MIAMI BEACH, Fla. – After the surgical removal of one or both breasts, managing excruciating pain, while dealing with hallucinations, nausea and other adverse effects of narcotic painkillers can be a daunting struggle.
Physicians worldwide are learning about extended-release drug formulations, as alternatives. And there is big money in that. Aside from minimizing the use of oral narcotics such as oxycodone, physicians also want new pain protocols to reduce hospital stays, so to decrease costs and exposure to drug-resistant super bugs.
Even more concerning after treatment is that "good old fashion morphine" and narcotic pain killers "may weaken the immune system in a way that makes it easier for breast cancer to come back," said Dr. Patrick Borgen, who is the chairman of the surgery department of Maimonides Medical Center in Brooklyn.
Breast cancer patients learn a lot about fearful pill-popping to manage acute pain during grueling treatments. And many survivors have co-existing conditions such as sleep disorders. The 32nd annual Miami Breast Cancer meeting running Thursday through Sunday offered information about the newest pain management strategies, according to Borgen, the conference chairman.
To deal with pain after surgery, some physicians attending the Miami conference said they are administering cocktails of medications intravenously and into the tissues through injection during surgery.
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To help patients deal with chronic pain and prevent addiction risks, some physicians say they are increasingly recommending non-drug integrative approaches -- such as acupuncture, meditation routines, Tai Chi exercises, chiropractic techniques, psychotherapy and physical therapy.
OPIOID EPIDEMIC: In the U.S., there were at least 16,235 deaths involving prescription pain killers in 2013. President Barack Obama allocated 2016 funding for states' monitoring programs aiming to improve addiction treatment and to make opioid antagonists available to first responders of injuries. More about the epidemic >
In the spacious conference rooms and at the luxurious restaurants of the Fontainebleau Hotel in Miami Beach, where healthcare professionals from all over the world were, the strong arming influence of pharmaceutical companies was felt. Several physicians mentioned Exparel, a non-opioid drug by Pacira Pharmaceuticals. The New Jersey-based corporation is one of many supporting the Miami conference's continuing medical education program.
Exparel uses Bupivacaine, a local anesthetic. During a lecture, Mayo Clinic's Dr. Valerie Lemaine compared the drug's slow release delivery to a pomegranate, because of its use of liposomes, tiny bubbles that can be filled with the anesthetic. Exparel is also known as Liposome Bupivacaine or Bupivacaine Liposome Injectable Suspension.
The drug has to be injected directly on the tissue and its effect can last for many hours after surgery. Once in the tissue, "the little fruits inside the particles will be slowly released as there is erosion of the membrane," Lemaine said.
Lemaine added that she has used the drug on patients undergoing mastectomy, implant breast reconstruction and cosmetic procedures. She is an assistant professor of plastic surgery ? and the vice chair for research in the division of plastic surgery in Rochester, Minn.
"I have found that it has made a difference in my patients," Lemaine said adding that her opinion is objective, because she doesn't have a financial relationship with the maker of the drug. Exparel, which can cost about $100 a day, can be diluted with saline solution, Lemaine said.
The U.S. Food and Drug Administration approved the drug October 2011. Its approved labeling did not indicate that it would be safe or effective for post-surgical pain, if used in procedures other than the surgical removal of hemorrhoids or the removal of an enlargement of the joint at the base of the big toe.
ACCORDING TO THE FDA: The drug had a "significant reduction" in pain compared to placebo for up to a day, FDA agreed. In a trial involving surgery to remove hemorrhoids, there was "minimal to no difference" between the drug and placebo from a day to three days. However, there was a decrease in opioid consumption through three days, FDA records show. More about the approval >>
Pacira reported Exparel sales surged. But investors got nervous when the FDA's Office of Prescription Drug Promotion issued a warning Sept. 25, 2014. Pacira "was overstating the efficacy" and touting its ability to be effective for up to three days, when in fact, it was approved only for 24 hours of relief, the FDA found.
A week before the Miami Breast Cancer meeting, Pacira announced that they had reached a mutually acceptable resolution with the FDA's OPDP. Pacira promised to ensure that its "sales force and other promotional channels" make accurate claims regarding duration of efficacy, after the drug is "administered into the surgical site to produce post-surgical analgesia."
Reet Lawhon, a physician who was a speaker during a Miami Breast Cancer meeting educational session for surgical oncologists, said that in his opinion the length of the effect of the drug after surgery was "absolutely amazing." But he is a Pacira consultant and shareholder.
The Institute of Safe Medication Practices classifies the drug as "a high-alert medication." This relates to the drug having a similar label to Propofol, a powerful anesthetic and "urges caution to avoid mistakenly using one for the other," said Susan Heins, a spokeswoman for the maker of Exparel.
Lawhon also warned during his lecture that if the drug is administered intravenously it can cause adverse cardiac effects.
"We are not at a point of giving people zero narcotics," Lawhon said. But he added that the use of the drug helps to lower their use."
AWARENESS MONTH: Let's talk about breast cancer
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