Detachment – forgiveness – hope for the future as parents of an addict

A Dad’s Road to Recovery

The month’s Guest Blogger, A Dad’s Road to Recovery, features a 3-part Series: Part 2:

My wife and I asked our son to leave our house over a year and a half ago and while being homeless he figured out a way to break into my house – overriding the alarm system to get what he wanted. Addicts can be very resourceful in finding ways to get what they want. After each episode of being violated I would pray to my higher power and turn over my situation over to him as the only thing I could do was file that police report [again] and continue on with my life. I learned over time not to be angry or resentful towards my son and in fact I learned how to forgive him. Why? Because that’s what addicts do – they steal, lie, and use drugs. I acknowledge my sponsors effort to show me the true value of forgiveness. When I learned how to forgive, the expectations went away and I began to have hope for the future and a recovering son. To this day I still have hope for the future, I am not angry nor am I frustrated or sad about the past.

New Developments in the Ongoing PhRMA v. HHS/HRSA Saga Over the Interpretation of the Exclusion of Orphan Drugs Under the 340B Program

By Michelle L. Butler

On July 21, 2014, the Department of Health and Human Services (“HHS”)/Health Resources and Services Administration (“HRSA”) announced the availability of an interpretive rule titled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program,” which is scheduled to be published in the Federal Register on July 23, 2014. 

In its Notice announcing the availability of the interpretive rule, HHS stated that, as the court “decision did not invalidate HHS’s interpretation of the orphan drug exclusion,” “there still is a need for HHS to clarify its interpretation of how the orphan drug exclusion in the 340B Program should be implemented to be consistent with [the statute].”  Consequently, HHS issued an interpretive rule, which states that HHS

interprets section 340B(e) of the Public Health Service Act as excluding drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA) Section 340B(e) does not exclude drugs that are transferred, prescribed, sold, or otherwise used for conditions or diseases other than for which the drug was designated under section 526 of the FFDCA.

Interpretive Rule, at 6.

In articulating the reasons for its interpretation, HHS discussed the purpose and effect of the Orphan Drug Act and the orphan drug exclusion in the Public Health Service Act.  HHS stated that “it is appropriate to construe the orphan drug exclusion consistent with FDA’s longstanding interpretation of the orphan drug provisions of the FFDCA – distinguishing the use of a drug for an orphan indication from its use for other (non-orphan) indications.”  Id. at 4.  Moreover, HHS stated that ‘[i]nterpreting the statutory language to exclude all uses of drugs with an orphan designation, including indications for other (non-orphan) diseases and conditions would nullify the benefits of the expansion of the 340B Program” for newly-eligible entities.  Id. at 5.  Accordingly, HHS “concluded that interpreting the statutory language to exclude all indications for a drug that has an orphan drug designation would be contrary to the Congressional intent of section 4340B(e) to balance the interests of orphan drug development and the expansion of the 340B Program to new entities.”  Id. 

According to the Notice, the effective date for the interpretive rule will be the date of publication in the Federal Register.  HRSA’s website contains information pertaining to implementation of the orphan drug exclusion, including orphan drug lists to be used to “assist all stakeholders in complying with HRSA’s policy.” 

HHS/HRSA’s decision to implement its interpretation of the statute as an interpretive rule appears to set the stage for another round of judicial review.  As previously described, in May, in a suit brought by the Pharmaceutical Researchers and Manufacturers of America (“PhRMA”), the United States District Court for the District of Columbia vacated HHS’s substantive rule on the orphan drug exclusion on the ground that HHS did not have the authority to promulgate its rule as a substantive rule.  Having reached its decision on this ground, the court did not come to a final decision on whether the rule could be upheld as interpretive, but seemed skeptical of the argument and invited further briefing on the subject.  PhRMA subsequently filed a motion requesting briefing on the matter of an interpretive rule, which HHS opposed as moot in light of its decision to issue “new, separate interpretive guidance.”  HHS argued in its opposition that any challenge to HHS’s interpretive guidance would be a challenge to “new agency action,” which would require a new suit or amendment of the complaint to include such a new claim.  Last week, PhRMA filed a reply brief to its request for briefing on whether the rule “(however packaged) can survive as an interpretive rule,” particularly in light of HRSA statements that PhRMA argues demonstrate the binding effect HRSA appears to intend for the interpretive rule to have.  We will continue to monitor the developments in this case as HHS/HRSA and PhRMA continue their battle over the orphan drug exclusion.

“not all marijuana users are of equal concern to us”


Keith Humphreys imagines the reactions of various stakeholders to this graph showing marijuana consumption Colorado.

  • He imagines public health workers expressing concern about the bottom two bars and trying to promote policies that will reduce the amount these heavy users consume.
  • Next, he imagines a corporate board room voicing interest in attracting users in the bottom two bars to their brand and finding ways to retain them.
  • Finally, he puts us in the legislature, which is torn between improving public health and the tax revenue these heavy users provide.

He adds that this illustrates that there is no such thing as value-free policy.



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What…Me Sober? 2014-07-22 16:04:22

We’re going through a page redesign, so things may be a little bit fluid for the next few days.  Please excuse.  All the posts should remain available at all times.  Thanks for your patience!

Lessons in the cunning, baffling and progressive nature of my sons’ addiction

A Dad’s Road to Recovery

The month’s Guest Blogger, A Dad’s Road to Recovery, features a 3-part series.   This is Part 1.

My journey through Al-Anon has taught me ways to deal with the repetitive actions of my 23 year-old son’s insistence to use heroin and commit crimes in order to get high and support his habit. I learned in step one that I was indeed powerless and that no action I could produce could turn my son into a normal person. Recently I completed all twelve steps with my sponsor and I became more knowledgeable on what it took to take care of me. My son got arrested four times in the past five weeks only to be released from jail a few days later as the jails are overcrowded. The cycle consisted of him getting released on his own recognizance and then a few days later he would get arrested again for similar crimes. His crimes ranged from possession of drugs, theft, burglary, and forgery. About a year ago while being homeless he went through a similar episode of drug use, theft, and forgery and spent 7 months in the County jail. I will say the jail time gave him time to think about his situation, attend 12 step meetings while in jail, and when he got out accumulated an additional 3 months of clean time. He attended about 90 Narcotics Anonymous meetings in 90 days. His road to recovery was beginning and then was shattered as quick as it began. It was after that the relapse of drug use and the crimes stated above occurred again.  Part 2 of this series will be posted on December 23.

SMART Handbook for Kindle Just Released

Now you can get a Handbook — NOW!

SMART Handbook for Kindle

The waiting is over! Carry your SMART Handbook with you everywhere, on your smartphone or tablet. Or read it on your personal computer or laptop. Thanks to the talents and persistence of Laurie, one of our dedicated volunteers, the frequently requested ebook option for the Handbook is now a reality. The new Kindle edition contains the entire contents of the SMART Handbook, 3rd. ed., is fully indexed for efficient searching using the Kindle app search feature and is now available for instant download. Cost: $7.99

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FDA Releases Report on Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases

By Alexander J. Varond —

FDA recently released its report entitled “Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases.”  The report fulfills the requirements set out in PDUFA V and in Section 510 of FDASIA, which require FDA to hold a public meeting to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases (“PRDs”), and to issue a report that includes a strategic plan for encouraging and accelerating such therapies See our previous posts here and here).

FDA’s 86-page report summarizes the difficulties facing sponsors of drugs for PRDs, outlines legislation and approaches to expedite and accelerate rare disease medical product development, provides an overview of the three-day workshop held on January 6-8, and sets forth FDA’s strategic plan.  The first two days of the workshop focused on “complex issues in developing drug and biological products for rare diseases,” while the third day focused on “complex issues in developing medical devices for pediatric patients affected by rare diseases.”

FDA noted that its strategic plan is not a legislative wish list, but is instead an outline of what FDA can reasonably achieve under its existing authority to encourage and accelerate the development of new therapies for PRD.  The report includes a helpful summary of FDA’s strategic plan that we include here:

Objective 1:  Enhance foundational and translation science for PRD

  • Drugs/biologics strategies
    • Facilitate the conduct of natural history studies for PRD
    • Publish draft guidance on common issues in rare disease drug development
  • Device strategies
    • Identify unmet PRD needs in medical device development
    • Refine and expand the use of computational modeling
    • Explore the use of registry data for use in both premarket and postmarket evaluation of medical devices intended for pediatric populations

Objective 2:  Strengthen communication, collaboration and partnering for PRD within and outside FDA

  • Drugs/biologics and devices strategies
    • Continue to foster interagency (public-public) and public-private partnerships
    • Continue to foster international collaborations
    • Continue to foster Intra-Agency collaborations

Objective 3:  Advance the use of regulatory science to aid clinical trial design and performance for PRD

  • Drugs/biologics strategies
    • Develop additional FDA guidance relevant to PRD
    • Increase engagement of the Study Endpoints and Labeling Development (SEALD) Staff early in instrument development to navigate COA process
    • Facilitate increasing the knowledge of biomarkers and COAs useful for PRD, including engaging with investigators and organizations in biomarker and clinical outcome qualification programs to advise during their development
    • Develop training programs for pediatric clinical investigators
    • Explore modeling and simulation approaches  (e.g., physiologically-based pharmacokinetic [PBPK] models) to provide preliminary data for drugs used in PRD to inform the design and conduct of PK/PD studies and other clinical trials for investigational drugs in PRD population
  • Device strategies
    • Develop expedited approval pathway for certain devices intended to treat unmet medical needs
    • Evaluate the results of an analysis of approved medical devices to explore the feasibility of shifting some premarket data requirements to the postmarket setting for future medical devices
    • Support the development of Medical Device Development Tools to improve clinical trial performance
    • Develop curriculum for undergraduate/graduate studies to increase understanding of regulatory approval process for device development
  • General strategies
    • Use FDA web-based resources to update and expand awareness of PRD product development issues
    • Increase awareness in pediatric rare disease researchers, product developers, and patient community of funding opportunities through OPD grant program

Objective 4:  Enhance FDA’s review process for PRO products

  • Drugs/biologics strategies
    • Foster FDA’s efforts to obtain patients’ and caregivers’ perspectives for incorporation in drug development
    • Further develop and implement a structured approach to benefit-risk assessment in the drug review process
    • Issue Rare Pediatric Disease PRV draft guidance document
    • Continue reviewer training for rare and PRD
    • Explore potential for innovation in data analysis
  • Device strategies
    • Further develop methods to implement the incorporation of patient preferences into assessments of premarket approval and de novo classifications of devices
    • Establish a patient engagement panel as part of CDRH’s Medical Advisory Committee
    • Analyze the HDE process for medical devices that diagnosis and treat PRD
    • Set standards for whole genome sequencing that can he used as a comparator
  • General strategies
    • Continue to enhance FDA’s expertise to review innovative products


Hunting For the Marijuana-Dopamine Connection

Why do heavy pot smokers show a blunted reaction to stimulants?

Most drugs of abuse increase dopamine transmission in the brain, and indeed, this is thought to be the basic neural mechanism underlying the rewarding effects of addictive drugs. But in the case of marijuana, the dopamine connection is not so clear-cut. Evidence has been found both for and against the notion of increases in dopamine signaling during marijuana intoxication.

Marijuana has always been the odd duck in the pond, research-wise. Partly this is due to longstanding federal intransigence toward cannabis research, and partly it is because cannabis, chemically speaking, is damnably complicated. The question of marijuana’s effect on dopamine transmission came under strong scrutiny a few years ago, when UK researchers began beating the drums for a theory that chronic consumption of strong cannabis can not only trigger episodes of psychosis, but can be viewed as the actual cause of schizophrenia in some cases.

It sounded like a new version of the old reefer madness, but this time around, the researchers raising their eyebrows had a new fact at hand: Modern marijuana is several times stronger than marijuana in use decades ago. Selective breeding for high THC content has produced some truly formidable strains of pot, even if cooler heads have slowly prevailed on the schizophrenia issue.

One of the reports helping to bank the fires on this notion appeared recently in the Proceedings of the National Academy of Sciences (PNAS). Joanna S. Fowler of the Biosciences Department at Brookhaven National Laboratory, Director Nora Volkow of the National Institute on Drug Abuse (NIDA), and other researchers compared brain dopamine reactivity in healthy controls and heavy marijuana users, using PET scans. For measuring dopamine reactivity, the researchers chose methylphenidate, better known as Ritalin, the psychostimulant frequently prescribed for attention-deficit hyperactivity disorder (ADHD). Ritalin basically functions as a dopamine reuptake inhibitor, meaning that the use of Ritalin leads to increased concentrations of synaptic dopamine.

In the study, heavy marijuana users showed a blunted reaction to the stimulant Ritalin due to reductions in brain dopamine release, according to the research. “The potency of methylphenidate (MP) was also reported to be stronger by the controls than by the marijuana abusers." And in marijuana abusers, Ritalin caused an increase in craving for marijuana and cigarettes.

 “We found that marijuana abusers display attenuated dopamine responses to MP including reduced decreases in striatal distribution volumes,” according to the study’s conclusion. “The significantly attenuated behavioral and striatal distribution volumes response to MP in marijuana abusers compared to controls, indicates reduced brain reactivity to dopamine stimulation that in the ventral striatum might contribute to negative emotionality and drug craving.”

Down-regulation from extended abuse is another complicated aspect of this: “Although, to our knowledge, this is the first clinical report of an attenuation of the effects of MP in marijuana abusers, a preclinical study had reported that rats treated chronically with THC exhibited attenuated locomotor responses to amphetamine. Such blunted responses to MP could reflect neuroadaptations from repeated marijuana abuse, such as downregulation of DA transporters.”

 Animal studies have suggested that these dopamine alterations are reversible over time.

Another recent study came to essentially the same conclusions. Writing in Biological Psychiatry, a group of British researchers led by Michael A.P. Bloomfield and Oliver D. Howes analyzed dope smokers who experienced psychotic symptoms when they were intoxicated. They looked for evidence of a link between cannabis use and psychosis and concluded: “These findings indicate that chronic cannabis use is associated with reduced dopamine synthesis capacity and question the hypothesis that cannabis increases the risk of psychotic disorders by inducing the same dopaminergic alterations seen in schizophrenia.” And again, the higher the level of current cannabis use, the lower the level of striatal dopamine synthesis capacity.  As for mechanisms, the investigators ran up against similar causation problems: “One explanation for our findings is that chronic cannabis use is associated with dopaminergic down-regulation. This might underlie amotivation and reduced reward sensitivity in chronic cannabis users. Alternatively, preclinical evidence suggests that low dopamine neurotransmission may predispose an individual to substance use.”

The findings of diminished responses to Ritalin in heavy marijuana users may have clinical implications, suggesting that marijuana abusers with ADHD may experience reduced benefits from stimulant medications.

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New Quest Study Examines Prescription Drug Misuse

drug-misuseQuest Diagnostics released a Health Trends™ report with a three-year analysis of prescription drug use from more than 1.4 million test results. The study examined the risks of prescription drug misuse and efforts at the state level to reduce abuse.

Patients, regardless of age or gender, sometimes use dangerous drug combinations and skip doses. Michael R. Clark, M.D., MPH, MBA, associate professor and director, Chronic Pain Treatment Program, Department of Psychiatry and Behavioral Sciences, is quoted in the press release, “Patients are still substituting, supplementing, and diverting their prescribed controlled substances.”

Five states have implemented multi-faceted prescription drug abuse prevention programs in recent years, and these same states showed the greatest rate of decline in prescription drug misuse. Florida, Georgia, Kentucky, Tennessee and New York experienced an average decline that was nearly 2.5 times greater than the average of all other states combined. Actions taken in these states included prescription drug databases, physician and patient education and public awareness campaigns. This portion of the study shows promising signs that the right strategies can help to make progress against the prescription drug epidemic.

Quest Diagnostics is a leader in prescription and workplace drug testing. In much the same way that this Health Trends report showed trends in prescription drug use, the Quest Diagnostics Drug Testing Index™ details trends of drug use by U.S. workers. For more information about our drug testing products and services, contact us online.

The 4 M’s of Relapse – Keeping ourselves focused under duress

Choices in RelationshipsToday I learned something that is a very handy tool during the trials and tribulations of a relapse of a loved one struggling with addiction. My friend told me about the ‘4 M’s of Relapse’. When your child relapses you don’t do the following; mother, manipulate, martyr or money. This is excellent advice yet not at all easy to do. Let’s look at the first M – mother. When my daughter would relapse the first thing I would want to do is ‘mother’ her by jumping in to take care of her, ease the pain, work on solutions and try to ‘make it all better’. But mothering is hurtful because it alleviates the loved one from feeling the consequences of their action which inadvertently keeps them in their addiction. Next is manipulate. Even with the best of intentions, manipulation is a way of trying to control our loved one. We take on the behaviors of the very ones we are trying to save through our manipulation. Next is martyr. When a relapse occurs many of us go into the ‘woe is me’ syndrome – how could she do this to me? Doesn’t she understand how stressed I am and how hard this is on the family? The list goes on, but being a martyr does nothing but turn us into a helpless victim. And the last, money. It is a natural response for us as parents to want to reach for our wallets and solve problems. We need to think about any money we are considering to bail out our loved one and what message it is sending and how it may dis-empower them to take responsibility for their actions.

The 4 M’s are a great tool to consider under duress. When we get the crisis call that our kid has relapsed and we begin to hear the wreckage that has ensued we can use the 4 M’s as a way to keep focused on being supportive but not begin problem solving or taking on the responsibilities. I know that when I’m concerned or worried I don’t always think clearly, but keeping this simple thought in the forefront will help to keep my actions in check.