The Light-LaMattina Debate: The Double-edged Sword of Big Pharma

Sombit Mishra

Drug discovery process is a double-edged swordThere's been a recent firestorm over Donald Light's paper titled Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.  Light's conclusion is that over 90% of newer drugs offer minimal or no additional clinical benefit over existing drugs. 

Interestingly, the most recent criticism of Light's paper comes from former president of Pfizer's Global Research John LaMattina, who shares examples of drugs that have fundamentally improved the treatment of AIDS, breast cancer, cardiovascular disease, gastric resections, depression and more. He contrasts the efficacy of these drugs vs. those available up until 1980. 

I'm not going to suggest that there is a winner here, as there are merits to both sides, but the debate does raise some interesting questions facing the future of pharma, namely whether pharma companies will choose to pursue development of more generics and forsake development of blockbuster drugs. 

Importantly, a number of blockbuster drugs are coming off patent within the next four years: Prevacid  (>$3.9 billion in sales), Singulair ($4.3 billion), Enbrel, Plavix ($8.1 billion), and Lipitor ($13.7 billion) [Source: Center for Study of Drug Development, Tufts University].  As pharma companies have acknowledged, these drugs are the bread and butter of their businesses.  They are responsible for their record profits over the past two decades.

At the same time, there are numerous challenges to developing blockbuster drugs vs. generics.

1) As the CSDD paper points out, the high failure rate of blockbuster drug discovery has caused costs of prescription drugs to skyrocket.  After all, higher prices are the only way to subsidize this type of inherently risky R&D.   This suggests that, at least from a cost perspective, developing incremental improvements and generics may bring down the cost of care in the short-term.  On the other hand, the therapeutic significance of incremental drugs are questionable in numerous cases.

2) The FDA is shying away from blockbuster drug discovery, making it even more risky for pharma companies to pursue new molecular entities (NMEs) that are high-risk, high reward.

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The double-edged sword of Big Pharma is that generics and incremental improvements often add uncertain clinical value over existing drugs, while blockbuster drugs are prohibitively expensive to produce and ultimately make healthcare more unaffordable for the most at-risk consumers.  Even though generics may bring down cost in the short-term, the long-term concern in drug discovery is that therapeutic significance/impact of NMEs will continue to decline.  

In the world of health IT, the answer to uncertainty in drug discovery should be to take the monetary emphasis off of new drugs and place it on care delivery, medication adherence, and prevention.