Posted on 10/08/2001 5:23:57 PM PDT by captain11
Sole Source of Anthrax Vaccine Isn't a Source at All Meant to be the source of the vaccine to be used to immunize the military from the deadly anthrax disease, Michigan's BioPort Corporation, the sole supplier of anthrax vaccine to the military has not produced a single dose since 1998, when it bought the plant from the state, according to Saturday's New York Times. Writing in the Times, correspondent Stephen Kinzer reports that BioPort has been plagued with problems from the very beginning, including poor documentation and improper procedures in the room where the vaccine was packaged, according to FDA inspectors. While the company says it hopes finally to begin producing anthrax this year it still must pass another FDA inspection, which has yet to be scheduled.
BopPort's problems are well known by the government. Last year, Arkansas GOP Senator Tim Hutchinson called the company's record "an unmitigated disaster," noting that its failures were "costing the American taxpayer millions and millions of dollars and jeopardizing the safety of our troops who we're not able to provide that anthrax vaccination." The company is not without its sympathizers, however. "There's a lot of criticism of BioPort," Tara O'Toole, deputy director of the Center for Civilian Biodefense Studies at Johns Hopkins University told the Times. "But to be fair, there's also a lot of talk that the Defense Department significantly underfunded the whole effort and didn't give it the priority it deserved." "In retrospect," O'Toole added "the whole notion of turning this over to a new contractor instead of an established pharmaceutical company looks questionable."
While BioPort is working frantically to get into production, the fact that there is at present no source in this country of a vaccine that could mean life or death to Americans in the event of an anthrax attack is a critical one, especially since many experts say that if terrorists launch a biological attack using biological agents, they would most likely use anthrax. The Times reveals that even though anthrax is reportedly hard to produce and spread in large doses, any enemy that was able to do so could inflict horrendous damage on their targets. "A 1993 government study found that spraying just 220 pounds of aerosol anthrax over Washington could kill up to three million people," the Times reported, noting that Osama bin Laden has also taken an interest in chemical and biological warfare. "It's a good bio-terror weapon and even better for biological warfare, and it's lying on the ground in places like Afghanistan" William Dietrich, an assistant professor at Harvard Medical School told the Times. Dietrich, who is researching the anthrax bacterium added. "If you have a collection of soldiers you want to kill without infecting your own population or soldiers anthrax has good properties with regard to that. If you can produce it and disperse it on a battlefield, you can kill a lot of people very quickly. It's a very terrible, high-fatality kind of illness that we don't have enough tools in our arsenal to stop." The Times says that should the company finally pass its next FDA inspection and can resume production, the first several million doses will go solely to the military. The Defense Department is BioPort's sole customer, spending $126 million in the plant over the last decade, according to the Times. The military plans to immunize all 2.4 million active and reserve troops against anthrax but have so far managed to begin immunizing only about 500,000, mostly those in the Persian Gulf. Anybody else will simply have to wait, scarce comfort at a time when an anthrax attack by terrorists remains a real possibility.Phil Brennan, NewsMax.com
The only laboratory in the U.S. capable of making crucial anthrax vaccine hasn't been able to produce a single dose of the vitally needed immunilogical substance in the face of a potential bioterror attack using deadly anthrax agents.
Monday October 8, 2001
Fuad El-Hibri – Chairman and CEO of BioPort.
Yes, yes, he's born in Germany and is an American citizen, but it scares the sh!t out of me to have him in charge of all Anthrax Vaccine. Especially when he has screwed it up badly.
So9
P.S. I thought I read earlier that some Naval Academy guy had a hqand in this company. What happened to him?
Yikes!!! bin Laden's money connections are with Citicorp!
| there is at present no source in this country of a vaccine that could mean life or death to Americans in the event of an anthrax attack
Given the side-effects track record of this vaccine, there is no way we would ever conduct a mass innoculation program on the public. |
DANGEROUS LIAISONS: Even though the family has disowned Osama bin Laden, bankers and business associates said they are reconsidering links to the group
AP
MANAMA, BAHRAIN
Respected across the Middle East, the Saudi Bin Laden Group renovated Islam's holiest sites, helped build the skyline in Saudi Arabia's capital -- and forged ties with the kingdom critical to its business.
But since Sept. 11, the business connections so carefully nurtured by the family have suddenly been threatened.
The family has disowned and repeatedly disavowed Osama bin Laden, the main suspect behind the world's worst-ever terrorist assault. Yet some of the Bin Laden Group's international bankers and business associates said they are reconsidering or even cutting their ties.
Inside the Saudi Arabian kingdom are the first signs of uneasiness over the royal family's decades-old relationship with the bin Ladens.
There is no evidence of financial links between Osama and the Bin Laden conglomerate, and it is widely accepted in the kingdom that his company ties are broken -- a necessity to ensuring the royal favor needed to secure prestigious contracts.
But some global businesses aren't taking any chances their images could be damaged.
Cadbury Schweppes, the London-based beverage and candy maker, has severed ties with a Saudi distributor owned by a Lebanese holding company in which the bin Ladens have a minority stake. Cadbury Schweppes said through a spokeswoman, Dora McCabe, that the Sept. 11 attacks prompted it to speed up an earlier decision to cut ties because of slow sales. Asked why, she said: "I think it's understandable."
Michael Walker, chief executive of Multitone wireless networking of Britain, suspended dealings with Baud Telecommunications, a Bin Laden Group subsidiary, after the terrorist attacks.
"At times like this, businesses such as ours ... have a duty to act with total integrity," Walker said, adding the company does "very little" of its business in Saudi Arabia.
The Saudi Bin Laden Group did not respond to several requests for comment made through telephone calls and a fax to a secretary in the company's headquarters in Jiddah. About a dozen of Osama's 53 siblings work in the conglomerate, which has US$3 billion to US$5 billion in annual revenue and businesses including mining and telecommunications.
At Citigroup, which provides banking services to the Bin Laden Group, spokeswoman Susan Weeks wouldn't elaborate on specific banking ties. But, she said: "Given the events of the past two weeks, we will be monitoring the situation closely."
The Dutch ABN Amro bank, which owns 40 percent of a Saudi bank that has counted the Bin Laden Group among its clients for seven decades, says it has no evidence of wrongdoing.
"If there is new information regarding a client which would lead us to reevaluate the relationship or review the relationship then we will not hesitate to do so," said ABN spokesman Jochem van de Laarschot.
Chas Freeman, Jr., a former US ambassador to Saudi Arabia, said he's heard that companies that have "had very long and profitable relationships are now running for public relations cover."
He attributed that to ignorance, noting the bin Laden remains "a very honored name" in the kingdom.
Freeman, now board chairman of Projects International Inc, a Washington company that helps arrange global business deals, says he's discussing proposals with the Bin Laden Group -- and that won't change.
Since its start in the 1930s by Osama bin Laden's father, Yemeni immigrant Mohammed bin Laden, the Saudi Bin Laden Group has built airports, hotels, palaces, power plants, roads and mosques. It carried out massive renovations at Mecca and Medina, the holiest sites in Islam, in the 1980s, and built the pyramid-shaped Faisaliah Center, a Riyadh skyscraper that opened last year.
It also restored Al Aqsa mosque in Jerusalem, the third-holiest site, after a 1969 fire.
Osama bin Laden studied economics and worked in the company before making jihad, or holy war, his career.
After he was caught smuggling weapons from Yemen in the early 1990s, Saudi Arabia stripped him of his citizenship and froze his assets in the kingdom.
Estimates of his share of the inheritance from his father's 1968 death, which was distributed 20 years later, begin at US$50 million.
Though striving to extend its business globally, the bulk of the Bin Laden Group's business is inside the kingdom. A lack of faith in the company at home ultimately could prove more devastating than losing overseas business.
Turki al-Sudairy, editor in chief of the English-language Riyadh Daily, which often reflects government views, took the unusual step of distancing the monarchy from the bin Ladens.
In a recent column, he noted that the Bin Laden Group had fared extremely well in the Mecca and Medina renovations.
"It was the Saudi government which planned and executed the expansion of the Holy Mosques and offered [the Bin Ladens] those exaggerated contracts," the influential editor wrote. Industry analysts estimate the project's total value to the Bin Laden Group at perhaps US$10 billion.
It appeared the views expressed in al-Sudairy were his own. Even so, such public grumbling is rare in the kingdom and could foretell shifting policy winds.
Tim Metz, a New York-based spokesman for the Bin Laden family on matters separate from the company, dismissed the notion the monarchy might want to distance itself from the bin Ladens. Metz noted the kingdom had evacuated 22 bin Ladens from the US after the Sept. 11 attacks because some feared reprisals by Americans.
BAD PUN ALERT!!!!
Not that I know of. The NewsMax story just came out today, and today marked the transition to a new level of seriousness in the Florida anthrax situation. This may be a FReep scoop, AFAIK.
http://jama.ama-assn.org/issues/v281n18/ffull/jst80027.html#a8
In experimental animals, antibiotic therapy during anthrax infection has prevented development of an immune response.28, 62 This suggests that even if the antibiotic-treated patient survives anthrax infection, risk for recurrence remains for at least 60 days because of the possibility of delayed germination of spores. Therefore, the working group recommends that antibiotic therapy be continued for 60 days, with oral therapy replacing intravenous therapy as soon as a patient's clinical condition improves. If vaccine were to become widely available, postexposure vaccination in patients being treated for anthrax infection might permit the duration of antibiotic administration to be shortened to 30 to 45 days, with concomitant administration of 3 doses of anthrax vaccine at 0, 2, and 4 weeks.
Submitted by
DOCTORS FOR DISASTER PREPAREDNESS
2509 N. Campbell
Box 272
Tucson AZ 85719
(520) 325-2680
Hearings on
U.S. DEPARTMENT OF DEPARTMENT OF DEFENSE
ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
March 24, 1999
Doctors for Disaster Preparedness is a national organization of physicians and scientists founded in 1983. We are dedicated to increasing public awareness of threats from both man-made and natural disasters, and to promoting life-saving preparedness including homeland defense.
We recognize a serious threat of biological and chemical warfare, as well as the potential for use of other weapons of mass destruction. The Department of Defense has responded to this threat by implementing the Anthrax Vaccine Immunization Program (AVID) to inoculate 2.4 million military personnel.
But the threat is not limited to military personnel engaged in warfare. Last year, the CDC received reports of a series of bioterrorist threats of anthrax exposure to domestic civilian targets. These were in the form of letters purportedly contaminated with the bacillus, or in telephone threats about contaminated ventilation systems.
Because of the potential exposure of civilians, we are concerned that the Anthrax Vaccine Immunization Program will be expanded to other diseases or contaminants, and used as a model for the mandatory vaccination of civilian children as well as adults
The Assistant Secretary for Defense for health Affairs, Dr. Sue Bailey, states that the AVID is "not primarily a medical program." Yet the DOD is administering to our soldiers a medical procedure which raises the following scientific and medical concerns:
1. VACCINE NO SUBSTITUTE FOR OTHER PROTECTIONS
Because of the wide diversity of agents that could be used, no single vaccine or combination of vaccines and antidotes is sure to be effective: thus, there is no substitute for shelter and adequate protective gear. We believe that both military and civilian populations should have access to the type of NBC shelters that are standard in Swiss homes.
2. LACK OF CLINICAL STUDIES
While anthrax has long been recognized as a serious threat, having been weaponized by a number of potential adversaries, currently available anthrax vaccine falls far short of optimal. The anthrax vaccine was licensed in 1970 on the basis of one published study, with only five inhalation cases.
Animal studies have shown survival rates as low as 4% and as high as 100% after anthrax challenge. A 1994 Staff Report for the Committee on Veterans Affairs is quoted as saying that ``its [the vaccine's] safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established'' (Lancet 351:657, 1998, quoting a ProMED-mail posting). The one U.S. producer, Michigan Biologic Products Institute (now Bioport Corp.), would have closed last year except for a last-minute plea by the Pentagon, because of serious concerns about its manufacturing practices.
3. MEDICAL EFFICACY IN DOUBT
Textbooks of military medicine and The Medical Letter (40:52-53, 1998) state that the anthrax vaccine is ``safe and effective.'' The British secretary of state for defence was vaccinated on camera in an effort to convince service personnel and the public of the vaccine's safety. However, several epidemiologists at the University of Bristol described the state of current thinking as one of ``clinical equipoise'' and recommended randomizing troops to receive or not receive vaccine (Br Med J 316:1322, 1998).
Certainly, there is a need to develop a better vaccine. Harrison's Principles of Internal Medicine states: ``The current vaccines are impure and chemically complex, elicit only slow-onset protective immunity, provide incomplete protection, and cause significant adverse reactions.''
4. VACCINE NO DEFENSE AGAINST NEW STRAINS OF ANTHRAX
The vaccine is not completely protective against all natural strains of Bacillus anthracis. An additional threat in the context of biological warfare is the potential use of genetically engineered strains, against which both vaccine and antibiotics may be ineffective (CMAJ 158:633, 1998). Russian scientists have already produced vaccine resistant strains
5. POTENTIAL IMPACT ON IMMUNE SYSTEM & LINK TO GULF WAR SYNDROME
Anthrax vaccine has been suggested as a possible cause for the Gulf War Syndrome. While evidence that anthrax vaccine alone can cause such a syndrome has not been forthcoming, it is possible that the combination of agents may have induced unexpected adverse changes in the immune response. Additionally, pertussis vaccine may have been administered as an adjuvant to increase the immune reactions to other vaccines, especially anthrax (Jamal GA: "Adverse Drug React"Toxicol Rev 17:1-17, 1998). There is a report that the anthrax-pertussis combination induced ``severe loss of condition and weight'' in animals (Nature 390:3, 1997).
6. POOR RECORD KEEPING & FOLLOW UP STUDIES
Fear and mistrust are fueled by poor record-keeping about chemical exposures and vaccines in the Gulf War. There are no adequate records of recipients of special immunizations not in general use (anthrax and botulinum) (Wegman DH et al.: Am J Epidemiol 146:704-711, 1997). The British defence ministry has also admitted that ``medical record-keeping in the Gulf was not satisfactory,'' according to researcher Alan Silman of the University of Manchester (Nature 384:604, 1996). Moreover, ``the MOD [ministry of defence] suffers from an excessive culture of secrecy'' (Nature 390:3- 4, 1997).
7. EXPANSION OF MANDATORY VACCINES TO CIVILIAN SECTOR
The questions raised about adverse reactions due to vaccine cocktails are highly pertinent in the civilian sector, now that such a large number of vaccines are mandated for administration to children, with exclusion from school and even charges of child neglect or abuse as penalties for noncompliance.
RECOMMENDATIONS & CONCLUSION
Because of the limited efficacy of the anthrax vaccine, prevention of exposure with shelters and protective gear remains indispensable. In addition to improved vaccines with limited toxicity, the Department of Defense should consider more advanced and less invasive tools, such as decontamination agents.
For example, a material developed by D. Craig Wright of Novavax, Inc, which may be able to rapidly destroy a wide variety of dangerous bacteria and viruses, including anthrax spores. The material, called BCTP, is made from water, soybean oil, Triton X 100 detergent, and the solvent tri-n-butyl phosphate. Laboratory mice and rats thrive when fed the material. Rapid inactivation of anthrax bacteria and spores combined with low toxicity could make BCTP a promising candidate as a broad-spectrum post exposure decontamination agent.
In summary, better passive protection measures and expanded research into vaccines are urgently needed. At present, mandatory vaccination of all troops with the available anthrax vaccine has raised a number of well-founded concerns that should be addressed openly. Our organization is available for any questions or concerns of this committee.
Department of Defense
Office of the Inspector General -- Audit
Contracting for Anthrax Vaccine -- Report No. D-2000-105 (PDF)
Date: March 22, 2000
http://www.dodig.osd.mil/audit/reports/fy00/00105sum.htm
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This reporter seems to be suggesting that this vaccine is a treatment for anthrax. I don't think that's true. So far as I can tell, common antibiotics can be used to prevent the disease from appearing in those who have been exposed (assuming they are treated in time).