The results, which are now available in The New England Journal of Medicine (read the abstract), placed Roche in a tight spot. The drugmaker is in the unenviable position of having to justify the cost of one of its drug that generates a significant revenue, but is not proven to be any more effective than another of its own treatments, which is much cheaper and so many doctors are comfortable using despite a lack of FDA approval. The price disparity is a budget problem for Medicare and is what prompted the National Institutes of Health to run the trial (back story).
To crawl out of this dilemma, however, Roche engaged in some questionable conduct. For one, the drugmaker funded its own study (look here) that reviewed 78,000 Medicare recipients with AMD showing those given Avastin had an 11 percent higher risk of dying. As one loyal reader point out, however, the absolute risk of such an unpleasant outcome was not enunciated. But if Lucentis patients face a 1 percent chance of death, then Avastin patients face a 1.11 percent risk, a difference that does not seem quite as horrifying. And even though Avastin is approved to treat several cancers - which, of course, can be fatal - the emphasis placed on a higher risk of death raises the wisdom of playing up this angle. Maybe Avastin is not so safe?
Moreover, the Genentech unit took the results on a lobbying trip to Washington DC, according to The Wall Street Journal. And not only did Genentech execs meet with key Senate committee staffers Tuesday about the safety and efficacy of the two drugs, but the lead researcher - Emily Gower of Johns Hopkins University - was there, as well. And Gower also met with a Medicare official.
As the paper notes, it is not typical for researchers to discuss unpublished research. In fact, the paper writes that a spokeswoman for the Association for Research in Vision and Ophthalmology, where Gower is scheduled to present the results of her study next week, hasn’t allowed Gower to speak journalists before the presentation. Gower could not be reached for comment and Genentech tells the paper that the DC trip was all about “scientific conversations,” not lobbying. Really?
A Johns Hopkins spokesman, meanwhile, tells us this: “She was not lobbying. That would be a gross mischaracterization. She was asked to inform select people, staffers on the Hill, regarding her specific research issues. I think she naively overlooked the role of Genentech lobbying in this effort. She was certainly not there in the interest of the company. She was there in the interest of the science. It was an error of judgment on her part. She was naive in how this whole thing was handled, frankly. But she was not there as a lobbyist for Genentech or for Roche. I assure you that was not her intent.”
What, if anything, will Johns Hopkins do? “I don’t think we formulated a positon on that yet,” says spokesman Gary Stephenson, who adds Gower was not paid for her time. “We certainly are looking into it and I promise you that it will be the subject of a thorough review.”
Genentech is known for aggressive lobbying, and lobbying is, of course, a permissable activity. But the folks at the Roche biotech unit should have known better than to selectively tout results of a study before an agreed-upon disclosure. As for ARVO, a spokeswoman tells us she does not know whether the annual meeting program committee will review the breach. As an aside, when journalists violate an embargo, they are routinely banished from receiving material from the miffed publication or organization. As for Gower, Genentech may have taken advantage, but she also should have known better, given the reasons for the study and what is at stake.
What do you think?
We all know the feeling: Once you’ve hit “send,” an email can’t be taken back. That’s why lawyers love them, and that’s why so many disastrous internal emails end up being turned into lawsuits that cost drug companies millions. From faking safety data to covering up crimes to discriminating against pregnant women, drug company executives have done it all. Here’s a look at 10 emails that the senders wish had never been written. You can click to enlarge any image.
Pfizer’s illegal painkiller sales team christen themselves “The Highlanders.” (A Pfizer sales team leader)
J&J buys a “black hole” that doesn’t pass the “smell test”
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