The Israeli newspaper, Haaretz, reports that four senior Israeli doctors
accused of conducting illegal medical experiments without informed consent
on elderly patients-many with dementia-were arrested. The details of the
State Comptroller’s Office report findings-which severely criticized the
hospitals involved were disclosed to the public by an investigative series
in Haaretz, as well as a TV investigative series "Fact."

According to a investigative report issued by the Israeli Health Ministry,
the doctors "conducted illegal and unethical testing on thousands of elderly
patients for years.  During one of the incidents described, twelve patients
died either during the experiments or shortly after they took place, but
these incidents were not reported to the Health Ministry or investigated, as
is required by law."

Haaretz (below) implicitly suggests that this case raises far wider
implications:
"some doctors received promotions, both in their professional and academic
careers, on the basis of the illegal tests. In some cases, the tests were
used as the basis for research studies published in local and international
medical journals. At least four doctors at the hospitals were named as
experts in Geriatrics based on the illegal tests they allegedly conducted
along with their colleagues."

If "expertise" rests on illegal / unethical research such expertise rests on
fraud. The question the public might ask is: What, if any, ethical standards can we
legitimately insist that medical researchers follow?

If research reports about human trials are accepted for publication in peer
reviewed science journals-and those trials were unethically conducted-the
journals lose their legitimacy as arbiters of science.  Editors of
prestigious American and British journals acknowledge that tainted journal
reports have seriously undermined the very integrity of medicine.
http://medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/j
ournal.pmed.0020138 

Following an internal inquiry, the Israeli Health Ministry’s actions
contrast sharply with oversight agencies in the UK and the US. The Health
Ministry’s director general "filed a complaint with the police and harshly
criticized the hospital Helsinki [ethics] committee for its failure to
protect the patients’ best interest.  And the National Fraud Squad
confiscated from the hospitals many documents pertaining to the
experimentation." 

In sharp contrast, following the catastrophic monoclonal antibody experiment
(TGN1412) that all but killed ALL six healthy volunteers because safety
precautions were not taken, the UK Medicines & Healthcare products Agency
(MHRA) attempted to sweep the systemic and specific violations under the
carpet. The MHRA announced its investigation: "has found no evidence to
suggest that there was any problem with the manufacturing of the
product….Neither have we found anything in the way the trial was run which
contributed to the adverse reactions experienced by the volunteers…" 

Haaretz reports: "The Health Ministry’s director general filed a complaint
with police following an internal inquiry into the affair and the fraud
squad confiscated from the hospitals many documents pertaining to the
experimentation.

One is reminded of how South Korea dealt with research fraud in the case
involving a prominent scientist, Hwang Woo-Suk, who was exposed for
falsifying cloning data. In that case, both the University of S K and the
government acted swiftly-the scientist was publicly humiliated and he
apologized. His American colleagues suffered no such consequences. In the
US, Canada, and the UK research fraud is not only tolerated,
Universities-even the National Institute of Health-punish the whistleblowers
rather than the perpetrators.

What lesson can be learned from the fact that small countries-such as South
Korea and Israel-take action against those who are found to have engaged in
research misconduct and violated ethical standards, whereas the major
research centers and government oversight agencies in the US and the UK are
prepared to sweep aside evidence of ethical violations.  The FDA
accommodates researchers who want to test experimental products on
incapacitated human subjects without having to obtain informed consent by
issuing an exemption rule.  www.ahrp.org/cms/content/view/357/28

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org <mailto:veracare@ahrp.org> 
 
~~~~~~~~~~~~~~~~~~~~~~~`

www.haaretz.com/hasen/spages/772409.html

Four top doctors arrested over illegal human experimentation 
By Ran Reznik, Haaretz Correspondent 

Four senior doctors at Kaplan Hospital in Rehovot and Hartzfeld Geriatric
Hospital in Gedera suspected of illegally experimenting on humans were
arrested Monday.

The national fraud squad has opened an investigation into the affair. The
four are suspected of abuse, aggravated assault, causing death through
negligence, fraud, forgery, breach of statutory duty, and disruption of
legal proceedings.

The Tel Aviv Magistrate’s Court on Monday extended by three days the remands
of Kaplan-Hartzfeld deputy director Dr. Shmuel Levi and Dr. Nadia Kagensky.
The third suspect, Dr. Alona Smirnov, was released to house arrest for five
days, and the fourth suspect was released following an investigation.

Police searched the houses of all four suspects and confiscated
incriminating documents.

Many of the details of the affair were revealed in a series of Haaretz
articles on the subject, as well as Channel 2 TV’s investigative documentary
series "Fact."

In May 2005, the State Comptroller’s Office slammed the hospitals over the
illegal experimentation in a report.

According to a report issued by the investigations department of the Health
Ministry and exposed by Haaretz, the hospitals in Gedera and Rehovot
conducted illegal and unethical testing on thousands of elderly patients for
years.

During one of the incidents described, twelve patients died either during
the experiments or shortly after they took place, but these incidents were
not reported to the Health Ministry or investigated, as is required by law.

The Health Ministry’s director general filed a complaint with police
following an internal inquiry into the affair and the fraud squad
confiscated from the hospitals many documents pertaining to the
experimentation.

The ministry’s investigation revealed that some of the patients were
included in the experiments without providing their consent, while some of
them suffered from severe mental damage, which prevented them from being
legally capable of providing consent.

According to the report, some of the tests did not even yield any medically
or scientifically beneficial results. Furthermore, some of the experiments
were conducted despite top doctors’ warnings that they were illegal or
unethical.

The report voices harsh criticism of the Helsinki committee at the
hospitals, responsible for approving the experiments and failing to protect
the public’s best interests.

The ministry’s report further condemns the hospital’s management for failing
to address the complaints and information handed to it over the past few
years, describing the flawed medical procedures.

According to the report, some doctors received promotions, both in their
professional and academic careers, on the basis of the illegal tests. In
some cases, the tests were used as the basis for research studies published
in local and international medical journals.

At least four doctors at the hospitals were named as experts in Geriatrics
based on the illegal tests they allegedly conducted along with their
colleagues.

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

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