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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by SLS on December 17, 2004, at 16:21:00
http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=7128209
Posted by thinkfast on December 17, 2004, at 18:59:39
In reply to Lilly Adds Warning to Strattera Label - Liver, posted by SLS on December 17, 2004, at 16:21:00
i threw mine out today!
Posted by King Vultan on December 17, 2004, at 20:22:51
In reply to Lilly Adds Warning to Strattera Label - Liver, posted by SLS on December 17, 2004, at 16:21:00
Sounds pretty minor--two liver problems reported out of 2 million users, with no deaths or liver transplantations involved. My guess is that in reality, it's not nearly as hepatotoxic as Tylenol is, which anyone can buy without a prescription.
Perhaps the warning will prompt further scrutiny and analysis, though, and more cases will be revealed that have not been reported up until now. Even so, I still think the number of reports at this point in time is incredibly trivial.
Todd
Posted by Dan Perkins on December 17, 2004, at 21:30:56
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by King Vultan on December 17, 2004, at 20:22:51
Look, if Lilly put a warning label on it, there is a much bigger problem than only 2 non-fatal liver problems out of 2 million users. I mean, if it were really only 2 people, why would they agree to add a warning label and attract all of this negative publicity? Two cases out of 2 million for any condition could easily be written off as chance (it is well within any conceivable margin of error), but for some reason they are making a point of saying that Strattera is the problem here, and the problem is always much much bigger than they admit to.
I don't know how serious this problem is, but I know that a major action like a label change isn't undertaken because 2 people have a problem. When are we going to learn that the pharmaceutical companies have our best interests at heart?
> Sounds pretty minor--two liver problems reported out of 2 million users, with no deaths or liver transplantations involved.
Posted by yxibow on December 17, 2004, at 22:33:11
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by Dan Perkins on December 17, 2004, at 21:30:56
> Look, if Lilly put a warning label on it, there is a much bigger problem than only 2 non-fatal liver problems out of 2 million users. I mean, if it were really only 2 people, why would they agree to add a warning label and attract all of this negative publicity?
Because of exactly the very conspiracy theory that I feel you may be alluding to; medications that have had benifits for the vast majority except 10 patient-lives out of a million have been pulled because the ambulance-chasers line up off and online ready to pull at the heartstrings of some who have nothing better to do than worry that floridation has ate their spleen. Now... I dont pretend to side with the drug companies... there have indeed been some disasters... drug companies market to the extreme, drugs should be made more cheaply available, the list goes on. But Lilly put the warning rather than get into a situation that BMS got into with the pull of Serzone from the market after a series of bad episodes, again in the small double digits of liver toxicity, but this time it had progressed beyond a mere warning.
It's a balance between having tools available for what is not necessarily noticed as life-saving methods for a market, e.g. schizophrenia (a $2+ billion dollar in the US) .. life saving being the restoration of hope and activity to at least some patients and the vast reduction of suicide, the same can similarly be said for bipolar --- and not having any tools at all because they're not perfect. Fifty years... heck I hope 25 years from now we'll look back at all the psychiatric medication and say that we were all groping in the dark. Some medications like Geodon have been returned to the market because post-post market studies have relieved them of a previously thought black box -- the QTc interval, one that still isnt on Mellaril.
Posted by Dan Perkins on December 18, 2004, at 8:16:43
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by yxibow on December 17, 2004, at 22:33:11
What medications can you name that are so helpful to people but have been pulled off the market b/c of "conspiracy theories" and "ambulance chasers??"
Billions of dollars are a stake and the drug companies have shown that time and again they put the interests of their shareholders of the interests of the consumers who take their medications. They don't pull drugs b/c of internet rumors, they pull drugs when the pile of dead bodies gets to high to ignore.Vioxx was approved and remained on the market for 4 years amid widespread skepticism ("conspiracy theories" I suppose you would call them) without merck pulling the drug and now we find that 55,000 people may have been killed.
> Because of exactly the very conspiracy theory that I feel you may be alluding to; medications that have had benifits for the vast majority except 10 patient-lives out of a million have been pulled because the ambulance-chasers line up off and online ready to pull at the heartstrings of some who have nothing better to do than worry that floridation has ate their spleen.
Posted by linkadge on December 18, 2004, at 9:39:26
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by Dan Perkins on December 18, 2004, at 8:16:43
The drug companies work day and night to preseve every penny they can gather. They know that adding a liver warning to Straterra will certainly make a big dint in their sales. Especially when straterra is marketed to an adult population as well, where liver problems are more likely.
The reason they say it is based on 2 cases is because they want to minimize panic and keep as many on the drug as possable, but in reality they
would not make this decision unless it was legally required, and 2 cases would not deem them legally required.
Linkadge
Posted by yxibow on December 18, 2004, at 16:01:00
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by Dan Perkins on December 18, 2004, at 8:16:43
My point was to address the gentleman who said "I'm throwing mine out today." I should have been more clear on that. Tests for liver function while on medication are fairly easy, I routinely have a panel of things for the polypharmacy that I face. Yes... if you look at severe trainwrecks like Vioxx then my argument doesnt hold, I agree. I was trying to carefully phrase things but its hard to phrase things carefully enough online. My point was more towards drugs like Geodon which were pulled because tests showed an elongation in the QTc interval --- which I fully agree is a bad thing --- before being returned to the market... however, drugs still prescribed routinely like Mellaril which elongate the QTc have never been examined in that light. I guess my point is that until Strattera is shown to have any more than a miniscule degree of reaction severity, if it overwhelmingly helps a patient, I would think the patient should still continue -- perhaps with a modest interval of ALT and Bilirubin tests. An average drug takes a number of years and countless millions to get to market; there is the flipside... the vast majority who aren't affected by a drug but who are faced with no other choice when it is pulled. Then people have to petition for orphan drug status. I'm just creating a healthy argument here. I speak for no side and I certainly don't want people to have liver injuries. I hope that clears things up.
Posted by Larry Hoover on December 18, 2004, at 16:44:12
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by yxibow on December 18, 2004, at 16:01:00
> My point was to address the gentleman who said "I'm throwing mine out today." I should have been more clear on that. Tests for liver function while on medication are fairly easy, I routinely have a panel of things for the polypharmacy that I face. Yes... if you look at severe trainwrecks like Vioxx then my argument doesnt hold, I agree. I was trying to carefully phrase things but its hard to phrase things carefully enough online. My point was more towards drugs like Geodon which were pulled because tests showed an elongation in the QTc interval --- which I fully agree is a bad thing --- before being returned to the market... however, drugs still prescribed routinely like Mellaril which elongate the QTc have never been examined in that light. I guess my point is that until Strattera is shown to have any more than a miniscule degree of reaction severity, if it overwhelmingly helps a patient, I would think the patient should still continue -- perhaps with a modest interval of ALT and Bilirubin tests. An average drug takes a number of years and countless millions to get to market; there is the flipside... the vast majority who aren't affected by a drug but who are faced with no other choice when it is pulled. Then people have to petition for orphan drug status. I'm just creating a healthy argument here. I speak for no side and I certainly don't want people to have liver injuries. I hope that clears things up.
I think the pendulum has swung too far.
For many years, no one questioned medication. Nor, for that matter, did they question adverse effects. It was all part of medical treatment.
Suddenly, the spotlight is on medication, and drug company profits. The litigious culture we inhabit today virtually demands spotless and perfect drugs. But there are no perfect drugs. There will always be adverse effects, some serious, occasionally fatal.
What strikes me most about the Vioxx information making it to press is that no article that I saw even mentioned the fact that only those people taking Vioxx above the recommended dose level had this adverse cardiac effect. Arguably, these individuals were sicker than those not taking high doses, but the drug is blamed for what really is not a huge effect, but which may also be due to confounding medical factors. More people die from tylenol every year than have allegedly died in the entire exposure to Vioxx, over all those years combined.
Under current medication guidelines, aspirin would never make it to market. I fear we've lost perspective.
Lar
Posted by Bill LL on December 20, 2004, at 10:26:58
In reply to Lilly Adds Warning to Strattera Label - Liver, posted by SLS on December 17, 2004, at 16:21:00
I would feel even MORE comfortable about using Strattera after reading this article.
I guess in today's environment, the lawyers want every conceivable warning on the label. I think that the label should say "Warning- this drug can cause all disorders known to man as well as some that are unknown".
Posted by mikerush on December 20, 2004, at 15:58:34
In reply to Re: Lilly Adds Warning to Strattera Label - Liver, posted by Bill LL on December 20, 2004, at 10:26:58
It's that drug companies have to cover everything or anything that can happen to someone while taking their drug. Tylenol is used by millions of people who also drink heavy not realizing that Tylenol is probably harder on their liver than drinking. People have committed suicide on Tylenol alone due to the fact that after so many grams are ingested it causes acute liver failure-I don't see this warning on their product.
This is the end of the thread.
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