The Food and Drug Administration (FDA) ruled that the controversial cholesterol drug Crestor does not increase the risk of muscle damage more than other cholesterol drugs, despite a report by advocacy group Public Citizen that found otherwise.
Public Citizen, who submitted a petition to the FDA to withdraw the drug from the market, analyzed data from the FDA's adverse event reporting system (AERs) that covered from October 1, 2003 to September 30, 2004. The analysis showed the rate of reports of life-threatening muscle damage, called rhabdomyolysis, from taking Crestor was 6.2 times higher than the rate for all other statins combined (13.1 reports per million prescriptions versus 2.1 reports per million prescriptions, respectively).
The group also found that AERs reports show an increased rate of acute renal toxicity, or serious kidney damage, with Crestor as compared to other statins. According to Public Citizen, before Crestor was approved one FDA medical officer was so concerned about this possibility that he said the drug would pose an "unacceptable risk because other currently approved statins do not have similar renal effects."
The FDA rejected the group's arguments, saying Crestor does not pose a greater risk of muscle damage, and there is "no convincing evidence" that it could cause serious kidney damage. They based their decision on their own review of AERs reports along with ongoing clinical trials and safety data that have surfaced since Crestor hit the market.
Other groups have also criticized the drug. The Lancet, a British medical journal, reportedly criticized AstraZeneca's marketing efforts and the FDA sent the drug maker two letters warning that Crestor's ads were misleading. Further, an FDA scientist told Congress in November 2004 that Crestor was one of five drugs that "warranted further safety study."
Crestor was the first cholesterol drug released after Baycol, another cholesterol drug, was pulled from the market in 2001 because it caused severe damage to muscles.
AstraZeneca was pleased with the FDA's decision--in 2004, Crestor brought in $908 million in worldwide sales ($608 million in the United States alone).
USA Today March 14, 2005
PublicCitizen.org March 10, 2005
Earlier this month I posted a blog entry regarding Public Citizen's (the consumer group founded by Ralph Nader) petition to the FDA to pull Crestor from the market as it increased the risk of a fatal muscle complication over 600 percent relative to all the other statins combined.
It couldn't be clearer that this drug needs to be pulled from the market, yet the FDA rejected the petition. There is simply no reason to have it on the market as it provides no advantage over any of the other statin drugs currently on the market.
To add insult to injury, statins are rarely ever needed to control high blood cholesterol. The best way to treat high cholesterol isn't with a drug that could potentially do great harm (and ALL of the statins are risky, not just Crestor). Two primary strategies that work well over 99 percent of the time if properly implemented are:
Daily cardiovascular exercise
Low-grain, low-sugar diet (as elevated insulin levels--often caused by diets high in grains and sugar--are a primary driving force behind high cholesterol.)
But going back to the insanity of the FDA decision, even one of the FDA's own physicians, Dr. David Graham, agrees that it is one of the six drugs that needs to be yanked. The FDA is already in major hot water for all the mismanagement, death and destruction they have unleashed on the public recently. For instance, 55,000 deaths from Vioxx when the evidence was clear that it should have NEVER been approved. I voiced these objections more than one year before it was approved. I sure look like a fortuneteller, seeing that I wrote the following in 1999:
"I would strongly advise against using these drugs [COX-2 inhibitors]. I suspect there is a high likelihood that they will be pulled from the market when the increased cardiac deaths are recognized." Mercola.com 1999 archive issue
"I would strongly advise against using these drugs [COX-2 inhibitors]. I suspect there is a high likelihood that they will be pulled from the market when the increased cardiac deaths are recognized."
Mercola.com 1999 archive issue
Please note that this was 18 months before the drug was approved and FIVE YEARS before it was finally taken off the market. As far as I can tell I was the first person to sound a warning about Vioxx publicly.
And now, the FDA is getting it wrong again big time. It's hard to believe they are choosing to keep Crestor on the market in light of all the bad PR they have been getting. I suspect major heads will roll from this decision, which clearly seems related to obvious conflict of interest financial ties to the drug companies. Crestor has sales of close to $1 billion a year--and that buys lots of influence at the FDA. I used to listen to Peter Paul & Mary (see picture above) in the early 60s and one of their great songs was "Where Have All The Flowers Gone?
I am reminded of this song because one of the chorus lines is:
"Oh, when will they ever learn? Oh, when will they ever learn?"
Yes indeed, when will they ever learn?
Related Articles:
The Truth About Cholesterol-Lowering Drugs (Statins), Cholesterol and Health Crestor and Other Statins: Are They Really Worth the Risk? The Dangers of Statin Drugs: What You Haven't Been Told About Cholesterol-Lowering Medication USA Today Exposes Conflicts of Interest in FDA Drug Approvals
The Truth About Cholesterol-Lowering Drugs (Statins), Cholesterol and Health
Crestor and Other Statins: Are They Really Worth the Risk?
The Dangers of Statin Drugs: What You Haven't Been Told About Cholesterol-Lowering Medication
USA Today Exposes Conflicts of Interest in FDA Drug Approvals