Vasectomy More Cost-Effective Than Salpingectomy for Permanent Contraception, Reveals Research

USA: Researchers have found in a new cost-effectiveness analysis that vasectomy is a more cost-effective permanent contraceptive option. While salpingectomy prevented more unintended pregnancies and reduced ovarian cancer risk, it only became the more cost-effective option at higher willingness-to-pay levels.

The investigation, published in Obstetrics & Gynecology by Jill Brown, MD, MPH, of the Department of Gynecologic Surgery and Obstetrics at the Uniformed Services University in Bethesda, Maryland, compared the long-term economic value of the two procedures for couples seeking permanent contraception. Using a decision-tree model created in TreeAge, the researchers analyzed outcomes for a hypothetical cohort of 800,000 individuals—the approximate number of Americans who undergo permanent contraception each year.
Effectiveness was measured in quality-adjusted life-years (QALYs), with a willingness-to-pay (WTP) threshold of $100,000 per QALY gained or lost. Cost estimates, probabilities, and utility values were sourced from existing medical literature.
The analysis calculated the incremental cost-effectiveness ratio (ICER) between salpingectomy and vasectomy and included a probabilistic sensitivity assessment with 10,000 simulations. A cost-effectiveness acceptability curve was then generated for WTP thresholds ranging from $0 to $200,000. Secondary outcomes included the number of unintended pregnancies as well as ovarian cancer cases and deaths.
The study revealed the following findings:
  • Salpingectomy had an incremental cost-effectiveness ratio (ICER) of $143,769 per QALY gained compared with vasectomy, exceeding the standard $100,000 threshold.
  • Vasectomy was more cost-effective in 81.5% of simulations at a willingness-to-pay (WTP) level of $100,000.
  • The cost-effectiveness advantage of vasectomy dropped to 14.7% when the WTP threshold increased to $200,000, indicating salpingectomy may be more attractive when higher costs are acceptable.
  • Salpingectomy was linked to 1,215 fewer unintended pregnancies annually compared with vasectomy.
  • It was also associated with 6,085 fewer ovarian cancer cases each year.
  • The procedure further resulted in 4,921 fewer ovarian cancer deaths, highlighting its broader public health benefits.
The authors concluded that, at a WTP threshold of $100,000, salpingectomy does not meet standard benchmarks for cost-effectiveness relative to vasectomy, despite its ability to lower both unintended pregnancy rates and the societal burden of ovarian cancer. They emphasized the importance of shared decision-making between healthcare providers and couples considering permanent contraception. According to the research team, counseling should incorporate not only the financial and contraceptive aspects of each procedure but also the long-term health benefits—particularly the reduction in ovarian cancer risk—associated with salpingectomy.
“The analysis highlights the nuanced balance between economic considerations and broader health outcomes when choosing a permanent contraceptive method, offering valuable insights for clinicians and couples making these critical decisions,” the authors wrote.
Reference:
Pearson, Amy BS; Shvartsman, Katerina MD; Zeng, Wu MD, PhD; Brown, Jill MD, MPH. Cost Effectiveness of Salpingectomy Compared With Vasectomy for Permanent Contraception. Obstetrics & Gynecology ():10.1097/AOG.0000000000006042, August 28, 2025. | DOI: 10.1097/AOG.0000000000006042

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Keeping Medicines Without Licence Amounts to ‘Offer for Sale’, HC Upholds Chemist’s Conviction

Shimla: The Himachal Pradesh High Court has upheld the conviction of a chemist under the Drugs and Cosmetics Act, 1940, for stocking allopathic medicines without a valid licence, stressing that such offences affect public health and must be dealt with strictly.

Justice Rakesh Kainthla rejected Sanjay K. Maanav’s challenge and affirmed the trial court’s 2007 conviction order as well as the appellate court’s 2012 judgment, holding that no case was made out for interference.

The case clearly clarifies that simply possessing unlicensed medicines can allow the Court to presume intent to sell, placing the burden on the accused to prove otherwise. It also underscores that such offences will attract deterrent punishment, as stocking drugs without authorization is viewed as a serious threat to public health.

The case dates back to June 15, 2001, when Drugs Inspector Navneet Marwaha, accompanied by police officials, conducted a raid at Maanav Health Clinic in McLeodganj. During the raid, the High Court recorded, “the accused was present in the clinic, and he had displayed a variety of allopathic drugs for sale.”

When asked to produce a valid drug licence or a registered medical practitioner’s certificate, Maanav instead produced photocopies of certificates from Akhil Bhartiya Ayurvedic Vidyapeeth, Agra and N.E.H.M. Investigations later confirmed these to be invalid since electro-homoeopathy is not recognised by either the State or Central Medical Councils. The drugs were seized and sealed on the spot.

In 2007, the trial court convicted Maanav under Section 27(b)(ii) of the Drugs and Cosmetics Act, sentencing him to one month’s simple imprisonment and a fine of ₹5,000, with a default imprisonment of 15 days. The appellate court upheld this in 2012.

In his revision petition, Maanav argued that he never stocked allopathic medicines, only electropathy preparations. His counsel claimed that the prosecution failed to prove intent to sell, an “essential requirement under Section 27(b)(ii).”

In support of his argument, Maanav relied on the Supreme Court’s ruling in Mohammad Shabir v. State of Maharashtra (1979), which had held that “mere possession” of medicines was not sufficient to attract penal provisions.

Alternatively, he pleaded for leniency, pointing out that more than two decades had passed since the incident and the accused had already undergone “the agony of trial, appeal and revision.”

The State opposed the revision strongly. Additional Advocate General Lokender Kutlehria argued that the accused kept large stocks of medicines openly displayed on racks, which itself proved intent to sell.

“The accused had no license or degree, yet he possessed a huge quantity of allopathic drugs. He was playing with the lives of the people, and no sympathy should be shown to him,” the State submitted.

The Himachal Pradesh High Court pointed out that the position had changed after the 1982 amendment to Section 18(a) of the Drugs and Cosmetics Act, which introduced the phrase “offer for sale” into the law. The Court referred to a Karnataka High Court judgment (State of Karnataka v. Kannika Stores, 1992) which clarified that once this amendment came into effect, keeping medicines on the racks of a shop amounted to an offer for sale and was prohibited under the Act.

The High Court, after reviewing the evidence, upheld the reasoning of the trial court. It noted:

“In the present case, the drugs were found on the rack inside the clinic and learned Trial Court had rightly held that this violated Section 27 of the Drugs and Cosmetics Act.”

“Thus, there is no infirmity in the judgments and order passed by learned Courts below convicting the accused of the commission of an offence punishable under Section 27(b)(ii) of the Drugs & Cosmetics Act.”

The Court stressed that subsequent amendments to the Act had made even “stocking” or “exhibiting” medicines without a licence a punishable offence. As the order explained:

“When possession is with the accused and when there is no consent, it is for him to say for what purpose he has stored them. A presumption of fact has to be drawn by the Court, and the gist of the evidence and complaint has to be taken together; the accused was not taken by surprise when the charge clearly mentions the purpose of storing for sale only. Therefore, I have no hesitation in holding that the Court can draw a valid presumption, particularly so when there is no proof of purchase of the drugs or need for storing them by the accused. The offence under Section 18(C) read with 27(b) (ii) of the Act has been squarely made out, and the accused has to be convicted.”

On the plea for reduction of sentence, Justice Kainthla was categorical:

“Learned Trial Court sentenced the accused to undergo simple imprisonment for a period of one month, pay a fine of ₹5,000/- and in default of payment of fine to undergo further simple imprisonment for 15 days. The accused was found in possession of allopathic medicines, and he had no certificate/ licence to possess them. Learned Trial Court had rightly noticed that the possession of these drugs adversely affected public health and should be seriously viewed. The Court cannot ignore the impact of the crime while imposing the sentence, and the learned Trial Court was justified in considering the same. Keeping in view the impact on public health, the sentence of one month cannot be said to be excessive. The plea on behalf of the accused to reduce it cannot be accepted because of the lapse of time since the incident. The Court has to impose a deterrent sentence to dissuade people from playing with the lives of others by stocking the allopathic drugs for sale. Therefore, there is no justification for the reduction of the sentence.”

Subsequently, the Court held;

“In view of the above, there is no reason to interfere with the judgments and order passed by the learned Courts below. Hence, the present revision fails, and the same is dismissed. Pending application(s), if any, also stand(s) disposed of.”

Also Read: CDSCO Criminal Prosecution Against IndiaMART Put on Hold by Delhi HC Till Sept 17

To view the official order, click the link below:

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FDA Approves INLEXZO™ for BCG-Unresponsive Bladder Cancer

The U.S. FDA has approved Johnson & Johnson’s INLEXZO™ (gemcitabine intravesical system) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This new therapy offers an alternative for patients who decline or are ineligible for bladder removal surgery (radical cystectomy).

Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

Full prescribing information for Inlexzo will be posted on Drugs@FDA.

Efficacy was evaluated in Cohort 2 of SunRISe-1 (NCT04640623), a single-arm, multi-center trial enrolling 83 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors following transurethral resection. Patients received the gemcitabine intravesical system into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months.

Tumor status was assessed with cystoscopy and urine cytology every 12 weeks during the initial two years of treatment, after which cystoscopy was performed at least every 24 weeks. Mandatory biopsies were performed at 24 and 48 weeks after treatment initiation.

The major efficacy outcome measures were complete response (CR) at any time (defined as negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response (DOR). CR assessment at each timepoint was based on central pathology review.

The CR rate was 82% (95% CI: 72, 90) and 51% of patients with a CR had a DOR ≥ 12 months.

The prescribing information includes warnings and precautions describing risks of administering gemcitabine intravesical system in patients with a perforated bladder, risk of metastatic bladder cancer with delayed cystectomy, magnetic resonance imaging (MRI) safety, and embryo-fetal toxicity.

The gemcitabine intravesical system delivers 225 mg of gemcitabine into the bladder, with an indwelling period following each insertion of 3 weeks prior to removal. The gemcitabine intravesical system is inserted once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent high-grade NMIBC, disease progression, or unacceptable toxicity.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. The gemcitabine intravesical system received breakthrough therapy designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

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Biologic Therapy may Lower Malignancy Risk in Psoriasis,suggests study

A new study has investigated the impact of biologic therapies on cancer risk among patients with psoriasis and found that these treatments may offer protective benefits compared to traditional topical therapies. Psoriasis is a chronic immune-mediated condition that often requires long-term management, and concerns about the potential for systemic therapies to influence malignancy risk have persisted among clinicians and patients alike. This research focused on comparing patients receiving biologic treatments, such as tumor necrosis factor inhibitors and interleukin-targeted agents, with those using only topical monotherapies. The study revealed that patients treated with biologic therapies experienced a lower incidence of malignancies over the observation period. While topical monotherapy is often considered safe and effective for managing mild disease, it does not provide systemic immunomodulatory effects that may influence the immune surveillance mechanisms associated with cancer development. Biologic therapies, by modulating specific inflammatory pathways implicated in both psoriasis and cancer progression, may reduce the risk of malignancy while simultaneously controlling skin disease. The findings underscore the importance of considering personalized treatment strategies for patients with psoriasis, especially those at elevated risk for cancer due to age, family history, or comorbidities. Clinicians are encouraged to weigh both dermatologic benefits and systemic protective effects when recommending biologic therapy. Furthermore, the study highlights the need for ongoing surveillance and long-term follow-up to better understand the relationship between immune-targeted treatments and malignancy risk in this population. While biologic therapies have previously been scrutinized for their immunosuppressive potential, this research provides reassurance that, when appropriately selected and monitored, these treatments may confer additional systemic benefits beyond skin clearance. Patients and healthcare providers should engage in shared decision-making, considering both disease severity and individual risk factors for malignancy, to optimize treatment outcomes and overall health.

Keywords: Psoriasis, biologic therapy, malignancy risk, cancer prevention, immune modulation, systemic therapy, tumor necrosis factor inhibitors, interleukin inhibitors, personalized medicine, long-term outcomes

Reference:
Zhang, Y., et al. Biologic therapy is associated with reduced malignancy risk in psoriasis: A cohort study. Journal of the American Academy of Dermatology. 2025. https://doi.org/10.1016/j.jaad.2025.07.015

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Valgus Knee Brace Eases Walking Pain in Osteoarthritis Patients: Trial Shows

Netherlands: Wearing a valgus knee brace can meaningfully reduce walking-related pain in patients with medial compartment knee osteoarthritis (OA), according to a randomized controlled trial published in PLOS One. After six months of use, patients reported both statistically significant and clinically important improvements in pain intensity during walking, along with a reduced reliance on pain medications.

The study, led by Corné J.M. van Loon from the Department of Orthopaedics, Rijnstate Hospital, Arnhem, The Netherlands, and colleagues, aimed to address a gap in prior research by not only assessing clinical outcomes but also incorporating patients’ perspectives on brace use. “Our trial evaluated both the effectiveness and the user experiences of the valgus brace, considering aspects such as wearing time, comfort, and perceived benefits, which are often overlooked in earlier studies,” the authors noted.
In this mixed-method randomized controlled trial, 46 participants with medial compartment knee OA were enrolled. Twenty-three participants in the intervention group received standard care plus a customized valgus brace, while the remaining 23 participants in the control group received regular care but no brace. Outcomes were assessed at baseline, 2 weeks, 3 months, and 6 months, with knee pain during walking, measured on a 10-cm Visual Analog Scale (VAS), being the primary outcome. Secondary measures included walking distance, overall health status, knee functioning, and satisfaction with the brace. To enrich the findings, qualitative interviews were conducted with a subgroup of brace users.
The key findings of the study were as follows:
  • At six months, the intervention group showed a 2.13 cm greater reduction in knee pain after walking compared to the control group.
  • This reduction was both statistically significant and clinically meaningful.
  • No significant improvements were noted for pain at rest or for physical functioning measures.
  • Qualitative findings revealed that many patients experienced benefits beyond pain relief, such as better body function and improved ability to perform activities.
  • Some participants reported mixed or negative views of the brace, while several others described positive overall experiences.
The authors emphasized that although their study demonstrated measurable pain reduction, the relatively small sample size may have limited the ability to detect additional benefits. They highlighted the need for larger, well-powered trials with longer follow-up to better understand the effectiveness of valgus braces. Further exploration of patient factors—such as age, activity level, BMI, and degree of OA—was also recommended, as these could influence both outcomes and user satisfaction.
Importantly, the study highlights that user experience plays a crucial role in determining the success of assistive devices like knee braces. Some participants suggested that factors such as comfort, fit, and wearing duration strongly influenced their perception of benefit. These insights may prove valuable for healthcare providers, manufacturers, and patients alike, guiding future brace design and prescription practices.
“The findings suggest that valgus bracing offers a promising, non-invasive option for alleviating walking-related pain in individuals with medial knee OA. While broader research is required, incorporating patient feedback alongside clinical outcomes could help refine and optimize brace interventions, ultimately improving quality of care for those living with osteoarthritis,” the authors concluded.
Reference:
(2025). Effectiveness and user experiences of a valgus brace in patients with knee osteoarthritis: A mixed-method randomised controlled trial. PLOS ONE, 20(9), e0330157. https://doi.org/10.1371/journal.pone.0330157

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Preemptive Genetic Testing Feasible for Reducing Chemotherapy Toxicity in GI Cancer, Finds Trial

USA: A prospective trial in gastrointestinal cancer patients found that preemptive DPYD/UGT1A1 genetic testing before chemotherapy was feasible, enabled timely results in over half of cases, and showed potential to lower treatment-related side effects and modifications.   

The research, led by Dr. Sony Tuteja from the Perelman School of Medicine at the University of Pennsylvania and published in JCO Precision Oncology, explored whether screening for genetic variants prior to starting chemotherapy could guide drug dosing and improve patient safety. The focus was on two pharmacogenes—DPYD, which influences the breakdown of fluoropyrimidines, and UGT1A1, which affects the metabolism of irinotecan. Variants in these genes can increase the risk of severe toxicity from standard chemotherapy doses.

A total of 288 adults with gastrointestinal cancers were enrolled, and 225 received chemotherapy regimens qualifying for evaluation. All underwent genetic testing before initiating treatment, and when significant variants were identified, oncologists were advised to reduce the drug dose accordingly. The median turnaround time for test results was 10 days, and 57.4% of reports were available before the first treatment cycle. Among patients with actionable drug–gene interactions, nearly 70% had results in time to allow dose adjustments, and clinicians consistently followed the genotype-based recommendations.

Key findings:

  • Severe treatment-related adverse events occurred in 38% of the tested group compared with 65% in the control group, though the difference was not statistically significant.
  • Treatment modifications were significantly lower in the tested group at 38% compared with 76% in the control group.
  • Treatment discontinuations decreased from 47% in the control group to 31% in the tested group.
  • In patients carrying high-risk genetic variants, the incidence of severe toxicity dropped to rates similar to those seen in patients without such variants.

The trial also revealed practical challenges. In some cases, chemotherapy began before results were available, often because treatment needed to start urgently. The limited number of variant carriers reduced statistical power for some analyses, and differences in disease stage and performance status between groups may have influenced toxicity rates. The study did not track all adverse effects using formal grading criteria but instead recorded the most severe events, such as those requiring hospitalization or emergency care.

Despite these constraints, the findings support the value of incorporating DPYD/UGT1A1 testing into routine oncology practice for gastrointestinal cancers. By identifying patients at greater risk of drug-related toxicity before treatment starts, clinicians can tailor chemotherapy dosing to improve safety without sacrificing efficacy.

Dr. Tuteja and colleagues suggest that expanding access to genetic testing and ensuring results are available before treatment begins could further enhance outcomes, with future work aimed at streamlining testing processes and broadening adoption across cancer treatment centers.

Reference:

Sony Tuteja et al. Implementation of DPYD and UGT1A1 Testing in Patients With GI Cancer: A Prospective, Nonrandomized Clinical Trial. JCO Precis Oncol 9, e2500086(2025). DOI:10.1200/PO-25-00086

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Oral Berotralstat Effective and Safe for HAE Prevention in Young Children: Study

A newly published retrospective cohort study (APeX‑P trial) in Journal of Allergy and Clinical Immunology: In Practice found that oral berotralstat—a once‑daily plasma kallikrein inhibitor—was well tolerated and highly effective in reducing hereditary angioedema (HAE) attack rates in children aged 2–11 years. Among the 29 pediatric participants (median age 8), berotralstat led to early and sustained reductions in attack frequency: whereas the baseline median attack rate was 0.96 per four weeks, most children maintained zero to near‑zero attack rates through week 48. There were no drug‑related serious adverse events, discontinuations, or Grade 3/4 toxicities. Mild common side effects included nasopharyngitis, headache, and upper respiratory infections. pharmacokinetics showed a median Tmax of 3.9 hours and consistent exposure levels, supporting reliable once‑daily dosing. These findings suggest berotralstat could be a game‑changer as a first approved oral prophylactic option for children under 12, a population previously limited to injectable prophylaxis. Given its safety and early efficacy, this therapy offers a promising long‑term management strategy that may improve quality of life and reduce the treatment burden for young HAE patients. Experts note that further real‑world studies and longer follow‑up are needed to confirm durability and generalizability across diverse pediatric groups. 

Reference:
Bernatoniene, J., Bourgoin‑Heck, M., Cancian, M., Yang, W., Hagin, D., Pagnier, A., … Stobiecki, M. (2025). Oral berotralstat prophylaxis in children aged 2–11 years with hereditary angioedema: interim results from the APeX‑P trial. JACI: In Practice. https://doi.org/10.1093/jac/dkaf265

Keywords: berotralstat, hereditary angioedema, pediatric prophylaxis, HAE prevention, oral plasma kallikrein inhibitor, attack reduction, safety in children, APeX‑P trial, quality of life, orladeyo

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Parents of children with health conditions less confident about a positive school year

As the new school year begins, some parents may be feeling more nervous than excited—especially those whose children have different health needs.

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Trauma-focused therapy shows promise for children struggling with PTSD

A specialist form of therapy could offer hope for some of the most vulnerable young PTSD sufferers, according to a University of East Anglia study.

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Higher doses of semaglutide can safely enhance weight loss for adults living with obesity, clinical trials confirm

A higher weekly dose of semaglutide (7.2 mg) can significantly improve weight loss and related health outcomes in adults living with obesity, including those with type 2 diabetes (T2D), according to the results of two large-scale, international phase 3 clinical trials.

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