News Article

An apology to Medarex CEO Howard Pien, 7 years in the making
Date: Oct 24, 2016
Author: Jim Edwards
Source: Business Insider ( click here to go to the source)

Featured firm in this article: Medarex Inc of Princeton, NJ

Seven years ago, when I was a reporter covering the pharmaceutical industry for, I became interested in a small company called Medarex. The company caught my eye because it was developing a drug for prostate cancer called ipilimumab. During the drug's R&D stage, the Mayo Clinic put out a press release from the researchers working on the drug -- who were funded by Medarex -- saying the drug had cured three men of inoperable prostate cancers. The release called ipilimumab the "Holy Grail" of cancer drugs.

This was a dumb thing for the researchers to do.

The clinical trial wasn't finished, the data wasn't peer-reviewed, and the release contained no stats that could be analysed for clinical significance. It was the equivalent of announcing that you'd discovered three people aged 110 who all smoked every day, and that therefore cigarettes were the cure for cancer. Normally, drug companies are very careful about the data they publish about their drugs. They want it to stand up to scientific scrutiny, and they want the FDA to respect that science when they ask for approval to sell the drug. They certainly don't invest their drugs with allusions to religious miracles.

The Medarex release flew in the face of all that.

In addition, Medarex CEO Howard Pien was richly compensated for his work at the company, even when that work didn't go well. At one point he was paid $5 million per year. He took a pay rise one year after his company's revenues and profits went down.

All this struck me as very odd, and so I twice wrote that if Pien ever got ipilimumab approved by the FDA I would write him a note of apology.

Time passed. I left CBS, stopped writing about pharma, and came to work at Business Insider. I forgot all about ipilimumab and Howard Pien. Medarex was acquired by Bristol-Myers Squibb.

But the FDA did indeed approve ipilimumab, in 2011. I knew this, and yet I forgot to make good on my note.

This weekend, some folks on Twitter reminded me of my old promise to apologise to Pien. So here it is:

I was wrong about ipilimumab. I apologise.

I should have written this years ago and I don't know why I did not. Better late than never, hopefully.

My apology comes with a small caveat, which is that ipilimumab (or Yervoy, as it has been branded) was not approved for prostate cancer. Instead, it has been approved for melanoma skin cancer. In fact, a recent trial showed that ipilimumab does not improve the overall survival rate of men with prostate cancer. (That's a problem, because the drug costs $120,000 a year to use.) And I still believe that Mayo Clinic "Holy Grail" press release was wildly irresponsible.

Nonetheless, it bugged me that I criticised Pien and Medarex and never went back to set the record straight. The drug came good in the end, and since it was acquired by Bristol-Myers Squibb it has twice notched more than $1 billion in annual sales.