Derivation of an empirical relation between the size of the nanoparticle and the potency of homeopathic medicines

Homeopathic medicines are often prescribed at very high dilutions and it is a clinically observed fact that the medicinal effect of the drug remains even at these high dilutions. The increase in potency of a medicine due to potentization is still debatable from physico-chemical point of view. Out of various hypotheses to explain this phenomenon, a recent hypothesis, advanced by us and supported by others, is that the size of the constituent particles decreases and eventually achieves nano dimension due to potentization. From the experiments performed by our group, the size of nanoparticles (NPs) of Cuprum metallicum, Zincum oxydatum, Aurum metallicum, Ferrum metallicum and Aconitum napellus (6cH, 30cH and 200cH) have been estimated. A general mathematical expression of the form y = a x-n has been derived which relates the size of NPs (y) with the corresponding potencies (x). There is no method to calculate the accurate potency of the homeopathic medicine, as the potency of a medicine depends to some extent on the method of preparation, for which a standardized procedure is warranted. Also, while handling a medicine, the solvent might evaporate causing a change in the potency. Thus by measuring the size of the NPs and using our proposed standard curve, the potency may be estimated. (AU)

Derivation of an empirical relation between the size of the nanoparticle and the potency of homeopathic medicines

Homeopathic medicines are often prescribed at very high dilutions and it is a clinically observed fact that the medicinal effect of the drug remains even at these high dilutions. The increase in potency of a medicine due to potentization is still debatable from physico-chemical point of view. Out of various hypotheses to explain this phenomenon, a recent hypothesis, advanced by us and supported by others, is that the size of the constituent particles decreases and eventually achieves nano dimension due to potentization. From the experiments performed by our group, the size of nanoparticles (NPs) of Cuprum metallicum, Zincum oxydatum, Aurum metallicum, Ferrum metallicum and Aconitum napellus (6cH, 30cH and 200cH) have been estimated. A general mathematical expression of the form y = a x-n has been derived which relates the size of NPs (y) with the corresponding potencies (x). There is no method to calculate the accurate potency of the homeopathic medicine, as the potency of a medicine depends to some extent on the method of preparation, for which a standardized procedure is warranted. Also, while handling a medicine, the solvent might evaporate causing a change in the potency. Thus by measuring the size of the NPs and using our proposed standard curve, the potency may be estimated...

The future of risk communication and the role of the pharmaceutical industry.

Risk communication is an interactive two-way process that various stakeholders (e.g., patients, regulators, industry) utilize to address prescription drug safety. This paper will specifically examine the pharmaceutical industry's engagement with risk communication as a tool for information exchange with patients and other stakeholders about the associated risks related to its medicines. Risk communications are not solely meant to inform; and rather effective two-way risk communications have the potential to change behavioral outcomes for the purpose of individual and societal benefit. Despite this indispensable role of risk communication for the pharmaceutical industry, more research is needed for the appropriate development and dissemination of risk communications. A crucial missing component for the crafting of pharmaceutical risk communications is the understanding of risk perceptions from the patient/consumer's perspective. This is necessary to see where any divergences in views may lie between the industry and its final consumer, which is crucial in tailoring communications to target a specific erroneous belief or to address what might be deemed as a needed behavioral shift. It is also necessary to develop communications in consideration of the levels of public trust in the industry as well as other perceived actors in the healthcare system. Even the most meticulously crafted and tested risk communications will fail to fulfill their purpose if the role of trust is not taken into consideration. These considerations can lead to the establishment of a "social contract" that effectively addresses what is required from both parties for continued and mutually beneficial interactions. Conducting risk perception research, addressing the role of trust, establishing a social contract, and having a realistic outlook on the impact of risk communications are necessary considerations as pharmaceutical risk communication evolves for the future.

Transparency and the Food and Drug Administration--a quantitative study.

In Europe and North America, there is increasing political pressure being put on health regulatory agencies to become more transparent. To date, however, there has been little academic evaluation--let alone analysis--of these transparency initiatives from a risk communication perspective. This review examines whether the U.S. Food and Drug Administration's Adverse Event Reporting System quarterly signal postings, put in place after the passage of the Food and Drug Administration Amendments Act 2007, will assist patients and doctors in their decision-making processes, on the basis of results of a quantitative Internet survey of 433 physicians and 1,000 American adults. The results indicate that there is significant disagreement between physicians and the public about when medical safety issues should be communicated in the first place, with physicians opposed to early signal postings while the public in general is in favor. In addition the findings show that if the public were to find their drugs listed on the Adverse Event Reporting System signals web postings, more than a quarter would stop taking their medicine. Going forward, the Food and Drug Administration needs to work to a greater degree with social scientists in developing scientific-based communication strategies, rather than developing transparency initiatives on the basis of stakeholder consultations.

Risk Communication and the Pharmaceutical Industry: what is the reality?

Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company's risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are used globally, we are not aware of any research into their effectiveness outside the ICH regions. What listed companies can communicate about benefits and risks is strongly influenced by the obligations of companies to the market and investors. There needs to be internal coordination for simultaneous release. Internal communications about significant issues should be restricted to those who know how to manage the risk of insider dealing from internal communications that may later be made public. Unfortunately, there is evidence that some companies do not have a cohesive strategy for communicating risk which should take into account all forms of promotional material and company-sponsored information sources on the Internet. A pharmaceutical company is not the only stakeholder responsible for communicating risks on their products. However, the relative roles and responsibilities of all relevant stakeholders are not defined and are often unclear. This means it is difficult to evaluate whether a company's actions might be duplicative or inefficient. We recommend that companies have a dedicated communications group whose role is to coordinate the company's communications strategy mapped to objectives that have been agreed with key stakeholders apart from just regulatory agencies. This same group can assess effectiveness of the communications, monitor audience reaction and adjust the communication strategy accordingly.