Blood Feud by Kathleen Sharp – KathleenSharp.com

 

Blood Feud by Kathleen Sharp

A True Story About Procrit, Amgen and Johnson & Johnson

 

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Kathleen Sharp

KATHLEEN SHARP is an acclaimed author and award-winning investigative journalist. She is the author of true-life thriller, Blood Feud, The Man Who Blew the Whistle On One of the Deadliest Prescription Drugs Ever, in addition to four acclaimed non-fiction books.

Sharp has written for The New York Times Magazine, Parade, Elle, Playboy, and Fortune, among many others. She’s produced segments for National Public Radio’s Morning Edition and appeared and consulted on film documentaries for Turner Classic Movies, the Biography Channel, and Bravo. Sharp has also contributed to several anthologies, including one that was nominated for an Edgar award. Her many awards include a first place prize for investigative reporting from the Society of Professional Journalists; an economic fellowship to study at the Graduate School of Business at the University of Washington; and a health-care fellowship from the University of Southern California’s Annenberg School for Communication. An avid runner, Sharp lives in Santa Barbara with her family.

View An Interview with Kathleen Sharp

 

Behind the Scenes of the Real-Life Thriller, Blood Feud

Tell us what BLOOD FEUD is about.

BLOOD FEUD is the true story of Mark Duxbury and Dean McClellan, two legendary sales reps for Johnson & Johnson who race against Big Pharma to blow the whistle on one of the riskiest, deadliest medicines ever, called epo. It’s also a behind-the-scene look at Johnson & Johnson and Amgen, the drug “partners” who wind up fighting over the $100 billion blockbuster.

What is Procrit?

Procrit is a top brand name for epo. It’s an anti-anemia drug that helps the body make red-blood cells, allowing patients to avoid blood transfusions. For decades, doctors have prescribed this medication to people suffering from AIDS, kidney disease, cancer and simple fatigue. About 20 million people have been injected with the drug.

By 1996, however, studies showed that Procrit and the other brands could cause heart attacks, tumor growth and even death. Just two months ago, in June 2011, I was shocked when the FDA announced that most patients should avoid the drugs entirely.

Yet, Procrit and the others are still on the market. And Medicare still pays for these expensive brands. Here’s a great example of how out healthcare dollars are wasted on risky blockbusters.

How did you find this story?

Whistleblower Mark Duxbury contacted me in 2004 after reading some of my work. He sent me his lawsuit, along with some documents, and urged me to write an article about Procrit’s overuse. But I was skeptical. His story seemed too outrageous to be true, so I put it aside for years. Yet, Duxbury kept calling. Charming and smart, he persuaded me that this was a huge story.

In 2007, Congress and the FDA began holding hearings on the deceptive sales practices and health risks behind these drugs. I scraped up some money and hopped on a red-eye flight to Washington DC. The next morning, I walked into a packed meeting and witnessed the significance of Duxbury’s tale.

Regulators had just slapped a “black-box” warning on the drug. Patients wanted it pulled from the shelves, but executives at Amgen and Johnson & Johnson were allowed to keep selling their dangerous products. That’s when I finally “got” it:  Here was an opportunity to describe the inner workings of a powerful global pharmaceutical industry as seen through the eyes of two of its star sales reps.

What kind of research did you do for writing this book?

I spent four years flying around the country and interviewing about 100 sources. I used documents from congressional hearings, regulatory meetings, and court proceedings along with reams of published news stories, company sales materials and the personal records of my main sources.

Why hasn’t anyone written about it before?

The New York Times has reported on bits and pieces of the epo story, while The Wall Street Journal featured Duxbury’s whistle blowing case as it wended its way through the U.S. District Court in Boston. Yet no one had laid out the entire story, partly because it’s so complicated. Here’s a 25-year-long saga that unfolds mostly behind the curtain, with such a scope as to be almost overwhelming. I spent four years flying around the country and interviewing about 100 sources. I used documents from congressional hearings, regulatory meetings, and court proceedings along with reams of published news stories, company sales materials and scientific studies. I wove boxes of this material through the personal accounts of my four main sources.

What does Johnson & Johnson say?

I contacted J&J representatives and lawyers about a dozen times over the year, asking for on-the-record interviews. But they consistently declined my requests. That stumped me: Here was a company that had set the gold standard for corporate accountability. After six people died during the 1982 Tylenol scandal, J&J recalled millions of bottles of Tylenol pills and launched a huge PR campaign to inform the public. Yet, in the wake of the much-larger Procrit crisis, when 100 times more patients have been harmed, J&J was stonewalling. That made me even more passionate about writing this story.

Tell us about former salesmen, Mark Duxbury and Dean McClellan, and their attorney Jan Schlichtmann, who signed agreements to work exclusively with you.

Duxbury was a star salesman at a J&J unit, selling the biotech drug throughout the Pacific Northwest. He had a strong sense of right and wrong, which is why he ultimately blew the whistle on J&J.

Duxbury’s best friend was Dean McClellan, who worked in the Southwest and became a Procrit sales legend. McClellan believed in the American Dream and in J&J, despite his friend’s warnings. McClellan refused to consider that J&J, whose famous credo pledged to put people first, would actually promote a drug illegally. But after news stories confirmed that he and J&J’s sales force had harmed patients by selling Procrit off-label, McClellan had to admit that his friend had been right all along. “We’ve been killing people,” he realized in horror. That’s when McClellan began secretly feeding Duxbury sales documents to use in his whistle blowing suit.

Jan Schlichtmann, as everyone knows, is the crusading attorney made famous by the bestselling book and Oscar-nominated movie A Civil Action. When Duxbury asked him to take on his suit, the lawyer eagerly agreed. But Schlichtmann found himself outflanked by J&J’s high-powered legal team and stymied by a Department of Justice that was managed, it turned out, by former members of J&J’s defense team.

This case has had more twists and turns than a thriller. Can you explain?

For a while, Duxbury’s case seemed lost. But in 2009, he and Schlichtmann won on appeal and prepared for trial. But then Duxbury died one night in his sleep.  Schlichtmann was devastated and I broke down and cried.  It was heartbreaking to have followed Duxbury to victory’s door only to have him pass away.

Schlichtmann eventually regained his foothold. Still, as Duxbury’s case moves forward, Schlichtmann wonders if he’s mired in another long-running travesty of justice—A Civil Action II.

Who is Sharon Lenox?

Sharon is the widow of a man who bled to death after receiving too much Procrit. She later learned that her husband had received high doses of epo despite repeated federal warnings. At an FDA meeting, she expressed her outrage about the lack of patient consent. Later, the FDA decided that all patients must sign a consent form before being injected with epo. To me, Sharon and her close-knit family represent the human cost of poorly-tested medicines and lax regulations.

Where is the Duxbury case now?  What do you hope will be the outcome?

The case is in federal court but 80-year-old Judge Rya Zobel has severely limited it. Federal law allows whistleblowers to try and prove their claims of national fraud.  But Zobel has restricted this trial to just five alleged instances of fraud, all in Seattle. “It’s a mockery of justice,” said Schlichtmann. Experts agree that Zobel’s ruling will probably be overturned later, yet Schlichtmann must try his case in 2012.

Whether he wins or loses, Schlichtmann will appeal until he’s allowed to press his entire case. He’ll try to prove that J&J promoted Procrit illegally for years on a nationwide basis. The evidence is astonishing and, naturally, I’m rooting for Schlichtmann.

In all your interviews, what one thing shocked you the most?

I’ve been appalled to see how little power patients have in this process. Amgen, J&J, hospital chains and doctors all played a roll in epo’s shameful overuse. But the sick and vulnerable were the last to be heard. In this case, the system favored the financial interests of a few over the heath and safety of millions.

What have you learned from writing this story?

BLOOD FEUD taught me that the FDA’s approval stamp is not the Good Housekeeping seal that most of us think it is. Nor is the DOJ the tough cop who pursues big cases of taxpayer fraud that could retrieve desperately needed Medicare dollars. Procrit is a great example of how our consumer protection agencies have been emasculated by corporations, lobbyists and our own leaders. Even now, our regulators are being starved for funds.

Why is it important that this story be told?  Who needs to read this book?

BLOOD FEUD impacts anyone who’s ever taken a prescription drug or used a medical device—or more than 150 million Americans. This book sheds light on how we pay for the most expensive, inefficient health-care system in the developed world. But at its heart, BLOOD FEUD is really a suspenseful tale about ordinary people going to extraordinary lengths in their quest for justice. Duxbury, McClellan and the others never set out to cure our deeply flawed system. But they always believed they’d get a fair hearing. To this day, they’re still waiting….

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