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. SWOOP DOWN LIKE A GIANT CONDOR C.O.N.D.O.R:
Citizens Opposed to Nasal Destruction of Olfactory Receptors
Make your own ZICAM Cold Remedy. First get a gallon bucket. Next get a gallon of all two active ingredients below. Next get 10,000 gallons of water (per directions 4X is 10,000 to 1 in Homeopathic language).
10,000 gallon Tank
Now shake real good and you now can give to your friends and family all the cold remedy nasal spray they could use in a lifetime. Best of all its now zinc free!!
Best of all ZICAm says it clinically-proven
Not statistically sound methods at all. Complete scam
The Zicam story to be told. Inventor of Zicam has two diploma mill degrees. Dr R. Steven Dvidson did this while only having a High School Diploma Mill degree at the time
Colbert Tweaks Zicam's Nose
Last week, the FDA, followed by Health Canada, issued consumer alerts on Zicam’s Cold Remedy nasal gel and swabs because at least 130 users reported suffering loss of the sense of smell, a medical condition called anosmia, after using the product. Despite the seriousness of this health risk to the public, Health Canada does not have the power to order the recall of the product – an authority gap that would have been rectified by Bill C-51. Yet luckily, in this case, the manufacturer Matrixx Initiatives has voluntarily withdrawn the products cited by the FDA.
News of the Zicam alert was picked up quickly by the mainstream media and has been covered by fellow skeptic Dr. Steven Novella at Science-Based Medicine. But nothing undercuts a product’s credibility quite as much as when the late night comedy shows get hold of the story, and on Monday, Stephen Colbert, calling himself a “born skeptic”, took his shots at Zicam and its developer. The video can be seen at The Comedy Network in Canada and at Comedy Central in the US.
“Shocking, disturbing news,” exclaimed Colbert, “which could affect millions …”
“… of dollars for the makers of Zicam.”Colbert cynically observed:
“I cannot for the life of me understand why the FDA would crack down on an unregulated heavy metal that you spray in your nose that can cause permanent damage.”About Zicam’s developer, Robert Steven Davidson, Colbert stated that he:
“got his PhD from the American University of Asturias, an unaccredited and now-defunct university in Spain. The American University of Asturias is the Harvard of fake schools. It’s even better than ‘Altered State’ and the ‘Beerniversity of Drinkachusetts’. And just five years later, Davidson got his Bachelor’s degree from the on-line virtual school, Excelsior College. That’s right, he got his PhD first. Getting your BA before your PhD is your dad’s way of doing things, just like researching your medicine’s side-effects before you release it.”The Washington Post article “ The Men Behind Zicam” stated that the health product’s co-developers “have unusual backgrounds” and confirms the backstory of Davidson receiving his doctorate from a “diploma mill”. The other patent holder, Charles Hensley, a professor at the Cleveland Chiropractic College “recently received a warning letter from the [FDA] about the sale over the Internet of an unapproved drug his company makes to treat bird flu” and “previously developed a weight-loss remedy that involves sniffing ‘specially developed aromas’.” Interestingly, the article pointed out that Davidson “declined to discuss whether any safety questions arose during Zicam’s development and testing.”
Even Rush Limbaugh got into the act. Limbaugh’s show is sponsored by Zicam, which implies an affinity between Limbaugh listeners and Zicam users. Colbert played a clip of Limbaugh calling the FDA’s crack down on Zicam “unprecedented”, saying that “the FDA has never done before what it did yesterday,” which is of course nonsense. The FDA releases alerts all the time on products that pose public health risks. Limbaugh claimed that the FDA’s action is a Democrat-inspired plot to get back at him personally, for which Colbert delivered his punchline:
“Now, that may smell like bullshit to some people, but not to users of Zicam.”Skeptics have been tracking this story for a while. Perhaps the initial legal action concerning anosmia and Zicam was reported by Dr. Stephen Barrett in his 2003 Homeowatch article “ Zicam Marketers Sued“. The case’s legal complaint stated that, when Dennis Christensen felt a cold coming on, he used Zicam Cold Remedy Nasal Spray as directed. Afterwards, he “felt an intense stinging and/or burning sensation in his nose”, and subsequent to this single use, he “has totally lost his sense of smell”, a condition which was medically assessed to be “in all likelihood permanent, total and irreversible”.
Other lawsuits followed. In their 2006 article “ Is Shelf Life Of Zicam Nasal Spray In Jeopardy?“, LawyersandSettlements.com reported:
“A second lawsuit was filed on December 18, 2003, in Etowah County, Alabama, by Janie Sutherland, and also named Wal-Mart as a defendant. The third lawsuit was filed in Maricopa County, Arizona, in January 2004, by 3 plaintiffs claiming to have lost their sense of smell and taste immediately after using Zicam. After that, lawsuits began sprouting up all over the country.”To the extent that:
“As of January 18, 2006, according to [Matrixx Initiatives'] filings with the Security and Exchange Commission, there were 49 different lawsuits pending against Matrixx involving approximately 400 individuals.”Then on 20 January 2006, according to the Washington Post article “ Paying Through the Nose“, the company settled out of court with 340 smelling-impaired plaintiffs for $12 million. About.com adds that “the company admitted no wrongdoing or admission that their products caused loss of the sense of smell.”
Denial of corporate liability is not unusual for this type of lawsuit and tracks with the company’s current PR strategy. On the Zicam website, William Hemelt, the president of Matrixx Initiatives, gives his video assurance that their products are safe, but since they want to work with the FDA, the company voluntarily withdrew the products cited in the health alert. Apparently, the problem is not that the products cause adverse reactions but that some consumers reported adverse reactions after using them. He also reassures us that “there is no credible evidence that Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs causes you to lose your sense of smell,” despite the fact that the company has received 800 consumer complaints about the products.
As skeptics, we accept that these reports are only anecdotal, but the number of reports should have spurred further analysis. If only the FDA had known about them, an investigation could have been initiated. So why did the company not report them to the FDA? Well, Matrixx Initiatives states:
“During the May 2009 audit, the FDA suggested – for the first time – that the FDA’s interpretation of new regulations required the Company to report to the FDA all complaints of diminishment of smell, rather than having those complaints available for FDA inspection. The FDA’s position is directly contrary to the written advice received from the Company’s FDA counsel shortly after the new regulations were adopted.”Apparently, this whole misunderstanding could have been cleared up if the FDA and the company’s lawyers had been on the ball. Perhaps the company is the innocent victim here, and certainly the product’s many true believers have tweeted their stalwart support. Equally unfortunate is that the company did not, apparently, understand its responsibility under the 2007 FDA regulations for the reporting of adverse reactions to these types of products, despite guidance on the FDA webpage that:
“An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is:Yet, homeopathic products are typically diluted to the point that not even a molecule of active ingredient is left in solution. How is it possible that a homeopathic product has any physiological effect at all, let alone a negative one. The reason is that not all homeopathic products are diluted to the point of absurdity, and one of those “underdiluted” products is Zicam. Skeptico, for his 2005 article “ If it has any ingredient in it, is it homeopathic?“, received the following e-mail explanation from Matrixx Initiatives:
“Zicam has only one active ingredient – zinc gluconate (Zincum Gluconicum). It is true that some homeopathic dilutions are very dilute. The [Homeopathic Pharmacopoeia of the United States (HPUS)] dictates the maximum strength a compound can be for OTC use. In the case of zinc gluconate, it is a 1X dilution. This means that 1 part of zinc gluconate is diluted with 9 parts water. In Zicam we use a 2X dilution. This takes the above dilution and further dilutes it by adding 1 part of it to 9 parts water. This produces a final 1:100 dilution.”I would have thought that, by homeopathy’s bizarro logic, a 2X dilution would be so “weak” that it’s hardly worth producing. Yet in both Canada and the US, a natural health product is deemed to be homeopathic, not by how diluted it is, but by whether it is listed in an approved homeopathic pharmacopoeia, as circular as that definition seems to be. As a result, Dr. Novella points out, Zicam ends up having enough residual active ingredient to have effects:
The Zicam situation inspired AP to write the article “ Zicam not alone in side effect reports“, which questions the lack of federal regulatory oversight for homeopathic products and featured some wry comments on homeopathy’s origin, such as:
“Homeopathy sprang from the inventive – some would say fanciful – mind of German physician and chemist Samuel Hahnemann”and
“with arcane ingredients like ‘nux vomica’ and ‘arsenicum album,’ many homeopathic medicines sound like something brewed in a druid’s kettle.”The article reports what, in a rational world, should summarize the fate of homeopathy:
“The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on homeopathic drugs. ‘The evidence is not there at this point,’ says the center’s director, Dr. Josephine Briggs.”Too bad she felt the need to qualify her statement with “at this point”. I’m certainly not going to hold my breath for supporting evidence to be found.
Nevertheless, the statement hints at the pointlessness of homeopathy, a sentiment further bolstered by this Zicam incident. Typical homeopathic products, which have no active ingredients, are ineffective, while faux homeopathic products like Zicam, which contain active ingredients, need to be studied and regulated outside the superstitious framework of homeopathy as mainstream health products using real science. Coddling homeopathy and sheltering it from strict regulation invites people to waste money and puts their health at risk.
25. June 2009 by barry
Categories: Alt. Med, Topics | Leave a comment
Here is the attorney that Matrixx hired for the SLAPP suit in order to keep Zicam on the market while people continued to use their sence of taste and smell. Says allot about him.. He will rot in hell someday
Kevin J. Parker Partner| Phoenix
Pharma & Healthcare 4/01/2015 @ 10:16AM 1,609 views FDA To Hold Public Hearing On Homeopathy Products
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The U.S. Food and Drug Administration has announced that a public hearing will be held on April 20 and 21 to collect information and comments from stakeholders on homeopathic products sold as prescription or over-the-counter (OTC) medicines. The agency’s White Oak campus in Silver Spring, Maryland, will host the meeting.
In details posted last Friday in the Federal Register, the agency stated that it is, “evaluating its current enforcement policies for drug products labeled as homeopathic from scientific, risk, and process perspectives. The Agency is now soliciting opinions about whether and how to adjust the current enforcement policies to reflect changes in the homeopathic product marketplace over the last approximately 25 years.” ( PDF here.)
How did we get here?
One could be forgiven for thinking that homeopathic drugs are an April Fools’ joke. The remedies trace back to German physician, Samuel Hahnemann, who was devising an alternative to the harsh practices of medicine in the late 1700s and early 1800s such as bloodletting and poisoning. He proposed that substances capable of causing disease symptoms when taken by healthy volunteers at high doses could be used to treat sick patients with diseases that match those symptoms, but only when given in dilute doses. In fact, homeopaths claim that a substance becomes more potent the more it becomes diluted by intense shaking, a process they call succussion.
Medical bottles containing homeopathic pills stand in the European Homeopathy Library in Koethen, eastern Germany, Wednesday, Dec. 16, 2009. (AP Photo/Eckehard Schulz)
The idea of Similia Similibus Curentur, or “like cures like,” seemed attractive in those times. But in most cases, those dilutions are so extensive that no molecules of the original chemical remains in the remedy that is sold. Hahnemann’s remedies were mostly 30C in homeopathy parlance: one to 100 dilutions of a substance made 30 times. That’s a dilution of 10 to the 60th power, or 1 followed by 60 zeros.
As an aside, today’s experimental pharmacologists consider Hahnemann’s work to be a misinterpretation of that of Austrian physician, Anton von Störk. A contemporary of Hahnemann, von Störk held that the substances in poisonous plants could be used to treat diseases when diluted below poisonous levels, but those levels still contained the plant chemical.
So it’s understandable that even some of today’s healthcare practitioners don’t always appreciate the differences between approved drugs with demonstrated safety and efficacy, herbal medicines and dietary supplements with at least a chance of efficacy, and homeopathic remedies. Even my alma mater, the former Philadelphia College of Pharmacy, gave a homeopathic entrepreneur an honorary doctor of science degree in 2009, much to my objection.
This historical discussion is necessary because the FDA was required to recognize homeopathic remedies as drugs by the passage in 1938 of the Federal Food Drug & Cosmetic Act (the FD&C Act). The original version of the bill was proposed in 1933 by New York Senator Royal Copeland, a homeopathic physician. Believe it or not, Copeland received his degree from a department of homeopathy at the University of Michigan at Ann Arbor in 1889. Only two years later was the first U.S. department of pharmacology established – at Michigan, by pioneering pharmacologist and fellow University of Michigan graduate, John Jacob Abel. That must’ve made for interesting faculty meetings.
The ratified version of the FD&C Act was signed into law in June, 1938, a week after Copeland died. The legislation, drafted primarily to combat sickness and deaths due to safety issues of remedies at the time, included a section from Copeland that recognized the non-governmental Homeopathic Pharmacopeia of the United States (HPUS) as the body that established standards of manufacturing for such products. At the time, most of the debate on the bill stemmed from manufacturers of truly active substances (such as Listerine) lobbying against additional government regulation. Additional bickering from the existing Federal Trade Commission as to which agency would prosecute false advertising claims overran any considerations of Copeland’s homeopathy provisions.
The 1938 law is widely heralded today as a major milestone in drug regulation that gave the first significant powers to the then-fledgling FDA. But, at the time, few recognized its importance. Five months after the bill’s passage, Harvard-trained lawyer and member of the New York bar David F. Cavers, then at the Duke University School of Law, wrote in an insightful, 41-page treatise in the journal Law and Contemporary Problems:
Perhaps the most striking characteristic of the history of the Food, Drug, and Cosmetic Act is the fact that this measure, which was of consequence to the health and pocketbook of every citizen of the country and which importantly affected industries whose annual product totals roughly ten billion dollars, never became the object of widespread public attention, much less of informed public interest. The affected industries were kept posted by their associations and their journals; some national women’s organizations sought to apprise their membership of major developments; but the public at large, including persons ordinarily well-informed on national affairs, knew little or nothing of what was transpiring in Congress. I suspect that today only a small fraction of the public knows that a new law has been enacted.
Why the hearing and why now?
Fast forward to today, homeopathic products are still sold side-by-side with real, active medicines in pharmacies and other retail stores. The FDA now appears to be interested in addressing some issues that were tabled in 1972 to review homeopathics for safety and efficacy and in 1988 under a section on homeopathic products in the agency’s Compliance Policy Guide regarding health fraud.
The FDA states that homeopathic remedies had traditionally only been offered by a limited number of manufacturers for use by the relatively small group of homeopathic practitioners. The products were not intended to be widely marketed directed to the public in an industry that now counts annual sales of nearly $3 billion.
Moreover, many of today’s homeopathic remedies actually do contain conventional amounts of medicines. For example, Zicam spray and Cold-EEZE lozenges are sold as homeopathic products but contain enough zinc to be tasted (as astringent) or cause side effects. These products can confuse consumers because they make disease treatment claims but then carry, in very small print, the disclaimer that, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
I’ve always held that it’s an ethical violation for any health-related company to sell homeopathic remedies regardless of the allowances of a 77-year-old law, especially when offered alongside real medicines. In Canada, a similar argument was made yesterday by André Picard in The Globe and Mail, particularly since a new act recognizing the practice of homeopathy takes effect today in Ontario. And Canadian pharmacist, Scott Gavura, PharmD, has written of his objection to Target pharmacies selling the Up & Up store brand of homeopathic inhalers for asthma.
Last September, shortly after CVS Health announced that tobacco products would no longer be sold in stores, I asked Troy Brennan, MD, CVS executive vice president and chief medical officer if unproven dietary supplements and homeopathics would be the next products taken off the shelves. Brennan said, “Since we’ve taken on the name CVS Health, we have to re-scrutinize everything that we’re selling in some parts of the stores. Over time, we’ll decide if we need to be making changes in what the offerings are.”
So, we’re in an age when states such as New York are acting against herbal medicine companies for selling remedies that allegedly have no active components. It follows, then, that action should be taken against products that are supposed to have nothing in them that do, as well as products that really do contain nothing. The agency, for their part, is very objective in their wording, saying that the goal is to hear discussion on, “the current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health.”
Seating at the hearing will be on a first-come, first-serve basis. Parties interested in making a presentation must submit a formal request and provide the content of their presentation by April 13. FDA encourages any interested parties send in written comments before April 16. Extensive details are available in the Federal Register and in condensed form at the FDA website. The agency also notes that the April 20-21 hearing can be viewed off-site via webcast.
For more health and pharmaceutical news and commentary, follow me on Twitter @DavidKroll, or here at Forbes.com.
Zicam’s website makes the misleading claim that “all of our Zicam® products are regulated by the FDA.” This is a common ploy of homeopathic drugmakers, claiming the FDA regulates them because the FDA could step in (as they’ve already done with Zicam) if consumers are being harmed. Unlike real drugs, though, Zicam has not been evaluated by the FDA for effectiveness or safety.
Neutersol, (the smoking gun that would have stopped Zicam Cold Remedy nasal spray if the FDA had not), is reborn as "Zeuterin":
FAQs - How does Zeuterin neuter a male dog?
"After the injection, the Zeuterin™ solution diffuses in all directions from the center of the testis. The specific concentration of Zinc (a targeted spermicide) used in our formula destroys spermatozoa in all stages of maturation in the seminiferous tubules and in the epididymis. The seminiferous tubules, which were replete with spermatozoa, are now emptied and collapse."
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