J. Douglas Bremner
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 One of the statins, cerivastatin (Baycol), was removed from the market because of at least thirty-one reports of fatal rhabdomy-olysis. crestor (Rosuvastatin) is another statin currently in the spotlight because it is associated with deaths from kidney failure; it has been identified in congressional testimony as a particularly dangerous drug that is still on the market. crestor is one of the most potent statins.
Because of concerns about crestor, in 2003 a consumer group urged the FDA to withhold approval of Crestor; however, the FDA still approved it. |
Melody Petersen
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 Lewis sink his last putt of the day to win the crestor Charity Challenge. Drugmaker AstraZeneca had created the contest to promote its new cholesterol pill, crestor. The name of the contest was brilliant. The crestor Charity Challenge evoked recollections of the Pepsi Challenge, a promotional gimmick that the soda pop manufacturer had used repeatedly in ads to create the impression that cola drinkers preferred the taste of its product to that of Coke. |
Bottom Line Health
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| One is whether the same benefits could be achieved using other statins instead of crestor because of concerns about its safety.
The consumer advocacy group Public Citizen has petitioned the US Food and Drug Administration (FDA) to take crestor off the market. But the agency concluded that the available evidence about Crestor's safety does not warrant its withdrawal from the market. Public Citizen isn't likely to change its stance, despite this new research.
"The study is a bit less impressive than perhaps is put forth," says Dr. |
J. Douglas Bremner
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| Because of concerns about crestor, in 2003 a consumer group urged the FDA to withhold approval of Crestor; however, the FDA still approved it. Since that time there have been 65 cases of rhabdomyolysis with crestor reported to the FDA, some of them fatal. Although death from statins is rare, given the large number of people who take these drugs, muscle pain (myalgia) in the absence of changes in laboratory values like CK are more common, affecting 2% to 3% of patients. Studies have shown that myalgia can be associated with changes in muscle tissue. |
Melody Petersen
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| The name of the contest was brilliant. The crestor Charity Challenge evoked recollections of the Pepsi Challenge, a promotional gimmick that the soda pop manufacturer had used repeatedly in ads to create the impression that cola drinkers preferred the taste of its product to that of Coke. The crestor Charity Challenge, which AstraZeneca was paying to sponsor at thirty-five professional golf tournaments around the country in 2005, sent an implicit message that crestor was better and safer than any of the other cholesterol-lowering pills. This was not the case. |
| Drugmaker AstraZeneca had created the contest to promote its new cholesterol pill, crestor. The name of the contest was brilliant. The crestor Charity Challenge evoked recollections of the Pepsi Challenge, a promotional gimmick that the soda pop manufacturer had used repeatedly in ads to create the impression that cola drinkers preferred the taste of its product to that of Coke. |
Bottom Line Health
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| The consumer advocacy group Public Citizen has petitioned the US Food and Drug Administration (FDA) to take crestor off the market. But the agency concluded that the available evidence about Crestor's safety does not warrant its withdrawal from the market. Public Citizen isn't likely to change its stance, despite this new research.
"The study is a bit less impressive than perhaps is put forth," says Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group. "Many patients were lost to follow-up. |
Melody Petersen
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| Physicians must tell their patients the truth" about crestor, the influential British medical journal The Lancet had stated in 2003. Compared with its competitors, the journal said, crestor has "an inferior evidence base supporting its safe use."
The erectile enhancement drug Cialis, on the other hand, could cause dangerous drops in blood pressure. A small number of patients taking it had mysteriously gone blind.
By marketing on the golf course, the drugmakers avoided federal rules that required them to tell consumers of the dangers. |
J. Douglas Bremner
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| Since that time there have been 65 cases of rhabdomyolysis with crestor reported to the FDA, some of them fatal. Although death from statins is rare, given the large number of people who take these drugs, muscle pain (myalgia) in the absence of changes in laboratory values like CK are more common, affecting 2% to 3% of patients. Studies have shown that myalgia can be associated with changes in muscle tissue.
All of the statins can cause problems with memory and joint pains. In fact, on Web sites like askthepatient.com statins are one of the most negatively rated drugs around. |
David Winston, RH(AHG), and Steven Maimes
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 Millions of people are taking prescription drugs such as Lipitor, Zocor, Pravachol, Mevacor, and crestor to lower cholesterol levels. The prescribing of these drugs is based on the hypothesis that high cholesterol levels cause heart attacks. Unfortunately, serious side effects have been reported for these drugs, which are prescribed for preventive purposes.
Cholesterol reduction in some cases can be achieved without drugs, and adaptogens can help. Several adaptogens, when used along with dietary changes, exercise, and supplements, can help reduce cholesterol levels. |
Brenda Watson and Leonard Smith
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 For example, in August 2003, the FDA approved a statin drug called crestor (rosuvastatin calcium). But because high amounts of it can cause muscle destruction that may lead to kidney damage (and failure), it can be prescribed only in small doses and requires doctors to monitor a patient's muscle enzymes and kidney and liver functions every three months. (For more about toxins and pharmaceutical drugs, see Appendix C.)
A connection has also been found between exposure to cadmium and lead and an increase in cholesterol levels. |
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| THE STUDY
For the trial, 507 patients at 53 health-care centers in the United States, Canada, Europe and Australia were given 40 milligrams (mg) of crestor daily.
Plaque build-up was measured at the beginning of the study and two years later using intravascular ultrasound (IVUS). The researchers were able to report information on 349 of the participants.
In total, 64% of the patients showed a regression of atherosclerosis. The average LDL level fell from 130.4 mg/dL (milligrams per deciliter of blood) to 60.8 mg/dL, a reduction of 53.2%. |
Hyla Cass, M.D.
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 For example, widely prescribed statin drugs, such as crestor and Lipitor, block the activity of an enzyme that creates cholesterol in the body—but this action depletes the body of a substance called coenzyme Q10, which is vital for heart health.
Enzyme
A protein that accelerates the rate of chemical reactions, without being damaged or changed by the reactions.
5. Increased loss of nutrients through the urinary system. Any drug that causes an increase in urination can drain the body's levels of water-soluble nutrients, including B vitamins and minerals such as magnesium and potassium. |
Greg Critser
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 AstraZeneca, the maker of crestor, has chosen to fight such charges, investing millions in a public relations and ad campaign to establish crestor as the next blockbuster statin. It is too soon to tell what will happen.
There is also the concern that wholesale adoption of statins essentially causes people to indulge in imprudent lifestyles — a kind of "I'm on Lipitor so give me my Big Mac and shut up" mentality. |
Bottom Line Health
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| But the agency concluded that the available evidence about Crestor's safety does not warrant its withdrawal from the market. Public Citizen isn't likely to change its stance, despite this new research.
"The study is a bit less impressive than perhaps is put forth," says Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group. "Many patients were lost to follow-up. And there is no comparison group, so we have no way of knowing if some other drug might not have accomplished exactly the same thing," he says. "It leaves many questions unanswered. |
J. Douglas Bremner
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| The statins like crestor that have greater potency are offset by more side effects. I recommend taking a statin that you can buy in generic form, like atorvastatin (generic Lipitor), since it costs much less. |
| Graham identified five widely prescribed drugs still on the market that are particularly dangerous, including Accutane, Bextra, crestor, Me-ridia, and Serevent. (In 2005 Bextra was taken off the market.)
While it's true that many drugs help people live longer and better lives, myriad others may be harmful in ways you're unaware of. Dr. Graham's testimony provided the public a fleeting glimpse of the knowledge that is normally hidden from view or frustratingly difficult for the average person to access. |
Melody Petersen
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| Compared with its competitors, the journal said, crestor has "an inferior evidence base supporting its safe use."
The erectile enhancement drug Cialis, on the other hand, could cause dangerous drops in blood pressure. A small number of patients taking it had mysteriously gone blind.
By marketing on the golf course, the drugmakers avoided federal rules that required them to tell consumers of the dangers. They also happened to be taking a page from the marketing manuals of R. J. Reynolds and other tobacco companies. |
Hyla Cass
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| For example, widely prescribed statin drugs, such as crestor and Lipitor, block the activity of an enzyme that creates cholesterol in the body—but this action depletes the body of a substance called coenzyme Q10, which is vital for heart health.
Enzyme
A protein that accelerates the rate of chemical reactions, without being damaged or changed by the reactions.
Increased loss of nutrients through the urinary system. Any drug that causes an increase in urination can drain the body's levels of water-soluble nutrients, including B vitamins and minerals such as magnesium and potassium. |
Andreas Moritz
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 Nexium, Prevacid, Lipitor, aspirin, Celebrex, crestor and other such drugs have become household words. Neighbors, friends and relatives are all taking at least one pill, and more often, several pills, each day for months and even years. Television, radio and print media are full of praise for their "life enhancing" benefits. Newspapers go even one step further. Not a day passes without an article or two heralding the latest study "demonstrating" the supposed benefits of the wonder drugs. |
Ray Moynihan and Alan Cassels
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 The newest statin, AstraZeneca's crestor, has also faced calls for its withdrawal, because of very rare but debilitating side effects of muscle wasting and kidney failure.5
The dawn of the new age of cholesterol came in 1987, when Merck launched the first of the statins, Mevacor, amid much excitement in the medical marketplace. Mevacor was approved to lower cholesterol levels, which meant the drug could be promoted and prescribed to otherwise healthy people—a potentially enormous market. |
Greg Critser
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| A recent advertisement for crestor, a new statin yet to fulfill its original sales ambition, is framed, in full color, by a cornucopia of fresh vegetables.) Does that mean many of the "wrong" people are taking statins? Perhaps. But there is also evidence that not enough of the "right" people are on them, particularly the poor.
Yet members of the statin-ACE tribe do share the winking notion that they have put fate on hold. Daily pills have become a reminder of risk, consciously reduced. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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 Other potential offenders include the antidepressants Paxil (paroxetine), Prozac (fluoxetine), and Zoloft (sertraline) and the cholesterol-lowering medicines Mevacor (lovastatin), Lipitor (atorvastatin), crestor (rosu-vastatin), and Zocor (simvastatin).
We can provide you with only a partial list of suspected fart producers. If you are watching what you eat, taking other precautions, and still suffering, you may want to discuss this issue with your physician. He might be surprised to learn that he is turning you into a gasbag. |
Ray Moynihan and Alan Cassels
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| Whatever the future of crestor and the other statins, or the prospects for more independent drug regulation and more unbiased guidelines, there is a growing skepticism about the selling of high cholesterol and the value of the drugs to treat it. In fact, right from the beginning of the cholesterol boom in the 1980s, critical thinkers like investigative journalist and health researcher Thomas Moore have been exposing the weaknesses in the arguments of those who would seem to welcome statins in the drinking water. |
| The timing could not have been better for the drug's manufacturer, as the journal article coincided with Crestor's launch into the massive U.S. market.
The American Heart Association seminar and the special journal supplement were both sponsored by AstraZeneca. So too was Dr. Brewer, though his links were not disclosed in his article in the journal supplement. At that time he was a paid adviser to the company, and a part of the company's stable of paid speakers. According to later public hearings in the U.S. Congress, Dr. |
| In the United States, decisions about whether or not a drug like crestor should be withdrawn are made by the Food and Drug Administration (FDA), the government body charged with assessing the safety and effectiveness of medicines. The FDA is well-known around the world, and its decisions can influence those of many nations. Yet just like the doctors, the patient groups, and the professional associations, the FDA itself now relies on partial funding from the drug companies whose products it is assessing. |
| The campaign against crestor has been led by Dr. Sidney Wolfe, the director of Public Citizen's Health Research Group. A six-foot-two piano-playing intellectual who walks to his Washington, D.C. office every morning, Wolfe is one of the most well-informed, aggressive, and influential health advocates in the world. Despite decades in the business, he continues to be outraged by what he sees as the unhealthy conflicts of interest that riddle the global medical establishment, even reaching into the heart of regulatory agencies like the FDA. |
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