Sometimes, having too much of a good thing can be a problem. Consider the famed Genentech unit now owned by Roche. The biotech has two — count ’em, two — biologics that are used to treat wet aged-related macular degeneration, a malady that afflicts many elderly people. One medication is Lucentis, which was approved by the FDA specifically for this purpose. The other is Avastin, an older cancer med that was not approved for this use but is relied upon by many ophthalmologists anyway.

Here’s the rub: Avastin costs around $50 for a wet AMD treatment, while Lucentis is a pricey $2,000 or so. And this is a big issue. A study publicized last year found that, in 2008, Medicare covered 480,000 Avastin injections and 337,000 Lucentis injections to treat wet AMD, but paid only $20 million for Avastin and $537 million for Lucentis. Consequently, a Senate committee voiced outrage and the National Institutes of Health began a head-to-head study.

For the past few years, Genentech has, not surprisingly, been fighting to ensure that Lucentis is the drug of choice for wet AMD, in order to bolster revenue. But its efforts have not always been so pretty. Last year, the biotech offered retinal specialists a confidential rebate for using Lucentis. At the time, Genentech maintained the rebates might have convinced physicians to use Lucentis for treating a newly approved indication, retinal vein occlusion. But others called it bribery that may unduly influence patient care.

Also, three years ago, Genentech restricted Avastin distribution to compounding pharmacies, which had been repackaging and selling the drug to ophthalmologists.
The biotech subsequently struck a deal to resume distribution, but not before blaming an FDA inspection of a manufacturing facility for the restrictions, a confusing step that engendered finger pointing about the extent of a manufacturing problem the agency uncovered and how this would have affected use of Avastin.

A few weeks ago, though, Genentech caused a much bigger ruckus with a lobbying trip to Capitol Hill. Just days before the NIH was set to release its study results — which indicated Avastin and Lucentis were about equally effective in treating wet AMD — the biotech visited select Congressional and Medicare staffers to brief them on the results of its own, separate study showing that risks with Avastin were slightly higher than with Lucentis.

What were those risks? The Genentech study found that AMD patients given Avastin had an 11% higher risk of dying. Genentech, of course, hopes such an outcome will alter the debate on Capitol Hill about the merits of using Avastin off-label to treat wet AMD. Consider, however, the absolute risk: If Lucentis patients face a 1% chance of death, then Avastin patients face a 1.11% risk. Of course, a higher risk is a higher risk, and the findings may prompt some to question the wisdom of off-label Avastin use. Still, when looked at this way, the difference does not seem nearly as disturbing. 

In other words, Genentech knocked one of its own drugs in order to bolster another.
Such a scenario is not especially unusual, though, in an industry where a new formulation of an existing drug is given preference over the older model. But what stirred controversy were the circumstances in which the lobbying occurred: Genentech was touting its study prior to an embargo that was scheduled to lift a few days later, when the Association for Research in Vision and Ophthalmology was to hold a conference. And Genentech staff had the lead researcher on their study accompany them on the Hill.

Of course, Genentech needed to do advance work. Knowing the NIH study was also about to become public, the biotech felt little choice but to do its best to persuade Senate and CMS staffers that the government-funded study was not the last word on the debate.  And the biotech does own the data in the study that was to have been presented at ARVO. So Genentech was within its rights to use the material as seen fit. Moreover, lobbying is also part of the give and take on the Hill.

In doing so, however, Genentech effectively broke an embargo by selectively touting results before an agreed-upon disclosure. By attempting to tell its side of the story prematurely, Genentech tried to game the system. Senate and CMS staffers should want to know the results, but the full implications of the study could not be known until results were disseminated and experts in the field, for instance, had a chance to review both the NIH and Genentech trial data for a fuller understanding.

Moreover, it is not typical for researchers to discuss unpublished work, even if the discussions occur just a few days before official disclosure or publication.
Nonetheless, Emily Gower of Johns Hopkins University, who was the lead author on the Genentech study, was encouraged to do most of the talking on the Hill, according to sources. In her view, she was reportedly just explaining the data, but she allowed herself to give the impression that she was part of a lobbying team.

The episode embarrassed Johns Hopkins, where some of her fellow faculty members were upset that she allowed Genentech to place her in such a position. Dr. Gower later told a reporter that her trip was an “error in judgment,” but that she was not paid for her time. In other words, she denied acting as just another member of the Genentech payroll. Nonetheless, a university spokesman says her participation is being reviewed, although whether she will face any action remains unclear, at least for the moment. 

For its part, ARVO took no action. The organization only considers an embargo to be broken officially when study results or an abstract are given to the media prior to presentation.  Ironically, the news of the lobbying trip leaked to the media, which then ran reports about the Genentech data and the conclusions prior to the formal presentation. Of course, no one could have known the results would leak. Then again, this was a Capitol Hill lobbying trip. But since Genentech owns the data, ARVO blinked.

When journalists break embargoes, medical journals or organizations sometimes restrict future access to studies. Allowing a double standard to be set is a bad precedent. Genentech, no doubt, will argue its first responsibility is to its shareholders and, therefore, taking the necessary steps to ensure Lucentis is the first choice for treating wet AMD is its highest priority. The biotech, after all, is permitted to fight like hell to grow its business and deliver its message, so long as the law isn’t broken.

Still, there is another issue in play. And this is the integrity of the presentation process for scientific data. Either an embargo is respected or not. There should not be any exceptions. The ARVO annual meeting program committee should have warned Genentech that disseminating the data — even though it was done so privately — was the wrong thing to do. Some may argue there was little to be gained by picking a fight after the fact; the deed was done. But by looking the other way, ARVO helped to undermine its own purposes.

As for Genentech, the biotech hoped to raised doubt in the minds of some Senate and CMS staffers about the results of the NIH study. That was the reason its own study was undertaken — to serve as a counterpoint to the NIH. Genentech has long claimed that off-label Avastin use for treating wet AMD is riskier business than using Lucentis. What better time and place to make that case? Making that first impression on the Hill — before the NIH study came out — was seen as paramount.  

Yet Genentech touts that its mission is to make good on the promise of biotechnology to manufacture and sell medicines to treat patients with serious or life-threatening medical conditions, according to its web site. At the end of the day, after all, drug makers are most successful when they deliver the best treatments. But scientific protocol calls for rounding up the best possible evidence to determine the best treatments, and protocol should include releasing the evidence in a way that allows everyone to absorb the details and digest the implications.

There is nothing surprising about the Genentech decision to make its lobbying trip. And while first impressions can make a difference, it is unlikely that any Senate or CMS staffers were going to make decisions based on a review of the Genentech data from the Johns Hopkins researcher without waiting to receive and understand the NIH study results. By selectively touting its results, Genentech not only helped undermined the presentation process, but its own credibility. Lobbying may be good for shareholders, but it may not always be the right choice for patients. 

Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor’s Business Daily. Ed blogs about the drug industry at Pharmalot, at www.pharmalot.com. He can be reached at [email protected].