This study is another reminder that the effect of a drug on cholesterol levels may not predict what happens to patients.
FORBES: AstraZeneca Study is Good News for the Public, Bad News for AstraZeneca
One unusual effect of the drug is that it appears to reduce the gradual brain shrinkage seen in MS patients over time, says Mundel.
FORBES: From Cicada Fungus To MS Drug: How Big Will Novartis' New Pill Be?
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.
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.
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.
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.
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.
One effect of tough action against drug firms trying to keep hold of monopoly profits on a diminishing number of best-selling drugs, will be an increase in the pressure for consolidation in the industry.
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.
She stressed that the findings don't have any effect on the use of the drug by hemophilia patients.
The news release also does not reveal whether higher doses of the drug showed more or less of an effect than lower doses.
This time the agency asked for a new study to test the effect of a high dose of the drug on heart rhythm.
WSJ: FDA Approves Amylin's Bydureon Diabetes Drug After Delays
To date, no drug has been approved in its leaf form because plants contain a complex composition of compounds with uncertain pharmacologies, metabolisms, side-effect profiles, toxicologies, drug interactions, and no control of relative concentrations.
The Medicare Prescription Drug Benefit that went into effect this year pays industry health plans to cover the drug expenses of senior citizens.
Prof Marais said the same effect is possible in other forms of targeted cancer drug treatment.
The "cure" took effect within only a few months of taking the drug.
Porges points out that because of the side effect issues, doctors may choose to try Copaxone instead of Avonex as half of a drug combo.
Merck is working on a drug that counteracts a major side effect of Niacin, an HDL-raiser that is already on the market.
Tredaptive included niacin, a statin and another drug meant to reduce the flushing side effect of niacin.
The niacin pill will be paired with another drug to curtail niacin's main side effect of unpleasing flushing or an overheated feeling.
"If parents are responsible, are monitoring their children's behavior, paying attention to them, spending time with them, that's going to have a positive effect and protect them from going down the path of alcohol and drug abuse, " says Maria M.
The study was based on data contributed by 596 patients with the disease, formally called amyotrophic lateral sclerosis or ALS. By showing that the drug didn't have any effect on progression of the condition, it contradicted a small study three years ago that suggested such a benefit was possible.
WSJ: ALS Study Falls Short, But Use of Social Media Holds Promise
And he answered questions on PFI hospital schemes, drug treatment places for those leaving prison and the effect of anti-terrorism laws on Muslim communities.
BBC: NEWS | UK | Politics | MRSA cover-up claim put to Blair
Milton Packer of the University of Texas, Southwestern, pointed out that if the available data on Simdax is pooled, the drug appears to have a neutral effect on the length of patients lives, and may actually extend them.
The prescription drug benefit portion of the law does not go into effect until 2006.
While not a huge effect, the results are all but certain to lead to approval of the drug, doctors said.
Analysis of tissue from mice killed during the course of the experiment showed that the drug was having its intended effect.
ECONOMIST: A way to counteract part of the process of growing old
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.
FORBES: High Potency Statins Linked To Increased Risk For Acute Kidney Injury
应用推荐