An official inquiry has been set up into allegations that the drug manufacturer Pfizer did not obtain official approval before testing a new drug on children during a meningitis epidemic in Nigeria five years ago.

The Nigerian doctor who supervised the clinical trial has said that his office backdated an approval letter and this may have been written a year after the study had taken place.

Pfizer, whose headquarters are in New York city, has admitted that the local ethics approval given to conduct the trial may not have been properly documented: “Pfizer takes this issue very seriously and is fully cooperating with the Nigerian authorities.”

In 1996 Pfizer sent a team to Kano in the north of Nigeria during an epidemic of meningococcal meningitis. To test the efficacy of its new antibiotic trovafloxacin (Trovan) they carried out an open label trial in 200 children, half of whom were given trovafloxacin and half the gold standard treatment for meningitis, ceftriaxone. Five of the children given trovafloxacin died, together with six who were given ceftriaxone. Pfizer said that 15000 people died during the epidemic.

The Washington Post has been investigating the trial and alleges that at least one child was not taken off the experimental drug and given the standard drug when it was clear that her condition was not improving—which is against ethical guidelines.

The newspaper also claims that Nigerian patients were not warned that animal studies had shown that drugs similar to trovafloxacin may cause joint damage, whereas US patients were told of the research in a subsequent trovafloxacin trial. The drug's licence was withdrawn in Europe because of liver toxicity and some deaths.

The letter granting ethical approval for the Pfizer trial was submitted to the US Food and Drug Administration in 1997 to support a licence application for trovafloxacin. However, Sadiq Wali, the medical director of the Aminu Kano Teaching Hospital, told the Washington Post that the letter was false and the hospital had no ethics committee at the time of the study. Abdulhamid Isa Dutse, the doctor who oversaw the trial at the hospital, told the newspaper that it was “possible” that the approval letter was drafted up to a year after the trial.

The Nigerian health minister, Tim Menakaya, has now appointed a federal investigative panel to determine whether the trial was conducted legally and if so whether it was morally right.

The investigation has generated a lot of publicity in the Nigerian press. The newspaper Vanguard said: “The government has a duty to tell us whether our children were used as guinea pigs and, if so, who committed such criminality and who is liable.”

Charles Medawar, director of Social Audit, the UK pressure group that monitors the pharmaceutical industry, said: “This particular case looks to be very bad, but I hardly think it is untypical.”



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1119465/

When the 14-year-old goes to bed at night, he dreams of becoming a soldier.

Anas survived the treatment, but was permanently damaged

His father, Muhammadu Mustapha, knows his son's dream is unlikely to come true.

"It's only a pipedream. You don't become a soldier with weak and wobbly legs and a permanently drooling mouth," he says bitterly.

"He tires too quickly. The other day, he was trying to draw water from a well and the small bucket almost pulled him into the well."

But Anas is lucky to be alive.

Deformities

Other children who were used in the controversial 1996 drug trial by US pharmaceutical giant Pfizer died.

The Americans and some local Nigerian doctors gave Anas this evil drug 

Anas's father

Anas, then only three years old, was the first child to be given the experimental antibiotic Trovan at the Infectious Diseases Hospital, Kano, during the drug trial.

Pfizer tested the then unregistered drug in Nigeria's north-western Kano State during an outbreak of meningitis which had affected thousands of children.

Officials in Kano say more than 50 children died in the experiment, while many others developed mental and physical deformities.

But Pfizer says only 11 of the 200 children used in the drug trial died.

"From our records, the fatalities were only 11, but the survival rate was 94 per cent," Pfizer spokesman in New York, Bryant Haskins, told the BBC News website.

Pfizer say the clinical evidence points to the deaths during the study being the direct result of meningitis and not the treatment provided during the study.

They say they always acted in the best interest of the children involved, using the best medical knowledge and practices available.

But following pressure from rights groups and families affected by the trial, the Nigerian government set up an expert medical panel to review the drug trial.

The experiment was "an illegal trial of an unregistered drug", the Nigerian panel concluded, and a "clear case of exploitation of the ignorant".

'Verbal consent'

Pfizer denies any wrongdoing and reiterates its position that its trial of Trovan was conducted in accordance with Nigerian regulations.

Hajara survived the trials but cannot now hear or speak

"These allegations against Pfizer, which are not new, are highly inflammatory and not based on all the facts," Mr Haskins, recently told Reuters news agency.

He also said the trial had helped save lives.

The company has previously said that "verbal consent" had been obtained from the parents of the children concerned and that the exercise was "sound from medical, scientific, regulatory and ethical standpoints".

But Mr Mustapha is still burning with anger.

"My son was ill and we took him to the hospital like any other family would. Then the Americans and some local Nigerian doctors injected Anas with this evil drug."

Another man, Hassan Sani, says his daughter Hajara, 14, was also given the drug.

He says the pill made his daughter deaf and unable to speak, and he wants the doctors involved to be treated as criminals.

Pfizer says these are symptoms of meningitis and there is nothing to suggest that Trovan killed or injured any children.

We did not suspect that our children were being used for an experiment 

Hajara's father

"The American doctors took advantage of our illiteracy and cheated us and our children. We thought they were helping us," Mr Sani says.

"We did not suspect that our children were being used for an experiment. They have cheated us and our children. All I can say is that God will judge them according to their evil deeds.

"Where there is a crime, there must be punishment."

Pfizer claim that the mortality rate for a second group not using Trovan was 4% higher than those that did.

'Charges'

After more than a decade of silence, the Nigerian government has decided to sue Pfizer, seeking $7bn (£3.5bn) in damages for the families of children who allegedly died or suffered side-effects in the experiment.

Kano State government has also filed separate charges against Pfizer.

But Mr Sani says compensation will not be enough.

"In addition to the compensation, they should be killed like the children they have killed," he says.

The Pfizer experiment was cited by many as a reason for the mass rejection of polio vaccinations in many parts of northern Nigeria in recent years.

Some local Islamic preachers said there was a western plot to sterilise Muslim women.

After several tests were carried out to proving the vaccine's safety, the programme has now been resumed.

Whether the families ever receive compensation, it will never be enough to bring back Anas's lost dreams of becoming a soldier.

http://news.bbc.co.uk/1/hi/world/africa/6768799.stm

Evil deeds!
They must have taken advantage of the high illiteracy rate in the north back then...

Rumour has it that the late emir of Kano Ado Bayero and Yakubu Gowon were compromised by Pfizer. So we need to sensitize, educate and create awareness for our people before our greedy politicians will take bribe from the white supremacists and allow them to use our people as guinea pig for Covid19 vaccine clinical trial. cc: lalasticlala pls do the needful

Build up yourself, no; accept humanitarian assistance, no