Prosecution Expert Witness Peter McDonald’s Testimony

Peter McDonald's testimony is available here (14 MB pdf). Pages are numbered 1322-1385.

Also see his exchange with Kary Mullis.

The photographs that you presented to the court yesterday that were at p. 540 of the fourth edition of Medical Virology, they are the Gallo photographs aren’t they?

I’m not sure. There is a reference around those photographs and I would – I hope I made it clear yesterday that those were not really good photographs. They were sort of photocopied out of the text book, and I think if we are talking about photographs we should actually look at some of the others taken by the previous expert witnesses.

Underneath the photographs it says they come from the 1985 photographs of – I will call it the Gallo group.

If that’s what it says, yes.

I am saying they are a group of photographs which certainly were challenged.

Look I agree with that and I think Dr.Gallo yesterday gave a very clear exposition as to the contamination of one out of – is it 46 culture lines?

48

Now I can tell you, Mr. Borick, that the sort of culture techniques and processes that Gallo and Montagnier and others went through at the time are hugely technically challenging and often prone to be contaminated, and people make huge efforts to set aside those cell cultures that have become contaminated, but there are some really – I will say “sneaky” viruses – that can pop in and mimic retroviruses, and it is not surprising that there was a contaminant in there. And you have got to remember that in those very early days before the virus had been regularly cultured, and one culture was seen to be the same as another culture…in a sense I could say that the gold standard had not been established in 1983 and it was very quickly established because the gene was sequenced and that is HIV.

Due to concerns over McDonald’s communications with Kary Mullis he was recalled as a witness and examined again (7.1 MB pdf).

Do you know of any AIDS patients who haven’t tested positive for HIV?

No, none at all. There were some reports very early on in the epidemic where there appeared to be people with AIDS in whom it was not possible to either find plasma RNA or detect antibodies. Subsequently, as the tests have become much more refined, there is not a single patient with AIDS in whom HIV has not been detected, either through mmolecular techniques or by culture.

AIDS, by definition, has to be associated with a positive antibody test, which means infection of HIV. I don’t dispute the fact that there is a rare condition of low CD4 cells that brings with it symptoms, but that is not AIDS.

“This report describes the field and laboratory investigation of eight patients who had clinical evidence of HIV infection, but repeatedly negative HIV-1 antibody screening results in the course of their clinical care. In all patients, HIV infection was proven by other diagnostic methods [PCR/viral load, p24 antigen and culture techniques]…Patient 1…had 3 negative HIV EIA [ELISA antibody test] results in the 2 years before admission, and 5 other documented negative EIA tests in the 8 years before that…Patient 2…HIV EIA result was negative during admission, but HIV infection was identified by HIV p24 antigen testing and DNA PCR…His wife was tested for HIV infection by HIV EIA and DNA PCR; the results of both tests were negative…Patient 3…HIV-1 EIA and an HIV-1/2 combination test administered 1 month [after hospital admission] were negative…HIV-1 p24 antigen tests were positive…The diagnosis of HIV infection was confirmed by HIV-1 DNA PCR. During the following 27 months, the patient had eight negative HIV EIA results; 3 HIV-1 DNA PCR tests and 3 HIV-1 RT PCR tests were positive…Patient 4…first HIV EIA, performed at the time of diagnosis of oral thrush 4 months [after persistent high fever], was negative…[8 months later, after worsening health problems] an HIV EIA result was negative…[but] specimens were positive by DNA PCR and p24 antigen tests…In the 11 months following the positive PCR and antigen tests at CDC, the patient had 3 negative HIV EIA results…Patient 5…results of two HIV EIA performed during the initial evaluation [for acute respiratory distress] were negative, although two quantitative RT-PCR tests were positive…Viral culture was positive; however, a later blood sample…was negative by HIV EIA and positive by p24 antigen EIA…The patient had 4 children…All were tested by HIV EIA, p24 antigen EIA, and RNA PCR with negative results…Patient 6…became acutely ill after vaccination for measles, mumps and rubella…[she had a] negative HIV EIA on 2 occasions, a positive HIV-1 p24 antigen result, and a positive HIV-1 DNA PCR result. Prior HIV EIA results were negative 2 years, 1 year and 2 weeks before hospitalization…Of her 17 lifetime sexual partners, four were tested at CDC by HIV EIA and HIV-1 DNA PCR; all test results were negative”

Sullivan PS et al. Persistently negative HIV-1 antibody enzyme immunoassay screening results for patients with HIV-1 infection and AIDS: serologic, clinical, and virologic results. AIDS. 1999 Jan 14; 13(1): 89-96.

“In October 1995, the Utah Department of Health referred to CDC blood samples obtained from a man who had had onset of persistent fatigue and malaise during January 1995. During January-June 1995, he had sought medical care at several clinics. When he was admitted to a hospital in June because of respiratory illness and recent weight loss of 27 lbs, HIV-EIA was negative. In August, he was admitted with lung-biopsy-confirmed Pneumocystis carinii pneumonia (PCP) and a CD4+ count of 129 cells/microL; an HIV-EIA again was negative…Two blood samples obtained in October and in December 1995 were analyzed by CDC and the Food and Drug Administration (FDA). Both samples were weakly reactive for antibody (signal/cutoff ratio less than 2.2) when tested by the HIV-EIA kit from manufacturer A, but were negative by kits from manufacturers B and C. Because antibody detection assays were negative or weakly positive, additional assays were conducted. Assays for HIV-1 p24 antigen using the kit from manufacturer D on both samples were so weakly reactive that neutralization assays were invalid; however, after the samples were subjected to base dissociation to disrupt immune complexes, the p24-antigen results became strongly reactive and neutralizable. Antigen results also were positive using EIA kits from manufacturers E and F without immune complex disruption, including a positive neutralization test (kit E). HIV infection was diagnosed based on the positive p24-antigen test results.”

CDC. Persistent lack of Detectable HIV-1 Antibody in a Person with HIV Infection – Utah, 1995. MMWR. 1996 Mar 8; 45(9): 181-5.

“We have seen an infant, born to seropositive parents, who was persistently seronegative for HIV antibody before the onset of severe immunodeficiency..The diagnosis of AIDS in this child rests on the opportunistic infections, decreased T4/T8 [immune cell] ratios, impaired T-cell immunity, loss of functional antibody, and seropositivity in the parents”

Marshall GS et al. AIDS in a child without antibody to HIV. Lancet. 1987; 1: 446-7.

Note that Salahuddin was in Gallo’s lab in 1984.

“Of 96 patients with AIDS or AIDS-related complex and healthy individuals at risk for AIDS, 4 had no detectable antibodies to viral proteins, though [HIV] was isolated from their lymphocytes. 3 of these subjects were symptom-free and 1 had lymphadenopathy. All 4 were sexual partners of patients with AIDS or AIDS-related complex…none of the patients studied here had evidence of impaired production of antibody other viruses”

Salahuddin SZ et al. HTLV-III in symptom free seronegative persons. Lancet. 1984 Dec 22/29; 2: 1418-20.

“349 homosexual or bisexual men with biopsy proven KS seen in a university hospital-based dermatology practice between 1981 and 1989 were tested for antibodies to HIV-1, and 343 were HIV-1 positive…Inhaled nitrite (poppers) use was reported by 5 [of the 6 who were HIV-1 negative]…Other workers have identified homosexual men with KS and no HIV infection.”

Friedman-Kien AE et al. Kaposi’s Sarcoma in HIV-negative men. Lancet. 1990; 335(8682): 168-9.

“Approximately one third of AIDS patients in the United States have been from New York City and San Francisco, where, since 1985, < 7% have been reported with HIV-antibody test results, compared with > 60% in other areas.” “If laboratory tests for HIV were not performed or gave inconclusive results and the patient had no other cause of immunodeficiency…then any disease listed in Section I.B [including a variety of infections and cancers] indicates AIDS if it was diagnosed by a definitive method [as opposed to presumptive]”

Revision of the CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome. MMWR. 1987 Aug 14; 36(1S): 1S-15S.

“Our attention is now focused on the considerably large number of the seronegative group (135/227, 59%) who were clinically diagnosed as having AIDS. All the patients had three major signs [from the WHO’s so-called ‘Bangui’ definition of AIDS]: weight loss, prolonged diarrhoea, and chronic fever. Many of them also had other AIDS-associated signs, such as lymphadenopathy, tuberculosis, dermatological diseases, and neurological disorders.”

Hishida O et al. Clinically diagnosed AIDS cases without evident association with HIV type 1 and 2 infections in Ghana . Lancet. 1992 Oct 17; 340(8825): 971-2.

“WHO case definition for AIDS surveillance

For the purposes of AIDS surveillance an adult or adolescent (>12 years of age) is considered to have AIDS if at least two of the following major signs are present in combination with at least 1 of the minor signs listed below, and if these signs are not known to be due to a condition unrelated to HIV infection.

Major signs

• weight loss >= 10% of body weight
• chronic diarrhoea for more than 1 month
• prolonged fever for more than 1 month (intermittent or constant)

Minor signs

• persistent cough for more than 1 month
• generalized pruritic dermatitis
• history of herpes zoster
• oropharyngeal candidiasis
• chronic progressive or disseminated herpes simplex infection
• generalized lymphadenopathy

The presence of either generalized Kaposi sarcoma or cryptococcal meningitis is sufficient for the diagnosis of AIDS for surveillance purposes.

Advantages of the WHO case definition for AIDS surveillance are that it is simple to use and inexpensive since it does not rely on HIV serological testing. Limitations of this case definition are its relatively low sensitivity and its low specificity particularly with respect to tuberculosis, since HIV-negative tuberculosis patients could be counted as AIDS cases because of their similarity in clinical presentation.”

WHO case definitions for AIDS surveillance in adults and adolescents. Wkly Epidemiol Rec. 1994 Sep 16; 69(37): 273-5.