A regional opioid conference last Wednesday, June 5, in Piketon, an hour west of Athens, featured a surprising keynote speaker – an executive for one of the major pharmaceutical companies in the crosshairs of state governments across the country for allegedly being complicit in the opioid epidemic.

Dr. Donald Kyle, vice president of discovery research and non-clinical sciences for Purdue Pharma LP, mainly discussed chemists’ efforts to produce non-addictive drugs for treating pain.

However, he also took questions about the controversy surrounding Purdue Pharma and other major pharmaceutical companies that have been slammed for helping to trigger the epidemic of opioid abuse that continues to plague communities across the country, including here in Appalachian Ohio.

State Street Laboratories, LLC, a diagnostic and toxicology testing lab, sponsored the regional conference on the opioid epidemic at its location in the Endeavor Center near Piketon. Jules Guei, Ph.D., founder and president of State Street Laboratories, delivered the welcoming remarks. Guei also teaches forensic toxicology at Ohio University in Athens.

Keynote speaker Kyle spoke at length about efforts by various pharmaceutical companies to produce non-addictive pain-killers. He 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 his employer Purdue Pharma, 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 allegations of “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.”

Last week, the article reported, 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.

California is just one of over 40 states that have sued Purdue Pharma, the article said.

“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’s 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 led to the charges that Purdue accepted from back in (2007).”

“I don’t work in that part of the business,’ Kyle added.

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 continued. “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,” he 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.”

 

IN HIS WELCOMING REMARKS, DR. GUEI stated 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 organized the conference “for the education of the communities in southern Ohio on how the opioid crisis has impacted the Appalachian region the most,” he said.

According to Guei, the opioid crisis can be overcome by educating communities on the dangers of the drugs. Guei stressed that treatments such as methadone, buprenorphine (Suboxone), and naltrexone (Vivitrol) should be brought into local communities without stigma and finger-pointing, and the opioid reversal drug, Naloxone (Narcan), should be readily available to the population because opioid use disorder (OUD), or opioid addiction, is a disease.

Guei also advocated for the opening of needle distribution places and safe-injection sites throughout area 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 Health Department, stated that Buprenorphine prescribing has been extended to physician’s assistants and nurse practitioners in Scioto County, and said her county is concerned about the rise of hepatitis C among opioid users.

Athens attorney Andrew Mollica encouraged the implementation of the “Good Samaritan” law, referring to the 911 Drug Immunity law, which “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.

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