What part of our corrupt Washington DC system are we have trouble understanding ?

When does “extremely careless ” crosses the line into intentional deceitful behavior ?

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DEA takes Utah to federal court for access to prescription drug database

http://fox13now.com/2016/07/06/dea-takes-utah-to-federal-court-for-access-to-prescription-drug-database/

The question that has to be asked is why isn’t the OFFICE OF CIVIL RIGHTS… which is part of the Dept of Education.. not defending HIPAA when the DEA is out to violate PHI (Personal Health Information) of Utah’s Prescription Monitoring Program ? Could it be.. as some has suggested that the whole Washington DC system is CORRUPT ?

SALT LAKE CITY — The Drug Enforcement Administration is asking a federal judge to enforce subpoenas served on Utah’s Department of Commerce seeking access to the state’s prescription drug database.

In court papers obtained by FOX 13, it appears the state of Utah is resisting the DEA’s attempts.

The DEA revealed in a declaration it is investigating a “licensed medical professional” in the Salt Lake City area. The court filings do not reveal who is under investigation, but the federal agency claims that person has been prescribing a lot of pills to people who turn around and sell them. The DEA claims those people are members of a “criminal organization” with overseas ties.

As part of its investigation into that physician, the DEA served administrative subpoenas on Utah’s Department of Commerce and the Utah Division of Professional Licensing for access to the controlled substance database. The state of Utah has apparently refused to grant federal agents access.

Utah Department of Commerce Executive Director Francine Giani declined to comment to FOX 13 on the subpoenas, referring the matter to the Utah Attorney General’s Office. It also declined to comment, but is expected to reply in court filings by next month.

Access to the controlled substance database recently required a warrant after state lawmakers changed the rules. It followed an incident where Unified Fire Authority firefighters found their records accessed by police looking into missing medications.

Greg Skordas, a criminal defense attorney who represented an accused firefighter in that case, said the problem with the DEA request is it involves more than the specific doctor — it would drag in patients, too.

“Administrative subpoenas are issued based on a very low standard. They’re really just investigative,” he said. “Whereas a warrant requires a higher level of what we call probable cause. You have to go to a judge and say, ‘I have probable cause to believe the information is where I’m looking,’ where an investigative subpoena you go to a judge and say, ‘I’m curious.'”

Skordas said the DEA has tried this same tactic in other states, and said the battle between subpoena and warrant may go beyond federal court in Salt Lake City to appellate level courts to weigh in.

“It’s all going to come to a head probably with the United States Supreme Court or with the circuit courts,” he said.

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17 Heroin Overdoses, 1 Death: Could Happen Anywhere Says DEA Agent

detroit.cbslocal.com/2016/07/06/17-heroin-overdoes-1-death-could-happen-anywhere-says-dea-agent/

THREE TIMES  the Heroin user in abt 10 yrs and FIVE TIMES the Heroin related deaths in abt 15 yrs.  Wonder why that is.. the DEA is not doing their job of preventing drugs from crossing the boarder ? Heroin is now the least expensive opiates ? All too many chronic pain pts have been denied their needed pain medication by prescriber and has turned to “the street” in an effort to help address their unrelenting pain. Remember the chemical name of Heroin is ACETYLMORPHINE… which metabolizes into MORPHINE in the body… it is about 2-3 times mg/mg stronger than Morphine. Still FRACTION OF  PEOPLE die every year from opiate overdoses than die from the use/abuse of the drug drugs ALCOHOL & NICOTINE !

The city of Akron, Ohio, is reeling with a rash of heroin overdoses within a 24-hour span.

Special Agent Rich Issacson with the DEA’s Detroit field division isn’t surprised.

“It’s a huge problem in Akron, Ohio but it’s also a huge problem across the United States,” said Issacson. “There is not a community in southeast Michigan that hasn’t been hit hard by the opiate abuse problems, that’s including pain killers, like hydrcodone and oxycodone products as well as heroin.”

Issacson says word of the deaths probably won’t scare a lot of people into rehab.

“On occasion when there’s talk of heroin overdose deaths – or a series of heroin overdose deaths; sometimes as counter-intuitive as it sounds – that actually sounds attractive to a heroin addict because they know that if that heroin caused the death of another user, that must have been pretty strong heroin,” Issacson said.

Police in Ohio say the calls began around 1 p.m. and continued through the afternoon and evening and three of the victims include a mother and her two daughters.

The Summit County Medical Examiner’s Office says a 44-year-old man died of a suspected overdose and an autopsy is set for Wednesday.

Edwards says 55 people have died from heroin overdoses in the city this year.

Heroin use has reached the highest level in 20 years in the United States, according to a recent global drug report that calls the trend “alarming.”

The UN Office on Drugs and Crime released its World Drug Report last month, which said heroin is the deadliest drug worldwide, and said its increasing use in the U.S. is of particular concern.

There were about one million heroin users in the U.S. as of 2014, almost three times the number in 2003. Deaths related to heroin use have increased five-fold since 2000.

There are an estimated one million heroin users in the U.S. as of 2014 … three times the number of a decade before.

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https://www.washingtonpost.com/national/health-science/pfizer-agrees-to-truth-in-opioid-marketing/2016/07/05/784223cc-42c6-11e6-88d0-6adee48be8bc_story.html

This is just a slippery slope for everyone.. the judicial system has gotten Pfizer to admit that they are against off-label use… which it is estimated that 1:5 outpatient Rxs are written for off-label.  Yet one of Pfizer’s products  (methylprednisolone)  is routinely use in off-label Epidural Spinal Injections. What happens if insurance companies start refusing to pay for any Rxs that are prescribed off-label ?

The reason that there is no studies on the long term use of opiates is that opiates were commercially available before the FDA and all their need for clinical trials and they were “grandfathered” as a FDA approved medication. Since no manufacturer would be granted a patent – and high price – on a opiate… no one was going to invest the money to prove the long term use/benefit. anecdotal evidence based on pt feedback, does not meet the FDA’s criteria for double blind studies.  Thus there is no “studies” that prove that opiates are beneficial for the long term treatment of pain.

http://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know

More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

https://www.pennlawreview.com/debates/index.php?id=50

Off-label promotion�pharmaceutical manufacturers� marketing of FDA-approved drugs for unapproved uses�is considered a First Amendment right by some, a threat to the safety and effectiveness of pharmaceutical drugs by others.

Pfizer, the world’s second- ­largest drug company, has agreed to a written code of conduct for the marketing of opioids that some officials hope will set a standard for manufacturers of narcotics and help curb the use of the addictive painkillers.

Though Pfizer does not sell many opioids compared with other industry leaders, its action sets it apart from companies that have been accused of fueling an epidemic of opioid misuse through aggressive marketing of their products.

Pfizer has agreed to disclose in its promotional material that narcotic painkillers carry serious risk of addiction — even when used properly — and promised not to promote opioids for unapproved, “off-label” uses such as long-term back pain. The company also will acknowledge there is no good research on opioids’ effectiveness beyond 12 weeks.

The terms of the agreement were reached with the city of Chicago, which two years ago sued five other opioid manufacturers over alleged misleading marketing of opioids. An announcement of the agreement is expected Wednesday. Pfizer has also been aiding the city’s investigation and lawsuit.

Stephen R. Patton, Chicago’s corporation counsel, called Pfizer “a company that has agreed to embrace what we think are the common-sense proscriptions that we are seeking as part of our lawsuit. We hope that this trailblazing agreement . . . will set the bar for others in this industry.”

But Adriane Fugh-Berman, an associate professor of pharmacology and physiology at Georgetown University School of Medicine, and director of Pharmed Out, which advocates rational prescribing practices, said she saw limited value in the agreement.

“Maybe it’s a first step, but I think counting on pharmaceutical companies to get us out of this opioid mess is not likely to be successful,” she said.

Aggressive, sometimes fraudulent marketing of OxyContin by Purdue Pharma, one of the targets of Chicago’s lawsuit, is widely blamed for the rapid growth of painkiller use across the United States. Around the turn of the century, the company mounted an aggressive campaign, initially claiming that the long-acting formulation reduced the risk of abuse and addiction.

The company swarmed primary care physicians, who had little expertise in pain management, in their offices and at ­company-sponsored conferences, at a time when the medical profession was concerned that it was not treating pain aggressively enough. Subsequent research has shown that the effort helped achieve stunning growth in the use of the painkiller, which was developed for severe pain after surgery and end-of-life care.

In 2007, Purdue pleaded guilty to criminal charges of misleading physicians, regulators and the public about the drug’s addictive qualities.

In its lawsuit, Chicago contends that in 2009, about 1,100 emergency room visits were the result of opioid misuse or overdose. The city also said it paid out $12.3 million in insurance claims for painkiller prescriptions between 2008 and 2015.

This year, the federal government has redoubled its efforts to address the crisis. The CDC released new guidelines that call on doctors to sharply curtail the use of narcotic painkillers. The Food and Drug Administration required that its strongest warning on immediate-release opioids include information about misuse, abuse, addiction, overdose, death and risk of neonatal withdrawal syndrome. The House and Senate each have approved bills that address the drug crisis.

Other cities and states, including Santa Clara and Orange counties in California and the state of West Virginia, have also sued pharmaceutical manufacturers and distributors for stoking the opiate epidemic.

New York City-based Pfizer actively promotes only one opioid painkiller, Embeda, which it acquired when it bought King Pharmaceuticals in 2011. A spokeswoman said she had no separate total for its sales, but a first- ­quarter report for 2016 shows that it is part of an “other” category of drugs that brought in $171 million worldwide.

Purdue’s blockbuster OxyContin, by contrast, produced $3.1 billion in revenue in 2010. So many opioids are sold, however, that the drug has never made up a large share of the opioid analgesic market. Last year it accounted for just 2 percent of the market, according to the company.

Pharmaceutical and biotechnology companies adhere to voluntary standards last updated in 2009 by their trade association, the Pharmaceutical Research and Manufacturers of America.

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State Legal Restrictions and Prescription- Opioid Use among Disabled Adults

CONCLUSIONS
Adoption of controlled-substance laws was not associated with reductions in potentially hazardous use of opioids or overdose among disabled Medicare beneficiaries, a population particularly at risk. (Funded by the National Institute on Aging and others.)

The New England Journal of Medicine

nejmsa1514387

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Chronic fatigue syndrome is in your gut, not your head

https://www.sciencedaily.com/releases/2016/06/160627160939.htm

Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn’t alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.

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Drug Used for Pain, Anxiety May Be Linked to Birth Defects

http://www.painmedicinenews.com/Clinical-Pain-Medicine/Article/07-16/Drug-Used-for-Pain-Anxiety-May-Be-Linked-to-Birth-Defects/36827/ses=ogst

The drug pregabalin (Lyrica, Pfizer), commonly used to treat pain, epilepsy, anxiety and other brain health disorders, may be associated with an increased risk for major birth defects (Neurology 2016 May 18. [Epub ahead of print]).

Pregabalin is approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy and pain after shingles or spinal cord injury. It also is used off-label for generalized anxiety disorder and other mental health issues.

Pregnancies of the women who took pregabalin during the first trimester were three times more likely to result in major birth defects than those of the women who did not take antiseizure drugs. Seven of the 116 pregnancies in women taking antiseizure drugs (6%) had major birth defects, compared with 12 of 580 pregnancies (2%) in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.

The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the CNS than the women who were not taking the drug, with four CNS defects out of 125 pregnancies (3.2%) compared with three CNS defects out of 570 pregnancies (0.5%).

“Pregabalin should be prescribed for women of childbearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital, in Switzerland.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain; 39 for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis; five for epilepsy; and one was taking it for restless legs syndrome.

A total of 77% of the women started taking pregabalin before they became pregnant. The women in the study stopped taking the drug at an average of six weeks into their pregnancies. Of the women taking pregabalin, 22 (13%) also were taking another antiseizure drug.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects, and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” Dr. Winterfeld said.

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Click on image to enlarge…

These is two letters that I received today as email attachments about forged Rxs floating around Kentucky. Notice that both letters remind Pharmacists to get ID’s on all controlled Rxs.  Just read all the illegal things that these people did.. from stealing Rx pads, putting phone numbers on the Rx blanks that are not the doc’s number… and on .. and on… but make sure that you get a ID.. what do you think the chances are that their Driver’s license or other ID’s ARE VALID ?  Are they in a state of denial… or just totally CLUELESS ?

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Filling a prescription? You might be better off paying cash

http://www.cnn.com/2016/06/23/health/prescription-drug-prices-pbm/

The Health insurance industry seems to playing the same game that house/car insurance companies use.. if you use your insurance.. they raise the price.. but.. unlike the situation with your car/house … they raise your premiums when you have a claim… it now appears that the health insurance companies are charging the pt a fixed copay.. even if the cost of the medication is less – sometimes substantially less  than the copay and the insurance then pockets the difference.  It is sort of like a SURCHARGE for using your prescription insurance.  It would also seem that Pharmacies/Pharmacists are contractually prohibited from telling the pt that they are being overcharged .. with the threat of being thrown out of the network..  Sounds like something you would hear from “THE GODFATHER” movie ? The patient is not prohibited from asking to pay cash for their Rxs.. if the cash price is less than the copay you would have otherwise been charged… To protect yourself… there are websites like www.goodrx.com that will give you the price at specific pharmacies in your area for your prescription.

“In some cases, consumers are blaming high drug prices on manufacturers, but really the cause of their costs may be the insurance company or the pharmacy or the pharmacy benefit manager,” said Adam J. Fein, who follows the drug industry for management advisory firm Pembroke Consulting in Philadelphia. “It’s very hard to figure this information out.”

A Bewildering Array Of Factors

How much consumers pay at the pharmacy counter depends on a bewildering array of factors, including health insurance policies that set copayments and deductibles, the pharmacies they choose, and which behind-the-scenes PBM their employer or insurer hires to manage claims and negotiate prices with pharmacies and drug makers.

The back-and-forth between pharmacists and PBMs is part of a long-running feud between the two groups. Not every PBM negotiates prices that allow for these overpayments, the pharmacists say, and not all drugs are affected.

Still, here’s how pharmacists say consumers are getting squeezed. At the pharmacy counter, patients pay their share of the cost — the copay — as set by their PBM and insurance plan.

 

Days or weeks later, the PBM firm takes back a portion of that patient payment from the pharmacy after the PBM determines what it will actually pay for the drug — a practice sometimes called a “clawback.” That money does not go to the consumer, but is generally kept by the PBM.

“It’s a fraudulent misrepresentation to the patient of what is the cost of the drug,” said Susan Hayes, principal with Pharmacy Outcomes Specialists, which audits pharmacy programs on behalf of insurers.

In a survey by the National Community Pharmacists Association taken in early June, members provided examples. None of the pharmacists would talk on the record for fear of being kicked out of the PBM networks, so their responses could not be independently verified.

One told surveyors that a major PBM required the pharmacy to collect a $35 copay for a generic allergy spray, then took $30 back from the pharmacy. Another said a PBM charged a $15 copay for insomnia drug Zolpidem, then took back $13.05. Patients were charged $30 above the cash price for a generic cholesterol medication at another pharmacy.

In effect, the customer has paid more for the drug than the PBM ultimately pays even though “they assume what they are paying is the cost of the drug,” said Susan Pilch, vice president for policy and regulatory affairs with the pharmacists’ group.

In response, the CEO of the benefit managers’ trade association blames pharmacists, whom he says should simply offer customers the cash price of the drugs — if cheaper — bypassing their insurance plans altogether.

 

“Not everything has to go through the plan,” said Mark Merritt, president and CEO of Pharmaceutical Care Management Association. “The only reason [for pharmacies] to process the claim is to keep the copay for themselves.”

While agreeing that in some cases consumers could get their drugs for less if they paid cash, Pilch said pharmacists are specifically barred from discussing the cash price under terms set by contracts between them and the PBMs. Its June survey of 650 pharmacists found that more than 38 percent said they were unable to tell patients about cheaper cash prices 10 to 50 times in the previous month.

“We are required to run it through insurance and we do not have the option of advising the patient regarding matters of the terms of their plan or their options, or we run the risk of being cut from the network,” she said.

For their part, PBMs say patients pay the amounts specified by their insurance plan benefit design. And the amounts they take back, they say, can help hold down cost and slow future premium increases to the insurers and employers who hire them.

Still, Louisiana lawmakers this month passed legislation to rein in the practice by directing pharmacists to tell patients about all their options — including less expensive alternatives.

Arkansas lawmakers last year passed a law that bars PBMs and pharmacies from collecting more from customers for medications than the pharmacy will ultimately be paid.

The laws “should eliminate these consumer clawbacks, which I believe are rare, but are an example of bad behavior by a PBM making a drug more expensive than it should be, said Pembroke’s Fein.

Marketplace Practices

Optum RX, a PBM that is part of UnitedHealth Group, was cited as a firm engaged in such efforts by the national pharmacy association and its affiliates in Arkansas and Louisiana.

UnitedHealth spokesman Matt Wiggin said only a small portion of claims were affected, although he could not give a specific percentage. The firm, he said, is moving to change its contracts to avoid the situation in the future.

At Cigna, another firm called out by the pharmacists, spokeswoman Karen Eldred would not say if it takes back a portion of the customer’s payments from pharmacists. But she said customers “would not pay more than the retail price (cash price) reported to Cigna by the pharmacy.”

A spokesman for Express Scripts, one of the nation’s largest PBMs, said the firm does not engage in the practices which “are not in the best interest of patients or the country,” said spokesman David Whitrap.

Market experts agree that shopping around and doing some leg work are tactics that will help consumers avoid paying too much because of the clawback.

Cigna, Express Scripts and other insurers also have apps and websites where members can check drug prices at multiple pharmacies and decide for themselves how best to proceed. But if a health plan or PBM doesn’t offer an app, consumers can check the cash price for prescriptions through one of the online websites like GoodRX or Blink health before heading to the pharmacy.

Join the conversation

In some cases, it might be less expensive to pay cash. But experts caution that such cash payments don’t always count toward annual drug deductibles. Consumers who expect a lot of drug costs might want to think twice about paying cash. But others may still find it saves them money, even if they never hit their deductible.

“The safest thing to do is always know what the pricing is in the marketplace,” said Mike Miele, an area president who advises employers on benefits for consulting firm Arthur J.Gallagher. “There are literally thousands of generics that are below $10.”

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Senate Easily Passes Bill Addressing Opioid Abuse

http://www.rollcall.com/news/senate_easily_passes_bill_addressing_opioid_abuse-246269-1.html

When  you have a Senate that contains 60 Attorneys… what can you expect except a focus on the Judicial system to handle the mental health disease of addictive personality disorder.

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