Fishbein Clarifies Allegations Press Release

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

 

HonestDoctor.org

 

FOR MORE INFORMATION, CONTACT:

Rand H. Fishbein, Ph.D. Tel: (301) 767-1691

Internet: www.HonestDoctor.org

E-Mail: HonestDoctor

 

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:

 

· failure to record thousands of adverse events,

· failure to obtain proper informed consent,

· failure to maintain satisfactory clinical and pharmacy records, and

· 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.