Evidence in Vioxx Suits Shows Intervention by Merck Officials

[cal04]

In 2000, amid rising concerns that its painkiller Vioxx posed heart risks, Merck overruled one of its own scientists after he suggested that a patient in a clinical trial had probably died of a heart attack. In an e-mail exchange about Vioxx, the company's most important new drug at the time, a senior Merck scientist repeatedly urged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the Food and Drug Administration and in a paper published in 2003, Merck listed the cause of death as "unknown" for the patient, a 73-year-old woman.

The discussion of the death is contained in several previously undisclosed Merck records, including e-mail messages from Dr. Edward M. Scolnick, Merck's top scientist from 1985 until 2002, and from Dr. Alise S. Reicin, a vice president for clinical research, that indicate Merck's concerns about data contradicting its view that Vioxx was safe.

In one e-mail message, Dr. Scolnick said the drug trial that included the woman's death had "put us in a terrible situation." In others, he fiercely criticized the F.D.A. and said he would personally pressure senior officials at the agency if it took action unfavorable to Vioxx. As lawsuits against Merck over Vioxx move toward trial, the documents could help plaintiffs paint a picture of the company that is at odds with Merck's public statements that it had no evidence of Vioxx's cardiac risks until last fall.

Theodore V. H. Mayer, a lawyer for Merck, said that it had disclosed all information from clinical trials to the F.D.A. and that Dr. Scolnick's e-mail messages merely reflected his concern that the F.D.A. weigh Vioxx's benefits and risks fairly. The e-mail discussion between the Merck scientists reflected an honest scientific debate over the cause of the woman's death, Mr. Mayer said.



http://www.nytimes.com/2005/04/24/business/24drug.html

[MisterP]

1. what? bloated, greedy corporations aren't motivated solely by the goodness

of their hearts and lie incessantly? I think I have to lie down now.

[Straight Shooter]

2. This crap goes on all the time in Big Pharma and medical device companies.

They weigh the pros and cons of settling liability claims against profits. Then they media train their top personnel to respond calmly to criticism, so they appear intelligent and concerned.

It's criminal.

[Eloriel]

3. "First do no harm" -- (and nominated)

ooops, that's for MDs, not pharmaceutical companies, isn't it? Too bad they don't have MDs on staff..... wait! They do!

And some people wonder why there are some of us who would go to almost any lengths to avoid taking pharmaceutical drugs. There's not a single one of them that *I* know of that doesn't violate that cardinal rule of the Hippocratic Oath: First, do no harm. They rationalize it by saying, "Oh, but the GOOD this drug does outweighs the harm." That's not how I see it. That's like saying (too much like saying!): this will only kill you a little bit. Harm is harm. I prefer herbal and other natural healing solutions that actually do NO harm if taken properly.

[Horse with no Name]

4. This happens in almost all clinical trials

In 1992 I had one of the first laparoscopic Nissen Fundoplications.
I signed papers and entered the clinical trials--I believe they were following the progress of 100 patients for the study.
I have a medical condition that necessitated the surgery so I was good to go. During the surgery, they collapsed my lung which caused subcutaneous emphysema. They did not tell me they collapsed it because it was just a small one and I was on high concentrations of oxygen to fix the problem. I complained that it hurt to breathe and was told it was from the surgery. I never questioned it until I got the bill--I was in the hospital for less than 24 hours and my bill was over $30,000. I almost flipped out. At that point, I requested medical records and detailed billing and found out what had happened.
I also acquired a drug induced Hepatitis from the anesthetic that they used.
Was readmitted within a week of going home and then rehospitalized into ICU the next week.
While I was in ICU, when the doctor came around to discharge me, they told me that they didn't realize it at the time, but my original medical condition that I needed the Nissen for supposedly now disqualified me from the study--they just didn't realize it,lol.
Anyway--these studies are skewed to the favor of who is doing it.
Best example is the drug neurontin. It's off-label use for chronic pain was pushed on patients in the 90's and we were TOLD by drug reps that it was better than narcotic analgesia for patients in severe chronic pain. They had more pain?
Give them more neurontin--it seemed you could give almost endless supplies of the drug. Of course the patients still complained of pain and the doctors all just said they just wanted their narcotics and wouldn't prescribe any further pain medication because THE DRUG COMPANY SAID that they wouldn't need additional analgesic.
The whole thing made me sick when it came to light that neurontin did NOT take care of their pain and the drug companies knew it but perpetuated the myth that it did to line their pockets.
I would venture to say that thousands if not millions suffered at home AND in the hospital settings because of the lies of the drug companies.

[reprobate]

5. This ain't nohin'. Wait 'till you hear how Pfizer will let millions die..

to protect their profits. Can't wait? then google "A-1 Milano Gene" and prepare to fume in anger.

I think it's long been apparent that The corporate stucture of our society is antithetical to human life. Not just their grabbing for profit, but knowingly making decisions that they are aware will cause the death of millions, thru inaction on their part. The living proof that our society is terminally ill is the fact that we knowingly not only let them do it, but reward them with profits when they do.

My big fear is that at some point there are those that will 'take it' no longer, and start targetting the management of corporations that participate in such anti-life activities. I, for one, will shed no tears for them. "As you sow, so shall ye reap."