Published in the Wall Street Journal, February 7, 2014
Super Bowl Against Cancer Needs Rules, Referees, Too
Dr. John C. Lechleiter really demonstrates a striking misunderstanding of football as he tries to draw analogies between winning the Super Bowl and winning the fight against cancer, “How to Win the Super Bowl Against Cancer” (op-ed, Feb. 4). First, cancer drug development like football has rules – rules that are blessedly established before the game begins. His allegation that, “…arbitrary expectations are increasingly being used to evaluate biopharmaceutical innovation against cancer.” means that he doesn’t like the rules. One need not get too much further into the article before he states, “First, it is almost impossible to predict the ultimate value of new treatments before they have been used widely in the actual practice of medicine”. I guess that Dr. Lechleiter doesn’t believe in clinical trials – trials which are the fundamental goal scoring mechanism of drug discovery – to continue the football metaphor.
In football, you must cross the goal line to score – in drug approval, you must prove that a drug is both safe and effective. Increasingly, payers and patients are insisting that these new discoveries deliver value for the money – just like everything else that we buy. In oncology, the FDA plays two-hand touch on defense – the standards are very low relative to all other fields of drug and device approvals. As an example, Eli Lilly has only three drugs cancer drugs on the market, Alimta, the most recent was initially approved for sale in 2009. The drug is approved for use against non-small cell lung cancer and mesothelioma, and was initially shown to extend life by up to 2.9 months, at a price reported to run as high as $300,000. While this may sound like a lot of money for exceedingly little benefit, consider that Lilly’s own Pronounce Trial concluded in June of last year, “The study did not achieve its primary superiority endpoint of improved progression-free survival without grade four adverse events (G4PFS)”.
Dr. Lechleiter goes on to assert, “Achieving better outcomes for more cancer patients more quickly is the best, and may be the only, way to increase the value of cancer care and make its costs more manageable.” This statement is as disingenuous as having Mick Jagger sing our National Anthem at halftime. How much better outcomes and at what price? If every month or two of extended life comes at a price of toxicity and $300,000, then all is lost.
The truth of the matter is that the Super Bowl has an extremely rigorous selection process to get into the game. Conversely, the FDA takes all comers with the money to play. The real question regarding drug discovery for cancer care is, if there really were a Super Bowl for cancer drug discovery – whose team would be on the field?
Wes Chapman, Nashville, Tennessee