Sunday, August 30, 2009

Controversial Treatment for Opioid Dependence

Attached an article which you probably have read already. Is anyone considering a response to the study? Its quite controversial and almost negating the current treatment approaches.
I found it especially troublesome that the authors claim that "It could be argued that another opioid-substitution medication, such as buprenorphine, might have been used as a comparison drug instead of methadone. The available evidence does not support this suggestion: a recent Cochrane review concluded that buprenorphine maintenance was significantly less effective than methadone maintenance.Thus, methadone maintenance remains the standard treatment and the proper comparison drug for an experimental substitution therapy."

Looking forward to your comments.

Bernd


Volume 361:777-786 August 20, 2009 Number 8

Diacetylmorphine versus Methadone for the Treatment of Opioid Addiction

Eugenia Oviedo-Joekes, Ph.D., Suzanne Brissette, M.D., David C. Marsh, M.D., Pierre Lauzon, M.D., Daphne Guh, M.Sc., Aslam Anis, Ph.D., and Martin T. Schechter, M.D., Ph.D.


ABSTRACT

Background Studies in Europe have suggested that injectable diacetylmorphine, the active ingredient in heroin, can be an effective adjunctive treatment for chronic, relapsing opioid dependence.

Methods:
In an open-label, phase 3, randomized, controlled trial in Canada, we compared injectable diacetylmorphine with oral methadone maintenance therapy in patients with opioid dependence that was refractory to treatment. Long-term users of injectable heroin who had not benefited from at least two previous attempts at treatment for addiction (including at least one methadone treatment) were randomly assigned to receive methadone (111 patients) or diacetylmorphine (115 patients). The primary outcomes, assessed at 12 months, were retention in addiction treatment or drug-free status and a reduction in illicit-drug use or other illegal activity according to the European Addiction Severity Index.

Results:
The primary outcomes were determined in 95.2% of the participants. On the basis of an intention-to-treat analysis, the rate of retention in addiction treatment in the diacetylmorphine group was 87.8%, as compared with 54.1% in the methadone group (rate ratio for retention, 1.62; 95% confidence interval [CI], 1.35 to 1.95; P<0.001). The reduction in rates of illicit-drug use or other illegal activity was 67.0% in the diacetylmorphine group and 47.7% in the methadone group (rate ratio, 1.40; 95% CI, 1.11 to 1.77; P=0.004). The most common serious adverse events associated with diacetylmorphine injections were overdoses (in 10 patients) and seizures (in 6 patients).

Conclusions:

Injectable diacetylmorphine was more effective than oral methadone. Because of a risk of overdoses and seizures, diacetylmorphine maintenance therapy should be delivered in settings where prompt medical intervention is available. (ClinicalTrials.gov number, NCT00175357 [ClinicalTrials.gov] .)

DISCUSSION:

Discussion:

In this trial, patients assigned to receive injectable diacetylmorphine were more likely to stay in treatment and to reduce their use of illegal drugs and other illegal activities than patients assigned to receive oral methadone. These findings are consistent with the results of European studies that suggest greater effectiveness of diacetylmorphine than methadone as maintenance treatment for long-term, treatment-refractory opioid use.10,12,13 Two of these trials showed no differences between groups in the rate of retention in treatment for addiction. However, the fact that control patients were eligible to receive diacetylmorphine at the end of the study period may have introduced a bias in the observed retention rates. In addition, patients currently enrolled in methadone maintenance treatment were eligible for the European trials but not for the present study. Although the definitions of clinical response varied among the trials, all of them considered the same variables (drug use, illegal activities, health, and social adjustment) and showed greater effectiveness of diacetylmorphine than of methadone for maintenance treatment.

Secondary analyses showed that both groups had significant improvement in many of the variables that were evaluated. The diacetylmorphine group had greater improvements with respect to medical and psychiatric status, economic status, employment situation, and family and social relations. These results are particularly noteworthy in view of the nature of the population and the time frame. The fact that patients who received diacetylmorphine had significant improvement in these areas suggests a positive treatment effect beyond a reduction in illicit-drug use or other illegal activities.

Buprenorphine versus Methadone

Reading the Cochrane study I found some significant discrepancies in the representation of buprenorphine treatment.


Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence.

Mattick RP, Kimber J, Breen C, Davoli M.

National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia, 2052. r.mattick@unsw.edu.au

BACKGROUND: Buprenorphine has been reported as an alternative to methadone for maintenance treatment of opioid dependence, but differing results are reported concerning its relative effectiveness indicating the need for an integrative review. OBJECTIVES: To evaluate the effects of buprenorphine maintenance against placebo and methadone maintenance in retaining patients in treatment and in suppressing illicit drug use. SEARCH STRATEGY: We searched the following databases up to October 2006: Cochrane Drugs and Alcohol Review Group Register, the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Current Contents, Psychlit, CORK , Alcohol and Drug Council of Australia, Australian Drug Foundation, Centre for Education and Information on Drugs and Alcohol, Library of Congress databases, reference lists of identified studies and reviews, authors were asked about any other published or unpublished relevant RCT. SELECTION CRITERIA: Randomised clinical trials of buprenorphine maintenance versus placebo or methadone maintenance. DATA COLLECTION AND ANALYSIS: Authors separately and independently evaluated the papers and extracted data for meta-analysis. MAIN RESULTS: Twenty four studies met the inclusion criteria (4497 participants), all were randomised clinical trials, all but six were double-blind. The method of allocation concealment was not clearly described in the majority (20) of the studies, but where it was reported the methodological quality was good.Buprenorphine was statistically significantly superior to placebo medication in retention of patients in treatment at low doses (RR=1.50; 95% CI: 1.19 - 1.88), medium (RR=1.74; 95% CI: 1.06 - 2.87), and high doses (RR=1.74; 95% CI: 1.02 - 2.96). The high statistical heterogeneity prevented the calculation of a cumulative estimate. However, only medium and high dose buprenorphine suppressed heroin use significantly above placebo.Buprenorphine given in flexible doses was statistically significantly less effective than methadone in retaining patients in treatment (RR= 0.80; 95% CI: 0.68 - 0.95), but no different in suppression of opioid use for those who remained in treatment.Low dose methadone is more likely to retain patients than low dose buprenorphine (RR= 0.67; 95% CI: 0.52 - 0.87). Medium dose buprenorphine does not retain more patients than low dose methadone, but may suppress heroin use better. There was no advantage for medium dose buprenorphine over medium dose methadone in retention (RR=0.79; 95% CI:0.64 - 0.99) and medium dose buprenorphine was inferior in suppression of heroin use. AUTHORS' CONCLUSIONS: Buprenorphine is an effective intervention for use in the maintenance treatment of heroin dependence, but it is less effective than methadone delivered at adequate dosages.

Publication Types:

* Meta-Analysis
* Review


PMID: 18425880 [PubMed - indexed for MEDLINE]

Monday, August 24, 2009

Universal Health Insurance

Attached you find a summary of a bill (HR676)which so far has not been discussed during the current healthcare refom debate.It should be at least considered as an option and not discarded just because its politically difficult to promote.
Bernd Wollschlaeger,MD



H.R. 676, “The United States National Health Care Act,”
Or “Expanded & Improved Medicare For All”
Introduced by Rep. John Conyers, Jr.


Brief Summary of Legislation

The United States National Health Care Act (USNHC) establishes a unique American universal health insurance program with single payer financing. The bill would create a publicly financed, privately delivered health care system that improves and expands the already existing Medicare program to all U.S. residents, and all residents living in U.S. territories. The goal of the legislation is to ensure that all Americans will have access, guaranteed by law, to the highest quality and most cost effective health care services regardless of their employment, income or health care status. In short, health care becomes a human right. With 47 million uninsured Americans, and another 50 million who are underinsured, the time has come to change our inefficient and costly fragmented non-system of health care.

Who is Eligible

Every person living or visiting in the United States and the U.S. Territories would receive a United States National Health Insurance Card and ID number once they enroll at the appropriate location. Social Security numbers may not be used when assigning ID cards.

Health Care Services Covered

This program will cover all medically necessary services, including primary care, inpatient care, outpatient care, emergency care, prescription drugs, durable medical equipment, hearing services, long term care, palliative care, podiatric care, mental health services, dentistry, eye care, chiropractic, and substance abuse treatment. Patients have their choice of physicians, providers, hospitals, clinics, and practices. There no co-pays or deductibles under this act.

Conversion To A Non-Profit Health Care System

Doctors, hospitals, and clinics will continue to operate as privately entities. However, they will be unable to issue stock. Private health insurers shall be prohibited under this act from selling coverage that duplicates the benefits of the USNHC program. Exceptions to this rule include coverage for cosmetic surgery, and other medically unnecessary treatments. Those workers who are displaced as the result of the transition to a non-profit health care system will be the first to be hired and retrained under this act. Furthermore, workers would receive their same salary for up to two years, and would then be eligible for unemployment benefits. The conversion to a not-for- profit health care system will take place as soon as possible, but not to exceed a 15 year period, through the sale of U.S. treasury bonds.

Cost Containment Provisions/ Reimbursement

The USNHC program will negotiate reimbursement rates annually with physicians, allow for global budgets (monthly lump sums for operating expenses) for hospitals, and negotiate prices for prescription drugs, medical supplies and equipment. A “Medicare For All Trust Fund” will be established to ensure a dedicated stream of funding. An annual Congressional appropriation is also authorized to ensure optimal levels of funding for the program, in particular, to ensure the requisite number of physicians and nurses need in the health care delivery system.

H.R. 676 Would Reduce Overall Health Care Costs


Families Will Pay Less

Currently, the average family of four covered under an employee health plan spends a total of $4,225 on health care annually – $2,713 on premiums and another $1,522 on medical services, drugs and supplies (Employer Health Benefits 2006 Annual Survey, Kaiser Family Foundation and Health Research and Educational Trust; U.S. Department of Labor, Bureau of Labor Statistics, Consumer Expenditure Survey.) This figure does not include the additional 1.45% Medicare payroll tax levied on employees. A study by Dean Baker of the Center for Economic Research and Policy concluded that under H.R. 676, a family of four making the median family income of $56,200 per year would pay about $2,700 for all health care costs.

Business Will Pay Less

In 2006, health insurers charged employers an average of $11,500 for a health plan for a family of four. On average, the employer paid 74% of this premium, or $8,510 per year. This figure does not include the additional 1.45% payroll tax levied on employers for Medicare. Under H.R. 676, employers would pay a 4.75% payroll tax for all health care costs. For an employee making the median family income of $56,200 per year, the employer would pay about $2,700.


The Nation Will Pay About the Same, While Covering All Americans

Savings from reduced administration, bulk purchasing, and coordination among providers will allow coverage for all Americans while reducing health care inflation in the long term. Annual savings from enacting H.R. 676 are estimated at $387 billion (Baker).


Proposed Funding For USNHC Program

· Maintain current federal and state funding for existing health care programs
· Establish employer/employee payroll tax of 4.75% (includes present 1.45% Medicare tax)
· Establish a 5% health tax on the top 5% of income earners, 10% tax on top 1% of wage earners
· ¼ of 1% stock transaction tax
· Close corporate tax loopholes
· Repeal the Bush tax cuts for the highest income earners

Sunday, August 23, 2009

Speak Up Against Propaganda

Sunday, August 23, 2009

Letter To The Editor:

RE: Recess Rally

Naturally, every American has the constitutional right to free speech but healthcare protesters are going too far by likening Obama to Hitler or claiming that government will control when people die. It especially puzzles me that the many of those protesters opposing meaningful and necessary healthcare reform are Medicare recipient benefiting from a government controlled, single-payer system! Would those same people be willing to turn in their Medicare cards in protest too? Would those people consider me a “death panelist” because I follow Florida Law and need to discuss advanced directives with them? According to their “logic” hospitals, nursing homes, home health agencies, hospices, and health maintenance organizations (HMOs), which are required to provide their patients with written information concerning health care advance directives, are part of the “death panels” too!
We have to tune down the hyperbolic and toxic rhetoric fueled by fearmongers and anti-government nut wings and return to a rational dialogue to resolve an urgent problem: how to provide healthcare for all Americans.

Bernd Wollschlaeger, MD,FAAFP,FASAM
Family Physician

Friday, August 21, 2009

Lets Get Real:

ver the last few months I witnessed the almost hyperbolic rhetoric used by my colleagues in organized medicine calling for a “battle for freedom” to protect the “sacrosanct patient-physician relationship” against the perceived intrusion by “big government.” They are now joining the chorus of fearmongers who paint the apocalyptic vision of a world dominated by government rationing of healthcare and imaginary death panels forcing seniors to sign living wills condemning them to die.
Meanwhile, those of us who call for a rational discussion about the issues are being marginalized.
The worst if still to come: in exchange for their support of health care reform health insurance companies are being handed the big price: to offer insurance to the uninsured without having to change their business practice. Fiercely defended by Republicans, ideologically motivated leaders in organized medicine and conservative Democrats the CEOs of health insurance companies can continue to reap fat profits by limiting and rationing healthcare for millions of policyholders who are clueless that their policies may not deliver the promised coverage. This win-win situation for insurance companies will result in a loose-loose situation for the average healthcare consumer because the basic principle of meaningful health care reform is missing: tight regulation of the health insurance market.
Uwe Reinhardt, a renowned economics professor at Princeton, got it right. In his recent blog entry “Who Needs The Public Option?” http://economix.blogs.nytimes.com/2009/08/21/who-needs-the-public-option/#more-27531 he states that “Citizens in the rest of the industrialized world have long had easy-to-understand, reliable, life-cycle health insurance. They do not wake up at night worrying that their health insurance might be rescinded over some willful or inadvertent omission on health status during the application for insurance. Nor do they worry that they and their families will lose their health insurance coverage when the family’s breadwinner loses a job or switches jobs or location of residence. It would be very rare, indeed, in those countries to see a middle-class family lose all of its savings and perhaps even its home over unpaid medical bills……….our health insurance system leaves most Americans basically “unsured”: Private, job-based health insurance purchased in the large-group market is stable and reliable only as long as an employee keeps that job. It is not permanent, nor portable. It leaves Americans exposed to considerable financial risk over their life cycle. It is not “insurance,” but “unsurance.”
Even though, I do not agree with his assertion that a public option is not a necessary condition for healthcare reform I wholeheartedly support his argument that we “must convince the public and the legislators who do not trust it that with the help of government – including a wide set of new government regulations – the industry can transform itself into a structure that can offer Americans the same permanent, reliable, easy-to-understand life-cycle financial security that citizens in other nations take for granted and Americans crave.”
The main challenge remains: either creating a purely private-sector model that will offer individuals reliable, life-cycle health insurance with relatively stable premiums, and at premiums that are defensible, or opting for a taxpayer funded single payer health care system (Medicare For All). As long as the typical employment-based health insurance premium for family coverage is $12,688 per year - and rising exponentially – I opt for the only logical solution: single payer healthcare for all Americans!
Bernd Wollschlaeger,MD,FAFP,FASAM