The Human Cost of FDA Decisions: For a Midwestern Family, A Breakdown in Drug Safety Hits Home

April 10, 2012
Michael Halpern
Former contributor

The consequences of unsafe drugs and medical devices are real—and nobody knows that better than Gwen B. of West Sacramento, California. We talked a few days ago after she responded to a UCS action alert with a story about her mother, Maxine, and I was moved enough to want to share her family’s story with you.

Gwen’s parents, Maxine and Eugene, were born and raised in eastern Nebraska. They settled on a farm near where they grew up. The couple cultivated corn and soybeans and raised hogs and cattle, and were blessed with two boys and two girls.

A family farm near Columbus, Nebraska

A family farm near Columbus, Nebraska. Photo: Flickr/Jason Grotelueschen

After retirement, they moved to a nearby town, but didn’t really slow down. They had a vibrant social life, lived independently, and were engaged in their church.  They were finally able to take some trips to various parts of the country where they had never been before.

“My mother was a very active farmwife,” said Gwen. “And she remained an active person well into her 70s. She would walk every day and spent a lot of time with her grandchildren.”

But age did bring some complications. Maxine had bad arthritis, and had tried a variety of treatments that hadn’t worked well. Around 2003, her doctor prescribed Vioxx, a drug that had won FDA approval in 1999 after the drug’s maker manipulated clinical trials to hide data suggesting that the drug increased the risk of strokes and heart attacks.

And Maxine didn’t think twice. “She believed what her doctors told her,” said Gwen. “I tend to be more skeptical, but she was trusting.”

This is part of a series of posts on drug safety reform at FDA.

At some point after being prescribed Vioxx, Maxine attended her granddaughter’s  second birthday party. “That’s the last time I remember her being herself,” Gwen told me.

Shortly after the birthday party, Maxine suffered a series of small strokes that affected her mind and memory. The next time Gwen saw her mother, she noticed a big difference.

“It was like something suddenly happened,” Gwen said.  “She couldn’t remember things and had to stop driving after a minor accident.” For Gwen, the change was painful. “I felt like I lost my mother at that point. She was no longer the person that I could confide in.”

A bridge over the Platte River near Columbus, Nebraska. Photo: Flickr user jasminedelilah

Less than a year later, Maxine suffered a massive stroke that left her unable to walk. She was wheelchair bound and had to move from her house to a nursing home, where she spent the last six years of her life. She died just last year.

Eugene eventually found that keeping up the house by himself was too challenging, and he was forced to move into an assisted living facility. He passed away in 2008.

“We always thought they’d live the rest of their days together,” said Gwen. It was difficult to see her mother spend those final years without the joy that she had throughout her life – deprived of the meaningful family and community activities that she had loved so much. And it was hard to see her father robbed of the vibrant retirement that he had shared with his wife.

There were hundreds of people who responded to the UCS action alert with experiences like Gwen’s. Tomorrow, I’ll share a tale on the opposite end of the spectrum: a man from Norwalk, Connecticut who is alive (and can share a wonderful life with his new wife) because of safe medical devices.