Vaccines in the short-term may accelerate the transition from subclinical MS to overt autoimmunity in patients with existing disease

Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases

JAMA Neurol. Published online October 20, 2014. doi:10.1001/jamaneurol.2014.2633

Importance  Because vaccinations are common, even a small increased risk of multiple sclerosis (MS) or other acquired central nervous system demyelinating syndromes (CNS ADS) could have a significant effect on public health.

Objective  To determine whether vaccines, particularly those for hepatitis B (HepB) and human papillomavirus (HPV), increase the risk of MS or other CNS ADS.

Design, Setting, and Participants  A nested case-control study was conducted using data obtained from the complete electronic health records of Kaiser Permanente Southern California (KPSC) members. Cases were identified through the KPSC CNS ADS cohort between 2008 and 2011, which included extensive review of medical records by an MS specialist. Five controls per case were matched on age, sex, and zip code.

Exposures  Vaccination of any type (particularly HepB and HPV) identified through the electronic vaccination records system.

Main Outcomes and Measures  All forms of CNS ADS were analyzed using conditional logistic regression adjusted for race/ethnicity, health care utilization, comorbid diseases, and infectious illnesses before symptom onset.

Results  We identified 780 incident cases of CNS ADS and 3885 controls; 92 cases and 459 controls were females aged 9 to 26 years, which is the indicated age range for HPV vaccination. There were no associations between HepB vaccination (odds ratio [OR], 1.12; 95% CI, 0.72-1.73), HPV vaccination (OR, 1.05; 95% CI, 0.62-1.78), or any vaccination (OR, 1.03; 95% CI, 0.86-1.22) and the risk of CNS ADS up to 3 years later. Vaccination of any type was associated with an increased risk of CNS ADS onset within the first 30 days after vaccination only in younger (<50 years) individuals (OR, 2.32; 95% CI, 1.18-4.57).

Conclusions and Relevance  We found no longer-term association of vaccines with MS or any other CNS ADS, which argues against a causal association. The short-term increase in risk suggests that vaccines may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease. Our findings support clinical anecdotes of CNS ADS symptom onset shortly after vaccination but do not suggest a need for a change in vaccine policy.

Continue reading “Vaccines in the short-term may accelerate the transition from subclinical MS to overt autoimmunity in patients with existing disease”

Mandatory HPV vaccination is unwarranted and unwise

2008 study posted for filing

Contact: Amy Molnar
journalnews@bos.blackwellpublishing.net
201-748-8844
Wiley-Blackwell

Article explores how mandate does not represent public health necessity

Washington, D.C. – November 12, 2008 – The HPV vaccine, sold as Gardasil in the U.S., is intended to prevent four strains of the human papillomavirus, the most common sexually transmitted infection in the world. The vaccine also prevents against cervical cancer. While the vaccine represents a significant public health advance, a new article in the Journal of Law, Medicine & Ethics suggests that it is premature for states to currently mandate the HPV vaccine as a condition for school attendance.

Gail Javitt, J.D., M.P.H., Deena Berkowitz, M.D., M.P.H., and Lawrence O. Gostin, J.D., LL.D., review the scientific evidence supporting Gardasil’s approval and the legislative actions in the states that followed and raise several concerns about state mandates for HPV vaccination.

To begin with, they assert that Gardasil is relatively new and long-term safety and effectiveness in the general population is unknown. Outcomes of those voluntarily vaccinated should be followed for several years before mandates are imposed.

Additionally, they argue that the HPV vaccine does not represent a public health necessity of the type that has justified previous vaccine mandates, so Constitutional concerns are raised. It is possible that state mandates could lead to a public backlash that will undermine both HPV vaccination efforts and existing vaccination programs.

Finally, they note that the economic consequences of mandating HPV are significant and could have a negative impact on financial support for other vaccines as well as other public health programs. Such consequences should be evaluated before the vaccine is mandated.

“HPV will not be the last disease that state legislatures will attempt to prevent through mandatory vaccination,” the authors conclude. “This is a good time to reevaluate the criteria that should be used to mandate vaccination of children as a condition of school attendance.”

 

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This study is published in the Journal of Law, Medicine & Ethics. Media wishing to receive a PDF of this article may contact journalnews@bos.blackwellpublishing.net.

Gail Javitt is affiliated with the Berman Institute of Bioethics at Johns Hopkins University and can be reached for questions at gjavitt1@jhu.edu.

A leading peer-reviewed journal for research at the intersection of law, health policy, ethics, and medicine, Journal of Law, Medicine & Ethics is THE authoritative source for health law teachers, practitioners, policy makers, risk managers, and anyone involved with the safe, equitable, and ethical delivery and promotion of the public’s health.

Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley’s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit www.wiley-blackwell.com or http://interscience.wiley.com

44th Health Research Report 25 NOV 2008 – Reconstruction

 

Editors Top Five:

1. What cures you may also ail you: Antibiotics, your gut and you

2. Roche ordered to pay $13M to users of acne drug

3. Potassium loss from blood pressure drugs may explain higher risk of adult diabetes

4. 14 drugs identified as most urgently needing study for off-label use, Stanford professor says

5. Pregnancy study finds strong association between two antidepressants and heart anomalies

In this issue:

1. Many doctors plan to quit or cut back: survey

2. Obese kids’ artery plaque similar to middle-aged adults

3. Evolution’s new wrinkle: Proteins with cruise control provide new perspective

4. Mandatory HPV Vaccination Is Unwarranted and Unwise

5. Plastic surgeons warn of malnutrition in body contouring patients

6. Soluble fiber, antispasmodics and peppermint oil should be used to treat IBS

7. Arsenic linked to cardiovascular disease at EPA-regulated drinking water standards

8. Calcium may only protect against colorectal cancer in presence of magnesium

9. Study helps clarify role of vitamin D in cancer therapy

10. What cures you may also ail you: Antibiotics, your gut and you

11. Indigo ointment may help treat patients with psoriasis

12. Broccoli may lower lung cancer risk in smokers

13. Exercise increases brain growth factor and receptors, prevents stem cell drop in middle age

14. Garlic chemical tablet treats diabetes I and II

15. Fake TV News: Widespread and Undisclosed

16. Red, red wine: How it fights Alzheimer’s

17. Roche ordered to pay $13M to users of acne drug

18. Melatonin may save eyesight in inflammatory disease

19. 14 drugs identified as most urgently needing study for off-label use, Stanford professor says

20. Stomach ulcer bug causes bad breath

21. Mineral oil contamination in humans: A health problem?

22. Pregnancy study finds strong association between two antidepressants and heart anomalies

23. Potassium loss from blood pressure drugs may explain higher risk of adult diabetes

24. Feed a cold, feed a fever: Research shows calorie cut makes it harder to fight flu

25. Pain is in the eyes of the beholder

26. Estrogen therapy could be dangerous for women with existing heart risk

Health Technology Research Synopsis

44th Health Research Report 25 NOV 2008

Compiled By Ralph Turchiano

www.healthresearchreport.me www.vit.bz

www.youtube.com/vhfilm http://www.facebook.com/engineeringevil

www.engineeringevil.com

 

Higher anaphylaxis rates after HPV vaccination: ” significantly higher – 5 to 20 fold – than that identified in comparable school-based vaccination program”

2008 study posted for filing

Contact: Kim Barnhardt
kim.barnhardt@cma.ca
613-731-8610 x2224
Canadian Medical Association Journal

Despite higher rates, HPV vaccine safe for use

OTTAWA, ONTARIO, CANADA – The estimated rate of anaphylaxis in young women after human papillomavirus (HPV) vaccination was significantly higher – 5 to 20 fold – than that identified in comparable school-based vaccination programs, according to a study published in CMAJ http://www.cmaj.ca/press/179_6_525.pdf. However, the overall rates of anaphylaxis were low with no associated serious lasting effects.

In a study of 114,000 women, a team of Australian researchers found 12 suspected of anaphylaxis, and confirmed 8 of these, in a 2007 vaccination program in New South Wales, Australia. Symptoms included difficulty breathing, nausea and rashes.

Dr. Julia Brotherton and colleagues postulate that reasons for an increased rate of anaphylaxis may include possible allergic reaction to the vaccine components, enhanced adverse event surveillance, higher rates of anaphylaxis in women from midadolescence compared with men, and an apparent increase in incidence of anaphylaxis in Australia.

The estimated rate of anaphylaxis following HPV vaccination was 2.6 per 100,000 doses administered compared with a rate 0.1 per 100 000 doses administered in a 2003 school-based meningococcal C vaccination program.

HPV vaccination programs will begin this fall in the United Kingdom and other European countries as well as in parts of Canada and the United States.

Dr. Brotherton stresses “the importance of good training for staff administering vaccines in school or other settings in the recognition and management of suspected anaphylaxis and its reporting.” They conclude that anaphylaxis following the HPV vaccine is rare and vaccine programs should continue.

Anaphylaxis is a rare but serious adverse event and highlights the importance of vaccine safety studies after vaccine licensing and careful management of reactions in immunization clinics, says Dr. Neal Halsey, Institute of Vaccine Safety, Johns Hopkins Bloomberg School of Public Health in a related commentary http://www.cmaj.ca/press/179_6_509.pdf. He states “before concluding that the HPV vaccine is associated with higher rates of anaphylaxis than other vaccines everywhere, cases in other populations should be reviewed….As of July 21, 2008, 11 cases have been reported [in the US] in 2008. Over 13 million doses of this vaccine have been distributed as of the end of 2007.”

A CMAJ editorial http://www.cmaj.ca/press/179_6_503.pdf states that this study indicates the HPV vaccine is “remarkably safe.” The study provides an excellent opportunity for Canada’s public health community “to restart public discussions about the safety of the HPV vaccine, the precautions taken to mitigate risks if anaphylaxis occurs, and the care taken in surveillance for adverse events following vaccination,” write Drs. Noni MacDonald, Matthew Stanbrook and Paul Hebert.

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Contact for research: Dr. Julia Brotherton or Professor Peter McIntyre, +61.2.98451417, JuliaB2@chw.edu.au, PeterM@chw.edu.au. Please note that Australia is 14 hours ahead of EDST.

Contact for commentary: Natalie Wood-Wright, Associate Director, Public Affairs, Johns Hopkins Bloomberg School of Public Health, 410-614-6029, for Dr. Neal Halsey

Contact for editorial: IWK Public Relations, 902-470-6740 for Dr. Noni MacDonald

 

38th Health Research Report 02 SEP 2008 – Reconstruction

Editors Top Five:

 

1.      How to stop a new type of heart attack
2.      Flu shot does not cut risk of death in elderly
3.      Scientists discover leptin can also aid type 1 diabetics
4.      Killer carbs — Monash scientist finds the key to overeating as we age
5.      Low cholesterol associated with cancer in diabetics

 

In This Issue:

 
1.      Silver-coated endotracheal tubes appear to reduce risk of pneumonia associated with ventilator use
2.      Arsenic exposure could increase diabetes risk
3.      Low level cadmium exposure linked to lung disease
4.      79 million US adults have medical bill problems or are paying off medical debt
5.      How to stop a new type of heart attack
6.      New research suggests diabetes transmitted from parents to children
7.      Positive thinking may protect against breast cancer
8.      Killer carbs — Monash scientist finds the key to overeating as we age
9.      The big gulp: consumers avoid extremes in soda sizes
10.  Low cholesterol associated with cancer in diabetics
11.  Anti-psychotic drug use in the elderly increases despite drug safety warnings
12.  New study shows health benefits of probiotic could extend to the entire body
13.  Anti-Cancer Flower Power
14.  Oral Administration of Lactobacillus from Breast Milk May Treat Common Infection in Lactating Mothers
15.  Scientists discover leptin can also aid type 1 diabetics
16.  Flu shot does not cut risk of death in elderly
17.  Researchers find high levels of toxic metals in herbal medicine products sold online
18.  Caesarean babies more likely to develop diabetes
19.  Olive leaf extract can help tackle high blood pressure and cholesterol
20.  Why do eyelids sag with age? UCLA study answers mystery
21.  New evidence on addiction to medicines Diazepam has effect on nerve cells in the brain reward system
22.  Study examines use of opioids
23.  Heart attack patients who stop statin risk death, say McGill researchers
24.  All types of antipsychotic drugs increase the risk of stroke
25.  Class of diabetes drugs carries significant cardiovascular risks
26.  National Study Shows Magnesium Sulfate Reduces Risk of Cerebral Palsy in Premature Births
27.  Sex hormones link to heart risk
28.  Large-scale Survey Links “Burnout” to Suicidal Thoughts in Med Students
29.  New evidence on folic acid in the diet and colon cancer
30.  Survey: ‘Tanorexia’ common among university students
31.  Post-marketing studies finding adverse events in drugs used in children
32.  Most vaccine-allergic children can still be safely vaccinated, Hopkins experts say
33.  Higher anaphylaxis rates after HPV vaccination: CMAJ study
34.  Safety of antithrombotic treatment in acute coronary syndromes
35.  Study finds B-vitamin deficiency may cause vascular cognitive impairment

Health Technology Research Synopsis

38th Issue Date 02 SEP 2008

Compiled By Ralph Turchiano

www.healthresearchreport.me www.vit.bz

www.youtube.com/vhfilm http://www.facebook.com/engineeringevil

www.engineeringevil.com

Controversial vaccine trial should never have been run in India, researchers say

Research published today in the Journal of the Royal Society of Medicine raises further questions about a trial of HPV vaccines in India.

The trial, which has now been halted and is the subject of an investigation by the Indian government, was examining the safety and feasibility of offering a vaccine against the virus associated with cervical cancer.

The new study by researchers at Queen Mary, University of London and the University of Edinburgh suggests that lack of data on cervical cancer in India does not support a trial of the vaccine to prevent the disease.

The trial was run by the international health charity PATH and involved more than 23,000 girls from Gujarat and Andhra Pradesh states. A committee of scientists commissioned by the Indian Government to look into the trial said that the study involved a number of serious ethical violations.

The research by Professor Allyson Pollock and colleagues examined a series of claims made by PATH about cervical cancer in India, among them that ‘in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide’.

They found that cancer surveillance, registration and monitoring in India in general – and specifically in the Gujarat and Andhra Pradesh regions – was incomplete, meaning that it would be impossible to tell whether the vaccine would be successful in preventing the disease.

In addition, figures that do exist for India show that incidence rates for cervical cancer are low and fell from around 43 cases per 100,000 in 1982/83 to around 22 per 100,000 in 2004/05. Brazil and Zimbabwe are reported to have around twice the rate.

Professor Pollock explained: “This trial has clearly raised serious concerns for the people and government of India. The aim of our study was to look at whether data on cervical cancer in the country justify the introduction of HPV vaccination.

“We found that current data on cervical cancer incidence do not support PATH’s claim that India has a large burden of cervical cancer or its decision to roll out the vaccine programme.

“The lack of information is important because it means that World Health Organisation criteria for monitoring the effectiveness of the vaccine cannot be fulfilled.

“Neither the epidemiological evidence nor current cancer surveillance systems justify the general rollout ofan HPV vaccination programme in India or in the two states where PATH was conducting its research.”

Professor Pollock continued: “It’s important to compare the burden of cervical cancer in India to other major health concerns, such as primary care, malaria, maternal anaemia and malnutrition, and consider best use of financial resources.

“HPV vaccine which is among the most expensive vaccines on the market is not justified as a health care priority for India.”