Bad Week for Vertex Pharma

Bad Week for Vertex Pharma

May 31st, 2012 // 3:00 pm @


This is not a good week for the executive team at Vertex Pharmaceuticals. Two days ago, the drugmaker revised previously announced interim results of a Phase II study of a combination cystic fibrosis treatment, taking the wind out of its once hot stock and tarnishing its credibility (see here). Now, the FDA has issued a so-called untitled letter for a promotional push for its Incivek hepatitis C treatment for including misleading material.

In the scheme of things, such a letter is an embarrassing slap, but may not have repercussions, unless a pattern develops. Taken together, though, these developments may underscore a growing concern that the Vertex team may have gotten sloppy or, perhaps, a little too far ahead of themselves. The study gaffe was blamed on a contract research organization, for instance. Several Vertex execs, meanwhile, sold bundles of stock after the positive study results were disclosed three weeks ago and the stock began rising 73 percent, as The Boston Globe noted.

Among the execs who sold Vertex shares was Nancy Wysenski, executive vp and chief commercial officer; Peter Mueller, executive vp of global R&D; Amit Sachdev, senior vp of corporate affairs and public policy; Paul Silva, senior vp and corporate controller; Lisa Kelly-Croswell, senior vp of human resources; and founder Josh Boger, who is also a director. A Vertex spokesman writes us to say most stock sales were due to pre-existing plans in which options are exercised automatically or sell shares at regular intervals or specific prices. Some sales were triggered when the stock hit a certain price. He declined to be more specific.

As for the letter, the FDA chastised the drugmaker for submitting a patient story that failed to match reality, at least as far as the agency is concerned. The proposed Vertex patient talk features “James M.,” a real guy who never quite says how he contracted hepatitis C, but portrays himself as an average sort who kicked around for awhile, had a good time and wound up with a diagnosis, a divorce and a four-year-old son to raise all around the same time (that’s James M. in the picture).

Worried and confused, he discusses how Incivek cleared the virus in six months. “Now that treatment is over and I’m cleared, I can take my son to the batting cage. We go sailing on my boat and take nice vacations. I even retired from the railroad and started a successful cab business, which I really enjoy. I’m loving life,” he says. “But more than that, I’ve found a new purpose” (you can read his ‘story’ here).

However, the FDA says Vertex went too far. The ad “misleadingly implies that most or all cirrhotic prior null responders (those who did not previously respond to treatment) who are infected with hepatitis C will successfully achieve Sustained Virologic Response (SVR) on Incivek combination therapy. FDA is not aware of substantial evidence or substantial clinical experience to support this implication. One patient’s treatment response does not constitute substantial evidence,” the agency writes in its May 25 letter.

The FDA continues by noting that the claims in the ad “also misleadingly overstate the efficacy of Incivek by suggesting that the usual outcome of treatment with Incivek is a positive effect on a patient’s interpersonal relationships, physical functioning, work productivity, and overall quality of life. FDA is not aware of substantial evidence or substantial clinical experience to support such effects of Incivek treatment for patients.”

There is more. The agency harps on the use of the word ‘cleared’ to describe the happy ending. “The claims of ‘cleared’… also omit important material information regarding treatment success in clinical trials. Specifically, the term ‘cleared’ misleadingly implies removal of HCV from the body, when this is not the case,” the agency writes. And the FDA lashes out for downplaying rashes as a side effect – ‘this was nothing,’ James said – when Incivek has been associated with serious skin reactions, including Stevens-Johnson Syndrome, that require a trip to the hospital Here is the FDA letter.

Of course, you will not be surprised to learn that the James M. story was not told exactly in his own words. In any event, a pair of Vertex spokespeople – yes, two for the price of one phone call – tells us that the story had not yet been delivered to hepatitis C patients and will now be revised. “We take the FDA feedback very seriously, we are evaluating the materials and are not moving forward until we’ve addressed the concerns,” one of spokespeople says. Whether the Vertex team experiences the same happy ending as James M., however, remains to be seen.

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