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Sorrento Therapeutics, Inc. received approval from the U.S. Food and Drug Administration for its non-opioid painkiller patch, ZTlido (lidocaine topical system) 1.8%.

ZTlido is indicated for the relief of pain associated with post-herpetic neuralgia (PHN), also referred to as post-shingles pain. ZTlido is a major advancement in analgesics because of its proprietary adhesion technology demonstrating 12-hour wear with efficient lidocaine delivery, even during exercise. ZTlido was designed to solve a problem that is commonly reported with transdermal/topical patches: they don’t stay on.

"Post herpetic neuralgia is a perfect example of why we have an opioid crisis," William Pedranti, chief operating officer at the Sorrento subsidiary SCILEX told Reuters. "There’s no opioids that are approved by the FDA to treat PHN (but) the number 1 prescribed product first-line is an opioid."

"Topical lidocaine is an important option for healthcare providers to have in their armamentarium for treating PHN, a difficult-to-treat neuropathic pain," stated Dr. Jeff Gudin, Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center. "The Centers for Disease Control and Prevention’s guideline of non-opioid treatments for chronic pain recognizes topical lidocaine as an alternative first-line therapy. ZTlido now offers providers and patients this option."

According to recent IMS data, more than 100 million prescription lidocaine patches were sold in the US in 2017. Sorrento intends to have Scilex complete the final steps necessary to commercial launch of ZTlido in the US with the objective to make the product commercially available to patients sometime in 2018.

ZTlido is comprised of a non-aqueous adhesive material containing 1.8% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is perforated in the middle and removed prior to application to the skin. The size of the topical system is 10 cm × 14 cm x 0.08 cm thick. ZTlido is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

The treatment’s approval puts the bandage-like patch into a market currently split between Endo International Plc’s Lidoderm, which has been on the market for nearly 20 years, and generic versions of that product.

ZTlido improves upon Lidoderm by offering better adhesion and delivers equivalent doses of the pain-relieving active ingredient, lidocaine, more effectively, the company said.

"We’re not saying that it (ZTlido) is a massively better product," Raghuram Selvaraju, an analyst at H.C. Wainwright said. "It is an incrementally better product, which we believe, is going to be actively promoted." Selvaraju expects U.S. sales of the drug to peak at $1.1 billion in 2025.
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/ 2018 News, Daily News
Ride-hail drivers are, by and large, untrained, self-employed workers driving their own cars on a part-time basis. They’re not medical professionals.

But as health care costs have risen and ride-hail has become more pervasive, people are increasingly relying on Uber and Lyft drivers to get them to the hospital when they need emergency care.

A recent (yet to be peer-reviewed) study found that, after Uber enters new markets, the rates of ambulance rides typically go down, meaning fewer people call professionals in favor of the cheaper option.

People have always taken taxis to the hospital, but ride-hail technology makes it much easier, especially in less densely populated cities. This money-saving tactic might make sense for people in noncritical condition, but it puts ride-hail drivers in an uncomfortable position. They’re forced to choose between assuming potential legal liability if something goes wrong, or dealing with a sense of guilt and the fear of getting a lower rating if they decline or cancel the ride.

If Uber drivers were employees of Uber, then Uber would be liable if something bad happened to a passenger en route to the hospital. But because drivers are independent contractors, they could be held responsible for any failure to provide care during the business transaction.

As independent contractors, Uber and Lyft drivers can turn down any ride that makes them uncomfortable. The companies also charge riders for cleaning fees and repay drivers for the expense, though drivers say this process is a major headache that can take weeks. Both companies said low ratings or demerits for canceling on a rider experiencing a medical emergency could be expunged from a driver’s record.

"Uber is not a substitute for law enforcement or medical professionals," an Uber spokesperson told BuzzFeed News. "In the event of any medical emergency, we encourage people to call 911."

Lyft said the same, adding, "If a driver encounters a passenger with an emergency situation, they should contact 911. After that, they should report the incident to our 24/7 critical response line so we can take appropriate action."

But drivers told BuzzFeed News that neither Uber or Lyft have provided them with direct guidance about what they should do when a passenger expects to be taken to the ER.

And it’s not just the patients who are put at risk when they opt to call a car rather than an ambulance. When drivers give rides to sick people, they’re exposed to germs and the possibility of infection. One driver remembered with horror picking a patient up at the hospital whose colostomy bag exploded on the way home. Another said he had to wipe down the backseat of his car after driving a woman in labor to the hospital. Experienced drivers recommend getting leather or plastic, never fabric, seats.

Uber and Lyft didn’t create this problem. Emergency medical transportation is expensive, with ambulance rides costing patients hundreds or even thousands of dollars, even if they have health insurance. More than half of Americans say an unplanned $1,000 expense would put them in debt.
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/ 2018 News, Daily News
In 2012, a five-man crew of employees of Key Energy Services, Inc. was working on an oil rig. A large sections of tubing was being pulled out of the well hole. A wet box was being used to deflect a liquid that was coming out with the tubing, in order to avoid getting crew members wet.

A sudden release of pressure from the well tubing caused a powerful blast; which blew the wet box upward and into a tree. After the blast, Norberto Gomez was found lying on the floor, with a head wound; he was hospitalized with a fractured skull.

The DIR Division of Occupational Safety and Health was notified, and dispatched an investigator. Cal/OSHA requested Key Energy’s Form 300 log, which is a log in which employers are required to record work-related injuries.

In June 2013, the Division issued four citations to Key Energy, including a citation for failing to fully complete the Form 300 log entries. The Form 300 citation was based on the failure to include complete information in column F, identifying the "object/substance that directly injured or made person ill."

Key Energy appealed the citations. The ALJ issued a decision upholding the Form 300 citation and imposed a $450 penalty. Key Energy petitioned for reconsideration. The Board denyied the petition for reconsideration. Key Energy then petitioned the superior court for a writ of mandate directing the Board to vacate its decision on the citation in issue. The trial court denied the writ. Key Energy appeals that denial.

The employer contends substantial evidence did not support the Board’s finding that it violated the regulation. The court of appeal concluded that substantial evidence supports the finding of violation in the unpublished case of Key Energy Services, Inc. v. Cal. Occupational Safety and Health Appeals Bd.

The heading of Form 300 column F states: "Describe injury or illness, parts of body affected, and object/substance that directly injured or made person ill. (e.g. Second degree burns on right forearm from acetylene torch)." For Gomez’s injury, the entry in column F reads: "Fractured skull-Forehead."

The ALJ rejected Key Energy’s argument that it was only required by the regulation to "use" Form 300, not to fully complete it. "It would be pointless to require employers to use the form 300, but not require them to fill it out correctly and completely." The ALJ added: "Even if Employer were unsure as to what actually caused the injury on December 10, 2012, Employer could have recorded ‘unknown’ in column ‘F.’ "

The court of appeal noted that the record contains no evidence supporting Key Energy’s argument. It offered no evidence regarding the reason for its omission of information from column F of Form 300 for Gomez’s accident. Shortly after the accident that injured Gomez, Key Energy conducted itself as if the wet box were the object that directly injured him. The record contained substantial evidence that Gomez was struck by the wet box ...
/ 2018 News, Daily News
The Department of Justice announced it will be filing a Statement of Interest in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors.

The plaintiffs include numerous cities, municipalities, and medical institutions that have borne the costs of the prescription opioid crisis. The plaintiffs seek to recover the costs associated with providing treatment and public safety measures relating to the opioid epidemic from those who allegedly used false, deceptive, or unfair marketing practices for prescription opioid drugs.

The Justice Department will primarily argue that the federal government - through various federal health programs and law enforcement efforts - has borne substantial costs from the opioid epidemic and seeks reimbursement.

Named in the litigation are opioid manufacturers Purdue Pharma LP, Johnson & Johnson, Teva Pharmaceutical Industries Ltd, Endo International PLC and Allergan PLC and the three biggest drug distributors in the country - AmerisourceBergen Corp, Cardinal Health Inc and McKesson Corp..

The consolidated litigation pending before U.S. District Judge Dan Polster involves at least 355 lawsuits filed by cities, counties and others.

Polster has been pushing for a quick, global settlement in the litigation and has invited state attorneys general who have cases in state courts or who are conducting a multistate probe of the companies to participate in those talks.

The first settlement hearing was held in January. A second one is expected March on 6.

The Justice Department is not expected to participate in the settlement discussions. Its statement of interest in the litigation will allow it to eventually get a share of the final settlement the companies pay.

Plaintiffs’ lawyers have not quantified the potential costs involved in the cases but have compared them with the litigation by states against the tobacco industry that led to 1998’s $246 billion settlement ...
/ 2018 News, Daily News
Richard Johnson worked as a firefighter for the City of South San Francisco (CSSF) from March 1973 to October 2001. He then worked for the City of Pacifica (Pacifica). He was exposed to known carcinogens during each period of employment. He was diagnosed nasopharyngeal cancer in 2007.

The cancer was found to have initially manifested itself during 2005, when Johnson first noted symptoms of nasal obstruction. The disability was found to have occurred in 2007, during Johnson’s employment with Pacifica.

Johnson filed a workers’ compensation claim against Pacifica. He invoked the presumption of section 3212.1 that cancer manifesting during (or within certain periods following) employment as a firefighter that involves exposure to known carcinogens arose out of and in the course of that employment.

Pacifica denied liability and joined CSSF as a party to the case. CSSF eventually settled with Johnson for all of his cancer-related compensation, and it then sought contribution from Pacifica. An arbitrator denied the petition, ruling that evidence of the latency period for the cancer suffered by Johnson showed the injurious exposure under section 5500.5(a) occurred during Johnson’s earlier employment with CSSF. The Workers’ Compensation Appeals Board (WCAB) upheld and adopted the arbitrator’s order.

CSSF petitioned for review, contending the WCAB, in adopting the arbitrator’s determination, erroneously utilized a more lenient preponderance evidentiary standard in applying section 5500.5(a), rather than the more stringent cancer presumption rebuttal standard provided in section 3212.1. The Court of Appeal affirmed the WCAB in the published case of City of South San Francisco v WCAB, City of Pacifica.

Labor Code section 3212.1 establishes a presumption that cancer manifesting during and for a specified period following employment in certain public safety positions, including firefighters, arose out of and in the course of that employment.

Section 5500.5, subdivision (a) (section 5500.5(a)), however, limits employer liability for a cumulative injury to the employer who employed the applicant during the one year preceding the earliest of (1) the date of injury or (2) the last date of injurious exposure to the hazards that caused the injury. Thus, either CSSF or Pacifica would be potentially responsible for compensation for the entire injury, dependent upon the proper application of section 5500.5(a).

The arbitrator determined the date of injury was in 2007. The dispositive issue was whether the last injurious exposure resulting in the injury occurred during CSSF or Pacifica employment.

The Court of Appeal ruled that an employer is not liable under section 5500.5(a) absent evidence that exposure during that employment was a contributing cause of the disease or injury, i.e., that the exposure was injurious.

Section 3212.1 does not eliminate the requirement that an industrial injury be proximately caused by the hazardous exposure. Instead, it applies presumptions of a causal link between exposure to the industrial hazard (a known carcinogen) and the manifested injury (cancer), unless the employer disproves the existence of such a link ...
/ 2018 News, Daily News
California received its first royalty check on $3 billion in bonds sold to support stem cell research. Now, debate is kicking up on whether a $190,346 check is enough of a return on investment to get voters’ OK for billions more to fund the state stem cell agency, the California Institute for Regenerative Medicine (CIRM).

The payment from City of Hope, a Los Angeles County-based research center, comes as supporters of CIRM gear up for a 2020 voter initiative to fund another series of billion-dollar bond sales. The current authority to sell bonds ends in 2019.

Connecticut, Maryland, New Jersey, and New York also are among the states publicly funding stem cell research, though none to the extent of California in issuing billions of dollars in bonds.

In the aggregate, CIRM has awarded $2.48 billion to fund stem cell research, including infrastructure such as lab construction at Stanford University and University of California campuses, since voters approved Proposition 71 creating the agency in 2004.

California Proposition 71 was on the November 2, 2004 general election ballot in California as an initiated constitutional amendment. Voters approved it. The measure has been codified as Article XXXV of the California Constitution and is also known as the California Stem Cell Research and Cures Initiative.

The City of Hope’s Beckman Research Institute paid the state $190,346 according to a CIRM royalty formula when the agency awarded the institute $5.125 million to develop stem cell therapies for glioblastoma, an aggressive form of brain cancer. The payment was announced Feb. 12.

The 2012 City of Hope award led to two clinical trials and a number of offshoot inventions subsequently licensed to a Mustang Bio, a subsidiary of Fortress Biotech Inc., CIRM spokesman Kevin McCormack said in a blog post.

But, as the original funding based upon Proposition 71 is about to run out, the promoters of CIRM are out with a new scheme to get another $5 billion from California taxpayers. The initial $3 billion in bonds were estimated to cost the state $5.5 billion to $6 billion in interest and principal over their 30-year life.

CIRM battled lawsuits over Prop. 71’s validity that hindered California’s ability to sell bonds and defended against complaints about built-in conflicts for the initiative requiring disease advocates and researchers sit on the governing board.

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/ 2018 News, Daily News
A medical doctor was arrested on federal charges of illegally selling prescriptions without a legitimate medical purpose to undercover operatives who visited the physician’s Victorville medical office.

Wendell Mark Street, 66, of Las Vegas, was arrested without incident at his residence by special agents with the Drug Enforcement Administration.

Street is a 1981 graduate of the Medical College of Wisconsin. He practiced at 14075 Hesperia Road in Victorville, Street surrendered his California medical license in 2016.

The 44 page Accusation filed by the California Medical Board in December 2014 essentially details prescriptions written to a number of patients who are identified only by their first and last name initials. Details are provided on how each of them was prescribed controlled substances in violation of law or professional standards. By February 23, 2016, Street and his attorney, Thomas Chapin Esq., signed a Stipulated Surrender of License.

The arrest is the result of a 10-count indictment returned by a federal grand jury on February 9. The indictment charges Street with five counts of illegally distributing the painkiller oxycodone and five counts of illegally distributing the tranquilizer alprazolam (often sold under the brand name Xanax). Street allegedly issued the prescriptions in 2013 in exchange for cash "while acting and intending to act outside the usual course of professional practice and without a legitimate medical purpose."

Street allegedly wrote prescriptions without performing any physical examinations in exchange for $200 to $300 in cash from each of two undercover investigators with the California Medical Board and an informant. During the investigation into Street, investigators executed a search warrant at his Victorville office in 2014.

Street is expected to make his initial appearance in the United States District Court in Las Vegas. The five counts related to illegal distribution of oxycodone each carry a statutory maximum penalty of 20 years in federal prison. The five counts related to alprazolam each carry a sentence of up to five years in prison.

This case is being prosecuted by Assistant United States Attorney Victoria A. Degtyareva of the Organized Crime Drug Enforcement Task Force ...
/ 2018 News, Daily News
A former Red Bluff City Councilman who pleaded guilty in November to four felonies was sentenced Thursday to a five-year, eight-month suspended prison sentence and placed on probation for five years. The Record Searchlight reported that the 44-year-old Suren Patel, who faced a maximum seven-year, eight-month sentence, pleaded guilty tin November to workers' compensation fraud, grand theft and two counts of public officer crime.

Under the sentence handed down Thursday, Patel will have to serve 364 days in jail, minus 120 days of custody credits, do 80 hours of community service and pay more than $12,500 in restitution. If he violates his parole, he faces nearly eight years in prison.

Tehama County Superior Court Judge Matthew C. McGlynn, who labeled Patel a thief who has shown no remorse for his crimes, imposed the suspended sentence as recommended by probation officials.

After court, Tehama County District Attorney Gregg Cohen, who argued that Patel deserved a prison sentence, said he was "disappointed" in the ruling because Patel violated his position of public trust as a Red Bluff City Councilman and should go to prison. "He certainly deserved it," he said.

Patel entered his guilty pleas on Nov. 17, but did so without being guaranteed a stipulated sentence, said Tehama County Assistant District Attorney Matt Rogers Patel was originally charged with seven criminal counts that included perjury, elder theft, and conspiracy to commit a crime.

Cohen has said Patel had been the subject of an investigation that started in 2015 that culminated in his July 2016 arrest in Florida.

Patel, the former owner of the American Best Valley Inn in Red Bluff, was arrested as he tried to board a plane, Cohen has said.

Among charges Patel faced were theft, not paying taxes to the city and fraud. Cohen said Patel did not pay taxes he owed to the city as owner of the American Best Valley Inn. He was investigated for embezzlement in connection to a complaint filed by a guest at the hotel who said her credit card was charged $6,000 after she stayed there, Cohen said. Restitution has been made in her case, he said.

Authorities opened the investigation against Patel in March 2015 and that May the District Attorney's Office took computers, cell phones and business records from the hotel.

During the investigation, the DA's Office learned Patel had not paid workers' compensation insurance and was committing welfare fraud by getting two employees benefits, Cohen has said.
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/ 2018 News, Daily News
An Oakland orthopedic surgeon, and popular AME, who surrendered his medical license last year on grounds of sexual and unprofessional conduct, has now also been suspended from participating in California's workers' compensation system.

The DWC said John David Warbritton III, M.D. was one of 20 medical providers it recently suspended from participating in the workers' compensation system, bringing the total number of providers suspended to 197.

Warbritton was a graduate of Harvard Medical School in 1980, and had an office at Frank Ogawa Plaza in Oakland. He surrendered his medical license on April 7, 2017, after the California Medical Board accused him of sexually harassing two of his workers' compensation patients.

Warbritton is also facing felony criminal charges in federal court for allegedly transporting child pornography.

The criminal indictment, which was filed on Oct. 13, 2016, alleges that Warbritton violated federal law by knowingly transporting child pornography. He was initially released on an unsecured bond.

But, after the United States Pretrial Services officer reported a violation of his conditions of release (possessing child pornography images on a mobile phone), the Honorable Magistrate Judge Elizabeth D. Laporte held a bail review hearing on January 17, 2017, and detained Dr. Warbritton. He was placed in the Santa Rita Jail.

Last May, he filed a Motion to Reopen his Detention Hearing. His lawyers claimed that "At the time of the alleged offense conduct and the subsequent pretrial release violation in this matter, Dr. Warbritton was suffering from both opioid use disorder and sexual impulsivity disorder." They claim he subsequently began treatment with Carolyn Ann Schuman, M.D. for his opioid addiction, and that "his incarceration ultimately allowed him to "dry out" from the use of opioids and allowed the Suboxone treatment employed by Dr. Schuman to take effect."

Prosecutors opposed the Motion claiming "defendant has been a hands-on offender because the defendant was arrested after returning to the United States from Thailand, where he admitted to agents he has spent long periods of time for the last several years" And among the child pornography taken from him by authorities, "one photo collage depicted the defendant along with an Asian female aged 8-10 years old. ....This photograph collage also raises concerns about whether the defendant may be a hands-on offender or someone who was preparing to do so."

Prosecutors concluding by saying there are no conditions of release that could reasonably assure the safety of the community. Warbritton remains in custody awaiting trial ...
/ 2018 News, Daily News
Crawford & Company announced the expansion of its service portfolio in Australia to include workers’ compensation. This capability will be delivered through Broadspire, the TPA solution of Crawford & Company. The company’s workers’ compensation service offering will support existing customers and other large insurers, corporations and government departments.

"We are excited to bring our workers’ compensation solution to the Australia market to complement our other professional claims solutions which are already well established in country," said Stuart Greaves, head of Broadspire Australia. "The expansion enables us to further Crawford’s mission of restoring and enhancing lives, businesses and communities as we work to provide the best care for those affected by injury."

As part of its market launch, Broadspire is sponsoring the 19th Annual National Workers’ Compensation Summit in Sydney to introduce the new service line to insurers, brokers, government bodies and self-insured organizations.

"Providing professional claims management on workers' compensation claims, along with appropriate clinical oversight for injured employees is a critical aspect of the services we provide," said Danielle Lisenbey, global president, TPA Solutions for Broadspire.

"Each risk management program is designed around individual client needs to help reduce claims costs and workers' compensation premiums."

Broadspire’s workers’ compensation claims solution includes injury management services, legal cost containment, subrogation and a full suite of analytics. This is combined with medical management and multi-disciplinary expertise that it says can help ensure a swift and healthy return to work for employees.
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/ 2018 News, Daily News
Anthem Blue Cross is accusing Sonoma West Medical Center and Palm Drive Health Care District of participating in a business fraud scheme that has resulted in more than $13.5 million in improper payments to the medical center.

In a Feb. 9 letter to both the district and medical center, According to the report in Reuters, Anthem threatened legal action and demanded the money be repaid. District and hospital officials say they’ve done nothing wrong and are preparing a response to the insurance giant.

The Anthem letter states that the medical center "appears to have conspired with several third parties to fabricate or misrepresent claims for toxicology testing services that were improperly billed to Anthem."

Anthem alleges the fraudulent billing began after Sonoma West Medical Center partnered with Florida-based Durall Capital Holdings and its testing laboratory, Reliance Laboratory Testing.

The partnership with Durall was forged last year as a way to help the financially strapped hospital. In exchange for more than $2 million in much-needed funds, the hospital agreed to conduct toxicology testing for Durall, using part of the money to buy equipment.

John Peleuses, the medical center’s CEO, said the arrangement has been extremely helpful for the hospital, which has actually started showing a profit since September.

The insurance company says that according to the medical center’s own public records, health care providers from around the country send their patients’ specimens to Reliance’s Florida facility, which then distributes specimens to various labs for screening, including the one at Sonoma West Medical Center.

"Reliance Labs keeps a portion of the specimen and conducts testing on it, while purportedly passing on a portion of the sample to Sonoma West for additional testing," Anthem’s letter states.

"Sonoma West bills Anthem for some or all of this testing - representing that it had performed the services when, in fact, it had not," the letter states.

Peleuses rejected the claim that no testing is being done at the Sebastopol hospital. "We dispute the assertions in the letter and a response to Anthem is being prepared to address their concerns," Peleuses said.

Anthem said a review of claims submitted by the medical center were for drug testing on urine samples where the patients "had no connection whatsoever with Sonoma West. That is, the patients were not treated at Sonoma West, nor were they treated by a physician connected with Sonoma West who ordered laboratory services to be performed at Sonoma West."

Anthem’s letter, written by the insurance company’s associate general counsel Steven Cohen, pointed out that the medical center, as a hospital, "receives substantially higher amounts for urine drug testing, often 10 times or more, relative to the lesser amount" Anthem would pay clinical laboratories like Reliance.

"Indeed, it is that reimbursement delta that appears to be the only value that Sonoma West brings to its partners in the scheme," Cohen wrote.

But Peleuses said there was nothing improper about billing at the higher rate, particularly in the case of rural hospitals which need higher reimbursement rates to stay competitive. Peleuses also said it was common for toxicology testing to be done by laboratories that do not take samples from patients.

Anthem gave the district and hospital until Friday to respond to several demands.

Alanna Brogan, executive director of the Palm Drive Health Care District, said a response would be submitted by Friday. "There are a number of inaccuracies in the letter and we will be responding to Anthem Blue Cross," she said The district has scheduled a closed session Friday at 10 a.m. to discuss the matter ...
/ 2018 News, Daily News
A vast research study that sought to settle a long-standing debate about whether or not anti-depressant drugs really work has found they are indeed effective in relieving acute depression in adults.

The international study - a meta-analysis pooling results of 522 trials covering 21 commonly-used antidepressants and almost 120,000 patients - uncovered a range of outcomes, with some drugs proving more effective than others and some having fewer side effects.

But all 21 drugs - including both off-patent generic and newer, patented drugs - were more effective than placebos, or dummy pills, the results showed.

"Antidepressants are routinely used worldwide yet there remains considerable debate about their effectiveness and tolerability," said John Ioannidis of Stanford University in the United States, who worked on a team of researchers led by Andrea Cipriani of Britain’s Oxford University.

Cipriani said these findings now offered "the best available evidence to inform and guide doctors and patients" and should reassure people with depression that drugs can help.

The study, published in The Lancet medical journal, found some differences in the effectiveness of the 21 drugs.

In general, newer antidepressants tended to be better tolerated due to fewer side effects, while the most effective drug in terms of reducing depressive symptoms was amitriptyline - a drug first discovered in the 1950s.

Some well-known medicines - such as the selective serotonin reuptake inhibitor (SSRI) fluoxetine, sold under the Prozac brand - were slightly less effective but better tolerated.

The scientists noted that their study could only look at average effects, so should not be interpreted as showing that antidepressants work in every patient. Only around 60 percent of people prescribed depression medication improve, Cipriani said.

"Unfortunately, we know that about one third of patients with depression will not respond to them," he said. "It’s clear there is still a need to improve treatments further."

Several experts not directly involved in the study said its results gave a clear message. "This meta-analysis finally puts to bed the controversy on antidepressants," said Carmine Pariante, a professor at Britain’s Institute of Psychiatry, Psychology and Neuroscience.

James Warner, a psychiatrist at Imperial College London, added: "Depression causes misery to countless thousands every year and this study adds to the existing evidence that effective treatments are available." ...
/ 2018 News, Daily News
Philip Sobol M.D., an orthopedic surgeon, agreed with Michael Drobot to receive kickbacks in exchange for performing surgeries at Pacific Hospital of Long Beach or referring spinal surgery patients to physicians who would perform the spinal surgeries at Pacific Hospital.

Sobol and Drobot concealed the kickbacks through a series of sham agreements including a management agreement and option agreement. Sobol received approximately $5.2 million dollars in kickbacks.

On November 24, 2015, Sobol entered into an agreement to plead guilty to a two-count information that charged him with Conspiracy in violation of 18 U.S.C. § 371, and Interstate Travel in Aid of a Racketeering Enterprise in violation of 18 U.S.C. § 1952.

Prosecutors filed a Sentencing Report in his criminal case on December 5. On February 24, 2017, the United States Probation Office reported that his sentencing range was 46-57 months’ imprisonment. The report noted that Sobol had agreed to pay restitution but "did not identify any victims from the harm."

But prosecutors say the Court should apply an additional two level increase because the offense involved more than ten victims.

Prosecutors reported that "it is difficult to determine exactly how many surgeries defendant referred where he received a kickback because the kickbacks were paid through sham management and option agreements that were designed to approximate the number of surgeries referred or performed at Pacific Hospital, Drobot admitted in his plea agreement that he paid between $10,000 and $15,000 per surgery performed."

His Sentencing Hearing was set for February 16, 2018. On that day, the federal court entered the following order.:

"Pursuant to the Sentencing Reform Act of 1984, it is the judgment of the Court that the defendant, Philip A. Sobol, is hereby committed on Counts 1 and 2 of the Information to the custody of the Bureau of Prisons for a term of 21 months. This term consists of 21 months on each of Counts 1 and 2, to be served concurrently."

"Upon release from imprisonment, the defendant shall be placed on supervised release for a term of three years. This term consists of three years on each of Counts 1 and 2 of the Information, all such terms to run concurrently.."

"It is further ordered that the defendant surrender himself to the institution designated by the Bureau of Prisons at or before 12 noon, on July 16, 2018. In the absence of such designation, the defendant shall report on or before the same date and time, to the United States Marshal located at the United States Court House, 411 West Fourth Street, Santa Ana, California 92701- 4516."

"It is recommended that the Bureau of Prisons designate confinement of defendant to the Lompoc, California facility." ...
/ 2018 News, Daily News
Although long derided as pseudoscience and still questioned by many medical experts, acupuncture is increasingly being embraced by patients and doctors, sometimes as an alternative to the powerful painkillers behind the nation’s opioid crisis.

The military and Veterans Affairs medical system has been offering acupuncture for pain for several years, some insurance companies cover it and now a small but growing number of Medicaid programs in states hit hard by opioid overdoses have started providing it for low-income patients. Ohio’s Medicaid program recently expanded its coverage after an opioid task force urged state officials to explore alternative pain therapies.

While there’s now been a lot of research on acupuncture for different types of pain, the quality of the studies has been mixed, and so have the results. Federal research evaluators say there’s some good evidence acupuncture can help some patients manage some forms of pain. But they also have described the benefits of acupuncture as modest, and say more research is needed.

While research continues, insurance coverage of acupuncture keeps expanding. California, Massachusetts, Oregon and Rhode Island pay for acupuncture for pain through their Medicaid insurance programs. Massachusetts and Oregon also cover acupuncture as a treatment for substance abuse, though scientists question how well it reduces the cravings caused by chemical dependency.

The California Medical Treatment Utilization Schedule for workers' compensation treatment contains an acupuncture section, and acupuncture is appropriate treatment in some circumstances.

The largest federal government insurance program, Medicare, does not pay for acupuncture. Tricare, the insurance program for active duty and retired military personnel and their families, does not pay for it either. But VA facilities offer it, charging no more than a copay.

Acupuncture has been practiced in China for thousands of years, and customarily involves inserting thin metal needles into specific points in the ears or other parts the body. Practitioners say needles applied at just the right spots can restore the flow of a mystical energy - called "qi" (pronounced CHEE) — through the body, and that can spur natural healing and pain relief.

In government surveys, 1 in 67 U.S. adults say they get acupuncture every year, up from 1 in 91 a decade earlier. That growth has taken place even though most patients pay for it themselves: 2012 figures show only a quarter of adults getting acupuncture had insurance covering the cost.

About a decade ago, the military and Veteran Affairs began promoting a range of alternative approaches to pain treatment, including acupuncture, yoga, and chiropractic care.

Now two-thirds of military hospitals and other treatment centers offer acupuncture, according to a recent study.

The military’s openness to alternatives is "because the need is so great there," said Emmeline Edwards of the National Center for Complementary and Integrative Health, a federal scientific research agency. "Perhaps some of the approaches have been used without a strong evidence base. They’re more willing to try an approach and see if it works."

Her agency is teaming up the Pentagon and the VA to spend $81 million on research projects to study the effectiveness of a variety of nondrug approaches to treating chronic pain.
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/ 2018 News, Daily News
The 2017 California legislative session ended with Governor Jerry Brown signing into law a number of bills affecting California employers:

The laws about what employers can ask job applicants continue to evolve. Here are two new areas of inquiry that are now not allowed:

AB 168 bars employers from asking job applicants about their previous salary. The legislation’s goal is to narrow the gender gap by preventing employers from basing offers on prior salary and thus, presumably, perpetuating historical discrimination. This will also remove the perceived gap in negotiating power between an employers and employees who must disclose their prior salary.

AB 1008 precludes employers from inquiring about an applicant's conviction history until after a conditional offer of employment; and Imposes new limitations upon and disclosure requirements for considering conviction history information.

Employers who wish to rely on criminal conviction information to withdraw a conditional job offer must notify the applicant of their preliminary decision, give them a copy of the report (if any), explain the applicant’s right to respond, give them at least five business days to do so, and then wait five more business days to decide what to do when an applicant contests the decision. There are exceptions for employers who operate health facilities hiring employees who will have regular access to patients or drugs.

And there are new requirements for leave, pay and other protection for workers.

SB 3 increases California's minimum wage to $11 in January 2018 and to $15 by 2022.

SB 63 requires employers with between 20 to 49 employees to provide up to 12 workweeks of "parental leave."

AB 450 prohibits employers from allowing federal immigration agencies access to worksites unless certain conditions are met.

SB 396 requires that the currently mandated sexual harassment training for supervisors be expanded to include gender identity, gender expression, and sexual orientation.

AB 46 - Public Employers Subject to Equal Pay Act Violations.

AB 1710 - Hostile work Environment Protections for Military Service Members ...
/ 2018 News, Daily News
Switzerland’s Novartis AG is preparing to auction its U.S. generic pill business, looking to shed a unit that has struggled amid fierce price competition, people familiar with the matter said on Friday.

The move illustrates how the unit has diverged from the fortunes of the rest of Novartis’ $10 billion Sandoz generics and biosimilars division. The company has fared better in manufacturing hard-to-make generic drugs, such as injectables and inhalables, than it has with easier to produce pills.

“It is a unique situation,” new Novartis Chief Executive Vasant Narasimhan told investors and analysts during the company’s fourth-quarter earnings call last month when asked about the future of the U.S. generic pills business.

“There are significant pricing declines. At least in the medium term, we don’t see a shift to that situation, and so we’re assessing how best to optimize that given that dynamic,” Narasimhan added, without saying what Novartis is looking to do with the business.

Novartis’ generic pills business could fetch as much as $1.6 billion based on estimated 12-month earnings before interest, taxes, depreciation and amortization of around $200 million, the sources said. A sale process for the unit will launch in the next few weeks and could attract other pharmaceutical companies or private equity firms, the sources added.

The sources asked not to be identified because the deliberations are confidential. Novartis declined to comment.

Sandoz was established in Basel in 1886 by Alfred Kern and Edouard Sandoz. By 1895 it had produced its first pharmaceutical substance, antipyrine, which was a fever-controlling agent.

In 1996, Sandoz was merged with rival Ciba-Geigy to form Novartis, one of the world’s biggest pharmaceutical companies which now has a market capitalization of 206 billion Swiss Francs ($223 billion).

Novartis has been looking for new blockbusters after its top seller, blood cancer drug Gleevec, lost its cancer protection. It is counting on approvals for new drugs against macular degeneration, a cause of blindness, and migraine, in partnership with U.S. drugmaker Amgen Inc (AMGN.O), as well as a pair of new multiple sclerosis drugs, to revitalize its growth.

Novartis also said last year it is considering a spin-off of its eyecare business Alcon ...
/ 2018 News, Daily News
Urine testing for patients with chronic pain has grown explosively over the past decade amid a rising death toll from opioid abuse. Pain doctors say drug testing helps them make sure patients are taking the drugs as prescribed and not mixing them with illegal substances.

Yet the testing boom costs billions of dollars annually and has raised concerns that some labs and doctors run urine tests needlessly - or charge exorbitant rates - to boost profits.

Some insurers have refused to pay, which can leave patients threatened with ruinously high bills they had no idea they had incurred.

"Surprise bills loaded with unexpected expenses and little explanation inflict sticker shock on vulnerable patients," said James Quiggle, communications director of the Coalition Against Insurance Fraud, whose members include insurers, consumer groups and government agencies. Quiggle said many "puffed-up bills straddle a fine line between abuse and outright fraud."

Prices for urine tests can vary widely depending upon complexity and the technology used. Some doctors' offices use a simple cup test, which can detect several classes of drugs on the spot. These tests rarely cost more than $200, and typically much less.

Bills climb higher when labs check for levels of multiple drugs and bill for each one, a practice insurers argue is seldom medically justified. An egregious example is featured in an NPR story about Sunset Labs LLC in Houston. After a patient had back surgery in late 2015, her surgeon prescribed an opioid painkiller and a follow-up drug test that seemed routine - until the lab slapped her with a bill for $17,850.

It charged $4,675 to check her urine for a slew of different types of opioids: $2,975 for benzodiazepines, a class of drugs for treating anxiety, and $1,700 more for amphetamines. Tests to detect cocaine, marijuana and phencyclidine, an illegal hallucinogenic drug also known as PCP or angel dust, added $1,275 more.

Indeed, Kaiser Health News now refers to the urine drug testing business as "Liquid Gold."

Kaiser Health News, with assistance from researchers at the Mayo Clinic, analyzed available billing data from Medicare and private insurance billing nationwide, and found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year.

There are virtually no national standards regarding who gets tested, for which drugs and how often. Medicare has spent tens of millions of dollars on tests to detect drugs that presented minimal abuse danger for most patients, according to arguments made by government lawyers in court cases that challenge the standing orders to test patients for drugs.

Payments have surged for urine tests for street drugs such as cocaine, PCP and ecstasy, which seldom have been detected in tests done on pain patients. In fact, court records show some of those tests showed up positive just 1 percent of the time.

Urine testing has become particularly lucrative for doctors who operate their own labs. In 2014 and 2015, Medicare paid $1 million or more for drug-related tests billed by health professionals at more than 50 pain management practices across the U.S. At a dozen practices, Medicare billings were twice that high.

Thirty-one pain practitioners received 80 percent or more of their Medicare income just from urine testing, which a federal official called a "red flag" that may signal overuse and could lead to a federal investigation ...
/ 2018 News, Daily News
42 year old Candelaria Vazquez, who lived in San Francisco, was sentenced to over 12 years in prison for her role in a conspiracy to manufacture, distribute, and possess with intent to distribute fentanyl. She pleaded guilty on November 8, 2016, to conspiracy to distribute fentanyl and conspiracy to launder drug proceeds.

According to the plea agreement, Vazquez admitted that she and her husband operated a pill press that generated thousands of fake oxycodone pills. Although stamped to appear like genuine oxycodone, the pills were in fact laced with fentanyl. Vazquez helped with the pill pressing operation and packaged, mailed, and delivered fentanyl pills for two years before the pair was arrested on June 10, 2016.

She also conspired to launder the drug proceeds, which were received in bitcoin and exchanged for cash using unlicensed bitcoin brokers.

Vazquez and her husband had distributed hundreds of thousands of fentanyl-laced pills via online marketplaces. Fentanyl is a dangerous and highly potent opiate about 100 times more powerful than morphine. Just two milligrams of fentanyl can constitute a lethal dose.

Fentanyl is particularly dangerous when it is used to create counterfeit pills. Illegal pill press operations will sometimes use fentanyl, which is cheaper than other opiates, to create fake pills that stamped to look like genuine oxycodone pills.

Because fentanyl is such a powerful opiate, a small difference in the amount of fentanyl in a homemade pill can make a huge difference in its potency. Counterfeit pills containing fentanyl have already been linked to numerous unintentional overdoses by users who believed they were ingesting a much less powerful opiate.

The prosecution is the result of an investigation by the Drug Enforcement Administration, United States Postal Inspector, Homeland Security Investigations, and the Internal Revenue Service.

This case is the product of the Organized Crime Drug Enforcement Task Force, a focused multi-agency, multi-jurisdictional task force investigating and prosecuting the most significant drug trafficking organizations throughout the United States by leveraging the combined expertise of federal, state and local law enforcement agencies.
...
/ 2018 News, Daily News
The United States Attorney for the Central District of California announced that his office collected $219,179,887 in criminal and civil actions in Fiscal Year 2017. Of this amount, nearly $56 million was collected in criminal cases, and more than $163 million was collected in civil actions.

The United States Attorney’s Office for the Central District of California worked with other U.S. Attorney’s Offices and components of the Department of Justice to collect another $431,216,222 in cases that were pursued jointly with at least one other office. The vast majority of this money was collected in civil actions. Overall, the Justice Department collected just over $15 billion in civil and criminal actions in the 2017 fiscal year, which ended on September 30, 2017.

Additionally, the United States Attorney’s office, working with partner agencies and divisions, collected $34,749,352 in asset forfeiture actions in FY 2017. Forfeited assets deposited into the Department of Justice Assets Forfeiture Fund are used to restore funds to crime victims and for a variety of law enforcement purposes.

The United States Attorneys’ Offices, along with the Justice Department’s litigating divisions, are responsible for enforcing and collecting civil and criminal debts owed to the United States, as well as criminal debts owed to victims of federal crimes. Federal law requires defendants to pay restitution to victims of certain federal crimes who have suffered a physical injury or financial loss. While restitution is paid to victims, criminal fines and felony assessments are paid to the department’s Crime Victims’ Fund, which distributes the funds to state victim compensation and victim assistance programs.

Of the approximately $56 million collected in criminal cases this past year, approximately $44.6 million in restitution was collected and disbursed directly individuals and private entities, and $1.6 million was paid directly to the Crime Victims Fund. Most of the remaining $10 million was disbursed to federal agencies that suffered losses.

The largest civil collections last year were from affirmative civil enforcement cases in which the United States recovered government money lost to fraud or other misconduct, or collected fines imposed on individuals and/or corporations for violations of federal health, safety, civil rights and environmental laws. In addition, civil debts were collected on behalf of several federal agencies, including the U.S. Department of Housing and Urban Development, the U.S. Department of Health and Human Services, the Internal Revenue Service, the Small Business Administration and the Department of Education.

During fiscal year 2017, prosecutors in the Central District of California recovered $42 million from a settlement with Pacific Alliance Medical Center to resolve allegations that the medical center had improper financial relationships with referring physicians. Additionally, the Office recovered $26.5 million from a settlement with the City of Los Angeles Department of Water and Power for environmental and property damage sustained as a result of the 2013 Powerhouse Fire, which scorched more than 30,000 acres in northern Los Angeles County and destroyed 58 structures.

The United States Attorney’s Office for the Central District of California is based in Los Angeles and has branch offices in Santa Ana and Riverside. Currently, approximately 275 Assistant United States Attorneys serve nearly 20 million residents of the counties of Los Angeles, Orange, Riverside, San Bernardino, Ventura, Santa Barbara and San Luis Obispo.

...
/ 2018 News, Daily News
Britain’s Indivior is launching a new weapon to fight the U.S. opioid crisis this month. The company believes its long-lasting Sublocade injection, which is being launched in the United States in the week of Feb. 26, will become a blockbuster medicine, despite the fact initial sales are likely to be slow.

The FDA approved Sublocade (buprenorphine extended- release) injection for subcutaneous use last year. It is the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

Sublocade is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support.

"The net revenue potential of this product is well above $1 billion but we don’t want people to be unrealistic about what we will achieve in the first year," the Indivior Chief Executive Shaun Thaxter said in an interview.

Sublocade represents a new approach to treating addiction. Instead of going to the pharmacy to pick up tablets or Indivior’s existing under-the-tongue film, the new injections will be delivered direct to doctors’ offices for administration.

Thaxter said it would take time for the new distribution model to bed down, adding: "We would expect to see some very noticeable sales growth by the last quarter (of 2018)."

Indivior has been treating addiction for more than two decades, initially selling tablets to help wean addicts off opioids including heroin and prescription painkillers. Now its big seller is Suboxone Film, which patients place under their tongue or inside their cheek once a day to suppress cravings.

Sublocade, which could be launched in Canada, Australia and Europe from late 2019, is the latest iteration and is designed to eliminate any risk that treatment could be diverted and misused by putting the product exclusively in the doctor’s office.

Competition is growing but Indivior has had some lucky breaks against rivals in recent months, with regulatory delays to both a rival long-lasting injection from Camurus and a generic version of its film from Dr. Reddy.

Ultimately, Indivior’s opioid addiction business could be in jeopardy if the epidemic of drug misuse is brought under control, but Thaxter said his researchers were widening their focus to other addictions, such as cocaine and alcohol.

"As we continue to expand the scope of our business beyond the opioid crisis to other addictions, there will continue to be sustainable business growth for shareholders as well," he said ...
/ 2018 News, Daily News