RU5781 Posted March 31, 2007 Share Posted March 31, 2007 I don't have a link (I'm sure it's all over the internet) put today the FDA put pressure on Novartis to recall Zelnorm. They found that the drug causes a higher incidence of stroke and heart attacks, and can also lead to heart valve problems. I work for a drug company and this was all over today. Link to comment Share on other sites More sharing options...
MadBuffaloDisease Posted March 31, 2007 Share Posted March 31, 2007 The moral of the story is...when a new drug comes out, wait a few years before taking it. Link to comment Share on other sites More sharing options...
The Dean Posted March 31, 2007 Share Posted March 31, 2007 The moral of the story is...when a new drug comes out, wait a few years before taking it. I thought the moral was, "only take street drugs". Link to comment Share on other sites More sharing options...
RU5781 Posted March 31, 2007 Author Share Posted March 31, 2007 The moral of the story is...when a new drug comes out, wait a few years before taking it. Zelnorm was approved in July of 2002. It had gone through Clinical Trials before that, so you're talking at least 7-8 years of data on the drug. Link to comment Share on other sites More sharing options...
MadBuffaloDisease Posted March 31, 2007 Share Posted March 31, 2007 I thought the moral was, "only take street drugs". Sure. They've been around for years. Link to comment Share on other sites More sharing options...
MadBuffaloDisease Posted March 31, 2007 Share Posted March 31, 2007 Zelnorm was approved in July of 2002.It had gone through Clinical Trials before that, so you're talking at least 7-8 years of data on the drug. All drugs go through clinical trials, controlled by the drug company. How many drugs still hit the market, only to be pulled years later for killing people? Link to comment Share on other sites More sharing options...
ieatcrayonz Posted March 31, 2007 Share Posted March 31, 2007 I don't have a link (I'm sure it's all over the internet) put today the FDA put pressure on Novartis to recall Zelnorm.They found that the drug causes a higher incidence of stroke and heart attacks, and can also lead to heart valve problems. I work for a drug company and this was all over today. Very Ed like!!!! Pharmacuticals. Another instant classic. TWO SHAY Link to comment Share on other sites More sharing options...
Mr Info Posted March 31, 2007 Share Posted March 31, 2007 I don't have a link (I'm sure it's all over the internet) put today the FDA put pressure on Novartis to recall Zelnorm.They found that the drug causes a higher incidence of stroke and heart attacks, and can also lead to heart valve problems. I work for a drug company and this was all over today. Curious - what is your position in the company? Are you a Sr. Scientist, work in IT, Marketing, HR, etc.? There are many people who work in a pharmaceutical organization that do not have a good understanding of the development, pre- and post-market work (clinical studies, stability, etc.) that is involved. Link to comment Share on other sites More sharing options...
moorman8 Posted March 31, 2007 Share Posted March 31, 2007 Curious - what is your position in the company? Are you a Sr. Scientist, work in IT, Marketing, HR, etc.? There are many people who work in a pharmaceutical organization that do not have a good understanding of the development, pre- and post-market work (clinical studies, stability, etc.) that is involved. Here is a nice overview (kinda long) but there is a good figure http://www.jabfm.org/cgi/reprint/14/5/362.pdf Link to comment Share on other sites More sharing options...
Mr Info Posted March 31, 2007 Share Posted March 31, 2007 Here is a nice overview (kinda long) but there is a good figure http://www.jabfm.org/cgi/reprint/14/5/362.pdf Thanks, good for others. This was a question for the original poster. I am very well aware of the entire process - both domestically and internationally. Link to comment Share on other sites More sharing options...
DC Tom Posted March 31, 2007 Share Posted March 31, 2007 All drugs go through clinical trials, controlled by the drug company. How many drugs still hit the market, only to be pulled years later for killing people? Not that many. And any drug has side effects, some dangerous. The problem is: most people don't understand the tradeoffs between side effects and their medical conditions, and most doctors are too busy or lazy or arrogant to tell them (I've met all three kinds). And keep in mind: the data on Zelnorm that caused it to be pulled was developed in a clinical trial done by the drug company submitted to the FDA. Clinical trials don't stop just because a drug hits the market, nor do companies tend to hide the results. Link to comment Share on other sites More sharing options...
RU5781 Posted March 31, 2007 Author Share Posted March 31, 2007 Curious - what is your position in the company? Are you a Sr. Scientist, work in IT, Marketing, HR, etc.? There are many people who work in a pharmaceutical organization that do not have a good understanding of the development, pre- and post-market work (clinical studies, stability, etc.) that is involved. I work in LSDS (Late Stage Development Services) dealing with Phases III and IV of the Clinical trial. Link to comment Share on other sites More sharing options...
The Dean Posted March 31, 2007 Share Posted March 31, 2007 I work in LSDS (Late Stage Development Services) dealing with Phases III and IV of the Clinical trial. OH...YOU'RE the guy who skews the data. Got it! Link to comment Share on other sites More sharing options...
RU5781 Posted March 31, 2007 Author Share Posted March 31, 2007 OH...YOU'RE the guy who skews the data. Got it! Haha, there is no skewing whatsoever. The FDA watches like a hawk, and if they suspect ANYTHING fishy went on (anything, to the point if they even suspected we randomized the patients incorrectly), the fines are astronomical. Link to comment Share on other sites More sharing options...
MadBuffaloDisease Posted March 31, 2007 Share Posted March 31, 2007 Not that many. And any drug has side effects, some dangerous. The problem is: most people don't understand the tradeoffs between side effects and their medical conditions, and most doctors are too busy or lazy or arrogant to tell them (I've met all three kinds). And keep in mind: the data on Zelnorm that caused it to be pulled was developed in a clinical trial done by the drug company submitted to the FDA. Clinical trials don't stop just because a drug hits the market, nor do companies tend to hide the results. I agree with everything you said. But my main point was that drugs still make it to the market that end-up killing their users. I'm advocating waiting 5 years before using a medication, since that seems to be the timeframe for drugs to show themselves. Link to comment Share on other sites More sharing options...
Mr Info Posted March 31, 2007 Share Posted March 31, 2007 I work in LSDS (Late Stage Development Services) dealing with Phases III and IV of the Clinical trial. Could you elucidate a bit more? That can mean several things: a physician monitoring clinical compendium as they are submitted, someone studying the stability data, you could be dealing with suppliers, manufacturing, packaging, and labeling. The marketing staff is involved in analyzing this data. You could even be in IT, managing the databases/security where this data is located, or perhaps in QA/QC or compliance. End stage development could mean any number of things. If it is not obvious, I work for a pharmaceutical company. Actually, I have worked for several in both R&D and manufacturing. And, yes, I have some open positions...good analytical scientists, microbiologists, and formulators. Link to comment Share on other sites More sharing options...
Mr Info Posted March 31, 2007 Share Posted March 31, 2007 I agree with everything you said. But my main point was that drugs still make it to the market that end-up killing their users. I'm advocating waiting 5 years before using a medication, since that seems to be the timeframe for drugs to show themselves. If you can wait that long, that should be more than adequate time to make that assessment. A lot of people are unable to wait that long. For example, I know some people who are having a difficult time managing pain since Vioxx was withdrawn. They have tried other analgesics but they have not been as effective. These people would be willing to accept the risk associated with Vioxx for the pain relief. However, if a similar analoque to Vioxx was released, they would probably try it right away to see if it was effective for them. Of course, the assumption is that this is all being performed and monitored under the care of a personal physician. And, no, I do not work for Merck. Link to comment Share on other sites More sharing options...
ieatcrayonz Posted March 31, 2007 Share Posted March 31, 2007 Haha, there is no skewing whatsoever. The FDA watches like a hawk, and if they suspect ANYTHING fishy went on (anything, to the point if they even suspected we randomized the patients incorrectly), the fines are astronomical. Now even I'm confused. Are you trying to make people think you're Ed or Holcomb's Arm? Link to comment Share on other sites More sharing options...
RU5781 Posted March 31, 2007 Author Share Posted March 31, 2007 Could you elucidate a bit more? That can mean several things: a physician monitoring clinical compendium as they are submitted, someone studying the stability data, you could be dealing with suppliers, manufacturing, packaging, and labeling. The marketing staff is involved in analyzing this data. You could even be in IT, managing the databases/security where this data is located, or perhaps in QA/QC or compliance. End stage development could mean any number of things. If it is not obvious, I work for a pharmaceutical company. Actually, I have worked for several in both R&D and manufacturing. And, yes, I have some open positions...good analytical scientists, microbiologists, and formulators. Check your PM. Link to comment Share on other sites More sharing options...
RU5781 Posted March 31, 2007 Author Share Posted March 31, 2007 If you can wait that long, that should be more than adequate time to make that assessment. A lot of people are unable to wait that long. For example, I know some people who are having a difficult time managing pain since Vioxx was withdrawn. They have tried other analgesics but they have not been as effective. These people would be willing to accept the risk associated with Vioxx for the pain relief. However, if a similar analoque to Vioxx was released, they would probably try it right away to see if it was effective for them. Of course, the assumption is that this is all being performed and monitored under the care of a personal physician. And, no, I do not work for Merck. There is a drug from Sanofi-Aventis awaiting approval called Acomplia (it probably won't be marketed under that name). They are expecting sales to be around 12 BILLION in its first year. The drug deals with the endo-cabbinoid (sp?) section of the brain (the first of its kind). It was originally developed to help people stop smoking marijuana. What they found out was, it stops addiction (alcohol, food, drugs, smoking), lowers your blood pressure, lowers your cholesterol, and raises your good cholesterol. Practically everyone is going to jump on this drug (myself probably included). Sanofi better hope and pray that there are no serious events associated with this drug, or they're done. The only documented side ffects are it could cause/increase depression, and could raise anxiety is a small portion of people. Disclaimer: I don't work for Sanofi-Aventis. I read about this is Reader's Digest a few years ago (when it was being developed) and have follwed it ever since. Link to comment Share on other sites More sharing options...
Recommended Posts