Category Archives: General Health

Latest Research: Modest Drinking Does NOT Confer Cardiac Benefits

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KR Biddinger et al. JAMA Netw Open. 2022;5(3):e223849. doi:10.1001/jamanetworkopen.2022.3849. Open Access: Association of Habitual Alcohol Intake With Risk of Cardiovascular Disease

NY Times Analysis of This Study: Does Moderate Drinking Protect Your Heart? A Genetic Study Offers a New Answer.

An excerpt:

“There is no level of drinking that does not confer heart disease risk. The risk is small if people have an average of seven drinks a week when compared with none. But it increases quickly as the level of alcohol consumption rises”

“The study, which may help resolve medical disputes over the effects of alcohol on the heart, involved sophisticated analyses of the genes and medical data of nearly 400,000 people who participate in the U.K. Biobank”

“Some researchers have reported that drinking modestly protects the heart because moderate drinkers as a group have less heart disease than those who drink heavily or those who abstain. Dr. Aragam and his colleagues also saw that effect. But the reason, they report, is not that alcohol protects the heart. It is that light to moderate drinkers — those who consume up to 14 drinks a week — tend to have other characteristics that decrease their risk, like smoking less, exercising more and weighing less than those who drink more heavily and those who do not drink.“

“Many earlier studies of alcohol consumption and heart health were observational, meaning the subjects were followed over time to see if the amount of drinking was linked to heart health. Such studies are only able to find correlation but not causation, researchers say. But the Biobank study’s use of Mendelian randomization is more suggestive of causality, and so its results might carry more weight.”

My take: Light alcohol consumption is NOT beneficial for your heart.

Distant Kite Boarder, Isle of Palms, SC

Shiny New Object: Gene Therapy in Gastroenterology

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It’s hard not to be fascinated by the emerging treatments in gene therapy. A great summary of this topic as it relates to gastroenterology:

RL Kruse et al. Gastroenterol 2022; 162: 1019-1023. Open Access: How to Embrace Gene Therapy in Gastroenterology

Key points:

  • Researcher’s have utilized viruses to introduce exogenous DNA in efforts to correct defects in genetic diseases. Adeno-associated virus (AAV) vectors are the most common vectors used. In addition, AAV have a natural tropism to the liver following intravenous infusion
  • “Highlighting programs with the most advanced efficacy, hemophilia gene therapies in the liver have advanced into phase 2/3 and have shown promising efficacy based on factor VIII or IX levels achieved and reduction in bleeding events, with the main questions being long-term expression and safety of the approach”

Limitations:

  • “Integrated AAV have been associated with an increased incidence of hepatocellular carcinoma in mice”
  • Antibodies to AAV may be present or develop after infusion…” this factor has precluded any redosing in trials because antibodies would neutralize all incoming vectors”
  • In hemophilia trials, in the liver there has been a slow decrease in the levels of expression over time 6 which indicates that years into the future patients will need to be redosed to maintain efficacy
  • “Practically, AAV can only achieve delivery in a fraction of cells within an organ”

Newer Approaches for Gene Delivery:

  • mRNA delivery: mRNA is being explored as a tool for gene therapy, because mRNA only requires cytoplasmic delivery for expression.
  • “mRNA can also express gene-editing enzymes like Cas9….However, gene editing presents inherent risks of off-targeting cutting or base editing that would occur in millions of hepatocytes, potentially leading to cancer”
  • “Nonviral approaches of DNA delivery could drop the costs of vector production at least 100-fold versus AAV…delivery of DNA through LNPs [lipid nanoparticles] has largely yielded inefficient gene expression”
  • “Hydrodynamic injection is a process where fluid pressure is used to deliver naked DNA directly into cell…injection into the biliary system through endoscopic retrograde cholangiopancreatography”

The authors note that gene delivery could be important in modifying more common disorders including nonalcoholic steatohepatitis, diabetes and autoimmune diseases.

My take: While this field of study is quite exciting, to me it is definitely a shiny object, like all of precision medicine, in that it may distract researchers and physicians away from more pressing common problems.

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For Policy Wonks: Bayh-Dole Act and Reducing Pharmaceutical Costs

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AB Engelberg et al. NEJM 2022; 386: 1104-1106 (Commentary). A New Way to Contain Unaffordable Medication Costs — Exercising the Government’s Existing Rights

This commentary notes that the National Institutes of Health (NIH) spends more than $40 billion each year to fund biomedical research. “We believe that medicines discovered at public expense should be affordable.”

A Few Excerpts:

  • “Existing laws provide two paths for achieving this result. First, the Bayh–Dole Act of 1980 gives the government a royalty-free license to use patented inventions that were discovered using federal funding. The government has never exercised its Bayh–Dole license”
  • “Second, 28 U.S. Code §1498, which dates to 1910, gives the government immunity from being sued for patent infringement in federal courts, while giving patent owners the right to receive reasonable compensation when the government makes or uses a patent-protected product”
  • Case in point: “Recently, the government signed a contract with Merck to purchase molnupiravir (Lagevrio), an oral antiviral drug that reduces the severity of Covid-19. The contract price of $712 per treatment is estimated to be more than 35 times the cost of producing the drug at a reasonable profit. Molnupiravir was discovered at Emory University using government funding, and Emory’s patent applications acknowledge the government’s Bayh–Dole license.5 Molnupiravir payments for Medicare, Medicaid, and VHA patients could cost the government billions in 2022. This amount could be reduced by more than 90% if the government exercised its license and allowed a generic manufacturer to supply the drug for patients in government-supported programs.”

My take: U.S. taxpayers should get a return on their investment when new medications are developed with government funding rather than paying more for these medications than any other country.

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Ravenel Bridge, Charleston SC (blue skies -no filter)

Digital Health Care Inclusion

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JA Rodriguez, et al. NEJM 2022; 386: 1101-1103 (commentary). Digital Inclusion as Health Care — Supporting Health Care Equity with Digital-Infrastructure Initiatives

Key points:

  • “With digital health tools such as telehealth and patient portals becoming prominent components of care delivery, the barriers to digital inclusion have grown increasingly apparent.1 For example, more than 100 studies have revealed disparities in portal use based on age, race, socioeconomic status, English-language proficiency, and other factors”
  • Barriers: digital redlining (discrimination by internet providers), limited broadband infrastructure/access, costs, and knowledge
  • “The recently enacted Infrastructure Investment and Jobs Act (IIJA) makes investments that could foster sustainable digital inclusion”
  • “The IIJA takes much of the responsibility for building digital infrastructure away from individual health care organizations and makes digital inclusion a public concern. The law includes $65 billion for digital-inclusion initiatives. It earmarks $42.5 billion for investment in broadband infrastructure by means of state deployment grants, promotes broadband affordability by providing $14.2 billion for $30-per-month subsidies for Internet costs for underserved people, and allocates $2.8 billion for the creation of digital-literacy programs. It also includes funds to support connectivity in tribal communities and broadband deployment in rural areas”
  • “The law charges the FCC with adopting rules to prevent “digital discrimination of access based on income level, race, ethnicity, color, religion, or national origin.” These policies are an attempt to overcome structural barriers to digital inclusion, such as redlining”
  • “By capitalizing on new policies, health care organizations could become a critical part of an environment of community-based players working toward digital inclusion”

Issues Not Addressed by Infrastructure Investment and Jobs Act (IIJA):

  • “Law doesn’t address changes that are needed to the design of digital health platforms (e.g., language translation) or to make workflows more inclusive (e.g., integration of interpreters into telehealth visits)”
  • “Simplification of interstate licensing laws for clinicians would also enable digital tools to increase access to care for marginalized populations”
  • Assuring adequate reimbursement for digital care

My take: Digital health literacy/availability is needed to improve outcomes.

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Island in Charleston Harbor with Ravenel Bridge in the distant (near Shem Creek)

COVID-19 Update: COVID.gov, Ivermectin Lack of Efficacy & Erectile Dysfunction Due to COVID-19

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Link: COVID-19 Government website. This site has information on (free) masks, free tests (up to 2 sets of 4 kits), vaccines and treatments.

The website is available in English, Spanish and Chinese. The administration is also making all of these tools available over the phone through the national vaccine hotline at 1-800-232-0233 (TTY 1-888-720-7489), which supports over 150 languages.

Link to article: Open Access (3/30/22): Effect of Early Treatment with Ivermectin among Patients with Covid-19

Highlights from Eric Topol’s Twitter Feed

COVID-19 Hospitalization Data from CDC on UnVax, Vax, and Vax + Boosted

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CA Taylor et al. MMWR 3/18/22, Open Access: COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Delta and Omicron Variant Predominance, by Race/Ethnicity and Vaccination Status — COVID-NET, 14 States, July 2021–January 2022

  • During the omicron wave, hospitalization among unvaccinated adults remained 12 times the rates among vaccinated adults who received booster or additional doses and four times the rates among adults who received a primary series, but no booster or additional dose.
  • The rate among adults who received a primary series, but no booster or additional dose, was three times the rate among adults who received a booster or additional dose
  • A previous study conducted before the Omicron-predominant period that showed increased risk for COVID-19–associated hospitalization among certain racial and ethnic groups, including Black adults, and suggested the increased hospitalization rates were likely multifactorial and could include increased prevalence of underlying medical conditions, increased community-level exposure to and incidence of COVID-19, and poor access to health care in these groups
  • The increase in transmissibility of the Omicron variant might have amplified these risks for hospitalization…the increased risk for hospitalization among Black adults during the Omicron-predominant period might also be due, in part, to lower proportions of Black adults receiving both the primary vaccination series and booster doses

My take: This study shows the value of getting vaccinated and booster shot. I would speculate that many of the unvaccinated have had previous infections and this further indicates that vaccination may provide greater protection than immunity following infection.

What’s Wrong with Step Therapy Reform: Safe Step Act

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RE Sachs, MA Kyle. NEJM 2022; 386: 901-904. Step Therapy’s Balancing Act — Protecting Patients while Addressing High Drug Prices

“Step therapy is a utilization-management strategy whereby insurers implement tiered treatment pathways for various conditions. Patients (and their physicians) who seek approval for restricted therapies must document unsuccessful attempts at treatment with less expensive therapies in earlier ‘steps.’ Most employer-sponsored insurance plans incorporate requirements for step therapy into their drug formularies.”

The fundamental flaw with step therapy: “Payers have turned to step-therapy protocols because we have failed to address high drug prices at a societal level, instead transferring the problem to the point of care and imposing administrative burdens on physicians and patients.”

While step therapy makes sense with high-cost, low-value medications, it is problematic with high-cost, high efficacy medications. To mitigate some of the harmful effects of step therapy, lawmakers have drafted the Safe Step Act.

“The Safe Step Act also lists five specific circumstances under which insurers would be required to grant an exception to step-therapy protocols. It would require exceptions in cases in which the required treatments have previously been ineffective for the patient, delay of effective treatment would lead to “severe or irreversible consequences,” required treatments are contraindicated, required treatments would prevent the patient from performing activities of daily living, or the patient’s condition is stable on the existing medication and the patient has previously received coverage approval for it. The act would also empower the executive branch to identify other circumstances that might require exemptions. Most of these exceptions, however, could create additional administrative burdens for patients and clinicians that might pose challenges for maintaining continuity of care.”

My take (from authors): “the Safe Step Act focuses on legal action at the individual-prescription level, failing to bring down drug prices while increasing administrative costs.”

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Chattahoochee River in Sandy Springs

Florida Surgeon General Hinders Public Health

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In response to the Florida Surgeon General’s comments about COVID-19 vaccine safety in children, the following editorial was published (from Eric Topol’s twitter feed) in The Washington Post –Opinion: Vaccines work for children. Ignore the nonsense spoken in Florida:

Here’s the data:

Vaccine effectiveness against hospitalization ranged from 73% to 94%.

Here is the MMWR/CDC article (open access) with full data: Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5–17 Years — VISION Network, 10 States, April 2021–January 2022

And safety data from MMWR/CDC (open access): Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17 Years — United States, December 9, 2021–February 20, 2022

AAP Views: Summary of data publicly reported by the Centers for Disease Control and Prevention Date: 3/2/22

Insider: Florida’s surgeon general breaks with CDC advice, says the state will be the first to ‘officially recommend against the COVID-19 vaccine for healthy children’

My take: It is disgraceful that a prominent physician would jeopardize the health of children and worsen vaccine misinformation more broadly. I think his actions merit review by the ABIM. If you want to share your views with the ABIM: Contact ABIM

Safe Sleep

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I would urge colleagues when they see infants in the first few months of life to always discuss safe sleep which is the number one cause of mortality in infants. A simple message can be added to standard ‘Smartphrases’ for every infant seen with reflux, colic and formula intolerance.

A terrific website that focuses on this crucial issue: Charlieskids.org; it has videos, do’s and don’ts as well as a link to Cribs for Kids (discounted safe crib website). In addition,this website has a book called “Sleep Baby Safe and Snug” which incorporates updated recommendations on safe sleep practices.

Here are some screenshots from CHOA’s twitter feed on this topic.

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