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.

Lung cancer in people who have never smoked is an increasingly recognized global health concern. A new study found that a rare inherited EGFR mutation may increase lung cancer risk by over 60 times in never-smokers.

Lung cancer in never-smokers is the seventh leading cause of cancer death worldwide. Approximately 60% to 80% of lung cancer cases in never-smokers globally occur in females.

The study, published in Science, found that a rare inherited EGFR T790M mutation can increase lung cancer risk by over 60 times in never-smokers and 25 times in smokers.

Smoking itself increases the risk of developing lung cancer fourfold in the general population.

What Did The Study Find?

To look for the rare mutation, researchers evaluated genotyping data from 3.37 million people and found that it occurs in about 1 in 15,850 people.

Among the 17 cancers and non-pulmonary conditions screened, the mutation showed a strong association only with lung cancer. Researchers also traced its origin to southern Appalachian populations in the US.

“Recognition of individuals more likely to carry EGFR T790M, including those with family history of lung cancer, multifocal lung cancer, or lung nodules or Southeastern US ancestry, may help to inform future screening and prevention strategies for those at highest risk,” said the researchers.

“Smoking is bad for lung cancer. This mutation is bad for lung cancer. When you do both, your risk is the sum of those two risks,” said Alexander Gusev, a quantitative geneticist at Dana-Farber. “So, you definitely don't want to smoke.”

The mutation was not linked to any of the 17 other common cancers studied, suggesting that its effects may be largely limited to lung cancer.

Could Genetic Testing Change Lung Cancer Screening?

“Today, lung cancer screening is driven almost entirely by smoking history,” said Jaclyn LoPiccolo, attending physician and lung cancer researcher at Dana-Farber Cancer Institute, who co-led the study.

LoPiccolo added that the findings raise the possibility that, in the future, screening could also be dictated by inherited genetic risk.

“If further studies confirm the benefit, people with EGFR T790M could be identified through genetic testing and offered personalized CT screening to identify lung cancers when they are at their most curable stage,” she said.

How Does The Mutation Increase Risk?

Although most lung cancers are associated with tobacco use or exposure, the proportion diagnosed in people who have never smoked has been rising. Yet the genetic factors underlying these cancers, particularly the role of inherited risk, are not well understood.

In 2005, researchers identified the rare inherited EGFR T790M mutation in a European family with multiple cases of lung cancer. Since then, the mutation has been reported in other families with unusually high rates of the disease.

In the study, LoPiccolo noted that the mutation occurs in about 1 in 15,000 people in the US population, but in certain areas of the Southeastern US, it can be as frequent as 1 in 2,000 people.

Other Lung Cancer Risk Factors

Lung cancer occurs when abnormal cells grow uncontrollably in the lungs. It remains the leading cause of cancer deaths worldwide, with an estimated 2.5 million new cases and 1.8 million deaths in 2022.

Beyond inherited genetic risk, lung cancer can also develop following exposure to second-hand smoke, air pollution, and workplace chemicals and carcinogens.

These include asbestos, silica dust, diesel exhaust, arsenic and other industrial chemicals.

Radon gas is another lesser-known risk factor. It is invisible and odorless, and prolonged exposure to high levels of radon can increase the risk of lung cancer.

A team of doctors at Mumbai’s Tata Memorial Hospital has identified a chemotherapy regimen that was better tolerated in people with high-risk penile cancer.

Published in the Journal of the National Cancer Institute, the BACuP trial compared paclitaxel with 5-FU (fluorouracil), with both drugs given alongside a platinum drug.

The study found that patients receiving paclitaxel had fewer serious side effects and treatment-related hospitalizations. They were also more likely to complete all four planned chemotherapy cycles.

However, the trial was too small to determine whether paclitaxel reduced cancer recurrence or improved survival.

What Did The Study Find?

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The trial included 49 men under 70 who had undergone surgery for penile cancer that had spread to the lymph nodes and had at least one feature linked to a high risk of recurrence.

They were randomly assigned to receive either 5-FU plus a platinum drug or paclitaxel plus a platinum drug. Both groups were scheduled to receive four cycles, three weeks apart.

Serious treatment-related side effects occurred in 77.3 per cent of patients receiving 5-FU and platinum, compared with 40.9 per cent of those receiving paclitaxel and platinum.

Paclitaxel was also easier to administer. 5-FU is usually delivered continuously through a vein over several days, sometimes using a pump, while paclitaxel can generally be given as an intravenous infusion in a day-care or outpatient setting.

Why Does The Study Matter?

Dr. Sandeep Nayak, Chairman of Oncology, MACS-Renova Oncology Institute, KIMS Hospital, Bengaluru, said that penile cancer carries a significant disease burden in India, yet for decades our adjuvant treatment decisions for high-risk, node-positive disease relied largely on retrospective observational data.

He noted that the goal after definitive surgical resection and lymphadenectomy is to prevent systemic recurrence. However, traditional 5-FU-based chemotherapy regimens have historically been notoriously difficult for patients to tolerate, leading to severe toxicities, frequent hospital admissions, and premature treatment dropouts.

“This trial provides evidence showing that the Paclitaxel-Platinum combination offers a far safer, outpatient-friendly regimen with drastically lower serious toxicities and an impressive completion rate of 83% (compared to 48% with 5-FU). Better patient compliance directly impacts real-world disease control,” said Dr. Nayak, who was not part of the study.

"Combined with early clinical presentation and timely surgical interventions, safer adjuvant options like this will meaningfully improve patient compliance and quality of life," he added while stressing the need for larger research.

What Is Penile Cancer?

Penile cancer is rare and is most common in men over 50. It is an uncommon malignancy in India, accounting for less than 1% of all male cancers.

Common symptoms include:

• A growth, lump or sore that does not heal within four weeks
• Bleeding from the penis or under the foreskin
• A rash or change in skin color
• A smelly discharge
• Difficulty pulling back the foreskin

The disease may be more treatable when found early. Treatment depends on the size and location of the cancer and whether it has spread, and may include surgery, chemotherapy or radiotherapy.

The Union Ministry of Health and Family Welfare has proposed mandatory CCTV surveillance at medical stores as an additional regulatory safeguard for prescription drugs.

The move, proposed under amendments to the Drugs Rules, 1945, through Draft Gazette Notification G.S.R. 791 (E), aims to strengthen regulatory oversight of Schedule H, H1 and X drugs.

Once implemented, it will help strengthen monitoring of the sale and distribution of these drugs and curb their unauthorized access and sale without valid prescriptions.

The proposed CCTV surveillance mechanism will also enhance transparency and accountability across the pharmaceutical supply chain, strengthening safeguards for public health. The draft proposal is now open to public objections and suggestions before it is finalized.

What Are Schedule H, H1 And X Drugs?

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Schedule H: Prescription-only medicines, including many blood pressure, diabetes and anti-infective drugs. They must carry the Rx symbol and cannot be sold without a prescription.

Schedule H1: A stricter category covering certain antibiotics, anti-tuberculosis drugs and sedatives. These medicines carry a red-boxed Rx warning and require medical advice.

Schedule X: The strictest category, covering certain high-risk narcotic and psychotropic drugs such as morphine, amphetamines and strong barbiturates. Their sale requires a specific government licence in addition to a standard retail drug licence.

Why Is CCTV Surveillance Being Proposed At Pharmacies?

India is seeing concerns over spurious and fake drugs, with chemists being the major point of contact for medicines for a majority of people.

A recent nationwide survey by LocalCircles, a community social media platform, showed that 64% of consumers said chemists never or rarely ask for a doctor's prescription, while only 31% mostly got a qualified pharmacist at their chemist.

Only 15% of those surveyed said the chemist mostly or always refused to sell medicines without a prescription.

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The survey also found:

• 13% said someone at the chemist assisted them who was not a qualified pharmacist.
• 15% said medicines were found to be fake or counterfeit.
• Another 15% said they received completely ineffective medicines.
• 26% said they were not provided a GST bill.

Counterfeit Medicines Seized In Bengaluru

In a recent shocking case, investigators in Bengaluru seized large counterfeit cancer medicines, life-saving drugs and injections used in intensive care units (ICUs) that were being supplied to hospitals, clinics and medical stores.

According to investigators, the medicines may have been supplied to more than 90 hospitals and clinics in Bengaluru.

A public interest litigation (PIL) has also been filed in the Supreme Court seeking a comprehensive national framework to check the manufacture and sale of counterfeit and adulterated medicines, including vaccines and cough syrups.

Drug Testing Data Shows Continued Quality Concerns

Data placed before Parliament shows that 1,41,322 drug samples were tested in 2025-26, the highest in five years. Of these, 3,012 were found to be Not of Standard Quality (NSQ) and 283 were found to be spurious or adulterated. A total of 779 prosecution cases were filed during the year, while 3,599 cases were filed over five years.

The Central Drugs Standard Control Organisation (CDSCO) has also continued issuing monthly drug alerts through 2026, flagging 240 NSQ samples in January, 194 in February along with four spurious drugs, 168 in March, 157 in May and 159 in June.