Matrixx Initiatives(MTXX) believes that its Zicam line of homeopathic cold remedies will relieve your cold symptoms. Jove Partners believes that it knows how to solve Matrixx’s own ailments: a sale of the company to a strategic investor.
Jove filed a 13D today, disclosing a 5.1% ownership stake and declaring that
The Reporting Persons appreciate the job that management has done and is
doing to build the Zicam brand. However, they believe that the value created to
date has not been appropriately recognized by the market and will not be fully
realizable as long as Zicam remains a stand-alone brand. In particular, the
Reporting Persons believe that the Issuer’s profit margins have been depressed
and should normalize over the next several years. The Reporting Persons believe
that this normalization could be meaningfully enhanced if the Issuer were
acquired by a strategic investor.
Matrixx fell far short of estimates for 2006, blaming a late cold season. Jove’s thesis, that Zicam would be a more profitable product as part of a larger company rings true. The difficulty of competing for pharmacy shelf space with behemoths like Johnson & Johnson(JNJ), which recently expanded its girth with its purchase of Pfizer’s(PFE) consumer products division, is great. Improvements in distribution and manufacturing from being part of a larger company could be substantial as well.
One potential concern are claims that Zicam has caused users to lose their sense of smell. The company has already settled several lawsuits, but it is unclear what potential future exposure might be. This would clearly be a concern of a potential buyer.
I previously noted Jove when they filed a 13D on Lifetime Brands(LCUT) and some background information on them can be found in that post.
Jove’s filing led to a 12% jump in Matrixx’s shares today(2/22) as investors seem to believe that the company is now likely to be acquired above the current price. With no debt, and a market cap minus cash of less than two times sales, Matrixx may indeed be a good fit for buyer who can grow sales and margins.
Disclosure: I hold no postion in MTXX
MATRIXX INITIATIVES INC
10-Q
11/8/2006
9/30/2006
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0000950153%2D06%2D002739%2Etxt&FilePath=%5C2006%5C11%5C08%5C&CoName=MATRIXX+INITIATIVES+INC&FormType=10%2DQ&RcvdDate=11%2F8%2F2006&pdf=
7. Legal Proceedings
Litigation
The Company is involved in various product liability claims and other legal proceedings. The Company’s legal expense for defense of these lawsuits continues to have a significant impact on the results of operations as the Company defends itself against the various claims.
Among the principal matters pending to which the Company is a party are the following:
Product Liability Matters
General. Numerous lawsuits have been filed against us alleging that our Zicam Cold Remedy nasal gel product has caused the permanent loss or diminishment of the sense of smell or smell and taste. As discussed in greater detail below, we believe these allegations are unfounded. The Company is incurring significant legal expense for defense of these lawsuits. Litigation expense for defense of the product liability lawsuits was approximately $1.6 million in the third quarter of 2006. In the third quarter of 2005, legal defense expense was $1.8 million, reduced by
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MATRIXX INITIATIVES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
reimbursement of approximately $300,000 from our principal insurance carrier, resulting in net legal expense of approximately $1.5 million. For the nine months ended September 30, 2006, litigation expense was approximately $4.8 million. In the first nine months of 2005, litigation expense was $4.7 million, reduced by reimbursement of approximately $1.7 million from our principal insurance carrier, resulting in net legal expense of approximately $3.0 million. We do not expect to recognize reimbursements from our insurance carriers for legal expense incurred in 2006 or any future periods.
Since June 30, 2006, three new product liability cases have been filed against the Company and five product liability cases have been dismissed. The following chart discloses the number of outstanding product liability cases and associated plaintiffs at the indicated dates:
December 31, 2005 June 30, 2006 October 20, 2006
Number of Pending Lawsuits 50 37 36
Number of Plaintiffs 427 52 51
Three of the pending lawsuits were filed as class action lawsuits covering named and unnamed plaintiffs. Various defendants in the lawsuits, including manufacturers and retailers, have received indemnification or other recovery from us for damages related to the lawsuits.
Settlement of Arizona Consolidated Litigation. On January 19, 2006, we entered into an agreement to settle claims made by approximately 90% of the plaintiffs in all of the Zicam Cold Remedy product liability lawsuits against the Company. This settlement related to the Arizona consolidated litigation, In Re Consolidated Zicam Product Liability Cases, Superior Court of Arizona (Maricopa County). The settlement documents acknowledge that Matrixx has denied and continues to deny any liability to the plaintiffs. Those plaintiffs who were eligible and elected to participate in the settlement program dismissed their claims with prejudice and provided written releases of their claims against the Company in return for their participation. Of the plaintiffs who did not participate in the settlement program, all but seven have dismissed their claims as of October 20, 2006. Matrixx paid $11.9 million to fund awards to be made under the settlement program. In addition, Matrixx paid $100,000 to cover the administration of the settlement program by plaintiffs’ counsel. The Company recognized a charge of approximately $4.3 million (after tax) in the fourth quarter of 2005 to cover the portion of the settlement program costs not expected to be covered by insurance.
Cases Dismissed Since June 30, 2006. The following cases have been dismissed since June 30, 2006, either as a result of settlement or otherwise: Hurst, Janet vs. Matrixx Initiatives, Inc., et al., filed May 13, 2005, in the United States District Court, Central District of California, Santa Ana, dismissed on July 27, 2006; Lesher, David vs. Matrixx Initiatives, Inc., et al., filed November 1, 2005 in the U.S. District Court, Northern District of Alabama, Middle Division, dismissed on August 31, 2006; Orlansky, Robin vs. Matrixx Initiatives, Inc., et al., filed February 9, 2005, in the Superior Court of California (San Diego County), dismissed September 18, 2006; Kenney, Patricia A. vs. Matrixx Initiatives, Inc., et al., filed July 13, 2005 in the Superior Court of California, County of Los Angeles, dismissed on August 30, 2006, and Sutherland, Janie vs. Matrixx Initiatives, Inc., et al., filed December 18, 2003, in the Circuit Court of Etowah, Alabama, removed to United States District Court for the Northern District of Alabama, Middle Division, dismissed on November 7, 2006.
Cases Filed Since June 30, 2006. The following cases have been filed since June 30, 2006: Bruno, Angelo vs. Matrixx Initiatives, Inc., et al., filed July 7, 2006, in the Superior Court of the State of California, County of San Diego, Case No. 868821; Sawyer, Robert vs. Matrixx Initiatives, Inc., et al., filed July 18, 2006 in the Supreme Court of the State of New York, County of Wayne, Case No. 59802; and Stanley, Carlie vs. Matrixx Initiatives, Inc., et al., filed August 30, 2006 in Los Angeles Superior Court, Case No. BC 357807.
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MATRIXX INITIATIVES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The Company has been advised that certain plaintiffs’ attorneys collectively represent approximately 200 additional potential claimants for whom they have not yet filed lawsuits. The Company is in the process of determining the number of potential claimants, the nature or basis of their purported claims, and when or if the potential claimants will ultimately file one or more lawsuits against the Company.
Plaintiffs’ law firms may continue to solicit potential claimants and, as a result, additional lawsuits may be filed against us. We cannot predict the outcome of the litigation but we will defend ourselves vigorously. If any liability were to result from one or more of these or future lawsuits, we believe our financial results could be materially impacted. Our financial results also could be materially impacted by the adverse publicity that may result from the lawsuits.
Company’s Position Regarding the Allegations. We believe the allegations relating to Zicam Cold Remedy are unfounded. Zicam Cold Remedy has been studied in two independent, placebo-control clinical studies. In those studies, there was no statistically significant difference in adverse events between the placebo and non-placebo groups, and there was no indication in either group of impairment to the sense of smell. Further, the incidence of smell disorders is reported at 1% to 2% of the population on average, and is very common in those over age 50. Upper respiratory infections are among the most common causes of impairment to sense of smell. Therefore, any product such as Zicam Cold Remedy designed to treat upper respiratory illnesses may be mistakenly associated with distortion of sense of smell. The rate of reported complaints of distortion of the sense of smell associated with Zicam Cold Remedy is well below these national incidence levels.
We convened a two-day meeting of our Scientific Advisory Board in September 2004 to review the findings of studies initiated in the first quarter of fiscal 2004. The Scientific Advisory Board is comprised of medical doctors and researchers who are independent of the Company. Matrixx provided honorariums for members’ attendance at meetings, travel expenses, and funded grants to design and perform research studies investigating the contention that Zicam Cold Remedy zinc gluconate nasal gel is associated with disorders of smell. Members of the Scientific Advisory Board presented the results of their studies on the epidemiology, anatomy, and physiology of smell disorders. It was the unanimous opinion of the Scientific Advisory Board that the cumulative scientific evidence does not support the contention that Zicam Cold Remedy zinc gluconate nasal gel is causally associated with disorders of smell. The Scientific Advisory Board may reconvene from time to time to review any new studies that may be initiated or published.
Insurance. We have submitted all of the existing lawsuits to our insurance carriers. In April 2004, we established a fully-funded deductible insurance program through a product liability insurance carrier. The settlement of the consolidated Arizona litigation exhausted this insurance program. In April 2006, we replaced the self-funded program with a limited traditional insurance program. This new insurance program does not cover previously existing lawsuits and only applies to any new claims made after it became effective (see Note 6 of the Condensed Consolidated Financial Statements).
Litigation Reserves. As of December 31, 2005, the Company had established a reserve of $1.3 million for any future payment of settlement or losses related to the cold remedy litigation. This reserve was based on certain assumptions, some of which are described below, and was the amount that the Company believed that it could reasonably estimate would be spent to resolve the remaining cases that have been filed. Some of the significant factors that were considered in the establishment of the reserve were as follows: the actual costs incurred by the Company up to that time in resolving several claims; the development of the Company’s legal defense strategy and structure in light of the Arizona settlement; and the number of cases that remain pending against the Company. There are events, such as the dismissal of any cases, the outcome of a trial, or rulings on pending evidentiary motions, that may have an impact on the Company’s conclusions as to the adequacy of the reserves for the pending product liability lawsuits. Litigation is inherently unpredictable and excessive verdicts do occur. Although we believe we have substantial defenses in these matters, we could in the future incur judgments or enter into settlements of claims that could have a material adverse effect on our results of operations in any particular period. Based on the number of pending and settled cases, the reserve was approximately $1.2 million on September 30, 2006. The Company will continue to review the adequacy of the associated reserves on a quarterly basis.
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MATRIXX INITIATIVES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Securities Litigation Matters
Two class action lawsuits were filed in April and May 2004 against the Company, our President and Chief Executive Officer, Carl J. Johnson, and our Executive Vice President and Chief Financial Officer, William J. Hemelt, alleging violations of federal securities laws. On January 18, 2005, the cases were consolidated and the court appointed James V. Sircusano as lead plaintiff. The amended complaint also includes our Vice President of Research and Development, Timothy L. Clarot, as a defendant and was filed March 4, 2005. The consolidated case is Sircusano, et al. vs. Matrixx Initiatives, Inc., et al., in the United States District Court, District of Arizona, Case No. CV04-0886 PHX DKD. Among other things, the lawsuit alleges that between October 2003 and February 2004, we made materially false and misleading statements regarding our Zicam Cold Remedy product, including failing to adequately disclose to the public the details of allegations that our products caused damage to the sense of smell and of certain of the product liability lawsuits described above. We filed a motion to dismiss this lawsuit and, on March 8, 2006, the Company received an Order dated December 15, 2005 granting the motion to dismiss the case, without prejudice. On April 3, 2006, the plaintiff appealed the Order to the United States District Court of Appeals, Ninth Circuit, Case No. 2:04-CV-886. In accordance with and subject to the provisions of the Company’s Certificate of Incorporation, Messrs. Johnson, Hemelt, and Clarot will be indemnified by the Company for their expenses incurred in defending these lawsuits and for any other losses which they may suffer as a result of these lawsuits. The Company has submitted this matter to its insurance carriers and may incur charges up to the deductible amount of $1 million. If any liability were to result from this lawsuit that is not covered by insurance, we believe our financial results could be materially impacted.
Federal Trade Commission Inquiry
On March 21, 2006, management received a letter from the staff of the Federal Trade Commission’s East Central Region (Cleveland, Ohio office) (the “FTCâ€), as supplemented by a letter dated October 16, 2006, notifying the Company that the FTC is conducting an inquiry into the Company’s advertising and promotional activities for the following products: Zicam ® Cold Remedy Nasal Gel; Zicam Cold Remedy Swabs; Zicam Cold Remedy Swabs for Kids; Zicam Cold Remedy RapidMelts; Zicam Cold Remedy Chewables; Zicam Cold Remedy Oral Mist; and Zicam Allergy Relief. The purpose of the inquiry is to determine whether the Company engaged in unfair or deceptive acts or practices in violation of the Federal Trade Commission Act. The Company has largely responded to the FTC’s request for information relating to the referenced Cold Remedy Products and is in the process of gathering requested information relating to Zicam Allergy Relief (which became part of the FTC inquiry for the first time via the October 16 letter). For the nine months ended September 30, 2006, the Company has spent approximately $500,000 to compile the requested information and respond to this inquiry. The Company intends to continue cooperating with the inquiry. The Company believes that its advertisements and promotional activities are accurate and comply with applicable laws and regulations in all material respects. The Company cannot predict the timeframe within which the FTC will review the requested information or respond to the Company.
On March 10, 2005, the National Advertising Division (NAD) of the Council of Better Business Bureaus, an investigative arm of the advertising industry’s voluntary self-regulation program, issued a press release announcing the results of a review of Matrixx’s advertising claims. The NAD determined, among other things, that Matrixx’s claims that its product, Zicam ® Cold Remedy Nasal Gel, resolves colds 3X faster when taken at the first sign of a cold, that using the product results in a less severe cold, and the promise that these benefits are clinically proven, were substantiated by competent and reliable scientific evidence.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
Through our 100%-owned subsidiary, Zicam LLC, we are engaged in the development, production and sale of over-the-counter pharmaceutical and healthcare products. Our initial items were the Zicam Cold Remedy nasal gel and Zicam Allergy Relief. In 2002, we introduced five new Zicam nasal gel products, improved package graphics for our entire Zicam product line and engaged a new sales team to represent our products to retailers. In 2003, we began shipping three new Zicam Cold Remedy products (Oral Mist™, Chewables™ and RapidMelts®). In the third quarter of fiscal 2004, we began shipping our six new Zicam Cough Mist™ products (Cough Mist Adult Cherry, Cough Mist Adult Honey Lemon, Cough Mist Adult Plus Decongestant, Cough Mist Adult Night Time, Cough Mist Kids Cherry, and Cough Mist Kids Plus Decongestant). During the third quarter of 2005, the Company began initial shipments of Zicam Cough Mist Max, four new Zicam Cold & Flu relief products (Zicam Cold & Flu Day, Zicam Cold & Flu Nite, Zicam Maximum Strength Flu Day, and Zicam Maximum Strength Flu Nite), and our new Nasal Comfort™ branded products. The Company began shipping three new Zicam products during the third quarter of 2006. The new items consist of two new Cold Remedy products (Zicam RapidMelts® +Vitamin C and Zicam Chewcaps) and a new cough relief item (Zicam Cough Melts). In early 2006, the Company decided to discontinue sales of several items that did not achieve widespread distribution. The discontinued items include three of the cough spray items (Honey-Lemon, Kids Cough, and Kids Cough +D) and the Zicam Nasal Moisturizer gel. We do not believe the discontinuation of these items will have a material affect on our sales.
The Men Behind Zicam
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/30/AR2006013001255.html
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
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/30/AR2006013001255.html
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Maker of Cold Spray Settles Lawsuits for $12 Million but Denies Claim That Zinc Product Ruined Users’ Sense of Smell
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/30/AR2006013001240.html
Paying Through the Nose
Maker of Cold Spray Settles Lawsuits for $12 Million but Denies Claim That Zinc Product Ruined Users’ Sense of Smell
By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, January 31, 2006; Page HE01
The manufacturer of Zicam Cold Remedy has agreed to pay $12 million to settle 340 lawsuits brought by consumers who claim the popular over-the-counter zinc nasal gel damaged or destroyed their sense of smell. The Phoenix-based manufacturer, Matrixx Initatives, says the agreement announced Jan. 19 is not an admission of liability, but rather an effort to end most of the litigation over the homeopathic remedy.
“The company still stands by the product, but this made good business sense,” said Matrixx spokesman Robert J. Murphy. The agreement was announced jointly by the company and Arizona lawyer Charles S. Zimmerman, on behalf of a consortium of lawyers representing plaintiffs around the country.
The Men Behind Zicam
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.
In the past two years, Murphy said, Matrixx has spent about $12 million in legal fees defending its flagship product, which has sold more than 10 million bottles since its debut in 1999. Five months ago Matrixx settled the only Zicam lawsuit that has gone to trial, brought by a 42-year-old Los Angeles computer consultant, with an undisclosed payment.
Approximately 400 lawsuits have been filed against Zicam since 2003, some by users who say they lost their ability to smell and taste after using the product only once. Matrixx has denied the allegations, saying no study has linked the spray with loss of smell, also known as anosmia. The company says the likely culprit is a virus, the most common cause of anosmia.
Under the terms of the agreement, 95 percent of eligible plaintiffs must accept the Arizona settlement; the average payment after legal fees would be about $21,000. Zimmerman, who called the settlement “very fair and appropriate,” said the amount would vary depending on the extent of injury determined by medical tests. The settlement does not cover about two dozen claims involving Zicam nasal swabs, which also contain zinc gluconate, or 32 lawsuits outside Arizona. Plaintiffs who reject the settlement are free to pursue their lawsuits, but are likely to have trouble finding a lawyer to represent them.
Zimmerman, a veteran product liability lawyer, and his colleagues have argued that Zicam destroyed delicate smell tissue when the drug’s pump bottles drove the viscous gel into the top of the nose with propulsive force. Zinc is used to destroy smell in laboratory animals and can be toxic to the sense of smell in people.
Matrixx said the spray gel, which package instructions say is supposed to be used in the lower part of the nose, does not reach high enough to inflict damage.
Last fall Matrixx introduced a new “control tip sprayer” that prevents the spray gel from being forcefully expelled. Murphy called the new tip “a product advancement that has been in the works since 2001” that is “completely unrelated” to the litigation. Production of the old sprayer has been discontinued, but those containers will be sold until supplies are exhausted, he said.
Zimmerman said the redesign was a result of the litigation and will protect consumers.
At one downtown Washington drugstore last week, only packages with the old sprayer — bearing an expiration date of January 2008 — were on the shelf.
In recent months Matrixx has embarked on an expensive national advertising campaign featuring testimonials from consumers, including radio talk show host Rush Limbaugh.
Officials at the Food and Drug Administration (FDA) say they have received adverse reports involving Zicam, which was invented by several California entrepreneurs with credentials unusual for drug developers. (See “The Men Behind Zicam,” at right.) The agency would not disclose the number of reports or comment further.
Because Zicam contains a naturally occuring mineral — zinc — which is generally recognized as safe, and because it is labeled as a homeopathic remedy, it is exempt from the regulations governing safety testing and manufacturing that apply to many drugs.
“This is not an FDA-regulated product,” Zimmerman said.
Another over-the-counter homeopathic zinc nasal spray, Cold-Eeze, has been the target of a small number of anosmia lawsuits. It was pulled in 2004 after a year on the market by the manufacturer, which cited disappointing sales.
Since 2000, two case reports published in medical journals have reported anosmia after Zicam use. Medical experts who are not connected to the litigation say that it has been known since 1938 that zinc can harm smell tissue in high enough doses. A year earlier, Canadian doctors had used a zinc nasal solution to kill the sense of smell in children as part of an ill-fated experiment to prevent polio.
Murphy said Zicam is safe and effective, and produced in accordance with FDA regulations. He called the case reports “anecdotal. ” The Canadian study, he said, is not relevant because it involved a different zinc solution.
But some experts say they aren’t so sure — and that the question is likely to linger because there is no incentive to study whether Zicam is linked to anosmia. (Research into the effectiveness of zinc gels, sprays and lozenges in fighting the common cold have yielded mixed results.)
“There’s no way to tell whether anosmia is just chance or a cause-and-effect relationship,” said Ronald Turner, a prominent University of Virginia cold researcher unconnected with the lawsuits, who published a study concluding that Zicam was ineffective in preventing or treating colds.
Turner conducted one of three company-financed studies of Zicam; two others found the product was effective. None reported unusual rates of anosmia.
Because the studies involved only a total of about 400 people, some side effects might not be recognized until large numbers of people used it, Turner said.
Several plaintiffs say they are disappointed by the Arizona settlement, but have been warned by plaintiff’s lawyers that talking to the media could jeopardize the agreement or their participation in it.
“It’s a pittance, but I’ll take it since I don’t have much choice,” said one plaintiff, who asked that his name not be published. “I would really like to see them have a warning label on that product. Best of all, I’d like my sense of smell back.” The settlement does not provide for a warning label, the parties said.
One Plaintiff’s Story
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Lisa Weatherington, a 50-year-old Army medical officer who lives in Bowie, is one of the 340 plaintiffs. Her case illustrates the difficulties inherent in determining what role, if any, Zicam played in her anosmia.
Weatherington said she used Zicam once two years ago to treat a burgeoning cold at the suggestion of her husband who said it worked for him. Seconds after spraying it, she recalled, she felt an intensely painful burning.
In early January 2004, Weatherington said, she realized she could no longer smell or taste anything. She said she called Matrixx to report the problem and was told the company had never heard of this problem — although the first report of ansomia after Zicam use appeared in a medical journal in 2000 and the first lawsuit was filed in October 2003. Matrixx declined to comment on her case citing the pending litigation.
Several doctors have told Weatherington she probably will never regain her sense of smell. Her superiors have told her the problem could hamper her military career because it will prevent her deployment to places where she would need to detect poisonous fumes.
“I love food and I used to love to cook for my family, ” said Weatherington who adds that she has gotten sick from eating spoiled shrimp she coudn’t smell. “Sometimes I just feel like crying.”
Robert I. Henkin, a neurologist who directs the Taste and Smell Clinic in Northwest Washington, said there’s no way to know for sure whether Weatherington, whom he is treating, lost her sense of smell because of a virus or because she used Zicam.
Terence Davidson, director of the Nasal Dysfunction Clinic at the University of California at San Diego, said he was skeptical that Zicam could cause anosmia — until he saw two patients in one week who were under 50 (most anosmia patients are older), had not had colds, and developed the condition hours after using the spray, an experience both described as deeply painful.
Post-viral anosmia typically occurs more gradually, said Davidson, adding that he has treated hundreds of such patients who seek treatment weeks after a severe cold. The burning pain many Zicam users describe, he said, is indicative of damage to sensitive olfactory tissue.
“The timing with these patients is very different than with post-viral anosmia patients,” said Davidson, who has testified as an expert witness for several Zicam plaintiffs.
But Anthony F. Jahn, a New York otolaryngologist hired by Matrixx to review zinc studies, disputed Davidson’s contentions.
The burning some patients report signals irritation — the same thing that happens when a swimmer gets water up the nose–but does not mean damage has occurred, Jahn said. Zicam, he added, is too thick to reach high enough up in the nose to harm tissue. Said Jahn, “I don’t see a mechanism by which this could happen.” ?
Comments: boodmans@washpost.com.
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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.
The following article was also published in the Orange County Register around the same time period.
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*****
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
====================================================
Zicam Clinical Study Analysis
by: painfullyblunt2004 11/02/05 12:57 pm
Msg: 115757 of 115857
There have been three clinical studies involving Zicam.
HIRT STUDY:
The first was the by Hirt, et al. that was published in October 2000. It involved only 213 people, and only 108 of those received treatment with Zicam. There was no serology performed to determine (a) whether the study subjects even had colds, or (b) whether any colds they had were from rhinovirus. And while the study concluded that Zicam reduced the length and severity of colds symptoms, we are still left with a fundamental design flaw. Even assuming for the sake of argument that the Zicam helped, we are left with the question of WHAT it helped. We don’t know whether ANY of the subjects even had a cold, as opposed to something else. And we don’t know whether any of them had a cold from rhinovirus.
TURNER STUDY:
The study by Turner, with was published in December 2001, corrected the serious design flaw in the Hirt study by first INFECTING the subjects with rhinovirus and then confirming through virology which subjects had a rhinovirus-caused cold. Rhinovirus was confirmed in 69 study subjects, with 32 of them receiving Zicam. The study concluded that “there was no effect of intranasal zinc treatment on rhinovirus infection,” and “there was no significant effect of intranasal zinc treatment on rhinovirus-induced illness” [i.e. symptoms]. You will not notice this Gel Tech LLC-funded study mentioned anywhere in Zicam promotional materials or on the Zicam web site (at least not the last time I checked).
MOSSAD STUDY
The Mossad study, which was published in January 2003, involved only 78 patients who were included in the final analysis. Virological studies were done on these participants, which identified only ELEVEN members of the zinc group (i.e. the ones who got Zicam) who had rhinovirus-caused colds. Oddly enough, the analysis was NOT confined to the 27 individuals who actually had rhinovirus-caused colds (11 zinc and 16 placebo), but rather included all 78 participants (51 of whom had God only knows). Mossad concluded that Zicam reduced cold symptom duration from 6 days to 4.3 days and that it reduced the severity of symptoms. However, what relevance is there to symptom duration and severity in participants who didn’t have rhinovirus-caused colds? Again, you are left with the question of, even assuming Zicam helped, WHAT did it help?
You have only these three studies done on Zicam. One of which concluded Zicam was essentially useless. The second of which had no idea WHAT the test subjects had. And the third which analyzed the data in a senseless manner–including those whom they KNEW didn’t have rhinovirus-caused colds.
Therefore, based on the three studies available, even the fundamental efficacy of Zicam on colds remains in question.
There have been two published articles on Zicam-induced anosmia. The first by Hirsch, et al. in October 2000 and the 2004 Jafek, et al. article. The first was a case report; the second was a case series. Moreover, there has been medical research since the 1930s that clearly documents the connection between intranasal zinc and anosmia.
The total number of subjects with confirmed rhinovirus colds in both the Hirt and Mossad studies COMBINED is 27 (Hirt=0; Mossad=27). The total number of subjects with confirmed rhinovirus colds in the Turner study is 69. That is a ratio in favor of the Turner study of 2.55 to 1.
In light of the Hirt “no serology” problem and the Mossad “fuzzy math” problem, comparing them to the Turner study is like comparing an 8th grade English composition to Tolstoy.
Hopefully this has been a helpful review of the medical literature as it relates to Zicam.
======================================================
..
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Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-25062
Telephone : (949) 608-2900
Warning Letter
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
November 23, 2005
W/L 08-06
Charles B. Hensley, Ph.D.
PRB Pharmaceuticals
300 Oceangate
Suite 910
Long Beach, CA 90802
Dear Dr. Hensley:
This letter concerns your firm’s marketing of the product “Vira 38” on your website, www,prbpharmaceuticals.com. According to your website, this product is intended to prevent, treat, or cure serious disease conditions. The statements on your website include, but are not limited to, the following:
Vira 38
“Highly effective flu medication.”
Shown to inhibit and prevent infection of Bird Flu Virus (H5N1) and Type A human influenza in vitro.”
“Human clinical research shows Vira 38 reduces the duration of influenza illness by 78%.”
“One of the anti-viral components is v38 AMF-1 which has been shown to inhabit infections from Type A influenza, SARS virus, Avian influenza virus, Staphylococcus aureus, and Streptococcus pneumoniae (two bacteria primarily responsible for secondary infections seen in influenza).”
“Vira 38 is a favorite among the Hong Kong doctors for the prevention and treatment of influenza.”
“vira 38 is currently used in Hong Kong to protect the live poultry market workers against the bird flu.”
“Vira 38 was used by the major SARS hospital to protect front-line doctors and nurses against SARS during the SARS outbreak of 2003.”
These claims are further supplemented by the metatags that you use to bring consumers to your website. These metatags include “life threatening diseases,” “influenza virus,” “SARS coronavirus.” and treatments”.
Vira 38 is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 321 (g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, this product is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. 321(P), because it is not generally recognized as safe and effective for its labeled uses. Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Vira 38 without such an approved application violates these provisions of the Act.
Furthermore, many of the conditions for which this product is offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use for these conditions cannot be written so that a layman can use thus drug safely for its intended purposes. (See 21 C.F.R § 201.5). Because your product’s labeling fails to bear adequate directions for its intended uses, it is misbranded under Section 502(f)(1) of the Act, 21 U.S.C., § 352(f)(1).
The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letter about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. It you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and the steps taken to assure that similar violations will not occur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturing firm. Address your reply to the U.S. Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, Attention: Pamela B. Schweikert, Director of Compliance.
A description of the new drug approval process can be found on FDA’s Internet Website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Sincerely,
/s/
Alonza E. Cruse
Director, Los Angeles District
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FOR IMMEDIATE RELEASE
P05-99
December 13, 2005
Media Inquiries:
Catherine McDermott, 301-827-6242
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888-INFO-FDA
FDA Acts to Protect Public from Fraudulent Avian Flu Therapies
The U.S. Food and Drug Administration (FDA) issued warning letters recently to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments.
“There are initiatives in place to deter counterfeiters and those who sell fraudulent or phony products to prevent or treat avian flu,” said Andrew von Eschenbach, MD, Acting FDA Commissioner. “The use of unproven flu cures and treatments increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren’t. I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims.”
FDA issued Warning Letters to nine firms marketing products making unproven claims that they treat or prevent avian flu or other forms of influenza. Eight of the products purported to be dietary supplements. Examples of the unproven claims cited in the Warning Letters include: “prevents avian flu,” “a natural virus shield,” “kills the virus,” and “treats the avian flu.” These alternative therapies are promoted as “natural” or “safer” treatments that can be used in place of an approved treatment or preventative medical product.
In the Warning Letters, FDA advises the firms that it considers their products to be drugs because they claim to treat or prevent disease. The Warning Letters further state that FDA considers these products to be “new drugs” that require FDA approval before marketing. The letters also note that the claims regarding avian flu are false and misleading because there is no scientific basis for concluding that the products are effective to treat or prevent avian flu. The companies have 15 days to respond to FDA.
Consumers who believe that they have seen a fraudulent product can report it to the FDA at http://www.fda.gov/oc/buyonline/buyonlineform.htm.
For information on helping prevent flu, see the Centers for Disease Control and Prevention http://www.cdc.gov/flu/protect/preventing.htm.
FDA Warning Letters:
Sacred Mountain Management Inc.
http://www.fda.gov/foi/warning_letters/g5630d.pdf
http://www.fda.gov/foi/warning_letters/g5630d.htm
BODeSTORE.com
http://www.fda.gov/foi/warning_letters/g5632d.pdf
http://www.fda.gov/foi/warning_letters/g5632d.htm
Melvin Williams
http://www.fda.gov/foi/warning_letters/g5634d.pdf
http://www.fda.gov/foi/warning_letters/g5634d.htm
Iceland Health Inc.
http://www.fda.gov/foi/warning_letters/g5636d.pdf
http://www.fda.gov/foi/warning_letters/g5636d.htm
PolyCil Health Inc.
http://www.fda.gov/foi/warning_letters/g5629d.pdf
http://www.fda.gov/foi/warning_letters/g5629d.htm
PRB Pharmaceuticals Inc.
http://www.fda.gov/foi/warning_letters/g5628d.pdf
http://www.fda.gov/foi/warning_letters/g5628d.htm
Chozyn, LLC
http://www.fda.gov/foi/warning_letters/g5631d.pdf
http://www.fda.gov/foi/warning_letters/g5631d.htm
Vitacost.com
http://www.fda.gov/foi/warning_letters/g5633d.pdf
http://www.fda.gov/foi/warning_letters/g5633d.htm
Healthworks 2000
http://www.fda.gov/foi/warning_letters/g5635d.pdf
http://www.fda.gov/foi/warning_letters/g5635d.htm
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Also Matrixx has only claimed that Zican has helped colds that are caused by Rhinovisus.
Frequency: In the US: Common colds most frequently occur from September to April in temperate climates. RV infections, which are present throughout the year, account for the initial increase in cold incidence during the fall and a second incidence peak at the end of the spring season. Colds occurring from October through March are caused by the successive appearance of numerous viruses, including parainfluenza, coronavirus, RSV, and influenza virus. Adenoviral infections occur at a constant rate throughout the season.
“It is estimated that about one third of “colds” are caused by rhinovirus infections.”
==========================================================================
http://www.emedicine.com/ped/topic2707.htm
Rhinovirus Infection
Last Updated: August 31, 2004 Rate this Article
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Synonyms and related keywords: RV infection, common cold, upper respiratory infection, URI
AUTHOR INFORMATION Section 1 of 9
Author Information Introduction Clinical Differentials Workup Treatment Medication Follow-up Bibliography
Author: Mai Ngoc Nguyen, MD, Staff Physician, Department of Pediatrics, Mattel Children’s Hospital, University of California at Los Angeles
Coauthor(s): James D Korb, MD, Program Director, Department of Pediatrics, Children’s Hospital of Orange County
Mai Ngoc Nguyen, MD, is a member of the following medical societies: American Academy of Pediatrics, and American Medical Association
Editor(s): José Rafael Romero, MD, Director of Pediatric Infectious Diseases Fellowship Program, Associate Professor, Department of Pediatrics, Combined Division of Pediatric Infectious Diseases, Creighton University/University of Nebraska Medical Center; Robert Konop, PharmD, Clinical Assistant Professor, Department of Pharmacy, Section of Clinical Pharmacology, University of Minnesota; Larry I Lutwick, MD, Director, Division of Infectious Diseases, Veterans Affairs New York Harbor Health Care System, Professor, Department of Internal Medicine, State University of New York at Downstate; Robert W Tolan, Jr, MD, Chief of Pediatric Infectious Diseases, St. Peter’s University Hospital and Capital Health System, Clinical Associate Professor of Pediatrics, Drexel University College of Medicine; and Russell Steele, MD, Professor and Vice Chairman, Department of Pediatrics, Head, Division of Infectious Diseases, Louisiana State University Health Sciences Center
INTRODUCTION Section 2 of 9
Author Information Introduction Clinical Differentials Workup Treatment Medication Follow-up Bibliography
Background: Rhinoviruses (RVs) are small (30 nm), nonenveloped viruses that contain a single-strand ribonucleic acid (RNA) genome within an icosahedral (20-sided) capsid. RVs belong to the Picornaviridae family, which includes the genera Enterovirus (polioviruses, coxsackieviruses groups A and B, echoviruses, numbered enteroviruses) and Hepatovirus (hepatitis A virus). Approximately 101 serotypes are identified currently.
This review focuses on the common cold because it most frequently is associated with RV. Nasopharyngitis, croup, and pneumonia, which uncommonly are caused by RV, also are discussed briefly. RV plays a significant role in the pathogenesis of otitis media and asthma exacerbations. Although incidence and prevalence are high, most cases are mild and self-limited.
Pathophysiology: RV can be transmitted by aerosol or direct contact. Primary site of inoculation is the nasal mucosa, although the conjunctiva may be involved to a lesser extent. RV attaches to respiratory epithelium and spreads locally. The major human RV receptor is intercellular adhesion molecule-1 (ICAM-1). The natural response of the human defense system to injury involves ICAM-1, which aids the binding between endothelial cells and leukocytes. RV takes advantage of the ICAM-1 by using it as a receptor for attachment. In addition, RV uses ICAM-1 for subsequent viral uncoating during cell invasion. Some RV serotypes also up-regulate the ICAM-1 expression on human epithelial cells to increase infection susceptibility.
Optimum environment for RV replication is 33-35°C. RV does not replicate efficiently at body temperature. This may explain why RV replicates well in the nasal passages and upper tracheobronchial tree but less well in the lower respiratory tract. Incubation period is approximately 2-3 days. Viremia is uncommon.
RV is shed in large amounts, with as many as 1 million infectious virions per milliliter of nasal washings. Viral shedding can occur a few days before cold symptoms are recognized by the patient, peaks on days 2-7 of the illness, and may last for as many as 3-4 weeks.
A local inflammatory response to the virus in the respiratory tract can lead to nasal discharge, nasal congestion, sneezing, and throat irritation. Damage to the nasal epithelium does not occur, and inflammation is mediated by the production of cytokines and other mediators.
Histamine concentrations in nasal secretions do not increase. By days 3-5 of the illness, nasal discharge can become mucopurulent from polymorphonuclear leukocytes that have migrated to the infection site in response to chemoattractants such as interleukin-8. Nasal mucociliary transport is reduced markedly during the illness and may be impaired for weeks. Both secretory immunoglobulin A and serum antibodies are involved in resolving the illness and protecting from reinfection.
Coronaviruses, reinfections with parainfluenza, and respiratory syncytial virus (RSV) are the most important of many other viruses that can cause common colds. Other viruses (eg, adenoviruses, influenza viruses) also can cause common colds but are more likely to cause acute nasopharyngitis and more severe respiratory infections.
Mycoplasma pneumoniae occasionally can present with common cold symptoms before developing into more extensive respiratory disease. Other pathogens include Coccidioides immitis, Histoplasma capsulatum, Bordetella pertussis, Chlamydia psittaci, and Coxiella burnetii.
Recent clinical studies indicate sinus involvement in common colds. CT scan abnormalities (eg, opacification, air-fluid levels, mucosal thickening) are present in adults with common colds that resolve over 1-2 weeks without antibiotic therapy.
Folklore to the contrary, no good clinical evidence reports that colds are acquired by exposure to cold weather, getting wet, or becoming chilled.
Frequency:
In the US: Common colds most frequently occur from September to April in temperate climates. RV infections, which are present throughout the year, account for the initial increase in cold incidence during the fall and a second incidence peak at the end of the spring season. Colds occurring from October through March are caused by the successive appearance of numerous viruses, including parainfluenza, coronavirus, RSV, and influenza virus. Adenoviral infections occur at a constant rate throughout the season.
Numerous studies demonstrate common cold incidence to be highest in preschool and elementary school-aged children. An average of 3-8 colds per year is observed in this age group, with an even higher incidence for children attending day care and preschool. Given the numerous viral agents involved and the many serotypes of several viruses (especially RV), younger children having new colds each month during the winter season is not unusual. Adults and adolescents typically have 2-4 colds per year.
Internationally: Seasonal increase in incidence during the winter months is observed worldwide.
Mortality/Morbidity: The most common manifestation of RV, the common cold, is mild and self-limited. However, rarely severe respiratory disease, including bronchiolitis and pneumonia, can occur in infants.
Race: American Indian and Eskimo people are more likely to develop the common cold and appear to have more frequent complications such as otitis media. These findings may be explained as much by environmental conditions (eg, poverty, overcrowding) as by ethnicity.
Age: Since antibodies to viral serotypes develop over time, highest incidence is found in infants and younger children. In addition, younger children are more likely to have the frequent, close, personal contact necessary to transmit RV. Contrary to the experience of adults, children also may be more contagious due to having higher virus concentrations in secretions and longer duration of viral shedding. CLINICAL Section 3 of 9
Author Information Introduction Clinical Differentials Workup Treatment Medication Follow-up Bibliography
History: RV directly can cause or indirectly can predispose to a variety of upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), which are less common.
Common cold
Nose dryness or irritation often is the first symptom and is followed within hours by profuse watery rhinorrhea, nasal congestion, and sneezing.
A sore throat or throat irritation is common.
Malaise, headache, and cough also are common symptoms of the common cold.
Fever is absent or low grade. Infants and preschoolers are more likely to experience fevers, which are often 38-39°C.
Nasal secretions typically become thicker and colored after the first few days of illness.
Irritability or restlessness is common.
Nasal obstruction can interfere with sleep and feeding.
Posttussive vomiting can occur.
Symptoms in adults and adolescents usually resolve by day 7; however, symptoms often last 10-14 days in younger children.
Acute otitis media
Viral URIs are common precipitating factors for acute otitis media (AOM), probably by causing respiratory mucosal inflammation, leading to eustachian tube obstruction.
Respiratory viruses are found in either the middle ear fluid or nasopharynx in approximately 40% of patients with AOM.
As many as 24% of patients with AOM have RV present in nasopharyngeal secretions. RV also has been obtained from middle ear fluid.
Patients whose symptoms are refractory to treatment with antibiotics are more likely to have positive viral cultures from the middle ear.
Sinusitis
Viral respiratory infections commonly cause more frequent and more severe asthma exacerbations in individuals of all ages.
Preceding RV infection can lead to bacterial superinfection.
Asthma exacerbations
Viral URI is the most common trigger for asthma exacerbations in children of all ages.
For children younger than 5 years, RV and RSV are the most commonly implicated pathogens. RV is the most commonly implicated pathogen for older children.
LRTI: RV may cause both pneumonia and bronchiolitis in infants.
Croup: RV may cause laryngotracheobronchitis in infants.
Acute nasopharyngitis
The patient’s physical examination reveals nasal discharge and a sore throat, including throat inflammation (eg, erythema, exudate, ulcers). Fever is common and can be high.
Acute nasopharyngitis most commonly is caused by adenovirus, enteroviruses, influenza, and parainfluenza.
RV is an uncommon cause of acute
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