Today's post is shared from the nytimes.com As the country struggles to combat the growing abuse of heroin and opioid painkillers, a new battlefield is emerging: the courts. The City of Chicago and two California counties are challenging the drug industry’s way of doing business, contending in two separate lawsuits that “aggressive marketing” by five companies has fueled an epidemic of addiction and cost taxpayers millions of dollars in insurance claims and other health care costs. The severity of drug abuse is well documented: Use of prescription opioids contributed to 16,651 deaths in the United States in 2010 alone, and to an estimated 100,000 deaths in the past decade. When people cannot find or afford prescription painkillers, many have increasingly turned to heroin. The lawsuits assert that drug makers urged doctors to prescribe the drugs far beyond their traditional use to treat extreme conditions, such as acute pain after surgery or injury or cancer pain, while underplaying the high risk of addiction. Such marketing, the plaintiffs say, has contributed to widespread abuse, addiction, overdose and death. Taking the drug makers to court recalls the tobacco liability wars of the 1990s, with government entities suing in the hope of addressing a public health problem and forcing changes from an industry they believed was in denial about the effects of its products. The tobacco settlement led to agreements by the tobacco industry to change marketing practices, which is a goal of the opioid lawsuits. ... |
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Showing posts with label Opioid. Show all posts
Showing posts with label Opioid. Show all posts
Monday, August 25, 2014
Chicago and 2 California Counties Sue Over Marketing of Painkillers
Tuesday, August 12, 2014
Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process
Photographer: Daniel Acker/Bloomberg The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products. At the same time, millions of Americans are putting it in their mouths every day, by way of a top-selling toothpaste that uses the antibacterial chemical to head off gum disease -- Colgate-Palmolive Co.’s Total. Total is safe, Colgate says, citing the rigorous Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug. A closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white -- and weren’t, until this year, available to the public. Colgate’s Total application included 35 pages summarizing toxicology studies on triclosan, which the FDA withheld from view. The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website. The pages show how even with one of the U.S.’s most stringent regulatory processes -- FDA approval of a new drug -- the government relies on company-backed science to show products are safe and... |
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Wednesday, March 5, 2014
Its Déjà Vu All Over Again
Today's post is shared from Judge David Langham and I would encourage to read his blog at: http://flojcc.blogspot.com/ David Langham is the Deputy Chief Judge of Compensation Claims for the Florida Office of Judges of Compensation Claims and Division of Administrative Hearings.
Zohydro is in the news yet again. This month the new medication will become available. Its manufacturer says it will market this only to a select few physicians whose experience with pain will assure their discretion and restraint in distributing this strong pain killer.
In November, I noted the approval of this new Opiod formulation, and in December, I wrote when over half the nation’s attorneys general wrote to the FDA urging that the approval receive greater scrutiny and perhaps reconsideration (Zohydro in the News Again).
Well, as Yogi Bera once said “its déjà vu all over again.” Zohydro is back in the news at the end of February. Now, an “activist” group is questioning the Food and Drug Administration (FDA)and has released a letter it sent to the FDA in late February. The group is called “Fed Up!” and their points are interesting.
They note that Zohydro is being marketed in the “midst of a severe drug addiction epidemic.” They note that Zohydro “will kill people as soon as it is released.” Dr. Andrew Kolodny calls it “a whopping dose of hydrocodone packed in...
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Thursday, October 24, 2013
FDA Proposes Changes in Pain Medication Prescriptions
The US FDA has announced proposed changes will be forthcoming in labeling for pain relief medication:
Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
"In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.
"The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications.
They also are meant to reduce problems associated with their use," says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," Throckmorton adds.
They also are meant to reduce problems associated with their use," says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," Throckmorton adds.
"He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.
Friday, July 27, 2012
Physicians Petition to Limit Opioid Abuse
Pharmaceutical reform has been a major topic of interest and reform efforts nationally in the workers' compensation arena. More particularly the alledged abuse of opioids have received particular attention. Several physicians have petitioned the FDA to change labeling requirements for such products.
"SPECIFIC ACTIONS REQUESTED FOR CHANGES TO OPIOID ANALGESIC LABELS:
1. Strike the term “moderate” from the indication for non-cancer pain.
2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain."
This effort appears to be yet another step in targeting distribution. It remains to be seen what will ultimately be the beneficial resolution to balance all stakeholders interests. The issue is indeed complicated. The efforts to reform pharmacuetical use is a tough balancing act. The ulterior motive of cost savings and profits generates sensationalism, but what makes good medical sense and what benefits the patient should not go unnoticed.
Related Articles on Opiods
"SPECIFIC ACTIONS REQUESTED FOR CHANGES TO OPIOID ANALGESIC LABELS:
1. Strike the term “moderate” from the indication for non-cancer pain.
2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain."
This effort appears to be yet another step in targeting distribution. It remains to be seen what will ultimately be the beneficial resolution to balance all stakeholders interests. The issue is indeed complicated. The efforts to reform pharmacuetical use is a tough balancing act. The ulterior motive of cost savings and profits generates sensationalism, but what makes good medical sense and what benefits the patient should not go unnoticed.
Related Articles on Opiods
May 24, 2012
A recent Texas case holding an employer liable holding an employed liable for a fatal opioid overdose arising out of work-related event highlights again that, the workers' compensation medical delivery system just isn't ...
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