Vioxx® Heart Attack and Stroke – Death

A heart attack that is caused by a suddent lack of blood to the heart–a myocardial infarction–results when one or more of the heart’s blood pathways (coronary arteries) become clogged or “occluded.” [1] The most common cause of cononary artery occlusion is when blood cells clot together and get stuck in the artery. [2] These clots are called “thrombi.” [3] As when water is unable to drain from a shower when the drain is covered with hair and soap, blood cannot flow through coronary arteries when blot clots obstruct the pathway, which in turn causes the heart tissue in the area to die. Similarly, strokes occur when clotting occurs in blood pathway to the brain. Clotting of blood is not an unusual function of the human body and usually occurs as a result of some form of injury.

Vioxx® was part of a class of drugs known as Non-Steroidal Anti-Inflammatory Drugs or “NSAID’s.” Vioxx® in particular was in a class of “Cox-2” inhibitors, which means that Vioxx blocked a particular enzyme in the body that is responsible for triggering pain and inflammation (cyclooxygenase). That’s the intended effect of Vioxx®. [4]

However, some believe that Vioxx also blocked a natural hormone-like substance in the body called prostacyclin. Prostacyclin is the body’s natural way of opening blood vessels and keeping the blood from clotting. This would be an unintended side effect of Vioxx®.

In 2005, the editors of the New England Journal of Medicine, a prestigious medical journal for medical professionals, printed an editorial accusing the manufacturer of Vioxx® of (Merck & Co., Inc.) concealing heart attacks suffered by three patients of a clinical study. The study had been published in the New England Journal of Medine (“NEJM”) in the year 2000.

Now almost six years later after the study’s altered results were published, this past Friday (4/21/06) we saw the fourth verdict against the Vioxx® manufacturer brought by victims of the drug. Punitive damages–or “punishment” damages–were awarded by the jury in three of these cases, indicating that NEJM’s editorial contention about concealing relevant side effect data, including the threat of death and paralysis, may have been accepted by each of the panels. Merck now accepts the contention that Vioxx® causes “thrombotic cardiovascluar adverse events.”

To say the least, this is concerning not only for the users of this particular drug but also users of any prescription drug approved by the Food and Drug Administration. What’s little known is that the FDA does not conduct testing on the drugs that it approves. The sole entity responsible for testing the drugs that are placed on the American market is the same entity that markets, sells and obtains profits from the drug. The FDA only reviews the data submitted by the testing entity to evaluate the propriety of the tests conducted, the protocol or test method and the test results in terms of whether the drug will pose an unreasonable risk of harm to the user.

If one is to believe that Merck changed the test results for Vioxx®, the system as it exists obviously allows unscrupulous companies to market and sell harmful drugs under the guise of safety (with FDA approval) to the American public without sufficient safeguards.

In fact and even more disturbingly, the drug was prescribed to countless patients with a pre-existing history of heart disease (which is when a person’s coronary arteries are already narrowed). So these unsuspecting patients with already narrowed arteries are given a drug that likely causes a reduction in the natural widening of arteries (which is already necessary for the pre-existing condition) and a reduction in blood clot protection (also already necessary for the pre-existing condition). Some also believe that the drug makes the blood cells “sticky,” causing even more clotting. The result of course is fatal and non-fatal heart attacks and strokes.

At present, three seperate juries have found that Merck knowingly sold a drug it knew to be harmful. These were not minor harms, but life-threatening ones. A member of the only agency monitoring drug safety admitted that the agency is incapable from protecting us from more Mercks.

I represent a number of Vioxx victims and will continue to contribute in bringing this company to justice on behalf of the victims of this killer drug.

Footnotes

[1] http://www.nlm.nih.gov/medlineplus/ency/article/000195.htm
[2] http://www.nlm.nih.gov/medlineplus/ency/article/000195.htm
[3] http://www2.merriam-webster.com/cgi-bin/mwmednlm?book=Medical&va=thrombus
[4] http://www.fda.gov/bbs/topics/ANSWERS/ANS00956.html