Roche, The Professor And Washington Lobbying
21 CommentsBy Ed Silverman // April 29th, 2011 // 9:29 am
Earlier this week, the long-awaited results of a head-to-head trial comparing two different drugs marketed by Roche’s Genentech unit were leaked. The upshot? The older Avastin cancer med is about as effective as Lucentis in treating a form of age-related macular degeneration. The significance? Avastin is not approved to treat the eye afflication, but is widely used off-label and costs up to $50 injection. Lucentis is approved to treat AMD, but costs an eye-popping $2,000 for an injection.
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 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As the paper notes, it is not typical for researchers to discuss unpublished research.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?
Should Johns Hopkins Take Action Against Its Researcher?
- No (87%, 332 Votes)
- Yes (13%, 48 Votes)
Total Voters: 380
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Paul
Ed, can’t believe how biased you’re becoming. Have you not heard of freedom of speech? There is nothing illegal, I think, in this. Can’t imagine Roche or any other company sitting doing nothing, which is what you hope and suggest.
From what I see, there are many confounding issues with this trial and a discussion with all sides having a say is the best way of resolving. You can’t claim to definitively know one side is right and the other wrong simply because the latter came from a Pharma company.
Let’s have a debate on the merits of the scientific data not on the basis of name calling. Also, how come it’s “questionable” to fo an analysis of real life Medicare data that shows a significantly different risk of side effects? This is find often and, in fact in the past you have made many claims and arguments yourself based on this kind of data.
Sounds like Genentech or Roche made major scientific advances with these drugs, don’t they deserve a voice in the debate?
Jake
Um, what the he’ll is the diff between “informing” and “lobbying”?
Jake
Paul, you’re so right. Nothing wrong with an academic being used by a large corporation as a lobbyist.
ed silverman
Hi Paul and Jake,
Thanks for the remarks. However, I posed a question because I realize there will be differing views about this episode, which is also why I offered a reader’s poll.
That said, if you will notice, I made a point of noting that lobbying is very much a permissable activity. The Roche team is free to lobby and discuss what it chooses in those sessions.
However, the issue I raised was not about the lobbying, but about timing. The data was to be presented at ARVO next week and also published by The New England Journal of Medicine at that time. In the interest of the integrity of the results, the Roche (or Genentech) team and Gower should have honored this. I’m not sure how selective and premature disclosure behind closed doors furthers a public debate.
As for the use of the word ‘questionable,’ I was referring to the way Roche presented the risk data in the abstract that is available on the ARVO site (as well as the aforementioned timing of the lobbying), not the fact that Roche scoured Medicare records in order to conduct the study.
Moreover, I did not engage in name calling. I attempted to point out issues that, I believe, merit further consideration. Please go back and read what I wrote carefully.
I hope this helps,
ed
Zach Barnes
How do you define lobbying? Were you there? I imagine not, so this article and many others are pure speculation. As a scientist, with the training and background of a scientist, I’m sure Dr. Gower has no interest in either acting as or becoming a lobbyist. In the business world it is common practice to bring a technical expert to a discussion to support findings and answer detailed questions.
You should also ask yourself, if the goal of the trip was to inform the government about the results of the trial when there could be a large impact to Medicare - is that a bad thing?
When we have such problems with Medicare already, should the government be blindsided with the results of the study when it is released at ARVO? Or do they have a right and a vested interest to prepare & formulate a position and understand its impact?
What is the purpose of your poll, anyway? Public opinion is by no means a contributor to the outcome of this is overblown ‘problem’
ed silverman
Hi Zach,
Thanks for your note. But either you missed the point or did not see my earlier comment.
The issue I raised has to do with timing. So as not to repeat myself, please see my comment above.
Regards
ed
Zach Barnes
It seems you too have missed my point. Perhaps I asked too many questions that you’re not interested in answering.
Allow me to be more direct: If there is a potential large impact of the outcome of a study like this to Medicare do you think the government has a right to be given a heads up before the general public?
ed silverman
Hi Zach,
To answer your question, this constituted premature and selective disclosure. Would offering an early glimpse to select investors be considered fair play?
I agree it’s a matter of public importance, but, to use the old cliche, there is a time and place for everything. After the results are disclosed publicly would have been a more appropriate approach.
Regards
ed
Zach Barnes
Ed - you still didn’t answer my question, is it not clear? (that one was intended to be rhetorical). In this specific case, which has the potential to have a large impact on Medicare if doctors chose to prescribe Lucentis over Avastin, does the government have a right to know before the results are made public?
This constituted disclosure to the Government, who has a vested PUBLIC interest, not to investors (which would have constituted insider trading). It’s absurd that you would make such a correlation.
Insider
THe study appears to be off label for one of the products so I would think talking about the results would be illegal. I don’t see how you present the results that are off label at a program if you are supported by the manufacturer?
ed silverman
Hi Zach,
Yes, I did answer you. The study results should be disclosed only at the designated time and place. Anything else is premature and selective, regardless of the audience - public or private, large or small.
After that, the government - which represents the public - has the right to review, inquire and, if need be, debate.
I hope this is clear.
Regards
ed
Zach Barnes
Thanks, Ed. Your position is clear, however I disagree with you.
I believe that because of the impact to Medicare in this specific case the Government should be allowed access to the results such that they can prepare a position on the matter. I am not alone in this belief.
This isn’t the first time or market segment to which the Government has had early access to information that has could have a direct impact on a public program such as Medicare. You are deluding yourself if you believe otherwise.
This whole thing is blown out of proportion.
ed silverman
Hi Zach,
I don’t mind that you disagree. I already explained my reasoning.
In any event, I don’t believe Medicare officials are or were being denied an opportunity to review the results and prepare a position.
Nor is Medicare being placed at a disadvantage by having to wait for the presentation and distribution of the results.
In fact, Medicare officials may find value in waiting in order to confer with others - experts in the field, perhaps - who would not learn the results until these are made public.
In that way, Medicare may develop a fuller understanding of all aspects of the matter, rather than formulate a position before the results are widely and properly disseminated.
In fact, the results may have been available still earlier, but Gower visited Washington this week only because Genentech asked her to do so. And that was in Genentech’s interest first and foremost.
But as you say, you disagree. So it is time to move on. Have a nice weekend.
ed
Paul
Sorry Ed, but your point on timing is not valid.
1) The cat (pun not intended) was out of the bag with all kinds of bits and pieces already out there and in the news
2) Roche could have waited and sat letting the misinformation spread or they could have acted right away to stop a snowball from becoming an avalanche
Timing is perfectly acceptable.
Also, although your point may have been “timing” focused, the whole rest of the article tried to point the finger at other items making it look like communication was one big impropriety.
ed silverman
Hi Paul,
The bits and pieces you refer to began leaking on Wednesday, the same day that the Genentech team was in DC. So in this case, it does not appear that Genentech sprung into action in response to the leaks or to prevent them.
And once again, the results were to have been presented at the ARVO conference - with a scheduled date. Timing is an issue. If Roche and Genentech want to lobby, they can do so after the results are out.
I appreciate your note and understand that you disagree.
Have a nice weekend
ed
Zach Barnes
Good job on your research, Ed, but the information started leaking out on this on April 4th, a month before ARVO when it was put on Dow Jones Newswire and published on a WSJ blog.
From the article:
ZURICH (Dow Jones)–A soon to be published analysis comparing Roche Holding AG’s (ROG.VX) cancer medicine Avastin and Novartis AG’s (NVS) eye drug Lucentis in treating an eye disease could fan health concerns over Avastin’s off-label use and thus avert a feared slide in Lucentis sales in the U.S.
According to extracts of an analysis of the Medicare patient claims database by the Johns Hopkins University, scheduled to be presented in early May at a meeting of the Association for Research in Vision and Ophthalmology, or ARVO, in Fort Lauderdale and which have been seen by Dow Jones Newswires, THE OFF-LABEL USE OF AVASTIN SHOWED A STATISTICALLY SIGNIFICANT INCREASED RISK FOR MORTALITY AND HEMORRHAGIC STROKE COMPARED TO LUCENTIS.
Michael
Right, Zach. The “leaks” started early April. That’s when genentech execs began passing it around, breaking the embargo to stave off the NIH study.
Their next step was to grab up Gower and start passing her around officeson the Hill, pissing off staffers so that they dimed her out to the Wall Street Journal.
Genentech’s behavior has been abysmal.
Michael
Here’s Gower getting owned on the Forbes blog.
http://blogs.forbes.com/davidwhelan/2011/04/29/genentech-once-known-for-innovation-is-pursuing-a-nexium-strategy-with-lucentis/
Zach Barnes
So, Michael, your goal is also to attack Dr. Gower? To what end, what do you get out of it? Why not shift the focus to the leak from ARVO and the fact that the story was published on Newswire that started this whole thing and also on Genentech? (since what they did was clearly so horrible)
It seems to me that the course of events has started with the ARVO leak and had a domino effect. Should the government rely on the information in the media to make decisions that affect policy? I sure as heck hope not. What if the only station they watched was Fox News?
None of the people writing the article or responding to the comments, including me, seems to have been privy to the conversations and reasons for the trip, which means it is all speculation and opinion based on a small number of facts. Thanks to the internet we get to suffer the opinion and speculation of a mass number of fools.
Has anyone considered that Dr. Gower was doing what she felt was in the best interest of the project and the Medicare program?
pharma gal
As they say, if you cannot convice them confuse them. And wth the mixture of academic etiquette rules, research methodology confusion, esoteric safety differences between treatments,etc confusion is easy to achieve. Bottom line doctors have done AMD off-label Avantis for a long time and it works. And comparing the Gower Medicare study with a head to head comparison is comparing apples and oranges. With the financial health of Medicare and the huge cost differential between off label Avastin and Lucentis there is no harm to at least have Medicare pay for off-label Avastin as first line therapy and maybe seek a subgroup of patients that would be at risk or harmed by the use of Avastin and approve Lucentis for that subgroup.
I know, this creates a double standard where Medicare ‘likes’ off-label use when it lowers the cost of health care but then uses off-label as a tool to deny payment where such use albeit safe and effective would drive up the cost of care.
ed silverman
Hi Zach,
I did not see the April 4 Dow Jones item, unfortunately. Although I notice the dispatch did not have the same level of detail that leaked out last Wednesday, only bottom line surmising. In any event, that does not change my explanation.
Again, there was a scheduled date for the release of the data. And again, Medicare officials are not put at a disadvantage by waiting for the official release and then pursuing whatever further review and analysis is required.
As to the reason for the DC trip to Washington, the purpose was explain the Hopkins study results to Senate and Medicare folks. Gower was there at the behest of Roche and Genentech. What do you think was the reason for this excursion?
As for Gower, she may well have had altruistic motives. I do not know because she did not respond to my phone and email messages. But the Johns Hopkins spokesman indicated the episode is going to be reviewed since there appears to be concern that she allowed herself to be perceived as taking part in a lobbying effort. What, if anything, the university might do, of course, remains to be seen.
Have a nice weekend,
ed