Posted on 12/23/2004 12:02:09 AM PST by neverdem
WASHINGTON, Dec. 22 - AstraZeneca's recent full-page newspaper advertisements defending the safety of its cholesterol-lowering pill, Crestor, are "false and misleading," in part because serious concerns remain about the safety of the drug, federal drug regulators said Wednesday.
The advertisements stated that "the F.D.A. has confidence in the safety and efficacy of Crestor" and that the agency "as recently as last Friday publicly confirmed that Crestor is safe and effective." Neither is true, said a letter from the Food and Drug Administration to AstraZeneca.
In fact, days before the advertisements ran, top agency officials were widely quoted expressing concerns about Crestor's safety. Public Citizen, a health advocacy group, has called for Crestor's withdrawal.
AstraZeneca stopped running the advertisements in November, well before receiving the drug agency's letter, said Emily Denney, a company spokeswoman. "We stand behind the ads and our communications around Crestor," Ms. Denney said.
Dr. Sidney Wolfe, director of Public Citizen's health research group, said the company's ads "are just misrepresenting F.D.A.'s position, making it appear that even F.D.A. cleared the drug; that's a lie." Dr. Wolfe predicted that the company would soon be forced to withdraw Crestor.
Since September, the Food and Drug Administration has sent out nine letters warning companies about false promotions. Most such letters scold companies for exaggerating a drug's benefits or underplaying its risks. Rarely does such a letter criticize a company for misrepresenting the agency itself.
AstraZeneca's advertising campaign defending Crestor was begun after Dr. David J. Graham, a safety official at the drug agency, told a Congressional panel on Nov. 18 that Crestor was one of five currently marketed drugs whose safety needed "to be seriously looked at."
Dr. Sandra Kweder, deputy director of the agency's office of new drugs, told the panel that Crestor's risks were "something that we are in the process of and have been evaluating very, very closely."
That same day, Dr. Steven Galson, acting director of the agency's center for drug evaluation and research, was quoted in The Washington Post as saying that the agency "has been very concerned about Crestor since the day it was approved, and we've been watching it very carefully."
The concerns largely revolve around Crestor's effect on the kidneys. According to an analysis by Public Citizen, there were 29 reports of kidney failure or insufficiency among patients given Crestor in the first year of its approval in the United States. Considering the limited number of prescriptions for the drug, that is 75 times the rate of kidney failure or insufficiency for all other similar drugs combined, Public Citizen said. The company responded that Crestor might actually improve kidney function.
The remarks by Dr. Graham and others created widespread concern among patients and physicians. In the week after the hearing, Crestor's share of new prescriptions among cholesterol-lowering drugs tumbled 22 percent, to 6.4 percent from 8.2 percent, according to information provided by J. P. Morgan.
So AstraZeneca placed full-page advertisements in newspapers across the country for several days. Crestor's decline in prescriptions then stopped. The drug's share of new prescriptions among cholesterol-lowering drugs has remained steady at about 6.4 percent in recent weeks.
But the advertisements were false, the drug agency wrote in an undated letter to Mark R. Szewczak, AstraZeneca's director of promotional regulatory affairs. For instance, they had a boldface line that stated, "A medication can be more effective and just as safe."
The advertisements went on to claim that Crestor "lowers bad cholesterol better than the leading medications in its class."
The Food and Drug Administration's letter, written by Dr. Christine Hemler Smith, stated, "This claim is misleading because it minimizes the risks associated with the 40 mg. dose of Crestor." AstraZeneca, the letter says, agreed to reserve the 40-milligram dose for those patients who failed to lower their cholesterol with a 20-milligram dose.
"F.D.A. is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are 'just as safe' as other" cholesterol-lowering drugs, the letter states.
Similarly, the agency took issue with the advertisements' claim that the drug agency had endorsed Crestor's safety.
Asked how the company could state in its advertisements that the drug agency had confirmed the safety of Crestor when the agency's top officials were saying that they were concerned about the drug, Ms. Denney said, "We believe that our communications have been consistent with what has been communicated to us and with what clinical trials tell us and post-marketing data tells us."
AstraZeneca executives once had high hopes for Crestor. Analysts predicted that sales would top $1 billion this year and reach $4.5 billion by 2007. But through the first nine months of this year, Crestor sales were $596 million.
With $9.2 billion in sales last year, Lipitor, by Pfizer, is the category's biggest seller, followed by Zocor, by Merck, which had $5 billion in sales, and Pravachol, by Bristol-Myers Squibb, with $2.8 billion.
Adding to AstraZeneca's woes, an Food and Drug Administration advisory panel recently voted against approving Exanta, a stroke-prevention drug. And the company reported last week that a large study of its cancer drug, Iressa, showed that it did not improve survival rates of patients. In the study's aftermath, the company said it would stop promoting Iressa to physicians, and the drug agency said it was considering forcing the drug's withdrawal.
The company has promised to overhaul its drug development efforts, and it is fiercely defending the image of Crestor.
According to an analysis by Public Citizen, there were 29 reports of kidney failure or insufficiency among patients given Crestor in the first year of its approval in the United States. Considering the limited number of prescriptions for the drug, that is 75 times the rate of kidney failure or insufficiency for all other similar drugs combined, Public Citizen said.
That statement appears to be hyperbolic nonsense. If anyone is worried, just go to your doc for a simple blood test. Make a point to tell your doc if you have unexplained muscle pain or weakness. Also consider stopping Crestor until you're reassured, but I wouldn't recommend it without discussing the matter with your doc, or you thought you had good reason to think you've had an adverse drug reaction.
That's an interesting article Scott, thanks for posting it. I've ballyhooed the benefits of cinnamon for a long time, though for different reasons.
You rock!
But they reduce the immune system, so be careful.
Crestor helped me, too. Lipitor didn't do squat for me. I was in bad shape earlier this year with my cholesterol topping out at 1639. Now thanks to Chrestor, Tricor, and Zetia, I'm down to 154.
How long have you been taking Crestor? I took Lipitor for three months and my choles went down 100 points.
I was shocked and alarmed at Crestor ads that showed people moving from the no-no zone whre they had to watch their diets into the happy zone of fast foods and bakeries. I felt it was extremely dangerous to suggest that people can go on with horrible eating habits just because they're taking a drug when in truth, all statins work faster and better if you curb your intake of fatty and high-carb foods.
In fact, for most people, eating the right stuff consistently and ignoring fatty and high-carb dishes will bring cholesterol down and keep it down. After perhaps a short course of statins, everyone can succeed if they have the will to do so. But Crestor encouraged lousy eating habits. You don't suppose they want people to need their drug forever, do you?
Unless you can achieve the recommended cholesterol guideline levels by diet and exercise, the drug companies want you to take their statins as long as they can make a profit.
FReepmail me if you want on or off my health and science ping list.
http://www.berkeleywellness.com/html/ds/dsFishOil.php
info on fish oil and immune system.
Very true -- but it MUST be from wild fish... not farm-raised fish. They basically feed farmed fish dog food (kibble) making the farmed fish no higher in Omega 3 than the beef or chicken we eat these days (except for people lucky enough to find grass-raised meat).
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