Vous vous souvenez de cet article très sérieux dont on a discuté ici et qui concerne les procés auxquels Pfizer doit faire face.
Oui mais vous avez raté les commentaires des lecteurs qui ont réagi sur le blog du WSJ
Eh voui, les familiers de Boursorama reconnaîtront Paxaloup. secondé par un damoiseau et in Pipo italien et même un Mike Bradford !
Je suis morte de rire, comme on aime à dire ici
February 2, 2009, 11:39 am
Pfizer Faces Celebrex, Trovan Lawsuits in Federal Court
Posted by Jacob Goldstein
Pfizer’s eventful week was capped on Friday by rulings in federal court that revived two separate lawsuits facing the company. The WSJ’s Law Blog has the legal nitty gritty, but here’s the gist:
An appeals court said 88 Nigerian families who are suing Pfizer over a 1996 study of the antibiotic Trovan can pursue their claims in the U.S. The ruling fell under a 1789 law that gives foreigners the right to raise claims in federal court in certain circumstances. There’s also been lots of action in Nigerian courts over this study, which evaluated the drug in children with meningitis.
In a statement cited by the New York Law Journal, Pfizer said its study was conducted with the consent of the children’s parents and “was consistent with both international and Nigerian laws.”
The Third Circuit Court of Appeals revived a securities lawsuit over the painkiller Celebrex.
The case turns on whether Pharmacia (which would later be acquired by Pfizer) hid the truth about the side effects of the drug. Basically, some investors are arguing that Pharmacia trumpeted six-month data that suggested Celebrex had fewer GI side effects than other arthritis drugs, even though the company knew the full, 13-month data would show no such benefit, the Legal Intelligencer reports.
Pfizer’s lawyers had argued that an FDA report on the study was a “storm warning” that led to a drop in the stock price and let the public know that the clinical study was longer than the six months. A lower court had dismissed the suit, arguing that the FDA report was enough of a warning.Comments
I just have to wonder just how far back the potential side effects of Celebrex were known before the storm came. The drug was originally developed by Searle, who was then bought by Pharmacia. Did the Searle researchers know more about the drug than they told? Were there concerns at that point about the potential for it to be linked to an increase in CV events? It now appears to be coming to light that those in charge at Pharmacia knew more than they were telling about the potential side effects of Celebrex. Did they know they weren’t being totally truthful? Was there key information that was known and suppressed? And now Pfizer holds the bag! It couldn’t happen to a nicer bunch, but what about those that were involved in any shenanighans from the beginning? Are they to go completely free? One has to wonder.Comment by Wonderer
- February 2, 2009 at 12:54 pm
Years ago, a lead physician, Dr. Walterspiel who worked on Trovan at Pfizer Groton, CT raised serious complaints all the way to the CEO about the unethical design and obvious safety problems implicit in the design of the Trovan clinical trials. Dr. Walterspiel was terminated and quietly and effectively silenced after raising these complaints. Despite this experienced physician’s warnings regarding the ethics and safety of the design of the Trovan study, Pfizer boldly proceeded forward with the Trovan study in Nigeria.
Someone should resurrect this physician’s story. It is time we stop this abusive power that corporations have lavishly and blatantly used throughout these years with little conscience toward human life or human dignity when profits come into the equation.
Pfizer is guilty as hell. Those Nigerian families deserve their day in court. Their dead and handicapped children who were entered into the Trovan trial do too.Comment by Trovan
-unethical clinical trials - February 2, 2009 at 1:51 pm
I agree. I’ve seen the same thing happen to others who dared to raise ethical concerns in Big Pharma. You’re viewed as disloyal, a traitor in the company, drawn, quartered and dismissed. The doc who tried to do the right thing is disgraced, while the firm proceeds with the wrong course of action. Unfortunately, when a doc enters pharma, they want you to leave your oath, your ethics and your moral compass at the door before you come in.Comment by Pharma Doc
- February 2, 2009 at 2:39 pm
PFE can’t get out of its own way. Due diligence be damned in their deals. They always assume the liabilities and don’t worry about the shareholders.Comment by Eatith
- February 2, 2009 at 3:57 pm
“Years ago, a lead physician, Dr. Walterspiel who worked on Trovan at Pfizer Groton, CT raised serious complaints all the way to the CEO about the unethical design and obvious safety problems implicit in the design of the Trovan clinical trials. Dr. Walterspiel was terminated and quietly and effectively silenced after raising these complaints.”
Yup. Complain to the CEO at Pfizer and you get the axe ASAP. So much for open door/no retaliation policy. Right Kindler?Comment by Yup
- February 2, 2009 at 7:41 pm
No sense in blaming Kindler. He wasn’t Pfizer back then. It was Bill Steere. I have reviewed this case and it seems full of bovine scatology to me.Comment by Mike
- February 3, 2009 at 12:36 am
NAPROXCINOD FROM NICOX NSAIDS
THE BEST IN THE WORLDComment by paxaloup
- February 3, 2009 at 6:49 am
je suis français et je vous conseille le seul AINS
qui n’a pas d’effets secondaires sur la TA ET la GI : le naproxcinod a blockbuster !Comment by paxaloup
- February 3, 2009 at 6:53 am
naproxcinodComment by blockbuster to come :
- February 3, 2009 at 7:16 am
mais je reconnais que le Celebrex reste un bien meilleur AINS que le naproxcinod !Comment by paxaloup
- February 3, 2009 at 7:22 am
noted that Celebrex has a detrimental effect on blood pressure but that the opposite of society NAPORXCINOD NICOX it reduces the latter. the potential of this medicine is enormous. hope that the FDA will agree itComment by smailait
- February 3, 2009 at 7:25 am
NAPROXCINOD pas NAPORXCINOD andouilleComment by paxaloup
- February 3, 2009 at 7:31 am
Nicox is the company, with future sales combined with integrity and ethic, what has lost Pfizer.
Invest in Nicox (nicox.com)Comment by Damoiseau
- February 3, 2009 at 8:07 am
Ey paxaloup it’s just a mistake i’ve just invert the O and the R so i know that it’s NAPRo and not NAPOR thanksComment by SMAILAIT
- February 3, 2009 at 8:12 am
NAPROXCINOD is NicOx’ lead drug. NicOx aims to develop NAPROXCINOD as an effective anti-inflammatory agent WITH NO DETRIMENTAL EFFECTS ON BLOOD PRESSURE and good gastrointestinal tolerability and safety.Comment by Mike Bradford
- February 3, 2009 at 8:31 am
Riteniamo che il naproxcinod presenti il potenziale per soddisfare l’esigenza di mercato in termini di farmaci anti-infiammatori caratterizzati da un profilo favorevole per quanto concerne la pressione arteriosa.Comment by Alfredo Pipo
- February 3, 2009 at 9:48 am
While pharma companies are certainly far-short of angelic, it is interesting that the bloggers above fail to note that THE TROVAN TRIALS HAPPENED DURING A MENINGITIS EPIDEMIC IN NIGERIA WHERE CHILDREN WERE DYING LIKE FLIES. Their strain of meningitis was resistant to the gold-standard so Pfizer brought in their experimental drug, Trovan, in. Yes, there may be side effects but it is important to note that the choice was either DEATH or the risk of side effects. In the US, there are thousands of terminally ill patients clamoring to have the FDA shortcut the path to use of experimental drugs. You can’t have it both ways. Another little note that the left-wing bloggers failed to report: the side effects the children have can also be attributed to the disease- meningitis attacks the brain and CNS. It cannot be attributed to the the drug. The way I look at it- the children survived a deadly disease. Yes they have lingering side effects but they could be DEAD AND HAVE NO SIDE EFFECTS AT ALL.Comment by NewYawkHawk
- February 3, 2009 at 9:55 am
There is more to the Nigerian Trovan trial debate than has been mentioned here. First, it is important to note that some illnesses are more common in developing countries—e.g., the “meningitis belt” in Africa, and thus studies need to be conducted in these settings, rather than in the U.S.
For example, in the 1996 meningococcal meningitis outbreak in Nigeria,
~12,000 children died over 6 months. (Three or four cases in a U.S. community would be considered an “outbreak.”) Pfizer’s study compared Ceftriaxone, given by intramuscular injections, to Trovafloxacin, given orally. Pfizer has been criticized regarding their informed consent documentation and IRB approval–not without justification, from the second-hand reports I’ve read, but…
What is rarely mentioned is that the survival rate was reportedly 94.4% Trovan vs. 93.8 Ceftriaxone. Nor is it widely known that Trovan was also being studied for meningitis in the US by well-respected pediatric infectious diseases specialists. The outcome in the US was clinical success in 79% of the Trovan patients vs. 81% in the Ceftriaxone group, and the longer-term sequelae showed no difference between the groups.
The Pediatric Infectious Disease Journal:Volume 21(1)January 2002pp 14-22
Nor is the value of developing oral treatments for infections generally discussed. Doctors Without Borders was treating other meningitis with intramuscular injections of Chloramphenicol—a wonderful drug that is now rarely used because it kills ~1/30,000 patients who receive it.
Multiple IM injections are painful, require sterile technique and more skilled health care workers than do oral medications. Supplies for injected drugs are more difficult and expensive to handle and administer, particularly in poorer, tropical countries.
Pfizer may not have not conducted this trial well or with adequate informed consent—I don’t know, as I wasn’t there. But I do know the horror of watching young people die from meningococcal disease, and I do understand the rationale and goal of developing an oral drug for a devastating disease that episodically kills thousands of children. While I am often critical of this company, they deserve a fair trial.
Judy Stone, MD
author, “Conducting Clinical Research: A Practical Guide…”Comment by Judy Stone, MD
- February 5, 2009 at 9:44 pm
The very words “Pfizer may not have conducted this trial well or with adequate informed consent” speaks for itself. Bottom line…Comment by Compassion for all
- February 5, 2009 at 11:00 pm