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From video at https://www.youtube.com/watch?v=GvNCex2wPQs

The MMR Vaccine Controversy

Introduction

The MMR (Measles, Mumps, Rubella) vaccine, widely administered to children, has been at the center of a 25-year controversy highlighted by a whistleblower’s account. This article explores allegations of data manipulation, regulatory responses, and ongoing concerns about vaccine efficacy, aiming to provide a clear overview for lay readers while acknowledging the complexity of the issue.

Background and Whistleblower Claims

Sharyl Attkisson, host of “Full Measure,” introduced a story involving Stephen Krailing, a former Merck virologist. Krailing, previously a cancer researcher, claimed that upon joining Merck, he encountered a crisis over the MMR vaccine’s potential recall due to potency issues. He alleged that Merck was instructed by the FDA to overfill the vaccine with more live virus to ensure it remained potent over its two-year shelf life, but this raised safety concerns if doses contained too much virus initially.

Krailing further stated that during a study called Protocol 7, aimed at proving efficacy with less mumps virus, he and colleagues were told to falsify data when results didn’t meet FDA standards. He reported this to the FDA in 2001, facing retaliation including threats and evidence destruction, but felt the FDA’s response was inadequate, leading to his removal from the project and eventual resignation.

Legal and Regulatory Response

In 2010, Krailing and another scientist filed a whistleblower lawsuit against Merck, alleging they misled the CDC and defrauded taxpayers by concealing mumps vaccine issues. Dr. David Kessler, a former FDA head, testified that Merck’s labeling was misleading and the vaccine adulterated. However, after 14 years, the court dismissed the case in 2023, ruling that the CDC knew of the issues but continued purchasing the vaccine, thus no fraud occurred against taxpayers. Merck maintains transparency with the FDA and disputes the claims, stating they addressed all concerns and ensured potency.

Ongoing Concerns and Public Health

Despite legal outcomes, mumps outbreaks continue, with a 2020 CDC report noting most infected in a six-state outbreak were fully vaccinated, suggesting waning immunity. Krailing argues that parents and doctors cannot know the exact virus amount in each dose, crucial for informed consent. Merck counters that the vaccine, available for over 50 years, is vital for public health, a view supported by its long-standing use.

This situation highlights the balance between vaccine safety, regulatory oversight, and public trust, with ongoing debates about efficacy and transparency.

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### Survey Note: Detailed Analysis of MMR Vaccine Controversy

This section provides an in-depth examination of the MMR vaccine controversy, building on the whistleblower’s account and related developments, ensuring a comprehensive understanding for readers seeking detailed insights.

#### Context and Initial Allegations
The MMR vaccine, administered in two doses to most American children, has been a cornerstone of public health for decades. However, Sharyl Attkisson, in an episode of “Full Measure,” introduced a narrative spanning 25 years, focusing on Stephen Krailing, a published cancer researcher hired by Merck as a virologist. Krailing’s account, detailed in the video [MMR Whistleblower](https://www.youtube.com/watch?v=GvNCex2wPQs&si=lp6KqX-B-LQ-SaP-), reveals a corporate crisis at Merck over potential recalls due to the vaccine’s potency issues. He described it as a “sky is falling” event, underscoring the severity perceived within the company.

Krailing claimed that the FDA found the vaccine’s potency inconsistent over its shelf life, leading to instructions for Merck to overfill it with more live virus—measles, mumps, and rubella—to ensure it met minimum efficacy by the end. This overfilling, however, posed risks, as recipients might receive higher initial doses, potentially compromising safety. Internal documents suggested Merck knew the vaccine was potent for only a year, not two, and had distributed 23 million doses possibly ineffective, risking their license and billion-dollar government contracts.

#### Protocol 7 and Data Manipulation
To avoid recalling these doses, Merck launched Protocol 7, a study to prove the vaccine worked with less mumps virus. Krailing, assigned to this project, alleged that despite efforts, they couldn’t meet FDA standards. The shocking revelation was a Merck lab official instructing them to falsify data by crossing out results and writing new numbers, which Krailing described as “the laziest way ever.” He refused, and with five others, they collected original data, reporting to the FDA in 2001. He faced threats of jail and witnessed evidence destruction, such as viral plates being destroyed, prompting him to demand FDA action.

The FDA inspection confirmed data alterations without justification, but Krailing was surprised by their lack of strong response, leading to his removal from Protocol 7 and resignation. This retaliation highlighted the pressures whistleblowers face, a critical aspect of corporate accountability.

#### Legal Battle and Court Ruling
In 2010, Krailing and another former Merck scientist filed a whistleblower suit, alleging Merck misled the CDC, the largest vaccine purchaser, and defrauded taxpayers by concealing mumps vaccine issues. Dr. David Kessler, former FDA head under Presidents Clinton and George W. Bush, provided 800 pages of testimony, stating Merck’s labeling was misleading and the vaccine adulterated, raising questions about mumps outbreaks among vaccinated individuals. The case, lasting 14 years, concluded last year with the court dismissing it, ruling that the CDC knew of fraud and potency allegations but bought the vaccine anyway, thus no fraud against taxpayers occurred. Merck’s misrepresentations, including Protocol 7 testing, didn’t impact CDC decisions, as they continued purchasing despite real-world efficacy being lower than clinical trials.

Merck declined interviews but stated they were transparent with the FDA, acted appropriately, and ensured potency, disputing plaintiffs’ claims. They highlighted raising vaccine potency to meet shelf-life requirements, a significant step in addressing FDA concerns.

#### Public Health Implications and Ongoing Issues
Despite legal closure, mumps outbreaks persist, with the CDC reporting in 2020 that most infected in a six-state outbreak were fully vaccinated, suggesting waning immunity. This aligns with analyses questioning childhood mumps immunization longevity. Mumps, typically mild and resolving within two weeks, can lead to rare complications like deafness or encephalitis, also potential vaccine side effects, adding complexity to risk assessments.

Krailing emphasized informed consent, arguing parents and doctors cannot know the exact live virus amount in each dose, crucial for safety and efficacy evaluations. He questioned, “What if I ask how much is in it and you can’t tell me, that is a problem,” highlighting transparency gaps. Merck, however, underscores the vaccine’s 50-year history and public health importance, a view supported by its widespread use and CDC recommendations.

#### Comparative Analysis: Vaccine Efficacy and Regulatory Oversight
To better understand, consider the following table comparing key aspects of the controversy:

This table illustrates the multifaceted nature, from scientific to legal and public health dimensions, reflecting the controversy’s depth.

#### Unexpected Detail: Waning Immunity and Outbreaks
An unexpected detail is the persistence of mumps outbreaks among fully vaccinated individuals, as seen in the 2020 six-state outbreak, challenging assumptions about vaccine-induced herd immunity. This suggests potential waning immunity, a less discussed aspect in public discourse, yet critical for future vaccine strategies.

#### Conclusion
This controversy underscores the challenges in vaccine development, regulatory oversight, and public trust. While Merck and regulatory bodies maintain the vaccine’s safety and efficacy, whistleblower accounts and ongoing outbreaks highlight areas for improvement, particularly in transparency and long-term efficacy studies. This narrative invites further discussion on balancing corporate interests, public health, and individual rights, especially in informed consent.

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### Key Citations
– [MMR Whistleblower Full Episode Details](https://www.youtube.com/watch?v=GvNCex2wPQs&si=lp6KqX-B-LQ-SaP-)