Complexity of Rescheduling or Descheduling Marijuana Under Federal Law

 We recently wrote about President Joe Biden’s pardon of federal marijuana convictions and raised some cautions concerning possible proposed rescheduling of marijuana under the Federal Controlled Substances Act (CSA). Even if President Biden is successful in persuading his administration to move to either deschedule or reschedule marijuana, we wouldn’t expect to see any significant change for many months, if not years.

To recap, 39 of the 50 states have adopted laws authorizing the medical use of marijuana notwithstanding federal prohibition under the CSA. Nineteen of those states have gone further, authorizing adult use marijuana under their state laws without regard to medical need. The state-level legalization of adult use marijuana appears to be accelerating. Just as the early advocates for medical marijuana legalization showed little concern for federal illegality, the adult use advocates seem unlikely to slow their move for broad legalization, whatever the federal government decides to do.

As we previously observed, rescheduling marijuana under the CSA is likely to create more difficulties for state medical marijuana compliance with the U.S. Food and Drug Administration (FDA). Therefore, descheduling – removing marijuana from the CSA completely – appears to be the most viable and prudent goal to reconcile federal and state regulation of marijuana. But whether the future of marijuana under the CSA is descheduling or rescheduling, the process will be complex.

The CSA authorizes the attorney general, working with subsidiary Department of Justice agencies like the U.S. Department of Health and Human Services (HHS), the FDA and the U.S. Drug Enforcement Administration (DEA), to reschedule, or even deschedule, substances after consideration of the drug’s medical use and its potential for abuse and dependence. However, the statutory process the DEA is required to follow to change the status of an already controlled substance is incredibly arduous.

The CSA mandates scheduling decisions be made by the DEA in conjunction with the HHS and the FDA based on medical and scientific data considering the relative abuse potential of a drug. The HHS must consider the following eight factors in making its recommendation:

• The drug’s actual or relative potential for abuse.
• The drug’s scientific evidence of its pharmacologic effect, if known.
• The state of current scientific knowledge regarding the drug.
• The drug’s history and current pattern of abuse.
• The drug’s scope, duration and significance of abuse.
• The risk, if any, to public health.
• The drug’s psychic or physiological dependence liability.
• Whether the drug is an immediate precursor of a controlled substance.

The HHS’ recommendations are then binding on the DEA as to scientific and medical matters. Rescheduling marijuana from a Schedule I to a Schedule II controlled substance, at a minimum, would require proof that marijuana has a currently accepted medical use in the United States. Descheduling marijuana would require a finding that it does not meet any of the criteria for scheduling. However, in response to a 2016 petition to reclassify marijuana, the FDA concluded that it has no accepted medical use in the U.S., has a high potential for abuse and lacks an acceptable level of safety for use even under medical supervision. Accordingly, the DEA denied the petition.

The rescheduling and descheduling processes involve similar analyses under the CSA, but both are unlikely to occur at this time. The DEA remains powerless to reschedule marijuana without a finding from the HHS that it has an accepted medical use or to deschedule without evidence that it should not be scheduled under the CSA at all. The current Schedule I status of marijuana makes it difficult for researchers to receive federal sources of funding to obtain the evidence-based clinical research necessary to support the rescheduling or descheduling of marijuana. While recent DEA policy has expanded the number of marijuana cultivators for research, the HHS is still far from obtaining the evidence necessary to support a change.

Beyond the regulatory roadblocks, the scheduling of marijuana also impacts the international treaty obligations of the U.S. The U.S. is a party to a United Nations treaty, the Single Convention on Narcotic Drugs, which requires the U.S. to control marijuana in the schedule that the DEA Administrator deems most appropriate. The courts have previously held that marijuana must be scheduled in Schedule I or II to satisfy the obligations under the treaty.

Even if a change is possible in the future, maintaining marijuana on the controlled substances list likely raises more problems than it solves. A more prudent approach is to deschedule it completely. However, because these processes are riddled with roadblocks, it is unlikely that the current scheduling of marijuana will change any time soon.

https://www.jdsupra.com/legalnews/the-complexity-of-rescheduling-or-8303986/

Why DexCom Is Soaring

 Shares of DexCom (DXCM 17.66%) were trading up by 13.9% as of 11:55 a.m. ET Friday. The big gain came after the diabetes-care technology company announced its third-quarter results following the market close on Thursday.

DexCom reported Q3 revenue of $769.6 million, up 18% year over year. It posted earnings of $101.2 million, or $0.24 per diluted share, based on generally accepted accounting principles (GAAP). In the prior-year period, it recorded GAAP earnings of $87.3 million, or $0.21 per diluted share.

Analysts' consensus estimate for DexCom's Q3 non-GAAP earnings had been $0.24 per share. It easily beat those expectations with non-GAAP earnings of $111.9 million, or $0.28 per diluted share.

In addition, the company tweaked its full-year guidance. For 2022, DexCom now projects revenue of between $2.88 billion and $2.91 billion. It previously forecast revenue in the range of $2.86 billion to $2.91 billion. However, it now expects its non-GAAP gross profit margin to be around 64%, slightly lower than the previous outlook of 65%.

NASDAQ: DXCM

DexCom

Today's Change

(17.66%) $17.89

Current Price

$119.14

 DXCM

KEY DATA POINTS

Market Cap

$40B

Day's Range

$109.89 - $121.77

52wk Range

$66.89 - $164.86

Volume

5,529,610

Avg Vol

2,710,994

Gross Margin

67.44%

Dividend Yield

N/A

DexCom's Q3 update could help convince investors that the company can navigate an uncertain macroeconomic environment better than most. There's one especially important key to DexCom's success: the new G7 continuous glucose monitoring (CGM) system. The company launched the G7 device in the United Kingdom, Ireland, Germany, Austria, and Hong Kong in the third quarter. 

The only negative for DexCom in Q3 was the strong U.S. dollar. The company's small decrease in its gross profit margin guidance was primarily due to currency-exchange headwinds.

DexCom CEO Kevin Sayer said in the Q3 conference call that the G7 could receive U.S. regulatory clearance before the end of 2022. That should position the company well to continue delivering strong growth in 2023 and beyond.

https://www.fool.com/investing/2022/10/28/why-dexcom-stock-is-soaring-today/

Senate GOP report on COVID origin suggests lab leak is ‘most likely’

 A report from the staff of the top Republican on the Senate Health Committee strongly suggests the virus that causes COVID-19 was introduced to the world by a lab leak in China, though it offers little new evidence.

The report from the office of Sen. Richard Burr (R-N.C.) concludes the emergence of the SARS-CoV-2 virus was “most likely the result of a research-related incident” in Wuhan, China.

“The hypothesis of a natural zoonotic origin no longer deserves the benefit of the doubt, or the presumption of accuracy,” the report stated

The report cited gaps in previously published scientific research arguing in favor of a “natural” origin from infected animals, as well as safety concerns at the Wuhan lab.

“Critical corroborating evidence of a natural zoonotic spillover is missing. While the absence of evidence is not itself evidence, the lack of corroborating evidence of a zoonotic spillover or spillovers, three years into the pandemic, is highly problematic,” the GOP report stated.

But the staff report stated that the findings lack indisputable evidence and will not settle the issue. 

“My ultimate goal with this report is to provide a clearer picture of what we know, so far, about the origins of SARS-CoV-2 so that we can continue to work together to be better prepared to respond to future public health threats,” Burr said in a statement. “I believe this interim report does just that.”

The report relied largely on existing public evidence, rather than new or classified information. It also cited the difficulty in relying on information from China, an issue that’s repeatedly stymied probes from the World Health Organization and U.S. intelligence.

“The lack of transparency from government and public health officials in the PRC with respect to the origins of SARS-CoV-2 prevents reaching a more definitive conclusion,” the report stated.

The report can provide a roadmap for how a Republican-controlled House or Senate will investigate the origins of the virus. The full Senate Health Committee is conducting an investigation, though Burr said the report was released separate from that effort.

The origins of the coronavirus have become intensely politicized, and Biden officials and outside scientists are bracing for a new wave of investigations.

The “lab leak” theory is popular among some Republicans, and Sen. Rand Paul (R-Ky.), who would become chair of the Health Committee next year in a Republican-controlled Senate, has vowed hearings on the issue. 

Paul and other Republicans on the committee say Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, is withholding important information. 

“If Dr. Fauci is truly open minded, as he claims to be, then he will release all texts, emails, communications, and grant records completely and without redactions,” said Sen. Roger Marshall (R-Kan.), a member of the Health Committee. 

“We owe it to the Americans who have lost their lives to the virus, their families, and those still struggling with the pandemic’s societal and economic consequences, to continue investigating the coronavirus’s origins,” Marshall said.

In the House, Republicans have made it clear that should they take control after the midterm, they want to hold hearings on the lab leak possibility and put Biden officials like Fauci in the hot seat.

Earlier this year, Republicans on the House Foreign Affairs Committee released their own report concluding the pandemic began with a virus that escaped from the Wuhan lab. 

But the Senate GOP report does not insinuate any of the more controversial theories for how the virus was introduced to the world. Contrary to Paul’s questioning of Fauci during numerous hearings, the report does not accuse Fauci or the National Institutes of Health of playing any kind of role in the pandemic’s origins.

In a statement, Senate Health Committee Chairwoman Patty Murray (D-Wash.) said the committee’s bipartisan investigation will continue.

https://thehill.com/policy/healthcare/3709108-senate-gop-report-on-covid-origin-suggests-lab-leak-is-most-likely/

COVID-19 did not make students’ test scores drop. Our COVID policies did

 Many of us are lamenting the national decline in public school students’ reading and math test scores over the past two years. Many seem to find it self-evident that this drop in test scores, which is most pronounced among socioeconomically disadvantaged and minority students, was caused by “COVID-19.”

But while test scores did plummet alarmingly, COVID itself is not to blame.

COVID is a condition to which we chose how to react. In many places, we made the wrong choice, nonsensically closing schools, inexplicably masking children and lazily cutting activities and extracurriculars.

So, let’s not kid ourselves. The potentially lifelong deficiencies in academics now disproportionately affecting socioeconomically disadvantaged and minority children are the entirely foreseeable results of our unconscionable choices.

These choices to close schools, mask kids and cut activities were not unconscionable simply because they were incorrect. Everyone makes mistakes. We used to bleed people when they were sick. Doctors thought blood-letting helped; they didn’t know any better.

The extraordinary thing about our choices surrounding COVID was that we did know better, but we apparently didn’t care to do better.

How do we know that we knew better? Because in private and parochial schools in the same cities where public schools closed (including the Philadelphia Catholic school that my own children attend), the doors reopened in fall 2020, the masks stayed on much too long but did eventually go away, and activities continued apace.

Sure, the doors never should have closed at all. But in spring 2020, reasonable people disagreed on exactly what we were dealing with, and we can allow some grace for good faith wrong decisions. And, sure, having teachers and kids wear masks that muffled their ability to speak and listen during lessons while taking them off to eat snacks and lunch was always illogical to the point of parody.

Still, these measures – reopening schools in fall 2020 after spring 2020 closures and treating masks like amulets – represented our best-faith efforts. This is what we did for the kids whose parents were able to find private solutions (i.e., private and parochial schools) to this public problem (i.e., a pandemic).

For less advantaged kids, we did the wrong things and called them the right ones. The emperor was clearly wearing no clothes, and most of us knew it but apparently did not care enough to say so.

Now, the entirely predictable result has come to pass: The kids who could least afford to have their already far less than ideal academic opportunities diminished have suffered the consequences of their elders’ dishonestly, irrationality and carelessness. And those elders now want to act like our kids’ test scores dropped because of something beyond our control. As though the dog ate our homework when, really, we chose not to do it —or, in this case, to assign it.

The dishonest way in which cities like mine treated public school families during the pandemic (closing their schools and saying it was to protect them when, right under their noses, wealthier and whiter school populations that surely would have accepted no less protection suffered exponentially less disruption) was insupportable.

Then again, our treatment of these families, of these children, is always insupportable.

COVID was an extraordinary situation, to be sure. But trapping predominantly disadvantaged, minority constituencies in schools that fail to educate their children –while manipulating the conversation to claim that this failure to educate is in fact for the students’ benefit – is the norm. After all, if you get rid of tests, the test scores won’t drop. After all, if you’re not in school, you won’t catch COVID there.

Meanwhile, in schools where students have better-resourced parents, the tests continue, and the doors stay open. So, let’s stop lying to ourselves about the societal failure we perpetrate (not just during COVID, but every day) against those least able to absorb it.

In Philadelphia, as in many cities where the public schools were failing long before COVID, there are thousands of families waiting for scholarships that would enable them to attend private and parochial schools.

We all know well enough what education and protection look like — before, during and after COVID. If we want to assist families that need help to educate and protect their children like we educate and protect our own, we should support the vouchers that would create school choice for those socioeconomically disadvantaged families, and we should give whatever we can to those scholarship programs until such vouchers level the playing field.

Facilitating the attendance of under-resourced kids in educational institutions that will in fact educate them is not just a pandemic-era problem. It is an everyday problem that was exacerbated by our choices during the pandemic, and that we should redouble our resolve to solve in its wake.

Elizabeth Grace Matthew writes about culture, politics and religion for various publications, including America magazine and The Philadelphia Inquirer. 

https://thehill.com/opinion/education/3709334-covid-19-did-not-make-students-test-scores-drop-our-covid-policies-did/

Wage growth ticks down, causing markets to soar

 New data showing a slowdown in wage growth on Friday is leading to a big day on the stock market.

Compensation rose 1.2 percent in the third quarter, a tick down from the 1.3 percent growth in the previous quarter, according to the data released Friday by the Labor Department.

Wage growth at an annualized rate for all workers fell by 0.2 percentage points to 5.1 percent from 5.3 percent between the second and third quarters, while private industry wage growth dropped by an even larger margin between the two quarters, to 5.2 percent from 5.7 percent.

The wage slowdown is a sign employers are paying less after the Federal Reserve’s series of interest rate hikes, and are being treated as good news by markets.

The Dow Jones Industrial Average of stocks gained nearly 600 points in early trading. The S&P 500 increased in value by nearly 1.5 percent, and the technology-heavy Nasdaq increased by 1.6 percent.

“Today’s Employment Cost Index tells us that, after hitting record-highs, wages are finally slowing down across most industries and occupations, posing less of a threat to inflation. Private sector wages and salaries increased 5.2 percent over the year, down from 5.7 percent in the prior quarter—still hot, but cooling,” Julia Pollak, an analyst at Zip Recruiter, said in an email to The Hill.

“Slowing wage growth is the result of a slowdown in worker turnover. As the number of workers quitting their jobs eases, employers are finding it easier to retain workers without large wage increases,” she wrote.

The Federal Reserve has been raising interest rates in order to bring down inflation, which has been over 8 percent for seven months in a row.

The new data could point to a change in Fed policy, which would help markets.

The Fed as of now is widely expected to raise rates further at its next meetings.

Pollak said she believes that the Fed’s interest rate hikes are proving to be effective in bringing down inflation.

However, inflation isn’t simply driven by wages, and the Federal Reserve has said it doesn’t currently observe a wage-price spiral driving inflation.

Rather, inflation is the result of many different factors in the international economy that have complex interactions.

Harvard economist Larry Summers said online Friday morning that “anyone who thinks that inflation is driven by particular factors that will soon reverse themselves” should reconsider their position.

Other data released Friday by the Commerce Department showed that consumer spending rose in September even as inflation wiped out wage gains.

Personal consumption expenditures rose 0.6 percent in September and 0.3 percent when adjusting for inflation, unchanged from August.

https://thehill.com/policy/finance/3709436-wage-growth-ticks-down-causing-markets-to-soar/

LeMaitre cut to Market Perform by Barrington

 From Outperform

https://finviz.com/quote.ashx?t=LMAT&p=d

Biotricity Launches Cardiac Disease Management Solution

 Biocare Cardiac is the first-of-its-kind comprehensive cardiac disease management solution combining diagnostics, RPM, disease and lifestyle management, and telemedicine for cardiologists and patients.

Biotricity, Inc. (NASDAQ:BTCY), a medical diagnostic and consumer healthcare technology company, today announced the U.S. launch of Biocare Cardiac. The national roll-out follows two successful pilot programs in Oklahoma City with CardioVascular Health Clinic, a medical facility providing high-quality cardiovascular care to more than 40,000 patients, and a four-month pilot with Lexington Heart Specialists in Kentucky, a medical practice providing high-quality cardiovascular care to more than 20,000 patients.

Designed to expand Biotricity's existing remote monitoring tools used today by more than 2,000 cardiologists nationwide, the easy-to-use solution puts actionable data at the physicians' fingertips to assist them in making treatment decisions quickly.

https://finance.yahoo.com/news/biotricity-launches-cardiac-disease-management-123000125.html