ME Letter December 2011
Posted on December 26, 2011 by Charles W. Lapp, MD
Contents
New Research Opportunities
Clinical Assessment of CFS
Rituximab
Fatigue Self-Help Skills
Pain Is A Problem!
Disposing of Medications
Hunter-Hopkins Is On Facebook
Ampligen Update
Happy Holidays, Merry Christmas, and best wishes for 2012
New Research Opportunities
Hunter-Hopkins has joined with several well-known practices to form
the Open Medicine Institute. Using EMR (Electronic Medical Records) we
will be able to share anonymous information and medical records for
the purpose of doing research as a group. We have already obtained
more than $500,000 in grants from the Centers for Disease Control to
study the Clinical Assessment of CFS. Patients who choose to
participate will have their de-identified records transmitted to a
central server so that a special team at the CDC can determine how
various medical groups diagnose and manage persons with CFS/ME (PWCs).
We hope that this will lead to a standard intake form and formal
approach to CFS/ME that can be taught to many other healthcare
providers. Participants in this project include Drs. Lapp and Black,
Dr. Dan Peterson, Dr. Cindy Bateman, Dr. Rich Podell, and several
others. Dr. Andy Kogelnick is the principal investigator.
Many of you have read an October study from cancer researchers in
Norway who =91discovered=92 a new treatment for CFS/ME. Drs. Oystein Fluge
and Olav Mella wrote in the October 19, 2011 PLos ONE edition that
they serendipitously treated two CFS/ME patients with the chemotherapy
drug, Rituximab, and the patients recovered from both their lymphoma
and their CFS/ME. They went on to study 30 more CFS/ME patients in a
randomized. placebo-controlled study. Of the 15 patients who received
Rituximab, ten (67%) had lasting improvements in fatigue and other
symptoms. The mean response from two treatments with the drug was 25
weeks (range 8-44 weeks), but response was somewhat delayed in onset
(2-7 months after treatment). There were no serious adverse events in
the study, although two patients with psoriasis noted moderate
worsening of their rash. See
http://www.biomedcentral.com/1471-2377/9/28, the published article,
and more details can be found at
http://www.research1st.com/2011/10/19/rituximab-trial.
The Open Medicine Institute has already begun discussions with the
Norwegian study group, and we are hoping to soon offer trials of
Rituximab in our office, pending approval by regulatory agencies and
funding for the drug.
Lastly, persons with chronic fatigue or Chronic Fatigue Syndrome are
invited to participate in a stud funded by the National Institutes of
Health to learn fatigue self-help skills. The study involves learning
stress reduction skills and other lifestyle techniques that can be
easily done at home. There are no in- person visits, and no medication
or other medical treatment is involved. Payment for full participation
is up to $498. You would need a Windows computer with an internet
connection. If you think you may be interested, please contact Elaine
Beun at (855) 672-1900. Our colleague, Fred Friedberg, PhD, is the
principal investigator in this study.
Pain Meds Are A Problem!
The abuse of prescription drugs is a serious social and health problem
in the United States today. Although we comprise less than 5% of the
world=92s population, we consume 80% of the global opiate supply and a
staggering 99% of all hydrocodone produced! In a 2009 national survey
of 68,700 persons over the age of 12, 21.8% admitted to using illicit
drugs in the past month. 55% of prescription drugs used illegally are
obtained free from a friend or relative.
CFS and FM are partly defined by moderate to severe pain, so naturally
many of our patients benefit from chronic opiate therapy. These
medications can provide significant benefit, but also have the
potential for misuse, abuse, and diversion. For these reasons, the
Drug Enforcement Agency, the Board of Medicine, and other regulatory
agencies are scrutinizing medical practices much more closely, and
requiring more stringent monitoring and controls.
We have necessarily commenced a new program for the management of pain
that will affect you =96 our patients and friends =96 directly. All
patients on opiates, narcotics, or controlled drugs will have to sign
a current Consent form agreeing to certain conditions. This is not
new. We have been obtaining consents since at least 2002. We will
contact patients on scheduled drugs at least quarterly to assess the
effectiveness and side effects of such medications, and patients will
be subject to mandatory random drug screens. We are making every
effort to follow nationally accepted guidelines for the use of
opiates, which include:
Periodic consultations with a pain specialist for some patients
Consolidating doses (that is, long acting drugs are preferred and
using two or more similar meds will be disallowed)
We will not be able to replace lost or damaged pills
Early refills may need to be denied
Obtaining medications from multiple providers or drugstores is forbidden
Unauthorized escalation of doses will be prohibited , etc.
These rules will not be troublesome for the vast majority of you. For
those who are affected, however, we beg your cooperation and hope you
will understand that we are only trying to reduce misuse and diversion
of these dangerous drugs. Thanks in advance for helping out!
Disposing of Medications
What do you do with medications that have expired, don=92t work, or are
just not needed? This question continues to stump the medical
profession and pharmacists alike. Pharmaceutical waste is found widely
in the environment, especially in drinking water. Antibiotics and
steroids are most common, but antidepressants, antibiotics, and
cardiovascular medications show up in amounts high enough to affect
many organisms, including animals and humans. Most medications found
in water sources come
from human waste! The body only absorbs a small amount of any
medication, and the rest is excreted unchanged into our sewer systems.
So what do you do with those unwanted pills and capsules? The best
method of disposal is incineration, but this requires pickup by a
company that specializes in hazardous waste management =96 not available
to most of us! Sometimes pharmacies and local service groups (for
example, Scouts) will offer periodic take-back programs. Otherwise,
put your medications in a sealable container, dissolve them with
water, and then mix in an undesirable substance such as kitty litter,
coffee grounds, or sawdust. The container and its contents can then be
disposed of in your ordinary trash pickup. When you discard your
medicine bottles be sure to remove labels and shred or otherwise
destroy them so people won=92t inadvertently find what you are taking
and where to pick up your refills! All personal information and the
prescription number should be destroyed or blotted out. It is
important to note that your pharmacist cannot take possession of
unwanted controlled substances unless a local police or drug
enforcement agency is participating with them in a take-back event. We
hope this helps!
Hunter-Hopkins Facebook Page
Don=92t forget to bookmark the Hunter-Hopkins site on Facebook. This
media source is managed by Michele Krisko (thanks Michele!) and Dr.
Black. Facebook not only provides a way to meet others with CFS/ME/FM,
but Michele and Dr. Black attempt to keep you up-to-date with the
latest reliable information! Find us by logging on to Facebook, then
searching =93Hunter-Hopkins Center.=94 See you there!
Ampligen Update
On December 2, Dr. Lapp and Research Coordinator Wendy Fallick met
with the staff of Hemispherx Biopharma for the annual report on
Ampligen, now also known generically as rintatolimod. Hemispherx
continues to provide data to the FDA. So far the FDA seems to be
stalling, and Hemispherx may need to press for accelerated approval
since there is no other drug that has been specifically designed and
promoted for CFS treatment. For the past couple years, Ampligen was
only available at Hunter-Hopkins and Sierra Internal Medicine (Dr. Dan
Peterson=92s office in Nevada), but three other sites have opened up in
the US and providers in South America and Europe have requested
permission to use the drug also.
For more details on Ampligen see our website, then click on =93Research=94
and then the =93Ampligen=94 tab.
Holiday GreetingsAs 2011 draws to a close we thank all of you for your
kind words, and sincerely hope that we have provided both hope and
help for you! We wish you all a happy holiday season, a heartfelt
Merry Christmas, and best wishes for health, happiness, and prosperity
in 2012.
Dr. Charles Lapp
Dr. Laura Black
And the Hunter-Hopkins Staff =97 Cyndi, Wendy, Pam, Nicole, and Darie
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