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Heart docs back Vytorin

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Day three of chatter about Vytorin's poor performance in the ENHANCE study, and the furor seems to be increasing. On one side: The notorious Dr. Steve Nissen--and various other experts and doctors--who say Vytorin either shouldn't be used at all, or might be useful after other statins have failed. On the other: The American College of Cardiology.

The elite group of heart specialists says that "major clinical decisions" shouldn't be made based on the new study data. "Conclusions should not be made until the three large clinical outcome trials are presented within the next two or three years," the ACC said in a statement. "Zetia remain[s] a reasonable option" for certain patients, the group added. Wall Street analysts called the ACC statement "a major win for Schering-Plough and Merck."

Meanwhile, other experts say that the outcomes studies aren't likely to show much advantage for Vytorin. And amid questions about why Vytorin ever got approved in the first place, the FDA says it's evaluating the data, including--Time magazine says--ads that claim the drug could overcome high cholesterol whether caused by diet or genetics. The New York Times weighed in with an editorial saying that unless and until the outcomes studies show big benefit for Vytorin, the drug "should be used sparingly." Stay tuned for more expert and quasi-expert judgment. We're sure plenty of it will continue to fly.

- here's the statement from the ACC
- see the report in Time magazine
- read the editorial from The New York Times
- see this item from the Wall Street Journal's Health Blog

Related Articles:
Vytorin fallout doesn't faze analysts. Report
Merck, Schering's Vytorin fails trial. Report
Merck, Schering left trial chief out. Report
Schering CEO defends Vytorin decisions. Report
Merck, Schering backpedal on Vytorin. Report

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Comments

Each and every time a doctor writes a prescription he is performing an experiment on his patient. The doctor may have an educated guess as to what those risks are from his prior experience, the experiences related by his colleagues and from peer review medical journals, however, while some side effects are relatively infrequent and/or minor, others can be fatal, or alter blood pressure severely causing a stroke, or can cause severe or fatal kidney or liver damage that cannot be repaired. Other side effects reported may have included erectile dysfunction, cataracts, alter the flavor of foods, tinnitis, double vision, constipation, headaches, urinary retention and so forth. There are drugs in common useage that cause deformities in an unborn child, and so on.

Nobody knows, or can predict what will happen to this patient with this dose at this time. This is why prescription drugs should only be used under the close supervision of a physician who can follow the patient and do adequate blood tests when necessary. A drug taken for years can have different effects as the patient ages or becomes pregnant. Patients take drugs or vitamins or herbs for different purposes that interact with a prescription drug and an unexpected or new side effect can occur. Allergies, drug resistance, drug intolerance, drug rash, drug interaction with other drugs the patient needs and so many other problems that it is impossible to explain here. Yet your doctor has to decide for you as to what is the best course of treatment for you.

Sometimes, when a patient becomes intolerant of a particular drug the doctor tries another drug from the same classs of compounds as the drug that caused the problem, however, in many casses the second drug has the same side effecrts as the first. On occaision, the second drug, even though it is related to the first turns out to be better than the first. This happened to me. I had crippling side effects on a particular anti-cholesterol drug that were so severe I had to be taken off the first one, lucky for me, the second one turned out to be better than the first and lowered my cholesterol lower than the first. This is probably the best reason to keep government out of the drug marketing business. Every drug marketed has some value and it is impossible to know in advance how implortant it will turn out to be. There are numerous drugs that came to market with the best intentions but had to be withdrawn later after severe side effects surfaced when used on a large scale. Other drugs have been around for trillions of doses, like aspirin, and new uses are still being discovered.

When a drug company markets a new drug related to an older drug, that is used for the same purpose, they are taking a big risk because there is no way to tell how well the new drug will do in the market and the cost of marketing is so high that it would be ridiculous to throw good money after bad. It would be better for government to avoid interfering with the marketing process because of the risks involved.

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