The Failing U.S. Health System

Posted on by

D Blumenthal et al; NEJM 2024; DOI: 10.1056/NEJMp241085. The Failing U.S. Health System

This article succinctly explains why the U.S. health system spends a lot and has the worst performance of similar countries.

Some excerpts:

  • “In Mirror, Mirror 2024, the Commonwealth Fund’s eighth report since 2004 comparing the health systems of 10 high-income countries…The United States has the lowest life expectancy among the 10 countries we studied, 4 years less than the 10-country average.”
  • “It also ranks last on measures of preventable mortality and “treatable mortality”…These measures capture deaths that could have been averted by means of preventive services or timely and effective treatment, such as deaths from hypertension, diabetes, cerebrovascular disease, ischemic heart disease, or renal failure. The United States had the highest excess mortality attributable to Covid-19 among people younger than 75 years of age in 2021. It also has the highest rate among the 10 countries of death from self-harm, which includes deaths by suicide, and the highest rate — by orders of magnitude — of death from assault, which includes deaths caused by gun violence.”
  • “The United States ranks last on measures of access to care and equity of care…Another contributor to access barriers is inadequate coverage among insured Americans because of high deductibles and copayments.”
  • ” The Affordable Care Act and related policies reduced the proportion of uninsured people to its current level of 7 to 8%. But 26 million Americans still lack insurance.”
  • “Providing insurance, however, will not be sufficient. The U.S. health care delivery system has profound problems … One such problem is the country’s worsening shortage of primary care clinicians”
  • ” the high prices charged by U.S. health care facilities and professionals, which far exceed prices in other health systems.3 … One of the reasons health care organizations are able to charge such high prices is that they have obtained increasing economic power in local markets as a result of consolidation — both horizontal consolidation among hospitals and vertical consolidation, which involves large organizations acquiring physician practices. The arrival of private equity investors who “roll up” physician practices in local markets and then raise prices has also contributed to the escalation of U.S. health care costs.4“
  • “The United States lags behind comparator countries when it comes to addressing the social determinants of health, such as poverty, homelessness, inequality, and hunger.”

My take (borrowed from authors): “What is the future of a country that allows an untold number of its people to suffer and die unnecessarily because of a lack of access to basic health services, inadequate public health measures, and a tattered social safety net?”

Related blog posts:

Non-Invasive Studies Often Fail to Detect Advanced Liver Fibrosis in Steatotic Liver Disease

Posted on by

N Ravanbakhsh et al. JGPN 2024; https://doi.org/10.1002/jpn3.12368. Comparing imaging modalities in the assessment of fibrosis in metabolic dysfunction-associated steatotic liver disease

Key findings:

  • TE and MRE did not have high correlation with liver biopsy in the detection of high-grade fibrosis
  • Fibrosis was identified in 90% of liver biopsies with bridging fibrosis in 15 (19%) and cirrhosis in 1 (1%)
  • AUROC curves of MRE and TE for detection of high-grade fibrosis were 0.817 and 0.750, respectively, and not significantly different.

The authors note that previous adults studies suggest that MRE is more accurate in the identification of liver fibrosis than TE (MRE detected ≥ F1 fibrosis with an AUROC of 0.82, while TE detected fibrosis with an AUROC of 0.67).20 

My take: Trying to identify accurate non-invasive testing is crucial to help identify patients most in need of treatment and for limiting costs.

Related blog posts:

Isle of Palms, SC

Financial Toxicity of Liver Transplantation and Cirrhosis

Posted on by

Using a nationally representative database spanning the years 2006-2021 with 1412 recipients, Lieber et al describe the patient financial burden after LT. Key findings:

  • 21% had extreme liability > $10K for 1-year post-LT care
  • 69% paid between $1 and 10K, with 48% having liability >$5K in the initial year following LT
  • Medication costs comprised ~30% of outpatient financial liability
  • Potential indirect costs from wages lost were $2,201–$6,073 per person

Ufere et al surveyed 207 adult recipients of liver transplant across 5 US transplant centers. Key finding: Nearly 1 in 4 experienced high financial burden (>/= 10% annual income spent on out-of-pocket costs)

The editorial by Ladner et al. notes that “LT is the only curative treatment for cirrhosis, with a 5-year survival of over 80% and, in most cases, returning patients from a chronic disease state to full physical and mental health.6 However, LT is resource-intensive, associated with an average cost of >$700,000, and is only performed in ~10,000 patients every year due to many barriers, including limited organ supply.7 Hence, this lifesaving therapy is currently provided to less than 1% of the patients affected by cirrhosis.8“

Ladner et al note that the financial burden of cirrhosis, though, is reduced after LT. “Without LT, the best that a patient can anticipate is to continue living with chronic liver disease/cirrhosis, with a baseline out-of-pocket cost of $19,390 per year. In this context, receiving an LT appears to be cost-saving for most (>80%) recipients of LT rather than a financial burden—with only 21% of recipients of LT having out-of-pocket costs >$10,000 during the first year after LT. In fact, the average out-of-pocket costs following LT appear quite similar to the $5,567 costs reported by patients without liver disease.5“

My take: LT is expensive. The financial burden needs to addressed with patients. However, for patients with cirrhosis, LT is usually a good value with lower out-of-pocket costs for 80% of recipients along with better quality of life, and longevity.

Related blog posts:

Sullivan’s Island, SC Lighthouse

Brave New World of Neuromodulators (2024) for Disorders of Brain-Gut Interaction

Posted on by

I Hanna-Jairala, DA Drossman AJG 2024; DOI: 10.14309/ajg.0000000000002800. Open Access! Central Neuromodulators in Irritable Bowel Syndrome: Why, How, and When

This is a terrific review article. The authors detail the rationale for neuromodulators, strategies for selecting among them, side effects, and dosing.

Background: “IBS is frequently associated with neuropsychiatric disorders such as depression and anxiety, which are considered triggers for the onset of symptoms or occur in response to having them (3). In the Rome Foundation global study that included 54,127 participants, subjects with psychological distress or clinically relevant somatic symptoms were 4.45 times more likely to have 1 or more DGBI than those without psychological distress. The same study reported that those who met specific criteria for bowel disorders presented clinically relevant psychological distress or somatic symptoms in 55.5% of cases (4). In addition, in a meta-analysis that included 7,095 subjects with IBS exclusively, the global prevalence of depression was 36%…Anxiety was present in 44% of patients with IBS….Central neuromodulators act on receptors along the brain-gut axis, so they are useful in treating psychiatric comorbidities, modifying gut motility, improving central downregulation of visceral signals, and enhancing neurogenesis in patients with IBS… Neuromodulator treatment is still considered off-label, many of the recommendations herein are based on expert consensus (6)”

Key points:

  • “The first-line treatment for pain management in IBS is using tricyclic antidepressants.” Nortriptyline and desipramine are less likely to cause constipation.
  • “Selective serotonin reuptake inhibitors (SSRIs) are useful when symptoms of anxiety and hypervigilance are dominant but are not helpful for treating abdominal pain….The SSRIs include fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, and escitalopram. …Sertraline, citalopram, and escitalopram tend to have the fewest pharmacokinetic drug interactions”
  • “SSRIs are first-line pharmacologic agents for treating anxiety disorders, but they have the potential to induce restlessness and exacerbate anxiety when the drug is initiated. They are typically initiated at half of the usual starting dose to minimize these potential anxiogenic adverse effects. The dose may gradually increase to the regular starting dose after about 1 week… SSRIs should be considered when a significant component of anxiety without pain is present.”
  • SNRIs: “In addition to showing benefits with depression and painful disorders, SNRIs have shown significant improvement in anxiety.” Thus, they may be useful as monotherapy for patients with pain and anxiety.
  • Tetracyclics: “The most representative agent of this class is nirtazapine (Table 5). However, their effects seem to be mainly on anxiety, early satiety, nausea, and other symptoms associated with esophageal and gastroduodenal disorders, so their use in IBS is limited.”
  • “It is important to explain to the patients, …neuromodulators are not necessarily used for the treatment of depression but are a therapeutic alternative in the management of DGBI. It helps to use the term “neuromodulator” instead of “antidepressant” (6,8) It also helps to clarify that these medications can treat pain and other GI symptoms independent of treating depression, and the dosages are often lower than those used for treating major depression. This will preclude any patient concerns that their symptoms are being underestimated or considered to be in their head (6,8).”
  • Using central neuromodulators for IBS requires long-term treatment. From our experience, 6–12 months of treatment or more are needed to increase the likelihood of remission.

Related blog posts:

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Moving Away From Placebo-Controlled Trials in Crohn’s Disease

Posted on by

Din, Shahida et al. The Lancet Gastroenterology & Hepatology; 2024: DOI: 10.1016/S2468-1253(24)00264-4.  Open Access! Harms with placebo in trials of biological therapies and small molecules as induction therapy in inflammatory bowel disease: a systematic review and meta-analysis

Background: “Placebo-controlled trials are especially important during the early phases of drug development, as use of placebo aids early detection of efficacy or futility.”

Methods: The authors performed a systematic review which identified 47 trials including 20,987 patients (14 267 [68·0%] receiving active drug and 6720 [32·0%] receiving placebo) were eligible. The studies involved multiple RCTs of biologics and small molecules in IBD.

Key findings:

  • The risks of worsening of IBD activity (Active treatment vs placebo: 563/13,473 [4·2%] vs 530/6252 [8·5%];RR 0·48)
  • Withdrawal due to adverse event (Active treatment vs placebo: 401/13 363 [3·0%] vs 299/6267 [4·8%]; RR 0·62)
  • Serious adverse event (Active treatment vs placebo: 682/14,267 [4·8%] vs 483/6720 [7·2%]; RR 0·69)
  • Serious infection (Active treatment vs placebo: 140/14 ,194 [1·0%] vs 91/6647 [1·4%]; RR 0·67)
  • Serious worsening of IBD activity (Active treatment vs placebo: 187/11,271 [1·7%] vs 189/5056 [3·7%]; RR 0·4)
  • VTEs (Active treatment vs placebo: 13/7542 [0·2%] vs 12/2981 [0·4%]; RR 0·45)
  • All of these adverse outcomes were significantly lower with active drug than placebo. 

My take: Now that there are proven medications that are effective for moderate-to-severe Crohn’s disease, head-to-head trials of novel drugs against existing drugs with proven efficacy, rather than placebo-controlled trials, should be prioritized.

Related blog posts:

Windy day at Isle of Palms, SC. There streams of sand flowing over the beach.

Hot Weather Affects Mail-Order Medications

Posted on by

NY Times (8/13/24, Emily Baumgaertner): Hot Summer Threatens Efficacy of Mail-Order Medications

An excerpt:

Doctors and pharmacists say the scorching temperatures enveloping the country could be endangering people’s health in an unexpected way: by overheating their medications.

Millions of Americans now receive their prescription medications through mail-order shipments, either for convenience or because their health plans require it. But the temperatures inside the cargo areas of delivery trucks can reach 150 degrees Fahrenheit in the summer, according to drivers — far exceeding the range of 68 to 77 degrees recommended by the national organization that sets standards for drug handling.

Mail-order pharmacies say that their packaging is weather resistant and that they take special precautions when medication “requires specific temperature control.” But in a study published last year, independent pharmaceutical researchers who embedded data-logging thermometers inside simulated shipments found that the packages had spent more than two-thirds of their transit time outside the appropriate temperature range, “regardless of the shipping method, carrier, or season…

Liquid medications like insulin or AUVI-Q, the epinephrine injection for allergic reactions, are often at heightened risk of degradation because excessive heat exposure can cause the evaporation of liquid components that were compounded at precise ratios. Aerosolized medications, too, are uniquely vulnerable because of the risk of pressure changes in the canister.

P.B.M.s [pharmacy benefit managers] often force mail order as the only option, constantly exposing our meds to destructive temperatures way outside the manufacturer’s specifications for days on end

My take: Worsening climate can even affect medication distribution. This article describes the consequences of medications affected by weather conditions including disease progression and liver transplant rejection. Lobbyists for P.B.M.s have effectively stifled regulations. For our patients with serious underlying diseases, mail-order medication efficacy is yet another concern. This NY Times article was published in August -hot weather is likely less of an issue at this time of year.

Related blog post: The Health Consequences of Climate Change

Colorado River near Moab, Utah

IV Fluid Shortage Due to Hurricane Helene

Posted on by

NBC News 10/3/24: Hospitals take steps to conserve IV fluid supply after Helene strikes critical factory

“Baxter International said it would temporarily close production at its North Cove, North Carolina-based facility, raising concerns about a potential nationwide shortage.”

“There are four primary manufacturers of IV fluids in the U.S. Baxter is the leader, accounting for about 60% of the market…In a statement published online Thursday, Baxter said it doesn’t yet have a timeline for when operations will be back up and running…A part of the problem, the company said, is that bridges to its site were damaged in the storm, limiting transport in and out.”

“The company is the main supplier for Mass General Brigham in Boston, which uses more than 100,000 liters of IV fluid from Baxter every month. On a call Thursday with reporters, Dr. Paul Biddinger, Mass General’s chief preparedness and continuity officer, said the health system received a letter from Baxter that said that due to the temporary closure, the system would receive only 40% of its usual supply from the manufacturer. “

My take: This is a nationwide problem and we need to conserve our supplies. This has happened before with Hurricane Maria hitting Puerto Rico in 2018.

  1. Use oral fluids/rehydration fluids when possible in place of IV fluids
  2. For many patients, IVFs can be used at lower rates or held overnight
  3. Would try to complete IVF bags that were started in ED or OR when patient transitions to a hospital floor bed before changing to a new IV fluid bag
  4. Nasogastric (NG) tube fluids can be administered more frequently

Related blog posts:

High Rate of Medication Errors in Pediatric Hospitals

Posted on by

T Badgery-Parker et al. J Pediatr 2024 272: 114087. Open Access! Child Age and Risk of Medication Error: A Multisite Children’s Hospital Study

Methods: This study from Australia included (1) prescribing errors identified from chart reviews from two hospitals as well as (2) medication administration errors assessed by direct prospective observation of 5137 administrations at a single hospital. In total, this study examined almost 70 000 medication orders and more than 5000 medication administrations.

Key findings:

  • There was a modest increase in prescribing errors with age
  • There was a high rate of errors across all age groups. The crude error rate for prescribing was 18.6/100 orders
  • Hospital A had 14.5 prescribing errors per 100 orders using paper prescribing, and this increased to 17.6 per 100 orders during implementation of electronic prescribing then fell to 11.7 per 100 orders a year later.11 Prescribing error rates at hospital B were higher (28 per 100 orders in 2016, falling to 20 per 100 orders in 2020).

From the associated commentary (DM Goodman): “The Institute for Healthcare Improvement describe the 5 rights of medication administration –right patient, right drug, right dose, right route, and right time. But to achieve these goals, the right systems must also be in place.”

My take: This study makes me wonder what the error rate in our hospital is –I would think it would be much lower than the rates described in this study. This study makes me more appreciative of the occasional call I get from the pharmacist to adjust the dosing and the built-in alerts in our EMR.

Related blog posts:

Ustekinumab Data at 4 Years -UNIFI Extension Study

Posted on by

W Afif et al. Am J Gastroenterol; 119: 910-921. Open Access! Efficacy and Safety of Ustekinumab for Ulcerative Colitis Through 4 Years: Final Results of the UNIFI Long-Term Maintenance Study

Background: In the initial UNIFI study, 44% and 38% remission rates were seen after 44 week treatment among patients with and without prior biologic exposure (See post: Ustekinumab for Ulcerative Colitis (UNIFI Trial)).

Methods: Ustekinumab induction responders who completed 44 weeks of maintenance treatment and agreed to enter the long-term extension continued their subcutaneous maintenance therapy (90 mg ustekinumab every 8 or 12 weeks [q8w or q12w] or placebo). Starting at week 56, randomized patients could receive dose adjustment to 90 mg q8w. 

Key findings:

  • Of the 348 patients randomized to subcutaneous ustekinumab at maintenance baseline (q8w and q12w combined), 55.2% were in symptomatic remission at week 200.
  • A greater proportion of biologic-naive patients (67.2% [117/174]) were in symptomatic remission than those with a history of biologic failure (41.6% [67/161]).
  •  Of the 171 patients with endoscopic evaluation at week 200, 81.6% (71/87) in the q12w group and 79.8% (67/84) in the q8w group had endoscopic improvement.
  • Safety: From weeks 156 to the final safety visit (up to week 220), no deaths, major adverse cardiovascular events, or tuberculosis occurred in patients receiving ustekinumab. Nasopharyngitis, UC worsening, and upper respiratory tract infections were the most frequently reported adverse events. “Exposure-adjusted analysis showed that ustekinumab AE rates were not greater than placebo.”
  • Immunogenicity: Overall, 5.5% (22/400) of randomized and nonrandomized patients who continued ustekinumab in the LTE were positive for ADA through the final safety visit. Overall, 5 of these 22 patients (22.7%) were positive for neutralizing antibodies. ADA were often transient and seemed to have no effect on efficacy.

My take: About ~25% of patients starting ustekinumab can expect to be in remission after 4 years based on this study. This estimate is based on a remission rate of ~55% at 200 weeks after achieving clinical remission in ~44% of the initial cohort patients at 44 weeks of treatment. The study provides additional data regarding a favorable safety profile.

Related blog posts:

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Identification of Low-value Care in Inflammatory Bowel Disease

Posted on by

S Singh et al. Clin Gastroenterol Hepatol 2024; 22: 923-932. Open Access! Common Instances of Low-value Care in Inflammatory Bowel Diseases

  • “Serological tests such as pANCA, ASCA, and other serological anti-microbial antibody tests for the diagnosis of IBD in patients with non-specific symptoms or in those with negative endoscopic and radiologic evaluation represents low-value care.“
  • “Making major therapeutic decisions based only on the presence of symptoms in patients with IBD, particularly CD, without objective confirmation of inflammation, represents low-value care. “
  • “Use of 5-ASA for the management of CD, particularly for patients at high risk of disease-related complications, represents low-value care. The safety of these medications must not be confused for their lack of efficacy in this setting. The utility of 5-ASA in a subset of patients with mild colonic CD who are at low risk of disease-related complications remains to be adequately studied.”
  • “Routine continuation of oral 5-ASA in patients with IBD who have been escalated to advanced therapies represents low-value care. Selective use of 5-ASA, particularly topical therapy in patients with persistent symptoms of proctitis despite optimized biologics may be appropriate.”
  • “Premature discontinuation of TNF antagonists in patients with IBD with partial but inadequate response or loss of response (after initial improvement) to index agent, without an attempt with accelerated dosing or therapeutic drug monitoring to potentially optimize therapy, represents low-value care.”
  • “Failure to consider dose de-escalation of TNF antagonists in patients who have achieved stable and persistent remission with intensive dosing regimens may represent low-value care.“

“Prolonged use of high-dose intravenous corticosteroids beyond 5 to 7 days without significant clinical improvement, in patients hospitalized with ASUC, represents low-value care. In these patients, escalation to rescue medical therapy or surgery should be strongly considered.”

My take: If the comedian Jeff Foxworthy wrote this article, each of the opinions would have started off with ‘You might be wastin money if…’