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First Edition: September 28, 2016

Kaiser Health News - Wed, 09/28/2016 - 6:33am
Categories: Health Care

Deadly Opioid Overwhelms First Responders And Crime Labs in Ohio

Kaiser Health News - Wed, 09/28/2016 - 5:00am

Jamie Landrum has been a police officer for two years in District 3 on the west side of Cincinnati. In late August, the city was hit by 174 overdoses in six days. Landrum says officers were scarce.

“We were literally going from one heroin overdose, and then being on that one, and hearing someone come over [the radio] and say, ‘I have no more officers left,’ ” Landrum said. Three more people overdosed soon after that.

Heroin isn’t new in Cincinnati, but the recent surge in overdoses is being blamed on an even more potent drug called carfentanil. It’s 100 times stronger than fentanyl, a more common synthetic opioid that is itself much stronger than heroin. Carfentanil is used to sedate elephants. It can be dangerous to even touch it without gloves.

City and county agencies in the Cincinnati area — from law enforcement to the county coroner — are straining to respond to the carfentanil wave.

Carfentanil is part of a shift to synthetic opioids in Cincinnati and around the country. Last year in Hamilton County, Ohio, there were more deaths attributed to fentanyl than to heroin.

Suspected carfentanil cases were first reported in the U.S. in July in Ohio. The rate of overdoses has dropped since that shocking 174 in six days, but not by much. There are currently 20 to 25 overdoses a day, on average, reports Hamilton County’s heroin task force. Police are calling it the new normal.

About an hour into a recent shift, Officer Landrum gets a call. A man has overdosed at an apartment building on the outskirts of town. His girlfriend found him and called 911.

By the time we get there, there’s a crowd outside. The man is unconscious in the back of the ambulance, and EMTs have given him three doses of Narcan, an antidote for opioid overdose. For a heroin overdose, one round of Narcan is usually enough.

EMTs clap and shout his name, trying to wake him up, but something’s wrong. They turn off the music blaring in the ambulance and continue working. After a few minutes, Officer Landrum gives me an update.

“This is the most I’ve ever seen,” she said. “He’s gotten four Narcans so far, and he’s still not awake.”

The EMTs decide to take him to the hospital. We follow, not knowing if the man will make it. “Whatever he got ahold of, it’s really bad,” Landrum said.

This story is part of a partnership that includes Side Effects Public Media, NPR and Kaiser Health News. It can be republished for free. (details)

For first responders, the arrival of carfentanil can be summed up with one word: More. More overdoses, more Narcan, more time spent on each call.

And when the efforts to save someone’s life fail, more work gets passed on to the Hamilton County Coroner’s Office.

“The caseload keeps getting larger and larger,” said Bob Topmiller, who heads the toxicology section at the coroner’s office, where they test blood and urine. “We may have had a 100- or 150-case backlog a year ago, and it’s almost doubled.” The time it takes to process a sample has also doubled, from one month to two.

Evidence of the deluge is all over the lab: Equipment spills into the hallways, envelopes cover the intake desk and everyone seems to be busy.

And it’s more than the number of cases causing the flurry of activity. It’s the fact that the drug was never meant for people.

“It’s what we don’t know about this drug that scares us,” said Dr. Lakshmi Sammarco, the coroner for Hamilton County. “We don’t have any human testing data. We don’t know what the lethal level really is. There is no therapeutic level — it’s not meant for human use.”

That means Sammarco’s team is using the samples coming in to try to extrapolate some important information, like the lethal dose per kilogram of body weight, or how long carfentanil stays in someone’s system — things that could help the people treating the overdoses.

Dr. Lakshmi Sammarco, the coroner for Hamilton County, Ohio, worries about the paucity of information about how carfentanil, an animal drug, affects humans. (Jake Harper/Side Effects Public Media)

Sammarco says this process is part of a pattern they’ve dealt with before, playing catch up with the suppliers as new drugs appear.

“However, in the spectrum of opiates, this is about max,” she said. “Out of all of them, carfentanil really is the most potent.”

For now, Sammarco can only say that there have been eight deaths in which carfentanil might be the cause. Her office is working to test samples dating back to July, when the drug first showed up in Ohio.

At the hospital, Landrum follows the overdose victim into the emergency room. After about half an hour, doctors and nurses stabilize him.

We leave after that. The man didn’t have any drugs on him, so he wasn’t charged with any crime. His girlfriend wouldn’t say where the drugs came from, though she did mention that the two of them had overdosed the week before.

“Believe it or not, we’ll probably be responding out for her here shortly,” said Landrum. Even after close calls, people keep using. Addiction is too strong.

What’s worse, the danger of carfentanil seems to act as an advertisement: People seem to equate near death with a really good high, and the problems in Cincinnati are attracting customers. Landrum says recently she met a couple from Indianapolis in town to buy drugs. Another officer talked to people from central Kentucky.

So far, the DEA says carfentanil has only been confirmed in Ohio and Kentucky. Other states are starting to test for it, bracing for its arrival.

This story is part of a partnership that includes Side Effects Public Media, NPR and Kaiser Health News.

Categories: Health Care

Election Buzz: Critics Of Legal Pot Say Addiction Becomes ‘A Disease Of The Family’

Kaiser Health News - Wed, 09/28/2016 - 5:00am

If pot laws were colors, a map of the U.S. map would resemble a tie-dye T-shirt. In some states, marijuana is illegal. In others, it’s legal for medical purposes. And still in others, it is even legal for recreational use.

Five more states could come into that last category this fall, as voters decide whether to legalize it in California, Nevada, Maine, Massachusetts and Arizona.

It was only six years ago that Arizona approved marijuana for medicinal use, and that’s a stark contrast to Oregon, where medicinal marijuana was legal for almost two decades before smoking pot for fun became OK last year.

Opposition to recreational use in Arizona has been organized and vocal. A group that includes two county attorneys sued, unsuccessfully, to get it off the ballot.

And then there are people like Debbie Moak, 59, who said she put her son in drug rehab when he was 20. “A lot of these kids who are going to be impacted the most by this, they won’t be voting in this election,” said Moak, who lives outside of Phoenix. “This is where we need to be the adult in the room and protect the kids.”

This story is part of a partnership that includes Oregon Public Broadcasting, KJZZ, NPR and Kaiser Health News. It can be republished for free. (details)

Moak said pot led her son to use harder drugs. Cocaine became his drug of choice, and he dropped out of college and eventually became homeless.

“It tears a family apart,” she said. “Addiction becomes a disease of the family, and I’ve lived it, in the trenches. And I don’t want to see this happen for any other family.”

But Moak used to see that pretty much daily, back when she ran a nonprofit called Not My Kid that worked to keep young people off drugs. For nearly two decades, she spoke to parents in pain because they were unable to reach their children who were sinking deeper into drug dependency.

She opposed the approval of medical marijuana because she feared it would lead to more acceptance of the substance she views as tremendously harmful.

Coming at this from a completely different direction is 60-year-old food editor Martha Holmberg. She lives in Portland, Ore., and says she smoked a lot of marijuana in high school and college then didn’t touch pot again until she finished bringing up her daughter. Now it’s part of the fabric of her social life.

“I don’t do it with people that I don’t know well,” Holmberg said. “But if I’m hanging out with girlfriends or we’re going over to a friend’s house, I will usually bring weed and say, ‘Hey, anybody want to get high?’ ”

Oregonian Martha Holmberg says she used to smoke pot in high schol and college, but stopped for years while raising her family. With pot legal in Oregon and growin in acceptance, she’s returned to smoking occasionally. (Kristian Foden-Vencil/Oregon Public Broadcasting)

Some do and some don’t. “And it all flows very comfortably in that situation,” she said. “It’s not like the pot smokers have to go off to the corner.”

Holmberg recently hosted two women writing a pot cookbook. And they needed somewhere legal to try out recipes. The main issue: How much weed to include in each dish?

The equivalent for alcohol would be to figure out whether you make a Moscow Mule with a finger of vodka or a pint. Holmberg says they proved to be a little too cautious.

“At the end of the evening people weren’t really very high,” she says. “I think some people were disappointed. We actually pulled out a vape pen for anybody who wanted to get high. But it was much better that way. People felt reassured.”

For some people in Arizona, the scene Holmberg described would be shocking. But the introduction of medical marijuana here in 2010 made it a lot more palatable for others. Like Lisa Olson, a mother of five who lives in Mesa, outside of Phoenix. She says pot helps ease the symptoms of her multiple sclerosis.

How does her marijuana use fit in with family life? “Basically, the way we ended up handling it was a lot like alcohol,” she said. “So my kids certainly see me drinking a glass of wine with most dinners. They know that’s not for them. That’s for the adults.”

She thinks adults should be able to use pot recreationally, too. For someone like Olson, who had always abstained from drugs, that’s quite a change. Once she saw how much good marijuana did for her, she felt it shouldn’t only be reserved for people with a few specific ailments.

She’s passed this newfound openness onto her children. Jake Olson, 20, said the “just say no” message he got from school wasn’t necessarily true. He appreciated hearing that there are times when use in moderation is OK and shouldn’t be equated with heavier drugs.

“It’s really funny because, you know, most teenagers don’t figure out things like that through their parents,” he said. “But I am that exception. I am that person who learned that maybe not all bad things are bad, from my parents.”

Patrick Caldwell, who also lives in Oregon, says pot acceptance is gradually taking hold in his state. But he will still only bring marijuana to certain events and situations. (Kristian Foden-Vencil/Oregon Public Broadcasting)

Acceptance is growing in Oregon. But it’s been a gradual process. Patrick Caldwell has a Portland business selling pot containers. He is 29 and brings cannabis-infused sodas to parties. He said he might share one at, say, a bachelor party but not at a family picnic. Caldwell doesn’t want pot to be taken lightly.

“I want my nephews to be able to make their own informed decision about cannabis without being influenced by the fact that I so regularly use it,” he said.

He thinks people need to respect what they’re getting into. But he hopes that in a few years, bringing pot to a family picnic will be no different than bringing a six-pack.

This story is part of a partnership that includes Oregon Public Broadcasting, KJZZ, NPR and Kaiser Health News.

Categories: Health Care

When Drug Reviewers Leave The FDA, They Often Work For Pharma

Kaiser Health News - Tue, 09/27/2016 - 6:30pm

More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.

Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, sought to understand the so-called “revolving door” between the FDA and the pharmaceutical industry, which he said is often discussed but hadn’t been quantified.

“We all know about these anecdotal cases” of a person who was  “often a major player at the FDA, someone in an important role — and then they leave the FDA and go and work for industry,” Prasad said, but he couldn’t find anyone who knew whether this happened “5 percent or 60 percent” of the time.

Use Our Content This KHN story can be republished for free (details).

Prasad and his colleague Dr. Jeffrey Bien, an internal medicine resident also at Oregon Health, tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010, using LinkedIn, PubMed and other publicly available job data. They found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the biopharmaceutical industry. Put another way, about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated. They published their findings in The BMJ as a research letter.

Going to work for industry after leaving the FDA is not inherently bad, but it does raise some questions.

“If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate,” Prasad said. “Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?”

Prasad focused his research on his own field — hematology-oncology — because it spawns a large number of new drugs and reviewers have a lot of autonomy, he said.

“There’s a lot of room for interpretation in deciding whether or not a cancer drug should be approved,” he said, because so many studies of cancer drugs rely on what’s called a “surrogate endpoint,” meaning that something other than survival or quality of life was measured to determine whether a drug worked. For example, shrinking a tumor may be a stand-in for survival. But according to one of Prasad’s previous studies, there isn’t always evidence that surrogate endpoints are linked to better health outcomes, suggesting that some approved drugs aren’t as beneficial as they appear.

“Sometimes, the public needs [the FDA reviewers] to be firm. If they’re not, no one else in the health care sector is going to be,” Prasad said, adding that once the agency approves a drug, the Centers for Medicare & Medicaid Services has to cover it and can’t negotiate prices under current laws. “The FDA is often the only real wall between ineffective, harmful drugs and patients.”

He and Brien tracked reviewers instead of higher ranking officials because reviewers provided a larger sample size, Prasad said. They would have liked to include reviewers named on denials as well, but the denial documents are secret, making it impossible to identify the reviewers.

Although Prasad said FDA reviewers have a lot of power over approvals, Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner until 2011, disagreed.

“There are just so many checks and balances within the review process that it’s really not up to one person by and large,” said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught.”

Sharfstein said he has met with companies to offer advice, but was not compensated for it.

The revolving door is a fair topic to study, he said, but having former FDA officials on the pharmaceutical industry payroll can have a public health benefit. Former FDA employees with deep knowledge of the approval process help make it go smoother by ensuring all the relevant research is complete and the latest pathways to approval are understood.

“Companies are very nervous about the FDA,” he said. “So they need to have an understanding of how the FDA works.”

FDA spokesman Jason Young said employees leave the government to work for industry at various agencies, not just the FDA.

“The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual,” he said, adding that these include protecting confidential information they learned at the FDA and a “cooling-off” requirement for senior officials before they can work for industry.

Former FDA Chief Dr. Margaret Hamburg, who left the administration last year, told Stat News in March that she would wait before jumping into an industry job, adding that “this perception of the revolving door is damaging to everyone” and that she would not consider “any boards of any company big or small that was regulated by the FDA for a couple of years.” She also is quoted as saying it is “unfortunate” that people think “a complete division” is necessary between the agency and the industry.

The FDA Alumni Association, whose slogan is “serving those who have served,” currently lists four job openings for former FDA employees. Three are at consulting firms and one is at a law firm seeking an “FDA compliance paralegal.” Of the consulting jobs posted, one is for a regulatory scientist and the other is for a regulatory toxicologist. The third is a food and cosmetic consulting job.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Health Care

Three Revenue Options to Shore Up Social Security

Center on Budget and Policy Priorities - Tue, 09/27/2016 - 1:54pm

Social Security faces a significant — though manageable — long-term funding shortfall.  If policymakers address it by reducing benefits, those cuts must be limited and carefully targeted to avoid causing significant hardship.  And they’d almost certainly be phased in slowly, which means they could not produce significant

Categories: Benefits, Poverty

IRS Doing Its Job to Inform Public About Insurance Options

Center on Budget and Policy Priorities - Tue, 09/27/2016 - 1:24pm

The IRS is launching a new initiative to inform millions of people who didn’t have health insurance in 2015 about the affordable coverage options they may have for 2017.  While the IRS’s efforts have come under fire from some in Congress, federal law clearly requires it to share this information.

Categories: Benefits, Poverty

Increasing Payroll Taxes Would Strengthen Social Security

Center on Budget and Policy Priorities - Tue, 09/27/2016 - 12:28pm

Social Security faces a significant — though manageable — long-term funding shortfall, which policymakers should address primarily by increasing Social Security’s tax revenues. 

Categories: Benefits, Poverty

Welsh Legal History

In Custodia Legis - Tue, 09/27/2016 - 7:57am

The following is a guest post by Clare Feikert-Ahalt, foreign law specialist for the United Kingdom and a number of Commonwealth jurisdictions at the Law Library of Congress.  Clare has previously written many interesting posts, most recently: FALQs: Brexit Referendum and The Case of a Ghost Haunted England for Over Two Hundred Years.

Frequently, the four countries that form the United Kingdom of Great Britain and Northern Ireland – England, Wales, Scotland, and Northern Ireland – do not get recognized as being separate countries, each with their own distinct legal history. Wales is often grouped together with England, when in fact it has a rich and diverse legal history of its own. It has also started to have a steady increase in legislative powers for areas that have been devolved to it as a result of the Government of Wales Act.

A few of the volumes of Welsh Legal History (Photo by Betty Lupinacci)

Recently, the Law Library of Congress was fortunate to receive a donation of thirteen bound volumes of Welsh Legal History, prepared by the Welsh Legal History Society. These volumes are a valuable contribution to the Law Library’s collection of Welsh legal materials and cover, in detail, a history of the law in Wales. The volumes were presented to the Law Library during a lecture given by Professor Thomas Glynn Watkin.

Professor Watkin provided a fascinating lecture titled Devolution and the Law in Modern Wales. This proved to be both a very relevant and topical discussion of both historical events and the development of modern events in light of the impending exit of the UK from the European Union. Interestingly, particularly in light of the recent EU referendum vote, Professor Watkin noted that the United Kingdom has evolved, either adding or removing a country, approximately once every hundred years.

It is not possible to do justice to Professor Watkin’s fascinating lecture in such a short space or time, so this post will provide only a very brief overview of some of the points raised. Professor Watkin managed to concisely detail the legal history of Wales up to modern times. He noted that the Statute of Wales 1284 provided Wales with its own courts, and thus a distinct legal identity, and that Welsh law was completely replaced with the introduction of English law across Wales in 1535/36. Welsh legislation and English legislation were identical until the Sunday Closing Act was introduced in 1881, which applied only to Wales. This was followed by the Welsh Church Act 1914. These pieces of legislation were the first that saw a movement towards providing a greater voice to the Welsh people. Fifty years later, 1964 saw the creation of the Office of Secretary of State for Wales by Harold Wilson.

v. 13 of Welsh Legal History (Photo by Betty Lupinacci)

Providing Wales with its own legislative assembly was no straightforward matter and in the first referendum, held in 1979, to determine whether Wales should have this legislative body, the vote was overwhelmingly against it. In the second referendum, held in 1997, the vote was closer than the Brexit referendum, with 50.3% of voters in favor of creating a legislative assembly and 49.7% against. The Welsh Assembly was subsequently created by the Government of Wales Act 1999. The areas of competence of the Welsh Assembly were significantly less than the Scottish Parliament, which was created at the same time. Over time, additional areas of legislative competence have been provided to the Welsh Assembly.

The draft Wales Bill, currently before Parliament, is expected to add more areas, although it is not as extensive as many were hoping. Professor Watkin noted that given the timing of the bill during the aftermath of the Brexit referendum, a great deal of uncertainty exists and many believe that the draft bill should be considered after the dust has settled and concrete plans are in place and underway for the UK exit from the European Union. Instead, he said, the bill looks likely to be pushed through and receive Royal Assent shortly.

Categories: Research & Litigation

First Edition: September 27, 2016

Kaiser Health News - Tue, 09/27/2016 - 6:27am
Categories: Health Care

Election Buzz: With Pot On The Ballot, States Weigh How To Police Stoned Drivers

Kaiser Health News - Tue, 09/27/2016 - 5:00am

In five states this fall — California, Arizona, Nevada, Maine and Massachusetts — voters will be deciding whether marijuana should be legal for recreational use. And any of those states that do legalize marijuana will have to wrestle with the question of how to enforce laws against stoned drivers.

It has been legal to smoke pot for fun in Colorado since January 2014, and the state modeled its marijuana driving-under-the-influence law on the one for alcohol. If a blood test shows a certain level of THC, the mind-altering compound in marijuana, the law says you shouldn’t be driving.

It sounds straightforward, but consider the case of Abby McLean, a stay-at-home-mom from the Denver suburbs.

McLean, 30, was driving home from a late dinner with a friend two years ago when she came upon a DUI roadside checkpoint.

“I hadn’t drank or smoked anything, so I was like, ‘Let’s go through the checkpoint,'” she recalled.

McLean is a regular marijuana user but she insists she never drives while high.

This story is part of a partnership that includes Colorado Public Radio, KPCC, NPR and Kaiser Health News. It can be republished for free. (details)

Still, the officer at the checkpoint told her he smelled marijuana and that her eyes were bloodshot. Eventually he whipped out handcuffs, and McLean said she started to panic: “Like, massive panic attack. And, ‘Oh, my God, I have babies at home. I need to get home. I can’t go to jail!’ ”

She didn’t go to jail that night, but she got home hours late. A blood test later revealed McLean had five times the legal limit of THC allowed in Colorado, which is five nanograms of THC per milliliter of blood.

It may sound like an open and shut case that could have resulted in any number of penalties. But McLean’s attorney, Nadav Aschner, had a field day in court with Colorado’s marijuana intoxication limit.

“Even the state’s experts will say that number alone is something, but generally not enough, and we really hammered that home,” he said. Aschner got a hung jury and McLean pleaded to a lesser offense.

Still, McLean’s trip through the criminal justice system is emblematic of numbers that suggest a sharp increase in marijuana DUI arrests in Colorado. So far this year, State Patrol data show that total DUI citations this year rose to 398 through early July, compared with 316 in for the same period 2015.

It turns out, measuring a person’s THC is actually a poor indicator of intoxication. Unlike alcohol, THC gets stored in your fat cells, and isn’t water-soluble like alcohol, said Thomas Marcotte, co-director of the Center for Medicinal Cannabis Research at the University of California, San Diego.

“Unlike alcohol, which has a generally linear relationship between the amount of alcohol you consume, your breath alcohol content and driving performance, the THC route of metabolism is very different,” Marcotte said.

That’s why adapting drunk driving laws to marijuana makes for bad policy, said Mark Kleiman, a professor of public policy at New York University. “You can be positive for THC a week after the last time you used cannabis,” he said. “Not subjectively impaired at all, not impaired at all by any objective measure, but still positive.”

Still, Colorado and five other states have such laws on the books because pretty much everyone agrees that driving stoned can be dangerous, especially when combined with alcohol.

What police say they really need is a simple roadside sobriety test. Scientists at UCSD are among researchers working on several apps that could measure how impaired a driver is. One has a person follow a square moving around a tablet screen with a finger, which measures something called “critical tracking.” Another app measures time distortion, because things can slow way down when a person is high.

The THC route of metabolism is very different.

Thomas Marcotte

Those tests are still experimental.

Denver District Attorney Mitch Morrissey said the uncertainty doesn’t mean Colorado should throw out its THC blood test. He said it may not be perfect, but it gives juries another piece of evidence to consider at trial.

“I think that putting in a nanogram level makes sense,” said Morrissey. “I can’t tell you what level it should be. I don’t think Colorado’s is right. I don’t think it should be as high as it is. I think it should be lower.”

Morrissey remembers trying alcohol DUI cases as a young prosecutor. The science wasn’t settled then either, the blood alcohol standard was about twice as high as it is now, and it took years for it to be lowered.

“I think that has to do with better testing better technology,” which Morrissey said will improve eventually for marijuana too.

In the meantime, some regular marijuana users, like Abby McLean, are scared to drive for fear of failed blood tests.

“I haven’t gone out really since then, because I’m paranoid to run into the same surprise, ‘Oh oh, there’s a DUI checkpoint.'”

This story is part of a partnership that includes Colorado Public Radio, KPCC, NPR and Kaiser Health News.

Categories: Health Care

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