How Does the U.S Compare to African Nations in HIV Treatment?

A recent commentary (WM El-Sadr et al. NEJM 2019; 380; 1985-7) shows how poorly we are doing in our efforts to diagnose and treat HIV in this country and what we need to do to make progress in eliminating HIV.

Overall, the U.S. overall viral suppression rate, which is the percentage of all people with HIV in whom the virus is suppressed, is only 51%.  In contrast, the rates for Nambia, Uganda, and Zambia are 75%, 55%, and 50% respectively (U.S. measures use slightly different denominators than other countries.)

From NEJM twitter feed: AIDS in America –Back in the Headlines at Long Last

Link to Podcast: Ending the U.S. HIV Epidemic

FDA News: FDA Warning for FMT, IB-Stim Device Approval, Teduglutide Approval

1.From John Pohl Twitter Feed:  FDA Warns of One Death Linked to Fecal Transplants (6/13/19)

An excerpt:

The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.

“Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of the individuals died,” the agency said Thursday…

Openbiome, a nonprofit stool bank based in Cambridge, MA, told Focus: “We are saddened to hear of the recent patient death due to an infection from a multi-drug resistant organism (MDRO) transmitted through a fecal transplant. OpenBiome material was not involved. OpenBiome screens its donors and fecal transplant material for MDROs and related risk factors, and this serious event further highlights the importance of rigorous screening and clinical oversight for all fecal transplant procedures.”

 2. FDA approval for IB-stim (a.k.a. Neuro-stim) device.

Link:: FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

An excerpt:

IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of three weeks in 52% of treated patients compared to 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients compared with 26% of patients who received the placebo.

:Kovacic K1, Hainsworth K2, Sood M1, Chelimsky G1, Unteutsch R1, Nugent M3, Simpson P3, Miranda A4. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.

Link to abstract of relevant study:  Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial.

3. FDA Approves Gattex (Teduglutide) for Pediatric SBS

From CenterWatch: Gattex New FDA Drug Approval

Pediatric SBS: “In a 24-week pediatric study 59 pediatric patients with SBS aged 1 year through 17 years chose whether to receive Gattex or standard of care (SOC)…Based on patient-diary data, patients who received Gattex 0.05 mg/kg/day experienced a 42% mean reduction in PS volume (mL/kg/day) from baseline (-23 mL/kg/day from baseline). At week 24, 38% of patients (10/26) were able to reduce PS infusion by at least 1 day per week. Patients reduced their PS infusion time by 3 hours per day on average compared to baseline.”

Related blog post: Teduglutide for SBS

Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O’keefe SJ, Forbes A, Heinze H, Joelsson B Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology 2012 Dec;143(6):1473-1481

Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O’Keefe SJ Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut 2011 Jul;60(7):902-14.

Briefly Noted: Costs of Physician Burnout

NPR coverage of story: What’s Doctor Burnout Costing America?

An excerpt:

The study authors calculate that for health care organizations, the cost of burnout comes out to $7,600 per physician per year. The study notes that their cost estimate is conservative, only taking into account lost work hours and physician turnover. But other research shows burned out doctors are also more likely to make medical mistakes, have less satisfied patients, and get sued for malpractice, all of which have indirect costs.

Related blog posts:

Do Gun Law Restrictions Work?

Those opposed to gun safety provisions (a.k.a. gun control legislation) argue that laws  will not prevent criminals from obtaining firearms illegally.  A recent commentary in NY Times provides some data that shows that states with more gun safety provisions have lower levels of gun-related deaths (especially suicides).

NY Times: A Gun Killed My Son. So Why Do I Want to Own One?

Related blog posts:

NY Times: “Millions Take Gabapentin for Pain. But There’s Scant Evidence It Works.”

NY Times: “Millions Take Gabapentin for Pain. But There’s Scant Evidence It Works.”

Thanks to Stan Cohen for pointing out this reference.

An excerpt:

The drug was initially approved 25 years ago to treat seizure disorders, but it is now commonly prescribed off-label to treat all kinds of pain, acute and chronic…

Two doctors recently reviewed published evidence for the benefits and risks of off-label use of gabapentin (originally sold under the trade name Neurontin) and its brand-name cousin Lyrica (pregabalin) for treating all kinds of pain…

Gabapentin and Lyrica, both sold by Pfizer, have been approved by the Food and Drug Administration to treat only four debilitating pain problems: postherpetic neuralgia, diabetic neuropathy, fibromyalgia and spinal cord injury. Even for these approved uses, the evidence for relief offered by the drugs is hardly dramatic…

In many well-controlled studies they found there was less than a one-point difference on the 10-point pain scale between patients taking the drug versus a placebo, a difference often clinically meaningless….

the number of people taking gabapentinoids more than tripled from 2002 to 2015…

Related blog post: Brave New World: Psychotropic Manipulation and Pediatric Functional GI Disorders

Near Cathedral of Barcelona

Self-Service Health Care??

A provocative commentary (DA Asch et al. NEJM 2019; 380: 1891-3) notes that the current approach to improving health care costs needs to be reconsidered.

“The physician-patient encounter is health care’s choke point.” Instead of pushing for more primary care visits, the authors recommend greater use of automation.  Examples in other industries have included:

  • TurboTax -helped reduce need for tax preparer’s
  • Automated tellers at banks -reduce costs at banks
  • Self-checkout at grocery stores -reduce costs at grocery stores
  • Websites to directly arrange travel rather than travel agents

Much of medical care can be algorithmic, including hypertension (which affects one-third of U.S. adults), hyperlipidemia, anticoagulation, diabetes, and “might be far more efficiently managed by a bot.”

“An efficient industry wouldn’t lead with primary care, but would reserve it for cases  for which lower levels of support haven’t been enough.”

The authors note that efforts to promote this will require removal of state-based regulation.  “There is not legitimate interest that benefits from making it hard for a patient in Kansas to get automated care with third-level support from a physician in Ohio.”

My take: The authors are right in their assertion: “Transformative change in any industry requires breakthroughs in productivity.”  Some of these changes are likely to be implemented given the cost escalations facing health care.

Magic Fountain, Barcelona

“Physician-Patient Relationship is Not Necessary to Sue Docs for Malpractice”

A recent ruling from the Minnesota Supreme Court:

Minnesota Medical Association: Physician-Patient Relationship is Not Necessary to Sue Docs for Malpractice

Thanks to Jeffrey Blumenthal for pointing out this reference. An excerpt:

The Minnesota Supreme Court issued a ruling on April 17 in the case of Warren v. Dinter holding that the existence of a physician-patient relationship is not a prerequisite for a medical malpractice action. Rather, a person may sue a physician for malpractice – even if that person was not a patient of the physician – if the harm suffered by the person was a “reasonably foreseeable consequence” of the physician’s actions….

The Warren v. Dinter case arises out of the care provided to a woman (Susan Warren), who complained of abdominal pain, fever, chills, and other symptoms to a nurse practitioner at Essentia Health Clinic in Hibbing. After testing showed that Warren had an elevated white blood cell count, the nurse practitioner suspected infection and sought hospitalization for her at Fairview Range Medical Center. The nurse practitioner’s call was randomly assigned to a hospitalist at Fairview to discuss admission. 

After a brief conversation, during which the physician was unable to view the patient’s medical record, …the physician did not recommend hospitalization during the conversation and the nurse practitioner did not seek hospitalization for the patient following the conversation. The patient subsequently died from sepsis caused by an untreated staph infection. Warren’s family sued both the nurse practitioner and the physician for medical malpractice…

Before its ruling April 17, Minnesota law has generally required the existence of a physician-patient relationship to sustain a malpractice action against a physician. The Court’s decision to rely on a broader legal theory of “foreseeability” represents a troubling change that puts Minnesota in the minority of states that do not require the existence of a physician-patient relationship for a malpractice action.

My take: While “foreseeability” was used as a determinant in this case, observers may foresee that the court’s ruling could erode informal advice (aka. curbside consults) that generally improves patient outcomes.  If physicians’ liability is significant, many may choose to not offer advice on patients that they have not fully evaluated.

Barcelona Esplanade/Adjacent to beach