Entries in pharmaceutical (2)

Tuesday
Apr192016

The rise of Pharming in Agriculture

Plants have been used for the treatment of diseases for thousands of years – long before researchers were able to identify and purify the active compounds. Salicin, which is found in willows, is a great example of such a compound. The bark and leaves of willow trees were being used to treat fevers and headaches around 400 B.C. However, it wasn’t until the 1800s that scientists discovered the active compound in willow trees (salicin) that conferred those beneficial properties.

In the last few decades, scientists have started using plants differently for the treatment of diseases. Sijmons et. al. demonstrated that gene insertion is possible in plants by showing that tobacco and potato plants could express the human serum albumin protein. This process of gene insertion is now referred to as pharming (a combination of “farming” and “pharmaceutical”). Initially, the field faced many challenges, including disapproval from anti-genetic-modification movements and regulatory uncertainty. Low yields as well as purification cost were other hurdles faced and it wasn’t until around 2009 that pharming obtained a realistic opportunity for commercial development. In 2012, the first pharming product (taliglucerase alfa, used for the treatment of Gaucher’s disease) was approved for use in humans. This attracted major pharmaceutical companies such as Mitsubishi Tanabe Pharma, which acquired Medicago (plant-based vaccines developer) in 2013.

 

The major benefit of pharming is that it does not require expensive infrastructure, as the plants are generally grown in an open environment. This enables the production capacity to be increased, by keeping the cost low. However, like any other process, pharming also has disadvantages. A major environmental concern is pollination/seed contamination. Other risks include accidental entry of the drug into food chains and consumption by non-targeted organisms.

Personally, I think there is still some way to go before pharming becomes the “go to” method for large-scale drug production. But interest in the process has increased exponentially in the past few years, suggesting that it has the potential to become an important technique in drug development.

~AKHD

P. Sijmons et. al. (1990) “Production of correctly processed human serum albumin in transgenic plants” Biotechnol. 8:217-21.

E. Stoger et. al. (2014) “Plant molecular pharming for the treatment of chronic and infectious diseases” Annu Rev Plant Biol. 65:743-768.

 

Tuesday
Oct202015

Consumers can expect more accessible explanation of risks in pharmaceutical advertisements 

Whether they are in print or some other broadcast medium, we are constantly bombarded with pharmaceutical advertisements. We are all too familiar with the format in which these advertisements appear: captivating images and/or compassionate and motivating speech with large text to draw your attention, convincing us that a particular agent can improve our lives in some otherwise ailing capacity. This is followed by a line of fine print, or the remaining few seconds of a commercial, rambling off a list of risks and side effects described in scientific jargon most viewers/listeners cannot understand. Even if we are able to comprehend the science, the risks are presented too quickly or in print too small to take in. Sure, most of these ads say to speak with your doctor about the risks before taking X drug, but why aren’t these risks easily and initially accessible to us? When we purchase food items, we may find printed cautions such that the food had been handled/manufactured with other products containing soy or peanuts (important for individuals with allergies or sensitivities to consider). If we as consumers are to take the drug into our bodies, then we should be fairly presented with the risks as well.

This may soon change, as the FDA is beginning to put into place regulations about how risks are displayed in direct-to-consumer advertising (DTCA) since the administration acknowledges that the way in which they are presented currently are not effective. The FDA proposes to use language more likely to be understood by consumers. However, there are other questions that are being raised: how to determine if the language is too technical or too simplistic for delivering information to consumers? How much information should ads contain so that they are sufficient without being too lengthy? Should all known risks and side effects be included or only those more likely to occur or those most serious? In the 30 years of DTCA, there have been a number of efforts to improve the way in which important information is conveyed to consumers. Questions such as those brought up above in addition to other issues and concerns will need to be addressed to improve message delivery in DTCA. What is clear is that companies should put in as much effort into delivering information about risks as they do into selling their products. 

-AB

Greene, J. A., & Watkins, E. S. (2015). The Vernacular of Risk—Rethinking Direct-to-Consumer Advertising of Pharmaceuticals. New England journal of medicine, 373 (12), 1087-1089.