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Hartley Medical: Environmental Monitoring - Active Air Sampling, Microbial
Hartley Medical: Environmental Monitoring - Active Air Sampling, Microbial


Chemotherapy-Induced Neuropathic Pain: The Pain of Surviving Cancer

KRN5500 Granted Fast Track Designation by the U.S.FDA

Newswise - Raleigh, NC -September 16, 2011 -- Thanks to greater awareness, earlier detection and improving therapeutic agents, people with cancer are living longer than ever before. One of the consequences of living longer is the symptom burden of cancer survivorship, which may have a substantial impact on quality of life for many survivors. One such burden is the pain syndromes resulting from cancer treatments. Chemotherapy-induced neuropathic pain is a neurotoxic effect of some chemotherapeutic agents such as paclitaxel, vincristine, cisplatin, oxaliplatin, thalidomide and bortezomib.


DARA BioSciences, Inc. (NASDAQ: DARA) is studying a new medication, KRN5500, for neuropathic pain in cancer patients and has reported positive results from a Phase II study. KRN5500 met its primary end-points of reduction of pain and safety.


KRN5500 is a novel spicamycin derived, non-narcotic/non-opioid/non-narcotic, analgesic agent produced by Streptomyces alanosinicus. A completed Phase II (DTCL100), double-blind, placebo-controlled, randomized, dose escalation study yielded positive results. The purpose of the study was to determine safety and efficacy of KRN5500 as treatment for neuropathic pain in patients with advanced cancer and neuropathic pain.


KRN5500 met its primary endpoints of safety and reduction of pain and was superior to placebo (p=0.03). Study results showed KRN5500 to be both statistically and clinically significant in alleviating neuropathic pain, reaching its primary end-point - reduction of pain from baseline.


Click here to read the full article. 



Hartley Medical   Environmental Monitoring   Active Air Sampling, Particulates
Hartley Medical: Environmental Monitoring - Active Air Sampling, Particulates




The 15th Annual

North American Neuromodulation Society's (NANS) Meeting


December 8th -11th, 2011

at the Wynn, Las Vegas, NV.





Gene Find Could Lead to Drug for Chronic Back Pain

A gene responsible for chronic pain has been identified, with scientists saying this could lead to drugs for treating long-lasting back pain.


Writing in the journal Science, University of Cambridge researchers removed the HCN2 gene from pain-sensitive nerves in mice.

Deleting the gene stopped any chronic pain but did not affect acute pain.


About one in seven people in the UK suffer from chronic pain, which can also include arthritis and headaches.


The researchers say their findings open up the possibility that new drugs could be developed to block the protein produced by the HCN2 gene, which regulates chronic pain.


The HCN2 gene, which is expressed in pain-sensitive nerve endings, has been known for several years, but its role in regulating pain was not understood.


For the study, the researchers removed the HCN2 gene from pain-sensitive nerves. They then carried out studies using electrical stimuli on these nerves in cell cultures to determine how they were altered by the removal of HCN2.


Click here to read the full article



ญญThe reimbursement for intrathecal drug therapy is a very complex process. I wanted to take some time to answer the question that I have been increasingly receiving, "What the heck is going on with reimbursement?" Therefore, I want to provide information regarding reimbursement issues to ensure proper payment for the treatment of your patients. One of the unique things about intrathecal therapy reimbursement is that it is extremely complicated with its various codes, diagnoses, treatment policies, and reimbursement rates. Overall, there is a lack of consistency with reimbursement from various insurance companies, third party payers, Medicare, and so forth. Administrative bodies have different policies/procedures for reimbursement, and if they are not adhered to they can delay or even deny proper reimbursement for services rendered. In today's world, this is something that requires you to pay close attention, and perform diligence.


Recently, we have heard of a few compounding pharmacies that are currently billing Medicare on behalf of the patients and physicians they serve. It is Hartley Medical's understanding that this is improper activity contrary to Medicare policies, and Medicare has issued several "desist" orders regarding this practice. We have selected to, and are currently doing, research into this topic. If we find that providing Medicare billing services on behalf of those we serve is ethically appropriate, then Hartley Medical will happily institute this service. Until that time, though, we will not act in ways that may be inconsistent with Medicare policies. After all, we want to provide superior service - which includes looking out for you and your patients.


So what is our advice for you? Follow and research your reimbursement to ensure proper payment, and examine reimbursement versus costs of goods to ensure profitability. I encourage you to seek counsel, or advisors - such as individuals from Medtronic, the various insurance companies, or even through Hartley Medical. By reaching out to these individuals, you can eliminate problems and ensure good cash flow. Do not look away for your reimbursement. I am increasingly hearing providers saying that they have a problem ... but the problems have been going on for over a year. Perform due diligence - look at reimbursement on either a monthly or quarterly basis to ensure proper remuneration and also profitability.


If you have any questions regarding reimbursement, please consider Hartley Medical as a source.








Just returned from the 18th Annual Napa Pain Conference at the Meritage Conference Center in Napa, CA. What an event! A special "thanks" to Dr. Eric Grigsby and the Napa Pain Institute for presenting such a fantastic event that gives the world of pain management an opportunity to not only converse with old colleagues and friends, but to establish new ones as well. And who wouldn't jump at the chance to taste some excellent wines with some of the country's preeminent pain clinicians? Superb!


This year's distinguished speakers were inspirational, and their topics were spectacular. I have had the pleasure of hearing a number of these doctors speak about a variety of topics over the years, yet I am still astonished by the histories, advances, and knowledge presented during their lectures. Notable among them, History of Intrathecal Therapy for Pain Control by Eliott S. Krames; Ultrasonography in Spine Interventions presented by Michael Gofeld, MD, DEAA; IT Gabapentin by Richard Rauck, MD; CSF Flow & Dynamics: Implications for IT Therapy by Eric Buchser, MD, DEAA; State of the Art Neuromodulation by Tim Deer, MD; Intrathecal Therapy Best Practices by Joshua Prager, MD, MS and Microdosing presented by Emil Annabi, MD.



Dr. Rauck's lecture presented information and data revolving around the study of intrathecal gabapentin. The doctor indicated that there have been 20 published studies examining gabapentin in animal and human applications. Recently, the phase II study examined a 21-day continuous infusion of over 150 subjects. A very important aspect, for me, was the daily dosing of gabapentin. The trial dosages were 1, 6, 30 mgs per day. The outcome did not show significant clinical effectiveness, and the trial was subsequently discontinued. Dr. Rauck had many personal thoughts on this drug study ... but perhaps the most interesting came from the posed question of: "Wrong Study? Or Wrong Drug?" Very intriguing. Some patients responded well, but most described his/her pain as no different than a placebo dose. Gabapentin demonstrated no toxicities to the spinal cord. But this finding left a lot of questions and considerations, such as that asked by the participant next to me of, "What were the statistics for people who found great relief vs. the entire patient population?"



During the "Micro-dosing" panel, there was a fascinating discussion by Dr. Emil Annabi, Assistant Professor for the Department of Anaesthesia and Director of Pain Management at the University of Arizona. He highlighted the problems with intrathecal therapy such as dose escalation. He stated that in his practice the mean starting dose was roughly 2.7 mgs/day of morphine, while the mean dose of the last follow-up was 4.7 mgs/day. During a retrospective study of his patients, Dr. Annabi found that dose escalation going from 5 mgs to 9.2 mgs occurred roughly within 12 months. He gave his true to heart (and, refreshingly, honest) beliefs of pain management information and concepts in treating his patients. "What is micro-dosing?" he asked. Answer, "The lowest effective IT dose to achieve analgesia."  


He went on to discuss his patient population, reviewing his concerns and problems with IT therapy - specifically with ER visits, dose escalations, granuloma formations, and respiratory depression. Dr. Annabi understood that he needed to give new consideration to the paradigm for treating of his patients with intrathecal drugs for chronic pain. One of his most notable concepts was his "Let's give this a try" attitude. He makes the offer to his patients to consider micro-dosing, and expresses that if it doesn't work out, he will return to their original therapy. But he sensed that it would work.


In introducing this particular therapy of micro-dosing, Dr. Annabi would go through a strict detoxification period - taking his patients off the narcotics over a period of 6 weeks. He would then introduce opioids at significantly reduced doses. His goals for patients were: pain control, reduction in side effects, to increase activities of daily living, improvement of functionality, reduction of hospital visits, and, ultimately, increase their quality of life.

This particular subject is controversial, and he really spoke from the heart and from his convictions. He strongly believed that this was something working for his practice, and that one can't ignore it. He concluded by thanking Dr. Michael Castillo, Dr. William Witt, and Dr. David Caraway for being pioneers in considering micro-dosing for the treatment of chronic pain.


I was thrilled to see everyone at this years' event. If you didn't get the chance to attend, you HAVE to mark your calendars for next year's. Thank you Napa Pain Institute, the hardworking staff at Neurovations, and all of the generous sponsors! This event continues to grow each year.


If I didn't get a chance to see you at this event, please find me during the NANS Conference in Las Vegas this December ... or give me a call anytime.



Bill Syringe





September is Pain Awareness Month

(derived from the American Pain Foundation's Web site)


American Pain Foundation  

Have you ever experienced chronic pain? If not, you can't even imagine the courage, mental strength, and determination of those who have and do endure pain on a daily basis. And if you have experienced it, you know what life can be like dealing with physical limitations ... learning to tolerate that in which you try, but sometimes can't, control. Now, imagine a world where people with pain are properly heard. Where these same people get the proper care and treatment that they desire - the care that they deserve. Imagine a World with Less Pain.


Can you imagine the possibilities? Good. Because now is the time to rally together and speak out for the rights of the more than 116 million Americans who live with pain! The American Pain Foundation has started a world-wide campaign to increase awareness for individuals who suffer from pain disorders. YOU can help the APF make a difference today.


Visit the American Pain Foundation's Web site ( and follow the three simple steps to help build awareness:


1. Attend their Facebook campaign event. Visit the "If I Lived in a World with Less Pain, I Could ..." Facebook campaign. 


2. Add your voice. Upload your video, photo, or written response describing what YOU could do If you lived in a world with less pain to the event page. 


3. Spread the word. Encourage everyone you know to participate in the "If I Lived in a World with Less Pain, I Could . . ." campaign. To spread the word, simply:

    • Share the Facebook event on your wall during September.
    • Ask your friends, family members, neighbors, colleagues, and health care providers to RSVP to APF's Facebook event and submit a response to the "If I Lived in a Word with Less Pain, I Could..." campaign.
    • Spread the word on Twitter! You can use the sample tweet below:
      • Sept is Pain Awareness Month! I am attending the "If I Lived in a World with Less Pain, I Could..."campaign. Join me!  


Let's all work together and promote Pain Awareness Month! 



Hartley Medical is the nation's leading provider of the highest quality sterile pharmaceuticals for intra-spinal, infusion therapy patients. Our world-class pharmacy is exclusively dedicated to the custom compounding of medications for the treatment of pain and movement disorders.


Owned and directed by William A. Stuart, RPh - acknowledged pioneer in the field of pharmaceutical sterile compounding - Hartley, prior to its national expansion, established itself as one of the most successful and professionally distinguished pharmacies in the state of California. 


We now serve over 400 leading pain physicians and premier health care institutions across the nation.  


Visit our Web site at


Disclaimer. The information contained in this publication is provided "as is" and without warranty, expressed or implied.  Hartley Medical assumes no responsibility for any damages of any kind resulting from the procedures contained herein. 
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