CFIDS and AIDS

CHLAMYDIA VERUS CORONAVIRUS:
IN THE PIG VERSION OF SARS
THEY'RE BOTH INVOLVED

By Charles Ortleb

According to a report in Reuters today, Chinese researchers think a form of chlamydia may be the real cause of SARS. According to the report Hong Tao, a scientists working at the Institute of Virology under the Chinese Center for Disease Control and Prevention, told a news conference that "The center studied samples of victims' lungs, livers, kidneys and other organs which showed a chlamydia-like agent appeared to have caused the outbreak of Severe Acute Respiratory Syndrome (SARS)."

But that doesn't settle the matter because the same Reuters report notes that "in Geneva, a spokesman for the World Health Organization said the U.N. agency was '99 percent' certain SARS was caused by a previously unknown strain belonging to the coronavirus family, a major cause of the common cold."

Maybe they're both right.

In the SARS-like epidemic of Porcine Reproductive and Respiratory Syndrome (PRRS) which has occurred in pigs all over China, there is a complex interaction of multiple agents which have made it very dificult to control PRRS. It's a little like AIDS in that secondary infections have clouded the picture of causation and pathology.

Monte McCaw, a scientist working at the College of Veterinary Medicine at North Carolina State University, has done a great deal to try and illuminate the complicated mess that PRRS has become. In a research report posted on the North Carolina Swine Veterinary group site in 1993, he writes about the PRRS problem in Quebec, Canada: "A particularly serious nursery pig pneumonia problem is occurring in Quebec, Canada which appears to be caused by a mixed infection of PRRS and an atypical Influenza (flu) virus. This syndrome causes proliferative pneumonia, a unique and very serious pneumonia of pigs. There is a high rate of death loss, poor performance, and LACK OF RESPONSE TO ANTIBIOTICS (because it is a VIRAL disease syndrome)."

In the same report, he discusses the complex problem of pneumonia in pigs during what could be called the PRRS Era: "While the involvement of viruses in causing pneumonia in pigs is well recognized, many "new" agents and syndromes are being discovered. Some of the new agents are not even confirmed to be independently pathogenic, but have been found in herds that are having nursery or grower pig pneumonia problems. Also, with the arrival of PRRS, many multiple virus pneumonia cases are being reported. Some of these viruses are difficult to grow, but cause very unique lung lesions which have led pathologists and virologists to look harder for new viruses. Therefore, many of these diagnoses are made by excluding the common problems and by seeing atypical lung lesions that are compatible with what researchers have reported rather than by isolation."

This is a disturbing list of viruses associated with porcine respiratory distress these days, according to McCaw's report:

Pseudorabies virus
Influenza virus
PRRS virus
Atypical influenza virus
Porcine respiratory corona virus
Porcine cytomegalovirus
Adenovirus
Paramyxovirus
Unnamed viral isolates from nursery pigs

And that's just the viruses. Chlamydia is one of the bacteria associated with porcine respiratory problems during the PRRS Era. It is so prevalent in pigs with PRRS that initially it was thought to be the cause, according to a USDA report. Researchers should keep all these agents in mind as they try to determine if the PRRS epidemic in pigs has anything to do with SARS. PRRS seems to come with a truckload of potential pathological friends.

Charles Ortleb is the author of The Closing Argument and the co-author of The Chronic Fatigue Syndrome Follies.

SCIENTIST SUGGESTS A FOOD
LINK TO SARS

By Charles Ortleb

In Today's Taipai Times, Chang Yun-Ping reports that "a National Taiwan University Hospital (NTHU) doctor yesterday suggested that the severe acute respiratory syndrome (SARS) may be spreading through contaminated food rather than through the saliva of those who are already infected."

Yn-Ping also reports that, "Doctor Chang Shan-chwen of the NTHU's Infectious Disease Department yesterday made the hypothesis based on clinical experience of SARS patients in Taiwan who developed symptoms of enterogastritis such as soft stools and diarrhea, followed by the respiratory illness such as fever and coughing two to three days later."

He also told the reporter that "because our SARS patients all suffered from an upset stomach before they started coughing, we could infer that the virus might first appear in the stomach, and is later transferred through the blood to the respiratory organs."

Interestingly, a corona virus that infects pigs is capable of causing both digestive and respiratory problems. And the corona virus is associated with Porcine Reproductive and Respiratory Syndrome which is widespread in China.

The corona virus in pigs seems to take two forms. According to a report by Jennifer May of Animal Disease Diagnostic Lab in West Lafayette, Indiana, "Porcine respiratory corona virus(PRCV) was first recognized in Belgium in 1984, when routine serological surveys from slaughterhouses identified high liters to transmissible gastroenteritis (TGE). Retrospective studies of source farms did not indicate occurrence of enteric disease."

May also notes that "PRCV is a mutant of TGE corona virus. PRCV and TGE virus share antigenic sites, but TGE has additional antigenic sites which PRCV does not have because of a deletional mutation. There are multiple strains of PRCV which have varied pathogenicity."

Charles Ortleb is the author of The Closing Argument and the co-author ofThe Chronic Fatigue Syndrome Follies.

THE SECONDARY INFECTIONS OF PRRS IN PIGS
MAY BE CLUES FOR THE CAUSE OF SARS IN PEOPLE

By Charles Ortleb

As scientists look more closely at the possbility that the Porcine Reproducive and Respiratory Syndrome epidemic in the pigs in China is the source of SARS, they should pay attention to the secondary infections of PRRS. Robert Desrosiers describes them on a site produced by the North Carolina Health Hogs Seminar:

"The list of secondary pathogens that can be associated with PRRS ( Porcine Reproductive and Respiratory Syndrome) problems is extensive: Actinobacillus pleuropneumoniae, Salmonella choleraesuis, Streptococcus suis, Haemophilus parasuis, typical and atypical strains of Influenza virus, porcine respiratory Corona virus, Pneumocystis carynii, etc. Most of these organisms can cause problems by themselves. However, they are frequently present in herds where no or few clinical signs are observed, as if they were in equilibrium with the immune defense system of the animals. When PRRS outbreaks occur, it seems that the virus may frequently destroy this equilibrium and give secondary pathogens the opportunity to, at least temporarily, 'win the battle.'"

At the end of his report, Desrosiers warns, "Some organisms affecting pigs can also affect humans. It is thus important to always wear gloves and to use the knife or scalpel with caution when doing autopsies."

Charles Ortleb is the author of The Closing Argument and the co-author of The Chronic Fatigue Syndrome Follies.

THE EXTENT OF PRRS IN CHINA

By Charles Ortleb

An posting about the 2003 International Conference and Exhibition on Pig Production, which will be held in China later this year, describes the spread of Porcine Reproductive and Respiratory Syndrome in China: "Porcine Reproductive and Respiratory Syndrome (PRRS) has been regarded as an economically important swine disease in many swine-producing countries since it was first reported in America in 1987. PRRS virus causes respiratory problems. Reproductive failure in pregnant sows and deaths in piglets. PRRS has been spread throughout most of provinces in China after it broke out first in China 1996."

PRRS AND PCV IN CHINA'S PIGS COULD
BE A MODEL OF THE TWO VIRUS
THEORY OF SARS IN PEOPLE

By Charles Ortleb

Although China does not like to admit that it has a Porcine Reproductive and Respiratory Syndrome epidemic in its pigs, agricultural experts in America assume it to be the case. And that being so, then one would also expect that pigs there would have the cascade of complications associated with PRRS, i.e. other viruses, like one called Porcine circovirus (PCV).
The PRRS virus and PCV seem to hang together and make a bad pathological situation even worse. Here's a description of their choreography I found on a site run by Pennsylvania State University (it's from the July, 2001 Veterinary News):

"Porcine reproductive and respiratory syndrome (PRRS) is characterized by reproductive failure (stillborn, mummified, or weak-born piglets) and interstitial pneumonia in young and growing pigs. Alveolar macrophages in the lung and follicular macrophages and dendritic cells in lymph nodes and tonsil are the major sites of PRRSV replication. Porcine circovirus (PCV) has been isolated from pigs with postweaning multisystemic wasting syndrome (PMWS). PMWS is characterized clinically by emaciation, dyspnea, and lymph node enlargement and pathologically by lymphoid depletion and lymphohistiocytic to granulomatous lymphadenitis, interstitial pneumonia, hepatitis, interstitial nephritis, and pancreatitis. Previous in situ hybridization (ISH) studies have localized the PCV genome predominantly within pulmonary alveolar macrophages and macrophages within lymph nodes, tonsil, spleen, and Peyer’s patch; the PCV genome has also been demonstrated within endothelial cells, enterocytes, pancreatic acinar cells, and renal tubular epithelial cells. The majority (60%) of porcine tissue submissions to the Iowa State University Veterinary Diagnostic Laboratory in which PCV genome or antigen are detected also contain PRRSV antigen (S. D. Sorden, unpublished data)."

Keep this in mind if you continue to hear 1) that SARS may come from pigs in China and 2) that it involves two viruses. Curious, no?

You'll be hearing a lot more about the pulmonary alveolar macrophages in the days ahead.

Charles Ortleb is the author of The Closing Argument and the co-author of The Chronic Fatigue Syndrome Follies.

A TORONTO DOCTOR SUGGESTS
THAT SARS COMES FROM PIGS

By Charles Ortleb

An article in the Winnepeg News today suggests that pigs in China may be the source of rhe growing SARS epidemic. Ken Connor reports that Dr. Jay Keystone, an infectious disease specialist at Toronto General Hospital told him, "Pigs may be the culprits behind the outbreak of SARS." According to Connor, Keystone suggested that the "killer bug originated in southern China, an area with a high concentration of pig farms."

If this is confirmed, it makes a lot of sense to look more closely at Porcine Reproductive and Respiratory Disease, which is an out-of-control AIDS epidemic in pigs all over the world, and one that has serious complications for the lungs.

A fascinating overview of the health of pigs in China, by Cai Bao xiang, gives one a sense of the complexities that SARS researchers may face. What follows is the text of the report which seems to have been translated or written in rather creative English:

Infectious Diseases of Pigs in China Today

Cai Bao xiang

Nanjing Agricultural University, 2100095, Nanjing, P.R. China

China is a country with the biggest population of pigs in the world. Its annual production reached over 984 million heads in 1996. The control and the research of swine diseases have always being emphasized. Pigs are raised in China mainly by rural farmers and recently there are increasing numbers of intensive pig production, which has accelerated the development of swine industry. However, infectious diseases of pigs caused severe economic loss with the farm scale and feeding density increasing while lagged managing and disease controlling. At present, respiratory diseases, infectious diarrhea,which are seriously damaged to the development of pig industry.

SWINE REPRODUCTIVE DISORDERSYNDROME

Swine reproductive disorder syndrome is named for a group of diseases caused by several different pathogens but have similar clinical signs. The main symptoms are infertility, fetal solution in early stage, stillbirth, abortion, and fetal death with mummification, the consequence is low reproduction rate of sows and survival rate of piglets. Sometimes the infection of sow can also cause death of newbom piglets ( such as PR,PRRS, Encephalomyocarditis) . These diseases spread gradually in all over country and by which caused declining of reproduction rate had become common phenomenon in breeding pig farms, especially in intensive farms. According to the investigation and material offered by some pig farms. 20-30 percent of reproduction rate decline was resulted from reproductive disorder, especially in primiparous sows. The great loss is a major factor for bad economic status of swine farms. Thorough controlling of swine reproductive disorders has become a key step in pig industry presently.

There are several disease causing porcine reproductive disorder, which include non-typical Hog cholera, Pseudorabies, Epidemic encephalitis B, Porcine parvovirus, Chlamydiosis and newly occurred Porcine respiratory and reproductive syndrome.

HC is one of infectious diseases which can cause severe economic loss. Since 1958, HC attenuated live vaccine through passage of rabbit had been used for controlling the disease in all over the country, the cases of typical acute HC are rare. However, there are great changes in epidemiology and pathogenicity of HC recently, which are characterized by reproductive disorders in sows and piglets infection before birth. There are reports about non- typical HC in Guangong, Jiangsu, Sichuan, Shandong, Liaoning and Beijing, Pregnant sows show abortion, fetal mummification,stillbirth, weak or health-like infected piglets in appearance, the survival piglets have no immune response(immune tolerance) and stunting, or muscle tremors, finally dead though they are vaccinated before lactation. The effective method to control HC is using high qualitative vaccine and suitable immune program, enhancing management, and eliminating the pigs infected by virulent HC virus with serological surveillance techniques.

PPV is recognized as an important factor causing reproductive disorder, which can cause fetal death and mummification while sows show no clinical syndromes. It was verified that PPV infection has been very common in China through serological investigation and virus isolation since 1980. The positive rate is 30-100% (average 80%) and hardly find a PPV negative farm. PPV can transmit not only horizontally but also vertically. PPV infection is mostly common in primiparious sows. Multiparious sows of new farms can infect in early stage pregnant. The method for controlling PPV include quarantining imported pigs by HI test, vaccinating the breeding boar. Killed vaccine is used for 5-6 month reserve sows when maternal antibody is disappeared, which induce strong immune response two weeks post-vaccination. Breeding sows are vaccinated at 2-4 weeks before mating, breeding boars at the age of 5 month. The vaccination is done once half a year later. Negative pig group can be developed by transferring piglets from infected room to uninfected room after weaning.

Epidemic Encehalitis B, also named as Japanese encephalitis B, is an acute viral zoonosis which transmitted by insects such as mosquito. When infected, Pregnant sows show abortion or stillbirth, boars have testis inflammation and growing pigs show lasting fever, piglets have encephalitis. The disease is stricture seasonally, often occurred from July to September. Most infected pigs are in apparent infection and have negligible clinical symptom. Epidemic Encehalitis B often display an outbreak in new farms and intensive farms. The infection rate is higher in southern areas than in northern areas in China. The main method to control this disease is the eradication of mosquitoes. Attenuated or killed vaccine can be used for prevention. The six-month reserve pigs or new sow which had mated are vaccinated in the bottom of April each year. The combined killed vaccine of PPV and Encephalitis prepared by Jiang Tiantong ( 1996) could control the two diseases effectively. With the tendency of the pig industry in China toward more intensive, PR outbreaks have occurred in several areas recently, which result in economic loss. Zhu Qinghu, et al (1996) reported that merely in Guangdong there were 26 farms prevailed in PR during 1988-1985. The infected breeding sows reached 19750 heads, which accounted for about 30 percent of the sow population among more than 100 intensive pig farms in that particular province. It caused death to the newborn piglets, especially the morbidity and the mortality of those within one-week old were almost 100%. PR in Beijing, Henan, and Hunan showed a tendency of increasing in 1997-1998. It has become one of diseases drawn the most attention.

The recently worldwide epidemic PRRS occurred in China in 1995. The first outbreak took place in Beijing in 1996. Many sows aborted with dead birth. and a lot of piglets died of respiratory complications, which has caused sever economic loss. Sun yingj, et al (1997) randomly sampled 32 farms out of 14 cities for the isolation of virus and for the IFA and ELISA serological tests. They not only found positive pigs for PRRS and isolated PRRS virus from the imported herds, but also examined PRRSV antiboby and isolated the virus from the domestic herds with reproductive disorders. It has apparently induced severe harms to the local pig industry in some areas. An increasing concern is focused on this subject.

RESPIRATORY DISEASES OF PIGS

Among the five major swine diseases which are internationally recognized to be attributable to the significant loss of the pig industry, three are three kinds of infectious respiratory diseases, namely, mycoplasmal Pneumonia(MP), Atrophic Rhintis(AR), and Actinobacillus Pleuropneumonia(AP).All three diseases are commonly existing in China, and have caused sever economic loss. There are safe and effective vaccines and handy diagnostic methods available for these diseases. In addition, Swine Influenza ( SI), Pseudorabies ( PR), and Porcine Reproductive & Respiratory Syndrome (PRRS) have also widely spread in China and caused substantial damages.

MP took an epizootic outbreak in China in the 50�Œs, of which morbidity and mortality both were high. Its epidemic slows down, yet current MP shows high morbidity and low mortality. Most of swine herds carry such a chronic pneumonia, and it is regarded as the most common swine disease in China. Its direct damage is not obvious, but the economic loss may exceed billion a year due to its wide spread and combination with secondary infections, low quality of breeding pig:increase of production cost, and decrease of feed conversion.

AR was transmitted into China in 1964 through the imported breeders, and quickly spread countrywide. According to the 1968-1989 survey in ten cities located in the provinces of Sichuan and Liaoning, 13698 heads were infected with AR and 4499 dead. However, the morbidity was much higher. Yang liuzhan conducted a serological census in 21 farms of six provinces in 1989, the positive rate was 62. 4 percents ( 655/1049) . The recent investigations among big and medium sized intensive farms showed that AR was widely present and its etiology has changed from single pathogen to dual,i.e. Bordetella bronchiseptica and the toxicogenic Pasteulla Multocida. The latter plays more important role in AR�Œs pathogenicity.

AP is a highly contagious respiratory disease caused y Actinobacillus Pleuropneumoniae, manifests the symptoms and pathology of pneumonia and pleuritis. Its existence was identified in 1987 in China. Among total 12 serotypes, types 2,4,5,7, and 8 have been isolated in China. Types 7 and 4 are the most common. The antibody of types 2, 9, and 10 were found as well as. Most cases are single serotype, but occasionally multiple infections with 2 or 3 serotypes are also notice. The epidemic varies depending on areas, and the morbidity may reach 60-80 percents in sever farms. Zhou Yifeng, et al (1994) found 18.4 percents of positive rate in AP antibody by the Blocking ELISA among 478 heads of 4 batches imported breeders in Shanghai. The Harbin Veternary Research Lab has developed in 1997 a mono- valent vaccine which is applicable to some specific areas.

SI has never become a large-scale epidemic outbreak in China. It rather is enzootic in various degrees The 1987-1989 statistics data from ten provinces covering Hebei and Liaoning indicated accumulative total 810 thousands pigs were infected, and 34 thousands dead. Types A3 (H3N2) and A1 influenza virus, which were isolated from the hog herds in Liaoning. Guizhou, Guangxiand Beijing, seemed to be similar to the influenza virus antigen isolated from human at the same time. The type C influenza virus was further isolated from the hog heads in Beijing 1985.

TRANSMISSIBLE DIARRHEA

Transmissible Diarrhea is typical multi- factor disease under intensive pig industry, which had caused sever economic loss. Diarrhea and enteritis often observed in clinic are an important factor of piglets death. and they will still be a difficult problem for a long time.

Diarrhea can be caused by infectious factor such as viruses ( Coronvirus, rotavirus, enterovirus), Bacteria (E.coli, Salmonella choleraesuis, Y.entercolitical Cl. welchii, Treponema hyodysenteriae), fungi and parasites (cococus,Crptosporidium, ascarid, Trichiurus et al)

Yellow scour and white scour (colibacillosis) are common diarrhea of piglets. Prevention is more important than other method to these diseases which include improving nurse and management of pregnant sows before and after birth, feeding the newborn piglets with colostrum in time, balancing the nutrition of the food, ensuring piglets not hungry or over eating, not changing the food suddenly to prevent all kinds of harm effect of stress.

The pregnant sows are vaccinated by Using live or killed vaccine in which the E.coli was isolated from the same area, the piglets can acquire passive immune protection. Hu Xinzheng(1993) reported that the pregnant sows were vaccinated at 40 days and 15 days before giving birth on neckmuscle ( 2ml/each) using combined killed vaccine (K88,K99,987P), the morbidity rate of the experiment group ( 5. 5%) was much lower that control group (72%). The protection rate is above 90%. There are gene engineering vaccine such as E.coli 987P, K88LTB, K88,K99,987P combined killed vaccine. All of these vaccines have protection to some degree in the primary application.

The antibiotics or other anti-bacterium drugs which can inhibit growth of isolated proved by drug sensitivity test for sick pigs could be used. When sensitivity of 231 strains of E. coli for 18 antibiotics were tested, Fang Yuling (1992) found that only Cefaparole and Pipemidic acid uncommonly used in clinic can inhibit or kill E. coli in 12 drugs which originally had strong activity for inhibiting or killing bacteria, other antibiotics showed higher resistance. Nevertheless, one of best method to control diarrhea of piglets in two weeks old is to administrate orally antibiotics or other drugs. Recently Quinolones such Enrofloxacin, Ciprofioxacin and Norfloxacin have been proved as effective drugs for the prevention and treatment of piglets diarrhea.

Microecological preparations (non-pathogenic live germ) is more and more used to control white and yellow scour of piglets. Bio-antagonist do not cause drug-resistance. However, antibiotics are prohibited to use when Microecological preparations is used, or non-pathogenic live E. coli will be killed and the effect is diminished. Theses preparations are convenient, cheap, no side-effect and safe to use. They also stimulate growth of piglets. Great progress have been made in researching and application of Microecological preparations in China.

Although many kind of viruses have been isolated from small intestine and feces, the most important viruses in clinic are TGEV,PEDV,RV, although the clinic signs of RV infection is mild than TGEV and PEDV infection. Sometimes white scour of piglets can be also caused by RV.

TGE and PED are regarded as two main diarrhea diseases of swine in China and abroad. Both TGEV and PEDV belong to the members of coronaviridae. The both show similarity in virus morphology, clinical signs, epidemiology and often coinfect pigs. However, there is no cross-reaction in antigenicity between the two viruses. The diseases often prevailed in spring and winter in most areas of China�Cwhich caused great loss to swine industry. According to statistics of the 1987- 1989 animal disease surveillance by Minister of Agriculture. the mortality of swine resulted from the two disease are 9.5% and 1.7% of total death. the coinfection rate is 30.8-46.2%. The loss is more than 100 million RMB because of the death and increasing of food consume. as well as drug fee. Harbin Veterinary Research Institute developed TGE frozen attenuated vaccine successfully in 1985. Now PED and TGE combined killed cell cultural vaccine is developing.The combined inactivated vaccine of TGEV and PEDV had developed by Guangzhou bureau of animal and plant quarantine.

The immunity of newborn piglets comes from maternal colostrum, so it is important for them to suck colostrum. When sows are vaccinated with vaccine against special pathogen, newborn piglets can acquire colostrum containing special antibody to viruses or gems causing diarrhea in piglets. The immune method is available to prevent and control RV, TGEV and E.coli.

It is an key subject to control reproductive disorder diseases, respiratory diseases and diarrhea for improving the survive rate and health of pigs and developing of pig industry in China. It is necessary to develop more effective vaccines and drug for prevention and treatment except for improving management andhygiene environment in future.

REFERENCES

Animal disease of China. Science press, 1993.

CIA Boxing,1995,Acct of Chinese veterinary Medicine, 15( 4):412-416.

Yang Hanshin et al, 1997, Journal of Chinese veterinary Medicine 23(10):9-10.

Sun Yingjie et al, 1997, Journal of Chinese veterinary Medicine 23(2):8-9.

Jiangtiantong et al, 1996, Journal of Chinese veterinary Science and Technology, 26(10):6-7.

Geeing Tijuana et al, 1997, Journal of Chinese veterinary, 23( 8):25-26.

Chou Hug et al, Chinese Journal of Animal and Poultry Infectious Disease, 1:61-63.

Ma Sequa et al, 1995, Chinese Journal of Animal and Poultry Infectious Disease,6:23-27.

Tong Kunzhou et al, 1996, Journal of Chinese Veterinary Science and Technology, 26(1):3-4.

Charles Ortleb is the author of The Closing Argument and the co-author of The Chronic Fatigue Syndrome Follies.

DOES PRRS IN CHINA'S PIGS HAVE ANYTHING TO DO
WITH THE EMERGING HUMAN EPIDEMIC OF SARS?

By Charles Ortleb

SARS, the deadly new flu that has emerged from China has already been called a "holocaust," and it seems to only have just started. Because its cause is still confused by the presense of at least two suspect agents that might be working together, it would seem that the jury should still be out, at least for the time being. Since the illness reminds us of Porcine Reproductive and Respiratory Syndrome (PRRS) in pigs, we decided to look into what is known about the occurrence of PRRS in China.

Apparently, just as China is slow to admit that it has a SARS epidemic on its hands, it also has dragged its heels where PRRS in swine is concerned. In April, 1999, Nicholas D. Giordano spoke on behalf of the National Pork Producers Council to the U.S. House International Relations Committee about the issue of pork exports to China. Apparently, China didn't want to import our pork, or the pork from Canada, because of the PRRS epidemic on our continent. In his testimony, Mr. Giordano said, "The Chinese, supposedly at the behest of the Australians, expressed concern to the Canadians about Porcine Reproductive and Respiratory Syndrome (PRRS). The PRRS virus is endemic to the world and it defies credulity to suggest that China - a country where serious porcine diseases are rampant - does not have PRRS."

To be continued . . .

Charles Ortleb is the author of The Closing Argument and the co-author of The Chronic Fatigue Syndrome Follies.

THE LAWSUITS BEGIN

A leading class action law firm has started the ball rolling. Hopefully, this is just the beginning of the class action lawsuits against the HIV/AIDS establishment.

On March 17, 2003, Milberg Weiss filed a complaint alleging violations of the federal securities laws by VaxGen, Inc. and certain of its officers and/or directors.

The pdf of the complaint

The text of the complaint:

MILBERG WEISS BERSHAD

HYNES & LERACH LLP

WILLIAM S. LERACH (68581)

DARREN J. ROBBINS (168593)

MARY K. BLASY (211262)

401 B Street, Suite 1700

San Diego, CA 92101

Telephone: 619/231-1058

619/231-7423 (fax)



Attorneys for Plaintiff









UNITED STATES DISTRICT COURT



NORTHERN DISTRICT OF CALIFORNIA





JANICE WHITKENS, On Behalf of Herself and All Others Similarly Situated,



Plaintiff,



vs.



VAXGEN, INC., LANCE K. GORDON and DONALD P. FRANCIS, M.D.,



Defendants.

))))))))))))No.



CLASS ACTION



COMPLAINT FOR VIOLATIONS OF THE FEDERAL SECURITIES LAWS











DEMAND FOR JURY TRIAL









SUMMARY AND OVERVIEW

1. This is a securities fraud class action on behalf of all purchasers of the securities of VaxGen, Inc. ("VaxGen" or the "Company") between August 6, 2002 and February 26, 2003 (the "Class Period"), against VaxGen and certain of its officers and directors for violations of the Securities Exchange Act of 1934 (the "1934 Act").

2. VaxGen is engaged in the development and commercialization of AIDSVAX, a vaccine designed to prevent infection or disease caused by HIV (Human Immunodeficiency Virus), the virus that causes AIDS. During the Class Period, defendants were completing the final stages of AIDSVAX's Phase III clinical trials required to obtain Food and Drug Administration ("FDA") approval to market AIDSVAX as an AIDS vaccine. Clinical trials were being run simultaneously in the U.S. and Thailand, with the results of the U.S. trial to be released in early 2003 and results from the Thailand trial to be released in late 2003. Throughout the Class Period, defendants caused VaxGen to make a number of positive statements about the status of the trial and describing their eventual plans to manufacture and market AIDSVAX, causing VaxGen's stock to trade at artificially inflated prices.

3. However, the true facts which were known by each of the defendants, but were concealed from the investing public during the Class Period, included:

(a) That the number of strains of HIV was increasing exponentially and AIDSVAX was proving ineffective in the clinical trials;

(b) That, by the beginning of the Class Period, the clinical trials in the U.S. were over 80% complete and defendants knew that the rate of HIV infection occurring in the clinical trials indicated an efficacy rate which was statistically irrelevant as compared to the infection rate being experienced in the general population; and

(c) That the efficacy rate being experienced in the Clinical trials would not meet FDA approval standards, nor those of the U.S. and world medical communities, so the "vaccine" was not commercially viable.

4. On the evening of Sunday, February 23, 2003, VaxGen shocked the market by reporting the long-anticipated results of the U.S. trials, disclosing that the "study did not show a statistically significant reduction of HIV infection within the study population as a whole, which was the primary endpoint of the trial." The partial disclosure of the overall failure of the U.S. clinical trial caused VaxGen's shares to plummet, declining over 50% to approximately $3 per share on February 24, 2003.

5. However, even when defendants released the results on February 24, 2003, they claimed that while the vaccine failed to demonstrate efficacy on U.S. caucasians, the trials had demonstrated 30%-84% efficacy rates in U.S. blacks and Asians. That analysis, the Company said, had less than a 1% chance of being due to random chance, making it highly statistically significant. VaxGen President Donald P. Francis touted the results as evidence that AIDSVAX could protect against HIV infection. As reported by The Wall Street Journal on February 24, 2003, the "results overall won't lead the Food and Drug Administration to approve the vaccine for use in the wider public, but the company hopes that further analysis, as well as results from another trial being conducted in Thailand on injection drug users, may prompt the agency to approve the vaccine for some ethnic minorities." These corrective statements had their intended effect and VaxGen's stock closed at close to $7 per share on February 24, 2003.

6. However, on February 26, 2003, defendants were forced to admit that the reliability of their earlier reports of higher efficacy rates for non-caucasians were impaired because they had not taken the requisite "penalties" to account for the fact that less than 500 of the 5000 clinical trial participants were non-caucasians, resulting in an extremely small subset of data being analyzed for non-caucasions. Such penalties are designed to reduce the statistical significance of results obtained from slicing a body of data into many smaller pieces. As the news that earlier promises that AIDSVAX could prove useful for non-caucasions fell apart, the stock declined further, resulting in a total loss in market cap since November 18, 2002 of approximately 85%.

JURISDICTION AND VENUE

7. Jurisdiction exists pursuant to *27 of the Securities and Exchange Act of 1934 (the "Exchange Act"), 15 U.S.C. *78aa, and 28 U.S.C. *1331. The claims asserted herein arise under **10(b) and 20(a) of the Exchange Act, 15 U.S.C. **78j(b) and 78t, and Rule 10b-5.

8. Venue is proper in this District pursuant to *27 of the Exchange Act and 28 U.S.C. *1391(b). Many of the acts giving rise to the violations complained of occurred in this District.

9. Defendants used the instrumentalities of interstate commerce, the U.S. mails and the facilities of the national securities markets.

THE PARTIES

10. Plaintiff Janice Whitkens purchased VaxGen publicly traded securities as described in the attached certification and was damaged thereby.

11. Defendant VaxGen is engaged in the development and commercialization of AIDSVAX, a vaccine designed to prevent infection or disease caused by HIV, the virus that causes AIDS. VaxGen has approximately 14.5 million shares outstanding and trades on the NASDAQ.

12. Defendant Lance K. Gordon, Ph.D. ("Gordon") is Chief Executive Officer and a director of VaxGen. Gordon serves on the Executive Committee of the VaxGen Board of Directors.

13. Defendant Donald P. Francis, M.D. ("Francis") is President and a director of VaxGen. Francis sits on the Executive Committee of the VaxGen Board of Directors.

14. The individuals named as defendants in **12-13 are referred to herein as the "Individual Defendants." The Individual Defendants, because of their positions with the Company, possessed the power and authority to control the contents of VaxGen's quarterly reports, press releases and presentations to securities analysts, money and portfolio managers and institutional investors, i.e., the market. Each defendant was provided with copies of the Company's reports and press releases alleged herein to be misleading prior to or shortly after their issuance and had the ability and opportunity to prevent their issuance or cause them to be corrected. Because of their positions and access to material non-public information available to them but not to the public, each of these defendants knew that the adverse facts specified herein had not been disclosed to and were being concealed from the public and that the positive representations which were being made were then materially false and misleading. The Individual Defendants are liable for the false statements pleaded herein at **19-20 and 30, as those statements were each "group-published" information, the result of the collective actions of the Individual Defendants.

15. In addition to the above-described involvement, each Individual Defendant had knowledge of the true status of the AIDSVAX clinical trials. Defendant Gordon, as CEO, and defendant Francis, as President, were responsible for the financial results and press releases issued by the Company.

FRAUDULENT SCHEME AND COURSE OF BUSINESS

16. Each defendant is liable for (i) making false statements, or (ii) failing to disclose adverse facts known to him about VaxGen. Defendants' fraudulent scheme and course of business that operated as a fraud or deceit on purchasers of VaxGen publicly traded securities was a success, as it (i) deceived the investing public regarding VaxGen's prospects and business; (ii) artificially inflated the prices of VaxGen's publicly traded securities; (iii) allowed Company insiders to obtain larger bonuses; and (iv) caused plaintiff and other members of the Class to purchase VaxGen publicly traded securities at inflated prices.

BACKGROUND

17. VaxGen was founded in November 1995 to complete the development of, and to commercialize, an AIDS vaccine in partnership with Genentech, Inc., which reserved the rights to market any AIDS vaccine ever developed. Genentech licensed to VaxGen the technology necessary for development and commercialization of GP-120 (now called AIDSVAX).

18. Clinical trials of AIDSVAX were run virtually simultaneously in the U.S. and Thailand commencing in 1999:

North America/Europe
Thailand

Participants
5,400
2,500

Began Enrollment
June 1998
March 1999

Completed Enrollment
October 1999
August 2000

Volunteers
5,100 gay men300 women
2,500 injectiondrug users

Trial Length
36 months
36 months

Primary Results Expected
First quarter 2003
Fourth quarter 2003





DEFENDANTS' FALSE AND MISLEADING

STATEMENTS ISSUED DURING THE CLASS PERIOD



19. On August 6, 2002, VaxGen issued a press release entitled "VaxGen Releases Second-Quarter Financial Results; Development Expenses In Line with Company's Expectations." VaxGen posted a net loss of $ 6.7 million, or $ 0.46 per share for its second quarter 2002, ending June 30, 2002. The loss was attributed by the Company to costs relating to additional personnel and infrastructure needed to facilitate the completion of the firm's Phase III trials, associated regulatory filings and advanced development of VaxGen's AIDSVAX. The release contained misleading statements which intimated that the Phase III trials were succeeding, stating in relevant part that,

Since the beginning of the second quarter, VaxGen has:

* Completed the seventh consecutive safety and conduct review of its Phase III trials;



* Revised its license and supply agreement with Genentech, Inc. on more favorable terms; and



* Hired Piers Whitehead, a leading vaccine industry expert, as vice president of Corporate and Business Development.



Additionally, the company's manufacturing joint venture, Celltrion, Inc., has secured 26 acres of land in Incheon, South Korea, on which to build a large-scale biopharmaceutical manufacturing facility for VaxGen's AIDS vaccine candidates and other biologic products. VaxGen, on behalf of Celltrion, hired Fluor Daniel, one of the world's largest design-construction firms, to lead the design and engineering of Celltrion's Incheon facility and a pilot plant in South San Francisco, Calif. VaxGen intends to use the pilot plant to complete production development and commercial launch of its AIDS vaccine candidates and/or other products.



20. On August 14, 2002, VaxGen filed its 10-Q for the period ended June 30, 2002. In the 10-Q defendants stated:

In its first phase of development, expected to be completed by 2005, we believe the Incheon facility will be capable of producing up to 200 million doses of AIDSVAX annually. Our facility in the South San Francisco area could produce up to 10 million doses of the AIDS vaccine annually and may also be used to develop other pharmaceutical products when it is licensed and operational, which we believe will occur in 2005. We expect to complete construction of our facility by the middle of 2003 and Celltrion the Incheon facility by the end of 2004. Additional time will be required to validate and license each facility. If AIDSVAX proves to be safe and effective, we intend to use the South San Francisco area facility to validate its manufacturing process, which would be a key component of its subsequent regulatory submission to the FDA. This facility, which will be located near our research and development facility, is expected to be used for commercial manufacturing of AIDSVAX at least through commissioning of the Incheon facility.

21. The statements described in **19-20 were false and misleading because by August 6, 2002, defendants knew that the AIDSVAX clinical trials were more than 80% complete and that the infection rates of trial participants virtually matched those being experienced in the general population, meaning the so-called "vaccine" had little or no efficacy and as such would not be commercially viable.

22. On November 5, 2002, VaxGen issued its third quarter 2002 earnings results and held an earnings conference call. The relevant portions of the transcript follow:

Carter Lee, Senior Vice President Finance and Administration, VaxGen: Good morning, everyone, and again welcome to our conference call. Beginning in 2002 we began preparing for success by spending for personnel infrastructure costs to support completion of the company's pivotal clinical trials. The costs incurred have been for the creation of regulatory, controlling systems group and adding personnel dedicated to the advance development of our production processes. Therefore, as expected our net operating losses have decreased for the fourth quarter and for the nine month period which is the same year last period [sic].

* * *



Lance Gordon, Director and CEO; VaxGen: Thank you very much, Carter. I'm very pleased to be with you all today by telephone and the magic of computers.



* * *



Moving on, Dr. Francis will be giving you more detail on the progress of our two phase III trials and I think the essential highlights here are that the company has completed on schedule in very high quality fashion the last safety review of the phase III pivotal clinical trial in Thailand, and is making preparations for completing the collection of data and analysis of the North American study. The final point, I'll give you a little more detail on here, VaxGen received very recently a contract with the U.S. National Institute of Health to supply vaccine for a large field trial which is anticipated to start in March of next year in Thailand. This additional field study is incremental to the studies being done on Aidsvax, and may result in additional indications in market expansions for VaxGen's product. The Army and the NIH are collaborating on a study looking at the combined use of our vaccine, which as I'm sure you're familiar is a preventive or prophylactic vaccine to prevent infection, using it in combination with a live viral approach being developed by, in this case, a convenient Aventis [sic] and that live viral approach is intended to have treatment impact. So we'll be looking at the combination of prevention of infection which has always been our goal, with a treatment regime. So that is anticipated to start shortly. The NIH contracted to purchase $3.3 million worth of product from VaxGen for that study.



* * *



Donald Francis, President and Director, VaxGen: Thank you, Lance. The next slide is entitled Aidsvax update which is indeed intended just for that, update you on our oldest ... product which is in development now, our AIDS vaccine which I think as everyone knows are the first and only phase III trials of a candidate AIDS vaccine. I think, as all of you know, we have an outside data safety monitoring board that reviews these two trials, both the North American and European trials and the Thai trial, called the Data and Safety Monitoring board, and they have now reviewed this every six months from the beginning of the trial, and each time we get remarkable information, and that information is * has been good news at each meeting and those reviews really deal with two issues.



One is the safety of the vaccine, and as you all know, vaccine safety is absolutely critical. If we get up to now 30,000 doses with this vaccine, it is really reassuring to know there have been no adverse events associated with the vaccine ... in excess of what we've seen in the placebo. So it's wonderful news. It got a large number of doses, [and] we do not see adversity associated with the vaccine. I think that lays the groundwork for a safe and hopefully effective vaccine. Equally important as to the successful company, is the successful trials in the logistical line conduct way [sic]. They have reviewed the trials and showed the follow-up of the volunteers in the trial, both the people at risk of sexual exposure in [the] North American and European trial and through intravenous drug use in Thailand, is extremely high. We will get an answer [as] to the efficacy of the vaccine and given that this is the first time in history that an AIDS vaccine trial has been done, that is reassuring from these outside experts that review our trial that we will have an answer.



The first one to come to completion will be the North American/European Phase III trial [and] all the data is coming in now, and will continue to come in, get cleaned up through the end of the year. That will be finishing the * all the clinical database, get it in the computer, ready for analysis, and then beginning early next year we will begin the analysis of that phase III trial and announce ... the results of that analysis sometime in Q1.



The Thai trial will follow several months behind, so 2003 will be a critical year for the Aidsvax vaccine as ... the first quarter of '03 will be the North American/European trial and the second half of '03 we will announce the results of the Thai trial, looking at both sexual transmission and blood borne transmission with two separate vaccines. We go to the last slide here, the time line that you have seen before and for all of you investors who have been here from the beginning, it actually goes back to the last several years with the phase I, II trials and these are the two trials in North American/European ... sexual transmission on the top and the Thai trials and intravenous drug users at the bottom. And there you see the length of time, the effort that it's taken to do these has been immense and I think it's time to really express our appreciation for the volunteers, the employees and the clinics that have staff that have worked on this and indeed the VaxGen staff that has designed and implemented this, not to mention the investors that have allowed this whole thing to happen and this groundbreaking event to really occur.



So it is a very exciting time and as we have mentioned here on previous web casts, now we can actually put other bars below this and extend it to the right. The first one that Lance mentioned will be the next phase III trial which will start in Thailand sometime in early '03. We expect being the prime boost, if you will, trial of the event of Pasteur vaccine, and VaxGen's vaccine given together and then the anthrax studies, again to the right side of this, and then hopefully we'll have other products to complement those as time goes on. So, with that, I want to again express the appreciation to everyone involved in this, the investors, the clinics, the volunteers, the staff of VaxGen and everyone who made this groundbreaking effort possible.



* * *



SEAN WOODS: Again, assuming complete success and from a purely pecuniary standpoint, your stock closed around $15 last night on the exchange. Would you anticipate a rather significant increase in the value of that stock, with the price earnings ratio of * again, as I said from a strictly pecuniary standpoint, have any of the analysts that you know of indicated a multiple in the price earnings ratio from $15 to, I've heard comments like this stock is going to go through the roof if all this stuff is successful, or what seems to be the analysts' consensus on [that], strictly from an investor standpoint?



UNIDENTIFIED: I think you certainly have identified where those answers are going to come from. They are going to come from investors like those of you who are on the telephone, and certainly the announcement that we're looking for next year will I think take a lot of the risk out of the company as we broaden the business, [add] additional products, as we validate our product opportunities through large clinical field trials such as Doctor Francis described. As to how the stock will react to product advancement, first * what we hope will be positive outcome for the pivotal clinical trials, and subsequent license application and we hope market launch in the not too distant future, those are things that can control and we're working very diligently, and I think [we're] very proud of our track record over the last several years of really meeting expectations and performing and making our marks.



* * *



DALE DEED: Yes. Then could we assume, that if this had a very high efficacy on the chimpanzee, provided now that we have very high levels of safety with the vaccine within humans, could we extrapolate out we could have a pretty high efficacy in the human beings as well?



UNIDENTIFIED: I think we can start extrapolating we're going to have high safety indications, all indications are we're going to have a very high safety profile. The ... the indication of 100% protection of our chimpanzees is certainly an indication that the vaccine has a high likelihood of being efficacious. But the question of how efficacious it is and for how long really will depend on the results of the ongoing studies.



23. The statements in *22 were false and misleading because the AIDSVAX clinical trials were now more than 97% complete and defendants knew that they demonstrated little or no efficacy. As a result, omission of any reference to the known abysmal efficacy rate of AIDSVAX rendered false and misleading defendants' statements that: (i) the Company was "preparing for success by spending for personnel infrastructure costs to support completion of the company's pivotal clinical trials ... and adding personnel dedicated to the advance development of our production processes"; (ii) AIDSVAX was an effective "preventative or prophylactic vaccine to prevent infection" that could be potentially be combined with live agents to treat existing persons who had already contracted AIDS; (iii) the "remarkable information" being returned by the "Data and Safety Monitoring board" did not disclose to defendants' AIDSVAX's abysmal efficacy rate; and (iv) the announcement of the trial's final results would "take a lot of the risk out of the company" by validating the Company's "product opportunities through large clinical field trials."

24. Particularly disturbing was defendants' response to the question about what effect the release of the trial results * which was rapidly approaching* would have on VaxGen's stock price. On that point, defendants' positive intimations as to the product soon being licensed, that there would be a "market launch in the not to distant future," and referring to the Company's "track record over the last several years of really meeting expectations and performing and making [their] marks," were false and misleading because defendants knew that disclosure of the efficacy rate in the not to distant future would be the death knell to AIDSVAX.

25. Similarly, defendants' response to the analyst's question that efficacy rates in chimpanzees could be extrapolated to provide efficacy rates in humans was misleading to the extent defendants equated the "100% protection of [their] chimpanzees" with "a high likelihood of being efficacious" in humans. Because defendants knew the efficacy rate being demonstrated was actually abysmal and because the market understood that defendants had access to the actual infection rates since at least November 2001, it was false and misleading to state that AIDSVAX had anywhere near a "high likelihood of being efficacious" in humans.

26. On these false statements, VaxGen's stock price rose to a Class Period high of $23.25 on November 18, 2002.

27. Defendant Francis appeared on CNN on Sunday December 1, 2002, making more positive reassurances about the marketability of AIDSVAX:

BLAKEY: Many experts believe the best way to stop the spread of the disease is a vaccine. So far, there is none but that may soon change. Don Francis of VaxGen is leading the race for an AIDS vaccine and plans to soon finish the final stage of human testing. VaxGen began testing the vaccine more than seven years ago. It would be the first to complete human testing for FDA approval in January. Though no vaccine is 100 percent effective, Francis would be pleased with only one-third efficacy.

DR. DON FRANCIS, VaxGen: There is certainly very good data out there in computer models that a 30 percent effective vaccine will ultimately drive the epidemic into the ground.



BLAKEY: The next hurdle, getting it manufactured.

FRANCIS: It will take us another couple years to actually bring up the manufacturing, get the licensing for the vaccine and move it forward.



BLAKEY: Still, different strains of HIV require different vaccines.



DR. PAT FAST, INTERNATIONAL AIDS VACCINE INITIATIVE: One can also make a new version of this vaccine that is applicable in other parts of the world.



FRANCIS: It will take us a year and a half, two years, to do that and think about how many infections are going to occur in that year and a half, two years, while we're developing this African vaccine.



* * *



BLAKEY: If everything stays on schedule and the current vaccine is successful, it will be ready for use in the U.S. sometime around the year 2005.



28. VaxGen shares traded as high as $21.43 per share on December 2, 2002.

29. The statements in *27 were false and misleading because the trial was now less than one-month away from being completed and abysmal efficacy rates were being reported to Francis, providing him no basis to believe that: (i) AIDSVAX's efficacy rate would ultimately "drive" anything, much less the AIDS epidemic, "into the ground"; (ii) that VaxGen's next hurdle was "actually bring[ing] up the manufacturing, get[ting] the licensing for the vaccine and mov[ing] it forward"; and (iii) that various versions of AIDSVAX could effectively be used as an AIDS vaccine around the world.

30. On Monday, December 16, 2002, VaxGen announced that AIDSVAX would get fast-track review at the FDA once the applications were filed. The Company's press release stated in relevant part:

VaxGen, Inc. announced today that the U.S. Food and Drug Administration (FDA) has designated HIV/AIDS vaccine candidates, AIDSVAX B/B and AIDSVAX B/E (rgp120), Fast Track Products for the prevention of HIV infection. The Fast Track designation will enable rapid regulatory review of AIDSVAX.



AIDSVAX B/B and AIDSVAX B/E are the only preventive AIDS vaccine candidates to advance to Phase III clinical trials. AIDSVAX B/B is being tested in a randomized, double-blind, placebo-controlled study of 5,400 people in the United States, Canada, the Netherlands and Puerto Rico. Primary results from the trial are expected to be announced in the first quarter of 2003.



VaxGen is also nearing completion of its Phase III trial of AIDSVAX B/E in Thailand. AIDSVAX B/E is designed to protect against HIV subtypes B and E, and the company expects to announce primary results of that trial in the second half of 2003. Subtype E is prevalent in Southeast Asia and the Central African Republic.

"Every day thousands of people become infected with HIV," said VaxGen President Donald P. Francis, M.D., D.Sc. "Designation of both AIDSVAX B/B and AIDSVAX B/E as Fast Track Products recognizes the severity of the pandemic and the unmet need for a vaccine to prevent new infections."



Under the FDA Modernization Act of 1997, the Fast Track Program of the FDA is designed to expedite the review of a new drug that is intended for the treatment (or prevention) of a serious or life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.



31. On these positive statements, shares of VaxGen surged more than 20%.

32. The statements in *30 were false and misleading as stated because the trial was now finished and defendants knew that the efficacy rate of AIDSVAX was far below any level the FDA would accept, and that as such, FDA approval would likely be denied, on a "fast track" basis or otherwise, and that AIDSVAX would not be commercially available in 2005.

33. On February 11, 2003, VaxGen released its financial results for the fourth quarter and year ended December 31, 2002 and held a press conference. The relevant portions of the transcript follow:

[CARTER LEE:] ... Now please refer to the slide entitled Natural Results for the time period ended December 31st, 2002 and 2001. Loss in operations was $10.6 million compared to $7.1 million for the year ago quarter. Increases in both R&D and G&A spending contributed to the loss. We attribute this primarily to the increase in personnel, the final closeout of expenses payable to our North American and European clinical sites and service fees associated with the completion of our trials and offset by a reduction of expenses paid through our licensing partner. The increased personnel costs and service fees include salary and benefit expenses for internal staffing and consulting services required to support our regulatory filings, the advanced development of our manufacturing processes and the monitoring and auditing expenses normally incurred at the end of the phase 3 trial. The change in G&A expenses are attributable to an increase in occupancy, personnel and insurance costs. Prior to the beginning of the fourth quarter of 2002, the Company acquired additional facilities to house the pilot manufacturing plant and support the manufacturing process and other R&D activities. Therefore, occupancy costs such as lease payments for the facilities, utilities and maintenance and repair expenses naturally increased. Excluded in the G&A line, there are $443,000 of non-cash expense, approximately $171,000 related to non-cash compensation and the balance is depreciation and amortization expense. As you can see, our spending increases are reflective of our preparations for success and the completion of our clinical trials.



* * *



[GORDON:] Before I move to the next slide, please let me share with you the scope of our HIV clinical effort....Now lets's take a look at the future on the next slide titled "2003 Time Line." We expect to announce the results from the first of our two phase 3 AIDS vaccine trials sometime this quarter. By the end of March we also expect to take occupancy of our GNP manufacturing facility in south San Francisco. If our AIDS vaccine trials are successful and we receive release from the F.D.A., we plan to use this facility in our efforts to gain F.D.A. approval for our manufacturing process and to provide in the range of 10 million [doses] of vaccine per year from that facility for public use.



34. The statements in *33 were false and misleading because they intimated that the soon-to-be-released test results would mark a "success," that the manufacturing process would soon commence, that the FDA approval process would soon commence, and that defendants had a reason to believe that AIDSVAX would be commercially viable. To the contrary, defendants knew that the trial was complete and they had know ever since October 2001 that AIDSVAX's nominal efficacy rates (well below the FDA's required 30%) demonstrated that the "vaccine" was not commercially viable.

THE TRUTH IS REVEALED

35. At midnight on Sunday, February 23, 2003, VaxGen announced initial results from the Phase III trials of AIDSVAX to prevent HIV infection in the U.S. The results for the Thailand part of the study would not be released until the end of 2003. According to the results disclosed, about 2.7% of placebo-treated patients became infected each year, and there were not any meaningful differences in infection rates for the AIDSVAX-treated patients. The press release issued the next day stated simply that the "study did not show a statistically significant reduction of HIV infection within the study population as a whole, which was the primary endpoint of the trial."

36. Trading was halted on VaxGen's stock before the beginning of trading on Monday, February 24, 2003. When trading resumed, news of the partial disclosure of the overall failure of the U.S. trial caused VaxGen shares to plummet over 50% to approximately $3 per share.

37. Then, on February 26, 2003, The Wall Street Journal published an article entitled "VaxGen Statistic Is Weaker Than Firm Initially Claimed," which stated in relevant part:

On Monday, VaxGen revealed that a three-year test of its AIDS vaccine, Aidsvax, had on an overall basis failed to protect volunteers from infection by HIV, the AIDS virus. But in an ethnic subgroup of 498 non-white, non-Hispanic volunteers, VaxGen said the vaccine appeared to provide protection in the range of 30% to 84%.



That analysis, the company said, had less than a 1% chance of being due to random chance, making it highly statistically significant. VaxGen President Donald Francis touted the results as evidence that Aidsvax can protect against HIV infection, although he also acknowledged they reflected preliminary analysis and could turn out to be a "statistical fluke."



Outside scientists and AIDS activists have criticized the claim of partial efficacy, largely because it was based on an analysis of just 29 HIV infections distributed between vaccinated volunteers in that subgroup and those who received a placebo.



VaxGen said it had followed good statistical practice by taking "penalties" related to its analyses of multiple subgroups. Such penalties are designed to reduce the statistical significance of results obtained from slicing a body of data into many smaller pieces.



Wednesday, however, Lance Ignon, VaxGen's vice president for communications, admitted that the company hadn't taken those penalties after all. Mr. Ignon said he didn't know how the erroneous information was released, adding that the company was "still trying to figure that out."



38. On this news, VaxGen's stock price, which had partially recovered to close at close to $7 on February 24, 2003, declined back down to the $4 range. The stock is now trading at approximately $3 per share, marking an approximately 85% decline in the price of VaxGen's stock since its Class Period high of $23.25 on November 18, 2003.

FIRST CLAIM FOR RELIEF



For Violation of *10(b) of the 1934 Act

and Rule 10b-5 Against All Defendants



39. Plaintiff incorporates **1-38 by reference.

40. During the Class Period, defendants disseminated or approved the false statements specified above, which they knew or deliberately disregarded were misleading in that they contained misrepresentations and failed to disclose material facts necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading.

41. Defendants violated *10(b) of the 1934 Act and Rule 10b-5 in that they:

(a) Employed devices, schemes, and artifices to defraud;

(b) Made untrue statements of material facts or omitted to state material facts necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading; or

(c) Engaged in acts, practices, and a course of business that operated as a fraud or deceit upon plaintiff and others similarly situated in connection with their purchases of VaxGen publicly traded securities during the Class Period.

42. Plaintiff and the Class have suffered damages in that, in reliance on the integrity of the market, they paid artificially inflated prices for VaxGen publicly traded securities. Plaintiff and the Class would not have purchased VaxGen publicly traded securities at the prices they paid, or at all, if they had been aware that the market prices had been artificially and falsely inflated by defendants' misleading statements.

43. As a direct and proximate result of these defendants' wrongful conduct, plaintiff and the other members of the Class suffered damages in connection with their purchases of VaxGen securities during the Class Period.

SECOND CLAIM FOR RELIEF



For Violation of *20(a) of the 1934 Act

Against All Defendants



44. Plaintiff incorporates **1-43 by reference.

45. The Individual Defendants acted as controlling persons of VaxGen within the meaning of *20(a) of the 1934 Act. By reason of their positions as officers and/or directors of VaxGen, and their ownership of VaxGen stock, the Individual Defendants had the power and authority to cause VaxGen to engage in the wrongful conduct complained of herein. VaxGen controlled each of the Individual Defendants and all of its employees. By reason of such conduct, the Individual Defendants and VaxGen are liable pursuant to *20(a) of the 1934 Act.

CLASS ACTION ALLEGATIONS

46. Plaintiff brings this action as a class action pursuant to Rule 23 of the Federal Rules of Civil Procedure on behalf of all persons who purchased VaxGen publicly traded securities (the "Class") during the Class Period. Excluded from the Class are defendants.

47. The members of the Class are so numerous that joinder of all members is impracticable. The disposition of their claims in a class action will provide substantial benefits to the parties and the Court. VaxGen had more than 14 million shares of stock outstanding, owned by hundreds if not thousands of persons.

48. There is a well-defined community of interest in the questions of law and fact involved in this case. Questions of law and fact common to the members of the Class which predominate over questions which may affect individual Class members include:

(a) Whether the 1934 Act was violated by defendants;

(b) Whether defendants omitted and/or misrepresented material facts;

(c) Whether defendants' statements omitted material facts necessary to make the statements made, in light of the circumstances under which they were made, not misleading;

(d) Whether defendants knew or deliberately disregarded that their statements were false and misleading;

(e) Whether the prices of VaxGen's publicly traded securities were artificially inflated; and

(f) The extent of damage sustained by Class members and the appropriate measure of damages.

49. Plaintiff's claims are typical of those of the Class because plaintiff and the Class sustained damages from defendants' wrongful conduct.

50. Plaintiff will adequately protect the interests of the Class and has retained counsel who are experienced in class action securities litigation. Plaintiff has no interests which conflict with those of the Class.

51. A class action is superior to other available methods for the fair and efficient adjudication of this controversy.

PRAYER FOR RELIEF

WHEREFORE, plaintiff prays for judgment as follows:

A. Declaring this action to be a proper class action pursuant to Rule 23(a) and (b)(3) of the Federal Rules of Civil Procedure on behalf of the Class defined herein;

B. Awarding plaintiff and the members of the Class compensatory damages;

C. Awarding plaintiff and the members of the Class pre-judgment and post-judgment interest, as well as reasonable attorneys' fees, expert witness fees, and other costs;

D. Awarding extraordinary, equitable and/or injunctive relief as permitted by law, equity, and federal statutory provisions sued hereunder, and any appropriate state law remedies; and

E. Awarding such other relief as this Court may deem just and proper.

JURY DEMAND

Plaintiff demands a trial by jury.

DATED: March 17, 2003
MILBERG WEISS BERSHAD

HYNES & LERACH LLP

WILLIAM S. LERACH

DARREN J. ROBBINS

MARY K. BLASY









DARREN J. ROBBINS



401 B Street, Suite 1700

San Diego, CA 92101

Telephone: 619/231-1058

619/231-7423 (fax)



Attorneys for Plaintiff













CERTIFICATION OF INTERESTED ENTITIES OR PERSONS





Pursuant to Civil L.R. 3-16, the undersigned certifies that as of this date, other than the named parties, there is no such interest to report.





ATTORNEY OF RECORD FOR

PLAINTIFF JANICE WHITKENS

AIDS DISSIDENT APPOINTED
TO SOUTH AFRICA GROUP
ADVISING MBEKI

In a move causing major indigestion in the AIDS/HIV establishment all over the world, Dr. Roberto Giraldo, a prominent dissident on the HIV theory of AIDS, has been named as one of the experts who will be advising the South African government. The Guardian today reported that "Aids activists renewed accusations that the authorities could not be serious about tackling the pandemic while listening to those who argued against the provision of life-extending medicine. Dr. Giraldo reportedly believes that the anti-retroviral drugs available in the west induce rather than treat Aids, and that the disease is caused by nutritional deficiencies - a belief apparently shared by President Thabo Mbeki, who has linked Aids to poverty. Critics said he was reluctant to accept a link with sexual behaviour."

One of the things that Dr. Giraldo can bring to the table is a keen understanding of the unreliable nature of the HIV tests. While Giraldo seems to be an HHV-6 denialist himself, his skepticism about HIV means the glass is more than half full.

Mbeki's courage in the face of HIV mob rule is inspiring. He deserves a Nobel Prize.

Dr. Giraldo gave us permission to reprint his essay on the HIV test here:

Tests for HIV are highly inaccurate

This article was written in June 2000
and posted during the Internet Discussion
of the South African Presidential AIDS Advisory Panel

For the last 6 years I have been working at a laboratory of clinical immunology in one of the most prestigious University Hospitals in the City of New York. Here I have had the opportunity to personally run and get to know in detail the current tests used for the diagnosis of HIV status, namely, the ELISA, Western blot and Viral Load tests.


1. The ELISA, Western blot, and Viral Load tests, used for the diagnosis of "HIV infection" are not at all accurate


There are many arguments against the accuracy of these tests to diagnose infection by what is known as HIV. For those who want to search the issue deeper I strongly recommend begin studying the 1993 article in Bio/Technology by Eleni Papadopulos-Eleopulos and her group of researches from Perth, Western Australia (12).


Here are some facts that support that a person who reacts positively on these tests does not mean that he/she is infected with HIV:


1.1. The definition of AIDS, as developed by the United States Federal Government’s Centers for Disease Control and Prevention, requires a positive result on the antibody test for HIV (1). This definition is accepted worldwide. The importance of HIV in this definition is so strong that, currently, many AIDS researchers, health care professionals and lay people, in following the lead of the United States Institute of Medicine, the National Academy of Sciences and most AIDS researchers now refer to "AIDS" as "HIV Disease" (2-7).

However, AIDS in Africa can be diagnosed without HIV test or any other laboratory test. This was decided by American public health officials at a conference in Bangui, in the Central African Republic in October 1985 (WHO’s Weekly Epidemiological Record 1986; 61:69-76 and Science magazine 21 November 1986). This allows health professionals to diagnosis AIDS in Africa based only on the symptoms and signs that a patient manifests.


1.2. The tests that are used most frequently to diagnose HIV status are the ELISA "screening test", the Western blot "confirmatory test" and the PCR "Viral Load test" (8-11). In the United States the ELISA and Western blot tests, when done together, have become known as "the AIDS test". These tests supposedly detect antibodies against HIV. The "Viral Load" or PCR test is a genetic test that makes copies of small fragments of nucleic acids that, it is claimed, belong exclusively to HIV. These are the same tests that are used to check for HIV in mothers, infants, children, and in the population at large. The problem with all of these tests is that a positive HIV reaction does not guarantee that the person is really infected with HIV at all (12-21).


1.3. Currently, a positive result on "the AIDS test" - ELISA and Western blot antibody tests - is synonymous with HIV infection and the attendant risk of developing AIDS (8-11).


However, these antibody tests are neither standardized nor reproducible, with respect to HIV they are themselves meaningless because they mean different things in different individuals, they also mean different things in different laboratories and in different countries (12). They are interpreted differently in the United States, Russia, Canada, Australia, Africa, Europe and South America (22-27), which means that a person who is positive in Africa can be negative when tested in Australia; or a person who is negative in Canada can become positive when tested in Africa (28). The other problem is that the same sample of blood when tested in 19 different laboratories gets 19 different results on the Western blot test (29).


1.4. The Western blot antigens, proteins or bands - p120, p41, p32, p24/25, p17/18 - which are considered to be specific to HIV, may not be encoded by the HIV genome and may in fact represent human cellular proteins (12-14,20,30).


1.5. The only valid method of establishing the sensitivity and the specificity of a diagnostic test in clinical medicine is to compare the test in question with its gold standard. The only possible gold standard for the HIV tests is the human immunodeficiency virus itself. Since HIV has never been isolated as an independent free and purified viral entity (31), it is not possible to properly define the sensitivity or the specificity of any of the tests for HIV (12). Currently, the sensitivity and the specificity of the tests for HIV are defined not by comparison to purified HIV itself, but by comparison of the tests in question with the clinical manifestations of AIDS, or with T4 cell counts (12). Abbott states, "At present there is no recognized standard for establishing the presence and absence of HIV-1 antibody in human blood. Therefore sensitivity was computed based on the clinical diagnosis of AIDS and specificity based on random donors" (32). Since there is no gold standard for defining the specificity of the tests used for the diagnosis of HIV infection, all HIV-positive results for HIV infection must be considered false-positives.


1.6. There are abundant scientific publications explaining that there are more than 70 different documented conditions that can cause the antibody tests to react positive without an HIV infection (12-14,17,19,30). In other words, there are more than 70 scientifically acknowledged reasons for false positives when testing for HIV. This fact has been abundantly documented in the scientific literature.


1.7. Of course, it is shocking to find out that a diagnosis of HIV infection is based on tests that are not specific for HIV. However, the scientific evidence tells us that a person can react positive on the test for HIV even though he or she is not infected with HIV (12-14,17,21,30,33).


1.8. The pharmaceutical companies that make and commercialize the kits for these tests acknowledge the inaccuracy of them, and this is why the inserts that come with the kits typically state the following: "Elisa testing alone cannot be used to diagnose AIDS, even if the recommended investigation of reactive specimens suggests a high probability that the antibody to HIV-1 is present" (32). The insert for one of the kits for administering the Western blot warns, "Do not use this kit as the sole basis of diagnosis of HIV-1 infection" (34). The insert that comes with a popular kit to run viral load warns, "The amplicor HIV-1 Monitor test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection" (35). The problem is that not only most AIDS researchers, journalists and lay people but health care workers themselves do not know these facts about the tests because they do not have access to them. There likewise appears to be little or no concern on the part of the knowing faculty of institutions to communicate these facts to physicians, let alone the general public.


1.9. Since the viral load results are given in copies per ml of plasma (35) AIDS researchers, health care professionals, and lay people may think that they represent copies or counts of the virus itself (12,36-41). However, the viral load test only makes copies of fragments of nucleic acids. It does not count HIV itself. A positive viral load test cannot be regarded as signifying the presence of the whole HIV genome, and therefore the test cannot be used to measure virus.


1.10. Results of the viral load test cannot be reproduced. This can be seen in the wide range of variability that is accepted in the quality controls set by the companies that make and commercialize the test kits. For example, Roche accepts low control having a range between 1,200 and 11,000 copies per ml [Lot # 0047], and high control having a range between 99,000 and 750,000 copies per ml [Lot # A00246] [Roche, Amplicor HIV-1 Monitor test Lot # B00985, expiration August 2000]. Most important of all, the problems with the lack of a gold standard for HIV infection also apply to the evaluation of the accuracy of the PCR or Viral load test (12,41,42). As a consequence, the specificity of the viral load test for HIV has never been defined properly. Therefore, all viral load positive results are likewise false-positives for HIV.


1.11. The fact that the defenders of HIV as the cause of AIDS, had to appeal to a genetic trick – the PCR test – is a strong argument against HIV as the cause of AIDS. To have to amplify tiny amounts of genetic material in the blood of the AIDS patients to try to identify HIV, instead of culturing the entire virus, isolate it and purify it, violates one of the central rules of infectious diseases: in the climax or maximum state of severity of any infectious disease is when the patient has the higher amount of microbes in his/her tissues. Is in those moments when it is easier to isolate and purify the microbes that are really causing a disease.


1.12. People have the right to make informed choices (43-45). However, the right of informed choice implies a right to good information. There is no justification for the fact that most people have not been informed about the serious inaccuracy of the tests for HIV infection. Withholding or obscuring these facts is a serious breach of public trust, violating as it does a person’s right to informed consent when making decisions about their health care. The legal implications of this situation have been noted (46).


2. Being "HIV-positive" does not mean that a person is infected with "HIV"


2.1. There are a growing number of scientific publications explaining in detail that the tests for HIV infection are not specific for HIV (12-14,47). There are many reasons other than a past or present HIV infection to explain why an individual reacts positive on these tests. In other words these tests can react positive in the absence of HIV (12-14,17-19,30).


2.2. Some of the conditions that cause false positives on the so-called "AIDS test" are: past or present infection with a variety of bacteria, parasites, viruses, and fungi including tuberculosis, malaria, leishmaniasis, influenza, the common cold, leprosy and a history of sexually transmitted diseases; the presence of polyspecific antibodies, hypergammaglobulinemias, the presence of auto-antibodies against a variety of cells and tissues, vaccinations, and the administration of gamma globulins or immunoglobulins; the presence of auto-immune diseases like erythematous systemic lupus, sclerodermia, dermatomyositis and rheumatoid arthritis; the existence of pregnancy and multiparity; a history of rectal insemination; addiction to recreational drugs; several kidney diseases, renal failure and hemodialysis; a history of organ transplantation; presence of a variety of tumors and cancer chemotherapy; many liver diseases including alcoholic liver disease; hemophilia, blood transfusions and the administration of coagulation factor; and even the simple condition of aging, to mention a few of them (12-14,17,18,30).


2.3. It is interesting to note that all of these conditions that cause the "HIV tests" to react positive in the absence of HIV, are conditions which are present with varied distribution and concentration in all of the conventionally recognized AIDS risk groups in the developed countries, as well as in the vast majority of inhabitants of the underdeveloped world. This means that in all probability many drug users [including mothers], certain gay males, and some hemophiliacs in the developed countries, as well as the vast majority of inhabitants in most countries of Africa, Asia, South America and the Caribbean, who have positive reactions to the tests for HIV, may very well do so due to conditions other than being infected with HIV (12-14,30,48).


2.4. Further, it is well known that people with or at risk for AIDS have high levels of antibodies - immunoglobulins - as a consequence of having been exposed to significant quantities of a variety of foreign substances such as recreational drugs, semen, factor VIII, blood and blood components, sexually transmitted infections and other infections (12-14,49). All these substances are oxidizing agents that cause oxidative stress (47,50,51).


2.5. Recently I had the opportunity to carry out an experiment by which I was able to demonstrate that all blood react positively on the ELISA test when run the test with neat or non-diluted serum. This could indicate that everybody has antibodies against what is supposed to be HIV. The ones that only react positively with straight or neat serum would have fewer amount of antibodies than the ones that continue reacting positively even when the serum is diluted 400 times (88). This possibility has been confirmed by Yugoslavian and Italian researchers (90)


2.6. There is also a great deal of scientific data indicating the widespread presence of non-specific interactions between what are considered to be retroviral antigens and unrelated antibodies (12,52-54). It is then possible to conclude that the tests for HIV react positively in the presence of those antibodies; in other words, that a positive result on an antibody test for HIV may be the result of previous antigenic over-stimulation, rather than a result of an HIV or any other retroviral infection (12-14).


2.7. Finally, it has been proposed that antibodies against HIV are surrogate markers for recreational drug use in the United States and in Europe (55,56).


2.8. On the other hand, even if "the AIDS test" were able to detect antibodies to HIV, it would not be logical to say that the presence of those antibodies indicate an active infection. The presence of antibodies to any virus simply means humoral immune response to that virus and not necessarily that the virus is still active and pathogenic (48,58). One can have antibodies against many germs without those germs being active, pathogenically active or even present at all (58,59). In most instances, antibodies against viruses indicate immunity. This is the very basis of vaccination against viral diseases (48,58,60). Even if the tests were specific for antibodies against HIV, the question would then be the following: Why is it that only in the case of AIDS the presence of antibodies indicates the presence of disease, rather than protection against it?


2.9. There is no justification for the fact that both patients and the general public have had all of the preceding facts withheld from them. Without the merits and demerits of the tests for HIV, people cannot make informed decisions.


3. The so-called "AIDS virus", HIV, may not even exist


Biophysicist Eleni Papadopulos-Eleopulos and her group of researchers at Royal Perth Hospital in Perth, Western Australia, were the very first scientists in mentioning the fact that HIV has never been isolated (12). For several years Papadopulos-Eleopulos and coworkers, have been publishing papers where they have described in detail, the scientific facts that support the assertion that the so-called AIDS virus, HIV, may not even exist (12-14,20,30,31,47,50,61-64):


3.1. The correct procedures (31) employed for over half a century to achieve isolation of a retrovirus are: a) to find in infected cell cultures particles with a diameter of 100-120 nM that contain the so-called condensed inner bodies or cores and that have surfaces studded with projections - spikes, knobs - b) In sucrose density gradients the particles band at a density of 1.16 gm/ml; c) At the density of 1.16 gm/ml there is nothing else but particles with the morphological characteristics of retroviral particles; d) The particles contain only RNA and not DNA, and the RNA consistently has the same length [number of bases] and composition no matter how many times the experiment is repeated; e) When the particles are introduced into secondary cultures they are taken up by the cells, the entire RNA is reverse transcribed into cDNA, the entire cDNA is inserted into the cellular DNA, and the DNA is transcribed back into RNA which is then translated into proteins; f) As a result of e the cells in the secondary cultures release particles into the culture medium; g) The particles released into the secondary culture medium have exactly the same characteristics as the original particles, that is, they must have identical morphology, band at 1.16 gm/ml and contain the same RNA and proteins (31).


None of these procedures have been achieved in the case of HIV (12,14,31,47).


3.2. None of the researchers who claim to have isolated HIV have shown the presence of particles with the morphological characteristics of retroviruses banding at 1.16 gm/ml (31).


Even the word "isolation" as used by the most noted researchers (65-67) is incorrect and misleading since neither Montagnier, Gallo nor Levy isolated HIV particles, particles of any other human retrovirus, or even virus-like-particles at all (12-14,30,31,47,61,68-74).


3.3. Since no "retroviral particles" [retroviruses] have ever been isolated from any culture (12-14,31,47,61-63,69-75), the existence of HIV has been established indirectly: by the presence in blood cultures of AIDS and "HIV-positive" individuals, proteins/glycoproteins such as gp 160/150, gp120, gp41/45/40, p34/32, p24, and p18/17, each claimed to belong to HIV; by the presence of enzymes such as reverse transcriptase that supposedly belongs to HIV; and by the presence of RNA or DNA fragments that supposedly belong to HIV (12-14,31,47,61-63,69-75).


However, none of these substances have been proven to belong to HIV at all (12-14,31,47,61-63,69-75). How can anybody prove that the substances found in those cultures belong to a viral particle that has never been found at 1.16 gm/ml? To prove that those substances are part of a retrovirus named HIV, it is absolutely necessary that the retroviral particles have been previously separated - isolated - from everything else. This has never been done with HIV (31).


3.4. It is interesting to note that the substances listed in 6.3. are claimed to appear exclusively when one co-cultures supposedly infected blood with abnormal cells from leukemia patients, or from umbilical cord lymphocytes (31). The problem is that the same substances can be obtained from the same cultures in the absence of the supposedly HIV-infected blood (31).


3.5. The cultures where the above substances have been found are cultures that have been heavily stimulated with substances such as phytohemagglutinin, IL-2, antiserum to human interferon, and other agents (31). These culture stimulants are oxidizing agents (31,47). The problem is that the same type of material can be observed in stimulated cultures of lymphocytes from healthy persons (31,76).


It is interesting to note than in the presence of antioxidants, no HIV phenomena can be observed in culture; nor can HIV substances be found (12,64,76).


3.6. The substances listed in 6.3. are not specific to HIV at all (31). For instance, it is currently known that reverse transcriptase can be found associated with entities other than retroviruses, including eukaryote cells, some animal and plant DNA viruses, and even some introns (77).


Gallo and co-workers have claimed that the cell-free supernatants from "infected" cultures have HIV-DNA (78,79). They forgot that by definition retroviruses are infectious particles that contain only RNA. When retroviruses enter a cell the RNA is reverse transcribed into DNA, which is then integrated into cellular DNA as a provirus, which means that "HIV DNA" will be present only in the cell and no where else (31).


There is also ample evidence that any RNA or DNA present in the supernatant of the cultures is there as an effect of stimulation by polycations and oxidizing agents, rather than as an effect of the presence of a retrovirus (31).


"HIV cloning" is likewise misleading. Without isolating a retroviral particle containing RNA inside its core, the cloning of that "specific HIV-RNA" is not possible (31).


3.7. To date nobody has presented evidence that the so-called HIV proteins or antigens [gp160/150, gp120, gp41/45/40, p34/32, p24, p18/17], are constituents of a retrovirus particle or even retrovirus-like particle let alone a unique retrovirus, HIV (31).


3.8. The proteins or antigens derived from stimulated cultures form the basis for the ELISA and Western blot HIV antibody tests (31,73). Fragments of RNA from stimulated cultures form the basis of the HIV viral load test (31,73). This is the main reason why the current tests used for the diagnosis of HIV are not specific for it (12-14,31,61,62).


3.9. In the January 1997 issue of the journal Virology, two independent groups of researchers published experiments claiming to isolate HIV. Now and for the first time in the history of HIV, the researchers followed the internationally accepted procedures to isolate retroviral particles. Not surprisingly, in the sedimented bands at 1.16 gm/ml of sucrose, where retroviruses are known to be located, nothing was found but cellular debris. At 1.16 gm/ml there was nothing that even looked like a retroviral particle (80-81). They could not have isolated HIV simply because HIV was not there to be isolated.


It has been proposed that all those substances that indicate the existence of HIV are nothing more than non-viral material altogether, induced by the agents to which the AIDS patients and cultures are exposed (31). When found in people, these substances would be seen as regular products of the stress response (82), secondary to exposure to chemical, physical, biological, mental, and nutritional stressor agents (48,51,57,83-87).


3.10. It is therefore possible to conclude that the entire model of AIDS as an infectious and transmissible viral disease has its basis on a non-existing organism. The foundation stone for the HIV-AIDS model then, is a ghost.


4. The real meaning of being HIV-positive


4.1. Above considerations allow one to propose that the reactivity on the ELISA, Western blot, and PCR tests is caused by multiple, repeated, and chronic exposure to chemical, physical, biological, mental, and nutritional stressor agents. The degree of reactivity would be proportional to the level of exposures to immunological stressor or oxidizing agents (12-14,20,30,31,63,88,89).


Positive results on ELISA and Western blot tests, can also be understood as the consequence of the presence of high levels of polyspecific antibodies, due to a state of chronic polyantigenic stimulation (52-54). The reactivity on the three main tests for HIV -ELISA, Western blot, and PCR or viral load - would be simply the result of the stress response (82,88,89,91-94).


4.2. Being "HIV-positive" - reacting positive on the tests for HIV – would then mean simply that the person has been exposed to many antigenic and toxic challenges, i.e., to many oxidizing agents (47,50,89). His or her immune system has been responding a lot to these immunogenic and immunotoxic challenges (51,57,89). The immune system of these "HIV-positive" individuals would be debilitated - oxidized - after it has been over-stimulated and intoxicated. Therefore, their risk for AIDS is higher than those who are "HIV-negative" (12,13,49,51).


4.3. Undoubtedly, there is almost a perfect correlation between the reactivity on the so-called "tests for HIV" and AIDS.


Exposure to immunological stressors makes the tests to react positively. At the same time, the exposure to immunological stressors or oxidizing agents is the cause of the mild to moderate levels of immune suppression present in all non-symptomatic individuals who react positively on the "tests for HIV." If the exposure to immunological stressor is not stopped, and if the individual is not disintoxicated, it is very probably that the non-symptomatic "HIV-positive" individual will worsen his/her immune suppression, and will develop the clinical manifestations of AIDS.


What we know as HIV has not causative role in AIDS. By the contrary, the HIV phenomenon is one of the effects of the stress response to multiple repeated, and chronic exposures to chemical, physical, biological, mental, and nutritional stressor agents.


5. Possible trial to find out the real meaning of the tests for HIV


To take blood from four groups of people and run the tests highly diluted, undiluted and at a wide spectrum of dilutions in between. a) The first group would be a group of healthy people of many age groups, b) the second group would be a group of people from the conventional AIDS risk groups, c) the third group would be a group of people with clinical conditions unrelated to AIDS, and d) the fourth group would be a group of patients with full manifestations of AIDS.


All groups would be subjected to both ELISA and Western blot tests. Additionally, all blood samples could be subjected to the viral load test for HIV.


The result of such experiment could determine whether these tests measurements bear any relationship to an individual’s level of exposure to stressor or oxidizing agents. If so, the tests could be salvaged as a measure of individual’s level of intoxication.


REFERENCES



CDC. Centers for Disease Control and Prevention. 1993 Revised Classification System for HIV Infection & Expanded Surveillance Case Definition for AIDS Among Adolescents & Adults. MMWR 1992; 41: 1-19.


FAUCI AS. Immunopathogenesis of HIV Infection. J Acq Immunodeficiency Syndromes 1993: 6:655-662.


STAPRANS SI and FEINBERG MB. Natural History and Immunopathogenesis of HIV-1 Disease. In: SANDE MA and VOLBERDING PA. The Medical Management of AIDS. 5th Edition. Philadelphia: W.B. Saunders Company, 1997: 29-56.


LEVY JA. Overal Features of HIV Pathogenesis: Prognosis for Long-Term Survival. In: HIV and the Pathogenesis of AIDS. Second Edition. Washington DC: ASM Press, 1998: 311-338.


VOLBERDING PA and COHEN PT. Natural History, Clinical Spectrum, and General Management of HIV Disease. In: COHEN PT, SANDE MA and VOLBERDING PA. The AIDS Knowledge Base. Boston: Little, Brown and Company, 1994: Section 4.


INSTITUTE OF MEDICINE & NATIONAL ACADEMY OF SCIENCES. Confronting AIDS. Washington DC: National Academy Press, 1986.


WORTLEY PM, CHU SY and BERKELMAN RL. Epidemiology of HIV/AIDS in Women and Impact of the Expanded 1993 CDC Surveillance Definition of AIDS. In: COTTON D and WATTS DH. The Medical Management of AIDS in Women. New York: John Wiley & Sons, 1997: 3-14.


FEINBERG MA and VOLBERDING PA. Testing for Human Immunodeficiency Virus. In: COHEN PT, SANDE MA and VOLBERDING PA. The Aids Knowledge Base. Boston: Little, Brown and Company, 1994: Section 2.


PINS MR, TERUYA J and STOWELL CP. Human Immunodeficiency Virus Testing and Case Detection: Pragmatic and Technical Issues. In: COTTON D and WATTS DH. The Medical Management of AIDS in Women. New York: John Wiley & Sons, 1997: 163-176.


METCALF JA, DAVEY RT and LANE HC. Acquired Immunodeficiency Syndrome: Serologic and Virologic Tests. In: DEVITA VT, CURRAN J, HELLMAN S, et al. AIDS: Etiology, Diagnosis, Treatment and Prevention. 4th Edition. Philadelphia: Lippincott - Raven, 1997: 177-196.


WEISS SH. Laboratory Detection of Human Retroviral Infection. In: WORMSER GP. AIDS and Other Manifestations of HIV Infection. New York: Lippincott- Raven, 1998: 175-200.


PAPADOPULOS-ELEOPULOS E, TURNER V & PAPADIMITRIOU JM. Is a Positive Western Blot Proof of HIV Infection ? Bio/Technology 1993; 11:696-707.


PAPADOPULOS-ELEOPULOS E, TURNER V, PAPADIMITRIOU J & CAUSER D. HIV Antibodies: Further Questions and a Plea for Clarification. Curr Med Res Opin 1997; 13:627-634.


PAPADOPULOS-ELEOPULOS E, TURNER V, PAPADIMITRIOU J, et al. Why No Whole Virus? Continuum (London) 1997; 4(5):27-30.


JOHNSON C. Playing Russian Roulete in the Lab: Can you Really Trust the AIDS Test? New York: The HEAL Bulletin, Special Edition, 1993.


JOHNSON C. Is Anyone Really Positive? Continuum (London); April/May 1995.


JOHNSON C. Factors Known to Cause False-Positive HIV Antibody Test Results; Zenger’s San Diego, California, September 1996: 8-9.


JOHNSON C. Whose Antibodies Are They Anyway? Continuum (London), September/October 1996; 4(3):4-5.


HODGKINSON N. Science Fails the "AIDS Test". In: AIDS: The Failure of Contemporary Science. How a Virus that Never Was Deceived the World. London: Fourth Estate, 1996: 232-262.


TURNER VF. Do HIV Antibody Tests Prove HIV Infection? Continuum (London) 1996; 3:8-11.


BAUMGARTNER M and The International Forum for Accessible Science. Information Dosier: United Nations Commission on Human Rights, Geneva, Switzerland. April 1998: 64.


CDC. Centers for Disease Control and Prevention. Interpretation and Use of the Western Blot Assay For Serodiagnosis of Human Immunodeficiency Virus Type 1 Infections. MMWR 1989; 38 :S1-S7.


ZOLLA-PAZNER S, GORNY MK & HONNEN WJ. Reinterpretation of Human Immunodeficiency Virus Western Blot Patterns. NEJM 1989; 320:1280-1281.


BURKE DS. Laboratory Diagnosis of Human Immunodeficiency Virus Infection. Clin Lab Med 1989; 9:369-392.


DE COCK KM, SELIK RM, SORO B, et al. AIDS Surveillance in Africa: A Reappraisal of Case Definition. BMJ 1991; 303:1185-1189.


MASKILL WJ & GUST ID. HIV-1 Testing in Australia. Australian Prescriber 1992; 15:11-13.


VOEVODIN A. HIV Screening in Russia. Lancet 1992; 399:1548.


CONTINUUM. HIV Positive ? - It Depends Where You Live. Take a Look at the Criteria that Determine a Positive HIV Test Result. Continuum (London) 1995; 3(4):20.


LUNDBERG GD. Serological Diagnosis of Human Immunodeficiency Virus Infection by Western Blot Testing. JAMA 1988; 260:674-679.


TURNER VF. Do Antibody Tests Prove HIV Infection?. Interview by Huw Christie editor of Continuum. Continuum (London) Winter 1997/8; 5(2):10-19.


PAPADOPULOS-ELEOPULOS E, TURNER VF, PAPADIMITRIOU JM & CAUSER D. The Isolation of HIV: Has it Really Been Achieved? The Case Against. Continuum (London) 1996; 4(3): S1-S24.


ABBOTT LABORATORIES. Human Immunodeficiency Virus Type 1. HIVAB HIV-1 EIA. Abbott Laboratories, Diagnostics Division. January, 1997 (66-8805/R5), 5 pages.


BUIANOUCKAS FR. HEAL’s Alternative AIDS Test. A Practical Alternative to T-Cell and Antibody Tests. HEAL (Health Education AIDS Liaison) Comprehensive Packet 1993.


EPITOPE, ORGANON TEKNIKA. Human Immunodeficiency Virus Type 1 (HIV-1). HIV-1 Western Blot Kit. PN201-3039 Revision # 6, page 11.


ROCHE. Amplicor HIV-1 Monitor test. Roche Diagnostic Systems, 13-06-83088-001, 06/96.


PIATAK N, SAAG MS, YANG LC, et al. High Levels of HIV-1 in Plasma During All Stages of Infection Determined by Competitice PCR. Science 1993; 259:1749-1754.


VAN GEMEN B, KIEVITS T, SCHUKKINK R, et al. Quantification of HIV-1 RNA in Plasma Using NASBA During HIV-1 Primary Infection. J Virol Meth 1993; 43:177-188.


KWOK S & SPINSKY JJ. PCR Detection of Human Immunodeficiency Virus Type 1 Proviral DNA Sequences. In: PERSING DH, SMITH TF, SMITH FC, et al. (eds.) Diagnostic Molecular Biology: Principles and Applications. Washington DC:ASM Press, 1993.


MULDER J, MCKINNEY N, CRISTOPHERSON C, et al. Rapid and Simple PCR Assay for Quantitation of Human Immunodeficiency Virus Type 1 RNA in Plasma: Application to Acute Retroviral Infection. J Clin Microbiol 1994; 32:292-300.


DEWAR RL, HIGBARGER HC, SARMIENTO MB, et al. Application of Branched DNA Signal Amplification to Monitor Human Immunodeficiency Virus Type 1 Burden in Human Plasma. J Inf Dis 1994; 170:1172-1179.


JOHNSON C. The PCR to Prove HIV Infection. Viral Load and Why They Can’t Be Used. Continuum (London) 1996; 4:33-37 and 39.


PHILPOTT P & JOHNSON C. Viral Load of Crap. Reappraising AIDS 1996; 4(10):1-4.


KENT G, DELANY L, HOPE T and GRANT V. Teaching Analysis. Informed Consent: A Case for Multidisciplinary Teaching. Health Care Analysis 1996; 4(1):65-79.


O’MARA P. Life, Liberty, and Informed Consent. Mothering September/October 1998; (90): 6-9.


SILVERMAN WA. Informing and Consenting. In: Where’s The Evidence ? Controversies in Modern Medicine.Oxford: Oxford University Press, 1998: 78-84.


CHRISTIE H. Wake the Law. Damaging, Non-Specific HIV Testing at the Hands of the Medical Industry Must Soon Prompt Large Finantial Compensation for "the Diagnosed" It’s Time to Sue! Continuum (London) Spring 1998; 5(3):28-29


PAPADOPULOS-ELEOPULOS E. Reappraisal of AIDS - Is the Oxidation Induced by the Risk Factors the Primary Cause? Medical Hypothesis 1988; 25:151-162.


GIRALDO RA. AIDS and Stressors IV: The Real Meaning of HIV. In: AIDS and Stressors. Medellín, Colombia: Impresos Begón, 1997: 133-173.


SHALLENBERGER F. Selective Compartmental Dominance: An Explanation for a Nonifectious, Multifactorial Etiology for Acquired Immune Deficiency Syndrome (AIDS), and a Rationale for Ozone Therapy and other Immune Modulating Therapies. Med Hypothesis 1998; 50:67-80.


TURNER VF. Reducing Agents and AIDS - Why Are We Waiting? Med J Austr 1990; 153:502.


GIRALDO RA. AIDS and Stressors II: A Proposal for the Pathogenesis of AIDS. In: AIDS and Stressors. Medellín: Impresos Begón, 1997: 57-96.


SNYDER HW and FLEISSNER E. Specificity of Human Antibodies to Oncovirus Glycoproteins: Recognition of Antigen by Natural Antibodies Directed Against Carbohydrate Structures. Proc Nat Acad Sci USA 1980; 77:1622-1626.


BARBACID M, BOLAGNESI D & AARONSON SA. Humans Have Antibodies Capable of Recognizing Oncoviral Glycoproteins: Demonstration that these Antibodies are Formed in Response to Cellular Modification of Glycoproteins Rather than as Consequence of Exposure to Virus. Proc Nat Acad Sci USA 1980; 77:1627-1621.


WING MG. The Molecular Basis for a Polyspecific Antibody. Clin Exp Immunol 1995; 99:313-315.


DUESBERG PH. AIDS Acquired by Drug Consumption and other Non Contagious Risk Factors. Pharmac Ther 1992; 55:201-277.


DUESBERG PH & RASNICK D. The Drug-AIDS Hypothesis. Continuum (London) 1997; 4(5):S1-S24.


GIRALDO RA. AIDS and Stressors III: A Proposal for the Natural History of AIDS. In: AIDS and Stressors. Medellín: Impresos Begón, 1997: 97-131.


ZINKERNAGEL RM. Immunity to Viruses. In: PAUL WE. Fundamental Immunology. Third Edition. New York: Raven Press, 1993: 1211-1250.


MIMS CA, DIMMOCK NJ, NASH A & STEPHEN J. The Immune Response to Infections. In: Mims’ Pathogenesis of Infectious Diseases. Chapter 6. London: Academic Press, 1995: 136-167.


EVANS AS. Viral Infections of Humans, Epidemiology and Control. New York: Plenum Publishing Corporation, 1989.


PAPADOPULOS-ELEOPULOS E. Is HIV the Cause of AIDS. Interview by Christine Johnson. Continuum (London) 1997; 5(1):8-19.


PAPADOPULOS-ELEOPULOS E, TURNER V, PAPADIMITRIOU J, et al. Between the Lines. A Critical Analysis of Luc Montagnier’s Interview Answers to Djamel Tahi. Continuum (London) 1997/8; 5(2):35-45.


TURNER VF. Where Have We Gone Wrong? Continuum (London) 1998; 5(3):38-44.


PAPADOPULOS-ELEOPULOS E, TURNER V & PAPADIMITRIOU J. Oxidative Stress, HIV and AIDS. Res Immunol 1992; 143:145-148.


BARRE-SINOUSSI F, CHERMANN JC, REY F et al. Isolation of a T-Lymphotropic Retrovirus from a Patient at Risk for Acquired Immune Deficiency Syndrome (AIDS) Science 1983; 220:868-871.


PAPOVIC M, SARNGADHARAN MG, READ E, et al. Detection, Isolation, and Continious Production of Cytopathic Retroviruses (HTLV-III) from Patients with AIDS and Pre-AIDS. Science 1984; 224:497-500.


LEVY J, HOFFMAN AD, KRAMER SM, et al. Isolation of Lymphocytopathic Retroviruses from San Francisco Patients with AIDS. Science 1984; 225:840-842.


BUIANOUCKAS FR. HIV an Illusion. Nature 1995; 375:197.


LANKA S. HIV: Reality or Artefact? Continuum (London) 1995.


LANKA S. Collective Fallacy. Rethinking HIV. Continuum (London) 1996; 4(3):19-20.


LANKA S. No Viral Identification: No Cloning as Proof of Isolation. Continuum (London) 1997; 4(5):31-33.


DE HARVEN E. Pioneer Deplores "HIV" "Maintaining Errors is Evil" Continuum (London) 1997/8; 5(2):24.


DE HARVEN E. Remarks on Methods for Retroviral Isolation. Continuum (London) 1998; 5(3):20-21.


PHILPOTT P. The Isolation Question. Does HIV Exist? Do HIV Tests Indicate HIV Infection? Here’s Why Some Scientists Say No. How an Australian Biophysicist and her Simple Observations Have Taken Center Stage Among AIDS Reappraisers. Reappraising AIDS 1997; 5(6):1-12.


HODGKINSON N.Origin of the Specious. Continuum (London) 1996c; 4(3):17-18.


KLATZMANN D & MONTAGNIER L. Approaches to AIDS Therapy. Nature 1986; 319:10-11.


DOOLITTLE RF, FENG DF, JOHNSON MS, et al. Origins and Evolutionary Relationships of Retroviruses. Quart Rev Biol 1989; 64:1-30.


LORI D, DI MARZO VERONESE F, DE VICO AL, et al. Viral DNA Carried by Human Immunodeficiency Virus Type 1 Virions. J Virol 1992; 66:5067-5074.


ZHANG H, ZHANG Y, SPICER TS, et al. Reverse Transcription Takes Place Within Extracellular HIV-1 Virions: Potential Biological Significance. AIDS Res Hum Retrovirus 1993; 9:1287-1296.


GLUSCHANKOF P, MONDOR I, GELDERBLOM HR, et al. Cell Membrane Vesicles are a Major Contaminant of Gradient-Enriched Human Immunodeficiency Virus Type-1 Preparations. Virology 1997; 230:125-133.


BESS JW, GORELICK RJ, BOSCHE WJ, et al. Microvesicles are a Source of Contaminating Cellular Proteins Found in Purified HIV-1 Preparations. Virology 1997; 230:134-144.


KOVAL TM. Stress-Inducible Processes in Higher Eukaryotic Cells. New York: Plenum Press, 1997: 256.


GIRALDO RA. AIDS and Stressors I: Worldwide Rise of Immunological Stressors. In: AIDS and Stressors. Medellín: Impresos Begón, 1997: 23-56.


GIRALDO RA. Polemica Cientifica Internacional Acerca de la Causa del SIDA. Investigacion y Educacion en Enfermeria (University of Antioquia, Colombia) 1996; 14(2):55-74.


GIRALDO RA. Papel de Estresantes Inmunologicos en Inmunodeficiencia. IATREIA (University of Antioquia, School of Medicine, Colombia) 1997; 10:62-76.


GIRALDO RA. AIDS and Stressors: AIDS in Neither an Infectious Disease nor is Sexually Transmitted. It is a Toxic-Nutritional Syndrome Caused by the Alarming Worldwide Increment of Immunological Stressor Agents. Medellín, Colombia: Impresos Begón, 1997: 205.


GIRALDO RA. AIDS in Neither an Infectious Disease nor is Sexually Transmitted. In: AIDS and Stressors. Medellín: Impresos Begón, 1997: 175-187.


GIRALDO RA. Everybody Reacts Positive on the ELISA Test for HIV. Continuum (London) 1999; 5(5):8-10.


GIRALDO RA, ELLNER M, FARBER C, et al. Is it Rational to Treat or Prevent AIDS with Toxic Antiretroviral Drugs in Pregnant Women, Infants, Children, and Anybody Else? The Answer is Negative. Continuum (London) 1999; 5(6): 38-52.


METLAS R, et al. Human Immunodeficiency Virus V3 Peptide-Reactive Antibodies are Present in Normal HIV-Negative Sera. AIDS Research and Human Retroviruses 1999; 15: 671-677.


MORIMOTO R, TISSIERES A, GEORGOPOULOS C. Stress Proteins in Biology and Medicine. Cold Spring Harbor Laboratory Press 1990: 450.


SCHLESINGER MJ, SANTORO MG, GARACI E. Stress Proteins: Induction and Function. Berlin: Springer-Verlag 1990: 123.


VAN EDEN W, YOUNG DB. Stress Proteins in Medicine. New York: Marcel Dekker, Inc. 1996: 578.


LATCHMAN DS. Stress Proteins. Springer, 1999: 422


Roberto A. Giraldo
www.RobertoGiraldo.com



********************

AT LEAST PART OF THE DEBATE ABOUT
HHV-6 AND HIV SEEMS TO HAVE
BEEN WON BY HHV-6

The degree with which HHV-6 is avoided as a topic of discussion by the AIDS establishment is breathtaking. (Also tragically, the AIDS rethinkers and dissidents are also HHV-6 denialists.) And the refusal to deal with HHV-6 could be costing millions of AIDS patients their lives with tremendous damage also occuring in the CFIDS part of the AIDS epidemic.

I recently noticed a page on Biotrin's site about the role of HHV-6 in AIDS. Biotrin is an Ireland-based biotech testing company that seems to be heavily involved in making transplants safer.

The page contains a summary of a study published in Journal of Medical Virology. The conclusions were based on a study of of 141 organs taken from the bodies of 11 seropositive HIV patients who died from AIDS.

According to the Biotrin's summary, "the results of this experiment showed that the quantity of HIV DNA found in organs was greatly increased when HHV 6 was also present. The tissues containing the greatest HIV viral load were the lymphoid tissues and this has been explained by the fact that both HIV and HHV 6 are tropic for T cells. The results showed that there was an association between HHV 6 and HIV 1 such that the greater the quantity of HHV 6 presence the greater the quantity of HIV 1 and vice versa. This observation was not noted with either CMV or HHV 7."

AIDS patients caught up in the HIV system are constantly having their blood monitored in all kinds of esoteric and high tech ways, and yet you never hear of anyone discussing their HHV-6 status or their HHV-6 viral load. Why?

Well here's one theory, and it is political. HHV-6 is a big threat to HIV because there are people who have died of HIV-negative AIDS who seemed to have succumbed to disseminated HHV-6 infection. The logic behind not calling these HIV-negative cases AIDS is worthy of Joseph Heller.

For years, my newspaper, New York Native, reported on HHV-6's role in AIDS. It drove the AIDS czars and czarinas crazy. The would rather let millions of people die from complications of HHV-6 than admit that the Native was right.

The real debate should be whether HIV is even necessary, or for the time being, how about what the role of HIV on HHV-6 replication? The more you know about HHV-6, the more it looks like Attila the Hun and the more HIV looks like Barney Fife.

What we need is litigation. A few lawsuits filed on the wrongful deaths of AIDS patients caused by a willful neglect of HHV-6 in their bodies might do the trick. There is certainly enough published medical information about HHV-6 to sway a judge and jury. Any takers?

PUBLIC HEALTH AND LAW ENFORCEMENT
MERGE IN SOUTH DAKOTA

According to an AP report in the Aberdeen American News today, a bill has passed the South Dakota Senate which "would authorize state officials to give prosecutors otherwise confidential information when people are being investigated for intentionally exposing others to the AIDS virus without their knowledge. A judge would have to issue an order before test results and other personal information could be released."

Also, according to the story, "the attorney general or prosecutors also could be alerted if Health Department officials suspect people of intentionally exposing others to HIV."

That should warm the hearts of AIDS activists everywhere.

WHY NOTHING MAKES SENSE IN THE
WACKY WORLD OF AIDS SPIN

Today in the Washington Post, Howard Kurtz pointed out a slight discrepancy:

"Vaccine for AIDS Shows Promise" -- last Monday's USA Today

"Large Trial Finds AIDS Vaccine Fails to Stop Infection" -- last Monday's New York Times

IS DON FRANCIS MASSAGING THE DATA
ON THE AIDS VACCINE?

A disturbing report today in The San Francisco Chronicle by Andrew Pollack suggests that the recent results of VaxGen's AIDS vaccine have an aroma that is all too familiar in AIDS in general and in the work of VaxGen president, Donald Francis, in particular. According to Andrew Pollack, "VaxGen may have overstated the effectiveness of its AIDS vaccine because it did not make the proper statistical adjustments to its data, an expert consulted by the company said Wednesday. Steven Self, a professor of biostatistics at the University of Washington, said the company should have lowered the level of confidence with which it said the vaccine appeared to protect blacks, Asians and other non-Hispanic minorities from infection by HIV. "

Apparently Don Francis thinks this is a minor matter and plans to proceed as though his results have been a breakthrough in the racial understanding of AIDS. We hope he stays on this track. People are finally getting a sense that there is something racist afoot here. To try and save his company's credibility, Francis may have no choice but to continue down this racist path and it appears that Anthony Fauci, the snippy Napoleon of HIV, will accompany him. They deserve each other and we wish them a safe journey.

POEM OF THE DAY

Another vaccine
from the HIV crooks.
It doesn't work,
so cook the books!

THE AIDS VACCINE FAILURE:
"SCIENTIST ZERO" STRIKES AGAIN

Ever since the clown known as Donald Francis assisted in the building the AIDS circus of death in the early '80s, he has provided one gruesome performance after another. Today the press is covered with announcements of his vaccine's failure. The good news is that this might slow down the very queer AIDS agenda that the breathless, hyperactive, out-of-control Donald Francis has been pushing for two decades. The bad news is that the desperate AIDS establishment has tried to spin a tiny blip in the statistics to suggest that the failed vaccine might work for Blacks. Let us all now get down on our knees and pray that the African-American community can smell a rat in this racial disparity. Is this the new racial medicine, a rebirth of the mindset that created the Tuskegee Syphilis Experiment? Stay tuned.

In November, Wired published a piece on Francis and his vaccine which has a rather revealing anecdote in it. According to Richard Martin, "Francis grew up in Marin country, California, the son of two physicians and the grandson of another. A breakneck competitive skier and wild-eyed liberal, he attended UC Berkeley in the late '60's and got swept up in the civil rights movement. Speaking at Berkeley's 2000 commencement, he disclosed that he hadn't stuck around long enough to pick up his undergraduate degree. As soon as he was accepted into medical school at Northwestern, he took six months off to travel in Europe. Though he earned an MD plus a doctorate in virology from Harvard, he never made it back to Berkeley to finish his undergraduate studies." According to Martin, "Francis is one of the few modern-day physicians with an MD but no BS."

Cool? I don't think so. That anecdote, of course, is meant to make him sound like a folk hero: someone who colors outside of the lines and thinks out of the box. But in science where great care must be given to process and logic and thorough attention to details (as the search for Shuttle pieces in several states attest), maybe our wild-eyed-liberal-breakneck-skier's work on AIDS may in fact have more in common with the classic snowjob than classic science. Having met Francis and talked with him on the phone, I've thought of him as arrogant and incompetent, while others (like Randy Shilts) have portrayed him as a white knight.

I wrote a piece many years ago about Francis called "Scientist Zero," which was a sarcastic reference to the urban myth of the "Patient Zero" of AIDS. My point was that if you had to pick one person who had done more than any other person to create the scientific disaster that AIDS is, it is wild-eyed Donald Francis. Francis was at ground zero when the bogus, homophobic, racist, political definition of "AIDS" was created. He played a major role in getting the CDC to name the retrovirus known as "HIV" the cause of AIDS. The manner with which he did that is riddled with a kind of intellectual conflict of interest that has now deprived many people of their lives.

Francis had been working with Harvard's Myron Essex on retroviruses before he got involved with AIDS. You could say that he had a retroviral chip on his shoulder and he used the AIDS epidemic to vindicate some of the funky, quacky, research that he did with Myron Essex, the discoverer of FOCMA, something that turned out not to exist. According to John Crewdson's book, Science Fictions, after working in Africa and India for the CDC, "Francis had taken a sabbatical to earn a doctorate in Max Essex's lab at Harvard." In And the Band Played On, Randy Shilts wrote that "after spending eight years studying feline leukemia, the major cause of cat deaths, Essex was more than casually interested in links between the disease and human disease. He and Francis were among the small minority of scientists who believed that viruses would one day be linked to cancer and other serious human ailments. Together, they had published eight articles on feline leukemia as well as a controversial piece suggesting that some human lymphomas, leukemias and cancers of the immune system might be linked to viral infections."

The case can be made that Francis used the AIDS epidemic to bolster the theories about retroviruses that he helped develop with Essex. While this conflict of interest may have given Francis only an underserved halo and power, it gave Essex something he could put in the bank. Ironically, in his bestseller, Randy Shilts also writes that, "Essex knew Francis had a penchant for quick conclusions stated in the most dramatic terms: he also knew that his former student had gained an international reputation for singular brilliance." One suspects that Francis' conclusions were singularly brilliant (and not just quick) when they supported Essex's own crackpot (see FOCMA) science.

The question for historians will be to determine the degree of bureaucratic thuggery that Francis and his associates in the AIDS establishment applied to anyone who tried to raise questions about their "science." Because they have built a multi-billion dollar house of cards around HIV, the silencing of critics has required enormous effort and eternal vigilance. These guys are good. Students of modern propaganda will marvel at the job that Francis and his buddies have done on AIDS. Since Francis helped turn Essex's FOCMA failures into the triumph of HIV fraud, it will be interesting to see what magic he can work with his collossal AIDS vaccine failure. Underestimate him at your own peril.

HOW MANY CASES OF CFIDS
ARE THERE IN SOUTH AFRICA?

A story in the Washington Post today about Gibson Kente, a famous South African playwright announcing that he is HIV positive, contains the obligatory bit of HIV agitprop: "An estimated one in five South Africans, or 4.7 million people, are infected with HIV, the virus that causes AIDS, giving the country the highest caseload in the world."

Okay, lets accept that as true for a split second. Then how many cases of CFIDS do they have in South Africa?

Given that CFIDS is contagious and involves the destruction of the immune system and other fun pathological things, and given that just about any contagious disease that is a problem in our country, seems to be an exponentially bigger problem in Africa (and similar venues) then curious minds want to know: where in the world are the CFIDS cases? South Africa should be awash in CFIDS. The State Department should be issuing endless statements about CFIDS threatening national security. Yuppie reporters should be sighing in the faux manner that Yuppies sigh, "Oh, we've lost Africa to CFIDS. And India is next."

The number one million has been bandied about when the American incidence of CFIDS is loosely discussed by CFIDS activists. Given that one million HIV positives in America (1 in 280 million Americans) represents our epidemic and 4.7 million (1 in 4) South Africans represents their epidemic, does some similar statistical relationship exist with the even more contagious CFIDS? Are there 4.7 million people with CFIDS in South Africa? Do 2 out of 5 South Africans have a serious form of immune dysfunction?

And that, of course, raises the question--how in the world do you distinguish CFIDS from AIDS in Africa? Is it the same dirty game of politics that is played in America? Here If you're African-American or a gay male and you suffer from immune dysfunction, you have AIDS, and if you're white and heterosexual (or lesbian) and suffer from the same immune dysfunction, you have fruity CFIDS.

If Mbeki really wants to make the AIDS activists and HIV establishment give virgin births to cows, these are the questions he should be asking. Better still, hold a conference on CFIDS in South Africa. Tony Fauci would retire on the spot. And as Martha Stewart says, that would be a good thing.

MAYBE AIDS IS NOT A SEXUALLY
TRANSMITTED DISEASE

WILL THE NEW STUDY
VINDICATE DUESBERG?

It has been a very emotional article of faith among the HIV establishment and the AIDS activists that AIDS is a sexually transmitted disease. All kinds of bizarre theories about the sexuality of Africans have peppered the official racist paradigm of AIDS. But a new study suggests that what is really driving the so-called AIDS epidemic in Africa is not sex but medical practices. In a Reuters report yesterday, Patricia Reanay writes that "Africa's AIDS epidemic may not have been fueled mainly by sexual transmission of the HIV virus but by unsafe medical injections and blood transfusions, a team of international researchers said Thursday."

She also notes that the "findings contradict widely held views about how the virus that causes AIDS spread through Africa, and could have implications for public health measures to fight the disease."

Can it be? A challenge to the official line on AIDS? Peter Duesberg must be thrilled. He is the first person to suggest that something was really funky about the model of AIDS that the CDC and the NIH have been promoting on the backs of gay people and people of color.

South Africa's President Mbeki should point to this study when people attack him for daring to question what a majority of AIDS researchers assume to be true. There may be many more surprises to come.

THE CREEPY ATTACKS ON
MBEKI CONTINUE

Business Day carries a story today about yet another attack on Thabo Mbeki because he is not doing what the AIDS establishment and the AIDS activists want him to, i.e. when they say jump he does not ask how high. Thus far he has refused to be the Steppin' Fetchit of AIDS in South Africa.

Why is there not a bold international effort among intellectuals to defend his right to ask questions and have a second opinion about AIDS orthodoxy? A friend has for years correctly noted that HIV is actually a religion and Mbeki is one of its heretics. One would think that apartheid writer/heroines like Nadine Gordimer would come to his defense, and yet, with friends like Gordimer, Mbeki doesn't need enemies. I'm still in a state of shock over something she wrote in a letter (with Anthony Sampson) to the New York Review of Books: "Both writers of this letter, Nadine Gordimer and Anthony Sampson, accept beyond any question that HIV causes AIDS."

The moral of Gordimer's story is that yesterday's heroic freedom-fighting intellectuals are tomorrow's pompous asses.

THE CLOSING ARGUMENT
INTERVIEW

Here's the interview I did with Cary Harrison about The Closing Argument. It's part of his February 16th program.

And here's the book itself. Read it for free.

THE DIRTY WAR AGAINST MBEKI
CONTINUES

The HIV thugs seem to want South Africa's President Thabo Mbeki to crawl on his knees through the streets of Johannesburg, begging for the forgiveness of the the American AIDS establishment and the AIDS activists as he admits that HIV is the real, official, no-doubt-about-it cause of AIDS. Thus far he has been brave and resisted their international pressure. Even after AIDS windbag William Jefferson Clinton joined the chorus, Mbeki seems to be sticking to his guns. Even though the Kaiser HIV/AIDS Daily Report is a useful compendium on the latest AIDS stories, it has a kind of "Get Mbeki" slant to it's coverage. Today's round-up of stories on South Africa is no exception. If you want to know more about what is going on in South Africa (and why the HIV tests are unreliable), go to Roberto Giraldo's site.

THE RACIST PARADIGM OF AIDS

Yesterday the Kaiser Daily HIV/AIDS Report ran this item: "HIV is 11 times more common in black women in Ohio than in white women, according to state health department figures, and the number of cases is increasing, the Columbus Dispatch reports. In Franklin County, women represented 17% of all HIV/AIDS cases in 2001, compared with 6% in the early 1990s, and "most" of the cases are among black women."

How many white women do you think have CFIDS in Ohio? If you're a white woman and you suffer from immune dysfunction, you're told you have "Chronic Fatigue Syndrome" and to take to your bed or see a shrink. If you are a black woman, you're told you have AIDS, and your life takes an ugly turn. You are stigmatized, potentially criminalized and coerced to take toxic fraud-based medications. (It's all in The Closing Argument.)

When are Black citizens going to wake up to the fact that they're being rolled on AIDS? Jesse Jackson is running around the country promoting this fraud, urging African-Americans to get with the racist program of HIV fraud. He should be ashamed of himself. Jesse Jackson is turning himself into the Pied Piper of AIDS in the Black community. He should be leading an investigation into the cover-up of HHV-6 and the relationship of CFIDS to AIDS.

And so should the folks at the Kaiser Daily HIV/AIDS Reports, but that is a story for another day.

AMPLIGEN IN THE NEWS AGAIN

The following headline orginates from Medstar: "AIDS patients whose bodies become resistant to the “AIDS Cocktail” drug treatments may find help from a nucleic acid drug that is under study. Ampligen® is a synthetic form of RNA and is thought to produce a positive immune system response. That response helps fight off a viral attack. Clinical trials are currently underway at more than twenty sites nationwide. Ampligen is also being tested for patients with Chronic Fatigue Syndrome."

Maybe if Ampligen works, the clowns who call themselves AIDS researchers can stop turning gay people and African-Americans into experimental toxic dumps. (Not that Ampligen is exactly Vitamin C.)

Ampligen has always been an interesting experimental treatment because the premise on which it is based supports the notion that CFIDS and AIDS are the same syndrome, something CFIDS patients would rather die than admit. (CFS activist Roger Burns has an excellent page of links on the subject of Ampligen.)

In her book, America's Biggest Cover-up, Neenyah Ostrom reports on the theory about CFS developed by Dr. Carter, the president of Hemispherix, the company that manufactures Ampligen: "At a conference held in late 1991, Dr. Carter discussed a clinical trial of Ampligen and explained that he thinks CFS could be called 'lymphokine overdose disease.'" And anyone with half a brain knows that AIDS is the ultimate "lymphokine overdose disease."

By the way, on the bioterrorism front, Wired News reported in 2001 that Ampligen was also being considered as a possible treatment for smallpox.

Click to learn more about CFIDS/AIDS.

CELIAC DISEASE AND CFIDS

In a story on Celiac Disease today in The Washington Post, David Brown notes that new "research is revealing that celiac disease may be one of the most common genetic diseases, affecting perhaps as many as 2 million Americans. A national survey published today, for example, estimates that 1 in 133 Americans has it."

It's tragic that The Washington Post, like most of the mainstream media, has ignored the CFIDS epidemic. Celiac Disease seems to be a major problem in people suffering from CFIDS. In a report in the CFIDS Forum, Alan Coccetto notes that "Medical studies are beginning to show now that Celiac disease can be present in CFS patients. During the past six months, I have had several long-term patients phone me with various test results confirming that Celiac disease is a definite problem among some of us with CFS. Most of these patients have been scoped and had intestinal biopsy proven Celiac disease. One doctor, from one of the 'top five' clinics in the US, concluded that the PWC had a type of neurological celiac disease! This is very interesting in light of the pathogens that we have been looking at (HHV-6, HTLV-II, etc.) with respect to their roles in the central nervous system."

Click to learn more about CFIDS/AIDS.

THE INCREDIBLE DISAPPEARING WEBSITE

A week ago you could type in "AIDSGATE" in Google and this site was number 8 on the first page of listings. Now you can't even find it in any of the pages of listings. We can't figure out what's going on. Can you? Maybe Google is using an old cache of sites.

GREASY PIG DISEASE

No, it's not a new malady affecting our top AIDS researchers. Greasy Pig Disease is caused by a form of staph and bears looking into because it is a complication of PRRS which looks like a CFIDS/AIDS epidemics in pigs. One PRRS researcher has suggested that PRRS might make a good model for studying AIDS. According to a report by PRRS researcher Monte McCaw, "We demonstrated last year that in utero infection of piglets by PRRSV greatly increased their susceptibility to Streptococcus suis disease after challenge at 5 days of age. Only 1 or 4 pigs died following infection with either PRRSV or Strep. suis alone. However, 20 of 22 pigs died which were infected with PRRSV in utero and then challenged with Strep. suis at 5 days of age. This year we evaluated some of the immune system cells and organs of piglets infected with PRRSV in utero. At birth and up to two weeks of age the thymus (lymphocyte immune cell maturing organ) of PRRSV infected piglets was only half the size of the thymus of uninfected pigs. The distribution of lymphocytes still in the thymus and also in the blood of the PRRSV infected piglets was greatly reversed, showing a CD 8 : CD 4 ratio of 12 : 1. This shift in CD 4 : CD 8 ratio is similar to that which occurs in AIDS patients who also become sick with many different secondary bacterial diseases."

Is the staph epidemic in people a byproduct of the PRRS epidemic in people? Can people get PRRS? Stay tuned.

It would be interesting to look into the staph epidemics breaking out in prisons around the country to determine if the victims of this disorder have an underlying monocyte-macrophage dysfunction. Many pigs with Greasy Pig Syndrome suffer from that dysfunction. Was that greasy bacon you had this morning from a greasy pig? Why has the media (with the exception of Nicholas Regush when he was at ABC) shown so little interest in the CFIDS/AIDS epidemic in pigs which parallels the one in people?

STAPH AND CFIDS

On February 3, the New York Times reported on the growing problem of "mysterious" staph infections on the West Coast. According to the David Tuller's report, "More than 1,000 jail inmates in Los Angeles County have suffered painful and aggressive skin infections caused by a bacterium resistant to many antibiotics, medical authorities say. The unusual outbreak over the last year is still not contained."

A better understanding of the staph epidemic may require a closer look at what is not being publicly admitted about the CFIDS epidemic, namely that there is a pandemic of HHV-6 which is devastating the immune systems of the general population and making people very susceptible to staph infections. Need an animal model, or a possible source for the staph problem in the environment? Check out the work of Dr. Turello who is working on the CFIDS epidemic in dogs and horses. According to a recent article of his which is posted on a leading CFS site, "Chronic Fatigue Syndrome (CFS) in human patients remains a controversial and perplexing condition with emerging zoonotic aspects. Recent advances in human medicine seem to indicate a bacterial etiology and the condition has already been described in horses, dogs, cats and birds of prey in association with micrococci-like organisms in the blood and Staph-positive blood cultures."

An article on the Aegis site provides a little background on the role of staph in "AIDS." Because the whole AIDS paradigm has been skewed by HIV fraud, thereby concealing the real epidemic of immunodeficiency in the general population, the staph epidemic could be "mysterious" for a long time. Lies and politics tend to make epidemics very "mysterious."

THE MEDICAL POLICE STATE GROWS

According to a story in the South Dakota Aberdeen American News, the South Dakota "state Health Department is seeking legal authority to alert prosecutors about people with the AIDS virus who are having sex without disclosing their medical status."

Imagine if the public health police tried to track the sex lives of people with the CFIDS form of AIDS. Every person with CFIDS with half a brain know that CFIDS is contagious and that people have gotten CFIDS from their sexual partners. They wouldn't dare criminalize the CFIDS form of AIDS because the most visible patients are white and heterosexual. (Check out The Closing Argument for more on this.)

Next week two men are going on trial in Aberdeen for violating South Dakota's HIV partner notification laws. In an amazing modern-day witch hunt, 30 men in Aberdeen were contacted at their homes or places of businesses by the police and told that they must get HIV tests as part of the investigation, sources in Aberdeen have told AIDSGATE. The two men could get as many as 90 years in prison if they are found guilty. An African-American man who may have been a victim of a sting operation by the health department in Huron, South Dakota is now serving a four year sentence in the South Dakota State penitentiary for violating the racist and homophobic AIDS laws of South Dakota.
Is this the world the AIDS activists and HIV establishment are building?

MORE BAD NEWS ABOUT THE
MIRACLE PROTEASE COCKTAILS

Reuters is reporting on a University of Kentucky study on mice that suggests, "that the drugs, known as protease inhibitors, may directly contribute to artery disease even before triglyceride and cholesterol levels rise."

These are the drugs that some people want to force patients to take. We hope all the class action lawyers out there are taking notes. When it comes, it's going to be a big one.

NEW CFIDS ABNORMALITY

Doctor's Guide recently reported on a new cardiac abnormality found in CFS patients: "A particular and quantifiable abnormality in the cardiovascular reactivity of most patients with chronic fatigue syndrome provides an new objective tool for assessing this disorder, suggest researchers in Israel."

THE COLLATERAL DAMAGE OF
THE HHV-6 COVER-UP

As long as the HIV establishment keeps the public from knowing the truth about the role of HHV-6 in CFIDS/AIDS, all kinds of people suffer from not knowing how widespread HHV-6 is in the general population and how many lives it is destroying. This story in the Albuquerque Tribune describes an out-of-control child whose problem was an underlying HHV-6 infection. Scores of children in this country and others are suffering from bizarre symptoms from HHV-6 because the AIDS establishment and the AIDS activists are committed to to protecting the big HIV lie at all costs. As more and more children suffer from autism and ADD, the true horror of the HHV-6 epidemic becomes clearer and clearer. The parents of these children have a major investment in getting to the bottom of AIDSGATE and the cover-up of HHV-6.

NOBODY WITH AIDS EVER DIES
AND YOUR HEART WILL GO ON AND ON

Gay.com today is reporting that a BBC soap opera is under fire from the AIDS Thought Police for the way it plans to kill off an HIV-positive character. The writers of the soap have the nerve to suggest that the character dies because his AIDS "cocktail" fails him. Well, Hello! God forbid that anyone suggests that anything isn't peachy keen in the fairy tale world that the AIDS activists and HIV con artists have presented in the media. We have a better suggestion for a way to write the HIV-positive character out of the soap. He decides to stop taking his miraculous toxic "cocktail" and the UN sends in troops, puts him under house arrest, forces him to take his medications at gunpoint and he dies under quarantine. Now that would be more reflective of the reality of AIDS.

HOMODEMIOLOGY

"Homodemiology" is a term we've coined to describe the science of blaming epidemics on gay people. We of course mean "pseudo-science." The biggest breakthroughs in homodemiology were made under the Nazis, until the AIDS researchers came along. The idea that "AIDS" and "CFIDS" are separate epidemics is a good example of homodemiology. The work on HHV-8 seems to be the latest discovery from the homodemiological discipline. This cartoon captures the essence of the current state of homodemiology.

Anyone who thinks that epidemiology isn't political is extremely foolish. Epidemiology is suffused with a society's prejudices and agendas. All the premises about AIDS were created by the very political homodemiologists who called themselves "epidemiologists" at the CDC in the early '80s. For anyone who wants to understand the politics of disease, we recommend this book by Sylvia Noble Tesh.

HORSES WITH CFIDS

According to an article in The CFIDS Forum written by Alan Cocchetto, CFS is becoming a major veterinary problem. Cocchetto writes "Dr. Walter Tarello, who has several publications on CFS in various animal populations has reported on an emerging problem in veterinary medicine - one that was reported from England that suggested that CFS exists in the animal population and that preliminary epidemiological studies seem to confirm the zoonotic implications of CFS."

According to Tarello, CFS in animals seems to also involve staph infections. Does this explain some of the growing staph problems in people around the world?

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PETS WITH CFIDS/AIDS

Some of the most interesting research on Chronic Fatigue and Immune Dysfuncton Syndrome involves pets. Many people with CFIDS symptoms apparently have pets with similar symptoms. No one as far as we know, has done a study of the transmission of AIDS to pets, but based on the work of Thomas Glass, and the overlap of CFIDS and AIDS, such research would make a great deal of sense. Research by Glass, published in a Chronic Fatigue Syndrome publication, notes that "Throughout the recognized existence of Chronic Fatigue and Immune Dysfunction Syndrome, anecdotal reports have linked domestic animals with CFIDS, but no formal scientiflc studies were reported (1,2). Cats and dogs were implicated by their owners most frequently. The usual association with the presence of the animal in the household of a CFIDS patient, followed by the development of strange diseases or dysfunctions in the animal, many of which mimic CFIDS. The severity of the diseases often necessitated euthanasia. In a fewer number of cases, the onset of CFIDS in the patient was associated with an exposure to a domestic animal which was later found to show signs of CFIDS."

AIDS MEDICINE = NAZI MEDICINE

Today's story in The Baltimore Sun about an informal version of what is called "Directly Observed Therapy" (DOT) is chilling. We hope that the AIDS activists who have helped create this civil liberties mess are happy.

The next step will be to incarcerate people who don't cooperate. After all, they're public health threats, right?

AIDS IN PIGS (Should that ham sandwich be wearing a red ribbon?)

The CFIDS/AIDS-like epidemic of PRRS in pigs gets more and more interesting. Now that a ciguatera-like substance (a toxin associated with tropical fish) has been found in CFIDS patients, it would be interesting to know whether pigs with immune problems similar to those in people with CFIDS/AIDS also test positive for ciguatera. Since ciguatera is not destroyed by heat, a positive finding would suggest that there could be some serious problems ahead for the pork industry. Given that PRRS in pigs now involves some serious liver damage, it shouldn't be surprising if pigs test positive for the ciguatera-like substance found in CFIDS patients. How many Americans know that there is an AIDS-like epidemic in pigs all over the country? Maybe Jane Teas, the woman who suggested in 1983 that AIDS is caused by a DNA virus called African Swine Fever Virus may turn out to be on the money. Stay tuned. (By the way, her career was sidetracked for a number of years because she dared to suggest something that the HIV establishment didn't want to hear.)

FASTEN YOUR SEAT BELTS

Thanks to Andrew Sullivan and the San Francisco Chronicle, we now know that the appointment of Jerry Thacker to the presidential AIDS advisory council was not just an aberration. The situation is far more ominous. Here's a paragraph from the Chronicle's story by Carolyn Lochhead:

"'It is very clear that increasingly people within the Christian right and in the conservative movement are seeking to blame gay white men for the spread of the epidemic,' said A. Cornelius Baker, executive director of the Whitman-Walker Clinic in Washington, an AIDS treatment organization. 'Not only that, they are seeking to blame white gay men for the plight of African Americans in this disease. It is unacceptable.'"

THE RACIAL POLITICS OF AIDS

Rather than turning on gay men, African-American citizens should take a close look at the Chronic Fatigue Syndrome epidemic. There they will find millions of Americans who have an AIDS-like illness who are neither African-American nor gay. But they have the same basic illness as AIDS patients. That is the real story and the real scandal. It's all detailed in The Closing Argument.

CIGUATERA AND AIDS
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As CFIDS researchers and activists try to understand the role of ciguatera-like toxins in CFIDS, they would be wise to revisit the notion that AIDS and CFIDS are actually part of the same epidemic. What they may have shown is that AIDS and CFIDS have cytokines and cytotoxins in common. Both so-called different syndromes have a kind of dementia in common. Both are very serious illnesses involving major chronic inflammation. Both involve a dynamic virus capable of destroying the immune system, namely HHV-6.

Here is a helpful description from AIDS Treatment Update by Raffi Babakhanian of the role of cytokines in AIDS:

"Cytokines are proteins produced by many different cells of the immune system which act upon other cells. They attach to receptors on the outside of cells causing the target cell to produce a certain reaction, depending on the cell and the cytokine. Often the target cell produces other cytokines in response to the initial cytokine. This complicated relationship is called the cytokine network, and it is one of the most important ways that the immune system (which is distributed throughout the body) communicates and orchestrates appropriate responses to various challenges, including viruses, bacteria, fungi and even tumours. Most cytokines are produced by T-lymphocyte cells and to a lesser degree by monocytes and macrophages.

There is growing evidence that initial HIV infection disrupts the normal balance of cytokines by causing the levels of certain cytokines to rise. As the disease progresses to AIDS, the production of these cytokines declines whilst the production of another group of cytokines increases. Some scientists think that this change from one group of cytokines to the other group directly causes many of the symptoms associated with AIDS including wasting, lymphomas, neurological damage and dementia. Cytokine imbalances may also help HIV to target CD4 cells and the lymph nodes, leading to the progressive immunosuppression and the opportunistic infections that follow."

The recent announcement that Chronic Fatigue Syndrome patients test positive for a ciguatera-type toxin could radically change the political landscape of CFIDS/AIDS.

Research sponsored by the National CFIDS Foundation found a link between an exotic fish toxin called ciguatera and the AIDS-like condition of Chronic Fatigue and Immune Dysfunction Syndrome. Because ciguatera is taken very seriously by the medical establishment, it is hoped that the finding will settle once and for all the issue of whether Chronic Fatigue and Immune Dysfunction Syndrome is a real disease.

The NCF was able to enlist the help of Dr.Yoshitsugi Hokama, one of the world's leading experts on ciguatera poisoning.

The NCF issued the following press release:

Neurotoxin Discovered in Chronic Fatigue Syndrome

Needham, MA November 17, 2002 -- Research sponsored by the National CFIDS
Foundation was formally announced at the International Symposium on Toxins
and Natural Products in Okinawa, Japan on November 17-19, 2002 by Dr.
Yoshitsugi Hokama. The research, for the first time, discovered ciguatoxin,
a potent neurotoxin, in the blood of Chronic Fatigue Syndrome patients.

"Chronic ciguatera poisoning has already been suggested as a scientific
model for Chronic Fatigue Syndrome (CFS)," stated Dr. Hokama. Ciguatoxins
are potent, heat stabile, non-protein, lipophilic sodium channel activator
toxins and are recognized as some of the most potent biological toxins
known. They produce dramatic neurological manifestations, such as peripheral
sensory or motor symptoms (including paresthesias, pain, burning, tingling,
numbness), central symptoms such as headache, autonomic dysfunction and also
affect multiple body systems (gastrointestinal, immune, hepatic, cardiovascular)
and the muscles.

Many CFS patients in the study had higher levels of the toxin than the
patients with cancer, hepatitis or acute ciguatera poisoning.

Quantitative assay results range from 1:5, the lowest toxin level, to
1:160, the highest toxin level. All CFS samples gave titres of at least
1:20, with the majority of titres from 1:40 to 1:160.

Dr. Hokama presented his preliminary findings in a lecture titled "Acute
phase lipids in sera of various diseases: Chronic Fatigue Syndrome,
ciguatera, hepatitis, and various cancer with antigentic epitope resembling
ciguatoxin as determined with Mab-CTX."

Dr. Hokama is a Professor in the Department of Pathology at the John A.
Burns School of Medicine at the University of Hawaii at Manoa. He is a
world expert in the area of fish toxins with hundreds of peer reviewed
publications to his credit. Hokama developed the Membrane Immunobead Assay
test for patient sera, using a specific monoclonal antibody for ciguatera
toxin (Mab-CTX). His current research into Chronic Fatigue Syndrome and a
ciguatera toxin connection was funded by the National CFIDS Foundation's
research grant program.

Gail Kansky, President of the National CFIDS Foundation, said, "We believe
this to be a significant breakthrough. CFS, which has come to include
myalgic encephalomyelitis, is a very severe illness that has not received
adequate funding or appropriate medical attention. Although there are still
many unanswered questions and much work to be done, research efforts will
ultimately turn the tide in the understanding of this disease and allow
patients to receive appropriate medical therapies. We are indebted to Dr.
Hokama and his colleagues for providing this monumental first step."

For more information on this study or Chronic Fatigue Syndrome, please
contact:
The National CFIDS Foundation
103 Aletha Road
Needham, MA 02492
phone: 781-449-3535
fax: 781-449-8606



To learn more about CFIDS/AIDS, go to The HHV-6 Site and read The Closing Argument.

Here we will cover developments in the science and politics of CFIDS/AIDS.