[NVIC June 8, 2006] Deadly Antibiotic Experiment on Children

Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *
* * * * * * * * * * * * * * * * * * * * * * *

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

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

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?

June 8, 2006
Halt Is Urged for Trials of Antibiotic in Children

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, Susan 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."

Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said in an e-mail
message, "We are engaged in ongoing discussions with the F.D.A. regarding

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

In his memorandum, Dr. Benjamin 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 Charles E. Grassley, the Iowa Republican who is chairman of the
Senate Finance Committee, as well as by Representatives Edward 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

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

Dr. Benjamin 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."

News@nvic.org is a free service of the National Vaccine Information
Center and is supported through membership donations.  Learn more about
vaccines, diseases and how to protect your informed consent rights

Become a member and support NVIC's work

To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm

To unsubscribe from this list, please go to
http://nvic.org/emaillistunsub.htm or send an email to
news-request@nvic.org and type UNSUBSCRIBE in the body of the email.

NVIC is funded through individual membership donations and does not receive
government funding. Barbara Loe Fisher, President and Co-founder.
NOTE: This is not an interactive e-mail list. Please do not respond to