Generic Cholesterol Drug OK’D: Patients May Face Switch From Zocor
By Patricia Anstett and Lubna Takruri, Detroit Free Press
Jun. 24–With Friday’s decision by federal regulators to approve a generic version of Zocor, one of the world’s best-selling, cholesterol-lowering drugs, consumers now face a decision: Should they switch to a cheaper medicine?
The decision might be made for them. Many health plans require their members to at least try generics first, if they are available.
“I expect that will happen; I’m counting on it,” said Dr. Stephen Smith, director of inpatient cardiology at Henry Ford Hospital in Detroit.
But will patients agree?
“I’m not sure I’d want to switch,” said Charles Perras, 80, of Shelby Township, who has been taking the brand name drug Vytorin since his heart bypass surgery last year.
He said his cholesterol levels improved with the drug and that he’d “hate to see that messed up.”
The issue arose Friday when the federal Food and Drug Administration approved simvastin, a generic form of Zocor. It has doctors in the field debating whether cholesterol-lowering drugs called statins are equal. Some say brandname drugs offer more benefits and fewer side effects than generics. But others say most of the 22 million Americans who take the drugs can switch to generics without problems.
“For most consumers, the thing to do is talk to their doctor, if they are taking any statin right now to lower their cholesterol, about these new options,” said Steven Findlay, health care analyst with the Consumers Union and managing editor of Consumer Reports Best Buy Drugs. “For most of them, switching is what they will want to do.”
For consumers who pay for their drugs out of pocket, using generic statins might save them as much as $1,800 a year, according to a report posted Thursday by Consumer Reports at www.crbestbuydrugs.com.cqaustin
Even those with prescription drug benefits likely will save $200-$300 a year in co-pays, the report said.
Simvastin, the drug approved Friday, is the generic form of Zocor, which generated $4.4 billion in worldwide sales last year. Lipitor, made by Pfizer Inc., is the best selling drug in the world with $12 billion in sales last year.
The decision is significant because two other generic statin drugs that have been approved are less potent than their name-brand rivals. They are pravastatin, a generic form of Pravachol, and lovastatin, a version of Mevacor.
“A lot of people who need the more potent drug have not had a generic choice,” Findlay said.
Statin drugs fight the buildup of cholesterol in arteries, helping to prevent heart attacks and strokes. They are prescribed to those unable to lower their cholesterol levels through diet and exercise. Some already have had heart attacks and strokes. For others, the problem runs in the family.
Despite his job as an exercise physiologist and an active sports life, John Silveri, 28, of Macomb Township, couldn’t lower his cholesterol.
“I just have the genes on both sides of my family” to develop high cholesterol, he said. He tried Lipitor first, then Lescol, another brand-name drug. He’s not sure if he’ll be required to switch to another medicine because Lescol already is one of the cheapest drugs available.
The FDA considers generics to be biologically equivalent to brand-name drugs, “which means when the patient takes the generic, the expected outcome is the same as” with “the branded version,” said Atheer Kaddis, director of clinical program development at Blue Cross/Blue Shield of Michigan.
But among doctors, there’s debate about whether the drugs are better. Some brand-name drugs also may cause fewer side effects and may be safer to take with other medicines, such as blood thinners.
“I’m worried people will have to take generic drugs that aren’t as effective,” said Dr. Tom Rafai, head of the lipid clinic for UnaSource, a large doctors group in Troy. He prefers two brand-name drugs, Crestor and Pravachol, for those reasons. Rafai works as a consultant for Novartis Pharmaceuticals Corp., maker of Crestor.
Dr. Joel Kahn, director of cardiac rehabilitation at Beaumont Hospitals in Royal Oak and Troy, sees fewer differences. Most doctors agree that the statin drugs “are pretty similar,” he said.
If he can help lower a person’s cholesterol to a target of 150, “it pretty much doesn’t matter which one you take,” he said.
Unfortunately, many of the drugs have not been compared head-to-head in research studies, said the Henry Ford Hospital’s Smith.
Most HMOs give doctors financial incentives if they lean toward prescribing cost-saving generic drugs, which are known in the field as copycat drugs because they contain the key ingredients in best-selling name brands.
“Sometimes my hands are tied,” when a patient has drug coverage under plans that insist they try generics first, said Dr. Theodore Schreiber, chief of cardiology at the Detroit Medical Center.
Kaddis is working with 40% of Michigan’s physicians to educate them about generics. Blue Cross offers physicians annual incentives of $1,000 to $2,000 if they hit specific measures within the programs, such as increasing the prescription rates of generics.
“The majority of patients that have high cholesterol can be treated effectively with Zocor or the generic version, as opposed to having to go to the higher-potency drug,” Kaddis said.
Major drug manufacturers, including Pfizer, aren’t giving up without a fight. Pfizer blanketed doctors with e-mails this week, saying Lipitor was better than the generics. And Merck, maker of Zocor, has an agreement with Dr. Reddy’s Laboratories Ltd., an Indian company, allowing it to sell an authorized generic version of Zocor.
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Copyright (c) 2006, Detroit Free Press
Distributed by Knight Ridder/Tribune Business News.
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