opens in a new tab or window" accusation against Simone Gold, MD, JD, in connection with her guilty plea on charges related to her participation in the Jan. 6 insurrection in the U.S. Capitol and her subsequent prison term.
The MBC's accusation lists two causes for discipline: "conviction of a crime substantially related to the qualifications, functions, or duties of a physician and surgeon, and general unprofessional conduct."
According to California's business and professions code, unprofessional conduct is defined as that which "breaches the rules or ethical code of the medical profession or conduct which is unbecoming a member in good standing of the medical profession, and which demonstrates an unfitness to practice medicine."
Gold's license is at stake. The accusation asks the medical board to issue a decision around revoking or suspending her license.
Gold, who is a founder of the controversial group America's Frontline Doctors, was "giving public speeches on COVID-19-related lockdowns, COVID-19 vaccinations, and the use of ivermectin and hydroxychloroquine as potential treatments," the MBC document states.
She "entered the east side of the Capitol building with her security guard," knowing "that she did not have lawful authority to enter," it continues.
After Gold pleaded guilty to entering and remaining in a restricted building, she was sentencedopens in a new tab or window to 60 days in prison followed by 12 months of supervised release. She was also ordered to pay approximately $10,025 in criminal monetary penalties, according to the MBC document.
During her prison term, Gold's license to practice medicine in California was placed on inactive status, and then returned to active status after she was released.
Gold had been an emergency room physician in the Los Angeles area, but moved to Naples, Florida about 2 years ago. She applied for and received a license to practice in that state last July. The Florida Department of Health reportedopens in a new tab or window her license status on Feb. 13 as "clear/active" with no disciplinary actions on file.
Last fall, leaders of America's Frontline Doctors filed a lawsuitopens in a new tab or window accusing Gold of misusing the organization's funds to buy a $3.6 million home in Naples and three cars, including a Mercedes Benz, for personal use.
The California licensing agency also wants Gold to repay the costs of investigating and enforcing this case, as well as any potential costs incurred if she is placed on probation.
Gold has promoted both ivermectin and hydroxychloroquine for the treatment of COVID, and although both drugs are approved by the FDA for some diseases, neither has been found effective for treating COVID-19.
he medical board's action was not done under the authority of California's new disinformation law
opens in a new tab or window, which prohibits licensees from providing false information about COVID vaccines or treatments in the context of direct patient care when that information is delivered maliciously and is contradicted by contemporary scientific consensus.
As of press time, Gold's representatives had not responded to a request for comment.
Buprenorphine, rather than a full agonist opioid, should be used for patients taking daily opioids for chronic pain, given its lower risk for overdose or misuse, new guidelines from the Department of Veterans Affairs (VA) and Department of Defense (DoD) recommended.
But "the guideline development group does not recommend use of opioid analgesics in the daily management of chronic pain," wrote James Sall, PhD, of the VA in New Braunfels, Texas, and co-authors in Annals of Internal Medicineopens in a new tab or window.
"The benefits that opioids can provide are small and are outweighed by the risks to the patient," they continued. "If the decision is made to use long-term opioid therapy for a patient, then buprenorphine should be considered because of its lower risk profile."
The updated guideline also calls for behavioral health assessments for all chronic pain patients and preoperative opioid and pain management education.
The field of pain medicine is likely to embrace this new buprenorphine recommendation, noted Chinazo Cunningham, MD, MS, of the New York State Office of Addiction Services and Supports in New York City, and Joanna Starrels, MD, MS, of the Albert Einstein College of Medicine in New York City, in an accompanying editorialopens in a new tab or window.
"The updated VA/DoD guideline is both conservative and radical," Cunningham and Starrels observed -- conservative because much is consistent with the CDC's guidanceopens in a new tab or window but "potentially transformative" by recommending buprenorphine instead of full agonist opioids.
"Although the VA/DoD guideline recommends that buprenorphine be prescribed for chronic pain if daily opioids are prescribed, the recommendation itself is likely to change decision-making about whether opioids should be prescribed," Cunningham and Starrels pointed out.
While the guideline is specific to the VA/DoD, "its influence is likely to expand into the greater U.S. healthcare system," they noted.
"Because buprenorphine is an opioid, with long-term risks like physical dependence, it will be important to take precautions to clearly and carefully message to patients and clinicians, closely monitor buprenorphine prescribing patterns by indication and formulation, evaluate public health benefits and harms, and identify unintended consequences," the editorialists continued.
Importantly, the quality of evidence for the buprenorphine recommendation is low and the recommendation is not clear about formulation, dosing, and the target patient population, they added.
VA and DoD leadership approved the joint clinical practice guidelineopens in a new tab or window in May 2022. The guideline development group used data from a systematic evidence review and graded recommendations and evidence as strong or weak. Besides using buprenorphine, the group recommended:
Screening for additional mental health conditions that potentially increase risk in chronic pain patients
Assessing for behavioral health conditions, history of traumatic brain injury, and psychological factors associated with higher risk for harm
Screening for pain catastrophizing and co-occurring behavioral health conditions to identify those at higher risk for negative outcomes when opioids are being considered in acute pain patients
Providing patients with pre-operative opioid and pain management education to reduce the risk for prolonged opioid use after surgery
The guidance is intended for clinicians who may be considering opioid therapy to manage patients with chronic pain, Sall and colleagues noted. It includes three one-page algorithms to help guide clinical decision-making.
"The guideline development group identified that more studies are needed examining the comparative effectiveness of different analgesic agents, the effectiveness of different tapering strategies, and the effectiveness of different risk mitigation strategies on the management of patients receiving long-term opioid therapy," they added.
Disclosures
Financial support for guideline development was provided by the VA.
Sall and co-authors reported no conflicts of interest.
The editorialists reported no conflicts of interest.
Primary Source
Annals of Internal Medicine
Source Reference: opens in a new tab or windowSandbrink F, et al "The use of opioids in the management of chronic pain: Synopsis of the 2022 updated U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guideline" Ann Intern Med 2023; DOI: 10.7326/M22-2917.
Secondary Source
Annals of Internal Medicine
Source Reference: opens in a new tab or windowCunningham CO, Starrels JL "Guideline promoting buprenorphine for treatment of chronic pain: transformative yet underdeveloped" Ann Intern Med DOI: 10.7326/M23-0229.
Amazon.com Inc's self-driving vehicle unit, Zoox, said on Monday it has successfully tested a robotaxi with employees as passengers on a public road in a move to bring it closer to commercial service for the general public.
The Feb. 11 test, conducted between two Zoox buildings a mile apart at its headquarters in Foster City, California, was part of the launch of a no-cost employee shuttle service that will also help the company refine its technology.
"Putting the vehicle on (an) open public road and validating our approach to all of the different requirements, including regulatory, is a big step and we would not have done it unless internally we were already looking at the line of sight for going commercial," Chief Executive Aicha Evans told reporters on a conference call.
Evans declined to provide a timeline for the commercial launch, which will need additional government clearances.
The industry's automated vehicle segment has not rolled out as fast as originally expected as the technology has proven tough to master. Ford Motor Co and Volkswagen AG last fall announced they would shutter their Argo AI self-driving unit and focus on driver-assistance technology that provided more immediate returns.
Companies still pursuing development of this technology include General Motors Co's Cruise unit and Alphabet Inc's Waymo.
Zoox's robotaxi - built as a fully autonomous vehicle from scratch rather than retrofitting existing cars for self-driving - comes without a steering wheel or pedals and has room for four passengers, with two facing each other.
Online retailer Amazon, which has been aggressively expanding into self-driving technology, bought Zoox for $1.3 billion in 2020.
But rapid interest rate hikes and weak consumer demand sparked fears of a global recession, forcing many companies, including automakers and tech giants, to trim their workforcesand claw back costs.
Zoox's tech chief, Jesse Levinson, said the company has been prudent about its growth but was still on track to reach 2,500 employees this year, up from just under 2,000 employees at the beginning of the year.
Now the White House — under fire for a lack of transparency over the incursions — must contend with frustrated lawmakers and a mystified public, amid the Biden administration’s failure to launch a coherent communications strategy about the shootdowns.
“In times of uncertainty, leaders need to be as transparent as possible with the public,” Larry Hogan, the former Republican governor from Maryland, tweeted Monday. “After shooting down three airborne objects, President Biden needs to communicate directly with the nation about what we know and what we don’t.”
With fighter jets downing unknown objects over U.S. territory, the White House has revealed little about what precisely is happening and whether the country is under threat. Are the objects harmless weather balloons or spy craft sent by foreign powers bent on doing Americans harm? President Joe Biden hasn’t said. In the absence of hard facts, uninformed speculation is filling the information vacuum, including whether the objects are visiting space aliens.
At one point, a U.S. Air Force general refused to even rule out that far-fetched possibility, though White House press secretary Karine Jean-Pierre clarified the question on Monday.
"There is no, again, no indication of aliens or extraterrestrial activity with these recent takedowns," she said.
The White House did not respond to a request for comment.
National Security Council spokesperson John Kirby said during Monday's White House briefing that the three most recent objects did not pose a threat to people on the ground, did not send any communication signals and did not have any maneuverability or propulsion capabilities.
The objects did, however, fly at altitudes that could "pose a threat to civilian commercial air traffic," which led to the president giving the order to shoot them down, he said.
"Efforts are actively underway right now at all sites to find what is left of those objects so that we can better understand and communicate with the American people what they are," Kirby told reporters, emphasizing the challenge to recover the objects from the rural terrain in Alaska and Canada and the bottom of Lake Huron.
Kirby also announced a new interagency team dedicated to studying the objects and future related policy, but he did not offer specifics about the objects themselves as confusion and frustration over the communication about the U.S. military firing multiple missiles in American and Canadian airspace over the weekend lingers.
With a U.S. military pilot shooting down a fourth object on Sunday afternoon, the White House has not seemed set on its message about what was shot down, who from the government should communicate about it, why there appear to be more unidentified objects, who they might belong to, what threat they pose or whether decision-making over shooting down such items has changed.
Kirby noted on Monday what two U.S. defense officials previously told NBC News: the military is using a wider range of radar data to monitor North American airspace since the Chinese spy balloon was spotted, and they’re taking deeper looks at a larger number of objects that they might have filtered out in the past.
After an unidentified object was shot down off the coast of northeastern Alaska on Friday, Biden gave a one-word answer in response to a question from the press — “Success." Canadian Prime Minister Justin Trudeau made public Saturday’s shootdown over the Yukon, though it was a U.S. F-22 that destroyed the object.
Jean-Pierre said on Sunday morning the public should understand that the administration intends to “detect and we’re always going to defend our airspace,” but she gave little insight into new standards or processes to do that — nor did she identify what the objects were.
The absence of information grew even more apparent when the fourth object was shot down over Lake Huron hours before the Super Bowl began on Sunday. Despite inquiries, White House communications remained largely quiet, a posture that has allowed conspiracy theories to fester.
National security officials have declined to identify the three most recent objects as balloons, their owners or their function, whether that be weather monitoring or surveillance by foreign actors. Democratic Majority Leader Chuck Schumer said on ABC’s “This Week” on Sunday, however, that intelligence officials believe that the second and third items were also balloons.
Many of the questions directed to the White House have been redirected to the Pentagon, as the Biden administration takes a guarded approach when it comes to inconvenient or untimely developments that distract from its larger message that the nation is making steady progress under a seasoned president. The White House used much the same playbook when it came to the classified documents found in Biden’s home and private office.
Sailors assigned to Explosive Ordnance Disposal Group 2 recovering a high-altitude surveillance balloon off the coast of Myrtle Beach, S.C., on Feb. 5, 2023. (U.S. Navy)
Robert Gibbs, who served as White House press secretary during the Obama administration, said in an interview that Biden’s administration should be over-communicating around the shootdowns, particularly as a lack of information can allow disinformation and misinformation to grow.
“They’re the ones that have to drive the narrative on this and I don’t think it’s helpful having different parts of the governmental apparatus knowing different levels of things and reporting that publicly,” he said. “That hurts their case that they’re the ones that have the information and are communicating it with the public.”
In the meantime, the White House is facing criticism from both sides of the aisle, as lawmakers attempt to work out what exactly happened.
“What’s gone on in the last two weeks or so, 10 days, has been nothing short of craziness,” Sen. Jon Tester, D-Mont., said on CBS’s “Face the Nation” on Sunday, mere hours before the fourth object was shot down over Lake Huron.
His Republican colleague from Montana, Sen. Steve Daines, agreed in a tweet on Sunday, calling the “lack of communication” from the White House “unacceptable.” In the face of White House reticence, the public is forced to rely “on leaks, speculation and worst of all disinformation from foreign governments.”
Rep. Jim Himes, D-Conn., shared his own concerns about insufficient transparency from the Biden White House in an interview Sunday on NBC News’ “Meet the Press.”
While he said it might be difficult to have immediate answers because of the remote areas where some of the objects were shot down, as they required grueling retrieval missions, Himes said it is troubling to see “massive speculation about alien invasions and additional Chinese or Russian action” bubbling up in the information vacuum.
“Maybe it’s because I’m in politics, and so I spend a lot of time talking to folks in grocery stores and town hall meetings,” he added. “You know, in an absence of information, people will fill that gap with anxiety and other stuff. So, I wish the administration was a little quicker to tell us everything that they do know.”
It is even unclear whether there are more objects in the air than previously known or if there are entirely new items appearing in American airspace. Has that information changed the requirements for shooting objects from American skies? That also remains unknown.
Biden made only the barest mention of the Chinese spy balloon in his State of the Union address last week: a two-sentence aside that left unanswered any number of questions about escalating U.S.-Chinese tensions.
“The problem is, it [the spy balloon] is illustrative of what China is doing. It’s a wake-up call. We have a serious problem with China. We’re not causing the problem; they’re causing it,” said John Bolton, a former national security adviser in the Trump White House.
“I think the mistake here is not adequately characterizing what happens when an unknown vehicle heads toward American territory,” Bolton added. “You should assume if it’s unidentified and doesn’t respond to communications, that you assume it’s potentially dangerous.”
FBI special agents process material recovered from the high altitude balloon at the FBI laboratory (FBI via AP)
What is known for certain is that, with missiles firing over the U.S. and Canada, the significance of the moment is difficult to ignore.
Gen. Glen VanHerck, who heads NORAD and U.S. North Command, noted his belief that “this is the first time within United States or American airspace that NORAD or United States Northern Command has taken kinetic action against an airborne object.”
Officials have attempted to scuttle the view that the objects were a severe threat to Americans. The most recent object shot down over Lake Huron was not considered a military threat, but a Pentagon statement said it could have had surveillance capabilities.
The only thing that was strictly emphasized about the three unidentified objects, according to one defense official, was that there was “no indication of aliens or extraterrestrial activity with these recent takedowns.”
Palantir Technologies said it expects 2023 to be its first profitable year as the maker of data analytics software benefits from cost cuts and the artificial intelligence boom.
The company has reduced employees' stock-based compensation and cut back on cloud expenditure in recent months in response to lower spending from recession-wary businesses, finance chief David Glazer told Reuters on Monday.
The slowing demand weighed on its 2023 revenue forecast, which at between $2.18 billion and $2.23 billion was below the $2.29 billion estimated by analysts, according to Refinitiv.
The downturn has especially hit Palantir's revenue from newly public firms that use its services as economic uncertainty torpedoes the market for U.S. stock listings. That revenue is expected to nearly halve in the first quarter to $16 million from a year earlier.
Still, company executives said the AI surge sparked by the rise of ChatGPT was proving to a be bright spot and would help its business in 2023, mirroring remarks from Big Tech firms.
"There are many different ways we can integrate with technologies like ChatGPT and apply those technologies to our customers data," said Chief Revenue Officer Ryan Taylor.
The company's revenue rose 18% to $509 million in the fourth quarter, beating analysts' estimates for the period when it signed deals with U.S. defense contractor Lockheed Martin Corp and the UK military.
Palantir, known for its work with the U.S. Central Intelligence Agency, has clinched more defense business following Russia's war with Ukraine, selling software to visualize an army's positions and help enterprises vet their supply chains or reduce costs.
It reported its first quarterly net income attributable to common shareholders of $30.9 million, or 1 cent per share in the October-December period, compared with a net loss of $156.2 million, or 8 cents per share, a year earlier.
The White House said on Monday that President Joe Biden plans to nominate the acting head of the National Highway Traffic Safety Administration (NHTSA) to serve in the top job.
Ann Carlson, the agency's chief counsel, was named acting head of NHTSA in September. She has overseen safety probes into Tesla and efforts to shrink traffic deaths and significantly boost vehicle fuel economy requirements.
For much of the last six years, NHTSA has been without a Senate-confirmed administrator. U.S. traffic deaths have risen sharply since the start of the COVID-19 pandemic. Road deaths jumped 10.5% in 2021 to 42,915, the highest number killed on American roads in a single year since 2005.In January, Carlson said the agency was studying the impact of vehicle size on roadway safety and was "very concerned" about the "degree to which heavier vehicles contribute to greater fatality rates."
The agency is "investing a lot of resources" in the Tesla probe, Carlson said in January, declining to commit to a timeframe for resolving the probe. "We're moving as quickly as we can, but we also want to be careful and make sure we have all the information we need."
In June, NHTSA upgraded its defect probe into 830,000 Tesla vehicles with driver assistance system Autopilot and involving crashes with parked emergency vehicles.
NHTSA is reviewing whether Tesla vehicles adequately ensure drivers are paying attention.
NHTSA plans to propose in April new fuel economy standards for the 2027 model year and beyond, which could dramatically reshape new cars on America's roads, Carlson said.
In March 2020, former President Donald Trump's Republican administration rolled back the standards to only 1.5% annual increases in efficiency through 2026, much less than the 5% annual increases required by former President Barack Obama. The Biden administration in 2021 reversed Trump's action and instructed NHTSA and the Environmental Protection Agency to begin work on the next round of tougher rules.
Acquisition of Phase 2 program with established clinical proof of concept strengthens pipeline of innovative targeted alpha therapies
In connection with the transaction, Fusion announces $60.0 million private placement financing
Fusion to host conference call at 4:45 p.m. ET
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) ("Fusion"), a clinical-stage oncology company focused on developing next-generation targeted alpha therapies ("TATs") as precision medicines, today announced the acquisition from RadioMedix, Inc. ("RadioMedix") of the investigational new drug application ("IND") for an ongoing Phase 2 clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting prostate specific membrane antigen ("PSMA") expressed on prostate cancers. Following the closing, the alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial will be known as FPI-2265.
Fusion will host a live conference call and webcast today beginning at 4:45 p.m. ET to discuss the acquisition. To access the live call, please dial 1-877-870-4263 (U.S.), 1-855-669-9657 (Canada) or 1-412-317-0790 (international) and reference Fusion Pharmaceuticals. A webcast of the conference call will be available under "Events and Presentations" in the Investors & Media section of Fusion's website at https://ir.fusionpharma.com/overview. The archived webcast will be available on Fusion's website shortly after the conclusion and will be available for 90 days following the event.
