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ATTENTION: Important HHS Public Consultation

by: SusanC

Sat Jun 23, 2007 at 14:08:00 PM EDT


HHS Public Health Emergency Medical Countermeasures (PHEMC) Enterprise Stakeholders Workshop
SusanC :: ATTENTION: Important HHS Public Consultation
CAVEAT: Do not be intimidated by the acronyms!  If you do, you may be doing exactly what some intend for you to do, if you know what I mean.  LOL

The workshop is an open meeting that seeks to bring together representatives from the pharmaceutical and biotechnology industries, professional societies, state and local public health organizations, the academic research and development community, public interest groups, stakeholder federal agencies, and Congress.

WHERE: Fairmont Washington DC, 2401 M Street, NW, Washington, DC 20037

WHEN: July 31- August 2, 2007

The 2007 HHS PHEMC Enterprise Stakeholders Workshop will provide an opportunity to discuss and receive individual stakeholder feedback on HHS implementation of

Right now, I'm at the information-gathering stage, and I'm nowhere near ready to give opinions as to the pros and cons of any of this.  At first look, the various plans and strategies that HHS will be receiving 'stakeholder feedback' on includes just about everything for pandemic flu except for NPI and personal preps.  In the next week or so, I will post what I can unravel, ie the truth behind all the acronyms, ;-D for everyone's understanding and input.  At this point, I'm inclined to be present for this process.  I'll decide as I find out more.

The big-picture concept to understand is this, this whole thing is what they mean when they say "All Hazards Preparedness". 

From this JAMA commentary The Pandemic and All-Hazards Preparedness Act
Improving Public Health Emergency Response, Hodge et al,

On December 19, 2006, President George W. Bush signed the Pandemic and All-Hazards Preparedness Act (PAHPA), which is intended to improve the organization, direction, and utility of preparedness efforts.

PAHPA

  • centralizes federal responsibilities,
  • requires state-based accountability,
  • proposes new national surveillance methods,
  • addresses surge capacity, and
  • facilitates the development of vaccines and other scarce resources.

Under this concept, a pandemic is perceived as one example of a variety of hazards, including CBRN (chemical, biological, radiological, nucelar) events as well as natural hazards like hurricanes or earthquakes, except that a pandemic is so much worse than any of these other hazards that investments made for a pandemic will cover everything else.  For example, enhancing disease surveillance, healthcare surge capacity, development of systems to rapidly distribute medicines and vaccines to local areas, boosting infrastructure robustness, all these developed as part of pandemic planning can be used for other disasters such as SARS, hurricane, any CBRN attack, etc.

The idea is to invest primarily in pandemic preparedness and address other threats along the way (not the other way around because of the scope and scale of a pandemic).  The implicit consequence of this rationale is that all resources that would have been split up to be spent on a variety of hazards can be put together and spent as part of a pandemic preparedness package.

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while theory and practice
always are different, this is one way to get panflu prep done within an all hazards framework without having all hazards dilute panflu. since panflu is the driver, the rest of the hazards learn to build off of what's done for panflu, not the other way around.

yes, this is how I understand it
that panflu takes center-place, and everything else tags along.

I'll post more details or explanations of the various components when they are ready.




All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
Pan Flu More Likely Passenger (Back Seat)
My initial review of last year's materials and the implementation plans they will be discussing make it appear that at best, Pan Flu will be discussed as a one-of-many threats being addressed by the programs they are focusing on here addressing research through advanced development, acquisition,  storage, maintenance, deployment and utilization of medical countermeasures against CBRN attacks and naturally occuring threats.

While it does sound like they are trying to identify measures that benefit the response to multiple threats (outbreak surveilance and communication capacities for instance), if it is to truly address Pandemic preparedness, the multiplying impact that NPI could have on the limited supply of antivirals and pre-pandemic vaccines should also be discussed.

I will not hold my breath.

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 


[ Parent ]
We're a public interest group, let's go to the meeting!
Many of us (myself included) bemoan the lack of govt action.  Here's a chance to hopefully help move them along on the correct path as we see it, but only if we are there.  If we don't have several members scattered amongst the audience, we will have no voice.  No voice means no power to guide. 

Sure, it might be just another rubber stamp meeting (though this one doesn't sound like it) but lets give them the benefit of the doubt and show up for the meetings.  Who knows, something good may come of it yet.  The only way to get our voices heard is if we speak up.  They MAY listen, but only if we are there.

I signed up and will attend, how about anyone else? 

Strider


there are variouos breakout sessions
so it's good to have different people with different interests or backgrounds to attend.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
The Pandemic Influenza Medical Countermeasures Panel
I'm just curious, looking around (as a non-medical person, non-scientist) as to what the medical countermeasures are being considered -- aside from antivirals and vaccines.

Here is some testimony from Jan. 2007

http://www.hhs.gov/a...

I'm just thinking, if a pandemic arrives pretty soon -- before we have enough vaccines -- and especially if it is resistant to Tamiflu or requires 2 to 4 times the expected dose -- what other countermeasures are there?  Do we have contracts out to stockpile other merications that might be of use?

I recall seeing research and discussion of various other options over the past months: especially, statins and prednisolone.... I wonder if these or others are being considered?

Pandemics are "Wicked Problems". - Average Concerned Mom


thank you, ACM
this is exactly the kind of info I want, and I don't know where to look for them!

Statins is definitely something to be considered.  Unfortunately, the response has been very lukewarm.  While everyone appears to think there is some merit, no institution has taken the lead in further evaluating the possibility.  This is certainly something that I will be pursuing vigorously in the context of Medical Countermeasures. 

Part of the problem is the lack of publicity about this 'consultation'.  I only got to know about this cos anon.yyz came across it accidentally, and posted it.  Dave Fedson, retired scientist and formerly Professor of Medicine at the University of Virginia, the staunch advocate of the need to find additional immuno-modulatory drugs for pandemic use to reduce the mortality, and who has been, by his own account, 'brow-beating' every single scientist and official he has access to (which is just about everyone in the influenza world) for the past 3-4 years, did not know about this opportunity to put his views across until I told him about it. 

Here's the April 07 press release http://www.hhs.gov/n...

FOR IMMEDIATE RELEASE
Wednesday, April 18, 2007

Contact: HHS Press Office
(202) 690-6343
HHS Releases Plan for Development and Purchase of Medical Countermeasures

HHS Secretary Mike Leavitt today released for display in the Federal Register the Department?s new roadmap for developing and purchasing medical countermeasures against a host of chemical, biological, radiological and nuclear (CBRN) threats.

at the very end of this press release

The public will be able to submit comments on the PHEMCE Implementation Plan through the Federal Register.  Furthermore, HHS will hold a Public Health Emergency Medical Countermeasures Enterprise/BioShield Stakeholders Workshop on July 31 ? August 2, 2007 in Washington, D.C., to provide an opportunity for feedback and discussion of the plan. The workshop is an open meeting that will bring together representatives of the pharmaceutical and biotechnology industries, professional societies, state and local public health organizations, the academic research and development community, public interest groups, stakeholder federal agencies and Congress.

I'm sure there's a lot more information somewhere within the labyrinth of the internet, whether on hhs or other websites, that bear relevance to our understanding of this crucial decision-making process.  Anyone who can find anything, even if remotely related, please post links! 

We cannot let our ignorance of process stand in the way of keeping tptb honest.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
Do You Have
A link to the agenda for this meeting?  Since I'm in town, I'd like to go if there are sessions which pertain to what I do.

Be kind, for everyone you meet is engaged in a great struggle.--Philo of Alexandria

I think this is the preliminary agenda
http://www.hhs.gov/a...

I am not like other birds of prey....

[ Parent ]
here's the link
it's a pdf file.




All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
3-day meeting
It's a 3-day meeting, But I think only the second day is specific to pandemic flu.

I'm not seeing a lot of time on the agenda for Q and A though...

Pandemics are "Wicked Problems". - Average Concerned Mom


[ Parent ]
actually the BARDA one
may be the more important one, for pandemic flu.

I'm still wading through the documents.  I'm not exactly sure I understand fully yet, so I'm holding off posting for another day or so.




All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
heh
I'm looking for some documents for you -- let me know if they are along the right lines!  I don't understand any of this stuff... but I can google search...

Pandemics are "Wicked Problems". - Average Concerned Mom

[ Parent ]
PREP ACT
http://www.pandemicf...

Dec. 4 2006

Public Readiness and Emergency Preparedness Act (PREP Act) for Pandemic Influenza Medical Countermeasures Utilization Protocol & Decision Tools

BACKGROUND

The Public Readiness and Emergency Preparedness Act (PREP Act) (Pub. L. 109-148), provides immunity from liability claims arising from administration and use of covered countermeasures to manufacturers, distributors, program planners and qualified persons involved in the administration and use of a covered countermeasure, as specified in a declaration by the Secretary of HHS [See section 319F-3 of the Public Health Service Act (42 U.S.C. §247d-6d)]. The exception to this immunity is willful misconduct acts by the covered persons.

HSC Pandemic Influenza Implementation Plan Action Item 6.1.11.2 states that HHS shall develop a protocol and decision tools for medical countermeasures to implement liability protections and compensation, as authorized by the PREP Act, within 6 months of the issuance of the Plan.  The protocol and decision tools are in fulfillment of that Action Item.

more...http://www.pandemicf...



Pandemics are "Wicked Problems". - Average Concerned Mom


Sanofi Pasteur H5N1 Influenza Virus Vaccine Briefing
http://www.fda.gov/o...

H5N1 Influenza Virus Vaccine
A/Vietnam/1203/2004 (Clade 1) 90 mcg/ml
VRBPAC Briefing Document
Version 1.0
29 January 2007

69 page document... (-:

Pandemics are "Wicked Problems". - Average Concerned Mom


Interesting
It is a decent document to skim through.

One thing that caught my eye so far - they say the first wave of 1918 had a 'normal' demographic in its mortality

Between pandemics, the vast majority of influenza-related deaths occur in the elderly, although infants and young children may also succumb. A similar pattern of age-specific
mortality occurred in the first wave of 1918 pandemic influenza. However, during the second wave, this pattern changed radically. Mortality among 0 to 4 year-olds rose considerably, but death rates in all other age groups less than 40 years old increased more dramatically, peaking at almost 15% in the 25 to 29 year age group. In contrast, in those over 50 years old, death rates were lower in the second wave than in the first and were especially low in the over 80s. [4]

It contains interesting background as well as interesting data on their testing so far - including risk/benefit discussion at the end of the document (starting at page 63).

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 


[ Parent ]
one thing I'm trying to determine
is what exactly is the HHS interpretation "Pandemic and All-Hazards Preparedness"?

By lumping everything together, you could say that, as I wrote earlier, we can invest in pandemic preparedness and all of those investments will work for everything else.

But when I look at the PHEMC implementation plan for CBRN, it specifically excludes pandemic influenza.  On page 2 of the pdf file

The HHS PHEMCE Implementation Plan for CBRN Threats excludes pandemic influenza, which is addressed in the HHS Pandemic Influenza Plan.

which sounds to me like the exact opposite of my original supposition.....




All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


Plan B
Of the $3B requested (not yet appropriated) funds for Panflu, only about 5% is earmarked for "Plan B" countermeasures.  If we can't prevent (vaccine) or mitigate (antivirals) the disease, we'll have to treat it. 
$156M for equipment and training does not seem like much to do that with, but I could buy the primers (training programs and treatment protocols) that could be disseminated to state/local governments.  In the end, the biggest expenditures will be in the treatment and recovery of the illness.  That's a lot of chicken soup.


Richard Mitchell, RRT-NPS
Dartmouth Hitchcock Medical Center/CHaD



[ Parent ]
tell me what is Plan B
Please educate this foreigner here!  LOL

Give me links and details, please.  Thanks!



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
Plan B
Medical Countermeasures.  We will have vaccines.  How effective will they be?  That cannot be sufficiently answered until we have a pandemic human virus.  A vaccine based on that virus will be the most effective, but can it be produced in time?  We will have antivirals.  How effective will they be?  The bad news from Australia has gotten some attention, but the truth is we won't know how effective any antiviral is until we have the pandemic human strain.

Unless there is some secret R&D going on at NIH-Bethesda, what 'countermeasures" are they referring to?  The closest thing we have to a plan for applying treatment countermeasures could be gleaned from current cases.  I must be looking in all the wrong places, because I cannot find any recent case information.  The Thai and HK-SAR cases remain the only ones published.  The Indonesians are as tight with their case files as they are with their sequences. 

Richard Mitchell, RRT-NPS
Dartmouth Hitchcock Medical Center/CHaD



[ Parent ]
the most recent
were in NEJM from Turkey and indonesia last year

Kandun IN, Wibisono H, Sedyaningsih ER, et al. Three Indonesian clusters of H5N1 virus infection in 2005. N Engl J Med 2006 Nov 23;355(21):2186-94

http://content.nejm....

Oner AF, Bay A, Arslan S, et al. Avian influenza A (H5N1) infection in eastern Turkey in 2006. N Engl J Med 2006 Nov 23;355(21):2179-85

http://content.nejm....


[ Parent ]
Thanks Greg


Richard Mitchell, RRT-NPS
Dartmouth Hitchcock Medical Center/CHaD



[ Parent ]
Who you calling "We" ?
Even now, a very small minority of citizens of developed countries will have acces to even Pre-pandemic vaccines (unless they figure out how to make it faster or stretch it further).  Same with antivirals.  No 300 million dose stockpile of either sitting around here in the US that I know of.

That's before we get to your very important questions of 'how effective will they be?'

Between Bill Gates and I, 'we' have billions.  But who gets to spend it?  Only in that sense do 'we' have either pandemic vaccines or anti-virals. 


ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 


[ Parent ]
Last years 2006 meeting has video casts - the next best thing to being there :)
Last years meeting and Dr. Leavitts opening remarks for
your review.

http://www.hhs.gov/a...

  Yea. Pandemic may not get its own podeum but preparedness is a multi task - multi disciplin item.

Kobie
"who is afraid of the big bad wolf?"


[ Parent ]
Hold me in attendance but I can not come.
Hi.

  The family has booked a cruse and I can not attened.

  Is there a way for me to post ideas and comments before hand? Kinda to pre-load some questions and solutions?

  And "Ooooooh Ahhhhh"  I do like the name:
HHS Public Health Emergency Medical Countermeasures (PHEMC) Enterprise Stakeholders Workshop
  Its got teeth!

  Can I pass it along to my pediatricians, doctors, EOC folks?

  Is this FREE??  My tax dollars at work?

  Enquiring minds want to know :) ha ha ha

Kobie

 


Federal Register
Well, they say you can submit feedback to the "Federal Register" but I have no idea how to do that.

http://www.gpoaccess...

I assume usually, organizations and shuch would write their opinion,s proposals, etc. for feedback consideration -- don't know that individuals can't just not sure how effective it would be.

(But I know nothing about politics....think I'm gonna have to learn though if this pandemic will just hold off long enough.)

Pandemics are "Wicked Problems". - Average Concerned Mom


[ Parent ]
the workings of government
(But I know nothing about politics....think I'm gonna have to learn though if this pandemic will just hold off long enough.)

:-)

Brookings has an executive seminar coming up on the workings of congress.  I'm tempted to take it.  If I do, I may be able to write up some '101' notes for everyone. 

Always assuming I have time, of course.  ;-)



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
SusanC, AFter watching the weekly address by Tony Blair you may fall asleep and US politics. :) n/t


[ Parent ]
Generally Feedback through Fed Reg is on Drafts of Rules etc
Generally Feedback through Fed Reg is on Drafts of Rules etc

For example, the Draft HHS PHEMCE Strategy was published in the Federal Register on September 8, 2006, two weeks before the 2006 workshop.  The comment period went for 30 days from publication of the Draft.


DATES: The public is invited to submit comments on the draft HHS PHEMCE  Strategy up to thirty days from the date of publication in the Federal  Register. After consideration of the comments submitted, HHS will issue  a final PHEMCE Strategy.

Comments: Address all comments to Dr. Susan Coller at
PHEMCSTRAT@hhs.gov.

I have not found any new Draft documents related to this subject matter that would be up for discussion at the workshop. 

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 


[ Parent ]
this is the place for that
Is there a way for me to post ideas and comments before hand? Kinda to pre-load some questions and solutions?

if you post them here, those who are going can take those ideas into consideration.  Note that nobody is going to say they 'represent' anybody but themselves, but what I often do is to say, on top of what I think, "here's another view that someone shared with me", as long as I myself think that view has merit.

Plus the comments and discussions will help everyone here a lot in their understanding.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...


[ Parent ]
Do you think palliative care at home will be a topic?
I suppose no one will want to admit that narcotic-type drugs are stockpiled anywhere, but I hope that TPTB will put some effort into educating the public about home nursing, including the use of OTC medications during both early and late stages of illness.  Especially useful would be suggestions on alternatives to morphine to ease the patient. (I wonder how many people even know about oral rehydration solution.)

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

[ Parent ]
Wow you got guts.
Palliative care at home.
  I fear it may be needed. If nothing can be cured at least ease the suffering.

  With teen age suicide and the what might happen the miss-use of palliative care is a concern of mine. Unlike 1918 we have so many "painless" ways to go.

  We also have far more machines. Falling asleep on your horse in 1918 is not as bad as falling asleep at the wheel in 2008.

  Also back in 1918, morphine, cocain and heroin where more available Source Harrison Tax Act 1917  :http://en.wikipedia....  Morphine info :http://en.wikipedia.... and its effects on the immune system.

  I can see alot of topics, palliative care being one.

  I think they will be surprised by what we know and our passion.

Kobie


[ Parent ]
I was thinking of herbal remedies,
because the attitude of the government about even pot for cancer patients is so severe and punishing that having opiates around "just in case" is very unlikely, IMO.  For example, kava kava, valerian, alcohol + caffeine??

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

[ Parent ]
Scan the handouts.
I was going to learn more about Tribal interactions. People, the deaf, different house of worship, wiccans and neo pagans I got covered.

  Native American Indians, prisions and institutions I do not.

  If any one can scan the handouts or find a POC for more questions.

Kobie


[ Parent ]
Some Resources and comments from last year's meeting
Final HHS PHEMCE Strategy (published March 20, 2007)

The HHS Public Health Emergency Medical Countermeasures Enterprise (HHS PHEMCE) leads the mission to develop and acquire medical  countermeasures that will improve public health emergency preparedness  as well as prevent and mitigate the adverse health consequences  associated with CBRN and naturally occurring threats. HHS PHEMCE is a  coordinated, intra-agency effort led by the Office of the Assistant  Secretary for Preparedness and Response (ASPR) and includes three HHS  internal agencies: The Centers for Disease Control and Prevention  (CDC), the Food and Drug Administration (FDA), and the National  Institutes of Health (NIH). Additionally, HHS PHEMCE collaborates with  its ex officio members: The Department of Defense (DOD), the Department  of Homeland Security (DHS), the Department of Veterans Affairs (VA) and other interagency stakeholders as appropriate.
...
The medical  countermeasure programs described will involve the full range of  activities from research through advanced development, acquisition,  storage, maintenance, deployment and utilization and will include all  of the PHEMCE.
...
The HHS PHEMCE Implementation Plan for CBRN Threats excludes  pandemic influenza, which is addressed in the HHS Pandemic Influenza  Plan. ...

CBRN = Chemical, Biological, Radiological/Nuclear attacks.

OPHEMC Pandemic Influenza Program
http://www.hhs.gov/a...

ASPR's Office of Public Health Emergency Medical Countermeasures (OPHEMC)

Assistant Secretary for Preparedness and Response (ASPR)
http://www.hhs.gov/a...

Pandemic and All-Hazards Preparedness Act of 2006
http://frwebgate.acc...

These excerpts of comments from last year's sessions http://www.hhs.gov/a...

From Work Session 1

Focus on Medical Countermeasures: ?Medical? and ?non medical? need to be more explicitly defined. For example, it is unclear which category applies to handwashing or diagnostics. Also, it is not clear whether HHS is responsible for non-medical countermeasures, and if so, for which ones. With these caveats however, participants agreed that overall it is logical to place a high priority on developing medical countermeasures to increase preparedness. It is also important however to identify non medical countermeasures that complement medical countermeasure strategies. Supportive care for example is a critical component of medical preparedness, particularly in those cases where the ?ideal? medical countermeasure does not yet exist.

From Work Session 2:

Role of the Public: Proactively engaging the public during the planning process will be important for effective communication. Public comments early in the process are necessary for developing policies that take the public?s voice into account. The lack of public and patient advocates at the current workshop shows that the public is not engaged in the process and the Federal Register is not known widely enough to obtain broad public input. Therefore, new forms of communication, such as town hall meetings and surveys, might be needed to enhance the dialogue with the public.

Comment: The more things change, the more they stay the same.  :^( 
...

Using Pandemic Flu as a Model: To determine whether pandemic flu is a good model for PHEMCE planning, more information is needed on national, local, and industry planning for pandemic influenza and how it compares to the universe of CBRN threats. Spending for an emerging infectious disease, such as a pandemic flu, is handled differently than for CBRN threats. The influenza model applies more to biological threats than chemical or radiation and/or nuclear threats because of the incubation time for biological agents. However, the phases involved in product development for all types of threats are similar and the countermeasures for influenza and other threats have some similarities. Experiences to be leveraged should not be limited to emerging infectious disease threats but should also include other events, such as natural disasters.

From Appendix 2 - Strategic Policies

Addressing Top Priority versus All Threats
While our primary goal is to prevent the health effects of an attack with WMD, we recognize that despite our best efforts we will not be able to develop and acquire medical countermeasures to prevent and reduce adverse health effects against all threats in all places at all times for all people. Consequently, the PHEMCE Implementation Plan will consider all CBRN threats weighing costs, risks, and benefits such as their relative priority, feasibility of use in an event, and cost to mitigate with MCM and non-MCM to develop the best strategy. Recognizing the scope of the threats and the limited resources, the investments will focus on the top priorities for medical mitigation. Where possible, HHS will aim to develop and acquire medical countermeasures that have the potential to address multiple threats, particularly for lower priority threat agents.

Comment: For purposes of a Pandemic threat, promoting  NPI (which would be a non-Medical Counter Measure) would entail discussing the costs, risks, and benefits of NPI (in the absence of best response - vaccine), including the priority, feasiblity of use and cost to mitigate.  Especially where these NPI could address multiple threats of various priority - they would seem to merit some attention and support.

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 


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