Is naloxone really needed in buprenorphine product?

The word on the street has been out for some time — it's not true that the naloxone in the buprenorphine combination product (Suboxone, for example) prevents euphoria if the opioid, which is meant to be dissolved in the mouth, is ingested. More than 20 years ago, this was the premise when the federal government subsidized the development of the first buprenorphine‐naloxone product, paving the way for Reckitt Benckiser Pharmaceuticals — now Indivior — to make a fortune on its Suboxone product. There was yet another delay when the patent expired, but generic manufacturers couldn't break the code for blending the naloxone with the buprenorphine, furthering the fortunes of RBP/Indivior.     

Indivior CEO steps down,pleads guilty over Suboxone

On June 30, the federal Department of Justice announced that Shaun Thaxter, CEO of Indivior, pleaded guilty for misrepresenting Suboxone's safety. Suboxone is buprenorphine combined with naloxone. Briefly, Indivior was trying to promote its new film, saying that its tablets caused a risk of pediatric exposure (see “Reckitt Pulls Suboxone Tablets, Citing Pediatric Exposures,” ADAW, Sept. 12, 2012, https://onlinelibrary.wiley.com/doi/10.1002/adaw.20347 ). It had just discontinued its own tablets and was trying to convert its patients to its patented film, because the tablets were off patent and it wanted to keep market share, crowding out any generics in a scheme commonly known as “evergreening.” Medicaid formularies in Massachusetts and Virginia were sold on the idea, and therefore agreed to approve Suboxone even to patients with children under the age of 6 living in the home. The interstate commerce made this a federal case.     

Is generic buprenorphine film as good as Suboxone?

When Indivior's popular Suboxone film went off patent, Dr. Reddy's was ready with the generic, and there are more companies now providing it as well — including Indivior itself (distributed by Sandoz). The point of generics, from a patient or payer point of view, is that they are less expensive than brand. But there can be problems — with quality, including of active ingredients. Patients frequently complain when their agonist medications are switched — whether it's from one type of methadone to another or, now, from Suboxone film to a generic.     

RB agrees to pay U.S. $1.4 billion for avoiding prosecution over Suboxone marketing scheme; Indivior trial next year

Reckitt Benckiser (RB) Group, previously Reckitt Benckiser Pharmaceuticals, former owner of Indivior, and maker of Suboxone, has agreed to pay the U.S. government $1.4 billion in exchange for not being prosecuted for marketing of the medication. In 2014, Reckitt Benckiser spun off Indivior, and the two companies are no longer connected. A separate trial will proceed against Indivior starting in May 2020.     

FDA relents on Brixadi,competitor to Sublocade

Last week, Braeburn won its fight against Indivior to bring its injectable form of buprenorphine, Brixadi, to the U.S. market. The Food and Drug Administration (FDA) granted Braeburn's request to the FDA to revoke the orphan drug designation for Indivior's Sublocade. However, the FDA has reaffirmed exclusivity for Sublocade until next November.     

Study: Elevated risk of substance use if parents use marijuana

Last month, JAMA Network Open published a study indicating that recent and past parental marijuana use confers a heightened risk for use of marijuana — and other substances — by their adolescent and young adult offspring who live in the same household. The article from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institute on Drug Abuse and McLean Hospital is in line with federal anti‐marijuana policy (marijuana is still illegal under federal law, although states have legalized it, both recreationally, in some cases, and medically, in more).     

Sublocade trial data published: Better than placebo

Sublocade, a buprenorphine injection that lasts a month, was approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017), but the data that led to the approval was not public. It was made public in an article by Sublocade manufacturer Indivior published Feb. 18 in The Lancet.     

HHS OIG doubles down on constraints against contingency management

Stimulant use disorders are on the rise resulting in exacerbation of the opioid epidemic, with stimulants often present in opioid overdoses.. Subcontractors are lining up to implement the new stimulant use disorder treatment provisions of the $1 billion annual State Opioid Response (SOR) federal grant program. And contingency management (CM), in which patients are given monetary rewards for not using drugs, is the best — by far — treatment for stimulant use disorder.     

NASADAD to NIDA: Connect research to practice

When the National Institute on Drug Abuse (NIDA) sought input on its five‐year plan, the people responsible for publicly funded prevention, treatment and recovery — state directors — called for returning to the days of communication between federal agencies like the Substance Abuse and Mental Health Services Administration (SAMHSA) and between NIDA researchers and the service delivery system. In an Aug. 7 letter to NIDA's strategic planning team, Robert I.L. Morrison, executive director of the National Association of State Alcohol and Drug Abuse Directors (NASADAD), noted that each state alcohol and drug agency has a critical role to play in NIDA initiatives. This role includes.     

DEA proposal for mobile methadone finally released

The federal Drug Enforcement Administration (DEA) has issued a long‐awaited proposed rule that would allow opioid treatment programs (OTPs) — treatment programs that use methadone — to transport the medication to patients via “conveyances” (such as vans). This means that patients would no longer have to go to the brick‐and‐mortar OTP.     

Perils of eliminating the x-waiver: Comments from former CSAT official

A highly unusual meeting took place in 2014—a group of experts, including federal officials, and top legislators – namely, former senators Carl Levin (D-Michigan) and Orrin Hatch (R-Utah) met in June of that year to discuss changing the Drug Addiction Treatment Act of 2000 (DATA 2000), which regulated buprenorphine prescribing up until it was eviscerated in the spending bill last month (see https://onlinelibrary.wiley.com/doi/epdf/10.1002/adaw.20431 ). The lawmakers wanted to raise the maximum number of patients one physician could have (at the time, it was 30 under DATA 2000, and 100 under the 2006 amendment; since then it has been raised further).     

Can Health Care Reform End Stigma Toward Mental Illness?

This article addresses the destigmatization of mental health through health care reform by incorporating antistigma efforts—a destaining of mental illness—through prevention and early intervention in community-based programs that would be mandated and funded through the auspices of Patient Protection and the Affordable Care Act (ACA). Mental health care policies under the ACA and the Mental Health Parity Act are briefly described, following a definition of mental health stigma and its impacts. Recommendations for statutory mandates in stigma reduction at the community and federal levels and guidelines for mental health/behavioral health providers form the article’s conclusion.     

Housing for Families but Not for People: Federal Policy and Normative Family Ideals in Midcentury California

Abstract

Scholars have documented the harmful effects of urban redevelopment in the middle of the twentieth century with a particular focus on “redlining” to achieve racial segregation. This article considers another way that the state influenced social geography. In the middle of the twentieth century, some city planners argued for housing for single people and childless couples, but federal guidelines and funding specified that new housing be for nuclear, heterosexual families with children. Two historical cases demonstrate how planners attempted to create housing for alternative households but were unsuccessful. These two cases show that in addition to the documented effects of shaping the economic and racial landscapes of cities, federal housing policy sent strong signals to people about acceptable family formations by limiting the type and quantity of housing stock available. By examining how planners attempted to move forward with housing for all types of households, this article shows that federal family-oriented policies were not uncontested even if they were usually implemented. These cases highlight the complicated relationship among federal policies, normative culture, and the built environment. This article proposes that we should further investigate the ways in which the built environment has served as a mediator between the state, as exemplified by housing policies, and culture—normative ideals about the family—in a recursive sense; while federal policies both reflected and projected dominant cultural ideology concerning the primacy and importance of nuclear families, urban redevelopment projects presented this relationship in built form when redevelopment took the form of housing for families but not for single people or childless couples.     

The federal Public Relations Administration: history’s near miss

Given the permanent hostility by Congress to public relations in public administration at the federal level of government, it is surprising how close the federal government came to establishing a wartime agency, entitled the Public Relations Administration (PRA), as part of its administrative structure in World War II.During the interwar years (1918–1941), the civilian and military leadership of the US engaged in elaborate planning for a possible future war, including recommending the creation of a superagency called the PRA. The 1933 version of the Industrial Mobilization Plan (IMP) submitted to Congress by the Army and Navy was the high water mark of institutionalizing public relations in public administration. This one-time opportunity to legitimize and professionalize public relations by the federal government was lost due to the opposition of President Franklin Roosevelt in 1939. This article relates how that planning effort unfolded and the factors that led to its stillbirth.     

Briefly Noted

A federal audit of opioid treatment programs (OTPs) — methadone clinics — in New York City found that of 115 random sample claims, 35 did not comply with Medicaid requirements, and that of 598 claims in a non‐random sample, 299 were billed in error. Extrapolating these errors, the federal Department of Health and Human Services (HHS) says the state improperly claimed at least $39.3 million in the federal share of Medicaid reimbursement, and owes that money back. Improper claims were mainly due to failure to record patients in the central registry, which exists to make sure patients aren't enrolled in multiple OTPs (18 of the 35 noncompliant claims). This was not an audit alleging fraud. Extrapolation as an accounting method for OTPs, where patients often come in every day, so that each patient has more than 300 claims a year, is questionable, but OTPs are used to this even in state audits. In other words, one OTP patient comes in six days a week, with six claims, and the database balloons. “You're extrapolating over our universe, and our universe becomes large because people come in for medication,” said Allegra Schorr, president of the Coalition of Medication‐Assisted Treatment Providers and Advocates, a New York–based membership organization, and board member of the American Association for the Treatment of Opioid Dependence. “When you're just trying to get money, this counts,” said Schorr. “They hit the lottery when it comes to an audit because of that extrapolation.” However, Schorr, who is also an owner and vice president of West Midtown Medical Group, a Manhattan‐based group that was the first OTP to dispense buprenorphine in New York state, stresses that compliance is always important. “It's critical that there is oversight,” she told ADAW. Meanwhile, the state is reviewing the audit and will respond. “The Office of Addiction Services and Supports (OASAS), in partnership with the NYS Office of Medicaid Inspector General, intends to review the specific findings of this audit cited by OIG [Office of Inspector General] to verify its accuracy and to determine an appropriate course of action,” said Evan Frost, spokesman for OASAS. “As a proactive measure, we will remind our OTP providers of their obligations to comply with state and federal laws and rules for providing and claiming Medicaid reimbursement and ensuring the quality of care for those receiving OTP services.” OA SAS regulates OTPs in the state. For the audit, go to https://oig.hhs.gov/oas/reports/region2/21701021.pdf     

As HIPAA changes loom,patients demand continued confidentiality for SUD records

In last week's issue, we wrote about the plans by the federal Department of Health and Human Services (HHS) to weaken the Health Insurance Portability and Accountability Act (HIPAA), citing regulatory burdens and the need for information‐sharing (see ADAW, Jan. 21). The plans, detailed in a request for information (RFI) issued Dec. 12, throw a wrench into the plans by the “make 42 CFR Part 2 like HIPAA” movement, which would erase the federal confidentiality regulation protecting substance use disorder (SUD) treatment records by watering it down to HIPAA standards. Now, with even HIPAA seeming too burdensome, the need is even greater to protect the consent provision of 42 CFR Part 2 — which is basically all that's left after the Substance Abuse and Mental Health Services Administration (SAMHSA) allowed information‐sharing for the vague “health care operations” without consent last year (see ADAW, Jan. 8, 2018). Last week, H. Westley Clark, M.D., J.D., dean's executive professor at Santa Clara University and former director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, made this abundantly clear in his comments to ADAW.     

Evaluating the effects of information technology on problem-oriented-policing. If it doesn't fit, must we quit?

Technologies promise to make our organizations more productive, efficient or effective. But our experience does not always fulfill this promise. Public safety agencies are the target of a barrage of new information technologies offering better performance, many of which are attractive because they can be financed through federal grants. But when evaluations are performed of these technologies, improvements do not always result. This article describes the experiences of a state police agency (SPA) during its use of cellular digital packet data (CDPD) systems to support its problem-oriented policing (POP) project. The CDPD system should have improved the SPA's POP operations; in practice, it was not as clear. Although participants believed the CDPD technology worthwhile, there were only a few minor differences between POP officers that did and did not use it. This evaluation suggests the need for better databases to measure performance as well as more informed federal funding of ways to assess the impact of technologies.     

Freundschaftsnetzwerke in den neuen Bundesländern

Social networks were a very important component of the society of the GDR. This suggests a study of these networks — especially friendship networks — in Germany’s new federal states. Ego-centered friendship networks in the present, as well as for the final days of the GDR, are analysed with network-analytic methods. The 83 participants of the examination were selected via snowball sampling. The results are not homogenous. Some impressively document how people reacted to the circumstances in the GDR, while others do not show any difference to studies from the old German federal states. Some further results show that changes have taken place.     

Variation in Artistic Circles*

Several theorists have suggested the use of social circles in studying patterns of interaction among artists. Crane has proposed that artistic circles approximate circles found among scientists. Kadushin feels that a particular type of circle—the movement circle—characterizes art. Research on the emergence of various artistic groups—the American Artists' Congress, American Abstract Artists, and the surrealist movement—indicates that these two frameworks are not adequate for understanding all artistic circles. What becomes clear is that artistic circles vary along a number of dimensions. First, there is variation in what brings artists together. At times it is the propagation of an aesthetic faith. At others it is a similar political orientation or issue. Finally, artists come together as a result of the practical concerns of making a living. Secondly, there is a wide variation in the types of structures around which these circles drape themselves. These may range from highly instituted structures, such as the federal government art projects, to a club or a bar. Finally, the linkages between these circles, unlike the invisible colleges in science, are individuals characterized not by their belongingness to a particular circle, but rather by their marginality to those circles. Simmel's social type, “the stranger,” is suggested as characterizing this type of individual.