Category: Legal
The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements
A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the...
Lawsuit Alleges School Wi-Fi Harmed Child with Electromagnetic Hypersensitivity
My mother had a favorite saying that rhymed: “All you need from dawn to dawn is someone else to blame it on.” WiFi involves mysterious emissions that you can’t see and that sneakily permeate our environment, and they have become a popular target for blame. A lawsuit has been filed against the Fay School in Massachusetts on behalf of a 12-year-old boy...
Battle of the feds: FTC tells FDA to do its job regulating homeopathy
Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under...
Do You Believe in Magic? Oregon Does. Chiropractic and Acupuncture for Pain.
Do You Believe in Magic? Do you believe in magic for a back pains fix How the needles can free her, where ever it pricks And it’s magic, if the chi is groovy It makes you feel happy like an old-time movie I’ll tell you about the magic, and it’ll free your soul But it’s like trying to tell a CAM ’bout...
Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation
The Society for Science-Based Medicine has commented on the FDA's reconsideration of how to regulate homeopathic products.
Naturopathic Medical Magic in the NW
As regular readers know, I live in the great Pacific Northwest, specifically Portland, Oregon. I am at home in the organic/hippy/environmental mind-set. It is what I grew up with. It is a relaxed, informal place to live. It is not much of an exaggeration to say that formal attire is tucking your tee shirt into your jeans. At least the metro area,...
Nevada’s new quack protection law
Practicing a licensed health care profession, such as medicine, without a license used to be a felony in Nevada. Not any more. As of July 1, quacks and charlatans are free to ply their trades unencumbered by the threat that they might have to answer to the regulatory authorities for their misdeeds, as long as they follow a few simple rules. This...
Homeopathic industry and its acolytes make poor showing before FDA
On April 21 and 22, the FDA held a public hearing: to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. . . . FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not...
Lawsuit Update
For those of you following the defamation lawsuit against me by Dr. Edward Tobinick, there has been a significant and positive update. For quick background, Dr. Tobinick filed a suit against me personally, the Society for Science-Based Medicine, Yale University and SGU Productions for an article I wrote here critical of his claims that perispinal etanercept can treat a variety of neurological...
Florida strikes out against Brian Clement
Brian Clement is a charlatan. Unfortunately, that doesn’t seem to be a problem for the State of Florida. I made two (which turned into three) attempts to get the state to take action against Clement or the Hippocrates Health Institute, where he serves with his wife Anna Maria Gahns-Clement as co-director. All of them failed. Brian Clement slithered through the cracks in...