Merck Disputes Voixx Report
A recent report in the British medical publication, The Lancet, stated that vioxx should have been pulled from the market four years ago. The drug, prescribed to many osteoarthritis patients, has been linked to a dramatic increase in heart attacks and strokes. The Lancet reported that the evidence pointing to this was available four years earlier, and this is when the drug should have been recalled.
Merck officials made a statement claiming that it was vigilant in monitoring and disclosing the cardiovascular safety" of the drug, and that the company "absolutely disagrees with any implication to the contrary." Referring to The Lancet's report, a Merck spokesman also stated that a further statement and critique has been placed on the company's website "to further clarify for the scientific community why Merck disagrees with the conclusions."
Merck claims that no evidence of these side effects was evident until a study that was performed earlier this year, and stated that up until this time "data from Merck's clinical trials showed no significant difference in cardiovascular risk."
However, although the drug was very recently withdrawn from the market, The Lancet still claims that the evidence was there four years ago, and that the drug should have been withdrawn years before now. Richard Horton, editor at The Lancet, stated: "The licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public health catastrophes. This controversy will not end with the drug's withdrawal."
FDA Memo Illustrates Extent of Vioxx Damage
A Food and Drugs Administration memo, which was published online, indicates that the recently withdrawn Cox-2 Inhibitor, Vioxx, could have contributed to around 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. The shocking figure was based upon a massive 92.8 millions prescriptions for the drug, which were issued during this time period.
The memo comes after FDA Associate Director for Science, David Graham, conducted a study with colleagues into the effects of Vioxx, and comparing this against the effects of another Cox-2 Inhibitor, Celebrex. Although the study showed that Vioxx did indeed increase the risk of heart attacks and stroke, Graham was advised not to present his findings at a conference in August, as he had planned to do, but to submit it for secondary opinion.
Merck Shares Plummet
Following the withdrawal of the arthritis drug, Vioxx, on September 30 th share prices of manufacturing giant, Merck, have plummeted. The stock fell by nearly thirty-eight percent following the withdrawal of the drug. However, shares fell by over ten percent again, further to the Wall Street Journal's publication of e-mails from company officials suggesting that Merck was aware of the dangers of Vioxx several years ago.
Trevor Polischuk, a drug analyst for Orbimed Advisors, stated that these e-mails will give fuel to those that want to lodge a lawsuit against the company for harm caused by the drug. He stated: "If the e-mails actually exist and say what they are purported to say, they appear at least superficially to be a smoking gun that lawyers could pull up as evidence against Merck." He did go on to say, however: "But it will probably be very difficult for plaintiffs to prove Vioxx hurt them because many patients probably had pre-existing heart problems."
One of the e-mails, which is said to have been written on March 2000, reportedly states that increased cardiovascular risks "are clearly there". This e-mail is said to have been written by research chief Edward Scolnick. A second e-mail, reportedly written by Merck research executive Alise Reicin, is said to suggest that high-risk patients be excluded from a trial so that the side effects of Vioxx "would not be evident."
