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Questions raised on opioid bill

A new house bill that seeks to combat the ongoing opioid crisis has come under attack due to speculation about how the bill was fast-tracked, the expense to patients and insurance companies and whether the plan can actually curb the effects of the epidemic.

Rep. Doyle Heffley, R-Carbon, sponsored House Bill 1698, which requires health insurance plans to cover at least three abuse-deterrent opioids if they provide coverage for an opioid painkiller. Abuse-deterrent opioids are painkillers that can interfere with drug euphoria, or even change the makeup of the drug if it is manipulated for snorting or injecting, making it less palatable for abuse. Some versions include a chemical like naloxone, a potent opioid antagonist that can cancel out the medication's effect if it is injected instead of taken orally.Heffley said the intent of the bill was to provide a therapeutic choice to patients and doctors, especially in cases where a patient or family member could be prone to opioid abuse.According to an Associated Press article released early this week, the bill, which passed the House in June by a 190-3 vote, is awaiting action in a Senate committee and has the support of Gov. Tom Wolf as he presses lawmakers to pass a package of legislation this fall.The AP reports the drug has been lobbied in the Senate by at least one major pharmaceutical company - Purdue Pharma, maker of OxyContin - and is similar to legislation shopped by drugmakers in as many as 20 other states.Heffley said it sprang from the recommendations of a 38-member opioid task force and advisory committee he helped assemble.The task force included two representatives of drugmakers - Purdue Pharma and Pfizer - and two representatives from organizations that are partially funded by drugmakers, the U.S. Pain Foundation and the American Academy of Pain Management.The group met in private, held no public hearing and included pharmaceutical industry representatives, The Associated Press reported.Heffley says the opposite."House Bill 1698 was introduced along with five other pieces of legislation (the recommendations from the task force) in November 2015. The task force took over a year to come up with the recommendations, and the report was released in June 2015. This was by no means fast-tracked. In fact the resolution is from last session," Heffley said.The task forceHeffley pointed out that the task force consisted of representatives from numerous government and civil groups."Representatives from 34 different groups, including the Pennsylvania Medical Society, the Department of Health, the PIAA, the Fraternal Order of Police, the Nurses Association, the Pennsylvania Department of Drug and Alcohol programs and many others served on the task force which came up with the recommendations," Heffley said.Glenn Pasewicz, the executive director of the Joint State Government Commission, said that task force's meetings were not subject to the state's open records laws."I strongly urge Rep. Heffley to consider releasing the minutes of these secretive task force meetings between drug company lobbyists and lawmakers. Pennsylvanians deserve to know whether our representatives are fighting for us or for the special interest groups," his Democratic challenger Neil Makhija said.The findings of the task force, found on the state website's documents section, includes a thorough analysis of House Resolution 659, the basis for the bill.According to Heffley, the bill was discussed over eight hearings across the state, including one in Scranton, during this past summer."At the hearings, which were attended and supported by members of both parties, we heard from advocates, doctors, individuals who have personally been impacted by the crisis and many more," Heffley said.Skeptics warn that abuse-deterrent painkillers carry the same risks of addiction as opioid versions that lack such properties.Dr. Andrew Kolodny, the executive director of Physicians for Responsible Opioid Prescribing, was quoted by The Associated Press, arguing that the abuse-deterrent formulations of painkillers were simply a way for the pharmaceutical agencies to profit off the addiction crisis."Addicts almost always begin with swallowing pills whole, and the fact that that's on the menu suggests to me that pharmaceutical lobbyists have been very successful in Pennsylvania," said Kolodny, who also is the senior scientist at Brandeis University's Heller School for Social Policy and Management."Instead of rewarding the price-gouging drug companies who caused this epidemic, we should make them pay for treatment centers and specialized drug courts that would actually help our community," Makhija said.EffectivenessDan McGrory, county administrator for the Schuylkill County Mental Health, Developmental Services, and Drug & Alcohol Programs, questioned whether other actions would be more beneficial."This is clearly a wait-and-see kind of situation," McGrory said. "To see this done instead of, or at the expense of, putting state dollars into community-based treatments is really a deep concern that we have."Heffley said this simply opens up treatment options for patients and doctors."Drug manufacturers will not benefit from this bill. My legislation provides doctors with the option to prescribe abuse-deterrent opioids to those patients they believe would benefit from such drugs. It maintains doctor's discretion and provides them with another option to consider when prescribing," Heffley said.However, abuse-deterrent opioids will cost about $600 to $2,800 more than their regular counterparts annually.Since these formulations are relatively new, drug manufacturers hold exclusive patent rights, therefore no generic equivalents are available yet.Chris Sorrentino, case management supervisor for the Carbon-Monroe-Pike Drug and Alcohol Commission, said that the abuse-deterrent formulations are not being forced upon patients."It's not saying it has to be prescribed, it's not saying doctors have to look at abuse-deterrent opioids first. It's an option," Sorrentino said.Heffley claims that the backlash for the bill stems from special interest groups, including insurance agencies."The insurance federation is trying to block the bill, because they don't want to pay for it," Heffley said. "Some special interests in Harrisburg do not want this bill to become law because they are currently profiting from this epidemic."A right direction?Heffley has stressed that this bill is a step in the right direction, essentially one of many approaches to the problem."This is one tool, of many, that is proven to deter opioid abuse. Abuse-deterrent opioids, which are time-released, will also cut down on the number of pills prescribed to patients and therefore the number of pills that can be bought, sold and misused," Heffley said.In fact, the U.S. Food and Drug Administration released a statement concerning abuse-deterrent formulas in March, which said "while the FDA recognizes that the ADFs are not fail-safe and more data are needed, ADF opioids do have properties expected to deter abuse compared to non-ADFs."McGrory is skeptical about abuse-deterrent opioids and their safety measures, especially as to whether or not this will prevent abuse."I think there is somewhat of a misconception about the nature of drug abuse. Our experience is that they're taking them orally, taking them by the handful," McGrory said.So, while special alterations to the makeup of a medication may prevent it from being crushed and snorted or injected, it could still just as easily be abused. In addition, patients and doctors would have to choose the deterrent option themselves, instead of the standard medication."If an abuse-deterrent medication does not diminish the value of the medication as a pain deterrent, why wouldn't you do that? If you believe this is a valuable step, why would you make it optional? And if people are going to abuse, why would they exercise the option?" McGrory said.The Pennsylvania Medical Society is neutral on the subject, opting to wait for proof of the drugs' potential."We're still learning, and as such are waiting to see the science behind tamper-resistant opioids as far as their impact on the opioid crisis," said Chuck Moran, director of media relations for the Pennsylvania Medical Society.Sorrentino agrees with Heffley's statements, echoing that this is one approach among many that could help with the addiction crisis - but it is no guarantee of success."Nothing is 100 percent foolproof. Is it possible that people could abuse the abuse-deterrent opioids? Yes, it's a possibility. But it does make it more difficult," Sorrentino said.The Associated Press contributed to this report.