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Diego Madrigal
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Zicam Warning Issued by FDA

11 comments

Zicam nasal gel can destroy or severely damage your sense of smell according to a warning issued by the Food and Drug Administration. The warning only applies to the nasal products, which I actually use. The warning was based on 130 complaints received by the FDA from people and their doctors stating that following use of those products people suffered a condition called "ansomia," which is a loss of the sense of smell.

Since 1999, the maker of Zicam has payed $12 million to settle over 300 lawsuits. However, they have never recalled the drug. In fact, even after this FDA warning, the maker of Zicam refuses to recall the drug. Nevertheless, before Zicam markets their drug again they will have to gain FDA approval.

Like I have said, I used this exact product and have not noticed any problems- but then again, I have not been looking. I wonder how many people have not noticed and are suffering from loss of smell. Hopefully the makers of Zicam recall their product and find a way to issue it again in a safe form.

11 Comments

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  1. floyd says:
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    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 had gotten a FDA warning letter about promoting bogus bird flu cure all

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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

  2. Tamela says:
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    I have used Zicam for the past two years to ward off seemingly imminent colds – and I have not had any effect on my sense of smell. I only use it for a day or so, and only a maximum of 3-4 times, though. Perhaps people are over-using the product.

  3. up arrow

    Tamela,

    Perhaps you’re right. I used the product about as frequently as you do and don’t think I’ve had any problems- at least none that were noticeable. It’d be interesting to see if those who were affected used it correctly. I don’t think the FDA would have issued it’s warning had it been solely user error, however.

  4. Gloria Venlet says:
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    I’ve used Zicam nasal gel for 7-8 yrs. and swear it has warded off numerous colds and my smeller is working perfectly. I have also spread the word and others use it because of my enthusiasm for the product.

  5. VCDaedalus says:
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    I’ve also used Zicam nasal gel and have recommended it. The instructions say to hold the swab against your nasal passage for several seconds, but the temptation is there to try and paint the inside of your nose with gel in a “some is good, more is better” attempt. I’ve done that.

    Losing your sense of smell is anosmia, not ansomnia. It can be pretty depressing, as one friend reported to me (non-Zicam-related).

  6. edwards says:
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    The domain (web address) matrixxclassaction.com is for sale at http://matrixxclassaction.com

    It’s a useful tool to educate consumers and investors.

  7. Jim Jace says:
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    “Excelsior College in Albany, N.Y.”

    Excelsior is a real, regionally accredited college that you can verify with CHEA or the Department of Education. Just want to clarify.

    The others look like blatant fakes, ala Warren National University, Breyer State and such.

  8. Sarah says:
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    Excelsior College is a fully accredited, nonprofit, and reputable school, previously known as Regents College, a NY state university.

    There exist many diploma mills and unaccredited or marginally accredited schools, but Excelsior College is not one of them.

  9. floyd says:
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    Here is Zicams inventor talking about his diploma mill degree.

    “Davidson’s knack for business goes back to his days at American University in ASTURIAS, Spain”

    San Fernando Valley Business Journal, June 23, 2003 v8 i13 p16(1)
    His business acumen helps company in biotech world. (Best Companies in the Valley–A Special Report). (biotechnology company Zengen Inc.)(president R. Steven Davidson)(Company Profile) Carlos Martinez.
    Full Text: COPYRIGHT 2003 CBJ, L.P.

    *****Article Begins*****

    His business acumen helps company in biotech world.

    R. Steven “Rob” Davidson always felt he was a problem solver. As president and CEO of Woodland Hills-based Zengen Inc., the 37-year-old Davidson heads what is arguably one of the best financed startup biotechs in the Valley.

    Davidson, who is the business brains behind the company, is the architect of the firm’s plan that relies on developing over the counter drugs to help fund ongoing research into the company’s proprietary peptide technology.

    Peptides are compounds derived from two or more amino acids combined. Amino acids are the chief components of proteins which are synthesized by living cells.

    It was just two years ago that Zengen sold off its interest in Zicam, an over-the-counter cold remedy and nose spray it developed, for $17 million which went toward ongoing research into peptides.
    “It’s a strategy that’s managed to work well for us,” said Davidson, who helped engineer the deal.
    Davidson figured that since over-the-counter medicines have fewer regulatory issues than prescription-based pharmaceuticals, they could be developed and marketed quickly, giving the company needed revenue to fund research.

    Today, Davidson hopes to strike gold again with over-the-counter eyedrops that the company is developing to further fund research efforts.

    Such funding strategy is unusual in an industry where research dollars are at a premium, said Brent Reinke, an attorney with Crosby Heafey Roach & May, who helps put together funding deals for biotechs.
    “It’s not unheard of, but it’s a creative way of getting funding,” Reinke said.

    Davidson’s knack for business goes back to his days at American University in ASTURIAS, Spain where he examined the European way of doing business. “I wanted to understand how people in the rest of the world did business and how those cultures worked,” he said. “It was very informal and it made me realize I wanted to start my own business instead of working for somebody else.”

    Growing up in a small family in New York, Davidson felt he always had a knack for learning and science. With a police officer for a father and a mother involved in various businesses, Davidson quickly learned the value of hard work and perseverance. “I knew that you always had to try harder to get where you wanted to go,” he said.

    Business over medicine
    Although he had originally set his eyes on a medical degree, Davidson was fascinated by the intricacies and challenges of business and eventually earned a master’s degree in business administration and a doctorate in biopharmaceutical studies.

    “I really loved medicine, but I thought business was the best direction for me,” he said.
    Soon Davidson established biotech startup Biotem Cytotechnologies and later formed Gel Tech LLC which eventually became Zengen where he developed Zicam.

    By joining with Dr. James Lipton, the creator of the peptide technology, Davidson sought to show the biotech and investment communities that the peptide molecules would work in different anti-bacterial and anti-microbial technologies.

    “We could do all kinds of great things, but we couldn’t afford to go for the big one,” Davidson said.
    “We went for a soft target — so we went for the anti-microbial or a treatment for yeast infections.”
    So far; the peptide molecules are showing promise in treating yeast and other infections, including serving as a therapy for organ rejection.

    Davidson’s business strategy and appreciation for the technology isn’t lost on Lipton, who has been researching peptide molecules since 1966.

    “He really has a remarkable business sense and dedication to the work,” Lipton said.
    Today, the company has established its subsidiary, Zensano, which develops over-the-counter medicines, to help fund research and. development for biotech products.

    With one unit developing over-the-counter products, a second developing products using peptide molecules, and a third unit developing drug delivery systems, Davidson has created a self-sustaining biotech that is arguably the envy of other startups.

    As for his future, Davidson hopes to push forward with Zengen’s cutting edge technology.
    “Big companies never attracted me,” he said.
    “Here, we’re doing a lot of different things so we’re not just a one trick pony. That’s exciting.”

    *****Article Ends*****

  10. Floyd says:
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    Partial list of R. Steven Davidson’s Published Education Credentials (Listing 3 different Ph.Ds)

    All 5 excerpts are currently available on the web for reference. No need to read entire article. The key sentence is in bold print in order to make it easier to spot.

    1. Eat Carbs to Lose Fat
    Men’s Fitness Magazine April, 2001
    Written by: Steve Stiefel Photos by: David Roth/Stone

    http://web.archive.org/web/20030811052300/http://www.mensfitness.com/nutrition/24

    Excerpt:
    “If you do the same workout every day, you’re going to plateau. It’s the same with your diet,” says R. Steven Davidson, who holds a Ph.D. in biochemistry from Columbia University.

    (To my knowledge, no one has called Columbia University and checked whether Davidson received a diploma. It would sure be interesting to confirm that he never studied there.)

    ==================================================

    TAKEN FROM MEN’S FITNESS MAGAZINE
    2. “For helping the body overcome allergies, the only treatment I’m impressed with at all is allergy shots,” says R. Steven Davidson, who has a doctorate in natural health sciences. “When you receive an allergy shot, you’re generally given a small dose of the allergen itself, which helps your body develop an immune response to that substance. Allergy shots help to desensitize the body’s response to allergens, and this may be the only treatment’ that truly works.”

    (To view entire article, please paste the entire link into your web browser)
    http://www.findarticles.com/cf_0/m1608/8_18/89389718/p3/article.jhtml?term=
    ===============================================

    TAKEN FROM MEN’S FITNESS MAGAZINE
    3. “Save your high-carb meals for your off days,”confirms R. Steven Davidson, who holds a doctorate in biochemistry. “You’re loading up on long-term energy you’re going to use later on, not right away.” But remember that the point of the high-carb rotation system is to increase metabolic efficiency, not to allow you to binge on your favorite sweets once or twice a week.

    (To view entire article, please paste the entire link into your web browser)
    http://www.findarticles.com/cf_0/m1608/10_17/80309844/p2/article.jhtml?term=
    =================================================
    TAKEN FROM ZENGEN’S WEBSITE

    4. Dr. Davidson received his MBA in International Finance and Ph.D. in Biopharmaceutical Project Management from the American University of ASTURIAS, Spain and performed post graduate studies at Villanova University.
    http://web.archive.org/web/20030624041237/http://www.zengen.com/board_of_directors_davidson.htm

    The above page was recently removed from the Zengen website. http://www.zengen.com but can still be found at the web archive.

    The exact same exact bio was recently removed from patentdiscovery.com and from innozen.com, which are other businesses he is/was involved in.

    (A Ph.D. in Biopharmaceutical Project Management is at best, highly unusual)

    The American University of Asturias
    (The American University of ASTURIAS was a diploma mill which was shut down by the Spanish government. It was denominated and shut down about 4 or 5 years ago for issuing illegal diplomas in Spain.) The Spanish government invalidated their diplomas. This can be verified by visiting several Spanish websites translated to English. These web pages still exist on the Internet.

    Until very recently, Davidson openly publicized his American University of Astrurias Ph.D. diploma on his websites. Matrixx Initiatives still refers to R. Steven Davidson contributions to the development of Zicam using the Ph.D. and MBA designations after his name.

    ==================================================
    TAKEN FROM MEN’S FITNESS MAGAZINE
    5. “The most important way to affect your total cholesterol is through improving diet and incorporating appropriate exercise,” says R. Steven Davidson, who has a doctorate in biochemistry. Even if you’re eating reasonably clean, you might be surprised at the effects a little more attention to diet can have on total cholesterol.

    (To view entire article, please paste the entire link into your web browser)
    http://www.findarticles.com/cf_0/m1608/9_17/80309796/p3/article.jhtml?term=

    OTHER CURRENT EXAMPLE OF DAVIDSON’S PUBLIC EFFORTS TO PUBLISH HIS FALSE EDUCATIONAL CREDENTIALS:

    http://chi.org/home/directory.php?pid=1&cid=2820&mode=2&mom=0

  11. terry allen says:
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    floyd, i’m a reporter looking into zicam. most of the links you cite for the credential no longer work. any advice? also how do you know that R Steven Davidson is the same person as the zicam founder. it is not that unusual a name.
    thanks,
    terry