Will Humble Marijuana, Public Health Law, Social Determinants, Wills Blog

Prop 207 Achieves Criminal Justice Reform & Sets Up a Retail Marijuana System

Arizonans approved Proposition 207 which will dramatically reform marijuana possession laws including allowing for the retail sale of up to 1 ounce of marijuana in authorized stores to folks over 21 years old. The law will take effect when the election is certified later this month.

There are many provisions in the new law. Here are a few highlights:

  • Adults 21 and older would be able to possess 1 ounce of marijuana with no more than 5 grams of it being marijuana concentrates (extracts).

  • Possessing more than 1 ounce but less than 2.5 ounces would be a petty offense. Minors caught with less than 1 ounce would receive up to a $100 fine and 4 hours of drug counseling for a first offense. A second offense would be up to a $100 fine and 8 hours of drug counseling. A third offense would be a class 1 misdemeanor.

  • Beginning July 12, 2021, people convicted previously of possessing less than an ounce of marijuana or six or fewer plants or paraphernalia can petition to have the record expunged.

  • Allows home cultivation of marijuana but limits it to 12 plants at a residence where two or more individuals who are at least 21 years old reside at one time.

  • The ADHS will need to establish recreational marijuana regulations before April 5, 2021, and existing medical marijuana dispensaries will be allowed to add a retail line of business when their licenses are approved in the spring of 2021. Medical marijuana dispensaries will be able to sell recreational marijuana to adults as a bridge until the ADHS issues licenses for recreational dispensaries).

  • A 16% excise tax (the same as cigarettes and alcohol) will be placed on recreational marijuana products. Money from the excise tax would fund various state agencies and be dispersed between community college districts, police and fire departments, and the Highway User fund. Medical marijuana will not be subject to this tax.

  • Marijuana use would remain illegal in public places (restaurants, parks, sidewalks, etc.). Smoking in a public place would be a petty offense.

  • No marijuana products could be sold that imitate brands marketed to children or look like humans, animals, insects, fruits, toys, or cartoons.

  • Marijuana edibles will be limited to a maximum of 10mg of THC per edible and limited to a maximum of 100mg of THC per package of edibles. This does not apply to medical marijuana.

  • Employers have the right to maintain a drug- and alcohol-free workplace.

  • Driving under the influence of marijuana remains illegal.

There are currently tens of millions of excess dollars in the Arizona Medical Marijuana in large part because I set the medical marijuana card fees way too high. Once certified, the law requires the transfer of $10M from the existing fund to the ADHS to fund programs for teen suicide prevention, maternal mortality review, poison control centers and programs to prevent Adverse Childhood Experiences. I imagine that the ADHS will be reaching out to stakeholders as they prepare to deploy those funds.

Prop 207 also releases $4M from the MM fund for grants to organizations to help people file for expungement of previous convictions of qualifying possession of marijuana charges.

Will Humble Disease Control, Wills Blog

Pfizer Announces Promising Efficacy Data for Their mRNA SARS CoV2 Vaccine

Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19. The announcement didn’t come with many details so I don’t have many details to share except the following:

The Phase III Trial was conducted in the U.S. and has enrolled about 44,000 volunteers. About half of the participants were in the placebo group and about half were in the group that got the vaccine (with a booster a month later). The company said that almost all of the 94 persons in the trial that ended up contracting COVID-19 were in the placebo group. Statistically speaking, they said that the Phase III data (which has not been disclosed) suggests that the vaccine is 90% effective at preventing COVID-19. They also said that no serious adverse events were identified.

A couple of cautionary notes are that these results haven’t been released or published in a peer-reviewed journal article. Also, many of the participants in the Phase III trial haven’t been followed up for even a full 60 days yet (important for identifying adverse events).

There are 11 vaccines in late Phase III trials right now including 4 in the U.S. This Pfizer vaccine as well as Moderna’s candidate use a new Messenger RNA technology that has never before been used to create a vaccine. Both Moderna and Pfizer expect to submit full Phase III trial data in the coming weeks.

Here’s a link to one of my previous blog posts that discusses how vaccines are tested and approved.

Will Humble Affordable Care Act, Disease Control, Federal Budget, Public Health, Public Health Law, Wills Blog

Election Result Musings

Federal

The result of the presidential election will no doubt have profound implications for public health. We can expect to see new leadership in most if not all the agencies under the US Department of Health and Human Services including CDC, HRSA, CMS, FDA etc. Those agencies have a great deal of latitude in the decisions they make and can change their regulations (CFR’s)… although changing regulations takes a lot more time than simple policy changes.  

Congress may be split between a House controlled by Democrats and a Senate controlled by Republicans (pending Senate run-off elections in Georgia). If there is a split, the we’re unlikely to see major public health legislation passed but we will see dramatically different decisions being made by the various federal agencies. We can also expect to see a series of Executive Orders issued in mid-January that will have implications for public health and the response to the pandemic.

The transition to the new administration will be happening over the next 72 days. Transitions are always a bit tumultuous and this one will be particularly so because of the pandemic. For example, the FDA will be making critical decisions about the safety and efficacy of the various SARS CoV2 vaccines during the transition period. The CDC is expected to be developing guidance for the prioritization of the early vaccine doses. Several of the HHS agencies will be working on plans to deploy the vaccines.

Dr. Fauci is in a particularly interesting position. As the most credible national voice for COVID public health policy he must be thinking about whether he can be more useful as a member of the existing administration or whether he can be more valuable if he were to retire from his position at the NIH (at least temporarily) and work with the incoming administration’s transition team.

State

At our last Public Health Policy Committee meeting we discussed developing a more aggressive public health policy agenda for the upcoming legislative session in anticipation of either the State House or Senate flipping to Democratic control.

As it turns out, it looks like the Democrats will remain in the minority in both chambers again. We’ll continue to think through our policy agenda.  In the mean-time, here’s the policy agenda from 2020: 2020 Legislative Session Priorities (ppt).

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Latest Epidemiological Report

Here is Dr. Gerald’s latest weekly epidemiology and hospital capacity report. Here is his narrative summary (below) and here’s his full weekly report.

 Cases and hospitalizations continue to increase state-wide with the more rural, previously spared counties leading the charge. Pima County saw a second straight week with a fairly large increase. Last week’s increase was due in part to a confirmed outbreak in a correctional facility. Even so, there is ample evidence of broader community-level transmission.

While not yet a crisis, hospitals capacity is at the point where Covid and non-Covid occupancy is placing a noticeable strain on personnel and resources.

Will Humble Disease Control, Wills Blog

Interesting New Studies and Essays

More than 90% of Mild to Moderate COVID-19 Patients have Strong Antibody Response

Most people with mild-to-moderate COVID-19 produce antibodies that can fight off the infection that remain at similar levels in the body for at least 5 months, suggests research carried out at Icahn School of Medicine at Mount Sinai in New York.

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Regeneron’s Two-Antibody COVID-19 Treatment “Cocktail” Reduces Viral Load

REGN-COV2, has met its primary endpoint of significantly reducing viral load and medical visits in ambulatory adults with COVID-19. However, the company is reviewing a possible change of dosages in the study after finding no significant difference in efficacy between the high and low doses of the treatment.

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Facial Masking for Covid-19 — Potential for “Variolation” as We Await a Vaccine

M. Gandhi and G.W. Rutherford N Engl J Med 2020;383:e101

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Evaluating and Deploying Covid-19 Vaccines — The Importance of Transparency, Scientific Integrity, and Public Trust

J.L. Schwartz N Engl J Med 2020;383:1703-1705

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CDC Releases Two New MMWRs

The first release describes an investigation of a university’s men’s and women’s soccer team where 17 COVID-19 cases were identified. Lax social distancing and mask use during social gatherings were thought to contribute to the spread.

The second release describes results from the Data Foundation’s COVID Impact Survey. Self-reported adherence to COVID-19 mitigation measures was lowest in the 18-29 age group, while those 60 years or older reported the highest adherence.

Will Humble Disease Control, Wills Blog

Journal Article of the Week

COVID-19 Mortality Risk in Down Syndrome: Results from a Cohort Study of 8 Million Adults

In this study, researchers compared risk factor for death from COVID-19 by doing an analysis of individual-level data in a cohort study of 8 million adults in the U.K.  Their primary outcome of interest was COVID-19 mortality within 28 days of a confirmed SARS-CoV-2 infection.

After adjusting for age and sex, ethnicity, BMI, care home residency, congenital heart disease, and a range of other comorbid conditions the researchers, found that folks with Down Syndrome had a 10 times higher risk of death if diagnosed with COVID-19.

As you interpret the study, keep in mind this this result is after age adjustment. Far and away the dominant risk factor for dying from COVID-19 is age, even among those with Down syndrome. Think of it this way. A 26-year-old man with Down syndrome starts out with a case fatality rate of that of a typical 26 year-old. You’d then factor in an additional 10-fold increased risk. 

A 26-year-old typical male would have an approximately 1/100,000 case fatality ratio (CFR) from COVID-19. A 26-year-old person with DS would then have a CFR of 1/10,000.

Compare that however, to a pair of 50-year-old males. The CFR starts out at approximately a 1/10,000. The peer with Down’s syndrome would have a CFR of 1/1,000. 

For perspective, an 80-year-old male has a CFR of about 1/200. Here’s the article where I retrieved the case fatality ratios.

Will Humble Disease Control, Wills Blog

Are Human Challenge Trials for COVID-19 Vaccine Worth the Risk & Are They Ethical?

In a normal clinical trial for a vaccine, a person in the vaccination group is given the vaccine while those in the placebo group get something like a saline injection. Both groups then go out to the community. Observations are made over time in both the vaccine and placebo groups to determine whether the vaccine protects people from infection.

There’s another kind of trial which speeds things up a lot called a “Challenge Trial”.  That’s when a person is vaccinated and then is later intentionally exposed to the virus to see whether they get sick.

There are obviously some ethical questions about challenge trials but they have some real advantages as well because they can speed up getting results by weeks or even months. You get cleaner data as well because you are sure about the exposure. So, in a public health emergency – when people are losing their lives every day- should we be using Challenge Trials to speed things up? After all, you know for sure that people are dying every day and that if you can speed up the trial, you’ll be able to save many lives by accelerating the trials.

Persons in Challenge Trials are volunteers. They are also done after  the Phase II trial has been completed so you have at least some information about the safety.

On the other hand, you may need to challenge persons that got the placebo (not the vaccine)…  posing clear ethical questions.  An alternative could be to challenge just the vaccine group (not the placebo group) with various doses of challenge virus and look to see whether there’s a dose-response. That might be a way around exposing the placebo group.

Anyway- take a look at this essay about Challenge Trials in Medscape this week.  Interesting short read.

Will Humble Disease Control, Public Health, Wills Blog

The Effects of Large Group Meetings on the Spread of COVID-19:

The Case of Trump Rallies

A group of researchers from Stanford University explored whether or not the large outdoor rallies (that are characterized by few if any mitigation measures) contribute to community spread after the events. They looked at 18 Trump campaign rallies to determine whether there was a subsequent rise in COVID-19 cases in those jurisdictions relative to control (placebo) jurisdictions that didn’t have a rally.

They used a collection of regression models to capture the relationships between pre and post-event outcomes including demographics and the trajectory of COVID-19 cases in matched counties. The regression models showed that COVID-19 cases increased by more than 250 per 100,000 residents following the rallies.

Extrapolating this figure to the entire sample, the report concludes that “these eighteen rallies ultimately resulted in more than 30,000 incremental confirmed cases of COVID-19. Applying county specific post-event death rates, we conclude that the rallies likely led to more than 700 deaths (not necessarily among attendees)“.

They conclude that: “Our analysis strongly supports the warnings and recommendations of public health officials concerning the risk of COVID-19 transmission at large group gatherings, particularly when the degree of compliance with guidelines concerning the use of masks and social distancing is low. The communities in which Trump rallies took place paid a high price in terms of disease and death.” 

Remember- this isn’t a peer reviewed article and has not been published except by the authors. In general, I’m reluctant to draw firm conclusions about cause and effect like this unless the work is published in a reputable peer-reviewed journal. However, it does make some intuitive sense that the rallies are likely contributing to community spread because few if any mitigation measures are adhered to at these events.

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Latest Epidemiological Analysis for Arizona

Here’s a link to Dr. Gerald’s latest Epi report for Arizona. Below is his introductory paragraph. You can go to the full weekly report at this link.

For the week ending October 25th, 7221 new Covid-19 cases were diagnosed in Arizona (Figure 1). This represents a 19% increase from last week’s revised tally of 6064 cases. Reporting delays continue to be minimal.

Accordingly, last week’s tally of 5779 new cases was only upwardly revised by 5% (285 cases) this week. Some of this backfill was also attributable to moving this report earlier in the week. Case counts continue to increase among all age groups (Figure 2 following page). Rising case counts warrant reappraisal of government policies as well as individuals’ adherence with face masks, physical distancing, and hand hygiene practices. Current transmission levels are just shy of those observed during the first week of June when 8239 cases were diagnosed. A mere 3 weeks later, Arizona’s case count reached a peak of 27796 cases.

Given the possibility of exponential growth, current conditions could deteriorate rapidly.

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