It is a terrible thing: at the dawn of the new Millennium, when the evolution seems to headily move forward, when the development of technologies outruns the time, people die from the side effects caused by medications - by the means called to heal and save.

The sad story of Vioxx (rofecoxib) started with its approval for marketing in 1999. The American Food and Drug Administration allowed selling the medication in the country after a number of clinical trials to evaluate the drug safety profiles were successfully conducted. The studies were sponsored by the manufacturer of the pill (Merck & Co).

However, even after the drug became available in the pharmacies, some studies were still in the process. The first trial to show the pills’ cardiovascular risks was the so-called VIGOR (1999/2000). Nevertheless, the manufacturer refused to pay any attention to its results, claiming them to be inconclusive and the study poorly organized.

Only after the above mentioned results were confirmed by the next study – APPROVe - Merck agreed that the pills exposed patients to a real danger of experiencing such adverse reactions as heart attack and stroke. The events then went on quickly: the company voluntarily (!) decided to remove the drug from the market stating that the safety of their patients had always been on the first place for them.

Oh, what a cynicism! The company’s authority had known since 1999 that people had been dying from their killer-drug, but only in September 2004 they suddenly remembered about their patients, having been taking their money without the remorse of conscience all the time before.

100,000 of heart attacks and 24,000 of cardiac deaths are linked to Vioxx. Thousands of people with undermined health, thousands of broken lives and lost hopes – these are the result of the “super aspirin” activity.

Vioxx was supposed to become a way out for those who were seeking for the alternative options of pain relief, because it was widely advertised as a stomach-protecting pill. It belongs to the group of COX-2 inhibitors – medications, which relieve pain without injuring stomach lining, since they do not inhibit COX-1 enzyme, as all the older pain-killers do. Besides, patients taking blood thinning medications were supposed to be able to use COX-2 inhibitors, as they did not affect blood clotting elements called platelets.

The story had ended a complete disaster and even a tragedy. These days scientists suggest that COX -2 enzyme is a cardioprotective protein, which activity is blocked by the COX-2 inhibitors, leaving a heart thus open to all the negative influences.

Another member of the group of COX-2 inhibitors is Bextra (valdecoxib) – a creation of Pfizer. Multiple trials, conducted after the tragic events with Vioxx, confirmed that the drug posed the same risks (and even with greater percentage) to the health of the users. Moreover, those taking Bextra were under a doubled risk of suffering a potentially life-threatening skin and mucous membranes condition Stevens Johnson Syndrome(SJS). 

Pfizer searched for the ways to make FDA let Bextra stay on the market. The manufacturer offered to include a “black box warning” on the pills package (which was actually done); they also tried to convince users and doctors that only people predisposed to cardiovascular disorders could experience severe side effects, or that only overdose could lead to adverse reactions.

No matter how hard they tried, they had to recall the drug form the market in April 2005.

These days the manufacturers of the COX-2 inhibitors are said to hope for the return of their once best-selling creations. Who knows, anything can happen in the world; and many people would not be surprised to observe such a story.

Though all the members of the COX-2 inhibitors are proved to have the same cardiovascular risks, the last drug Celebrex (celecoxib) is still available on the market with a “black box warning”.

It seems pharmaceutical companies have all the means to research and create new drugs, to properly organize studies and trials on animals, as well as on people, to evaluate all the risks and future benefits of their medications. It sometimes seems they have enough time and finances to create the drugs capable of saving lives. But do they have enough wisdom to do it properly, anyway?