Crestor Debate Intensifies
January 1, 2005 08:24

The Food and Drug Administration is raising questions about the cholesterol-lowering drug Crestor, the newest in a class of drugs known as statins. The consumer group Public Citizen has long been calling for Crestor's recall, citing a higher risk for a serious muscle disorder called rhaddomyolysis.

The Early Show medical correspondent Dr. Emily Senay notes that Crestor's statin cousins include Lipitor and Zocor.

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Crestor lowers a person's bad cholesterol, the "LDL," and raises good cholesterol, the "HDL."

If you need to lower your cholesterol, and diet and exercise aren't lowering it enough, statins are an excellent way to do it, Senay points out. Your first choice should be one of the statins that's been on the market longer, such as Lipitor, Zocor, Prevachol or the generic Lovastatin. ... Crestor ... supposed to be more aggressive and in some cases, ... cholesterol level.

(WebMD) A patient taking the cholesterol-lowering drug Crestor has died, the drug's manufacturer reports.

...Crestor and all other members of the family of cholesterol-lowering drugs known as statins.

http://www.cbsnews.com/stories/2005/01/11/health/webmd/main666161.shtml

(WebMD) A patient taking the cholesterol-lowering drug Crestor has died, the drug's manufacturer reports.

The death occurred in December 2004. Initial reports suggested the patient died of a muscle-damaging disease linked to Crestor and all other members of the family of cholesterol-lowering drugs known as statins. The same side disease, rhabdomyolysis, drove Baycol off the market.

Rhabdomyolysis is a condition in which muscle cells break down. This floods the blood with muscle proteins, sometimes leading to fatal kidney failure.

Sources: Emily Y. Denney, spokeswoman, AstraZeneca. John P. Cooke, professor of medicine and director of vascular medicine and biology, Stanford University, interviewed May 18, 2004. Sidney M. Wolfe, MD, director, Public Citizen Health Research Group, interviewed May 18, 2004.

http://www.cbsnews.com/stories/2005/01/11/health/webmd/main666161.shtml

AstraZeneca faces fresh questions over the safety of its cholesterol-lowering drug Crestor after it was linked to the death of a patient who was taking it. The company confirmed the death and has informed the regulators but said it was not clear the drug was the cause.

Although fatalities are linked to the class of drugs known as statins, of which Crestor is a member, there has been a specific campaign against AstraZeneca's drug, which increases the spotlight on its safety record.

Public Citizen, a US pressure group, has called for the drug to be pulled from the market and has said that it causes more side-effects than other statins, following its examination of doctors' reports to the US drug regulator. Heather Tomlinson Tuesday January 11, 2005 The Guardian

By Rosie Murray-West, City Correspondent (Filed: 11/01/2005)

Astrazeneca, the troubled pharmaceutical company, yesterday admitted that a patient taking its cholesterol-lowering drug Crestor had died of a condition that is possibly related to the drug. Crestor had already been associated with safety issues after a senior member of US drug regulator, the Food & Drug Administration, raised his own concerns. Yesterday's fatality report said that the death was "possibly attributed" to Crestor, and may have been due to rhabdomyolysis - the muscle-wasting condition that was a fatal side-effect of Bayer's withdrawn cholesterol-lowering drug Baycol, also known as Lipitor. Bayer is now facing large numbers of lawsuits relating to the withdrawal. Crestor is the company's most important new drug and has been viewed by analysts as a potential $3billion-a-year seller. The company has seen its stock tumble 28pc on a series of product setbacks since September. Yesterday the company's shares fell as much as 2.5pc at one stage but recovered to end the day down just 6 at ?19.32 after analysts' notes suggested the company could be taken over.

The cholesterol-lowering drug Crestor may be linked to the death of a patient, Astra Zeneca said on Monday. Staffan Ternby, information officer at Astra Zeneca, said yesterday that there is no proven link between Crestor and the fatality but at the same time a link cannot be ruled out.

http://www.thelocal.se/article.php?ID=845&date=20050113

Scientists Question if Patients Can Take Mevacor Safely Without Supervision

http://my.webmd.com/content/article/99/105193.htm

An FDA expert advisory panel is considering whether a popular cholesterol-lowering drug can be sold without a prescription.

The panel is scheduled to vote Friday on whether the statin drug Mevacor, sold generically as lovastatin, can be used safely without the aid of a doctor.

AstraZeneca PLC has sent a letter to British doctors advising that patients of Asian origin should be limited to 20 milligrams of its anti-cholesterol drug Crestor to reduce the risk of side effects.

The recommendation already exists for patients of Japanese and Chinese origin, and is being expanded, said AstraZeneca spokesman Steve Brown in London.

Studies show Crestor enters the bloodstream in higher concentrations in Asians than Caucasians.

U.S. prescribing guidelines mention the findings but do not explicitly recommend the lower dose. When the drug was approved by the FDA, AstraZeneca agreed to study the drug's effects on Asians in the United States, said company spokeswoman Emily Denney in Fairfax. That study is ongoing, she said.

The drug is now available in up to a 40-mg dose in the United States.

Crestor is nearing approval in Japan at doses ranging from 2.5 mg to 20 mg. About 150,000 of the globe's 15 million deaths from heart disease each year are in Japan, the company said.

Buoyed by tougher cholesterol-reduction guidelines and findings that it is the most potent anti-cholesterol drug at a given dose, AstraZeneca hopes to capture 20 percent of the statin market. But sales have been slower than expected because of competition and safety concerns.

In a report Wednesday, London equity firm Druganalyst suggested that AstraZeneca chief executive Tom McKillop had not been forthright with investors about prospects for its new drugs, including Crestor.

Bloomberg News contributed to this article. Contact Richard Sine at 324-2878 or rsine@delawareonline.com.

The drop for Pfizer's painkillers, Celebrex and Bextra, and AstraZeneca's cholesterol-lowering drug, Crestor, underscore how quickly sales of even established drugs can be hurt by negative publicity about their safety. http://www.usatoday.com/news/health/2005-01-13-drug-sales_x.htm

New findings that a little-known protein is as important as cholesterol in predicting heart attack and stroke could someday save tens of thousands of lives - and boost the prospects of AstraZeneca's embattled drug Crestor. Two studies published Thursday in the New England Journal of Medicine suggest that high levels of C-reactive protein, or CRP, can predict heart attacks and stroke as well as high levels of LDL, or "bad" cholesterol. So-called statin drugs, such as Lipitor, can reduce CRP as well as cholesterol, the studies show. CRP is produced as part of the body's reaction to inflammation. Ridker is now heading a major study, funded by AstraZeneca, to see whether Crestor reduces heart disease among people with high CRP levels but low cholesterol. If his theory proves accurate, Crestor may be the first of the statins in line to take advantage of a vast untapped market.

Contact Richard Sine at 324-2878 or rsine@delawareonline.com.

Scottsman.com reports that ASTRAZENECA, Europe?s third largest drugmaker, has confirmed that its cholesterol-lowering drug Crestor has been linked to the death of a patient.

The death, possibly due to the severe muscle-wasting condition rhabdomyolysis, has been reported to regulators worldwide, company spokesman Steve Brown said.

Mr Brown said the circumstances surrounding the death, which occurred in the latter part of 2004, were complicated and the company still believed Crestor?s safety profile was similar to that of other so-called statin drugs.

He declined to say where the death occurred or what dose of Crestor the patient had been taking. Crestor is the Anglo-Swedish company?s most important new drug but the product has been dogged by allegations over its safety.

Lawyers are circling the British-based AstraZeneca, amid debate over the safety of its cholesterol-lowering drug Crestor. Privately, drug company executives say the major firms each spend hundreds of millions of dollars a year on legal fees and costs.

Meanwhile, Bush is trying to cut a deal for big pharma!

INSTITUTIONAL shareholders of AstraZeneca have been holding ongoing discussions with the drug giant's remuneration committee, led by chairman Sir Peter Bonfield, about a new package which would give chief executive Sir Tom McKillop a substantial pay rise.

The decline in value follows regulatory setbacks to AZ's potential blockbuster drugs - particularly cholesterol treatment Crestor.

Drug firms seek profit in giveaways

Christopher Lemley is a marketing professor at Georgia State University who has seen it all when it comes to consumer advertising of prescription drugs. Yet even he was impressed when GlaxoSmithKline sent him a free pillowcase.

AstraZeneca Pharmaceuticals LLP is running a consumer-oriented promotional campaign that provides a 15-day, free supply of Crestor, its drug to treat high cholesterol, even though Crestor is under scrutiny for a possible higher risk of muscle deterioration and kidney problems.

The Washington consumer group Public Citizen has petitioned the FDA to have Crestor removed from the market. Dr. Sidney Wolfe, director of the medical research group at Public Citizen, said consumers should not take Crestor even if they get it for free.

Maybe all the change to eating beef like the west is taking its toll on the brain, not just the heart...

AstraZeneca and its Japanese pharmaceutical partner received final regulatory approval on Wednesday to sell the cholesterol-lowering drug Crestor in Japan.

AstraZeneca and Shionogi & Co., a Japanese drug maker, will jointly market Crestor in Japan. The approval was expected after Japan's Pharmaceuticals Affairs Council had recommended the OK in late December. The council also recommended that the drug not be given in a dose higher than 20 milligrams.

Crestor has been dogged by safety concerns, and AstraZeneca has advised British doctors that patients of Asian origin should be limited to 20 milligrams of Crestor to reduce the risk of side effects.

UK drugs group AstraZeneca said the recent death of a patient taking the controversial cholesterol-lowering treatment Crestor was not associated with the drug. It said that the patient's doctor had concluded that the death was due to an infection, although the deceased had a muscle-wasting disease associated with Crestor. The patient was on a cocktail of other drugs. Three people have died while taking Crestor. In the other two cases, post mortem examinations suggested the drug was not the cause but sales are suffering. AZ announces full-year results today. Crestor is among the statin drugs that can cause the potentially fatal muscle-wasting disease rhabdomyolysis and kidney damage. Campaigning group Public Citizen has called for it to be withdrawn and says it is more dangerous than other statins. http://www.guardian.co.uk/business/story/0,3604,1399457,00.html