Kano, Nigeria vs Pfizer Pharmaceuticals: An Update

by Paul I. Adujie

Since the publication of my previous article on the illegal, unapproved and unethical clinical trials by Pfizer, in which Pfizer inflicted 11 deaths, injuries and sundry disfigurements upon innocent Nigerian children in Kano, there have been new developments – developments in which Pfizer is seeking, essentially, to have it both ways!

Among these recent developments are the informed withdrawal and re-filing, with amendments to the law suit filed by representative of Nigerian victims of Pfizer’s illegal actions. The amendments enable the originators of the litigation to adjust and re-emphasize, and it does emphasize, the gravity and most egregious nature of the illegal and unethical activities that were conducted by Pfizer upon helpless, sick, innocent and hapless Nigerian children. Pfizer’s murderous illegalities resulted in the death of 11 of our children.

Furthermore, Pfizer has recently moved a motion or filed an application in which Pfizer has argued, urged and asked a Nigerian court to quash or dismiss the pending litigation against Pfizer arguing that Pfizer is an American company, over which a Nigerian court may not exercise any jurisdiction.

Subsequent substantive hearings in these court proceedings have been scheduled and rescheduled, some others have been adjourned, certain parts are adjourned, up until October 2007. There are criminal and civil legal cases that have been filed against Pfizer. These cases are currently proceeding simultaneously and some portions, pending or making some progress. These cases against Pfizer were brought by Kano State and the Nigerian Federal Government of Nigeria. Nigeria is expected to prevail in the quest for compensation verdict or judgments against Pfizer to benefit the victims of Pfizer’s illegalities that resulted in death, maiming and sundry disfigurements of Nigerian children

At this stage though, the applications or motions by Pfizer is very significant; this is so, in view of the fact the fact that Pfizer had previously deployed this tactic in New York successfully. Pfizer had a couple of years ago, argued that an American court in New York, did not possess the requisite jurisdictional predicate to enable the American court to permit the parties (the Nigerian victims/plaintiffs with their legal representatives on the one hand, and Pfizer the offending defendant on the other) to litigate or canvass issues of law and fact before the American court, sitting in New York.

The American court in New York dismissed the suit initiated by the Nigerian victims of Pfizer’s illegal, unapproved, untested and profit motivated inhumane clinical trials, using innocent Nigerian children in a guinea pig-like medical or pharmacological experiments. That judgment in essence, was that Nigeria is the proper venue or forum, as the activities or events being litigated occurred, transpired or took place in Nigeria. This is being appealed.

Pfizer has in Nigeria, now resuscitated its old winning argument used successfully before a New York court. Pfizer is now using the same arguments before a court in Nigeria. Pfizer has in effect, literarily, regurgitated its jurisdictional predicate defense; A defense that Pfizer had similarly adduced before an American court in the very recent past. Pfizer is now invoking this same defense to vitiate and deflect its responsibilities to compensate Nigerian victims of Pfizer medical misadventures.

Jeanne Lenzer, an American journalist, and prolific writer on medical and pharmaceutical matters, sent an e-mail to me last week in reaction to Pfizer’s spurious defense in courts, both in America and Nigeria. Jeanne Lenzer titled her e-mail to me, “incredible, rage and fury!” She did so upon learning of the new developments in the cases in Nigeria.

She and I have had previous conversations about these cases in Nigeria brought against Pfizer and what appears to be Pfizer’s tone-deaf attitude, since the inception of these cases. Jeanne Lenzer’s words describe and aptly encapsulates my feelings exactly. It is incredible, it is outrageous! Pfizer’s actions and current attitude has caused all reasonable persons to be irate at Pfizer for the killings of innocent Nigerian children, only to want to dodge compensations for victims, in Pfizer’s current desperate tactics.

Pfizer is amazingly casual and cavalier over its actions which led to the death of Nigerian children. Pfizer has demonstrated extreme depravities by first conducting illegal clinical trials in Kano, with Trovan, an untested and unapproved drug. A drug which American regulatory agency, the Foods and Drugs Administration, specifically forbade use on children. Despite Pfizer’s knowing infliction of injuries and death on Nigerian children; Pfizer continues to be evasive, as it denies responsibilities and clear liability. Pfizer has a duty to compensate the Nigerian victims of its illegal actions in Kano.

Pfizer’s atrocious clinical trials in Nigeria are reminiscent of the infamous Tuskegee experiment on African Americans as human guinea pigs, Tuskegee experiment was illegal and it violated local, state and federal laws. An experiment in which, victims who were exposed Syphilis, were deliberately left untreated.

Similarly, Pfizer’s willfully and knowingly, violated American and Nigerian laws, when Pfizer proceeded to inflict injuries and death on Nigerian children with the use Trovan on children in Kano. Pfizer violated well-established international clinical trial protocols. Pfizer engaged in flagrant violations of laws and engaged in unethical practices. Pfizer, in complete disregard for common sense and human decency.

Clearly, Pfizer does not put any value or any worth, on the lives of Nigerian children! Hence Pfizer knowingly caused the death of 11 innocent Nigerian children in Kano as Pfizer maimed and injured many other children. All these, as a result, and due to Pfizer’s greed for profits or money at the expense of human lives in Nigeria. Pfizer’s attitude to the Nigerian children, should therefore be seen for what it is, extremely obnoxious.

I am irate at Pfizer for its offensive attitude in connection with the murderous killings of innocent Nigerian children in Kano. Pfizer has shown no remorse. Pfizer’s rotten attitude and its devaluation of the Nigerian lives informed and influenced its

warped and twisted clinical trials in Kano, which was replete with illegalities and sundry ethical violations.

Pfizer has not demonstrated a scintilla of regret, over the unwarranted deaths, maiming and disfigurements caused by Pfizer to Nigerian children in Kano.

There ought to be public outrage against Pfizer. One has to wonder why there is no fury and umbrage in Nigeria directed at Pfizer. Where is the Nigerian Media/Press? Where are the Nigerian medical and pharmaceutical professionals/workers?

What would it take to enlighten and inform the Nigerian public of Pfizer’s actions, including its current attempt to avoid accountability for Pfizer’s killing of innocent Nigerian children?

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Tim August 13, 2007 - 12:22 pm

Paul is right on this one. Not only nigerian professionals but the govt. is dereclicting in duties. Why sue Pfizer after about 11 years? The govt. should have frozen the companies assets and suspended its license till it agreed to adequate compensation and tendered unreserved apology! America cant tolerate 10% of the crime perpetrated on Nigerians without jailing those involved, disparaging us on their tv and fining/closing the company.

Paul I. Adujie August 12, 2007 - 5:52 pm

Thank you Mr. Cletus E. Olebunne, for your comments…. Pfizer has a pattern of infractions it would appear. It pays compensations in Australia, where no one died.

Pfizer's fate in Australia and I have posted it under my recent article. See? Nobody died, Pfizer is made to pay fines….. but in Nigeria, 11 innocent children died in the hands of Pfizer and countless others were maimed and Pfizer denies them compensation!

Pfizer was held to account and made liable in Australia, and yet, NOBODY died in the Australian case! SEE BELOW.

Pfizer has to pay fine over Celebrex ad in Australia

Pfizer will have to pay a A$100,000 ($85,454) fine for an ad

Australia's Reader's Digest, which promoted its COX-2

inhibitor Celebrex (celecoxib) for arthritis to the general public.

The code of conduct committee of the industry association

Medicines Australia said Pfizer's article was a "seemingly

flagrant disregard" of the code of conduct, breaching points

9.4 (promotion to the general public) and 9.5.2 (patient

education). The company has been told not to distribute the

article again directly to the general public.

Direct-to-consumer advertising of medicines is banned in

Australia, although advertising certain diseases is allowable.

Pfizer's four-page advertising feature, entitled "Choose to

Move: Living with Arthritis", included four references to

Celebrex product information and another reference to the

drug's consumer medicines information. In its defence, Pfizer

said that the ad had been drafted for a healthcare audience,

and that it was an "unfortunate oversight that in this instance

the referencing had not been adequately changed for

distribution to the general public".

The complaint was made by an unnamed academic at NSW

University, but Healthy Skepticism, the Australian-based

organisation that highlights the techniques used by

pharmaceutical companies to promote their drugs, followed

up the charge with a detailed account of the faults of the ad

on its website.

Healthy Skepticism points out that the ad's photo of two

arthritis sufferers was used extensively in Celebrex

promotional campaigns targeting doctors.

"This is a common approach used by drug companies to

sidestep the ban on direct-to-consumer advertising of

prescription medicines in Australia. The same illustration is

used in the promotion to consumers and to prescribers.

However, the name of the product advertised (in this case

Celebrex) is omitted in the consumer promotion to avoid

blatant DTCA. If doctors are shown the brochure by patients,

they cannot fail to recognise the product being promoted."

Healthy Skepticism says: "Confusing, misleading,

incomplete, deceptive, this consumer advertorial by Pfizer is

a very worrying example of de facto DCTA. Patients and the

public need reliable information they can trust. Consumer

information provided by drug companies aims to promote

sales first and is fundamentally biased. There is no role for

industry in the provision of information about diseases or

comparing treatments."

cInforma UK l.td 2007 ] http://www.scripnews.com ] July 6th 2007 ] No 3274

Cletus E. Olebunne August 11, 2007 - 11:47 am

Paul thanks for taking on this issue. This occurrence is exposing the decay in the system. It showcases the professional quality of Nigerian agencies—where they are NOT focusing. It also says a lot about the mindset of our professional class. You asked, where is the Nigerian media/press? Where are the Nigerian medical and pharmaceutical professional/workers? Your other question should have been, where are the Nigerian lawyers.

In my years attending seminars and conferences as a member of Regulatory Affairs Professional Society, (RAPS), and American Chemical Society (ACS), or as a voluntary member in the Institutional Review Board (IRB), I am yet to meet a Nigerian lawyer with specialization in pharmaceutical or chemical laws and regulations. This is the realty of our professional position in the healthcare industry—we are mostly involved in the worker category in this industry, and not necessarily in the profession with deep understanding of the regulatory aspect of it. If a media/press house does not have a scientist/lawyer qualified in the sense of knowledge to write about this case, then the media won’t be heard. If the medical doctors are only at the hospitals—be it ob-gyn delivering babies or pediatrician sticking needles, and not clinical investigators. If our nurses are at the bedsides and not knowing that they may also participate in the clinical research as protocol or site set-ups staff. If our chemists/biochemists are only working with test tubes, and not take the extra time to learn the regulations in the profession. If our pharmacists are only dispensing medicines, and not involved in the making of medicines—from clinical research to development. And if we continue to professionally exist with the mindset of “to each their own”, and not understand that every professional can indeed be involved in one organization/firm, and do away with the mentality of my “profession”/job is more important or better. Then this is what you get—absence of outrage in a situation like this. Why, because, to be professionally outraged in global and heavily regulated industry as the healthcare, in this case the pharmaceutical, you got to have your facts together.

Pfizer may want to submit a motion questioning the jurisdiction of the case, but is Nigeria a participant on the International Conference of Harmonization (ICH). There is common guideline on protocol and ethical issues in pediatric clinical studies—ICH E6: E11—Clinical Investigation of Medical Products in the Pediatric Population.

Pfizer may not have a case in their motion if Nigeria is a participant in ICH. Below is an excerpt from the ICH E6 guideline.

Cletus E. Olebunne


Ethical Issues in Pediatric Studies (2.6)

The pediatric population represents a vulnerable subgroup. Therefore, special measures are needed to protect the rights of pediatric study participants and to shield them from undue risk. The purpose of this section is to provide a framework to ensure that pediatric studies are conducted ethically.

To be of benefit to those participating in a clinical study, as well as to the rest of the pediatric population, a clinical study must be properly designed to ensure the quality and interpretability of the data obtained. In addition, participants in clinical studies should benefit from the clinical study except under the special circumstances discussed in ICH E6.

1. Institutional Review Board/Independent Ethics Committee (IRB/IEC) (2.6.1)

The roles and responsibilities of IRBs and IECs, as detailed in ICH E6, are critical to the protection of study participants. When protocols involving the pediatric population are reviewed, there should be IRB/IEC members or experts consulted by the IRB/IEC who are knowledgeable in pediatric ethical, clinical, and psychosocial issues.

2. Recruitment (2.6.2)

Recruitment of study participants should occur in a manner free from inappropriate inducements either to the parent(s)or legal guardian or the study participant. Reimbursement and subsistence costs may be covered in the context of a pediatric clinical study. Any compensation should be reviewed by the IRB/IEC. When studies are conducted in the pediatric population, an attempt should be made to include individuals representing the demographics of the region and the disease being studied, unless there is a valid reason for restricting enrollment.

3. Consent and Assent (2.6.3)

As a rule, a pediatric subject is legally unable to provide informed consent. Therefore pediatric study participants are dependent on their parent(s) or legal guardian to assume responsibility for their participation in clinical studies. Fully informed consent should be obtained from the legal guardian in accordance with regional laws or regulations. All participants should be informed to the fullest extent possible about the study in language and terms they are able to understand. Where appropriate, participants should assent to enroll in a study (age of assent may be determined by IRBs and IECs or be consistent with local legal requirements). Participants of appropriate intellectual maturity should personally sign and date either a separately designed, written assent form, or the written informed consent. In all cases, participants should be made aware of their rights to decline to participate or to withdraw from the study at any time. Attention should be paid to signs of undue distress in patients who are unable to clearly articulate their distress. Although a participant's wish to withdraw from a study must be respected, there may be circumstances in therapeutic studies for serious or life-threatening diseases in which, in the opinion of the investigator and parent(s) or legal guardian, the welfare of a pediatric patient would be jeopardized by his or her failing to participate in the study. In such a situation, continued parental or legal guardian consent should be sufficient to allow participation in the study. Emancipated or mature minors (defined by local laws) may be capable of giving autonomous consent.

Information that can be obtained in a less vulnerable, consenting population should not be obtained in a more vulnerable population or one in which the patients are unable to provide individual consent. Studies in handicapped or institutionalized pediatric populations should be limited to diseases or conditions found principally or exclusively in these populations, or situations in which the disease or condition in these pediatric patients would be expected to alter the disposition or pharmacodynamic effects of a medicinal product.

4. Minimizing Risk (2.6.4)

However important a study may be to prove or disprove the value of a treatment, participants may suffer injury as a result of inclusion in a study, even if the whole community benefits. Every effort should be made to anticipate and reduce known hazards. Investigators should be fully aware before the start of a clinical study of all relevant preclinical and clinical toxicity of the medicinal product. To minimize risk in pediatric clinical studies, those conducting the study should be properly trained and experienced in studying the pediatric population, including the evaluation and management of potential pediatric adverse events.

In designing studies, every attempt should be made to minimize the number of participants and of procedures, consistent with good study design. Mechanisms should be in place to ensure that a study can be rapidly terminated should an unexpected hazard be identified.

5. Minimizing Distress (2.6.5)

Repeated invasive procedures may be painful or frightening. Discomfort can be minimized if studies are designed and conducted by investigators experienced in the treatment of pediatric patients.

Protocols and investigations should be designed specifically for the pediatric population (not simply re-worked from adult protocols) and approved by an IRB or IEC as described in section II.F.1.

Practical considerations to ensure that participants' experiences in clinical studies are positive and to minimize discomfort and distress include the following:

§ Personnel knowledgeable and skilled in dealing with the pediatric population and its age-appropriate needs, including skill in performing pediatric procedures

§ A physical setting with furniture, play equipment, activities, and food appropriate for age

§ The conduct of studies in a familiar environment such as the hospital or clinic where participants normally receive their care

§ Approaches to minimize discomfort of procedures, such as (1) topical anesthesia to place IV catheters, (2) indwelling catheters rather than repeated venipunctures for blood sampling, and (3) collection of some protocol-specified blood samples when routine clinical samples are obtained.

IRBs and IECs should consider how many venipunctures are acceptable in an attempt to obtain blood samples for a protocol and ensure a clear understanding of procedures if an indwelling catheter fails to function over time. The participant's right to refuse further investigational procedures should always be respected except as noted in section II.F.3.


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