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.

Statins have long had the job of lowering LDL cholesterol and protecting the heart. But new a study has emerged stating that these medicines may have another significant benefit for the brain.

A 15-year Danish study involving more than 132,000 people with type 2 diabetes found that those who started taking statins earlier had a 15% lower risk of developing dementia compared with those who started treatment later. Even later, statin use was associated with a 10% lower risk.

The researchers suggest that the timing of treatment is key as prolonged exposure to high cholesterol and other cardiovascular risk factors could contribute to damage that accumulate over many years.

The findings, presented at the European Society of Cardiology Congress and published in The Lancet Regional Health – Europe, come as researchers are constantly exploring the connection between cholesterol, blood vessels, and brain health.

Connection Between Cholesterol And Brain

The brain is an enormous delivery network in which billions of cells depend on a constant supply of oxygen and nutrients delivered through tiny blood vessels.

High levels of LDL cholesterol can contribute to atherosclerosis, where fatty deposits build up inside arteries. Over time, this can damage blood vessels and restrict blood flow.

Damage to the brain's blood vessels can contribute to vascular cognitive impairment and vascular dementia, while strokes can also increase the risk of subsequent cognitive decline.

Also read: Hormone Replacement Therapy May Lower Dementia Risk In Women, Shows Study

Statins Were Not Proven To Prevent Dementia

This study merely observed the correlation between statins and dementia risk, meaning it did not establish a definite cause-and-effect relationship. People who start statins earlier may also differ from those who start later in other ways, including their overall management of diabetes and cardiovascular risk.

The researchers therefore say more work is needed to determine whether statins have a direct protective effect on the brain.

Also read: Bruce Willis’ Daughter Rumer Undergoes ‘Terrifying’ Genetic Tests Amid Dad’s Dementia Diagnosis

Does Lower Cholesterol Mean Better Brain Health?

It is important to note the difference between treating unhealthy LDL cholesterol levels and assuming that everyone should aggressively lower cholesterol to prevent dementia. Statins remain as the medication to reduce cardiovascular risk.

Their potential brain benefits are an additional area of research. So, people must not blindly start popping statins to lower the risk of neurodegenerative diseases like dementia.

There is another reassuring point for people already taking statins. The concerns that these medicines may result in the increase of dementia risk have not been supported by the strongest available evidence.

A large review of randomised trials earlier this year found that most reported statin side effects were no more common than with placebo, including reported memory problems.

The most interesting takeaway may not be that “statins prevent dementia.” The evidence isn't strong enough to make that claim yet. It is that heart health and brain health are deeply intertwined.

Managing cholesterol, blood pressure, diabetes and other cardiovascular risk factors, along with regular physical activity and a healthy diet, may help protect the blood vessels that keep the brain functioning.

The Maharashtra Food and Drug Administration (FDA) has recently sparked headlines for bringing several known brands under its tight scrutiny. Cipla was one of them after the drug regulator cancelled one of its facility’s licenses over alleged violations associated with Reactin Plus tablets.

Soon after that, the Bombay High Court questioned the manner in which the action was taken, prompting the Maharashtra Food and Drug Administration (FDA) to withdraw its cancellation order.

The dispute has now become more about how far a regulator can go while enforcing drug safety rules, and whether due process was followed before cancelling the license.

Why Did Maharashtra FDA Cancel Cipla Facility’s License?

Maharashtra FDA recently conducted an inspection of Cipla Pharma & Life Sciences’ carrying and forwarding facility at Wadki in Pune.

During an inspection in June, FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, described it as an “analgesic and antipyretic”. The FDA said this amounted to unauthorised advertising of a prescription drug and violated provisions of the Drugs and Cosmetics Act and Rules.

The regulator seized Reactin Plus stock worth around Rs 11.19 lakh and instructed that the product be recalled.

But the FDA said the recall directions were not fully complied with. A subsequent inspection also found discrepancies between physical stock, computerised records and purchase and sales data.

Medicines were reportedly found stored directly on the floor, with inadequate proper storage arrangements. Deficiencies were also identified in the handling of expired medicines.

Based on these findings, the FDA cancelled the drug-sale licenses of the facility with effect from August 27.

Maharashtra FDA Commissioner Tukaram Mundhe said, “The Food and Drug Administration will not show any leniency regarding the safety of medicines and the health of citizens.”

He added, “Any entity within the pharmaceutical manufacturing and distribution system found violating regulations will face stringent legal action.”

Also read: FSSAI Proposes Red Front-Of-Pack Warning Labels On Junk Food: How Will This Benefit Consumers’ Health?

Why Did The Bombay High Court Step In?

Cipla challenged FDA's action before the Bombay High Court. On August 30, the court criticised the regulator's approach, describing it as “high-handed” and saying the FDA had gone “overboard”. The court also questioned whether the principles of natural justice had been followed.

During the hearing, the court asked, “Do you feel you are a Lord and you can do anything?”

The court's concern was not necessarily that the FDA should not regulate Cipla. Instead, it questioned the manner and procedure through which the license was cancelled.

Following the court's intervention, the Maharashtra FDA withdrew the cancellation order and said it would issue a fresh show-cause notice before passing an order.

So, the license has been restored for now, but that does not mean the underlying regulatory concerns have disappeared.

Also read: Everest Hing Sale Prohibited By FSSAI; 3 Other Masalas Flagged For Violations

What Does Cipla Say?

Cipla has maintained that the matter is under judicial consideration and therefore declined to comment in detail. The company said the FDA order relates to the operations of a C&F warehouse, rather than allegations concerning the medicine's safety or effectiveness.

According to mint, Cipla said, “Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety.”

The company also clarified that the FDA order “does not allege any concerns relating to the safety, quality or efficacy of its products”.

Reactin Plus Is Safe

The FDA action focuses on violations related to labelling, recall compliance, storage, inventory records and distribution practices.

It did not establish that Reactin Plus was unsafe, ineffective, or contaminated. Cipla has specifically said the order did not concern the product's safety, quality, or efficacy.

One of the country's most popular condiment brands, Everest, is under tight FSSAI scrutiny after the food regulator ordered a temporary ban of sale of its hing (asafoetida) and a few masalas.

The Food Safety and Standards Authority of India (FSSAI) has prohibited the sale of compounded hing manufactured by Everest Food Products and Laljee Godhoo and Company after laboratory testing found samples that did not meet food safety standards.

The regulator has spotted compliance issues in three Everest spice blends. They include egg curry masala, chicken masala, and its widely sold garam masala.

To clarify, the three Everest masalas have not been banned permanently. They have been flagged for non-compliance, and the company has been asked to explain the violations and submit an action plan to resolve the said issues.

Why Is Everest's Hing Under Fire?

The action against hing came after a consumer complaint that prompted FSSAI to begin surveillance of major hing brands.

Samples were collected from Everest's facility in Mumbai and its manufacturing unit in Umbergaon, Gujarat, to be sent for laboratory testing.

According to FSSAI, its compounded hing samples tested contained only 0% to 3% alcohol-soluble extract, despite the prescribed minimum being 5%.

Compounded hing, which is not pure raw asafoetida, is a regulated food product made by blending raw hing with other ingredients like starches, flour, and gum Arabic. The required alcohol-soluble extract helps establish whether sufficient raw asafoetida is present in the final product.

FSSAI said the test results indicated that the products contained 30% to 40% less raw hing than required.

The regulator also found a separate problem in six varieties of raw hing tested at the Laljee Godhoo facility. Their starch content ranged between 15% and 32%, while the permitted maximum is 1%.

Also read: FSSAI Proposes Red Front-Of-Pack Warning Labels On Junk Food: How Will This Benefit Consumers’ Health?

What About Everest's Egg Curry, Chicken And Garam Masalas?

The regulator also detected non-compliance in Everest egg curry masala, chicken masala, and garam masala. However, unlike the hing products, these three spice blends have not been prohibited from sale.

The companies have been asked to explain the violations and submit action plans elaborating how they intend to comply with the food safety standards.

FSSAI has also advised the manufacturers to voluntarily recall substandard hing products already in the market.

Also read: US FDA Recalls Injectables Over Fiberglass, Steel Particles: See Affected Drugs

Motive Behind FSSAI's Action

FSSAI's action is a preventive food safety measure. The regulator said the manufacturers must address the violations and ensure their compounded hing meets the prescribed standards. The prohibition on the product will remain in place until compliance requirements are met.

For consumers, the episode also highlights the fact how food adulteration or substandard manufacturing is not always visible to the naked eye. A spice may look, smell and taste perfectly fine while still failing a major food safety standard.

Laboratory testing is therefore crucial for identifying problems like incorrect composition or inadequate levels of the ingredient in a product.

This comes at a time when FSSAI is tightening rules over food standards and labelling. Just days ago, the regulator proposed hexagonal red, front-of-pack warning labels for packaged junk foods that are high in sugar, salt or saturated fats. It told the Supreme Court that the aim is to make such information easier for consumers to understand.