In a recent case against opiate manufacturers the State of Ohio alleged that drug companies should never place their desire for profits above the health and well-being of their customers or the communities where those customers live. Because they know prescribing doctors and other health-care providers rely on drug company statements in making treatment decisions, drug companies must tell the truth when marketing their drugs and ensure that their marketing claims are supported by science and medical evidence. The Defendants use promotional activities and materials that falsely deny or trivialize the risks of opioids while overstating the benefits of using them.
The Australian pot industry desire for profits above the health and well-being of their customers or the communities where those customers live require
A wake up call on how very important it is for both clinical trials and labeling must be completed before Medical Marijuana comes on the market here in Australia.
Please take the time to read this important paper regarding how very important it is for both clinical trials and labeling must be completed before a drug comes on the market here in Australia.
At the center of the company’s marketing aimed at physicians was a single sentence in OxyContin’s original label:
“Delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”
Purdue’s marketing campaign relied on that sentence, which claimed OxyContin was believed to be less likely to be abused than other prescription opioids, according to depositions from various sales reps and physicians that were pitched on the drug. But that claim was not backed up by clinical studies.
Officials from Purdue Pharma, the company behind OxyContin, said in depositions from a 2004 West Virginia lawsuit that the company did not hold clinical trials to show that OxyContin was less likely to be addictive or abused. Purdue sales reps leaned heavily on that messaging of lower abuse potential to push the drug during the first six years following its launch.
After the meeting, in July 2001, the FDA approved a new label for OxyContin. The changes included adding a black box warning to the label signifying the drug’s serious or life-threatening risks, and removing the sentence “Delayed absorption as provided by OxyContin tablets is believed to reduce the abuse liability of a drug” from the drug’s label that the FDA originally approved in 1995. The label also said it lacked data to “establish the true incidence rate of addiction in chronic pain patients.”
“The stunning thing is that this was written in 2001. I mean, it's 2017, so we're talking 16 years later,” said Alexander of Johns Hopkins. “Since this time, the problem has only progressively gotten worse and worse, year over year. … And so even in 2001, you know, the alarm had already sounded about this stuff.”
Also relevant to this is the article Leung, PTM, Macdonald, EM, Stanbrook, MB, Dhalla, IA & Juurlink, DN 2017, 'A 1980 letter on the risk of opioid addiction', New England Journal of Medicine, vol. 376, no. 22, pp. 2194-5, open access http://www.nejm.org/doi/full/10.1056/NEJMc1700150 .
ATODA's Research eBulletin, November 2017 issue, summarises it http://www.atoda.org.au/publications/research-ebulletin/ :
Could a letter-to-the-editor have initiated the western world’s opioid overdose crisis?
In 1980 the prestigious New England Journal of Medicine published a one-paragraph letter to the editor, titled ‘Addiction rare in patients treated with narcotics’. Its final sentence reads ‘We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction’. Over the intervening years it has been claimed that this was a key driver of the high levels of opioid dependence seen in many western nations. To ascertain the veracity of this claim, Canadian researchers conducted a bibliometric analysis of correspondence on this topic in the Journal from the date of its publication (1980) until March 30 this year. They wrote that ‘We identified 608 citations of the index publication and noted a sizable increase after the introduction of OxyContin (a long-acting formulation of oxycodone) in 1995…Of the articles that included a reference to the 1980 letter, the authors of 439 (72.2%) cited it as evidence that addiction was rare in patients treated with opioids.’
Their data led them to conclude that ‘…a five-sentence letter published in the Journal in 1980 was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy. We believe that this citation pattern contributed to the North American opioid crisis by helping to shape a narrative that allayed prescribers’ concerns about the risk of addiction associated with long-term opioid therapy. In 2007, the manufacturer of OxyContin and three senior executives pleaded guilty to federal criminal charges that they misled regulators, doctors, and patients about the risk of addiction associated with the drug. Our findings highlight the potential consequences of inaccurate citation and underscore the need for diligence when citing previously published studies.’
Estimating the Prevalence of Opioid Diversion by “Doctor Shoppers” in the United States
Mixing fentanyl with heroin amplifies the potency of both drugs. Once injected, smoked, or snorted, the killer heroin creates a frighteningly powerful high. Since heroin and fentanyl both have depressant effects, users feel exaggerated drowsiness, nausea, confusion, sedation and, in extreme instances, unconsciousness, ..
A string of deaths in Melbourne are believed connected to the extremely dangerous "drop dead" drug fueling the worst opioid crisis in United States history.
The 10 overdoses, involving a suspected mix of heroin and fentanyl, are thought to be the first deaths attributed to the concoction outside of North America, where last year drugs killed more than 60,000 people.
“While the media tend to emphasize heroin or fentanyl as the ‘primary’ drug problem, it is clear from our research that the users of these drugs tend to use many other drugs,” said Dr. Eric Wish, Principal Investigator of NDEWS and Director of UMD’s Center for Substance Abuse Research (CESAR). “To be effective, treatment must focus on each person’s total drug problem, rather than on a single drug.
According to data from the most recent Emerging Threat Report, there were 344 identifications of opioids in drug evidence analyzed by the DEA’s laboratory system in the third quarter of 2017. Of these opioid identifications, nearly two-thirds (64%) were identified as fentanyl, either as the only controlled substance (44% of the 219 fentanyl identifications), in combination with heroin (45%), or in combination with other controlled substances (11%; data not shown). The DEA Emerging Threat Reports can be found on the NDEWS website at: https://ndews.umd.edu/resources/dea-emerging-threatreports.
Drug Free Australia
'My Story’ saw a group of five Normanton community members share their story of hardship and determination
on video to overcome their personal difficulties, as well as share their messages to empower and inspire others.
The ‘My Story’ project is part of a Mount Isa Police District strategy to address attitudes and beliefs about the drug Ice.
Those featured in the video were asked to tell their story and how drugs and/or alcohol impacted their life. Each of them were able to recall a turning point that caused them to turn to drugs and alcohol. They told their story about why they chose to quit, and gave a powerful and unique message to others to stay away from drug and alcohol dependence.
You can help by sharing their video on social media. Mount Isa Police and Normanton community encourage other communities to get involved in sharing their story. Contact Mount Isa Police to get involved in the ‘My Story’ project.
Injecting room will cost $5.6 million per life saved
A proposed Melbourne injecting room will inevitably present similar costs to the Sydney facility, which saved the lives of only 4 opiate users in its first 9 years of operation while referring a tiny percentage to recovery.
In Australia there is one opiate overdose fatality for every 110,000 injections, but the Kings Cross injecting room supervises only 58,000 opiate injections each year.[i] These 58,000 injections fall well short of the 110,000 injections that must be supervised before the facility can claim it saved the one life that would otherwise have been lost. It takes the Sydney facility almost two years and $5.6 million[ii] to save a single life.
The ratio of deaths to injections is well documented in this country where up to 85% of Australia’s opiate overdose deaths occur amongst long-term dependent users[iii] who inject multiple times daily, rather than amongst casual users. The many studies of overdose deaths amongst Australian opiate users strongly agree that one out of every 100 dependent opiate users die each year from overdose.[iv],[v],[vi],[vii] This means that if 100 dependent opiate users were all housed in the one charity-run housing facility, each injecting an average 3 times daily,[viii],[ix] one would likely die each year. This group of 100 users would between them inject around 110,000 times each year,[x] with only one injection in that 110,000 being fatal. The Sydney injecting room supervises 160 opiate injections per day despite having capacity for more than 300. This under-utilisation only adds to its inordinately high costs for little benefit.
Alternately, the $5.6 million spent to save a single life in Kings Cross will fund 950 Naltrexone implants per year. The Western Australian government has funded implants in that State for the last 19 years, presently contributing $3 million annually. Implant Naltrexone constantly resident in the blood works like Naloxone which nullifies any effect of opiates. Of those 950 implant patients, 9-10 (1 in every 100) would have otherwise died. Furthermore, the person whose life was saved in the Sydney facility today may die tomorrow injecting at home, while the same does not occur with active implants.[xi]
For the cost of just one life saved in a proposed North Richmond injecting room, implants will save at least nine times as many, something Victorian coroners need to consider. Ultimately there is no contest between the two when compassion for the lives of Melbourne’s opiate users is uppermost. A Victorian injecting room will be a waste of public money.
Drug Free Australia
0422 163 141
[i] [ix] https://uniting.org/who-we-help/for-adults/sydney-medically-supervised-injecting-centre/what-the-uniting-sydney-msic-does shows an average 180 injections per day and the last government-funded evaluation shows that more than 10% of injections are not opiates - http://www.health.nsw.gov.au/mentalhealth/programs/da/Documents/msic-kpmg.pdf p 112
[ii] The Sydney injecting room spends about $3 million annually on its operation, apart from other side-programs funded by the NSW Department of Health – see http://www.justicehealth.nsw.gov.au/publications/201516NSWHealthAnnualReport.pdf p 108
[iii] https://ndarc.med.unsw.edu.au/sites/default/files/ndarc/resources/Mono.46.PDF p 14 This is a Federal Government Monograph reviewing the extant literature on heroin overdose
[iv] https://ndarc.med.unsw.edu.au/sites/default/files/ndarc/resources/NDARC%20monograph%2044.pdf This was the study that calculated the number of heroin users in Australia for 1997, where one of its calculations estimated the number of users by multiplying deaths for that year by 100
[viii] https://uniting.org/__data/assets/pdf_file/0007/136438/MSIC-final-evaluation-report-2003.pdf p 58 The first government-funded evaluation of the Sydney facility, done mostly by NSW University teaching faculty colleagues of its then medical Director, Dr Ingrid van Beek, noted that dependent users injected ‘at least’ 3 times daily
[x] That is, 100 injectors injecting ‘at least’ 3 times daily for 365 days annually = 109,500 injections
[xi] http://www.journalofsubstanceabusetreatment.com/article/S0740-5472(07)00249-8/abstract) note no deaths during the active implant stage – Drug Free Australia thereby recommends Naltrexone implant maintenance as an alternative to injecting rooms, where users will become abstinent at their own pace
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