Biotech firm buys UK professor's anti-overdose nasal spray

Pharmacy Professor Daniel Wermeling at the University of Kentucky invented a nasal spray to fight heroin overdoses, and a biotech firm has bought the product, which may be on the market within six months, pending approval by the U.S. Food and Drug Administration. The device "contains a single dose of a mist form of naloxone and delivers the drug in a way similar to how Flonase is used to treat allergies," Mary Meehan reports for the Lexington Herald-Leader.

The product is on a fast track for approval because of the rising rates of heroin overdoses across the country, said UK Provost Tim Tracy, former dean of UK's pharmacy school. Wermeling doesn't know exactly when his product will be on the market, but he said the FDA approved another fast-track, anti-overdose therapy after only 14 weeks. The fast-track program speeds development of drugs to treat serious or life-threatening conditions. "Last year, 233 people [in Kentucky] died with heroin in their systems, according to the state medical examiner's office," Meehan notes.

Wermeling has been developing the project at UK since 2009 with the help of more than $5 million in federal and state tax dollars. Tracy said Indivior PLC, the spinoff pharmaceutical company that bought the nasal spray, will be able to manufacture, market and distribute the product. Right now, emergency responders and hospitals must draw naloxone, branded as Narcan, in a syringe to provide the correct dose.

Louisville opens first needle exchange in state; officials predict rural counties will be slow to follow

Photo by Scott Utterback, The Courier-Journal

Louisville Metro Public Health & Wellness opened its mobile needle-exchange program Wednesday, June 10, making Louisville the first place in Kentucky to implement such a program.

Lexington and Northern Kentucky are expected to follow soon, but officials say that establishing needle exchanges in much of Kentucky will be "more politically complex," Mike Wynn reports for The Courier-Journal.

"We're going to see some parts of our state where this is available and others where it is not," Scott Lockard, president of the Kentucky Health Departments Association, told Wynn. "Rural areas are opting for a slow and deliberate approach, heavy on education and dialogue," he said, and some communities won't even consider a exchange because of "seemingly endless hoops to jump through."

Bullitt County, south of Louisville, is a prime example. There, officials told Wynn that they plan to do a needs assessment and host a community forum with input from law enforcement and mental health experts.

"It's a work in progress," Public Health Director Andrea Renfrow told Wynn. "We are not able to go as quickly as Louisville Metro."

One critic, Magistrate Joe Laswell, told Wynn that he had talked to many voters who are against the exchanges and want to know why police wouldn't arrest addicts when they show up to swap out dirty needles. "I believe in charging and incarcerating," he said, apparently unaware that the addicts would need to have drugs in their possession to be charged.

Lockard, who heads the Clark County Health Department, told Wynn that he won't ask his board to take a vote until August and that he can't predict the political outcome when it goes to city and county officials.

In three other Bluegrass counties, Scott, Harrison and Nicholas, the board of the Wedco District Health Department wants to start a needle exchange, reports The Cynthiana Democrat, but can't proceed in any of the counties without approval of the fiscal court.

So, despite the two-year debate that just ended in Frankfort over the law, it's not really over.

Democratic state Rep. John Tilley of Hopkinsville, the legislature's biggest proponent for needle exchanges, told Wynn that giving city councils and fiscal courts final authority over the programs was necessary to sooth critics and pass a comprehensive heroin bill this year.

Opponents of the law say the exchanges promote drug use, while proponents cite evidence that doesn't support those claims, but instead "help prevent the spread of deadly and expensive diseases and pull addicts into treatment programs while keeping dirty needles out of parks and off the streets," Wynn writes.

A Lexington Herald-Leader editorial wrote about needle exchanges: "Congressional critics rely on a gut feeling that providing needles endorses drug use, but 20 years of research argues otherwise." Listing that where there are syringe exchange programs:

• Participants are five times more likely to get treatment.
• HIV and hepatitis C declines among drug users.
• Participants can get referrals to substance abuse treatment, disease prevention education, vaccinations, condoms, counseling and testing for communicable diseases.
• Costs are more than recaptured. A 2011 European study found that $1 spent on needle-exchange programs yielded $27 in health-care cost savings, prompting an international report to call needle exchanges "one of the most cost-effective public health interventions ever funded."

The federal Centers for Disease Control and Prevention recently reported that new cases of hepatitis C more than tripled in Kentucky, Tennessee, Virginia and West Virginia between 2006 and 2012, mainly from the use of dirty needles. Officials fear an outbreak of HIV and AIDS will follow.

Free overdose-reversal kits are given to Kentucky hospitals with the highest recent rates of heroin-overdose deaths

Kentucky hospitals with the highest rates of heroin overdose deaths are receiving funding for heroin/opiate overdose reversal kits, which will be provided free of charge to every treated and discharged overdose victim at the pilot project hospitals, according to a state press release.

The funding for these kits is through the Substance Abuse Treatment Advisory Committee, which oversees the distribution of a $32 million pharmaceutical settlement fund that is used to expand treatment in Kentucky. The committee has allocated $105,000 to purchase these kits for the pilot hospitals: the University of Louisville Hospital, the University of Kentucky Medical Center in Lexington, and the St. Elizabeth Healthcare in Northern Kentucky.

In 2013, 230 Kentuckians died from heroin overdoses. Final numbers for heroin overdoses in 2014 are not yet available, but the Office of Drug Control Policy estimates heroin was involved in 30 percent of all drug-overdose deaths, according to the release.

Attorney General Jack Conway chairs the committee and First Lady Jane Beshear serves on it. They announced recently that about 500 of these kits will be made available to the St. Elizabeth system, which treated 545 people in 2013 and 745 people in 2014 for heroin overdoses.

“There is evidence the collaborative efforts in our community are having an effect,” St. Elizabeth interim president and CEO Garren Colvin said in the release. “A report earlier this month indicated that heroin-related overdose deaths are down in Northern Kentucky. ... To continue to battle heroin issues in our community and throughout Kentucky, it is going to take education and collaboration at the local and state levels.”

Naloxone, which is also known as Narcan, is the drug in the free Naloxone Rescue kits and "has no potential for abuse and immediately reverses the effects of heroin overdose by physiologically blocking the effects of opiates," says the release.

One of the challenges for access to these kits is that they are not covered by Medicaid or many private insurance companies and are too expensive for most people to purchase. Health experts anticipate that when the U.S. Food and Drug Administration approves the nasal mist form of the drug, most insurance companies and Medicaid will cover it.

“As Kentuckians expand access to mental health treatment, including addiction recovery, it’s more important than ever to have community access to tools like Narcan,” Jane Beshear said in the release. “Often, an overdose experience is what finally drives people suffering from addiction to seek help.”

State health commissioner backs needle exchanges, most controversial part of anti-heroin legislation passed this year

The Kentucky General Assembly cracked down in 2012 on "pill mills" that dispense painkillers irresponsibly, and addicts responded by going for heroin, creating a big problem in much of the state. The 2015 legislature passed laws to crack down on heroin, including local needle-exchange programs, the most controversial feature of the package.

In a column distributed to Kentucky newspapers, state Health Commissioner Stephanie Mayfield defends and promotes the local programs, which are subject to local approval.

“To some, a needle exchange may sound like a program that helps intravenous drug users feed their habit,” Mayfield writes. “To the contrary, the intent of an NEP is to protect public health and create a path for heroin users to get treatment while preventing the spread of diseases through the sharing of needles.

Needle exchanges reduce the number of HIV/AIDS and hepatitis cases in a community, Mayfield writes. "The use or even the accidental stick of a dirty needle can lead to hepatitis, HIV/AIDS infection and other dangerous diseases. . . . About 15 percent of all HIV cases that have occurred in Kentucky have been among injecting drug users."

Stephanie M. Gibson

Mayfield also says needle exchanges protecting people from accidental sticks from dirty needles discarded in public places. "Intravenous drug users submit dirty needles to the NEP for proper disposal in exchange for clean needles," she writes. "Researchers have also found that injecting drug users who participated in an exchange were more likely to reduce or stop injecting than drug users who had not participated in a needle exchange."

Research has also shown that needle exchanges "do not encourage the initiation of drug use nor do they increase the frequency of drug use among current users," Mayfield writes, noting that there are 203 such programs in 34 states.

"The presence of NEPs in communities does not expand drug-related networks nor does it increase crime rates. . . . Needle exchange programs actually create a path for injecting drug users to get help because the programs offer information on how to find available treatment options. In fact, NEP participants are more likely to enter a drug treatment program than nonparticipants."

More recent studies show that needle exchanges "provide opportunities for disease testing and education leading to a decline of at-risk behaviors, resulting in HIV incidence dropping as much as 80 percent within this population," Mayfield writes. "Many Kentucky communities are desperate for the ability to reach out to members who suffer from addiction, to help slow the spread of diseases and provide treatment referrals to people they might otherwise never have the chance to reach. This law gives them that opportunity."

Congress is taking on opoid abuse and the nationwide increase in drug overdoses

Federal officials have become increasingly concerned about the rapid increase in drug overdoses across the country. The House Energy and Commerce Committee, in a series of hearings on the topic, is looking at how states are dealing with this problem. The next meeting is scheduled Thursday, May 28.

Senate Majority Leader Mitch McConnell and Sen. Ed Markey of Massachusetts, in a bipartisian effort, wrote a letter to Department of Health and Human Services Secretary Sylvia Mathews Burwell this week, asking her to call on the surgeon general to address opoid abuse and made a request for more information regarding its recently announced initiative to reduce opoid-related deaths and addictions, according to a press release.
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"This crisis of opioid related overdoses strikes without regard to geography, age, race, or socio-economic status and it requires an immediate and sustained response," McConnell said in a statement, calling opioid abuse a "public health crisis."

In the final hours of the last legislative session, Kentucky passed a bipartisan heroin bill that included an emergency clause for it to take effect immediately. This new law allows judicial discretion to determine if low-level traffickers should go to jail or be ordered to treatment; stronger sentencing for high-volume dealers; increased money for treatment; optional needle exchange programs; a "good Samaritan" provision; and increased access to Naloxone, a drug that can reverse the effects of an overdose.

Opoid-related overdose deaths are largely caused by prescription drug and heroin.

In Kentucky, of the 722 deaths autopsied in 2013, 230, or 32 percent, were attributed to heroin, compared to 143, or 20 percent in 2012, according to the 2013 Overdose Fatality Report.

Nationwide, the death rate from painkiller overdoses nearly quadrupled between 1999 and 2013 and heroin related deaths increased by 39 percent and the number of Americans seeking treatment for painkiller addiction has increased by 900 percent since 1997, according to the release.

Indiana's health commissioner, Jerome Adams, is scheduled to speak at Thursday's House committee meeting to discuss the state's recent HIV and hepatitis C outbreaks, which is tied to needle sharing among drug users. Adams will discuss the state's needle exchange programs, which was put in place to help combat this problem.

New health-related laws deal with heroin, dating violence, end-of-life care, prescriptions, colon-cancer and newborn screening

By Melissa Patrick
Kentucky Health News

FRANKFORT, Ky. – The Kentucky General Assembly passed several health-related bills this session, including high-profile measures on heroin and dating violence. It did not pass many others, including one that would have a great influence on the state's health: a statewide smoking ban, which passed the House for the first time ever, but never got out of an unfavorable committee in the Senate. Here's a roundup:

Heroin: Kentucky's heroin-overdose epidemic was caused partly by a 2012 legislative crackdown on prescription painkillers, which steered users to the illegal drug. Last year's bill died because of deadlock over sentences for traffickers and needle-exchange programs for addicts, and Gov. Steve Beshear and legislators gave this year's bill top priority. It was not finally negotiated until a few hours before passage, but Beshear signed Senate Bill 192 into law less than 12 hours after it passed so that its emergency clause could put it into effect immediately.

SB 192 includes both a needle-exchange program and harsher penalties against traffickers, the main points of contention between the House and Senate, but requires local governments to approve needle exchanges and allows judges to be lenient in sentencing addicts, to help them get treatment. It allocates money for drug-treatment programs, allows increased access to Naloxone, a drug that reverses the effects of an overdose, and allows jailers to provide medically assisted treatment for inmates with opiate addiction.

Dating violence: After 10 years of lobbying and debate, the dating violence bill will allow dating partners to get interpersonal protective orders from a judge if they have been the victim of dating violence, sexual abuse or stalking. This year's bill largely dissolved social conservatives' opposition by creating a new chapter in the law for dating violence, with the same protections as the domestic-violence law. Kentucky is the last state to offer protection to dating-violence victims. House Bill 8 was sponsored by Rep. John Tilley, D-Hopkinsville, who also sponsored the House heroin bill.

Beshear has signed these bills into law:

Prescription synchronization: SB 44, sponsored by Sen. Julie Raque Adams,R -Louisville, will allow patients with multiple prescriptions, in consultation with their health-care provider and their pharmacist, to synchronize prescriptions so that they may be picked up at the same time.

Medical order scope of treatment: SB 77, sponsored by Sen. Tom Buford, R-Nicholasville. will create a medical order scope of treatment (MOST) form that specifically directs the type of treatment a patient would like to have, and how much intervention he or she would like to have, during end-of-life care.

Colorectal cancer screening: SB 61, sponsored by Sen. Ralph Alvarado, R-Winchester, will require that a fecal test to screen for colon cancer, and any follow-up colonoscopy, be considered preventive measures that health insurance is required to cover without imposing additional deductible or co-insurance cost. The governor also signed a similar measure, HB 69, sponsored by Rep. Tom Burch, D-Louisville, which contains an amendment by Sen. Julian Carroll, D-Frankfort, for a Medicaid savings study.

Newborn screenings for fatal disease: SB 75, sponsored by Sen. Alice Forgy Kerr, R-Lexington, will require all newborns to be tested for Krabbe disease, a neurological disorder that destroys the protective coating of nerve and brain cells and is fatal once symptoms occur.

Spina bifida: SB 159, sponsored by Adams, will require medical providers to supply written, up-to-date, accurate information to parents when their unborn child is diagnosed with spina bifida so they can make informed decisions on treatment.

Emergency care for strokes: SB 10, sponsored by Sens. Stan Humphries, R-Cadiz, and David Givens, R-Greensburg, requires that local emergency services have access to a list of stroke-ready hospitals, comprehensive stroke centers and primary stroke centers in Kentucky. Emergency medical providers will set their own protocols for assessment, treatment and transport of stroke patients.

Alcohol and drug counselors: HB 92, sponsored by Rep. Leslie Combs, D-Pikeville, creates an enhanced licensing program to recognize three levels of certified alcohol and drug counselors, with different levels of education. The goal is to increase the number of counselors in the state.

UK cancer research center: HB 298, sponsored by Rep. Rick Rand, D-Bedford, revises the state budget to authorize $132.5 million, half of the cost, for a new medical research center at the University of Kentucky. The university says it will raise money to cover the other half.

These health bills awaited the governor's signature Monday morning:

Physician assistants: HB 258, sponsored by Rep. Denver Butler, D-Louisville, to allow physicians to supervise up to four physicians at the same time, rather than two.

In-home care: HB 144, sponsored by Burch, to establish a 60-day, hospital-to-home transition program through an approval waiver from the Department for Medicaid Services.

Pharmacist-practitioner collaboration: HB 377, sponsored by Rep. Dean Schamore, D-Hardinsburg, to allow collaboration between pharmacist and practitioners to manage patients' drug-related health needs.

Tax refund donations: SB 82, sponsored by Sen. Max Wise, R-Campbellsville, to put an income tax check-off box on tax forms to allow people the option of donating a portion of their tax refund to support pediatric cancer research, rape crisis centers or the Special Olympics.

Health related bills that were left hanging:

The smoking ban, HB 145, sponsored by Rep. Susan Westrom, D-Lexington, never got a hearing in the Senate Veterans, Military Affairs and Public Protection Committee, and neither did the Senate companion bill, SB 189, sponsored by Adams.

Three bills challenged Medicaid managed-care companies. SB 120, sponsored by Alvarado, would have created a process for health-care providers to appeal the companies' decisions to the state passed the Senate, but not the House.  And the following two bills that never got out of the Senate: SB 88, also sponsored by Alvarado, which challenged the $50 "triage fees" MCOs pay for emergency-room visits that they conclude were not emergencies, and would have required them to pay contracted fees instead and SB 31, sponsored by Buford, which would limited the amount of co-payments. Also not getting House action was Alvarado's SB 6 would have created review panels for lawsuits seeking damages from health-care providers.

Heroin bill finally passes and is signed into law; Naloxone program put into motion; dating-violence bill sent to Beshear

By Melissa Patrick
Kentucky Health News

The long-negotiated bill to tackle Kentucky's heroin-overdose epidemic passed in the final hours of the 2015 legislative session.

Almost immediately after the heroin bill passed the Senate, a bill to offer immediate civil protections to dating partners who are victims of dating violence was passed after being held in the chamber since February 13 -- likely because Democratic Rep. John Tilley of Hopkinsville, chair of the House Judiciary Committee, was the original sponsor of both bills.

Tilley told reporters that the passage of the two bills meant it had been a successful session.

Gov. Steve Beshear signed the heroin legislation, Senate Bill 192, into law Wednesday, March 25, less than 12 hours after it passed, so that its emergency clause could put it into effect immediately. The dating violence bill, House Bill 8, has been delivered for his signature.

"Senate Bill 192 is tough on traffickers who bring these deadly drugs into our communities, but compassionate toward those who report overdoses or who admit they need help for their addiction," Beshear said in a release. "I applaud our legislators for putting aside partisan interests for the greater good of all Kentuckians who have been affected by this devastating drug."

The bill passed the Democrat-controlled House 100-0 and the Republican-controlled Senate 34-4. Republican senators John Schickel of Union, Joe Bowen of Owensboro, Chris Girdler of Somerset and Paul Hornback of Shelbyville voted against it.

The stickiest issues were a needle-exchange program, which many senators opposed, and tough new penalties for drug traffickers, which Tilley and many House members said would not be effective. The new law allows needle-exchange programs of approved by local governments, and the tough penalties, but allows the judge to be lenient in sentencing if the defendant is an addict.

The bill also allocates money for drug treatment programs; includes a "good Samaritan" provision that allows a person to seek medical help for an overdose victim and stay with them without fear of being charged; access for addicts and their families to the drug Naloxone, a drug that reverses the effects of an overdose; and allows the Department of Corrections to provide an approved medication to inmates to prevent a relapse in their addiction.

"The bill includes provisions that are important to law enforcement and me: increasing penalties for large volume traffickers, expanding access to treatment, and getting heroin overdose reversal kits into the hands of our first responders. I know this legislation will save lives," Attorney General Jack Conway said in a news release.

Hornback argued that "forced rehab doesn't usually work," providing addicts with Naloxone and free needles simply enables them and the bill does not allow addicts any "consequences for their actions."

He said that while he knows there are people dying from heroin overdoses,"I didn't make that decision for them and I for one, and a lot of my constituents are tired of paying for people's bad decisions and that is what this (bill) does."

Tilley said in an interview after the vote that needle exchange programs are proven to work, will save taxpayers money and are absolutely necessary to "stem the tide of two tidal-waves that are headed Kentucky's way: HIV and Hepatitis C and Hepatitis B."

"The cost of treating someone with HIV is $350,000. The cost of treating someone with Hepatitis C is $85,000. The budget now had a $55 million hit just with the explosion of Hepatitis C last year. We can't afford that in Kentucky," he said. Advocates say the programs can be a gateway to treatment and rehabilitation.

Meanwhile, Conway and first lady Jane Beshear announced that funding for Naloxone kits would be made available to the hospitals in Kentucky with the highest rates of heroin overdose deaths. The kits will be provided free to every treated and discharged overdose victim at the pilot-project hospitals.

They made the announcement at the University of Louisville, which treated 588 people in 2013 for heroin overdoses, a news release said. In 2013, the latest data available, 230 of the 722 autopsied overdose deaths, or 32 percent, were caused by heroin, according to the Kentucky Office of Drug Control Policy.

Tilley and Republican Sen. Whitney Westerfield, also of Hopkinsville, "forged a friendship that allowed the two men to work out differences on a pair of high profile bills fraught with political pitfalls," Adam Beam reports for The Associated Press. "Westerfield, a former prosecutor, is running for attorney general against the son of Democratic Gov. Steve Beshear, giving Democrats all the reason in the world not to work with him."

The AP notes that Republican Sen. Chris McDaniel wrote the first draft of the heroin bill that passed the Senate in January, but it omits McDaniel's other role: candidate for lieutenant governor on a slate headed by Agriculture Commissioner James Comer. As the Senate prepared to give the final bill final passage, Republican Floor Leader Damon Thayer accused the House of not passing McDaniel's bill because of his candidacy.

Read more here: http://www.kentucky.com/2015/03/25/3767938_political-compromises-brokered.html?rh=1#storylink=cpy

Deaths from drug overdoses and prescriptions for opiate treatment drugs are both rising, worrying state officials

Despite measures to discourage prescription drug abuse, Kentucky health officials report overdose deaths continue to rise and opioid treatment drugs are being prescribed "at alarming rates," Kevin Wheatley reports for cn|2's "Pure Politics."

A shift to cheaper, readily available heroin is partly to blame, Audrey Haynes, secretary of the Cabinet for Health and Family Services, told the legislature's Interim Joint Committee on Health and Welfare Wednesday.

Haynes told the committee that heroin overdose deaths in Kentucky increased 207 percent from 42 in 2011 to 129 in 2012; Kentucky ranks highest in hospital admissions for heroin abuse among surrounding states and the national average; more women age 18-44 in Kentucky die from drug overdoses than the U.S. average; and the state has shown a 165 percent increase in neonatal abstinence syndrome in newborns from 2008 to 2013.

Another issue, Wheatley writes, is that opiate treatment drugs like buprenorphine, which can be prescribed by physicians, have been seized by police in arrests at higher rates, creating a concern among health officials that it is being used illegally.

The medical director of the Department for Medicaid Services, John Langefeld, told Wheately that data show a 241 percent increase in buprenorphine prescriptions for Medicaid recipients from January 2012 to this May and that police seizures of this drug have increased "threefold" since tougher laws on prescription drug abuse took effect in July 2012.

UK professor develops nasal spray to deliver standard antidote to painkiller overdose; fast-tracked, in final clinical trials

A new lifesaving product to treat painkiller overdoses is in its final round of clinical trials at the University of Kentucky and is being fast-tracked by the U.S. Food and Drug Administration.

The product is a nasal-spray application of the anti-opoid drug naloxone, developed by Daniel Wermeling, professor in the UK College of Pharmacy, through his startup company AntiOp Inc.

Opioids are the class of pain-killing drugs that are related to morphine, including prescription drugs such as hydrocodone and oxycodone as well as illegal drugs such as heroin. Naloxone is the the standard treatment for suspected opioid overdose, according to a UK news release.

Naloxone is now administered by injection. The spray eliminates the need for needles, with a ready-to-use, single-use delivery device inserted into the nose of an overdose victim. The product delivers a consistent dose, absorbed across the nasal membranes even if the patient is not breathing.

"The goal is to make the medication available to patients at high risk of opioid overdose and to caregivers, including family members, who may lack specialized medical training," Wermeling said. "The treatment could be given in anticipation of EMS arrival, advancing the continuum of care and ultimately saving lives."

Nationwide, deaths from opioid overdose are on the rise, according to the federal Centers for Disease Control and Prevention. Kentucky, with a long history of opoid abuse, ranks third in the nation for drug overdoses, with more than 1,000 dying each year. Heroin abuse is on the rise, with 230 deaths, or 31.9 percent, of autopsied overdose deaths attributed to heroin in 2013.  This is a 60 percent increase from the previous year, according to the Kentucky Office of Drug Control Policy.

Congratulating Wermeling on his success, UK President Eli Capilouto said, "The epidemic of opioid abuse in our state presents an enormous and urgent challenge, not only for health care providers and law enforcement but also for us here at the University of Kentucky. Dr. Wermeling's project is putting a powerful new tool into the hands of those on the front line of the fight against heroin, both here in Kentucky and beyond."

Wermeling's research was supported by a three-year, $3 million grant from the National Institutes of Health through the National Institute on Drug Abuse with additional funding from the Kentucky Science and Technology Corporation. His company partnered with Reckitt Benckiser Pharmaceuticals in May to accelerate the production and worldwide marketing of the product.