Atlantic Health Partners Offers NY AAP District II Members the Best Fluzone Prices!

Practices who join Atlantic Health Partners and order Sanofi’s Fluzone by April 30^th will receive the lowest prices and best terms!  In addition, Atlantic offers your practice the most favorable prices and terms on the entire portfolio of Sanofi and Merck vaccines.

Our partner, Atlantic, is committed to ensuring that providing vaccines to your patients has a positive impact on the operational, financial, and clinical performance of your practice.

Many of your colleagues are already benefitting from Atlantic’s program, most notably from the savings and excellent customer service.  Atlantic also offers:

• Medicare Part D immunization program
• Reimbursement support and advocacy
• Medical supply discounts
• Lower office supply prices through Staples
• Additional discounts on Wellconnect Patient Recall Program

We encourage you to contact Jeff or Cindy at (800) 741-2044 or info@atlantichealthpartners.com to learn more about how your practice can benefit from joining Atlantic now.

Talking Points on Gardasil (posted 7/11/2008)

Human Papillomavirus (HPV) Vaccination:

• CDC continues to recommend HPV vaccination because of its importance for the health of women. CDC maintains this is a safe and effective vaccine.  However, as with all vaccines, we will continue to review the safety of this vaccine and take appropriate action if there are issues with the vaccine.
• Parents and providers are encouraged to report any adverse events to the Vaccine Adverse Event Reporting System http://vaers.hhs.gov/ (phone 1-800-822-7967).
• Parents are encouraged to discuss HPV vaccination with their pre-teen’s doctor.  The routine recommendation is to administer HPV vaccine at ages 11 and 12 years.
• People who miss vaccination at those ages can get the vaccine through age 26.
• Syncope, or fainting, is a common event occurring with needle injections and vaccinations, especially in adolescents.  CDC recommends that patients who receive HPV vaccine remain in the clinic for 15 minutes after vaccination to avoid potential injury from a fall.
• HPV disease and vaccine information is available at http://www.cdc.gov/vaccines/vpd-vac/hpv/default.htm

HPV Disease

• HPV is a common virus.  It is the major cause of cervical cancer in women.
• HPV infection usually occurs in people in their teens and early 20s.
• There are about 20 million people currently infected with HPV.
• Each year in the U.S., about 11,000 women will be diagnosed with cervical cancer and 3,600 will die.
• Women have an 80% chance of developing HPV by the time they are 50.
• Because the vaccine is a preventative and not a cure, it is important that the vaccine be given prior to beginning sexual activity.

HPV Vaccine

• On June 8, 2006, the Food and Drug Administration (FDA) licensed the first vaccine developed to prevent cervical cancer and other diseases in females caused by certain types of genital human papillomavirus (HPV).  The quadrivalent vaccine, Gardasil®, protects against four HPV types (6, 11, 16, and 18), which are responsible for 70% of cervical cancers and 90% of genital warts.  On June 29, 2006, the Advisory Committee on Immunization Practices (ACIP) voted to recommend routine vaccination of females 11 and 12 years of age. Catch up vaccination is recommended for females 13 though 26 years who have not been previously vaccinated.  Gardasil was tested in over 11,000 females (9 through 26 years of age) in many countries around the world, including the U.S.  These studies found that the HPV vaccine was safe and caused no serious side effects.  Adverse events were mainly injection site pain.  This reaction was common but mild.
• Since licensure, more than 12 million doses of Gardasil vaccine have been distributed in the U.S. In 2006, a total of 2,151,000 doses were distributed and in 2007, another 11,317,902.  At this time, the U.S. does not have a national registry for immunization and vaccination and therefore cannot report the total number of people who have received Gardasil.
• The number of serious adverse events reported to VAERS following HPV vaccine is less than 7% of the total number of reports received.  In comparison, the overall average in VAERS for any serious adverse event ranges from 10%–15%; thus, the percentage of serious reports for Gardasil is less than the overall average.

VAERS REPORT – A Case Currently in the News

• In late March 2008, a 14 year old girl’s physician submitted a report to the Vaccine Adverse Event Reporting System (VAERS) describing progressive muscular weakness which occurred approximately four months after the patient received her third dose of Gardasil.  In addition, the patient’s physician directly contacted the CDC to follow-up on the case.
• Upon receipt of the inquiry, CDC’s Clinical Immunization Safety Assessment (CISA) Network began a review of the case.  Through the CISA Network, CDC and the FDA have received permission from the family to collect medical history from the treating physician, the family, and the medical records.  CDC and FDA, in collaboration with internal and external clinical experts, continue to follow the child’s clinical course.
• Because the patient has symptoms of peripheral motor neuropathy, CDC and FDA scientists reviewed the VAERS database and found no other reports describing lower motor neuron lesion, amyotrophic lateral sclerosis, or peripheral motor neuropathy occurring after Gardasil vaccination.

Other Gardasil Reports in VAERS

• CDC and FDA are conducting an ongoing study of VAERS reports describing other adverse events after Gardasil. For more information visit: http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm
• As of April 30, 2008, VAERS received 7,802 reports after Gardasil vaccination in the U.S. Less than 7% of reported adverse events were considered serious, about half of the average for reports for other vaccines.  A report to VAERS does not mean there is a connection between the vaccine and the report.  It means the event took place following vaccination.
• VAERS data are updated continuously and the number of reports and the type of adverse events will vary depending on the date of analysis.
• VAERS defines serious adverse events by the Code of Federal Regulations as adverse events involving hospitalization, death, permanent disability, and life-threatening illness.
• Between the date of its licensure in June 2006 and April 30, 2008, VAERS has received 15 reports of death following Gardasil vaccination in the U.S. Only 10 reports contained the level of information adequate for further analysis.  After careful review of those reports, we could not establish the causal relationship between vaccination and death.  For the remaining 5 reports of death, we were unable to obtain any patient identifying information; therefore we could not confirm death.
• While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.
• Information on Gardasil vaccine reports to VAERS can be found on the Immunization Safety Office’s web page at http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm.

Statement of the Committee on Infectious Diseases of the American Academy of Pediatrics, District II, New York State regarding thimerosal and the Measles/Mumps/Rubella (MMR) vaccine

Pediatricians may once again face questions about thimerosal, autism, and the MMR vaccine, following the opening episode of “Eli Stone” on ABC, Thursday, January 31, 2008, in which the titular lawyer successfully argues in court that MMR caused a child’s autism, and wins a 5.2 million dollar settlement from the vaccine manufacturer.  The committee has compiled the information below, with references, to prepare and enable pediatricians to give detailed, accurate answers.

1. At present, pediatric vaccines used for the recommended immunization of infants and children are already thimerosal free or significantly thimerosal reduced.  The producers have, over the last four years, completely removed or reduced thimerosal to trace amounts in all childhood vaccines.  The only routinely administered vaccines that contain thimerosal are adult tetanus boosters and some influenza vaccines.  Thimerosal reduced or thimerosal free pediatric influenza vaccines have recently been developed, but their mass production is more complicated, so quantities remain limited and the cost is much higher.
2. Current scientific research indicates that thimerosal has no negative impact on infant or child health and development.  The committee is sympathetic to parental concerns regarding possible exposure of infants and children to a harmful substance.  However, the thimerosal controversy is largely based on misinformation, half-truths, and emotional but scientifically unsound personal stories.  The type of mercury contained in thimerosal is ethylmercury.  The known toxicity of mercury is based on human exposure to a different form of mercury, called methylmercury.  Methylmercury is a form of mercury that accumulates in the body.  It is true that in 1999, the American Academy of Pediatrics and the United Public Health Service recommended the removal of thimerosal from vaccines, but that recommendation was made as a precaution because there was inadequate data on effects of human exposure to ethylmercury.  In 2001, the Institute of Medicine (an impartial and highly respected unit of the National Academy of Science) concluded that the hypothesis of a causal relationship between thimerosal and developmental delay was biologically plausible; however, the evidence at that time could neither prove nor disprove the hypothesis.  Subsequent scientific data and studies on ethylmercury found that it was metabolized differently from methylmercury.  Unlike methylmercury, ethylmercury does not accumulate in the body.   The ethylmercury found in thimerosal is rapidly excreted from the body in the stool. In 2004, the Institute of Medicine reviewed the new data, and concluded that thimerosal has no negative impact on infant or child health and development  including no relationship whatsoever with autism.[1] A 2003 scientific study, based in Denmark, has shown that although Danish vaccines have been thimerosal free since 1990, during the period 1971-2000, the number of autistic children in Denmark has continued to increase, and that the increase continued in children born after the discontinuation of thimerosal. [2] A study of similar design of almost 28,000 children in Montreal born from 1987 to 1998 found the prevalence of pervasive developmental disorders to be high and increasing as in most other countries, but that this increase occurred despite a significant decrease in thimerosal exposure from vaccinations. [3] Finally, a 2007 study in the New England Journal of Medicine conducted by the Centers for Disease Control and Prevention’s Vaccine Safety Datalink found no pattern of association with thimerosal exposure and developmental outcome in 1047 boys and girls aged 7-10 years, and no support for a causal link between prenatal and postnatal thimerosal exposure and neuropsychological outcomes and functioning in childhood. [4]
3. The MMR vaccine is safe.  First of all, MMR vaccine in the U.S. has never contained any thimerosal.  Period. With regard to thimerosal, thimerosal reduced vaccines contain 0.0 – 0.5 mcg of rapidly excreted ethylmercury.  On the other hand, the average 6 ounce can of chunk light tuna contains over 20 mcg of mercury, in the concerning methylmercury form.  The same size can of solid white albacore tuna contains over 60 mcg of methylmercury. [5] By this rationale, those who seek to ban the annual pediatric influenza vaccine that contains 12.5 mcg of ethylmercury, should be banning the sale and consumption of canned tuna, and virtually all fish and shellfish.  By published EPA and FDA standards, all of these quantities of mercury are considered well below recommended exposure levels.[6][7]
   MMR was originally linked to autism, because of a controversial 1998 study led by British surgeon, Andrew Wakefield, which studied bowel symptoms in 12 autism spectrum children and concluded ,”We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.”  Although no causal connection had been shown in the study, Wakefield called for suspension of MMR, and recommended administration of single doses of each component.  Numerous follow-up studies by investigators around the world failed to show any causal connection between increasing rates of autism and introduction of the MMR vaccine.  By 2004, 10 of 13 co-authors published a retraction that read, “We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.”  The General Medical Council, regulator of the British medical profession, has brought charges against Wakefield for serious professional and scientific misconduct.
4. The MMR vaccine is still important.  Measles is a highly contagious viral illness, and prior to the introduction of the vaccine in 1963, virtually everyone got measles.  Over half of children aged 6 had measles, and by 15, 90% had it.  There were 3-4 million cases every year, with about 500 deaths.  Complications are common and include pneumonia and diarrhea, as well as rare complications like encephalitis (1/1000 cases) and corneal ulcerations.[10] In the 45 years since the introduction of measles vaccine, the incidence of measles in the U.S. population has fallen by 99.9% to just 30 cases for all of 2007.[11]  Many of these cases were imported from other countries.  Globally, measles remains a significant problem.  Over half a million deaths from measles occur annually, or about 5% of all childhood mortality, especially in those less than 5 years old.[12]  In less than two generations, we in the United States have forgotten how contagious and potentially dangerous measles is. 
5. Television shows that imply vaccines and thimerosal are harmful send the wrong message to the population and potentially create major health risks and unnecessary health costs.  Shows like “Eli Stone” suggest to the public that there are safety problems with current routine vaccinations.  This is not the case and such an unfounded implication undermines the critical role the immunization program plays in public health.  It needlessly frightens parents, as well as all Americans who face a real health threat from vaccine preventable infections, rather than thimerosal.  Shows like “Eli Stone” are junk science with an agenda masquerading as entertainment, and are as irresponsible and reprehensible as encouraging people not to use condoms because a latex allergic reaction is worse than contracting sexually transmitted infections like syphilis, gonorrhea, or HIV.
    

We ask that parents, guardians, and families carefully review the facts, and not be swayed by their emotions or the hype involved with the thimerosal controversy.  Mercury exposure from thimerosal is not the same as mercury exposure from fish or other environmental sources of mercury.  Receiving the MMR vaccine cannot result in mercury exposure levels exceeding either EPA or FDA guidelines, since MMR contains zero mercury.

We empathize with the parents of children with developmental delays, who only want answers and to ensure their children are safe from harm.  As pediatricians and parents, we share the same goal for the children under our care.  But we also have a responsibility to advocate for the children and protect them from the devastating and potentially life-threatening complications of measles, mumps, and rubella.

We urge parents and families to boycott “Eli Stone” and other shows of its ilk.  It only contributes to, rather than minimizes, public fears and concerns by legitimizing anti-thimerosal pseudo-science. It undermines the effectiveness of immunization programs that protect the public health.  It is an insult to healthcare professionals who work tirelessly on behalf of children. And it is clearly pandering to parents’ fears, manipulating the public to create controversy and buzz all in the name of ratings, free publicity, and advertising dollars for ABC.  We should not reward or legitimize ABC and its programs for such crass behavior.

Committee Members:

Paul J Lee, MD, FAAP, Co-Chair                Leonard R. Krilov MD, FAAP, Co-Chair
David Annunziato MD, FAAP                     Howard J. Balbi MD, FAAP
Kenneth Bromberg MD, FAAP                   David DiJohn MD, FAAP
Brinda Doriswamy MD, FAAP                   Abby J. Greenberg MD, FAAP
Donald S. Gromisch MD, FAAP                 Margaret R. Hammerschlag MD, FAAP
Marc Lashley MD, FAAP                              Sharon Nachman MD, FAAP
Sujatha Rajan MD, FAAP                              Lorry G. Rubin MD, FAAP
Sunil K. Sood MD, FAAP

REFERENCES

1. Institute of Medicine.  Immunization Safety Review: Vaccines and Autism.  Washington, DC: National Academies Press; 2004.
2. Madsen KM, Lauritsen MB, Pedersen CB, et al. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. 2003;112:604–606
3. Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D. Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations.  Pediatrics 2006 Jul;118(1):e139-50.
4. Thompson WW, Price C, Goodson B, et al, for the Vaccine Safety Datalink Team. Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years.   N Engl J Med 2007;357:1281-92.
5. http://www.cfsan.fda.gov/~frf/sea-mehg.html, accessed Jan 30, 2008.
6. http://www.cfsan.fda.gov/~dms/admehg3.html, accessed Jan 30, 2008.
7. http://www.fda.gov/CBER/vaccine/thimerosal.htm, accessed Jan 30, 2008.
8. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998. 351 (9103): 637–41.
9. Murch SH, Anthony A, Casson DH, et al. Retraction of an interpretation. Lancet 2004; 363 (9411): 750.
10. Pickering LK, Baker CJ, Long SS, McMillan JA, eds.  Red Book: 2006 Report of the Committee on Infectious Diseases. 27^th ed.  Elk Grove Village, IL: American Academy of Pediatrics; 2006.
11. Centers for Disease Control and Prevention.  MMWR 2008;56:1360.
12. Brenzel L, Wolfson LJ, Fox-Rushby J, et al.  Disease Control Priorities in Developing Countries (2^nd Edition).  New York: Oxford-University Press; 2006.