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Pharma Controversy: Vaccines and Autism

When was the medication introduced to the public?

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  • 1998 – infamous Andrew Wakefield’s article
  • The MMR vaccine and autism connection
  • 14 years later – new investigation
  • Childhood vaccines and autism – no connection
  • Nowadays – no legitimate evidence found
  • 20% of people support this connection

At the end of the 20th century, Andrew Wakefield conducted his research, revealing the connection between childhood vaccines and autism. 14 years later a similar study was managed, but even though professionals did the same investigations, they did not find evidence to prove this link (Marla, 2012).

What is the indication for the medication, including the patient population that most commonly receives a prescription for the medication (age, sex, ethnicity)?

  • The MMR (measles-mumps-rubella) vaccine
  • 12-15 months and 4-6 years old
  • Regardless of sex and ethnicity
  • No mother’s antibodies after 1 year
  • Licensed for use until 12 years

The MMR vaccine is one of the most common vaccines used globally to protect children’s health. Kids should receive 2 doses after being 1 year old as they stop receiving mother’s antibodies and become vulnerable (CDC, 2016b). This vaccination is required as associated diseases are very catching.

What are the pharmacokinetics for the medication?

  • Vaccination – expected lifelong MMR immunity
  • Antibodies detectable after 2 or 3 weeks
  • Whole disease prevention lasts 11 years
  • 1 month and more between injections
  • At least 1 injection for adults
  • 0.5 ml of the vaccine in the upper arm

The MMR vaccination should be managed in 2 doses with 1 month – 11 years period between them (“M-R-Vax II,” n.d.). One dose can be enough for adults who had no vaccination.

What is the pharmacodynamics for the medication?

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  • Vaccine with elements of viruses
  • Injection – production of antibodies
  • Promotion of active immunity to MMR
  • Complications but lifelong virus persistence
  • Side effects – worsened health condition

With the help of this vaccine, professionals ensure that children have immunity to MMR. However, it often leads to health issues that require additional treatment and affect well-being.

How is the medication dosed?

  • Dosage 0.5ml for children and adults
  • 2 doses for small children
  • 1st – 12 months; 2nd – 4-6 years
  • Last administration – 12 years old
  • Interval – no less than 4 weeks
  • Possible 1-2 doses for adults

The dosage of MMR vaccine is the same for people of all ages but the number of doses may vary, as adults may have required immunity (CDC, 2016a).

What kind of monitoring is required with the medication?

  • Vaccine safety monitoring by the CDC and FDA
  • The Vaccine Adverse Event Reporting System
  • The Vaccine Safety Datalink
  • The Clinical Immunization Safety Assessment Project
  • Side effects and associated health risks

Vaccine safety monitoring is required because it allows revealing how people are affected by this preventive treatment (CDC, 2017). Professionals can share vaccine-related data within numerous medical centers in this way, which affects their ability to cope with the side effects of different severity levels.

What are some of the most common side effects?

  • Common – mild and short-lasting effects
  • 7-11 days – a mild form of measles
  • 3-4 weeks – a mild form of mumps
  • 1-3 weeks – issues with joints
  • Rare – idiopathic thrombocytopenic purpura and seizures
  • Extreme – a severe allergic reaction

Side effects after the vaccination are commonly mild. They last for 1-3 days and do not affect the overall health condition further. More critical cases are rarely observed as well as extreme issues, such as a severe allergic reaction (NHS, 2015).

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What is the average cost of the medication?

  • A part of a general check-up
  • Average vaccination price – about $246
  • Out-of-pocket or/and health insurance coverage
  • Doctors can estimate associated costs individually
  • Pediatricians or family practitioners to approach

The MMR vaccination is usually managed during a regular check-up. Its costs differ, depending on the location and provider but “Amino’s median network rate for an MMR vaccine is $246” (Marcus, 2017, para. 2). This amount can be totally or partially covered by health insurance.

Identify a clinical practice guideline or professional group of healthcare providers that recommend the use of the medication?

Describe the clinical guideline including the author(s) or professional group that supports it. Include how the guideline came to be: consensus, random control trials, etc.

  • The Advisory Committee on Immunization Practices (ACIP)
  • McLean, Fiebelkorn, Temte, and Wallace
  • Based on 339 scholarly sources
  • Statistical evidence from 20th-21st centuries
  • Consensus: current recommendations and recent revisions

The ACIP “comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States” and have experience in various healthcare fields (CDC, 2012, para. 1).

Identify and describe the controversy that surrounds the use of this medication or class of medications, in detail.

  • 12 children with developmental disorders
  • Biopsies – a pattern of intestinal inflammation
  • 8 cases of autism after vaccination
  • Based on parents’ feedback only
  • No support from other studies
  • Lack of legitimate evidence – controversy

The controversy associated with vaccination and autism started because of the results of the research study published 20 years ago. There was no sufficient evidence to support the author’s conclusions, as they were mainly based on parents’ beliefs and assumptions. Further studies did not ensure the population that this connection is impossible even though they provided reliable data.

Relate it to economics, ethics, morality, politics, medication side effects, medication effectiveness, access to treatment, or a combination of these.

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  • Vaccination – minimal risks of MMR epidemics
  • Vaccination for everyone – equality and safety
  • Vaccination – possible complications, including autism
  • Autism – untreatable disease; no normal life
  • Autism or MMR – worse influences

The MMR vaccination is obligatory because it prevents the development of epidemics of catchy diseases. However, it may cause autism, which prevents people from living normally while MMR can be treated. So what is worse?

Who has been impacted by the controversy?

  • Children with the weak immune system
  • Parents who make decisions for children
  • International travelers including adults without immunity
  • Healthcare personnel who contact with patients
  • Women of childbearing age – pregnancy issues

The discussed pharma controversy affects all people who do not have immunity to MMR, as they can catch these viruses (CDC, 2016b). However, the most vulnerable population includes children and women who are going to have kids.

What does the literature conclude (or not) about the use of the medication or class of medication?

You will use peer-reviewed articles that are current within 5 years to conduct your research.

  • Vaccination causes autism – no evidence
  • Controversy without any reasonable support
  • Community’s fear associated with a myth
  • Mainly genetic factors to consider
  • Vaccinations recommended

Taylor, Swerdfeger, and Eslick (2014) believe that people’s fear associated with the connection between autism and MMR vaccination is unreasonable. Uno, Uchiyama, Kurosawa, Aleksic, and Ozaki (2015) support this view, stating that research results do not prove the existence of this link.

What are the alternatives to the controversial medication or class of medications?

  • The MMR vaccine required usually
  • Alternative – three separate vaccines
  • Exception – existing immunity to MMR
  • No other options without vaccination
  • Alternative – complex and resource-consuming

Professionals encourage people to have the MMR vaccination because it is the easiest way for them to be protected from these diseases. Alternative prevention also requires vaccination but it is scheduled differently. As a rule, providers do not recommend it.

Name at least 2 alternatives, how they are dosed, side effects, cost, and how they are monitored.

Cite the source of your facts within the presentation.

  • Complex vaccination – three separate injections
  • Single-ingredient for measles, mumps, rubella
  • 2 vaccinations: 2nd dose is to be MMR
  • Possible MMRV vaccination – MMR and varicella
  • Costly, the same side-effects and monitoring

The MMR vaccine alternatives do not differ much from the original preventive injection and professionals try to ensure parents that the MMR vaccination is the best option (Pearce, Cortina-Borja, Mindlin, & Bedford, 2013).

Decide whether you will use this medication in your own clinical practice. Will you prescribe it? Will you prescribe it with caveats? Will you use an alternative?

  • Preferable intervention – the MMR vaccination
  • Should be recommended to all patients
  • Regular caveats needed as for all interventions
  • Possible use of alternatives (MMRV preferable)
  • No necessity to avoid the MMR vaccination

I will surely use the MMR vaccination in my clinical practice because it is rather safe and its side effects are not critical. I will prescribe it with caveats for patients not to be afraid of them but I will not recommend its alternatives.

References

CDC. (2012). About ACIP. Web.

CDC. (2016a). Administering the MMR vaccine. Web.

CDC. (2016b). Measles, mumps, and rubella (MMR) vaccination: What everyone should know. Web.

CDC. (2017). Measles, mumps, and rubella (MMR) vaccine safety. Web.

Marcus, O. (2017). How much does an MMR vaccine cost? Web.

Marla, C. (2012). Vaccines & autism: Controversy persists, but why? Web.

M-R-Vax II. (n.d.). Web.

NHS. (2015). MMR vaccine side effects. Web.

Pearce, A., Cortina-Borja, M., Mindlin, M., & Bedford, H. (2013). Characteristics of 5-year-olds who catch up with the combined measles, mumps, and rubella vaccine: Findings from a contemporary UK cohort. The Lancet, 382(3), S16.

Taylor, L., Swerdfeger, A., & Eslick, G. (2014). Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies. Vaccine, 32(29), 3623-3629.

Uno, Y., Uchiyama, T., Kurosawa, M., Aleksic, B., & Ozaki, N. (2015). Early exposure to the combined measles-mumps-rubella vaccine and thimerosal-containing vaccines and risk of autism spectrum disorder. Vaccine, 33(21), 2511-2516.

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StudyCorgi. (2022) 'Pharma Controversy: Vaccines and Autism'. 3 March.

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