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Flawed AIDS Drug Study Exposes NIH Misconduct  February 02, 2005
By Jonathan M. Fishbein

.Whistleblower Says U.S. Bungled AIDS Study .Lawsuit Filed Over Woman Who
Died in AIDS Drug Trial.Docs Worry AIDS Drug Use May Be Halted
In a White House ceremony on June 19, 2002, President Bush announced an
important new AIDS initiative to combat the spread of HIV from mothers to
their newborns.

It was a bold and courageous effort to deal with one of the greatest public
health scourges of our time.Yet, it is a vision marred, perhaps irrevocably,
by a rash of allegations of scientific and professional misconduct now
swirling around the National Institutes of Health Division of AIDS (search)
(DAIDS).

DAIDS is the focal point for a considerable portion of government funded
clinical trials on new AIDS therapies and preventive strategies. If these
allegations are not promptly addressed, many of us in the AIDS community
feel they could undermine not only U.S. international AIDS initiatives, but
U.S. credibility in the field of AIDS research across the board.

Until recently, I was the Director of the Office of Policy in Clinical
Research Operations at the National Institute of Allergy and Infectious
Disease Division of AIDS. In that capacity, I was responsible for ensuring
the integrity of government-funded AIDS drug trials by insisting upon good
clinical practice and the rigorous oversight of all AIDS-related field work.

It was an impossible task. At every turn I found my efforts frustrated by a
management system guided more by politics than by sound science. Nepotism
and bureaucratic intrigue permeate DAIDS. Scientists are pressured to
produce results at the expense of regulations whose purpose is to protect
the safety, rights and welfare of study subjects, not to mention the
preservation of scientific integrity.

For seven months, I learned of numerous instances of scientific and
professional misconduct at DAIDS. I brought some of these to the attention
of my supervisor as I am required to do by law. My vigilance was rewarded
with a notice of termination and slander against my good name and
reputation. Frustrated, I decided to step forward as a whistleblower in the
hope that public exposure would bring about the needed change. That has yet
to happen. Instead, NIH has worked fervently to suppress my allegations and
delegitimize my credibility. They will not succeed.

According to the U.N, at least 38 million people are infected with the
HIV/AIDS (search) virus worldwide and approximately 3 million die each year.
I refuse to sit idly by and let NIH perpetuate bad science while the list of
AIDS victims continues to grow. As a physician, as a scientist, my duty is
to them.

Among the most serious charges I have leveled against NIH is that the agency
knowingly and cunningly covered-up evidence of shoddy conduct in a trial
examining the safety and efficacy of nevirapine (search) to prevent the
maternal-to-child ("vertical") transmission of the deadly AIDS virus.

In announcing the United States' New Mother and Child HIV Prevention
Initiative (search) on June 19, 2002, President Bush stated "we will support
programs that administer a single dose of nevirapine to the mother at the
time of delivery, and at least one dose to the infant shortly after birth."

Unfortunately, the agency permitted the president to make that statement
knowing that it was unable to verify the integrity of the data at that time.
Nor did they advise the president that they were aware that nevirapine can
have serious side effects.

Far from being a wonder drug, nevirapine can be very dangerous. It has been
subjected to numerous changes in its labeling by the FDA, owing to reports
of liver toxicity (search) and a potential for fatal rashes when
administered in multiple doses. But with the administration of just one
dose, viral resistance can result in half the patients to whom the drug is
prescribed. In resource-poor countries, there are often no other affordable
options available to treat these infected women once a nevirapine-resistant
virus emerges.

This was not the conclusion reached by NIH-backed researchers from The Johns
Hopkins School of Medicine when they undertook a landmark study of
nevirapine in Uganda in the late 1990s. The study, known as HIVNET 012
(search), purported to show that the drug was safe and effective in
preventing HIV transmission to newborns.

What was not immediately apparent was that some of the most basic procedures
of Good Clinical Practice (search) were absent from their work.

The original HIVNET results were published Sept. 4, 1999 in Lancet, one of
the world's foremost medical journals. They were hailed by many in the AIDS
community as an unqualified victory in the fight against AIDS.

As most of the international AIDS research community, as well as the World
Health Organization (search), embraced these findings, the NIH and the
investigators are unwilling to admit to any flaws.

However, when third party auditors from nevirapine's manufacturer,
Boehringer Ingleheim, looked into how the Uganda trial was run, they found
critical compliance issues that compromised the integrity of the study.
Boehringer had only recently used the HIVNET data to support its application
to the FDA to obtain licensure of nevirapine for preventing vertical
transmission of HIV (search). A second audit sponsored by DAIDS essentially
confirmed what the manufacturer discovered. With the validity of the data
very much in question, Boehringer Ingelheim withdrew its license application
to the U.S. FDA.

The NIAID swung went into action. Deputy Director LaMontagne assured the
public "there is no question about the validity of the data," citing only
that "the problems are in the rather arcane requirements in record keeping."
This was quite an understatement and a willful deception of the public. From
there, DAIDS maintained the deceit by concocting an expensive and elaborate
"remonitoring" of HIVNET 012 in which the conclusions were never in doubt.

And as if that weren't enough, DAIDS used threats and intimidation to
silence those employees who knew the truth and might potentially speak out.

I, for one, will not succumb to such behavior and be silenced.

In 2002, President Bush stood shoulder to shoulder with Senate Majority
Leader Bill Frist, Secretary of Health and Human Services Tommy Thompson and
Dr. Anthony Fauci, the Director of the National Institute of Allergy and
Infectious Diseases (NIAID), and announced the African AIDS initiative with
much fanfare. It now appears that this endorsement of nevirapine may have
been premature. No policy, no matter how well intentioned, should be based
on poor science. Yet that is what HIVNET 012 was.

Of even greater importance is what the experience with HIVNET 012 has taught
us about one government agency. NIH is broken and needs to be overhauled.
Those responsible for suppressing the truth about poor scientific conduct
and deceiving the public should themselves be reprimanded and removed from
positions of authority. Acts of retaliation by senior managers against
employees simply doing their job should be fully and fairly investigated.

What is clear is that in the battle against the world's most deadly
diseases, scientific misconduct of whatever stripe cannot, and should not,
be tolerated.

For the good of Americans suffering from HIV/AIDS and for the millions
overseas so afflicted, the Bush administration's leadership in this matter
is urgently needed.

Jonathan M. Fishbein, M.D.is a former Director, Office for Clinical Research
Policy at the Division of AIDS (DAIDS) at the National Institute of Allergy
and Infectious Disease (NIAID), the National Institutes of Health (NIH). A
full discussion of Dr. Fishbein's case, including supporting documents, can
be found at: HonestDoctor.org.