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May
4

UPDATE – The lollypop story gets big

Actiq has hit the big-time.
Newsweek’s latest edition will feature an article on the off-label prescribing of the highly potent narcotic lollypop, an article noting that as much as 80% of scripts for Actiq are for off-label use.
Sources indicate this was brought to the reporter’s attention by an unusual source – the risk management department of The Washington Post, Newsweek’s sister publication, noticed a high incidence of Actiq scripts among its workers comp patients, and started digging into the issue.


Cephalon, Actiq’s manufacturer, strongly denies it promotes the drug for off-label usage, but internal sources at the company appear to reject those claims.
This has gotten the attention of Connecticut’s Attorney General as well as Rep. Henry Waxman, chair of the House Oversight and Government Reform Committee.
At the request of several consulting clients, I have been in contact with Cephalon to address the specific issue of off-label prescribing in workers compensation. Cephalon’s response was received last month, and is being shared with several larger WC PBMs and payers.
UPDATE
From a contact in the WC PBM industry comes this tidbit – overheard at the American Pain Society conference in DC this week – a Cephalon rep said “without off-label prescribing, we’d be out of business…”


5 thoughts on “UPDATE – The lollypop story gets big”

  1. In a recent Pain Management conference, a Cephalon rep was overheard to say: “every one of our products has significant use off-label. In fact, if it weren’t for off-label use, we’d be out of business.”

  2. What is even more shocking is the 87.6% increase in the manufacturer AWP of this product within a 12-month period (Jan-Dec 2006). This medication should be used as a last resort when other short-acting opioid analgesics do not provide adequate (acute) pain relief.

  3. I suffer from an EXTREMELY RARE gynecological disease that effect less than 1% of the women in the entire world. It is so rare that only OB/GYNS or anesthesiologists who specialize in this area of pain management are familiar with it. It has NO CURE. We searched the world over and consulted the BEST of doctors. The pain is SO EXCRUCIATING. My worse pain attacks feel like I am in the potocin induced transition part of active labor without an epidural. Without Actiq, I would be dead already. Other meds do not compare. My doctor told me years ago, people who suffered my degree of pain committed suicide. Actiq gives me at least a partial life to live (the worst attacks still leave me almost immobile, but able to LIVE THROUGH IT AND SURVIVE.) I thank G-D EVERY DAY that He enabled Actiq to come about so my husband still has a wife and my five young children a mother. SHAME on those people who are so judgmental. If they would have but ONE second of my pain, they would COME RUNNING to get a prescription filled. Oh and one more thing. I NEVER got a “high” because I ONLY use it for when I REALLY need to do so.

  4. Maybe someone from the medical field can explain–in layman’s terms–the difference between chronic pain caused by terminal cancer, and chronic pain caused by other sources such as migraines, back pain, endometriosis, degenerative disks, etc?
    An awful lot of holier-than-thou lawyers and medical folks out there who seem to know what’s best for everyone–yet they’re not suffering, and their patients suffer twice. First with the pain of their affliction, and then with the pain of knowing their doctor dismisses their pain.

  5. I like others on this forum, suffer from a rare and painful condition. It is called Pseudotumor Cerebri. When I was finally diagnosed I had one of the highest CSF pressures my physician had ever seen even though his career includes nearly thirty years as a Neurologist specializing in headache pain. I was one of the first patients in my area to have a lumboperitineal shunt inserted to try to reduce the pressure after a myriad of medications proved ineffective. The pressure was so high it caused a condition called empty cella syndrome, meaning that the pressure of the CSF caused the pituitary gland to be smashed flat against the top of the area in which in normally hangs in the brain, making it impossible to see with an MRI, CT or X-Ray. I was rapidly losing my vision due to the pressure on my optic nerves and the pain and vomiting from the headaches completely took over my life. After the shunt and diuretics we were able to save, at least so far, what remained of my vision but I had lost most color vision and all depth perception and am totally night blind. The pain and vomiting was sending me to the hospital emergency room or the headache clinic several times a week for injections of Demerol and Phenergan and I was just miserable the rest of the time. My CSF pressure was more than seven times normal before the shunt and the lowest they could adjust the shunt to once it was inserted, still left it more than three times normal. While this helped arrest the loss of vision, it did little to reduce the frequency or severity of the headaches and I spent most days and nights in either the tub or hovering over the toilet. After years of trying many different pain medications and finally having to make due with Darvocet and Fiorinal along with the hospital and clinic visits my physician finally convinced me to try Methadone. Because I grew up with an alcoholic, I was loathe to use a narcotic, afraid I would become a junkie. My physician assured me that people who are truly in pain, real pain, rarely become addicted to the medication and it would improve my quality of life. I finally relented and began taking Methadone. While it did help with the day to day pain, I was still experiencing terrible headaches and vomiting episodes more than five times a week, most weeks, and they became much, much worse when the weather was changing, the barometric pressure changes prior to a cold front or hurricane caused horrible headaches and once the vomiting began often it went on for two to three days before letting up. So while I was better than I had been, I was still having to make trips to the hospital or clinic for intervention several times a month. Finally after a couple of years of the Methadone and Darvocet, my pain management physician suggested Actiq for the worst of the pain. It has been a Godsend. Thanks to the Actiq, I am actually able to get away from the house knowing that if I feel a severe headache coming on, the Actiq will control it until I can get home and sometimes it will even abort it. The doctors tried every kind of medication you could imagine to try and give me a decent quality of life before I would even try the Methadone, but I was allergic to many of them and most were simply ineffective or became ineffective after using for a few months. The Actiq doesn’t cause euphoria or sleepiness, I don’t think about it when I don’t have a bad headache and I am very, very grateful that my physician prescribed it for me. I finally have periods where I am relatively pain free, at a level four or five as opposed to the nine to ten that I was usually having to deal with. It is simply disgusting to me how people who do not have to deal daily with terrible pain feel they have the right to judge what is the proper treatment for those of us who do. I am sure there are those who abuse these medications, but people who genuinely suffer with pain are being helped by having access to them. I have read where there have been a few, very few deaths that may have been contributed to by misusing narcotic pain medication. While those deaths are tragic and sad, there are hundreds of thousands of patients living happier and healthier and more productive lives because their doctors had the knowledge of and courage to prescribe these medications for them. If the government wants to look into senseless and needless causes of deaths in this country they should turn their attention from a medication that has done so much good for so many and to cigarettes and other easily accessible tobacco products. In order to get Actiq and other narcotic pain medications legally a patient must be seen regularly by a licensed physician who monitors their health while they are using them, as opposed to being able to walk into any gas station and purchase tobacco, which provides no treatment for an illness, but instead, causes many of the very diseases whose symptoms are among those for which Actiq offers relief. I really believe that before banning a medication that doesn’t have a proven record of dangerous side effects, these people should be required to suffer through some very severe and unrelenting pain, and be aware that there is an effective medication available which will relieve that pain, but because a very few people may have caused their death by either misusing or abusing it, some bureaucrat has decided they can’t have it…for their own good. If they knew that it was their loved ones or they, themselves who might one day be suffering with some horrible, daily, lingering pain and the only medication that was effective had been pulled off the market by some ignorant do-gooder, they might think twice about second guessing physicians who are pain management specialists.

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Joe Paduda is the principal of Health Strategy Associates

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