As we discussed last week, Purdue Pharma is the maker and advocate of pushing OxyContin, legal heroin, in the name of profit.  We are now a week closer to the FDA hearing where Purdue Pharma's application for their new "tamper proof" OxyContin will be reviewed.  In last week's newsletter, we discussed some of the "dirty little secrets" about OxyContin that Purdue doesn't want anyone to know.  We pointed out that Purdue certainly has no interest in people finding cures for their pain because then they purchase less of their product.

   In this newsletter we will discuss the growing consensus among medical professionals that continued use of opioids like OxyContin actually increases pain-not alleviates it.  During Larry G's Prescription Addiction Radio Show last Sunday night, Dr. Steve Gelfand discussed the growing number of properly done medical studies by respectable medical researchers that have reached this conclusion. 

   Before addressing Dr. Gelfand's comments and the results of other studies, it will be helpful to define a few terms.  Generally, there are two types of pain that we experience.  One is called neuropathic pain-which occurs when the nerves in the central or peripheral nervous system are not functioning properly.  The other is the pain that we experience from injury or sometimes from chemicals in the body, such as by taking an opioid.  These pain signals are sent to the brain by a sensory receptor cell called a nociceptor.

   The studies often refer to hyperalgesia.  Hyperalgesia simply means an increased sensitivity to pain which can be caused by damage to the nociceptors.

TOLERANCE OR OPIOID-INDUCED PAIN

   It is widely known by medical practitioners that many people who are prescribed opioids like OxyContin for pain find that they have to continually increase the amount of opioids they take daily in order to get the same pain relief.   In some cases, our patients were prescribed 20 milligrams of OxyContin per day and a year later were taking over 200 milligrams per day and were hopelessly dependent or addicted.  Even on the higher dose, these patients said that the pain was actually worse than when they started.

   For a long time, it was assumed that this increase in dosage was required because the opioid receptors became less sensitive to the opioids and larger doses were required to achieve the same stimulation of the receptors which would produce enough endorphins to control the pain.  This is called opioid tolerance. 

   Now Dr. Gelfand and many other respected medical practitioners are challenging this tolerance theory. They agree that tolerance is real, but they also have concluded that a significant amount of the increased pain experienced by people taking opioids is actually caused by the opioids.

DR. STEPHEN GELFAND

   Dr. Gelfand is a board-certified rheumatologist with more than 30 years of experience in the field.  Rheumatologists treat arthritis, fibromyalgia (pain in the muscles and tissues), tendonitis and other soft tissue and joint disorders.  Dr. Gelfand's patients are experiencing pain-often very severe and debilitating pain. He is the author of numerous articles on rheumatology and is considered an authority in his field.

   Abraham Lincoln said, "Important principles may, and must, be inflexible."  In a society where doctors like Dr. Stephen Gelfand can receive lucrative contracts from drug companies if they recommend the use of their products, Dr. Gelfand chooses to follow what should be a doctor's most important principle--the welfare of his patients has to come first.  This principle stand has cost him money and sometimes subjected him to criticism from other doctors who have placed the value of the dollar over the welfare of the patient, but Dr. Gelfand persists in his writing and on radio shows like Larry G's Prescription Addiction show to point out that the claims of the makers of the opioids are exaggerated and often just plain false.

   Rather than allowing his patients to become more and more dependent on opioids and paying him a lucrative fee each time they see him, Dr. Gelfand explains to his patients who have been taking higher and higher doses of opioids in an attempt to control their pain that they are on a path that will lead only to more pain and a deteriorating quality of life.  He educates them on the medical literature that is concluding that the continued use of these opioids is actually making their pain worse.  He explains that there are real alternatives, and Dr. Gelfand's patients experience less pain and a much improved quality of life through the use of non-opioid treatments.

   In a letter to the FDA, Dr. Gelfand cited twenty-one articles/studies in the medical literature pointing out the dangers of opioid treatment for pain and the growing agreement that opioids actually increase pain. 

STUDIES SHOWING OPIOIDS INCREASE PAIN

   In the November 13, 2003 New England Journal of Medicine, Dr. Ballantyne and Dr. Mao published "Opioid Therapy for Chronic Pain".  One of their conclusions was, "Long-term use of opioids may also be associated with the development of abnormal sensitivity to pain, and both preclinical and clinical studies suggest that opioid-induced abnormal pain sensitivity has much in common with the cellular mechanisms of neuropathic pain. Opioid-induced abnormal pain sensitivity has been observed in patients treated for both pain and addiction... Repeated administration of opioids not only results in the development of tolerance (a desensitization process) but also leads to a pro-nociceptive (sensitization) process...  Thus, the need for dose escalation during opioid therapy - that is, the development of "apparent" opioid tolerance - may be the result of pharmacologic opioid tolerance, opioid-induced abnormal pain sensitivity, or disease progression."

   In "Postoperative Hyperalgesia: Its Clinical Importance and Relevance", published in Anesthesiology:Volume 104(3) March 2006, pp 601-607, Dr. Wilder-Smith and Dr. Arendt-Nielsen point out,

   "We therefore have early evidence that opioids may cause hyperalgesia and that this can negatively impact early pain outcomes. However, further studies are clearly needed in this area, particularly with regard to chronic pain outcomes."

   In the Pain Physician, 2007 May;10:479-91, Dr. J. C. Ballantyne made three compelling points.  In layman's terms, these were:

   · There is no strong evidence supporting the long-term use of opioids for pain.

   · There is strong evidence of opioids increasing pain. 

   · The idea that it is all right to increase opioid dosages as tolerance increases is in serious doubt.

   · Epidemiological (study of disease origin) studies are less positive, and report failure of opioids to improve QOL (quality of life) in chronic pain patients.

   In the Journal of  Pain 2006: 125: 172-179, Dr. Eriksen states, "...it is remarkable that opioid treatment of long term/chronic non-cancer pain does not seem to fulfill any of the key outcome opioid treatment goals: pain relief, improved quality of life and improved functional capacity."

   The February, 2008, issue of PAIN, the publication of the International Association For The Study of Pain, states, "Clinicians should consider the possibility of OIH (opioid induced hyperalgesia) when contemplating an adjustment of opioid dose when (1) previous opioid dose escalation has failed to provide the expected analgesic effect and (2) there is an inexplicable exacerbation of pain after an initial period of effective opioid analgesia. Increasing opioid dose may not always be the answer to ineffective opioid therapy, and under certain circumstances a smaller amount of opioid may lead to more effective pain reduction."

WHAT DO WE KNOW?

   It is not disputed that:

   · OxyContin is causing thousands of deaths because it is being used as a replacement for heroin;

   · OxyContin is causing deaths and addiction even though it was prescribed originally by a physician;

   · Purdue's attempt to get the FDA to allow them to promote a "tamper proof" version of OxyContin does nothing to address the devastation caused by the legal use of their drug;

   · There are serious questions about the testing procedures and labs used by Purdue to "prove" that their new version of OxyContin is safer from being used like heroin;

   · Neither Purdue nor the FDA is addressing the growing evidence that their drug may actually be creating pain and not relieving it.

   · The FDA appears to be prepared to accept as true the statements from a company that only a year ago pled guilty to lying about the addictive quality of OxyContin-something that raises serious doubts about the integrity of the FDA.

CONCLUSION

   Purdue Pharma is a corporation that employs thousands of people.  Many of their employees have children.  I would not want to be one of those parents who has to explain to their children why they continued to work for a company that admitted to lies that deliberately and directly, not indirectly or through some strange accident but deliberately, led to thousands of deaths, addiction and ruined lives all across America. 

   What do they say when their children ask about the classmate that died after taking the drug their parents helped make?  

   What do they say if their children ask why Purdue kept pushing more and more drugs in spite of the growing agreement that opioids actually increase pain?

   What they say when they explain what type of work their parents do?  Do they say, "My dad makes OxyContin-legal heroin."

   Unlike the Nazi guards at the concentration camps, these Purdue employees can't say that they were only following orders--they were free to get other jobs. 

   I guess they can try to explain that they were making good money and this bought things.  They certainly can't say that they didn't know that their employer's products were destroying more and more lives every day.

   At Novus Medical Detox Center, we daily work to help people regain their lives caused by prescription drugs like OxyContin.   The FDA must take steps to control this dangerous drug-OxyContin-"Legal Heroin".