Author: WorkCompAcademy

An advisory panel to the U.S. Food and Drug Administration unanimously voted in favor of approving the first cannabis-derived medicine in the country, a childhood epilepsy treatment developed by GW Pharma. According to the story in Reuters, the drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and an FDA decision is expected by June 27.

The syrup contains less than 0.1 percent of tetrahydrocannabinol (THC), the substance that makes people high.

The FDA panel found that the drug’s benefits outweighed the risks to treat patients aged 2 years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.

The agency does not have to act on the recommendations of its experts, but usually does.

“The overall tone of the meeting was positive, with the FDA having identified no obstacles to approval,” Cantor Fitzgerald analyst Elemer Piros said, adding that he expects the drug will be approved much before June 27.

The panel’s backing comes after the FDA staff on Tuesday gave a favorable review, citing three clinical studies that showed the drug reduced frequency of seizures in patients with the disease when added to a current therapy.

Analysts said an approval will also confirm the therapeutic benefits of CBD. “This should aid CBD in being efficiently rescheduled by the Drug Enforcement Administration.” Under the U.S. federal law, marijuana is considered to have no medicinal value.

However, the FDA panel highlighted the limited association between the use of CBD and elevated liver enzymes, which Cantor Fitzgerald’s Piros believe could lead to a boxed warning label, the severest form of FDA warning.

It is estimated there are about 14,000-18,500 patients with LGS, and 1 in 40,000 sufferers of Dravet Syndrome in the United states, for which there is no approved treatment. Some LGS patients have to wear helmets to avoid brain injuries from “drop seizures” that cause loss of muscle strength.

Amazon Business, which sells bulk items to business customers, has shelved its plan to sell and distribute pharmaceutical products after considering it last year, according to people familiar with the matter.

Instead, CNBC reports that the company has found that business to be more challenging than expected. The setback illustrates the challenges of getting into the medical supply and pharmaceutical space, even for a company as big as Amazon. .

The change in plan comes partly because Amazon has not been able to convince big hospitals to change their traditional purchasing process, which typically involves a number of middlemen and loyal relationships, and perhaps illegal incentives as have been demonstrated in national civil and criminal litigation.

Moreover, Amazon would also need to build a more sophisticated logistics network that can handle temperature-sensitive pharmaceutical products, according to these people.

Still, Amazon hasn’t completely ruled out getting into the pharma distribution space eventually. Multiple reports have speculated that the company will someday add a direct-to-consumer prescription drug business. Amazon Business could also reconsider getting into the pharma space once it gains more scale, multiple people said.

Meanwhile, the company continues to explore other health-care projects through different teams across the company, including Alexa and the secretive Grand Challenge team, sometimes referred to as “1492.”

Amazon has started a secret skunkworks lab dedicated to opportunities in health care, including new areas such as electronic medical records and telemedicine. Amazon has dubbed this stealth team 1492, which appears to be a reference to the year Columbus first landed in the Americas.The stealth team, which is headquartered in Seattle, is focused on both hardware and software projects.

Amazon has been selling medical products like glucometers, gloves and stethoscopes to medical clinics for several years. It now has the necessary licensing in 47 out of 50 states and the District of Columbia, according to its website.

But Amazon has struggled to land contracts with large hospital networks, despite convening an advisory board that includes major hospital executives, according to two people familiar. These groups of hospitals have long-standing contracts with distributors, like Cardinal Health and McKesson. Many hospitals also own a stake in entities called group purchasing organizations that negotiate on their behalf, leveraging their collective negotiating power.

The CNBC report points out that that the health-care supply chain is well-entrenched and will be hard to break into, according to one expert. “The hospital and health-care systems have entangling alliances with their existing purchasing and supply chain partners,” said Tom Cassels, head of strategy and business development at Leidos Health. “It’s very difficult to replicate the Amazon buying experience in health care,” he said.

But, in an industry that is now well known for marketing, by some, by way of illegal kickbacks and perks, one must be left to wonder if that is yet another discovered or undiscovered impediment for the Amazon platform.

Interest in medicines, which use engineered viruses to carry healthy genetic material into the cells of sick people, has exploded recently as the first wave of gene-fixing drugs reach the market. That has left some drug companies scrambling for sufficient capacity at a time when the industry is also grappling with shortages of DNA-carrying viral vectors.

And now General Electric, the powerhouse industrial company, is raising its bet on biotechnology with the launch of prefabricated manufacturing units for producing virus-based gene and cell therapies, novel anti-cancer treatments and vaccines.

GE, better known for making jet engines and turbines, sees an opportunity in the fast-growing field. It aims to build on its existing expertise in biotech manufacturing by delivering a “factory-in-a-box” service specifically for viral vector-based medicine.

The U.S. conglomerate already makes off-the-shelf modular factories for other complex biological medicines, such as monoclonal antibodies.

Its so-called KUBio factories are cheaper and faster to construct than traditional factories, offering GE a way to win business for its growing life sciences business. Depending on the factory design and the drug being made, an equivalent KUBio could reduce build costs by as much as 50 percent, according to the company.

Taiwanese manufacturer of biologics, JHL Biotech, recently upped the ante and ordered an entire high-tech pharmaceuticals factory. Made by GE in Germany, Sweden and the U.S., the components for the world’s largest single-use modular plant for making biopharmaceuticals, recently left Europe for JHL’s new site in Wuhan, the capital of China’s Hubei Province.

GE Healthcare’s KUBIo includes everything from bioprocessing equipment to the building and overall project coordination. The modules at the site arrive 80 to 90 percent pre-equipped with the heating, ventilating, and air conditioning (HVAC) system, the clean room, most of the utility equipment, and all of the piping necessary to run the plant.

When the sixty-two completed KUBio modules that make up the factory reach the destination at Wuhan’s Biolake Science Park , they will help JHL make affordable biologics for markets where they are otherwise prohibitively expensive.

Biologics, also called biopharmaceuticals, are a new class of medicines made from strings of complex proteins. They are now leading the charge against disease and represent the fastest growing class of drugs. They range from synthetic insulin to medicines that can be used to treat cancer, rheumatoid arthritis and other diseases.

GE is also stepping up operations within the wider supply chain that is needed to deliver cell therapies like Novartis’ Kymriah and Gilead Sciences’ Yescarta, both of which were approved in 2017 for treating certain blood cancers.

Last year, for example, GE Healthcare bought British-based Asymptote, a specialist in freezing, preserving and transporting large volumes of living cells. Overall, GE says it expects to have a $1 billion-a-year gene and cell therapy business by 2025.

The are now more than 700 viral vector-based therapies in clinical trials, spurring demand for biologically secure bioreactors to churn out products. Since most such treatments are targeted therapies designed for small patient populations, GE is betting that drug companies will prefer its flexible small-scale KUBio units to large traditional factories.

Dr. Anthony Steven Bianchi, MD currently still holds a California license as a physician. His office location is 6042 N Fresno Street, Suite 101 in Fresno.. He now claims to practice Occupational Medicine at this address which the Associated Press claims to be a clinic evaluating and treating workers’ compensation cases in its expose of sexual misconduct in medicine.

The Disciplinary Records of the Medical Board of California provide great detail on his tawdry history with female patients. The details of his behavior are alleged in great detail in these state documents, and they should not be read by anyone who reacts badly to graphical detail.

Disciplinary charges were first filed against Bianchi by the Medial Board of California in 2012. According to the allegations of a December 2012 First Amended Accusation, he engaged in sexual misconduct with female patients as a gynecologist dating back to 2009. His activities with two of them were specific in the Accusation.

On November 13, 2013, Bianchi and his attorney signed a Stipulated Settlement and Disciplinary Order. He admitted that the Medical Board could make a prima facie case against him based upon the Complaint. He was placed on probation which included that he undergo a complete psychiatric evaluation, enter into psychotherapy, and complete a Professional Boundaries Program. He was placed on probation for a period of five years from the date of the Disciplinary Order. Thus his probation would end on December 20, 2018.

A follow up disciplinary action was filed by the Medical Board on May 5, 2015. The Board alleged in its disciplinary action, that, while he was practicing as a gynecologist, he placed a chair against the exam room door, put his fingers into an inappropriate area of a female patients anatomy while exposing himself. This alleged patient abuse occurred in 2009 but was brought to the attention of the Board in 2013 after the victim heard about the prior discipline

These episodes led to disciplinary Orders by the state’s medical board in 2012 and in 2016. Bianchi agreed not contest the charges, and he held onto his medical license. Probation did not require him to notify any subsequent patients of his probationary status, despite the fact he was required to notify his malpractice carrier and employer.  

The AP article that uses his case as an example claims that “When the doctors are disciplined, the punishment often consists of a short suspension paired with mandatory therapy that treats sexually abusive behavior as a symptom of an illness or addiction.”.

The AP goes on to say that decades of complaints that the physician disciplinary system is too lenient on sex-abusing doctors have produced little change in the practices of state medical boards. And the #MeToo campaign and the rapid push in recent months to increase accountability for sexual misconduct in American workplaces do not appear to have sparked a movement toward changing how medical boards deal with physicians who act out sexually against patients or staffers.

The sentencing of Larry Nassar, a former doctor for the U.S. Olympic gymnastics program convicted of abusing more than 150 women and girls, has put a high-profile case of physician misconduct in the spotlight.

But across the country, most doctors accused of sexual misconduct avoid a medical license review entirely. A study last year found that two-thirds of doctors who were sanctioned by their employers or paid a settlement as the result of sex misconduct claims never faced medical board discipline.

“There’s been a failure of the medical community to take a stand against the issue,” said Azza Abbudagga, a health services researcher with nonprofit advocacy organization Public Citizen.

She published a report recently detailing sexual misconduct among physicians. Its findings showed that of the 253 doctors reported to the National Practitioner Data Bank for having been sanctioned by their respective hospitals or health care organizations for sexual misconduct, or paid a settlement that stemmed from such an allegation, 170 of them were not disciplined by state medical boards, even though all boards have access to the reports filed with the data bank.

Is $448 enough compensation for a full day’s work for a certified interpreter servicing a hearing and deposition in California? What about $225 for half a day’s work? Some of them who are responding to the newly proposed fee regulations do not think so.

The DWC wants to know, so it is seeking public comment on the proposed interpreter fee schedule regulations it posted to its online forum on April 2, 2018.

A document made available online by the DWC shows that early comments to the proposed interpreter fee schedule centered around the amount, which, as one commenter observed, is only a “marginal improvement from the measly $52 per hour rate in 2015.”

Another complained about the percentage of the interpreter’s fee that interpreting agencies charge as a commission. “As it stands today, they take 30-50%. No one is even mentioning the disproportionate ratio of the broker’s commission versus the interpreter’s fee. We the interpreters are the service providers, not the agencies or brokers.”

She also complains that there “is no allowance for parking fees or for mileage, which, especially for interpreters who live and work in rural areas, in all fairness must be taken into consideration.”

A Korean interpreter complains that the fee schedule “is hopelessly removed from the market rates.” He concludes that “the new lower rates will serve a single purpose of benefiting the insurance companies.”

The chief objective of the proposal is to create a uniform fee structure, which it said is based on the federal court system.

Interpreters’ compensation has become a thorny issue in California ever since amendments have been introduced in the Labor Code and other state laws over the past three years to curb the incidence of medical fraud.

In May 2017, a group of interpreters even took the DWC to court over the new system of compensation for interpreters. In June, the same group led the fight against allowing “provisionally certified” interpreters to work if certified legal and medical interpreters are not available, which the group claimed has led to the undercutting of fees.

The regulation is also introducing a streamlined process for claiming payments, which includes detailed invoice information and billing codes. It also requires full documentation on the process of selection and arrangement of interpreters, especially if “alternative” interpreters were selected in the absence of a certified interpreter.