Monday, January 21, 2008

Trouble in Big Pharmadise

This past week saw the demise of block buster drugs from our friends at big pharma. These cholesterol lowering drugs (Vytorin and Zetia), either didn't work any better than older drugs or in the case of Zetia, actually increased the amounts of fatty plaque in the carotid artery. This is on the heels of many major big pharma failures over the past few years including Bextra, Celebrex, Avandia, and others. What's going on and what does it have to do with stem cells?

Big Pharma now spends two dollars on ads for every dollar it spends on research. Big pharma has also retreated from the development of one time use drugs like antibiotics. Why? Big pharma has become intoxicated with big business plans. The best long-term biz plan is a "lifetime" drug, or one where the patient needs to take the medication every day forever. The big block buster categories of these drugs have become pain medications, anti-inflammatory medications, and cholesterol medications. The focus on marketing over science has created a problem that is evident from these drugs periodically being pulled from market. In these cases, the business plan trumps the science.

How does all of this fit into stem cells? Over the past few years we've seen an explosion of ways to modify cells to become stem cells, modify stem cells with gene therapy, expose stem cells to experimental drugs and cytokines, etc... While these efforts are to be applauded on a basic science front, there is also a plurality of data documenting multiple types of tissue repair using adult mesenchymal stem cells without such modifications. The Regenexx procedure is an example of this type of minimal manipulation, meaning deploying the repairmen of the body in various ways to repair diseased or damaged tissue. While we may be able to eventually build a better stem cell, these approaches where cells are modified are a bit concerning. Watching the Will Smith movie "I am Legend" this weekend was a great example of what can happen with these approaches. In this movie, a cure for cancer is developed by modifying a virus. The innocuous virus cures cancer, but then mutates into a deadly disease which kills 90% of the world population. While this is a bit severe, the more we manipulate cells to get them to do what we want them to do, the more likely we'll produce unintended consequences. Big pharma is learning these lessons now, with drugs being yanked off the market every few months.

With adult stem cells, we have an opportunity to teach big pharma and modern medicine that the next block buster drug is already within us.