Skepfeeds-The Best Skeptical blogs of the day

FDA Revises Recommendations for Rotavirus Vaccines

Posted in Skepdude by Skepdude on May 14, 2010

READ THE FULL RELEASE AT FDA.GOV

The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.

The FDA also considered the following in its decision:

  • Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
  • The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
  • The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.

READ THE FULL RELEASE AT FDA.GOV

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FDA “Reverses” Its Position on Amalgam Fillings?

Posted in SkepticBlog by Skepdude on June 20, 2009

READ THE REST OF THIS ENTRY AT “SKEPTICBLOG”

Not.

Although, if you follow the alt-med news, you may have seen an article from six months ago or so trumpeting “FDA Reluctantly Admits Mercury Fillings Have Neurotoxic Effects on Children“. Wow! So, the FDA has finally admitted that the mercury in amalgam fillings is having devastating results on our children’s health. It’s on the Internet, so it must be true.

This headline grabbed my attention, in part because I had done a Skeptoid episode debunking the silly “smoking teeth” video on YouTube, made by some anti-amalgam people. In it, they dipped an extracted tooth in water and then filmed the water vapor rising off of the tooth using a fluorescent screen; only they said it was mercury vapor, and that it represented the constant flow of mercury into your body from amalgam fillings. (Mercury vapor is far heavier than air, it wouldn’t rise, it would sink.) It was a textbook case of alarmism.

The American Dental Association has always maintained that amalgam fillings are safe. They do release mercury, but it’s at the same rate as a gold or silver watch or ring releases gold into your body. It’s orders of magnitude below safe levels, and so amalgam’s many benefits have always far outweighed any risks.

The FDA actually changed its position in 2006, saying that more study is needed, but did not go so far as to say that amalgam shouldn’t be used or that people should consider having existing amalgam fillings removed. Removal of an amalgam filling would alone release far more mercury than keeping it for a lifetime would.

So I was pretty intrigued by this article. It seems to suggest that there had been some recent ruling or change, however, no mention of any such event was made in the article. The best I could determine was that this article was referencing the 2006 change. My guess is that it was a slow news day, so this “Natural News” web site trawled and found this old item which could be easily manipulated. According to the article:

The warning was one of the conditions that the FDA agreed to in settling a lawsuit filed by several consumer health groups.

Whether that’s true or not I don’t know, because the article gives no references or sources.

READ THE REST OF THIS ENTRY AT “SKEPTICBLOG”

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Tom Harkin Tips His Hand

Posted in Neurologica by Skepdude on March 4, 2009

My primary blog post today (as every Wednesday) is over at Science-Based Medicine. But I wanted to reinforce a very important point we have been discussing over there regarding Senator Tom Harkin.

Harkin, along with Orrin Hatch, was the force behind DSHEA – the Dietary Supplement Health and Education Act of 1994 that removed herbs and supplements, essentially, out from under FDA regulation. This resulted in the explosion of the supplement industry, happily jumping through this giant loop hole manufactured for them.

DSHEA is bad law and has significantly weakened health protection for Americans. Harkin is clearly a true-believer when it comes to supplements and cultish medical practices. However, the top contributor to his campaign in 2007-2008 was from employees of Herbalife, a multi-level marketing company selling supplements and herbs with dubious health claims. Hatch’s home state is Utah, which is considered to be the epicenter of the supplement industry.

Recently Harkin hosted a senate hearing and invited some of the luminaries of the CAM movement to speak. The clear purpose of this hearing was to push a specific agenda – to hijack Obama’s healthcare reform initiative to further infiltrate pseudoscience and sectarian medical beliefs into the healthcare system. David Gorksi and Peter Lipson both discuss this issue at SBM.

But here is the money-quote from Harkin.

One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.

How transparent.

READ THE REST OF THIS ENTRY AT “NEUROLOGICA”