- New Research Opportunities
- 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 ‘discovered’ 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’s 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 – our patients and friends – 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’t 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 – 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’t 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’t 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 “Hunter-Hopkins Center.” See you there!
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’s 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 “Research” and then the “Ampligen” tab.
As 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 — Cyndi, Wendy, Pam, Nicole, and Darie
This newsletter is published periodically by Hunter-Hopkins Center, P.A., 7421 Carmel Executive Park, Charlotte, North Carolina 28226, USA.. Telephone (704) 543 9692, Fax (704) 543 8547.
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