Kano, Nigeria vs Pfizer Pharmaceuticals: An Update

by Paul I. Adujie

Nigerians must NOT allow Pfizer to get away from the atrocities, which Pfizer committed in Kano. Nigerians must not allow Pfizer to benefit from its ability to speak from both sides of its mouth. Pfizer must not be allowed to get away with its multiple murderous killings of 11 innocent Nigerian children. We know that Pfizer is humongous multinational pharmaceutical corporation, a behemoth; but Pfizer is not above the law, rules, ethics and other well established clinical trials, protocols. Pfizer violated all these, in its actions in Kano Nigeria.

Even now, Pfizer is seeking to defeat the Nigerian victims of its illegal and ethical acts in Kano. It is clear that Pfizer puts profit, money and greed above human lives in Nigeria. And out of greed, Pfizer is attempting to truncate the compensation cases that have arisen from Pfizer’s atrocities; Pfizer used an argument of absence or lack of jurisdiction over Pfizer itself, as defense in America, and now, as well in Nigeria.

If Pfizer succeeds in Nigeria, with its current argument of “absence or lack of jurisdiction” it would have eluded sanctions and accountability in America and Nigeria. Pfizer would have in effect established that it is above the laws in two continents, that Pfizer is above the law, period. And no one can hold them to account, that must not be allowed to happen.

On a related note, matters of jurisdictional predicate, and exercising such, over Nigerians and Nigerian entities, have been litigated in the most recent past and in an equally high profile case. A civil case initiated by some Nigerians, such as Chief Anthony Enahoro and the Abiolas etc. Certainly, must have heard or subsequently become aware of the fact that two American court in Detroit, Michigan and later, another court in Chicago, Illinois assumed jurisdiction over General Abdulsalami Abubakar, former head of state of Nigeria, as he was sued a couple of years ago, for human rights violations by parties already mentioned.

Nigerian former leader has faced civil legal action in Detroit and Chicago respectively, in the United States. Abubakar lawyers argued absence or lack of jurisdiction of an American court over the former Nigerian leader, unsuccessfully. This, despite the fact that a Nigerian head of state has political immunity, and enjoys diplomatic immunity.

Such political and diplomatic immunity or protections from legal encumbrances or impediments, which may arise from actions undertaken in such leader’s official capacity, while acting as a head of state. A former Nigerian head of state, ought to be afforded, bestowed or be able to enjoy full diplomatic immunity and protections. And persons of General Abubakar’s stature, caliber and high political profile, is so entitled.

Besides, all these have happened, even though Nigeria is a friendly nation with America, with full cordial economic, trade and diplomatic relations

Regardless of these age-old established traditions and conventions, treaties and immutable usual practices of diplomatic finesse; two American courts, in Detroit, and then, Chicago, assumed jurisdiction over our former political leader, all, to our national chagrin. Perhaps to enable political propaganda at the expense of Nigeria?

Why then, as it appears, all of a sudden, an American court, removed itself, from considering the serious and very grave charges proffered against Pfizer in New York, over Pfizer’s illegal and unethical clinical trials in Kano Nigeria which resulted in 11 deaths and injuries to many Nigerian children.

Why then would an American suddenly lack or refuse to exercise jurisdiction over an entity that is, for all intent and purposes, both American and Nigerian? An entity that is actively engaged in business activities in Nigeria, with consequences touching Nigerians directly, including the aforementioned 11 deaths in Kano that resulted from Pfizer’s acts?

Could this sudden shift of the goal post in the middle of an important tournament, be as a result the economic consequences that would be visited on an American wrongdoer corporation as Nigerians succeeds in making Pfizer account illegalities committed in Nigeria?

Could it be because an American company is about to be exposed in Nigerian courts and compelled to pay for its horribly brutal actions? Could it be because of the consequent liability and great economic loss which Pfizer must suffer, liability which Pfizer endure as a result of verdicts and judgments that will arise in favor of Nigerian victims?

Nigerian victims of Pfizer’s ignominious acts in Kano, have rightly asked and demanded compensation from Pfizer. Pfizer perpetrated acts of horrors against countless innocent Nigerian children and these children’s who are compelled to haplessly grapple and tackle with the after-effects of Pfizer’s illegal, unethical and depraved clinical trials in Kano City.

Pfizer and other corporations operating in Nigeria, must be informed that they are not above the laws. They must learn to respect the laws and lives in Nigeria

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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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