Thursday, July 8, 2004
It was on this date in 1997 that CNN broke the news that the miracle combination of diet drugs known as fen-phen was causing leakage in users’ heart valves. What many don’t know is that the first person to figure it out was a cardiac sonographer at Fargo’s MertitCare named Pam Ruff.
According to an article for Science News, Ruff noted two unusual echocardiograms in December 1994. Among the heart-structure images she created, she found leaky valves for two relatively young women – a disorder that was rare for anyone under the age of 50. She also noted that both women were using the fen-phen diet regimen. Following a gut feeling, she pulled one patient, Donna Prochniak, aside and whispered, “I think it’s those pills.”
Ruff approached MeritCare cardiologists about a possible link between fen-phen and valvular heart disease, but they felt that what she had found was probably a coincidence; there hadn’t been any previous reports that would cause them to believe otherwise.
But Ruff wasn’t entirely convinced. “We continued to see patients come through that had been on this combination of diet drugs,” she said, “(and) these patients had valves that were remarkably similar to the ones (I’d) seen.”
Over the next two years, Ruff put together twenty files of women, most in their 30s or 40s, who had leaky heart valves and were using fen-phen. None of them had a history of rheumatic fever, an infection that could have caused heart damage such as this.
Over time, cardiologist Jack Crary became more convinced that Ruff’s suspicions showed merit and should be investigated. A woman he was treating was using fen-phen, and he knew that previously, nobody had diagnosed her with a heart murmur. Yet now she had a murmur that he could hear very clearly. In fact, she was showing signs of heart failure.
“I became quite concerned as I was sitting there talking to her,” Dr. Crary told Science News. He knew that if a connection between fen-phen and valvular heart disease truly existed, millions of people were possibly being affected. “I went back and reviewed the cases that Pam had collected,” he said. “It was the same story over and over.”
Dr. Crary put in a call to researchers at the Mayo Clinic in Rochester, MN. Something clicked for Mayo cardiologist, Heidi Connolly, who remembered an odd glistening white substance in the heart of a 41 year-old patient she’d operated on. The woman had been using fen-phen.
Connolly, Crary, and their colleagues soon compiled 24 cases of women who had taken the diet regimen – most were in their 30s and 40s – who now exhibited the telltale symptoms of valvular heart disease.
When CNN broke the story, an interview with Donna Prochniak was included – she was the woman to whom Pam Ruff said, “I think it’s those pills.” Prochniak had since undergone heart surgery and had almost died. She was scared, and she was angry. And she wanted to live long enough to see her granddaughter grow up.
Convinced by mounting medical evidence, the FDA took the unusual step, two months later, of asking drug companies to pull the diet regimen off the market. The companies complied, but unfortunately, more than 6 million people had already used fen-phen by then.
Dakota Datebook written by Merry Helm