The evangelicals I wish the world would see

I consider myself to be an evangelical Christian. I believe I meet the definition as put forth by the National Association of Evangelicals. I’m saddens me that the term “evangelical” has taken on an increasingly negative connotation, especially among younger people. I had a recent experience in an academic context in which the charge of being an “evangelical Christian” was levied against me by someone who thought my beliefs should disqualify me for a leadership position that would have represented a significant promotion.

The evangelicals I know care about the people and causes that Jesus cared about during his earthly ministry. They may not necessarily fit the narrative that many in the media would like to propagate about our community. I can’t help but think that evangelicals would have a very different image in our larger culture if more people had the opportunity to get to know some of the folks I was surrounded by during the last three days.

I was fortunate to have been invited to be part off Evangelicals for Life, a conference that took place this past weekend in Washington D.C. under the sponsorship of Focus on the Family and the Ethics and Religious Liberty Commission (ERLC) of the Southern Baptist Convention. I was honored to be among so many faithful and compassionate Christians who live out the Gospel in so many different settings.

I had the pleasure of meeting Eric Brown, a photographer from Nashville, and his wife, Ruth who shared the story of their daughter (Pearl) in words and pictures. Pearl was diagnosed in utero with Alobar prosencephaly, a condition resulting from the complete failure of the brain to divide into right and left hemispheres and there is a single brain ventricle instead of two.

Screenshot courtesy of ERLC

Speaker after speaker at the conference talked about the importance of caring for the vulnerable during every stage of life. Russell Moore, President of the ERLC opened the conference by sharing teaching on Matthew 14 in which he observed that ” a culture of life cannot coexist with a culture of porn or a culture of abuse”  and that ” the pro-life witness will never flourish where women are not valued.” Jim Daly, the President of Focus on the Family, spoke openly about his experience in foster care and the ministry he and his wife share as foster parents. Benjamin Watson, a tight end for the Baltimore Ravens who is a finalist for the NFL’s Man off the Year award in part because of the work that he and his wife have done in partnership with the International Justice Mission to combat human trafficking and other forms of violence against the poor.

I had the privilege of participating in a panel on special needs and mental health with Kelly Rosati. Kelly has served for a number of years as the Vice President of Community Outreach for Focus on the Family. During our panel discussion (unfortunately, there is no video available), Kelly shared perhaps the most powerful illustration I’ve ever heard from a parent struggling to care for a child with mental illness of the importance of support from the church. Kelly did share some of her experiences in a presentation that was videoed on The Challenges and Rewards of Foster Care.

Screenshot courtesy of ERLC

While the conference has ended, video of all of the main stage presentations is available for free on demand by clicking here.

I wish that the men and women I was surrounded by for several days this past week were the public face of evangelical Christianity. Their lives reflect religion that is pure and undefiled.
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shutterstock_291556127Key Ministry encourages our readers to check out the resources we’ve developed to help pastors, church leaders, volunteers and families on mental health-related topics, including series on the impact of ADHD, anxiety and Asperger’s Disorder on spiritual development in kids, depression in children and teens, pediatric bipolar disorder, and strategies for promoting mental health inclusion at church.

Posted in Adoption, Advocacy, Culture of Life, Key Ministry, Mental Health | Tagged , , , , , , , , , , , | 1 Comment

We’re looking for some people to join us on a mission from God

Image courtesy of Wikimedia Commons

We’re about to embark on a mission from God. Unlike Jake and Elwood, we’re not called to save the orphanage in which we were raised from foreclosure. But we’ve been working for a long time on a project I’ve sensed God has prepared us to do since the beginning of our ministry. And we’ll need the help of all our our friends and extra help from some truly special friends if we’re to fulfill our mission to the best of our ability.

As many of you know, I’ve been working on a book for the last two years that provides a model for churches seeking to minister with children and adults with common mental health conditions and their families. Thanks to the efforts of my ministry teammates past and present and some great people at Credo Communications and the Zondervan division of Harper Collins Publishing, Mental Health and the Church is scheduled for release on February 6, 2018.

For the book to have an impact pastors, ministry leaders and families impacted by mental illness need to know the book exists. And that’s where you come in.

Our Key Ministry team is looking to assemble a launch team to help the world discover the resources available through Mental Health and the Church. We’re looking for friends with access through social media to pastors, church leaders, persons with mental illness and their loved ones who are willing to share their platforms with us to help get the word out to those likely to be most interested in mental health inclusion ministry.

While I’m hoping all of our blog readers will help us spread the message about the book, we’re looking for a few dozen people willing and able to assume a larger role in helping our team with publicity. Some of the responsibilities of persons serving on our launch team will include…

  • Reading an advance copy of the book by January 28th.
  • Writing a blog post or posting a video review related to Mental Health and the Church from January 28th (nine days before the scheduled release date) and March 8th (thirty days following the scheduled release date).
  • Posting reviews of the book on Amazon, Barnes and Noble, Christian Book or ChurchSource.
  • Sharing posts about the book from Key Ministry and fellow members of the launch team at least once a week during February and March.
  • Inviting your friends and social media followers to free Key Ministry training events promoting mental health ministry and inclusion in the church to take place following the book’s initial release.

Some of the ways through which our team plans to show our appreciation to members of our launch team will include:

  • An advanced, electronic copy of the typeset manuscript
  • Two copies of Mental Health and the Church… one containing a personalized note of thanks from the author, and a second copy for team members to donate to their church’s library.
  • Enhanced visibility for your content as posts are promoted through Key Ministry’s  social media platforms and links to your blog or website included on a new section of Key Ministry’s website dedicated to mental health resources.
  • Launch team members will be provided with images and links to share through your social media platforms and platforms managed by organizations you represent.
  • A guest post or interview with the author for your blog or podcast.
  • The opportunity to apply for a slot on one of our Key Ministry writing team, if desired.

If you’d like to be considered for the Mental Health and the Church launch team, click here to submit an application. You’ll be asked for some basic contact information, a link to your blog or website, information about your social media presence and some information about why you’re interested in mental health inclusion ministry. A Key Ministry team member will be in touch with you by January 15th to let you know if you’ve been accepted to the launch team.

If you have the connections, qualifications and experience we’re looking for, we’d be honored to have you join us as we begin this new phase of our mission.

 

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What God accomplished through Key Ministry in 2017

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The second best gift

Christmas Eve 2017 represents Key Ministry’s fifteenth birthday. On behalf of our Board and ministry team, we extend our thanks to everyone who has generously supported us through their time, talent, treasure and prayer. You all share in whatever success we’ve experienced in extending the love of Christ to families of kids with disabilities. Best Wishes to you and your family for a Merry Christmas and a Blessed and Joyous 2018!

Tonight and tomorrow morning, Christians everywhere will gather for worship to honor God for providing us the greatest gift of all…the gift of Jesus, who through atoning for our sins made it possible for us to be in relationship with God and to enjoy His presence forever. As I found a little time to reflect upon my blessings today, I found myself thinking about another gift God’s given to me and many of my friends – a gift I hope more of our readers are able to explore and enjoy during the year ahead.

I was fortunate to find a church as an adult that encouraged each member of the congregation to identify opportunities for ministry and provided the resources, support and encouragement necessary to do ministry.

The Catholic scholar Timothy George wrote about the priesthood of all believers as a cardinal principle of the Reformation. Here, he examines the teaching of Luther and Calvin regarding the rights and responsibilities of individual Christians with regard to personal ministry.

But for Luther, the priesthood of all believers did not mean, “I am my own priest.” It meant rather: In the community of saints, God has so tempered the body that we are all priests to each other. We stand before God and intercede for one another, we proclaim God’s Word to one another and we celebrate his presence among us in worship, praise, and fellowship. Moreover, our priestly ministry does not terminate upon ourselves. It propels us into the world in service and witness.

John Calvin interpreted the priesthood of all believers in terms of the church’s participation in the threefold office of Christ as Prophet, King, and Priest. Specifically, every Christian is mandated to be a representative of Christ in his redemptive outreach to the world: “All believers … should seek to bring others into the church, and should strive to lead the wanderers back to the road, should stretch forth a hand to the fallen and should win over the outsiders.” In other words, the priesthood of believers is not a prerogative on which we can rest; it is a commission which sends us forth into the world to exercise a priestly ministry not for ourselves, but for others—“the outsiders”—not instead of Christ, to be sure, but for the sake of Christ and at his behest.

For Calvin, the priesthood of all believers was not only a spiritual privilege but a moral obligation and a personal vocation.

One of my greatest joys over the past fifteen years of serving through Key Ministry has involved the opportunity to provide some wonderful people with a platform for doing ministry. We have an incredible team of writers who produce new articles and posts that offer encouragement and support to tens of thousands of families each month. We’re looking forward to twelve new voices joining our team in 2018 as the work of SNAPPIN’ Ministries continues under our umbrella. I’m especially looking forward to the opportunity to gather together on April 20-21st for Inclusion Fusion Live when dozens of fabulous leaders and speakers, most of whom are not ordained clergy or ministry professionals will come together in suburban Cleveland to help churches connect with and bless families impacted by disability.

Here’s my question to you as 2017 comes to a close and 2018 promises new opportunities. Will you embrace all of the gifts God has given you in the year ahead, including the ability to serve and represent Jesus in extending his love to those who are hurting? Is this the year you’ll respond to the small, still voice calling you out of your comfort zone to respond to the needs God has placed before you? Let us know how we might encourage and support you if your next step involves sharing the Gospel with families struggling as a result of physical, mental health, intellectual or developmental disabilities.

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Key Ministry is celebrating fifteen years of connecting churches and families of kids with disabilities for the purpose of making disciples of Jesus Christ. The costs of providing free training, consultation, resources and support to church leaders and families has again outstripped our revenues.  Please consider helping us continue our work through a financial gift of $15, $150 or $1,500 if you’re able to help us cover our budget shortfall in 2017 and expand the work of our ministry in 2018 and beyond!

 

 

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How a hidden disability kept one family from church

From the earliest days of our ministry, our team at Key has been focused on helping churches minister to kids with “hidden disabilities”…significant emotional, behavioral, developmental or neurologic conditions lacking outwardly apparent physical symptoms. Some friends in a like-minded ministry have produced a wonderful video that illustrates the challenges one family impacted by a hidden disability experienced in maintaining their involvement at church.

Tory White is a staff member at CLC Network, a ministry organization based in Grand Rapids, Michigan that equips congregations and Christian schools to glorify God through purposeful, innovative inclusion of persons with varied abilities. Several years ago, Tory contracted Lyme disease, a bacterial infection frequently associated with fever, muscle pain, fatigue, cardiac symptoms, a characteristic rash and a wide variety of neurologic symptoms. Listen as Tory describes how her illness impacted her family’s experience of church…

I thought there were several important lessons for churches in the message Tory communicated…

Online church services are an important lifeline to families affected by disability.

The sensory aspects of our worship services often represent a significant barrier for persons with hidden disabilities. In Tory’s case, the volume of the music during the praise and worship component of the service was so overwhelming that she needed to leave.

Little things matter. In Tory’s case, the type of bread used during communion intensified her sense of isolation from her larger church community.

No church can do everything, but every church can do something. Tory recognized this reality in the video…

What we realized we were looking for in a church was more than any one church could provide.

Barb Newman from CLC Network spoke in the video about the principle of universal design for worship – the idea that all of God’s people are invited to access the Gospel message and be included in all aspects of worship and the entire worshiping community benefits from worship services that are designed and led with the goal of including everyone.

Check out the video and the links included in the post to learn more about CLC Network and universal design for worship. And block out April 21st and 22nd on your calendar to come join us and our friends in Cleveland at Inclusion Fusion Live to learn more about how churches can more effectively welcome individuals and families impacted by hidden disabilities.
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On December 24th, Key Ministry will be celebrating fifteen years of connecting churches and families of kids with disabilities for the purpose of making disciples of Jesus Christ. The costs of providing free training, consultation, resources and support to church leaders and families has again outstripped our revenues.  Please consider helping us continue our work through a financial gift of $15, $150 or $1,500 if you’re able to help us cover our budget shortfall in 2017 and expand the work of our ministry in 2018 and beyond!

 

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What I want for Christmas…

I was working on the resource pages on mental health inclusion for our website that support our ministry’s soon to be released book for pastors and ministry leaders this past Friday morning when the phone rang.

A friend in another city was on the line. My wife and I support the ministry with students that she and her husband lead in their city.  My friends had hosted another family for Thanksgiving dinner who moved to their area in the last year or two. Their guests have an eight year old child with Down syndrome. In the course of conversation, my friends discovered that their guests were having a very difficult time finding a church prepared to welcome families of kids with a disability. My friend shared that their middle-school age daughter offered to be a “buddy” to her dinner companion at the church they attend if there were no other alternatives. She asked if our ministry knew of churches in her city that she could recommend to her dinner guests. One church came to mind immediately, and our Key Ministry team kicked into gear to find some more suggestions.

That’s what Key Ministry does. Whether it’s a family struggling to find a place to worship because of a child or teen with an emotional or behavioral condition, adoptive parents looking for a congregation to come alongside them while raising a child dealing with the lingering effects of trauma or neglect or a mom and dad parenting a child with a developmental or intellectual disability, we help connect churches and families of kids with disabilities for the purpose of making disciples of Jesus Christ.

We give churches the free training and resources they need to welcome families of kids in their community with a broad range of disabilities. We travel to conferences and present monthly trainings online. We use our online groups and web platforms to help connect families with churches. We have a dedicated team of writers who are an ongoing source of encouragement and support to families experiencing the challenges associated with raising a child with a disability.

In the coming year, we plan to host a disability ministry conference in Northeast Ohio to train hundreds of church staff and volunteers from congregations across the U.S. We’re presenting the first comprehensive inclusion model for churches seeking to welcome families of children and adults with mental illness. We’re discussing a significant expansion of our family support ministry. We’ll continue to expand the range of free resources that has drawn over 179,000 unique visitors to our website thus far in 2017 and over 2.5 million page views to date to our blogs for church leaders and families. And we’ll continue to be very responsible stewards of the resources God provides through our ministry supporters.

We’re currently running a deficit of approximately $5,000 in 2017. Thanks to a large team of extraordinarily dedicated volunteers and a small but extremely productive staff, we’re on track to do our work this year for less than $60,000. If we were able to raise $100,000 in support over the next twelve months, we could easily double or triple the reach of our ministry and host the most impactful disability ministry conference in North America in 2018.

I have what I need this Christmas. What I want is for our Key Ministry team to have the resources to help families impacted by disability to find what they most need… a church where every member of the family might come to know Jesus and grow in faith in him. Thanks for your prayers, encouragement and financial support!

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KM_ForFamilies_Logo_Color_RGBKey Ministry helps connect churches and families of kids with disabilities for the purpose of making disciples of Jesus Christ. In order to provide the free training, consultation, resources and support we offer daily to church leaders and families, we depend upon the prayers and generous financial support of readers like you. Please pray for the work of our ministry and consider a financial gift to help us cover our shortfall in 2017 and expand the work of our ministry in 2018 and beyond!

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Want to help us put on a conference?

Our team is hosting a disability ministry conference in Cleveland next April. We want the pastors, church staff and volunteers in attendance to leave with the tools and resources they need to launch new ministries or expand the scope of their existing ministries. We want family members of persons with disabilities to leave prepared to support the spiritual growth of their loved ones and to expand the impact of their personal ministries. And we can’t do it without your help!

Key Ministry is pleased to announce that we’ll be hosting Inclusion Fusion Live on April 20th-21st, 2018 at Bay Presbyterian Church in Bay Village, Ohio. Unlike our disability ministry web summits from 2011, 2012 and 2014, we’ll be gathering together in person at the church that provided us with the support to launch our ministry fifteen years ago. The theme of the conference is Every Church Can Do Something.

In accordance with the conference theme, the Program Committee is seeking dynamic speakers who will offer workshops, symposia and briefer “TED Talk” type presentations that will serve as catalysts for churches and individuals to take the next steps in growing their disability ministries. We’ll also be offering extended half-day or day-long workshops for church leaders on the following topics and more…

  • Starting a respite ministry
  • Starting a special needs ministry
  • Developing a church-wide mental health inclusion strategy

How can you help?

First, you can save the dates of April 20th-21st and plan to join us in person and share this post with pastors, church leaders, volunteers and family members who might wish to join us as well. We anticipate there will be a registration fee for some of the extended workshops offered by our ministry partners, but much of the content will be made available for free.

We’ll be looking for friends to help us spread the word about the conference when registration opens in the second half on January. You can sign up here to receive e-mails and notifications as the conference takes shape in the coming weeks.

Finally, we’re looking for engaging speakers with practical tools and ideas for growing disability ministry. Ours is not a “closed club.” Any mature Christian with great resources to share is welcome to submit a proposal to our Program Committee through this link. Submission of a proposal is not a guarantee of acceptance. Speakers have the option of submitting presentations for a program track for ministry leaders or a track for families. Breakout speakers will be offered a free space among our vendor tables to share their messages and products with the entire audience at Inclusion Fusion Live.

Prospective speakers need to provide their submissions by Friday, December 15th and will receive notification if accepted from the Program Committee by Monday, January 15th.

We look forward to seeing many old friends…and lots of new ones at Inclusion Fusion Live this coming April in Cleveland!


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KM_ForFamilies_Logo_Color_RGBKey Ministry helps connect churches and families of kids with disabilities for the purpose of making disciples of Jesus Christ. In order to provide the free training, consultation, resources and support we offer daily to church leaders and families, we depend upon the prayers and generous financial support of readers like you. Please pray for the work of our ministry and consider a financial gift to help us cover our shortfall in 2017 and expand the work of our ministry in 2018 and beyond!

Posted in Inclusion Fusion, Key Ministry, Training Events | Tagged , , , , , | Leave a comment

Join Key Ministry at Evangelicals for Life and the 2018 March for Life!

On behalf of our staff and volunteers at Key Ministry, we’d be delighted to have you join us as our team has been invited to participate in the 2018 Evangelicals for Life conference, scheduled around this year’s March for Life in Washington DC on January 18th-20th.

The conference is being co-hosted by the Ethics and Religious Liberty Commission of the Southern Baptist Convention and Focus on the Family. Evangelicals from across the country will gather in Washington DC to be inspired and equipped by top speakers including Russell Moore and Jim Daly. Other speakers known to friends of our ministry include Joni Eareckson Tada, Kelly Rosati and Sharen Ford from Focus on the Family, Shannon Royce and Wesley Smith. I’ll be a panelist for the “Special Needs and Mental Health” breakout session on Saturday, January 20th at 9:00 AM.

The March for Life will be held Friday, January 19, 2018, on the National Mall, during a block of time built into the Evangelicals for Life conference. Reduced rates are available at the JW Marriott where the conference sessions will take place, in close proximity to the White House and the National Mall. A free simulcast of the main stage sessions will be available on Thursday and Friday evenings.

Registration for the conference is $139, but tickets are only $119 until Dec. 6  If you use Key Ministry’s discount code at checkout (GRCEVICH) between now and November 18th, you’ll save an additional 20% off your registration costs. Click here for discounted registration. 

I hope to see lots of old friends…and meet a number of new friends at Evangelicals for Life and the March for Life!

Neither Key Ministry nor Dr. Grcevich receive any financial benefit from your conference registration.
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KM_ForFamilies_Logo_Color_RGBKey Ministry helps connect churches and families of kids with disabilities for the purpose of making disciples of Jesus Christ. In order to provide the free training, consultation, resources and support we offer every day to church leaders and family members, we depend upon the prayers and generous financial support of readers like you. Please pray for the work of our ministry and consider supporting us financially!

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Mental illness didn’t cause the church shooting in Texas

Photo: New York Times

It appears our society is in denial about the root cause of the mass murders committed in recent weeks at a church in Nashville, a country music concert in Las Vegas, and yesterday, at the First Baptist Church in Sutherland Springs, TX.

Some like to think that incidents such as the church shooting yesterday morning outside of San Antonio that claimed the lives of 26 men, women and children who left their homes intending to honor and worship God are the result of insufficient gun control laws. The man responsible for yesterday’s atrocity in Texas should have been legally prohibited from purchasing a gun after having served time in a military prison following a court martial for domestic violence for assaulting his first wife and their child, and had been denied a concealed carry permit by the state. Why anyone would think that someone who ignored the laws against murder and killed 26 people would pay any attention to restrictions upon purchasing guns is beyond me.

Others suggest that mental illness must be responsible for the type of event that occurred at the small Baptist church in Texas yesterday. If we could develop some sort of test that would help determine who among us might become violent, increase access to mental health services or develop better treatments for persons at risk of becoming aggressive, incidents such as yesterday’s shooting would become less and less frequent.

The common thread between those two positions is the need to believe that we can somehow reestablish a sense of being able to control the expression of random and apparently senseless acts of violence perpetrated against innocent victims and restore our fragile sense of safety when we venture out into public…to work, to go to a concert, or to attend a worship service. Both positions also minimize or avoid the need to acknowledge an unpleasant truth that most people on both sides of America’s great cultural and political divide would like to ignore.

EVIL is the root cause of the mass shooting in Las Vegas, and the shootings in churches in rural Texas, Nashville, and several years ago, at an historically African-American church in Charleston, South Carolina. As a society, we seek to minimize the existence of evil because recognition of evil threatens our shared delusion that any absolute standard of right and wrong exists. We want to be masters of our own universe and to decide for ourselves what is right and what is true. To acknowledge that some clear standard for right or wrong conduct exists requires us to recognize that a source for such a standard exists outside of ourselves…and acknowledge the Creator of the universe who established the standards!

What makes me most angry about the words and actions of our leaders in the aftermath of incidents such as the massacre in Texas is the perpetuation of stigma by attributing hateful and violent actions to the presence of mental illness. They cause people to needlessly fear friends, neighbors and family members who are among the fifty million Americans with an  identified mental health condition.

As I write this blog post, we have absolutely no reason to believe that the shooter in Texas had been diagnosed or treated for any mental health condition, or reason to believe that he  met criteria for any condition other than antisocial personality disorder…a description of long standing patterns of social interaction or behavior that’s not amenable to mental health treatment. Yet our need for a scapegoat causes too many of our leaders or others in a position of influence to blame the presence of the most common disability in our culture for actions that cause great pain and anguish.

Think of it this way…does attributing crimes such as the one committed yesterday at a little church in Sutherland Springs, TX to mental illness make it more or less likely that other churches will embrace the need to welcome persons with mental illness into their worship services and fellowship activities? And if as a result of blaming mass murder on mental illness persons with mental illness are less likely to be welcomed into local churches, whose agenda is advanced? God’s or the enemy’s?

The gunman in South Texas didn’t have a mental health problem…he had a spiritual problem! As did the gunman in Las Vegas. And Dylan Roof…the young man convicted and sentenced to death for the murder nine members of Charleston’s Emanuel AME church two years ago. While each of them might be thought of has having a “debased mind,” the Bible teaches the condition of their minds (and souls) has a cause other than mental illness.

And since they did not see fit to acknowledge God, God gave them up to a debased mind to do what ought not to be done.  They were filled with all manner of unrighteousness, evil, covetousness, malice. They are full of envy, murder, strife, deceit, maliciousness. They are gossips, slanderers, haters of God, insolent, haughty, boastful, inventors of evil, disobedient to parents, foolish, faithless, heartless, ruthless. Though they know God’s righteous decree that those who practice such things deserve to die, they not only do them but give approval to those who practice them.

Romans 1:28-32 (ESV)

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shutterstock_291556127Key Ministry encourages our readers to check out the resources we’ve developed to help pastors, church leaders, volunteers and families on mental health-related topics, including series on the impact of ADHD, anxiety and Asperger’s Disorder on spiritual development in kids, depression in children and teens, pediatric bipolar disorder, and strategies for promoting mental health inclusion at church.

Posted in Controversies, Key Ministry, Mental Health | Tagged , , , , , , , | 1 Comment

Why your kid’s Concerta isn’t working as it should… Chapter Two

The FDA has again approved a generic version of the most commonly prescribed medication for teens in the U.S. without requiring proof that the new product works as well as what kids are currently taking. The FDA took this action after withdrawing approval of the last two generic versions of Concerta approved through the same process.

ConcertaWhen Concerta first hit the market in 2000, it revolutionized the treatment of ADHD because it offered the first truly effective method for prolonging the effects of methylphenidate (the active ingredient in Ritalin and many other stimulant preparations) so that kids no longer needed to go to the principal’s office or nurses’ office in the middle of the school day. When Adderall XR followed in 2001 and Strattera in 2002, a vast increase ensued in the number of children and teens identified with and treated for ADHD. Out of the roughly 25 medications currently approved for ADHD, Concerta remains very popular because of the consistency of its’ effects throughout the school day and immediately after school. It is widely used in teenagers because of its’ beneficial effects on driving performance.

A basic principle in understanding how extended-release stimulant products work is that the manner in which the drug is released into the body (the drug delivery system) has profound effects on the pharmacodynamics (the observed benefits/response to the drug). We have a number of approved medications for ADHD in which methylphenidate is the active ingredient. In addition to Concerta, Ritalin LA, Metadate CD, Daytrana, Quillivant and Focalin XR are all extended-release methylphenidate products. The effects of the product at specific times throughout the day result from differences in how the medication is released and absorbed into the body with each unique delivery system, and form the basis of how we decide which product we choose for an individual child. Allow me to illustrate…

Concerta utilizes something called the OROS delivery system (see featured picture at the top of this blog post) to release methylphenidate into the body. It was developed by a team of scientists in California who observed a phenomena referred to as “tachyphylaxis” with earlier attempts to develop long-acting methylphenidate-based stimulants. Essentially, people taking stimulants develop some degree of tolerance to the drug acutely in response to an individual dose. While the absolute level of the drug in someone’s system matters, a rising blood level is often necessary to sustain the beneficial effects of medication over the course of a school or work day.

Concerta was designed to release an initial dose of stimulant within the first two hours of ingestion…22% of the active drug is contained within the coating of the pill. After this overcoat dissolves, a laser-drilled hole in the end of pill is uncovered. As the pill passes through the stomach and the gastrointestinal track, water taken up into the pill results in changes in internal pressure that leads to a “pulse release” of small amounts of medication as it passes through the gut. The effects of Concerta were tested in a laboratory classroom setting, in which raters blinded to whether kids received active drug or placebo scored the observable behavior of kids throughout a twelve hour day, and an age-appropriate mini-math test (PERMP) was administered at intervals throughout the day to measure medication effects on cognitive performance. The results are pictured below. A significant benefit of Concerta is the consistency of improvement in cognitive performance throughout the day.

OROS Lab Classroom

In contrast, Focalin XR utilizes a “beaded” delivery system to release methylphenidate into the body. Focalin XR is a capsule containing two types of beads. The outer coating of the capsule dissolves very quickly (within ten minutes) upon ingestion. 50% of the beads inside Focalin XR release almost immediately after the coating of the outer capsule dissolve, while another 50% have a different coating designed to dissolve approximately four hours after the capsule is swallowed. One advantage of Focalin XR is that parents can crack open the capsule and sprinkle the contents in yogurt or applesauce when kids can’t swallow pills, whereas Concerta won’t work if the pill isn’t swallowed intact. Another advantage with 50% of the medication released immediately is that the medication kicks in very quickly in the morning with demonstrable benefits at 30 minutes (see below). In practice, Focalin XR has a pronounced peak effect in late morning and is very effective for most kids throughout the school day. At the same time, the cognitive effects of the drug fall off much more quickly during the latter part of the day compared to Concerta, and drug company marketing claims aside, I find in my patients that Focalin XR is a good choice for kids who need medication to cover the duration of their school day, but not much longer.

Focalin XR Lab Classroom

Daytrana is a patch worn on the hip in which methylphenidate is absorbed through the skin as a result of an osmotic gradient…the difference in the concentration of methylphenidate in the patch vs. the difference in the concentration of methylphenidate in the capillaries supplying blood to the skin. A unique benefit of Daytrana is that it will last longer than any of the other stimulant products on the market…it was originally developed to be a 16-18 hour drug. Because the testing required for approval by the FDA examined the effects of the product over a twelve hour period, the company that manufactures Daytrana isn’t permitted to share that information with prescribers. The cognitive effects of Daytrana also peak later in the day than with other products (see below), making Daytrana very helpful for many kids who struggle with homework after school. Comparing the laboratory classroom studies of Daytrana to Concerta and Focalin XR, an obvious downside to Daytrana is that it doesn’t work as well during the first half of the school day. Many parents resort to either putting the patch on their child very early in the morning while they’re still sleeping to overcome this effect, or give their child a small dose of immediate-release methylphenidate (Ritalin or immediate-release Focalin) when they first  apply the patch on in the morning.

Daytrana Lab Classroom

My point is that what makes Concerta work like Concerta is the OROS delivery system. The same drug (methylphenidate) released through a different delivery system produces a VERY different response.

The arrival of generic Concerta was delayed for a number of reasons…the makers of Concerta fought the lawsuits of the generic manufacturers aggressively, and pursued a legal strategy involving what’s referred to as a “Citizen’s Petition” requiring generic companies seeking to copy Concerta to demonstrate a similar pattern of ascending blood levels throughout the day. Because Johnson & Johnson (the parent company that owned the rights to Concerta) owned the patent on the OROS release system, companies seeking to make a generic version had to do so with a different delivery system.

Concerta 27Concerta 18Ultimately, Watson Pharmaceuticals (subsequently acquired by Actavis) was approved to manufacture a generic equivalent of Concerta. As often occurs in these situations, the lawyers for Johnson & Johnson  and Watson worked out a deal to avoid years of legal battles in Concerta 54Concerta 36which J & J would continue to manufacture Concerta through their Alza subsidiary that Watson would sell at a discount as an “authorized generic,” with the two companies splitting the profits. The brand Concerta and the Activis version of Concerta are equivalent…they are manufactured in the same factory, using the same equipment and the same drug delivery system as in the original Concerta. Pictures of the “authorized generic” using the OROS system are shown above:

The next two versions of versions of generic Concerta (manufactured by Mallinkcrodt and by Kremers Urban) each used very different drug delivery systems (release mechanisms) in an effort to replicate the therapeutic effect of Concerta.

M54 M36 M27In the case of the Mallinkcrodt product (pictured at right), an overcoat containing immediate-release methylphenidate that dissolves within the first hour after ingestion. The core of the pill contains a diffusion-controlling membrane that releases methylphenidate as water in the gastrointestinal tract passes through the membrane. The membrane is designed to release methylphenidate over a period of time roughly corresponding to the release period resulting from the OROS delivery system in Concerta.

KU 27KU 18The Kremers Urban generic (pictured at right) uses an extended-release bead technology to release methylphenidate at a controlled rate. The pill resembles a conventional tablet in appearance, featuring an overcoat containing immediate release stimulant that releases during the first hour as the tablet disintegrates and a core of extended-release stimulant beads operating with a similar mechanism as those in Focalin XR.

Here are links to the FDA-required product information or “labels” for Concerta, the Mallinkcrodt generic version and the Kremers Urban generic version that are being substituted for Concerta. It appears that the FDA allowed the generic manufacturers to “cut and paste” the data from Concerta’s pharmacokinetic studies and clinical trials and present this information as if it represented trials each company conducted with their own unique product.

The absorption of the original Concerta depends to some degree on an individual’s GI transit time…i.e., how long it takes for the pill to pass through the gut. Bead release systems (as in the Kremers Urban version) typically depend upon the acidity of the contents of the stomach at the time the extended-release bolus of medicine is needed. One would anticipate an individual child or teen might absorb significantly more (or less) medicine at different times during the day when two products that on average deliver roughly the same amount of medication over the same time period depend upon different physiologic processes.

When the FDA requires generic companies to do studies demonstrating “equivalency” to a brand medication, the amount of medication taken up into the body (measured by what we refer to as the “area under the curve” or AUC) is required to be within 80-125% of that observed with brand name drug. With some types of medication, that variability makes little difference. With stimulants, small differences in either the rate at which the medicine is absorbed or the time at which the medicine is absorbed make a PROFOUND difference in the benefits or side effects experienced by an individual child or adult. The FDA doesn’t require generic companies to conduct comparison studies showing that the products work as well in practice as the brand name drugs they’re intended to replace. Neither Mallinkcrodt nor Kremers Urban was initially required by the FDA to conduct a study showing that their drug works as well in practice as the brand or authorized generic versions of Concerta.

Restating my earlier point, what makes Concerta work like Concerta is the OROS delivery system. The same drug (methylphenidate) released through a different delivery system produces a VERY different response.

Ultimately, a small, randomized study was published in Clinical Pediatrics demonstrating the superiority of the “brand” Concerta and generic Concerta using the OROS delivery system marketed by Actavis, compared to the Kudco and Mallinckrodt versions of generic Concerta using non-OROS delivery systems. In response to this study and consumer complaints, the FDA demanded that each company submit additional data demonstrating their products to be equivalent to Concerta. Mallinckrodt did not comply with the request, while data submitted by Kremers Urban was deemed insufficient.

Given the calls that have started coming into my office over the last day or so, there’s a very good possibility that a similar scenario will play out again as the newest generic version of Concerta, manufactured by Osmotica through their Trigen subsidiary hits the market this month. The FDA again allowed a generic manufacturer (Osmotica) to substitute the data from Concerta’s clinical trials in their product-specific information, instead of requiring them to publish pharmacokinetic data specific to their product.

The drug delivery system being used with the Trigen system is more similar to the OROS system used in Concerta, but it’s still different. Families will also face tremendous pressure to switch to the new product because the FDA approved a 72 mg version of the Trigen generic (the most common Concerta dose in teenagers) because insurance companies and pharmacy benefit managers will save money by paying for half as many pills as are currently required. I hope the Trigen version works as well as Concerta. It might be more potent. It might be less potent. We have no more way of knowing how it will work than we did with the Kremers Urban and Mallinckrodt products for which approval was withdrawn by the FDA.

The last time the pharmacies began switching kids to cheaper generic versions of Concerts, I had over ten kids show up in my office reporting a significant decline in the effectiveness of their medication. I wrote much of this post after seeing a mother and her daughter who reported problems with medication when the appearance of her pill changed. I sent them back to the drugstore with new prescriptions for the brand Concerta or the authorized generic version. The pharmacist told the mother it was illegal for them to fill the prescription for the original product (not true) even though she was willing to pay for the prescription “out of pocket” and threatened to call the police if she insisted on having my prescription filled.

I encourage families of kids who are taking Concerta to be prepared on your next trip to the pharmacy. If you have no other affordable option, make a point of informing your child’s prescriber and the FDA if they don’t respond as well to the new generic or experience more side effects on the new generic.

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