Daily News: Disease

Working together (yes!), Congress tries to speed medicine approvals

Tampa Tribune (FL)

08-07-14

Aug. 06--My Aunt Ruth was a remarkable lady, active and strong well into her retirement years. Even when she was diagnosed with Parkinson's disease, doctors told her not to worry. They told her it would take many years, if ever, before she would feel the full effects.

The doctors were wrong.

Her Parkinson's escalated rapidly, robbing her within two years of the ability to do even the simplest tasks. I could barely make out her voice over the phone when she would call, begging to know if I knew of anyone who could help.

Whatever medications she was being given were basically useless. She essentially was an invalid when she died.

Anyone who has been in that position with a loved one understands the helplessness you feel, and cures aren't coming nearly fast enough. According to medicinenet.com, getting a new drug from the drawing board to market takes an average of 12 years, even with all of the amazing research going on around the world.

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So consider that as we look inside the chambers of the House Energy and Commerce Committee. A bipartisan group that includes two local members of the U.S. House of Representatives -- Gus Bilirakis (Republican) and Kathy Castor (Democrat) -- is giving the public a rare respite from the normal bickering that goes on in Washington.

Instead of tearing apart members of the opposing party, your elected representatives are working together to see if they can get new treatments approved and to market faster.

"This isn't political at all," Bilirakis said. "I want to take the politics out of it."

The committee is examining the steps a new drug takes from discovery to delivery. The process includes input from the public at roundtable discussions beginning at 1:30 p.m. Aug. 19 and Aug. 22 at the Bethany Center in Lutz.

You don't have to live in Bilirakis' district to participate.

"It will be an open discussion," he said. "We want to find out people's concerns and discover what barriers they are facing. I know there are a lot of frustrated people out there."

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There are thousands of proposals for new drugs every year, and most of them don't make it off the drawing board. It takes millions of dollars in research and marketing in addition to the time it takes to develop a treatment, and you have to think that some of those drugs that don't make the cut now might have promise.

That requires a culture change.

"Decades ago, health care was very physician-centric and actually very paternalistic. We all recognize that today," Janet Woodcock of the Food and Drug Administration told the House committee earlier this year. "It was kind of, 'The doctor knows best; don't ask any questions.'"

I think that's what frustrates people the most, especially when the need -- as it was with my aunt -- is desperate. I know she would have volunteered for any treatment that would have given a sliver of hope.

Can the discovery of effective new treatments be accelerated on the front end with more research? Once the drugs are made, are there steps the FDA can take to shave years off the time it takes to get them to patients?

Good questions.

"That's why we want to have this discussion," Bilirakis said. "We want to be able to treat Parkinson's, Alzheimer's, and what have you. We know there are a lot of people out there with chronic diseases and they need help.

"We want to give people hope, and that's really why we're here in Washington -- to make a difference."

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