Kano. North of Nigeria. 1996
Meningitis outbreak. Three white people (The Wise Men coming back?) arrived to the site. "We are going to help you". The white selected two groups of 100 children each one. They were called group A and group B. Group A took an already known drug (only a third of the normal dose), and group B tested a new drug for curing meningitis (“TROVAN”). After the experiment, the white people left Kano.
According to several sources, 11 children died, and others were left with serious disabilities as blindness, deafness, liver damage, mental retardation, and paralysis.
An image of a supposed victim:
USA and Europe. 1999. Bad luck.The use of the new drug (“TROVAN”) was severely restricted in the USA and marketing authorization was withdrawn in Europe, after FDA acknowledged that the company tests were not reliable.
What the company has said (information found in their website):
The company has great sympathy for everyone who suffered during the devastating meningitis epidemic in 1996. With a survival rate of 94,4%, the new drug was at least as effective as the best treatment available at that time, with a survival rate slightly less than 90%. The new drug helped saving lives (94,4% is much better than 90%).
We proposed to conduct a trial in Nigeria with the goal of bringing to that country a life saving. (We care for Africa, and this was our unique objective).
We obtained all the approvals from the government (no need to mention how the approval was negotiated).
Extracts of these approvals. NAFDAC (Nigerian Agency): “We have been supplied with adequate information about the drug and its proposed investigational use by the sponsor” “The drug may be legally used by investigators in Nigeria” Kanos’ State Ministry of Health: “Approval is also hereby given for your staff to participate in treating patients at our hospitals”.
There was no regulation or law in Nigeria requiring ethical committee approval before conducting the trial (even when starving or dying, ethical is important)
Local Nigerian nurses explained orally (not need for papers) -in the native language- (can you believe this people did not understand English?) the detail of the study to parents or guardians (kids without parents) and participation was voluntary (what do you prefer, to die or to take the drug?)
Patients (yes, patients!) were randomized (luck always plays a role in our lives) to receive either the known drug or the new one, and were given a bracelet and a pink identification card both stating which drug he or she had received (where did I hear this before?)
Five scientific articles also express support for the use of the new drug in children as "medically indicated and ethically justified" (God is on our side!)
Patients in the study already had serious symptoms of meningitis (We did not test it on sane people!).
At the end of the study, any child who required attention was transferred to a local hospital at our expense (and do not think it’s cheap)
The already known drug, even after the reduction to a 1/3 of dose, also proved its efficacy (group A was luckier)
All clinical evidence points to the fact that any deaths occurring during the study were the direct result of the illness and not the treatment provided to the patients (it was the meningitis who killed them, not us!)
Survivals of meningitis can suffer the very same long term complications unjustly and erroneously attributed to the drug.
We also contributed with N18 million to Kano State in medicines, equipment and materials (you know, they are very poor)
The company has a long history of commitment to the well-being of the Nigerian people (quite long commitment)
The settlement. 2009
As you could imagine people are ungrateful. Nigerian government and Kano State sued the company. After several legal trials that lasted for years, an agreement was reached in 2009. Kano State dropped the case and the company accepted to pay more than $75 million, of which $10 million were for the lawyers (their reduced fee for the poor), $35 million to the State (that cares for people) and $30 million to a Meningitis fund to help the families of the children that participated in the study (don't ask how these families receive help; it's evident!)
As it’s mentioned in a press release by the company on December, 9, 2010: “As is common practice, the agreement was covered by a standard confidentiality clause agreed to by both parties.” (no need to make it public, transparency does not help here)
Cable from the USA Embassy in Abuja. April 2009 (Wikileaks)
The company underscored that the Nigerian representatives wanted lump sum checks and that the company is concerned with potential transparency issues (we have enough evidence to be worried about transparency of the Nigerian government)
The $75 million figure was reasonable because the suits had been ongoing for many years costing the company more than $15 million a year in legal fees (very reasonable)
Company's management considers Nigeria a major growth market for its products and having this case behind it will help in efforts to rebuild its image here (business is business, we have to sell them our drugs)
Anyway, what's a pity is that the children of the study will never be able to buy one of the company’s best sellers:
We have to recognize that the company, Pfizer, takes these matters very seriously, and this honors them. To prove that, they have a complete compliance code:
The BLUE BOOK: Summary of Pfizer Policies on Business Conduct
Integrity is the
foundation of the
trust we need to
work together for a
healthier world
Q At a dinner party, a neighbor said that his wife, who uses a Pfizer product to treat her diabetic infection, had stayed home because of sore throat. Do I need to inform the company?
Q My spouse has an ownership interest in a potential vendor that Pfizer is seeking to use to develop certain advertising materials. However, in my role I will not have any decision-making responsibilities as which vendor is selected. Do I need to report anything?
Q My co-worker keeps telling racially charged jokes. He thinks they are funny, but the jokes make me feel uncomfortable. What should I do?
Q My co-worker has recently been coming into work with alcohol on her breath. While she doesn´t seem impaired, I worry that she may be drunk on he job. I’m afraid to confront her. What should I do?
All of them very serious matters: your wife not attending a dinner, a conflict of interests with your wife, racial charged jokes and drunk partners (by the way, woman as usual).
Now let’s focus on matters that are related with the sponsored studies (that’s how we called them):
Patient Privacy
Patient information must be kept strictly confidential.
This is the reason why some documents related with the tests in Kano were lost.
A commitment to Respect for People
We recognize that people are the cornerstone of
Pfizer’s success, we value our diversity as a source
of strength, and we are proud of Pfizer’s history of
treating people with respect and dignity.
We are very proud to know that people in Kano will always remember how we treated them with respect and dignity.
A commitment to Community
We play an active role in making every community
in which we operate a better place to live and work,
knowing that its ongoing vitality has a direct impact
on the long-term health of our business.
Specially in the long term!
Human Subject Protection
in Clinical Research
All Pfizer-sponsored clinical studies adhere to globally recognized principles of international ethics. Our policies on conducting ethical research are regularly reviewed. We have adopted detailed internal procedures to rigorously ensure ethical and top quality research design, conduct, and follow-up. These procedures reveal Pfizer’s respect for the health, well-being and safety of research participants, as well as for the culture, laws, and regulations of the countries in which studies are conducted.
In the next page:
Animal Welfare
We accept our responsibility for conducting animal research in a humane and ethical manner. Very proposed use of animals in our research is thoroughly evaluated; all animal experiments are carefully planned and conducted to minimize or avoid pain, distress, or discomfort; and the health and well-being of all animals under our care are attended to meticulously. We expect our vendors and third party research organizations to adhere to the same high standards and to comply with all applicable laws and regulations.
We treat animals the same as humans!
No comments:
Post a Comment