Research Misconduct: An Ethinic Double Standard?ALLIANCE FOR HUMAN

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[sSRI-Research] Research Misconduct: An Ethinic Double Standard?

 

 

 

Research Misconduct: An Ethinic Double Standard?ALLIANCE FOR HUMAN

 

RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

News reports and commentary by U.S. scientists, about a South Korean

scientist's fabrication of human cloning research (published by the

U.S. journal, SCIENCE) smack of an ethnic double standard.

 

Mark S. Frankel of the American Association for the Advancement of

Science (AAAS): " We have a history of dealing with these kinds of

matters, and we have gotten better at it. The Koreans are at a very

nascent stage of dealing with these kinds of things. " The AAAS owns

the journal Science, which published the disputed work. [see:

Washington Post:

http://www.washingtonpost.com/wp-dyn/content/article/2005/12/24/AR2005122400735_\

pf.html

]

 

" gotten better at it? " Really? That claim flies in the face of a

continuing stream of almost daily revelations of research fraud.

Indeed, research fraud at major American universities is on the rise:

 

A survey of 3,000 government-funded scientists, published in NATURE

(June 2005) found that a third of American biomedical scientists have

engaged in questionable research practices, raising serious questions

about the integrity of the nation's multibillion-dollar research

enterprise. See: http://www.ahrp.org/infomail/05/06/11.php

 

Medical journal editors have failed utterly to protect the integrity

of their publications by failing to establish truly independent review

and data analysis. In fact, peeer-review as currently constituted is

rigged. The current peer-review system is no more credible than

industry sponsored ghost written articles that now pollute those

journals. Fraudulent reports that conceal negative research findings

are flooding the most prestigious medical journals--including the New

England J of Medicine, JAMA, and the rest.

 

One cannot help but note the contrast between the laid-back manner in

which the media and journals treat U.S. research misconduct and the

South Korean case of cloning fabrication by Dr. Hwang Woo Suk.

American scientists who have been shown to have concealed negative

findings and penned their name to ghost written articles have not been

forced to acknowledge their misconduct publicly. Dr. Hwang has done

just that.

 

In a December 20 article in The New York Times, Global Trend: More

Science, More Fraud, Senior Times medical writer, Lawrence Altman

blamed increased scientific misconduct on research conducted abroad--

" without the benefit of [u.S.] standards. " He stated: " a series of

scientific scandals in the 1970's and 1980's challenged the scientific

community's faith in these mechanisms to root out malfeasance. In

response the United States has over the last two decades added extra

protections, including new laws and government investigative bodies.

And as research around the globe has increased, most without the

benefit of such safeguards, so have the cases of scientific misconduct. "

 

But that is contradicted by a relentless series of public revelations

demonstrating that fraud and resesrch misconduct are undeniabley in

evidence at premier American research institutions--including the

National Institutes of Health. A few examples other than Vioxx and

the false antidepressant pediatric trial reports:

 

 

1. the Boston Globe reported " in the worst case of scientific fakery

to come to light in two decades, a top obesity researcher who long

worked at the University of Vermont admitted yesterday that he

fabricated data in 17 applications for federal grants to make his work

seem more promising, helping him win nearly $3 million in government

funding. " Eric T. Poehlman, a leading specialist on metabolic changes

during aging, acknowledged that he altered and made up research

results from 1992 to 2002, including findings published in medical

journals that overstated the effect of menopause on women's health.

See: http://www.ahrp.org/infomail/05/03/18a.php

 

2. The BMJ reported that the FDA took action against American

cardiologist Dr. David Faxon, immediate past president of the American

Heart Association for medical ethics violations, such as:

falsification of data, false claims about his role in a clinical trial

comparing aspirin to a new drug, falsifying medical records to

facilitate inclusion of patients that should have been excluded. Dr.

Faxon was former chief of cardiology at U of So. Calif in Los Angeles

and is currently chief of cardiology at the U of Chicago. See:

http://www.ahrp.org/infomail/1202/14.php

 

3. THE WALL STREET JOURNAL reported Cash Injection: As Universities

Get Billions in Grants, Some See Abuses; Cornell Doctor Blows Whistle

Over Use of Federal Funds, Alleging Phantom Studies; Defending a Star

Professor

http://proquest.umi.com/pqdweb?did=ˆ2532681 & Fmt==3 & clientId=

485 & RQT=09 & VName==PQD

 

4. NIH medical safety officer, Dr. Jonathan Fishbein blew the whistle

on AIDS Clinical Trials in Africa. He lost his job for telling the

truth--until finally being reinstated.

 

5. Pfizer lawsuits: On May 14, 2004, Pfizer pleaded guilty in federal

court to criminal fraud charges for the unlawful promotion and

marketing of Neurontin. Pfizer agreed to pay $430 million in

settlement. The human casualties resulting from false claims published

in scientific journals, was not even addressed in the stat attorneys

general lawsuit. See http://www.ahrp.org/infomail/04/07/26a.php

 

6. A study published in the Journal of the American Medical

Association (JAMA) in 2004 found that 65% of negative findings-- of

harmful effects--were not fully reported in medical-journal articles.

See: Source: " Empirical Evidence for Selective Reporting of Outcomes

in Randomized Trials, " JAMA, May 26, 2004 See:

http://jama.ama-assn.org/cgi/content/abstract/291/20/2457

 

Given the massive failure of " peer-reviewed " journals to detect fraud,

or to take action when fraud is detected, one wonders what " standards "

Dr. Lawrence Altman may have been referring to? The Washington Post

reported yesterday: " The editor of Science, Dr. Donald Kennedy of

Stanford University, said yesterday that he would allow the paper to

be retracted if all the other authors agreed with the request. Dr.

Gerald P. Schatten of the University of Pittsburgh, the senior author,

asked to withdraw his name from the article on Monday. "

 

What's more, whereas the Korean stem cell fraud case was discovered

before patients were harmed, the same cannot be said in defense of

U.S. corporations and U.S. academics whose research misconduct and

aggressive marketing of defective drugs, vaccines, and medical devices

has resulted in tragic human consequences--namely, in tens of

thousands of preventable deaths, and hundreds of thousands of patients

suffering life-threatening long-term effects.

 

The selective moralizing directed at " foreign " researchers reminds one

of how William Bennett for more than 20 years commanded the culture

wars. Bennett, who served as Secretary of Health Education and

Welfare, and as " drug czar " under George H.W Bush, was known for his

finger-wagging morality sermons in which he inveighed against the

decline in " family values " in sermons and books such The Book of

Virtues; Broken Hearth: Reversing the Moral Collapse of the American

Family. That is, until it was disclosed he " made millions lecturing

people on morality--and blown it on gambling. "

 

Before acquiring the nickname, " The Bookie of Virtue, " Bennett

commanded $50,000 in fees per sermon railing against moral decline.

When confronted about his multi-million dollar gambling habit, Bennett

said: " I've gambled all my life and it's never been a moral issue with

me. " See, Washington Monthly:

http://www.washingtonmonthly.com/features/2003/0306.green.html

 

Below Barry Meier of the NYT reports the latest revelations about

Guidant corporation's failure to disclose the potentially lethal

electrical defect of its defibrillators.

 

" Officials of the Guidant Corporation projected in an internal report

that some patients might die as a result of short circuits in a

company heart device, but it did not publicize the flaw because it

apparently viewed the overall failure rate as acceptable, company

records filed in connection with a lawsuit show. "

 

How does the damage from Dr. Hwang's fabrication compare with the

tragic consequences resulting from the failure of U.S. researchers and

their corporate sponsors to notify physicians and the public about

potentially lethal defects in marketed medical products? Who has the

authority to decide what is an " acceptable " death rate due to a defect

in a medical device?

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.nytimes.com/2005/12/20/science/20rese.html?pagewanted==print

THE NEW YORK TIMES

December 20, 2005 F-1

Global Trend: More Science, More Fraud

By LAWRENCE K. ALTMAN and WILLIAM J. BROAD

EXCERPT:

The South Korean scandal that shook the world of science last week is

just one sign of a global explosion in research that is outstripping

the mechanisms meant to guard against error and fraud. Experts say

the problem is only getting worse, as research projects, and the

journals that publish the findings, soar.

 

Science is often said to bar dishonesty and bad research with a triple

safety net. The first is peer review, in which experts advise

governments about what research to finance. The second is the referee

system, which has journals ask reviewers to judge if manuscripts merit

publication. The last is replication, whereby independent scientists

see if the work holds up.

 

But a series of scientific scandals in the 1970's and 1980's

challenged the scientific community's faith in these mechanisms to

root out malfeasance. In response the United States has over the last

two decades added extra protections, including new laws and government

investigative bodies.

 

And as research around the globe has increased, most without the

benefit of such safeguards, so have the cases of scientific

misconduct. Most recently, suspicions have swirled around a dazzling

series of cloning advances by a South Korean scientist, Dr. Hwang Woo

Suk. xxxx cutxxxx

 

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

http://www.washingtonpost.com/wp-dyn/content/article/2005/12/24/AR2005122400735_\

pf.html

THE WASHINGTON POST

Ethics in Research Debated

By Rob Stein

EXCERPT:

The stunning revelation that a South Korean researcher faked

landmark stem cell experiments has sparked an intense new debate about

the safeguards designed to prevent and catch scientific fraud. While

it remains unclear what motivated Hwang Woo Suk, the case has

highlighted how the increasingly rapid pace of science, and rising

international competition, may be intensifying the temptation to fake

results, experts said. " The system broke down, " said Laurie Zoloth,

director of the Center for Bioethics, Science and Society at

Northwestern University. " We have to ask hard questions. "

 

The stem cell fraud case joins a rogues' gallery of hoaxes that have

shaken the scientific world periodically. From the 1912 Piltdown man

claim by British researchers that they had discovered the " missing

link " to a recent claim by U.S. researchers that they had discovered

new basic elements, history is pockmarked with infamous cases of

scientific fraud. " The notion of a scientist faking data has,

unfortunately, probably been around as long as there has been

science, " said Marcel C. LaFollette, a historian who studies and

writes about scientific integrity.

 

The stem cell case has parallels with some earlier hoaxes, according

to Alex Boese, who studies and writes about such cases. In the

Piltdown man claim, for example, the British researchers may have been

motivated in part by national pride. " At the time, it was assumed that

whatever country discovered the missing link would be the root of

mankind, " Boese said. " Maybe in this case South Koreans wanted to

prove their scientific credentials. " With each new revelation comes a

new round of questions about how well science polices itself and

whether the system needs to be changed.

 

Currently, research is largely self-monitored through a patchwork of

safeguards designed to make sure studies are ethical and conducted

well. Universities, hospitals and other research centers have internal

review boards that approve studies before they are begun to make sure

they are ethical and well designed, then monitor their conduct.

Scientists submit their findings to journals, which ask experts in the

field to review them. xxx cut xxx

 

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

http://www.nytimes.com/2005/12/24/business/24guidant.html?adxnnl==1 & emc==eta1 & ad\

xnnlx=35517914-Eiy9HPI+f3mIsHJ+aetVFA & pagewanted==print

 

THE NEW YORK TIMES

December 24, 2005

Files Show Guidant Foresaw Some Risks

By BARRY MEIER

 

Officials of the Guidant Corporation projected in an internal report

that some patients might die as a result of short circuits in a

company heart device, but it did not publicize the flaw because it

apparently viewed the overall failure rate as acceptable, company

records filed in connection with a lawsuit show.

 

Guidant had also determined in mid-2002, a company report shows, that

the consequences of the defibrillator's electrical failure, while

rare, could be " life threatening. " Despite that assessment, Guidant

kept selling potentially flawed devices and did not notify doctors

about the defect until last spring, when the problem was about to be

made public.

 

The Guidant documents were filed Thursday in a Texas state court by

plaintiffs' lawyers in connection with a personal injury lawsuit

involving the defibrillator, which is known as Prizm 2 DR. The records

appear to be the first internal Guidant documents to have emerged in

court filings since the company began facing a wave of lawsuits this year.

 

A spokeswoman for Guidant, which is based in Indianapolis, said in an

e-mail message yesterday that the company, as a matter of policy, did

not comment on pending litigation. Guidant officials have previously

said, however, that the company did nothing wrong.

 

The emergence of the Guidant records could intensify the company's

legal problems as well as intensify a broader debate about when

manufacturers of heart devices should alert physicians about product

risks.

 

In addition, New York State and the city of Bethlehem, Pa., have filed

lawsuits against Guidant seeking reimbursement for device-related

health care costs.

 

One of the Guidant records shows that the company projected in May,

before disclosure of the defibrillator's problems, that about 0.15

percent of the units - or 15 units out of every 10,000 - were likely

to short-circuit. In such episodes, Guidant estimated that 12 percent

of the patients whose units failed, or about 1 in 10, would experience

either a Severity Level 5 or Severity Level 4 event. A company chart

defines Level 5 as death and Level 4 as life threatening.

 

Another Guidant document filed in connection with the Texas lawsuit

shows that the company determined in February that it would not reopen

its own investigation into the device's problem until the number of

failures exceeded a specific number at a given point.

 

That acceptable failure rate, a chart on the document indicates, was

about 15 devices a year, a rate of slightly more than one a month. The

document does not state the internal standard that Guidant uses to

notify doctors about product failures. Guidant did so in late May when

it learned that The New York Times was preparing an article about the

Prizm 2 DR failure. At that time, the number of device malfunctions

reported to Guidant fell within the company's acceptable rate of

failure, documents show.

 

In a posting on its Web site yesterday, Guidant said that it knew of

two patient deaths associated with short circuits in the Prizm 2 DR

and five other patient deaths associated with short circuits in

devices called the Contak Renewal and Contak Renewal 2. The flaws are

all associated with Guidant's use of an insulating material in a way

that caused it to deteriorate.

 

Dr. William H. Maisel, a cardiologist at Beth Israel Deaconess Medical

Center in Boston, said yesterday in a telephone interview that all

heart device makers typically perform hazards assessments after

discovering a device flaw. But Dr. Maisel said he remained troubled

that Guidant did not disclose the data about the short circuits and

the statistical analysis the company performed.

 

" For Guidant, these people are numbers, " said Dr. Maisel, who is the

chairman of the Food and Drug Administration advisory committee that

reviews heart devices. " Their descriptions are full of numbers. But

for me, these patients are people. "

 

Largely as a result of the Guidant episode, device makers, doctors and

the F.D.A. are trying to develop uniform guidelines for manufacturers

to disclose product flaws to physicians. Doctors can then weigh such

risks against those posed by added surgery in deciding whether to

replace a device early.

 

Guidant initially said that it believed that the risk of replacing a

Prizm 2 DR might outweigh those posed by the device itself. It was in

early 2002 that Guidant learned from reports that the Prizm 2 DR was

prone to short-circuiting. In April and November of that year, company

engineers took steps to prevent the short from occurring. But Guidant,

which has said the April fix appeared to cure the problem, kept

selling older models out of inventory even after an improved one was

available.

 

In its June 2002 assessment, Guidant described the flaws " overall

health risk index " as " very low. " At about the same time that Guidant

discovered the problem with the Prizm 2 DR, the company was awaiting

approval from the F.D.A. to market the Contak Renewal. Company

officials have repeatedly declined to describe the steps they took, if

any, at that time to determine if the Contak Renewal might also

short-circuit.

 

The Guidant documents at issue were filed late Thursday in a Texas

state court in Corpus Christi by a plaintiffs' lawyer, Robert C.

Hilliard. His motion is seeking to have a judge lift a confidential

order governing Guidant records produced in connection with a lawsuit.

Two patients, Beatrice O. Hinojosa and Louis E. Motal, are seeking

damages from Guidant, citing, among other things, a failure to warn

them about the unit's defects. The Texas lawsuit, which is scheduled

to begin in late February, could be the first Guidant case in the

current wave of lawsuits to go to trial.

 

Company Offers Profit Warning By Bloomberg News

Guidant said yesterday that fourth-quarter profit might fall as low as

17 cents a share as demand for its defibrillators dropped after a

recall. Fourth-quarter revenue may decline to $790 million to $820

million, and earnings, to 17 cents to 23 cents a share including legal

expenses related to product recalls and merger activities, Guidant

said in a regulatory filing. The company forecast revenue of $3.8

billion to $4 billion in 2006 and profit of $1.48 to $1.58 a share.

The company said on Dec. 14 that it had received seven reports of

deaths related to heart defibrillator failures since the company

recalled 109,000 of the devices in June. Boston Scientific and

Johnson & Johnson are bidding to acquire Guidant.

 

a.. Copyright 2005The New York Times Company

 

 

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