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Mixed Signals On Medical Warnings

Jan 2, 2005 | USA TODAY

What's a consumer to do?

The back and forth on Crestor is dizzying. The newest and most-powerful cholesterol drug on the market is safe, insists its maker. No, it's not, some consumer advocates argue.

Crestor maker AstraZeneca says reports of adverse reactions to the drug are comparable to other cholesterol drugs. Advocacy group Public Citizen says those same reports show the drug has a higher-than-average rate of problems.

The debate isn't just between the company and Public Citizen. A Food and Drug Administration scientist last month told Congress that the drug is linked to kidney failure and a rare, but serious muscle disorder called rhabdomyolysis. He said Crestor is one of five drugs that needs more scrutiny. But, shortly afterward, the FDA issued a statement saying scientist David Graham's testimony does not reflect the agency's views.

All the while, a multimillion-dollar advertising blitz for Crestor continues. On television, viewers repeatedly see a Crestor commercial featuring a jogging woman fretting about her cholesterol. Readers of newspapers and magazines see full-page ads with coupons offering 15 days of free pills.

Caught between ubiquitous marketing and conflicting science, many consumers can't tell what to believe.

''Isn't it a shame we have a drug that's been on the market and reasonable people can disagree over whether it's too toxic to use?'' says Jerry Avorn, a professor at Harvard Medical School and author of ''Powerful Medicines, The Benefits, Risks and Costs of Prescription Drugs.'' ''No drug should be on the market this long and still have these questions unresolved.''

While all the talk may scare some patients, Avorn does not think that's bad. ''Americans, both patients and doctors, are more comfortable than they should be,'' he says. ''They think that somehow the safety of drugs is assured when they are marketed.''

The Crestor debate is set against a backdrop of growing concern over drug safety and comes just three years after another cholesterol drug, Baycol, was pulled from the market. It was linked with at least 31 deaths from rhabdomyolysis, which occurs when muscle tissues die and release toxins that can cause organ damage or kidney failure.

Ultimately, more attention to drug safety may result in changes at the FDA, longer approval times for drugs or increased oversight of drugs once they hit the market.

But the first effect may be to cool Americans' belief that newer is better and to steer them toward a wait-and-see approach that some doctors and consumer advocates have long urged.

''The real key is for people to go with newest drugs last,'' after trying older drugs with longer track records, ''not first,'' says Jay Cohen, an associate professor of Family and Preventive Medicine at the University of California-San Diego and author of ''Over Dose: The Case Against the Drug Companies.''

Insurers' warnings

Some large insurers already do that, placing most new drugs in a category that either requires prior approval before a prescription is written or requires that the patient make a larger co-payment toward the drug.

That gives the insurer time to consider the evidence in favor of the drug and weigh any safety concerns. Cost is also an issue with many new drugs, as they are often more expensive than the older products they aim to replace.

Insurers WellPoint, Premera Blue Cross, Anthem and Kaiser Permanente are among those with cautious policies on Crestor, which is in a class of drugs called statins. Those insurers encourage doctors and patients to try the older drugs first by offering them at a lower cost than Crestor.

David Campen of Kaiser Permanente, the nation's largest nonprofit HMO, says the generic statin drugs, along with name brands Zocor and Lipitor, work for most patients. Long-term studies of patients using those two drugs have shown that they not only bring down cholesterol levels, but also help prevent heart disease. Crestor is too new for such studies.

''If you have something that (you already know) is safe and effective for the vast majority of patients who have high cholesterol, why not use that first?'' says Campen, medical director for pharmacy services.

Kaiser Permanente patients filled 709,020 prescriptions for statin drugs in the first nine months of the year; only 293 were for Crestor.

Less drug testing

A concern about new drugs is that the tests leading to FDA approval often involve only a few thousand people not enough to reveal rare but significant side effects that may occur once in 10,000 patients. Those who don't try drugs when they are first marketed benefit from what doctors, drug companies and the FDA learn after tens of thousands of consumers do use them.

Some doctors say waiting a year or two before trying a new drug is long enough.

Sidney Wolfe, a doctor who heads Public Citizen's health research group, urges consumers not to use new drugs for the first seven years on the market, unless the drug is truly a breakthrough and there are no other options. Seven years are enough for regulators to uncover serious side effects and take action, he says.

Crestor's supporters say the drug offers advantages over the other statins. AstraZeneca says some patients on other drugs do not reduce their cholesterol enough.

AstraZeneca ads say Crestor lowers the so-called bad cholesterol an average of 46 percent at Crestor's typical starting dose of 10 milligrams. The ads say that's better than the performance of other brand-name statin drugs.

But the ad does leave out the generic competitor, lovastatin, which Consumer Reports magazine just named as the ''best buy'' in the statin category for many patients who need only a moderate reduction in cholesterol.

Crestor's ads imply that Crestor patients may be able to take a lower dosage of that drug than of another statin.

That's important, supporters say, because the possibility of side effects increases with a drug's dosage and strength. Warnings on statins include the possibility of rhabdomyolysis and of liver damage. Also, some patients do better on one drug than another, for reasons not always understood.

''It's important to have a variety of statins for patients to go with,'' says Michael Davidson, director of preventive cardiology at Rush University Medical Center in Chicago, who has done consulting for AstraZeneca. ''All the data we've seen says that Crestor is a safe statin.''

But Cohen says many patients with elevated cholesterol don't need a drug with Crestor's strength. A less-powerful statin might lower their cholesterol 25 percent to 35 percent.

''Most people with high cholesterol don't have major cardiovascular disease and don't need superstrong dosing,'' says Cohen, a doctor whose opinion is shared by some other doctors.

Cohen suggests patients ask doctors: ''Which is the mildest treatment that will do the job?''

An advertising blitz

''Mild'' is not an adjective associated with AstraZeneca's marketing, which touts Crestor's strength. AstraZeneca spent $122 million on TV and print advertising for Crestor from January through September - $28 million more than Pfizer spent on Lipitor, the top-selling cholesterol drug, says TNS Media Intelligence/CMR.

But its share of statin prescriptions remains well below AstraZeneca's goal of 20 percent. Crestor is the fifth-most-commonly prescribed statin in the United States, behind Lipitor, Zocor, Pravachol and generic lovastatin, according to IMS Health, a pharmaceutical information firm.

Even as it tries to whittle into competitors' leads, AstraZeneca also has had to counter concerns about Crestor's risks. The company's pre-market medical studies showed that Crestor at high doses was linked with rhabdomyolysis, the same disorder that led to Baycol's withdrawal. Seven patients taking a high dose of Crestor, 80 milligrams, developed the condition during pre-market tests. None died.

Those studies led AstraZeneca to withdraw its FDA application to market an 80-mg pill. In August 2003, the company was given approval to sell Crestor in doses ranging from 5 mg to 40 mg. AstraZeneca recommends a starting dose of 10 mg for most patients, although British health regulators suggest 5 mg may be more appropriate.

In its first week on the market, Crestor took off, garnering more than 18,000 prescriptions. Two months after it received FDA approval, company leaders were already calling it a ''megabrand.''

But a month later, the respected British medical journal The Lancet blasted AstraZeneca in a sharply worded editorial.

AstraZeneca ''pushed its marketing machine too hard and too fast'' with Crestor, the journal said. Physicians ''must tell their patients the truth'' that, compared with rival drugs, Crestor ''has an inferior evidence base supporting its safe use.''

Disputing the critics

AstraZeneca fired back in a Nov. 1, 2003, letter to The Lancet, saying 10,000 people had taken part in the drug's pre-market tests - more than for any other statin. The company had seen nothing unexpected in adverse-event reports since Crestor's launch.

''Post-marketing surveillance confirms its safety profile to be similar to that of other marketed products in the statin class,'' wrote Tom McKillop, chief executive of AstraZeneca.

But Crestor took another public relations blow in March when Public Citizen's Wolfe petitioned the FDA to remove the drug from the market. Public Citizen has a strong record as a drug-safety watchdog: Of 25 drugs that it has petitioned the FDA to remove over the years, 16 were withdrawn and five received new restrictions, Wolfe says. The FDA has not responded to the Public Citizen's petition.

The group said Crestor is more likely than other statins to lead to rhabdomyolysis.

AstraZeneca disputes that, saying Public Citizen relied on reports of muscle problems among patients in the pre-market trials who were taking 80-mg doses - dosages not approved by the FDA and not sold. Patients taking lower doses in the pre-clinical trials did not experience an unusual rate of muscle problems, the company says.

In October, Public Citizen criticized Crestor again, saying the FDA had received 29 reports of patients experiencing serious kidney problems, including kidney failure, since the drug's launch. That equals a rate per million prescriptions about 75 times higher than other statin drugs, Wolfe says.

He also says that by August, 65 reports of the muscle disease had been reported among patients taking the drug in the United States, many of them on a 10-mg dose. The rate of the muscle disorder, Wolfe says, is only slightly lower than that of the recalled Baycol.

'Uniquely dangerous'

''We think it's uniquely dangerous,'' Wolfe says.

AstraZeneca spokeswoman Emily Denney counters Wolfe, saying the company had investigated all 29 reports of kidney problems and found ''no causal relationship'' between them and the drug. Denney says the rate of the muscle disorder among Crestor patients worldwide is ''in line'' with other statins. All statins carry warnings that use could lead to muscle or liver problems.

''We have the utmost confidence in the safety and efficacy profile of Crestor,'' says Jim Blasetto, director of clinical development for Crestor.

A study published in February in the journal Cardiology, which reviewed AstraZeneca's pre-market clinical trials, concluded that statin drugs, including Crestor, may have a protective effect on the kidneys.

''My experience with Crestor suggests it is a safe statin,'' says Donald Vidt, one of the study's co-authors, who has been a paid consultant for AstraZeneca. He is also a consultant in the Department of Nephrology and Hypertension at the Cleveland Clinic.

Crestor's maker directs consumers to a company Web site, www.rosuvastatininformation.com, for more information about the drug. One chart on that site shows the rate of muscle-disorder reports per million Crestor prescriptions is comparable with other statins on the market, but it does not give the exact numbers of reports for any of the drugs, so it is hard to assess exactly where Crestor falls.

Other bar charts compare kidney failure reports for people taking Crestor and the other statins, showing kidney failures as a percentage of all adverse events reported to the FDA for each of the drugs. Again, consumers are not told the underlying number of cases from which the ratios are derived. Denney said the company would not release the totals.

But comparisons would be touchy even with precise numbers of adverse-event reports. Those reports, which are voluntary submissions to the drug company or the FDA by doctors and patients, are considered imperfect because not all adverse events get reported, nor are all reported problems caused by the drug in question.

Still, adverse-event reports are one of the ways the U.S. monitors drugs after they hit the market.

''The claims for its (Crestor's) danger as well as its safety are based primarily on these spontaneous reports, which everyone in the field recognizes are very unreliable,'' says Harvard doctor Avorn.

''Until this is clarified why not use the drugs that have been out there for years, where we know we have very solid safety track records and demonstrated outcomes?''


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