July 1, 2001-Bitter Pill: The Fen-Phen Story
The people manufacturing and selling the combination of Fenfluramine and Phentermine knew that its use as a prescription weight-loss drug would endanger the health of some customers and might be deadly. Those people dispensed with the truth in the name of profit. Many of the physicians prescribing the drug thought little or not at all about the side effects. Granted, some of those physicians harbored good intentions, wanting to help overweight patients achieve some happiness. Other physicians were more greedy than well-intentioned. They, too, dispensed with the truth in the name of profit.
Government regulators at the federal Food and Drug Administration (FDA) - some of them physicians, some of them former pharmaceutical industry employees - dispensed with the truth because they failed to care enough about the well-being of the citizens paying their salaries. When it came to regulating Fen-Phen manufacturers and marketers, too many FDA officials decided they would go along to get along. After all, lucrative jobs in the pharmaceutical industry awaited when government service ended.
Then there are the victims, the ingesters of Fen-Phen, most of them women. They had no opportunity to dispense with the truth, because the truth told to them turned out to be a lie.
In chronicling this saga, Mundy, an experienced investigative journalist, finds few true heroes or heroines. If there is a leading character in the book, it is probably Alex MacDonald, a plaintiff's lawyer from Boston. MacDonald is a hero in the limited sense that he cared a great deal about his client, Mary Linnen, who started taking fen-phen during spring 1996, on the advice of a Boston endocrinologist, to lose weight. After less than a month, Linnen, only 30, began experiencing health problems - shortness of breath, dizziness. Linnen stopped ingesting fen-phen, but the 23 days worth of pills had destroyed Linnen's lungs. After intense suffering, Linnen died in February 1997. It seemed inevitable that MacDonald, retained by Linnen's family, would draft a lawsuit involving American Home Products, the parent company of pharmaceutical manufacturer Wyeth-Ayerst; Fisons, a company selling Phentermine; and Interneuron, a company involved in the invention of drugs that came to be prescribed for weight loss.
Another candidate for hero could be Dr. Leo Lutwak, the FDA staff member who tries from within the agency to clamp down on the potentially lethal fen-phen, only to be rebuffed by federal government superiors who are too in awe of pharmaceutical-company clout to simply do the right thing.
My candidates for hero/heroine are a physician and a nurse in Fargo, N.D. - Jack Crary and Pam Ruff, although they are barely mentioned. An echocardiogram sonographer at the MeritCare Clinic in Fargo, Ruff was analyzing tests run on a 40-year-old woman suffering from shortness of breath and constant fatigue. Ruff had never seen aortic and mitral valves like this, given the patient's age and medical history. Curious, Ruff asked the woman if she had been taking any drugs. Fen-Phen, the woman replied, as a way to lose weight.
Ruff, who knew nothing at that point about the Fen-Phen movement, could not contain her curiosity. She mentioned the test results to her supervisor, who had seen a similar valve phenomenon that same afternoon on a different patient. Had that patient ingested any drugs recently, Ruff asked. Yes, the supervisor replied. Fen-Phen.
'Another med tech might have, probably would have, racked it up to coincidence, or perhaps made a little notation to the cardiologists involved,' Mundy writes. ' But Pam Ruff had spent her childhood overdosing on Nancy Drew books. Within a week, she'd quietly began her sleuthing Pam began an unpaid, unfunded study at MeritCare, and for the next two years she kept track of every case at the clinic involving valve disease.'
Ruff qualifies for heroine status in part because she had nothing selfish to gain from her role. She simply cared about patients. Cardiologist Crary started hearing from Ruff. Her charting of cases looked thorough, but Crary could find nothing in the medical literature on a relationship between valve disease and Fen-Phen.
Crary did his best to block out Ruff's pestering, until the week before Christmas 1996, two years after Ruff started her charting. That week, Crary examined a longtime patient.
He took a look at the echocardiogram, the kind Ruff produced regularly. Why were the valves showing up so weird, Crary wondered? Had she been taking any drugs? Crary asked his patient. Fen-Phen, she replied. Like Ruff, he began bucking the conventional wisdom from the medical, pharmaceutical and regulatory establishments to crusade for a ban on Fen-Phen as a weight-loss drug.
That ban finally occurred, thanks in large part to Ruff and Crary. As Mundy sent the book to the printing press, Crary was still practicing medicine in Fargo while immersed in community-oriented, non-medical volunteer work that pays nothing. Ruff relocated to a medical center in the sunny South, Mundy adds.
As for MacDonald, he had won more than $ 50 million in settlements for his clients through the first half of 2000, including about $ 15.5 million for Mary Linnen's family. Other lawyers in other jurisdictions pulled down big bucks, too, causing American Home Products to create a liability reserve fund in the billions.
A happy ending? Not exactly. Those damages cannot end the suffering of fen-phen victims estimated to number in the hundreds of thousands.
If you or a loved one has suffered an injury as a result of taking any drug or supplement, call Law Offices of Robert Dourian now at 800-790-8856 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.