InfoMail for February 22, 2002

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

February 22, 2002 

Alzheimer’s Drug Tests Halted When 12Volunteers Contract Encephalitis

FYI

The culture that led to the death of 19-year old, NicoleWan, a University of Rochester student, and the culture that led to the death of18-year old Jesse Gelsinger, has not changed.

As long as medical research is being driven byprofit-seeking drug manufacturers, not by cautious medical scientists who havetaken an oath to "do no harm," human subjects of research are at highrisk of harm. Drugs and biologics of unproven safety are being injected intohuman beings–even when experts warn about potential harm.

The Washington Post reports (below) that a multi-site,international Alzheimer’s vaccine trial was halted when 12"volunteers" who were inoculated are now suffering from encephalitis.The Post reports that the vaccine had "generated unusually intenseenthusiasm among scientists and patient advocates during the past twoyears." Bu the harmful consequences, the Post notes, were reported in a"low profile update".

The Alliance for Human Research Protection (AHRP) reportsthat a government-sponsored multi-site, clinical trial of Prozac, involvingchildren 8 to 18 has been terminated by NIMH.

http://www.clinicaltrials.gov/ct/gui/c/w2r/show/NCT00005015?order=8&JServSessionIdzone_ct=xe80v8xkf1
Contact: Benedetto Vitiello, M.D. Child and Adolescent Treatment and PreventiveIntervention R
Bethesda, Maryland, United States 1-301-443-4283

The rationale given for conducting the experiment onchildren is based on an unproven claim: "Pediatric bipolar disorder is nowrecognized as a significant health problem." Others would argue that theknown short term adverse drug reactions and unknown long-term effects ofpsychoactive drugs is a major health problem–especially in children whosedeveloping brains may be harmed.

AHRP has filed a Freedom of Information request with NIMHasking for the documents, adverse event reports, and the reason for the study’stermination.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A48989-2002Feb21?language=printerTest of Alzheimer’s Vaccine Is Halted 12 Volunteers Said to Be Seriously IllWith Brain Inflammation

By Rick Weiss
Washington Post Staff Writer Friday, February 22, 2002; Page A01

Twelve volunteers inoculated with a highly toutedexperimental vaccine designed to reverse the course of Alzheimer’s disease havefallen seriously ill with brain inflammation, forcing the vaccine’s manufacturerto stop giving the shots and raising doubts about the product’s clinicalpotential, according to sources familiar with the study.

The vaccine, made by the Irish pharmaceutical company Elanand known by its code name AN-1792, had generated unusually intense enthusiasmamong scientists and patient advocates during the past two years, as experimentsin mice suggested it could halt the progression of Alzheimer’s and perhaps evencure the deadly disease.

Alzheimer’s gradually robs people of their minds. Itaffects 2 million to 4 million elderly Americans and is expected to affect 15million by 2030. Even the best treatments today have a very modest impact.

Taking an unprecedented immunologic approach to treating abrain disease, the vaccine aims to elicit an immune system attack against"beta amyloid," the brain protein believed to be at the root ofAlzheimer’s.

Although animal studies and early human safety studiessuggested the vaccine was reasonably safe, the strategy was controversial.Immune reactions typically cause inflammation, and inflammation in the brain cancause serious problems or death.

Company officials have released few details about theproblems. A spokesman said an independent committee is reviewing data from thestudy, which has enrolled about 360 people with mild to moderate Alzheimer’s infour European countries and 11 U.S. sites.

But sources familiar with the study, including some whohave been in contact with Elan officials, said there is little question thevaccine triggered the brain reactions, which some called encephalitis (aninflammation of the brain) and another called "meningoencephalitis,"an inflammation of the brain and surrounding membranes.

Both syndromes can cause symptoms ranging from fever,headache and vomiting to altered consciousness, muscle weakness and seizures.

Some scientists had warned that the vaccine might triggersuch complications or even exacerbate Alzheimer’s, a disease some believe iscaused by natural inflammatory processes.

One such critic, Trey Sunderland, chief of the geriatricpsychiatry branch at the National Institute of Mental Health, said yesterdaythat the vaccine may have caused the encephalitis in volunteers directly or itmay have caused a disruption of blood vessels in the brain. That would allowviruses or other infectious agents to enter and cause encephalitis.

Elan, which is developing the vaccine with Wyeth, apharmaceutical division of American Home Products Corp. of Madison, N.J., wouldnot say yesterday how quickly it had halted inoculations after the first fewpatients were diagnosed. The company also would not say what, if any,information was being shared with other volunteers who might be at ongoing riskof encephalitis.

A company spokesman said only doctors at individual testsites could speak to that issue, but officials at several sites yesterday saidthey had been told by the company not to talk to reporters.

Even when things go well, experts said, clinical trialsinvolving people with cognitive deficits pose extraordinary challenges to thenotion of "informed consent" — the requirement that volunteers bemade aware of all the risks of a study and of any changes in those risks duringthe course of a study.

An Elan spokesman yesterday said the company "followsall appropriate clinical standards to ensure the well-being of all patients instudies and is working closely with their physicians." All those whoexperienced ill effects "have been treated and are respondingappropriately," said the spokesman, who refused to characterize theirhealth further.

The company first mentioned the emerging problem Jan. 18,in a low-profile "update" posted on its Web site. In the secondparagraph of the update, the company noted that four patients in thehigh-profile study had "clinical signs consistent with inflammation in thecentral nervous system," and that further dosing of patients in themulti-center international trial had been "temporarily suspended." Itdid not say when the diagnoses were first made.

Since then, the number has climbed to 12, at several testsites, according to sources in contact with Elan officials. One of those,William Thies, vice president of medical and scientific affairs at theAlzheimer’s Association, said he still believes the general approach ofimmunotherapy for Alzheimer’s has a promising future, though details of thevaccine might have to change.

Elan has said it is developing products that are similarto AN-1792 but more refined.

"I think everyone is puzzled" about why theproblems happened, said Marilyn Albert, an Alzheimer’s researcher atMassachusetts General Hospital, who heads the Alzheimer’s Association’s medicaland scientific advisory council. But in all likelihood, Albert said, "theycan’t go forward with this formulation."

It is the second major setback for Elan this month. Thecompany announced earlier that certain officers and directors were being sued byshareholders alleging violations of U.S. securities laws, and that the companywas under investigation by the Securities and Exchange Commission.

© 2002 The Washington Post Company

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