¿Podría volver el Vioxx? (inglés)
Merck's top scientist now says he would consider putting Vioxx back on the market.
Research chief Peter Kim announced the news before an advisory panel to the Food and Drug Administration. Doctors on the panel were debating whether Celebrex and Bextra, two Pfizer (nyse: PFE - news - people ) medicines that work similarly to Vioxx, cause heart attacks and whether their risks mean patients should no longer have access to them. Also up for debate were older drugs such as ibuprofen, sold by Johnson & Johnson (nyse: JNJ - news - people ) as Motrin.
After looking nervous for some time, Kim stepped up to the microphone and waited for the panel's head to address him. When Merck (nyse: MRK - news - people ) pulled Vioxx off the market because it increased the risk of heart attacks and strokes, it had stated that the company believed it would be possible to continue to market Vioxx with a strong warning label. Now, he said, the science was again evolving and some therapies that had looked safe for the heart may not be.
"Given this new data," Kim said, "it is not clear that the cardiovascular risk seen in Approve makes Vioxx unique in the class of similar drugs marketed in the U.S." Approve is the cancer-prevention study that turned up the heart risk for Vioxx.
Vioxx, he pointed out, was the only medicine that eased some patients' pain. It was the only drug in its class proven to reduce the risk of gastrointestinal problems, and it lacks the potential for a type of allergy seen in both Celebrex and Bextra. "Merck is a data-driven company," Kim said. However, he said the company has not altered its position on the withdrawal of Vioxx, and that to say anything further would be "speculation."
Kim said he's looking forward to hearing the advisory committee's thoughts and concerns, and to discussing the outcomes of the meeting. For tonight, at least, ahead of most of the FDA panel's biggest decisions, investors will be happy to speculate.
Garret FitzGerald, a pharmacologist at the University of Pennsylvania, said that he thought the move would help recapture the lost value of the drug to some patients. "It does illustrate the value of recognizing a problem and dealing with it."
http://www.forbes.com
Research chief Peter Kim announced the news before an advisory panel to the Food and Drug Administration. Doctors on the panel were debating whether Celebrex and Bextra, two Pfizer (nyse: PFE - news - people ) medicines that work similarly to Vioxx, cause heart attacks and whether their risks mean patients should no longer have access to them. Also up for debate were older drugs such as ibuprofen, sold by Johnson & Johnson (nyse: JNJ - news - people ) as Motrin.
After looking nervous for some time, Kim stepped up to the microphone and waited for the panel's head to address him. When Merck (nyse: MRK - news - people ) pulled Vioxx off the market because it increased the risk of heart attacks and strokes, it had stated that the company believed it would be possible to continue to market Vioxx with a strong warning label. Now, he said, the science was again evolving and some therapies that had looked safe for the heart may not be.
"Given this new data," Kim said, "it is not clear that the cardiovascular risk seen in Approve makes Vioxx unique in the class of similar drugs marketed in the U.S." Approve is the cancer-prevention study that turned up the heart risk for Vioxx.
Vioxx, he pointed out, was the only medicine that eased some patients' pain. It was the only drug in its class proven to reduce the risk of gastrointestinal problems, and it lacks the potential for a type of allergy seen in both Celebrex and Bextra. "Merck is a data-driven company," Kim said. However, he said the company has not altered its position on the withdrawal of Vioxx, and that to say anything further would be "speculation."
Kim said he's looking forward to hearing the advisory committee's thoughts and concerns, and to discussing the outcomes of the meeting. For tonight, at least, ahead of most of the FDA panel's biggest decisions, investors will be happy to speculate.
Garret FitzGerald, a pharmacologist at the University of Pennsylvania, said that he thought the move would help recapture the lost value of the drug to some patients. "It does illustrate the value of recognizing a problem and dealing with it."
http://www.forbes.com
posted by Klip7 at
4:19 PM
