Japan could become one of the first countries in the world to end the HIV epidemic, says the president of Gilead Sciences Japan, Kennet Brysting. The idea for now could seem a little too ambitious, but it is not entirely unrealistic, given that the availability of medicines that can prevent transmission of HIV. Drugs are not the cure, but control over the spread of virus to the point where the disease is no longer a major public health threat.

What Is The Role Of Preventative HIV Medicines?

Gilead's have two key drugs, Truvada and lenacapavir. These two are playing a crucial role in prevention. Truvada is taken as a daily pill, while lenacapavir requires two injections per year. It can make the virus undetectable in infected individuals and prevent transmission to those who are not infected yet. In trials, lenacapavir showed 100% efficacy in preventing HIV infections. This is why it is describe as "almost a vaccine".

In 2024, Japan also approved Truvada for HIV prevention, but the country has yet to approve lenacapavir for the same. Until now, people in Japan had been importing generic versions of Truvada or purchasing it from clinics that source it from overseas.

HIV In Japan

Up until now, Japan reported around 25,000 HIV infections, whereas 669 new cases were reported in 2023. For seven consecutive years, the number of new infections remained under 1,000. The downward trend thus shows that the virus has been controlled, however, getting to zero new infections remains the ultimate goal.

Brysting too acknowledged that simply having effective drug is not enough. What is important is to have a proper implementation, access and healthcare support to make sure that these treatments are widely available and effective.

What Are The Challenges In Implementation?

The biggest challenges is testing rates. There is a need to increase testing rates. At this very moment, around 86% people infective with Japan have been tested, but the goal is to increase it up to 95%, with an ideal goal of 100%. Without widespread testing, many infected people may not even know that they are infected and it could transmit the virus.

Another measure issue is the cost of preventative medication. While Japan's health insurance covers treatments for diseases, it does not cover preventative drugs. Those who purchase Truvada for prevention, pay around $470 per month. Some clinics in Tokyo offer generic alternatives too, which is cheaper, but they are not ideal.

Better Healthcare Support

Brysting expressed concern that individuals importing medications might not be consulting doctors regularly, which is essential for monitoring HIV status and overall health. Truvada users need to be tested for HIV initially and every three months, along with screenings for other infections and kidney function checks. Without proper medical supervision, there is a risk of misuse and inadequate protection.

Gilead is in discussions with Japanese authorities to improve access and insurance coverage for Truvada, and progress is being made. Japan has shown efficiency in approving critical medicines, as seen during the COVID-19 pandemic when Gilead’s remdesivir was approved in just three days.

What Is The Way Ahead?

Gilead at this moment is not only focused on HIV and hepatitis C, but also expanding into oncology with innovative treatments like CAR-T cell therapy, which strengthens a patient's immune system to fight cancer.

However, Japan’s strict approval processes can slow down drug availability. Phase 3 clinical trials often need to be conducted within the country, and Japan tends to approve medicines much later than other regions. For instance, Truvada was approved for prevention in Japan 12 years after the U.S. and nearly 20 years after its approval for treatment. inancial factors also play a role. The Japanese government adjusts drug prices annually, often reducing them, which can make long-term investment challenging for pharmaceutical companies.

Kerala's decision to switch from an expensive branded medicine for children with spinal muscular atrophy (SMA) with a much cheaper Indian-made alternative has sparked a dispute over the drug’s safety, regulatory procedures and parents' right to know what treatment their children receive.

Health Minister K Muraleedharan has defended the switch to Natco Pharma's generic risdiplam, which is sold as Natsmart. However, some parents and opposition leaders have questioned why bottles supplied to children at the Sree Avittom Thirunal (SAT) Hospital in Thiruvananthapuram were labelled “Physician's Sample” and “For Clinical Trials Only”.

The controversy has since expanded beyond the medicine's price. It now concerns how the drug reached the hospital and what evidence backs its use in children already receiving treatment.

Why Did Kerala Switch To The Generic SMA Medicine?

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SMA is a rare inherited disorder that causes progressive muscle weakness and wasting because of the loss of motor neurons. It can affect movement, swallowing and breathing. Its treatment may need to continue over a long period.

The branded risdiplam, Evrysdi, is manufactured by Swiss pharmaceutical company Roche. Its reported market price is around ₹6.2 lakh per bottle. Natco's generic alternative, Natsmart, is listed at ₹15,900 per bottle. The Kerala government has negotiated even a lower procurement price.

The difference could substantially reduce public expenditure. The state has been providing risdiplam free to eligible children through its KARE programme. Reports indicate that around 109 children are receiving treatment under the scheme.

The generic switch was intended to make treatment more affordable.. Public health expert B Ekbal has backed the decision, arguing that lower-cost medicines can expand access without compromising quality.

The debate is not over whether generic medicines should be used. Opposition leaders, including former chief minister Pinarayi Vijayan, say their objections concern the handling of the medicine that were labelled for clinical trials and the transparency of its distribution.

‘Clinical Trial’ Label Alarmed The Parents

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The controversy surfaced after families received bottles bearing the clinical trial and physician sample labels. Parents questioned whether their children had been given medicine intended for testing and whether they had adequately informed before.

Former Kerala health minister and CPI(M) leader K K Shailaja raised concerns about quality and the need for transparency and evidence before changing treatment.

“Just because a new company offers a price reduction doesn’t mean we can purchase everything. Besides price reduction, quality is what matters most. Some companies might lower prices just to push unsold products or for other interests,” she said, according to The South First.

The government says the labels indicate that they belong to sample stock and do not mean that the children were enrolled in a clinical trial.

Dr R Shankar, who heads the technical committee that evaluated the medicine, said, “If the concern is over the label, there was ‘physician’s sample’ written on it. It means it is a tested molecule. The container contains the same medicine.”

Hospital authorities said the disputed bottles were taken back after parents raised concerns. The minister has maintained that this was done to address their apprehensions, not because the government had concluded that the medicine was unsafe.

Muraleedharan has said the switch was based on an expert committee's recommendations and that the drug had received regulatory approval.

On October 24, he said, “People had concerns, but the doctors have addressed them. The treating doctors themselves have cleared the doubts.” He also said he would provide further clarification in the state Assembly on October 26.

Also read: Keralam Senior Citizens Bill: What It Means For India’s Ageing Population

SMA Patient Says The Generic Medicine Worked For Her

Amid the concerns, SMA patient Seba P A has defended Natsmart, saying she has taken Natco's generic risdiplam since April through a patient assistance programme. “Taking Natsmart produces the same effect as when I was taking Evrysdi,” she said. “I have felt no issues due to the change in brand.”

Seba also said bottles supplied to her free of cost carried the same physician sample and clinical trial labels. She argued that the labels were intended to prevent the free medicine from being resold.

Is the Generic SMA Drug Safe?

Natsmart contains risdiplam, the same active pharmaceutical ingredient as Evrysdi. The Central Drugs Standard Control Organisation (CDSCO) has approved Natco's formulation for marketing in India.

They maintain that the generic medicine is suitable for patients and that the labels do not indicate an ongoing clinical trial involving the children.

However, questions have been raised about bioequivalence evidence, quality checks and the process followed before procurement. Bioequivalence studies are used to establish whether a generic formulation delivers an active ingredient into the bloodstream at a rate and to an extent comparable with the reference medicine.

The dispute therefore cannot be resolved by comparing prices or relying solely on individual patient experiences. Families need clear information about the product's approval, the evidence for its use in children, the significance of the labels and the safeguards in place to monitor adverse effects.

A combination of two cancer drugs cut the risk of death by 58% in people who have advanced small cell lung cancer, an aggressive form of the disease, according to results from a Phase 3 clinical trial.

The combination pairs Imdelltra (tarlatamab), developed by Amgen, with Imfinzi (durvalumab), an immunotherapy made by AstraZeneca.

In the DeLLphi-305 trial, patients who received both drugs lived a median of 21.1 months, compared to 12.7 months among those who received Imfinzi alone.

The findings were presented at the European Society for Medical Oncology (ESMO) Congress in Madrid on October 24, 2026, and published in The New England Journal of Medicine.

More About Imdelltra-Imfinzi Trial

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The results indicated that using tarlatamab earlier in treatment could be beneficial. It is currently approved in the United States for adults with extensive-stage small cell lung cancer that has progressed during or after platinum-based chemotherapy.

The trial examined its application as a maintenance treatment after patients had completed initial chemotherapy and immunotherapy without their cancer progressing.

“For a disease where durable survival has remained extremely difficult to achieve, the magnitude and consistency of benefit in DeLLphi-305 are striking,” said Jacob Sands, an associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and an investigator in the trial.

The Phase 3 trial included 563 patients with extensive-stage small cell lung cancer whose disease had not progressed after initial treatment with Imfinzi, platinum-based chemotherapy and etoposide. The main findings were:

- 58% lower risk of death: The combination reduced the risk of death compared to Imfinzi alone.

- 21.1 months median overall survival: This compared to 12.7 months in the Imfinzi-only group.

- Nearly 80% alive at one year: About 79% of patients receiving the combination were alive after 12 months, compared to 53% of those receiving Imfinzi alone.

- 66% lower risk of progression or death: Median progression-free survival was 7.4 months with the combination, versus 1.9 months with Imfinzi alone.

These results indicate that the combination improved both overall survival and the time patients lived without their cancer progressing.

More About The Two Drugs

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Imdelltra, also known as tarlatamab, is a bispecific antibody that brings immune system T cells into contact with cancer cells, helping the immune system recognise and attack them.

Imfinzi, or durvalumab, blocks the PD-L1 protein, which some cancer cells misuse to evade immune attack.

The two drugs therefore target different aspects of the immune response. Researchers hope that combining them will improve the body's ability to control the cancer.

Jay Bradner, Amgen's executive vice-president of research and development, said, “These results represent an unprecedented advance for patients with extensive-stage small cell lung cancer, demonstrating a magnitude of survival benefit rarely seen in this aggressive disease.”

Side effects related to grade 3 or higher treatment occurred in 20.9% of the patients who received the combination, compared to 10.8% of those receiving Imfinzi alone.

Cytokine release syndrome, an inflammatory reaction caused by immune system activation, occurred in 49.6% of patients who received Imdelltra. Most cases were mild or moderate, and one was classified as severe. No deaths were reported.

The findings provide evidence that adding tarlatamab to maintenance immunotherapy can extend survival in extensive-stage small cell lung cancer. The researchers also reported benefits among patients with brain or liver metastases.

Despite promising findings, researchers say that the trial focused on a particular cancer type and treatment. Regulatory authorities will need to examine the evidence adopting this combination for earlier stage of treatment.

The legalisation of recreational marijuana in the United States may have led to increase in hospitalisations for multiple cardiovascular hospitalisations, including heart attacks, heart failure and abnormal heart rhythms, according to a new study published in BMJ Open.

Researchers studied more than 50 million hospital records from 2012 to 2018 and compared cardiovascular hospitalisation patterns in the western United States, where recreational cannabis sales began earlier, with trends in other regions.

They found that hospital admissions for three cardiovascular conditions increased faster in the West after legalisation, sparking questions about the health consequences of legalising recreational marijuana.

The study, titled Cannabis legalisation and cardiovascular hospitalisations in the United States: nationwide difference-in-differences analysis, 2012–2018, was led by Samuel D. Slavin and colleagues.

It analysed records of hospitalisations for acute heart failure, heart attacks, atrial fibrillation, ischaemic stroke, venous thromboembolism and ventricular tachycardia.

Cardiovascular Hospitalisations Increased After Marijuana Legalisation

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The analysis found that, for each additional year of recreational cannabis sales in the western region, hospitalisation rates rose faster than in other regions for these three heart conditions:

• Atrial fibrillation: approximately 2.3% faster per year.
• Heart failure: approximately 3.7% faster per year.
• Heart attacks: approximately 3.1% faster per year.

Atrial fibrillation is an abnormal heart rhythm that can increase the risk of stroke. Heart failure occurs when the heart cannot pump blood effectively to meet the body's needs, while a heart attack occurs when blood flow to the heart is blocked.

Hospitalisation rates for the other conditions also increased, but the differences were not as significant. The researchers say that their study addresses a gap in existing research.

“While several studies have examined the association of recreational cannabis legalisation on psychiatric conditions, substance use, emergency visits, and traffic accidents, ours is the first study to examine the association with cardiovascular hospitalisations,” they wrote.

Cannabis And Heart Health

Cannabis contains compounds that can affect the cardiovascular system. Tetrahydrocannabinol (THC), its main psychoactive component, can increase heart rate and affect blood pressure.

Researchers have also examined links between cannabis use, blood vessel function and blood clot formation. However, cardiovascular effects may vary depending on the product, frequency of use and method of consumption.

The study suggests that legalisation may have wider health implications because it can change the availability and use of cannabis products across a population. However, the researchers did not directly state that cannabis use caused the hospitalisations observed.

The findings show an association between legalisation and changing hospitalisation trends, not cause and effect proof.

The analysis compared regional hospitalisation patterns rather than tracking individual cannabis users. Researchers could not distinguish between different methods of cannabis consumption, examine trends separately for each state or fully account for changes in illegal cannabis use.

The authors said, “While an observational study cannot prove causality, our findings point to potential adverse effects of recreation legalisation on population health.”

They added, “Globally, our findings support a cautious approach to legalisation laws accompanied by data collection on [cardiovascular] outcomes.”