Monday, August 25, 2008

official - HIV scientific papers riddled with Errors

an extract from Fear of the Invisible



Senior Investigators - 'HIV scientific papers riddled with Errors'



The CDC, America's foremost disease control institution, currently acknowledges: ‘Four papers from Dr Gallo's laboratory, demonstrating that HTLV-III retrovirus was the cause of AIDS, were published in Science in May 1984'.

I needed to understand these key experiments - and this task would surely be made easier since, not only did I have the Science papers, but the related laboratory documents unearthed by the above scientific and Congressional investigations and by John Crewdson. These included original research notebooks, drafts of key papers, laboratory correspondence, all relating to the discovery of HIV. It was a priceless resource that would surely give me all I needed.

I soon discovered that there had been astonishingly five major investigations between 1990 and 1995 into possible fraud in Gallo's HIV research, several of these overlapping with the others. The first was the one that I have already mentioned, run by the NIH's Office of Scientific Integrity (OSI) and the Richard's Panel. Its goals, set in October 1990, were to focus ‘particularly' on the integrity of the first of the four papers published in Science in May 1984, the one on which Popovic was the lead author, since this paper described the key experiments cited in the application for a Patent on the HIV Test.

The second inquiry was under a powerful Congressional Investigative Sub-Committee headed by Rep. John Dingell. It would prevent key documents from being shredded by the NIH. The third was under the Inspector General of the Department of Health and examined criminal fraud in the ‘HIV Test' patent application. The fourth was under the Office of Research Integrity of the Department of Health and Human Resources and looked for fraud, deception and ‘scientific misconduct' in the Gallo Science papers. And the fifth and last was by the US Secret Service, the body normally charged with safeguarding the security of the US President. It would check the related laboratory documents in the finest forensic lab in Washington. If any were forged, it would find out.

All together, this was by far the most formidable governmental investigation into the honesty of scientific research ever undertaken. Clearly the issues at stake were considered extremely important. But Gallo was by now no little scientist. By 1990 he was the head of an NIH laboratory with an annual budget of around $12 million, and his annual salary was over $200,000. In a letter he sent around this time, he described himself as ‘the most cited scientist in the world for the decade of the 1980s.' He had in truth become enormously influential.

One of the first press reports on these inquiries was in the Chicago Tribune of February 25th, 1990. The headline was ‘U.S. agency probing AIDS virus discovery.' It said ‘The inquiry is examining much of the related research conducted in recent years by Dr. Robert C. Gallo, the nation's most prominent AIDS researcher.'

But, from contemporary press reports, Gallo's laboratory was not as upright as might be expected. A newspaper report of 29th April 1990 stated: ‘A 16-month congressional inquiry [by Dingell into Gallo's laboratory] has uncovered evidence suggesting that rare and valuable viruses, among them the AIDS virus, were appropriated' and sold privately. HTLV-3 [HIV] went on the black market for a price of around $1000 a milligram. The person suspected was Syed Zaki Salahuddin, ‘one of Gallo's long-time assistants.' He was also the lead author of one of the four Science papers of May 4th, 1984.

On May 1st 1990 this investigation further found that ‘hundreds of thousands of dollars in government equipment and supplies cannot be accounted for by scientists at the National Cancer Institute' and that a million dollars had been paid to a company partly owned by Salahuddin and his wife. He was later found guilty and sentenced to pay back $12,000 and do 1,750 hours of community service.

I soon learnt, from the OSI investigation records, that Gallo had confessed to it in 1990 that he had not found the AIDS virus in 1982, as reported in the Science papers. He admitted to it that he had only detected the enzyme RT in 1982, and had not found the virus itself. The investigators reported that he had lied when he claimed he did ‘more than fifty' detections and produced ‘ten true isolates' of the AIDS virus in 1982. They concluded that he did not find the virus before 1984.

But, in the apparent belief that people have forgotten this confession, Gallo is now astonishingly repeatedly making the same claim - that he found HIV in 1982 before anyone else. He did so in his recent bookand he did so, even most seriously, in sworn testimony in 2007 to an Australian court. (More on this below.) So for me, discovering his earlier confession was something of a shock.

In 1990-91 more evidence of wrongdoing in Gallo's lab surfaced in the OSI investigation into his HIV research. But at this point the new head of the NIH, Bernardine Healy, intervened. She hauled in Gallo, subjected him to a severe dressing down; laying down that in future he would not be able to absent himself from laboratory duties without permission, nor even publish a paper or give an interview without permission. Then, after hopefully silencing him, she turned her attention to the OSI.

The OSI chief, Suzanne Hadley, was then drafting the final OSI report and about to conclude that Gallo's chief investigative scientist, Mikulas Popovic, the primary author of the most significant of the four Science papers, had falsified the data in this paper - and to recommend that he be condemned for scientific misconduct.

But, when Popovic heard of this, in desperation he had produced long-hidden key evidence. He gave Hadley a 1984 typed draft of the key Science paper that he had kept hidden overseas. Among other things, this draft revealed that Robert Gallo had extensively changed this paper at the last moment to hide their use of the French virus.

With this it seemed the evidence was at hand to prove Gallo guilty of illegal use of the French virus and thus of scientific deceit. Hadley composed her OSI report accordingly. She concluded: ‘Dr. Gallo has claimed credit for the Popovic et al. paper and the other 1984 papers, so must he bear responsibility for the falsehoods in the Popovic et al. paper. Accordingly the OSI finds that Dr Robert Gallo engaged in scientific misconduct.'

This was a damning conclusion. This OSI report now should have gone to the Richards Panel for review - but at this point Healy intervened, removing Haley from her duties at the OSI. The indictment of Gallo was deleted from her report.

But the watered down report that was published after her departure was still highly critical of Gallo. It accused him of ‘an unhealthy disregard for accepted standards of professional and scientific ethics.' It included her findings that Dr. Gallo must share responsibility with Dr. Popovic for ‘imprecise and non-meticulous science', and that Gallo's alteration of a key 1983 Institut Pasteur paper prior to publication was a ‘gratuitous, self-serving, and improper act.' (Gallo had served as Peer Reviewer for a Pasteur Institute paper on the AIDS virus - and had unilaterally changed it prior to publication!) But the report then strangely concluded that none of this was ‘scientific misconduct!' This conclusion seems to have been added without any consideration of what the report actually documented. On the issue of whether Gallo stole the French virus, the report now came to no conclusion.

But the accusations would not go away. The Chicago Tribune was able to report on August 11, 1991: ‘Dr. Robert C. Gallo, the government's most prominent AIDS researcher ... made untrue and misleading statements in a sworn declaration defending the patent from a legal challenge by French scientists.'

into the 1984 article by Robert C. Gallo which reported the isolation of the AIDS virus concludes that this report is riddled with fabrication, falsification, misleading statements and errors.' This was astonishing. The report of which it spoke is the very scientific article that is cited today as establishing for all time that HIV causes AIDS - the first of the four published by Gallo et al in Science in May 1984. If eminent scientific bodies found it so riddled with errors, then why is it still cited?

Possibly because, when these investigations commenced, about a billion dollars had already been invested in ‘HIV infection' prevention and related research. There was thus much riding on the credibility of these foundation papers of HIV research.

A year after these investigations commenced, pressure had really started to mount on Gallo and Popovic. The NIH decision to remove Suzanne Hadley, the Head of the OSI inquiry, had proved so controversial that a new inquiry had to be set up independent of the NIH to complete the work. It was to be managed by the Office of Research Integrity (ORI) of the Department of Health in the President George Bush Administration. The ORI asked the scientists previously working with the NIH inquiry to assist them- saying, if they found reason to present charges against Gallo or Popovic, these would be sent to a departmental legal committee for assessment and action.

The talk of an NIH cover-up to protect Gallo's AIDS research that year also reached Representative Dingell, the head of the powerful Congressional Investigative sub-committee that had previously indicted a scientist working in Gallo's lab for theft, as I mentioned above. Dingell now immediately ordered the OSI files on Gallo and Popovic moved to his office - and asked the NIH for the services of Hadley. It could not refuse him - so she resumed her investigation but now with considerably greater Congressional investigative powers. An aide to Dingell explained: 'Everything Hadley has told us has checked out 100% against documents the committee has received from NIH. She's obviously been treated very shabbily.'

That year Gallo also got into trouble in Africa. His laboratory had developed a vaccine based on transplanting into the shell of another virus a putative part of HIV. It seems this was easier than using HIV itself as it was difficult to find. This vaccine was injected into a few Congolese in Africa and Paris and three of them died. It was then discovered that his vaccine had only been approved for use on animals! But Gallo escaped with only a mild reprimand.

In May 1991, knowing what the OSI was about to deliver its report, Gallo wrote to Nature, confessing that he now realised that the French virus and his own were the same. He blamed his error on inadvertent laboratory contamination. Then a similar confession appeared in the UK from a leading British virologist and colleague of Robert Gallo, Dr. Robin Weiss, the scientist I had first met when he was chairing the NIH workshop on SV40, and again when he was chairing the Royal Society debate on the polio vaccine and HIV.

Weiss now confessed that the AIDS virus he claimed to isolate in 1985, a year after Gallo, was in fact the very same one that the Institut Pasteur had sent him earlier. Like Gallo, his explanation was inadvertent laboratory contamination. He also, like Gallo, had used the French virus to secure a UK patent for the HIV test.

By now Dingell was pushing for a criminal investigation into Gallo's AIDS research - and was angry at the ‘waffling by the Bush Administration' that his efforts met. Charges were justified, he maintained, since ‘a landmark 1984 article in which Gallo reported isolating the AIDS virus contains falsified data.'

Then another damning report appeared. The Richards Panel, set up to supervise the OSI investigation, had decided not to let the matter rest after NIH produced the watered-down OSI report. They were mindful that they had been appointed by two of the most important scientific bodies in the USA - and therefore had a duty to report honestly what they had discovered.

They issued their own report in January 1992. It stated there was ‘a pattern of behaviour on Dr. Gallo's part that repeatedly misrepresents, suppresses, and distorts data and their interpretation in such a way as to enhance Dr. Gallo's claim to priority.' They said his failure to acknowledge his use of the French virus represented ‘intellectual recklessness of a high degree' in the ‘intellectual appropriation of the French viral isolate...'

In February 1992 the Chicago Tribune reported a government investigation had discovered ‘a landmark 1984 article reporting Robert C. Gallo's isolation of the AIDS virus contains numerous falsifications of data and misrepresentations of the methods employed.'

In April 1992, a Prime Time television investigation stated: ‘It may be the greatest scientific fraud of the twentieth century.' It continued over a portrait of Gallo: ‘Eight years ago this man was hailed as the genius who discovered the AIDS virus.' But now it was a story ‘of how a fight for wealth and glory can interfere with the desperate attempt to conquer a deadly disease.'

In July that year, another member of Gallo's laboratory was found guilty of a federal crime. This time it was Prem Sarin, the second in charge of his laboratory for more than a decade. He had embezzled $25,000 that should have been spent on AIDS research.

When Dingell in late 1992 discovered he was missing some of the Gallo research documents, he sought to discover why. He wrote on 24th November 1992 to the Director of the NIH: ‘we have received reliable information that documents from the Gallo/Popovic investigation were being shredded at the NIH's Office of Scientific Integrity.' He continued ‘NIH's actions...show a clear pattern of obstruction and attempted deception ... particularly when juxtaposed with the curious diligence the NIH showed in its efforts to seek out and destroy the person or persons suspected of blowing the whistle on the shredding.'

A year later President Clinton gave the NIH a new director, Dr. Harold Varmus, a scientist of great repute who was not inclined to protect Gallo. In June 1993 the Chicago Tribune reported that ‘the government's long-running case against its star AIDS researcher, Dr. Robert C. Gallo, has been expanded to include a broader range of misconduct surrounding his decade-old claim to have discovered the cause of AIDS.'

The ORI by now had drawn up a powerful Indictment (‘Offer of Proof') against Gallo and Popovic. This it presented to the Department of Health's lawyer-based 'Research Integrity Adjudication Panel'. It was broad ranging and powerful. Here are some excerts:



§ 'Research process can proceed with confidence only if scientists can assume that the previously reported facts on which their work is based are correct. If the bricks are in fact false...then the scientific wall of truth may crumble...Such actions threaten the very integrity of the scientific process.'



§ 'In light of the groundbreaking nature of this research and its profound public health implications, ORI believes that the careless and unacceptable keeping of research records [for proving HIV the cause of AIDS by Gallo and his team] ...reflects irresponsible laboratory management that has permanently impaired the ability to retrace the important steps taken. '



§ [This] 'put the public health at risk and, at the minimum, severely undermined the ability of the scientific community to reproduce and/or verify the efforts of the LTCB [Gallo's 'Laboratory for Tumor Cell Biology'] in isolating and growing the AIDS virus.'



§ 'Gallo's failings as a Lab Chief are evidenced in the Popovic Science paper, a paper conspicuously lacking in significant primary data and fraught with false and erroneous statements.'



§ Gallo 'repeatedly misrepresents distorts and suppresses data in such a way as to enhance his own claim to priority and primacy in AIDS research.'



§ 'The [lead] Science paper contains numerous falsifications... the paper was replete with at least 22 incorrect statements concerning LTCB research, at least 11 of which were falsifications amounting to serious deviations from accepted standards for conducting and reporting evidence.' Some of the captions to micrographs, descriptions of experiments and enclosed tables were 'false and misleading'.



§ 'The absence of virtually any assay data for the parent cell line is simply unbelievable. [Especially since this was] used to develop and patent the HIV antibody blood test.'



§ Gallo, 'in violation of all research protocols, impeded scientists wanting to follow up on his research ... imposed on others the condition that they did not try to repeat his work.'



This is only a selection from an absolutely devastating indictment.

The Adjudication Panel, to which this indictment was submitted for action, was made up of lawyers not scientists. It decided to first consider the case of Popovic - and came to an amazing conclusion. They fully accepted that Popovic had published careless inaccurate and deceptive research, but still deemed him ‘innocent' since the 'intent to deceive' had not been proved. They finished by astonishingly praising Popovic's research as published in Science in May 1984 as important for all time.

This utterly shocked the scientists who had helped produce the ORI report. Their indictment had been supported with the testimony of over 100 scientists, and they had been expressly directed not to try to prove ‘intent' in their indictment. How could the Panel now absolve Popovic from blame on the grounds they had not tried to prove ‘intent'? How could they absolve him of responsibility while accepting their conclusion that the key research he did on HIV was deeply flawed, contained false statements, and might have sent AIDS research off in the wrong direction? Furthermore, how could an Adjudication Panel made up solely of lawyers conclude by praising this research, when they as scientists had condemned it? They wondered darkly just who had advised the lawyers?

The Panel was next to consider the case of Robert Gallo - but in face of the decision on Popovic, the ORI in disgust felt it had no choice but to drop its attempt to find Gallo guilty of scientific misconduct since they had been misdirected over the need to prove ‘intent'. They nevertheless declared their ‘fundamental disagreement' with the Panel's understanding of ‘the importance of clarity, accuracy and honesty in science,'

But Gallo was not yet clear. The Secret Service now presented the evidence they had unearthed to the Dingell Inquiry. They had been charged to examine for fraud the laboratory documents that Gallo had presented as legal evidence. They had discovered that many were ‘fixed' before being presented. Documents written on different dates were changed on the same day. They found incriminating overlapping imprints of the changes on the enclosing folders.

This was the clearest evidence of criminal fraud and was immediately presented to the State Attorney General in January 1994 in the expectation that a criminal prosecution would now be ordered, but he ruled it was ‘out of time'. Too long had elapsed under the Statute of Limitations since the fraud was carried out. Gallo thus may have escaped prosecution on a technicality.

But the investigators were not content to leave it there. Hadley and others went to see Varmus, the new Director of the NIH, to present the new damning evidence, including more now produced by the Inspector General's Inquiry on fraud in the Patent application for the HIV test. The Inspector General had even expressed doubts on whether the related experiments were ever done! The Patent Examiner also now acknowledged ‘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 Gallo's application.'

Varmus was persuaded - and had to act. In June 1994 Gallo was given a choice: prepare to leave the NIH - or face a new investigation that might be harder to escape from unscathed. He decided to leave - in a year's time. It was then headlined on July 12th that: ‘US, France settle AIDS virus dispute. The NIH will give up millions in profit from Test Patent.' The Financial Times reported: ‘US climb down in feud with the French over AIDS research.' The NIH had at last acknowledged that there was justice in the French claim against them as the employer of Gallo.

However the Dingell Investigation never reached a formal conclusion. When the Republican Party took control of the House of Representatives at the end of 1994, Dingell lost his chairmanship of the investigating sub-committee -and the Republicans promptly killed the investigation of the Reagan-endorsed Robert Gallo. However Dingell's staff would have none of this. They did not want their years of research wasted, so they issued an unofficial final 'Staff Report' of 267 pages, detailing their findings. Their report might not have been official, but it received a highly favourable review in the top UK medical journal, the Lancet.

The Chicago Tribune summarised the Staff Report's findings in two scathing pieces, one on 1st January 1995 entitled ‘In Gallo Case, Truth deemed a Casualty' and the other an editorial on 6th January entitled: ‘Defending the Indefensible Dr. Gallo'.



This Staff Report had reported:



§ 'The cover-up ... advanced to a more active phase in mid-March 1984, when Dr. Gallo systematically rewrote the manuscript for what would become a renowned LTCB paper (Popovic et al.; Science).' [LTCB stood for Gallo's Laboratory of Tumor Cell Biology]



§ 'The evidence is compelling that the oft-repeated [HIV] isolate claim - ... dating from 1982/early 1983, are not true and were known to be untrue at the time the claims were made.'



§ 'Many of the samples allegedly used for the pool [the supposed HIV culture] were noted in the LTCB records to be contaminated with mould.'



§ 'The notion that Dr. Popovic used such samples in an effort to obtain a high-titre virus-producing cell line defies credulity.'



§ 'The [early] February 1984 experiment was so faulty and so many aspects of it so questionable, that little or no confidence can be placed in any of its claimed findings.'



§ 'Contrary to the claims of Gallo and Popovic, including claims in their patent applications [for the HIV Blood Test], several of the putative pool samples contained no HIV, while others did not even come from AIDS or pre-AIDS patients.'



The report then concluded:



'The result was a costly, prolonged defence of the indefensible in which the LTCB 'science' became an integral element of the US government's public relations/advocacy efforts. The consequences for HIV research were severely damaging, leading, in part, to a corpus of scientific papers polluted with systematic exaggerations and outright falsehoods of unprecedented proportions.'



The report presented detailed evidence that destroyed the central claim made by Gallo in these famed Science papers; to have isolated HIV in dozens of AIDS patients in experiments conducted in 1982 and 1983. They said he did not have the tools needed to do this - and consequently could not have isolated or identified a single AIDS virus!

The Staff report also recorded that when Gallo was asked ‘to substantiate this claim' [that he had found the AIDS virus in 1982] by his immediate boss Dr Samuel Broder, the National Cancer Institute director, he had ‘responded with a list of samples, only one of which dated from 1982.' ‘When that sample was checked against records, it was found to be marked ‘N.D.' meaning ‘Not Done' - or ‘Not Determinable.' Gallo then admitted under interrogation that he had only detected the enzyme RT, not the virus, at the time. The investigators concluded; ‘No evidence was supplied that any of these samples had ever been tested and found positive for HIV. In fact no such evidence existed.' It then added that the US Secret Service found many Gallo laboratory records were falsified prior to being presented as evidence.

On May 25th 1995 came the news that ‘Dr. Robert C. Gallo, the government's best-known and most controversial AIDS researcher, is departing the National Cancer Institute after a 30-year career that included the discovery of the first human leukaemia virus and a bitter international controversy over his contribution to finding the cause of AIDS. Gallo said he plans to set up his own Institute of Human Virology in a renovated warehouse in downtown Baltimore.'

But, the Science papers he authored, despite being found scandalously fraudulent, were never withdrawn, nor corrected, which to my mind is scandalous given the prestige of the institutions that had condemned them and the consequence of leaving them uncorrected. Thus thousands of researchers still consult them in all innocence. Today thousands of papers on HIV and AIDS refer back to them, and all medical authorities point to them too. The US Center for Disease Control (CDC) still state on their website that the key foundation papers in AIDS research are ‘four papers from Dr Gallo's laboratory, demonstrating that HTLV-III retrovirus [HIV] was the cause of AIDS.' It does not mention that they were found ‘polluted with systematic exaggerations and outright falsehoods of unprecedented proportions.'

The findings of all these high level investigations of the 1990s were thus swiftly and shockingly buried. Few AIDS scientists now know that these seminal AIDS papers were thoroughly discredited by scientists belonging to the most eminent of scientific bodies. This is an extraordinary state of affairs. It is totally amazing, almost unbelievable.

It is as if these highly prestigious top-level investigations never existed - yet they only completed their work in 1995. They are now not even mentioned in the AIDS research history assembled by AVERT and referenced on the UK government's AIDS website.


See AIDS Timeline, 1981-1988, on US government health website linked on www.cdc.gov

Quoted in John Crewdson: Science Fictions page 439 fn. 37 ch 21.

Joan Shenton, Positively False, p50

Gallo stated ‘we had more than 50 detections and more than 10 true isolates of HIV-I.' Emphasis added; 4/26/90 OSI interview; transcript p. 58.

Robert Gallo. In his book Virus Hunters

John Crewdson, Chicago Tribune, Ill.: Aug 11, 1991. pg. 1

Lies, Errors Cited in article by Crewdson, John. Chicago Tribune, Ill.: Sep 15, 1991. pg. 11

Chicago Tribune, Apr 14, 1991 3 Dead in AIDS Vaccine Test

Peter Duesberg. Inventing the AIDS virus. Page 164.

Chicago Tribune, November 6th, 1991

Chicago Times of May 27th, 1992.

John Crewdson, Criminal inquiry urged in AIDS lab scandal Chicago Tribune: Nov 6, 1991

Cited in John Crewdson. Page 443.

Chicago Tribune, July 8, 1992

Chicago Tribune June 6, 1993

The Office of Research Integrity - Offers of Proof Report 1993.

Chicago Tribune U.S. INQUIRY DISCREDITS GALLO ON AIDS PATENT DIAGNOSTIC TEST. CLAIMS WERE RIDDLED BY HOLES, PROBE SAYS. June 19, 1994.

He said ‘we had more than 50 detections and more than 10 true isolates of HIV-I.'Emphasis added; 4/26/90 OSI interview; transcript p. 58.

Gallo-to-Fischinger; August 14, 1985.

The fraud uncovered by the Secret Service is extensively described in Science Fictions by John Crewdson, published by Little Brown in 2002, pages 506-510

Chicago tribune, May 25th 1995

See the Timeline published in The Scientist in November 2006. It states the credit was equally shared between Gallo and the French in 1987 - and totally omits any mention of this later high level controversy. http://www.the-scientist.com/article/flash/23586/1/

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