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Brian Deer: VaxGen's AidsVax

 
Materials gathered by Brian Deer from his investigation for The Sunday Times of London of VaxGen Inc of California, and its "world's first Aids vaccine" which flopped in two controversial clinical trials in 2003


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The VaxGen Experiment: During a three-continents Sunday Times investigation of the proposed Aids vaccine AidsVax, which in February and November 2003 failed in trials, Brian Deer found a crushing scientific consensus that VaxGen's controversial technology couldn't work, but had been promoted through political pressure and private deals. The Sunday Times Magazine October 3 1999

Evidence for the prosecution: During his inquiries, Deer was passed documents dated March 22 1999 which showed that, long before VaxGen offered shares to the public, the most important government cheerleader for AidsVax - Dr William Heyward, head of HIV vaccine research at the Centers for Disease Control - had a secret deal to join the company. Out of public duty, Deer gave some to the inspector-general, health and human services, who launched a formal inquiry

Go with the flow: From CDC in Atlanta, Heyward had lobbied policymakers and approved $8m in grants for VaxGen. But the company had already drawn this chart on his future duties, and in January 2000, he joined ex-CDC staffer Dr Donald Francis, VaxGen president, who also hired former CDC deputy director Dr Walter Dowdle to head its influential data monitoring board

United States v William L. Heyward: With Deer's papers, federal attorneys brought charges against Heyward, accusing him of violating anti-graft laws intended to check corruption in public service. Heyward, now a VaxGen vice-president, eventually admitted the conflict, paid a $32,500 fine and escaped a high-profile criminal trial that might have proved devastating to the AidsVax project

Mission accompliced: While Heyward was still in government employment, the company directed journalists to him - as these media pack pages show - giving themselves his apparently independent endorsement. CDC's prestige also helped the stock price of VaxGen Inc to soar following an October 1999 press announcement about the agency's involvement. Heyward had championed VaxGen's position for years, as in a string of science papers
 

PIONEERS OR PEDDLERS?

Animal magic: Ex-company chief Dr Donald Francis claimed chimps "are mirrors of what happens in humans."
Deep shit: Heyward. In a 49-second interview with Deer, he said:"I don't know what you're talking about."

For journalism by Brian Deer on other topics, click here

For more on vaccines see Deer's
MMR investigation

  Investor lawsuits (1): [pdf file] Following the federal prosecution of the VaxGen vice-president Dr William Heyward, the company was hit on March 17 2003 with the first class action lawsuit alleging securities fraud. This complaint filed by attorneys Milberg Weiss in US District Court for Northern California alleges that the company concealed facts, made false claims to cause VXGN stock to trade at inflated prices, and made misleading statements on trial data. VaxGen rejected the action as meritless

Investor lawsuits (2): [pdf file] A second, third and fourth legal complaint, also rejected by VaxGen Inc, were filed by law firm groups headed by Green & Jigarjian, Haldenstein Adler and Glancy & Binkow. Others followed

Of chimps and chumps: Company claims in its IPO prospectus [pdf] as to why they say they believed AidsVax would work rested on antibodies in volunteers during small-scale tests, and two unverifed experiments described by AidsVax inventor Dr Phillip Berman in chimpanzees. Preparing a Sunday Times report for March 16 2003, Brian Deer raised with VaxGen these experiments, carried out at Genentech Inc before that company abandoned AidsVax as not worthy of further development

AidsVax's political history: Given the controversies gathered on these web-pages, one obvious question is: how did this fiasco happen? In 1998, New York Newsday reported on the intensely political background to Aids research in general and the quest for a vaccine in particular. Legal process will now try to resolve whether, against this background, VaxGen misled investors over the possibilities for AidsVax to actually have an impact on the disease. Many critics are now asking: will the law succeed where science has failed?

VaxGen product AidsVax "forgets one century of science" says expert when interviewed by Brian Deer

Scientists caught napping: On February 24 2003, VaxGen broke with its declared plans for unveiling data and announced the failure of its US clinical trial in the middle of the night, ET, giving themselves a clear run with off-hours media staff. Aids activists were outraged by the stunt, and scientists who might have challenged VaxGen's spin on the data were for the most part asleep

Playing the race card: According to VaxGen's results, the trial failed to show efficacy, but under company subgroup analysis it was claimed that among blacks and Asians the vaccine had astounding protective powers. VaxGen slides, however, revealed a weird clustering of infections in the placebo group - caused by one Chicago man - and message board chat raised anxieties over race

Berman's big moment: On March 31 2003, AidsVax inventor Dr Phillip Berman made a rare appearance at one of Vaxgen's many conference calls - this time from a symposium in Canada. During his 30-minute presentation of material from the US trial, the stock market responded, as this chart shows. In January 2004, Berman quit VaxGen, with founding president Dr Donald Francis

Work in progress: The $8m CDC grant went to five of the US centers participating in the VaxGen clinical trial. At this link, an April 2001 CDC press notice backgrounds the crucial project Heyward was involved in setting up. This substudy of VaxGen's trial may have been badly distorted by selective recruitment of volunteers who behave abnormally compared with controls - suggested by this chart     Longtime observer: Since reporting in 1981 the first recognized death in the UK from what would later be known as Aids, Brian Deer has followed both the epidemic caused by HIV and issues connected with other vaccines, such as the DTP-DPT. His investigations for The Sunday Times in the field of medicine won him a British Press Award in 1999, the UK version of a journalism Pulitzer Prize

Vehement denials: In reply to the criticisms, VaxGen Inc argued that the failed trials of AidsVax would help battle Aids, regardless of their outcome. At this link the company denies any conflict of interest by Dr Heyward, and at this link it offers its own account of the fierce opposition AidsVax has encountered, suggesting that criticisms were themselves motivated by conflicts of interest

Stansberry spam: For all the incredulity among vaccine scientists, one man who stood above the herd with Drs Francis, Heyward and Berman was Porter Stansberry, an Agora "investment analyst" who hyped the stock and claimed to have "proof" that AidsVax worked. Even as insiders and institutions dumped VaxGen, Stansberry's mailshots promised miracles. He later challenged Brian Deer

Contact Brian at this link: Were you misled by CDC's apparently disinterested endorsement of the "world's first Aids vaccine"? Do you feel the company told you the full story? To contact Brian Deer about these, or anything else, please email him through this link

 

Maker of failed Aids vaccine in fraud claim

The Sunday Times,
March 16 2003

Brian Deer

The firm behind the world’s first vaccine claIming to offer protection against Aids faces allegations of securities fraud after a four-year trial of the drug ended in failure last month.

Milberg Weiss, the American law firm leading the pursuit of the energy company Enron, plans to file a multi-million- dollar claim against the medical firm this week.

It will allege that VaxGen, of Brisbane, California, cheated thousands of small investors in the firm by allowing "favoured" insiders to sell stock before it was announced last month that the vaccine did not work. After the news, VaxGen's shares fell from a 12-month high of $23.25 to $3.

The company said last week that the allegations would be contested vigorously.

VaxGen began large-scale tests of its AidsVax in 1998, recruiting 5,400 subjects. The trial was launched amid excitement among investors but incredulity among many Aids experts.

“The whole thing was ridiculous,” said Dr Robert Gallo, co-dicoverer of HIV, last week. “I don’t know of a serious scientist in the world who would have expected this to work.”

Nevertheless, AidsVax was launched by medical entrepreneurs fronted by Dr Donald Francis, a former employee of the US government's Centers for Disease Control and Prevention. Francis, who grossed nearly £4.5m from VaxGen in its first three years, was backed by his old government employer, which gave the trial £5m and helped the firm to brush aside high-level opposition.

In 1999 The Sunday Times revealed that a government official who played a vital role in securing the £5m grant for VaxGen also had a secret deal to join the company. This official - Dr William Heyward - was later prosecuted under federal conflict of interest laws and was fined £20,500.

Milberg Weiss will allege that Francis, Heyward and others in the firm knew the trial was set to fail. It is focusing on institutional stock sales before the results were announced on February 24, including sell-offs by Vulcan Ventures, owned by Paul Allen of Microsoft.

Small shareholders say they were encouraged by company statements that all volunteers in small-scale trials "developed neutralising antibodies to HIV"; and that AidsVax had "protected" chimpanzees.

What the company did not emphasise was that an evaluation of HIV infections among volunteers found antibodies to be weak, transient and too narrowly type-specific to protect. Last week Vulcan Ventures declined to comment on the allegations about VaxGen.

A spokesmen for VaxGen said: "If indeed this lawsuit exists, the fact that the lawyers gave it to a newspaper before VaxGen speaks volumes about its lack of merit. VaxGen has complied with all securities laws and, if need be, will defend itself vigorously."



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