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https://www.regulations.gov/document?D=FDA-2017-N-1094-0001
https://www.regulations.gov/comment?D=FDA-2017-N-1094-0001
As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.
Participants are expected to include individuals from a broad set of Federal, State, and private stakeholder groups that are working on the challenges of improving pain management while addressing the opioid abuse epidemic. The Federal Agencies participating include FDA, the Drug Enforcement Administration, the Department of Veterans Affairs, the Centers for Disease Control and Prevention, the Department of Defense, the Centers for Medicare & Medicaid Services, the National Institute on Drug Abuse, and the Substance Abuse and Mental Health Services Administration, and the Indian Health Service. Public participation and comment are encouraged.
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Nurse Replaces Surgeon General After Obama Appointee Resignswww.nytimes.com/2017/04/21/us/politics/surgeon-general-trump-administration.html
Rear Adm. Sylvia Trent-Adams, now the acting surgeon general. Credit United States Department of Health and Human Services
Surgeon General Vivek H. Murthy, an Obama administration holdover, was asked to resign by the Trump administration on Friday. He was replaced by his deputy, Rear Adm. Sylvia Trent-Adams, one of the first nurses to serve as surgeon general.
Admiral Trent-Adams will for now be in an acting role. As of Friday evening, she had already replaced Dr. Murthy on the surgeon general’s Twitter account, and her portrait had replaced his on the agency’s Facebook page. One of the first comments on that post asked, “Where is Dr. Murthy?”
Alleigh Marré, a spokeswoman for the Department of Health and Human Services, confirmed Dr. Murthy’s resignation in an emailed statement on Friday, saying he was asked to step down “after assisting in a smooth transition into the new Trump administration.”
Ms. Marré said Dr. Murthy will continue to serve as a member of the Commissioned Corps of the Public Health Service.
Admiral Trent-Adams may be the first surgeon general who is not a doctor. She is not the first nurse, though. Dr. Richard Carmona, who served under President George W. Bush, was a nurse and a physician, and he sometimes referred to himself as the first nurse to serve as surgeon general.
It was not immediately clear why Dr. Murthy was relieved from duty. There is a long history of surgeons general creating unwanted controversy for their political bosses; among the only ways that the government’s top medics usually gain attention is when they leave office under a cloud.
Dr. Carmona blasted the Bush administration after he was not asked to serve a second four-year term. He accused White House officials of repeatedly trying to weaken or suppress important public health reports because of political considerations.
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Dr. Vivek H. Murthy was asked Friday to resign as surgeon general. Credit United States Department of Health and Human Services
And Dr. C. Everett Koop, the most famous surgeon general in the country’s history, largely achieved his fame by defying the Reagan administration’s policies or wishes on a host of public health issues.
Surgeons general have little staff or power but generally use their positions to call attention to important public health priorities.
Dr. Murthy has for years made headlines for calling gun violence a public health threat. In 2014, the National Rifle Association urged the Senate not to confirm him.
Dr. Murthy did not immediately respond to requests for comment on Friday, and employees at the Department of Health and Human Services privately expressed surprise at his sudden departure.
Admiral Trent-Adams received a doctorate in philosophy from the University of Maryland. She was a nurse officer in the Army and also served as a research nurse at the University of Maryland. She joined the Commissioned Corps of the Public Health Service in 1992 and served as the deputy associate administrator for the HIV/AIDS bureau of the Health Resources and Services Administration before joining the surgeon general’s office.
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Before the heroin epidemic became a nationwide problem, claiming thousands of lives; Plano, Texas, was already entrenched. And like many of the places caught in the cross hairs of the continuing heroin crisis, Plano is the last place that one would expect to be swept into the opioid tidal wave.
For six years she termed herself the “chief propagandist” — or spokeswoman — for the Drug Enforcement Agency (DEA). Before that, as a Plano mother and teacher, Belita noticed what was happening in her community. She described Plano as an area rivaling Newtown, Connecticut, or Cape Cod — tight-knit regions where tragedy strikes hard and deep.
She explained that “[Plano] has the best school districts in the state of Texas…it’s a gated community. And in 1998, for heroin to be that prevalent in the community was stunning. Stunning. We got all the media attention because we were this upscale Texas neighborhood that nobody thought would be inundated with heroin.”
Nelson decided to take action, saying, “I decided I’d had it. I was going to organize my community and fight this thing at the grassroots level. But we were never grassroots because the first thing I did was go on the Oprah show for the DEA.”
Belita stresses that she was never officially employed by the DEA but traveled for six years as a sort of unofficial spokeswoman for the agency. The group recruited her because their goals aligned, and in many ways, she was perfect for the role. She was a mother who had witnessed the toll of heroin first-hand. She was passionate and knew what she was talking about. Belita spoke to schools and parent groups and appeared on television networks.
With the help of a former Dallas Cowboy, she founded the Starfish Foundation to tackle heroin addiction. That organization ran until 2004 when one of the employees pocketed the donation money and left the foundation scrambling in the dark.
In our interview, Belita was hesitant to speak too openly but mentioned that when she first went to work with the DEA (she was contacted and became familiar with agency’s goals), she was told “‘Marijuana is safe, we know it’s safe, but it’s our cash cow and we will never, ever, give it up.’” When the DEA seizes a car or makes a drug bust, it’s likely they’ll find wads of money. They turn in the pot (or other drugs) — and keep the cash. Civil asset forfeiture law essentially gives the police and feds free reign, and they have confiscated billions of dollars from Americans, a majority of whom have not been charged with a crime.
Belita, like many people, posits that the DEA is not willing to give up the long disproven idea that marijuana is a “gateway drug.” Unlike heroin, most people are open to trying marijuana. At high school or college parties, it’s much more likely that a joint is being passed around than a needle. While a joint conjures up images of Bob Weir or SOJA on stage, a needle brings to mind a lifeless Philip Seymour Hoffman or Basquiat.
Belita cut ties with the DEA in 2004 after becoming frustrated with the system and the government’s need to keep marijuana criminalized, despite knowledge that the drug was safe.
While at the Starfish Foundation, Belita heard time and time again the tale of pot-smoking teenagers who were pushed into heroin simply because marijuana carries harsh penalties. And it’s a story that’s been told repeatedly. Today Belita works for the Gridiron Cannabis Foundation, a nonprofit dedicated to fighting CTE, concussions, Alzheimer’s disease, Parkinson’s disease, Multiple Sclerosis, neuropathy, dementia, chronic infammation, Leukemia, and brain and other cancers. But the group’s pockets that only stretch so far.
In contrast, her opposition — and the opposition of anyone fighting the heroin epidemic and hoping to legalize marijuana — are big pharma companies.
Recently, we’ve seen pharma companies hit the grassroots to secure influence. Anti-Media and a number of other news outlets recently reported on an opioid company pumping half a million dollars into Arizona anti-marijuana groups in an effort to keep the plant illegal. These sorts of campaigns do not serve the dead in Plano and the hundreds of thousands around the nation suffering from opioid addiction. Rather, they benefit CEOs and pharmaceutical groups who have invested millions in developing drugs that minimize pain. Unfortunately, they come with a dangerously high likelihood of addiction.
Big pharma corporations see dollar signs in every painkiller that moves across a counter, but some of which could easily be replaced by marijuana, which is increasingly proven to help decrease pain. So the American consumer, from Plano, Texas, to Portland, Maine, is faced with the dilemma — is it better to be a living Bob Weir or a dead Basquiat?
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https://www.fda.gov/Safety/Recalls/ucm554329.htm?
Bellmawr, New Jersey, C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.
This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death. C.O. Truxton, Inc. has not received any reports of adverse events related to this recall.
The product is indicated for use as a sedative or anticonvulsant and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 0463616010 6, lot number 70952A, expiration date 11/17. The 15 mg Tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30 mg Tablet is debossed with “West-ward 450” on one side and scored on the reverse side. The product was distributed Nationwide in the USA to Physician & Veterinarian Treatment Centers.
C.O. Truxton, Inc. is notifying all customers on record who purchased the affected product via US Mail which includes a recall letter, recall response form and is arranging for full credit returns, replacements, etc. of all recalled product. Consumers/distributors/retailers that have recalled product should stop using the product and return their product to their place of purchase.
Consumers with questions regarding this recall can contact C.O Truxton, Inc. by phone at (856) 933-2333, Monday to Friday between the hours of 9am and 5pm (EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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A Glencoe woman hugged her attorneys after a jury in Chicago awarded her $3 million Thursday in a lawsuit against a pharmaceutical company that she blamed for her husband’s suicide.
“We won!” she mouthed to one of her lawyers.
Wendy Dolin’s husband, Stewart, stepped in front of a CTA Blue Line train in the Loop on July 15, 2010. He had been taking paroxetine, a drug for depression and anxiety, and his widow claimed in her lawsuit that GlaxoSmithKline failed to warn her husband’s doctor of the drug’s increased risk of suicidal behavior, leading to his death.
GlaxoSmithKline makes Paxil, a brand-name version of paroxetine. Though Stewart Dolin was taking the generic form, his widow’s suit argued — and the jury agreed — that the pharmaceutical company was still responsible because the drugs are identical and have the same labeling.
Stewart Dolin was a corporate attorney and a partner at the Reed Smith law firm at the time of his death. He was 57.
Wendy Dolin called the verdict “a great day for consumers,” though she said the result was bittersweet.
“This for me has not just been about the money. This has always been about awareness to a health issue, and the public has to be aware of this,” she said after the verdict was announced in federal court following three days of jury deliberations.
“None of us here are anti-drug. That’s not the issue,” Dolin added, “but we are patient advocates and we hope that people will start asking better questions.”
Officials from the pharmaceutical company said the verdict was disappointing and that they plan to appeal.
“GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable,” the company said in a statement. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”
Wendy Dolin’s suit, which alleged negligence and wrongful death, originally named the generic drug manufacturer and its distributor as defendants, but U.S. District Judge James Zagel ruled earlier to release them from the suit, saying they had no control of the drug’s label.
“We’re hoping this sends a clear signal to (GSK) that they need to change the label” to indicate a suicide risk for those over the age of 25, said R. Brent Wisner, one of Wendy Dolin’s attorneys, who called the lack of such labeling “outrageous.”
“We’re just really happy that we finally had a chance to bring all this to court for the first time (and) show all these documents to the public which had, until this day, been under seal,” he said.
Wendy Dolin now advocates for patient safety and aims to raise awareness about akathisia, a state of restlessness or anxiety that sometimes occurs as a side effect of certain antidepressant and antipsychotic drugs. She has started a nonprofit organization, the Medication-Induced Suicide Prevention and Education Foundation in memory of Stewart Dolin.
“I think Stewart would be very proud of his family and how we’ve all stood together and made a difference,” Wendy Dolin said, “that we didn’t allow this injustice.”
If a corporate entity can be held responsible for medication that they originally produced… can be held responsible for a pt committing suicide when taking that medication..
It is a know fact that chronic pain pts have a twice possibility of committing suicide.. so if some entity fails to treat chronic pain or reduces a otherwise stable chronic pain pts medication and they commit suicide.. could they he held responsible for their suicide ?
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The unprecedented scourge of opioid overdose deaths, which is devastating the Midwest, has not spared Minnesota. Like most other states in the region, increases in deaths have skyrocketed — by as much as fivefold within a few years.
Unfortunately, it appears Minnesota is heading down the same misguided path that kickstarted the nationwide plague seven years ago — simply stopping the pills.
Minnesota’s state Attorney General Lori Swanson recently joined her Wisconsin counterpart Brad Schimel in a media campaign called “Dose of Reality.” It seeks “to raise awareness about how to safely use, store, and dispose of opioid prescription painkillers.” Both Swanson and Schimel have bought into a false narrative that sounds plausible but has, in fact, had the opposite effect, hurting both addicts and pain patients alike.
Much of the narrative is a result of bungling at the Centers For Disease Control and Prevention. The agency, which failed to understand addict behavior, developed a naïve and simplistic strategy that may have sounded reasonable but backfired horribly. Turning off the spigot of opioid medications at the pharmacy has been an unmitigated disaster by any measure.
Addicts are dying in record numbers, but not from pills such as Vicodin or Percocet. This is the false narrative. The real killers are injectable narcotics like heroin and its evil cousin fentanyl. Perhaps worse, patients with severe pain who have been living barely tolerable lives now must fight increasingly Draconian regulations to obtain the medication they need to survive.
We should have learned our lesson in 2010, the year abuse-resistant OxyContin was approved. The evidence was there for all to see. As OxyContin use plummeted, addicts switched in droves to heroin. This should have, but did not, prevent another false narrative: that today’s deluge of addiction resulted from over-prescribing opioids to patients with legitimate needs who later became addicts.
Is the narrative convincing? Yes. Accurate? Anything but. Multiple reviews — including a systematic, evidence-based analysis known as a “Cochrane Review” of 26 studies — and a 38-study review in the journal Pain concluded that a very small number, about 10 percent, of people who took opioids to manage pain become addicted. Rather, the vast majority of today’s addicts became so because of the recreational use of opioid pills; they later progressed to injectable narcotics once the pills became prohibitively expensive and difficult to obtain.
Beginning around 2013, an already-bad situation began to worsen. The demand for heroin became so great it was supplemented with, or replaced by, fentanyl, which is not only far more dangerous but also very easy to synthesize. Even chemists with marginal skills, mostly in China, can prepare large quantities of the drug in a short period of time. From there, it makes its way to Mexico, the source of virtually all fentanyl in the United States.
The result of this confluence of events could not be clearer. In Massachusetts, during the first quarter of 2016, more than 90 percent of overdose deaths involved fentanyl, heroin, or both, compared to 10 percent for prescription opioid pills. Data from the departments of health in Ohio, Philadelphia, and Florida show that heroin and/or fentanyl is responsible for about 80 percent of opioid overdose deaths. Kentucky, despite a crackdown on pill mills and doctor shopping, ranks third in the nation in heroin/fentanyl deaths, which have tripled since 2010.
The notion that the unwinnable war on drugs can be won by counting Vicodin prescriptions is perversely wrong. The crack and methamphetamine epidemics did not begin from prescriptions. Neither did this one.
Worse still, the federal Drug Enforcement Administration is now seizing deadlier analogs of fentanyl, some of which are over 100 times more potent. Overdose deaths will only increase as these “super fentanyls” make their way into bags of “heroin.”
The lesson we should have learned in 2010 is that the only policy worse than not restricting opioid pills is over-restricting them. Pain patients suffer, and more addicts die. Everyone loses.
Jonathan “Josh” Bloom is the director of chemical and pharmaceutical sciences for the American Council on Science and Health in New York City (acsh.org).
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http://www.spokesman.com/stories/2017/apr/19/deaths-of-despair-stalk-millennials-in-unforgiving/
Ryan Johnson was 22 when he succumbed to a heroin addiction that had intensified as the Erie, Pennsylvania, high school graduate grew disillusioned with his future. His mother found him in his room with his head slumped and lips blue.
It was June 28, 2014, the day of his sister’s master’s-degree graduation party.
“He just saw his life as not what he wanted it to be, and he didn’t know how to get it there,” said Sue Johnson, who lay next to her son’s corpse for an hour. He had dropped out of a two-year culinary program and was working part-time, low-wage jobs. He often compared himself with his peers in college and his athletic, academic older sister.
The fates of the less-educated and those who graduate from universities diverge in dire ways. Middle-aged white Americans without four-year degrees are at increasing risk of dying, a well-documented trend driven not only by drug use but also by alcoholism, suicide, and slowing progress against heart disease and cancer. Outcomes may worsen further as millennials-Johnson’s generation-grow older.
“America is not a great place for people with only a high school degree, and I don’t think that’s going to get better anytime soon,” said Angus Deaton, a Nobel Prize-winning Princeton University economist.
It’s too soon to tell whether millennials will die at higher rates in middle age than today’s 45- to 54-year-olds, said Anne Case, a Princeton economist who identified the “deaths of despair” trend with Deaton, her spouse and co-author. But in stories like Johnson’s, there are reasons to worry.
Case and Deaton have a theory for why mortality has risen for less-educated whites. For all the debate over whether college is worthwhile, high school graduates who go straight into the workforce have higher unemployment, weaker wage growth, and less chance of marrying than their predecessors and educated peers. Community supports have broken down, and as disadvantage snowballs, premature deaths rise.
Those problems could intensify for the next generation that reaches middle age. Many millennials, born after 1980, joined the workforce during the Great Recession, so they faced low starting salaries and tough job prospects. And they’re saddled with student debt. Still, almost two-thirds lack a bachelor’s degree, which in today’s economy is a near-prerequisite for jobs that provide higher wages and benefits.
Meanwhile, marriage is happening later and less often. Religious affiliation and union membership have declined, so when life doesn’t work out well for millennials, they’re on their own.
While blacks and Hispanics without college degrees are also falling behind economically and socially, middle-age mortality has worsened for whites in particular over the past 20 years-a fact some attribute partly to social context.
“For whites, their reference group is previous generations of whites,” said Shannon Monnat, a Penn State University professor who studies the opioid epidemic in rural America. “When they look back on their parents and grandparents, it feels like their generation is doing worse.”
Such decline runs deep in Erie, where Johnson attended school and worked a string of part-time restaurant jobs. Nestled against the gray-green waters of one of America’s Great Lakes, the town has been declining since the 1970s. Its population dropped below 100,000 in 2014 for the first time since 1920.
Formerly grand red-brick factories have broken windows and vine-covered exteriors. The local General Electric Co. plant, which makes locomotives for export, has shed almost half its workforce in recent years-1,500 jobs were cut last year, and 950 were moved to Texas in 2013. While service industries including health care show signs of life, high-paying jobs that require only a high school education are increasingly limited.
“A lot of that leads to despair, to hopelessness,” said Scott Slawson, a longtime GE welder and union local president. “It’s a scary path we’re on.”
Erie’s suicide rates have risen, with 48 last year, up from 29 a year on average for the past half-century, according to county coroner Lyell Cook. There were 95 drug deaths in surrounding Erie County last year, up from a historically normal 40, and 35 drug deaths in 2017 as of mid-March, with another 12 likely overdoses awaiting toxicology reports.
The opioid crisis, born of heavy prescribing of addictive pills and compounded by readily available street heroin, has added fuel to the fire for people already facing a tough labor market.
“It stems from depression,” said Jack Martin, a 63-year-old funeral director who’s dealt with many overdose deaths. That’s especially true for younger victims. “When they look down the road: Am I going to get married? Am I going to be successful? Am I going to have enough money?”
Just 71.3 percent of 25- to 34-year-olds who graduated high school but didn’t go on to college were employed in 2016, versus 85.2 percent of college graduates.
Signs of distress are already showing up. Today’s 20- to 34-year-olds are killing themselves at higher rates than people of similar age in 2000. Alcohol-induced deaths have been rising across age groups, and the rate doubled for 25- to 34-year-olds from 1999 to 2015, based on Monnat’s analysis of Centers for Disease Control and Prevention data.
Nationally, 25- to 34-year-olds make up the biggest share of opioid overdoses, and their proportion has been climbing, based on Kaiser Family Foundation data.
Johnson started using opioids in high school after breaking his collarbone, first in football and again while wrestling, and he got hooked on his prescription, his mother thinks. He was a functional addict at first, caring and warm, but things slipped out of control after he graduated and found that his skills-art and cooking, but not academics-meant little in the workforce. After dropping out of culinary school, he went to rehab for the first of three times.
At one point, things were looking up: He was clean and got a full-time job making wood pallets. But his co-workers did drugs, and before long, he was using again.
“That was the thinking there: It’s a stupid job. It doesn’t matter if you’re high to work it,” his mother said.
The cycle ended in June 2014. While she was getting ready for the party for her daughter, who had earned a degree in occupational therapy, Sue Johnson went to wake her son. She couldn’t: He had overdosed.
The next year, Martin, the funeral director, started teaching students at a local high school about opioid abuse. He brings health classes to his funeral home and shows them the white-tiled preparation room and the cold, steel table where he lays out bodies.
“I actually scare the crap out of them,” he said. “But it works.”
He shows them pictures of heroin-dead, explaining that just years before their bodies passed through this sterile room, the deceased had walked high school halls. Among the pictures is a snapshot of Johnson, shaggy-haired and smiling.
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Have you ever notice that anytime somebody wants to get something changed.. it normally involves two things MONEY .. donated to a political campaign or MONEY to pay a law firm to file a lawsuit.
President Trump tried to put a temporary ban on immigrants from a handful of middle east countries and Attorney Generals from two different states – challenged his executive orders in the courts.
Cities, counties and states have filed lawsuits against the three major drug wholesalers for the “opiate epidemic” in their particular geographic areas. They are suing business entities that do not sell any products directly to the general public. Their customer base is pharmacies, hospitals and the like.
The DEA uses laws and their interpretation of the laws (Control Substance Act 1970) to intimidate healthcare providers and my money is on the fact that many of those interpretations are actually UNCONSTITUTIONAL… but until someone challenges their constitutionality in our court system the DEA will continue to apply and enforce those laws. Keeping the 81 billion that funds the war on drugs is a pretty good incentive to maintain the status quo. A lot of paychecks are being covered with that money.
We know that there are numerous drug/alcohol treatment centers that are supporting various anti-opiate groups. Members of Congress have proposed laws that would encourage treating “addicts” with a C-III medication (suboxone) and letting them be dependent on that medication rather than being dependent on a C-II legal medication.
Those 45 million Alcoholics, 35 million Nicotine addicts, 2.1 million opiate addicts and the 100+ million chronic pain pts are just “conduits” for a whole array of business to make money.
Two things that the chronic pain community has in common is under/untreated pain and a LACK OF UNITY. Just look at the hundreds – or thousands – of Face Book pages devoted to pain and/or disease where pain is a major component.
You can also divide the chronic pain community into to groups.. those that have had their pain management meds cut and those that have yet to have their pain management meds cut.
How many chronic pain pts have contacted a law firm about suing some entity that is adversely impacting their quality of life ?… and a equal number have received a “NOT INTERESTED”… and because someone who is handicapped/disabled, elderly, unemployable… in our legal system… the value of their life is “very little” so there is no financial upside for the law firm to take the case on a contingency basis. It has been estimated that 90% of the families with a chronic pain pt… is struggling financially because one spouse can’t work and/or the cost of therapy.
Congress is currently considering a CAP on medical malpractice lawsuits damages at 250,000.. just about ensuring that no law firm will take on a case on a contingency basis. After all about 40% of Congress is attorneys.. they know what they are doing and who they are doing it to.
IMO, nothing is going to change until those in the chronic pain community gets their act together – UNIFY – create a non profit to create a legal defense fund.. With a 100 million chronic pain pts… it wouldn’t take much effort to create a legal defense fund with 5-10-15 million and I can assure you that if the chronic pain community approaches a major law firm with that much money behind them… you won’t hear “NOT INTERESTED”…
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