samtsai.com

NEW ORLEANS — A federal jury handed Merck & Co. a major victory when it cleared the drug maker of any responsibility in the death of a 53-year-old Florida man who had a heart attack after taking its once popular painkiller Vioxx for less than a month.

This was the second court victory for Merck, and the first in a federal court. The company had argued in this case that plaintiff lawyers never proved any link between Vioxx and the heart attack Richard “Dickey” Irvin suffered in 2001. Merck’s lawyers contended Irvin’s age, gender and diet all put him at risk for heart attacks.

Source: canada.com

Well, it’s still not known definitively whether Vioxx can induce heart attack. Usually people who take Vioxx have other systemic illness and take other medications that may potentially interact with Vioxx, thereby confounding the conclusion regarding the safety of Vioxx.

This is a major problem associated with any NEW drug. There are potential risks involved when taking innovative pharmaceutical therapeutics. Phase III clinical trial is tested on healthy normal human being where a new drug may not have any major harmful side effect. When the drug is released and marketed for phase IV clinical trial, that’s where the problem starting to appear. Phase IV trial targets the public in general without selecting specific age/gender groups. When a new drug is particularly useful for geriatric patients who also take a multitude of various medications, drug-drug interaction and thus harmful side effects may take place. The more number of medications involved, the more complicated the potential drug-drug interaction, and the more difficult to delineate which drugs are the ones that cause the interaction. Thus, in order to know the exact etiology, it can takes tens of years to elucidate the underlying problem. Vioxx is a fairly new recent drug, so its pharmacokinetic profile is certainly less characterized than other older drugs, such as aspirin. Undountedly, there are always risks involved when taking a new invented drug. In order to provide a better quality of care, both doctors and particularly PATIENT THEMSELVES have to consider both risks and benefits of taking a new drug. Informed consent should be given to patients, but sometimes is still insufficient because people may not remember exactly the drug effects their doctors discussed with them during their visits. So whenever something wrong happens with the new drug, it’s not just doctor’s responsibility but also patients’.

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