Implantable pain disk may help those with cancer
Consistent pain relief may come from button-sized implantable disk to distribute medication
Dr. Suzanne A. Nesbit and Dr. Stuart A. Grossman show a polymer disc that's inserted under the skin and releases pain medication. (Algerina Perna, Baltimore Sun / April 30, 2012)
In poor countries the cost is considered too high for drugs like morphine when such opioids are often stolen, abused or not taken according to instruction.
But some Johns Hopkins University scientists have been working on a solution for those patients, as well as some in the United States, that uses a flexible button-sized disk implanted under the skin that releases consistent doses of painkiller over a month. No pills, no measuring, no trips to the clinic.
If an upcoming clinical trial for safety goes well, the device could be available next year, doctors say. It also could be retooled to treat other diseases and injury, and maybe even some opioid addicts.
"With all the problems, the health officials [in developing countries] would prefer to spend money on antibiotics that cure diseases, vaccines that prevent diseases or children with a long life ahead of them rather than those with terminal cancer," said Dr. Stuart A. Grossman, a Johns Hopkins professor of oncology, medicine and neurosurgery and a pain management expert in Hopkins' Sidney Kimmel Comprehensive Cancer Center.
Grossman grew up overseas but when he returned to India and other poor countries as an oncologist and worked in cancer centers he saw how hard it was for patients with cancer to get opioid pain medications. He and others began working on a solution about 15 years ago. They came up with something that works a little like Norplant, the rods inserted under the skin that release contraceptives over weeks.
Only this round, plastic disk just over a centimeter wide delivers hydromorphone, a more potent form of morphine, through a channel in its center. The rest of the device is sealed to prevent an initial burst of the drug that could kill a patient.
The disk could be made wider to deliver drugs longer, or thicker to deliver higher doses. It eventually could deliver a different drug or be used by veterinarians on animals. But for now, the scientists are focusing on one device for cancer patients that would cost about $50 a month, or about the same as the bill for relatively cheap morphine pills.
With Hopkins' blessing, Grossman patented the device and formed a company called Axxia. Dr. Suzanne A. Nesbit, a clinical pharmacy specialist in pain management and a research associate in the Hopkins oncology department, will run the clinical trial, which was delayed a bit when the maker of the plastic they preferred decided to stick to producing the soles of shoes.
They're working with a new plastic that already is approved for medical implants by the U.S. Food and Drug Administration but requires some fine tuning.
The clinical trial for the disk will be conducted in the Philippines, Singapore and East Baltimore, where Hopkins has a presence.
Grossman said a U.S. manufacturer would make the drug device and Axxia will rely on pharmaceutical companies around the world to distribute it and train doctors unaccustomed to assessing pain, dosing and monitoring patients.
Some of those who treat pain and addiction believe the disk would serve some populations well and look forward to having another tool for tricky patients, though they also see some challenges.
There are an estimated five million Americans on opioid therapy for pain, or 2.5 percent of the population, though most take a short-acting, low-dose Vicodin or similar pill and not every day, said Dr. Nathaniel Katz, the director of the nonprofit Program on Opioid Risk Management at the Tufts Health Care Institute.
Opioids don't work well managing everyone's pain, and about 5 percent of people who take them become addicted to the medications. Others don't stick to their regimen, said Katz, who is also the CEO of a pain-drug development company called Analgesic Solutions.
There may be a role for Grossman's pain disk in addicts and those who don't follow their prescriptions, he said.
"There are people out there who would benefit from having something in their body releasing drugs at all times that doesn't involve the patient and can't be changed by them," he said. "These are people who you fear might overdose if you give them pills, or there is an abuser in the household, or the person has mental illness like PTSD, or Parkinson's disease."
Many don't have consistent pain, and it would be better if they could change their dosage as needed, Katz said. But when that's not possible, some relief is better than none, Katz added.
The disk, he said, may not solve all illicit use of the drug. Even though they are meant to be implanted by a doctor, addicts are crafty and will find ways to acquire them, melt them down and ingest them, said Katz, adding many such recipes end up on Internet.