State Street Laboratories, LLC, a diagnostic and toxicology testing lab located at the Endeavor Center on Shyville Road near Piketon, sponsored a regional conference on the opioid epidemic at the Endeavor Center on June 5.
Jules Guei, Ph.D, the founder and president of State Street Laboratories, LLC, delivered the welcoming remarks, stating that the mission of his company, which he founded in 2017, “is for the improvement of human health through diagnostic testing and education.” State Street Laboratories, LLC, organized the conference “for the education of the communities in southern Ohio on how the opioid crisis has impacted the Appalachian region the most.”
According to Guei, the opioid crisis can be overcome by educating communities on the dangers of opioids. A faculty member in forensic toxicology at Ohio University, Guei stressed that treatments such as methadone, buprenorphine (Suboxone), and naltrexone (VIvItrol) should be brought into our communities without stigma and finger-pointing and to make the opioid reversal drug, Naloxone (Narcan) readily available to the population because the opioid use disorder (OUD), or opioid addiction is a disease.
Guei also advocates for the opening of needle distribution places and safe-injection sites throughout our communities because he believes doing so will decrease the spread of HIV and hepatitis C, which result from needle sharing by opioid users.
The first guest speaker, Lisa Roberts, RN, from the the Portsmouth City Department of Health, stated that Buprenorphine prescribing has been extended to nurse assistants and nurse practitioners in Scioto County, and said Scioto County is concerned about the rise of hepatitis C among opioid users.
Attorney Andrew Mollica encouraged the implementation of the “Good Samaritan” law. Good Samaritan law, or the 911 Drug Immunity law, “encourages citizens to call 911 should an episode of drug overdose be witnessed.”
Hocking County Judge Fred Moses, who runs a drug court, stated that jail “is not the answer to the (opioid) crisis,” and said that through the naltrexone (Vivitrol) program, an 80 percent success rate among opioid use disorder patients entering the job market after completing his program has occurred.
The keynote speaker at the conference, Dr. Donald Kyle, vice president of Discovery Research and non-clinical sciences for Purdue Pharma, discussed the chemists’ efforts in producing non-addictive drugs for treating pain.
According to Kyle, Vertex Pharmaceutical company has developed a NaV1.8 channel blocker that is currently in a Phase 2 clinical trial. “They’ve done three studies now, one with pain associated with bunionectomy, one with pain associated with osteoarthritis and one with small fiber neuropathy,” Kyle said. “They show efficacy in all three and Vertex is moving on into Phase 2b with these compounds ... this doesn’t touch the opioid receptor so there is no euphoria, no constipation, no respiratory depression or anything like that.
“Another approach is that a drug abuser wants to get high right now,” Kyle said. “So what about designing molecules ... that take a longer time to penetrate into the central nervous system, delaying the potential for euphoria. Drugs like that (are) maybe less preferred so therefore used less.”
According to Kyle, Nektar (Therapeutics) has developed a compound, NKTR181, a derivative of oxycodone. “If FDA approved, this analgesic may offer lower abuse potential,” Kyle said. “It’s a little less potent and it’s a little less efficacious than oxycodone ... It takes more concentration of the NKTR compound to get the same level of analgesia that we are getting from the oxycodone ... It’s tamper resistance is intrinsic, which means you can’t defeat it by crushing the tablets or defeating the formulation or doing some kinds of chemical extraction. They’re waiting for their FDA approval letter and they expect that to be coming out in the third quarter of this year.”
A new drug, ZH853, is four times more efficacious than morphine, according to Kyle. “ZH853 produces analgesic just like morphine, a hundred-fold lower dose than morphine,” Kyle said. “It also has a prolonged effect compared to morphine. The analgesia lasts for a long time before it starts to drop off, whereas morphine starts dropping off fairly quickly and that’s typical for most opioids ... Morphine produces a strong respiratory depression. The ZH 853 produce(s) almost no respiratory depression.”
Kyle estimates the drug will be commercially-launched in five to seven years. “With the opioid crisis on us right now, it’s a great profile, but the timing just doesn’t work,” he said. “But it’s a good example of some of the science that goes on in the chemistry community right now.”
Kyle also briefly described a new Purdue Pharma drug for pain treatment
“It produces analgesia but doesn’t cause constipation, it doesn’t cause respiratory depression and it doesn’t cause euphoria in a monkey model,” Kyle said. “That’s pretty exciting. We’re not the only group that’s working on a new generation of opioids. Other groups are doing it as well.”
During a question-and-answer session that followed Kyle’s presentation, he addressed the recent and past litigation involving Purdue Pharma, the producer of the painkiller, OxyContin.
In federal court in 2007, Purdue Pharma pleaded guilty to “felony misbranding of OxyContin,” and settled with California and 26 additional states for “deceptive marketing practices,” according to a June 3, 2019, article in the San Francisco Chronicle, “California latest state to sue Purdue Pharma over OxyContin marketing” by Alexei Kosoff.
Purdue Pharma is being similarly sued again by numerous states.
This week, California sued the pharmaceutical firm “for allegedly misleading the public about the safety of its painkiller OxyContin and contributing to the nationwide opioid abuse epidemic.” California’s lawsuit alleges that “Purdue expanded its sales force and promotion, causing it to be overprescribed and leading to it’s current opioid crisis,” according to the San Francisco Chronicle article.
“I find myself often as the guy from Purdue in the room and that’s fair,” Kyle said. “Obviously, I think the opioid crisis is tragic. It’s real ... I think that there are a number of factors that contributed to that.”
Kyle said Purdue Pharma pleaded guilty to felony charges (in 2007) “for what they called misbranding or not fairly representing the risks of addiction.”
“I looked at our own label for OxyContin when it was launched back in 1995,” Kyle said. “Just from my own perspective, at the very top of the label, in bold letters, it said this is a controlled substance, this is a schedule II, there’s a very high risk of abuse, overdose, misuse, overdose can lead to fatal outcomes and things like that clearly represented in the label. I guess what I’m trying to say is the pharmaceutical companies, I feel, are saying that the labeling has always warned about the danger of these things. “
According to Kyle, pharmaceutical companies’ marketing is, by law, based on what is written on the bottle.
“The FDA has to approve all that,” Kyle said. “So you’re really not allowed to say anything about your product that’s not clearly written on the label. It has to be FDA approved before you can use the marketing materials. Purdue, back in the day, I guess, there were some marketing statements that were made that were outside of the bounds of what the FDA thought was appropriate. And that lead to the charges that Purdue accepted from back in (2007).”
“I don’t work in that part of the business,’ Kyle said.
Kyle joined Purdue Pharma in 1998.
“I’d say that’s probably an area that companies can do better at, and that’s really balancing the equation and making sure people really do understand the risks and benefits of opioids,” said Kyle. “But actually that’s the physician’s main task when prescribing an opioid, is to balance the risks-benefits ... I think the pharmaceutical companies could partner better with academic research ... In the area of pain there’s an unmet need and there’s such a need for new, non-addictive medication.”
“I want to bring solutions to the problem,” Kyle added. “So, inside our company, I’m one of the advocates for, let’s take the information that we have that’s not published and share it with the people. Let’s take some of our compounds and share it with academic research to advance the science to solve the problem.”
Kyle said better communications in the marketing (of drugs) and changing the way prescriptions are handled could be beneficial as well.
“I think all these things will have a major benefit,” Kyle said. “It’s just that it’s a shame that it took an opioid crisis to bring things together to find a solution. I just wish it could have been done in advance.”