Power and responsibility in all the wrong places

mU8NMGqzWRQSRikWZCaTggwPeter Sheath did a guest post a while back at Memoirs of an Addicted Brain that took the treatment field’s inventory:

Unfortunately many of the people working in treatment do not see any need for self-reflection and continued self-development. They have come to believe that they simply don’t have time. I’ve travelled all across the UK, delivering training, coaching and consultation, and it’s the same everywhere. Blame, intimidation, threats and arrogance become the tools of rehab, the vehicles of control. It’s just easier that way.

. . .

Unfortunately, and here’s the rub: when we have absorbed the ideology that addiction is a disease and we need to sort it out or cure it, we are unknowingly removing from the person the very thing that is going to get them well. By assuming the “expert” status we are telling people that they are sick and, as such, unable to take responsibility for their recovery. Walk into any treatment centre anywhere and suddenly you become completely incapable. You can’t even fill in a form yourself and you certainly have no capacity or competence to manage your medication. Even if you begin to take responsibility by getting honest and telling the workers you have used again, they will need to take a confirmatory drug test to prove it! “You will need to undergo an assessment, looking at everything that’s wrong with you…” Using a form filled out by a worker, because you can’t do it yourself. The process is repeated by any further “expert” you may need to see. Any initiative on your part will be viewed the same way: as an obstruction. If you don’t want a script or you want to go straight to detox, you will be met with, “you’re not ready for that yet”, or the classic, “people die doing it that way.”

Perhaps I'm the Wrong Tool by Tall Jerome

Perhaps I’m the Wrong Tool by Tall Jerome

His focus is on the UK, but a lot of this is true for the US as well, even if it manifests differently.

I’m grateful to work in a place that makes it our responsibility to engage clients as active participants in their own recovery by utilizing strategies like peer support, recovery planning and Personal Medicine.

Read the rest of Sheath’s post here.


Filed under: Uncategorized

At Risk for Relapse?

7 Risk factors for relapse
-Bill Abbott, SMART Recovery® Facilitator

7 Risks for Relapse

Over the course of time I’ve observed several sets of circumstances that seem to increase the risk of a person with an addictive problem to sustain a relapse – that is, falling back to the former behavior. I must honestly state that this is an observational piece and I am not sure that there is any science behind it. Nevertheless it certainly does make sense that some of these circumstances do heighten the risk for  a temporary or even permanent stepping out of the stages-of-change process which we call addiction recovery.
 

    7 Risk Factors for Relapse

      Fantasy
      Rumination
      Boredom
      Persisting Frustration
      Intense Emotion
      Social Disconnection
      Opportunity

What follows is a short description of each of these.

Fantasy By this I mean thinking about a possible future scenario in which your behavior of choice has become usual or frequent. Falling into this category would be “romancing” the use of a particular substance or behavior. By this I mean forgetting the negatives and remembering the positives of the “using or doing” experience.

Rumination Rumination is the opposite of fantasy in some ways. This is thinking about the past in a circular fashion. Reinforcing  negative thoughts and continuing feelings of guilt or shame about one’s previous behavior would fall into this category.

Boredom Boredom is self-explanatory. When one is bored one is also prone to ruminate or fantasize.

Persistent frustration By this I mean a situation which is ongoing and for which there seems to be little opportunity or choice to make a change. For example, being “trapped” in a job that you do not like or responsible to a supervisor who is consistently and persistently difficult.

Intense emotion Any emotion that is extremely intense and tends to persist awhile would fall into this category. For example, grief over a loved one’s death or the loss of employment or a divorce.

Social disconnection This is a slightly harder one to understand. By this I mean being cut off or isolated from our usual activity or community. Man is a social animal and even though he does not need be with people all the time, to be separated can be painful and cause suffering. This might occur because of self-imposed isolation, or conversely it might be caused by rejection or ostracism.

Opportunity  This may be the biggest one of all and certainly adds to any of the previous ones should it arise. By this I mean having the time or space where one feels one can safely resume the previous behavior without being noticed or “caught”.

Suffice it to say that more than one of these can present itself at any point during the recovery process.

Being aware of these factors, I think, is the most important point I’m trying to make. Knowing in advance or knowing that it is occurring as a risk to relapse can arm oneself to taking measures to counteract it and not fall into the trap leading to lapse or relapse.


Bill Abbott is a long time SMART volunteers who, in addition to numerous other SMART volunteer activities, facilitates weekly SMART meetings in the Boston area and online.

 


 

OGD Management Review Results in Forfeiture of Generic ACTONEL 180-Day Exclusivity Eligibility

By Kurt R. Karst –      

The hope is that years from now (but hopefully not too many years), once the review and performance metrics FDA agreed to as part of the Generic Drug User Fee Amendments are in full effect and 10-month ANDA reviews (resulting in timely tentative and final approvals) are the norm, we’ll look back at posts like this one just to refresh our recollection as to how FDA, in the “dark ages,” went about determining that a sponsor forfeited eligibility for a period of 180-day exclusivity under FDC Act § 505(j)(5)(D)(i)(IV).  We’re already in a period of relative calm when it comes to forfeiture, with only a dozen or so FDA decisions so far this year.  But that calm is probably a bit misleading, as forfeiture decisions that would have come up at 30 months after ANDA submission have been delayed to 40 months as a result of the enactment of Section 1133 of the 2012 FDA Safety and Innovation Act (“FDASIA”) (see our previous post here).  

It’s been a while since we last posted on an FDA forfeiture decision.  But that’s the topic of today’s post . . . a recent and interesting case concerning generic ACTONEL (risedronate sodium) Tablets approved under NDA No. 020835.  And the case serves as a gentle reminder of FDA’s “our failure is your failure position” when it comes to the failure-to-obtain-timely-approval forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV).  First things first, however . . . a little statutory background.

Under FDC Act § 505(j)(5)(D)(i)(IV), 180-day exclusivity eligibility is forfeited if:

The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.

The 2007 FDA Amendments Act clarified FDC Act § 505(j)(5)(D)(i)(IV), such that if “approval of the [ANDA] was delayed because of a [citizen] petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final Agency action on the petition (inclusive of such beginning and ending dates) . . . .” FDC Act § 505(q)(1)(G).  Forfeiture decisions involving this provision have been invariably linked to a change in or review of decision under FDC Act § 505(j)(5)(D)(i)(IV).  FDA has yet to make a stand-alone decision under FDC Act § 505(q), adding a specific number of days to the 30-month forfeiture date. 

FDASIA made further changes with respect to the application of FDC Act § 505(j)(5)(D)(i)(IV) to certain ANDAs.  In particular (though not relevant to the case at hand), for an ANDA submitted to FDA between January 9, 2010 and July 9, 2012 initially containing a Paragraph IV certification (or that is amended during that time to first contain a Paragraph IV certification), the time to obtain timely tentative approval (or final approval if tentative approval is not warranted) is 40 months during the period of July 9, 2012 and September 30, 2015, and not 30 months.

FDA’s application of the exception (i.e., the “unless”) provision at FDC Act § 505(j)(5)(D)(i)(IV) was, at first, very narrow and draconian (and it still is to some extent).  For example, FDA explained in an October 2008 Letter Decision that “[t]his express description of the circumstances in which exclusivity will not be forfeited for failure to obtain tentative approval makes it clear that, under other circumstances in which an applicant has failed to obtain tentative approval, regardless of what party might be responsible for that failure, the first applicant will forfeit exclusivity” (emphasis added).  Although FDA still sticks to a “our failure is your failure position,” as we explained in a post back in June 2013, the Agency has shown some willingness to allow a little wiggle room under FDC Act § 505(j)(5)(D)(i)(IV).  In particular, FDA has rejected as too draconian “but for” causation in its application of the statutory forfeiture provision.  As we explained back then:

FDA has determined that even if one of the causes of failure to get tentative approval by the 30-month forfeiture date was a change in or a review of the requirements for approval imposed after the application was submitted, a first applicant will not forfeit eligibility notwithstanding that there may have been other causes for failure to obtain tentative approval by the 30-month forfeiture date that were not caused by a change in or review of the requirements for approval.  That is, to avoid forfeiture, an applicant need only show that acceptability of one aspect of its ANDA (e.g., chemistry, labeling, or bioequivalence) was delayed due, at least in part, to a change in or review of the requirements for approval, irrespective of what other elements may also have been outstanding at the 30-month date.  In other words, “but-for” causation is not required in order to qualify for the exception under FDC Act § 505(j)(5)(D)(i)(IV).  FDA has apparently determined that this interpretation best effectuates the policy embodied in the exception, insofar as it does not penalize first applicants for reviews of or changes in approval requirements imposed after their ANDAs are submitted that cause the failure to obtain approvals or tentative approvals within 30 months, and continues to incentivize applicants to challenge patents by preserving (in many instances) the opportunity to obtain 180-day exclusivity.

In the case of forfeiture of 180-day exclusivity eligibility for generic ACTONEL Tablets, 150 mg, FDA builds on to and hammers home the Agency’s “our failure is your failure position.” 

Teva Pharmaceuticals USA (“Teva”) submitted the first ANDA to FDA – ANDA No. 079215 – containing a Paragraph IV certification for two strengths of generic ACTONEL Tablets: 75 mg and 150 mg.  The first Paragraph IV for the 75 mg strength was submitted on September 10, 2007 as part of the company’s original ANDA submission, and a second Paragraph IV for the 150 mg strength was submitted on August 12, 2008 as part of an amendment to ANDA No. 079215.  Teva’s eligibility for 180-day exclusivity for the 75 mg strength was forfeited pursuant to FDC Act § 505(j)(5)(D)(i)(II) when the company withdrew the strength from ANDA No. 079215 on December 98, 2009, but Teva continued to pursue approval of the remaining 150 mg tablet strength. 

Years passed, and it was not until August 17, 2011 that FDA finally tentatively approved ANDA No. 079215.  This is, of course, more than six months past the date that is 30 months from the August 12, 2008 submission of the 150 mg strength amendment to the ANDA (i.e., February 12, 2011).  (Final ANDA approval was granted on June 13, 2014.) 

Although FDA has not yet posted on the Agency’s Drugs@FDA website a copy of the approval letter for ANDA No. 079215, we were able to get our hands on a copy of FDA’s internal 180-Day Exclusivity Forfeiture Memorandum.  In that memorandum, FDA’s Office of Generic Drugs (“OGD”) details the basis for the Office’s conclusion that Teva forfeited 180-day exclusivity eligibility pursuant to FDC Act § 505(j)(5)(D)(i)(IV), even though as of February 11, 2011, one day prior to the 30-month forfeiture date, all OGD review disciplines had completed review of the ANDA:

We note that although no individual disciplines were outstanding at the 30-month forfeiture date, FDA had not completed its final review of the ANDA by that date.  The decision to approve (or tentatively approve) an ANDA involves not only the disciplines’ evaluations of their respective portions of the ANDA, but final review by [OGD] management.  That final step did not take place by the 30-month forfeiture date, and was complete on August 17, 2011.  We also note that any claim that a company should not forfeit because of the possibility that FDA’s delays caused the company’s failure to obtain tentative approval by the 30-month forfeiture date is unavailing.  Under section 505(j)(D)(1)(IV) of the FD&C Act, exclusivity is forfeited “unless” there is a review of or change in the requirements that has delayed approval or tentative approval of the ANDA.  The statute does not permit, let alone require, either FDA or an ANDA applicant to comb through the ANDA review records and decide whether, had the review been conducted more quickly, the application could have received tentative approval before the 30-month forfeiture date.  Notably, section 1133 of FDASIA . . . , which, among other things, extended the 30-month forfeiture period to 40 months for certain ANDAs, reflects Congress’s understanding both that the length of time that it takes FDA to review an ANDA might contribute to a sponsor’s failure to obtain tentative approval by the 30-month forfeiture date, and that in such instances forfeiture nonetheless may occur.

We’ve always found FDA’s “our failure is your failure position” problematic from a fairness standpoint; however, no company has yet taken FDA to task in a lawsuit challenging the Agency’s interpretation and application of this position.  That’s probably because finding the perfect case is very difficult.  After all, what ANDA file is clean enough from a response timeframe to make such a challenge? 

Say what you mean, mean what you say, and don’t say it mean

mom daughter arguing trust distrust angerThere’s a saying that has been very helpful along my journey – ‘Say what you mean, mean what you say but don’t say it mean’.  Many times the first part ‘say what you mean’ is the easiest.  I can often express what I mean to say, even in the heat of the moment when I’m upset or stressed.  The second part ‘mean what you say’ is where the challenge starts for me.   ‘Mean what you say’ is where you hold your loved one accountable to the consequences of their actions.  Those consequences are the very thing that helps the addict to seek recovery.  Yet when your child is in a situation that you find to be dangerous or uncomfortable it is hard to stick to what you said you would not do.  Every situation is different but to say one thing and do another is mixed messages and keeps the bad behavior reinforced in many instances.

Getting a call that your loved one has relapsed, been hurt or worse, this is the call we parents dread when we have said coming home is not an option.  I have learned so much through these experiences about how the most loving thing you can do is stick to what you said.  At one point I had told my daughter I would not allow her to come home if she relapsed and yet when she had no where to go, I caved and let her come home.  Two days later she crashed her car while seriously intoxicated.  I had been gently coached by a parent who had been through this when I told him that I let her come home.  He said, “Your very actions to rescue your daughter from the consequence of her action may very well kill her one day”.  While this seemed harsh at the time – it was 2 days before the accident.  His words haunted me, he was so right.  I did not hold her accountable due to my fears.  I became very resolved from that moment on to ‘Say what I mean, mean what I say and don’t say it mean’.  When I stuck to the boundaries and accountability she began to take responsibility for her action and the consequences helped her realize the gravity of her decisions.   It has made all the difference in her recovery and mine.

Breaking the Stigma, Thomas J. MacDonald

28 years ago this weekend I was 20 years old .. I was in the middle of losing my battle with addiction . I had been trying to get sober for a while ..One night I went out had a few beers and tried to get some late night Chinese food.. I was in the back seat of the car of a person a just met .. She decided to make a U turn on the downside of a hill .. We got hit broadside at over 80 mph .. (Drunk driver never convicted) The truck basically hit me in the head ..i woke up in the hospital emergency room and was in and out of consciousness for about a week ..my injuries were a broken pelvis , ruptured spleen. Tore up shoulder .. And a broken face ..I spent about 2 weeks in the hospital .. And years of rehab to deal with all the damage ..I am lucky to be alive ..,the reason I am sharing is .. I got so addicted to the never ending supply of Percocet I was prescribed and from October to January 15th i went on a downward spiral that makes the car accident seem like a fender bender .. On January 14th I got arrested for driving under the influence and would have been incarcerated and on a path of no return ..it's only the Grace of God that I was saved from my addiction .. It's been 27 years since I put down the booze and drugs ... And I have been blessed with miracles every day after ...if you know someone or if you are suffering from any type of addition all I can say is your not alone and don't give up trying before the miracle happens in your life .. God is great and can do anything .. I know .. I am a living miracle... Please keep your eyes open on the road this weekend .. It's crazy out there ..


Anyone that has read this blog for a while knows that I enjoy making sawdust. Some of my efforts may go to the fireplace but that is not my intention. I enjoy working in my shop; that was my place of peace when Alex was using. I enjoy the peace and creativity of my wood shop. If I wasn't down there making something I was trying to learn from many of the masters on TV. One of those master craftsman I admire for his skill and his ability to put such difficult to master skills into simple easy to follow lessons is Tommy MacDonald, host of Rough Cut Woodworking with Tommy Mac.

A few years ago Tommy came to the Kansas City Woodworking Show. During his talk to hundreds of fellow woodworkers he sidetracked from talking about tuning a hand plane to safety and what can happen if your mind isn't on your work while in the shop.

After he finished and everyone was done getting pictures and autographs I made my way to this master craftsman. He was probably ready to get out of there but he stayed. I related how I got 8 stitches in my chin from doing something stupid while I was thinking about my son and his addiction and not paying attention to the work I was doing.

Tommy told me about his addiction to alcohol and drugs. He told me how hard it was on his family and his father. I could relate to his father as I listened.

I give Tommy my blog address and e-mail. The next morning Tommy had e-mailed me and told me he had read parts of my blog. He told me to "hang in there," recovery is possible. Alex had been trying to quit and I was still scared he would relapse once again and I would lose him forever. Tommy filled my tank with hope and just the right words when I needed them the most.

Yesterday morning I opened the computer and looked at Facebook. Tommy Mac had written what you read above posted on his page. He told his supporters and fans all over world of his recovery.

Master woodworkers take the gnarliest, ugliest piece of wood from a tree called a burl and create beautiful works of art. Next time you see a person suffering from addiction or alcoholism and they seem gnarly and ugly, do not discount that person as a "less than" it just might be another Tommy MacDonald.

Here you can find pictures of some beautiful works of art that Tommy has created.

http://www.tommymac.us/tommys-furniture-projects/
https://www.facebook.com/thomas.j.macdonald/photos_stream

I wouldn't dare post pictures of my stuff next to these pieces of fine woodworking. For those that haven't seen my work just do a search on my blog using the term "woodworking".


Home at Last

Getting back to the Throw Back Sunday posts after a little break. This one was originally posted in February 2007.
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vid2_1

PBS’s series NOW had a segment on a housing first approach with a man named Footie who is chronically homeless and an alcoholic. He’s clearly a late stage alcoholic, frequently has seizures and may have some cognitive impairment due to years of heavy drinking and seizures. (Streaming video of the entire episode is available at the link above.)

The story made a pretty compelling case for this approach with this him, arguing that it was impossible to address his higher order needs when his physiological and safety needs were not being addressed. Footie was provided an apartment with no contingencies. The approach could make a lot of sense in many cases–the question is which cases and under what conditions?

I had several reactions to the segment. First, had Footie ever been provided with comprehensive treatment of and adequate dosage, duration? Why no contingencies? Maybe his housing shouldn’t be contingent upon abstinence, but how about participation in treatment? If the fear is that this might be a set-up, how about reviewing it at monthly or quarterly intervals so that a bad week does not put him back on the street? Why not at least make it recovery-focused? If this approach is good for Footie and raises his functioning and quality of life to his potential, who’s functioning and quality of life might be reduced to something below their potential? At Dawn Farm, we see some clients who would probably benefit greatly from a recovery-focused housing program that is not contingent upon abstinence. However, how many of clients who are currently in full recovery would have settled into an apartment like Footie’s and never achieved stable recovery and a full, satisfying life? Many, I think.

UPDATE: This isn’t to say it shouldn’t be done, but rather how to go about it in a way that doesn’t lower the bar for all homeless addicts and fail to address what caused their homelessness. Maybe one way to approach it is to ask, “Absent their addiction, would this person still be likely to be homeless?” In the case of Footie, the answer is “probably so”. In the case of most of our homeless clients, the answer is “unlikely”.

Of course, another big question is how to prioritize services in the context of scarce resources.


Filed under: TBS, Uncategorized

OD Awareness and both/and approaches

NARCAN-KITYesterday was International Overdose Awareness Day. Where do we stand?

This crisis has brought some good policy changes. Naloxone distribution programs are spreading fast and good Samaritan laws are spreading too. These policy changes will undoubtedly save lives, and that’s important.

There’s also no doubt that there are a lot of deaths that these programs won’t prevent. Consider the death of Phillip Seymour Hoffman. As is common, he appears to have died while using along, which casts doubt on any suggestions that naloxone and good Samaritan laws would have saved him. Even for those they save, they don’t offer a way out of their suffering and a lives that they hate.

fr2plus-overview-main-450x330How are we doing in terms of access to treatment of adequate intensity and duration? We don’t have much in the way of statistics for that, but it’s save to say that we’re not doing so well. We’ve got models that work really well, but we only use them with health professionals, lawyers and pilots.

Too often, we’ve had one faction calling for more treatment and another calling for harm reduction.

Naloxone is not enough. And, even access to quality treatment of adequate duration and intensity were improved, we couldn’t engage and successfully treat everyone.

We need a both/and approach rather than an either/or approach. Let’s increase access to naloxone and make sure that every rescue is followed by the kind of care an addicted health professional would get.

 

 


Filed under: Uncategorized Tagged: Drug overdose deaths, International Overdose Awareness Day, naloxone, opioid addiction, opioid overdose deaths, Phillip Seymour Hoffman

Are “recovery ghettos” really a concern?

"He left me for the glass pipe."

Beauty, Hunts Point. Courtesy of Chris Arnade. Click image for more in his series.

Cassie Rodenberg’s blog has had a couple of heartbreaking posts recently. They look at the lives of women in the culture of addiction–prostitution, pimp boyfriend, sexual assault, having to provide sex for a place to stay, etc.

It brought back Bill White’s book, Pathways and his discussion of sex within the culture of addiction. Not only does the use of sex as a vehicle to maintain access to drugs or other needs within the context of addiction detach sex from pleasure, intimacy and love, it also is a consequence and contributor to the objectification of others–people become objects to be used or avoided.

All of this got me thinking more about a post a while back where I discussed a post from Bill White on the need for “recovery spaces” and how the concept was getting some push back. DJ Mac (who is supportive of the concept of recovery spaces) titled his post, Does recovery space equal recovery ghetto? Much of the discussion seemed to be between people who are culturally empowered, mobile, do not live in a ghetto and have never been trapped in a ghetto.

Cassie’s posts reminded me that, for some, ghetto isn’t just a metaphor–it’s their world.

These people need more than harm reduction.

They need more than MI, CBT or 12 step facilitation.

They need Recovery Management.

Bill White calls on us to raise our expectations of ourselves and the system while focusing on recovery and the community as the locus of healing. [emphasis mine]

Addiction treatment must always adapt to the evolving context in which it finds itself. Such redefinition may push treatment toward the experience of retreat and sanctuary in one period and toward the experience of deep involvement in the community in another. I would suggest that the focus of addiction counseling today should not be on addiction recovery-that process occurs for most people through maturation, an accumulation of consequences, developmental windows of opportunity for transformative or evolutionary change, and through involvement with other recovering people within the larger community. The focus of addiction counseling today should instead be on eliminating the barriers that keep people from being able to utilize these natural experiences and resources. Our interventions need to shift from an almost exclusive focus on intervening in the addict’s cells, thoughts and feelings to surrounding and involving the addict in a recovering community.

Over the years Bill shifted his language to emphasize “community renewal”:

A major focus of RM (Recovery Management) is to create the physical, psychological, and social space within local communities in which recovery can flourish. The ultimate goal is not to create larger treatment organizations, but to expand each community’s natural recovery support resources. The RM focus on the community and the relationship between the individual and the community are illustrated by such activities as:

  • initiating or expanding local community recovery resources, e.g., working with A.A./N.A. Intergroup and service structures (Hospital and Institution Committees) to expand meetings and other service activities; African American churches “adopting” recovering inmates returning from prison and creating community outreach teams; educating contemporary recovery support communities about the history of such structures within their own cultures, e.g., Native American recovery “Circles,” the Danshukai in Japan;
  • introducing individuals and families to local communities of recovery;
  • resolving environmental obstacles to recovery;
  • conducting recovery-focused family and community education;
  • advocating pro-recovery social policies at local, state, and national levels;
  • seeding local communities with visible recovery role models;
  • recognizing and utilizing cultural frameworks of recovery, e.g., the Southeast Asian community in Chicago training and utilizing monks to provide post-treatment recovery support services; and
  • advocating for recovery community representation within AOD-related policy and planning venues.

It’s worth noting that, over the years, Bill has written about recovery employment, housing, education, etc,

It can be overwhelming. But, the alternative is despair.

UPDATE: This post was re-titled based on reader feedback.


Filed under: Uncategorized