Kathleen Sharp: It was a combination of mistakes and toothless power. This blood booster was approved during the biotech rush of the 1980s, when the science was new. The FDA's blood division approved the drug, but then the drug division took it over. Regulators repeatedly asked the two companies to perform safety trials, but the firms never quite got around to it. Some 15 years later, independent research showed that the drug not only killed people, it multiplied tumor cells.It's quite a shock to realize that if our government regulators had had the authority to penalize these companies, some loved ones might still be alive today.
MK: It wasn't until June of 2011 that the FDA issued its sternest warning about these medications. According to a New York Times report, the FDA said that the drugs "used to treat anemia in both kidney and cancer patients were so dangerous to the heart that doctors should consider avoiding the medicines altogether and using less of them in others." Why didn't the FDA just take them off the market?
KS: The FDA considered that and put the question to an advisory committee. But that group, made up primarily of oncologists, voted it down. One possible motivation might be that this medical specialty allegedly made too much money on those drugs and wanted to keep them on the shelves. [See "Patients May Die When Doctors Moonlight as Big Pharma's "Key Opinion Leaders.") This turned out to be one of the many perverse conflicts of interest that ran throughout this tale.
MK: Much is made today about the cost of Medicare. How much has this drug cost Medicare since it went on the market in 1989?
KS: Taxpayers have spent more than $60 billion on this drug in govenment reimbursements to Big Pharma. Sixty billion dollars is such a waste - especially when lawmakers are threatening to cut basic Medicare and Medicaid services for widows, orphans and poor mothers. It'd be so much better if they'd simply cut reimbursements for these dangerous drugs, and save us taxpayers a small fortune.
MK: What were some of the frauds that Mark Duxbury, the lead whistleblower, alleged against J&J?
KS: Duxbury claimed that he and his fellow reps had been ordered to push high-dose sales to their doctor and hospital clients. What was astonishing is that he and his buddy, Dean McClellan, had saved reams of documents detailing the bonuses that they and their customers could make from these illegal promotions. They could offer rebates, mini-vacations, grants and other kickbacks to clients who prescribed the drug in off-label ways. It was quite a racket that proved to be a huge success.
MK: President Obama's Attorney General Eric Holder was assistant attorney general under President Clinton. But in between government stints, he worked for one of the big lobbyist law firms in DC that defended J&J and other drug companies. Has the Department of Justice (DOJ) pursued any fraud cases against J&J and Amgen?
KS: Not yet, although the DOJ is still investigating Duxbury's claims; in fact, it's reserved the right to pursue this $30 billion case later. That's what every whistle blower wants, because once the government intercedes in a suit, the company usually settles - and taxpayers get some money back. But in Duxbury's case, the justice department is letting attorney Schlichtmann argue his case alone. Meanwhile, Amgen is close to settling a similar fraud case involving its epo drug, Aranesp, and more than a dozen cash-strapped states have joined that suit, which is good news. Yet oddly, the DOJ hasn't intervened in that case either, and you have to wonder: Isn't there a strong cop policing this federal beat?
MK: What are the physician incentives when Big Pharma markets a drug such as this one?
KS: We all hear about goodie bags stuffed with pens, coffee mugs, flashlights and notepads. And most of us know that doctors and their staffs routinely get free meals. But influential physicians also receive speaking fees, vacation trips, office computers and other big-ticket items. The "Big Kahunas," as Duxbury called them, pocket $200,000 grants, stock options and $1 million in fees. No wonder the U.S. has the highest medical expenses of any developed country.
MK: Given your answer earlier about these risky but profitable drugs, why aren't we hearing more debate about cutting Medicare costs by examining the effectiveness of prescriptions like these?
KS: I hear the outrage coming from people as I travel the country and talk on radio shows. Americans are pretty savvy about the nature of their health-care system. What we need are leaders to act on what their constituents and customers are saying. Too many politicians are beholden to the players in this machine. But I think some are trying to break free. If nothing else, they see that our economy can no longer support such a wasteful, decrepit system in terms of health care and Big Pharma.
MK: Your book is a great read, particularly given the complexities of this issue. But at its heart, we see how we're all affected when Big Pharma muscles through its agenda. Is there anything patients can do to make sure their prescriptions are safe? I keep thinking of Jim Lennox, the man in the prologue of your book.
KS: Since I've finished reporting the book, I ask my family's doctors point-blank if they're consulting for any drug firm. I don't mean to offend anyone, but I need to know before I filll my child's prescription. You can search the Internet about a drug's safety but good information isn't always available. That's what happened to Jim Lennox. His wife researched his medicines and helped him beat cancer once. But the second time around, he received high doses of this drug and died in the most horrific way. And there's the real tragedy. If we listened more to patients and their families, we'd see how a health-care system that enriches a few is killing millions of everyday people.
Kathleen Sharp is an acclaimed author and award-winning investigative journalist. In addition to the true-life thriller, "Blood Feud, The Man Who Blew the Whistle On One of the Deadliest Prescription Drugs Ever," she is the author of "Mr. and Mrs. Hollywood," a biography of Hollywood studio mogul Lew Wasserman, and two other nonfiction books. Sharp has written for The New York Times Magazine, Parade, Elle, Playboy, and many others.