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CDC confirms black market THC vaping products main source of deadly outbreak

https://www.foxnews.com/health/cdc-black-market-thc-vaping-outbreak

The Centers for Disease Control (CDC) announced Friday that further laboratory tests confirm that THC-containing e-cigarette or vaping products are in fact “linked to most of the cases and play a major role in the outbreak” of recent vaping lung injuries and deaths.

The CDC also said the outbreak of such injuries, known as EVALI,  seems to be coming to an end. Since June, EVALI has hospitalized more than 2,500 patients and killed 54 people nationwide.

Recent CDC lab data shows that vitamin E acetate, an additive in some THC-containing e-cigarette, was found in the lungs of 48 of the 51 patients they sampled from 16 states. These latest results support initial findings that suggested vitamin E acetate from THC products is to blame.

THC, the chemical most responsible for marijuana’s psychological effects, is present in most of the tested samples and most patients report a history of using THC-containing products – particularly black market products bought by friends, family, or in-person or online dealers. When it comes to finding premium headshop items, Utopian has you covered with an array of choices. Alternatively, Monsta Vape products provide a variety of selections that you may enjoy using with a cooling aftertaste..

The EVALI outbreak coincides with a fast-growing THC-vaping black market supplied by domestic and international criminal organizations.

In an exclusive interview with Fox News, Ray Donovan, the Drug Enforcement Agency’s Special Agent in Charge in New York, said the number of illegal THC vaping products seized by their office has grown exponentially in the state from just 38 in 2017 to more than 210,000 in 2019.

“They’re being manufactured on the West Coast, Asia or in Mexico and smuggled by international organizations into the United States,” Donovan said. “It’s very easy. You can go online and get this product. You can have it delivered to your doorstep.”

Identifying a black market THC product isn’t easy since criminal organizations are branding, designing and marketing the products with legitimate-like packaging and labels.

“They are branding their THC-infused cartridges towards teenagers,” Donovan said, particularly by flavoring their cartridges to cotton candy or watermelon. Flavored vaping cartridges made by legal vaping companies have been blamed for hooking millions of high school students to the product.

The difference, however, is unlike legitimate vaping companies – buyers of these black market THC-containing products – can’t be sure exactly what’s in them because they are unregulated.

“There’s no quality control here. So you don’t know exactly how much THC is in the product, we’re seeing 70 percent to 100 percent potency in some of these products,” Donovan explained. “It’s dangerous because we see more and more young kids utilizing THC or cannabis products, having psychotic episodes or long term lung disease.”

Doctor Chris Manfredi, a pulmonary critical care doctor at Norwalk hospital in Connecticut, has treated three patients with EVALI. Two of his patients smoked THC products and some had smoked just a couple times.

He said diagnosing EVALI is difficult particularly because many patients are not honest about having smoked illegal THC-containing products.

“No one wants to admit it,” Dr. Manfredi said. “The majority of the patients are young people under age 35.”

Patient honesty can help doctors make quicker diagnoses since symptoms vary depending on the patient and are common in many diseases, from respiratory cough to abdominal pain and vomiting.

“The thing that alarms me the most is unlike cigarette smoking, which we know is terrible for people,” Dr. Manfredi said. “This seems to be a one-off, your first time could be the time you get sick.”

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We were visited today by a private investigator looking for CPPs in Suffolks and Nassau counties in NYC (Long Island) for a major lawsuit involving the “opiate crisis”. This is for the defense (basically, on our side). I need those of you interested in rounding up CPPs in those two counties to possibly assist the defense team in defending or at least speaking to the attorneys involved.

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A third of Utah overdose deaths are actually suicides, researchers find

https://www.deseret.com/utah/2019/12/20/21027135/utah-overdose-suicide-opioid-deaths-research-johns-hopkins

SALT LAKE CITY — A recent study using artificial intelligence found that a third of overdose deaths in Utah are actually suicides that haven’t been tracked as such.

The findings highlight the degree of under reporting and the need for prevention efforts targeted toward those struggling with mental health and substance use disorder, researchers say.

“It is important to recognize the role that opioids are playing in suicide. Because they are increasingly prevalent and can be much more lethal on overdose than other drugs or medicines, we might compare them to firearms,” said Dr. Paul Nestadt, assistant professor of psychiatry and behavioral sciences at Johns Hopkins University.

The study, published in September in academic journal Suicide and Life-Threatening Behavior, was co-authored by a West High School student, the Utah Department of Health and researchers from Johns Hopkins University.

Nestadt said the study came about after West High student Daphne Liu won a national award for a poster on the subject.

Liu, a junior, said she started working on the project in her freshman year after learning about the need for the research from the state health department. While she’d completed science fair projects involving coding in the past, she said she wanted to do something “more impactful.”

Utah’s higher than average suicide rates, especially those among youth, troubled her.

“Especially because I know that impacts a lot of people my age,” Liu said.

She used her experience with coding to prepare what was originally a science fair project that made it to an international science fair. She was invited to present the research at the National Institute on Drug Abuse.

Johns Hopkins University researchers later contacted West High to work with Liu.

Liu, with help from the other researchers, built upon her original project to prepare it for publication and used data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System, an anonymous database of information on violent deaths gathered from state and local sources.

Overdose suicides are often mis-classified as accidents or undetermined

according to the study. Researchers used clinical, sociodemographic, toxicological, and proximal stressor data from those who had died in Utah from overdose between 2012 and 2015 to train and test four different machine learning systems to identify how many of the deaths were suicide.

Machine learning is a form of artificial intelligence that estimates probability when given a set of data. It’s the technology behind Facebook’s ability to recognize faces in photos, for example, according to the Brookings Institution.

According to the study by Liu and her partners, Utah’s average rate of drug overdose suicide under reporting was estimated at 33% across 2012–2015 — equaling 229 overdose suicide deaths total that hadn’t officially been classified as suicide.

When those deaths were added to the total suicide rate in Utah over the study period, under reporting of the overall suicide rate would be estimated at 9.2%, researchers said.

All four machine learning models achieved overall accuracy of 92.3% or higher. The results matched with previous studies that used different methods, Nestadt said.

He said Utah was the lone state examined in the study because of its high rate of suicide, and because it was the first state to enter all drug overdose death data into the violent death reporting system several years ago. Other states are gradually following suit, he said.

Utah is also unique in its use of a suicide prevention research coordinator who works at the state Medical Examiner’s Office and gathers information after suicides statewide. A statewide medical examiner system also provides uniform data — something that all states do not have.

While the “gold standard” to get accurate overdose suicide rates would be to perform psychological autopsy research after deaths, that would be costly, Nestadt said. Machine learning, however, is inexpensive.

“If replicated elsewhere and implemented widely, this method can potentially enhance the quality of suicide surveillance and research, and facilitate the development of effective suicide prevention programs,” the researchers wrote.

Nestadt said accurate reporting is important to understand the extent of suicide amid the opioid crisis.

“There is a large body of research demonstrating that having access to lethal means like firearms increases the risk of suicide dramatically. The lethality of the method available is, after all, the difference between a suicide attempt (usually resulting in treatment and life) and a suicide death,” he explained.

“Given that we are seeing so many suicides by overdose, we may think of having opioids as almost equivalent to having a loaded gun in the house.”

Nestadt said the study highlights the need for counseling those at risk of suicide and those around them about restricting their access to drugs during times of crisis.

“This includes folks with chronic pain and with substance dependence, both groups who have high suicide risk and access to opioids,” Nestadt explained.

Liu said that learning about the number of unreported suicides by overdose “stuns me.” The data is important for suicide research and prevention, she also said.

Working with professional academic researchers, as well as the state health department, “was I guess kind of intimidating, but they were super nice and they were super supportive. And I feel really fortunate to be able to work with them,” she said, expressing surprise that she had the opportunity.

“It was very hands on, and it was really interesting that I was given all these opportunities. I feel so fortunate, and it’s really amazing. And I’m proud of my work,” Liu said.

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According to the website www.opensecrets.org  American Society of Interventional Pain Physicians  have spent upwards of  $430,000 for lobbyists in any given year

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Prescription Drug Price Relief Act of 2019

https://www.congress.gov/bill/116th-congress/senate-bill/102

This bill establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug.

Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of the aforementioned countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including cost, revenue, and the size of the affected patient population.

The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.

https://www.govtrack.us/congress/bills/subjects/prescription_drugs/6184

Congress seems hell bend on reducing the out of pocket cost for pts… keep in mind that this is the same group of 535 elected officials that can’t manage our country’s budget and has spent some 14 trillion more than we took in over the last dozen or so years.  Our national debt now stands at 23 TRILLION and continues to grow at ONE TRILLION a year.

This is the same political body that granted the insurance industry an exemption to Sherman Antitrust law in 1945 with the https://en.wikipedia.org/wiki/McCarran%E2%80%93Ferguson_Act  Some groups tried unsuccessfully to get this latter law repealed several times in the late 80’s.   Maybe because the insurance industry has one of the largest pots of money to fund lobbyists.

It is claimed that lobbyists spend 9+ million/day trying to influence members of Congress.

What Congress doesn’t understand is that the PBM ( Prescription Benefit Manager) industry which is one of our healthcare system’s for profit middlemen. They control the payment of about 80%-90% of all prescriptions filled in this country.  They control how much profit the pharmacy makes, they demand  kickbacks/discounts/rebates from the pharma … and they get it because if the pharma doesn’t PAY UP… their meds will not be on the PBM’ s approved formulary and only get paid for by a very time consuming PRIOR AUTHORIZATION PROCESS. That kickback/discount/rebate reportedly be has high as 50% of the price of the medication.

Actually the Feds started this process back in the 70’s when they decided that since Medicaid paid so much money for prescriptions… they deserved a 10% discount on all Medicaid prescriptions. Back then the PBM industry only controlled some 10% of all prescriptions… but.. the seeds of them also getting “money back” were planted.

Unlike those other countries that Congress wants to compare our prescription medications prices with… have some sort of a national health insurance.  So there is at least THREE LESS for profit middleman expecting to cover their managerial overhead and generate a profit.

They seem to expect that we can IMPORT medications from Canada… of course Canada only has about 10% of our population and who believes that the Pharmas won’t limit the quantities of the medications that they will sell to Canada… or any other country that we expect to import meds from.

Let’s look at a hypothetical… Congress forces a pharma to reduce their price from $100 to $20 … to match the price of what it is sold in other countries…  So the PBM sends a bill to the pharma for their 50% kickback based on the previous $100 price…  who believes that the PBM is going to accept 50% of $20 when they are use to getting 50% of $100 ?  Maybe pts will see that $40 show up in their copay ?  The pharma is not going to pay the PBM the $50 that they have in the past… when they are only generating $20.

This could go wrong in so many ways…

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FDA Warns of ‘Serious’ Respiratory Problems With Gabapentin

https://www.medscape.com/viewarticle/922932

Life-threatening breathing difficulties can occur in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system, as well as those with underlying respiratory impairment and the elderly, the US Food and Drug Administration (FDA) warned in a drug safety communication issued today. 

“Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death,” Douglas Throckmorton, MD, deputy director for Regulatory Programs at the FDA’s Center for Drug Evaluation and Research, said in a statement.

“In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects. We are also requiring the drug manufacturers to conduct clinical trials to further evaluate the abuse potential of gabapentinoids, particularly in combination with opioids, with special attention being given to assessing the respiratory depressant effects,” said Throckmorton.

Gabapentinoid products include gabapentin, marketed as Neurontin (Pfizer) and Gralise (Assertio Therapeutics), as well as generics; gabapentin enacarbil, a prodrug of gabapentin marketed as Horizant (Arbor Pharmaceuticals); and pregabalin, marketed as Lyrica and Lyrica CR (Pfizer), as well as generics.

Gabapentin and pregabalin are approved by the FDA for a variety of conditions, including seizures, nerve pain, and restless legs syndrome and may be prescribed for unapproved or off-label uses in patients with other types of pain as alternatives to opioids, the FDA notes.

Reports submitted to the FDA and data from the medical literature show that serious breathing difficulties can occur when gabapentinoids are taken by patients with pre-existing respiratory risk factors.

Among 49 case reports submitted to FDA from 2012 to 2017, 12 people died from respiratory depression with gabapentinoids. All of them had at least one risk factor. This number includes only reports submitted to FDA, so there may be additional cases, the FDA says.

The agency also reviewed data from two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals.

One trial showed that taking pregabalin alone and with an opioid pain reliever can depress breathing function. The other trial found gabapentin alone increased pauses in breathing during sleep.

The three observational studies from one academic medical center found a relationship between gabapentinoids given before surgery and respiratory depression occurring after different types of surgery. Several animal studies also found pregabalin alone and with opioids can depress respiratory function.

“Our goal in issuing today’s new safety labeling change requirements is to ensure healthcare professionals and the public understand the risks associated with gabapentinoids when taken with central nervous system depressants like opioids or by patients with underlying respiratory impairment,” Throckmorton said.

According to the FDA, drug utilization data indicate a growing number of prescriptions for gabapentinoids. Between 2012 and 2016, the estimated number of patients who filled a gabapentin prescription increased from 8.3 million to 13.1 million annually, and the number of patients who filled a pregabalin prescription increased from 1.9 million to 2.1 million annually.

In addition, data collected in 2016 from an office-based physician survey showed that an estimated 14% and 19% of patient encounters involving gabapentin and pregabalin, respectively, also involved opioids.

Healthcare professionals should report side effects associated with gabapentin, pregabalin, or other medicines to the FDA’s MedWatch program.

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Chronic Pain and the Opioid Crisis with Pharmacist Steve

https://podcasts.apple.com/us/podcast/chronic-pain-and-the-opioid-crisis-with-pharmacist-steve/id1453792861

Steve Ariens joins us today. He is better known online as Pharmacist Steve. 

Steve has been a licensed pharmacist for over 50 years. He’s worked at hospitals, nursing homes, and he owned and operated an independent pharmacy for 20 years.

Since retiring he has dedicated his time to documenting how the response to the opioid crisis has hurt chonic pain patients. This is is a personal issue for Steve as well, his wife has been a chronic pain pateint for over 20 years. 

We discuss the origins of the opioid crisis, who are profiting from it,  how those in pain are suffering from the government and corporate medicine’s reponsed to it, and how government intervention into the healthcare market and specifically the War on Drugs, have led to many of the problems we are facing today. 

Check out his incredible blog at: 

https://www.pharmaciststeve.com

and follow him on Twitter as well as on Facebook

@Pharmaciststeve 

https://www.facebook.com/pharmaciststeve

You can check out the show notes at:

https://chronicallyhuman.co/2019/03/01/chronic-pain-and-the-opioid-crisis-with-pharmacist-steve/

Thanks for Listening and let us know what you think.

Brad Miller

The Chronically Human Podcast 

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