Friday, October 25, 2013

Do You Take Vicodin?

 
The U.S. Food and Drug Administration Thursday recommended strict new rules governing how doctors prescribe hydrocodone-based pain pills, which have been abused by millions of Americans.

The FDA's new policy, expected to be approved later this year, changes the classification of painkillers containing hydrocodone to Schedule II from Schedule III drugs, making them harder to obtain.

... The reclassification is expected to be approved by the U.S. Department of Health and Human Services and formally adopted by the Drug Enforcement Administration. The change could take effect next year.

The FDA reclassification would require patients to take prescriptions for hydrocodone-based pain pills to a pharmacy, where now they can have doctors call in a prescription. The new rules also allow for fewer refills before a patient must return to a doctor's office for a new prescription.

Thursday, October 24, 2013

F.D.A. Seeks Tighter Control on Prescriptions for Class of Painkillers

F.D.A. Seeks Tighter Control on Prescriptions for Class of Painkillers
The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers.
The move, which represents a major policy shift, follows a decade-long debate over whether the widely abused drugs, which contain the narcotic hydrocodone, should be controlled as tightly as more powerful painkillers such as OxyContin.
The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems.

READ MORE »

http://www.nytimes.com/2013/10/25/business/fda-seeks-tighter-control-on-prescriptions-for-class-of-painkillers.html?emc=edit_na_20131024

Christmas! | Carole...

 
 
"It's very hurtful when friends and family move on with their lives and leave me behind…like a once loved and treasured teddy bear who is now stored away in an affectionate cupboard of their lives but no longer cared enough about to want to come and see"
 
* * *
 
The first year I was on my own, I called everyone I could think of and they all had excuses why I couldn't join them on Christmas.
 
Due to delivery glitches, the mailed gifts from my aunt and my good friend didn't arrive on time, so I sat there on Christmas looking at a pile of gifts under the tree, things I'd painstakingly handmade or carefully shopped for ... for people who didn't give a damn that I was alone on Christmas.  But not one single thing under the tree for me to open.  And several of the people I had gifts for, when I mentioned it to them after the holidays, they were "too busy" to come fetch them and wanted me to spend more money mailing the gifts to them.  It wasn't even worth coming to see me if they knew they were getting a gift in return.
 
The same thing the next year -- I again tried to wangle an invitation and no one wanted me, but at least this time I hadn't wasted the effort of getting presents for anyone.  And will never again waste time getting presents for anyone until I actually have an invitation in hand for Christmas.  If I'm not worth their time to spend Christmas with, then they're not worth my time in getting a present for them.
 
 

Wednesday, October 23, 2013

Here's an oldie but goodie

 
Myths, with research cites: http://www.aacfs.org/images/pdfs/myths.pdf

November CFSAC postponed to December

Note: From CFSAC listserv-

Due to the shutdown of the federal government, the next CFSAC meeting
is being postponed until December 10-11, 2013 from 12:00 p.m. to 5:00
p.m. (EDT).  The agenda will be posted on the CFSAC website no later
than November 15, 2013.

We now have the capacity to accept pre-recorded video testimony for
public comment and will continue to schedule public comment via phone
and accept written submissions.  The Federal Register Notice will be
posted no later than November 18 and include detailed instructions for
joining the webinar and requesting public comment.  Information will
also be posted on the CFSAC website at www.hhs.gov/advcomcfs.

Please know that we value your involvement and regret any
inconvenience that this delay may have caused you.  Thank you for your
patience as we work through this challenging time.

Thank you,
CFSAC Support Team


The CFSAC Support Team
http://www.hhs.gov/advcomcfs/index.html

Sign up for the CFSAC listserv to receive the latest updates about CFSAC:
http://www.hhs.gov/advcomcfs/cfsac_email_list.html

Learn more about the Health Insurance Marketplace at HealthCare.gov!

Should Morgan Freeman Speak Out About Fibromyalgia?

Tuesday, October 22, 2013

Nominations for CFSAC due

Note: From the CFSAC listserv-

Reminder:  nominations for CFSAC members are due by 5pm ET on Oct. 28.

The Office of the Assistant Secretary for Health (OASH), within the
Department of Health and Human Services (HHS), is seeking nominations
of qualified candidates to be considered for appointment as a member
of the Chronic Fatigue Syndrome Advisory Committee (CFSAC).   CFSAC
provides advice and recommendations to the Secretary of HHS, through
the Assistant Secretary for Health (ASH), on a broad range of issues
and topics related to myalgic encephalomyelitis/chronic  fatigue
syndrome (ME/CFS).  The appointments of several Committee members are
scheduled to end during the 2014 calendar year.  Nominations of
qualified candidates are being sought to fill the positions that are
scheduled to be vacated.  The Committee composition consists of seven
scientists with demonstrated expertise in biomedical research
applicable to ME/CFS, four individuals with demonstrated expertise in
health care delivery, private health care services or insurers, or
voluntary organizations concerned with the problems of individuals
living with ME/CFS.   The vacant positions cover all of these
categories.  To qualify for consideration of appointment to the
Committee, an individual must possess demonstrated experience and
knowledge in the designated fields or disciplines, as well as expert
knowledge of the broad issues and topics pertinent to ME/CFS.

Individuals selected for appointment to the Committee will serve as
voting members and can be invited to serve terms of up to four years.
As Special Government Employees, committee members receive a stipend
for attending Committee meetings.  Committee members also are
authorized to receive per diem and reimbursement for travel expenses
incurred for conducting Committee business.

Nomination materials should be typewritten, 12-point type, and
double-spaced.  If mailed, please submit original documents.  The
nomination materials should be submitted (postmarked or received) no
later than 5:00p.m. ET on the date specified under DATES.  The
following information must be part of the nomination package submitted
for each individual being nominated:  (1)  a letter of nomination that
clearly states the name and affiliation of the nominee, the basis for
the nomination (i.e., specific attributes which qualify the nominee
for service in this capacity), and a statement that the nominee is
willing to serve as a member of the Committee; (2) the nominator's
name, address, and daytime telephone number, and the home and/or work
address, telephone number, and e-mail address of the individual being
nominated; and (3) a current copy of the nominee's resume or
curriculum vitae.  Federal employees should not be nominated for
consideration of appointment to this Committee.  An individual may
self-nominate.

The Department makes every effort to ensure that the membership of
Federal advisory committees is fairly balanced in terms of points of
view represented and the committee's  function.  Every effort is made
to ensure that a broad representation of geographic areas, females,
ethnic and minority groups, and people with disabilities are given
consideration for membership on Federal advisory committees.
Appointment to this Committee shall be made without discrimination on
the basis of age, race, ethnicity, gender, sexual orientation,
disability, and cultural, religious, or socioeconomic status.
Nominations must state that the nominee is willing to serve as a
member of CFSAC and appears to have no conflict of interest that would
preclude membership.  Potential candidates are required to provide
detailed information concerning such matters as financial holdings,
consultancies, and research grants or contracts for an ethics analysis
to be conducted to identify potential conflicts of interest.

ELECTRONIC SUBMISSIONS:  Nomination materials, including attachments,
may be submitted electronically to cfsac@hhs.gov.  Telephone and
facsimile submissions cannot be accepted.

DATES:  Applications for individuals to be considered for appointment
to the Committee must be received no later than 5 p.m. ET on October
28, 2013 at the address listed below.

ADDRESSES:  All nominations should be mailed or delivered to Martha
Duncan Bond, Alternate Designated Federal Officer, Chronic Fatigue
Syndrome Advisory Committee, Office  on Women's Health, Office of the
Assistant Secretary for Health, Department of Health and Human
Services, 200 Independence Avenue, SW, Room 719E, Washington, DC
20201. Nomination materials, including attachments, may be submitted
electronically to cfsac@hhs.gov.

FOR FURTHER INFORMATION  CONTACT:  Martha Duncan Bond, Alternate
Designated Federal Officer, Chronic Fatigue Syndrome Advisory
Committee, Office on Women's Health, Office of the Assistant Secretary
for Health, Department of Health and Human Services, 200 Independence
Ave., SW, Room 719E, Washington, DC 20201.  Inquiries may also be made
to cfsac@hhs. gov.

SUPPLEMENTARY INFORMATION:   CFSAC was established on September 5,
2002.  The purpose of the CFSAC is to provide advice and
recommendations to the Secretary ofHHS, through the ASH, on issues
related to ME/CFS.  CFSAC advises and makes recommendations on a broad
range of topics including:  (1)  the current state of knowledge and
research; the relevant gaps in knowledge and research about the
epidemiology, etiologies, biomarkers, and risk factors relating to
ME/CFS; and potential opportunities in these areas;  (2)  impact and
implications of current and proposed diagnostic and treatment methods
for ME/CFS;  (3)  development and implementation of programs to inform
the public, health care professionals, and the biomedical, academic,
and research communities about ME/CFS advances; and  (4)  strategies
to improve the quality of life of ME/CFS patients. Management and
support services for Committee activities are provided by staff from
the Office on Women's Health, which is a program office within the
OASH.  The CFSAC charter is available at
http://www.hhs.gov/advcomcfs/charter/index.html.

--

The CFSAC Support Team
http://www.hhs.gov/advcomcfs/index.html

Sign up for the CFSAC listserv to receive the latest updates about CFSAC:
http://www.hhs.gov/advcomcfs/cfsac_email_list.html

Learn more about the Health Insurance Marketplace at HealthCare.gov!

Stand with our Experts

[Permission to repost in full]



HHS / IOM Contract – Fooled Us Once, Shame On You for Abusing the Disabled!



The warp speed of this potential train wreck initiative whizzes light-years
faster than the majority of ME and cfs patients can think, much less move.
We're sure HHS & IOM know this.  (And so we continued to be abused.) Given
HHS's corruption of CFSAC's definition recommendation, we are certain the
HHS and its hired hand's giant brushing aside of the ME & cfs community's
outcry in solidarity with our veteran experts against this contract is
deliberately breakneck.  This is at least as haphazard as the original CDC
investigators who, in the guise of authority, bopped to Lake Tahoe and
literally took a hike instead of carefully examining very ill patients and
heeding the professionals who called on them for help.   (Anyone remember
THAT government effort?  You know - the one that obliviously redefined
life-robbing M.E. into the innocuous 30-year "cfs" disaster that has
permanently maimed or killed a lot of good, hardworking people, abuse that
continues to this day, and has been career nightmares for our dedicated
doctors and researchers too?  Let's not forget about "misappropriated"
(stolen) millions, other millions frittered on "CFS" branding campaigns, and
fixation on fatigue rather than on wide-ranging studies on cytokines, spinal
fluid proteins, organs infested with viruses, and…  well, you know - all
that list of grossly abnormal stuff researchers have documented in PWMEs
that's magically supposed to go away with CBT and GET.)



NO WAY - not again!  When a long list of lifelong experts state loud and
clear, "FOLLOW OUR LEAD" - with hoards of beaten-down, undead patients
cheering from their sick beds if they are able, only to be ignored yet
again - it would be really, really naive to think good science is happening,
rather than politics and backroom-ing all over again.  We will not allow
this to happen again!  Fool us once… we've suffered and died for 30 years,
strung along, fooled over and over.



Well, our money's on a more informed, outspoken generation of ME/cfs
advocates – patients and researchers alike!  Given its history with ME &
cfs, HHS has no right to hand a million-dollar hammer to their exclusively
chosen contractor to smash apart the pieces of the ME puzzle that have been
rapidly amalgamating with advances in technology - clues that these experts
have painstakingly pieced together for an entire generation.  We question
IOM's integrity for accepting this contract.  They apparently didn't bother
researching M.E.'s turbulent history before signing on.  (We don't need to
question HHS.  Their track record speaks volumes.)  HHS may have funds on a
scale that our researchers desperately need, but no amount of money gives
HHS the authority to define a disease they've historically misrepresented,
harming countless patients over decades.  Definitions belong to experts in
the field, authorities on the disease who have fought for nickels and dimes
to bring to light the disease processes wracking our bodies.  To reiterate
what we've said elsewhere regarding HHS and its departments regarding ME
(cfs):  History has shown repeatedly that stakeholder input is gratuitously
listened to with seeming sincerity, expert advice is solicited, then
promptly disregarded as preconceived plans move ahead (or not).  Fool us
twice (times ten, but we're cognitively impaired, so shame on you again, HHS
& IOM, for repeatedly exploiting the disabled).



To the HHS and its departments: Redeem yourselves and your predecessors for
the lives lost and still suffering, undead, from this disease!  Help, do not
hinder!  FOLLOW OUR EXPERTS' LEAD!

https://dl.dropboxusercontent.com/u/89158245/Case%20Definition%20Letter%20Sept%2023%202013.pdf

In the mean time, think about the public apology you or your successors are
going to send out.  (Restitution is virtually impossible, unless by that
time reanimation is medically possible.)



Request for Legal Action [See Footnote below]



It is far beyond Name-us.org's scope and ability to set in motion legal
action to cancel the contract between HHS & IOM to redefine ME.  (We would
be right on that if we could!)  HHS could do it with the stroke of a pen, if
they chose to heed our experts' sagacious advice.



We hope (if not already in motion) ME & cfs experts can quickly organize
legal action against this political –  most certainly not scientific –
maneuver on the part of HHS/IOM.  Until we hear word of any initiation of
legal action to cancel this contract, http://www.name-us.org  has posted on
its homepage some email addresses of Congressmen and others.  To them you
can cc your support of the Open Letter to Secretary Sebelius, signed by 35
of our most respected ME & cfs experts:

https://dl.dropboxusercontent.com/u/89158245/Case%20Definition%20Letter%20Sept%2023%202013.pdf \



Also, we've linked to the excellent petitions our advocates (thank you all!)
have been circulating on this issue.  Please sign the petitions and act in
any other way you can.  Nothing is too small, even if it's just one or two
sentences to your Congressmen in support of the Open Letter.  Once upon a
time I had a friend who told me she called her Congressman on an issue, and
when following up later, he told her if he had only heard from at least one
other constituent on the matter, he would have taken action.  I try to
remember this lesson when writing seems too overwhelming with M.E.



http://name-us.org/#BULLETIN



http://name-us.org/#follow_our_experts_lead



Lois Ventura

Co-Founder

National Alliance for Myalgic Encephalomyelitis

http://www.name-us.org



Footnote [Partial quote http://www.seidmanlaw.com/Contract-Terminations/ ,
emphasis added, and note that this firm represents the contractor!]:
"Terminations for Convenience: The following is from Paul J. Seidman and
David J. Seidman's "Maximizing Termination for Convenience Settlements/
Edition II - Part I," Briefing Papers No. 08-3, at 1-2, 10, February 2008:



"  The "Termination for Convenience of the Government" clause in a
Government contract conveys broad rights on the Government to terminate the
contract when termination is in the Government's interest. The Government
may cancel the contract simply because its needs change regardless of
contractor fault. In return for this privilege, the Government agrees to pay
the terminated contractor its incurred costs and certain continuing costs in
a traditional Government contract. Alternatively, in a contract for
commercial items or services under Federal Acquisition Regulation Part 12,
the Government agrees to pay the terminated contractor the percentage of
contract price reflecting the percentage of completion and charges resulting
from termination."



So let's get this thing cancelled, and not waste any more of our REAL
research money!



(For Tom)

Monday, October 21, 2013