OPPOSE HB 1316: Pneumococcal Vaccine and Hepatitis A Vaccine Mandate

Click here to view PROVE's "Meet the Victims" newsletter to the Texas Senate (info on vaccine injures, Hep A vaccine and pneumococcal vaccine) 

• MANDATED PNEUMOCOCCAL VACCINE WOULD INVOKE MANDATED INSURANCE COVERAGE LEADING TO  HIGHER INSURANCE PRICES AND LOST COVERAGE FOR BASIC HEALTH CARE
  Texas statutes require that if a vaccine is mandated for use by law that a health benefit plan must provide coverage.¹  It has been well studied that state health insurance mandates drive up the cost of policies and increase the number of uninsured.² Texas already leads the nation in the number of residents without health insurance coverage.  According to a recent study by the National Academy of Sciences, 28.4 percent of the state's population is already uninsured, and most of them are working families.³  Higher costs will force even more people to drop insurance - a Congressional Budget Office study estimates that for every one percent increase in premiums, 200,000 Americans lose their insurance. ³ The last thing families in Texas need is another insurance mandate, and forcing the use of this vaccine by law is a sneaky way of forcing an insurance mandate without using those words in the bill.  One insurance company we spoke with (Golden Rule) said their chief actuary estimated that if this bill passes, they will have to raise family premiums over $100 per year per child in Texas.  All of the other vaccine mandates in Texas put together cost families about $114 per year per child.  This mandate would effectually double the cost of premiums for vaccine coverage.  
  
   
• VACCINE MANDATE NOT NEEDED - PNEUMOCOCCAL VACCINE ALREADY HIGHLY RECOMMENDED AND ACCESSIBLE TO ALL
  According to a study published in the American Academy of Pediatrics' own journal, 99% of pediatricians already recommend PCV7 for children younger than 2 years old⁴,  so clearly pediatricians don't need a mandate in place to alter their behavior to encourage the use of this vaccine.
  
  Additionally, this vaccine is already available to every child in the state if the parent wants their child to have it.  Many private insurance companies already cover this vaccine voluntarily⁵, and families certainly have the option to shop around and purchase higher priced policies with coverage if that is desired.  Of course we've never met a doctor who has turned down cash as payment, but for those families who either can't afford it or whose insurance plans don't cover it, they can go to any one of over 6000 providers in the Texas Vaccines For Children Program (TVFC) and receive the vaccine for free⁶ (purchased and distributed by the federal government using our tax dollars) or to any one of the 300⁵ of the Texas based Federally Qualified Health Centers or Rural Health Clinics through the federal Vaccines for Children Program.⁷ Only the children who are underinsured (who have insurance but their insurance doesn't cover PCV7) are inconvenienced with having to go to a Federal Health Center or Clinic to receive their free shot, and according to the Department of State Health Services, of the 750,000 children in day care, only 4% if them are underinsured and would have to go to a Federal Health Center or Clinic to receive their free shot.⁵
  
  It all boils down to this: all of this nonsense about presumably needing a mandate is to force the insurance companies of 4% of the kids in day care to pay for this vaccine so the parents don't have to be inconvenienced to go to a federal clinic where they can get it for free. 
  
   
• PNEUMOCOCCAL VACCINE TOO EXPENSIVE AND NOT COST EFFECTIVE - VACCEINE MANDATE WOULD GENERATE WINDFALL FOR DOCTORS AND SINGLE MANUFACTURER
  According to the Centers for Disease Control's (CDC's) price list, pneumococcal vaccine is one of the most expensive childhood vaccines on the market where the cost to give a child all four proposed required doses costs almost as much as all the other infant vaccines combined. The federal bulk purchase price through the Vaccines for Children Program is $51.58 per dose ($206.32 for the series)and the private sector wholesale cost per dose is $65.95⁸  ($275.80 for the series). 
  
  According to a study funded by the vaccine manufacturer itself on behalf of the CDC, this vaccine is ineffectual from a cost savings perspective.  This is the first vaccine where the manufacturer's list price does not result in a cost savings to society (the cost in terms of vaccine development and distribution versus the cost of lives saved and mitigating illness).  The break-even price of PCV7 is reported to be $46 per dose from the societal perspective and $18 per dose from the health care payer's perspective⁹  - far lower than the actual list prices of $51.58 and $65.95 respectively.  When you couple this information with the impact on health insurance premiums and availability, mandates for its usage don't make financial or medical sense.
  
  We called some pediatricians and found that in the private sector in Austin, Texas, they are charging $132 per dose - DOUBLE their wholesale cost and a whopping $528 for the series - and then they add on top of that a $25 administration fee each of the 4 times the shot is given.
  
  You don't have to be a whiz with numbers to see why a pediatrician would rather force insurance companies to pay for the vaccine when they can make a profit of 66 dollars a dose times four doses rather than simply administering a vaccine distributed and paid for by the Vaccines for Children program.  It is also important to note that there is only one manufacturer, Wyeth Pharmaceuticals, of this PCV7 vaccine called Prevnar, and this mandate would be nothing short of a windfall for pediatricians and Wyeth Pharmaceuticals.
  
  The costs may continue to climb long after this bill is passed because of its open ended language requiring pneumococcal vaccines. The CDC states that additional pneumococcal conjugate vaccines containing 9 and 11 serotypes are being developed.¹⁶  This language requires any of these vaccines to be automatically mandated when they are available potentially costing even more money.      
  
   
• Flawed Clinical Trials Did Not Prove Safety - MANDATES WILL COST MORE THAN MONEY
  In the trials for this vaccine, Wyeth and Kaiser Permanente compared one experimental vaccine (pneumococcal) against another experimental vaccine (meningococcal), which seriously compromised the scientific validity of the trial. Children in groups who got the pneumococcal vaccine suffered more seizures, irritability, high fevers and other reactions. There were 12 deaths in the Prevnar group, including 5 Sudden Infant Death Syndrome (SIDS) deaths.¹⁰
  
  Since the PCV7 vaccine was licensed in 2000, there have been 9,040 PCV7-related adverse events reported to the federal government (VAERS), including 1081 hospitalizations and 286 deaths.¹¹
  
  Each 0.5ml dose of Prevnar contains 0.125 mg. of aluminum¹⁰, a metal that the American Academy of Pediatrics admits is neurotoxic to humans.¹²  Federal regulations state: "The amount of aluminum in the recommended individual dose of a biological product shall not exceed 1.250mg" ¹³ The problem is that multiple vaccines containing aluminum are given on the same day.  DTaP, HepB, Hib, and Prevnar, all contain aluminum, and when the vaccines are given on the same day as what typically happens, infants receive up to 1.475mg of aluminum, exceeding the maximum dose.  Aluminum is eliminated from the body primarily through the kidneys.  Infant kidney function (glomerular filtration rate) is low at birth and doesn't reach full capacity until 1-2 years of age.  Therefore infants may not be able to effectively excrete aluminum in this and other vaccines, contributing to heavy metal toxicity.^14,15
  
  Also, the vaccine manufacturer's product insert states that "Prevnar has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility."¹⁰
  
   
• Disease NOT SERIOUS ENOUGH THREAT TO ENOUGH CHILDREN TO JUSTIFY MANDATE
  There are 90 known serotypes of Streptococcus Pnuemoniae bacteria - the PCV7 vaccine only covers seven strains (the seven most antibiotic resistant strains)¹⁷.  In other words, the same doctors who overperscribed antibiotics causing antibiotic resistance are now asking legislators to mandate the overuse of another product bringing about another new set of consequences.
  
  Additionally, the CDC explains that pneumococci bacteria are common inhabitants in up to 70% of normal adults.  This is not a bacteria that normally makes people sick. It is common in the people we are around everyday.  The immunologic mechanism that allows disease to occur in some is not clearly understood, however, disease most often occurs when a predisposing condition exists, particularly pulmonary disease.¹⁶   
  
  According to the CDC, prior to the introduction of the PCV7 vaccine, the number of children affected by pneumococcal disease in the whole United States was 13,000 cases of bacteremia, 700 cases of meningitis, and 200 children died.¹⁶  Vaccine mandate proponents like to cite that there were over 5 million cases of ear infections, but the vaccine was shown no more than 7% effective against ear infections¹⁰.  If you consider that only a small percentage of these cases were in Texas, and only a fraction of these children are in day care, and that the CDC reported that in 2003, 60% of Texas children had already voluntarily received 3 or more doses of PCV7 vaccine¹⁸, you simply can't justify a case to force the vaccine by law.
  
   
•  WHERE DO YOU DRAW THE LINE?
  At what point is enough enough?  With over 200 vaccines in the development pipeline, legislators are going to have to show some restraint over which vaccines are forced for use by law and which ones we are all forced to pay for.  Our bodies and our wallets won't be able to survive otherwise.

References:

1. Texas Statutes: Insurance Code §1367.053 (a) (2).
2. Council for Affordable Health Insurance: Health Insurance Mandates in the States - 2005.  http://www.cahi.org/cahi_contents/resources/pdf/MandatePubDec2004.pdf.
3. Institute of Medicine Report - Insuring America's Health: Principles and Recommendations, p 167. http://books.nap.edu/books/0309091055/html/167.html#pagetop
4. Abstract for "Influence of insurance status and vaccine cost on physicians' administration of pneumococcal conjugate vaccine" published in Pediatrics. 2003 Sep;112(3 Pt 1):521-6.
5. Phone conversation with Casey Blass, Department of State Health Services, Immunizations on 3/28/05.
6. http://www.tdh.state.tx.us/immunize/kit1.htm#overview
7. http://www.cdc.gov/nip/vfc/Parent/eligible_children.htm
8. CDC Vaccine Price List Updated February 2005.  http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm
9. Lieu TA, Ray GT, Black SB, Butler JC, Klein JO, Breiman RF, et al. Projected cost-effectiveness of pneumococcal conjugate vaccination of healthy infants and young children. JAMA 2000;283:1460-8.
   Referenced at http://www.aafp.org/afp/20010515/1991.html.
10. Manufacturer's Product Insert for Prevnar: http://www.wyeth.com/content/ShowLabeling.asp?id=134.
11. FDA and CDC's Vaccine Adverse Event Reporting System (VAERS) Data through 2004.
12. Aluminum Toxicity in Infants and Children (RE9607), Pediatrics Volume 97, Number 3 March, 1996, pp. 413-416.   
13. 21CFR Title 21. Vol 7. Sec. 610.15.
14. Simmer, K. Aluminium in Infancy. In: Zatta PF, Alfrey AC. (Eds) Aluminium Toxicity in Infants'  Health and Disease. 1997, World Scientific Publishing.
15. Unspoken Risks: The Impact of Mass Vaccination on our Future, Sherri J. Tenpenny, DO.  Presented to the American Chriropractic Association in July, 2004.
16. Epidemiology and Prevention of Vaccine-Preventable Diseases, Eigth Edition, January 2004, The Department of Health and Human Services Centers for Disease Control and Prevention.
17. Butler JC, Hoffman J, Cetron MS, et al. The continued emergence of drug-resistant Streptococcus pneumoniae in the United States. An Update from the Centers for Disease Control and Prevention's Pneumococcal Sentinel Surveillance System. J Infect Dis. 1996; 174:986-93.
18. U.S., National Immunization Survey 2003. http://www.cdc.gov/nip/coverage/nis/03/tab03_antigen_state.xls

April 5, 2008