If You Like Zicam, Tell the FDA
On June 16, the FDA warned consumers to stop using the over-the-counter cold treatment Zicam after associating use of the product with potential permanent loss of the sense of smell (anosmia). The makers of Zicam voluntarily recalled the product, but requested a meeting with the FDA to present and “defend scientific data, developed during more than 10 years of experience with the products, demonstrating their safety.” If you disagree with the FDA’s action, here's how to let them know.
Since FDA issued the warning, several Zicam users have written to defend the product and to question the agency’s action based on 130 reports of ansomia among millions of Zicam users.
How to Express Your Opinion: Readers who would like to let the FDA know what they think of the Zicam warning should contact the FDA’s Center for Drug Evaluation and Research (CDER). CDER can be contacted using their Online Comment Form, or by email at druginfo@fda.hhs.gov. Readers can also send surface mail to CDER at:
U.S. Food and Drug Administration
Division of Drug Information (CDER)
Office of Training and Communication
WO51-2201
10903 New Hampshire Avenue
Silver Spring, MD 20993
- Kristina Duda, R.N., About Guide to Cold and Flu, presents the results of Zicam research in Can Zicam cause you to lose your sense of smell?
Also See: FDA Warns Against Zicam Use
Comments
Inventor of Zicam has 2 DIPLOMA MILL degrees.In fact Dr. R. Steven DAVIDSON had a ph.d/mba from the American University of Asturias (Spain). In fact he had a MBA from a DIPLOMA MILL with only having a High School education. Co Inventor Charles Hensley gotten a warning letter about promoting bogus bird flu cure all (see below)
“And it’s not easy to take the company’s claims for safety of the product at face value when the man who claims to have developed the product, one Robert S. DAVIDSON, parts his name in the middle (as in R. Steven DAVIDSON) and boasts a Ph.D. in “biopharmacuetical project management” from the so-called American University of Asturias, a Spanish-based DIPLOMA MILL “university” that was shut down by the Spanish government after being caught issuing what purported to be advanced degrees in almost anything, to anyone whose checks didn’t bounce. “
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The Men Behind Zicam
Tuesday, January 31, 2006; Page HE05
Like other scientific entrepreneurs, Robert Steven DAVIDSON thought zinc might be a promising treatment for the common cold. But unlike many inventors of drugs, DAVIDSON and his colleague Charles B. Hensley, who hold patents on Zicam, have unusual backgrounds.
DAVIDSON received a bachelor’s degree in 2004 from a “virtual” university, Excelsior College in Albany, N.Y. He lists himself as a PhD, a degree he obtained from an unaccredited and now-defunct university in Spain.
His colleague and co-inventor Hensley holds a doctorate in physiology from the University of Southern California and is currently chief executive officer of PRB Pharmaceuticals based in Cypress, Calif. Hensley recently received a warning letter from the Food and Drug Administration (FDA) about the sale over the Internet of an unapproved drug his company makes to treat bird flu. Hensley previously developed a weight-loss remedy that involves sniffing “specially developed aromas.”
DAVIDSON, who has contributed articles to Men’s Fitness magazine, says his doctorate in biopharmaceutical project management and his MBA in international finance were earned at the American University of Asturias in Asturias, Spain, in the late 1990s. The school was closed in 2000 for violations of Spanish law, records show, and is considered a DIPLOMA MILL by American authorities.
DAVIDSON, who sold his interest in Zicam several years ago when he left to start another biotech firm, said he was unaware of any problems with the school in Spain. It is unusual to earn a doctorate before a bachelor’s degree, he said in an interview, but his advanced degrees are legitimate. “I did work, a research paper and a dissertation.”
He declined to discuss whether any safety questions arose during Zicam’s development and testing.
DAVIDSON said he met Hensley years ago at Cleveland Chiropractic College in Los Angeles, where he was taking classes and Hensley was a professor.
On Nov. 23, the FDA sent Hensley a letter about Vira 38, an antiviral compound marketed on PRB’s Web site as effective in treating influenza, bird flu and SARS. The regulatory agency told Hensley he was violating federal law by selling an unapproved drug and warned that he and his company could face further legal action including “seizure of illegal products.”
Hensley did not respond to e-mails or telephone calls.
– Sandra G. Boodman
COLD-EEZE SQUEEZE
By CHRISTOPHER BYRON
November 8, 2004 — Remember when all of a sudden there wasn’t enough flu vaccine to go around, and the subject somehow came up in one of the Presidential debates? And remember when George Bush said, in so many words, “Look, it’s simple, just don’t get a flu shot this year…”?
Well, out here at Curmudgeonly Arms, where the baleful moan of the cold north wind sweeps over the moors from November to May sending the body count of its victims soaring, the Curmudgeonlies stood brave, tall and true, for we figured, No flu vaccine? No problem!
That is because we Curmudgeonlies have long known the secret to a winter free of the wheezing and sneezing that afflicts the rest of humankind when the cruel winds blow.
Our secret is, of course, Cold-eeze throat lozenges, which a person may purchase at any reputable pharmacy (or indeed 7-Eleven), for $5.00 at retail give or take ? which is to say, for roughly half the price of a standup pepperoni-and-cheese pie at Ray’s Famous Pizza.
So imagine our consternation upon learning, from a wanderer through the wintry gloom, that Cold-eeze ? when spritzed into the nose as a nasal aerosol instead of taken orally as a lozenge ? might not actually kill you but can apparently destroy your sense of smell.
What’s that? Cold-eeze nasal spray, a health menace?
Yes, verily it is so ? at least if one is to judge from a lawsuit that was filed last week in Bucks County, Penn.
As reported by our informant, his words broken by the staccato of his hacking and consumptive cough, eight different consumer plaintiffs in the suit say they used Cold-eeze nasal spray and now wouldn’t be able to smell Osama bin Laden if he were standing right next to them.
Fortunately, the honest tradesmen at Quigley Corp., producers of Cold-eeze, had already begun heading for the nasal spray exit door when the lawsuit hit.
They had informed their distributors in mid-September that the company had decided to drop the nasal spray product line because consumer demand for it hadn’t developed as expected.
THIS was followed in due course by last week’s lawsuit, and quicker than you could say “Anybody got a Kleenex?” the company response had hit the PR newswires, asserting that even a “cursory look” at the suit had been enough to convince Quigley brass that the complaint was “frivolous and without merit,” and that the company intends to defend itself “vigorously” because the only thing Cold-eeze destroys is germs.
Being of an odd and suspicious sort, it thus took no time at all before our shingle-wracked manservant, Igor, could be observed struggling up the twisting stairway to my writer’s garret at the top of the north tower.
Presenting himself breathless at the doorway, and with his hunchback blocking further progress, he declared: “Here, sire, take a whiff of these…!” and placed upon the floor before me a folio of Quigley Corp. documents.
He had arranged them for ex-Clinton national security affairs advisor Sandy Berger to filch from the files of the U.S. Securities and Exchange Commission.
Then cackling in his special way, he departed, maneuvering his hunchback down the darkened staircase and across the courtyard to his abode in the corn crib, his parting words still ringing hauntingly, and mysteriously, in my ears: “Beware the ides of evil, sire, when darkness exhalts the moor.”
The documents that Igor left behind for my perusal do give one pause, for they show that lawsuits by customers claiming damages from the use of Cold-eeze nasal spray had been accumulating against Quigley since as early as February of this year, when a Connecticut woman named Paige D. DAVIDSON claimed using Cold-eeze nasal spray destroyed her sense of smell and that she’d never gotten it back.
Then in September, a Minnesota couple ? Sheryl and Howard Polski ? claimed the same thing, asserting that they too used had some Cold-eeze nasal spray, in December 2003, and that their colds had gone away but so had their senses of smell and taste, never to return.
In fact, even as lawyers for the Polskis were preparing their complaint, Quigley’s brass were informing the company’s distributors that they were dropping the nasal spray form of Cold-eeze from Quigley’s product list. A month later, on Oct. 13, the company filed a Form 8K report at the SEC, making the news public to everyone.
QUIGLEY’S strategy for waving away these claims with words like “frivolous” and “without merit” seems to rest heavily on the assertion that Cold-eeze nasal spray was exhaustively safety-tested in what last week’s press release from the company described as a “double-blind, placebo-controlled study” prior to introducing it to the market in September 2003.
But Igor’s documents showed that references to double- blind placebo-controlled studies have appeared nearly two dozen times in Quigley’s SEC filings over the last seven years, and the references have nothing to do with the nasal spray form of the treatment.
Instead, the references all involve one or the other of two early 1990s studies that purported to test the efficacy of the key ingredient in Cold- eeze ? so-called zinc gluconate ? when consumed in lozenge form as a means of treating the common cold.
In fact, it would appear that Quigley would never have become involved in the marketing of a zinc-based nasal spray had it not been for the apparent success a rival company called Matrixx Initiatives Inc. had been having with its own zinc- based nasal spray, which it called Zicam, and had begun marketing in late 1999.
But by the time Quigley announced in February 2003 that it was going to be bringing its own version of a zinc-based nasal spray to market later that year, Matrixx Initiatives was already hip-deep in lawsuits from nearly 100 customers who claimed that they’d used Zicam and lost their sense of smell.
Those claimants now top 175 and are continuing to grow.
And it’s not easy to take the company’s claims for safety of the product at face value when the man who claims to have developed the product, one Robert S. DAVIDSON, parts his name in the middle (as in R. Steven DAVIDSON) and boasts a Ph.D. in “biopharmacuetical project management” from the so-called American University of Asturias, a Spanish-based DIPLOMA MILL “university” that was shut down by the Spanish government after being caught issuing what purported to be advanced degrees in almost anything, to anyone whose checks didn’t bounce.
Requests for an interview with DAVIDSON were fielded at his California office by a cagey fellow who identified himself simply as “Dave,” and promised to get the request to DAVIDSON.
At press-time neither man had returned the call.
* Please send e-mail to: cbyron@nypost.com
This has all the makings of a massive, company-destroying class action suit. Expect lawyers to piile on both on behalf of “injured” consumers and irate investors. The domain (web address) matrixxclassaction.com has already been registered and is for sale. It’s likely to be just one of many vehicles lawyers will use to educate consumers and investors, attract plaintiffs.
If I understand correctly. Zicam made false allegations about Cold-eze and then got a taste of their own medicine? Not sure what to make of this? But damn! it worked for me. Online Degrees? Send me one in HowtoInventandsuckeranation and underwaterbasketweaving.
Floyd, remarkable documentation of the people who brought us Zicam. It’s no wonder Zicam crashed and burned.
May 31, 2009 I ALLEGE Ken Dowd (1st page of 8 sent to US SENATE) 2009
I allege–Dr. Glenn Bradley, was a Norvartis Pharmaceutical Executive Board Member, Basel, Switzerland, and CEO, Ciba Vision Corporation, maker and distributor of contact lenses, Duluth, Georgia, 30096, USA, purchase Wesley-Jessen Corporation, maker and distributor of contact lenses, Des Plaines, Illinois. Wesley-Jessen problems of expired, misbranded, and mislabeled product now was passed to Ciba Vision Corporation. An illegal program was written to allow these contact lenses to pass the Licensed Program. Consequently, 2001 thru 2004, lenses were shipped all over the world, as well as, many millions of lenses adjusted into the inventory, illegally. DISBAR NORVARTIS PHARMACEUTICAL, FEDERAL AND STATE LAW AGENTS TO JAIL.
OBSTRUCTION OF JUSTICE —-I HAVE THE PROOF
My group lead, and myself wrote to the FDA, Atlanta, GA. FDA, Ombudsman, Rockville, MD., and the FDA Compliance, Rockville, Md. July, 2004 until this date, nothing has happen on this case. Although FDA, Ronald Swann, destroyed the physical evidence, the Uniform Federal Barcode is saved for ==13 YEARS== at Ciba Vision. Let’s look at some manifests. Norvartis/Ciba Vision Corporation hid at least $50 million dollars and put it in inventory, after taking a tax credit for lost lenses. MY CASE HAS NO CASE NUMBER: FDA-Atlanta, GA., USA can open case.
I wrote the US Senate in 2005, 2006, 2007, 2008, and, now 2009. The entire US Senate is obstructing justice. There is a page in this packet showing all who received Certified Letters/Return Receipt. JAIL THE FBI, CIA, FDA, SENATORS, FTC, SEC AND ATLANTA,GA. FDA OFFICALS, FBI, OIG, CHIEF JUDGE, US ATTORNEY.
21 CFR 801.6 Medical devices; misleading statements: Among representations in the labeling of a device which render such device misbranded is a false and misleading representation with respect to another device or a drug or food or cosmetic.
FDA, RONALD SWANN, WROTE TO ME THREE TIMES STATING HE HAD OPEN THE CASE. I HAVE TWO LETTERS FROM THE APPEALS BOARD STATING THE CASE IS CONFITDENTIAL. FDA, RONALD SWANN CAN NOT OPEN A CASE, AND THE APPEAL LETTERS ARE ALL FELONIES–NO CASE NUMBER.
If these felony letters are not enough, I can be polygraph by an FBI or State polygraph.
There are presently 22,000 lobbyists in Washington DC, spending up to $17 million a day, each day Congress is in session, about 160 days. Media is afraid: 139 newspapers in Ohio received copies of the felony letters, before Obama, Clinton, and McCain campaigned. NY Times, LA Times, and Wash. Post received Cert/Return letters.
KICK OUT THE CORRUPT GOVERNMENT OFFICIALS. This case will do it. Ken Dowd, PO Box 2018, Duluth, Georgia,30096 USA Telephone 770-831-8581 I need a publisher. I polygraph.
My wife and I have been using Zicam nasal gel for at least 6 years and have had no problems with it at all. It is the only thing that works for a cold. We are healthy people and don’t get colds often, but when we do, we use Zicam. So do all our relatives. This is a very unfortunate thing for you to do to a wonderful company with wonderful products. Please reconsider your stance on this and do not let the other drug companies influence your decision. They really can afford to lose a little money with this competition for the health and welfare of the citizens of the USA and the world. Too bad you listen to the FDA and not to us.
Thank you.
Yesterday I was running around to different pharmacies franticly looking for any Zicam nasal gels because I got a cold and thats when I found out the gels were pulled off the shelves. Being very upset, I went back home searching the cabinets to find an older nasal gel with just enough to knock out the current cold I have in just one day.
I have been using Zicam nasal gels for almost 4 years now and never had any side effects except for one (1)…..it works! The nasal gel formula does exactly what the documentation says it does and if you follow the instructions (I know most people don’t) you will get the desired results you are looking for.
Considering these products have been in production for almost several years now, I don’t understand the motivation to take the gel products off the market now because of isolated incidents (Yes, isolated incidents — 175 out of 10’s of thousands product users is isolated)
It sounds like the FDA needs to work with Zicam to better educate the consumer not just pull it off the shelves.
I just sent an email to the FDA stating that I’ve been using Zicam nasal gel since it came out. It has been marvelous in knocking out any colds I have received. I have had no loss in my since of smell. I have 2 bottles left and will continue to use them until they expire or run out. Again, the FDA over reacts!
I don’t really give a rip what the “experts” say…I LOVE this product – it works, and has saved me many a sick day, not to mention expensive trips to the doctor.
I have tried other Zicam products, and they’re good, but the swabs are the best.
My sense of smell hasn’t been affected, and I can’t understand why on earth 130 or so whiners get to rule the rest of us.
JMO.
I WANT MY ZICAN SWABS BACK!
I have used the Zicam Gel Swabs for the last several(3 to 4) years at the first sign of a sore throat and most of the time they kept me from getting a sinus infection which comes after the sore throat. They are the only thing I have ever used in the past 60 years that stopped the sore throat/sinus infections that I have had since I was 11 years old, I am 72. I wonder if the small amount of people that have had problems were using it as directed in the end of their noses or sticking the swabs all the way to the back of their noses? After all these years I find something that works and it is taken off the market because of a small minority of complaints compared to the number of users. Our Government/Lawyers at work!
I have been using Zicam for years with no side effects. This is the only product on the market that works in fighting and preventing the comon cold. This product needs to be put back on the shelves.
Oh, thank you government/fda for protecting me because I’m much too stupid to think for myself! 175/1,000,000 odds are much too great to risk never being able to smell the BS you and the rest of the federal government are trying to shove down my throat. How about you put a warning label on zicam like, hmmmm, CIGARETTES, and give zicam the freedom to make money selling a product that works well for the vast majority of people, and give me the freedom to take my chances using it? Did you know that more than 20 tylenol in a day can be a LETHAL dose? I just bought a bottle with 200 tylenol in there! Who is going to stop me from taking 25, 30, or even (gasp) 40 tylenol in one day? Looks like you have work to do FDA!
I can’t believe they have taken away Zicam gel and swabs. I LOVE ZICAM. I use to get horrific colds that knocked me down for days. Which would follow with a cough that would last for weeks and sometimes develop into bronchitis. Since I found Zicam over 8 years ago, I have NOT had a cold. As soon as I start feeling like one is coming on I start using it and it goes completely away. I use it when people around me are sick and I use it everytime I get on a plane. I HAVE NEVER had a problem with it. I hope and pray they bring it back.
I just gave my testimony to the FDA. Like many of you, I have, for years, enjoyed the positive results of using Zicam. My best guess would be that Big Pharma doesn’t like it when a lowly little company has a huge success with a simple product. It’s kinda like the Right Wing is beating up on Acorn because they got the vote out, and the election went Left instead of Right, so Right Wing must seek revenge over any organization that would dare to outsmart them!
I think it is unfair to remove Zicam Cold Remedy Nasal Gel from the market, because a FEW others who can’t follow directions and MISUSE the product have had loss of smell. I have used both the Swabs and Spray Gel for 9 years, without side effects, and they have stopped the cold from worsening, it never goes into my head or chest, it stops the sore throat, I never get a cough, it REALLY WORKS!
HERE IS THE TRUTH ABOUT ZICAM!
I have reduced the amount of money spent on other cold products from the use of this product! Less illness means I no longer miss work or school, and no loss of pay due to a cold. If I no longer need other products or have to see a doctor because the cold is moved into my chest and I get Bronchitis from the cough, then I spend less on medical care!
SO WHO REALLY WANTS ZICAM OFF THE MARKET? the 130 people out of Millions of users who can’t smell (which could be due to their cold as well) OR THE MEDICAL SUPPLY INDUSTRIES THAT HAVE LOST SALES DUE TO IMPROVED HEALTH FROM ZICAM USERS? THINK ABOUT!
When was the last time the FDA intervened over 130 complaints out of millions of users? Misuse of TYLENOL products have damaged THOUSANDS of people over the last 25 years, and all the FDA said was issue stronger warnings! That came with Millions of consumers and Medical Professionals complaints about Tylenol!
ZICAM IS A VICTIM HERE not the 130 users who can’t follow directions! I’m outraged by the idea that I can’t get the product due to a voluntary recall that is really a POLITICAL issue! Everytime I sneeze, cough, and feel sick due to the cold this season, I get more angry about this issue!
The FDA warning is POPPYCOCK! Claiming that quality of life is at risk for the 130 idiots who misused it! Cigarettes and Alcohol are much more harmful and lead to loss of life by both users and victims of users behaviors, not just (Quality of Life) Yet, they remain available!
WAKE UP! It’s about medical corporations loss of money because ZICAM REALLY WORKS!
I am so bummed they took Zicam off the market. This product was a lifesaver to me as a mom with small kids who always brought germs home. I told everyone I knew how great it was. I am hoarding what little supply I have left. Shame on people who tried to make money by phony suits against a great product.
My son and i have used zicam nasal spray and nasal swabs for many years at the first sign of a cold and according to directions on package. We have NOT had a cold that lasted more than the initial first or second day. Before Zicam, my son’s colds always led to ear infections and bronchitis and many missed work days and school days and expensive doctor visits and prescriptions of the dreaded antibiotics. THANKS A WHOLE LOT FDA! Our sense of smell is just fine so bring back the product!
I have just started to use Zicam products because I was so sick of me and my kids being treated like lab rats at the doctor!! And I heard Rush Limbah swear by them, that they actually work. I trust him as much as I trust my own parents so, I thought I would give it a try and, violla!! No more sinus problems!! And no bad side effects. I was so happy that I didn’t have to go to the doctor anymore!,, Until I heard that the FDA was pulling it off the market! What am I to do now? I just know deep in my heart that the government, OOPS! I mean the FDA is doing everything it can to keep us all under its huge squashing thumb, and has no real interest in us the people! Only the dough in their own gigantic pockets! Am I right or am I right!? Come on now, we’re already losing our freedom so much since the last election, please help a little and give those great remidies back!!
ZiCam Gel Swabs stop colds before they get serious. This is the ONLY cold remedy that has ever worked for me in this manner. I’ve been using the product for four years and was introduced to it by a corporate employee at Walgreens. My family and friends swear by it. We are dismayed at it being pulled from the market. Then, of course, other cold remedy companies must find this product to be serious competition. My sense of smell is still keen, by the way.