The Compound Eye

Policy Focus

e-cigarettes: To ban or not ban? 

Last week US health officials reported what could be the country’s first death linked to vaping. The officials said that an adult patient in Illinois, who contracted a serious lung disease after vaping, had died and that they considered it the first death in the US linked to e-cigarettes. The debate on whether e-cigarettes should be banned or not has been on-going in multiple countries. Reports suggest that the Indian Union Health Ministry is preparing an ordinance banning the production, import, distribution and sale of electronic cigarettes in India. Banning e-cigarettes is one of the 100-day goals of the Ministry of Health and Family Welfare.

ICMR had called for an ban on Electronic Nicotine Delivery System (ENDS) in a white paper released on 31st May, 2019, on the eve of World Tobacco Day. The white paper suggests that inconsistencies in nicotine presence in ENDS, inadequate data on health risk and lack of evidence for it as a smoking quitting aid as reasons for banning ENDS. In response, 62 specialists had written to the ICMR to reconsider their decision, citing issues with the white paper. Their critical appraisal alleges the white paper to have selectively referenced publications which cite the harmful effects of e-cigarettes. 

Further one of the major contentions of ICMR’s white paper is the lack of long-term evidence to determine the hazard potential of e-cigarettes. The critical appraisal notes that it is accepted practice, even among pharmaceutical products, to rely on post-marketing surveillance to examine long-term health effects, as it is unviable for any product to be marketed only after decades of research. 

You can read further on the critical appraisal here

CompoundTake: The main concern about e-cigarettes is that their attractive nature is tempting teenagers and young adults to get addicted to nicotine. These users may also later start dual use: vaping and smoking cigarettes. Critics argue that vaping results in health-risk reduction and e-cigarettes are significantly less harmful to health than cigarettes. Much like the association between food consumption and their risk to cause cancer, publications associating vaping and health risks are divided. Some show risk reduction by switching from smoking to vaping, some don't. Further the presence of strong tobacco lobbying groups and funded research makes select publications suspect. Most of the vaping products are also owned by cigarette companies. The inadequate data on the risk:benefit of vaping has resulted in many countries including Singapore and Brazil to ban e-cigarettes. 

The ban on e-cigarettes leads to a different question: if e-cigarettes are a health risk and should be banned, why are cigarettes allowed? Cigarettes have already become entrenched in the system and banning them now would be challenging. Banning cigarettes would fuel an underground market, resulting in the sales of unregulated cigarettes. The tobacco industry also uses the high number of people it employs - from farmers to factory workers - as a weapon to resist any attempt at banning tobacco.  

E-cigarettes remain a controversial issue - but the recent reports from US can help make a better assessment of their health effects. But finally evidence is needed from studies in India to answer three questions: 

a) Are e-cigarettes less harmful than traditional cigarettes?

b) Does the introduction of e-cigarettes reduce the number of people smoking traditional cigarettes? 

c) Do e-cigarettes tempt more people to start using nicotine-based products than traditional cigarettes? 

Note: This CompoundTake is only about the use of nicotine for recreational purposes. It does not take into account the use of nicotine in a pharmaceutical setup. 

It's Controversial

Substandard medical drugs 

Katherine Eban's book Bottle of Lies has renewed public focus on flawed manufacturing policies and poor regulatory oversight that result in substandard medical drugs. In recent news, the FDA has handed over an F483 (this is the worst review that FDA can give a drug manufacturer) to Dr Reddy's Laboratories for its manufacturing facility. This is the 5th F483 given to Dr Reddy's over the last 3 years. 

In the recent past, many Indian drug manufacturers have received various levels of warnings from the FDA. This raises a concern on the kind of drugs these companies make, a majority of which may be consumed by Indian consumers. This concern and the brief observations alluded to in Eban's book of regulatory lapses demand questions of India's drug regulator. 

In the backdrop of these events, the CBI has arrested Dr. Naresh Sharma, Deputy Drug Controller (I) at Central Drugs Standard Control Organisation (CDSCO) headquarters on August 16 on corruption charges. 

Dr Sharma’s arrest coincides with CBI unearthing a major corruption racket where it booked a CDSCO inspector based in Himachal Pradesh. The inspector has been alleged to have taken a INR 1 lakh bribe to approve substandard samples of dobutamine injection made by Amritsar-based Kwality Pharmaceuticals which had failed a CDSCO trial. Dobutamine is a is a life-saving drug used for patients suffering from heart failure.

This pharmaceutical problem is not unique to India, but for a country aiming to be the medicine factory for the world and home to 1.2 billion consumers, such arrests are alarming. They lead to two outcomes - tarnishing India’s image and confidence in our healthcare industry and jeopardising the constitutional right to health of Indian citizens.

Science in India

Clinical Trial Networks and Strengthening Clinical Trial Capacity: 

DBT has announced a request for proposals (RFP) for the following projects:

RFP 1: To establish Clinical Trial Networks (CTNs) for hospital-based trial in specialties of Diabetology, Ophthalmology, Rheumatology and Oncology. Institutions that apply will require to have infrastructure for patient-based clinical trials - hospitals and public/private medical should be able to apply (Pg 13-17)

RFP 2: To study epidemiology of Dengue & Chikungunya in different age-groups at existing Demographic Surveillance System / Demographic and Health Surveillance / Demographic, Development and Environmental Surveillance System (DSS/DHS/DDESS) site(s) and to further prepare the sites for conduct of GCP compliant field-based clinical trials. The study would provide important information for vaccine/diagnostics  development and help plan trials for prospective candidates. (Pg 20-22)

RFP 3: Establish new DSS/DHS/DDESS sites within the country to have complete geographical representation of potential trial sites and to study epidemiology of Dengue & Chikungunya in different age-groups at these sites. The objective of this RFP is to strengthen the field presence of existing institutes to boost geographical representation. (Pg 23-24)

RFP 4: To establish data management platform: An IT platform for community-based data collection, analysis and reporting. The increased awareness through strengthening of existing data collection sites would result in the requirement of a data management platform. Such a platform might also require integration of existing data sets. An existing data collection and management tool which can be deployed quickly at the collection sites would be ideal. (Pg 25-27)

Deadline for submission of Letter of Intent: 10th October 2019 

You can find the detailed proposal here

Meanwhile, here is some diet-related news:

Another benefit of restricting diet? A team led by Dr. Arnab Mukhopadhyay from the NII, has demonstrated in C. elegans that diet-induced stress during early development delays the deterioration of endoplasmic reticulum later in life, thus delaying ageing and increasing longevity. 

Yet another benefit of restricting diet? The burning of the Amazon rainforest. Not the most intuitive connection. While the wildfires raging in the Amazon rainforest may constitute an "international crisis," they are hardly an accident. The vast majority of the fires have been set by loggers and ranchers to clear land for cattle. Countries are now floating the idea of banning beef imports from Brazil - currently the world's largest beef exporter - to help save the burning of the Amazon. 

Microplastics in water are okay? This one seems counter-intuitive. But according to WHO, there is no evidence that microplastics in water are a health hazard to humans. Critics suggest that this assessment is based on a limited study. The WHO argues that more comprehensive and long-term data would help, but current focus on microplastics may distract water suppliers and regulators from removing microbial pathogens, such as those causing deadly diarrheal diseases. Doesn't that sound flimsy? 

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Shambhavi Naik Research Fellow
shambhavi@takshashila.org.in
080 4372 5304

Takshashila Institution

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