In a message dated 12/21/2004 9:07:56 P.M. Pacific Standard Time,
honestdoctor@comcast.net writes:


HonestDoctor.org

FOR MORE INFORMATION, CONTACT:
Rand H. Fishbein, Ph.D. Tel: (301) 767-1691
Internet: _www.HonestDoctor.org_ (http://www.honestdoctor.org/)
E-Mail: _HonestDoctor@comcast.net_ (mailto:HonestDoctor@comcast.net)

FOR IMMEDIATE RELEASE

Fishbein Clarifies Allegations: NIH Officials Betray Public Trust, Perpetuate Widespread Cover-up of Clinical Trial Data

* * * * *
Washington, D.C., December 22, 2004. There have been some incorrect
assertions and inferences in the press regarding the exact nature of my
allegations against the National Institutes of Health (NIH) and its
officials. This
statement clarifies my position.

My sole criticism of the HIVNET 012 clinical trial rests with the issue
of scientific integrity. It is my contention that NIH-sponsored researchers
knowingly failed to abide by the most fundamental tenets of Good Clinical
Practice (GCP) when studying the effects of the drug nevirapine on
African research subjects. GCP is an internationally recognized standard for
conducting clinical research. Its purpose is to assure the public that
test data is credible and that the safety, well-being, and rights of
clinical trial subjects are protected. The failings of the HIVNET 012
researchers were compounded by NIH officials, who not only deceived the
public, but knowingly withheld critical information from the President,
necessary for him to make an informed decision about a major foreign
policy initiative. Publicly, they have trivialized the deficiencies in the
trial by calling them "procedural".

The integrity of the HIVNET 012 study has been compromised in a number of
ways. Some of the more egregious include:
1 failure to record thousands of adverse events,
2 failure to obtain proper informed consent,
3 failure to maintain satisfactory clinical and pharmacy records, and
4 failure of the investigators to assess adverse events through direct
observation.

Furthermore, the Office for Human Research Protections (OHRP) cited
serious issues of non-compliance with regulations that assure the
protection of human research subjects. This was the judgment of auditors
from Boehringer-Ingelheim, and Westat Corporation. It also was the
finding
of the DAIDS Remonitoring Team before their conclusions were rewritten by
Edmund Tramont, Director, Division of AIDS, NIAID to cover-up the gross
errors in the researchers.
GCP is essential to assuring that clinical trial data is true and
accurate.

Without adherence to this standard, no honest assessment of the safety and
efficacy of nevirapine in preventing the spread of HIV/AIDS from mother to
child can be made from the HIVNET 012 data.

NIH and the HIVNET 012 researchers have violated the public trust by
ignoring rules and regulations designed to protect the well-being of
vulnerable patient populations and the integrity of scientific research.
Americans and Africans alike should be outraged by this behavior.

Faulty scientific research, disguised through government deceit, exacts a
high cost on the public and the credibility
of American medical research. Without the preservation of high research
standards and intellectual honesty in clinical
research, the health and safety of the public is placed in grave jeopardy.


The issue I chose to bring to the fore is not nevirapine, but the issue of
misconduct in the NIH research establishment. All NIH employees have a
mandatory duty under
law and regulation to report waste, fraud, and abuse to
the appropriate authorities: All NIH employees have a responsibility to
assist in efforts to combat fraud, waste, and abuse in all NIH programs
and have the responsibility to
report such matters to the appropriate official following the procedures
described in Section F of this chapter, ~Procedures for Reporting
Allegations.

NIH Policy Manual, Chapter 1754, Part C (Policy); 45 CFR Part 73, Subpart
M. Adding to this tragedy is the fact that NIH senior management failed in
their role as guardians of the public trust to address the allegations of
wrongdoing when I reported them. It is they who should have recognized
these lapses in procedure and ethical judgment when I stepped forward.

Instead, they chose to shoot the messenger.

To this day they persist in denying that any wrongdoing took place. As a
result, the NIH has fueled suspicions about the intentions of American
scientists around the globe and has set back the cause of AIDS research
years, if not decades. Reform and new leadership can not come soon enough
to NIH.

Countless lives depend upon it.

Today, I call upon the Congress of the United States to direct that a full
and independent investigation into the misconduct at NIH be carried out.

Those responsible for covering up scientific misconduct must be held
accountable. At stake is nothing less than the credibility of American
medical research and with it a critical element of American foreign
policy.

Jonathan M. Fishbein, M.D.


==

Heatlthfully and Hopefully,

Kelly Jon Landis



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