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VIOXX Withdrawn

materia3

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May 1, 2004
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Merck & Co. announced this morning it will withdraw its arthritis drug Vioxx wordlwide.

Studies by the U.S. Food and Drug Administration indicate patients taking Vioxx have 50% higher risk of heart attack and sudden cardiac death than those taking Celebrex.

Merck is withdrawing the drug following data from a new three-year trial of Vioxx, designed to evaluate the effectiveness of the drug's standard 25 milligram dose in preventing recurrence of colorectal polyps. Such polyps often become cancerous.

In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo.

from a Merck & Co Press Release
 
Excellent, this shows that drugs trials are doing their job: identifying risks with medicines.

So much for "big Pharma" hiding unflattering results.
 
The Don said:
Excellent, this shows that drugs trials are doing their job: identifying risks with medicines.

So much for "big Pharma" hiding unflattering results.

And they did it themselves? Before the study was over even? As soon as the data began showing a problem? Impossible. :D
 
The Don said:
Excellent, this shows that drugs trials are doing their job: identifying risks with medicines.

So much for "big Pharma" hiding unflattering results.

Very true. This is one example we should remember.
 
I had someone on another message board tell me today that this would NEVER happen with a vaccine - that while they might pull a drug that poses a health risk, they're incapable of making similar determinations with vaccines.

Of course, that means Rotashield never happened.
 
sodakboy93 said:
I had someone on another message board tell me today that this would NEVER happen with a vaccine - that while they might pull a drug that poses a health risk, they're incapable of making similar determinations with vaccines.

Of course, that means Rotashield never happened.

Tell them it's not true. See for example the recall of IMOVAX HRV at:

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm53d402a1.htm

Or about Evans' BCG vaccine in Ireland having been recalled in 2002.

The action of Merck this morning stands in sharp contrast to the all out fight put on by unregulated makers of "natural" ephedra or ephedrine (MaHuang) containing products, a substance known to cause potentially fatal and any number of actually fatal cardiac arrhthymias. Not one of these firms, faced with the evidence that ephedra was dangerous, would voluntarily recall their products. Non-prescription ephedrine had be outlawed instead for this to happen. This was a long and litigous process with hearings and investigations and all the while people were dying from its side effects.

VIOXX was a number one money making drug for Merck which must now tell users to switch to a competitor's product:
Pfizer's Celebrex.

Is Merck happy about this? No. Will heads roll? Without a doubt. But as big Pharma, you can know , trust and appreciate they have a strong moral and fiscal obligation to halt the sale of any product found to be un-safe. Their liability is just too great. On the other hand, compare this with the no name makers of natural products who have few or no assets or insurance and will just reopen under a new name should they incur some major liability; lawyer's would hardly bother to even take such cases as they know at the end of the day they and their clients would get nothing.

The natural or supplement industry also shields itself with its "no claims" policy. There are few or no claims on their packages. Instead they rely on pamphleteers and books written for hire by dubious authors to put their product claims across to the public.

More so in recent years has the World Wide Web served as an important and far reaching means for the makers of these products to publicize their un-tested claims.
 
materia3 said:
Is Merck happy about this? No. Will heads roll?
By way of putting some numbers on this, Merck lost more than a quarter of its market value today alone, and it was already well off its high for the last year or two. The potential liability Merck could be facing in litigation could be of a similar order of magnitude.

Regulators are also taking a closer look at all drugs in the same class, which potentially threatens the introduction of a new drug by Merck that they're already marketing overseas.

Merck is pretty well screwed.
 
Zombified said:
Merck is pretty well screwed.

hardly. Merck is a giant company with an extensive and varied product line. this is merely a setback. a large one, but still only a setback.
 
sodakboy93 said:
I had someone on another message board tell me today that this would NEVER happen with a vaccine...

I had someone on another thread suggest that medicine was safe because some stupid commie liberal fought to ensure their safety.
 
EdipisReks said:
hardly. Merck is a giant company with an extensive and varied product line. this is merely a setback. a large one, but still only a setback.
I didn't say they were going bankrupt. However, they could end up getting bought by another pharma corp, and no matter what they will be many years recovering.

Regarding their product line, their biggest seller (cholesterol drug Zocor) will soon lose patent protection in 2006, and one of the new drugs they want approval for in the US is in the same class as Vioxx...

In another interesting twist, somebody traded an unusually large number of put options the day before this announcement, making a killing today. Insider trading perhaps...?
 
Zombified said:
I didn't say they were going bankrupt. However, they could end up getting bought by another pharma corp, and no matter what they will be many years recovering.

Regarding their product line, their biggest seller (cholesterol drug Zocor) will soon lose patent protection in 2006, and one of the new drugs they want approval for in the US is in the same class as Vioxx...

In another interesting twist, somebody traded an unusually large number of put options the day before this announcement, making a killing today. Insider trading perhaps...?

Merck has several drugs, including HIV and cancer drugs, in the pipe. they'll be fine. and being bought by another pharmcorp could potentially be good for both Merck and the shareholders.
 
materia3 said:
The action of Merck this morning stands in sharp contrast to the all out fight put on by unregulated makers of "natural" ephedra or ephedrine (MaHuang) containing products, a substance known to cause potentially fatal and any number of actually fatal cardiac arrhthymias. Not one of these firms, faced with the evidence that ephedra was dangerous, would voluntarily recall their products. Non-prescription ephedrine had be outlawed instead for this to happen. This was a long and litigous process with hearings and investigations and all the while people were dying from its side effects.
It's even more than that. It's the fact that this study was actually done.

OK, the original purpose of the study was to see whether the drug might protect against bowel cancer or something like that. But consider that altmed equivalent. We think our snake-oil might protect against bowel cancer? OK, let's just say so (well, not quite in so many words, but the same way as all the other claims get made). Actually look to see if the claim is true before marketing it for that purpose? Don't make me laugh!

Then, shock, horror, the data show something that wasn't expected, that the incidence of stroke and heart attack was higher in people taking the drug long-term. Do we think that alt-med, even in the unlikely event of its having started such a study, would have collected those data? Or taken them seriously? Again, flying pig time.

One more adverse effect thrown up by a properly controlled large-scale drug trial. To go with osteoporosis and retinol, and lung cancer and beta-carotene. And even HRT and heart disease. Things nobody even suspected from simply looking at patients anecdotally.

OK, the ephedrine was a bit obvious, but supposing other herbal or altmed products were doing stuff like the Vioxx was doing? How would anyone ever know? Nobody is doing the studies, nobody is obliged to do the studies, it's just plain scary.

Rolfe.
 
ANOTHER VIEW

What's the bet that...

1) Merck withdrew the drug to avoid being hit by a lawsuit.

2) There is no real effect here.

On the second point. Remember that the purpose of the study was to show if Vioxx reduced the incidence of polyps in the colon (colonic polyps are a precursor of colon cancer). The finding of an increased risk of heart attack and stroke therefore sounds like "data mining" to me. It could just be a chance effect. Remember the studies on electromagnetic radiation where data mining suggested that EMR caused leukaemia, but subsequent studies looking specifically for this effect failed to find one.

BJ
 
Re: ANOTHER VIEW

BillyJoe said:
What's the bet that...

1) Merck withdrew the drug to avoid being hit by a lawsuit.

2) There is no real effect here.

On the second point. Remember that the purpose of the study was to show if Vioxx reduced the incidence of polyps in the colon (colonic polyps are a precursor of colon cancer). The finding of an increased risk of heart attack and stroke therefore sounds like "data mining" to me. It could just be a chance effect. Remember the studies on electromagnetic radiation where data mining suggested that EMR caused leukaemia, but subsequent studies looking specifically for this effect failed to find one.

BJ

The FDA first noticed the effect in data analyzed four and one-half years ago. At the time, they ordered warning labels be put on VIOXX. This new data supports the earlier findings in a big way, and Merck took action.

Merck's withdrawl is a certain invitation for U.S. lawyers to being playing the "class action" suit game. They will advertize like mad, looking for anyone who was prescribed VIOXX. They will then launch class action suits in which they (the lawyers) get $1 for each $3 they get for the plaintiffs. You do the math. I'll bet a Google search will reveal the ads are already out there.

[Edited to add:]

Hoo boy
 
Well now it's a good time to buy stock in Merck.

Seriously, I resent being babysat once more with the implication that I cannot weigh the benefits and risks involved in a medication. Assuming that this time correlation is also causation, that is.
 
Is there anything here about having taken this drug in the past would possibly make one more subject to heart attack/stroke incidence in the future even though use is discontinued?
 
KFCA said:
Is there anything here about having taken this drug in the past would possibly make one more subject to heart attack/stroke incidence in the future even though use is discontinued?

Unknown at this time, according to an FDA spokesman.
 
Re: ANOTHER VIEW

BillyJoe said:
1) Merck withdrew the drug to avoid being hit by a lawsuit.

HAHA! NO way! You can't even imagine the lawsuits that are about to come out of this one! I'm sure there were hundreds (if not thousands) of lawyers across the U.S. yesterday that started salivating when this news was announced.

-TT
 
Is there a suggestion that Merck did not take action at the earliest opportunity. If they did, how can legal action succeed? Or doesn't it matter over there? Surely you cannot be expected to act on information that is not yet available.

It's ironic isn't it that, in the process of trying to extend the indications for using their drug, Merck succeeded only in destroying their drug completely.
 

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