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