Cleveland Plain Dealer, human subjects article series by Bill Sloat & Keith Epstein

A DELICATE CALCULATION ONLY A BALANCE BETWEEN SCIENCE AND ETHICS CAN PROMOTE THE HEALTH OFHUMANKINDPlain 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 / ALLSection: EDITORIALS & FORUMPage: 6BColumn: EDITORIALSRecord Number: 09820005Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

UGANDAN TB STUDY REFLECTS ETHICAL DILEMMAPlain Dealer, The (Cleveland, OH) - November 22, 1998

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

Inexcusable reasons were given for allowing the participants to believe they were receiving treatment, only to begiven 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 protectthe health of the citizens in Uganda than we would in this country. The question is not whether there are differentethical standards in a socioeconomic rather than in an epidemiological setting. These researchers are from theUnited States, which opposes unethical research protocols.

Caption: PHOTO BY: MIKE LEVY / PLAIN DEALER PHOTOGRAPHER A bedridden woman rests in Rubaga Hospital inKampala, Uganda.

Edition: FINAL / ALLSection: EDITORIALS & FORUMPage: 4DColumn: LETTERSRecord Number: 09826156Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

VA DID STUDIES WITHOUT CONSENT PSYCHIATRIC PATIENTS USED IN EXPERIMENTSPlain Dealer, The (Cleveland, OH) - February 16, 1997Author: 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 theirmedication was withheld without telling them of the risks, according to the sworn statement of a senior VAresearcher.

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: METROPage: 1BRecord Number: 09047057Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

CLOSING CHAPTER ON EXPERIMENT CINCINNATI HOSPITAL OFFERS A SETTLEMENT TO PATIENTS' SURVIVORSPlain Dealer, The (Cleveland, OH) - February 21, 1997Author: 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 radiationexperiment 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 researchwon't happen again.

Edition: FINAL / ALLSection: OHIOPage: 5BDateline: CINCINNATIRecord Number: 09052037Copyright 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 WEREDUMMIESPlain Dealer, The (Cleveland, OH) - November 9, 1998Author: 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 infectedwith HIV, with the form letter she got from Case Western University, waits her turn at a tuberculosis clinic at RubagaHospital. PHOTO (COLOR) BY: MIKE LEVY / PLAIN DEALER PHOTOGRAPHER (Page 8A) A bedridden womanrests in a tuberculosis ward at Rubaga Hospital. TB, the world's most deadly infectious organism, is particularlydeadly for HIV patients because each disease speeds the other. PHOTO (COLOR): NO CREDIT (Page 8A) A coffinstrapped 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 RubagaHospital in Kampala. PHOTO (COLOR): NO CREDIT (Page 8A) Soldier Dominic Lusiba displays his medical cardfrom 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 aU.S.-sponsored research project. PHOTO (COLOR): NO CREDIT (Page 9A) Efurance Ndibarekera returns homeafter attending a clinic at St. Francis Hospital. BOX: Yesterday: Although the United States has strict safeguards toprotect 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 tomedical centers around the world. BOX: FACTS ABOUT UGANDA Location: Eastern Africa, west of KenyaComparative area: Slightly smaller than Oregon National capital: Kampala Population: 20,604,874 (July 1997estimate) 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 otherinfectious disease, according to the World Health Organization, which declared the disease a global emergency in1993. - 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'spopulation 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 infectedwith TB and HIV-positive is 30 times more likely to become sick with TB because of a weakened immune system. TBis the leading cause of death among people who are HIV-positive, accounting for almost one-third of AIDS deathsworldwide. Up to 50 million people may be infected with drug-resistant strains of TB. 1996 INCIDENCE COUNTRYRATE PER 100,000 The Congo 333 Uganda 300 Phillippines 280 Afghanistan 278 South Africa 250 Peru 250Nigeria 222 Bangladesh 220 Indonesia 220 India 220

Edition: FINAL / ALLSection: NATIONALPage: 1ASeries: SECOND OF TWO ARTICLESDateline: KAMPALA, UGANDARecord Number: 09813100Copyright 1998, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

U.S. MEDICAL RESEARCHERS FLOUT RULES AROUND WORLDPlain Dealer, The (Cleveland, OH) - November 8, 1998Author: KEITH EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

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

So firm is the underlying presumption that patients in experiments must be treated fairly and honestly that theprotections of federal law apply not just to Americans but to any person, anywhere in the world, used in U.S.-financedresearch.

Caption: PHOTO BY MIKE LEVY / PLAIN DEALER PHOTOGRAPHER This was the main office for the Case WesternReserve University study at Mulago Hospital in Kampala, Uganda. Uganda is one of the countries where the Centersfor Disease Control and Prevention failed to obtain written assurances meant to safeguard patients. CHART: Theseare the countries where the Centers for Disease Control and Prevention failed to obtain written assurances thatsafeguard patients involved in medical research SOURCES: Centers for Disease Control and Prevention GRAPHICBY PLAIN DEALER Memo: Today: Although the United States has strict safeguards to protect people involved in medical research, the countryhas 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 fromUganda to medical centers around the world.

Edition: FINAL / ALLSection: NATIONALPage: 1ASeries: FIRST OF TWO ARTICLESDateline: WASHINGTONRecord Number: 09812059Copyright 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 TESTINGPlain Dealer, The (Cleveland, OH) - March 30, 1998Author: 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 theirconsent 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, isconducting 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 mayhave contributed to what is known as Gulf War Syndrome.

Edition: FINAL / ALLSection: NATIONALPage: 1ARecord Number: 09589113Copyright 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 DRUGPlain Dealer, The (Cleveland, OH) - January 25, 1998Author: 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 inBosnia in 1996, has formally cited the Pentagon for understating risks and breaking other rules intended to protectAmericans from unethical experimentation.

The investigation uncovered "significant deviations," reminiscent of similar violations by the military during the PersianGulf War, when it failed to keep vital records, monitor effects, and properly inform troops they were receiving anunlicensed drug and vaccine.

Caption: BOX: GUIDELINES AND BROKEN RULES SOURCE: Food and Drug Administration GRAPHIC BY PLAIN DEALER


OBJECTION TO GULF WAR VACCINE WAS OVERIDDEN U.S. TROOPS NOT TOLD EFFECTS OF BOTULISM SHOTS WERE UNKNOWNPlain Dealer, The (Cleveland, OH) - December 21, 1997Author: 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 anexperimental vaccine without warning them that the effects were unknown, according to documents obtained by ThePlain Dealer.

The ruling, by the ethics committee at the Army's biological defense research station at Fort Detrick, Md., wasoverridden after the Defense Department cited national security concerns. The botulinum toxoid vaccine was given to8,000 troops, who were not told that it was unlicensed.

Edition: FINAL / ALLSection: NATIONALPage: 16ADateline: WASHINGTONRecord Number: 09355132Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

PLAIN DEALER WINS 4 TOP AWARDSPlain 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 Societyof Professional Journalists' annual competition.

Among the winners were reporters Diane Solov and Mark Tatge, who captured the Best Defense of the FirstAmendment category for their pursuit of records as they covered the proposed sale of Blue Cross & Blue Shield ofOhio to Columbia/HCA Healthcare Corp.

Edition: FINAL / ALLSection: METROPage: 6BRecord Number: 09264109Copyright 1997, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

DRUG TRIALS BEING REVIEWED NATIONWIDE INQUIRY INTO TESTING ORDEREDPlain Dealer, The (Cleveland, OH) - January 27, 1997Author: 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 thetesting, 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.


GLENN PROPOSES CRIMINAL SANCTIONS FOR EXPERIMENTS WITHOUT CONSENTPlain Dealer, The (Cleveland, OH) - January 23, 1997Author: 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 obtainconsent from people participating in experiments.

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


FDA FINDS DEFECTS IN CLINICAL DRUG TRIALS DRUG TESTS DEFECTIVE 300 TIMES, FDA SAYSPlain Dealer, The (Cleveland, OH) - January 19, 1997Author: 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 newpharmaceuticals 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.


BIOETHICS COMMISSION STRUGGLES AS ITS FUNDING DRIES UPPlain 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 advisorycommittee 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 onunsuspecting 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:

[email protected]


PROPOSAL FOR PROTECTION IN RESEARCH PRAISEDPlain Dealer, The (Cleveland, OH) - January 10, 1997Author: KEITH C. EPSTEIN and BILL SLOAT PLAIN DEALER REPORTERS

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

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


NEXT OF KIN NOT TOLD OF DRUG FDA CITES POLICY FOR ITS SILENCE ON DEATHSPlain Dealer, The (Cleveland, OH) - December 15, 1996Author: 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: Anexperimental cancer drug.

Caption: BOX: RESEARCHERS FAILED TO DOCUMENT CONSENT AT 46 SITES SOURCE: From FDA records GRAPHIC BYJAMES OWENS / PLAIN DEALER

Edition: FINAL / ALLSection: NATIONALPage: 15ASeries: DRUG TRIALS - Do Pople Know The Truth About Experiments? AN INVESTIGATIVE ANALYSIS First of fourarticlesIndex Terms: MEDICAL RESEARCH ; CLINICAL TRIALS ; EXPERIMENTAL DRUGS ; MEDICAL MALPRACTICEMEDICAL TESTSRecord Number: 08850058Copyright 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'SABODOMEN. HOURS LATER, SHE DIEDPlain Dealer, The (Cleveland, OH) - December 15, 1996Author: 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 portraitshowing his late wife, Laura, is flanked by two of their children, Bernadette McCloskey and Dennis Michalski. PHOTO 2BY DAVID I. ANDERSEN / PLAIN DEALER PHOTOGRAPHER Alexander Michalski says his late wife, Laura, was "mylove, my friend." PHOTO 3 BY CHUCK CROW / PLAIN DEALER PHOTOGRAPHER Hahnemann University Hospital inPhiladelphia was the site of the pioneering radiologist's research using a solvent to dissolve gallstones. PHOTO 4 BYALAN DIAZ ASSOCIATED PRESS PHOTOGRAPHER FDA inspectors questioned why there was no written evidencepeople 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: RESEARCHSITES WITH THE MOST CONSENT PROBLEMS GRAPHIC BY JAMES OWENS / PLAIN DEALER COMMONPROBLEMS FOUND BY THE FDA GRAPHIC BY JAMES OWENS FDA INSPECTIONS AND PERCENTAGE OF TIMESANCTIONS ARE RECOMMENDED GRAPHIC BY JAMES OWENS / PLAIN DEALER WHAT PEOPLE MUST BETOLD GRAPHIC BY JAMES OWENS / PLAIN DEALER

Edition: FINAL / ALLSection: NATIONALPage: 1ASeries: DRUG TRIALS - Do People Know the Truth About Experiments AN INVESTIGATIVE ANALYSIS First of fourarticlesIndex Terms: MEDICAL MALPRATICE ; MEDICAL RESEARCH ; MEDICAL TESTS ; CLINICAL TRIALS ;EXPERIMENTAL DRUGSRecord Number: 08850107Copyright 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 CONDUCTINGAND PAYING FOR TESTS ON UNSUSPECTING AMERICANSPlain Dealer, The (Cleveland, OH) - December 16, 1996Author: 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 shesigned up her daughter, Sacheen, for a hepatitis vaccination, she didn't know the vaccine's safety was being tested onchildren at the Standing Rock Sioux Reservation. PHOTO BY: JACK KUSTRON / ASSOCIATED PRESSPHOTOGRAPHER (A) Dr. Bernadine Healy, dean of the Ohio State University medical school and formerdirector 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 CONSENTPROBLEMS GRAPHICS CHART: JAMES OWENS / PLAIN DEALER (Page 8A) LANDMARK EVENTS IN HUMANSUBJECT PROTECTION From 1977 through 1995, federal Food and Drug Administration inspectors find 2,201consent problems, records show. PHOTO BY: RAMON MENA OWENS / PLAIN DEALER PHOTOGRAPHER (Page9A) Ricardo Munoz is buried in an East Los Angeles cemetary. GRAPHICS CHART: JAMES OWENS / PLAINDEALER (Page 9A) Positions dedicated to monitoring government-sponsored human research Problems found by theFDA within government research facilities BOX: YESTERDAY: At least 1,000 Americans in 23 states have been used inmedical 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 stillconducting medical tests on unsuspecting Americans. TOMORROW: More than half the foreign research submitted tothe Food and Drug Administration over the last decade was unreliable. WEDNESDAY: Local ethics committees, thefront 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: [email protected] your name and a daytime telephone number.

Edition: FINAL / ALLSection: NATIONALPage: 1ASeries: DRUG TRIALS Do People Know the Truth About Experiments? AN INVESTIGATIVE ANALYSIS Second offour articlesRecord Number: 08851146Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

U.S. RECORDS SHOW CONSENT FORMS OFTEN INCOMPLETEPlain Dealer, The (Cleveland, OH) - December 16, 1996Author: 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 farbeyond chilling accounts of Cold War radiation experiments.

Such research has been sponsored by agencies with sterling reputations for benefiting society: The National CancerInstitute, the National Institutes of Health, the Department of Veterans Affairs.

Caption: PHOTO BY: JOE TABACCA / ASSOCIATED PRESS PHOTOGRAPHER A White House committee questioned theuse of addicts from the Northport Veterans Administration Hospital on Long Island in an Energy Department study.


FOREIGN TESTS DON'T MEET U.S. CRITERIA HYPE, HOPE AND HEARTBREAK A CHRONIC CONDITIONPlain Dealer, The (Cleveland, OH) - December 17, 1996Author: 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. GeoffreyDusheiko'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 hadinvolved 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 DEALERBOX:THE SERIES SUNDAY: At least 1,000 Americans in 23 states have been used in medical research withoutrequired evidence of their informed consent. YESTERDAY: Decades after notorious syphilis experiments on blacks atTuskegee and radiation studies on civilians during the Cold War, the government is still conducting medical tests onunsuspecting Americans. TODAY: More than half the foreign research submitted to the Food and Drug Administrationover the last decade was unreliable. Verifiable scientific records from other countries were missing in 54 percent ofrequests for new drug approvals in the United States. TOMORROW: Local ethics committees, the front line inprotecting test subjects, frequently fail to ensure that people know they are being used in medical research. If you havecomments about the series, call 999-5260, fax 999-6366 or e-mail the reporters at: [email protected] Include yourname and a daytime telephone number.

Edition: FINAL / ALLSection: NATIONAL

OVERSEERS OPERATE IN DARK ETHICS PANELS ONLY MANAGE CURSORY REVIEWS OF RESEARCHPlain Dealer, The (Cleveland, OH) - December 18, 1996Author: 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 amother 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 requiredevidence of their informed consent. MONDAY: Decades after notorious syphilis experiments on blacks at Tuskegee andradiation studies on civilians during the Cold War, the government is still conducting medical tests on unsuspectingAmericans. YESTERDAY: More than half the foreign research submitted to the Food and Drug Administration over thelast decade was unreliable. TODAY: Local ethics committees, the front line in protecting test subjects, frequently fail toensure 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: [email protected] 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, yourconsent forms, are you informing the patients?' - I'd like to do that, but we don't have the time or the staffing. This is notwork that is perceived as making a contribution to research.' DR. JOHN BAUM, chairman of the University ofRochester's Research Subjects Review Board BOX: JAMES OWENS/PLAIN DEALER FAILURES ON THE FRONTLINE PHOTO BY: ASSOCIATED PRESS PHOTO 1 Nicole Wan, a University of Rochester sophomore enrolled in aresearch 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 companiesassume ethics committees know what they are doing, but "this is sadly not always the case."

Edition: FINAL / ALLSection: NATIONALPage: 1ASeries: DRUG TRIALS - Do People Know the Truth About Experiments? Last of four articlesIndex Terms: GUINEA PIGS ; DRUG OVERDOSES ; EXPERIMENTS ; ETHICSRecord Number: 08853152Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

RESEARCH STANDARDS OVERSEAS VARY GREATLY EUROPEANS WORRY ABOUT FRAUD, SLOPPY DRUG EXPERIMENTSPlain Dealer, The (Cleveland, OH) - December 17, 1996Author: 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 itsgrowing reliance on research from outside the United States, where standards tend to be less strict and widelydivergent.

"It's our little secret. ... It's frightening. I could tell you so many stories. We all can," said German pharmacologistJoachim 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 ofthe British Pharmaceutical Industry, says: "Nearly every one of us has some experience with fraud." PHOTO 2 Cafeowner Harry Noble of Rainhill, Merseyside, one of Dr. Geoffrey Fairhurst's patients, says the doctor didn't tell him hewas part of a drug research study.

Edition: FINAL / ALLSection: NATIONAL

Page: 10ASeries: DRUG TRIALS AN INVESTIGATIVE ANALYSIS Third of four articlesIndex Terms: DRUG TRIALSRecord Number: 08852058Copyright 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 THERAPYPlain Dealer, The (Cleveland, OH) - December 18, 1996Author: 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 patientthe 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 treatmentseemed to be the experimental one? What if people receiving conventional therapy appeared more likely to die? Shouldthey be told?

Edition: FINAL / ALLSection: NATIONALPage: A22Series: DRUG TRIALS - Do People Know the Truth About Experiments?Index Terms: GUINEA PIGS ; PATIENTS AND TREATMENT ; INFANT MORTALITYRecord Number: 08853164Copyright 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 DECEPTIONPlain 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 / ALLSection: EDITORIALS & FORUMPage: 10BColumn: EDITORIALSRecord Number: 08854023Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

GLENN URGES TIGHTER MEDICAL RESEARCH RULESPlain Dealer, The (Cleveland, OH) - December 21, 1996Author: 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," aset 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.


FDA NOT TRACKING ADVERSE EFFECTS OF TESTING DRUGSPlain 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 orreactions - have been reported by researchers testing investigational new drugs on humans because the data havenever been computerized.

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

Edition: FINAL / ALLSection: NATIONALPage: 1ASeries: DRUG TRIALS - Do People Know The Truth About Experiments?Record Number: 08857181Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

DANGEROUS DOSES OF BUREAUCRACYPlain Dealer, The (Cleveland, OH) - December 27, 1996Author: 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 itscitizens as guinea pigs in medical research (Dec. 16).

Unfortunately, in the case of vaccines, informed consent flies out the window after they are licensed. Mandatoryvaccination laws in all 50 states negate proper informed consent. In fact, vaccines that are not completely safe oreffective 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 forVaccine Safety.

Edition: FINAL / ALLSection: EDITORIALS & FORUMPage: 8BColumn: LETTERSDateline: DAYTONRecord Number: 08862023Copyright 1996, 2002 The Plain Dealer. All Rights Reserved. Used by NewsBank with Permission.

NORPLANT DISTRIBUTOR AGREES TO CONSENT FORMSPlain Dealer, The (Cleveland, OH) - July 29, 1995Author: 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 signconsent 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 drawbacksbefore approving it in 1990, but abandoned the effort in the face of stiff resistance from distributor Wyeth-Ayerst Laboratories.


Cleveland Plain Dealer, human subjects article series by Bill Sloat & Keith Epstein

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