Pfizer to Pay Tens of Millions for Deaths of Nigerian Children in Drug Trial Exp

[truth seeker]

Looks like Pfizer got off cheap...

The original story on SOTT is here: http://www.sott.net/articles/show/169742-Pfizer-may-soon-face-its-Nigerian-guinea-pigs

(NaturalNews) Pharmaceutical giant Pfizer has agreed to pay $75 million to settle a class action lawsuit filed against it by Nigerian parents who claim the company caused harm to their children by using them as guinea pigs in a nonconsensual, unlicensed drug trial.

The case began in 1996, when Pfizer needed a human trial to gain approval for its new antibiotic Trovan. When an epidemic of meningitis, cholera and measles broke out in Kano, Nigeria, the company quickly put together a research team and flew them to that country. Pfizer set up a tent right near the medical station where Doctors Without Borders were giving free treatments and recruited 200 children to participate in an unlicensed drug trial.

Parents say they were not told that proven medications were being distributed only yards away, that their children were being enrolled in a drug trial, or that animal studies had suggested that Trovan could cause liver and joint damage.

Eleven of the 200 children in the study died, and parents claim that others suffered from brain damage, organ failure and other severe side effects.

The case broke when Pfizer researcher Juan Walterspiel, who had been schedule to take part in the trial but was left behind, wrote a letter to Pfizer's then chief executive William Steere, saying that the Kano study was "in violation of ethical rules."

"Some of the children were in critical condition and most of them malnourished, which made oral absorption even more unpredictable," he wrote. "At least one died after a single oral dose."

Class action lawsuits were filed against the company in a variety of jurisdictions in Kenya and the United States, while various levels of the Nigerian government also filed their own lawsuits against the company.

The current settlement comes in a class action suit filed in Nigeria. In addition to a pending class action suit in the United States, Pfizer may still face criminal prosecution in Nigeria. In January 2008, a Nigerian judge issued arrest warrants for several top company officials after they failed to appear in court.

Sources for this story include: www.independent.co.uk.

 

[Jeremy F Kreuz]

Eleven of the 200 children in the study died, and parents claim that others suffered from brain damage, organ failure and other severe side effects.

That is a morbidity rate of 5.5 %. As comparison: MSF treated during the same period in Kano/ Nigeria 42444 cases with Oily Chloramfenicol of which 3569 cases died. That is a morbidity rate of 8,4 %. (data from MSF's handbook for handling a meningitis epdemic)
Over the timespan of 10 years intervention in meningitis epidemics with oily chloramfenicol, MSF reports a morbidity of 10% and a 20% neurological damage in survivors. (Non treated menigitis has a morbidity of 50 - 80 %)

from wikipedia:

Chloramphenicol is a bacteriostatic antimicrobial originally derived from the bacterium Streptomyces venezuelae, isolated by David Gottlieb, and introduced into clinical practice in 1949. It was the first antibiotic to be manufactured synthetically on a large scale, and alongside the tetracyclines, is considered the prototypical broad-spectrum antibiotic.

Chloramphenicol is effective against a wide variety of Gram-positive and Gram-negative bacteria, including most anaerobic organisms. Due to resistance and safety concerns, it is no longer a first-line agent for any indication in developed nations and has been replaced by newer drugs in this setting, although it is sometimes used topically for eye infections. In low-income countries, chloramphenicol is still widely used because it is exceedingly inexpensive and readily available.

The most serious adverse effect associated with chloramphenicol use is bone marrow toxicity, which may occur in two distinct forms: bone marrow suppression, which is a direct toxic effect of the drug and is usually reversible, and aplastic anemia, which is idiosyncratic (rare, unpredictable, and unrelated to dose) and generally fatal.

Not a drug that seems very innocent. And the testing of that drug?

From the WHO site:

Pharmacokinetic data from a study conducted in Pakistan of oral chloramphenicol palmitate use in 14 severely malnourished and 14 well nourished children suffering from pneumonia was presented. Each child was given 25 mg/kgevery six hours for five days. Therapeutic levels (10μg/l) were achieved in 10 malnourished and 12 well-nourished children at some time during 5 days of therapy. Toxic levels (25μg/l) were seen in one malnourished and two well nourished children. There was wide variability in the serum levels. In general, the mean serum levels were lower in malnourished than well-nourished children, although there were nosignificant differences between the two groups. One malnourished and three wellnourished children needed a change of therapy. Of the three well nourished children, one had developed toxic levels and another did not achieve therapeutic level.

Pharmacokinetic data from two different studies in The Gambia, one conducted in 1990 on 36 patients and another in 1994 on 16 patients showed similar results. There was a great deal of variability in serum levels, and in general the sick malnourished children achieved lower serum levels than the well nourished children.

Combined pharmacokinetic data from 20 Gambian and 10 Filipino children given intramuscular chloramphenicol and 20 Filipino children given oral chloramphenicol were presented. All children were less than 3 months old. There was wide variability in the serum levels obtained in Filipino children who received oral chloramphenicol. Children who received intramuscular chloramphenicol were able to achieve therapeutic levels. It was concluded that oral chloramphenicol should not be used in young infants less than 3 months of age, and if necessary they should be treated with injectable chloramphenicol.

Data were presented from a double blind trial of two intramuscular injections of either oily chloramphenicol (100 mg/kg) or ceftriaxone (75mg/kg) 24 hours apart for the treatment of bacterial meningitis in 2-35 months old children. Three hundred children from one hospital each in Mali and Niger were enrolled.

In Islamabad, the dexamethasone group had an increased risk of sequelae (especially hearing deficit) and worsened mortality
The Islamabad study was a placebo-controlled double-blind, and included children 2 months to 12 years who were treated with ampicillin and chloramphenicol

Two studies have been conducted in Chandigarh, India. The first study described changes in body water compartments in children with acute meningitis. Thirty children were studied, together with age matched controls.Children with meningitis had significantly higher extracellular water level ( 311 ml/kg compared with 271 ml/kg in controls). The excess in extracellular water was higher in
the more severely ill children. Children who developed complications or sequelae hada higher extracellular water than those who did not. Inappropriate secretion of ADH was diagnosed in 14/30 children. In the second study, 50 children were randomised to receive either
maintenance fluids or restricted fluid intake to 65-70% of normal maintenance levels. Children on reduced intake showed a significant decrease in total body water,

Pzifer just sended the 'wrong' guy to do the testing and did not pay off the right people (as there was no time?). They got caught and pay (very little) to silence everything else that is going on. In the meantime sick, malnourished infants of 3 months were/ are used as guinea pigs.

 

[Tigersoap]

This was more or less the base for the movie "The constant gardener" as the gossip said.

_http://www.imdb.com/title/tt0387131/

 

[Jeremy F Kreuz]

from wikipedia:

When it went on the market in 1998 Trovan became one of Pfizer's top-selling drugs. When first-quarter earnings were announced in April of that year, the company's earnings had increased by 15% over the previous year, with analysts attributing much of that increase to the sales of the "new antibiotic" Trovan. Pfizer had spent hundreds of millions of dollars developing Trovan. In the first year it brought over US$160 million and investors expected it to eventually bring in US$1 billion per year.

In June 1999 the U.S. Food and Drug Administration advised doctors to limit the prescription of Trovan after it had been found "strongly associated" with 14 cases of acute liver failure and six deaths. The FDA had received over 100 reports of liver problems in people taking Trovan, which was at that time being prescribed at a rate of 300,000 patients per month in the United States.

$ 75 million compensation is indeed very cheap for a drug that brought in billions.

from the pfizer websitë:

TROVAN is still used:

Trovan Tablets and Injection are being distributed only to hospitals and long term nursing care
facilities for patients initiating therapy in these facilities.

for:

Hospitalized Community Acquired Pneumonia, Nosocomial pneumonia, Community acquired pneumonia, complicated intra-abdominal infections, including post-surgical infections, Gynecologic and pelvic infections, septic abortion and post-partum infections, complicated skin and skin structure infections, including diabetic foot infections.

This sounds like a last hope antibiotic when all else fails (due to mulitresistance) used for infections acquired during operations/ stays in hospitals. So when there were too many side effects for general consumption (and further increase of resistance against classic antibiotics?) the drug was restricted to hospital and long term nursing care where is it helpful to treat infections caused inside the hosptials/nursing care homes.

TROVAN is defenitely not used for epidemic meningitis infection which is caused by Neisseria meningitidis. From the other clinical trials Pfizer did, these are the bacteria TROVAN has effect on:

S. pneumoniae, H. influenzae, M. catarrhalis, S. aureus, K. pneumoniae, L. pneumophila, M. pneumoniae, C. pneumoniae, P. aeruginosa, E. coli

So what were they testing in Kano, Nigeria?

from the MSF guideline for Meningitis:

while other pathogens can cause bacterial meningitis, they are not responsable for large outbreaks. The most common pathogens causing non epidemic meningitis are H influenza and S pneumonia. (often associated with pneumonia with a very high mortality rate.)

They were defenitely not there to test a drug that could help during a epidemic, at least not one for treating meningitis. Where they testing what effect their drug had on S pneumonia, responsable for a pneumonia with a very high mortality rate, a desease that is frequent in the more developed world? Was that the reason why they could not ask permission to do clinical trials?

From MSF guideline

there may also be more unusual clinical features, related to a particular site of meningococcal colonisation. These include articular, pericardial bronchopulmonary manifestations.

from the Pfizer website: general precautions

Moderate to severe phototoxicity reactions have been observed in patients who are exposed to direct sunlight while receiving some drugs in this class. (trovan) Therapy should be discontinued if phototoxicity (e.g., a skin eruption, etc.) occurs.

Syndromes of meningitis: (among others): photophobia (patients with meningitis cannot stand the light and should be treated in dark/obscured places).