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A DELICATE CALCULATION ONLY A BALANCE BETWEEN SCIENCE AND ETHICS CAN

PROMOTE THE HEALTH OFHUMANKIND


Plain Dealer, The (Cleveland, OH) - November 16, 1998

The ethical and procedural questions raised by the work of U.S. medical researchers abroad defy pat answers.

As recent articles by Plain Dealer reporters Bill Sloat and Keith Epstein point out, ethics rules regularly are broken;
patients involved in research often are unaware of the implications of participating; and host countries' social,
economic and technological conditions often are ill-suited to maintaining ethical purity.

Edition: FINAL / ALL


Section: EDITORIALS & FORUM
Page: 6B
Column: EDITORIALS
Record Number: 09820005
Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

UGANDAN TB STUDY REFLECTS ETHICAL DILEMMA


Plain Dealer, The (Cleveland, OH) - November 22, 1998

Once again, the United States had the opportunity to exercise moral and ethical leadership in its international
concerns. And once again, we failed to step up to the plate. I am referring to the recent Plain Dealer article on the
tuberculosis research in Uganda.

Inexcusable reasons were given for allowing the participants to believe they were receiving treatment, only to be
given vitamin C, an innocuous placebo. I believe that, no matter what the foreign researchers and officials felt about
the efficaciousness of the prevention efforts, as international leaders, we have a responsibility to do no less to protect
the health of the citizens in Uganda than we would in this country. The question is not whether there are different
ethical standards in a socioeconomic rather than in an epidemiological setting. These researchers are from the
United States, which opposes unethical research protocols.
Caption:
PHOTO BY: MIKE LEVY / PLAIN DEALER PHOTOGRAPHER A bedridden woman rests in Rubaga Hospital in
Kampala, Uganda.
Edition: FINAL / ALL
Section: EDITORIALS & FORUM
Page: 4D
Column: LETTERS
Record Number: 09826156
Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

VA DID STUDIES WITHOUT CONSENT PSYCHIATRIC PATIENTS USED IN EXPERIMENTS


Plain Dealer, The (Cleveland, OH) - February 16, 1997
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

Psychiatric patients at the nation's Veterans Affairs hospitals have been subjected to experiments in which their
medication was withheld without telling them of the risks, according to the sworn statement of a senior VA
researcher.

Not disclosing the risks of withdrawing medication was "the norm and practice" during the 1980s, Jack Hirschowitz,
chief of psychiatry at the VA hospital in the Bronx, N.Y., testified in an affidavit filed in an Ohio lawsuit.

Edition: FINAL / ALL


Section: METRO
Page: 1B
Record Number: 09047057
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

CLOSING CHAPTER ON EXPERIMENT CINCINNATI HOSPITAL OFFERS A SETTLEMENT


TO PATIENTS' SURVIVORS
Plain Dealer, The (Cleveland, OH) - February 21, 1997
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

John Stillwell had skin cancer.

He checked into Cincinnati's University Hospital for help and wound up participating in a Cold War radiation
experiment sponsored by the Department of Defense in 1971.
Caption:
PHOTO: ASSOCIATED PRESS Maryann Vaughn, Rose Mary Roesch, Charles Stillwell and Mary Ann Houchins -
relatives of cancer patients used in military radiation experiments in Cincinnati - want assurances such research
won't happen again.
Edition: FINAL / ALL
Section: OHIO
Page: 5B
Dateline: CINCINNATI
Record Number: 09052037
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

LIVING PROOF UGANDANS IN AMERICAN-RUN STUDY EXPECTED TREATMENT, BUT


SOME PILLS WEREDUMMIES
Plain Dealer, The (Cleveland, OH) - November 9, 1998
Author: BILL SLOAT and KEITH EPSTEIN PLAIN DEALER REPORTERS

Her husband lay dying, his spirit draining away into the earth as silimu consumed his body.

Joyce Namugenyi knew she would never see him again on this side of life.
Caption:
PHOTO (COLOR) BY: MIKE LEVY / PLAIN DEALER PHOTOGRAPHER Joyce Namugenyi, 41, a widow infected
with HIV, with the form letter she got from Case Western University, waits her turn at a tuberculosis clinic at Rubaga
Hospital. PHOTO (COLOR) BY: MIKE LEVY / PLAIN DEALER PHOTOGRAPHER (Page 8A) A bedridden woman
rests in a tuberculosis ward at Rubaga Hospital. TB, the world's most deadly infectious organism, is particularly
deadly for HIV patients because each disease speeds the other. PHOTO (COLOR): NO CREDIT (Page 8A) A coffin
strapped to the back of motorbike is a common sight in Uganda, deadly crossroads of tuberculosis and AIDS.
PHOTO (COLOR): NO CREDIT (Page 8A) A health care worker checks X-rays at a tuberculosis clinic at Rubaga
Hospital in Kampala. PHOTO (COLOR): NO CREDIT (Page 8A) Soldier Dominic Lusiba displays his medical card
from the research project. PHOTO (COLOR) BY: MIKE LEVY / PLAIN DEALER PHOTOGRAPHER (Page 9A)
Efurance Ndibarekera, 36, with her 3-year-old daughter, Caroline, is among the Ugandans who signed up for a
U.S.-sponsored research project. PHOTO (COLOR): NO CREDIT (Page 9A) Efurance Ndibarekera returns home
after attending a clinic at St. Francis Hospital. BOX: Yesterday: Although the United States has strict safeguards to
protect people involved in medical research, the country has flouted its own rules in dozens of nations. Today:
American researchers' use of an untreated control group is at the heart of a debate extending from Uganda to
medical centers around the world. BOX: FACTS ABOUT UGANDA Location: Eastern Africa, west of Kenya
Comparative area: Slightly smaller than Oregon National capital: Kampala Population: 20,604,874 (July 1997
estimate) Life expectancy: Total population: 36.69 years Male: 39.3 years Female: 40.1 years (1997 estimate)
Telephones: 54,900 (1989 estimate) Tevevisions: 193,000 (1992 estimate MAP: New York Times Uganda BOX BY:
PLAIN DEALER (Page 9 A) Tuberculosis ... Kills 2 million to 3 million people each year, more than any other
infectious disease, according to the World Health Organization, which declared the disease a global emergency in
1993. - TB FACTS Tuberculosis (TB) is a contagious disease that spreads through the air when infected people
cough, sneez talk or spit. Someone in the world is newly infected with TB every second. One-third of the world's
population is infected with TB. Five to 10 percent of people infected with TB become sick or infectious at some time
during their life. The TB bacilli can lie dormant for years, contained by the immune system. Someone who is infected
with TB and HIV-positive is 30 times more likely to become sick with TB because of a weakened immune system. TB
is the leading cause of death among people who are HIV-positive, accounting for almost one-third of AIDS deaths
worldwide. Up to 50 million people may be infected with drug-resistant strains of TB. 1996 INCIDENCE COUNTRY
RATE PER 100,000 The Congo 333 Uganda 300 Phillippines 280 Afghanistan 278 South Africa 250 Peru 250
Nigeria 222 Bangladesh 220 Indonesia 220 India 220
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Series: SECOND OF TWO ARTICLES
Dateline: KAMPALA, UGANDA
Record Number: 09813100
Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

U.S. MEDICAL RESEARCHERS FLOUT RULES AROUND WORLD


Plain Dealer, The (Cleveland, OH) - November 8, 1998
Author: KEITH EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

A legacy of medical exploitation, from secret Cold War radiation experiments to notorious syphilis studies on unwary
blacks, has led the United States to adopt some of the world's toughest protections for people on whom scientists test
new drugs, devices and vaccines.

So firm is the underlying presumption that patients in experiments must be treated fairly and honestly that the
protections of federal law apply not just to Americans but to any person, anywhere in the world, used in U.S.-financed
research.
Caption:
PHOTO BY MIKE LEVY / PLAIN DEALER PHOTOGRAPHER This was the main office for the Case Western
Reserve University study at Mulago Hospital in Kampala, Uganda. Uganda is one of the countries where the Centers
for Disease Control and Prevention failed to obtain written assurances meant to safeguard patients. CHART: These
are the countries where the Centers for Disease Control and Prevention failed to obtain written assurances that
safeguard patients involved in medical research SOURCES: Centers for Disease Control and Prevention GRAPHIC
BY PLAIN DEALER
Memo:
Today: Although the United States has strict safeguards to protect people involved in medical research, the country
has flouted its own rules in dozens of nations.

Tomorrow: American researchers' use of an untreated control group is at the heart of a debate extending from
Uganda to medical centers around the world.
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Series: FIRST OF TWO ARTICLES
Dateline: WASHINGTON
Record Number: 09812059
Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

RESEARCHERS LINK ANTIDOTE TO GULF WAR SYNDROME `INVESTIGATIONAL' DRUG


DISPENSED TO SOLDIERS BEFORE HUMAN TESTING
Plain Dealer, The (Cleveland, OH) - March 30, 1998
Author: BILL SLOAT and KEITH EPSTEIN PLAIN DEALER REPORTERS

It was meant to help protect American troops. Instead, it may have helped harm them.

Federal officials find it plausible that an experimental nerve gas antidote given to thousands of soldiers without their
consent may have contributed to the mysterious ailment known as Gulf War Syndrome.
Caption:
PHOTO BY: KAREN TAM / AP Dr. Mohamed Aabou-Donia, a researcher at Duke University Medical Center, is
conducting studies that could link pyridostygmine bromide to symptoms suffered by Gulf War veterans. PHOTO BY:
JODI STEWART / AP Veteran Roger Flinn, at his home in Hixson, Tenn., wonders whether a nerve gas antidote may
have contributed to what is known as Gulf War Syndrome.
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Record Number: 09589113
Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

ARMY MISLED TROOPS WHO GOT VACCINE IN BOSNIA FDA BLASTS MILITARY FOR
IMPROPER USE OF UNAPPROVED DRUG
Plain Dealer, The (Cleveland, OH) - January 25, 1998
Author: BILL SLOAT and KEITH EPSTEIN PLAIN DEALER REPORTERS

The Food and Drug Administration, investigating the use of a research vaccine on thousands of U.S. soldiers in
Bosnia in 1996, has formally cited the Pentagon for understating risks and breaking other rules intended to protect
Americans from unethical experimentation.

The investigation uncovered "significant deviations," reminiscent of similar violations by the military during the Persian
Gulf War, when it failed to keep vital records, monitor effects, and properly inform troops they were receiving an
unlicensed drug and vaccine.
Caption:
BOX: GUIDELINES AND BROKEN RULES SOURCE: Food and Drug Administration GRAPHIC BY PLAIN DEALER
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Record Number: 09525092
Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

OBJECTION TO GULF WAR VACCINE WAS OVERIDDEN U.S. TROOPS NOT TOLD
EFFECTS OF BOTULISM SHOTS WERE UNKNOWN
Plain Dealer, The (Cleveland, OH) - December 21, 1997
Author: KEITH EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

Just months before the Persian Gulf War, an Army review board ruled it would be unethical to give soldiers an
experimental vaccine without warning them that the effects were unknown, according to documents obtained by The
Plain Dealer.

The ruling, by the ethics committee at the Army's biological defense research station at Fort Detrick, Md., was
overridden after the Defense Department cited national security concerns. The botulinum toxoid vaccine was given to
8,000 troops, who were not told that it was unlicensed.

Edition: FINAL / ALL


Section: NATIONAL
Page: 16A
Dateline: WASHINGTON
Record Number: 09355132
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

PLAIN DEALER WINS 4 TOP AWARDS


Plain Dealer, The (Cleveland, OH) - September 21, 1997

Staffers from The Plain Dealer received four first-place and three second-place awards yesterday in the Ohio Society
of Professional Journalists' annual competition.
Among the winners were reporters Diane Solov and Mark Tatge, who captured the Best Defense of the First
Amendment category for their pursuit of records as they covered the proposed sale of Blue Cross & Blue Shield of
Ohio to Columbia/HCA Healthcare Corp.

Edition: FINAL / ALL


Section: METRO
Page: 6B
Record Number: 09264109
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.
DRUG TRIALS BEING REVIEWED NATIONWIDE INQUIRY INTO TESTING ORDERED
Plain Dealer, The (Cleveland, OH) - January 27, 1997
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

The inspector general of the U.S. Department of Health and Human Services has ordered a nationwide inquiry into the
testing, without fully informed consent, of experimental drugs and medical devices on Americans.

"We are hoping to examine the underlying reasons for these problems," said Inspector General June Gibbs Brown.

Edition: FINAL / ALL


Section: NATIONAL
Page: 1A
Dateline: WASHINGTON
Record Number: 09027123
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

GLENN PROPOSES CRIMINAL SANCTIONS FOR EXPERIMENTS WITHOUT CONSENT


Plain Dealer, The (Cleveland, OH) - January 23, 1997
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

Sen. John Glenn yesterday proposed the nation's first criminal sanctions for medical researchers who fail to obtain
consent from people participating in experiments.

The Human Research Subject Protections Act would apply standards known as the "Common Rule" to tens of
thousands of clinical trials in the United States, including those sponsored by government agencies and drug makers.

Edition: FINAL / ALL


Section: NATIONAL
Page: 4A
Dateline: WASHINGTON
Record Number: 09023124
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

FDA FINDS DEFECTS IN CLINICAL DRUG TRIALS DRUG TESTS DEFECTIVE 300 TIMES,
FDA SAYS
Plain Dealer, The (Cleveland, OH) - January 19, 1997
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

The Food and Drug Administration uncovered major defects in more than 300 clinical trials submitted as proof that new
pharmaceuticals were appropriate for human use, according to a senior FDA official.

That represents nearly 10 percent of all new drug applications reviewed by the agency since 1977.

Edition: FINAL / ALL


Section: NATIONAL
Page: 1A
Record Number: 09019065
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

BIOETHICS COMMISSION STRUGGLES AS ITS FUNDING DRIES UP


Plain Dealer, The (Cleveland, OH) - January 17, 1997
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

The Clinton administration has provided only one-fourth of the money needed by a special White House advisory
committee set up to suggest better protections for people used in medical experiments.

The National Bioethics Advisory Commission was formed in the wake of revelations about radiation tests conducted on
unsuspecting Americans during the Cold War.
Memo: Keith Epstein and Bill Sloat may be reached at (202) 638-1366 or (513) 631-4125.

E-mail for the reporters may be sent to:

70404.247@compuserve.com
Edition: FINAL / ALL
Section: NATIONAL
Page: 7A
Dateline: WASHINGTON
Record Number: 09017073
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

PROPOSAL FOR PROTECTION IN RESEARCH PRAISED


Plain Dealer, The (Cleveland, OH) - January 10, 1997
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

A White House advisory commission yesterday embraced proposals by Sen. John Glenn to significantly expand
safeguards for people participating in medical research, and to create an independent watchdog agency over
government research.

"Long overdue," Harold T. Shapiro, chairman of the National Bioethics Advisory Commission, said of the reforms that
would substantially broaden informed consent requirements to apply to patients used in privately sponsored research.

Edition: FINAL / ALL


Section: NATIONAL
Page: 12A
Dateline: WASHINGTON
Record Number: 09010141
Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

NEXT OF KIN NOT TOLD OF DRUG FDA CITES POLICY FOR ITS SILENCE ON DEATHS
Plain Dealer, The (Cleveland, OH) - December 15, 1996
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

The Maryland death certificate of Ralph W. Koontz says that he died of septic shock, pneumonia and lung cancer.

The National Cancer Institute and the federal Food and Drug Administration recognized another contributing factor: An
experimental cancer drug.
Caption:
BOX: RESEARCHERS FAILED TO DOCUMENT CONSENT AT 46 SITES SOURCE: From FDA records GRAPHIC BY
JAMES OWENS / PLAIN DEALER
Edition: FINAL / ALL
Section: NATIONAL
Page: 15A
Series: DRUG TRIALS - Do Pople Know The Truth About Experiments? AN INVESTIGATIVE ANALYSIS First of four
articles
Index Terms: MEDICAL RESEARCH ; CLINICAL TRIALS ; EXPERIMENTAL DRUGS ; MEDICAL MALPRACTICE
MEDICAL TESTS
Record Number: 08850058
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.
IN THE NAME OF HEALING AROUND 10:40 A.M., HOSPITAL WORKERS BEGAN INFUSING
A SOLVENT ALSO USED AS AGASOLINE ADDICTIVE INTO LAURA MICHALSKI'S
ABODOMEN. HOURS LATER, SHE DIED
Plain Dealer, The (Cleveland, OH) - December 15, 1996
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

She was given a code name, "TE3."

To this day, the federal government won't say who she was or what it knows about how she died.
Caption:
PHOTO 1 BY DAVID I. ANDERSEN / PLAIN DEALER PHOTOGRAPHER Alexander Michalski, holding a portrait
showing his late wife, Laura, is flanked by two of their children, Bernadette McCloskey and Dennis Michalski. PHOTO 2
BY DAVID I. ANDERSEN / PLAIN DEALER PHOTOGRAPHER Alexander Michalski says his late wife, Laura, was "my
love, my friend." PHOTO 3 BY CHUCK CROW / PLAIN DEALER PHOTOGRAPHER Hahnemann University Hospital in
Philadelphia was the site of the pioneering radiologist's research using a solvent to dissolve gallstones. PHOTO 4 BY
ALAN DIAZ ASSOCIATED PRESS PHOTOGRAPHER FDA inspectors questioned why there was no written evidence
people consented to be part of a clinical trial at the Mt. Sinai Medical Center in Miami Beach. PHOTO 5 BY MIKE LEVY
/ PLAIN DEALER PHOTOGRAPHER Roger Bull Sr. is one of Dr. Chavonee Aroonsakul's patients. BOXS: RESEARCH
SITES WITH THE MOST CONSENT PROBLEMS GRAPHIC BY JAMES OWENS / PLAIN DEALER COMMON
PROBLEMS FOUND BY THE FDA GRAPHIC BY JAMES OWENS FDA INSPECTIONS AND PERCENTAGE OF TIME
SANCTIONS ARE RECOMMENDED GRAPHIC BY JAMES OWENS / PLAIN DEALER WHAT PEOPLE MUST BE
TOLD GRAPHIC BY JAMES OWENS / PLAIN DEALER
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Series: DRUG TRIALS - Do People Know the Truth About Experiments AN INVESTIGATIVE ANALYSIS First of four
articles
Index Terms: MEDICAL MALPRATICE ; MEDICAL RESEARCH ; MEDICAL TESTS ; CLINICAL TRIALS ;
EXPERIMENTAL DRUGS
Record Number: 08850107
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

`USING OUR KIDS AS GUINEA PIGS' AN INVESTIGATION OF MEDICAL RESEARCH


RECORDS SHOWS THE U.S. GOVERNMENT IS STILL IN THE BUSINESS OF CONDUCTING
AND PAYING FOR TESTS ON UNSUSPECTING AMERICANS
Plain Dealer, The (Cleveland, OH) - December 16, 1996
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

Not long after school started in the fall of 1991, Sacheen White Tail came home with a note from her teacher.

It was addressed to her parents, and no, the sixth-grader wasn't in any kind of trouble.
Caption:
PHOTO BY: RAMON MENA OWENS / PLAIN DEALER PHOTOGRAPHER Ella-Mae White Tail says that when she
signed up her daughter, Sacheen, for a hepatitis vaccination, she didn't know the vaccine's safety was being tested on
children at the Standing Rock Sioux Reservation. PHOTO BY: JACK KUSTRON / ASSOCIATED PRESS
PHOTOGRAPHER (Page 8A) Dr. Bernadine Healy, dean of the Ohio State University medical school and former
director of the National Institutes of Health, says researchers have a "heightened obligation" to patients in clinical trials.
PHOTO BY: RAMON MENA OWENS / PLAIN DEALER PHOTOGRAPHER (Page 8A) "When you say ` experimental,'
it scares off a lot of people," ays Tim Yellow, tribal health director for the Standing Rock Sioux. GRAPHICS CHART:
JAMES OWENS / PLAIN DEALER (Page 8A) FEDERAL RESEARCH SITES WITH THE MOST CONSENT
PROBLEMS GRAPHICS CHART: JAMES OWENS / PLAIN DEALER (Page 8A) LANDMARK EVENTS IN HUMAN
SUBJECT PROTECTION From 1977 through 1995, federal Food and Drug Administration inspectors find 2,201
consent problems, records show. PHOTO BY: RAMON MENA OWENS / PLAIN DEALER PHOTOGRAPHER (Page
9A) Ricardo Munoz is buried in an East Los Angeles cemetary. GRAPHICS CHART: JAMES OWENS / PLAIN
DEALER (Page 9A) Positions dedicated to monitoring government-sponsored human research Problems found by the
FDA within government research facilities BOX: YESTERDAY: At least 1,000 Americans in 23 states have been used in
medical research without required evidence of their informed consent. TODAY: Decades after notorious syphilis
research on blacks at Tuskegee and radiation studies on civilians during the Cold War, the government is still
conducting medical tests on unsuspecting Americans. TOMORROW: More than half the foreign research submitted to
the Food and Drug Administration over the last decade was unreliable. WEDNESDAY: Local ethics committees, the
front line in protecting test subjects, frequently fail to ensure that people know they are being used in medical research.
If you have comments about the series, call 999-5260, fax 999-6366 or e-mail the reporters at: tgaumer@plaind.com
Include your name and a daytime telephone number.
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Series: DRUG TRIALS Do People Know the Truth About Experiments? AN INVESTIGATIVE ANALYSIS Second of
four articles
Record Number: 08851146
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

U.S. RECORDS SHOW CONSENT FORMS OFTEN INCOMPLETE


Plain Dealer, The (Cleveland, OH) - December 16, 1996
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

The government's use of Americans in medical research without written evidence of their informed consent goes far
beyond chilling accounts of Cold War radiation experiments.

Such research has been sponsored by agencies with sterling reputations for benefiting society: The National Cancer
Institute, the National Institutes of Health, the Department of Veterans Affairs.
Caption:
PHOTO BY: JOE TABACCA / ASSOCIATED PRESS PHOTOGRAPHER A White House committee questioned the
use of addicts from the Northport Veterans Administration Hospital on Long Island in an Energy Department study.
Edition: FINAL / ALL
Section: NATIONAL
Page: 9A
Record Number: 08851001
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

FOREIGN TESTS DON'T MEET U.S. CRITERIA HYPE, HOPE AND HEARTBREAK A
CHRONIC CONDITION
Plain Dealer, The (Cleveland, OH) - December 17, 1996
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

Trouble started on Oct. 12, 1994, when two inspectors from the Food and Drug Administration entered Dr. Geoffrey
Dusheiko's cramped office on the 10th floor of London's Royal Free Hospital and flashed their badges like FBI men.

They got straight to the point. Did ribavirin really work?


Caption:
PHOTO BY:MICHAEL CRABTREE Dr. Geoffrey Fairhurst was denounced by his peers in England who said he had
involved his patients in pharmaceutical trials without their knowledge. CHART:RESEARCH PROBLEMS: FOREIGN VS.
U.S. Based on a Plain Dealer analysis of Food and Drug Administration inspections worldwide, 1977 through 1995,
involving drugs seeking FDA approval for use in the United States. GRAPHICS BY:JAMES OWENS/PLAIN DEALER
BOX:THE SERIES SUNDAY: At least 1,000 Americans in 23 states have been used in medical research without
required evidence of their informed consent. YESTERDAY: Decades after notorious syphilis experiments on blacks at
Tuskegee and radiation studies on civilians during the Cold War, the government is still conducting medical tests on
unsuspecting Americans. TODAY: More than half the foreign research submitted to the Food and Drug Administration
over the last decade was unreliable. Verifiable scientific records from other countries were missing in 54 percent of
requests for new drug approvals in the United States. TOMORROW: Local ethics committees, the front line in
protecting test subjects, frequently fail to ensure that people know they are being used in medical research. If you have
comments about the series, call 999-5260, fax 999-6366 or e-mail the reporters at: tgaumer@plaind.com Include your
name and a daytime telephone number.
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Series: DRUG TRIALS AN INVESTIGATIVE ANALYSIS Third of four articles
Record Number: 08852096
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.
OVERSEERS OPERATE IN DARK ETHICS PANELS ONLY MANAGE CURSORY REVIEWS
OF RESEARCH
Plain Dealer, The (Cleveland, OH) - December 18, 1996
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

Twice each month, the University of Rochester summoned them: Four scientists, three doctors, a nurse, a priest, and a
mother whose daughter died of cancer.

They convened around a long table in a conference room on the third floor of the Department of Medicine.
Caption:
BOX: SUNDAY: At least 1,000 Americans in 23 states have been used in medical experiments without required
evidence of their informed consent. MONDAY: Decades after notorious syphilis experiments on blacks at Tuskegee and
radiation studies on civilians during the Cold War, the government is still conducting medical tests on unsuspecting
Americans. YESTERDAY: More than half the foreign research submitted to the Food and Drug Administration over the
last decade was unreliable. TODAY: Local ethics committees, the front line in protecting test subjects, frequently fail to
ensure that people know they are being used in an experiment. If you have comments about the series, call 999-5260,
fax 999-6366 or e-mail the reporters at: tgaumer@plaind.com Include your name and a daytime telephone number.
BOX: `To do what we should do, go out every so often and say to the researcher, `Let me look at your records, your
consent forms, are you informing the patients?' - I'd like to do that, but we don't have the time or the staffing. This is not
work that is perceived as making a contribution to research.' DR. JOHN BAUM, chairman of the University of
Rochester's Research Subjects Review Board BOX: JAMES OWENS/PLAIN DEALER FAILURES ON THE FRONT
LINE PHOTO BY: ASSOCIATED PRESS PHOTO 1 Nicole Wan, a University of Rochester sophomore enrolled in a
research project sponsored by the National Institutes of Health, died after getting an overdose of lidocaine. PHOTO BY:
TERRY WILIAM HARRIS/PLAIN DEALER PHOTOGRAPHER Consultant Arthur Horowitz says drug companies
assume ethics committees know what they are doing, but "this is sadly not always the case."
Edition: FINAL / ALL
Section: NATIONAL
Page: 1A
Series: DRUG TRIALS - Do People Know the Truth About Experiments? Last of four articles
Index Terms: GUINEA PIGS ; DRUG OVERDOSES ; EXPERIMENTS ; ETHICS
Record Number: 08853152
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

RESEARCH STANDARDS OVERSEAS VARY GREATLY EUROPEANS WORRY ABOUT


FRAUD, SLOPPY DRUG EXPERIMENTS
Plain Dealer, The (Cleveland, OH) - December 17, 1996
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

With human lives and huge investments at stake, the global pharmaceutical industry has a sense of anxiety over its
growing reliance on research from outside the United States, where standards tend to be less strict and widely
divergent.

"It's our little secret. ... It's frightening. I could tell you so many stories. We all can," said German pharmacologist
Joachim Schwarz, whose North Carolina contract research company, Quintiles, runs experiments for drug companies
on four continents.
Caption:
PHOTOS BY:ASSOCIATED PRESS PHOTO 1 Frank Wells, the recently retired medical director of the Association of
the British Pharmaceutical Industry, says: "Nearly every one of us has some experience with fraud." PHOTO 2 Cafe
owner Harry Noble of Rainhill, Merseyside, one of Dr. Geoffrey Fairhurst's patients, says the doctor didn't tell him he
was part of a drug research study.
Edition: FINAL / ALL
Section: NATIONAL
Page: 10A
Series: DRUG TRIALS AN INVESTIGATIVE ANALYSIS Third of four articles
Index Terms: DRUG TRIALS
Record Number: 08852058
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

SECRECY IN TESTS LED TO TROUBLE PARENTS OF BABIES NOT TOLD OF THERAPY


Plain Dealer, The (Cleveland, OH) - December 18, 1996
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

Doctors confront a dilemma when they experiment on people: Are they healers or scientists? Should they give a patient
the best treatment possible, or do they use their patients as a means to discover better treatment for others?

Harvard University researchers at a Boston hospital faced a twist on the familiar conundrum: What if the better treatment
seemed to be the experimental one? What if people receiving conventional therapy appeared more likely to die? Should
they be told?

Edition: FINAL / ALL


Section: NATIONAL
Page: A22
Series: DRUG TRIALS - Do People Know the Truth About Experiments?
Index Terms: GUINEA PIGS ; PATIENTS AND TREATMENT ; INFANT MORTALITY
Record Number: 08853164
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

CAN'T ASK, WON'T TELL MEDICAL MIRACLES ARE TAINTED WHEN THEY COME AS A
RESULT OF ARROGANCE AND DECEPTION
Plain Dealer, The (Cleveland, OH) - December 19, 1996

When do hamsters get more scrupulous attention than people?

When they're involved in drug trials.

Edition: FINAL / ALL


Section: EDITORIALS & FORUM
Page: 10B
Column: EDITORIALS
Record Number: 08854023
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

GLENN URGES TIGHTER MEDICAL RESEARCH RULES


Plain Dealer, The (Cleveland, OH) - December 21, 1996
Author: BILL SLOAT and KEITH EPSTEIN PLAIN DEALER REPORTERS

Sen. John Glenn said yesterday that all U.S. medical research on humans should be covered by the "Common Rule," a
set of federal regulations for obtaining informed consent that covers the government but exempts private industry.

"Basically, the Common Rule should apply across the board," said Glenn, who is preparing such legislation.

Edition: FINAL / ALL


Section: NATIONAL
Page: 12A
Record Number: 08856087
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

FDA NOT TRACKING ADVERSE EFFECTS OF TESTING DRUGS


Plain Dealer, The (Cleveland, OH) - December 22, 1996
Author: BILL SLOAT and KEITH C. EPSTEIN PLAIN DEALER REPORTERS

The Food and Drug Administration is unable to determine how many "adverse events" - unexpected deaths, injuries or
reactions - have been reported by researchers testing investigational new drugs on humans because the data have
never been computerized.

For three years, records show, the agency has failed to act on a potentially life-saving recommendation that it track with
available computer technology such adverse effects, which drug makers and their contract scientists are required to
report.

Edition: FINAL / ALL


Section: NATIONAL
Page: 1A
Series: DRUG TRIALS - Do People Know The Truth About Experiments?
Record Number: 08857181
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

DANGEROUS DOSES OF BUREAUCRACY


Plain Dealer, The (Cleveland, OH) - December 27, 1996
Author: KRISTINE M. SEVERYN, R.Ph, Ph.D.

Congratulations to reporters Bill Sloat and Keith Epstein for their thorough expose on our government's use of its
citizens as guinea pigs in medical research (Dec. 16).

Unfortunately, in the case of vaccines, informed consent flies out the window after they are licensed. Mandatory
vaccination laws in all 50 states negate proper informed consent. In fact, vaccines that are not completely safe or
effective are required for day care, school and college admission and even for employment.
Memo:
Severyn, a registered pharmacist with a doctorate in biopharmaceutics, is founder and director of Ohio Parents for
Vaccine Safety.
Edition: FINAL / ALL
Section: EDITORIALS & FORUM
Page: 8B
Column: LETTERS
Dateline: DAYTON
Record Number: 08862023
Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

NORPLANT DISTRIBUTOR AGREES TO CONSENT FORMS


Plain Dealer, The (Cleveland, OH) - July 29, 1995
Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

The distributor of Norplant has volunteered to do what regulators wanted five years ago - require that women sign
consent forms before having the long-term contraceptive surgically placed in their arms.

The Food and Drug Administration was attempting to ensure women were fully aware of Norplant's potential drawbacks
before approving it in 1990, but abandoned the effort in the face of stiff resistance from distributor Wyeth-Ayerst
Laboratories.

Edition: FINAL / ALL


Section: NATIONAL
Page: 1A
Dateline: WASHINGTON
Record Number: 08210115
Copyright 1995, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.