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

, former deputy director, Center for Science & Democracy | April 10, 2012, 3:19 pm EDT
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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.

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  • AmyCat =^.^=

    This is VERY similar to what happened to my mom. She was an active fund-raiser for a local museum and a hospital, kept house for herself and my father, and enjoyed travel with Dad and a busy social life… but her doctor gave her VIOXX for her arthritis, and she had a near-killer stroke. She spent the last four years of her life in a wheelchair, though she and Dad were fortunate enough to be able to afford an in-home caregiver, so she was able to stay with Dad. Gwen, thank you for sharing your story.

  • Another way in which the drug companies manipulate their profits is by advertising their drugs to medical personnel so they believe the newer more expensive products are significantly different from older generic products, when in fact many new drugs are essentially the same as an older one, tweaked to get a new patent. Many new (and older doctors) don’t learn the prices of drugs they prescribe and never realize the impact of prescribing one that has a minimal improvement, over one that the person’s insurance might cover more fully or that might be available on a very cheap basic drug list thru a pharmacy that provides such service. By the way, I think those pharmacies like Walmart (yes there is something good about Walmart) and Target that have those programs are to be commended.

  • Susan

    May I throw a different curve your way? I understand about stockholders and profits, but why does the FDA and our government allow these companies to use terrorists’ tactics. I have only seen a short blurb once about critical drug shortages, is it no one cares or understands?
    I’m a paramedic and people look to us in a time of medical crisis, little do they understand that pharmaceutical companies have stop making critical first line emergency drugs because there’s no profit, except to actual save a human life. These companies hold the FDA and our government hostage over approving their new expensive drugs in order to get our life saving drugs back in the hospitals and ambulances.

    • Michael Halpern

      Interesting point, Susan. My understanding is that Congress is aware of this problem, and is considering bipartisan legislation that would require companies to give more notice to the FDA about shortages of critical drugs. The hope is that FDA will be able to ensure that supplies don’t run out.

      Others have proposed that an independent clearinghouse be set up to monitor all phases of the drug production process and coordinate among drug companies to prevent shortages.

      Profit certainly plays a role in companies’ unwillingness to make some of these drugs. One would hope that patriotism, and not just the bottom line, could motivate companies to make drugs that are crucial. Exacerbating the problem: in some cases, the FDA has shut down plants because they did not meet safety standards, and then had to find other companies willing to make these drugs.

      President Obama did issue an executive order in the fall that raised awareness about this problem, but it will take congressional action for more meaningful change. This issue is getting some attention, however. For example, Just a couple of days ago, the Washington Post published an article with the headline Hospitals Scramble on the Front Lines of Drug Shortages.


  • Chris b

    I would imagine this story is all too common. But who can blame the companies? Their goal is to maximize profits for their shareholders, and to try to do a little good along the way. That is why we need checks and balances. Still it is sad when the system breaks down.

  • Sylvia Winner

    The FDA should have the power to send the heads of lying drug com panies to jail and the facts should be widely publicized.

  • Sylvia Winner

    Companies that knowingly lie about their drugs should be criminally punished and their lies should make the headlines in newspapers all across the country at the same time that their liers should go to jail for minimum 50 years.

  • Peter Rupp

    We really have to depend on our doctors because we can’t research the safety of every drug. And they have to in turn depend on the FDA for that information. They certainly can’t depend on the drug companies. The FDA, simply put, needs more power and money to stop these sorts of tragedies, and the companies should be criminally punished when they lie and say their drugs are safe.