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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(c) 2010-2024 Jon L Gelman, All Rights Reserved.
Showing posts with label Analgesic. Show all posts
Showing posts with label Analgesic. 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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Tuesday, July 29, 2014
Take Two: Just How Good Are Generic Meds Anyway?
A few days ago I wrote a post about generic painkillers and the fact that doctors themselves—who should know better—often don't use them. "If physicians aren't really sold on generics in their own personal lives," I asked, "does this mean they're not really sold on them in their professional lives too?" Well, perhaps I got it backwards. A friend sent me a link to a Forbes article from last year about the FDA retracting its approval of a generic version of Wellbutrin: The episode is bringing momentum to a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no. |
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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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Saturday, November 16, 2013
Class I Recall: Medtronic's Worldwide Voluntary Field Action on Guidewires
Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.
Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.
Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.
The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guide wire
Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website – specifically, http://www.medtronic.com/for-healthcare-professionals/index.htm.
Observations and consequences of the coating issue related to these guidewires should be reported to Medtronic in the United States by calling +1-877-526-7890 on weekdays from 8am to 5pm U.S. Central Time.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or - Call FDA at +1-800-FDA-1088
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
….
Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
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Wednesday, October 30, 2013
Leading Coal Industry Law Firm Withheld Evidence of Black Lung Disease
A miner’s struggle for benefits due to black lung disease spotlights aggressive tactics by a mining company law firm. Jackson Kelly recently was named by U.S. News & World Report as the nation’s top firm in mining law. But its actions are sometimes unethical, according to current and former judges, lawyers and state disciplinary officials. As a result, sick and dying miners have been denied benefits and affordable medical care. The firm, documents show, over the years has withheld unfavorable evidence and shaped the opinions of doctors reviewing miners’ medical claims by providing the physicians only what the lawyers wanted them to see. In a pending case involving a West Virginia miner named Gary Fox, Jackson Kelly was found to have withheld pathology reports from two doctors who concluded that Fox likely had black lung. The Center for Public Integrity - See more at: http://www.fairwarning.org/2013/10/68752/#sthash.lbQd8rOJ.dpuf |
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F.D.A. Shift on Painkillers Was Years in the Making
Narcotic pain killers have been the subject of concern and regulation by employers' and their insurance carriers nationally. The evolution of the FDA proposed action to regulate is revealed in today's post is shared from the NYTimes.com
When Heather Dougherty heard the news last week that the Food and Drug Administration had recommended tightening how doctors prescribed the most commonly used narcotic painkillers, she was overjoyed. Fourteen years earlier, her father, Dr. Ronald J. Dougherty, had filed a formal petition urging federal officials to crack down on the drugs. Since then, narcotic painkillers, or opioids, have become the most frequently prescribed drugs in the United States and have set off a wave of misuse, abuse and addiction. Experts estimate that more than 100,000 people have died in the last decade from overdoses involving the drugs. For his part, Dr. Dougherty, who foresaw the problem, retired in 2007 and is now 81 and living in a nursing home. “Too many lives have been ruined,” his daughter said. The story behind the F.D.A.’s turnaround on the pain pills, last Thursday, involved a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and... |
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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.
Tuesday, September 24, 2013
Use Only as Directed
During the last decade, more than 1,500 Americans dieda fter accidentally taking too much of a drug renowned for its safety:acetaminophen, one of the nation’s most popular pain relievers.
Acetaminophen – the active ingredient in Tylenol– is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. Davy Baumle, a slender 12-year-oldwho loved to ride his dirt bike through the woods of southern Illinois, died from acetaminophen poisoning. So did tiny five-month-old Brianna Hutto. So did Marcus Trunk, a strapping 23-year-old construction worker from Philadelphia. The toll does not have to be so high. The U.S. Food and Drug Administration has long been aware of studies showing the risks of acetaminophen – in particular, that the margin between the amount that helps and the amount that can cause serious harmis smaller than for other pain relievers. So, too, has McNeil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol into a billion-dollar brand and the leader in acetaminophen sales. Yet federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose,which the agency calls a “persistent, important public health problem.” The FDA has repeatedly deferred decisions on consumer protection seven when they were... |
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Sunday, September 8, 2013
Price of Vicodin Three Times More in Maryland and Pennsylvania When Dispensed by a Physician
New studies from Cambridge-based Workers Compensation Research Institute (WCRI) says the average price paid for physician-dispensed Vicodin, a commonly dispensed narcotic pain medication in Maryland and Pennsylvania, was three times more than the price paid for the same drug dispensed at a pharmacy ($1.46 versus $0.37 per pill in Maryland and $1.22 versus $0.37 per pill in Pennsylvania).
According to the studies, the average prices paid to physician-dispensers were often more than double the prices paid for the same drugs dispensed at a pharmacy. Issues related to physician dispensing in Maryland have been debated, but no change has been made. Physician dispensing has been growing rapidly in Pennsylvania. In 2011, physicians dispensed 23 percent of workers’ compensation prescriptions and were paid 38 percent of what was spent for all prescriptions for injured workers. This was an increase from 17 percent of all prescriptions and 18 percent of total prescription costs three years earlier. “In many states across the country, policymakers are debating whether doctors should be paid significantly more than pharmacies for dispensing the same drug,” said Dr. Richard Victor, WCRI’s executive director. “One question for policymakers is whether the large price difference paid when physicians dispense is justified by the benefits of physician dispensing.” The Maryland study found that prices paid to physician-dispensers for many common drugs... |
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Wednesday, September 4, 2013
One Claim Going OTOC
By now you've likely heard of this claimant fraud case as reported in the San Diego County News Yolandi Kohrumel, 35, went to work for Staples about 10 years ago. After three months on the job she claimed a box fell on her big toe and broke it. She received treatment and benefits. But the big toe is connected to the foot bone, which is connected to the leg bone, which is connected to the hip bone, which is connected to the back bone.... An EAMS search on her claim reveals wrist, back, lower extremities, nervous system and "other body systems" claimed. The party service list is filled with very familiar names to those who do workers' compensation litigation in Southern California. Eventually Kohrumel even got approval for 24 hour care, provided for, of course, by relatives - her husband at first and then her father. You get the picture. Claim out of control. Which means either something is REALLY wrong with this lady, or it's fraud. The claims administrator, ESIS, followed the law and did what it could to dispute elements of the claim that didn't add up - such as the 24 hour care provided by her South African husband who did not have a work permit (so dad stepped in to "provide care"). Surgeries, pain pills, lots of doctors, crutches, wheelchairs, lots of TTD payments. She even convinced the claims administrator that she needed a bigger place to live for her wheelchair access and the administrator went for it. Well, that became Kohrumel's undoing because the... |
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