Category Archives: General Health

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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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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Masks Work -Here’s the Data

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Open Access: MMWR: Effectiveness of Face Mask or Respirator Use in Indoor Public Settings for Prevention of SARS-CoV-2 Infection — California, February–December 2021

Methods: This interview-questionnaire study used a test-negative case-control design, enrolling persons who received a positive (case-participants) or negative (control-participants) SARS-CoV-2 test result, from among all California residents, without age restriction, who received a molecular test result for SARS-CoV-2 during February 18–December 1, 2021. A total of 652 case- and 1,176 control-participants were enrolled in the study equally across nine multi-county regions in California.

Limitations included the following:

  • This study did not account for other preventive behaviors that could influence risk (eg distancing)
  • This analysis relied on an aggregate estimate of self-reported face mask or respirator use across, for some participants, multiple indoor public locations
  • Estimates do not account for face mask or respirator fit
  • Data collection occurred before the expansion of the SARS-CoV-2 B.1.1.529 (Omicron) variant
  • Face mask or respirator use was self-reported
  • Variability of exposures

COVID-19 Outcomes in U.S -Why It Has Been So Bad

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NY Times (2/1/22): U.S. Has Far Higher Covid Death Rate Than Other Wealthy Countries

An excerpt:

Some of the reasons for America’s difficulties are well known. Despite having one of the world’s most powerful arsenals of vaccines, the country has failed to vaccinate as many people as other large, wealthy nations. Crucially, vaccination rates in older people also lag behind certain European nations.

The United States has fallen even further behind in administering booster shots, leaving large numbers of vulnerable people with fading protection as Omicron sweeps across the country...

Washington Post (2/1/22): Researchers are asking why some countries were better prepared for covid. One surprising answer: Trust.

An excerpt:

A new study [Lancet] of pandemic preparedness across 177 countries and territories appears to have found a key element in Vietnam’s success: trust...

These factors were key for pre-coronavirus rankings such as the Global Health Security Index, which in 2019 listed the United States and Britain as most prepared for a catastrophic biological event, like a pandemic — and Vietnam 74th out of 117 countries.

Instead, better outcomes appear to have gone hand in hand with high levels of trust in government and other citizens. Perception of government corruption was correlated with worse outcomes. Researchers measured trust with polling data from the World Values Survey and Gallup...

The pandemic has “eroded trust in the government,” Bang Petersen said. “It actually seems as if the pandemic has worsened the problem that this study identified.”

AAP Policy: COVID-19 Vaccine for Children 5 Years and Older

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FROM THE AMERICAN ACADEMY OF PEDIATRICS| POLICY STATEMENT. Open Access: COVID-19 Vaccines in Children and Adolescents. Committee on Infectious DiseasesPediatrics (2022) 149 (1): e2021054332.https://doi.org/10.1542/peds.2021-054332

Key points:

  • “The AAP recommends COVID-19 vaccination for all children and adolescents 5 years of age and older who do not have contraindications using a COVID-19 vaccine authorized for use for their age.”
  • “Children with previous infection or disease with SARS-CoV-2 should receive COVID-19 vaccination, according to CDC guidelines.”
  • “Given the importance of routine vaccination and the need for rapid uptake of COVID-19 vaccines, the AAP supports coadministration of routine childhood and adolescent immunizations with COVID-19 vaccines (or vaccination in the days before or after).”

Also, more data on vaccine effectiveness from Eric Topol’s Twitter feed):

Vaccines reducing Covid deaths by 99% and hospitalizations by 98% with vaccination and a booster

Genus Medical Technologies v FDA -Lack of Judicial Deference to FDA Expertise

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A recent commentary (PJ Zettler et al. NEJM 2021; 385: 2409-2411. A Divisive Ruling on Devices — Genus Medical Technologies v. FDA) highlights another challenge facing the FDA’s role in regulating devices, especially as the definition of devices and medications becomes more murky.

Key points/excerpts:

  • In April 2021, however, the U.S. Court of Appeals for the District of Columbia decided, in Genus Medical Technologies v. FDA, that products meeting the FDCA’s definition of a device “must be regulated as devices”…The Genus case concerned a challenge to the discretion of the FDA to classify Genus Medical Technologies’ Vanilla SilQ line of diagnostic barium sulfate contrast agents as drugs rather than as devices…FDCA’s drug and device definitions overlap.
  • Ultimately, the D.C. Circuit Court held that products meeting both definitions must be regulated as devices because the FDCA’s “text unambiguously forecloses the FDA’s interpretation.” The court did not give the FDA so-called Chevron deference, a doctrine under which courts defer to an agency’s reasonable interpretation of a statute that it implements, if the statute is ambiguous.
  • Because technological innovation often outpaces legal change, we believe it could serve both public health and industry for the FDA to retain some discretion regarding the most appropriate regulatory pathways for anticipated and as-yet-unforeseen device classes… overly restricting the FDA’s flexibility to use its expertise could endanger important public health priorities, especially when there are compelling reasons why Congress permitted flexibility.
  • The Genus decision comes at the end of a decade of growing challenges to the FDA’s authority to regulate. From court decisions in the early 2010s that were sympathetic to arguments that FDA policies regarding off-label drug promotion violate the Constitution’s First Amendment, [and] to the political (and legislative) success of right-to-try laws

My take: This commentary shows the difficulties the FDA faces as the judiciary curtails its discretion. While the legislative branch could codify FDA authority, this is unlikely. As such, this will limit FDA oversight in some new medical products. When problems arise, it is likely that the FDA (not the courts) will be blamed despite the fact that their ability to regulate has been undermined.

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Omicron Data

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This data from NY Times shows that deaths due to COVID-19 are following a familiar pattern and spiking about 3 weeks after a spike in cases; this time the spike is being driven by omicron cases. However, this wave may in fact have lower severity per case; with this current wave, the number of reported cases is probably undercounted by a greater degree than in previous spikes due to widespread availability of home testing and the likelihood of more asymptomatic cases. Thus, it could be that the death rate per case would/will be significantly lower if/when all cases are accounted for.