[NVIC] Deadly Antibiotic Experiment on Children

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" Protecting the health and informed consent rights of children since 1982. "

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BL Fisher Note:

In order to try to cure ear infections in babies, which often develop after

vaccination, one vaccine manufacturer is testing a deadly antibiotic on

babies with the blessing of a gutless FDA. The cowboy mentality that now

prevails at the FDA and CDC, the federal health agencies responsible for

the public health, is allowing drug companies to literally get away with

murder as they ruthlessly test dangerous pharmaceuticals on babies and

children.

The FDA is supposed to be policing the pharmaceutical industry, not acting

as its treasurer and public relations agency. Any individual in government

or industry, who participates in the killing or crippling of children and

adults in clinical trials of drugs and vaccines known to cause harm, should

be held accountable in a court of law. The same should hold true for

individuals in government, industry or medical organizations who participate

in the making of national health policies involving mandatory use by

citizens of drugs and vaccines which can injure and kill.

Voluntary, informed consent to medical interventions which can injure and

kill is a human right. How many of the parents, who allowed their babies to

participate in a trial using an antibiotic which had already killed adults,

had been fully informed about how deadly it was?

http://www.nytimes.com/2006/06/08/science/08drug.html?ei=5094 & en=6935b665675

4232e & hp= & ex=1149825600 & partner=homepage & pagewanted=print

THE NEW YORK TIMES

June 8, 2006

Halt Is Urged for Trials of Antibiotic in Children

By GARDINER HARRIS

A Food and Drug Administration official called in May for a drug company to

halt clinical trials of an antibiotic in children because the drug could be

deadly, according to internal memorandums sent to other F.D.A. officials.

The drug, Ketek, made by Sanofi-Aventis, is being tested as a treatment for

ear infections and tonsillitis in nearly 4,000 infants and children in more

than a dozen countries, including the United States, according to postings

on a government Web site. But Ketek, which is currently approved for use

only in adults, has been reported to cause liver failure, blurred vision and

loss of consciousness in adults.

" How does one justify balancing the risk of fatal liver failure against one

day less of ear pain? " Dr. Rosemary Johann-Liang, an official in the Office

of Drug Safety at the agency, wrote in one of the memorandums, a copy of

which was obtained by The New York Times.

Sanofi-Aventis is sponsoring four clinical trials in children ages 6 months

to 13 years, according the Web site posting. The drug agency approved plans

for the trials.

There is growing evidence that Ketek is unusually toxic, according to a

recent review by F.D.A. safety officials. Twelve adult patients in the

United States have suffered liver failure, including four who died; 23

others suffered serious liver injury.

The safety officials wrote in their review that the agency should consider

forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict

its uses, even in adults, or add a prominent warning to its label about

potentially fatal side effects.

More than five million prescriptions for Ketek have been written in the

United States since its approval two years ago.

Asked about the memorandum written by Dr. Johann-Liang, an F.D.A.

spokeswoman, Bro, said that it was " a preliminary, raw assessment " and

that " the final decision will be made by experts who have the full benefit

of a large section of opinion and scientific fact. "

Feltmann, a spokeswoman for Sanofi-Aventis, said in an e-mail

message, " We are engaged in ongoing discussions with the F.D.A. regarding

Ketek. "

Other antibiotics cause liver failure, but Ketek seems to do so almost four

times as often, the safety officials concluded in the review.

Ketek can also cause blurred vision and loss of consciousness, problems that

are unique to it. In her memorandum, Dr. Johann-Liang asked how

Sanofi-Aventis's investigators were going to assess whether infants were

suffering blurred vision.

" If we cannot monitor for this event in infants/young children appropriately

in the clinical trial setting, what can we conclude from the safety results

of the trial? " she asked.

Dr. Danny , an infectious-disease specialist at Duke University who

was consulted separately by the drug agency, concluded that the pediatric

trials with Ketek were a cause for concern and " hard to support, " according

to the memorandums obtained by The New York Times.

Dr. did not respond to voice-mail or e-mail messages left for him

yesterday.

In his memorandum, Dr. said that in up to 87 percent of cases,

pediatric ear infections resolved within a few days without treatment. Tests

of an unusually risky antibiotic in infants with ear infections might be

justified if the infants had already been treated unsuccessfully with safer

antibiotics first, he wrote.

Sanofi-Aventis planned to give Ketek as a first-line therapy, according to

the company's trial descriptions.

The drug agency's actions in regard to Ketek are being investigated by

Senator E. Grassley, the Iowa Republican who is chairman of the

Senate Finance Committee, as well as by Representatives J. Markey of

Massachusetts and Henry A. Waxman of California, both Democrats.

Sanofi-Aventis first asked the agency to approve the drug in February 2000.

But officials demurred, citing reports of side effects. So the company

undertook a study of Ketek in 24,000 patients to prove its safety. The trial

was marred by fraud. One of the investigators on the study is now in federal

prison; another lost his medical license.

The F.D.A. said it dismissed the study's results and instead asked the

company to report its experience with Ketek in Europe, where it was approved

in 2001. Although it is unusual for the agency to approve a drug based upon

its use elsewhere, in April 2004, it . did just that, approving Ketek to

treat sinusitis, bronchitis and pneumonia.

Since then, problems with the drug have continued to mount. By April, the

agency had reports of 110 cases of liver problems associated with Ketek,

most of which occurred in otherwise healthy people, according to the safety

review. In one, a 49-year-old woman took no more than two doses of the drug

before becoming nauseous and vomiting. She was hospitalized five days later

and died.

Since they are submitted voluntarily, these kinds of case reports usually

represent only a small fraction - estimates range from 1 percent to 10

percent - of actual drug problems. The reports that the F.D.A. has received

so far are unusual because of their " rapid tempo and severity, " the agency's

internal safety report said.

The agency officials estimated that Ketek caused acute liver failure in 23

people for every 10 million prescriptions, about four times the rate of such

events seen in other antibiotics.

In 1999, sales of the antibiotic Trovan were severely restricted after it

was shown to cause liver failure in 58 people for every 10 million

prescriptions.

In her memorandum, Dr. Johann-Liang suggested that Ketek's risks outweighed

its benefits.

She noted that powerful antibiotics known as fluoroquinolones can also

damage the liver. But she said that those drugs were available in

intravenous forms and " are also used for more serious infectious diseases

rather than solely for minor upper respiratory indications, " as Ketek is.

Dr. Johann-Liang wrote in her memorandum that the parents of patients in

Sanofi-Aventis's pediatric trials must be better informed about Ketek's

risks " in order for any of these trials to continue to proceed. "

She added that the parents " need to know that the 'close monitoring' for

visual events is not possible in very young children, and the long-term

consequences of such adverse reactions are unknown for the developing

system. "

Dr. agreed that the brochure about the trials and informed-consent

material given to parents " must address in plain language the risks, and

severity of risks, of adverse events. "

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