What Does Unmet Medical Need Really Mean in "Pharma Speak"?
Every major pharmaceutical company on the planet declares that it “invests billions of dollars into R &D to develop novel medicines to address unmet medical needs”. Further, pharmaceutical company advocates and lobbyists frequently justify the high costs of medicines by suggesting that they are necessary because companies must reinvest a portion of their profits into R & D to discover new drugs. After receiving several comments posted to BioJobBlog informing me that high drug prices are necessary in order for pharma companies to continue to meet unmet medical needs, I decided to delve a little deeper into what “addressing unmet medical needs” really means in the pharmaceutical industry. My personal favorite that seems to fit pharma’s interpretation of “addressing unmet medical needs” is the development of no fewer than 3 medications (Viagra®, Levitra® and Cialis®, with several more in clinical trials) to treat erectile dysfunction (ED). For those of you who don’t know, all three drugs have almost identical mechanisms of action. Who knew that so many men had this serious, potentially life-threatening medical condition? Don’t get me wrong–there are men that must take these drugs to …well…rise to the occasion. That said, pharmaceutical marketers realized early on, that this class of drugs could yield billions of dollars–not necessarily as ED treatments (the number of men who actually suffer from ED is relatively small) – but as recreational drugs to enhance male sexual performance. The booming sales figures for these drugs indicate that the pharmaceutical marketers were absolutely spot on in their thinking. Thanks to these pioneering medical marketers men all over the world no longer have to fret about dying or succumbing to the perils of ED.
Another class of medications that warrants mention is the statins. This class of drugs is routinely used to lower blood cholesterol levels to reduce the risk of hypertension, heart attack and stroke. At present, there are 9 statins on the market (with almost identical mechanisms of action) and 3 combination products either marketed or being developed. Everyone knows (or should know by now) that high cholesterol is not good for your health. That said, is the unmet medical need in the cholesterol control market so large that it requires 12 different medications to deal with it? Or maybe (and I am just guessing here) that every company that developed a “new” statin in recent years did so to grab a piece of the $10 billion per year Lipitor® market that Pfizer created?
Finally, Lilly and Daiichi Sankyo are developing a new antiplatelet drug called prasugrel to treat thrombosis and related clotting disorders. Business analysts are extremely high on prasugrel and estimate that if approved, the drug could yield over $1.2 billion per year in sales. Prasugrel is touted to be more potent than Plavix®, the leading anti-clotting drug marketed by Sanofi-Aventis and Bristol-Myers Squibb. Not surprisingly, both clopidogrel (Plavix®) and prasugrel work in almost exactly the same way to prevent clotting (as their generic names indicate). However, in early clinical studies prasugrel caused 4 times as much uncontrolled bleeding than Plavix®. So, why are Lilly and Daiichi Sankyo willing to continue to spend billions of dollars to develop another clopidogrel-like molecule? Unfortunately, the answer is relatively simple– Plavix® will lose patent protection in 2011 and Lilly/ Daiichi Sankyo are betting that they can snatch a share of $6.0 billion dollar Plavix® market that will be eroded by generic competition. Why develop a new medication with a different, untested mechanism of action when a market for similar products has already been created for you by your competitors?
Paradoxically, pharmaceutical companies used to the most innovative companies in the world. However, in the past 20 years or so, pharmaceutical companies have jettisoned innovation in favor of a less risky “me too” approach to business. Simply put, it is less risky to develop drugs that work like previously approved drugs (and already have large established markets) than it is to invest larges sums of money to develop new unproven drugs that may actually address unmet medical needs. It is a good thing that the biotechnology industry came along when it did……!
Until next time…
Good Luck and Good Job Hunting!!!!!!!!!!!!
