centered on conflicts of interest and on FDA warnings against this type of chlorohexidine

use.

On the Health Watch USA website, there's a YouTube presentation by Matthias Mievault

[spelled phonetically], who raises serious concerns about research integrity problems,

including the recent meta-analysis, which is performed by the World Health Organization

for their current recommendations regarding surgical antisepsis using chlorohexidine.

And of course, you'll all remember the NQF chlorohexidine Charles Denim [spelled phonetically]

debacle.

All of this I feel is starting to form a pattern, which I feel needs careful evaluation, and

is also of significant concern.

Finally, it would be very interesting to have a world map which designates countries having

over the counter antibiotic sales, and to determine what percentage of the world's population

currently can obtain an antibiotic without a prescription.

Thank you.

>> Martin Blaser: Thank you.

Does anyone have any further comments?

Yes, please.

Please identify yourself.

>> Lisa McGiffert I'm Lisa McGiffert with Consumer's Union,

and a couple of comments about the report, even though I know you've already voted on

it, but as expressed by Elizabeth Jungman, Consumer's Union is also concerned with the

use of taxpayer money for private enterprise as envisioned by this report.

I'd like to also talk about post market studies.

Numerous recommendations to speed through FDA approval of devices and diagnostic tests

with a post market study.

These studies often don't start for years after the device is out there and they have

three to five years before reporting results, which could lead to many patients being harmed

or misdiagnosed without coming to the attention of the FDA.

So I recommend that we -- that you look into specifying that these studies begin immediately.

That is, in exchange for putting untested products on the market due to logistical problems,

like responding to a rare bacteria, the companies and healthcare providers using these untested

products should be required to sign an agreement to submit data regarding its use and results

as soon as it starts, and for that data to be looked at as you go along as far as the

results to make sure that patients aren't harmed and that they're actually working.

Thank you.

>> Martin Blaser: Thank you.

Do we have any further comments?

So that closes the period of public comment.

Now we go back to the council and ask does anyone have any final comments to make?

Hearing none, this meeting is adjourned.

Our next meeting is planned for January 24 to 25, 2018.

Please visit our website for all updates, including the final report from this council

from this meeting.

Thank you.

For more infomation >> PACCARB 7th Public Meeting Day 2, Pt 5: Council Discussion and Vote, Public Comments and Adjourn - Duration: 24:46.

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[NEWS]Boris Johnson wants PM to deliver public sector pay rise – funded by layoffs - Duration: 3:25.

Boris Johnson wants PM to deliver public sector pay rise – funded by layoffs

BORIS Johnson has called on Theresa May to give five million state employees a good wage rise – but pay for it by cutting their number.

The government should also act to increase the poorest private sector workers' wages, the Foreign Secretary said.

Boris Johnson has called on Theresa May to give five million state employees a good wage rise – but pay for it by cutting their number.

The Foreign Secretary has said the current minimum wage of £7. 50 an hour - rising to £9 by 2020 - is not enough.

The current minimum wage of £7. 50 an hour - rising to £9 by 2020 - is "not enough", he insisted.

The two controversial declarations will be seen as another challenge to the PM's authority, as pay levels are outside of his Foreign Office brief.

In an interview ahead of the Tories' annual conference on Sunday, Boris told The Sun: "I want people to be paid more. "People get up unbelievably early and they work unbelievably hard, they deserve to be properly paid.

Quizzed how he would come up with the billions needed to break the current 1% wage rise freeze, Mr Johnson suggested cutting the number of state-employed staff. He said: "You can pay people more, but shrink your wages bill.

"I'll be honest with you. I do think you can always find ways of reducing expenditure on things that are not necessary. "Any minister who tells you you can't find savings, it is not true.

The government can also "help people" laid off in any new public sector cull into jobs in the flourishing private sector, Boris added. He said: "There has been a huge expansion in the private sector jobs in the UK economy since 2010.

Chancellor Philip Hammond is under massive pressure to end the seven year-long austerity pay cap and award inflation-linked rises to state workers such as teachers, nurses and soldiers in his Budget in November.

In an interview ahead of the Tories' annual conference on Sunday, Boris told The Sun that he was 'people to be paid more'.

Mr Johnson also issued a warning to the Tory party not to shift to the left in a bid to win back some of Socialist Labour boss Jeremy Corbyn's cult popularity.

On the current level of the minimum wage, Boris said: "We brought in a National Living Wage.

"I think that is the right thing to do but it is obviously not enough, and I would of course see people getting decently rewarded for their hard work. I really believe in that.".

Mr Johnson also issued a warning to the Tory party not to shift to the left in a bid to win back some of Socialist Labour boss Jeremy Corbyn's cult popularity.

  Theresa May forces Boris Johnson and Philip Hammond to team up over Brexit.

Instead, he called on Conservatives to be "more courageous" about making the argument for the free market, engage "mano a mano" in the fight, and "find new ways of invigorating people about our ideas".

Boris added: "It would be a mistake for us to go chasing after Corbyn down some leftist cul de sac. "He is bathing in this orgiastic adulation from Corbynistas who are conspiring in this myth that he won the election.

"Young people don't have to go back to the 1970s. You don't have to time travel, you just have to travel round the world – Venezuela.".

The way to tackle Mr Corbyn's assault on capitalism is to "make markets work better for people", he also insisted. Boris added: "We need to be courageous about making our arguments.

"We have got to be engaged mano a mano with all this left wing nonsense which has been peddled again and we have got to find new ways of invigorating people about our ideas".

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