Pharmagossip recently highlighted a new study by Prof. Donald Light of UMDNJ which states that “new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs.”
That’s a bold claim. Is it true?
I’ve relied on Light as a source in the past and found his arguments to be powerful. However, he also tends to overstate his case. Here’s an old story about his criticisms of the Gates Foundation effort to cure malaria. He’s yet to be proven right or wrong, but almost no one has taken up his position that the effort is misguided.
So I decided to look through Light’s PowerPoint presentation on his data. (Does absolutely everything have to be in PPT? Please?) There appears to be some statistical wiggle room, to say the least.
Look at slide 2, where he notes that the FDA recorded 32,000 cardiac events related to Vioxx. (Side thought: see here for a brief critique of why relying on FDA adverse event reports isn’t the wisest thing).
Then, on slide 3, we find that according to Light’s calculations cardiac events have jumped to 1.9 million. That’s a big slippage. Either the FDA missed 98% of all cardiac events — despite most people thinking that the FDA tends to overstate adverse events — or this number is wrong.
Put another way, if you took Vioxx, the odds of experiencing a cardiac event were either 5% or 0.09%, depending on whether you go with the Light or the FDA, respectively.
Knowing Prof. Light, I’m about to receive a lengthy email that will require several writethrus of this post.
Let me just say this: Most people think Michael Moore is the biggest threat to Big Pharma. They’re wrong. It’s probably Light. Unlike his bearded colleague, Light actually musters the stats in favor of his points. One of these days he’s going to do some damage with them …