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Tag: stakeholders

The FDA and their Transparency Initiative may interest some of you as thyroid patients

The FDA....In case you are interested, the following represents Phase 3 of the FDA Transparency Initiative, which could end up benefiting thyroid patients as we deal with the upcoming clinical trials for natural desiccated thyroid. The links at the bottom give more understanding, as well.

For Immediate Release: March 12, 2010

FDA Task Force Seeks Public Comments on Increasing Transparency With Regulated Industry

As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.

Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.

The FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency — biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines — are integral to public health and to the U.S. economy.

The agency formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.” The Task Force is developing recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information.

The Task Force held public meetings in June 2009 and November 2009. Based upon input received thus far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and the agency intends to issue draft proposals for public comment soon.

The request for comment for the third phase follows a series of listening sessions with members of regulated industry in January 2010. Transcripts and summaries of those listening sessions are available at http://www.fda.gov/transparency and at http://www.regulations.gov.

For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

  • Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
  • The guidance development process
  • Maintaining open channels of communication with industry routinely and during crises
  • Providing useful and timely answers to industry questions about specific regulatory issues

Electronic comments may be submitted to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA—305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA—2009—N—0247.

For more information:

FDA’s Safe Use Initiative–think they will listen to our cries about T4-only meds?

EarplugsAs a thyroid patient who was profoundly harmed by the use of Synthroid and Levoxyl in the treatment of my hypothyroidism, and as an activist who sees this same harmful truth with potentially millions of other patients, I find this recent news interesting.

But you gotta wonder if they will be wearing noise reduction headsets and ear plugs…or not…when it comes to the scandal of synthetic T4-only medications.  Will they?

Just today, the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) announced the Safe Use Initiative, “a program aimed at reducing the likelihood of preventable harm from medication use”.

Statements I gleaned from this initiative include:

1. Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health–as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.

2. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use.

3. Medications offer great benefit, but they come with risks. Whenever medications are not used optimally, risks of harm can increase significantly.

4. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm.

This initiative is actually far broader than what I gleaned above, and also involves self-abuse, exposure of dangerous medications to children, dire side effects, and more. Five areas are also specifically targeted:  Consumer medication information (CMI), Medication dosing devices, Acetaminophen toxicity, Alcohol-based surgical preps, and Medications in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this initiative, or do their job overall, you have to wonder if they will listen to and include the problems associated with being treated with a T4-only medication as experienced by millions of patients worldwide. Continuing symptoms of hypothyroidism while on this inadequate treatment is widespread and damaging for many, causing hands reaching deep in pockets to pay for numerous doctors appointments, besides antidepressants, anti-anxiety meds, blood pressure meds, statins, cortisol meds for adrenal fatigue, and other medications which we would have never needed, and would have been preventable, if we had been on natural desiccated thyroid like Naturethroid or Westhroid in the first place.

Many patients on thyroxine, T4-only medications will also report actual hospital visits due to the side effects of a poor treatment.

In other words, thyroxine aka levothyroxine aka T4 treatment has been an unsafe and harmful treatment, causing millions to suffer unnecessary injuries and side effects for over 50 years of its useless and popular use.  It fits the Safe Use Initiative. Or at the very least, it calls for the FDA to listen to patient experience with this lousy choice to treat hypothyroidism.

Listen to us, FDA. Listen and be wise.

P.S. See the blog post below about a genetic reason why so many do lousy on T4.

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