U.S. INQUIRY DISCREDITS GALLO ON AIDS PATENT
Diagnostic test claims were riddled by holes, probe says

By John Crewdson

Chicago Tribune 19 June 1994

A two-year inquiry by the inspector general's office of
the Department of Health and Human Services has found no evidence
to support Dr. Robert C. Gallo's claim that he was the original
inventor of the widely used diagnostic blood test for AIDS.

Nor has the inquiry, a summary of which was obtained by the
Tribune, provided support for the government's position that it
is entitled, on the strength of Gallo's AIDS test research, to
the lion's share of the millions of dollars in annual royalties
paid by companies that make and sell the test.

Although the summary, like most federal investigative reports,
contains no conclusions, it notes that the patent examiner who
granted HHS the 1985 patent on Gallo's AIDS test told
investigators she would not have done so had she known that
French scientists already had developed such a test.

The patent examiner was among more than 50 scientists and
former and current government officials questioned during the
most extensive inquiry thus far into the circumstances
surrounding the Franco-American dispute over Gallo's decade-old
claim of having invented the AIDS test and discovered the virus
from which it is made.

According to the summary, the patent examiner acknowledged
that "had she been aware of (the French AIDS test research) at
the time she examined the blood test application of Gallo, she
would have suspended prosecution of the Gallo application
interference" between Gallo's application and one filed months
earlier by the French.

The summary notes that Gallo, who heads a research
laboratory at the National Cancer Institute, failed to tell the
Patent Office that scientists at the Pasteur Institute of Paris
already had performed "extensive work" with the AIDS virus and
had used it to make an AIDS blood test of their own.

Despite a legal obligation to disclose all information
"material" to his claim of inventorship, the summary says, Gallo
failed to inform the Patent Office that his laboratory had
cultured the French AIDS virus, called LAV, "for an extended
period and used it for many of their experiments."

According to the summary, Gallo later told investigators his
assertions were untrue. "There is a point where I say I didn't
grow LAV," Gallo is quoted as having acknowledged. "And, of
course, LAV was grown."

The 35-page inspector general's summary, which provides a
detailed chronology to "bring focus" to Gallo's statements and
actions, includes a number of key statements attributed to Gallo
-some made under oath-that are contradicted by evidence gathered
in the inquiry.

According to the summary, after the dispute arose in 1985, HHS
officials insisted that Gallo, not Pasteur, had been "first to
identify the virus and to describe the virus antibody test."

The inquiry leaves little question, however, that Pasteur
scientists were first to discover the AIDS virus, to isolate it
successfully from several AIDS patients, to describe it in a
scientific article, and to use it to make a diagnostic blood test
for antibodies to the AIDS virus.

The summary also notes that more than a month before Gallo
applied for the patent, another HHS agency, the Centers for
Disease Control, informed Gallo that the French AIDS test was
as accurate as his own at detecting AIDS virus antibodies in
blood samples from AIDS patients.

In briefs filed with the Patent Office, HHS lawyers later
dismissed the fact that Pasteur had sent Gallo a sample of its
newly discovered AIDS virus as having had "no significance" for
Gallo's research.

The summary asserts, however, that someone in Gallo's lab
simply renamed the French virus, changing its designation from
LAV to MOV, and continued to use it in the experiments that led
to the development of Gallo's blood test.

The AIDS isolate Gallo later called HTLV-3B, the virus
with which the U.S. version of the AIDS test is still
manufactured, also has been shown to be the French virus LAV.

The AIDS test, one of the government's few lucrative
inventions, has produced at least $20 million in royalties for
HHS since 1987, compared with $14 million for Pasteur during the
same period. Gallo has so far received more than $700,000 from
the sale of the AIDS test in addition to his government salary.

The French first began to seek an expanded share of the AIDS
test royalties in 1991, after Gallo admitted that HTLV-3B is
really LAV-the result, he said, not of any misappropriation but
of an "accidental contamination" in his laboratory.

The inspector general's report, however, states, "The claim
that 3B was contaminated by LAV comes into question since there
appears to be no evidence there ever was a 3B to be
contaminated."

The formula for dividing the AIDS test royalties, which the
French want to redraw, was worked out as part of a settlement
announced by President Ronald Reagan and French Prime Minister
Jacques Chirac in 1987, when far less was known about Gallo's
AIDS test research.

In its chronological presentation of facts, for example, the
inspector general's summary confirms a central complaint made by
the French, most recently in a letter sent last week by Maxime
Schwartz, the Pasteur Institute's director, to Dr. Harold Varmus,
who heads the National Institutes of Health.

"The French test kit was developed in the absence of any input
from the American scientists," Schwartz told Varmus, "whereas
there is no evidence that the American test could have been
developed if the American scientists had not received the French
virus."

The French, initially angry that Gallo took credit for their
discoveries after they provided him with their new-found virus
and related materials, now assert that they were deliberately
misled by the Reagan administration about the facts of the case.

In last week's letter to Varmus, Schwartz declared, "A cover-
up of the true facts was deliberately undertaken so that we would
settle." He said the French could no longer "abide by a sharing
of royalties based on what would appear as a previous
administration's deliberate fabrication."

Although HHS has so far refused to entertain the French
appeal, that position may become more difficult to maintain in
the face of the inspector general's summary. An NIH official said
Varmus could not be reached for comment on his reaction to the
inspector general's report.

Sources familiar with the inspector general's inquiry said
that although Gallo, as a prospective inventor, had a legal
obligation to tell the Patent Office about the Pasteur's research
on the AIDS test and his own work with the French virus, the
Patent Office had to share responsibility for improperly granting
Gallo the patent.

The examiner who handled the Gallo patent, one source said,
told investigators she hadn't known until after the Gallo
patent was granted that the French had filed their own
application months ahead of Gallo. The examiner blamed the mix-
up on a breakdown in Patent Office tracking procedures.

Among the items never brought to the examiner's attention, the
sources said, was a scientific article, published two weeks
before the Gallo application was filed, in which Pasteur
scientists provided the first description of the blood test for
AIDS.

Earlier this year, federal prosecutors decided not to bring
criminal charges against Gallo, citing what the inspector
general's summary calls "several obstacles, jurisdictional
concerns and procedural rules governing criminal prosecution,"
including the five-year federal statute of limitations.

The prosecutors advised the inspector general in the same
letter, however, that their decision did not mean they believed
Gallo "should continue to receive . . . annual royalty payments"
from the AIDS test. One source close to the prosecutors said
the language had been added to the letter "for a reason."

The inspector general's inquiry, which encompasses events from
1983 to 1994, was far broader than an earlier HHS investigation
that had been limited to a single 1984 article in which Gallo
reported his discovery of the AIDS virus.

That investigation concluded Gallo deliberately "misstated
the role that the French virus . . . played in his work with the
AIDS virus" by removing all references in the article to his
assistants' use of LAV and then inserting a sentence claiming
that LAV had never been successfully cultured.

Those investigators reluctantly withdrew their misconduct
charges last November, saying that, while they had not changed
their opinion about the facts, they did not believe they could
get a fair hearing from the government appeals board that decides
cases of science fraud.

Despite the withdrawal of the misconduct finding, the Gallo
case has continued to smolder "like an underground fire that
won't go out," as the authoritative newsletter, Science &
Government Report, described it last month.

The publication quoted Frederick Richards, the Yale University
professor who headed a blue-ribbon committee of scientists that
oversaw the misconduct investigation, as calling for a reopening
of the misconduct inquiry based on evidence that had emerged
since the withdrawal.

Among other items, Richards referred to the recent discovery
by congressional investigators of a 1987 computer analysis, by
scientists at the Los Alamos National Laboratory, showing that
Gallo's HTLV-3B was merely Pasteur's LAV by another name.

A memo from those scientists, written to senior NIH officials
just nine days after the Franco-American settlement was
announced, said the government's assertions that Gallo had made
an independent discovery amounted to a "double fraud."

"The major purpose of this whole investigation," Richards was
quoted as saying, "was to find out whether they stole the virus.
The answer is, they stole the virus. But we didn't know that at
the time."

The first indication that the Gallo matter was not concluded
in the eyes of NCI and NIH came last April, at a congressional
hearing on fraud in government-sponsored breast cancer research.

The NCI's director, Dr. Samuel Broder, who had earlier
ordered the removal of Dr. Bernard Fisher of the University of
Pittsburgh as chief of the nation's largest breast cancer
research group, was asked whether he applied the same standards
of fitness and suitability to NCI's own scientists, particularly
Gallo.

Broder replied that "the issues involving Dr. Gallo have
until recently been complicated by a formal inquiry process," a
reference to the misconduct investigation. Broder said he had
been "awaiting the results of that process" before reviewing "the
situation and the facts of Dr. Gallo's case."

Last month Broder sent Gallo a list of questions about his
early AIDS research that had not been addressed by either the
misconduct investigation or the inspector general's inquiry.
Broder gave Gallo until the end of May to produce the answers.

One question concerned an article Gallo published in 1985,
just as the dispute with the French was taking shape, in which he
claimed to have produced his first confirmed isolate of the AIDS
virus in "the fall of 1982"-several months before the French
first isolated their AIDS virus in January 1983.

In addition to asking Gallo to provide data supporting that
claim, Broder asked him to document the source of the AIDS
virus isolate which Gallo called MOV, and which the inspector
general's summary says merely was a new name given to LAV.

A source close to Broder and Gallo, who spoke only on
condition of anonymity, said Gallo had been unable to provide
the requested documentation for his purported 1982 discoveries,
to identify the origin of MOV or to answer many of the other
questions.

Last Monday, the Charleston, S.C., Post and Courier reported
that Gallo was being "courted" by the Medical University of
South Carolina, which has its headquarters there.

The university's cancer research center is headed by Dr. Peter
Fischinger, one of Gallo's former NCI superiors. Fischinger is
mentioned in the inspector general's summary as one of the
officials who helped delay publication of data showing that
Gallo's HTLV-3B was genetically identical to LAV.

The article quoted Gallo as saying he was "listening" to
offers from the university and had "cut the umbilical cord with
the National Institutes of Health," which he described as "not
quite what it used to be. There is not quite the joy of life
there now."

The university's president, James B. Edwards, who served as
secretary of energy in the Reagan administration, told the
newspaper he would "like very much" for Gallo to work there.
I would like him to be working in our lab when he gets the Nobel
laureate," Edwards said.

The newspaper noted that the university currently is cutting
back on staff, but suggested that lack of funds would not be an
obstacle to its recruitment of Gallo. It said Edwards noted
that " Gallo's HIV test patent alone brings in millions, and his
work would quickly pay its own way." *