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Thursday, Mar 28, 2024

Take an Aspirin, Go to Bed

I’m the typical male when it comes to doctors. Well, actually, I might be worse. You don’t want to know the last time I had a checkup. So why don’t I go? The same reason many males don’t. I’m chicken. I don’t to want to find out I might have some dread disease. I’d rather wait until I’m sick when I fear dropping dead even more. But I also have some good excuses. You know, doctors’ offices are filled with sick people. Yuk, all that sneezing and coughing. Who wants to get sick just trying to stay healthy? Then there are those pens. I’m sure you’ve seen them. We’re not talking retro fountain pens, or the latest slick gel contraption. It’s those cheap plastic pens, stamped with drug names, that doctors use to write prescriptions. I can’t even pronounce most of those names, but I’m a business journalist and this much I do know: they’re the telltale signs of a visit from a sales rep. And in case you don’t know, drug companies often employ attractive females to convince doctors to prescribe what they are selling. So whenever a doctor prescribes some medication to me, I’m always wondering, “Did I really need it?” or, “Wouldn’t the generic be cheaper?” Maybe the doc just couldn’t get that sales rep out of his head. So what am I getting at here? Well, it looks like I can thank our own Amgen Inc. for proving I’m not an oddball when it comes to my suspicion of doctors. The Thousand Oaks biotech pleaded guilty last month to a criminal charge of marketing its anemia drug Aranesp for unapproved uses. It also paid $136 million in criminal fines, forfeited $14 million and forked over $612 million to settle related civil litigation, including whistleblower lawsuits. Add that up and it’s a whopping $762 million! So what does marketing drugs for unapproved uses mean? Prosecutors at the U.S. Attorney’s Office in Brooklyn said the company promoted the use of Aranesp for cancer patients who were not undergoing chemotherapy, instead of only for patients having chemotherapy. Why is that such a bad thing? Wouldn’t some super drug that raises red blood cell counts make any cancer patient feel better, maybe even improve their chances? Well, the Food and Drug Administration never approved such an “off-label” use, because it had never been tested. Maybe you think the FDA is some stodgy bureaucracy – and it is – but its conservative approach can pay off. Turns out when Amgen finally got around to testing the drug on cancer patients not on chemotherapy the results were more than a bit disturbing: the drug increased the death rate. The chief whistleblower was one of those sales reps. Her name was Jill Osiecki and she told the New York Times that Amgen’s sales culture changed around 2000 when new management arrived and the company found itself in a pitched battle with Johnson & Johnson over its competing anemia drug. It was a war waged in doctor offices, clinics and hospitals. And the patient was the loser. Osiecki secretly recorded 13 sales meetings that laid out the company’s sales tactics. One method dubbed “reactive marketing” trained the sales reps to ask leading questions so the doctors would ask about off-label uses. In the upside-down, inside-out world of drug marketing, it’s OK for doctors to ask about or prescribe drugs off-label as long as they are not encouraged to do so by drug makers. The evidence was so overwhelming, Amgen copped to a criminal charge, though no specific executive was charged. The company’s chief compliance officer issued a statement saying the government raised “important concerns” and “we did not live up to our standards.” I would say so. Here’s what’s even more disturbing. The criminal settlement came as a surprise, but Amgen had telegraphed to the market something was up in October 2011 when it set aside $780 million to settle unspecified whistleblower complaints. So when the day of reckoning came on Dec. 18, the company’s stock dropped a measly 21 cents to $89.29. What to make of all this? Kevin Sharer, chief executive when all this was going on, stepped down from his post in May and just last month left the board. How convenient. His nicely managed exit was announced in December 2011 – two month after the money was set aside for the settlement. What’s more, all the news reports noted it was a relatively small case. Similar ones involving other drug makers topped $1 billion while GlaxoSmithKline paid $3 billion. To be fair, Amgen has now signed a corporate integrity agreement that could leave the new management facing personal criminal charges in case of further shenanigans. Let’s hope the company has learned its lesson. Here’s what painfully clear. The industry’s unrelenting push for doctors to prescribe more and more drugs for every conceivable illness has played a big role in health care inflation, which has burdened employers with huge costs. It turns out such practices also can be deadly. As for me, the next time I feel sick, I’m taking an aspirin and going to bed. Laurence Darmiento is editor of the Business Journal. He can be reached at [email protected].

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