Medicare population has “among the highest and fastest-growing rates of diagnosed opioid use disorder.

The Obama Administration’s Final Say on Opioids

http://allianceforpatientaccess.org/the-obama-administrations-final-say-on-opioids/

CMS is suppose to be the entity with OVER-SIGHT of the quality of healthcare services provided to Medicare and Medicaid.  They are suppose to keep a Star Rating System over these providers…now they are expected to have some of the health care providers that they oversee – PHARMACISTS – to become stool pigeons … reporting to CMS …  CMS suggests that pharmacists should “identify prescribers with potentially illicit prescribing practices or beneficiaries (patients) who may be overusing opioids.”  So does this mean in CMS’s view point that there is no such thing as the under/untreatment of pain ?

This month’s change in presidential administrations prompted some final words – and policy – from federal agencies on the subject of opioids.

First, the Centers for Medicare and Medicaid Services issued a controversial Opioid Misuse Strategy.  Then, the Food and Drug Administration’s commissioner outlined a call for continued action on opioid abuse, including better options for pain management.  And now, patients wait to see whether these ideas will hold under the new administration, and how President Donald Trump’s policies will balance the needs of patients in pain against the epidemic of abuse and overdose.

Opioid Misuse Strategy

CMS issued its strategy on January 5, acknowledging that the Medicare population has “among the highest and fastest-growing rates of diagnosed opioid use disorder.”  Medicaid recipients exhibit an even higher incidence.

The document surveys current efforts to address the national opioid misuse epidemic, focusing on CMS’ four priority areas:

1) Implementing more effective person-centered and population-based strategies

2) Expanding naloxone use, distribution, and access, when clinically appropriate

3) Expanding screening, diagnosis, and treatment of opioid use disorders

4) Increasing the use of evidence-based practices for acute and chronic pain management.

Those ideas were largely overshadowed, however, by the document’s suggestion that pharmacists should serve as watchdogs for physicians and patients.  In a strategy characterized as “Big Brother” by the pain community, CMS suggests that pharmacists should “identify prescribers with potentially illicit prescribing practices or beneficiaries (patients) who may be overusing opioids.”  The document explains that, “This information can be referred to health plans to investigate provider and beneficiary behaviors…”

Bob Twillman, PhD, of the Academy of Integrative Pain Management speculated that the scheme would foster distrust between pharmacists and physicians, rather than encouraging cooperation to ensure patients’ safe and appropriate treatment.

Final Words from Commissioner Califf

Two weeks later, outgoing FDA Commissioner Robert Califf, MD, had some final words of his own regarding the opioid crisis.  In an FDA Voice post, Dr. Califf lists the ways opioid abuse has impacted communities across the country and pinpoints several effective responses, such as the approval of abuse-deterrent opioid formulations and better product labeling.

“Efforts in this area must be continued and strengthened,” Dr. Califf argues, calling for “better” and “more holistic” ways to treat pain. “We need…to define the most effective non-medication approaches to pain and how to deliver them in a complex and financially constrained healthcare system,” Dr. Califf notes.  He also calls for more research funding on the issue of treating pain.

Both Califf’s remarks and CMS’ strategy highlight the challenges that continue to surround pain treatment and addiction in the United States.  Will access to safe, personalized and multimodal treatment materialize under President Trump’s administration?  Patients wait to see.

An App That Makes It Easy to Pester Your Congress Member

An App That Makes It Easy to Pester Your Congress Member

https://www.wired.com/2014/05/countable/

Joe Trippi pioneered the use of social media as a fundraising tool. As campaign manager for Democratic presidential candidate Howard Dean in 2004, he started a trend that has reinvented that way politicians run for office. But he believes that many politicians are still missing out on the power of the internet once they’re elected.

“There’s been a lot of focus on winning campaigns, but there’s been less focus on governing,” Trippi says. “There are a lot of tools out there for campaigns to talk to voters, but not as many looking at how to give citizens and voters more impact on actual elected leaders in Congress.”

‘There’s been a lot of focus on winning campaigns, but there’s been less focus on governing.’

That’s why Trippi is working with an internet startup called Countable, which seeks to give citizens a greater voice in national politics. The company’s online service, which launches to the public today, gives you a simple and concise overview of the bills your national representatives are debating, and it lets you instantly send emails to these representatives, telling them how you would like them to vote.

Countable joins a growing wave of online tools that can improve the dialogue between citizens and representatives, including Madison, which lets you add your thoughts to both proposed bills and existing policies, and ThinkUp, a tool the White House uses to gauge popular sentiment through social media. The new service is most similar to Democracy OS, which lets governments and non-profits set up websites where people can discuss issues and vote on particular topics. But instead of building a platform that government operations must install on their own computer servers, Countable is offering a ready-made service.

In other words, you don’t have to wait for your representatives to adopt anything. All you have to do is sign up and start sending your thoughts to Congress.

 

countable-inline.jpg

Politics in Plain English

Countable was founded by Peter Arzhintar and Bart Myers. The pair previously founded the web TV company SideReel, which they sold in 2011. “We were talking about what to do next, and we’re both passionate about politics,” says Myers, who was also involved in the Dean campaign in 2004. “We were interested in what happened with campaign finance reform and SOPA, but we were disappointed with the tools that were out there to drive advocacy and let the average voter to get involved.”

They noticed that there were plenty of sites where you can find lists of bills being debated by Congress, but understanding those bills usually required quite a bit of specialized knowledge. They decided that one of the best ways to improve the political process would be to simply create a site that explained each bill that the House and Senate is voting on in plain English. So they built Countable.

For now, you need a Facebook account to use the new service. Countable taps your Facebook profile information to determine your name, location, and your national representatives. It then shows you the next piece of legislation your representatives are expected to vote on, with a short summary of the bill and a list of pros and cons. You can click “yea” or “nay” to automatically send an e-mail to your representatives, or you can “skip” it. You can also click on the bill’s name to pull up more details, including voting activity, costs, links to media coverage, and the full text of the bill.

Countable then keeps track of how your representatives vote on bills compared to the way you wanted them to vote, giving you a “compatibility ranking” for each one. But the company will also use this data to target adverting.

The startup just closed its seed funding round, and it’s now working on an iOS app, which Myers says should launch in about a month. So things are just getting started, and the company plans to add more tools to the service in the future, such as the ability to get voting recommendations from advocacy groups that you trust, ask your friends how you should vote, or suggest changes to a bill. It may eventually cover state level politics as well.

It’s All in the Details

One of the biggest challenges the company faces is providing enough information for citizens to develop informed opinions, without overwhelming them with details. “Fortunately, most pieces of legislation can be reasonably straight forward,” Myers says. “It’s when you get into complicated legislation with different political motivations associated with it that things get hard.”

For example, politicians often add amendments to bills that contain additional regulations or spending unrelated to the bill in question. Myers says that Countable will post updates to bills that have such riders. “Being able to call that out is actually a benefit in what we do,” he says.

The company is hiring writers from a variety of backgrounds, including politics and marketing, to ensure that the content is both accurate and understandable. Myers says the company strives to offer a balanced view of the pros and cons of each piece of legislation. “The editorial team represents multiple different political view points, but it will never be perfect,” he admits. To improve develop the editorial process, the company is also advised by former Reuters News publisher Andrew Goldner.

‘It’s hard not to worry about a company that is compiling dossiers on people’s positions on every single bill in Congress.’

The other issue is e-mailing your representatives may not be that effective. And since Countable doesn’t do much to verify that you are who you say you are, a lobbyist or advocacy group could sign-up for multiple accounts and make it look like constituents feel more strongly about an issue than they actually do. But Myers says this isn’t much an issue, at least for now. “When talking with representatives, it’s not a major concern,” Myers says. “You can already e-mail your representatives without verifying your identity.”

Instead, he says, representatives are just keen to find a way to gather data from constituents in a new way. “Most of them would still prefer to get feedback by phone,” he says. “But millennials can barely call their parents, let alone their representatives.”

But the biggest issue facing the company is privacy. It’s hard not to worry about a company that’s compiling dossiers on people’s positions on every single bill in Congress, but Myers says the startup won’t sell data about how its users vote on particular issues to fundraisers or anyone else. “We’re not building a lead-gen business,” Myers says. “Fortunately, our investors are in total agreement. But the terms of service are such that if that ever changes, people will be notified.”

Soda/Sugar: the NEXT CONTROLLED SUBSTANCE ?

By the Numbers: Americans’ Soda Habit Hard to Shake

http://www.medpagetoday.com/PublicHealthPolicy/by-the-numbers/62731?

About half of Americans drank at least one sugary beverage daily, accounting for one of every fifteen calories consumed each day, according to a study released by the National Center for Health Statistics on Thursday.

The study, based on federal survey data collected from 2011-2014, analyzed consumption of regular sodas, energy drinks, fruit drinks and coffee or tea products containing added sugars. The most recent official Dietary Guidelines for Americans, released a year ago, recommend choosing drinks without added sugars, such as unmanipulated fruit juices or even plain water.

Men consumed more calories through such drinks than women in all age groups, and in both sexes, consumption decreased with age.

 

There were significant differences in sugary drink use by race. Black and Hispanic men led all groups with 213 and 215 daily calories, respectively. On average, sugary drinks accounted for about 9% of daily calories in those two groups. For many that number is likely far higher — one quarter of males reported drinking two or more such drinks every day.

experts say money is still getting across the border in immense amounts

CBP vehicle inspections

More drug profits slipping into Mexico as border seizures plummet

http://tucson.com/news/local/border/more-drug-profits-slipping-into-mexico-as-border-seizures-plummet/article_4642d8bf-9bee-5e4e-906b-f2d24fb2eff8.html

Maybe if we decriminalized/legalized all drugs… all those profits and taxes could be kept in the USA.. We have abt a 60 BILLION trade deficit with Mexico and doubt if this “product trade” is counted in that total 

Claudia Zuniga Aguilar’s daughter needed braces, so she decided to smuggle drug profits into Mexico for a cartel.

The Chandler resident was caught with $9,998 in her purse and wallet as she drove through the Nogales port of entry on March 15, U.S. District Court records show.

Zuniga Aguilar, 45, told customs officers she picked up the cash from a man in a Costco parking lot in Mesa. She was supposed to deliver it to an ice cream shop in Sonora in exchange for the down payment on her daughter’s orthodontia.

 

The seized money was just below the $10,000 cash reporting requirement, a tool used by U.S. Customs and Border Protection officers to prevent illicit cash smuggling. But as Zuniga Aguilar’s case shows, CBP officers also can seize any amount of money if they believe it’s the result of illegal activity.

CBP officers have seized $45 million in illicit currency at Arizona ports of entry since fiscal year 2005 and $211 million borderwide, according to agency statistics obtained by the Arizona Daily Star through a records request.

Those statistics also show cash seizures plummeted at ports of entry in Arizona and along the rest of the border in recent years. The reason for the decline is unclear, but experts point to smugglers using prepaid bank cards, trade-based money laundering and other tactics to evade detection.

Seizures rose borderwide from $8 million in 2005 to a peak of $37 million in 2009, a year in which the Laredo Field Office in Texas saw 78 percent of total seizures, or $29 million. But since then, cash seizures spread out more evenly along the border and the overall amount of seized cash dropped to $7 million in 2016.

Arizona ports saw a similar rise and fall, with seizures ranging from $500,000 to $1.82 million between 2005 and 2008. The next year, seizures rose to nearly $5 million and then peaked at $12.1 million in 2011.

In 2016, customs officers at Arizona ports seized $960,000, a 92 percent drop from the peak in 2011.

But experts say money is still getting across the border in immense amounts.

“We’re certain it’s a billion-dollar industry, and millions of dollars are going across the border, all of the time, weekly, monthly, we know this money is getting across,” said Erica Curry, a spokeswoman for the Drug Enforcement Administration’s Phoenix Field Division.

Authorities have begun to figure out how to police for the standard method of bulk cash smuggling in vehicles or strapped to bodies, but new methods mean new challenges, said Christopher Wilson, deputy director of the Mexico Institute at the Woodrow Wilson International Center for Scholars, a nonpartisan research center.

“There are so many different mechanisms that can move money across the border that it’s just very difficult,” he said.

Estimates of drug sales vary wildly, with the Justice Department saying in 2009 that Mexican and Colombian cartels sell anywhere from $18 billion to $39 billion worth of drugs in North America each year.

Although seizures by U.S. authorities plunged in recent years, busts by Mexican military and police in northern Sonora continue to yield multimillion-dollar seizures.

Last January, Mexican federal police seized $1 million — or $40,000 more than CBP officers in Arizona seized in fiscal year 2016 — from a truck on the highway between Santa Ana and Altar, Sonora, about 60 miles south of the border.

Mexican authorities seized a total of $26.5 million in a string of three incidents from November 2014 to July 2015 at the Sonoyta port of entry, across the border from Lukeville, according to news releases from the Mexican military reported by Mexican media.

In one incident, $13 million was stashed in empty fruit boxes inside a truck headed to Guadalajara. In another, $11.5 million was hidden among a load of strawberries bound for Mexico City. In the third incident, $2 million was tucked under a false floor of a truck.

On the other side of the border, CBP seized $1.8 million at Arizona ports from October 2014 to September 2015 and $13 million borderwide.

Feeding the cycle

When Rigoberto Mondaca, 66, tried to sneak through the southbound inspections at the pedestrian gates of a Nogales port of entry in July, CBP officers found $12,230 strapped to his lower back and hidden inside his shoes.

Mondaca admitted to officers he was trying to smuggle drug profits into Mexico, court records show. He was unemployed and he was offered $20 for every $1,000 he successfully smuggled into Mexico.

In a separate case, DEA agents watched Reynaldo Zamora pick up a package from an unidentified man at the Roy Laos Transit Center in Tucson in January 2015. When he arrived at the Nogales port the next day, CBP and DEA agents were waiting for him.

Authorities seized $29,175 from Wells Fargo envelopes that were taped around his ankles and hidden under his socks.

Smugglers like Mondaca and Zamora fit the profile of “contractors” who are paid to do a job, rather than smugglers who are “deeply involved” in cartel operations, Wilson said.

The illicit nature of drug trafficking means it is a cash-based market, Wilson said. “And that cash income has to get back to the people who owned and sold the drugs.”

The low-level smugglers move the money across the border and into the hands of the drug cartel or criminal organization, where the money fuels the trafficking cycle by paying for salaries, new product and bribes, Wilson said.

And when the money returns to Mexico, it perpetuates the cycle of violence that surrounds drug trafficking, Curry said.

“Not only in the United States, and definitely in Mexico, any time you have money, any time you have profits being transported, or stashed, or stored in a location on its way to the grand profiteer, I think it creates a vulnerability along that path for theft, robbery, home invasion, for violent crimes like assault or murder,” she said.

But before the cash can get to the border, it often has to make it to cities in Arizona or another border state.

Follow the money

State and federal court records regularly include civil cash seizures, in which cash is seized but the person is not charged with a crime.

 
 

In a November 2015 incident, Arizona state troopers working on Interstate 10 in Cochise County pulled over two truckers from Miami and found $517,000 concealed in rolled-up tarps.

Two months earlier, DEA agents at the Tucson International Airport found $24,800 in the inner lining of a purse and a sunglass case carried by a woman flying from New York.

Inspectors at the U.S. Postal Service processing center in Phoenix found $20,900 inside a vacuum-sealed bag hidden in a Priority Mail Express package in January 2015. The man who sent the package had sent six other packages to the same address in the previous four months, court records show.

In May, Pima County sheriff’s deputies made a traffic stop on South Craycroft Road near East 22nd Street that netted a man who used various bank accounts to launder at least $90,000 in marijuana sale proceeds from the East Coast, court records show.

Deputies also seized $7,000 stashed in the pants of the man’s accomplice, along with three debit cards that were not in his name.

The use of various bank accounts, known as funnel accounts, is a common method of money laundering, according to the U.S. Department of the Treasury. With funnel accounts, drug proceeds are deposited at branches in various states and then withdrawn at a single location, usually in a border state. From there, the cash is smuggled across the border or used to buy goods that are resold in Mexico.

New methods

After the Mexican government restricted the deposit of U.S. dollars in Mexican banks and currency exchange houses in 2010, the U.S. Treasury Department warned that money launderers were using funnel accounts and trade-based money laundering to move money across the border.

And just as smugglers use varied techniques to move cash to the border region, experts say the drop in cash seizures at the border since 2009 could be the result of new ways of moving money across the border, such as prepaid bank cards.

“The debit card, the gift cards, that’s a fairly new method of laundering money, but the end result is the same,” Curry said. “Any means they can use to clean up the money — trade-based, funnel accounts, peso exchanges, any of those — they will use to clean up money.”

 

Although bank cards are a relatively new smuggling tool, customs officers are “avidly” looking for them, said CBP spokeswoman Teresa Small.

If officers suspect someone is trying to smuggle bank cards loaded up with illicit drug profits, they are legally able to search for the cards, she said.

inspection authority

“Our border search authority allows us to be able to inspect anything,” Small said.

Through interviews and inspections of wallets and baggage, “we’re able to get a good sense if someone is trying to evade the laws,” she said.

Trade-based money laundering is a bit more convoluted than most other methods, Wilson said.

“They buy something with that cash in the United States, a big piece of machinery, and then they sell it in Mexico,” Wilson said.

In those cases, legitimate companies might move the equipment across the border without realizing they’re involved in money laundering, he said.

Federal agents watched Dennis and Alfonso Brown Barrientos meet their father, Dennis Brown Lopez, in a Walmart parking in June 2015.

The brothers’ frequent border crossings through Douglas had tipped Homeland Security agents to possible smuggling activity.

The agents watched the brothers remove the rear panels of their father’s truck and stuff bundles of cash into the compartment. The brothers later told authorities a man in Tucson gave them a bag with the cash, as well as water and candy, earlier that day.

When they arrived at the port of entry an hour after leaving the Walmart parking lot, CBP officers searched their vehicles and recovered $99,990, court records show.

The brothers began smuggling currency five months earlier, usually $3,000 to $5,000 each time. After a few successes, they started smuggling $100,000 per trip. Alfonso said he was paid between $200 and $1,000 for each trip.

Using intelligence, such as red flags raised by license plates, is the best way to stop cash smuggling, Wilson said.

“You can’t put a dent in this issue by sort of just in broad strokes trying to increase border security,” Wilson said. “It needs to be much more targeted than that, and to be more targeted we need better intelligence generation, better intelligence collection and processing.”

Increasing random trunk searches would place a strain on legitimate southbound traffic and commerce, Wilson said, noting ports of entry were designed primarily for inspections of northbound traffic, rather than traffic into Mexico.

Dogs frequently are used to catch drug and people smugglers at ports of entry, and CBP also uses dogs “as needed” to bust cash smugglers, Small said. But in most cases, officers’ training is enough to find hidden cash.

After catching a smuggler, one of the most difficult tasks can be making criminal charges stick, Curry said. “It’s not illegal to sell a car; it is not illegal to buy a car,” she said. “We have to prove that the money they’re using came from the illegitimate sale of narcotics in the United States.”

Another challenge is the international scope of the crimes, Curry said.

“The DEA can’t just reach into Mexico and begin investigating organizations in Mexico,” Curry said.

As long as trafficking organizations are based in Mexico, she said, “we really have to rely on cross-border cooperation to stem the flow of drugs and money.”

 

Julianne Stanford is a journalism student at the University of Arizona who was an apprentice at the Star. Star reporter Curt Prendergast contributed to this report. Contact him at cprendergast@tucson.com or 573-4224.

Selling something that gets you high isn’t necessarily illegal

Synthetic drugs make sentencing troublesome for courts, prosecutors

http://www.chicagolawbulletin.com/Articles/2017/01/26/Synthetic-drugs-sentence-1-26-17.aspx

The men who sold it called it Mr. Miyagi, a mind-altering chemical compound mixed with vegetable material and resembling marijuana.It was clear the drug was meant to be smoked for a potent high, notwithstanding the deceptive label that the product was potpourri not fit for human consumption. But less clear was how to punish the people who pushed it.

As drug enforcement authorities sound alarms over the effects and accessibility of synthetic drugs, the Mr. Miyagi case in Louisiana is but one example of how courts are struggling for consistency in dealing with substances that are developing faster than the laws to govern them.

The result is a sentencing process that’s often bogged down by complex science and can yield uneven results in courtrooms around the country.

“It’s been a challenge for the courts and for the regulatory agencies to manage and make appropriate, logical decisions relating to these new substances,” said Greg Dudley, a West Virginia University chemistry professor who has testified in synthetic drug cases.

“If they’re interpreted differently in different courts, you end up with broad disparities in sentencing for similar offenses.”

Now the federal panel that sets sentencing policy is studying ways for courts to better handle cases involving drugs such as “bath salts,” which can provoke violent outbursts, and the party drug Molly.

The issue matters, given the sustained popularity of synthetic drugs — man-made compounds that mimic more conventional street drugs and hallucinogens and are sold under catchy names in stores and on the internet.

Drug Enforcement Administration officials have repeatedly warned about the products’ harmful effects but say it’s hard to police them.

Those who make synthetic drugs can alter their chemical makeup faster than regulators can ban them, and those who sell them can skirt the law through misleading labeling.

Meanwhile, the DEA’s forensic testing laboratories are “overwhelmed with the amount of substances” they’re trying to identify and analyze, said spokesman Russ Baer.

Amid concerns about consistency in punishment, the U.S. Sentencing Commission is doing a two-year study on synthetic drugs that, among other things, will look at whether to update the drug quantity table that federal judges rely on at sentencing.

Judges use the table to come up with the starting point for the sentence based on the amount of drugs involved, then factor in considerations like a defendant’s criminal history and level of responsibility. That’s easy for drugs like marijuana, cocaine and heroin that are listed on the table.

Problem is, “bath salts” and similar synthetic or designer drugs aren’t included.

In prosecutions involving those drugs, judges consult the table to find the most similar drug to the one in their case, based on chemical makeup and pharmacological effects. They then convert the drug quantity in their case to the equivalent quantity of marijuana to calculate a base offense level. But that often causes confusion.

Selling something that gets you high isn’t necessarily illegal “unless it’s kind of like something on the list,” said Lloyd Snook, a Virginia defense lawyer.

“Well, how kind of alike does it have to be? Who knows?” Snook said.

The commission says it’s heard complaints about days-long hearings with dueling chemistry experts, disagreements about which drug is most analogous and varied sentences in similar cases.

The Mr. Miyagi case, for instance, turned on a dispute over which drug was most similar to the product the defendants’ sold — pure THC, marijuana’s principal ingredient, or marijuana itself.

A federal appeals court sided with the government’s conclusion that it was most like THC. Since sentencing guidelines treat one gram of THC as equivalent to 167 grams of marijuana, the defendants, Thomas William Malone and Drew T. Green, were held responsible for 233,800 kilograms of marijuana and given long prison sentences. Each was sentenced to nearly 10 years in prison.

The defendants had argued it was most like marijuana and that a 1:1 ratio was appropriate, an assertion that if accepted would have resulted in lighter punishments.

But, in an example of the disparate outcomes the guidelines sometimes yield, the ringleader in the case, sentenced in Florida, received only probation. And another man who worked with Malone and was charged in a similar case was allowed to avoid a conviction in New York by entering a diversion program, a supervised remedial plan for petty offenders.

“You just have a nightmare situation that cannot be explained to a defendant because it makes no sense,” said Malone’s attorney, Steven Sadow. “He’s at the mercy of what the judge chooses to do with the ratio and how the judge treats certain people.”

Some judges have openly struggled with formulas. In Florida, U.S. District Judge Donald Middlebrooks said he found no scientific basis for the standard marijuana-to-THC ratio and rejected it in a case involving a designer drug known as XLR-11.

“Although I asked each of the experts at the hearing, no one could provide me with a reason for this ratio, which has major implications in determining the base level offense,” Middlebrooks wrote. “After my own research and a phone call to the Sentencing Commission, I still could find no basis for this ratio.”

Snook, the lawyer, said he was glad the commission was studying the problem but thought Congress might need to get involved.

“There are a lot of reasons why it’s an arbitrary and capricious system and why it ought to get changed,” he said.

FDA, has yet to inspect nearly 1,300 drug manufacturing facilities, mostly based abroad, that are supplying the U.S.

More than 1000 drug plants never inspected

http://cen.acs.org/articles/95/i5/1000-drug-plants-never-inspected.html

In a recent audit of FDA, the Government Accountability Office found that the agency has yet to inspect nearly 1,300 drug manufacturing facilities, mostly based abroad, that are supplying the U.S.

China, the world’s largest manufacturer of active pharmaceutical ingredients, is also the country with the largest number of drug plants that FDA never visited, the audit reports. According to GAO, 243 of the 535 pharmaceutical facilities in China that export to the U.S. (45%) have yet to be inspected.

In India, a major exporter of formulated generic drugs, 33% of the nearly 600 pharmaceutical plants supplying the U.S. have not been visited. And in South Korea, 90% of 171 facilities have yet to be inspected.

GAO does note that FDA inspects more plants abroad than it used to. In 2010, FDA had sent inspectors to only one-third of the drug plants supplying the U.S.; the proportion is now two-thirds. Recently opened FDA stations in foreign countries are increasing the safety of the U.S. drug supply, GAO observes.

GAO does not discuss in detail the risk posed by uninspected facilities. But the agency notes FDA uses a risk-based approach to prioritize which plants, whether in the U.S. or abroad, most urgently need to be inspected.

The public health threat is hard to estimate, but it is likely minimal, says Peter Saxon, president of Saxon International Associates, a New Jersey-based consulting firm that advises foreign drug producers on U.S. drug manufacturing regulations. If FDA has not already inspected the plants, then the facilities likely produce over-the-counter medications, he says.

“There is a risk that the OTC drugs will not work. But if they are adequately tested when they arrive in the U.S., then the risk is low,” Saxon says.

FDA hopes to complete inspecting all drug manufacturing facilities that supply the U.S. in the next three years, GAO notes. But this objective won’t be reached unless the hiring freeze recently instituted by President Donald J. Trump is lifted, Saxon says. Several FDA offices are currently understaffed, he notes.

A Local Pharmacy Lawsuit Stirs up Community Controversy

A Local Pharmacy Lawsuit Stirs up Community Controversy

http://www.wearewvproud.com/story/34347849/a-local-pharmacy-lawsuit-stirs-up-community-controversy

Attorney General Patrick Morrisey has recently filed a lawsuit against several pharmacies in West Virginia for over supplying prescriptions….. but tonight that lawsuit is seeing community backlash.

Community members are in shock after Attorney General, Patrick Morrisey, filed a lawsuit alleging Crab Orchard Pharmacy over prescribed prescription drugs. “It really disturbed me, the information when I started looking at it, it just didn’t add up with the kind of people that they are,” said a Raleigh County Community Member, David Chada.

Chada filled his prescriptions at Crab Orchard Pharmacy for years and said Morrisey’s lawsuit is something he believes is false. “I figured out it just doesn’t match up, I figured I have to find out how much is too much,” said Chada.

Chada turned to the internet to do his own research and from there his finding makes him believe maybe Morrisey made a mistake. “I thought there should be something out there if these people are really that bad and this just seems really odd,” said Chada.

Chada took it upon himself to write a letter to Attorney General, Patrick Morrisey, explaining he doesn’t think his accusations against the pharmacy add up. “The WV Board of Pharmacy regularly reviews with respect to dispensing narcotics and if Crab Orchard had been dispensing for years, there would have been some prior documentation of questionable activities,” said Chada.

In response Curtis M. Johnson with the Attorney Generals office stated, “our office has a phenomenal track record with regards to its consumer protection filings. We seek to fairly enforce the statute as no one is immune from complying with state law. Our complaint speaks for itself as to the specific allegations. We look forward to the discovery process.”

 

 

 

Two Iowa Lawmakers Launch Crusade Against Opioid Epidemic

Two Iowa Lawmakers Launch Crusade Against Opioid Epidemic

whotv.com/2017/01/25/two-iowa-lawmakers-launch-crusade-against-opioid-epidemic/

95% FAIL ADDICTION RECOVERY… because our Surgeon General has stated that addiction is a “brain disease” and generally… you cannot CURE a brain disease…you can only TREAT/MANAGE a brain disease.

DES MOINES, Iowa  —  A pair of Iowa House Democrats say colleagues aren’t taking the opioid addicition seriously enough, so they are going to do something about it.

Democrats Chuck Isenhart and Timi Brown-Powers say they were assigned to a bipartisan subcommittee that was supposed to meet before the session to draw up legislation to combat opioid addiction.  However they say the other members never called for a meeting and no work was actually accomplished.

Now they are taking it on themselves to do something about it.  On Wednesday the two lawmakers held a press conference to discuss the seriousness of the issue and to lay the groundwork for some of what can be done about it.

They were joined by Cedar Rapids Police officer Al Fear who is part of a special eastern Iowa anti-heroin task force.  Fear says the number of deaths from opioids and heroin continues to climb steadily while the number of hospitalizations for overdoses has doubled in the last year.

He describes the nationwide epidemic as a storm that is moving from the East coast to the West Coast.  Right now he says the eye of the storm is over Ohio and the outskirts of the storm are just touching eastern Iowa.

He warns that opioids and heroin are not discriminating drugs.  They will consume white and black, rich and poor.  The time for action, he says, is now.

Amongst the things he would like to see lawmakers act on this session are:

  • increased funding for treatment centers
  • more treatment beds statewide; most facilities are full with 30 day waiting periods
  • an emphasis on addiction education in school
  • make anti-withdrawal drugs covered by insurance; $5 could treat a patient for a month

Fear thanked the legislature for approving the anti-overdose drug “Narcan.”  He says it is already saving the lives of addicts in the state of Iowa.

 

Pain Expert: ‘I Haven’t Prescribed an Opioid in a Decade’.. VIDEO ON LINK

Pain Expert: ‘I Haven’t Prescribed an Opioid in a Decade’

Daniel Clauw, MD, states the case for avoiding opioids in chronic pain

http://www.medpagetoday.com/PainManagement/PainManagement/62730?

Daniel Clauw, MD, is professor of medicine, anesthesia, and psychiatry at the University of Michigan and director of the Chronic Pain and Fatigue Research Center. In this era of increasing opioid abuse and overdoses, and harsh criticism for physicians’ use of opioids in the setting of chronic pain, he shared his (not at all subtle) opinion in a “Doc to Doc” conversation with me.

Despite treating patients with a range of chronic pain issues, from fibromyalgia to interstitial cystitis to low back pain, Clauw says, “I haven’t prescribed an opioid for chronic pain in at least a decade.” With that phrase, he has thrown down the gauntlet to other docs who feel that opioids are an acceptable, if lamentable, option for chronic pain treatment. Indeed, Clauw feels that doctors jump too quickly to opioids when patients might be better managed with tricyclics, gabapentinoids, or even complementary and alternative therapies.

Are docs responsible for the opioid epidemic? Clauw states that we have certainly played a role. He calls out surgeons and dentists who prescribe 30 days (or more) of opioids routinely postoperatively. Surgeons “give these large prescriptions of opioids because they don’t want to be called back for pain … I get that that makes your job easier.”

Whether you find his viewpoint insightful or woefully unrealistic, his advice may very well stick with you. Watch the video to hear all of his observations.

F. Perry Wilson, MD, MSCE, is an assistant professor of medicine at the Yale School of Medicine. He earned his BA from Harvard University, graduating with honors with a degree in biochemistry. He then attended Columbia College of Physicians and Surgeons in New York City. From there he moved to Philadelphia to complete his internal medicine residency and nephrology fellowship at the Hospital of the University of Pennsylvania. During his post graduate years, he also obtained a Master of Science in Clinical Epidemiology from the University of Pennsylvania. He is an accomplished author of many scientific articles and holds several NIH grants. He is a MedPage Today reviewer, and in addition to his video analyses, he authors a blog, The Methods Man. You can follow @methodsmanmd on Twitter.

 

Newspapers don’t usually report on suicide cases for fear of copycats.

Woman’s online journal of disorder paves way for new medical courses

http://www.kpaddock.org/

 

Apparently most newspaper editors are totally disconnected from the fact that the USA has 40,000 – 50,000 suicide every year and ONE MILLION ATTEMPTS.

Robert Paddock is a quiet man with a single mission in life – to tell the story of his late wife’s struggle with chronic pain and raise awareness of her illness.

He also wants people to know her suicide wasn’t meaningless. That she lives on.

Robert describes Karen as his “best friend,” and was devastated when she ultimately lost her battle with her daily, debilitating headaches and committed suicide on Aug. 7, 2013.

When Robert approached the newspaper, he wanted someone to write about his wife’s suicide. An editor explained to him that newspapers don’t usually report on suicide cases for fear of copycats. But Robert was humbly insistent.

“Her case is something different,” Robert said.

And it was.

“My name is Karen Shettler Paddock. I am dead. I committed suicide on August 7, 2013, as I could no longer stand the excruciating headache caused by a Intracranial Hypotension, more commonly known as a Cerebrospinal Fluid (CSF) Leaks. A condition that is more common that many think (for example Actor George Clooney had a CSF Leak and considered suicide), yet is so unknown that some doctors argue the condition does not even exist,” reads the opening page of Karen’s online journal.

Robert has made it his personal mission to help others by maintaining Karen’s online journal. Karen wrote for more than 20 years about her life with chronic, debilitating headaches and struggle to find a diagnosis. Her illness became so severe that she saw no other way to relieve her pain than to take her own life.

Yet out of this tragedy, some hope has arisen.

Instructors at the Duke University of Medicine are using Karen’s journal, found at http://www.kpaddock.com, as a case-study to teach students how to recognize the symptoms of a Cerebrospinal Fluid (CSF) Leak, the rare disease that Karen suffered from.

Karen’s journal has also inspired those suffering with chronic pain across the globe. Many people have already personally reached out to Robert to know that Karen’s story has helped them – some were considering suicide and sought treatment after reading Karen’s journal. Others were able to recognize their symptoms and get tested for a CSF Leak after hearing about her struggles.

Karen’s first-hand account of her illness gave an honest, heart-wrenching depiction of what it is like to live with debilitating pain day-to-day.

One of the most baffling symptoms of her illness is that Karen’s headaches would go away when she was lying down, only to return when she stood up for any length of time.

“CSF is a very misunderstood condition because when you’re lying down you feel better. When you wake up in the morning your brain is full of fluid and your muscles are relaxed which plugs the leaks,” Robert said.

“You want to get up and get on with your life. But a few hours later, this debilitating headache comes back. Because of this, it’s sometimes called an ‘afternoon headache’,” he added.

Karen felt that many of her friends and family did not understand her condition, and it lead to her feeling extremely isolated from everyone but her husband and beloved dogs.

“People that have not experienced severe unrelenting pain for months or years expect you to suck it up and continue your normal daily activities. Chronic pain makes you feel alone. Like no one understands how much pain you are in,” wrote Karen Paddock in her online journal.

Karen went from doctor to doctor seeking a diagnosis for her symptoms and for years heard that she was healthy and only seeking attention.

“Many of those doctors told her that ‘it was all in her head’ or that she was making up her symptoms to get attention,” Robert said.

Yet her headaches continued.

Karen saw more than 35 different doctors who were unable to give her a proper diagnosis or provide relief from the pain she experienced.

“My depression is from the pain I feel, too. I think sometimes, that if we do not fit the typical symptoms that doctors learned about in medical school, that they blame our problems on us. Like they think it is all our fault,” Karen wrote.

In her frustration, Karen began researching on her own.

“She became a huge supporter of the Franklin Library. As far as book-based learning goes, she could have gotten a doctorate in her condition,” Robert said.

Eventually, Karen’s contact with the outside world became extremely limited. In addition to Robert and her pets, Karen tried to interact online a few hours a day with others who suffered with chronic pain. When building Karen’s website, Robert poured through emails and more than 9,437 Facebook private messages to compile a 20-year medical history of Karen’s struggles with her CSF Leak.

Eventually, a specialist in Pittsburgh was able to give Karen a proper diagnosis. But her body ultimately rejected the spinal patches that were supposed to provide her with relief. Only four doctors in the world specialize in treating CSF Leak, and Robert believes we don’t know enough about the illness to properly treat it long-term.

“Research into such leaks is only about 10 years old We just don’t know enough on how to treat CSF Leak without causing rebound pressure issues that cause the exact same excruciating headaches,” Robert said.

In an effort to learn more, Robert is trying to set up a $750,000 Fellowship program at Duke to train more doctors and fund better research equipment that will locate CSF Leaks sooner. Those who would like to donate can do so through http://www.kpaddock.com

When asked how he dealt with Karen’s death, Robert turns the conversation back to Karen’s story. His ultimate goal is that her story be told and help others.

On her last day, Karen wasn’t just having a headache. Her symptoms included issues with her vision, nausea, dizziness and hearing. She spoke to her next-door neighbor earlier in the day, and he said that she appeared fine. Robert says that chronic pain sufferers often learn to mask their pain so well that they will continue smiling on the outside, even though they feel horrendous inside.

Robert still misses Karen every day. She was the love of his life, and his constant companion. Without her, he says he feels an ache in his heart that will never go away.

He is determined not to let others take the path that Karen chose to take.

“I tell them not to do this, that if we don’t raise awareness of their illness and pain no one will ever know when they need help,” Robert said.