Merck settles suits over Vioxx

highway80west · 11-09-2007, 12:33 PM

Merck Settles Vioxx Suits for $4.85 Billion - AOL Money & Finance

Man, this really makes you wonder. I am sure that Merck must have conducted clinical trials with test subjects who felt no side effects from the pain-killer.

My younger sister took Vioxx when it was on the market, and when she realized it was too much, she was told to quit taking that medication. No painkiller in the world can help her. She's now losing sensations in her left leg.

fxashun · 11-09-2007, 02:38 PM

Now people that take the other drugs that Merck makes are gonna wonder why they have to pay so much.

highway80west · 11-09-2007, 03:09 PM

Quote:

Originally Posted by fxashun

Now people that take the other drugs that Merck makes are gonna wonder why they have to pay so much.

I should clarify this:

My sister got hurt twice on the job, but at different times. She hurt her knee first, then many years later she hurt her back.

It is mostly due to her back injury that came with pain, when she had to take the Vioxx medication. When other people were having debilitating side effects with taking the drug, my sister's doctor told her to stop taking it. Goodness knows what may have happened if she continued taking it.

She is going to be in pain for the rest of her life. And my comment about her knee remains.

She does see a pain specialist. I don't know what she is taking, but I know of one pain medication that makes her sleepy.

As for Merck, I guess Vioxx has probably the worst pain medication they ever made.

musica · 11-09-2007, 07:14 PM

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sgtdmski · 11-10-2007, 05:20 AM

With any medicine there are side effects. The problem with Vioxx is still up in the air, some say it caused heart attacks and strokes if used for as little as 30 days, others say that it takes continuous use for 6 months. Here, like everything else the good must be weighed against the bad. In this case, the over use of the drug by some caused them to have ill effects, in other cases there were no side effects at all. In either case, right or wrong, the drug did what it said it would do, relieve pain, pain that usually would not have been treatable with other drugs.

Merck spent billions to develop and test the drug, the FDA approved it, then after having been on the market, additional problems were discovered. So it is Merck's fault right........don't forget, the FDA approved its use.....where is the government's liability??

dmk

highway80west · 11-10-2007, 10:07 AM

Quote:

Originally Posted by sgtdmski

With any medicine there are side effects. The problem with Vioxx is still up in the air, some say it caused heart attacks and strokes if used for as little as 30 days, others say that it takes continuous use for 6 months. Here, like everything else the good must be weighed against the bad. In this case, the over use of the drug by some caused them to have ill effects, in other cases there were no side effects at all. In either case, right or wrong, the drug did what it said it would do, relieve pain, pain that usually would not have been treatable with other drugs.

Merck spent billions to develop and test the drug, the FDA approved it, then after having been on the market, additional problems were discovered. So it is Merck's fault right........don't forget, the FDA approved its use.....where is the government's liability??

dmk

You are correct, Sgt. Both parties were in this together. I am curious as to what the clinical trials showed.

Is it true that before drug is introduced, that there are clinical trials prior to the release of the drug?

I once participated in a clinical trial for a blood pressure medication. My BP was outstanding when I took part in it. My doctor and I believed that I was taking the actual medication, when I actually took placebos instead. The study was conducted by Bayer. And you get the sense that it was a double-blind study.

sgtdmski · 11-10-2007, 10:42 PM

The FDA requires several different clinical trials prior to the release of a drug. Hell before clinical trials can begin on humans, there are months if not years of testing in the laboratory. This website gives a great look at how a drug goes from idea to the market.

dmk

CrazyFlamingos · 11-11-2007, 09:58 AM

The fact is that Merck knew the dangers years ago. That is why they were sued and why they settled a suit that they were sure to lose.

Does the FDA bear some responsibility?

Of course they do. But is there any legal recourse against the FDA for the victims? Probably not.

Quote:

Vioxx Briefing Paper: A Timeline

Merck's Cover-Up Before Dr. David Graham Blew the Whistle in Nov. 2004

1998:

Merck conducts clinical trial (unpublished) called Study "090" which finds that among 978 patients, serious cardiovascular problems occurred six times more often in those taking Voixx than those not taking Vioxx (Merck said study not large enough to draw conclusions).

May 1999:

Vioxx is introduced with U.S. Food and Drug Administration (FDA) approval and no warning regarding cardiovascular risks is required to be placed on the label.

1999:

Merck conducts VIGOR Study—then, the largest-ever clinical trial of Vioxx—a study of 8,000 people designed to see if Vioxx was safer on the stomach than other pain relievers.

March 2000:

VIGOR study is concluded; Vioxx was found safer on stomach, but those taking it had a five-fold increase in heart attacks.
Merck's research president writes internal email in which he stated that "heart problems 'are clearly there,' and 'It is a shame, but it is a low incidence and it is mechanism-based as we worried it was.'"1
Dr. Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic, concludes based on the combination of both Study 090 and VIGOR that there is strong evidence that Vioxx is unsafe.

Sept 2001:

FDA sends a warning letter to Merck saying that sales representatives "have engaged in false or misleading promotional activities" and that its advertising "minimizes the potentially serious cardiovascular findings." They required Merck "to correct false or misleading impressions and information."2

2001:

FDA asks Merck to change the Vioxx label in order to make the warnings about cardiovascular risks more prominent on the packaging, but does not require the language to be placed in the "warnings" section on the label (Merck complies a year later).
Dr. Eric Topol conducts study (published in the journal of the American Medical Association) of available Vioxx data which finds "a very substantial worrying risk of heat attacks and strokes—across the board—from the VIGOR trial and about Vioxx."3

2002:

Merck makes the FDA-mandated labeling change to the packaging of Vioxx, but does not put the information in the "warnings" section on the package.

Large epidemiologic study reported a two-fold increase in risk of heart attack with high-dose Vioxx.
2004:
Merck spends over $1.7 million to oppose bills such as the Pharmaceutical Market and Drug Safety Act.4

Aug 2004:

Dr. Graham, Associate Director for Science and Medicine in FDA's Office of Drug Safety, reports his Vioxx study which said that Vioxx "increased the risk of heart attack and sudden death by 3.7 fold for high-dose and 1.5 fold for low-dose, compared to Celebrex."

FDA announces its approval for Vioxx use in children with rheumatoid arthritis.
September, 2004: Merck receives results of its APPROVe study which indicated that patients taking Vioxx for longer than 18 months were twice as likely to suffer a heart attack or stroke than those taking a placebo.
Merck "voluntarily withdraws" Vioxx from the market.

Nov 2004:

The FDA puts a report describing Dr. Graham's study on its website on election day.
The Lancet (British medical journal) publishes study that concludes that Vioxx should have been taken off the market several years ago.
http://www.atla.org/pressroom/facts/products/vioxxtimeline.aspx

fxashun · 11-11-2007, 10:17 AM

Another fact is that no one is gonna pay for this except the consumer. There needs to be some other "punishment" other than just a civil lawsuit which isn't that strong a deterrent.
I propose a drug company that gets found guilty of willful negligence should lose one or more of their patents on other drugs that they produce, or they become subject to government price controls for "X" number of years. THAT would be a much stronger deterrent IMHO.