NOVEMBER NEWS

Don't Take The Bait!

In the past month, BANA's office has received two phone calls that showed signs of being fishing expeditions. What were the callers after? They wanted to trap us into saying something that would allow them to make trouble for biofeedback. One call was from a woman who started out by being rude, demanding and aggressive, and got worse from there. She demanded to know what right we had to issue any sort of credentials to biofeedback practitioners (in fact BANA doesn't issue credentials), and whether our credentialing process had government approval. I think she might have been a Seattle Times reporter; see the story below on a series of articles which appeared in the Times shortly after I received the call, and which includes material about the EPFX machine. The other call was from a genial, confused elderly gentleman --- whose confusion came and went depending on whether he was posing as a patient or trying to get me to say things about biofeedback that I can't legally say. He pretended to need a referral to a biofeedback practitioner who could help cure him of an ailment that under FDA regulations biofeedback can't claim to address. The sad truth is that every biofeedback professional, sooner or later, is going to get a call like one of these, maybe from someone who is better at hiding their aims than the two people I spoke to were. Anyone working in the alternative health field always has to be aware that any call, email, letter, or office visit may be from someone who is out to harm us. How do you protect yourself? Do as I did with these two calls: stay within the law. Only make claims about biofeedback that are allowed by the FDA. Explain that you're not a doctor and can't practice medicine. Above all, never claim to be able to diagnose, prescribe, or treat any disease. Every day, assume that any call, office visit, or email may be from someone who can and will hang you out to dry. In today's climate you can't afford to take risks.

Seattle Times Series Sparks Controversy Over EPFX

A series of articles run in the Seattle Times in the last part of this month has sparked an FDA investigation into the EPFX machine and has prompted Congressman Jay Inslee, D-WA, to call for a Congressional investigation of "energy medicine machines", including the EPFX. At issue in the case of the EPFX are claims made by the device's manufacturer, William Nelson, and by sales literature, training videos and some practitioners, that the machine can diagnose and treat disease. These claims are contrary to Federal law in the United States, and since the EPFX has been registered with the FDA as a biofeedback machine the claims are subject to FDA jurisdiction. No word yet about whether Congress will choose to open an investigation; we'll keep an eye out for updates on that subject. The articles have also sparked a motion within the Washington State Chiropractors Association to ban use of the EPFX device by its members. That motion will be discussed at their December 6 meeting.

The full series of articles can be found here: http://seattletimes.nwsource.com/html/medicaldevices/

FDA Double Standards at Work

It's remarkable what you can learn by visiting the FDA website (http://www.fda.gov). Between 11/1/07 and 11/26/07 the FDA recalled 3 natural health products as unsafe. One was determined to contain an ingredient which can cause reduced vision in users. The other two were found to contain compounds analogous to prescription drugs used to treat erectile dysfunction, and were claimed to present a risk of lowering the blood pressure of users who also take certain prescription drugs. During the same time period the FDA recalled 1 prescription drug due to evidence that it increased mortality in surgery patients. On the other hand, between those same dates the FDA said it was concerned about 8 prescription drugs which have been demonstrated to cause side effects including impaired heart function, sudden deafness, suicidal thoughts and impulses, aggressive behavior, heart failure, mania, anxiety, hallucination, life-threatening rashes (including one form of rash which literally destroys human skin), and increased risk of mortality for patients who are part of the drug's target audience. Several of the drugs had restrictions placed on their use. That's right. Those 8 drugs weren't banned or recalled --- not even the ones proven to significantly increase a patient's risk of death. A natural remedy believed to cause even one of these side effects would be removed from the market. Prescription drug manufacturers whose products presented these side effects were warned to advise doctors of the side affects and to rewrite their labels. Parallel safety standards for prescription drugs and natural remedies? We can't have that!

Children Forcibly Vaccinated in Maryland

A nasty incident took place at the county courthouse in Prince George's County, MD earlier this month. 1600 families in the local school district had school-aged children who either hadn't been vaccinated, or whose records had been lost by the school district. These children weren't allowed to attend school until they got their shots, and the school district was losing federal funding due to the childrens' absence. The school district asked a sympathetic judge to rule that the children had to be vaccinated, and he agreed. On November 17, the families were forced to come to the courthouse to have the children vaccinated on the spot. According to witnesses, the parents weren't told that they could request a waiver on religious or medical grounds. Instead they were told that if they did not have their children vaccinated before leaving the courthouse, they would be arrested. In the case of some children, this was stretched to include vaccinations that Maryland law doesn't require. Officials obviously knew that what they were doing would make waves. The courthouse was surrounded by armed police officers with dogs, and activists and reporters weren't allowed to come within 50 feet of the building. The only adults allowed to enter the courthouse were parents and county employees. That makes me wonder if the powers that be wanted to make sure nobody told the parents about their other choices. And what did the judge have to say about it? He thought that the lines of unhappy children were "cute" and compared being forced to get their shots to being made to go to church.

Read more --- complete with links to other details --- here: http://vitaminlawyerhealthfreedom.blogspot.com

FDA Calls for Comments on Food Labeling

The FDA has issued a call for comments on the reference values to be used to calculate the percentage of daily value for nutrients in food labeling. For those of you not familiar with the labeling process, the reference values give a baseline for recommended daily intake. If a can label shows that one serving of the soup inside provides 25% of daily sodium values, that means that the amount of sodium in a serving is 25% of the reference value for sodium. Do you have opinions about the present reference values? Recommendations for what you think the new reference values should be? You have until January 31, 2008 to comment. All comments should refer to Docket #2006N-0168. To comment directly via the FDS website, go to the link given below. Sadly, like the rest of the technical material on the FDA site, the description of the docket and its contents are written in Government-speak, so you'll need patience and a good dictionary to wade through it.

To comment, go here: http://www.fda.gov/dockets/ecomments

New Website of Interest!

One of our members drew my attention to a new website that's being put up: Envision4Health.com. (See complete address below.) This fascinating site will be offering a lot of information for Alternative therapies professionals about how to effectively and legally do your work. It will also offer plenty of information about nutrition, food supplements, prescription and over-the-counter drugs, and natural alternatives. Furthermore, the site hosts pages for the Natural Therapies Research Board, which has completed three important research projects, is engaged in three more, and will be posting its results to the Envision4Health site. Among the information to come is a compilation of US and Canadian regulations governing biofeedback, and a study on the quality of relaxation attained by Quantum devices versus that attained by standard GSR devices. The site is still being built, so right now many portions of it aren't in place yet, but it promises to be a great resource when it's finished --- and there's a lot of good stuff on it already! In particular, check out their mission statement; what's not to love?

To visit the site, go to: http://www.Envision4Health.com

That's it for November! We'll be following several of these stories into December and if anything develops we'll include updates in the December newsletter.

In closing, may you and yours celebrate a joyous holiday season, whichever holiday you celebrate.

Yours for Health,
Sara Greer
Executive Director, BANA

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