May 3, 2018

Trump Administration Should Use Rarely Invoked Authority to Expand Access to Opioid Overdose Antidote

Full Statements from Speakers at the Baltimore Press Conference

Dr. Leana Wen, health commissioner of Baltimore
Robert Weissman, president of Public Citizen
Amy Collier, director of the Community Services Division for the Catholic Charities of Baltimore
Nathan Fields, a community health educator for the Baltimore City Health Department
Perry Hopkins, an overdose survivor whose life was saved through a rapid administration of naloxone

View the press release about this event.



Statement of Dr. Leana Wen, Health Commissioner, Baltimore City Health Department

Last month, the surgeon general issued an advisory encouraging increased access to naloxone. In Baltimore, we already have these policies in place. In October 2015, I issued a standing order – a blanket prescription for naloxone – to all 620,000 Baltimore residents. Since then, everyday people have saved the lives of more than 1,800 family members, friends and neighbors throughout our city. First responders have saved the lives of more than 10,000 individuals. We have seen firsthand that training residents on how to use naloxone and distributing this lifesaving medication will save lives and allow people with opioid use disorders the chance to be connected with treatment.

Unfortunately, we are forced to ration naloxone because we simply don’t have the resources to obtain enough of this lifesaving antidote. Every week, we count the doses we have left and make hard decisions about who will receive the medication and who will have to go without. The surgeon general emphasized the importance of community members who may come into contact with people at risk for opioid overdose to know how to use naloxone and have it in reach. I agree. All 620,000 Baltimore residents should have naloxone as a part of their medicine cabinet and we should be able to provide it to them. We provide the public with Narcan, the nasal spray version of naloxone, as it’s easy for anyone to use. Currently, the Baltimore City Health Department pays $75 per kit for Narcan. The cost for us to supply a kit to every city resident would be $46.5 million.

We have worked hard to enact policies to make naloxone accessible. We know what works. Now we need the resources. The federal government needs to follow the surgeon general’s policy guidance with specific and substantial funding commitments and to back up the surgeon general’s advisory. Imagine if this were Ebola, and hundreds of people were dying across the country every single day. There would be no question that the federal government would step in and provide the front lines the resources needed to save lives.

We are in the middle of a national epidemic. We should not be priced out of the ability to save lives.

 

Statement of Robert Weissman, President, Public Citizen

Declaring the opioid addiction epidemic to be a public health emergency, as President Trump has done, is a completely empty gesture unless it is accompanied by action – unless the government acts as if there is a bona fide emergency.

That means the government must do the hard things, like providing robust resources to address the epidemic and aggressively addressing the stigma associated with addiction.

But it also means doing the easy things, like using existing authorities, achievable with the stroke of a pen, to slash prices for lifesaving naloxone therapy with easy-to-use delivery devices.

Under 28 USC Sec. 1498, any officer of the U.S. government has the authority to use a patented invention without permission from the patent holder. The patent holder is entitled to reasonable compensation.

Today, we are calling on Kellyanne Conway, counselor to the president and the administration’s “Opioid Czar,” to exercise this authority for the patented delivery devices for naloxone.

In practical terms, this would mean the government would authorize and purchase generic versions of Narcan and/or Evzio (Narcan is naloxone with a nasal spray; Evzio delivers naloxone with a talking injector) and distribute the products to local and state governments, nonprofit providers and others. Alternatively, the government might authorize recipients of federal funding to address the opioid addiction epidemic to procure the naloxone treatments from generic providers.

This approach would cut prices to a fraction of their current level and make lifesaving naloxone far more available. Narcan lists for $75 a dose and is available to public providers at $37.50 a dose. Evzio lists for more than $4,000 and is newly available to public providers at $180 a dose. Yet naloxone is available from suppliers in India for as little as 15 cents a dose, meaning that a dose with the generic version of a patented delivery device could be priced dramatically below current U.S. levels.

The surgeon general has just recommended that Americans carry naloxone on a routine basis. At current prices, there is little chance of the surgeon general’s recommendation being followed. With a program that slashes prices for naloxone with easy-to-use delivery devices and brings prices closer to actual cost, dramatic progress could be achieved.

The federal government routinely employs 28 USC Sec. 1498 “government use” authority, particularly in the military realm, where defense contractors frequently use patented inventions without authorization of the patent holder and work out compensation later.

The federal government has made less frequent use 1498 authority for pharmaceuticals, but that is only because of the political power of Big Pharma, not because of any legal or feasibility hurdles. 

The most recent use of 1498 authority in the pharmaceutical context occurred in 2001, during the post-September 11 anthrax scare, when amid public debate about use of 1498 authority, Secretary of Health and Human Services Tommy Thompson demanded that ciprofloxacin patent holder, Bayer, match the price of generic makers. Bayer quickly cut its price in half.

We are now facing a public health emergency of a different kind, one which is sure to be much more durable than the anthrax scare, and one that is costing tens of thousands of lives annually and devastating communities across the country. We have available lifesaving drug devices that could save many of those lives, but they are being rationed due to high cost and insufficient commitment. There is an easily available means for the government to lower price, reduce rationing and save lives.

In response to our petition, counselor to the president Kellyanne Conway and the Trump administration can choose to act or they can choose not to act. They can choose to lower prices and save lives. Or they can choose to perpetuate the rationing of livesaving treatments and avoid offending Big Pharma – at the cost of letting people across the country die for lack of access to affordable, easy-to-use naloxone delivery devices. The choice is exactly that simple.

 

Statement of Amy Collier, Director of the Community Services Division, Catholic Charities of Baltimore

I direct the Community Services division of Catholic Charities, which houses 19 programs in Baltimore city and Baltimore, Carroll, Harford and Anne Arundel counties. Our programs and services include Head Start/Early Head Start, emergency shelter, day shelter, meal service, permanent supportive housing, transitional housing, rapid re-housing, workforce development and immigration services. 

Our programs include:

  • Weinberg Housing and Resource Center – Baltimore City’s largest emergency shelter serving 275 individuals nightly (Baltimore City)
  • Our Daily Bread Employment Center (meal program) – serving 700-900 individuals daily (Baltimore City)
  • Christopher’s Place Employment Academy – serving 60 formerly homeless men in residence, nightly (Baltimore City)
  • My Sister’s Place Women’s Center – serving 100 women and children daily (Baltimore City)
  • Sarah’s House – emergency shelter, project-based voucher, rapid re-housing – 66-bed emergency shelter, 22 project-based voucher units  (Anne Arundel County)
  • Anna’s House – emergency shelter, permanent supportive housing, rapid re-housing, 25 households (Harford County)
  • Baltimore City Head Start – serving 667 children and families
  • Carroll County Head Start/Early Head Start – serving 192 children and families
  • Harford County Early Head Start – serving 60 children and families

Catholic Charities operates numerous programs that serve individuals who are at great risk for drug overdose. Many of our programs serve individuals living in poverty and experiencing homelessness, including those who use emergency shelters, transitional housing programs, meal programs, workforce development programs and Head Start/Early Head Start programs. Many individuals who Catholic Charities serve suffer from an addiction to drugs, which often is coupled with behavioral health challenges and the experience of traumatic situations.

In many of Catholic Charities’ programs, we implement a low-barrier model where services are provided without the conditions of being clean and sober or participating in case management or other programming. It is our core value to treat everyone with dignity and respect. Catholic Charities provides services to meet basic needs and invites individuals to participate in more holistic services to address some of the underlying causes of their current situation of homelessness, poverty and other circumstances.

Providing a population that has an extremely high prevalence of substance use access to Narcan truly has been lifesaving. After contemplating the potential cost of Narcan, we determined that the need was so great that we began a pilot program. In November 2016, the pilot began in three of our most heavily populated programs, including Baltimore’s largest emergency shelter. Staff training was provided on the proper administration of Narcan, and systems were developed to store, administer and track the use of Narcan. In one year, Catholic Charities was able to participate in saving more than 40 lives by making Narcan available to trained staff in our programs. In November 2017, the pilot program became permanent, and other programs were added to the list of Narcan use sites. Once again, the cost of Narcan was contemplated, but the great need prevailed.

In June 2017 at the Weinberg Housing Center, we experienced six overdoses in a 12-hour period. All of the individuals were revived with Narcan.

The availability of Narcan in our programs not only has saved lives, it also has served as a catalyst for change in the lives of some of the individuals that we have helped to save. After the administration of Narcan, case managers talk with clients about their substance use and encourage them to seek treatment.

Our supply of naloxone is running out, and we are in need of a donor for the upcoming fiscal year. If money was no object, we would make naloxone available in the majority of Catholic Charities’ 200 locations.

There is a tremendous need for Narcan to be affordable and readily available. It is difficult to think about the tragedies that would occur in our programs without the availability of Narcan. Catholic Charities has been able to partner with the Baltimore City Health Department to obtain Narcan for our programs, but the high cost may put an end to that. Our ability to access Narcan without a significant cost has been invaluable.

Narcan is a lifesaving and oftentimes life-changing drug that should be available to all programs serving vulnerable populations. It is extremely easy to use, and within seconds, it can reverse the deadly effects of drug overdose and give someone a second chance to achieve their full potential. To date, 59 individuals could have died without access to Narcan just in two of Catholic Charities’ programs. It is imperative to make this drug affordable for all at-risk individuals.

 

Statement of Nathan Fields, Community Health Educator, Baltimore City Health Department

As someone who has worked in the field of substance abuse for 18 years, I am very aware of the problem our country is facing with the opioid epidemic. I started working at the Baltimore City Health Department in 2003 during the inception of the Stay Alive Overdose Prevention Program. When we held our first overdose prevention class, there were some people who didn’t think we should be training people to use a drug to revive someone who was dying. We certainly have proved them wrong.

I come with a unique set of skills and personal experience that overqualify me for the task that has been bestowed upon me. I’m going into my 24th year of sobriety. This experience has provided me the opportunity to connect with others with shared experiences and to impact the communities most unreachable through traditional outreach. I’m also very energetic and passionate about the public health of those most at risk in Baltimore.

The work I do is important. It saves lives. But we need more naloxone to save more lives.

Just the other night I was working an evening shift on Baltimore and Gay. A young lady from a nearby club told me that one of the young ladies she works with overdosed last night. She asked if she could she be trained to reverse an overdose. I taught her the signs of an overdose. I explained that an overdose, simply put, is respiratory failure. Naloxone will block opiate receptors, allowing that person to breathe again. I told her first to call 911 and demonstrated how to use naloxone. About an hour later another young lady arrived saying she had used her naloxone the night before, and needed a new naloxone kit. I want to be able to give naloxone to the people who need it. We have such a low supply left. With limited funds to buy more and rising naloxone prices from drug manufacturers, we have to keep very close track of how many we have left.

I have trained or assisted several thousand citizens to respond to and reverse opioid overdoses from both illicit and prescription drug use.

In recognition of how important my work is dispensing naloxone, I have been featured in different media outlets and was invited to speak at the White House.

True story – we were at the press conference where Dr. Wen was signing the standing order to provide naloxone to all Baltimore residents. Someone ran into the building hollering that there was someone overdosing outside. I grabbed a naloxone kit and ran, followed closely by my colleague and the fire department chief. Because we were able to administer naloxone, the person survived the overdose.

Take it from me, take it from someone on the front lines – we need more naloxone and we need it now.

 

Statement of Perry Hopkins, Overdose Survivor Revived by Narcan

I’ve been a lifelong Baltimore resident for more than 57 years, which includes a long history of drug abuse that began when I was barely a teenager at 13 years old. From there I consistently used recreational drugs like beer and marijuana into my mid-twenties. At 28, I discovered heroin and it changed my life for the worse.

I stand before you today after having my life saved due to access to Narcan. My girlfriend and I are both past users. We live in a one-bedroom apartment in Baltimore. One night we finished dinner, snorted some opioids and later were in the kitchen. I was washing dishes and she was putting food away, and I passed out from the drugs we smoked. I went face-first into the sink. Everything was soaked, there were suds in my hair and on my clothes.

Despite the routine nature of our usage, my girlfriend knew instinctively to get a kit of Narcan we had in the apartment. This kit had a magnet on it and we kept it on the refrigerator. She snatched it off the fridge and administered a full dose to me and she said I didn’t budge one bit. She then ran into the bedroom and got another Narcan kit. She administered that to me and I took one deep breath and went back to unconsciousness. I was back on my way to dying there on the floor. She remembered we had a third kit in the nightstand next to our bed, retrieved it and administered to me again. It was only after this third attempt that I regained any semblance of consciousness. That third kit was the last kit of Narcan we had in our apartment. If I had needed a fourth, I likely wouldn’t be standing here today.

It was these experiences that have led me into a life of advocacy for drug treatment. I currently train people in Baltimore on how to administer lifesaving opioid antidotes like the one that saved me. Even more, I am involved in onsite community training.

I am over eight months clean. I value my work as a community organizer with Communities United and I remain an active member of self-help groups citywide and plan to undergo training to be a recovery coach. The public availability of Narcan saved my life and it can save other lives too. Bringing this antidote to more people motivates me, keeps me focused and has me committed to preventing more people from needlessly having to die.

With Baltimore being a heroin capital of the East Coast, its paramount, necessary and mandatory, that production of Narcan be increased and made available. Its availability even outweighs drug education and outreach because the potency of opioids on the street means each person can need two to three Narcan kits to be revived only once. Right now, the supply of lifesaving kits does not meet the demand of the chemical, and that’s killing us.

The need for treatment is equally important. I suffered and still suffer post-withdrawal symptoms. But we can never forget that white, cold silence that results from overdosing which feels like the blanket of death. Something more needs to be done and it needs to be done now. Help us help our communities.

###