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THE FDA SAYS THAT
"...it cannot fulfill its mission because___"
You can fill in the blank

I read a news article today that reports that Vytorin is no more effective than a PLACEBO for treating Aortic Stenosis.

"Vytorin did not help people with heart-valve disease avoid further heart problems, but did appear to increase their risk of cancer," according to a study presented at a press briefing. These findings "will heighten concerns about Vytorin's safety and effectiveness, said Steven Nissen, M.D., a former president of the American College of Cardiology and a longtime critic of Vytorin."

Some might argue that this isn't very important - unless you're one of the people being treat for aortic stenosis with the drug, Vytorin. However, let's look at the larger picture. Vytorin is yet another FDA-approved drug that is shown to be of no value. This is not a unique situation and I think we should all be concerned.

I suggest that this example demonstrates serious shortcomings in the federal agency that we look to for protection from harmul food, drugs, and cosmetics, the FDA.

I have reproduced the FDA Mission Statement further down on this page. Briefly, it states that the FDA is RESPONSIBLE for protecting the public health.

They asked us to believe them when they said that tomatoes caused salmonella infections. Then they said the tomatoes were safe. We're supposed to believe them and start eating tomatoes again - as if nothing happened (except that several tomato growers - and their employees - were completely devastated by the erroneous FDA report). Now they "think" the outbreaks happened because they found salmonella on a jalapeno pepper - but they don't know exactly where the pepper originated or how it might have gotten salmonella on it. But, that pepper MIGHT be the source of the outbreak. Now, what do we believe? I pray the pepper growers don't suffer the same loss of business the tomato growers had.

I've done a little research - with the help of a recent article by Dr. Jonathan Wright. In November 2007, the FDA published a document in which they admit their shortcomings and describe in detail WHY they are unable to meet their goals and objectives.

This LINK goes directly to the FDA site. The document is marked "Confidential" so the agency might not be too happy that people are accessing it.

I've made a copy of the complete document and have saved it to my website.
If the FDA link doesn't work use THIS ONE
This is a copy of just the index to this FDA document. I've marked some of the headings. I think they have used an interesting choice of words. I wonder how many FDA employees are aware of this 60-page document - or how many of our elected officials have heard of it. I suggest that it would be a valuable exercise to take the time to make sure our legisolators have a copy. I plan to send a copy - with a letter - to my Senators, Durbin and Obama (he MIGHT have time to read it between trips outside the country), and to my congressman. Feel free to copy the pdf file and print it or send it electronically. It is a Federal document, published on the FDA website. It is in the public domain and every citizen is free to use it in whatever way he or she sees fit.

FDA Science and Mission at Risk
Report of the Subcommittee on Science and Technology

Prepared for the FDA Science Board November 2007

Table of Contents

FDA Mission Statement
1.0 Executive Summary
   1.1 Overview
   1.2 Major Findings
     1.2.1 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak
     1.2.2 The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability
     1.2.3 The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate
  1.3 Summary Statement and Recommendations
  1.4 The Structure of This Report
2.0 Context: The Changing FDA Environment
  2.1 Growing Disparity between Responsibilities and Resources
  2.2 The Criticality of Science
  2.3 The Changing Nature of Science
3.0 Discussion of Key Findings and Recommendations
  3.1 Science: Capability, Capacity and Organization
     3.1.1 Finding: FDA does not have the capacity to ensure the safety of food for the nation
     3.1.2 Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA
     3.1.3 Finding: There is insufficient capacity in modeling, risk assessment and analysis
     3.1.4 Finding: The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization
3.2 Workforce: Securing Critical Scientific Capability and Capacity
     3.2.1 Finding: The FDA has substantial recruitment and retention challenges
     3.2.2 Finding: The FDA has an inadequate and ineffective program for scientist performance
     3.2.3 Finding: The FDA has inadequate funding for professional development
     3.2.4 Finding: The FDA has not taken sufficient advantage of external and internal collaborations
3.3 Information Infrastructure
     3.3.1 Finding: The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain
     3.3.2 Finding: The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
     3.3.3 Finding: The FDA cannot provide the information infrastructure support to regulate products based on new science. MORE...
 
FDA Mission Statement
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
  • You can help fix a broken agency.
  • Send the document to your legislators, with a cover letter.
  • They will learn something even if they only read the first couple of pages.

VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet.

Aortic Stenosis is abnormal narrowing of the aortic valve. A number of conditions cause disease resulting in narrowing of the aortic valve. When the degree of narrowing becomes significant enough to impede the flow of blood from the left ventricle to the arteries, heart problems develop.

Placebo: An inactive substance that looks the same as, and is administered in the same way as, a drug in a clinical trial