Part 3: How did Gardasil pass FDA review?

Examiner.com

May 26, 3:29 AMVaccines ExaminerNorma Erickson

According to the FDA mission statement, their job is to “help the public get the accurate, science-based information they need to use medicines and foods to improve their health.” The job of the FDA is to protect and advance public health through the regulation of drugs, food, medical devices, cosmetics and blood products. Gardasil is but one of these products.

In order to accomplish this tall order, science must be the driving force behind all FDA decisions. Unfortunately, many scientists within the agency seem to feel science no longer plays a crucial role in the FDA’s regulatory decisions.

In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 scientists at all FDA centers, regional offices, and headquarters to examine the state of science at the FDA. 997 FDA scientists from around the country responded to the survey. Most of the respondents (66%) had been with the FDA over five years; almost a third (33%) of them had worked for the FDA for more than fifteen years.

Here are some of the responses to the UCS/PEER survey:

  • 70% of the responding scientists said the FDA had insufficient resources to effectively perform its mission.
  • 39% said the FDA is not acting effectively to protect the public health.
  • 57% indicated that FDA leadership did not consistently stand behind scientific staff, or managers, who put forth scientifically defensible positions that may be politically controversial.
  • 53% of those who responded felt they were not afforded appropriate time and resources to keep up with advances in their field of expertise.
  • 36% said they could not openly express any concerns about public health within the agency without fear of retaliation.
  • 40% said they could not express any concerns about public health outside the agency without fear of retaliation.
  • 22% indicated they felt FDA decision makers expected them to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.
  • 37% said the FDA is not as committed to product safety as it is to bringing products to the market.
  • 81% believed the public would be better served if the independence and authority of FDA post-market product safety systems were strengthened.
  • 63% said the laws and regulations that govern the FDA, including the agency’s structure, need change for the agency to better serve the public.
  • 47% of the respondents indicated they knew of cases where commercial interests inappropriately induced, or attempted to induce, the reversal, withdrawal or modification of FDA determinations or actions.

These responses, coming from FDA employees, paint a dismal picture of public health and safety in the United States. If this is the way people who work within the FDA feel, how can the American public be expected to trust decisions made by the agency?

How can the citizens of the United States feel secure in the knowledge that new drugs such as Merck’s HPV vaccine – Gardasil are safe, effective and necessary?

Sources: “Voices of Scientists at FDA:  Protecting Public Health Depends on Independent Science,” and “2006 UCS and PEER Survey of U.S. Food and Drug Administration Scientists.”

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.