Avoiding health hazards from endocrine disruptors

The Indian drug industry, recognised as the generic leader of the globe, is the lifeline for billions of the nation. It is striving hard to match global standards in terms of quality as well as pricing.

The pharmaceutical industry so have an equal role in enhancing patient care and can also be rightly called as custodians of healthcare , maybe as important as doctors. With this honour also comes a great responsibility, responsibility to be aware, to implement changes which impact health of millions of people.

The Government of India ban on use of PET bottles in primary packaging especially for females especially reproductive age, children and ageing population, is one such step which should get support from the industry.

Today plastic a man-made chemical has become an important part of the modern life. Human and even wildlife populations cannot avoid coming into contact with plastics. Considering the importance of the widespread presence of plastics in our life, it is imperative to have a relook at them in light of environmental contamination with endocrine disruptors.

Endocrine disruptors, a cause for concern
Chemicals that mimic or antagonize the actions of naturally occurring estrogens are defined as having estrogenic activity (EA), which is the most common form of endocrine disruptor activity. Chemicals having EA can create many health-related problems, such as early puberty in females, reduced sperm counts, altered functions of reproductive organs, obesity, altered sex-specific behaviours, and increased rates of some breast, ovarian, testicular, and prostate cancers. Fetal, newborn, and juvenile population are especially sensitive to very low doses of chemicals having EA.

Plastic resins and manufacturing protocols collectively use many monomers and additives that may exhibit EA because they have physicochemical properties, often from an insufficiently hindered phenol (HP) group, that enable them to bind to ERs. Because polymerization of monomers is rarely complete and additives are not chemically part of the polymeric structure, chemicals having EA can leach from plastic products at very low (e.g., nanomolar to picomolar) concentrations that individually or in combination can produce adverse effects, especially in fetal to juvenile mammals.

This leaching of monomers and additives from a plastic item into its contents is often accelerated if the product is exposed to common-use stresses such as ultraviolet (UV) radiation in sunlight, microwave radiation, and/or moist heat via boiling or dish washing. The exact chemical composition of almost any commercially available plastic part is proprietary and may consist of = 100 chemicals, almost all of which can leach from the product, especially when stressed. Unless the selection of chemicals is carefully controlled, some of those chemicals will almost certainly have EA, and even when using all materials that initially test EA free, the stresses of manufacturing can change chemical structures or create chemical reactions to convert an EA-free chemical into one with EA.

In a report by Chun Z. Yang et al,on a research conducted at the University of Texas, published in 2011, most of the > 500 commercially available plastic products were sampled—even those that are presumably BPA free—release chemicals having detectable EA, especially if they are assayed by more polar and less polar solvents and exposed to common-use stresses.

This study highlighted that, to reliably detect such leachable chemicals having EA, unstressed or stressed plastic resins or products should be extracted with more polar (e.g., saline) and less polar (e.g. ethanol (EtOH)solutions and exposed to common-use stresses (boiling water, microwaving, and UV radiation- like sunlight).

In fact, the study concluded that almost all commercially available plastic items would leach detectable amounts of chemicals having EA once such items are exposed to boiling water, sunlight (UV), and/or microwaving.

These findings are consistent with recently published reports by Wagner and Oehlmann 2009 that PET products release chemicals having EA and that different PET products leach different amounts of EA.

This is a very significant study in the context of Indian subcontinent as our ambient temperatures are above 40 degrees Celsius and these temperature while transportation and storage reaches above 60 degree Celsius. Also as the medicines are stored from 12 months to 24 months , the leaching of dangerous EA could reach at an alarming levels. Currently the medicines in these stressed conditions and are tested at temperatures up to 28 degree Celsius.

So in our naturally stressed climatic conditions the leaching from PET containers will be very high and do we want our fragile and susceptible population exposed to it.

Avoiding potential health problem
It is almost impossible to gauge how much EA anyone is exposed to, given such unknowns as the number of chemicals having EA, their relative EA, their release rate under different conditions, and their metabolic degradation products or half-lives in vivo. In addition, the appropriate levels of EA in males versus females at different life stages are currently unknown.

Exposures to to chemicals having EA even in very low doses can change the structure and function of many human cell types and can alter cellular/molecular/systemic changes in various cells, organs.

Recent epidemiological studies strongly suggest that chemicals having EA produce measurable changes in the health of various human populations (e.g., on the offspring of mothers, or sperm counts). As we are aware of in-utero exposure of drug and its implications by our past experience of various drugs like Thalidomide, would we like to repeat our mistakes or support government on the ban.

Pharmaceutical industry carries with it an important responsibility of safe medicine and it should support the government and look into options of other safe packaging option like glass not only for vulnerable population but for all, as right for safe packaged medicine is a right of all.