The financial stakes stemming from the study are huge. Medicare officials estimate there could be 50,000 or more new cases of macular degeneration a year: Treating just one year's worth of new patients with Lucentis would cost $1.2 billion, vs. $60 million with Avastin.
Genentech is making no promises that it will act upon the trial's final results, which are expected in two to three years. The company has raised concerns that safety issues were not properly addressed.
"No matter the outcome, we continue to believe Lucentis is the most appropriate treatment for wet AMD," said Krysta Pellegrino, a company spokeswoman.
Companies routinely help finance clinical trials, but such trials almost never pit two products from the same company against each other.
"It's a very unusual situation where a company would be trying to compare its own drugs," said Dr. Frederick Ferris, director of clinical research at the National Eye Institute. "I'm not sure usual situations are all that relevant in this particular case."
Still, health officials pleaded with Genentech to participate in the clinical trial comparing the two drugs. At one point the company considered doing so by providing the medicines in masked, identical vials, according to e-mail exchanges obtained by the Senate Aging Committee.
"Good news is that the Board supports the proposed studies," said one e-mail sent in June 2007 from Charlie Johnson, a company vice president, to Dr. Daniel Martin, the chairman of the study who works at the Emory University School of Medicine.
In the end, the board did not support the study. Martin made a final plea.
"The fact that we are comparing your drugs and you are not involved is very awkward and can easily give way to anti-Genentech sentiments," Martin said. "The leaders of this study are only interested in answering the many scientific and patient management questions that we face with our patients every day, but some investigators and the press want this study to be more than that. Your involvement would be very helpful to both of our causes."
