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Friday, August 24, 2018

DOJ Blocks Two ‘Reckless’ Ohio Docs From Prescribing Opioids


The US Department of Justice (DOJ) has won a court order that temporarily prevents two “reckless” Ohio physicians from writing opioid prescriptions — a never-before-used weapon in the government’s ongoing battle to combat the opioid crisis, according to a DOJ news release.
The US Attorney for the Northern District of Ohio was granted temporary restraining orders against Michael P. Tricaso, DO, of Akron, and Gregory J. Gerber, MD, of Sandusky, on August 17, according to the Akron Beacon Journal. It is the first time the federal government has used such a tactic to stop physicians it believes are prescribing opioids illegally under the Controlled Substances Act.
The two doctors are barred from prescribing while the US attorney’s office — in conjunction with the Drug Enforcement Administration (DEA), the Federal Bureau of Investigation, the Office of Inspector General of the Department of Health and Human Services, the Ohio attorney general’s Medicaid Fraud Control Unit, the State of Ohio Board of Pharmacy, the Cuyahoga Falls Police Department, and the State Medical Board of Ohio — continues its criminal investigation.
“Today’s announcements are a warning to every trafficker, every crooked doctor or pharmacist, and every drug company, every chairman and foreign national and company that puts greed before the lives and health of the American people: this Justice Department will use civil and criminal penalties alike and we will find you, put you in jail, or make you pay,” said US Attorney General Jeff Sessions in remarks delivered in Cleveland on August 22.
“These doctors were simply drug dealers in white lab coats,” said US Attorney Justin Herdman, in the DOJ statement. “They illegally prescribed painkillers and other drugs for no legitimate medical purpose.”
DEA Special Agent in Charge Timothy Plancon called the physicians’ actions “reckless” in the release, saying their “corruption has had a tremendous affect in opioid addiction that is plaguing America.”

Undercover Operation

The government alleges that Tricaso — who worked as a “gym doctor” for a fitness center — sold steroids and other controlled substances on many occasions to an undercover DEA agent. He offered to sell the agent Percocet (a combination of acetominophen and oxycodone) without a prescription and to write prescriptions for 20 pills or less, saying that would prevent monitoring by pharmacies or the DEA.
Gerber worked as a private physician. The US Attorney alleges that from 2013 to 2016, Gerber received $175,000 from Insys Therapeutics, Inc, to promote Subsys, a liquid formulation of fentanyl. The payments constitute kickbacks under the False Claims Act.
An undercover agent also received prescriptions for oxycodone, dronabinol, and alprazolam from Gerber, despite having no pain complaints. Gerber performed only minimal examinations and then wrote the prescriptions, according to the government.
The justice department has allocated extra resources for law enforcement agencies working to address the opioid crisis in Ohio. “We are sadly well aware that Ohio at is the center of the drug epidemic,” said Sessions, noting that in 2016, Ohio had the second-highest overdose death rate in the nation.

Michigan’s Health Director Faces Trial in Two Flint Deaths


Michigan’s director of the Department of Health and Human Services will stand trial on involuntary manslaughter charges stemming from the deaths of two men linked to Legionnaires’ disease in the Flint area in 2015, a judge ordered this week.
According to the Associated Press (AP), the director, Nick Lyon, is accused of not issuing a timely alert about the outbreak of Legionnaires’ disease in the wake of Flint’s lead-tainted water scandal. AP reports that Lyon is the highest-ranking official to face criminal charges in the scandal.
An expert who had been a local public health official in Ohio for more than 3 decades told Medscape Medical News the judge’s decision is “sobering.”
According to multiple media reports, cases of Legionnaires’ disease have been linked by some experts with Flint’s water scandal. In 2014 and 2015, water wasn’t properly treated, and lead leached into the drinking water.
AP reported that at least 90 cases of Legionnaires’ disease occurred in Genesee County, including 12 deaths. More than half of those affected had spent time at McLaren Hospital, which was on the Flint water system.
Lyon and Michigan Gov. Rick Snyder announced the outbreak in January 2016, “although Lyon concedes that he knew that cases were being reported many months earlier,” AP reports.

Judge Says Deaths Could Likely Have Been Prevented

District Court Judge David Goggins said the deaths of Robert Skidmore, 85, and John Snyder, 83, two men who contracted the waterborne Legionnaires’ disease after being hospitalized at McLaren, could likely have been prevented had the Legionnaires outbreak been publicized. The judge said keeping the information from the public was “corrupt.”
The Detroit News reported that Goggins found that “Lyon knew about the outbreak in 2015.”
AP reported that Lyon’s attorney, John Bursch, said the judge’s decision was “mystifying” and quoted Bursch as saying outside court, “We had 20 pages of argument in our legal brief that he didn’t address.”
Lyon denies wrongdoing. AP reports Lyon’s defense team said there was “not enough solid information to share earlier with the public.”

Defense Says Ruling Could Have “Chilling Effect”

Crain’s Detroit Business reported that Bursch previously had told the judge that prosecuting Lyon for manslaughter and misconduct in office could create a precedent and have a “chilling effect” on state employees, whose actions could be second-guessed by a prosecutor.
Teresa C. Long, MD, MPH, was assistant health commissioner and then health commissioner of Columbus, Ohio’s public health department from 1986 to 2017. She was regularly faced with decisions as to when to notify about outbreaks.
She is now special adviser for community engagement and partnership and an adjunct associate professor at Ohio State University’s College of Public Health in Columbus.
Long told Medscape Medical News that she is not aware of a case similar to Lyon’s.
“As a local health official, I always depended on the best science available to make the difficult decision that would protect or further impact the health of our community. It’s balancing the duty to protect the privacy of patients or persons involved in an outbreak investigation with the duty to inform or warn the public or any party who could be exposed or at risk,” she said.
These were already extremely difficult decisions, Long said, but this ruling may cause “additional thought.”
“This will be very sobering, but I think public officials will ultimately fall on the side of protecting the health of the public,” she said.
The judge’s ruling did not change the mind of Governor Snyder about Lyon’s employment.
AP quoted the governor as saying Lyon “has my full faith and confidence” and that Lyon would remain Michigan’s health director.
AP reports that 14 current or former state and local officials have been charged with crimes related either to Legionnaires’ disease or lead in the water. Four took misdemeanor plea deals, and the other cases are in progress.

Tossed By Pfizer, Drug In New Haven Overdose Back As Black-Market Menace


When the victims were struggling to breathe and the medics were working over them, there was no time to think about the journey of a synthetic drug as it traveled from the trash bin of a Connecticut pharmaceutical giant to clandestine overseas labs to the center of the recent mass overdose on the New Haven Green.
But a whole group of people, from recovery counselors and doctors, to lawmakers and law enforcers, are troubled by the presence of the iterations of Fubinaca and similar synthetic compounds in cities with populations drawn to their cheap price, growing availability, and the ease in which the drugs are mixed with the potpourri-like synthetic K2 and smoked in what looks like its less insidious sister, a marijuana cigarette.
The route that versions of the substance took to surface on a Brooklyn sidewalk in July 2016 where it knocked down 33 people, or the New Haven Green, where it led to 114 ambulance transports, or in Texas, or in Pennsylvania, is in itself a demonstration of the daunting challenges they present to law enforcement and to health care.
Ab-Fubinaca was formed in 2009 in a lab at Pfizer Pharmaceutical, the massive drug company with an extensive research and laboratory operation in Groton.
Pfizer scientists thought they may have had a fix on a new drug to relieve pain and suffering in cancer patients, oncology being one of the fields that the drug giant is focusing on, along with vaccines, immunotherapy and gene therapy.
The company applied for a patent outlining in the application form the chemical “entity” — the structure of, and formula for the compound they hoped to produce. The scientists conducted laboratory experiments.
It wasn’t working.
Top White House Drug Official Visits New Haven After K2 Mass Overdose »
In short order, the research was halted and the drug was abandoned by Pfizer even before it was tested on humans, spokeswoman Sally Beatty said. These starts and stops aren’t unusual in a research lab.
“It’s the way science works,” Beatty said.
All work on the drug was stopped before the application had a chance to advance in the U.S. Patent Office, and a patent was never issued. Pfizer would receive a notice from the office in 2013 that the application had been abandoned.
But a blueprint was out in the world. There is enough information in these drug-patent applications, which are in the public domain, for other scientists in other labs to continue the development. This information sharing is also the way science works, and most of the time, it is for the good.
But not always.
“It’s a balancing act,” said Rod Marriott, drug-control chief for the Connecticut Department of Consumer Protection. “Public information versus the harm the information might cause to the public.”
Overdose Victims Aid Police In Search For K2 Suspects »
Nefarious scientists in clandestine labs are forever looking for abandoned research drugs they can exploit, especially in the area of synthetic narcotics.
Consider the plight of John W. Huffman, a highly regarded professor and organic chemist at Clemson University. He and his team blended THC, the ingredient in marijuana that makes the smoker high, with synthetic “cannabinoid” compounds to research the effect on receptors in the human nervous system. It didn’t take long for people in Germany to start mixing the new compounds with “Spice,” their version of K2, to produce a dangerously potent high.
Born with good intent the “JWH” series of synthetic compounds is now illegal in the U.S., classified as a controlled substance. As for Huffman, he has served as an expert witness and has cooperated with law enforcement.
In Connecticut, three of the JWH compounds are expressly banned and designated as “schedule 1 drugs” — with no medical purpose.
Nationally, AB-Fubinaca is also a designated schedule 1 controlled substance. Among the effects of the group of related Fubinaca compounds are drowsiness, lightheadedness, and fast or irregular heartbeat. The more severe reactions include psychosis, seizures, kidney injury, hyperthermia and death.
But the various Fubinaca compounds have long been stars in the black-market labs of China and other locations in Asia.
Sen. Richard Blumenthal of Connecticut, speaking after the New Haven outbreak, said K2 laced with versions of Fubinaca and other compounds flow across the Mexican border, and is also available cheap on the Internet.
“China is the enemy when it comes to synthetics,” Blumenthal said. “It’s not happening without the tolerance” of the Chinese government.
And with the drugs now prevalent in the U.S., “we’re not going to arrest our way out of the problem,” Blumenthal said.
Since there were no laboratory trials for the Fubinaca group, overdose victims have served as the test groups.
After the Brooklyn outbreak in 2016, Roy Gerona, a research scientist at the University of California, San Francisco, and several colleagues tested blood and urine samples of eight of the overdose victims, most of whom had displayed “zombie-like” symptoms after smoking synthetic cannabis.
Writing in the New England Journal of Medicine in January 2017, Gerona and his co-authors reported that AMB-Fubinaca, another iteration of the Pfizer research drug, was identified in all eight patients. It had acted like a “strong depressant” that accounted for the zombie-like behavior, and was “an example of the emerging class of ultrapotent” synthetic drugs that pose a public-health concern .
These synthetics, the researchers wrote, “shifted from research tools to drugs of abuse in 2008.” That’s when samples of K2, or “Spice” as it is known in Europe, were first found to contain one or more of the “JWH” compounds.
“Since then, new synthetic cannabinoids have been developed in clandestine laboratories in China and South Asia and distributed by ‘dark net’ retailers, street drug dealers, and organized crime groups as inexpensive alternatives” to cocaine and other traditional drugs of abuse,” the team wrote in the New England Journal.
And what makes reigning in the synthetic menace so difficult for law enforcement and regulators is that one tiny change in the formula produces a whole new drug, noted Marriott, consumer protection’s drug-control chief.
“In the synthetic world, there are many iterations of the same drug — Fubinaca may not be Fubinaca anymore, simply because small components were changed,” said Marriott.
He said these drugs can defy urine screens and other drug tests, and developing new tests that can keep up with the latest synthetic concoctions is expensive and challenging, Marriott said.
The rapid changes “make it hard to track down the source or write laws that encompass all of the compounds,” he said.

Administration, Senate move forward on pricing transparency proposals


Months after President Donald Trump rolled out his administration’s drug pricing “blueprint,” wheels are in motion in Washington, D.C., as legislators and the federal government work to implement proposals pushing more transparency.
On Thursday, the Senate voted to include legislation from Sen. Chuck Grassley, R-Iowa, and Sen. Dick Durbin, D-Ill., that directs the HHS to form rules about requiring pharmaceutical pricing in DTC advertising. The legislation came in the form of an amendment to a healthcare spending bill; the House of Representatives still needs to approve its own version of the bill.
Speaking on the amendment Thursday, Sen. Chuck Grassley said on the Senate floor that “pharmaceutical companies are already interested in consumer education. We just want them to take it one step further.”
The drug industry opposes the proposal. A PhRMA representative said in a statement that price disclosures in DTC ads “would not benefit patients as they are often not the prices insurers pay and are generally not a good indicator of what patients will pay at the pharmacy counter.” Plus, she said, such a law would “raise significant legal issues, including First Amendment concerns.”
Senator Dick Durbin
✔@SenatorDurbin
The amendment @ChuckGrassley & I introduced on transparent drug pricing was supported by Democrats & Republicans, @AARP@AmerMedicalAssn, 76% of Americans, Pres Trump & HHS. The only group who opposed it? Big Pharma.
Unanimously passing it today is a big win for consumers.
Meanwhile this week, the Office of Management and Budget posted a proposed regulation called “Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency.” Exact details on the proposal remain unclear. An HHS spokesperson said in a statement the agency can’t comment on pending regulations, but that the administration’s “blueprint to lower prescription drug prices and reduce out-of pocket costs clearly states that HHS is looking at options to require drug-pricing transparency.
“It should not come as a surprise that this would require rulemaking,” she added.
The moves come after Trump and HHS secretary Alex Azar presented their drug pricing blueprint in May. The plan calls for more negotiation, more transparency, incentives to lower list prices and lower out-of-pocket costs for patients. After the announcement, numerous industry watchers said they felt the proposals came short of the measures needed to lower prices. Wells Fargo analyst David Maris, however, wrote that the administration is “actually trying to address some of the root causes of price inflation and lack of affordability.”
Already since the press conference, the FDA has started highlighting complaints by generics companies against their branded counterparts for regulatory abuses that stifle generic competition. Additionally, CMS has allowed Medicare Advantage plans to implement step therapy for new patients and negotiate prices in an effort to control pharmaceutical costs.

Herbalife Nutrition to Present at Ag Chem International Annual Meeting


Herbalife Nutrition (NYSE: HLF), a premier global nutrition company whose purpose is to make the world healthier and happier, is presenting two papers on tea extraction at the Association of Official Agricultural Chemists (AOAC) International’s Annual Meeting and Exposition taking place in Toronto, Canada, from Aug. 26-29.
“At Herbalife Nutrition, we’ve implemented an industry-leading botanical science program to guarantee that the highest quality botanical ingredients are used in our products and our research on tea extraction will help further document the science of DNA quality,” said Gary Swanson, senior vice president, Global Quality, Herbalife Nutrition.
The first paper, entitled “DNA Quality and Quantity Analysis of Camellia Sinensis through Processing From Fresh Leaves to a Green Tea Extract Product,” is being co-presented by Herbalife Nutrition and University of Guelph as part of our work with the NHP Research Alliance. Herbalife Nutrition quality scientists Yanjun Zhang, Ph.D., and Zhengfei Lu, Ph.D., and Adam Faller, Ph.D. Candidate from College of Biological Sciences, University of Guelph, Ontario, Canada, conducted a study to measure multiple DNA variables after each step in the processing of a green tea extract (GTE) product, in order to document DNA quality and quantity. This work demonstrated successful DNA extraction, PCR amplification, sequencing and identification using a highly-processed botanical extract product. The results saw a 41.1% decrease in mean extractable genomic DNA through farm processing (p<0.01) and a 99.7% decrease through facility processing (p<0.05) demonstrating successful DNA extraction, PCR amplification, sequencing and identification using a highly-processed botanical extract product.
The second paper evaluating tea extraction, entitled “Qualification and Certification of Tea Extracts using NMR,” is being presented by Herbalife Nutrition quality scientist Congmei Cao, Ph.D. Multiple lots of different tea extracts with controlled processing procedures were evaluated to determine the representative chemical profile of tea extract using chemometrics and nuclear magnetic resonance spectroscopy (NMR). This is an advanced approach that meets the need of Herbalife Nutrition for botanical authentication and can also be adopted by other companies in the nutraceutical industry. The principle components for differentiating the tea extracts were identified and quantified. After assessment of stability and homogeneity, these characterized tea extracts will be certified as in-house reference materials with intended use for identification of specific tea extracts and quantification of principle components in these tea extracts.
In addition, the AOAC has accepted nine other poster submissions from Herbalife Nutrition scientists that cover a range of analytical methodologies and advancements in areas including alternative sweetener testing, DNA extraction, protein powder testing, botanical extraction and aloe testing, among others.

AT&T, Softbox, Merck Test Drone Flights of Medical Supplies in Puerto Rico


AT&T* is taking part in a proof of concept with Softbox to test connected medical payloads carried by drones. The goal? Successfully and safely deliver temperature-sensitive medicines using drones.
An LTE-connected drone carrying Softbox’s thermal-insulated packaging system “Skypod,” which includes a smartbox powered by AT&T’s Internet of Things (IoT) technology, successfully completed demonstration flights. The field trial with Merck, the pharmaceutical company, took place in locations across Puerto Rico. Softbox, based in the UK, provides specialist temperature control packaging to the pharmaceutical industry.
“Merck is pleased to collaborate on this innovative new model for delivering medicines to patients in areas affected by natural disasters,” said Brenda Colatrella, executive director, Corporate Responsibility at Merck. “We’re proud of our long history of expanding access to our medicines and vaccines and collaborating to provide humanitarian assistance. The drone test flights give us hope that we will be able to provide a reliable supply of our medicines for disaster.”
AT&T’s IoT technology tracks the Skypod with data viewed on a web and mobile app dashboard. The data includes near-real time external and internal temperatures of the box and its location. Light exposure data helps signal if there is box tampering during daylight, by determining if the box is open or closed.
The dashboard app will flash alerts to help drive appropriate action. For example, it will send an alert if there is a change to the temperature range of 2°C to 8°C. It will also send an alert if the drone goes outside of defined geofencing parameters.
AT&T and Softbox have adapted the Skypod from a connected flask prototype developed in the AT&T Foundrywhich they showcased earlier this year. The AT&T Foundry is a network of innovation centers that collaborates with startups, technology providers and enterprises to move ideas to market faster through rapid prototyping. It moved the IoT sensors that track temperature and location from the lid of the original prototype and fit them into the smartbox.

King Bio Recalls 32 Homeopathic Kids’ Meds Due to Microbial Contamination


Children’s medicine manufacturer King Bio has recalled 32 different homeopathic medicinesdue to microbial contamination, the company announced late Wednesday. The recall was voluntarily made by the company.
North Carolina-based King Bio said a small percentage of its products that were manufactured between Aug. 1, 2017, and April of this year tested positive for microbial contamination. The company said it was “out of an abundance of caution” that it was recalling the products, which are billed as natural remedies. King Bio said use of the drug products that have been contaminated could “potentially result in increased infections that may require medical intervention,” the company said in a statement. Those infections could be life-threatening, the company added. The company did not elaborate on what kind of microbial contamination was discovered, nor did it specify when it became aware of the contamination.
King Bio said it has not yet received any reports of injury or illness. If there are adverse reactions or other issues due to the product, they may be reported to the FDA’s MedWatch Adverse Event Reporting program.
The King Bio medicines that have been recalled, which bear the “Dr. King’s” label, include those developed to treat flu, colds, rashes, stomach aches, teething, chicken pox relief and more. A full list of recalled medications and their lot numbers can be found at the U.S. Food and Drug Administration information page about the recall.
Some of the medicines include:
  •          DK Attention & Learning Enh.
  •          Chicken Pox Symptom Relief
  •          Children’s Appetite & Weight
  •          Children’s Appetite Enhance
  •          Children’s Cough Relief
  •          Children’s Fever Reliever
  •          Children’s Growth & Development
  •          DK Nosebleed Relief
  •          DK Newborn Tonic
  •          Children’s Ear Relief Formula
  •          Bed Wetting Prevention
  •          Kid’s Sleep Aid
King Bio said it is in the process notifying its distributors and customers by letter and is also making arrangements for the return and replacement of the recalled products. King Bio said consumers and retailers who have the recalled products in their possession should discontinue use or pull the products from the shelves and reach out to King Bio at a special email address, recall@kingbio, in order to make arrangements to return the products. The recalled products were distributed nationwide between August 2017 and July 2018.