Pfizer facing 4 court cases in Nigeria
Sat, 11 Aug 2007 11:58:37 GMTBy HEIDI VOGT, Associated Press Writer
KANO, Nigeria - A security guard in this dusty Nigerian city is living with tragedy — a 14-year-old son whose dazed eyes, slow speech and uneven gait signal brain damage. Mustapha Mohammed says he knows who to blame — Pfizer Inc., the world's largest drug maker.
New York-based Pfizer is facing four court cases — two filed by the Nigerian government and two by officials in the northern Nigerian state where Mohammed lives — over a decade-old drug study that included Mohammed's son.
The company, which denies any wrongdoing, is accused of using a 1996 meningitis epidemic to push through a sloppily managed drug study that contributed to death in some and infirmities in others.
The fallout provides a case study of the ethical dilemmas that arise when Western medical priorities run into Third World poverty and ignorance. The communication gap between those handing out medical alms and those receiving has bred mistrust and anger in Kano — with damaging, far-reaching effect.
The Pfizer case was cited as one reason residents of Kano and the state of the same name boycotted a polio vaccine in 2003, fearing it was a plot to make Africans infertile. Polio exploded in Nigeria and eventually spread to 25 previously polio-free countries.
Though the meningitis epidemic is long over and the polio vaccination program is back on track, misinformation and suspicion persist.
Mohammed is sure no one asked his permission to test a drug on his child. But he also wasn't asking many questions when he rushed his son to the hospital in 1996.
"We were desperate for drugs. We just took it in good faith," said Mohammed, who lives in a tiny house off a dirt road in one of Kano's poorer neighborhoods. Mohammed — who can't read or write — only later found out that the pink paper he kept with Pfizer's name and treatment dates meant his son had been in the study.
Pfizer says it explained the study to families using practices in line with U.S. and international guidelines, even employing Nigerian nurses and doctors who spoke Hausa, a main Nigerian language. Written permission was obtained when possible, or oral consent if parents were illiterate.
Across town, Abu Abdullahi Madaki can't be sure if her daughter Firdausi took part in the Pfizer study. Citing privacy concerns, Pfizer has declined to release the names of the 200 children it treated.
All Madaki knows is she took a feverish 8-month-old infant to the hospital in 1996, and now her daughter suffers severe brain damage that left her unable to sit up or talk.
Meningitis — a brain infection — leaves 10 percent to 20 percent of survivors with mental damage, hearing loss, or learning disabilities, according to the World Health Organization.
But Madaki said: "My younger sister had meningitis, but it was nothing like this. My younger sister is now a mother with children."
Madaki, who is illiterate, said she'd always felt that the hospital did something wrong. She decided when she heard about the charges against Pfizer on the radio that her daughter must have been in the study.
Pfizer says it brought the drug — an antibiotic called Trovan — to Nigeria as a humanitarian effort. Trovan had already been tested on humans in the U.S. It was a tablet, which could be easier to use with children than the standard meningitis treatment — a painful injection.
More than 11,000 children died in Nigeria during the epidemic.
"When this epidemic occurred, the government asked people to come and help them," said Ngozi Edozien, regional director of the Pfizer branch that covers Nigeria. She said Pfizer wanted to help, but could only offer Trovan through a clinical study because the drug was not yet approved.
Edozien argued that approval to use Trovan to treat epidemic meningitis would not have been a windfall for the company, but for the poor countries that face the disease. She also noted that Pfizer donated medical supplies and equipment to the government to help in the epidemic.
Trovan was approved in the U.S. in 1997 to treat a number of infections, though not for meningitis. It was later pulled from the market because it was shown to cause serious liver damage.
Death rates were similar among the 100 children taking Trovan and the 100 Pfizer gave the standard meningitis treatment. Five of the Trovan subjects died, compared with six in the control group — rates comparable to those of Western hospitals, according to Pfizer.
Still, families and the government argue that Pfizer kept some children on Trovan even though their condition was worsening, that the doses of the standard treatment should have been higher and that dubious procedures used in pushing the experiment through mean Pfizer should be held accountable for any future health problems in those it treated.
It's hard to know if truly "informed consent" is possible during a health care crisis among a widely uneducated, isolated population.
"If you're sick and trying to get health care and somebody says to you, 'Do you want to be in a research study?' If somebody is not familiar with the idea of a research study, it becomes more difficult for them to evaluate," says Benjamin Wilfond, head of Seattle's Treuman Katz Center For Pediatric Bioethics.
But if the people of Kano were uninformed, it's not just a U.S. drug company that's to blame. Lawyers for the study families say the government failed to guard its citizens.
Ali Ahmad, who brought a class action suit on behalf of Kano subjects against Pfizer in the U.S., said he also wanted to sue the Nigerian government, but no government workers would testify.
The U.S. suit was turned down in New York for lack of jurisdiction, though Ahmad said lawyers are in the process of appealing and refiling the case.
He argues that the Nigerian government is now taking advantage of the families' plight to enrich itself. A victory in the Nigerian cases will not mean money for families, but for government coffers in a country that watchdog groups routinely call one of the most corrupt in the world. The federal government is seeking $7 billion in damages and the state government $2 billion; they each have filed one criminal case and one civil suit.
Government lawyers say they were slow to file charges because the details of the 1996 trial have been hard to get from Pfizer. They claim that the administration was duped along with the study subjects.
"What the government did was to give Pfizer the benefit of the doubt, and obviously naively trusted Pfizer," said government prosecutor Babatunde Irukera.
Six years after the meningitis outbreak, a Kano doctor printed out a series of diatribes he found on the Internet calling the polio vaccine a Western plot to reduce the world's Muslim population. Many of the area's influential Muslim clerics took up the cause and led a 16-month boycott.
Local officials say Kano was primed to believe the rumors. Residents already found it strange that they were given free polio doses but nothing for bigger killers like malaria and measles. And the Pfizer controversy was still simmering.
"When people heard about , they started really hiding their children," said Alhahi Ibrahim Jibrin Mai-Anguwa, head of a 3,000-person neighborhood ward in Kano.
The state governor stopped the vaccination program while doses were sent abroad for testing, a move that shocked the West but may actually be the bright spot in Kano's story — an official listening to the concerns of his constituency. When test results confirmed the vaccine was safe, people began to embrace it again.
But some damage can't be erased.
Twice a week, mothers arrive in the physical therapy ward of a Kano hospital carrying children with the jerking legs and lifeless arms of polio for massages and sessions under heat lamps.
Four-year-old Fatima Yau, whose mother refused to have her immunized in 2003, lies on the examination table with legs splayed out flat and unresponsive.
Her mother says she's hopeful for Fatima's future. Her daughter just started school. She's carried to classes each morning on an older sibling's back.
Feds pull funding for L.A. hospital
Sat, 11 Aug 2007 06:09:08 GMTBy ROBERT JABLON, Associated Press Writer
LOS ANGELES - Federal regulators said Friday that they are pulling $200 million in funding from a troubled hospital that serves one of the city's poorest neighborhoods, forcing it to all but shut down.
The decision came after the county-run Martin Luther King Jr.-Harbor Hospital failed two federal inspections.
At a news conference late Friday, Los Angeles County's chief medical officer told reporters that the hospital would close its emergency room Friday night and that patients would be moved to other hospitals within two weeks. The emergency room was closed at 7 p.m. Friday.
"We brought every resource to bear, but in the end it just wasn't enough, fast enough," Dr. Bruce Chernof said.
King-Harbor will remain open 16 hours a day, seven days a week, to offer outpatient care to people with routine medical problems, Chernof said. Ambulances will be available to take the more seriously ill to other hospitals.
During the past few years, Los Angeles County tried to improve patient care through disciplining workers, reorganizing management, closing the trauma unit and reducing the number of inpatient beds to 48.
Yet Herb Kuhn, acting deputy administrator for the U.S. Centers of Medicare and Medical Services, said a federal inspection as recently as last month found "conditions at the facility have placed the health and safety of patients at great risk."
"While some progress has been made, significant problems persist," Kuhn said in a statement.
The federal agency plans to end its hospital provider agreement with King-Harbor on Wednesday. The hospital can apply for reinstatement, but that would take three to four months because federal regulators would want to be assured that King-Harbor's problems have been corrected.
The federal action means the hospital is no longer eligible for reimbursement for the costs of caring for Medicare patients. The county has warned that loss of the funding — about half the hospital's budget — would force King-Harbor to close.
King-Harbor, which has about 1,600 employees, handled about 50,000 emergency room patients last year. A contingency plan is already in place to shift patients to other hospitals, and officials have said they would try to find a private operator to take over the facility and reopen it, perhaps in a year.
"This is good news because it brings closure to this never-ending saga," county Supervisor Michael Antonovich said in a statement. "It allows the county to move forward in bringing quality medical care to an area where the status quo chose to keep a bag over their head."
The hospital was built after the 1965 Watts riots to bring health care to poor, minority communities in south Los Angeles. In recent years, poor patient care has been blamed for several deaths.
A woman died in May after writhing untreated on the floor of the emergency room lobby for 45 minutes. In February, a brain tumor patient languished in the emergency room for four days before his family drove him to another hospital for emergency surgery.
The hospital failed a federal inspection in September 2006 but managed to remain open under a reorganization that shifted services to Harbor-UCLA Medical Center and reduced inpatient beds from 250 to 48.
The second inspection last month found that the hospital still had failed to comply with federal standards in eight of 23 areas, ranging from nursing services to patients' rights, according to a letter to King's administrator, Antoinette Epps.
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Associated Press Science Writer Alicia Chang contributed to this report.
Army starts new psychiatric program
Sat, 11 Aug 2007 03:18:48 GMTBy ROBERT WELLER, Associated Press Writer
DENVER - The Army has launched a nationwide program to teach soldiers and their families how to identify signs of possible psychiatric injuries suffered in the war on terrorism that may have gone unnoticed.
The Army is responding to widespread reports that soldiers returning from Iraq and Afghanistan with mild brain damage and post-traumatic stress disorder were treated as malingerers or unfairly dismissed from the service.
The training program, called "chain-teaching," was implemented last week at the Pentagon and is intended to reach all active-duty soldiers and reservists within 90 days.
Fort Carson officials plan to discuss the program with media Tuesday, base spokesman Capt. Gregory Dorman said.
The military has acknowledged facing an unprecedented problem, and said that even with the best treatment and preparation, some soldiers will suffer lifelong mental injuries.
"At no time in our military history have soldiers or Marines been required to serve on the front line in any war for a period of 6-7 months, let alone a year, without a significant break in order to recover from the physical, psychological, and emotional demands that ensue from combat," a military report released in May said.
Previously, the draft had guaranteed commanders had replacements for those who had spent considerable time in combat.
Capt. Scot Tebo, surgeon for the 4th Infantry Division's 3rd Brigade Combat Team, said the goal is to identify soldiers with problems as soon as possible so treatment can begin.
"It is important to remember, although you may not be struggling, your battle buddy may be," Tebo told the Fort Carson Mountaineer.
The program will teach soldiers and their families to spot possible indications of post traumatic stress disorder, brain damage and other injuries resulting from service in combat. Additional resources will be available online.
Australia recalls antiinflammatory drug Prexige after two deaths
Sat, 11 Aug 2007 19:41:42 GMTSYDNEY - Australia's drugs watchdog said Saturday it had ordered the recall of the anti-inflammatory medication Prexige after it was linked to two deaths.
The Therapeutic Goods Administration said Australia was the first country to withdraw the drug, which is in the same class of pharmaceuticals as Vioxx, withdrawn by manufacturer Merck in 2004.
Technically called lumiracoxib, Prexige is produced by the Switzerland-based company Novartis AG, which said it had contacted health authorities in 50 countries where the drug is sold about the withdrawal.
The move followed a review of eight cases where people suffered severe liver damage after using the drug. Two of those people died and another two required liver transplants.
&;As a result of those case reports we have taken this straight to our drug safety committee who met yesterday,&; said Rohan Hammett, the TGA's principal medical adviser.
&;They recommended that it immediately be deregistered.&;
Australia was the first country to recall the drug, Hammett said.
Prexige is taken by about 60,000 people in Australia and is prescribed for osteoarthritis, post-operative pain, pain related to dental procedures and painful menstruation.
The TGA has recommended people taking Prexige seek an alternative medication and have liver function blood tests. It is a non-steroidal anti-inflammatory drug, technically called a Cox-2 inhibitor.
Another Cox-2 inhibitor, Vioxx or Rofecoxib, was voluntarily recalled by manufacturer Merck in 2004 due to adverse health conditions in patients taking it.
&;Regulators around the world have been watching this class of drugs very closely since Vioxx and hence we've acted very quickly,&; Hammett said.
Novartis said it supported the decision.
&;Cleary, patient safety is of the utmost importance,&; said Nick Kurstjens, the company's chief scientific officer for Australia.
Egyptian girl dies during female circumcision
Sat, 11 Aug 2007 20:09:37 GMTCAIRO - A 13-year-old Egyptian girl has died during an illegal operation to mutilate her genitalia, the Al-Masri Al-Yom daily reported on Saturday.
Karima Rahim Massud died as the result of problems with the anasthaesia in the Nile Delta village of Gharbiya. Her death was discovered after her father sought a death certificate from another doctor.
The medical practice where the operation took place has been closed, and the doctor is being interrogated, the newspaper said.
Female genital mutilation, also known as female circumcision, is a practice that dates back to pharaonic times in Egypt. It is common in a band that stretches from Senegal in West Africa to Somalia on the east coast, and from Egypt in the north to Tanzania in the south.
The practice, which affects both Muslim and Christian women in Egypt, was banned in 1997 but doctors were allowed to operate &;in exceptional cases.&;
Female circumcision can cause death through haemorraging and later complications during childbirth. It also carries risks of infection, urinary tract problems and mental trauma.
In June, following the death of 12-year-old Bedur Ahmed Shaker, Health Minister Hatem al-Gabali issued a decree banning every doctor and member of the medical profession from performing the procedure.
The ban must still be translated into law and could face a tough debate in parliament, but is likely to be passed.
A government survey in 2000 said the practice was carried out on 97 percent of the country's women aged between 15 and 45 years of age.
Religious leaders, usually silent on taboos relating to female sexuality, have also started to speak out against the practice, which many Egyptians believe is a duty under Islam and Christianity.
After the death of Shaker, chief mufti Ali Gomaa declared female circumcision forbidden under Islam.
Mohammed Sayyed Tantawi, the sheikh of Al-Azhar university, the top Sunni Muslim authority, and Coptic Patriarch Chenouda III also declared it had &;no foundation in the religious texts&; of either Islam or Christianity.
