Most of us can’t help it. When we see a car wreck on the highway, we slow down to catch a glimpse. That’s the feeling I had while reading about two drug giants colliding in the marketplace. And it’s shaping up to be quite a car wreck. So we’re going to slow down a bit to take a look.
In last week’s “Cresting the Wave” (10/15/03) I told you about the launch of a new cholesterol-lowering statin drug called Crestor, manufactured by AstraZeneca (AZ), the fifth largest drug company in the world. AZ reps have made no secret of their hopes that Crestor will effectively rival Pfizer’s Lipitor, the long-time statin king with annual sales of about $8 billion. Excuse me for saying it, but that takes some brass.
Brass bumpers, that is. Because when you gun your car through that kind of heavy traffic, you’re bound to get banged around by the FDA approval process and insurance companies, while charting a high-speed collision course with the big Hummer: Lipitor.
Quick – someone call 911!
How fast was I going, officer?
AstraZeneca’s pitch for Crestor is that it’s less expensive and more effective than Lipitor, with similar side effects. And the new drug is already selling like hotcakes in the U.K., Canada, and several other countries where it’s been available since last February.
Meanwhile, here in the U.S., the FDA pulled Crestor over for doing 80 in a 40.
In the original clinical trials presented to the FDA, some of the subjects who took 80 mg developed kidney damage. (Not really all that shocking given that, as a class of drugs, statins have always been associated with kidney toxicity.) So the folks at the FDA said, “Try again,” and AZ resubmitted Crestor at doses of 40 mg or less. The FDA gave the green light, and Crestor was introduced in the U.S in September.
Stuck in traffic
Within just a couple of weeks of Crestor’s U.S. launch, AstraZeneca announced that the new drug had already captured more than 2 percent of the new prescriptions written for statin drugs in the U.S. These impressive stats were released at a high-profile meeting with investors at AZ’s U.S. headquarters in Fairfax, VA. But the party was spoiled when, that very same day, Wellpoint (the second largest private health insurer in the U.S.) announced that prescriptions for Crestor would not be covered because of concerns over the safety of the drug.
This was a blow. It meant that more than 13 million Americans in the Wellpoint system would have to pay for Crestor out of pocket. But perhaps even worse than that, when reps for Wellpoint made the announcement, they used the “B” word: Baycol.
Baycol was A.G. Bayer’s entry into the statin market a few years ago, and talk about car wrecks! In the e-Alert “Pot, Meet Kettle” (3/5/03) I told you how Baycol had been yanked from the market in 2001 because of adverse reactions, including acute kidney failure and more than 30 deaths. Bayer was sued by thousands of patients, and spent well over a $1 million settling many of the cases out of court.
So when Dr. Robert Seidman, Wellpoint’s chief pharmacy officer, told reporters that the insurance company was being cautious because, “We’ve already been Baycolled,” the seed of doubt was planted by making the association between Bayer’s dangerous product and the kidney problems attributed to Crestor in those early 80 mg trials that the FDA rejected.
So was Wellpoint simply protecting clients by denying the Crestor coverage? Tom McKillop, AZ’s chief executive, reportedly told a writer for TheStreet.com, “I don’t believe for a moment that it’s about side effects.”
Crazy like a fox
Less than a week after Wellpoint ruined AZ’s day, Reuters reported that a new UK study had revealed that in a group of 14,000 heart disease patients, statins failed to lower cholesterol to recommended levels in about half the subjects. The headline read: “Statin Drugs Fail Half UK Heart Patients-Study.”
Now you might think that on the heels of this news AZ executives would have started pulling out their hair again, but not so. Because the statin drugs this study focused on were the older statins, such as atorvastatin (brand name: Lipitor) and simvastatin (brand name: Zocor). The newer type of statin drug known as rosuvastatin (brand name: Crestor) wasn’t included in the study.
So this was a lucky break for AZ, right? Well, it was perhaps more than just a break. Because the research was sponsored by AstraZeneca. I’m not saying anyone falsified the results. They didn’t need to. Previous studies have already shown that statin drugs significantly lower cholesterol in less than half of those who take it. So the “failed” effectiveness was virtually a foregone conclusion.
I brake for drug giants
See where this is going? With large shares of a $20-billion-per-year statin market at stake, the players in this market aren’t going to leave anything to chance.
According to one report, AstraZeneca may be planning to invest as much as $1 billion to promote Crestor this year. That means two things: 1) We’ll be seeing even more commercials warning us that we must save our lives by taking statins to lower our cholesterol, and 2) These Goliaths – Crestor and Lipitor – are on a collision course, with Zocor right there in it with them as well.
I’ll keep you posted as more details are reported. Until then buckle up! It’s going to be a bumpy ride.
To Your Good Health,
Health Sciences Institute
“The New Statin” Nicholas Regush, Red Flags Weekly, 10/6/03, redflagsweekly.com
“AstraZeneca’s Crestor” Jeff Hwang, The Motley Fool, 10/2/03, fool.com
“US Blow to AstraZeneca” Nils Pratley, The Guardian, 10/4/03, guardian.co.uk
“AstraZeneca: U.S. Crestor Sales Encouraging” Ben Hirschler, Reuters, 10/2/03, reuters.com
“Insurer Will Not Cover Crestor” Fred Biddle, The News Journal, 10/2/03, delawareonline.com
“Statin Drugs Fail Half UK Heart Patients – Study” Reuters, 10/5/03, reuters.com