29 Feb 2024 : The Hindu Editorial

Topic 1 :  The rocky vista of medicinal cannabis that research is bringing into view

Context

The frequency and potency of cannabis use have exploded over the last two decades, partly because of the surge of interest in cannabis as medicine.

About

• The cannabis plant (Cannabis sativa) has long been of interest to psychiatrists for its perceived effects on mood and cognition.
• There is currently significant research interest in using cannabis-based compounds to manage and/or treat schizophrenia and cannabis-use and heroin-use disorders.
• Recently, researchers at the University of British Columbia in Canada floated a new clinical trial to examine whether cannabidiol could be used to treat bipolar depression.

The psychotomimetic agent

• The major psychotomimetic agent in C. sativa is a compound called delta-9-tetrahydrocannabinol (THC).
• There is growing interest in another cannabinoid, cannabidiol (CBD), which may have antipsychotic, anti-inflammatory, and neuroprotective properties.
• The plant’s flowering parts are more potent than its leaves.
• Marijuana is a combination of buds and leaves of pollinated female plants, and is usually cultivated outdoors.

The cannabinoid system

• The human cannabinoid system has two cannabinoid receptors, called CB1 and CB2.
• The naturally occurring substrate of the CB1 receptor is anandamide, a compound whose name comes from the Sanskrit word ‘ananda’, meaning bliss.
• CB2 is found in the spleen and testes and to a lesser extent in the central nervous system (CNS).
• CB1 is found diffusely throughout the CNS. The CNS is involved in the release of various neurotransmitters, including dopamine, noradrenaline, and serotonin.
• CB1 is like a traffic cop: it controls the levels and activities of other neurotransmitters.
• The CB1 receptor is relevant to the drug’s mind-altering effects. To stimulate these receptors, our bodies produce molecules called endocannabinoids.
• These are endogenous: they occur naturally within the body.
• The endocannabinoid system (ECS) comprises a dense network of chemical signals and cellular receptors. The cannabis plant works its effect by hijacking this machinery.

The bodily functions

• The cannabinoid system modulates a host of bodily functions, including pain, memory, psychomotor control, sleep, and appetite.
• THC in particular has acute effects on motor control and impairs fine movement.
• High doses of recreational cannabis use can disrupt short-term memory.
• Impaired attention is believed to be mediated by another part of the brain called the hippocampus, which is involved in memory and learning.
• This might indicate a possible role for THC in the extinction of bad memories in post-traumatic stress disorder (PTSD).

The rimonabant debacle

• Since ECS regulates hunger, it was thought that blocking the CB1 receptor could result in weight loss.
• There is a well-established association between THC exposure and a craving for high-fat, high-sugar foods.
• On this basis, in 2006, Sanofi-Aventis marketed a CB1 blocker called rimonabant in Europe as an anti-obesity drug.
• But while it did cause weight loss, it carried a risk of depression and suicidality and was eventually withdrawn.
• Nonetheless, THC and synthetic cannabinoids are also being used to stimulate appetite in people with HIV-AIDS and cancer.
• The anti-nausea property of THC is useful to ameliorate nausea associated with chemotherapy.
• Cannabinoids are also used to treat acute and chronic pain syndromes.
• Nabilone, a synthetic cannabinoid, has been shown to ameliorate chronic neuropathic pain, headache, and fribromyalgic pain.
• Sativex, which contains both THC and CBD, has been used to manage pain associated with multiple sclerosis.

Way forward

• Jurisdictions around the world are legalising medical use of cannabis; some have also legalised recreational use.
• If India were to ever decriminalise cannabis, policymakers should ensure it isn’t commercialised and that there are protections against use by children, adolescents, and those with established mental illnesses — the populace most vulnerable to the detrimental effects of cannabis.

Topic 2 :  India’s fight against rare diseases

Context

The tragic death of 19-year-old child actress Suhani Bhatnagar from dermatomyositis, a rare disorder that causes inflammation in muscles, came in the same month as Rare Disease Day, which is marked today.

Data

• According to the World Health Organization, rare diseases afflict 1 or less per 1,000 population.
• Barely 5% of the over 7,000 known diseases worldwide are treatable.
• Most patients typically receive only basic treatment that alleviates symptoms.
• Some require exorbitantly priced antidotes and supportive medication throughout their lives, which they can’t afford.

Rare diseases in India

• India accounts for one-third of the global rare disease incidence, with over 450 identified diseases.
• These range from widely known ones such as Spinal Muscular Atrophy and Gaucher’s disease to lesser-known ones such as Mucopolysaccharidosis type 1 and Whipple’s disease.
• Resource constraints apart, India languishes near the bottom on awareness, diagnosis, and drug development for rare diseases.

Policy and challenges

• A revised policy, the National Policy for Rare Diseases (NPRD), was announced in 2021, but problems persist.
• We still don’t define ‘rare diseases’, a failure the policy attributes to a lack of sufficient data, as if regular data collection and epidemiological assessments are not the government’s job.
• Timely and accurate diagnosis is indispensable for the robust management of any disease, yet for rare disease patients, it takes an average of seven years for their conditions to be diagnosed.
•  Physicians are generally unaware of how to interpret the signs and symptoms; healthcare professionals must be trained to improve their diagnostic accuracy.
• Expectant mothers with a history of rare diseases in their family must undergo mandatory pre-natal screening and post-natal diagnosis and care.
• Worse, treatments approved by the Drugs Controller General of India are available for just about 20 rare diseases and can be availed only from Centres of Excellence (CoEs).
• Since CoEs are few (12), unevenly distributed, and uncoordinated, late diagnosis, inadequate therapies and lack of timely availability are the norm.
• Funds are a major challenge too. The Budget’s allocation for rare diseases, although increasing over the years, remains low.
• As chronic rare diseases usually require lifelong management and therapy, this amount is woefully inadequate.
• Consequently, the CoEs are wary of beginning any treatment that they may need to suspend later, leaving them vulnerable to judicial action from patients and their kin.

Suggestions

• The Central government should frame a standard definition of rare diseases, increase budgetary outlays, dedicate funding for drug development and therapy, and increase the number of CoEs while also ensuring better coordination and responsible utilisation of funds.
• State governments must introduce social assistance programmes and develop satellite centres under the CoEs.
• Public and private companies could be co-opted for funding; CSR initiatives and partnerships can be leveraged to meet shortfalls.
• Finally, the issue of exorbitant drug prices and availability must be addressed.
• Last year, the government waived off GST and customs duty on medicines for rare diseases.
• But this exemption applies only to drugs which are to be “imported for personal use” and not to the ones commercially available in India.

Conclusion

• Rare diseases cannot be left to market forces: there just aren’t enough market incentives for drug manufacturers. The government must incentivise domestic manufacturers under the Production-Linked Incentive Scheme, reduce clinical trial requirements in appropriate cases, and look into options such as repurposed drugs and bulk-import. But first, it must withdraw GST on life-saving drugs.