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Report Shows Pfizer Fudged Drug Studies
CHICAGO - A study of internal company documents suggests Pfizer Inc altered or omitted unfavorable study findings to expand its epilepsy drug Neurontin's market, U.S. researchers said on Wednesday, offering a look at how drugmakers influence scientific research.
A study of internal company documents suggests Pfizer Inc altered or omitted unfavorable study findings to expand its epilepsy drug Neurontin's market, U.S. researchers said on Wednesday, offering a look at how drugmakers influence scientific research. (AP Photo/Mark Lennihan, file) Clinical trials are supposed to answer a specific, predetermined scientific question, but a comparison of Pfizer documents and published studies on Neurontin for conditions other than epilepsy found that eight out of 20 study reports never made it into medical journals.
And in eight of the 12 published studies, the primary outcome -- the answer to the main scientific question -- was changed by Pfizer, the world's biggest drugmaker, from the original study design.
"There were a lot of primary outcomes that were shifted around between the planning of the protocol and the reporting of the study," said Kay Dickersin of Johns Hopkins University in Baltimore, whose study appears in the New England Journal of Medicine.
"Some primary outcomes were lost altogether. Some were brand new. Some were secondary outcomes that were upgraded to primary," she said in a telephone interview.
The studies, all funded by Pfizer, showed how the drug worked in people with problems like migraines or pain, which are off-label uses of the drug.
Once a drug is approved, doctors are free to prescribe it as they see fit, and while companies are not permitted to market a drug for anything but the approved use, they can hand out reprints of studies published in medical journals showing how the drugs work in patients with different problems.
Dickersin got the documents while serving as an expert witness against Pfizer, which in 2004 paid $430 million to settle a lawsuit over illegal promotion of Neurontin.
Pfizer was sued again last year by lawyer Thomas Greene, who brought the original case against the company for off-label marketing practices, for holding back negative study results and changing the design of its trials to produce more favorable results.
That case was the latest in a string of allegations against the pharmaceutical industry suggesting it has controlled the flow of clinical trial research to boost its marketing position.
Pfizer spokesman Chris Loder said in a statement the suggestion that the company attempted to mislead the medical community is untrue and was "derived from a report created for litigation and coauthored by plaintiffs' expert witness."
Dickersin said the studies she reviewed are still not publicly available.
She said while there can be legitimate reasons to change a study's primary goal or endpoint, that change needs to be included in a formal amendment and published in a journal.
Not taking that step leaves a false impression, and in the case of companies, reveals the competing interests of scientists and marketing departments, she said.
To improve transparency, Dickersin said study protocols and primary endpoints should be required when companies register their clinical trials on the public database clinicaltrials.gov.
"It's important for us not to give up on trying to understand this because if we don't, the truth of science will not be upheld," she said.
(Editing by Philip Barbara)
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20 Comments so far
Show AllHow much more evidence do you need before you are willing to overturn Corporate charters and end this kind of abuse?
Oh my gosh, are you suggesting socialism?
At the very least.
Better yet, I advocate the destruction of the capitalist monopoly, and a return to livable small scale communities.
Tell me where and when.
Count me in!
i just can't bring myself to that awful place where i would even consider the notion that corporations would lie for money
how cynical you all are
they love jesus don't they
and america
don't they...
hello...
is anyone out there...
Another scary thing to contemplate: a LOT of the [legal] drugs sold here in the States are made in China. I wonder how long it will be before someone discovers that the drugs they were taking were contaminated with some harmful substance in a Chinese factory....
Its a freedom of speech issue. They were offering opinions!
Anything for the almighty market share and screw the American people, we can always make more of them!
PS: Big anything needs to go!
Yes, with the help of the Christers to ensure that every fetus conceived is one more sheep born. One more guinea pig for them. One more walking wallter. One more wage slave. One more soldier to fight their wars. Wow! What a wonderful world we live in!
Whaaaaaaat? Pfizer fudging drug studies? Butt...butt...butt...how can that be? How's that possible? Such honest folks? Naaaaw, I don't believe you. You must be pulling our chain.
Still, we wonder why we're all dying of strange diseases or why we're facing a plague like Alzheimer's and Diabetes. Still, some wonder why some of us won't touch any of the shit these bastards put out on the market for the idiots to self-medicate and slowly commit suicide with. Well, here's the perfect example of why.
I guess the best known case of a change of primary outcome occurred when that Pfizer heart drug was in phase I clinical trials but later marketed for ED (Viagra).
This is news?
Pfizer - Situational ethics-R-us ( ethics is an oxymoron where Pfizer is concerned)
I was in a drug study for Pfizer's Lyrica. Along with having serious side-effects that cause permanent damage, it also causes weight gain. During the study, they tried to blame me for gaining weight even though my food intake and my exercise levels had not changed at all. In a year, I gained 30 lbs while on Lyrica. To try to hide this effect, they put me on water pills, which had no effect whatsoever. They were willing to do whatever they could to hide this side-effect during the study...
The month after getting out of the study, my body shed 20 of the 30 lbs I had gained. Over the next few months, the other 10 lbs fell off too. During that time, my food intake and exercise levels did not change, so it is clear that the drug was responsible for the weight gain and getting off of it was responsible for my body returning to its pre-study state...
On top of that, the drug can cause permanent blurred vision. Although I received $18 per visit during the study, it will now cost me several thousand $$$ to correct my vision that was 20/20 before the drug study. As a result, I will never participate in another one of these sham drug studies...
Unfortunately, the FDA approved Lyrica for sale in the US even though for me, it had very limited benefits and caused substantial physical problems. IMO, this drug should not be on the market...
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The profile of side effects from real-life users is pretty identical to anti-depressants. I am still having severe problems, one of the worst is a badly-damaged nervous system, which affects a lot of other "body works." This is several years after being off the drugs, for thousands.
I feel for you. I get notices in the mail all the time about doing drug studies (don't know where they picked up my address), but I felt I was enough of a guinea pig for Paxil during the years on and this now 3-1/2-year post-Paxil period. No thanks. Enough is enough. And my vision. It changed in several different ways during withdrawal. I have permanent floaters in both eyes and my night vision is night good. I have to be very careful when I drive at night and if it's raining I try to avoid it. We've had whole threads devoted to these problems on PaxilProgress and one thing is certain -- it has nothing to do with age, these long-term issues are across the board.
I know they make a point in the Lyrica commercial of saying "this is not anti-depressant." What is that statement supposed to mean? Does that mean it's safer? Are they saying that anti-depressants are dangerous drugs, but Lyrica isn't (which it obviously isn't consider that side-effect profile, which is, as I said, almost identical to an AD side-effect profile)?
I don't know if I'll ever truly heal. I live in hope. But I am through being a guinea pig.
As far as manipulated drug studies, this is Pharma's MO and has been for several decades now. And we're going to read headline after headline like this for a very long time. What often goes hand-in-hand with stories like this is the basic uselessness of many pharmaceuticals -- i.e. 1-in-100 "helped" is often cited in articles. This was brought out in articles on both ADs and statins between December of 2007 and January of 2008. I remember vividly the articles from Pharma right after these studies came out fighting back. Sad thing is Pharma wins because your average GP listens to the drug rep only.
Lily's Zyprexa has also been in litigation for these same types of side-effects. They pay settlements and it's business as usual.
Fortunately, my eyesight can be corrected for about $2400 per eye. The procedure is the same as if I had cataracts. They have to replace the lens with a plastic one. Since the plastic is not flexible, there is a good chance that I will have to wear glasses after the surgery. I had perfect vision before taking Lyrica in the drug trials, so I'm really not happy about having to wear glasses. They did mention that Lyrica could cause blurred vision but never made it clear that the vision problems would be permanent even after getting off the drug...
Since that study, I have read blurred vision as a side effect on a lot of drugs. I refuse to take any of them. They really need to tell people that they are permanently risking their vision by taking some of these medications. For most, vision is extremely important, more so than the ailment they are trying to treat...
The sad part is that Lyrica offered me no benefit for FMS and CFS. I gave up my good vision for nothing. And now Pfizer is profiting handsomely off of the sales of this dangerous drug, which should never have been approved by the FDA. They are now allowed to sell this drug to people who are desperate for an effective treatment for FMS. Pfizer is allowed to profit handsomely while risking the health of desperate people...
.
I was given Nuerontin after I "assaulted," my psychiatrist. It helps prevent siezures. In people I come in contact with. And migraines.
careful with that shit.... ya can't just quit 'cold turkey' from some of these drugs or ya might have a difficult time waking up.
"drug dealers"
"drug pushers"
enough said?
Just remember, they and their cohorts helped write the medical bill, along with the insurance companies and the various Medical Associations. 1,190 pages. Buried in all that verbiage is a promise that this will not harm the profits of any of these companies; in fact it should increase them. So, it must be a good bill, right?
If you are a billionaire corporation, it is. If you are a poor wage slave trying to get help, forget it!