Development and testing of Vioxx.

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Though it seems that Merck withdrew the drug after FDA’s report on the side effects, I personally believe Merck’s scientists were already aware of what possible issues could arise due to use of Vioxx and therefore Merck did not actually show its responsible attitude towards the society. I also think that the company’ scientists were also having knowledge of the fact that the drug could possibly introduce cardiovascular complications for the patients who frequently used Vioxx.

My opinion can be bolstered by the report published in the Wall Street Journal in 1997 in which Dr. Alise Reicin, one of the Merck’s scientists, reported the possible outcomes of using Vioxx. Furthermore, the same scientist was also willing to present his findings to his seniors but that report was somehow suppressed which did not came out to the general public. As it implies, the company was concerned more with the monetary benefit than the individual’s safety and hence Dr. Alise’s findings were taken for granted.

Food and the Drug Administration (FDA) approved Vioxx in May 1999 for the treatment of osteoarthritis and subsequently in 2001 Vioxx became a bestseller. The sales of the medication reached high values of $2.1 billion only in the Unites States of America which consisted of about 10 percent of the total revenue generated by Merck that year.

A study group named VIGOR researched on arthritis patients taking Vioxx and found that comparative to other group of prescription medication name naproxen (Aleve), the risks for higher rate of hearts attacks were more evident in the patients who were using Vioxx for cure.

Then in 2000, Merck became more concerned with the side effects of their bestselling drug and paid attention to reformulating the composition of Vioxx by adding certain chemical agents that would effectively reduce cardiovascular risks and prevent the blood from clotting inside the veins, which blocked the blood flow and resulted in heart attacks. But as I mentioned before about the irresponsible attitude of the company towards the society, Merck continued to sell its product despite knowing the negative effects and hence put the public’s health in jeopardy.

Then soon after VIGOR’s study, FDA was alerted and urged Merck to include the warnings related to the use of Vioxx for arthritis and therefore after the notice Merck did as asked and with the new label in market, extra information was provided with each Vioxx prescription.

To support my argument furthermore, another research in August 2004, by FDA scientist Dr. David Graham, on the patients of “Kaiser Health Maintenance Organization” found that Vioxx had three times more risks of heart attack than in patients who used Celebrex – medicine by Pfizer pharmaceutical company. Merck, however, did not accept the study results and argued that the patients’ records used for the study were undependable in comparison with double clinical studies.

The situation got even worse and the results more reliable when in September 2004, scientists involved in research of the colon polyp study further clarified that Vioxx caused more than just twice the risks of heart attacks as compared to another medicine placebo. As a consequence of these results, the president of Merck’s research lab, Dr. Kim, rechecked the data issued in the report and had become more curious and focused on finding a solution to this issue which in the long run would damage the company reputation.

After the different research studies, and reports by scientists primarily linked with the field, ambiguous opinions rose in the market. They had two choices for the product:

  1.  Either include the label “High health risk” on the product and continue its sale
  2. Or completely withdraw the drug for the mere sake of public safety.

So all the above arguments and studies clearly imply that the company was aware of the issues from day one. This point is also further illuminated by the fact that the company also withdrew its decision to reformulate the medication because they were more concerned about the revenue they could get from the sales than the risks imposed on the public’s health.

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