Showing posts with label evidence-based medicine. Show all posts
Showing posts with label evidence-based medicine. Show all posts

Thursday, June 5, 2014

Routine vaccination leaves man quadriplegic? Open Letter to Channel Nine

Like several other outlets, Channel Nine News reported the story of Ben Hammond, a Western Australian father of five, who came down with a debilitating episode of what is purported to be ADEM after a whooping cough booster. Now the Northern Rivers Vaccination Supporters have written an Open Letter to Channel Nine, which I am reposting here with kind permission, since it is, in contrast to Channel Nine's piece, evidence based and factual and important.

AN OPEN LETTER REGARDING A RECENT CHANNEL NINE NEWS STORY, THEIR INACCURATE PORTRAYAL OF VACCINE RISK, AND THE IMPORTANCE OF THE ADULT WHOOPING COUGH BOOSTER.

A news story that aired nationally on 2nd and 3rd June, 2014 on the Channel Nine News network and the Today Show was inaccurate and grossly irresponsible.

The story featured Perth father Ben Hammond, who received a Diptheria/Tetanus/Pertussis booster, and became seriously ill eleven days afterwards. Ben’s condition was said to be ADEM (Acute Disseminated Encephalomyelitis), a rare auto immune condition. This disease lead to Ben becoming quadriplegic for several months.

First of all, we wish to express our sorrow and sympathy for everything this man and his family have been through. By all accounts they have suffered a great deal physically, emotionally, and financially.
We are not writing to challenge or diminish what has happened to the Hammonds. This family deserves the support and generosity of the public to help them get back on their feet. We support a full investigation into the cause of his illness, so there is transparency on the facts of whether the vaccine caused it and the risks.
However the story breaches the Australian Communications and Media Authority Code of Practice (1):

• Section 4.3.1: The article was not factual or accurate and did not represent
  viewpoints fairly. It did not state:
    o How rarely, if ever, it has been shown that ADEM can be
       caused by vaccination
    o Any evidence to support this allegation
    o Why adults require the Whooping Cough (pertussis)
       booster
    o The relative risk to babies of whooping cough, versus
        the risk of the alleged vaccine reaction
• Section 4.3.2: It could cause public panic about vaccines and place
  newborn babies at risk

Why adults require Whooping cough boosters:
The Hammonds were offered a free booster during the time that Australia was experiencing the world’s largest Whooping Cough epidemic. This peaked at 38,500 cases in 2011. In response to thousands of babies being hospitalised and tragically over ten babies dying nationally, State governments have distributed millions of doses of the vaccine for free to new parents since 2009. Without the program, the number of grieving families would have been significantly higher.
Our group includes families whose babies have died from Whooping Cough, and who have worked hard to raise awareness of the need for adult boosters. This has saved lives, particularly of vulnerable premature babies.

Adults need a booster because of waning immunity, this happens both after the vaccine, and following ‘natural’ infection. Recent research has shown that this can occur as quickly as after four years(2). Unfortunately, nationally, less that 12% of adults have had a Whooping Cough booster (3). This means if there is an outbreak, an adult is susceptible to catching the disease, and passing it on to others. For most adults, this causes an irritating coughing illness that can last for months and lead to rib fractures and pneumonia; in young infants it can be deadly. Babies cannot have their first dose of protective vaccine until they are 6 weeks to 2 months old, so these very young babies must rely on adults being up-to-date with their boosters to be protected (4).

Risk of whooping cough to babies:
The story did not state the relative risk of acquiring ADEM after a vaccination, when compared to the risk of a baby catching whooping cough.

   • Nearly all babies that catch whooping cough require care in hospital.
   • It tragically proves fatal in 1 in 200 who catch it (5).
   • There is no cure for whooping cough. Babies face months of disease, and once it takes hold, the only treatment is supportive, with oxygen, and for critical cases, ventilation and ECMO (life support that, at best, also carries a very high mortality) (6).

Thankfully new research has shown that if a woman gets vaccinated when pregnant, this may halve the risk of the baby catching whooping cough (7). However, we are concerned your program will negatively impact on the uptake of this vital public health measure.

The facts about ADEM:
The news story should have featured a medical expert, to provide some facts about ADEM. Without the context of how rarely ADEM occurs after a vaccination, this omission could greatly damage public confidence in the vaccination program.

The alarmist headlines used such as “Routine vaccination almost fatal” “Vaccine danger” “Man becomes quadriplegic following routine vaccination” “One shot left him crippled” “Destroyed his life” and “Vaccination nightmare” were not counterbalanced with any information portraying the real-life risk of developing ADEM. Instead, we were solely given the Hammonds' own assertion of it’s cause.

ADEM may or may not be associated with some vaccines. We know that it occurs at such an extremely low rate it is impossible to determine causality with any scientific accuracy.
Indeed it is so rare the risk is something like 8 out of 1 million risk to the general population. Out of those cases, less than 5% follow immunisation, and it is much more likely to follow infection by one of the vaccine preventable diseases (8). There are many common and not-so-common bacteria and viruses that induce ADEM at much higher rates than those associated with vaccination.
The only vaccine proven to induce ADEM is the Semple form of the rabies vaccine. Other vaccines have all been implicated, most commonly the MMR vaccine, but the majority of the studies that correlate vaccination with ADEM onset use small samples or case studies (because there are so few cases to begin with). Large scale epidemiological studies have not shown an increased risk of ADEM following vaccination.

Also misleading was the implication Mr Hammond had “no immune system" and “no kidney or liver function” from the vaccine. ADEM should not cause organ dysfunction or immune suppression (although medication used to treat it can), and the paralysis it causes is usually temporary.
We take vaccine safety and transparency about that safety very seriously, and support the Hammond's use of the media to highlight the rare possibility of adverse vaccine reactions. The family deserves respect, and privacy, and we understand their need for financial assistance. We hope Ben’s case highlights the importance of a no-fault vaccine injury compensation program in Australia, for when adverse reactions to vaccines do occur.

However, unnecessarily scaring people away from vaccination programs such as against whooping cough could deter adults from having a booster, and place vulnerable newborns at high risk. News reports regarding vaccination should be clear and balanced. They need to present the relative risks of an adverse reaction to a vaccine when compared with the risks from vaccine preventable diseases. The media’s role in public perception of healthcare, risk of disease, and vaccine safety should not be underestimated, nor the responsibility taken lightly.


1: http://tinyurl.com/ltbyrl4

2: Wendelboe, A. M., Van Rie, A., Salmaso, S., & Englund, J. A. (2005). Duration of immunity against pertussis after natural infection or vaccination. The Pediatric infectious disease journal, 24(5), S58-S61
3: http://www.aihw.gov.au/publication-detail/?id=10737418409
4: http://www.chainofprotection.org/adultimmunisation
5: http://tinyurl.com/pwfthsw
6: http://tinyurl.com/msyg6pg
7: http://tinyurl.com/k3rp7t3
8: Huynh, W., Cordato, D. J., Kehdi, E., Masters, L. T., & Dedousis, C. (2008). Post-vaccination encephalomyelitis: literature review and illustrative case. Journal of Clinical Neuroscience, 15(12), 1315-1322.



Wednesday, March 19, 2014

Welcome on the blo(g)ck Vaxplanations

There is a new blog on the block - Vaxplanation sets out to explain the myths around vaccination (we can never have enough of those). Their first post takes down a sad denialist piece which trivialised the dangers of measles and propagated loads of old anti-vaccine lies, well, myths. The piece is not only eloquent, but also spiked with the right amount of information, snark and some lovely memes, driving home the essentials - vaccination is safe, not vaccinating is the wrong choice.


Welcome Vaxplanations - looking forward to your next!


Friday, March 7, 2014

75 studies that show no link between vaccines and autism UPDATED to 107

Edited to fix links and to add more studies for a new total of 107 on 11 March 2014

Guest blog, compiled by Allison Hagood, Luci Baldwin, Kathy McGrath and Nathan Boonstra and originally published on the "Your Baby's Best Shot" Facebook page. I am grateful for the permission to repost!

If anyone still tries to pull the "vaccines cause autism" card on you, provide them with a link to this note!

Albizzati, A., Moré, L., Di Candia, D., Saccani, M., Lenti, C.  Normal concentrations of heavy metals in autistic spectrum disorders.  Minerva Pediatrica.  2012. Feb;64(1):27-31 http://www.ncbi.nlm.nih.gov/pubmed/22350041

Afzal, MA., Ozoemena, LC., O’Hare, A., Kidger, KA., Bentley, ML., Minor, PD. Absence of detectable measles virus genome sequence in blood of autistic children who have had their MMR vaccination during the routine childhood immunization schedule of UK.   Journal Medical Virology.  2006 May;78(5):623-30.  http://www.ncbi.nlm.nih.gov/pubmed/16555271

Ahearn WH. What Every Behavior Analyst Should Know About the "MMR Causes Autism" HypothesisArchive of Behavior Analysis in Practice.  2010.   Spring;3(1):46-50. http://www.ncbi.nlm.nih.gov/pubmed/22479671

Allan, GM., Ivers, N.  The autism-vaccine story: fiction and deception?  Canadian Family Physician.  Oct 2010; 56(10): 1013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2954080/

Andrews, N., Miller, E., Grant, A., Stowe, J., Osborn, V., & Taylor, B. (2004).  Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United Kingdom does not support a causal association.  Pediatrics, 114, 584-591. http://www.ncbi.nlm.nih.gov/pubmed/15342825 

Andrews, N., Miller, E., Taylor, B., Lingam, R., Simmons, A., Stowe, J., Waight, P.  Recall bias, MMR and autism.  Archives of Disease in Childhood.  Dec 2002; 87(6): 493–494.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1755823/pdf/v087p00493.pdf

Baird, G., Pickles, A., Simonoff, E., Charman, T., Sullivan, P., Chandler, S., Loucas, T., Meldrum, D., Afzal, M., Thomas, B., Jin, L., Brown, D.  Measles vaccination and antibody response in autism spectrum disorders.  Archives of Disease in Childhood.  2008 Oct;93(10):832-7. doi: 10.1136/adc.2007.122937. Epub 2008 Feb 5.  http://www.ncbi.nlm.nih.gov/pubmed/18252754

Berger, BE., Navar-Boggan, AM., Omer, SB.  Congenital rubella syndrome and autism spectrum disorder prevented by rubella vaccination--United States, 2001-2010.   BMC Public Health.  2011 May 19;11:340. doi: 10.1186/1471-2458-11-340. http://www.ncbi.nlm.nih.gov/pubmed/21592401

Black, C., Kaye, JA.  Relation of childhood gastrointestinal disorders to autism:  nested case-control study using data from the UK General Practice Research Database.  British Medical Journal.  2002; 325(7361):419-21.  http://dx.doi.org/10.1136/bmj.325.7361.419

Bower, H.  New research demolishes link between MMR vaccine and autism.  British Medical Journal.  1999.  Jun 19;318(7199):1643. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1116011/

Chen, W., Landau, S., Sham, P., & Fombonne, E. (2004).  No evidence for links between autism, MMR and measles virus.  Psychological Medicine, 34(3), 543-553. http://www.ncbi.nlm.nih.gov/pubmed/15259839

Christie, B.  Scottish expert group finds no link between MMR and autism.  British Medical Journal,  2002. May 11;324(7346):1118. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1172158/

Clements, CJ., McIntyre, PB.  When science is not enough – a risk/benefit profile of thiomersal-containing vaccines.   Expert Drug Opinion Safety.  2006. Jan;5(1):17-29. http://www.ncbi.nlm.nih.gov/pubmed/16370953    

Dales, L., Hammer, S. J., & Smith, N. J. (2001). Time trends in autism and in MMR immunization coverage in California.   JAMA, 285(9), 1183-1185. http://www.ncbi.nlm.nih.gov/pubmed/11231748

De Los Reyes, EC.  Autism and immunizations: separating fact from fiction.  JAMA Neurology.   2010;67(4):490-492. doi:10.1001/archneurol.2010.57. http://archneur.jamanetwork.com/article.aspx?articleid=799645

DeWilde, S., Carey, IM., Richards, N., Hilton, SR., Cook, DG.  Do children who become autistic consult more often after MMR vaccination?  British Journal of General Practice.  2001 Mar;51(464):226-7.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1313956/

Demicheli, V., Jefferson, T., Rivetti, A., & Price, D. (2005).  Vaccines for measles, mumps and rubella in children. Cochrane Database Syst Rev, 4. (a review of 31 studies) http://www.ncbi.nlm.nih.gov/pubmed/22336803

DeStefano, F.  MMR vaccine and autism: a review of the evidence for a causal association.   Molecular Psychiatry.  2002;7 Suppl 2:S51-2.http://www.ncbi.nlm.nih.gov/pubmed/12142951

DeStefano, F., Chen, RT.  Autism and measles, mumps, and rubella vaccine: No epidemiological evidence for a causal association.  The Journal of Pediatrics.  2000 Jan;136(1):125.  http://www.ncbi.nlm.nih.gov/pubmed/10681219    

DeStefano, F., Bhasin, T. K., Thompson, W. W., Yeargin-Allsopp, M., & Boyle, C. (2004).  Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan AtlantaPediatrics, 113(2), 259-266. http://www.ncbi.nlm.nih.gov/pubmed/14754936

DeStefano F., Price CS., Weintraub, ES.  Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism.   Journal of Pediatrics.  2013 Aug;163(2):561-7. doi: 10.1016/j.jpeds.2013.02.001. Epub 2013 Mar 30. http://www.ncbi.nlm.nih.gov/pubmed/23545349

DeStefano F., Thompson, WW.  MMR vaccine and autism: an update of the scientific evidence. Expert Rev Vaccines. 2004 Feb;3(1):19-22.  http://www.ncbi.nlm.nih.gov/pubmed/14761240

DeStefano F., Thompson, WW.  MMR vaccination and autism: is there a link?  Expert Opinion on Drug Safety.  2002 Jul;1(2):115-20.  http://www.ncbi.nlm.nih.gov/pubmed/12904145

DeStefano, F.  Chen, RT.  Negative association between MMR and autism.  Lancet. 1999 Jun 12;353(9169):1987-8.  http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(99)00160-9/fulltext

DeStefano, F., Chen, RT.  Autism and measles-mumps-rubella vaccination:  controversy laid to rest?  CNS Drugs.  2001. 2001;15(11):831-7.  http://www.ncbi.nlm.nih.gov/pubmed/11700148

D’Souza J., Todd T.  Measles-mumps-rubella vaccine and the development of autism or inflammatory bowel disease: the controversy should end.  Journal of Pedatric Pharmacology and Therapeutics.   2003 Jul;8(3):187-99. doi: 10.5863/1551-6776-8.3.187. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3469143/

D’Souza, Y., Fombonne, E., Ward, BJ.  No evidence of persisting measles virus in peripheral blood mononuclear cells from children with autism spectrum disorder.  Pediatrics.  2006 Oct;118(4):1664-75.  http://www.ncbi.nlm.nih.gov/pubmed/17015560

Doja, A., & Roberts, W. (2006).  Immunizations and autism: A review of the literature.  The Canadian Journal of Neurological Sciences, 33(4), 341-346. http://www.ncbi.nlm.nih.gov/pubmed/17168158

Elliman, D., Bedford, H.   MMR: where are we now?  Archives of Disease in Childhood.   2007 Dec;92(12):1055-7. Epub 2007 Jul 11.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2066086/ 

Farrington, C., Miller, E., & Taylor, B. (2001).  MMR and autism: further evidence against a causal association.  Vaccine, 19(27), 3632-3635. http://www.ncbi.nlm.nih.gov/pubmed/11395196

Fitzpatrick, M.  The end of the road for the campaign against MMR.  British Journal of General Practice.  2007 Aug;57(541):679.  http://www.ncbi.nlm.nih.gov/pubmed/17688775

Fombonne, E., & Chakrabarti, S. (2001).  No evidence for a new variant of measles-mumps-rubella–induced autism.  Pediatrics, 108(4), e58-e58. http://www.ncbi.nlm.nih.gov/pubmed/11581466

Fombonne, E., Zakarian, R., Bennett, A., Meng, L., & McLean-Heywood, D. (2006).  Pervasive developmental disorders in Montreal, Quebec, Canada: Prevalence and links with immunizations.  Pediatrics 118(1) e139-e150; doi:10.1542/peds.2005-2993. http://pediatrics.aappublications.org/content/118/1/e139

García-Fernández, L., Hernández, AV., Suárez Moreno, V., Fiestas, F.  Addressing the controversy regarding the association between thimerosal-containing vaccines and autism.  Revista Peruana de Medicine Experimental Salud Publica. 2013 Apr;30(2):268-74. http://www.ncbi.nlm.nih.gov/pubmed/23949514

Gentile, I., Bravaccio, C., Bonavolta, R., Zappulo, E., Scarica, S., Riccio, MP., Settimi, A., Portella, G., Pascotta, A., Borgia, G.  Response to measles-mumps-rubella vaccine in children with autism spectrum disordersIn Vivo 2013 May-Jun;27(3):377-82. http://www.ncbi.nlm.nih.gov/pubmed/23606694

Glasper, EA.  New evidence reaffirms the safety of the MMR vaccine.  British Journal of Nursing. 2002 Jun 27-Jul 10;11(12):794.  http://www.internurse.com/cgi-bin/go.pl/library/article.cgi?uid=10298;article=BJN_11_12_794_0

Halsey, NA., Hyman, SL.  Measles-mumps-rubella vaccine and autistic spectrum disorder: report from the New Challenges in Childhood Immunizations Conference convened in Oak Brook, Illinois.   June 12-13, 2000.   Pediatrics.  2001 May;107(5):E84.  http://www.ncbi.nlm.nih.gov/pubmed/11331734

Hayney MS.  Vaccine Safety:  no link between thimerosal and autismJournal of American Pharmacists Association.  2003. 2004 Nov-Dec;44(6):725-6. http://japha.org/article.aspx?articleid=1039011   

Hertz-Picciotto, I., Green, P., Delwiche, L., Hansen, R., Walker, C., & Pessah, I. (2010).  Blood mercury concentrations in CHARGE Study children with and without autism. Environmental Health Perspectives, 118(1), 161-166. doi:10.1289/ehp.0900736 http://www.ncbi.nlm.nih.gov/pubmed/20056569

Hensley, E. Briars, L.  Closer look at autism and the measles-mumps-rubella vaccineJournal of American Pharmacist’s Association.  2003.  2010 Nov-Dec;50(6):736-41. doi: 10.1331/JAPhA.2010.10004.  http://www.ncbi.nlm.nih.gov/pubmed/21071320 

Heron, J., Golding, J., ALSPAC Study Team.  Thimerosal exposure in infants and developmental disorders: a prospective cohort study in the United Kingdom does not support a causal association.  Pediatrics.  2004 Sep;114(3):577-83. http://www.ncbi.nlm.nih.gov/pubmed/15342824

Hessel, L.  Mercury in vaccines.  Bulletin of the National Academy of Medicine. 2003;187(8):1501-10.  http://www.ncbi.nlm.nih.gov/pubmed/15146581

Hiroshi, T., Suzumura, S., Shirakizawa, F., Wada, N., Tanaka-Taya, K., Arai, S., Okabe, N., Ichikawa, H., Sato, T.  An epidemiological study on Japanese Autism concerning Routine Childhood Immunization History.  Japanese Journal of Infectious Diseases.  56, 114-117, 2003. http://www0.nih.go.jp/JJID/56/114.pdf

Honda, H., Shimizu, Y., & Rutter, M. (2005).  No effect of MMR withdrawal on the incidence of autism: a total population study.  Journal of Child Psychology and Psychiatry.  46(6), doi: 10.1111/j.1469-7610.2005.01425.x.  http://www.ncbi.nlm.nih.gov/pubmed/15877763

Hornig, M., Briese, T., Bule, T., Bauman, M.L., Lauwers, G., Siemetzki, U., Hummel, K., Rota, PA., Bellini, WJ., O’Leary, JJ., Sheils, O., Alden, E., Pickering, L., Lipkin, W.I.  Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.  2008.  PLoS One, 3(9), e3140. doi: 10.1371/journal.pone.0003140. http://www.ncbi.nlm.nih.gov/pubmed/18769550  

Hurley, A., Tadrous, M., Miller, ES.  Thimerosal-containing vaccines and autism: a review of recent epidemiological studies.  Journal of Pediatric Pharmacology and Therapeutics.  2010 Jul-Sep; 15(3): 173-181.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3018252/

Hviid A., Stellfeld, M., Wohlfahrt, J., Melbye, M.   Association between thimerosal-containing vaccine and autism - No causal relationship found.  JAMA. 2003 Oct 1;290(13):1763-6. http://www.ncbi.nlm.nih.gov/pubmed/14519711

Insitute  of Medicine (US) Immunization Safety Review Committee.  Immunization Safety Review:  Vaccines and Autisms.  Washington (DC): National Academies Press (US); 2004. http://www.ncbi.nlm.nih.gov/pubmed/20669467

Iqbal, S., Barile, JP., Thompson, WW., DeStefano, F.  Number of antigens in early childhood vaccines and neuropsychological outcomes at age 7–10years.  Pharmacoepidemiology and Drug Safety.  2013 Dec;22(12):1263-70. doi: 10.1002/pds.3482.  Epub 2013 Jul 12. http://www.ncbi.nlm.nih.gov/pubmed/23847024

Jefferson, T., Price, D., Demicheli, V., Bianco, E., European Research Program for Improved Safety Surveillance (EUSAFEVAC) Project.  Unintended events following immunization with MMR: a systematic review.  Vaccine.  2003 Sep 8;21(25-26):3954-60. http://www.ncbi.nlm.nih.gov/pubmed/12922131

Jick, H., Kaye, JA.  Epidemiology and possible causes of autism.  Pharmacotherapy. 2003 Dec;23(12):1524-30.  http://www.ncbi.nlm.nih.gov/pubmed/14695031

Kaye, J. A., del Mar Melero-Montes, M., & Jick, H.  Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis.  2001.  British Medical Journal, 322(7284), 460-463.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1071423/

Klein, K. C., & Diehl, E. B.  Relationship between MMR vaccine and autism.   2004.  Annals of Pharmacotherapy, 38(7-8), 1297-1300.  http://www.ncbi.nlm.nih.gov/pubmed/15173555

Kuwaik, GA., Roberts, W., Zwaigenbaum, L., Bryson, S., Smith, IM., Szatmari, P., Modi, BM., Tanel, N., Brian, J.  Immunization uptake in younger siblings of children with autism spectrum disorder.  Autism.  2014 Feb;18(2):148-55. doi: 10.1177/1362361312459111. Epub 2012 Oct 8. http://www.ncbi.nlm.nih.gov/pubmed/23045216

Lazoff, T., Zhong, L., Piperni, T., Fombonne, E.  Prevalence of pervasive developmental disorders among children at the English Montreal School Board.  Canadian Journal of Psychiatry.  2010 Nov;55(11):715-20.  http://www.ncbi.nlm.nih.gov/pubmed/21070699

Lingam, R., Simmons, A., Andrews, N., Miller, E., Stowe, J., & Taylor, B. (2003).  Prevalence of autism and parentally reported triggers in a North-east London population.  Archives of Disease in Childhood, 88(8), 666-670.  http://www.ncbi.nlm.nih.gov/pubmed/12876158

Madsen, K.K., Hviid, A., Vestergaard, M., Schendel, D., Wohlfahrt, J., Thorsen, P., Olsen, J., Melbye, M.  A population-based study of measles, mumps, and rubella vaccination and autism.  2002.  The New England Journal of Medicine, 347(19), 1477-82.  http://www.ncbi.nlm.nih.gov/pubmed/12421889

Madsen KM., Hviid, A., Vestergaard, M., Schendel, D., Wohlfahrt, J., Thorsen, P., Olsen, J. Melbye, M.  MMR vaccination and autism--a population-based follow-up study.  Ugeskr Laeger.  2002.  Dec 2;164(49):5741-4.  http://www.ncbi.nlm.nih.gov/pubmed/12523209

Madsen, K.M., Lauritsen, M.B., Pedersen, C.B., Thorsen, P., Plesner, A.M., Andersen, P.H. & Mortensen, P.B.  Thimerosal and the occurrence of autism:  negative ecological evidence from Danish population-based data.  2003.  Pediatrics, 112, 604-606. doi: 10.1542/peds.112.3.204 http://www.ncbi.nlm.nih.gov/pubmed/12949291

Madsen, KM.  Vestergaard, M.   MMR and Autism:  what is the evidence for a causal association?  Drug Safety.  2004;27(12):831-40. http://www.ncbi.nlm.nih.gov/pubmed/15366972

Makela, A., Nuorti, J., & Peltola, H. (2002).  Neurologic disorders after measles-mumps-rubella vaccination.  Pediatrics, 110(5), 957-963.  http://www.ncbi.nlm.nih.gov/pubmed/12415036

Marin, M., Broder, KR., Temte, JL., Snider, DE., Seward, JF., (CDC).  Use of combination measles, mumps, rubella, and varicella vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP).  MMWR Recommendations and Reports.  2010 May 7;59(RR-3):1-12.  http://www.ncbi.nlm.nih.gov/pubmed/20448530

Marwick, C.  US Report finds no link between MMR and autism.  British Medical Journal.   May 5, 2001; 322(7294): 1083.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1120232/

MacDonald, NE., Pickering, L. Canadian Paediatric Society, Infectious Diseases and Immunization Committee.  Autism Spectrum Disorder:  No causal relationship with vaccines.  Paediatric Child Health 2007;12(5):393-5.  http://www.cps.ca/documents/position/autistic-spectrum-disorder-no-causal-relationship-with-vaccines

Meadows, M.  IOM Report:  no link between vaccines and autism.  FDA Consumer. 2004 Sep-Oct;38(5):18-9.  http://www.ncbi.nlm.nih.gov/pubmed/15595144

Meilleur, AA., Fombonne, E.  Regression of language and non-language skills in pervasive development disorders.  Journal of Intellectual Disability Research.  2009 Feb;53(2):115-24. doi: 10.1111/j.1365-2788.2008.01134.x. Epub 2008 Nov 27. http://www.ncbi.nlm.nih.gov/pubmed/19054269

Miller, E.  Measles-mumps-rubella vaccine and the development of autism - epidemiologic evidence against such an association is compelling.  Seminars in Pediatric Infectious Diseases.  2003 Jul;14(3):199-206.  http://www.ncbi.nlm.nih.gov/pubmed/12913832

Miller, E., Andrews, N., Grant, A., Stowe, J., Taylor, B.  No evidence of an association between MMR vaccine and gait disturbance.  Archives of Disease in Childhood.  2005.  Mar;90(3):292-6. http://www.ncbi.nlm.nih.gov/pubmed/15723921

Miller, L., Reynolds J.  Autism and vaccination – the current evidenceJournals for Specialists in Pediatric Nursing.  2009 Jul;14(3):166-72. doi: 10.1111/j.1744-6155.2009.00194.x. http://www.ncbi.nlm.nih.gov/pubmed/19614825

Mrozek-Budzyn, D., Kiełtyka, A.  The relationship between MMR vaccination and the number of new cases of autism in children.  Przeglad epidemiologiczny.  2008;62(3):597-604. http://www.ncbi.nlm.nih.gov/pubmed/19108524

Mrozek-Budzyn, D., Kiełtyka, A.,  Majewska, R.  Lack of association between measles-mumps-rubella vaccination and autism in children:  a case-control study.  Pediatric Infectious Disease Journal.  2010 May;29(5):397-400. doi: 10.1097/INF.0b013e3181c40a8a. http://www.ncbi.nlm.nih.gov/pubmed/19952979

Mrozek-Budzyn, D., Majewska, R. Kiełtyka, A. & Augustyniak, M.  Lack of association between thimerosal-containing vaccines and autism.  Przeglad epidemiologiczny.  2011, 65(3), 491-495. http://www.ncbi.nlm.nih.gov/pubmed/22184954

Muhle, R., Trentacoste, SV., Rapin, I.  The genetics of autismPediatrics. 2004 May;113(5):e472-86.  http://www.ncbi.nlm.nih.gov/pubmed/15121991

Nelson, KB., Bauman, ML.  Thimerosal and autism?  Pediatrics.  2003.  Mar;111(3):674-9.http://pediatrics.aappublications.org/content/111/3/674.long

Offit, PA., Coffin, SE.  Communicating science to the public:  MMR vaccine and autism.  Vaccine.  2003.  Dec 8;22(1):1-6. http://www.ncbi.nlm.nih.gov/pubmed/14604564

Stratton, K., Ford, A., Rusch, E., Wright Clayton, E.  Committee to Review Adverse Effects of Vaccines; Institute of Medicine.  Adverse Effects of Vaccines: Evidence and Causality.  Washington, DC: The National Academies Press, 2012. (a review of more than ONE THOUSAND studies).  http://www.nap.edu/catalog.php?record_id=13164

Patja, A., Davidkin, I., Kurki, T.,  Marku, J., Kallio, T., Valle, M., Peltola, H.  Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up.  2000.  Pediatric Infectious Diseases Journal.  2000;19:1127-34.  http://www.nccn.net/~wwithin/MMR.pdf

Parker, S.K., Schwartz, B., Todd, J., Pickering, L.K.  Thimerosal-containing vaccines and autistic spectrum disorder: A critical review of published original data.  2004.  Pediatrics, 114, 793-804. http://www.ncbi.nlm.nih.gov/pubmed/15342856

Parker, S. Todd, J., Schwartz., B., Pickering, L.K.  Thimerosal-containing vaccines and autistic spectrum disorder: A critical review of published original data.  2005.  Pediatrics. Jan;115(1):200.  http://www.ncbi.nlm.nih.gov/pubmed/15630018

Pichichero, ME., Cernichiari, E., Lopreiato, J., Treanor, J.  Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study.  Lancet. 2002 Nov 30;360(9347):1737-41.  http://www.ncbi.nlm.nih.gov/pubmed/12480426

Peltola, H., Patja, A., Leinikki, P., Valle, M., Davidkin, I., & Paunio, M.  No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study.  1998.  Lancet, 351(9112), 1327. http://www.ncbi.nlm.nih.gov/pubmed/9643797

Plotkin, S., Gerber, J. S., & Offit, P. A. (2009).  Vaccines and autism: a tale of shifting hypotheses.  Clinical Infectious Diseases, 48(4), 456-461. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2908388/

Price, C. S., Thompson, W. W., Goodson, B., Weintraub, E. S., Croen, L. A., Hinrichsen, V. L., DeStefano, F.  Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism.  2010.  Pediatrics, 126(4), 656-664. http://www.ncbi.nlm.nih.gov/pubmed/20837594

Roehr B.  Study finds no association between vaccines and autism.  2013.  British Medical Journal.  Apr 3;346:f2095. doi: 10.1136/bmj.f2095. http://www.ncbi.nlm.nih.gov/pubmed/23554072

Richler, J., Luyster, R., Risi, S., Hsu, W. L., Dawson, G., Bernier, R., ... & Lord, C. (2006). Is there a ‘regressive phenotype’ of Autism Spectrum Disorder associated with the measles-mumps-rubella vaccine?  A CPEA Study.  Journal of Autism and Developmental Disorders, 36(3), 299-316. http://www.ncbi.nlm.nih.gov/pubmed/16729252

Rumke, HC., Visser, HK.  Childhood vaccinations anno 2004. II. The real and presumed side effects of vaccination.  Nederlands Tijdschrift voor Geneeskunde.  2004 Feb 21;148(8):364-71. http://www.ncbi.nlm.nih.gov/pubmed/15032089  

Schechter, R., Grether, JK.  Continuing increases in autism reported to California's developmental services system: mercury in retrograde.  Archives of General Psychiatry.  2008 Jan;65(1):19-24. doi: 10.1001/archgenpsychiatry.2007.1. http://www.ncbi.nlm.nih.gov/pubmed/18180424

Schultz, ST.  Does thimerosal or other mercury exposure increase the risk for autism?  A review of the current literature.  Acta Neurobiologiae Experimentalis. 2010;70(2):187-95. http://www.ncbi.nlm.nih.gov/pubmed/20628442

Shevell, M.,Fombonne, E. Autism and MMR vaccination or thimerosal exposure: an urban legend?  Canadian Journal of Neurological Sciences.  2006 Nov;33(4):339-40. http://cjns.metapress.com/content/xqxx6ha3ufaeuunv/?genre=article&issn=0317-1671&volume=33&issue=4&spage=339

Smeeth, L., Cook, C., Fombonne, E., Heavey, L., Rodrigues, L. C., Smith, P. G., & Hall, A. J. (2004). MMR vaccination and pervasive developmental disorders: a case-control study.  The Lancet, 364(9438), 963-969. http://www.ncbi.nlm.nih.gov/pubmed/15364187

Smith, M. J., & Woods, C. R.  On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes.  Pediatrics.  2010. 125(6), 1134-1141. http://www.ncbi.nlm.nih.gov/pubmed/20498176

Solt, I., Bornstein, J.  Childhood vaccines and autism – much ado about nothing?  Harefuah. 2010 Apr;149(4):251-5, 260.  http://www.ncbi.nlm.nih.gov/pubmed/20812501

Singh, VK. Rivas, WH.  Detection of antinuclear and antilaminin antibodies in autistic children who received thimerosal-containing vaccines  - mercury as in thimerosal-containing vaccines is likely not related to autoimmune phenomenon in autism.   Journal of Biomedical Science.  2004 Sep-Oct;11(5):607-10.  http://www.ncbi.nlm.nih.gov/pubmed/15316135   

Steffenburg, S., Steffenburg, U., Gillberg, C.  Autism spectrum disorders in children with active epilepsy and learning disability:  comorbidity, pre and perinatal backgound, and seizure characteristics.   Developmental Medicine and Child Neurology.  2003 Nov;45(11):724-30. http://www.ncbi.nlm.nih.gov/pubmed/14580127   

Stehr-Green, P., Tull, P., Stellfeld, M., Mortenson, PB., Simpson, D.  Autism and thimerosal-containing vaccines: lack of consistent evidence for an association.   American Journal of Preventive Medicine.  2003 Aug;25(2):101-6.  http://www.ncbi.nlm.nih.gov/pubmed/12880876

Taylor, B.  Vaccines and the changing epidemiology of autism.  Child: Care, Health and Development Journal.  2006 Sep;32(5):511-9.  http://www.ncbi.nlm.nih.gov/pubmed/16919130

Taylor, B., Miller, E., Farrington, C., Petropoulos, M., Favot-Mayaud, I., Li, J., & Waight, P. A. (1999).  Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association.  Lancet, 353(9169), 2026-20. http://www.ncbi.nlm.nih.gov/pubmed/10376617

Taylor, B., Miller, E., Lingam, R., Andrews, N., Simmons, A., & Stowe, J.  Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: population study.  2002.  British Medical Journal, 324(7334), 393-396. http://www.ncbi.nlm.nih.gov/pubmed/11850369

Taylor, B., Lingam, R., Simmons, A., Stowe, J., Miller, E., Andrews, N.  Autism and MMR vaccination in North London: no causal relationship.   2002.  Molecular Psychiatry.                   7 Suppl2:S7-8.  http://www.ncbi.nlm.nih.gov/pubmed/12142932

Thjodleifsson, B., Davidsdóttir, K., Agnarsson, U., Sigthórsson, G., Kjeld, M., Bjarnason, I.  Effect of Pentavac and measles-mumps-rubella (MMR) vaccination on the intestine.  Gut.  2002 Dec;51(6):816-7.  http://www.ncbi.nlm.nih.gov/pubmed/12427783

Thompson, WW., Price, C., Goodson, B., Shay, DK., Benson, P., Hinrichsen, BL., Lewis, E., Eriksen, E., Ray, P., Marcy, SM., Dunn, J., Jackson, LA., Lieu, TA., Black, S., Stewart, G., Weintraub, ES., Davis, RL., DeStefano, F.,  Vaccine Data Link Safety Team.  Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years.  New England Journal of Medicine.  2007 Sep 27;357(13):1281-92.  http://www.ncbi.nlm.nih.gov/pubmed/17898097

Uchiyama, T., Kurosawa, M., & Inaba, Y.  MMR-vaccine and regression in autism spectrum              disorders: negative results presented from Japan.  2007.  Journal of Autism and Developmental       Disorders, 37(2), 210-217.  http://www.ncbi.nlm.nih.gov/pubmed/16865547

Uno, Y., Uchiyama, T., Kurosawa, M., Aleksic, B., & Ozaki, N.  The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder:  first case–control study in Asia.  2012.  Vaccine, 30(28), 4292-4298. http://www.ncbi.nlm.nih.gov/pubmed/22521285

Verstraeten T., Davis, RL., DeStefano, F., Lieu, TA., Rhodes, PH., Black, SB., Shinefield, H., Chen RT. Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.   Pediatrics.   2003 Nov;112(5):1039-48. http://www.ncbi.nlm.nih.gov/pubmed/14595043

Whitehouse, AJ., Maybery, M., Wray, JA., Hickey, M.  No association between early gastrointestinal problems and autistic-like traits in the general population.  Developmental Medicine and Childhood Neurology.  2011.  May;53(5):457-62. doi: 10.1111/j.1469-8749.2011.03915.x. Epub 2011 Mar 21.  http://www.ncbi.nlm.nih.gov/pubmed/21418197

Weisser, K., Bauer, K., Volkers, P., Keller-Stanislawski, B.  Thimerosal and immunizations - evidence does not support the hypothesis of a potential relationship between neurodevelopmental disorders and thiomersal-containing vaccines.  2004. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz.  Dec;47(12):1165-74. http://www.ncbi.nlm.nih.gov/pubmed/15583887

MMR vaccine is not linked to Crohn’s disease or autismCommun Dis Rep CDR Weekly. 1998 Mar 27;8(13):113.  http://www.ncbi.nlm.nih.gov/pubmed/9592960

Monday, August 5, 2013

Measles in the Netherlands: I'll call it

I was tempted last week, when the measles cases in the Dutch Bible Belt topped 600, but then I didn't. It suddenly appeared morbid, petty and like I wanted it to happen. By last Thursday, 780 measles cases had been reported in the current outbreak. So I'll do it.

There'll be a death. Soon.

In Europe, for about every 1000 reported measles cases, there is one death. The latest outbreak was in Wales, it ended last month with 1219 cases and one death, Gareth Colfer-Williams, who died of giant cell pneumonia, a specific complication of measles. But that particular area in the Netherlands has had its own outbreak in 1999/2000, totalling 3292 cases, over 150 hospitalisations and 3 deaths. It is eerie how this pans out to 1 in 1000. As a side note, 94% of patients were totally unvaccinated and only 1 of the 3292 had had 2xMMR. In fact, the vaccine works so well, that unvaccinated individuals were 224 times more likely to acquire measles than were the vaccinated. But I am getting side tracked. I called it. I hope I am wrong.

Saturday, April 6, 2013

Welcome Necromancers - find the Wakefield threads here

I was wondering why we had a necromancer on an old thread linking directly to Andy Wakefield's site, that one callously disregarding anything but Wakefield's (business) interests. I discovered the potential explanation on page 25 of the Guardian magazine:

In his book Callous Disregard, Wakefield claims his findings of autistic enterocolitis have been "independently confirmed in five different countries". He cites five studies, two of which were authored by his friend, collaborator and Autism Team star Arthur Krigsman. One of those studies appeared in Autism Insights, a medical journal on whose board Krigsman sat in 2010. Two other studies were by Italian doctor Federico Balzola. According to the justthevax blog, the first of these was a case report of a single adult autistic patient with an inflamed bowel, and the second a "meeting abstract" that "never saw the light of day as a peer-reviewed study". The last one, a study by Dr Lenny Gonzalez, while not reporting finding a distinct "autistic enterocolitis", concludes that "autistic children have a high incidence of gastrointestinal disease". (my bold)
Ok, I admit, I am vain, and that section did generate a squee. The whole article is worth reading though, very well researched by Alex Hannaford, who is not shy to call Wakefield's operation what it is "Autism Inc.", a money generating machine. Hannaford tried to proffer Wakefield's (and Polly Tommey's) comments, but they only sent their lawyers' roboresponse (Wakefield did not fabricate data, there is such a thing as autistic enterocolitis, yada yada). Instead, he interviewed (among others) the lovely Autismum Martine O'Callaghan, founder of the cwtch-network, whose autistic son Cledwyn is just as lush as Michael Fitzpatrick's son James, and Ari Ne'eman, founder of the Autistic Self Advocacy Network. Not surprisingly, they emphasise the need to improve quality of life of autistic children and adults, by appropriate services (for example schools). Excellent article - read it.

Now for those who'd like to insist that really, Wakefield's works have been independently verified, please read my previous two blog posts:

"Independent" the Wakefield way (really something for the fail blog)

and

Still no independent confirmation of Wakefield's claims 

and feel free to add research you think we may have missed to discuss. Can I ask though that instead of just dropping a link into the comments, or basic copypasta from the usual anti-vaccine conspiracy sites, you leave one article at a time, with a proper, i.e. retrievable, citation and a blurb in your own words (much as we did in those blog posts) stating what was done in those papers and how this supports the "vaccines lead to gut damage leads to autism" notion? Cheers.


Monday, October 1, 2012

Pregnant women in the UK to be offered whooping cough vaccination

The British Department of Health announced last week, that starting from today, pregnant women will be offered the whooping cough vaccine to protect their new borns. The idea is that when vaccinated during pregnancy, the maternal antibodies will be passed through the placenta to the baby before birth and will protect the infant in the first couple of months of their lives, when they cannot yet be vaccinated. This move comes after nine infants, all under three months old, died of pertussis in the UK of 302 under 3 month olds who contracted the disease (yes, that is a mortality of 3 percent, 3 of 100). The HPA welcomes this move, after having received notification of 1230 whooping cough cases in August 2012 alone.

Whooping cough is not a mild disease by any stretch of the imagination - the BBC has several testimonials from mothers of babies, but also older kids:
Nine year old Zara Mummery was seven when she caught whooping cough. One night she was coughing so much she stopped breathing.
"It was very frightening, but I remember that my mum brought me into the bathroom and she called the paramedics.
"She was just screaming on the phone 'my child's going to be dead, please come'."
Her mother Katrina said she couldn't get her daughter to breathe.
"It was like she froze. It was one of the most terrifying things any parent can go through, to think they have lost a child."
Zara spent a week in hospital on very strong antibiotics and is now fit and well.
 While the number of cases in the UK are increasing at an alarming rate,


it is worth remembering what the situation was like before the introduction of the vaccine. 
Before routine vaccination in 1957, whooping cough outbreaks in the UK were on a huge scale. It could affect up to 150,000 people and kill 300 in a single year.
What is already being remarked in vaccine-critical circles is that the dTaP/IPV booster vaccine, Repevax, is not recommended for use in pregnant women in the UK. The package information states:
Pregnancy
The effect of REPEVAX on embryo-foetal development has not been assessed. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. Limited post-marketing information is available on the safety of administering REPEVAX to pregnant women.
In their FAQs for GPs, the reason for the recommendation despite this disclaimer is provided:
Why does the Patient Information Leaflet state that Repevax® should not be used in pregnancy?
This says that the vaccine is not recommended for use in pregnancy because of the routine exclusion of pregnant women from clinical trials, and not because of any specific safety concerns or evidence of harm in pregnancy. Use in pregnancy is not contraindicated.
The CDC recently published the reasoning behind their older recommendation to vaccinate pregnant women against pertussis, and, using data from VAERS and two smaller studies, found that vaccination during pregnancy is safe. There is good indication that vaccine-induced antibodies pass through the placenta and hence would protect the newborn.

This new recommendation could save lives - I'll tell my pregnant friends about it - you should, too.



Tuesday, September 25, 2012

Buy this Book Before Big Bad Pharma has it Pulled off the market

Here's Ben Goldacre holding the first copy of his new book "Bad Pharma" (I will hold mine tonight, squee):


Those of you who have followed the story of "Bad Science" will know that the first edition was missing a chapter, because the dangerous quack discussed in that story was suing Dr. Goldacre. The chapter appeared online after the law suit and was added to the second edition of the book.

Now Ben might be facetious when he asks his readers to buy the book before it gets pulled, but it is not an unrealistic worry given his previous experience and industry practise. What can you expect? Luckily, Ben Goldacre generously shares the whole Introduction here:
So to be clear, this whole book is about meticulously defending every assertion in the paragraph that follows.
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies doesn’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in its life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part, they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.
In short - the book that everyone should read and that could be the beginning of something amazingly beautiful: evidence-based medicine.

For those of you in the US - ask a European friend to send you the book or bridge the time until January 2013 with reading Ben's excellent blog.

NOTE: I linked to Amazon.co.uk and Amazon.com up there, but if you have a chance, support your local book store and buy it there.

Edited to add: David Colquhoun, the excellent pharmacologist and skeptic has weighed in. I have changed the book link to a store which pays taxes in the UK following his example.

Monday, September 17, 2012

"QUACK" says the Quack, the Board says "NEIGH" - it's quiet now, what do you say?

with apologies to Sandra Boynton


On 22 August 2012, the Maryland State Board of Physicians revoked Mark R. Geier's license to practise Medicine (dare I say "finally"?). This follows almost a year of legal proceedings (covered very well by Todd W. at Harpocrates Speaks, here, and here and by Kathleen Seidel at Neurodiversity.com, here and here) - visually:


On September 15, 2011, the Board charged Mark R. Geier, M.D., with numerous violations of the Medical Practice Act, including: (1) unprofessional conduct in the practice of medicine; (2) willfully making or filing a false report or record in the practice of medicine; (3) willfully failing to file or record any medical report as required under law; (4) practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine; (5) grossly overutilizing health care services; (6) failing to meet appropriate standards for the provision of quality medical care; and (7) failing to keep adequate medical records, under Md. Health Occ. Code Ann. § 14-404(a) (3) (ii), (11), (12), (18), (19), (22), (40), respectively. 
A five-day evidentiary hearing was held before an Administrative Law Judge ("ALJ") ofthe Office of Administrative Hearings in December of 2011. On March 13, 2012, the ALJ issued a Proposed Decision finding that Dr. Geier had violated numerous provisions of the Medical Practice Act and recommending that his license be revoked. Exceptions and responses were filed by both parties. An oral exceptions hearing was held before the full Board on May 23, 2012. This Final Decision and Order is the Board's final administrative decision in this case.
Carole J. Catalfo, the Executive Director of the Maryland State Board of Physicians has had it. Her ruling leaves nothing open to interpretations - she finds (footnotes removed):
(1) Dr. Geier failed to meet basic medical standards for evaluating patients and conducting medical examinations and keeping adequate records of treatments and diagnoses. He failed to conduct an adequate initial evaluation of any of these patients and failed to make an adequate record of an examination for any of these patients. He began treatment often without sufficient information about the patients' physical condition. In many cases, [Dr. Geier] had no information at all about the Patients' physical condition.,
This is consistent with the details that came out in the case of Dr Geier's son David Geier practising Medicine without a license (Justthevax passim). She further finds:
(2) Dr. Geier treated patients with Lupron, a medication that is not approved by the FDA in the absence of precocious puberty. He did not, however, perform an adequate examination to determine whether these patients had precocious puberty, or the cause of these patients' symptoms. ../.
(3)
Based on his theory that Lupron therapy is appropriate in certain situations in which
its administration is not approved by the FDA or the American Academy of Pediatrics, Dr. Geier purported to treat patients who met his profile with Lupron. With the exception of Patient E, however, none of these patients met even Dr. Geier's profile for Lupron therapy.
This abhorrent practise to "diagnose" any child with "precocious puberty" irrespective of age and physical evidence to be able to prescribe Lupron, a strong hormone modulator, which essentially equals chemical castration is part of Team Geier's proprietary theory. They postulate (I paraphrase - see père et fils Geier here) that excessive testosterone binds mercury from vaccines in the body/brain, and that the administration of Lupron will release the mercury which can than be chelated. That is complete gobbledygook of course, but unfortunately, far too many parents believed them (read Kathleen Seidel's outstanding series on "The Lupron Protocol") - the Geiers claimed to have treated more than fifty children already in 2006. Consequently, following Lupron prescription:
(4) Dr. Geier prescribed chelation therapy to patients who failed to display the need for chelation. He began this therapy without documenting a reason for the treatment and without adequate documented informed consent. He violated the standard of quality care by so doing. He also violated the standard of quality care by prescribing for patients the drug DMPS, a drug not approved for any use in the United States.
(5) Dr. Geier provided a consent form to the parent of Patient I that named an FDAapproved drug and which falsely stated that it was to be used in the chelation treatment when another drug, DMPS, which was not FDA-approved, was to be used (and in fact was used) in the chelation treatment. 
It gets worse:
(6) After prescribing these treatments without an adequate previous medical examination and without adequate informed consent, Dr. Geier then failed to adequately monitor whether these treatments were working.
"Experimental" treatments on human patients will have to undergo review by an institutional review board, which is supposed to advise and control the physicians. The Geiers' review board was made up of family and friends:
(7) Dr. Geier provided drug therapy to Patient I according to a protocol not approved by the FDA after telling the parent that his protocol was approved by an Institutional Review Board, when in fact the Institutional Review Board consisted entirely of persons affiliated with his practice and did not meet the requirements of federal or state law.
The court further finds that Dr Geier had parents sign an "informed consent" form that named the wrong drug (FDA licensed) to be applied, while an unlicensed drug ended up being used on their children (8). He inflated his credentials, claiming an American Board of Medical Specialties certification he did not have (9). The Board also finds that the record keeping of Dr. Geier was too poor to even be suitable for assessing patient progress. Nevertheless, he made decisions to continue or alter medication (10). Dr. Geier falsely made a diagnosis of precocious puberty in patients who did not have this condition and he did not perform the necessary medical examinations to be able to make this diagnosis (11)

It appears that Mark Geier had objections to Dr. Grossman as an expert witness, saying that she was not a "true peer". Given her impressive list of qualifications, I would almost tend to agree with that notion - the court states:
Dr. Grossman is board certified in pediatrics and developmental-behavioral pediatrics and has been an Associate Professor of Pediatrics, the Director of the Behavioral and Developmental Pediatrics Fellowship Program at the University of Maryland School of Medicine and the head of the Division of Behavioral and Developmental Pediatrics at that institution. She has also held many other positions of great responsibility in her 35-year career in pediatrics. She testified knowledgeably about the standard of care applicable to pediatric patients in general and to these patients in particular. The Board is satisfied that she was appropriately admitted as an expert in this case.
I felt like hugging Carole Catalfo for the following statement:
The fact that she may not have been familiar with the details of some of Dr. Geier's idiosyncratic theories, theories that appear to be supported in large part by literature that he or his son created and which have been rejected to some extent by the Institutes of Medicine of the National Academy of Science, does not detract from the weight of her testimony about the quality of the actual medical treatment provided to these patients, in the Board's opinion.
True that! The deconstruction of Mark Geier continues, as Dr Catalfo observes:
Dr. Geier, however, is not a "trained clinician." He completed only a one-year residency in obstetrics and gynecology, has no formal specialized training in the treatment of autism, and is not Board certified in any medical specialty.
The board also had few good words about the statements of Dr. Jerry Kartzinel (if the name rings a bell that is because you have seen him on this with Andy Wakefield):
The Board also notes that Dr. Kartzinel's testimony on the adequacy of Dr. Geier's physical examinations of these patients was particularly unpersuasive. ../..
He testified that a physical examination of the patients is highly overrated (Tr. 200) and that the physician "generally ... can bide by his eye" (Tr. 148-49) and just try to "get a gestalt," and that it is not even necessary for the physician to document that "gestalt" in the medical record. (Tr. 182) It is sufficient for the physician then to "step back and say, did I get a clinical response that everybody is thrilled with, or was it a swing and a miss," according to Dr. Kartzinel. (Tr. 155) In the Board's opinion, what Dr. Kartzinel describes as an acceptable medical examination and mode of treatment is not acceptable at all, and it is questionable as to whether this conduct can even be described as "medical."
Traurige Gestalt* is more like it. The hubris that those phrases reveal is not untypical amongst the "brave maverick doctors".

In their ruling, the State Medical Board do not speak to the allegation that Dr. Mark Geier let his unqualified son, David, practise Medicine. The Board state that this is being dealt with elsewhere (it has been) and that:
The Board will not make a decision in this case on this same factual issue based upon the less complete record made in this case. In light of the egregious violations of the standard of quality care and the deliberate unprofessional conduct set out in the numbered facts recited above, a decision as to whether Dr. Mark Geier also allowed Mr. David Geier to practice medicine without a license would have no effect on the sanction that the Board would impose on Dr. Mark Geier.
Read the Sanction in full, very slowly, word by word to understand that these proceedings dealt with a high number of unambiguous violations and there is really no room for a "misunderstanding" of what happened:
The ALJ commented that Dr. Geier abused the trust that these patients' families placed in him. "By dissembling, misrepresenting, failing to see his patients for months and years before treating them, applying a protocol-based treatment to children who do not fit the protocol, using non-FDA-approved drugs without fully informed consent, and for all of the other violations found and discussed in this Proposed Decision, he abused that trust. I agree with the State that these actions betray the relationship of a physician to a vulnerable child and his desperate parents."
The Board agrees.
The ALJ proposed that the Board revoke Dr. Geier's license. Dr. Geier has displayed in this case an almost total disregard of basic medical and ethical standards by treating patients without properly examining or diagnosing them, continuing treatment without properly evaluating its effectiveness, and providing "informed consent" forms that were misleading and in at least one case blatantly false. He provided treatments supposedly according to an investigational protocol, but the investigation was approved only by a sham Institutional Review Board, and he applied protocols to patients who did not fit his own profile. He provided treatment by a drug not approved for use in this country while informing parents that a different drug would be used. His actions toward his patients were not those of an honest and competent physician, nor do they appear to be those of an objective and ethical researcher. Dr. Geier made little use of those methodologies that distinguish the practice of medicine as a profession. At the same time, he profited greatly from the minimal efforts he made for these patients. In plain words, Dr. Geier exploited these patients under the guise of providing competent medical treatment. Such a use of a medical license is anathema to the Board. The Board has no hesitation in revoking his medical license.
Which they do:






What do I say? For the moment, I remain very quiet and listen to the weeeeeee sound that the Geiers' descent makes - they have been falling for a while and they have not hit rock bottom yet. It is likely that the repeated practising Medicine without a license and the number of other behaviours that led to this license revocation will have further consequences (like fines or even jail time). I also think that some insurance companies might want to have another look at the diagnosis and prescription practise of Dr Geier. Some parents (especially if they had to pay out of pocket) might want their money back.

Most of all though, as a parent, I am relieved that vulnerable children are safe from unlicensed drugs in uncontrolled treatment of undiagnosed conditions based on untrue hypotheses. My hope is that those who were treated with Lupron will not have sustained permanent damage and will find trained specialists to take care of their (hormonal and other) needs.

*sad figure

Hat tip to Stephen Barrett, MD

ETA: now also very nicely covered by Todd W. on Harpocrates Speaks