And there is a real drug effect on top of that.
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Researchers in the Canadian Network for Observational Drug Effect Studies (CNODES) performed a retrospective observational analysis of administrative databases in Canada, the UK and the US containing more than 2 million patients newly treated with statins. 59, 636 of the subjects already had chronic kidney disease.
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Merck is setting a good example by evaluating the drug in steps, carefully assessing its effect on patients, and not proceeding toward approval before testing the effect of the drug on patient outcomes in a large study.
Now some researchers are wondering if after Avastin is stopped, cancer cells spread more aggressively than before, dulling the drug's effect.
But CVT's scientists argued that they had done basic science that showed their drug's effect on heart rhythms was not harmful at all.
Also, the safe and effective levels of drugs such as sibrafiban are not yet known, and the patients included in the study may not have been high risk, so the drug's effect would be small, they added.
The Medicare Prescription Drug Benefit that went into effect this year pays industry health plans to cover the drug expenses of senior citizens.
In 2006, the Medicare Prescription Drug Benefit goes into effect, and that could mean the government, eventually, will be the main buyer for many prescription drugs.
The case illustrates the difficulty of pinning a side effect to a particular drug based on the scant reports of side effects that come to the FDA. It is extremely difficult to link a side effect, like an inflamed pancreas, with a particular drug.
Merck not only caught up by skipping a stage of trials (a risky move that often backfires), but its Januvia pill emerged with the entire market for the class when the Novartis drug ran into side effect problems at the FDA and was never approved.
The Food and Drug Administration has been emphatic about its preference for centralized cardiograph monitoring, and drug and biotech companies, in effect, are forced to utilize this technology to streamline new drug approvals.
Auroras scientists use a fluorescent marker to tell them whether a candidate drug molecule has had an effect on the target molecule.
Happily, the cancer drug Erbitux had a curative effect on him, as did the methods of Dr. Everett Nokes.
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This study is another reminder that the effect of a drug on cholesterol levels may not predict what happens to patients.
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Analysis of tissue from mice killed during the course of the experiment showed that the drug was having its intended effect.
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Not only does the technique tell you that your drug has had the desired effect it can also flag side effects you hadnt suspected.
It would be great to have a new drug that had a wonderful effect on lowering cardiovascular risk with incurring any untoward risks.
Stephen O'Sullivan, the assistant general counsel for Pharmacia, says that the proposed changes would have a chilling effect on new drug research and development.
One unusual effect of the drug is that it appears to reduce the gradual brain shrinkage seen in MS patients over time, says Mundel.
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If new symptoms turn up after taking a new medicine, they could be a side effect of the drug, not a symptom of the disease.
Some experts, though, warn against another commonly taken "cure" - paracetamol, which the US Food and Drug Administration says amplifies the effect on the liver.
It is far easier to demonstrate that a drug is having the desired effect in these diseases than in more complicated cancers that involve solid tumors.
Researcher Dr John Kastelein, from the Academic Medical Center in Amsterdam, The Netherlands, said the only side effect of the drug was some mild stomach problems.
Because of their small size the mipomersen trials were not powered to assess cardiovascular outcomes, though cardiovascular benefit is of course the ultimate intended effect of the drug.
At best, it signals broad trends or prompts action if there is a proven or at least a strong correlation between the drug and a suspected side effect.
It can add warnings, but these don't always have a big effect on a drug's use (see: " Fix No. 5: Forget Labels") and can get bogged down in negotiation.
Unfortunately, the reviewers found that limitations in the design of the trials, their conduct, and the way they were reported precluded any conclusions about the effect of the drug on complications.
Additionally, the "Ecstasy hangover" - feelings of excessive tiredness and irritability, alongside an inability to think clearly - is thought to be caused by an over-depletion of the chemical as the drug ceases to have an effect.
But if the toxic effects were caused directly by the intended effect of the drug (blocking gamma secretase), that would raise serious questions as to whether it is safe to continue with other trials of gamma secretase drugs now ongoing at other drug companies including Bristol-Myers Squibb.
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