Pfizer drug facing FDA pushback on possible more-aggressive marketer role

By Christy Gutowski What began as a provocative presentation to an FDA advisory panel on Wednesday night has now turned into a furious public debate that has pitted proponents of expanding the use of Pfizer …

By Christy Gutowski

What began as a provocative presentation to an FDA advisory panel on Wednesday night has now turned into a furious public debate that has pitted proponents of expanding the use of Pfizer Inc.’s experimental drug against critics who worry that rheumatoid arthritis sufferers are already undertreated and be diluted by what they call an overly optimistic view of Pfizer’s.

The panel, consisting of more than 20 physicians and researchers, spent more than six hours hearing from Pfizer and its leading opponent: the Arthritis Foundation, a nonprofit group that bills itself as a leader in arthritis research and advocacy.

When the panel agreed unanimously at the end of the night that rheumatoid arthritis patients should not be tested in patients younger than 65, the conversation switched into hyperdrive.

Based on data they presented, Pfizer is pitching to expand the use of tafamidis, an experimental drug, to the wider rheumatoid arthritis patient population. After dozens of other drug companies failed to make a mark with rheumatoid arthritis, the FDA in 2013 approved biologic drugs — extremely potent treatments that are taken in pill form — after these companies had showed better results in clinical trials in smaller patient populations.

But activists, including those representing patients on the panel, questioned Pfizer’s optimistic view of how older patients — many of whom are Tofranil patients — could benefit most from the drug.

“If this disease is so hard to treat, why does the drug need to work harder and faster?” asked Dr. Barbara Stafford, chair of rheumatology and immunology at Wake Forest Baptist Medical Center, one of the panelists.

If approved, tafamidis would be the first biologic in treatment to be tested to show efficacy in a patient population that falls outside the guidelines for the FDA’s working medicine (RM) program, according to Pfizer. A working medicine program monitors safety and efficacy of clinical trials and FDA approval.

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