Abbott Laboratories aggressively promoted its Niaspan cholesterol treatment, almost tripling U.S. use of the medication, in the seven-year period before studies in 2011 found the drug ineffective, a study found.
From 2002 to 2009, niacin and its brand-name counterpart Niaspan, now sold by Abbott’s spinoff company AbbVie Inc., rose 191 percent in the U.S., to 696,000 prescriptions a month. A combination of assertive marketing and stronger medical guidelines for reducing cholesterol levels drove that increase, according to research published today in the journal JAMA Internal Medicine.
Abbott and AbbVie boosted Niaspan prices to almost completely offset prescription numbers that fell starting in 2011, according to sales data compiled last month by Bloomberg. Two studies released then and in 2012 found the medicine didn’t help patients and may have hurt them. Price increases helped AbbVie hold on to revenue from the drug even as evidence against it mounted.
“Some of it was the advertising, another, especially in the U.S., was that the guidelines for cholesterol have been a little more aggressive in terms of decreasing LDL,” or bad cholesterol, said Cynthia Jackevicius, the study’s lead author and a professor at Western University in Pomona, California.
Niacin, a form of vitamin B3, has been around since 1956 as a treatment for patients whose bad cholesterol is too high. Side effects to the drug, noted on its label, include red skin rashes and itching. Abbott bought the brand version Niaspan in 2006 when it acquired Kos Pharmaceuticals for $3.4 billion.
Approved for sale in the U.S. in 1997, Niaspan generated $5.11 billion in sales for Abbott through 2012. Last year it was Abbott’s sixth-biggest product, with $911 million. Since the negative 2011 study, monthly Niaspan prescriptions have fallen by about 33 percent as of April, according to data compiled by Bloomberg.
U.S. cholesterol guidelines, published by the National Institutes of Health, were updated in 2001. They called for higher good cholesterol and for lowering multiple types of bad cholesterol, compared to previous guidelines. Niaspan was used along with drugs like Pfizer Inc.’s Lipitor and Merck & Co.’s Zocor as a way of “driving down the numbers if you couldn’t do it with a statin” alone, said David Frid, a physician with the Cleveland Clinic’s preventative cardiology department.
Abbott’s extended-release version of the medicine also cut down on side effects like flushing, Frid said, making doctors more likely to use it.
“There was the continued belief that raising HDL had a clinical benefit, there was the focus on non-HDL cholesterol lowering and there was the availability of a form of niacin that made the side effects not as bad,” Frid said in a telephone interview. “Those were the things that drove it.”
The increase in niacin use was pronounced in the U.S. The research also found that the number of prescriptions in America was six times as great as in Canada in 2009. Canada also has more restrictive laws on drug advertising. Most of the growth in niacin use was from Abbott’s Niaspan, which is an extended-release version of the drug, according to the study.
The company’s television and online ads, said that the drug can help raise HDL levels, cut the risk of heart attacks and slow the build-up of arterial plaque. Because the medicine has been approved for decades in its generic form of niacin, though, it hadn’t been the focus of any recent major trial.
“New prescriptions, and prescriptions for niacin in general, were increasing in both countries despite no new evidence,” Jackevicius said in a telephone interview.
AbbVie, based in North Chicago, Illinois, was spun off from Abbott at the start of this year into a drugs-only business. Abbott, meanwhile, continues to operate the company’s device, diagnostic and nutrition units. AbbVie has called Niaspan an important treatment option, despite the studies that show no heart benefit from the medicine.
Other experimental treatments that have tried to artificially raise good cholesterol levels haven’t proved effective. Trials of Pfizer’s good-cholesterol raising drug torcetrapib were halted in 2006 over safety concerns.
Doctors seek to lower bad cholesterol and raise good cholesterol to cut the risk of heart disease. That can be accomplished through drugs, diet, and exercise.
“By having a secondary target, it may have prompted some physicians to use niacin to reach those goals, rather than thinking about the clinical goals,” she said. “It just hasn’t translated, in the populations it’s been studied in, into improved clinical outcomes.”