Thursday, May 31, 2007
The rate of heart attacks (a.k.a. acute myocardial infarctions) was twice as high after anthrax vaccination [9.2 vs. 4.6 events per 100,000 persons/year]. Two related disorders, coded as "other acute and subacute form of ischemic heart disease" and "other forms of chronic ischemic heart disease" were more than twice as common after anthrax vaccination as before [18.8 vs. 7.1 total]. Click here to see the raw data.
Monday, May 28, 2007
|Medical Associations Investigate Anthrax Vaccine Trial that Sickened Dozens of Soldiers |
This is an update on the Israeli vaccine injury situation. The Israeli Medical Association's ethics bureau will investigate whether "volunteer" soldiers were actually given proper informed consent, guaranteed the most minimum risk as a result of their volunteer participation, and otherwise treated ethically as specified by the Helsinki Declaration. The Physicians for Humans Rights organization will also be investigating. Wouldn't it be wonderful if their US counterparts took the same initiative?
|w w w . h a a r e t z . c o m|
Last update - 01:15 28/05/2007
Secret IDF anthrax vaccine trial on soldiers to be investigated
By Yuval Azulai, Haaretz Correspondent
The Israel Defense Forces will provide the ethics bureau of the Israeli Medical Association with all the details of secret experimental anthrax vaccine trials it carried out on over 800 soldiers since 1999.
A committee will be established to probe whether the trials adhered to World Medical Association ethical requirements relating to human clinical trials as set out in the Helsinki Declaration.
The IMA probe will comprise specialists in infectious diseases, and members of the Israeli delegation to the Helsinki committee which devised the international standards for clinical trials on humans. Chairman of the IMA Ethics Bureau, Professor Avinoam Reches, said on Sunday that the probe's findings will be made public.
The Israel Medical Corps requested that the IMA investigate the experiments after Channel 2 television's current affairs program, Uvda, revealed earlier this month that dozens of participants still suffered unexplained medical symptoms.
Following the expose, the Defense Ministry and former IDF chief medical officer issued statements saying the experiment had been carried out because Iraq was expected to use spores of the deadly anthrax bacteria to attack Israel.
Israel did not possess sufficient quantities of the vaccine to field such an attack, and was therefore compelled to produce the vaccine rather than importing it.
Years after the receiving the experimental Israeli vaccine, soldiers continued to suffer unexplained skin tumors, severe lung infections, serious migraine headaches, bronchitis and even epilepsy symptoms.
However, the IDF did not take responsibility for their ongoing treatment at civilian medical centers, and they were not allowed to discuss the experiment under any circumstances despite its likely connection to their continuing health problems.
One of the soldiers who took part in the experiment told Uvda "They said that one group would receive the American vaccine, and the other group would receive the experimental Israel vaccine."
"They specifically explained to us that the vaccine is not dangerous and that we were not being injected with the actual virus, not even the dead virus. Instead, they said they would inject us with the altered DNA of the virus. They said it was very advanced," added the soldier.
The Ethics Bureau investigation committee will hear testimonies from Israel Medical Corps staff responsible for carrying out the secret experiments, as well as from soldiers who received the vaccine.
Israeli non-profit group Physicians for Human Rights has requested the soldiers' testimonies as well, in order to pressure the authorities to create an independent probe commission into the medical practices of the IDF and Defense Ministry.
Saturday, May 26, 2007
Women are Inordinately Harmed by Anthrax Vaccine
There is consensus regarding the fact that women have 2 to 3 times the rate of adverse reactions as men. Every study that has looked into this issue has found the same thing. The following four studies were done by 3 groups of different military researchers, and the last by CDC researchers: because Congress has asked that the role of gender be investigated with respect to adverse effects of the anthrax vaccine. The studies whose abstracts are listed below are all published since 2001, and are peer-reviewed articles in the medical literature. Two authors say this finding needs more study. Two authors say that the acute adverse reactions all resolved. However, if you read the complete studies, you will find that long-term active surveillance (by medical professionals asking questions or performing exams on study subjects) was not conducted in any of the studies, and the evidence that all reactions resolved is tenuous at best. Women also have more autoimmune disorders, in general, than men do.
1. Vaccine. 2001 Dec 12;20(5-6):972-8.
Anthrax vaccine: short-term safety experience in humans.
* Pittman PR,
* Gibbs PH,
* Cannon TL,
* Friedlander AM.
Division of Medicine, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, USA. firstname.lastname@example.org
Bacillus anthracis is the major terrorist and biological warfare agent of concern to civilian and military medical planners. The licensed anthrax vaccine, adsorbed (AVA) is believed to be an effective prophylactic medical countermeasure against this threat. Our objective in this report was to expand the safety database for this vaccine by assessing data on self-reported, short-term safety of AVA during more than 25 years of use, measured by local and systemic adverse events temporally associated with the administration of AVA. A minority of AVA recipients reported systemic and injection site reactions. Females reported a higher incidence of injection site and systemic adverse events than males. Data show a difference in incidence of local reactions between lots. A prospective, randomized, placebo-controlled study to actively examine reactogenicity is needed to more completely define the extent and nature of reactions associated with receipt of AVA in humans as well as to confirm the gender lot differences in local reaction rates.
2. J Occup Environ Med. 2003 Mar;45(3):222-33.
Analysis of adverse events after anthrax immunization in US Army medical personnel.
* Wasserman GM,
* Grabenstein JD,
* Pittman PR,
* Rubertone MV,
* Gibbs PP,
* Wang LZ,
* Golder LG.
Preventive Medicine Department, Tripler Army Medical Center, Honolulu, Hawaii, USA. email@example.com
A broad range of health effects in a cohort of 601 health care personnel, immunized with anthrax vaccine adsorbed (AVA) as a military occupational health requirement, were assessed to evaluate adverse events both qualitatively and quantitatively. Active surveillance showed that localized reactions were common and occurred more often in women than men. Five patients were reported to the Vaccine Adverse Event Reporting System, but only one event could be definitively attributed to immunization, a large localized reaction. Two separate cohort studies, one using nested data from a standardized health risk appraisal instrument and the other comparing rates of outpatient visits and hospitalizations, did not reveal significant differences between AVA-immunized and unimmunized individuals. Our findings suggest that AVA is relatively reactogenic but do not indicate serious adverse health effects due to immunization.
3. Vaccine. 2003 Oct 1;21(27-30):4399-409.
Using a structured medical note for determining the safety profile of anthrax vaccine for US soldiers in Korea.
* Hoffman K,
* Costello C,
* Menich M,
* Grabenstein JD,
* Engler RJ.
Military and Veterans Health Coordinating Board, 20420-0002, Washington, DC 20420-0002, USA. firstname.lastname@example.org
Selected military personnel are immunized with an FDA-licensed anthrax vaccine unless there are clinical contraindications. The objective of this analysis is to capture the experience of soldiers receiving anthrax vaccine to assist in better patient-provider communication and clarify the safety profile of the vaccine in this population as a quality-assurance initiative. Between August 1998 and July 1999, 2824 soldiers immunized against anthrax at one military clinic completed a structured medical note that was reviewed by a clinician. Female gender, prior vaccine-associated adverse events, and medication use were significantly related to higher reports of adverse events. All reported immediate consequences resolved.
4. Pharmacoepidemiol Drug Saf. 2007 Mar;16(3):259-74.
Short-term reactogenicity and gender effect of anthrax vaccine: analysis of a 1967-1972 study and review of the 1955-2005 medical literature.
* McNeil MM,
* Chiang IS,
* Wheeling JT,
* Zhang Y.
Anthrax Vaccine Safety Team, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. email@example.com
PURPOSE: In the 1960s, the Centers for Disease Control and Prevention (CDC) held the investigational new drug (IND) application for the anthrax vaccine and collected short-term safety data from approximately 16,000 doses administered to almost 7000 individuals. While some recent anthrax vaccine safety studies have suggested that women experience more injection site reactions (ISRs), to our knowledge the IND safety data were not previously examined for a gender-specific difference. METHODS: We identified and analyzed a subset of the IND study data representing a total of 1749 persons who received 3592 doses from 1967 to 1972. Original data collection forms were located and information extracted, including: vaccine recipient's name, age at vaccination, gender, dose number, date of vaccination, lot number, grading of ISR, presence and type of systemic reactions. Overall and gender-specific rates for adverse reactions to anthrax vaccine were calculated and we performed a multivariable analysis. RESULTS: We found an ISR was associated with 28% of anthrax vaccine doses; however, 87% of these were considered mild. Systemic reactions were uncommon (<1%) and most (70%) accompanied an ISR. Our dose-specific analysis by gender found women had at least twice the risk of having a vaccine reaction compared to men. Our age-adjusted relative risk for ISR in women compared to men was 2.78 (95%CI: 2.29, 3.38). CONCLUSIONS: Our results for both overall and gender-specific reactogenicity are consistent with other anthrax safety studies. To date, possible implications of these gender differences observed for anthrax and other vaccines are unknown and deserve further study.
Soldiers from every other country that used anthrax vaccine have had medical problems, although information is limited
Meryl Nass, MD
May 26, 2007
Dozens of Israeli soldiers who volunteered to take part in classified anthrax vaccine experiments years ago are reportedly still ill as a result, according to Israeli media. Here’s the article:
British authorities have claimed that 50% of troops accepted the vaccine voluntarily.1 But in one study of voluntary vaccinations, only 21% of the soldiers offered vaccinations completed the four dose series.2 The authors concluded, “Although the old vaccine is considered safe, the number of adverse reactions and incapacity reported by a military medical unit was unexpected.” Another study at five Royal Air Force bases found that only 4 to 22 per cent of those volunteering for anthrax vaccinations chose to complete all four doses.3
A study of veterans and Gulf War illness symptoms found that soldiers who received anthrax vaccine for the Gulf War were 1.5 times as likely to report chronic Gulf War illness as those who did not, and that those who received anthrax vaccine for the Bosnia deployment were over 3 times as likely to report a similar chronic illness.4
Some British troops believe anthrax vaccine contributed to birth defects in offspring:
“Anthrax vaccine inquiry soldiers demand
02 Mar 2004 - 0:00 PDT
UK soldiers have asked for an inquiry into anthrax vaccines after several babies were born with defects.
Spokesman for the National Gulf Veterans and Families Association Charles Plumridge said he had received a number of calls 'from mothers and husbands whose wives are now pregnant and are worried their babies may be born with some form of defect'.
The association has written to British Prime Minister Tony Blair demanding a public inquiry into vaccinations given to soldiers before the US-led war in Iraq was launched last March.
According to the group, since the war, pregnant women treated at the 33rd Military Field Hospital in Gosport, southern England, have suffered two miscarriages, three premature births, one still birth and a forced termination because a foetus was not developing properly.
In each of the seven cases, at least one of the parents received a vaccination against anthrax.
In some of the cases, babies suffered limb defects or skin problems, according to the association.
A spokeswoman for Britain's Ministry of Defence said the anthrax vaccinations were voluntary.
'Congenital disabilities are unfortunately common, affecting about one in 33 live births', said the spokeswoman.
She added that a number of studies had shown a high rate of congenital disabilities in children of veterans of the 1991 Gulf War, but that these studies were not connected to vaccination programs.”
Canada’s Department of National Defense hired contractor Goss-Gilroy Inc. to study risk factors and Gulf War Illnesses.5 The 1998 study found that soldiers who had received anthrax and / or plague vaccinations during the first Gulf War deployment were 1.92 times as likely to suffer from chronic fatigue as those who did not receive these biological warfare vaccines.
In 2000, a decision by military judge Guy Brais ended Canada’s mandatory anthrax vaccination program. His ruling stated,
“It was sufficient and the court is satisfied on the balance of probabilities that the defense has successfully demonstrated that the anthrax vaccine contained in lot 020 was unsafe and hazardous and could be responsible for the important symptoms reported by so many persons who received that vaccine…
In those circumstances, the court concludes that the accused's right to life, liberty and security of the person in section 7 of the Charter of Rights and Freedoms were infringed. And as the court stated earlier, the government, through its Department of National Defense and the Canadian Forces, could never be justified to impose inoculation of soldiers with an unsafe and dangerous vaccine as a limit of their rights under section 7.” 6
Since the Afghanistan war began in 2002, Canadian troops have not even been offered voluntary anthrax vaccinations: 7
March 5, 2007
No anthrax vaccine for Afghanistan troops: DND
By DENE MOORE
MONTREAL (CP) - Canadian military officials say they're not considering a mandatory anthrax vaccination campaign even though the U.S. military has made the controversial inoculation mandatory for its soldiers serving in Afghanistan.
As of April 30, all U.S. soldiers heading to Afghanistan will have to be immunized against anthrax.
The U.S. Department of Defence has announced that all branches of its military will have to inoculate service members heading to high threat areas, including Iraq, Afghanistan and the Korean Peninsula.
But Gloria Kelly, spokeswoman for the Canadian Forces health services group, said Monday that the Department of National Defence is not considering the same.
"At this point in time, we are not requiring our people to have anthrax vaccinations nor are we considering it," Kelly said from Ottawa.
Both the Canadian and U.S. militaries ceased mandatory anthrax immunizations after questions arose about the safety and efficacy of the vaccine.
The U.S. army continued to offer a voluntary vaccination but only about half of U.S. soldiers signed on.
The U.S. Food and Drug Administration has since declared the anthrax vaccine safe and effective, opening the door to the mandatory program south of the border.
"The anthrax vaccine will protect our troops from another threat - a disease that will kill, caused by a bacteria that already has been used as a weapon in America, and that terrorists openly discuss," Dr. William Winkenwerder Jr., assistant secretary of defence for health affairs, said in a U.S. defence department statement announcing the program.
"The threat environment and the unpredictable nature of terrorism make it necessary to include biological warfare defence as part of our force protection measures."
In little more than six weeks, all U.S. soldiers heading to Afghanistan will have to be immunized against anthrax, a bacterial infection that commonly occurs in domesticated animals.
Anthrax has not been used in combat but five people died and 17 were sickened when anthrax spores were sent through the U.S. mail in the wake of the Sept. 11, 2001, terrorist attacks.
Dr. Ron Wojtyk, of Canadian Forces health services, said the threat of anthrax exposure in Afghanistan is not sufficient enough to make the vaccine mandatory.
Wojtyk said the U.S. is deployed in areas where the threat is more pressing, such as Iraq.
"If we deploy to an area where there is a threat of anthrax or possible release on a bioterrorist type of scenario, then there would be an order for anthrax and it would be mandatory," Wojtyk said Monday.
Canada has about 2,500 troops in southern Afghanistan as part of NATO's International Security Assistance Force.
During the 1991 Gulf War western troops were immunized against anthrax.
The Canadian military received special permission from Health Canada to use the vaccine developed for the U.S. Department of Defence, although it was not approved for use by the general public.
Despite concerns about the manufacturer and possible adverse side effects, in the spring of 1998, on the heels of a similar directive within the U.S. military, the Canadian Forces made the anthrax immunization mandatory for troops serving in Kuwait. Many soldiers refused the inoculation, citing concerns of a link with so-called Gulf War syndrome. Canada later discontinued the vaccination.
The U.S. Department of Defence, at the behest of a U.S. district court, discontinued in October 2004.
Nearly three quarters of soldiers vaccinated prior to deployment to Afghanistan suffered severe acute reactions, according to Australian defense documents released in early 2004.8 Yet, asked on TV about the safety of the anthrax vaccine, Australian Minister of Defense Robert Hill had claimed two months earlier that, “there hasn't been any adverse reactions, let alone extreme reactions.” 9
No reports of the vaccinated soldiers’ subsequent health status have been provided to the public.
“The Australian Medical Association has called upon the military to prove the vaccination is safe. ‘If they have that data, the medical profession in Australia would very much like to see it,’ the Association's president Kerryn Phelps told Australian Broadcasting Corporation radio.” 10
"Anthrax vaccine serious side-effects kept from soldiers who were vaccinated
21 Feb 2004 - 0:00
Australian authorities vaccinated all its soldiers against anthrax before they went to Iraq. What it did not do, however, was to tell them that most of its soldiers who returned from Afghanistan previously, got ill from taking the same vaccine.
Thank God the soldiers sent to Iraq did not have the unusual side effects the previous soldiers had had.
Most of the Australian troops sent to Afghanistan in 2001 became ill, said the Australian government.
Officials are saying they did not tell the soldiers bond for Iraq because they did not want to make them anxious. They also said that they did not expect the soldiers this time round to suffer any side-effects.
75% of the soldiers sent to Afghanistan became ill as a result of taking the Anthrax vaccine. Confidential papers were released to an Australian newspaper under Freedom-of-Information Rules.
The soldiers experienced swelling, a high level of pain and flu-like symptoms as well. They never found out what caused the side-effects, suspended the vaccination programme for several weeks and then resumed it.
Australian military doctors have suggested that other factors could have contributed to the side-effects felt in Afghanistan. The soldiers were working at constantly changing altitudes, they had high physical workloads and the temperatures fluctuated a great deal.
In 2003, the authorities still went ahead and vaccinated all their troops sent to Iraq, even though they knew what had happened to their troops who had taken this vaccine before. The authorities did not even know what had caused the side-effects.
In order to demonstrate faith in the vaccine, Robert Hill, Australia's Defence Minister, vaccinated himself just before the troops were sent to Iraq.
About 40 service people were sent back from Iraq because they refused to be jabbed (vaccinated). They have not been disciplined.
So far, no unusual side-effects have been reported since the troops came back from Iraq.
'We were in a position where all we would have been able to tell them was that there had been a problem,' Air Commodore Tony Austin told reporters.
'We had not been able to identify a cause from that and we had absolutely no evidence to suggest that we were likely to see that again, based on overseas experience and our own experience when we reinstituted the programme in Iraq. So, I think to have advised people of that would have been quite counterproductive. I think that would have increased anxiety levels amongst our people.'
Opposition party defence spokesman, Chris Evans said 'The defence department hasn't been honest with the troops, hasn't been honest with the parliament, and the minister needs to provide answers as to what's gone on here."
France did not vaccinate its troops for the first Gulf War, and has a low incidence of Gulf War illness in its veterans. An interesting, but brief, article was published by Reuters about this in 2000 but there was never any follow-up. Go to the next page for the article:
2 Hayes SC and World MJ. Adverse reactions to anthrax immunisation in a military field hospital. J Royal Army Med Corps. 2000 Oct;146(3):191-5.
3 Enstone JE, Wale MCJ, Nguyen-Van-Tam JS et al. Adverse medical events in British service personnel following anthrax vaccination. Vaccine 2003; 21:1348-54.
4 Unwin C, Blatchley N, Coker W et al. Health of UK servicemen who served in Persian Gulf War. Lancet 1999: 353: 169.
5 This study was posted on the Canadian Department of National Defense website from 1998 for several years but is no longer online. The study has not been published. This author has a copy, obtained via download.