| Posted at 8:44 AM on Apr 07, 2008 by jamesdouglasbremner, #29253 |
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AWESOME. thank you Dr. Bremner AND concernedcitizen!
Thank you so much for coming here and clarifying your quote. I was happy to hear that you felt that you weren't deliberately misquoted. I was a little confused by what was in an article written for the Financial Times - pharma wire. I kinda' thought that somebody deliberately changed what you said so that it didn't exactly contradict what the Merck guy said. I was glad to find out that you didn't think that. I think that it is a shame that reporters never republish corrected stories.
I have worked for a very big pharmaceutical company. I see from your website that you have a sense of humor and I hope I don't offend by next comments. Here are my thoughts as I read that article.
Dr Douglas Bremner, director of Emory’s Clinical Neuroscience Research Unit,(Dr. Bremner? I wonder who that is. I will have to find his website and look to see what he has authored That is how I found out that your quote was different.) noted that drugs can cause psychiatric effects when the targeted receptor also exists in the brain.(I had already gotten that far to know that there were researchers who claimed to have located them in the brain.) But he added that it’s unclear whether the brain has leukotriene receptors. (I was puzzled about the word "unclear." Unclear could mean not widely accepted. So I went back to the journal databases to try to find more. And I wasn't going to pay money to try to read some of them so it was a bit limited.)
He noted that despite the updated label, the side effects ”sort of flew below the radar.” (It sure seems that way. But I have a very hard time believing that.) However, he painted a grimmer picture of the effect on the market, saying this would affect Singular sales badly. People are likely to stop taking it, he added. (That is going to be a very difficult decision for many, many people. How do patients know what to do? It's not like we can put on our research hats and go out to our laboratories in our garage. I have allergies but never took Singulair.)
Over the past year, Merck has updated its safety label to include reports of tremors, depression, suicidality, and anxiousness, the FDA said. (Pharmaceutical companies don't update safety labels for no good reason. They want to sell drugs. Every side effect is a lost sale. It's not like Merck's legal department tells them to put blanket disclaimers on their products.)
(This guy--Dr. Philip's--statement looks to me like a cleverly worded public relations statement maybe written by the PR department - damage control unit).)
But Dr George Philip, senior director in clinical research for Merck, noted that none of the reports of suicidality came out of clinical studies. He added that post-marketing reports can be ”sketchy” and ”not well-defined” - making it more difficult to determine whether the drug caused the change in behavior.
Asked about whether certain high-risk patients should avoid Singulair, he said, ”It may be part of the dialogue moving forward. These are still unanswered questions.” (I think that many people will lose respect for Merck management over this issue.)
In another quote:
"We have no indication that anything about the mechanism of Singulair is consistent with these events (Thank you so much Dr. Bremner for confirming that we know about how this particular leukotriene receptor antagonist could potentially interfere with brain function)," said George Philip (man with forked tongue!!!!!!), director of research and product development, according to AP. "But because suicide is a life-threatening event we thought it was important to provide this information in the product label." (Did they put suicide on all of their product labels just because it was a life threatening event?)
In a statement released by Merck, they state that in their own analysis of trials of more than 11000 patients, there was no associated risk between them taking the drug and an increased risk of suicidal thoughts. (What did the interview questionaire look like? How are you breathing? Better? Good. See you next time?)
THANK YOU, Dr. Bremner for doing what you do!
doug bremner leukotriene receptors breaking story neural systems parallels medical conditions inflammation brain drugs relationship com blog bremner neuroscience research unit clinical neuroscience research journal databases psychiatric effects next comments financial times dr douglas difficult decision sense of humor pharmaceutical company merck hard time emory hats shame allergies radar