Uncle Sam facilitating shipments of illegals into USA ?

Posted on May 17, 2018 by Pharmaciststeve

Online Sales of Illegal Opioids from China Surge in U.S.

https://mobile.nytimes.com/2018/01/24/us/politics/senate-investigation-china-mail-opioids.html#

WASHINGTON — Nearly $800 million worth of fentanyl pills were illegally sold to online customers in the United States over two years by Chinese distributors who took advantage of internet anonymity and an explosive growth in e-commerce, according to a Senate report released on Wednesday.

A yearlong Senate investigation found that American buyers of the illegal drugs lived mostly in Ohio, Pennsylvania and Florida. The Chinese sellers primarily used Bitcoin, the digital currency, as their preferred method of payment and shipped the drugs through other countries to reduce the risk of the opioids being seized by customs officials, Senate investigators said.

The 104-page bipartisan report was produced by the Senate Homeland Security Committee’s investigations arm. It was requested by Senators Rob Portman, Republican of Ohio and the panel’s chairman, and Tom Carper of Delaware, the committee’s top Democrat. They will discuss the report’s findings in a hearing set for Thursday and are expected to press law enforcement and Postal Service officials for details on plans to combat the growing opioid shipments.

China has a large pharmaceutical industry and hosts thousands of illegal labs that manufacture counterfeit and illicit drugs, Senate investigators said. The country has long been identified by American officials as the source of much of the illegal opioids flowing into the United States.

 The report, Senate investigators say, shows how easy it is for Americans to buy the drugs online, and why officials at the post office and Customs and Border Protection has struggled to track and stop the shipments.

The Senate investigators said drugs traffickers are exploiting a loophole in the international mail system to send hundreds of pounds of deadly opioids into the United States each year.

 Commercial shippers such as UPS and FedEx are required by law to supply Customs and Border Protection with advanced data about packages before they are shipped. The information includes names, addresses and the contents of the packages. That information is matched against intelligence and other enforcement data to flag suspicious parcels.

But customs officials say they currently do not receive advanced shipping data from all packages shipped through Postal Service that can help the agency spot opioids hidden in international packages. The service is not required to obtain advanced data from foreign postal organizations; mailed packages are inspected manually by customs officers at nine mail facilities in the United States that receive international mail.

Congress is considering legislation that would require foreign post offices to provide that electronic information, but the Postal Service said many poor countries are unable to produce the data.

But even with the advance data, some drugs get through, federal law enforcement officials said. Drug trafficking organizations continue to use FedEx and UPS to send heroin and opioids into the country, according to investigators with Homeland Security Investigations, a division of Immigration and Customs Enforcement.

Investigators said synthetic drug traffickers are getting more creative in how they ship drugs through the postal system, exploiting the sheer volume of international mail and sending smaller packages.

According to federal investigators, the use of illegal fentanyl and other opioids in the United States has exploded since 2014. Nearly 43,000 Americans died from opioid overdoses in 2016, the most recent data available, according to the Centers for Disease Control.

Last October, President Trump declared the opioid crisis a public health emergency but did not make any new funding available to combat it.

On Monday, Patrick Kennedy, a former Democratic representative from Rhode Island and a member of Mr. Trump’s commission to address the opioid crisis, said the administration’s efforts were “essentially a sham.”

Nearly two weeks ago, Mr. Trump signed legislation to provide Customs and Border Protection officers with additional screening devices and other tools to detect illicit drugs.

The legislation provides $9 million to the agency to buy portable chemical screening devices and new laboratory equipment at land-based ports of entry, airports and international mail facilities.

 

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While CPP suffer from opiate shortages… FDA INVESTIGATES subcontractor producing faulty data ?

Posted on May 16, 2018 by Pharmaciststeve

FDA Uncovers Errors in Opioid Database

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA – a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. “The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year.”

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

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Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA released a statement saying it identified the problems in its database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two healthcare research firms.

 

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The Lethal Success of Pain Pill Restrictions

Posted on May 16, 2018 by Pharmaciststeve

www.edsinfo.wordpress.com/2018/05/15/the-lethal-success-of-pain-pill-restrictions/

In a speech on Monday, Attorney General Jeff Sessions said the Justice Department is striving to “bring down” both “opioid prescriptions” and “overdose deaths.”

A study published the following day suggests those two goals may be at odds with each other, highlighting the potentially perverse consequences of trying to stop people from getting the drugs they want.  

Columbia University epidemiologist David Fink and his colleagues systematically reviewed research on the impact of prescription drug monitoring programs (PDMPs), which all 50 states have established in an effort to prevent nonmedical use of opioid analgesics and other psychoactive pharmaceuticals

The review covers 17 studies, 10 of which looked at the relationship between PDMPs and deaths involving narcotic pain relievers. Three studies “reported a decrease,” six “reported no change,” and one “reported an increase in overdose deaths.”

The picture looks worse when you take into account deaths involving illegally produced drugs, which now account for a large majority of opioid-related fatalities. Fink et al. found six studies that included heroin overdoses, half of which reported a statistically significant association between adoption of PDMPs and increases in such incidents.

Restricting access to pain pills also seems to be increasing the percentage of opioid users who begin with heroin. A 2015 survey of people entering treatment for opioid use disorder found 33 percent had started with heroin, up from 9 percent in 2005.

If the aim is preventing drug-related deaths, this shift is counterproductive, to say the least. Because their purity and potency are inconsistent and unpredictable, illegally produced opioids are much more dangerous than pain pills.

Comparing deaths counted by the federal government to its estimates of users suggests that heroin is more than 10 times as lethal as prescription opioids.

Policies that drive people toward more dangerous drugs help explain why deaths involving heroin and illicit fentanyl have skyrocketed in recent years, even as opioid prescriptions have declined.

That trend includes a 252 percent increase in heroin-related deaths and an astonishing 628 percent increase in deaths involving the opioid category that consists mainly of fentanyl and its analogues.

Final CDC figures for 2017 are not available yet, but the provisional numbers indicate there will be more increases.

In addition to magnifying the risks that nonmedical users face, the crackdown on pain pills is hurting patients.

Many people who have successfully used opioids to treat severe chronic pain for years now find it difficult or impossible to obtain the medication they need to maintain a decent quality of life.

The article below is of the same tone: ridiculing a government immune to facts, which persistently prosecutes a non-problem (use of pain medication) to solve a problem (addiction).

New Research Reinforces Earlier Studies Suggesting PDMPs Are Adding to Opioid Overdose Rate – May 9, 2018 – By Jeffrey A. Singer

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SPECIAL REPORT: The Other Side of the Opioid Epidemic

Posted on May 16, 2018 by Pharmaciststeve

http://www.centralillinoisproud.com/news/local-news/special-report-the-other-side-of-the-opioid-epidemic/1164359700

We often hear about the opioid epidemic from the perspective of those who are addicted But what about the other side of the coin, people who use prescription opioids as a means of treating chronic pain?

Jennifer Bowersock lives her life day to day.

“I am never out of pain, I am in pain from the second I wake up to the second I fall asleep.” Bowersock explains.

Open heart surgery put her on a painful road to recovery.

“Some days I’m good, I can get out of bed, function normally. Then, other days it’s very depressing, you just can’t move, I can’t get out of bed.” Bowersock says.

She takes prescription opioids to take the edge off and help her sleep. Three years later, she can’t imagine life without them.

“I probably wouldn’t be able to function at all.”

For Shari Burdick it was a diagnosis with Degenerative Disc Disease 10 years ago. Debilitating pain put her out of her longtime job in the school cafeteria.

“I have a new normal, it’s not the normal I used to have.” Burdick says.

Physical therapy and injections didn’t help with the crippling pain. Prescription opioids help her do more of the things she loves, like cooking and spending time with her grandkids.

Shari has been on her medication for 5 years and in that time, has seen changes with every trip to the pharmacy.

“You don’t get as much in one prescription as you used to, they cut it back. You can’t get it early, I mean if you pick up your prescription on a certain day it’s exactly a month later that you can get it. Not a day sooner. They’re very strict with it.” Burdick explains.

If anyone understands why new guidelines are being put in place to limit the supply of opioids available, it’s Burdick.

“My younger brother died from an overdose of opioids so yes I can see both sides of it.” Burdick says.

“Most people don’t realize the other side of the coin, that legitimate pain patients are getting caught up in the hysteria over the opioids.” Pharmacist, Mike Minesinger, says.

Minesinger is owner and pharmacist at Alwan Pharmacy. He says if prescriptions are going to be cut back, it needs to be done gradually and humanely.

“I’m just seeing reports of people who are being suddenly taken off of them. You know, their suicide rate goes up or you know, alternatively, they switch to street drugs because they can’t get the prescription anymore.” Minesinger explains.

Dr. Dennis McManus is Director of the Central Illinois Pain Clinic. When it comes to prescribing to his patients at the clinic, he takes a tough stance, telling them it’s the medicine contributing to their pain.

“We’re having a lot of people dying, more people than died in the Vietnam War, more people dying than the height of the AIDS epidemic, people are dying and the question is what’s going on? My stand point is there’s just no good evidence for the use of chronic opioids in chronic pain.” Dr. McManus explains.

Dr. McManus says the evidence shows long-term opioid use actually increases our sensitivity to pain.

“The best way to avoid the problem is not to create the problem in the first place.”

The Centers for Disease Control published a guideline for prescribing opioids for chronic pain in 2017. In it, the CDC says clinicians should prescribe the lowest effective dosage and should prescribe no greater quantity than for the expected duration of pain severe enough to require it. The CDC goes on to say 3 days of less will often be sufficient, more than 7 days is rarely needed.

If the benefits don’t outweigh the harms, the CDC recommends physicians try other therapies and work with patients to taper opioids to lower dosages or discontinuation.

Still, for patients like Bowersock and Burdick, they wish they didn’t need the treatment they call life-changing.

“Try living a day in our life to take them and somebody that doesn’t need them, you’re making it that much harder for the people that actually do need them.” Bowersock says.

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Is There a Fibromyalgia “Brain Signature”?

Posted on May 16, 2018 by Pharmaciststeve

https://www.medpagetoday.com/resource-centers/contemporary-fibromyalgia-approaches/fibromyalgia-brain-signature/884

Fibromyalgia currently lacks a clear-cut, objective method to confirm its diagnosis, complicating clinicians’ jobs and frustrating patients. However, researchers may be getting much closer to identifying neurophysiological markers that are diagnostic of fibromyalgia.

Patients with fibromyalgia experience widespread pain, altered cognition, fatigue, and sleep dysfunction. On top of these burdensome symptoms, it often takes several years, several doctors, a few misdiagnoses, and numerous tests before a diagnosis of fibromyalgia is confirmed. What’s worse, these patients might have to fight an uphill battle to convince clinicians, family, friends, and coworkers that their condition is a “real” one.

To provide an objective diagnostic marker for fibromyalgia, researchers recently used a multisensory approach to identify a brain signature that distinguishes individuals with fibromyalgia from individuals without it.

Of the 72 subjects who participated, all of whom were women, 37 had a confirmed diagnosis of fibromyalgia according to the 1990 American College of Rheumatology criteria.

The other 35 were healthy controls matched for age, education status, and handedness (all were right-handed).\

Participants were exposed to visual and auditory stimulation and were asked to perform a finger opposition task.

A functional magnetic resonance imaging (fMRI) based neurologic pain signature (NPS) (previously validated to predict experimental pain and discriminate it from other unpleasant/arousing emotional experiences) was applied to the subjects during pain processing.

In addition, researchers discriminated patients with fibromyalgia from healthy controls using activation patterns during painful pressure (FM-pain) and during nonpainful multisensory stimulation.

Patients with fibromyalgia experienced greater NPS than healthy participants when exposed to the same painful stimuli. Furthermore, when pattern response values were combined for the NPS, FM pain, and multisensory patterns using logistic regression, this combined classifier was able to discriminate patients from healthy participants with 92% sensitivity (confidence interval [CI], 84% – 98%) and 94% specificity (CI, 87% – 100%).

Tor Wager, PhD, director of the cognitive and affective neuroscience laboratory and professor in the department of psychology and neuroscience and the Institute for Cognitive Science at the University of Colorado, Boulder, and author of the study, said, “Abnormal responses to multisensory events was the strongest individual predictor of whether a person had fibromyalgia. This suggests it is a systemic, rather than pain specific, neurological disorder.”

The identification of a fibromyalgia-specific brain signature has the potential to launch the medical community far ahead of the past notion that the condition was in patients’ heads. According to Daniel G. Arkfeld, MD, associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California (USC), and director of rheumatological education at the Keck Hospital of USC, “It is an old idea that fibromyalgia is a made-up disorder and doesn’t exist. Results of studies such as this, as well as others that have shown high levels of substance P [a pain-promoting or algesic neurotransmitter] in the spinal fluid of patients within fibromyalgia,

Show that there is a neuropathophysiologic basis for the unique syndrome of fibromyalgia.”

The use of such a brain signature has implications beyond improving fibromyalgia diagnosis. “There is a need for objective measures in fibromyalgia. This research may help point toward appropriate targets for a more directed approach in treating fibromyalgia,” said Dr. Arkfeld. Dr. Wager concurred, “We need to diagnose patients and group them based on the underlying neuropathology. Then we have a better chance of finding the best treatments based on an individual’s biology.”

In other words, the use of fMRI technology to observe brain patterns in real time when patients with fibromyalgia are experiencing pain and multisensory stimulation may allow patients to be diagnosed using objective measures, and may also lead to advances in fibromyalgia treatment due to the enhanced understanding of the disorder it affords. There may come a time in the not-so-distant future when fibromyalgia enters its own era of targeted medicine, with therapies tailored to individual disease characteristics such as those included in the brain signature.

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FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

Posted on May 16, 2018 by Pharmaciststeve

www.fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain/

The Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous.

The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

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Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.

 

 

 

 

 

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#CVS Health…where health is everything… especially a healthy bottom line

Posted on May 16, 2018 by Pharmaciststeve

 

 

 

 

 

 

 

 

 

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opioid committee defeated!

Posted on May 15, 2018 by Pharmaciststeve

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aimed to enhance patient safety and reduce the risk of unintentional overdose and death

Posted on May 15, 2018 by Pharmaciststeve

Hi Steve, just wanted to let you know that it happened to me now too – got a letter from my dr and he is stopping prescribing any opiates here in Ohio. Here’s what the letter he sent me reads: As your ongoing primary care provider I deeply value your trust and reliance on me. Being a dedicated professional, I am committed to delivering excellent care to my patients. As you may be aware, the opioid crisis is significantly impacting our community. The Ohio State Medical Board and Ohio Board of Pharmacy have recently issued additional rules regarding controlled medication prescribing, aimed to enhance patient safety and reduce the risk of unintentional overdose and death. Accordingly, UH(University Hospital) is taking a strict stand with regard to patient safety and the usage of controlled medications, including pain medications and anxiety medications (e.g. opioids and benzodiazepines).(Note I do not take any anxiety meds) Given the importance of optimal symptom management, along with challenges in complying with the new regulatory requirements, I will no longer be prescribing controlled medications. As a result, I would like to refer you to a provider who specializes in the treatment of your symptoms, and can reevaluate and potentially establish a new plan of care. Since I would like to discuss specific referrals with you, please call the office to make an appointment at your earliest convenience. I look forward to continuing as your primary care physician for all of your general medical needs, and I look forward to seeing you soon.

 

I think you are probably right – however my dr has been being pressured by DEA for almost 2 years now – he wasn’t keeping records as good as he should have been initially and got that squared away but they kept coming back – he’s 3 years away from retirement and now Ohio just instituted new laws making it even more restrictive so knowing all of this I honestly can’t blame my doc for making this change so he can finish out his last couple years and then retire. But sadly 2 months ago he told me he wasn’t going to leave me high and dry but now he’s gone back on his word. I don’t have the money to be a test patient with laws though I am disabled and could file against the laws Ohio is setting up.

Sure sounds like to me that this is another hospital/corporation that has decided to CYA themselves and mandate all their employee/prescribers to stop prescribing all controlled substances.  To me.. that sounds like practicing medicine without a license and since the vast majority of pts taking controlled substances are dealing with a protect class under the Americans with Disability Act.  One would suspect that the hospital/corporation has “deep pockets” and I suspect that there are other state/fed laws that are being violating and who knows if the laws/regulations that Gov Kasich and the bureaucrats have enacted are actually constitutional ?

 

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Breakthrough Blood Test Shows the ‘Color of Pain’

Posted on May 15, 2018 by Pharmaciststeve

https://www.painnewsnetwork.org/stories/2018/5/7/breakthrough-blood-test-shows-the-color-of-pain#

A revolutionary new blood test developed by Australian researchers could give doctors instant insight into the severity of chronic pain by identifying colored biomarkers in the blood.  The “painHS” test uses advanced light spectrum analysis to identify the molecular structure of pain in immune cells.

“We are literally quantifying the color of pain,” explains neuroscientist Mark Hutchinson, PhD, a professor at the University of Adelaide Medical School in Australia.  “We’ve now discovered that we can use the natural color of biology to predict the severity of pain. What we’ve found is that persistent chronic pain has a different natural color in immune cells than in a situation where there isn’t persistent pain.”

Hutchinson and his colleagues discovered molecular changes in the immune cells of chronic pain patients. These pain biomarkers can be instantly identified through hyperspectral imaging, giving doctors the ability to measure a patient’s pain tolerance and sensitivity.

The test could potentially provide physicians with the first biology-based test to measure pain as the “5th vital sign” and to justify prescribing pain medication or other therapies.

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Hutchinson was quick to point out that the test is not intended replace a patient’s description of pain to their physician.  Pain is subjective and varies from patient to patient, depending on their medical condition and many other factors.  Current tests used to measure pain in adults, such as the sad and smiley faces of the Wong-Baker pain scale, are so simple they were initially developed for young children.

“Self-reporting (by patients) is still going to be key but what this does mean is that those ‘forgotten people’ who are unable to communicate their pain conditions such as babies or people with dementia can now have their condition diagnosed and treated,” said Hutchinson, who believes the test could also revolutionize pain treatment in animals.

“Animals can’t tell us if they’re in pain but here we have a Dr. Doolittle type test that enables us to ‘talk’ to the animals so we can find out if they are experiencing pain and then we can help them.”

Hutchinson says the test could also help speed the development of new drugs that could target particular kinds of chronic pain, and could eliminate the need for placebos in clinical trials by giving an instant indicator of a treatment’s effectiveness.

“We now know there is a peripheral cell signal, so we could start designing new types of drugs for new types of cellular therapies that target the peripheral immune system to tackle central nervous system pain,” he explained.

Hutchinson thinks the “painHS” test could be widely available to pain specialists and general practitioners in as little as 18 months and could provide a cost-effective tool to measure the severity of pain in patients with back problems, cancer, fibromyalgia, migraines and other conditions.

Several other blood tests have already been developed to diagnose patients with specific chronic pain conditions such as fibromyalgia.

IQuity Labs recently introduced a blood test that can identify fibromyalgia by analyzing ribonucleic acid (RNA) in blood molecules. EpicGenetics launched the first fibromyalgia blood test in 2013. That test looks for chemokines and cytokines, which are protein molecules produced by white blood cells.

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