PharmEcology II: A Study in Statin

With the recent change in guidelines from the AHA and ACC, as many as 70 million Americans may end up taking Statins to reduce their chance of heart attack and stroke. Already, Lipitor (atorvastatin) was the greatest selling medication of modern times with over 40 million Americans taking the drug at its peak. At an average of 20 mg per pill, this resulted in over 292 metric tons of lipitor produced per year*.

At 250 Tons, Hong Kong’s Tian Tan Buddha weighs less than the lipitor consumed every year in the US

Despite this large scale, few outside of the Green Chemistry field are aware of the myriad of environmental impacts from the supply chains used to produce Lipitor.  Creating Lipitor requires a complex series of chemical reactions. Along the way, various different solvents, raw materials and catalysts are needed to finally create the active pharmacological ingredient that can reduce cholesterol in humans.

Synthesis of Atorvastatin(Lipitor), courtesy of newdrugapprovals.wordpress.com

Acetonitrile is one solvent used in the synthesis of Lipitor. Acetontirile is produced from the catalytic ammoxidation of propylene. Propylene (aka propene) is itself derived from fossil fuels, namely natural gas and coal.  The industrially produced ammonia used in the process comes from Natural Gas. Aside from the odd fact that your cholesterol is lowered at least in part thanks to fossil fuels, there is also the case of the Beijing Olympics.

Beijing’s Air – The Olympics were a temporary respite

Beijing’s notorious air pollution was under the microscope prior to the 2008 Olympic Games. The Chinese authorities instituted a number of measures, such as shutting down factories near the city and reducing car use, to clean up the air. Some of these factories were producers of Acetonitrile. Those closures, combined with the shutdown of Texan facilities impacted by Hurricane Ike, resulted in a global shortage of Acetonitrile.  The shortage of Acetonitrile resulted in a price spike, directly impacting the bottom line of all those that use the solvent, including pharmaceutical companies.

This small lesson highlights how understanding the supply chain of your products could have potentially resulted in avoiding a commodity price spike…and the embarrassing, or potentially liable, connection to worsening health outcomes in heavily polluted developing countries…

On the flip side of these petrochemical derived substances is a potential opening for renewable supplies and green chemistry. Ammonia, which accounts for over 1% of total global energy use, is possible to derive from renewable electricity when using Hydrogen derived by hydrolysis (see Iceland). Propylene is also a target of green chemistry with some companies using microbes to synthesize the needed compound rather than relying on natural gas or coal.

J. Craig Venter is collaborating with Exxon to create biofuels from algae

But back to Big Pharma. Supply chain accountability starts at the bench: each solvent, catlalyst and substrate has its own set of sources and associated impacts. Following the principles of Green Chemistry keeps the focus in the right direction, but a broader view is needed in the industry to ensure that price spikes such as the Acetonitrile incident don’t happen again. If Acentonitrile came from sustainable sources, or if a green alternative was found, Pharma companies could have used their engagement with the manufacturers to not only show their commitment to the environment but also ensure a reliable source of solvent  with less potential liability from the downstream health effects of their suppliers. And that’s a strategy that works for the triple bottom line.

*Unofficial back of the envelope calculations figuring 20mg avg statin pill API * 1 dose per day * 40,000,000 patients * 365 days/yr = 292,000,000,0000 mg or 292 metric tonnes.

truthful eco-labeling

Recently while I was shopping on Amazon for a sustainable source of coffee to satisfy my morning buzz, I came across a coffee shop that was selling unique coffee grown in the Cerrado region of South America. After all I learned of the Cerrado through my XMNR courses, the largest and most ancient grassland savanna that mankind has a privilege to experience, it was upsetting to see someone describing it as “native” because I knew the region needed tremendous industrial transformation of its acidic soil in order to be suitable for growing any products at all. When I asked the seller if it was sustainable, he answered “I would think so, coffee is native to Brazil!!”

Across the web and the grocery aisle, terms like sustainable, natural, and organic have been reduced to marketing phrases. The promulgation of a myriad of labels and standards, together with a lack of transparency on what actually makes a product sustainable, has made it nearly impossible to shop for ethically sourced consumer goods without a masters in sustainability! This is not something we should expect from the average consumer.

Can we seriously know the veracity, sourcing, standards and impacts of every one of these labels?

 

A similar situation existed with medicines in the 1800s. Charlatans of all types sold medicines with wild claims and even those destined for doctors offices could not be assured that what was in them was the actual pharmaceutical. On top of that, a variety of regulations from different states within the US created a dizzying set of standards that essentially made companies selling in multiple states have to create a different type of product for each market, even if it was the same thing they were selling! The situation was dangerous to the public, bad for business, and stymied the progress of medical science. It was not until a coalition of a crusading chemist, women’s activists clubs, and multi-state businesses came together to push the federal government into creating the FDA that the safe foods and effective medications we come to rely upon today were standardized. It was an early example of a cross-sectorial collaboration between the public, business, academia and government – Collective Impact if you will.

Best Pain Remedy on Earth – Yup, sure.

Fast forward to 2013, and we have the multiple sets of organic, rainforest friendly, energy efficient and green labels that confronts and confuse us when we try to make ethically based purchases. It would seem obvious that what we need is an “eFDA”, or at least a set of agreed upon standards that can simply guide us when making purchasing decisions. We need a Nutrition Facts label for sustainability. And just as the Nutrition Facts uses agreed upon scientific standards to show us what is in our food, we need similar standards to show us where our products come from, as well as the environmental, social and economic impacts created in the process of production. Think of how much water to produce a can of beans, or how much energy to manufacture a laptop, or how many trees to create the toilet paper.

Mark Bittman recently wrote in the NYT about his dream food label which would encompass nutrition, “foodness” and welfare in a simplified, standardized label:

simple and to the point

The most difficult part, and the one with the most opportunity for sustainability professionals is that of “welfare”, which he writes would encompass the following:

“The third is the broadest (and trickiest); we’re calling it “Welfare.” This would include the treatment of workers, animals and the earth. Are workers treated like animals? Are animals produced like widgets? Is environmental damage significant? If the answer to those three questions is “yes” — as it might be, for example, with industrially produced chickens — then the score would be zero, or close to it. If the labor force is treated fairly and animals well, and waste is insignificant or recycled, the score would be higher.”

As Bittman notes, his proposal is not an end but a beginning of the conversation about how to create sustainability food labels. And for sustainability professionals, the subject of unified, simple and effective labeling is one that will require a Collective Impact approach. There is too much competition for grants and market position among for and non-profits alike in the green label field, for the sake of the planet we need to begin to come together around a label we can all agree upon, and read!