Wednesday, June 11, 2014

Why can't Ampligen be approved?


Why can't Ampligen be approved?


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Billie Moore
NJCFSA Advocacy Chair

To: The ME/CFS Patient Community

We are requesting your help to continue
to push the FDA towards treatments.

Please cut and paste the following message and
send it to the email addresses below.

It is important that ME/CFS stay high on the
FDA's agenda.

Currently Congressman Upton from Michigan is
leading a team of other Congressional members in
an initiative called 21st Century Cures that seeks
to increase the pace of medical breakthroughs.

His initiative gives us fertile ground to continue
to press Congress and the FDA that FDA must
work to fill the pipeline and provide Ampligen an
approval with conditions.

Again, if we get one drug across the line - many
more will follow.

From: The FDA Treatment Team - Cort Johnson,
Bob Miller, Billie Moore, Pat LaRosa, Dr. Janet
Smith, Anita Patton, and Lori Chapo-Kroger

Please cut and paste the message below and
send to the following offices:

To:

margaret.hamburg@fda.hhs.gov
janet.woodcock@fda.hhs.gov
janet.maynard@fda.hhs.gov
howard.koh@hhs.gov

Cc:

mark.ratner@mail.house.gov
monica.volante@mail.house.gov
rachel.stauffer@mail.house.gov
robb.walton@mail.house.gov
catie.fulton@mail.house.gov
christopher.stewart@mail.house.gov
kathryn.allen@mail.house.gov
mitchell.vakerics@mail.house.gov
Mark.Iozzi@mail.house.gov
alicia.siani@mail.house.gov


To: Drs. Woodcock, Hamburg, Maynard

Cc:  Congressional Members - Upton, Pitts,
DeGette, Cassidy, Heck, Benishek, Burgess,
Ellmers and Engel, Holt

FDA FAILS TO APPROVE A DRUG DEEMED
SAFE FOR ME/CFS

Leaves Chronically Ill and Desperate Patients to
Take Untested Off-label Medications.

FDA says they will approve drugs with serious
adverse events if they believe the drugs are
effective, but FDA won't approve a drug that is
SAFE.

They say they can manage the adverse events
of drugs.

But what about the adverse events from
medications never tested on ME/CFS patients -
where is their data on efficacy and safety for
those medicines?

ME/CFS expert Dr. Charles Lapp, who has treated
thousands of ME/CFS patients and has infused
Ampligen for more than 25 years, said:

"Even if Ampligen doesn't improve a patient, it
does no harm."


The experts said it works, and the FDA Advisory
Committee said it's clear that some patients are
experiencing benefit.

More than 700 patients provided testimony
requesting approval of Ampligen, and more than
4,000 signed a petition asking for the drug to be
approved.

In April of 2014 FDA admitted they do not
understand the disease.

FDA has failed in its Risk-Benefit process leaving
the nation with more than $22 billion in costs,
unrelieved suffering of patients, and deaths from
ME/CFS.

THERE IS NO OTHER DRUG IN THE PIPELINE.
WE DEMAND A HEARING

FDA must answer to the patients they are
leaving to suffer.

The hearing should address:

Why this disease has no high-priority designation
to get drugs approved for this very sick
population of over one million people (same
number as with HIV/AIDS)?

Why can't Ampligen be approved now under a
conditional approval?

Why has the FDA failed to convene a meeting of
ME/CFS experts, representatives from those drug
companies making drugs now used off-label for
the disease, and patients to find out how the
FDA can stimulate drug company interest in
ME/CFS?

WE DEMAND A CONGRESSIONAL HEARING.

The FDA must live up to their charge and help
those with chronic illnesses.

We have a right to treatment, and our voices
and our experts need to be heard!

Support us, please!


(your name)

(USA: your city and state)

(Outside USA: your city and country)

(years you have been sick)





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PEM, NOT Chronic Fatigue, is why patients
  are bedridden, homebound, unemployed,
         and unable to walk a block.
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1 comment:

HIV-NEGATIVE AIDS? said...

Simply google "WHO OWNS THE FDA?" --- and you will understand why this is insanity is our reality.

www.cfsstraighttalk.blogspot.com