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Medical Forum / General / Nutrition / August 2005House Bill HR 3156 Gutting Supplement Law
http://debunkbigpharma.blognation.us/blog/_archives/2005/7/30/1091118.html Excerpt of Email interview I'm waiting for a response from. Comment: Representative Davis your new amendment to the DHSEA, HR 3156 seems to unravel the sprint of the original law by allowing congress to throw out science in favor of popular vote. The new risk-benefit analysis and unreasonable risk judgment can be determined without conclusive scientific proof. Q. How can you promise that your new version of the DHSEA will not allow discrimination of natural substances because they may be unpopular with congress even though they are relatively safe and not statistically harmful? Comment: I know you are fighting to keep Ephedra illegal. We can argue until we are blue in the face on the relative safety of Ephedra. I understand Ephedra is used as a base for Crystal Meth production. I understand you feel one way to stem the tide of drug abuse is to make as many Crystal Meth base substances illegal as possible... I think the american consumer has the right to all information in order to make informed purchases. I would like all supplements to have the same level of information as to safety, effectiveness, and label accuracy as does aspirin and hundreds of other over the counter products now. As it stands, those who sell supplements don't have to report adverse reactions, the law leaves it up to regulators to discover it by some accident. Many assays done about contents find on a regular basis that contents don't match label information, even to there being any of the claimed items at all. I agree with current proposals that all adverse reactions need to be reported and routine assays of contents be required. This is the minimal information necessary for an informed buying decision. > I think the american consumer has the right to all information in > order to make informed purchases. COMMENT: I think everybody has the right to a BMW. I just wish we all could afford one. > I would like all supplements to > have the same level of information as to safety, effectiveness, and > label accuracy as does aspirin and hundreds of other over the counter > products now. COMMENT: Why? Aspirin is rather poisonous. You want the makers of vitamin C pills to work as hard to collect safety info as the makers of aspirin? By what rationale? > As it stands, those who sell supplements don't have to > report adverse reactions, the law leaves it up to regulators to > discover it by some accident. COMMENT: Don't look now, but those who sell aspirin don't have to collect or report adverse reactions, either. If they did, your bottle of aspirin would be a lot more expensive. > Many assays done about contents find on > a regular basis that contents don't match label information, even to > there being any of the claimed items at all. COMMENT: Indeed, and that is illegal NOW. I doubt that there's anybody who disagrees that content fraud is fraud, and should be illegal. And in fact, it is. But just how do you propose to enforce content claims? A government agency which takes pills off the shelf and assays them? Your taxes will go up *quite* a bit. Why should I pay the government to assay or test products I have no interest in buying? Isn't that what UL or Consumer Reports is for? > I agree with current > proposals that all adverse reactions need to be reported and routine > assays of contents be required. COMMENT: You want adverse reactions reported for vitamin pills but not vegetables or hamburgers or roller skates or seeing a Chris Rock or Pauli Shore movie? This is going to go to some central government office? :) You want a different standard for routine assay for vitamin pills than you get now for assay of gasoline at your local station or sugar you buy at the grocery store? How do you know somebody isn't diluting your saffron in the spice section? > This is the minimal information necessary for an informed buying decision. Well, buy Consumer Reports and pay for it, then. I don't know why you think information should be free. Or paid for by the taxpayer socialistically, any more than houses or cars or anything else is. SBH SBH The below mostly irrelevant and largely strawman arguments, with a basic appeal to allow the fraud and marketing used now to push "food supplements" to not allow the consumer have the information needed to make informed purchases. Questions about label/content fraud and safety are left out to dry at the pleasuer of the pill pushers. The required informatin is known about aspirin and vitamins, the latter used as a boogie man, but not about the "food supplement" products which are often powerful drugs whose safety are a pig in a poke. As citizens we do pay for these matters not to be a toss of the dice for many products and there is no rational reasons this segment of the market of human consumables should be left chance and the pleasure of those who sell them. >> I think the american consumer has the right to all information in >> order to make informed purchases. [quoted text clipped - 63 lines] > >SBH I have no idea where you get your information. What supplements are powerful drugs, I would like to get my hads on some of those. 2 weeks ago I wreaked my bike and tore my forearm open requiring 12 stitches + I broke my elbow. For over two weeks I have been taking over 150 pills a day in order to help my revovery. Nutrition was not good enough, I got a shot of antibiotic in my butt. That 1 shot cost $ 112 and got the swelling down caused by an infection. If supplements are powerful unregulated drugs why do I have to take 150 pills per day to get 1/4 of the effect of 1 antibiotic needle. Today I got my stitches out and my doctor said I'm making remarkable progress considering the type of cut and infection. It depends in part on what a "supplement" is. The current bill lists so broadly so many things to avoid regulation on health grunds that there is confusion. I'm not talking about vitamins and minerals, which have always been otc products, just like aspirin. I have in mind the bulk of "food supplements' whose real intention is to act as a drug in some fashion and are sold as such while skirting the medical claims rules. To give an example, chinese red yeast rice is used to control lipid levels. It's active ingredient was found to be identical to a perscription statin drug. Many such things sold as supplements have as active ingredients biochemicals which evolved to be toxic to things that feed on plants as a defence. Without information these are a pig in a poke as to human effects at various levels and interactions with other drugs. Sorry to hear about your accident, hoping for rapid recovery. The reason the drugs you take work in predictable ways and in known safe ways is because research on purpose was done, too often information missing in supplemets. >I have no idea where you get your information. What supplements are >powerful drugs, I would like to get my hads on some of those. 2 weeks [quoted text clipped - 9 lines] >Today I got my stitches out and my doctor said I'm making remarkable >progress considering the type of cut and infection. The only problem with adverse effects being reported is most of them can not be directly proven to be the result of the supplement. If you take a new type of Echincea and come down with a cold you could report that Echincea gave you a cold. That would go down in a government record as a negitive side-effect. One death reported by the FDA in congressional testamony being attributed to Ephedra was a death by car crash. The guy was DUI and DOA but since he had Ephedra in his blood his death was caused by Ephedra. The Baltimore pitcher who died from Heatstroke was dressed in sweats, not drinking water and playing ball in 106 degree temps. He took some Ephedra pills and they killed him, not his high blood pressure or heat stroke. Today I took some Ginger pills and farted, should I call it in as an adverse reaction. I'm thinking about it. Reporting and collecting this information is standard activity in most > human consumables. If during a drug study a person gets a headache which everyone aggres is not due to the item, it gets reported as an adverse event. Many of the items listed in the drug insert info comes from this and headache will be there just because it happened during the trial. Because doing such reporting can have flaws not intended means we should not do it? Why not in prescriptin drug research then?? If there is some question as to source, then further research is warrented to find the single item at fault. We should buy a pig in a poke because such things happend and be even more clueless as to the adverse effects cause? >The only problem with adverse effects being reported is most of them >can not be directly proven to be the result of the supplement. If you [quoted text clipped - 10 lines] >Today I took some Ginger pills and farted, should I call it in as an >adverse reaction. I'm thinking about it. Another problem with added red tape is $$$money$$$. Drug companies have boat loads of it. The vitamin company Solgar was bought for $ 150 million last month. The drug company Pfizer's ad budget for the drug Lipitor is $ 120 million per year. Also the NEJM blasted the FDA for having a financial conflict of intrest involving their desision to keep deadly Cox-2 inhibitor drugs on the market. ----New England Journal of Medicine Blasts FDA for Conflict of Interest---- by debunkb1gpharma at 09:50AM (PDT) on July 18, 2005 | Permanent Link | Cosmos Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees Advisory committees to the Food and Drug Administration (FDA)help the agency make decisions about the approval of medications and medical devices, among other issues. Membership on these committees is subject to detailed policies and procedures formanaging potential conflicts of interest and for balancing possible conflicts against the agency's need for advisers with relevantscientific expertise (see box).1,2 Two recent high-profile meetings have raised questions about the agency's approach and whether it should change. http://content.nejm.org/cgi/content/short/353/2/116?query=TOC Vol 353:116-118 July 14, 2005 #2 http://debunkbigpharma.blognation.us/pdf/f/NEJM%20116.pdf ----Pfizer Spent $120 Million Marketing Lipitor Last Year---- by debunkb1gpharma at 09:13AM (PDT) on June 27, 2005 | Permanent Link | Cosmos Pfizer Seeks Creative Ideas on Lipitor NEW YORK Pfizer has contacted agencies beyond incumbent Merkley + Partners for creative ideas on its best-selling Lipitor drug, with an eye toward repositioning the brand, sources said. Major media spending on Lipitor has increased in each of the past four years, from about $50 million in 2001 to nearly $120 million last year, according to Nielsen Monitor-Plus. In the first four months of 2005, spending totaled about $35 million. Estimated revenue on the account is $6-8 million. --Andrew McMains and Kathleen Sampey Vitamins are the boogy man always brought up in this topic, as long as the label is valid no other regulation is needed as they have been fully researched. What you are arguing for is bett regulation to make sure all companies sell safe effective human consumabeles, in which I join with you. Because thereis laxity in regulation should it be ended? If these things happen with more less public awareness of the examples you mention, what can we imagine for the supplement industry where things are not so open by a mile on purpose under law? If we can save money with no regulation, then drop it for all human consumables. >Another problem with added red tape is $$$money$$$. Drug companies >have boat loads of it. The vitamin company Solgar was bought for $ 150 [quoted text clipped - 45 lines] > >--Andrew McMains and Kathleen Sampey >http://debunkbigpharma.blognation.us/blog/_archives/2005/7/30/1091118.html > [quoted text clipped - 3 lines] >seems to unravel the sprint of the original law by allowing congress to >throw out science in favor of popular vote. Entering this bill number to http://thomas.loc.gov/ ..says that it is not a valid bill number. Is this internet apocrypha? A reply from Rep Susan Davis about HR 3156 Rep Davis wants to ban DHEA because some people in the govenrment don't want people taking DHEA. No science, no real reasons, just control issues. Rep Davis wants to put more controls on all supplements other than vitamins and minerals. In her letter she does not explain any scientific reasons why DHEA or any other supplement should be banned. HR 3156 unravels the sprit of the current supplement bill and replaces science with emotion. --------------------------------------------- I noticed the statement in your blog that HR 3156 would impact vitamins and minerals. HR 3156 actually excludes vitamins and minerals from the provisions of the bill. Below is the text from the bill: `SEC. 416. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY. `(a) Limitation on Applicability- Notwithstanding the other subsections of this section, this section does not apply to any dietary supplement that meets the conditions described in paragraphs (1) and (2), as follows: `(1) The supplement bears or contains one or more of the following dietary ingredients: `(A) A vitamin. `(B) A mineral. `(C) A concentrate, metabolite, constituent, extract, or combination of any vitamin or mineral. `(2) The supplement does not bear or contain-- `(A) an herb or other botanical, an amino acid, or a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or `(B) a concentrate, metabolite, constituent, extract, or combination of any ingredient specified in subparagraph (A). ------------------------------------------------ August 2, 2005 Dan Gilliland 2121 1/2 Spray St San Diego, CA 92107 Dear Dan, Thank you for expressing your opposition to increased federal regulation of Dehydroepiandrosterone (DHEA). I appreciate hearing from you and welcome the opportunity to respond to your comments. As you may know, DHEA is made from cholesterol by the adrenal glands, which sit on top of each kidney. Production of this substance peaks in the mid-20s and gradually declines with age in most people. What this drop means, or how it affects the aging process, is unclear. In fact, scientists are somewhat mystified by DHEA and have not fully sorted out what it does in the body. However, researchers do know the body converts DHEA into two hormones that are known to affect us in many ways - estrogen and testosterone. Currently, DHEA supplements can be bought without a prescription and are sold as "anti-aging remedies." Some proponents of these products claim DHEA supplements improve energy, strength, and immunity. DHEA is also said to increase muscle and decrease fat. Consequently, DHEA is popular. According to the Nutrition Business Journal, about $47 million worth of DHEA was sold in the United States in 2003. However, the National Institute on Aging cautions consumers about taking DHEA without first consulting your physician. Since DHEA is regulated as a dietary supplement, a firm does not need FDA approval and does not need to prove its products are safe or effective before marketing. Also, there is no specific guarantee the substance in the container is authentic or that the indicated dosage is accurate. Because of these differing standards, hormone-like substances sold as dietary supplements may not be thoroughly studied, and, therefore, the potential consequences of their use are not well understood or defined. In addition, these over-the-counter products may interfere with other medications. Throughout my career, I have been a vocal advocate for quality care and greater information exchange. Many find dietary supplements like vitamin C and folic acid beneficial to their health. However, I am concerned that the current regulatory framework is porous. Let me assure you I am not interested in restricting all dietary supplements from the marketplace. However, I am interested in seeing the FDA take reasonable steps to ensure the public health and protect our loved ones. Again, thank you for taking the time to share your perspective on this important matter. I hope you will continue to contact me about the federal issues that concern you. As your representative, I both need and value your thoughts and ideas. With warm regards, Susan A. Davis Member of Congress ************************************************************************** DISCLAIMER I cannot guarantee the integrity of the text of this letter unless it was sent to you directly from my Congressional e-mail account: Susan.Davis@mail.house.gov. If you would like to be removed or added to my e-mail update list, please send your name and address to this account and type "REMOVE" or "ADD" in the subject line. Thank you. ************************************************************************** |
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