Wednesday, July 13, 2011

The Sky Is Falling--What if New Drugs Actually Had to Add Value?

John C. Lechleiter, CEO of Eli Lilly, warns us in a Wall Street Journal op-ed (subscription required) of a truly terrible fate that might befall the U.S., if only American policymakers are so misguided as to follow the example now being set in Germany.

And just what are those terrible Germans doing? I hope you're sitting down when you hear this. They seem to have an effective system in place to require that new drugs do something of value before they'll pay for them.

According to Mr. Lechleiter, you can kiss drug innovation goodbye if this thing were to happen in the US. The scenario that he depicts is a bit hard to follow but let me see if I can hit the high points. First, he makes a claim that most regular readers of this blog will find hard to swallow--"Contrary to myth, so-called blockbuster medicines are not the result of slick marketing campaigns but of demonstrated success in the actual practice of medicine." For a different perspective see: But for now, let that pass. The next step in the reasoning is that a drug may be a really fine drug but you cannot tell that when the drug is first introduced; it is only with extended clinical experience that you can see how really fine it is. Now, this reasoning runs contrary to what John Ioannidis has cogently argued: (showing mathematical reasons why the early reports of a drug's efficacy almost always overestimate its benefits compared to later data). So now we come to Mr. Lechleiter's grand conclusion, which is that if we did what the Germans are doing, then promising and powerful new drugs will get nixed right out of the starting gate and will never show us their real potential.

So the reasoning about the future public being robbed of valuable drug advances turns out to rest on some pretty shaky premises. Plus Mr. Lechleither--as typically occurs with those who try to market drugs-- seems to focus solely on efficacy and to dismiss concerns about safety. I'm grateful to my colleague Don Light, author of The Risks of Prescription Drugs that's mentioned in one of the above posts, for recently calling my attention to some published work by Mary Olson on the relationship between quicker FDA approval and greater risk of later adverse reactions (which I may detail in a later post). Olson has actually calculated an increase in the hospitalization and death rates due to adverse drug reactions for each so many months that the FDA approval time is shortened.

In sum--Mr. Lechleiter is upset that a careful pre-marketing vetting of new drugs will stifle valuable innovation. This fear seems to ignore two things. First, if we demand that drugs prove their mettle first, and then agree to pay for them, it is unlikely that we'll keep very many useful new drugs off the market, but we can save a ton of money on not-very-useful drugs. Second, if we took longer before we allowed new drugs to be marketed, evidence available today suggests that the safety factor would be enhanced. It is quite possible (see Don Light's book) that more lives are lost today in the US due to adverse reactions to prescription drugs than are saved by truly lifesaving new drugs (which are reliably estimated to be a tiny fraction of all new drug approvals).

Now we come to what may seem a gratuitous ad hominem attack--but I am sorry, if somebody treats me as if he thinks I am a complete idiot, then I am likely to get my back up. Mr. Lechleiter spends most of his article decrying the terrible model provided by Germany and hoping that the US will never follow that lead. (Don't worry, Pharma is spending every lobbying buck they can lay their hands on to make dead sure of that.) Then at the end he has the nerve to say: "We share Berlin's goals of generating value and limiting unnecessary costs in health care. We see ways of harnessing and improving health-outcomes research."

Come again? You have just trashed Germany's system precisely because they do certain things, and apparently very effectively--and then you have the gall to tell us you share the same goals? And this is supposed to make the pharmaceutical industry trustworthy brokers in our eyes?

Lechleiter JC. An ObamaCare drug preview in Germany. Wall Street Journal, July8, 2011, A13.

1 comment:

Marilyn Mann said...

Of possible interest, according to this article Germany recently reviewed ezetimibe and did not find evidence that it offered additional benefit over a statin alone or even compared to placebo.

As you know, ezetimibe is a drug that was approved in 2002 based on its ability to lower LDL and to this day there is still no evidence that it lowers the risk of cardiovascular events. The sponsors delayed in starting an outcomes trial and that trial, called IMPROVE-IT, is still ongoing and will be for a couple of more years.