Study of 2 drugs places spotlight on Genentech
Maker of both eye treatments says it won't be swayed
WASHINGTON - What does a company do when there's anecdotal evidence two of its drugs are equally effective in treating a leading cause of blindness in the elderly - one costing patients $60 per treatment and the other $2,000?
In the case of Genentech Inc., nothing.
The company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration. Nor would it help finance a National Eye Institute study comparing the effectiveness and safety of Avastin, a cancer drug, and the more expensive eye drug, Lucentis.
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."
Genentech routinely provides financial support for clinical trials, Pellegrino said in an interview. But in this case, she said, "Our resources would be better spent looking at other diseases where there are no treatments."
Dr. Philip Rosenfeld, who has treated hundreds of his eye patients in South Florida with Avastin, said Genentech had little economic incentive to help finance the trial - unless it was confident Lucentis was truly superior.
"By the fact that they didn't support the clinical study leads me to conclude that in reality there is no difference between the two drugs," Rosenfeld said. As lawmakers await the results of the trial, they are already considering what steps, if any, could be taken to steer the Medicare program to the less costly drug.
An internal memorandum from congressional aides to the Senate Aging Committee's chairman, Herb Kohl, Democrat of Wisconsin, recommends that lawmakers consider urging Medicare officials to pay no more for one drug than the other when it comes to treating the eye disease.
Medicare's contractors already have authority to pay the same amount for items that achieve much the same result - such as hormones used to treat prostate cancer.
If the drugs are shown to work comparably, "it would surprise me if the contractors did not quickly use that concept," said Dr. Steve Phurrough, director of coverage and analysis at the Centers for Medicare and Medicaid Services.