Tag: COVID

11/9/21

The Unseen Surge of Alcohol Use

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Although the increase in overdose deaths preceded the COVID pandemic, the pandemic seems to have accelerated the trend. In December of 2020, the CDC reported that drug overdose deaths in the U.S. rose 29.4% that year, mostly from illicitly manufactured fentanyl. Overdose deaths involving psychostimulants increased 10 times from 2009 to 2019. This increase was a mixture of opioids and psychostimulants as well as psychostimulants alone. But all the attention on these two drug classes seems to have overlooked the unseen surge of COVID-related increases with another drug—alcohol.

Using death certificate data from the National Center for Health Statistics, White et al found that almost 1 million people died from alcohol-related causes between 1999 and 2017. The number of death certificates mentioning alcohol more than doubled during that time frame. The Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), George Koob, said:

Alcohol is not a benign substance and there are many ways it can contribute to mortality. The current findings suggest that alcohol-related deaths involving injuries, overdoses, and chronic diseases are increasing across a wide swath of the population. The report is a wakeup call to the growing threat alcohol poses to public health.

The researchers found that nearly half of alcohol-related deaths were from liver disease (31%) or overdoses on alcohol alone or with other drugs (18%). By the end of the study, alcohol-related deaths were increasing among people in almost every age, racial and ethnic group. Death rates increased for women (85%) more than men (35%). Women also appeared to be at a greater risk for several alcohol-related consequences than men—including cardio-vascular disease, liver disease, alcohol use disorder. Dr. Koob said:

Taken together, the findings of this study and others suggests that alcohol-related harms are increasing at multiple levels – from ED visits and hospitalizations to deaths. We know that the contribution of alcohol often fails to make it onto death certificates. Better surveillance of alcohol involvement in mortality is essential in order to better understand and address the impact of alcohol on public health.

The researchers said alcohol-related deaths were highest among males, individuals between 45 and 74 years of age, and non-Hispanic American Indians or Alaska Natives. Rates increased for all age-groups except 16 to 20 and 75 and over. The largest increase was among non-Hispanic White females. These findings confirm the increasing burden of alcohol on public health.

On his blog, William White observed how the alarm over recent drug surges with opioids and methamphetamines could be obscuring surges in alcohol consumption and its related consequences. In addition to the White et al study, William White also referred to Sherk et al, whose researchers found that even light or moderate alcohol consumption increased the risk for a number of health consequences, including cancer, heart disease and traumatic injuries. More than one quarter (27%) of alcohol-related hospital stays were experienced by individuals who drank within the weekly guidelines.

The low-risk drinking guidelines for men were no more than 14 drinks per week and no more than 4 drinks per day. Low risk guidelines for women were no more than 7 drinks per week and no more than 3 drinks per day. Sherk et al concluded drinkers who followed weekly low-risk drinking guidelines were not immune from harm. They suggested guidelines of one drink per day for both sexes. The researchers clearly demonstrated that alcohol abuse and the related consequences were increasing before the COVID pandemic.

Alcohol Abuse and COVID

As stay-at-home orders began in some US states to lessen COVID-19 transmission in March of 2020, Nielsen reported a 54% increase in national sales of alcohol for the week ending Mach 21, 2020. The World Health Organization warned that alcohol use could potentially worsen health vulnerability, risk-taking behaviors, mental health issues and violence. The WHO suggested existing rules and regulations to protect health and reduce the harm caused by alcohol, such as restricting access, should be reinforced during the COVID-19 pandemic. “Any relaxation of regulations or their reinforcement should be avoided.”

Pollard, Tucker and Green looked at “Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US.” The data were collected using the RAND Corporation American Life Panel (ALP), a nationally representative, probability-sample panel of 6,000 participants. A sample of 2,615 ALP members ages, 30-to-80, were invited to participate in the baseline survey.

Comparisons before and during the COVID-19 pandemic were made on the number of days participants reported any alcohol use and heavy drinking, and the average number of drinks consumed over the previous 30 days. Heavy drinking was defined as 5 or more drinks for men and 4 or more drinks for women within a couple of hours. Adverse consequences were assessed by the 15-item Short Inventory of Problems associated with alcohol use in the previous 3 months. Comparisons were made overall, and across self-reported sex, age, and race/ethnicity.

These data provide evidence of changes in alcohol use and associated consequences during the COVID-19 pandemic. In addition to a range of negative physical health associations, excessive alcohol use may lead to or worsen existing mental health problems, such as anxiety or depression, which may themselves be increasing during COVID-19. The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19.

It does seem that concern with overdoses from opioids and methamphetamine in the midst of COVID overshadowed the growing problem with increasing alcohol consumption and its related consequences during the pandemic. William White observed that alcohol use is historically pervasive in the U.S. and “so infused into the cultural water in which we all swim that we fail to see it. That blindness has exacted, and continues to exact, an enormous toll on individuals, families, and communities.” The findings of the above discussed research studies reinforce the need for continued efforts with public and professional alcohol-related education, alcohol treatment resources, screening for alcohol problems and recovery support for individuals and families effected by alcohol use disorders. We cannot let concerns with the pandemic or opioid epidemic draw our attention away from the growing problem with alcohol-related deaths.

01/26/21

Learning from COVID Drug Development

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On December 11, 2020 the FDA issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine. Then on December 18th, the FDA issued an EUA for the Moderna COVID-19 Vaccine. The FDA News Releases for both drugs said the data provided clear evidence both vaccines may be effective in preventing COVID-19. The known and potential benefits for both drugs were said to outweigh the known and potential risks. “In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”

In December of 2019, no one knew COVID-19 existed and now there are two vaccines being distributed in the US that are both around 95% effective in preventing the novel coronavirus. Despite the unprecedented speed of their development, there were not any compromises with the safety or the scientific integrity of the process. According to Dr. Anthony Fauci, the speed was “a reflection of the extraordinary scientific advances in these types of vaccines which allowed us to do things in months that actually took years before.” He wanted to settle the concerns some people have about the rush of development and approval. Despite the politicization of the process, there was an independent body of people with no allegiance to the administration or to the pharmaceutical companies who were the first ones to review and then approve the data from the companies’ late-stage clinical trials. “We need to put to rest any concept that this was rushed in an inappropriate way . . . Help is on the way.”

The FDA requires that a vaccine be at least 50% effective, according to the latest guidance. By comparison, two doses of the measles vaccine is about 97% effective, and flu vaccines range from about 40% to 60% effective, according to the Centers for Disease Control and Prevention (CDC).

The FDA just finalized the guidance for EUAs in January of 2017. The purpose of this guidance was to explain the FDA’s current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug and Cosmetic Act, as it was amended or added to by the Pandemic Reauthorization Act of 2013 (PAHPRA).

The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats.

The Washington Post published an article that addressed common concerns about the COVID-19 vaccines. First, it is not just the vulnerable who should get the vaccine. Vaccines protect more than just the person who is inoculated. The more people who are vaccinated means there are fewer people the virus can infect, “lowering the infection rate and the risk for us all.” Another reason is to protect those who cannot get it. The first two approved vaccines were only approved for individuals over the ages of sixteen for the Pfizer-BioNTech COVID-19 Vaccine and 18 for the Moderna COVID-19 Vaccine.

Your decision not to get vaccinated could affect other people around you. Individuals with a weakened immune system may need to rely on the immunity of others to keep them healthy. Not getting a vaccine would be like refusing to wear a mask. We will likely have to wear masks through 2021. In fact, vaccinated people should wear masks and follow social distance guidelines. While the vaccine is effective at reducing symptomatic illness, it is not yet known whether it reduces the likelihood of contracting the coronavirus and being an asymptomatic carrier.

As more people get vaccinated and the US gets to community or herd immunity, there will come a point when we can do away with the masks. “In the meantime, vaccination is a crucial tool. It doesn’t replace other tools but is a powerful measure that can help save lives and help the economy recover.” Allergic reactions can be treated without lasting consequences, but the same is not true for COVID-19. At this time, it is not known what component of the vaccine triggers allergic reactions, but there is not reason for people with food or medication allergies to avoid the vaccine as long as they are monitored in a health-care setting.

All viruses mutate and it may turn out that people will have to receive regular booster shots, like with tetanus or the flu shot. Enough mutations could eventually reduce the potency of existing vaccines. A study of the Moderna vaccine found it was effective for at least 119 days. But some experts believe immunity should last at least a year. “The theoretical necessity of future vaccinations doesn’t override the urgency of getting one now.”

For those worried about political interference in expediting approval, it’s critical to emphasize that no shortcuts were taken in research or the approval process. Vaccine safety was tested in phase 3 trials involving tens of thousands of participants. External committees of scientists vetted the data and produced independent recommendations to support vaccine authorization.

The Allegheny Health Network (AHN) posted a series of frequently asked questions (FAQs) and answers that addressed further questions about the COVID-19 vaccines. The further information there included that no doctor’s order will be necessary to get the vaccine, but you will have to schedule an appointment. AHN said the vaccine is free to all Americans and will be available at retail pharmacies. “Remember, some vaccines require two doses to be effective. It’s extremely important you get both and follow the suggested timeline.”

Who knows where we’ll be with COVID in another twelve months! But there are some things we’ve learned through this pandemic about drug companies and hopefully will continue to insist on. Drug development can be done quickly and safely. Pharmaceutical companies can be open and transparent about their research and allow truly independent, external committees to verify their findings. People can trust the results of drug development when the clinical trial process is not statistically or methodologically manipulated to show what the researchers want to find.

The widespread mistrust of science that became evident during the pandemic seems partly due to the previous manipulation of drug development by the pharmaceutical companies. Like good illusionists, they directed our attention to what they wanted us to see and away from what they wanted to hide. Going forward, open, transparent drug development can restore the trust that is now lacking for the COVID vaccine. During the pandemic drug companies showed they could do COVID Drug Development quickly and safely. We need to remember these things and hold the drug companies accountable to these standards.

01/19/21

Co-Occurring COVID Surges

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We’re now all getting ready to queue up for one of the COVID vaccines. But while our attention was on COVID surges and the political circus, there were also a surge of drug overdose deaths. The CDC reported in the twelve months ending in May 2020, there were over 81,000 drug overdose deaths in the US, the largest number of drug overdoses ever for a 12-month period. After declining 4.1% from 2017 to 2018, the number of overdose deaths increased 18.2% from June 2019 to May 2020. The increases appear to have accelerated during the COVID-19 pandemic.

The recent increase in drug overdose deaths began in 2019 and continued into 2020, before the declaration of the COVID-19 National Emergency in March. However, provisional overdose death estimates indicate that from the end of February 2020 to the end of March 2020 there was an increase of 1,511 deaths. From the end of March 2020 to the end of April 2020 there was an increase of 2,146 deaths. And from the end of April 2020 to the end of May 2020 there was an increase of 3,388 deaths. These totals were the largest monthly increases since provisional 12-month estimates began to be calculated in January 2015. See the figure below taken from the CDC Health Alert Network report.

Not surprisingly, synthetic opioids were the main driver of the increases in overdose deaths. “State and local health department reports indicate that the increase in synthetic opioid-involved overdoses is primarily linked to illicitly manufactured fentanyl.” Not all of the reporting jurisdictions (the fifty states plus the District of Columbia and New York City) had available data on synthetic opioids. Of the 38 jurisdictions with available synthetic opioid data, 37 reported increases in synthetic opioid overdose deaths for the time period (June 2019 to May 2020); 18 increases were greater than 50% and 11 increases were between 25% and 49%. See Figure 3 in the above linked CDC report for information on which jurisdictions were not included.

Historically, deaths involving illicitly manufactured fentanyl have been concentrated in the 28 states east of the Mississippi River, where the heroin market has primarily been dominated by white powder heroin. In contrast, the largest increases in synthetic opioid deaths from the 12-months ending in June 2019 to the 12-months ending in May 2020 occurred in 10 western states (98.0% increase). This is consistent with large increases in illicitly manufactured fentanyl availability in western states and increases in fentanyl positivity in clinical toxicology drugs tests in the West after the COVID-19 pandemic. Increases in synthetic opioid overdose deaths were also substantial in other regions: 12 southern states and the District of Columbia (35.4%), 6 midwestern states (32.1%), and 8 northeastern states and New York City (21.1%) (Figure 3).

Overdose deaths from cocaine increased by 26.5% from June 2019 to May 2020. The recent deaths are due primarily to overdose deaths involving both cocaine and synthetic opioids. In contrast, overdose deaths from psychostimulants like methamphetamine have been increasing without synthetic opioid co-use. The rate of increase was faster than overdose deaths involving cocaine and is now greater than the number of cocaine-involved deaths. There was a projected increase of 34.8% of overdose deaths from psychostimulants from June of 2019 to May of 2020.

During a recent webinar, “COVID-19 and Its Impacts on Substance Abuse,” a past president of the American Medical Association (AMA) said it was imperative that we continue to talk about health issues other than COVID that are impacting our nation. “We are appropriately focused on COVID, it is still top of mind for most people, and it’s understandable that we can lose focus on other issues … but we still have to make sure we are focused on the overdose epidemic that we continue to experience in this country.” The AMA said that science, evidence and compassion must continue to guide patient care and policy change as the nation’s opioid epidemic develops into a more alarming and convoluted drug overdose epidemic.

The federal government has eased regulations that make it easier for doctors to treat patients with substance use disorder during the pandemic. But it is not clear that all states will take advantage of these relaxed policies. The DEA has issued guidance that allows practitioners to prescribe buprenorphine to new patients with opioid use disorder after a telephone evaluation.  A SAMHSA (Substance Abuse and Mental Health Services) policy allows stable methadone patients to obtain up to 28 days of take-home medication. “With social distancing recommendations and inconsistent public transportation availability, this policy assists patients that might not be able to visit an opioid treatment program on a daily basis.”

In the midst of COVID surges and the steady rise of drug overdose deaths, there is another COVID-related escalation happening with mental health symptoms in the U.S. and around the world. The 2020 Commonwealth International Health Policy Survey found that one-third of U.S. adults reported experiencing stress, anxiety and great sadness that was difficult to cope with since the COVID outbreak started. Americans were more likely than people in other countries to report mental health concern. Past research showed that Americans were already more likely to experience emotional distress, yet it seems the pandemic has contributed to higher rates of emotional distress in several countries. “The negative impact of COVID-19 on mental health has been immediate, and the pandemic is certain to have long-term effects in every country it has touched.”

Fifty-six percent of U.S. adults who reported experiencing any negative economic consequences of the pandemic also reported having mental health distress. The pandemic’s economic toll has contributed to higher levels of mental distress in other places as well. In all five countries for which reliable estimates could be calculated, people who said they experienced any type of economic insecurity since the start of the outbreak were several times more likely to also report stress, anxiety, and great sadness that was difficult to cope with alone.

The New York Times reported there is growing evidence that a small number of COVID patients with no history of mental health problems are developing severe psychotic symptoms weeks after contracting the virus. A British study published in The Lancet found 10 individuals out of 153 patients hospitalized with COVID-19 had new-onset psychosis. A Spanish study published in the journal Psychiatry Research also found ten individuals with new-onset psychotic episodes in COVID-19 patients. In COVID-related social media groups, medical professionals discussed seeing patients with similar symptoms in the Midwest, Great Plains and other places in the U.S. Neurological, cognitive and psychological symptoms could emerge even in patients who did not have serious lung, heart or circulatory problems.

A 36-year-old nursing home employee in North Carolina who became so paranoid that she believed her three children would be kidnapped and, to save them, tried to pass them through a fast-food restaurant’s drive-through window.A 30-year-old construction worker in New York City who became so delusional that he imagined his cousin was going to murder him, and, to protect himself, he tried to strangle his cousin in bed.A 55-year-old woman in Britain had hallucinations of monkeys and a lion and became convinced a family member had been replaced by an impostor.

Experts speculate that these brain-related effects may be linked to either vascular problems or surges of inflammation caused by the disease process; Another possibility is the body’s immune system response to the coronavirus. Persistent immune activation is a leading explanation for memory problems and what has become known as “COVID brain fog.” Some post-COVID psychosis patients needed weeks of hospitalization while doctors tried different medications. There have been past reports of post-infectious psychosis and mania with other viruses, including the 1918 flu, SARS and MERS.

We don’t know what the natural course of this is . . . Does this eventually go away? Do people get better? How long does that normally take? And are you then more prone to have other psychiatric issues as a result? There are just so many unanswered questions.

While we appropriately focus our attention on COVID, let’s not forget about the growing problem with drug overdoses and not neglect the emergence of post-COVID psychosis. As the AMA exhorted, science, evidence and compassion must guide us in addressing the COVID pandemic, the overdose epidemic and the concurrent rise of mental health concerns.

For other articles on drug overdoses or anxiety in the midst of COVID, see “Drug Overdose Deaths: In the Shadow of COVID-19” and “An Epidemic Emerging from the Pandemic?”