Talk:Abdullahi v. Pfizer, Inc.

Comments

Reasons for maintaining article status:

1. This article is merely a summary of four judicial opinions.

2. It is not clear why a summary of one judicial opinion, with discussion of the procedural history would be acceptable, but a discussion of four related opinions would violate wikipedia.

3. The only original sources quoted are case law. I also quote a newspaper article, that has, to my knowledge, been quoted twice by wikipedia. —Preceding unsigned comment added by Timsmyth (talk • contribs)

This article needs to be cleaned up

First of all the "summary" is too long. We need a summary of the summary, preferably outlining the main points. Secondly the pictures don't seem to have much to do with the actual case. Adding in a picture of the different courts of appeals in the US should be removed for something more pivotal to this case. Also Jimmy Carter shouldn't have his picture in there just for "getting involved". This article is very poorly done as of right now. Fatrb38 (talk) —Preceding undated comment added 11:23, 28 February 2009 (UTC).

NPOV Check

A trial litigation should involve the information for the both sides. However, this article is not giving much information about the Pfizer side of the lawsuit.--Gultepe.e (talk) 15:35, 3 March 2009 (UTC)

The reason for that I would assume to be the fact that Pfizer never responded to the allegations found within the lawsuit. (other than your standard boiler plate denials). All Pfizer did was file various motions for dismissal of the case based upon lack of juristiction and other such legal moves. The factual allegations were never addressed by Pfizer so it appears that we do not have their side to tell here at the moment.

As the article notes in response to Plaintiffs’ allegations, Pfizer filed a motion to dismiss, pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure and the court denied this motion. Then Pfizer attempted to have the lawsuit dismissed on the grounds of forum non conveniens which the court granted provided Pfizer consented to suit and acceptance of process in Nigeria. However the Court of Appeals vacated this dismissal and remanded the case back to the District Court after the plaintiffs could not prove that the alternative forum (Nigeria Court System) was corrupted. As such at this point in time Pfizer has yet to respond to the allegations found within the lawsuit proper. So we simply do not have their side to tell. Additionally they settled one case out of court in Nigeria recently; so again their responses remain hidden.

So this really would not be a NPOV issue as there is simply no other side to present. The article does not address the allegations raised within the lawsuit, but only Pfizer’s legal maneuvers to have it dismissed and the various actions taken by the courts. All the relevant facts are stated within the article in that regard. Indeed the article does need extensive editing, but not to comply with a NPOV standard but to reduce the amount of quoted text used and to make it more readable.96.254.92.203 (talk) 03:34, 23 October 2009 (UTC)Davidtfull (talk) 03:35, 23 October 2009 (UTC)

This page's subject become a section of the 1996 incident?

Is the 1996 incident notable enough to warrant a wikipaedia page of its own. If it is then the ongoing litigation could become a section in that new page. Litigation as a page in itself seems unusual. —Preceding unsigned comment added by 94.6.94.47 (talk) 03:11, 21 January 2011 (UTC)

2009 settlement

Just tagged 2009 settlement section as requiring update. The section states: "An out-of-court settlement was reached and will be put in writing at a meeting scheduled to take place in Rome, Italy in March 2009" and we're passed 2009 (the tag propoclol suggests a comment on the talk page if it's used) Icarusgeek (talk) 15:36, 25 April 2011 (UTC)

Quotes from Non-Neutral POV Prominent Figures

I removed the quote from Tom Lantos because it does not add factual material to the article and promotes a non-neutral point of view. The problem with quotes of this type is that they become "back door" approaches to introducing the opinions and non-neutral POV of editors into articles. One merely picks a prominent political figure whose opinion is similar to one's own, and by quoting that third party, is free to inject their own opinions into the article.

The person who added the Tom Lantos quote to this article may see Mr. Lantos as someone whose opinion he values. Would you be equally comfortable with someone adding value-laden quotes from Rush Limbaugh, Strom Thurmond, George Wallace, or Newt Gingrich? Perhaps a quote about Bill Clinton's character from Newt Gingrich in the first paragraph of the Wikipedia article on Clinton?

I think this is something we want to stay away from.

Respectfully,

Alfred Bertheim (talk) 07:48, 14 February 2013 (UTC)

Your logic applies to all references Alfred - one can cherry pick a review citation from the medical literature or academic book and exclude opposing viewpoints. On those grounds we could advocate for the deletion of the whole of the wikipedia encyclopaedia. For NPOV if a differing opinion from another prominent person exists then you can add that in to add balance. I am not sure about your comparison of republicans commenting on democrats - is there evidence of Tom Lantos being 'anti-pharma' or 'anti-medicine' or does he have a personal dispute with Pfizer? If not then the comparison is not relevant.--MrADHD | T@1k? 18:37, 19 February 2013 (UTC)

Hi Mr. ADHD,

I agree with you entirely regarding the cherry picking of citations from the medical literature. One way that Wikipedia tries to address this is by discouraging the use of primary references, and of case reports in particular. In my own edits I try to pick sources based on quality, and let them form my opinion rather than seeking references that support what I already believe. When they are available, I use systematic reviews from highly regarded, non-pharma supported sources such as the Cochrane Collaboration and the National Institute for Health and Clinical Excellence.

Unfortunately, even at the review level, it is possible for those trying to promote a certain point of view to cherry pick. But Wikipedia's policy is designed to minimize that sort of thing to the extent possible.

I think the quoting of public figures falls under the same concerns that are behind Wikipedia's policy on other easily cherry-picked sources. Alfred Bertheim (talk) 01:38, 21 February 2013 (UTC)

Okay but we are talking about a powerful corporation or very deviant monsters within a corporation who preyed on vulnerable powerless helpless children acutely sick with meningitis and abused them via fiddling with the dosage of medicines to deliberately kill them by lowering the dose of their antibiotic in order to get the 'results they want'. Normally on articles about child murders and extreme child abuse cases words such as evil, psychopath, monsters etc are used. However, in this article all we have is a senior politician who describes child abuse and child killing as 'appalling' and you think that a politician describing this as 'appalling' violates WP:NPOV? It does not violate WP:NPOV Alfred! Pfizer or people within Pfizer committed a wicked crime (for which they seem remorseless and unrepentent as well which makes it worse) and it is WP:FRINGE to call it anything less than appalling.--MrADHD | T@1k? 15:41, 23 February 2013 (UTC)

Please read WP:NPOV and WP:FRINGE to understand why describing child murder and very severe child abuse as 'appalling' is both neutral and mainstream.--MrADHD | T@1k? 19:37, 23 February 2013 (UTC)

Hi Mr. ADHD

I agree entirely that child murder is appalling, and have no issue with characterizing it as such. My issue is the assumption that events occurred literally as described by the plantiffs.

I freely admit that I am not an expert on this story, but the article as currently constituted contains no citations of eyewitness testimony from reliable financially disinterested third parties. The Nigerian government sought damages from Pfizer equivalent to 4% of the Nigerian GDP at the time. Nigeria regularly makes the list of the world's most corrupt countries, and there is little doubt that much of any award would go directly into the pockets of those officials leading the prosecution (http://transparency.org/cpi2012/results). Given the sorry state of human rights in Nigeria (Please see the Wikipedia article on this subject) I'm not sure that any "Independent Board of Medical Experts" can be considered truly independent. What we seem to have here is a conflict between a company with a history of ethical malfeasance and a corrupt national government, with no neutral witnesses.

As I noted in the article, the disabilities suffered by those who were enrolled in the trial were characteristic of those caused by meningitis, and not of adverse effects of the Pfizer drug. The mortality rate was also in line with that seen historically in antibiotic-treated children in African meningitis epidemics, though admittedly the mortality rates have varied so widely this latter statement is not saying much.

My position is not that Pfizer is innocent, only that in the absence of reliable and financially disinterested witnesses, its impossible to say for sure what actually happened. No independent court has ruled on the evidence and entered a judgement. A neutral POV requires Wikipedia editors to point out the relevant facts, and let readers make their own mind up as to what actually happened.Alfred Bertheim (talk) 15:53, 24 February 2013 (UTC)

Hi Alfred, for the Nigerian government to pull off such a conspiracy they would need to draw the families of the children into the conspiracy, the hospital staff etc which seems far fetched. Undoubtedly corruption exists in Nigeria but so to does religious faith and morality and surely such a conspiracy which would involve hundreds of people someone would come forward to Pfizer out of good conscience? How could the Nigerian government control the large numbers of people required to pull off such a conspiracy? Pfizer hired private investigators to dig for corruption and failed to find evidence of such a conspiracy to which you allude. Lack of evidence is probably because Pfizer or someone sympathetic to Pfizer destroyed evidence related to the case - documents, records etc going walkies.

Yes, the injuries are from meningitis but some of those children probably wouldn't have died or been injured if they had gotten the correct dosage of their cephalosporin drug.

Tom Lantos is actually a financially disinterested third party unless I am mistaken? Obviously ideally we want a court ruling but statements from the likes of him is about as best we are going to get. Do you have a source that says that the families of the children affected are mistaken or are being deceptive? Or that their legal teams are wrong or are being deceptive? If not then it is neutral to include Tom Lantos outside opinion on its own as it is not our fault Pfizer does not have people criticising the alleged victims. We are hear to summarise all notable viewpoints per WP:WEIGHT and WP:NPOV.--MrADHD | T@1k? 16:56, 24 February 2013 (UTC)

I think Lantos is financially disinterested, but he's just a guy like you and me expressing an opinion, and using him as counterpoint to the lack of court ruling seems a bit much to me. Also, he is a Holocaust survivor and perhaps emotionally biased to assign credibility to any story of crimes against humanity.

As for the families, I don't think they're in a conspiracy. But I doubt many of them are technically qualified to say what a standard dose of antibiotic is.

Again, I don't think we're really going to ever know exactly what happened here. But if you feel strongly about it, its fine with me if you change it back. I don't feel all that strongly about this issue. I just worry about the precedent that it sets. Alfred Bertheim (talk) 18:32, 24 February 2013 (UTC)

The issue is not Lantos' impartiality but the notability of his remarks. It's hard to find out their context because the reference seems to now be behind a pay-wall, but the word "panel" in the headline is suggestive. Far from being "just a guy like you or me" who is "emotionaly biased" by the Holocaust, Lantos spoke as a member of the House International Relations Committee as well as Congressional Human Rights Caucus (now renamed in his honor) and was in a far better position to participate in events than Rush Lindbaugh. The next step should be to clarify what "the report" in the removed sentence refers to. Sparafucil (talk) 09:27, 5 March 2013 (UTC)

In May 2006, however, at least one member of the United States Congress, Representative Tom Lantos of California, the senior Democrat on the House International Relations Committee, described the report’s findings as “absolutely appalling” and called for Pfizer to open its records.

Good points. I was unaware that Lantos had a related official role, and withdraw my objection as his comments are clearly notable. I suggest removing the phrase "at least" because it doesn't really add any new information to the sentence. I agree that the identity of the "report" is important.

I note that the intro to this article now contains a completely unsourced statement that Pfizer administered a "drastically substandard" dose of cephatrioxone to the control arm of the trial. Can we agree to either find a reliable source for this statement, or remove it in conjunction with adding the Lantos quote back in. I understand that people who believe this story occurred as alleged want this article to convey moral approbation. But I think we have to maintain Wikipedia standards, and unsourced statements are not part of that.

Pfizer maintains that the survival rate in both arms of its trial were higher than those of patients otherwise treated at the same facility, apparently referring to the use of chloramphenicol by Medicins sans Frontiers. http://www.pfizer.co.za/Themes/Content%20Themes/Pfizer_2012/Templates/general.aspx/?pageidref=1874. Chloramphenicol is rarely used in the US because of its association with bone marrow toxicity, leukemia, and aplastic anemia. Alfred Bertheim (talk) 12:36, 5 March 2013 (UTC)

The report reviewed by Lantos was the one generated by the Nigerian Medical review panel. http://money.cnn.com/2006/05/06/news/companies/pfizer_reut0506/index.htm Alfred Bertheim (talk) 13:11, 5 March 2013 (UTC)

I note that Mr ADHD has now added a reference to court documents in support of the claim that Pfizer used a "dramatically substandard" dose of cephatrioxone in the control arm. The reference is to a court document that I am unable to find online. Could you provide a link? As no US court ever ruled on the issues in this case, I suspect you are citing the plantiff's allegations, rather than a court ruling. This cannot be considered a reliable source. Furthermore, such claims seem to be contradicted by the observation that the death rate in the control arm was similar to the Trovafloxacin arm. Alfred Bertheim (talk) 13:39, 5 March 2013 (UTC)

It's actually in the statement by the defense, a pdf under "External links" at the bottom of the article. Thanks for the CNN link with Lantos 2006 promise to introduce legislation; I hope we can get the article more up to date. Sparafucil (talk) 21:33, 5 March 2013 (UTC)

Well, I'm learning all kinds of new things here Sparafucil. Thanks for that

You are entirely correct that the dose of cephatrioxone used by Pfizer in the trial, 100 mg/kg followed by 33 mg/kg on subsequent days is less than what is listed in the US package insert, which calls for 100 mg/kg every day.

On the other hand, I note

• that Pfizer's statement of defense states that the doses administered provide CSF levels well beyond what is needed for treatment, and that a study by Doctors Without Borders has demonstrated that doses substantially less than those used by Pfizer are highly efficious. The paper is here http://www.ncbi.nlm.nih.gov/pubmed/16039333, unfortunately the full article is behind a paywall. In case you do not have access, I quote: "[We]randomly assigned patients to receive either ceftriaxone (100 mg/kg to a maximum of 4 g, one intramuscular dose) or oily chloramphenicol (100 mg/kg to a maximum of 3 g, one intramuscular dose).... A second single dose (ceftriaxone 75 mg/kg or chloramphenicol 100 mg/kg) was given after 24—48 h in case of clinical failure, which was defined as: state of consciousness remaining severely altered....Rate of treatment failure at 72 h was about 9% both overall and for ceftriaxone and chloramphenicol separately (table 2); it was judged equivalent across the two treatment groups.

The cefatrioxone regimen used by Pfizer performed better than the chloramphenicol protocol used by DWB in the same epidemic, and comparibly to trovafloxacin, which is a very potent antibacterial.

The survival rates were high by historical measures in both arms.

If Doctors Without Borders can reduce the dose of cefatrioxone used by 90% relative to the standard dose based on MIC measurements and pharmacokinetic measurements and not be accused of unethical behavior, I have to assume that its not a completely unreasonable thing for Pfizer to do as well. It seems to me that based on the DWB paper, the similar mortality rate in the trovafloxacin and cephatrioxone arm, the lower mortality rate seen in both arms relative to the chloramphenicol regimen employed by DWB in the same epidemic, and the high survival rate relative to historical norms, I'm not comfortable that one can confidently say that Pfizer deliberately underdosed children to make its drug look better. If the article is going to make that conclusion, we should go over to the Doctors without Borders article and make the same accusation against them as well.

Regards and thanks for the stimulating discussion. Alfred Bertheim (talk) 04:50, 6 March 2013 (UTC)

P.S. I'd be very interested to see the informed consent document used by Doctors Without Borders for their clinical trial, which was designed to demonstrate that a 90% reduction in antibiotic dose would be equally effective. EVen if the rationale is excellent, how exactly does one ask permission from a mother of a child with meningitis, "oh by the way, we're going to use the same antibiotic we usually use in these cases, but at 10% the normal dose."? Alfred Bertheim (talk) 04:57, 6 March 2013 (UTC)

References

Ceftriaxone dose in intro - Unsourced claims

The intro states that Pfizer used a 33 mg/kg dose of ceftriaxone in the control arm. A search of the PDF verison of the source cited for the 33 mg dose in the text ("The Politics of Polio in Northern Nigeria") shows that this book discusses the Pfizer trial solely in terms of whether the use of Trovan was ethical, and does not discuss the dose of ceftriaxone or even mention the name of the drug. Pfizer's "Statement of defense", linked at the bottom of the page, states that they used a 100 mg/kg dose, followed by daily 33 mg/kg doses. Thus, unless there are other sources, the only source we have for the Pfizer dose of ceftriaxone is Pfizer's statement that they used 100 mg/kg with follow-up doses of 33 mg. The 33 mg/kg single dose claim is unsourced.

The intro also states that the standard dose recommended by Medicins Sans Frontiers is 100 mg. THe official recommendation by the World Health Organization at that time was not 100 mg/kg but 50-80 mg per kg. It is cited in the same document used as a source for the Medicins Sans Frontier's recommendation. Since the document is a request by MSF to WHO to change the recommended dosing regimen, it would seem that WHO is the more authoritative source and the correct one to cite.

Lastly, whether the "less than the FDA recommended dose..." claim is true is ambiguous. The FDA prescribing information for ceftriaxone recommends a dose of 100 mg/kg per day, but does not specify the number of days of therapy. The difference between the Pfizer and the FDA regimens does not seem clear cut enough to highlight in the intro, especially given that it exceeded the WHO recommended dose that was extant at that time.

So not to beat the drum too hard, but the article appears to conflict with the best/only available sources in claiming that Pfizer underdosed ceftriaxone. It appears that they used doses in excess of the WHO recommended dose.