Triggers for parents of addicts and alcoholics

TelephoneThose in recovery often face “triggers” that test their resolve, triggers exerting a gravitational pull that jerks us back to the dark side.  And no, I’m not talking about the addict’s relapse here; I’m talking about the mother of the addict’s relapse.

The cell phone, marvel of modern technology, holds a power that can make me relapse to the fear and utter despair of days gone by.  When my old ring tone chimes from someone else’s purse, I jump out of my skin.  Pavlov’s proof: I’ve been classically conditioned to associate an otherwise innocuous sound with the experience of terror.  And even today, if my son doesn’t answer his phone right away, my busy little mind tends to dive into wild imaginations of doom and gloom.  But I have made tremendous progress; in the old days, when my son’s phone went straight to voicemail, I was known to call him 30 times (or more) in one hour. I give thanks every day for recovery from my addiction to his voicemail greeting.

I’ve learned to replace the obsession in my mind with more constructive preoccupations, such as dwelling on a phrase that relaxes me or helps me feel secure.  Sometimes, it’s the Serenity Prayer. Sometimes, it’s just asking the Universe to lift my burden of worry. With allies like that in my corner, I know that I am stronger than the siren song of relapse.

FDLI Conference on Food Safety and FSMA Just a Couple of Weeks Away

The Food and Drug Law Institute is sponsoring a conference titled "Food Safety: Latest FSMA Developments & Enforcement Actions in a Changing Business Climate," scheduled for September 9.  The conference will feature a regulatory update by Michael Landa (Director of FDA/CFSAN), an exploration of the seven proposed rules that have been issued to implement FSMA, a case study on recalls that includes Roberta Wagner (Deputy Director for Regulatory Affairs at CFSAN), and a discussion of FDA’s enhanced enforcement authorities that includes Jeffrey Steger (Assistant Director of the Consumer Protection Branch in DOJ’s Civil Division).  To close out the conference, HP&M’s Ricardo Carvajal will moderate a session on the business aspects of food safety.  More information on the agenda and registration is available here.

The Non-Answer – helping other learn and grow

Choices in RelationshipsI was reminded today how sometimes not giving an answer or advice is the best thing to ‘not’ do. It is always so tempting to jump in with ways to solve problems and help our friends and family. And sometimes that is the right thing to do. But in some situations, sitting back and letting our loved one traverse the maze of their decisions is an opportunity for growth. My son came to me with a concern that he had. It wasn’t major, but it was troubling him. In the past I would have jumped into action with solutions, or worse, distractions so he wouldn’t feel the pain of situation. As a co-dependent, I don’t like others to feel bad. But I’ve learned that it isn’t my business to manage other people’s feelings. So when my son plopped down in the chair across from me, I just sat and listened. I asked some questions to help him think through various alternatives he could consider. But I tried my best not to tell him what to do or distract him by changing the topic. I know my place is to be there to support him and coach him, but not direct and manage him. By staying listening but not intervening I allow him to learn and grow.
I also know that in the past when my daughter would come to me in a crisis due to her struggle with addiction, I learned not to react. This was not easy in the beginning; I didn’t always realize what was taking place. But over time I realized that her problems became my problems when I jumped into action and alleviated her of the consequences. I had been given advice once that if you let 24 hours pass by, many times the loved one would either solve the issue or the crisis would diminish. This is so true! I learned to sit and be patience and trust in the capabilities of those who created the dilemma in the first place.

Name that Drug – Pain Game: The Substitute Player

DATIA focusDATIA focus is the quarterly publication of the Drug & Alcohol Testing Industry Association (DATIA). DATIA focus features a regular, popular column titled, “Name that Drug” where interesting facts about a mystery drug are described in advance of the name being revealed.

The latest edition of “Name that Drug” was written by Dr. Vinnette Batiste M.D., Alternate Responsible Person (RP) at Quest Diagnostics, and is entitled, “Pain Game: The Substitute Player.” Give the article a read and see if you can solve the “Name that Drug” mystery on page 60 in the summer edition of DATIA focus.

In Generic PRECEDEX Litigation, Hospira Wins Temporary Restraining Order; Court Orders Recall of Generics, then Backtracks

By Kurt R. Karst –    

The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials, has been anything but sedate.  On the morning of August 18, 2014, there was no sign of the controversy that would erupt later that day after FDA issued its long-awaited Letter Decision addressing issues raised in the Agency’s January 15, 2014 “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of generic PRECEDEX. 

As we reported earlier this week, FDA ruled that ANDA sponsors could omit (i.e., carve out) from their generic drug labeling information protected by U.S. Patent No. 6,716,867 (“the ‘867 patent”).  The ‘867 patent is currently listed in the Orange Book for PRECEDEX with a “U-1472” patent use code defined as: “INTENSIVE CARE UNIT SEDATION, INCLUDING SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCEDURES.”  (The ‘867 patent was previously listed in the Orange Book with a “U-572” patent use code defined as “INTENSIVE CARE UNIT SEDATION.”)  

Hospira – and ANDA sponsor Sandoz, Inc. (“Sandoz”), which is eligible for a period of 180-day exclusivity based on a Paragraph IV certification to the ‘867 patent – contended that FDA was prohibited from omitting any labeling information related to the ‘867 patent, because the patent, as reflected by the U-1472 patent use code narrative, covers both approved uses for PRECEDEX – i.e., (1) sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting, and (2) sedation of non-intubated patients prior to and/or during surgical and other procedures – thereby leaving ANDA sponsors with carved-out labeling without an approved use.  Specifically, Hospira, citing the U.S. Supreme Court’s decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012)), where the Court noted in dicta that “the FDA will not approve an ANDA if the generic’s proposed carve out label overlaps at all with the brand’s use code,” argued in comments to FDA that because the patent use code for the ‘867 patent fully covers the first indication and may overlap with the second indication, an ANDA sponsor whose application contains a “section viii” statement to omit patent-protected information must carve out both the first and the second indications in their entirety, thereby precluding approval of any ANDAs with carved out labeling.  FDA, however, concluded otherwise:

Both the original and the revised use codes are limited to “intensive care unit sedation.”  Although the revised use code includes additional language specifying some of the types of patients that Hospira claims are encompassed within the “intensive care unit sedation” use, i.e., non-intubated ICU patients prior to and/or during surgical and other procedures, it does not broaden the claimed method of use beyond “intensive care unit sedation.” . . .  Nor does the clarified use code and its explicit inclusion of a subset of patients that may undergo procedural sedation somehow expand the patented use to encompass and prevent approval for all patients who seek to use the drug for the separately delineated procedural sedation indication. . . .  FDA previously has determined that it can approve ANDAs for broad, general indications that may partially overlap with a protected method of use, so long as any express references to the protected use are omitted from the labeling.  The procedural indication and related information in the labeling do not impermissibly disclose the use of Precedex for procedures in the ICU (i.e., for the use covered by the use code).  ANDAs therefore may be approved for the second indication, consistent with how FDA has implemented use codes and allowed carve outs in other circumstances.

FDA also approved two ANDAs: (1) ANDA No. 202881 from Mylan Institutional LLC (“Mylan”), which began selling drug product; and (2) ANDA No. 203972 from Par Sterile Products.

In the wee hours of August 19, 2014, Hospira took action against FDA.  The company filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction in the U.S. District Court for the District of Maryland seeking from the court a stay of FDA’s Letter Decision, rescission of any ANDA approvals predicated upon that Letter Decision, an order FDA to recall any product sold or distributed under such an ANDA approval, and an injunction prohibiting FDA from granting any further or additional approvals predicated upon the Letter Decision.  According to Hospira, FDA’s Letter Decision that led to the ANDA approvals violates Section 505(j)(2)(A)(viii) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) concerning ANDA labeling carv-outs, as well as the rulemaking requirements of the Administrative Procedure Act (“APA”):

Instead of complying with statutory and regulatory requirements, FDA adopted an unauthorized procedure (the opening of Docket No. FDA-2014-N-0087) and then relied upon that unauthorized procedure to make a decision which is contrary to law.  Absent injunctive relief, FDA’s unauthorized approach will allow generic versions of Precedex on the market without those generics’ first establishing, as the law requires, that they do not infringe Hospira’s rights under its method-of-use patent, and FDA will have applied a “rule” within the meaning of the [APA] which rule FDA adopted without complying with any of the rulemaking requirements of the Act. . . .

Here, in the face of demonstrable and FDA admitted overlap between the indications included in the generic’s labeling and Hospira’s patent use code, FDA has acted unlawfully in issuing a decision which allows approval of generic versions of Precedex.

In addition, FDA has not adopted a regulation, pursuant to the notice and comment rulemaking requirements of the APA, to modify its prior rule and authorize the agency to approve a generic version in an “overlap case” such as this (assuming, without conceding, that FDA would have statutory authority to adopt such a rule).  In its review and approval of applications for generic versions of Precedex, FDA has unlawfully applied a new substantive rule without FDA’s complying with the rulemaking requirements of the APA.  Because FDA’s past or imminent approvals of generic versions of Precedex rests entirely on this unauthorized, unlawfully adopted new rule, any resulting generic drug approval decisions are invalid.

The Maryland District Court (Judge George Jarros Hazel) scheduled an emergency hearing on Hospira’s Motion for Temporary Restraining Order for Tuesday, August 19, 2014 at 3PM.  Both Mylan and Sandoz entered the case as intervenors, and Sandoz filed a brief in support of Hospira’s Motion for Temporary Restraining Order and/or Preliminary Injunction saying, among other things that FDA’s Letter Decision and ANDA approvals deprives Sandoz of 180-day exclusivity. 

Then came Judge Hazel’s late-night Memorandum Opinion and Order on August 19th.  In granting Hospira’s Motion for Temporary Restraining Order, Judge Hazel ruled that Hospira demonstrated that it is likely to succeed on the merits regarding its contention that FDA violated FDC Act § 505(j)(2)(A)(viii), and with respect to Hospira’s APA claim:

Here, the first indication for Precedex is entirely covered by Plaintiff’s use-code.  As to the second indication, there is, at the very least, some overlap.  Because its use-code statement asserts that its method-of-use patent overlaps with all approved indications, Plaintiff further contends the FDA must reject any ANDA application based upon a section viii statement.  FDA, on the other hand, contends that it can approve ANDAs for broad, general indications that may partially overlap with a protected method of use, so long as any express references to the protected use are omitted from the labeling. Notably, however, Plaintiff’s interpretation has been endorsed by the United States Supreme Court in its recent decision of [Caraco], in which the Court stated (albeit as dicta) that “the FDA will not approve such an ANDA if the generic’s proposed carve-out label overlaps at all with the brand’s use code.”  At this juncture, the Court therefore finds that FDA’s decision was at odds with relevant authority.

Furthermore, to now permit FDA to approve generic versions of Precedex on the basis that it can approve ANDAs for broad, general indications that overlap with a protected method of use would be tantamount to a change of the rules.  Such a change would require FDA to employ the formal rulemaking procedures of the [APA], which it indisputably did not do.  Moreover, even if the Court were to assume for argument’s sake that the governing statute is ambiguous under Chevron U.S.A., Inc. v. Nat. Res. Def. Council, 467 U.S.837 (1984), given the prior understanding of the law by the Supreme Court, the Court cannot find, at this current juncture, FDA’s interpretation to be reasonable.

But Judge Hazel did not stop there.  In his Order, which will continue in full force and effect until September 2, 2014, Judge Hazel not only stayed FDA’s Letter Decision and any future FDA actions under it, as well rescinding ab initio any FDA actions already taken pursuant to that Letter Decision, but he took the highly unusual – and perhaps unprecedented – move in a Hatch-Waxman case of ordering FDA to recall any product sold or distributed under the two ANDA’s approved for generic PRECEDEX.  

If it stands, the court’s decision could have significant implications on Hatch-Waxman law.  For some, it could be the long sought-after (and thus far illusive) Northwest Passage route to avoid some generic drug labeling carve-outs.  Companies may seek to clarify Orange Book method-of-use patent listings – and may petition FDA regarding the same – in efforts to prevent generic drug labeling omissions and to force Paragraph IV patent certification submissions. 

UPDATES:

  • On August 20, 2014, the Court issued a paperless Order denying Mylan's Motion to File Response to TRO by 5 pm August 20 2014.  According to the Court, “Mylan and Sandoz have each been permitted to intervene in this matter and the Court gave consideration to their arguments at the motion hearing on the TRO. The Court did not request post-hearing briefing and did not consider the brief filed by Intervenor Sandoz prior to issuing its ruling. Both Mylan and Sandoz will be permitted to submit memoranda pursuant to the scheduling order to be set during today's scheduling call for future motions.”
  • On August 20, 2014, Mylan filed a Motion to Stay Paragraph 3 (product recall) & Paragraph 4 (rescission of actions made pursuant to FDA's Letter Decision) of the Court's August 19th Order. 
  • On August 20, 2014, the Court issued a paperless Order granting Mylan's Motion to Stay.  According to the Court, “Paragraphs 3 and 4 of the Court's August 19, 2014 [Order] are stayed pending Defendant Mylan's Motion for Reconsideration.”
  • Par Sterile Products joins the party after the Court grants the company's Motion to Intervene.

The Chemistry of Modern Marijuana


Is low-grade pot better for you than sinsemilla?

First published September 3, 2013.

Australia has one of the highest rates of marijuana use in the world, but until recently, nobody could say for certain what, exactly, Australians were smoking. Researchers at the University of Sydney and the University of New South Wales  analyzed hundreds of cannabis samples seized by Australian police, and put together comprehensive data on street-level marijuana potency across the country. They sampled police seizures and plants from crop eradication operations. The mean THC content of the samples was 14.88%, while absolute levels varied from less than 1% THC to almost 40%.  Writing in PLoS ONE, Wendy Swift and colleagues found that roughly ¾ of the samples contained at least 10% total THC. Half the samples contained levels of 15% or higher—“the level recommended by the Garretsen Commission as warranting classification of cannabis as a ‘hard’ drug in the Netherlands.”

In the U.S., recent studies have shown that THC levels in cannabis from 1993 averaged 3.4%, and then soared to THC levels in 2008 of almost 9%. THC loads more than doubled in 15 years, but that is still a far cry from news reports erroneously referring to organic THC increases of 10 times or more.

CBD, or cannabidiol, another constituent of cannabis, has garnered considerable attention in the research community as well as the medical marijuana constituency due to its anti-emetic properties. Like many other cannabinoids, CBD is non-psychoactive, and acts as a muscle relaxant as well. CBD levels in the U.S. have remained consistently low over the past 20 years, at 0.3-0.4%. In the Australian study, about 90% of cannabis samples contained less than 0.1% total CBD, based on chromatographic analysis, although some of the samples had levels as high as 6%.

The Australian samples also showed relatively high amounts of CBG, another common cannabinoid. CBG, known as cannabigerol, has been investigated for its pharmacological properties by biotech labs. It is non-psychoactive but useful for inducing sleep and lowering intra-ocular pressure in cases of glaucoma.

CBC, yet another cannabinoid, also acts as a sedative, and is reported to relieve pain, while also moderating the effects of THC. The Australian investigators believe that, as with CBD, “the trend for maximizing THC production may have led to marginalization of CBC as historically, CBC has sometimes been reported to be the second or third most abundant cannabinoid.”

Is today’s potent, very high-THC marijuana a different drug entirely, compared to the marijuana consumed up until the 21st Century? And does super-grass have an adverse effect on the mental health of users? The most obvious answer is, probably not. Recent attempts to link strong pot to the emergence of psychosis have not been definitive, or even terribly convincing. (However, the evidence for adverse cognitive effects in smokers who start young is more convincing).

It’s not terribly difficult to track how ordinary marijuana evolved into sinsemilla. Think Luther Burbank and global chemistry geeks. It is the historical result of several trends: 1) Selective breeding of cannabis strains with high THC/low CBD profiles, 2) near-universal preference for female plants (sinsemilla), 3) the rise of controlled-environment indoor cultivation, and 4) global availability of high-end hybrid seeds for commercial growing operations. And in the Australian sample, much of the marijuana came from areas like Byron Bay, Lismore, and Tweed Heads, where the concentration of specialist cultivators is similar to that of Humboldt County, California.

The investigators admit that “there is little research systematically addressing the public health impacts of use of different strengths and types of cannabis,” such as increases in cannabis addiction and mental health problems. The strongest evidence consistent with lab research is that “CBD may prevent or inhibit the psychotogenic and memory-impairing effects of THC. While the evidence for the ameliorating effects of CBD is not universal, it is thought that consumption of high THC/low CBD cannabis may predispose users towards adverse psychiatric effects….”

The THC rates in Australia are in line with or slightly higher than average values in several other countries. Can an increase in THC potency and corresponding reduction in other key cannabinoids be the reason for a concomitant increase in users seeking treatment for marijuana dependency? Not necessarily, say the investigators. Drug courts, coupled with greater treatment opportunities, might account for the rise. And schizophrenia? “Modelling research does not indicate increases in levels of schizophrenia commensurate with increases in cannabis use.”

One significant problem with surveys of this nature is the matter of determining marijuana’s effective potency—the amount of THC actually ingested by smokers. This may vary considerably, depending upon such factors as “natural variations in the cannabinoid content of plants, the part of the plant consumed, route of administration, and user titration of dose to compensate for differing levels of THC in different smoked material.”

Wendy Swift and her coworkers call for more research on cannabis users’ preferences, “which might shed light on whether cannabis containing a more balanced mix of THC and CBD would have value in the market, as well as potentially conferring reduced risks to mental wellbeing.”

Graphics Credit: http://www.ironlabsllc.co/view/learn.php

Swift W., Wong A., Li K.M., Arnold J.C. & McGregor I.S. (2013). Analysis of Cannabis Seizures in NSW, Australia: Cannabis Potency and Cannabinoid Profile., PloS one, PMID: 23894589

The Family Disease of Addiction and Alcoholism

This is an “encore” post from My3Sunz

For a long time I did not understand how my loved one’s substance abuse was my problem. In fact, I was quick to point out that they were the ones with the problem, not me! Then I heard an analogy of the how this family disease works. If you put a frog in boiling water, it will immediately jump out. If you put a frog in tepid water and slowly turn up the heat, it will cook to death because it did not recognize the change in temperature was in fact lethal. True or not, the story has been used in 12-step rooms to illustrate the family disease. Alcoholics Anonymous has recognized the family disease since inception, but oddly, there is limited research to support the family disease model. Nonetheless, professionals in the treatment community often look at substance abuse as a disease that affects the entire family.  Many professionals suggest the family attend a 12-Step meeting.  Another term equated with the family disease is codependency,  a condition that develops in relationships where the non-addicted person enables the abuser to continue. According to Wikipedia, “Codependency describes behavior, thoughts and feelings that go beyond normal kinds of self-sacrifice or care taking.”

It took a long time for me to understand this “family disease” notion. I could not deny the similarities of other people in like-situations. Like me, their loved one’s drinking and drugging was upsetting them (to put it mildly). We seemed to share the same symptoms. Upon hearing the frog in boiling water story, it clicked. As the heat turned up, my reaction was to normalize and cope with increasingly bizarre and unacceptable behavior. There were “incidences” that were escalating, but I casually excused it – “Oh, he was in the wrong place at the wrong time.” As time passed, no matter how bad the chaos and insanity really was, I did not feel the temperature rise!

Eventually, with help, I realized my inability to control them (denying the temperature change) and that I was going to boil to death. My rescuing behavior created an environment that made it easier for them to continue. I was hurting not only them, but myself and others around me too. It was time to jump out of the pot!

FDA Issues Draft De Novo Guidance Incorporating FDASIA Modifications

By Jennifer D. Newberger

On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). 

The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FDC Act), as amended.  This process was added to the FDC Act by the Food and Drug Administration Modernization Act of 1997 (FDAMA) to address novel devices that lack a predicate device but pose only a low to moderate risk, making them ill suited to the PMA process. 

Under FDAMA, before a device could utilize the de novo process, a device first had to be found not substantially equivalent (NSE) to a predicate device through the 510(k) process, even if the submitter and FDA agreed no appropriate predicate existed.  Due to the burdensome, time consuming nature of the de novo process, it was under utilized.

In September 2011, FDA issued a draft guidance document attempting to streamline the de novo process.  We discussed this draft guidance here.  Under that draft guidance, a person could submit a 510(k) and de novo petition simultaneously, and FDA could begin review of the de novo petition immediately upon issuance of the NSE letter. 

In July 2012, Congress amended section 513(f)(2) through passage of the Food and Drug Administration Safety and Innovation Act (FDASIA).  Under section 607 of FDASIA, a finding of NSE is not required before submitting a de novo petition.  Instead, if a person believes the device is low to moderate risk but no appropriate predicate exists, the person may submit a de novo without previously submitting a 510(k).  With the passage of FDASIA, the draft guidance issued in September 2011 was essentially mooted. 

The latest draft guidance describes the process of submitting a de novo petition under FDASIA, focusing primarily on the information to include in a de novo petition or a request for a Pre-Submission meeting prior to submitting a de novo request.  The information to include in a de novo petition includes the following: 

  • a recommendation whether the device should be regulated as Class I or Class II;
  • whether the device should be subject to 510(k) requirements;
  • if a Class II device subject to 510(k), the petition should include a proposed special controls document, describing the intended use, risks, and risk mitigation strategy for the device;
  • supporting protocols and data;
  • a summary of benefits and known and potential risks; and 
  • risk and mitigation information. 

In addition, the submission must include a “classification summary” demonstrating that the submitter has thoroughly researched legally marketed devices and concluded that no appropriate predicate exists.  To demonstrate that the submitter conducted such a search, the de novo submission should include:

  • a description of the databases searched and terms used to establish no predicate exists; 
  • regulations, PMAs, and/or product codes that may relate to or are potentially similar to the subject device; and 
  • a rationale for why the subject device does not fit within or is different from the identified regulations, PMAs, and/or product codes. 

The draft guidance states that if a submission fails to include this information, it will be put on hold.

While it seems appropriate for a submitter to demonstrate that it has conducted a reasonable search and concluded that no appropriate predicate exists, there is a potential for overly burdensome implementation of these search requirements by FDA.  If FDA places a de novo submission on hold after concluding that insufficient information has been provided, FDA should help guide the submitter in searching for or identifying information FDA believes may be relevant.

The de novo process has long been in need of remediation.  FDASIA provided the basis for that remediation, and the guidance should help industry take advantage of this process.  Hopefully this more streamlined process will allow innovative, moderate risk devices to more easily enter the marketplace.

Did You Say "I Love You" Today?

Did you tell someone that you love them today? Did you show someone today that they are a special person in your life? What would you say or do if you knew tomorrow was not coming?

Last night I was coming home from work. It was a beautiful evening and work had taken me to the country and a drive around the lake. I was following a SUV and we were cruising along not fast, just the speed limit on a two lane country highway in Kansas. In an instant the world exploded.

A one ton truck was coming the opposite way and all of a sudden it clipped the very end of a trailer being towed by a truck in front of the SUV. The one ton truck swerved directly into the SUV. A head on collision at 55 miles per hour. The two vehicles hit with such impact the both left the ground and spun around 180 degrees.

I slammed on my brakes and was barely able to steer around the truck while avoiding another pickup coming towards me. I stopped fifteen feet in front of the truck. The driver was half ejected from the truck and be was barely breathing. I called 911 and went to tend to the driver. His breathing hesitated and his eyes met mine. I reached down to his hand and lifted it in mine to check his pulse. He exhaled his last breath.

I went to the SUV and the driver of that vehicle obviously did not make it. I could tell from following he never knew what hit him. He didn't even have time to hit his brakes.

Still on 911 talking to the dispatcher I kept repeating that they're dying, they are dying, hurry. Emergency vehicles arrived quickly, probably 3 minutes. There were people stopping but the two drivers were already gone.

I was close enough that as I swerved to avoid hitting the truck, debris and fluids was showering down onto the hood and top of my truck. Broken windshield pieces and a windshield wiper were in the bed of my truck.

Life is a matter of seconds all strung together. One second later and it would have been me instead of the SUV. My life, his life they are all the same. Sadness grips another family that is unspeakable. When the name was released I looked on Facebook. He was a husband and father to three children. He was 39 years old. I have an unspeakable sorrow in my heart for someone I had never met until I saw him in the SUV.

No one expects it to be their day. Life is about seconds that mean minutes and turn into days. Seconds matter to each of us. We allow our seconds to tick by without telling and showing people how much they mean to us.

Did you say "I love you to someone today?" Did you show someone today that they are a special person in your life?

Don't let the most important second of your life tick away.

http://www.wibw.com/home/headlines/271761781.html


Young people’s experiences of 12 step groups

Students on Campus 6DJ Mac highlights a recent study of 302 18-24 year olds entering residential treatment and their opinions of 12 step groups. The study also included follow-up at 3, 6 and 9 months.

He pulls a few quotes from the paper and one, in particular, leapt out to me.

Clinicians can highlight that 12-step specific content was rarely cited as a reason for discontinuing 12-step attendance among young adults.

He also summarized their findings:

What was most helpful?
  • Removing a sense of isolation
  • Validating experiences
  • A sense of belonging, acceptance and validation
  • Installation of hope (being inspired/encouraged by another member who has a similar problem).
  • Altruism (members help and support each other).

12-step specific responses were rare leading the authors to conclude that ‘general group therapy factors were more important to these young adults in early recovery/post-treatment.’

What did they like least?
  • Meeting structure (length, repetition)
  • Having to motivate oneself to get there

Interestingly, less than 1% of young people found meetings unhelpful.

Why did they stop going?
  • Logistical barriers (e.g. lack of transport)
  • Low recovery motivation and interest
Why did some never attend?
  • Didn’t need treatment
  • Don’t have a problem

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