Silicon Investor - GUMM - Eliminate the Common Cold

[StockDung] THE GUMM FRAUD FAFO

StockDung — 7/17/2025 10:27:18 PM

[StockDung] On August 10, 2022, federal prosecutors in Los Angeles indicted Hensley on fraud...

StockDung — 11/28/2023 12:33:11 PM

On August 10, 2022, federal prosecutors in Los Angeles indicted Hensley on fraud and identity theft charges, alleging he used the Desilu name to scam investors. Hensley has been charged with 11 counts of wire fraud and one count of aggravated identity theft. Prosecutors said Hensley collected $331,000 from investors, money that was used for his personal expenses including trips to Las Vegas. [8]

[StockDung] FURTHER VINDICATION. INVENTOR OF ZICAM CHARGED IN MASSIVE SECURITIES FRAUD SWOOP...

StockDung — 8/11/2022 9:51:40 PM

FURTHER VINDICATION. INVENTOR OF ZICAM CHARGED IN MASSIVE SECURITIES FRAUD
SWOOP DOWN LIKE A GIANT CONDOR C.O.N.D.O.R:
Citizens Opposed to Nasal Destruction of Olfactory Receptors

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

Department of Justice
U.S. Attorney’s Office
Central District of California

FOR IMMEDIATE RELEASE

Wednesday, August 10, 2022

South Bay Man Indicted for Alleged Scheme that Used Name of Famous Television Production Company to Swindle Investors

LOS ANGELES – A South Bay man was charged today in a federal grand jury indictment alleging he used the “Desilu” name – the same name used by Lucille Ball and Desi Arnaz’s television production company famous for shows such as “I Love Lucy” and “Star Trek” – to dupe investors into giving him money for sham investments, money that was actually used for personal expenses that included trips to Las Vegas.

Charles Hensley, 68, of Redondo Beach, is charged with 11 counts of wire fraud and one count of aggravated identity theft. He will be summonsed into United States District Court for an arraignment in the coming weeks.

According to the indictment returned today, from August 2017 to May 2018, Hensley successfully pitched investments in companies he owned, including Desilu Studios Inc. and Migranade Inc., which he operated out of offices in Manhattan Beach and other locations in Southern California. While Hensley claimed his businesses were real and successful, in fact, the indictment alleges, they were little more than shell corporations used as part of an investment scam.

In 2016, Hensley began using the name Desilu, which was similar to the name Desilu Productions Inc., the company that produced classic television shows during the 1950s and 1960s. He then claimed he was making new content for his company, Desilu Studios.

Hensley allegedly told investors he was extremely wealthy and was backing Desilu Studios with his personal funds. In fact, according to the indictment, Hensley had few assets, and he repeatedly bounced checks and overdrew bank accounts to get cash and pay expenses.

Hensley also allegedly provided victim-investors false and misleading valuation letters that purported to show that Desilu Studios was valued at more than $11 billion and Migranade at more than $50 million. In fact, the indictment alleges, the companies had little to no assets and were worth nowhere near the represented value.

In addition to these false statements, Hensley allegedly misrepresented that his companies had acquired valuable intellectual property, distribution agreements, subsidiaries and development rights, and that they were actively developing projects and bringing products to market, including new film and television projects using the Desilu name. In reality, Hensley did not own the intellectual property and other assets he said he did, and he used misleading representations regarding new film and television productions he was supposedly producing to dupe victim-investors into giving him money.

The indictment further alleges Hensley falsely represented that Desilu Studios was about to go public and that the company’s stock was worth more than its face value and more than investors were paying and would increase in value following its imminent initial public offering. In fact, according to the indictment, none of this was accurate and Hensley stole someone’s identity to list as Desilu Studio’s chief financial officer in offering materials.

The overall scheme allegedly impacted multiple victim-investors, including some who wired the approximately $331,000 identified in the wire fraud counts. In addition to these victims, Hensley allegedly also targeted multiple companies in the entertainment industry. In this part of the scheme, Hensley allegedly used some of the same misrepresentations to convince owners and executives to sell their companies to him in exchange for Desilu Studio’s stock that, unbeknownst to them, was worthless. The indictment further alleges that Hensley touted these purchases to the individual investors, further misleading them about his purported acquisitions of valuable assets.

If convicted, Hensley would face a statutory maximum sentence of 20 years in federal prison for each wire fraud count plus a mandatory two-year prison sentence for the aggravated identity theft count.

An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.

The FBI and IRS Criminal Investigation investigated this matter.

Assistant United States Attorney Kerry L. Quinn of the Major Frauds Section is prosecuting this case.

Topic(s):

Financial Fraud

Component(s):

USAO - California, Central

Contact:

Ciaran McEvoy Public Information Officer ciaran.mcevoy@usdoj.gov (213) 894-4465

Press Release Number:

22-155

Updated August 10, 2022

[StockDung] Supreme Court rules against makers of Zicam Consumer Reports News: March 23, 201...

StockDung — 12/17/2021 11:15:04 AM

Supreme Court rules against makers of Zicam
Consumer Reports News: March 23, 2011 01:45 PM

The Supreme Court unanimously sided yesterday with investors suing Matrixx Industries, makers of Zicam, for failing to reveal indications of the over-the-counter cold remedy's dangerous side effects--including loss of smell.

The shareholders, in a 2004 lawsuit against Matrixx, argued that by withholding reports of adverse events, the company had defrauded investors. The company's defense was that early reports of Zicam's side-effects were statistically insignificant. (Consumer Reports Health experts and other medical professionals had warned of Zicam's adverse effects prior to the Food and Drug Administration's official warning in 2009, which lead to the drug's removal from store shelves.)

Justice Sonia Sotomayor wrote for the court:

Given that medical professionals and regulators act on the basis of evidence of causation that is not statistically significant, it stands to reason that in certain cases reasonable investors would as well.The Supreme Court's decision allows the shareholder lawsuit to continue, allowing the lower courts to decide if Matrixx's failure to release such adverse events reports to investors is tantamount to securities fraud. Wrote Sotomayor:

The inference that Matrixx acted recklessly (or intentionally, for that matter) is at least as compelling, if not more compelling, than the inference that it simply thought the reports did not indicate anything meaningful about adverse reactions.However, in its decision for the shareholders, the Supreme Court Justices also said their ruling "does not mean that pharmaceutical manufacturers must disclose all reports of adverse events."

See our recent report on flu supplements.

Matrixx Initiatives, Inc., et al. v. Siracusano et al. (PDF) [US Supreme Court]
Supreme Court Rules Against Zicam Maker [NY Times]

Drugmaker Investor Lawsuits Backed by U.S. Supreme Court [Bloomberg]

—Paul Eng

[StockDung] In 2014, Yesenia Melgar commenced an action entitled Melgar v. Zicam LLC, et al....

StockDung — 11/27/2021 4:46:26 PM

In 2014, Yesenia Melgar commenced an action entitled Melgar v. Zicam LLC, et al. Melgar claimed that Zicam deceived customers by falsely representing that Zicam products "reduce the duration and severity of a cold." The court allowed the case to become a class action suit that included a variety of Zicam products. In 2018, a settlement was reached. Zicam agreed to pay $16,000,000 to people that had purchased Zicam products between the dates of Feb. 15, 2011 and June 5, 2018. [18]

[StockDung] Cure Pharmaceutical CEO Robert Davidson on the COVID-19 Pandemic | Innovators wi...

StockDung — 3/4/2021 7:10:33 AM

Cure Pharmaceutical CEO Robert Davidson on the COVID-19 Pandemic | Innovators with Jane King
youtu.be

[StockDung] The IRS says Tampa investment executives Richard Frueh and Donald Gunn owe more ...

StockDung — 12/26/2020 11:07:53 AM

The IRS says Tampa investment executives Richard Frueh and Donald Gunn owe more than $2 million in back interest, thanks to a tax-shelter that advisers said was a 'no-lose' proposition. Says their lawyer: Frueh and Gunn were victims of 'incredible, if not criminal, advice' from supposedly reputable bankers, accountants and lawyers.
by: Adam Hughes Staff Writer

Helter Shelter

By Francis X. Gilpin

Associate Editor

GunnAllen Financial Inc. took three years to turn a profit. But when it did in 1999, Richard A. Frueh and Donald J. Gunn Jr., co-founders of the Tampa investment firm, were making so much money that they started pondering tax shelters.

They went to a wealth manager at what was then First Union National Bank. Wachovia Corp. acquired the bank in 2001.

First Union managed the wealth of Frueh and Gunn so well that the partners are now being dunned by the Internal Revenue Service for millions of dollars in back taxes and penalties.

Frueh and Gunn, chief executive and president of GunnAllen, respectively, say they are among a legion of victims of supposedly reputable accountants, bankers and lawyers who have been caught peddling questionable tax-avoidance schemes while raking in huge fees that they seldom disclose to their affluent clients.

A federal grand jury in New York is looking into the particular chain of financial and legal advisers that allegedly took Freuh and Gunn. Among the apparent targets of the grand jury are the Big Four accounting firm KPMG LLP, the First Union wealth-management operation inherited by Wachovia and a New York law firm formerly known as Brown & Wood LLP.

Frueh, Gunn, and two other GunnAllen principals, David K. Savage and Ralph C. Johnson, are among the first of Tampa Bay area's business elite to confirm publicly that they participated in KPMG-recommended tax shelters that the IRS has deemed abusive.

$2 million in back interest

The GunnAllen executives are in company with other prominent figures. Last year, citing an IRS court filing, The Wall Street Journal reported that 29 well-known American corporations, including Clear Channel Communications Inc. and Washington Mutual Inc., attempted to reduce their federal tax liability by a combined $1.7 billion through just one of KPMG's elaborate gambits.

GunnAllen doesn't quite play in the billion-dollar leagues yet. But the 9-year-old investment firm paid $9.5 million last year to buy the Tropical Sportswear International Corp. headquarters to house an expanding base of operations in Tampa. At the time of the purchase, Freuh told The Tampa Tribune that GunnAllen planned to spend another $3.5 million to install a trading floor and other amenities.

GunnAllen advertises more than a dozen services for clients. Among them is tax planning.

According to a lawsuit the GunnAllen executives filed last month, the men owe the IRS more than $2 million in back interest alone, an amount that increases at an annual rate of 9% as they haggle with tax collectors.

How did GunnAllen's top executives get into tax trouble?

During the early 1990s, Frueh was a Tampa executive for two brokerages, Chatfield Dean & Co. and Sovereign Equity Management Corp., which ran into regulatory problems. In 1996, Frueh and Gunn went out on their own and started GunnAllen. Their subsequent success is one reason they began searching for ways to shelter their growing incomes from federal taxation.

Inexperienced about tax matters

Tampa securities attorney Scott C. Ilgenfritz, who filed their fraud and professional malpractice suit in Hillsborough County circuit court, portrays the GunnAllen principals as innocents.

"Frueh, Gunn, Savage and Johnson have been and are successful businessmen," Ilgenfritz states in the court complaint. But the shareholder in the Tampa office of Johnson Pope Bokor Ruppel & Burns LLP goes on to note: "None of the individual plaintiffs are knowledgeable or experienced about tax-related matters."

Ilgenfritz and his clients didn't respond to calls from the Gulf Coast Business Review before the newspaper's deadline.

The big earners at GunnAllen began considering the tax shelters when one of their bankers made a presentation to them in 1999.

Rick Simonetti, a regional managing director for First Union at the time, was once Savage's certified public accountant and formerly did audit work for Deloitte & Touche USA LLP.

On Sept. 1, 1999, Simonetti hooked up Frueh, Gunn and Savage with a trio of financial consultants via conference call from First Union's downtown Tampa office.

Simonetti talked up a convoluted financial transaction called a "contingent deferred swap," which the lawsuit claims he termed a conservative investment strategy adopted by "numerous similarly situated investors in the Tampa area."

Two representatives of another Big Four accounting firm, PricewaterhouseCoopers LLP, were present to assure the GunnAllen men that the swap could convert their ordinary income into capital gains that would be taxed at lower rates. Phrases such as "tried and true," "bulletproof," "smart thing to do," and "no-lose situation" were heard throughout the discussion, according to the lawsuit.

A U.S. Senate investigations subcommittee reported in February that First Union/Wachovia helped identify and reel in wealthy clients for KPMG, PwC and Ernst & Young LLP. The three Big Four accounting firms then introduced the clients to attorneys who issued boilerplate opinions endorsing the legality of whatever tax shelter the banks and accounting firms were pushing.

First Union/Wachovia representatives told Senate investigators last year that KPMG and PwC typically paid the bank $100,000 for each referral of a rich client for tax advice. Between 1997 and 2002, First Union/Wachovia estimated it collected about $13 million in referral fees from the accounting firms.

A maze of partnerships

In 2000, Simonetti returned with another plan for the GunnAllen men after selling them a modified version of the 1999 swap. The GunnAllen crew was working on a proposed outdoor amphitheater for Tampa at the time. Simonetti told Savage that a certain complicated loan product could finance the project while creating tax losses for the next 12 years.

Simonetti, who now works for Wachovia, declined to comment.

Clear Channel ended up developing an amphitheater in Tampa. GunnAllen sponsors a VIP club at the Ford Amphitheatre.

KPMG and company joined the swap and the loan together through a maze of funds and partnerships. The lawsuit says KPMG took a $1.5 million investment from the GunnAllen principals and used it to help Union Bank of Switzerland, better known as UBS AG, and others create $29 million in tax losses.

With KPMG handling the paperwork, the GunnAllen executives were apportioned a share of the losses to declare on their personal income tax returns, according to the lawsuit.

Senate investigators later unearthed an internal UBS memorandum that labeled the whole maneuver as "an illegal capital gains tax evasion scheme" for American citizens. "I am concerned that once IRS comes to know about this scheme," a UBS capital markets executive wrote, "they will levy huge financial/criminal penalties on UBS for offering tax evasion schemes."

Employees warned

First Union and KPMG weren't going to tell.

Another document discovered by Senate investigators shows employees of the bank and the accounting firm were warned in 1999 that supplying additional information to "customers or anyone else" beyond what was in their marketing materials would result in forfeiture of their commissions and their future exclusion from similar lucrative sales efforts.

A spokesman for KPMG declined comment on the lawsuit. A Wachovia spokeswoman couldn't be contacted before the Review's deadline.

By the summer of 2002, the IRS began auditing the 1999 tax returns of Frueh, Gunn, Savage and Johnson. The following spring, IRS auditors added the men's returns for 2000 and 2001 to their to-do list.

First Union sent letters to the men urging a defiant stance with the IRS. "Incredible, if not criminal, advice," is how their attorney Ilgenfritz now characterizes that counsel.

[StockDung] Zicam inventor Robert Davidson had two diploma mill degrees. A PHD and Masters d...

StockDung — 11/26/2020 10:14:25 AM

Zicam inventor Robert Davidson had two diploma mill degrees. A PHD and Masters degree and at the time had No undergraduate degree.

[StockDung] Robert S Davidson Chief Executive Officer, Cure Pharmaceutical Holding Corp CUR...

StockDung — 8/2/2020 8:44:58 PM

Robert S Davidson Chief Executive Officer, Cure Pharmaceutical Holding Corp

CURRENT POSITION
Chief Executive Officer, Cure Pharmaceutical Holding Corp
TENURE AT CURRENT POSITION
12/2016-PRESENT
PREVIOUS POSITION
Chief Executive Officer, Makkanotti Group Corp
EDUCATION
State University of New York
American Military University
BOARD MEMBERSHIPS
Cure Pharmaceutical Holding Corp
Makkanotti Group Corp
INDUSTRY
Biotech & Pharma

CURRENT PRICE

CURR:US1.59USD

-0.06-3.88%
AS OF 07/31/2020
SEE QUOTE

Board Memberships

TITLE
COMPANY
TENURE

Board Member
Cure Pharmaceutical Holding Corp
12/2016–PRESENT

Board Member
Makkanotti Group Corp
07/2011–12/2016

Chairman
Health Sport Inc
12/2009–UNKNOWN

VIEW MORE

Career History

TITLE
COMPANY
TENURE

Chief Executive Officer
Cure Pharmaceutical Holding Corp
12/2016–PRESENT

Chief Executive Officer
Makkanotti Group Corp
07/2011–12/2016

President/CEO
Zengen Inc
01/2002–07/2005

VIEW MORE

Education

[StockDung] SEC Charges Two New Defendants in Fraudulent Microcap Manipulation Scheme Orches...

StockDung — 8/2/2020 8:43:37 PM

SEC Charges Two New Defendants in Fraudulent Microcap Manipulation Scheme Orchestrated Through International AccountsLitigation Release No. 24583 / August 30, 2019Securities and Exchange Commission v. Morrie Tobin et al., Civil Action No. 1:18-CV-12451 (D. Mass. filed November 27, 2018)
The Securities and Exchange Commission filed an amended complaint charging Brian Quinn, a California resident, and David Skriloff, a New York resident, for their roles in a scheme to profit from the manipulation and illegal sale of stock of a publicly traded company, Environmental Packaging Technologies Holdings, Inc., of which Skriloff was the CEO.

On October 2, 2018, the SEC filed an emergency action and obtained an asset freeze against Roger Knox and Wintercap SA, charging them with a scheme that generated more than $165 million of illegal sales of stock in at least 50 microcap companies. On November 28, 2018, the SEC chargedMorrie Tobin, Milan Patel, Matthew Ledvina, and Daniel Lacher, with scheming to hide Tobin's ownership and control over Environmental Packaging and CURE Pharmaceutical Holding Corp. by using offshore entitites to hold his stock and by establishing accounts to sell that stock at Wintercap.

Acording to the SEC's amended complaint, Quinn helped facilitate a reverse merger between a public shell company secretly controlled by Tobin and a private-bulk packaging company for which Skriloff served as CEO. Skriloff, who continued as the CEO of the combined entity, Environmental Packaging, allegedly raised money from investors, which the defendants used to pay a stock promoter to tout the stock of Environmental Packaging, while creating the impression that the promoter's recommendation came from a neutral third party. Skriloff also allegedly attempted to disguise the payment to the stock promoter as part of a purported consulting agreement. The amended complaint further alleges that, during the promotional campaign, the price of Environmental Packaging shares more than doubled and Tobin profited from the higher share price. According to the amended complaint, Skriloff, as the CEO of Environmental Packaging, also made misstatements in public reports filed with the SEC about the reverse merger and the company's connection to the promotional campaign.

The amended complaint also alleges that after the SEC halted trading in the securities of Environmental Packaging on June 27, 2017, the defendants took steps to obstruct the SEC's investigation - and conceal their own involvement in the matter - by arranging to change the names listed on Wintercap account records.

The SEC's amended complaint, filed in the U.S. District Court in the District of Massachusetts, charges each of the defendants with violating various federal securities laws, including the antifraud provisions of Sections 17(a)(1) and (3) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 and Rules 10b-5(a) and (c) thereunder. It also charges Tobin, Patel, Ledvina, Lacher, and Quinn with violating the securities registration provisions of Sections 5(a) and (c) of the Securities Act. The amended complaint further charges Skriloff with violating Section 17(a)(2) of the Securities Act of 1933 and Section 10(b) of the Exchange Act and Rule 10b-5(b) thereunder, aiding and abetting the other defendants' violations of Section 10(b) of the Exchange Act and Sections 17(a)(1) and (3) of the Securities Act, and aiding and abetting Environmental Packaging's violation of Section 17(a)(2) of the Securities Act. The SEC seeks a permanent injunction against future violations, disgorgement of allegedly ill-gotten gains plus prejudgment interest, penny stock bars, and monetary penalties. The SEC also seeks an order barring Skriloff from serving as an officer and director of a public company.

The SEC's continuing investigation and litigation is being conducted by J. Lauchlan Wash, Trevor Donelan, Eric Forni, David Scheffler, Rebecca Israel, Jonathan Allen, Kathleen Shields, Susan Anderson, and Amy Gwiazda of the SEC's Boston Regional Office, in coordination with the Enforcement Division's Microcap Fraud Task Force. The SEC appreciates the assistance of the FBI and the U.S. Attorney's Office for the District of Massachusetts, the Financial Industry Regulatory Authority (FINRA), the British Columbia Securities Commission, the Ontario Securities Commission, and the Malta Financial Services Authority.

[StockDung] ICE USES FAKE UNIVERSITY TO SNAG IMMIGRATION FRAUD SUSPECTS. DHS targets student...

StockDung — 1/31/2019 11:02:43 AM

ICE USES FAKE UNIVERSITY TO SNAG IMMIGRATION FRAUD SUSPECTS. DHS targets student visa exploitation
Fox News - JANUARY 31, 2019

IMAGE CREDITS: DEPARTMENT OF HOMELAND SECURITY.

The Department of Homeland Security set up a fake Detroit-area university to target foreign students who wanted to stay in the U.S. without proper authorization in a “pay to play” scheme, according to reports.

Joann Debartolo & Tom Ravana were hit by an illegal alien and due to medical bills they are now at risk of losing their home.

Eight people were arrested and charged with conspiracy to commit visa fraud and harboring undocumented immigrants for profit, Matthew Schneider, U.S. Attorney for the Eastern District of Michigan, told the Detroit Free Press. Six were arrested in Detroit, one in Florida and other in Virginia.

(Nikola Spasic / EyeEm / Getty Images)

The fake institution, dubbed the University of Farmington, had been operated by Homeland Security in Farmington Hills since 2015 and had a website touting its “dynamic business administration and STEM curriculum.” The school had no faculty or classes and no curriculum.

Read more

William Gheen joins Alex Jones to beg the question: will Ann Coulter run against President Trump for the 2020 election to drum up support for the policies and causes true conservatives care about?

[StockDung] Melgar v. Zicam LLC and Matrixx Initiatives, Inc. Home Notice En Español File ...

StockDung — 10/3/2018 2:31:20 PM

Melgar v. Zicam LLC and Matrixx Initiatives, Inc.

Home Notice En Español File a Claim Court Documents Contact

MELGAR V. ZICAM LLC AND MATRIXX INITIATIVES, INC.
United States District Court for the Eastern District of CaliforniaIf You Purchased Certain Zicam Products, You May Be Eligible to Receive a Payment as Part of a Proposed Class Action Settlement

WHAT IS THIS ABOUT?A Proposed Settlement has been reached in a class action lawsuit in the United States District Court, Eastern District of California, (the “Action”) that may affect your rights. The Plaintiff claims that Zicam LLC and Matrixx Initiatives, Inc. (“Zicam”), made false and misleading statements about the effectiveness of certain Zicam products in violation of state and federal law. Zicam denies this claim. The Court has not ruled in favor of Plaintiff or Zicam. Instead, the parties agreed to a Proposed Settlement to avoid the expense and risks of continuing the lawsuit.

AM I A MEMBER OF THE CLASS?The class is defined as all residents of the United States of America who purchased any of the following Zicam products in the United States from February 15, 2011 through June 5, 2018: RapidMelts Original, RapidMelts Ultra, Oral Mist, Ultra Crystals, Liqui-Lozenges, Lozenges Ultra, Soft Chews, Medicated Fruit Drops, and Chewables (the “Products”).

WHAT DOES THE SETTLEMENT PROVIDE? Subject to Court approval, the parties have agreed to a Settlement under which Zicam will pay $16 million in cash. In addition to paying class member claims, the $16 million settlement fund will be used to pay notice and administration costs, Plaintiff’s attorneys’ fees, Plaintiff’s costs and expenses, and an incentive award to the Class Representative.

To recover a cash payment as part of this Settlement you must submit a Claim Form for the Products you purchased during the class period. Claims based on purchases of up to five units of the Products will be paid without requiring proof of purchase. Claims based on purchases of six or more of the Products will require proof of purchase. Your payment will be adjusted based on the number of claims submitted. This adjustment may increase or decrease your recovery.

WHAT ARE MY RIGHTS?You have a choice of whether to stay in the Class or not, and you must decide this now. If you stay, you will be legally bound by all orders and judgments of the Court, and you won’t be able to sue, or continue to sue, Zicam as part of any other lawsuit involving the same claims that are in this lawsuit. This is true even if you do nothing.

You Can Accept the Settlement. Class Members who wish to receive a cash recovery must submit claims by October 3, 2018. You can file a Claim Form on this website under the File a Claim section to the left. Read the instructions carefully, fill out the form, and submit it online on or before October 3, 2018. Alternatively, you may also submit a Claim Form by mailing it to the following address: Zicam Class Action, c/o RG/2 Claims Administration, P.O. Box 59479, Philadelphia, PA 19102-9479. It must be postmarked no later than October 3, 2018. If you fail to submit a timely Claim Form and do not exclude yourself from the Settlement, then you will be bound by the Settlement but will not receive any cash.You Can Object to the Settlement. If you believe any part of the Settlement is unsatisfactory, you may file a written objectionwith the Clerk of the Court for the Eastern District of California and send copies to the following Counsel representing the Class and Zicam:

Plaintiff’s Counsel
L. Timothy Fisher
Bursor & Fisher, P.A.
1990 North California Blvd., Suite 940
Walnut Creek, CA 94596

Zicam’s Counsel
Robyn E. Bladow
Kirkland & Ellis LLP
333 South Hope Street
Los Angeles, CA 90071

Objections to the Settlement will be considered by the Court, but only if such objections are filed in writing with the Court and sent to Plaintiffs’ and Zicam’s counsel by October 3. 2018.

You Can “Opt Out” of the Settlement. If you exclude yourself from the Class – which is sometimes called “opting-out” of the Class – you won’t get any cash recovery from the Proposed Settlement. To exclude yourself, mail notice including your name, current address, signature, and a statement that you want to be excluded from Melgar v. Zicam LLC, Case No. 2:14-cv-00160-MCE-AC, to Zicam Class Action, c/o RG/2 Claims Administration, P.O. Box 59479, Philadelphia, PA 19102-9479. Such notice must be postmarked no later than October 3, 2018.

THE FAIRNESS HEARING
On November 15, 2018, at 2:00 pm, the Court will hold a hearing in the United States District Court for the Eastern District of California to determine: (1) whether the Proposed Settlement is fair, reasonable, and adequate and should receive final approval; and (2) whether the application for Plaintiff’s attorneys’ fees of up to one-third of the total $16 million settlement fund, plus reimbursement of out-of-pocket expenses, should be granted. Objections to the Settlement will be considered by the Court, but only if such objections are filed as explained above. You may hire your own lawyer to appear in Court for you if you wish; however, you will be responsible for paying that lawyer.

HOW CAN I GET MORE INFORMATION?If you would like to read the more detailed notice or other documents about this lawsuit and your rights, you may view these documents under the Notice page, the File a Claim page or the Court Documents page of this website.

You may also contact the Settlement Administrator by email at info@rg2claims.com, or by writing to: Zicam Class Action, c/o RG/2 Claims Administration, P.O. Box 59479, Philadelphia, PA 19102-9479.

[StockDung] Financers of R Steven Davidson's Fuse Science Inc, Tiger Woods promoted stock da...

StockDung — 9/10/2018 11:58:16 AM

Financers of R Steven Davidson's Fuse Science Inc, Tiger Woods promoted stock day of recogning

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SEC Charges Microcap Fraudsters for Roles in Lucrative Market Manipulation Schemes

Litigation Release No. 24262 / September 7, 2018Securities and Exchange Commission v. Barry C. Honig, et al., No. 18-civ-08175 (S.D.N.Y., filed September 7, 2018)
The Securities and Exchange Commission today charged a group of ten individuals and ten associated entities for their participation in long-running fraudulent schemes that generated over $27 million from unlawful stock sales and caused significant harm to retail investors who were left holding virtually worthless stock.

According to the SEC's complaint, from 2013 to 2018, a group of prolific South Florida-based microcap fraudsters led by Barry Honig manipulated the share price of the stock of three companies in classic pump-and-dump schemes. Miami biotech billionaire Phillip Frost allegedly participated in two of these three schemes. Honig allegedly orchestrated the acquisition of large quantities of the issuer's stock at steep discounts, and after securing a substantial ownership interest in the companies, Honig and his associates engaged in illegal promotional activity and manipulative trading to artificially boost each issuer's stock price and to give the stock the appearance of active trading volume. According to the SEC's complaint, Honig and his associates then dumped their shares into the inflated market, reaping millions of dollars at the expense of unsuspecting investors.

The SEC's complaint, which was filed in federal district court in Manhattan, charges Honig, John Stetson, Michael Brauser, John R. O'Rourke III, Mark Groussman, Frost, Elliot Maza, Robert Ladd, Brian Keller, John H. Ford, Alpha Capital Anstalt, ATG Capital LLC, GRQ Consultants, Inc., HS Contrarian Investments, LLC, Grander Holdings, Inc., Melechdavid, Inc., OPKO Health, Inc., Frost Gamma Investments Trust, Southern Biotech, Inc., and Stetson Capital Investments Inc. with violating antifraud, beneficial ownership disclosure, and registration provisions of the federal securities laws and seeks monetary and equitable relief.

The SEC's continuing investigation is being conducted out of its New York Regional Office by Katherine Bromberg and Charu Chandrasekhar of the Enforcement Division's Retail Strategy Task Force, Tim Nealon, Ricky Tong, Joseph Darragh, and Michael Paley of the Enforcement Division's Microcap Fraud Task Force, and Jon Daniels of the Enforcement Division's Cyber Unit , with the assistance of Edward Janowsky and Steven Vitulano of the New York Regional Office Broker Dealer and Exchange Examination Program. The litigation will be led by Nancy Brown, Ms. Bromberg, and Mr. Daniels, and the case is being supervised by Mr. Wadhwa. The SEC appreciates the assistance of the Financial Industry Regulatory Authority.

[StockDung] H.I.G. Capital Completes Sale of Matrixx Initiatives March 12, 2018 06:00 AM Ea...

StockDung — 4/24/2018 12:19:25 PM

H.I.G. Capital Completes Sale of Matrixx Initiatives

March 12, 2018 06:00 AM Eastern Daylight Time
MIAMI--( BUSINESS WIRE)--H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with $24 billion of equity capital under management, is pleased to announce that one of its affiliates completed the sale of its portfolio company Matrixx Initiatives, Inc. (“Matrixx” or the “Company”) to Gryphon Investors.

Matrixx, based in Bridgewater, New Jersey, manufactures and markets Zicam® brand homeopathic and allopathic over-the-counter (“OTC”) products. The Company has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products that utilize innovative drug delivery systems for over 20 years.

In February 2011, H.I.G. acquired Matrixx through a take-private transaction and recruited a new management team. The company implemented a top to bottom transformation that resulted in several successful new product offerings, a new marketing strategy, and a new go to market approach that has bolstered the Zicam brand and household usage nationwide.

H.I.G. Managing Director Fraser Preston commented, “Matrixx is an exceptional company with a bright future. We are proud of the work we did in partnership with the very talented management team to reverse the negative growth trajectory at the time of our acquisition, and successfully transform the Company over the course of our ownership while substantially growing EBITDA. After 38 plus consecutive months of share gains, Matrixx and the Zicam branded family of products have a bright future.”

About Matrixx Initiatives, Inc.

Matrixx Initiatives, Inc. is an OTC healthcare company that develops and markets Zicam® products. Zicam, LLC, its wholly-owned subsidiary, markets and sells Zicam® products in the cough and cold category. The Company markets Zicam brand homeopathic and allopathic OTC products, including Zicam Cold Remedy in multiple oral delivery forms; as well as Zicam Allergy and Congestion Relief products. For more information regarding Matrixx products, go to www.Zicam.com. To find out more about Matrixx Initiatives, Inc., visit www.matrixxinc.com.

About H.I.G. Capital

H.I.G. is a leading global private equity and alternative assets investment firm with $24 billion of equity capital under management.* Based in Miami, and with offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco, and Atlanta in the U.S., as well as international affiliate offices in London, Hamburg, Madrid, Milan, Paris, Bogotá, Mexico City and Rio de Janeiro, H.I.G. specializes in providing both debt and equity capital to small and mid-sized companies, utilizing a flexible and operationally focused/ value-added approach:

1) H.I.G.’s equity funds invest in management buyouts, recapitalizations and corporate carve-outs of both profitable as well as underperforming manufacturing and service businesses.

2) H.I.G.’s debt funds invest in senior, unitranche and junior debt financing to companies across the size spectrum, both on a primary (direct origination) basis, as well as in the secondary markets. H.I.G. is also a leading CLO manager, through its WhiteHorse family of vehicles, and manages a publicly traded BDC, WhiteHorse Finance.

3) H.I.G.’s real estate funds invest in value-added properties, which can benefit from improved asset management practices.

Since its founding in 1993, H.I.G. has invested in and managed more than 300 companies worldwide. The firm's current portfolio includes more than 100 companies with combined sales in excess of $30 billion. For more information, please refer to the H.I.G. website at www.higcapital.com.

ContactsH.I.G. Capital
Fraser Preston
Managing Director
fpreston@higcapital.com
or
Miriam Rafiqi
Principal
mrafiqi@higcapital.com

[StockDung] Do Vitamin Supplements Prevent Colds? Know the facts before you rush to the drug...

StockDung — 8/22/2017 3:43:09 PM

Do Vitamin Supplements Prevent Colds? Know the facts before you rush to the drug store.

HEALTHY LIVING
05/12/2017 10:01 am ET Updated Jun 08, 2017

By Allison Fox

Jupiterimages via Getty Images

The Question: Will supplements really prevent a cold or shorten one from lingering?

The Answer: Dietary supplements and other over-the-counter products aimed at cold prevention, like Zicam or Emergen-C, sound miraculous in theory. But do they actually help to eliminate that nasty bug? The answer from experts is a resounding “no.”

Zicam promises to be a “ cold shortening” homeopathic remedy, and some variations of the product use zinc at the major active ingredient. (The brand does make other products that are pharmaceutical-based, so be sure to check the label.) Emergen-C is a popular dietary supplement made from vitamin C which claims to provide extra support to the immune system. Another variation of the dissolvable powder includes melatonin for sleep and relaxation.

“Nothing cures the cold,” Kathleen Deegan, a registered dietitian and adjunct professor at the School of Nursing at the University of San Francisco, told HuffPost. “They’re trying to promote the antioxidant capacity of vitamin C...and there is not much in the literature that supports vitamin C preventing a cold.”

Research suggests that a vitamin overload will do very little to prevent a cold or help you out once you’re in the throes of one. But not only that, taking too much can have consequential health effects.

How natural supplements could backfire

Just one serving of Emergen-C provides 1,000 milligrams of vitamin C, which is well above the recommended daily dose. Adult men should get 90 milligrams a day, and adult women should get 75 milligrams per day, according to the National Institutes of Health.

Most people meet these requirements through their diet because it is easy to do so ? for example, just a half cup of red peppers is enough to get your daily values. And statistically, most American men and women meet the recommended daily intake, according to data from the National Health and Nutrition Examination Survey.

The mineral is responsible for helping the body’s immune system, but the upper limit for vitamin C is 2,000 milligrams per day. While vitamin C is a low-toxicity mineral, it is important to note that consuming above the 2,000 milligram limit could possibly lead to diarrhea, nausea and abdominal cramps, according to the National Institute of Health.

Zinc, on the other hand, is actually dangerous if you overdo it. Your body requires only a minimal amount of the supplement to reap its healthy benefits, which includes helping the immune system fight of viruses and bacteria. Men need just 11 milligrams a day, women just 8 milligrams, according to the Institute of Medicine. Most people get enough zinc through their diet.

“I would definitely not recommend people taking individual supplementation of zinc,” Deegan said. “There’s just not enough research to support that [zinc supplements prevent illness]. There just isn’t ? and there’s a lot in the literature to support [the toxicity].”

The upper limit for zinc for adults is 40 milligrams per day. Beyond that, people can experience nausea, vomiting, decreased appetite, stomach cramps, diarrhea and headaches. And, ironically, too much zinc over a long course of time can actually decrease immunity, according to the National Institute of Health.

Furthermore, some zinc nasal sprays and gels have been linked to losing the ability to smell.

Skip the nonsense and eat your nutrients instead

“I am extremely in support ? especially in terms of diet and nutrients ? of doing things the most natural way possible,” Colin Robinson, a clinical instructor of medicine at the University of California, Los Angeles, told HuffPost. That means instead of taking supplements, you should aim to get zinc and vitamin C from a healthy, well-rounded diet of fruits and vegetables, he explained.

Oysters are high in zinc. Red meat, crab, lobsters and fortified breakfast cereals will also do the trick. Beans, nuts, whole grains and dairy products provide a bit of zinc, too, according to the National Institute of Health.

Research shows to eat more sweet red peppers, orange juice, grapefruit juice and kiwi for vitamin C. Broccoli, Brussels sprouts and strawberries are good sources as well.

Eating this way will help you hit the recommended levels of each nutrient, as well as contribute to your health overall.

Additionally, here’s surefire way you can effectively and safely lower your risk of getting a nasty bug ? and it’s free: Scrub those hands. Research shows it’s one of the most foolproof ways to halt germs from getting into your system.

“You know the best way to prevent a cold? Wash your hands three to four times a day. And get plenty of sleep,” Deegan stressed.

It’s age-old advice from someone with nothing to sell. Sounds right to us.

Correction: The original version of this article misspelled Kathleen Deegan’s last name. It is Deegan, not Duggan. Language has also been amended to better describe the range of Zicam products.

[StockDung] Yet another CRIMM who at one time worked for GunnAllen being brought to justice....

StockDung — 3/29/2017 10:52:12 AM

Yet another CRIMM who at one time worked for GunnAllen being brought to justice. Joseph A. Vitale joins a long list of former brokers that conned the public.

==============================================================
U.S. SECURITIES AND EXCHANGE COMMISSIONLitigation Release No. 23791 / March 27, 2017Securities and Exchange Commission v. LottoNet Operating Corp., et al., Case No. 17-cv-21033-Lenard/Goodman (S.D. Fla.)SEC HALTS BOILER ROOM SCHEME INVOLVING STATE LOTTERY TICKETSThe Securities and Exchange Commission today announced charges against a Florida-based company, its CEO, and its top sales agent accused of conducting a boiler room scheme that solicits investments in a business purportedly facilitating online and cell phone sales of lottery tickets in various states.

The SEC has obtained an emergency court order freezing the assets of LottoNet Operating Corp., David Gray, and Joseph A. Vitale. The SEC's complaint alleges that they misrepresented to investors that their money would be used to develop and market LottoNet and that sales agents did not receive commissions. At least 35 percent of investor proceeds were allegedly paid to boiler room sales agents in the form of commissions, and LottoNet allegedly siphoned investor funds for personal spending on clothing, wedding-related expenses, and strip clubs.

According to the SEC's complaint, which was unsealed in federal court today, among the pitches used in sales agent scripts prepared for cold calls to investors was "you're looking at a monthly dividend payout of $8,500 every month" on a $25,000 investment if LottoNet reaches 1 percent market share. The scripts also allegedly touted the purported safety of the investment, noting a 60 percent return as a "worst case" scenario if the company was ever sold. The SEC alleges that while LottoNet has raised a total of approximately $4.8 million from investors, the company had only paid $10,525.43 in investment returns to investors through the end of February. Sales agents allegedly have been paid more than $1.1 million out of investor funds.

The SEC's complaint further alleges that Vitale, who personally raised at least $1.4 million from investors, used the alias Donovan Kelly in an apparent attempt to hide from investors that he is permanently barred by the Financial Industry Regulatory Authority (FINRA).

The SEC's investigation, which is continuing, has been conducted in the Miami office by Kate Zoladz, Gary Miller, and Allen J. Genaldi. The case is being supervised by Elisha L. Frank and the litigation is being led by Amie Riggle Berlin. The SEC appreciates the assistance of FINRA.

# # #

https://www.sec.gov/litigation/litreleases/2017/lr23791.htm

Modified: 03/27/2017

who had worked at Gunnallen being brought to justice

[StockDung] Zicam, Matrixx Initiatives sued over alleged sale of fake medicine Robbie Harge...

StockDung — 1/13/2017 4:31:59 PM

Zicam, Matrixx Initiatives sued over alleged sale of fake medicine

Robbie Hargett Dec. 31, 2015, 10:43am

NEW YORK (Legal Newsline) – A New York man is suing cold medication manufacturers over claims their products are no more effective than a placebo.

Alan Gulkis, individually and for all others similarly situated, filed a class-action lawsuit Dec. 17 in the Southern District of New York against Zicam LLC and Matrixx Initiatives Inc., alleging deceptive trade practices, false advertising, breach of express warranty and unjust enrichment.

Zicam and Matrixx manufacture and distribute homeopathic formulas, including Zicam Pre-Cold Medicine, under the Zicam brand name.

The suit states these companies sell fake medicine to consumers looking for cold-symptoms treatment.

According to the suit, double-blind placebo-controlled trials showed Zicam Pre-Cold Medicine acted no differently than a placebo.

The suit further states that the defendants claim this medication shortens and reduces cold symptom severity, and prevents full cold symptoms from occurring, even though they know studies show the medication is no different than a placebo. As a result, Gulkis and others in the class allegedly were deceived into purchasing products that were not effective for their represented purpose.

Gulkis and other class members seek compensatory, statutory, and punitive damages, plus disgorgement, restitution, and costs and expenses of the suit, together to exceed $5 million. They are represented by attorneys Joseph I. Marchese, Scott A. Bursor and Philip L. Fraietta of Bursor & Fisher in New York City.

Southern District of New York Case number 7:15-CV-09843-CS

[StockDung] Class Certification Granted In Zicam Lawsuit ‹ All News March 31, 2016 ...

StockDung — 1/13/2017 4:29:11 PM

Class Certification Granted In Zicam Lawsuit
‹ All News March 31, 2016
On March 31, 2016, Chief Judge Morrison C. England, Jr. of the United States District Court for the Eastern District of California granted a motion to certify a class of purchasers of Zicam Pre-Cold Products, clearing the way for a jury trial later this year on claims that Zicam misrepresented the effectiveness of its Pre-Cold Products. Judge England also denied Defendants’ Motion for Summary Judgment and Defendants’ Daubert Motions. The Court noted that “the term ‘Pre-Cold’ … suggests the product prevents the cold” and the evidence Plaintiff offered in support of her claim that “Defendants’ products are no more effective than a placebo (i.e., that they do nothing)” is “sufficient to create a genuine issue of material fact” best left to a jury.

“Judge England’s order certifying the class, denying Defendants’ motion for summary judgment on the merits, and denying Defendants’ motion to exclude expert testimony is a significant development in this case, allowing purchasers of these ineffective Pre-Cold Products to join together to prosecute this action,” said L. Timothy Fisher, one of the firm’s partners handling the matter. “We look forward to moving this case toward trial, where we will prove that the Zicam LLC and Matrixx Initiatives, Inc. violated the law by misrepresenting the efficacy of these cold products.”

This was Bursor & Fisher’s 13th victory in our last 14 contested class certification motions, and its 12th victory in the last 13 summary judgment motions brought against class action claims prosecuted by the firm.

Click here to read Judge England’s order.

[StockDung] Matrixx Initiatives old CEO Carl Johnson reduced to being CEO of manipulated pen...

StockDung — 8/5/2016 7:05:51 PM

Matrixx Initiatives old CEO Carl Johnson reduced to being CEO of manipulated penny stock (currently at 7 cents." http://www.nasdaq.com/symbol/ergo/stock-chart

Avoid this stock like if it had gonorrhea. Inventor of Zicam has two diploma mill degrees!! Further Vindication!!

========================================
Entia Biosciences Inc : Entia Biosciences, Inc. Names Chief Executive Officer to Manage Growth of Consumer Health Products and To Launch New Medical Food Brands
08/13/2015 | 09:56am EDT

New Business Strategy to Capitalize on Unique, Innovative and Proprietary Entia Products

SHERWOOD, OR / ACCESSWIRE / August 13, 2015 / Entia Biosciences, Inc. (OTCQB: ERGO), today announced that Carl J. Johnson has joined the Company to serve as its President and Chief Executive Officer and member of the Board of Directors. Mr. Johnson has more than 40 years of experience in managing the introduction and marketing of new health-related products as well as executive leadership roles where he last served as President, CEO and Board Member of Matrixx Initiatives, Inc. from 2001 until 2008. Mr. Johnson will be an important addition to the Entia's growth plans and his prior experience will provide focus and commercial discipline to future efforts.

Founder, current CEO and Board Chairman, Marvin S. Hausman MD, will remain Chairman and fill the new and important position of Chief Science and Technology Officer for Entia. This period is a critical time for the Company as it launches its proprietary ErgoD2(R) medical foods for the therapeutic benefit of several chronic diseases. Entia is entering a new phase of commercial activity preparing for the launch of the unique, innovative and proprietary ErgoD2(R) medical food products. Additionally, Entia Biosciences, Inc. is encouraged by the early success of its GROH(R) cosmeceutical product line and is evaluating more aggressive marketing support for these products. This division of responsibilities is an expected apportionment of professional responsibilities as Entia not only expands into a whole new medical industry but also requires greater management of the food studies and product launches. From the many preliminary preclinical and clinical study results observed to date, Entia's all-natural, organic, gluten-free mushroom-based food, ErgoD2(R)-discovered by Hausman, is demonstrating medical potency.

By way of background, Mr. Johnson helped lead Matrixx Initiatives, Inc. and its Zicam(R) brand of cough and cold products grow from $10 million to over $100 million in revenue. He presently serves as a member of the Board of Directors of Prestige Brands Holdings, Inc. (NYSE-PBH). He also served as a Board Member of Matrixx Initiatives from February 2011 to February 2014 and as Interim CEO when the business was acquired by HIG Capital. Previously from 1993 to 2001, Mr. Johnson was Vice President of Commercial Development with Perrigo Company where he was responsible for the procurement of new products and technologies and contract manufacturing services with emphasis on Abbreviated New Drug Applications (ANDA) products. From 1972 through 1989, Mr. Johnson worked at Johnson & Johnson (NYSE-JNJ) where he held a number of high-level marketing and sales positions in JNJ's Baby Product's Company. He also served as Vice President of Sales & Marketing for the introduction of Acuvue(R) disposable contact lens products.

According to a statement by Dr. Hausman, "Entia has come a considerable ways from discovery of ErgoD2(R) to introducing our nutraceutical line, creating and sponsoring our own, premium brand cosmeceutical products-GROH(R) and now, developing and launching our own medical food products aimed at actually providing therapeutic benefit for the treatment of certain diseases. The entry of Mr. Johnson should change the entire presence, brand and market awareness of the Company. Mr. Johnson is an experienced executive with a proven track record to help us make these important transitions. His experience in creating, synthesizing, launching and developing 'top-of-mind awareness' of health products in the past is the exact combination of talents we need to further Entia Biosciences, Inc. position and reach across a broad collection of markets. Already, Carl has greatly helped Entia focus our internal attention into the products you will see us pursue as well as help me address the capital markets to better fund the cash requirements to make this plan come to fruition. We expect Carl's contributions will accelerate the growth of our existing nutraceutical and cosmeceutical products as well as help with the launch of our medical food line resulting in broader penetration and increased sales of our ErgoD2(R)-based products."

Carl Johnson commented, "I am very excited to join Entia because of the Company's prospects in all three market areas. Regarding the medical food business, I believe we are at the very beginning of what will become a major new health/therapeutic category. The growth of this new category is driven by the high cost of developing new ethical drugs, the lengthy time-to-market new drugs require, society's increasing demand for organic and whole-food therapies as well as the emerging shift in retail drug merchandizing to provide point-of-care assistance in their outlets. I am pleased to lead Entia as it ventures from its current product base to the medical food opportunity."

About Entia Biosciences, Inc.

Entia is an authority on the clinical effects of oxidative stress and free radical reactions and is bringing this expertise to the fields of food science biotechnology and Nutrigenomics. The Company identifies, scientifically validates, patents, and commercializes solutions that address multi-billion dollar markets for health, beauty and agriculture. Its first pure, 100% organic substance is derived from "energized" mushrooms that are biologically high in two beneficial components-- L-Ergothioneine, a naturally occurring amino acid and master antioxidant as well as vitamin D, an important vitamin that supports one's immune system. ErgoD2(R), our name for this powerful combination, is the foundation for our nutraceutical and beauty product lines and will be evaluated in clinical trials as a medical food. www.entiabio.com

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risks associated with the transaction described in this press release, and other risks identified in the filings by Entia Biosciences with the Securities and Exchange Commission. Further information on risks faced by the Company and its shareholders are detailed in the Form 10-K for the year ended December 31, 2014 and in its subsequent Quarterly Reports on Form 10-Q. These filings are or will become available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Entia does not undertake any obligation to publicly release the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

CONTACT:

Marvin S. Hausman, M.D.
Chief Science Officer
Entia Biosciences, Inc.
13565 SW Tualatin-Sherwood Rd.
Sherwood, OR 97140
(503) 334-3575
info@entiabio.com

SOURCE: Entia Biosciences, Inc

[StockDung] 'Herbal Viagra' and 14 other supplements may increase disease risk Published ...

StockDung — 7/28/2016 6:24:30 PM

'Herbal Viagra' and 14 other supplements may increase disease risk

Published July 28, 2016
FoxNews.com

Facebook10 Twitter34 livefyre5 Email Print

(iStock)

Some supplements currently available on store shelves may increase the risk of cancer, cardiac arrest and organ damage, an investigation by Consumer Reports reveals. The ingredients are present in products available online or at major retailers such as Walmart, CVS, GNC, Costco and Whole Foods.

With the help of independent doctors and dietary-supplement researchers, analysts identified 15 supplement ingredients that may pose health risks to consumers. The Food and Drug Administration (FDA) does not regulate diet products and supplements, and a growing body of research suggests their potential risks outweigh perceived benefits.

Among the ingredients the firm identified is Yohimbe, also called ‘herbal Viagra,’ as it treats low libido and erectile dysfunction. According to the analysis, the substance can cause seizures, and liver and kidney problems, among other risks including death. Green tea extract powder, which is used for weight loss, can exacerbate anemia and glaucoma, damage the liver and also possibly cause death, among other problems. Kava is used to reduce anxiety and improve insomnia, but it may raise the risk of Parkinson’s and depression, as well as cause death.

More on this...

Weight-loss supplements may contain banned drug 'Health' supplements send 23,000 to emergency rooms in US each year Dietary supplement sellers could face fresh challenges in 2016 The report identified the following supplement ingredients as risky:

· Aconite

· Caffeine powder

· Chapparral

· Coltsfoot

· Comfrey

· Germander

· Greater celandine

· Green tea extract powder

· Kava

· Lobelia

· Methylsynephrine

· Pennyroyal oil

· Red yeast rice

· Usunic acid

· Yohimbe

Consumer Reports found that the ingredients’ possible harm depends on individuals’ pre-existing health conditions, as well as the quantity and length of time they have consumed the substances. Their findings also suggested that many of the ingredients have the potential to interact with over-the-counter and prescription medications, like statins, aspirin and warfarin.

[StockDung] Snake oil is an expression that originally referred to fraudulent health product...

StockDung — 5/6/2016 1:36:11 PM

Snake oil is an expression that originally referred to fraudulent health products or unproven medicine but has come to refer to any product with questionable or unverifiable quality or benefit. By extension, a snake oil salesman is someone who knowingly sells fraudulent goods or who is themselves a fraud, quack, or charlatan.

A snake oil recipe from the 18th century, printed in Spain

The use of snake oil long predates the 19th century, and it was never confined to the Americas. In Europe, viper oil had been commonly recommended for many afflictions, including the ones for which rattlesnake oil was subsequently favored (e.g., rheumatism and skin diseases). [1]

Contents [ hide]

1 History

2 From cure-all to quackery

3 See also

4 References

5 External links

History[ edit] Chinese laborers on railroad gangs involved in building the First Transcontinental Railroad first gave snake oil, a traditional folk remedy in Traditional Chinese Medicine to treat joint pain such as arthritis and bursitis to their fellow workers. [2] When rubbed on the skin at the painful site, snake oil was claimed to bring relief. This claim was ridiculed by rival medicine salesmen, and in time, snake oil became a generic name for many compounds marketed as panaceas or miraculous remedies whose ingredients were usually secret, unidentified, or mischaracterized and mostly inert or ineffective.

Patent medicines originated in England, where a patent was granted to Richard Stoughton's Elixir in 1712. [3] Since there was no federal regulation in the United States concerning safety and effectiveness of drugs until the 1906 Food and Drugs Act [4] and various medicine salesmen or manufacturers seldom had enough skills in analytical chemistry to analyze the contents of snake oil, it became the archetype of hoax.

The snake oil peddler became a stock character in Western movies: a traveling "doctor" with dubious credentials, selling fake medicines with boisterous marketing hype, often supported by pseudo-scientific evidence. To increase sales, an accomplice in the crowd (a shill) would often attest to the value of the product in an effort to provoke buying enthusiasm. The "doctor" would leave town before his customers realized they had been cheated. [2] This practice is also called grifting and its practitioners are called grifters.

From cure-all to quackery[ edit]

A report of the 1917 decision of the United States District Court for Rhode Island, fining Clark Stanley $20 for "misbranding" its "Clark Stanley Snake Oil Liniment".

The composition of snake oil medicines varies markedly among products.

Stanley's snake oil — produced by Clark Stanley, the "Rattlesnake King" — was tested by the United States government in 1917. It was found to contain [3]

mineral oil
1% fatty oil (presumed to be beef fat)
red pepper
turpentine
camphor

This is similar in composition to modern-day capsaicin-based liniments or chest rubs. None of the oil content was found to have been extracted from any actual snakes.

The government sued the manufacturer for misbranding and misrepresenting its product, winning the judgment of $20 against Clark Stanley. Soon after the decision, "snake oil" became synonymous with false cures and "snake-oil salesmen" became a tag for charlatans.

Historical intrepreter Ross Nelson as "Professor Thaddeus Schmidlap", resident snake-oil salesman at the Enchanted Springs Ranch and Old West theme park, Boerne, Texas.

See also[ edit]

References[ edit]
Jump up ^ Klauber, Laurence M. (1997). Rattlesnakes, vol II. University of California Press. p. 1050. ^ Jump up to: a b Graber, C (2007-11-01). "Snake Oil Salesmen Were on to Something". Scientific American. Retrieved 2011-12-04. ^ Jump up to: a b Nickell, J (1998-12-01). "Peddling Snake Oil; Investigative Files". Skeptical Inquirer ( Committee for Skeptical Inquiry) 8 (4). Retrieved 2011-12-04. Jump up ^ "The Long Struggle for the Law". Food and Drug Administration. Retrieved 2011-12-04.

[StockDung] Homeopaths prepare to launch fight against pending federal policy change CARLY...

StockDung — 2/24/2016 4:35:47 PM

Homeopaths prepare to launch fight against pending federal policy change

CARLY WEEKS
The Globe and Mail Published Tuesday, Feb. 23, 2016 4:53PM EST
Last updated Tuesday, Feb. 23, 2016 5:01PM EST
theglobeandmail.com

Canada’s homeopathy community is launching a fight against a pending federal policy change that will prohibit companies from making unsubstantiated claims on certain products aimed at children 12 and under.

Under the new policy, Health Canada will no longer approve any health claims for homeopathic cough, cold and flu products aimed at children unless they are backed by scientific evidence. The change will end the near-monopoly that homeopathic manufacturers have in marketing cough and cold remedies to children. Since 2008, makers of over-the-counter cough and cold medication have not been allowed to market their products to children because of reports of serious injuries and deaths related to dosing problems with those products.

Proponents of evidence-based medicine say the change is long overdue, but still does not go far enough because it does not apply to other products marketed to young people or to any products targeting adults.

The homeopathic community says the change, which comes into effect as of July, runs counter to Canada’s regulations on natural health products and is too restrictive.

The Canadian Consumers Centre for Homeopathy, a national homeopathy advocacy group, has created a petition to stop the change and is urging consumers to “swamp” federal Health Minister Jane Philpott with messages about how well homeopathic remedies work for their children. The group did not respond to a request for comment.

The Canadian College of Homeopathic Medicine, a school that trains homeopaths, shared the petition on its Facebook page, asking the public to spread information about the “restrictive legislation.” The college declined an interview request and asked a reporter not to contact it again.

Last year, the Canadian Homeopathic Pharmaceutical Association, which represents manufacturers and distributors, wrote a letter to then-health minister Rona Ambrose asking her to scrap the change so that parents can make “more informed choices.” The group also says it is unaware of evidence of products causing any harm.

Homeopathic products are made by taking a molecule of the illness and diluting it in water over and over again. The remaining formula is so dilute that it does not contain any of the disease molecule, but homeopaths say it has the power to fight sickness.

There is no credible scientific evidence to support these claims. Despite this, Health Canada has approved well over 100 homeopathic cough, cold and flu products aimed at children 12 and under.

The products were approved because under Health Canada’s rules, natural health products do not have to meet the same safety or efficacy bar as prescription or over-the-counter drugs. For instance, a natural health product can be approved if a manufacturer provides evidence that its ingredients have been in use for at least 50 years. While some companies may submit scientific studies, they are rarely, if ever, the type of high-quality double-blind randomized controlled trials that are typically required for drugs.

Michael Kruse, chair and interim executive director of Bad Science Watch, an advocacy group, says homeopathic products have had too much freedom for too long. “We certainly had argued from the beginning that any claims that are approved by Health Canada for these products should be scientifically vetted,” Kruse said. “If there’s no evidence, then they should not be allowed.”

Dr. Michael Rieder, chair of the Canadian Pediatric Society’s drug therapy committee, said Health Canada’s move should not be seen as an attack on all natural health products, but merely a raising of the bar in terms of the quality of claims that companies are allowed to make.

“The regulator is supposed to make sure that any and all health products that are sold are both safe and effective,” he said.

Last year, Health Canada also introduced a new requirement for homeopathic nosodes – often referred to by homeopathic practitioners as “alternative vaccines” – to carry a warning label that they are not vaccines and that they cannot prevent infection.

theglobeandmail.com

[StockDung] GunnAllen exec details demise of the Tampa brokerage firm in new book Jeff Harr...

StockDung — 2/19/2016 8:16:27 PM

GunnAllen exec details demise of the Tampa brokerage firm in new book
Jeff Harrington, Times Staff Writer
Tampa Bay Times Monday, May 19, 2014 9:15am

David Levine's friends jokingly suggest he should look under his car seat for a bomb. Or maybe start wearing a Kevlar vest.

He has to have enemies, they figure, after writing such a harsh, tell-all book about the costly demise of the once-thriving Tampa brokerage firm GunnAllen Financial and broader problems within the securities industry.
In his recently published, 426-page book called The Financial "Fix," Levine spreads the blame for a rogue environment that led to GunnAllen's collapse into bankruptcy four years ago. The chief culprits as he identifies them:

• Bad brokers within the company — perhaps as many as 50— who brought down 700 or so good brokers and left thousands of clients in the lurch.

• A management team that built its business by hiring ethically questionable brokers who no one else wanted and then was reluctant to fire or discipline them.

• The Financial Industry Regulatory Authority (FINRA), the self-regulated overseer of the securities industry, only cared whether GunnAllen had enough money to operate and not whether investors were being hurt. By keeping the company afloat, FINRA profited from fines coming in to the agency.

Levine, 48, was initially recruited as a consultant to GunnAllen, became its executive vice president, and wound up staying "till the bitter end," he says.

In 2011, Levine was censured and fined by the Securities and Exchange Commission, accused of improperly taking customer information for 16,000 accounts with him when he left GunnAllen. Levine insisted he did nothing wrong and had the company's permission.

He has since renounced the securities industry, leaving his license behind. And he has refashioned himself as a man on a mission to warn companies and individual investors to be careful who they invest through.

At his Boca Raton company, InvestorProtector Solutions, he has given himself the title managing protector.

Some excerpts from a recent interview with the Times:

Why did you write the book?

To me, GunnAllen was a symptom of a much larger problem. It wasn't Tampa; it wasn't GunnAllen. What I saw there was that the financial industry was deeply flawed.

I went in there as one of the good guys trying to clean it up. When I left, the toll personally and professionally was awful. Then I had a problem with the SEC for something that was authorized with the firm. I thought: "This is nuts. The company is covering up its failings. Now I'm getting blamed for taking a list that was given to me."

First I got angry. Then I started looking at this and realized this was ridiculous.

The problem was FINRA. … The firm should have been shut down by FINRA (for operational problems). FINRA just said that you lack adequate capital. (GunnAllen) needed to pony up more money. It was that simple.

I came to the shocking conclusion (that) FINRA is running a Ponzi protection scheme. The (agency) is constantly taking in more money that it ever (pays out) to investors. If it weren't for those fines, FINRA would be operating at a loss.

How did FINRA's "Ponzi protection scheme" unfold in GunnAllen's case?

GunnAllen had multiple examples of churning. … What would have happened if the regulators shut the firm down? (Instead) it was settled with a fine and the fine was payable in installments. Literally like on a credit card.

You had a firm that should have been put out of its misery but was allowed to cause more harm to investors so it could continue to pay its fine.

How did you end up at GunnAllen?

I came on as a consultant at a monthly rate. I wound up becoming an employee and an officer and getting more involved in management.

When did you sense problems?

Fairly quickly. I remember coming in one day and seeing a guy basically escorted from the building — one of their top brokers. He had tried an extortion scheme on a public company. When I came on, there was also a new compliance officer and new CFO. There was a whole wave of new people.

I refer to it as the new guard versus the old guard. It was very much a house divided. I was doing battle with a bunch of people.

There was generally speaking less of a failure to supervise than a failure to fire. There were multiple cases where misconduct was known. The one that is the most notorious was (one-time star Michigan broker) Frank Bluestein (who raised $74 million in what the SEC described as a Ponzi scheme targeting elderly investors.) The irony there is that by all accounts, Frank didn't exhibit warning signs.

What bothered me was when we knew there were issues and management wouldn't act.

There were other cases of bad broker behavior as well. Like Neal Smalbach, who was convicted of defrauding seniors.

Neal Smalbach was more harmful locally. It was not in the same size (as Bluestein) but the pattern was similar. They were both financial predators who would lure people in. Neil would do free dinner seminars. They're the ones that really stuck out (along with) Jeff Southard (who was sentenced to 15 years on charges of securities fraud and money laundering). … Southard and Smalbach had warning bells ringing from the day they became affiliated with GunnAllen.

So this was a case of bad supervision?

It was failure to fire bad brokers. And they shouldn't have hired these guys in the first place.

I would say, "Why are we offering money to guys … that most firms won't hire?" Yet we're offering them an upfront check and very high payout.

After an investor group led by Tampa businessman John Sykes secured a controlling interest in GunnAllen, he put his right-hand executive, Gordon Loetz, in charge as CEO. How did Loetz's sudden death in 2009 from a boating accident change things?

I felt like Gordy was making changes. Literally, the weekend of Gordy's death, Gordy had said that management changes are coming, and we had to restructure the company. I was told we were going to right-size the firm. I was told we were going to get rid of the opposition and the high-risk people.

When Gordy died, the hope I had for GunnAllen pretty much died.

Who ran the company then?

Scott Bendert, who had been (chief financial officer) of the holding company. If you go back to Sykes' history, Gordy and Scott were put in together. He had his core team, but he lost the leader. Scott's a good guy, but he's a numbers guy. Gordy was making changes.

Eventually, Sykes pulled out of the company.

There were other firms like us. There were many firms that weathered the storm.

John had already lost a ton of capital (but) had he put up more money, he could have ridden this storm through. (In a separate interview with the Times, Sykes challenged the accuracy of how he was portrayed in Levine's book. He said his team did get rid of some bad brokers and he put more than $15 million into the company, including $1.6 million when he left to help management keep afloat. Most of the money, he said, went to pay legal bills tied to past mismanagement.)

In an interview back at the end of 2009, you defended GunnAllen's financial shape and accused some journalists and recruiters of making up stories that scared clients.

The truth is GunnAllen was always very thinly capitalized. … I don't know that I was downplaying the capital (in 2009). I was saying that we had three different deals on the table (to put more money into GunnAllen).

There was very much the hope something would happen. What happened was FINRA came in and said, "You don't have the capital." So we never got the chance.

You've talked about the markets being rigged so investors don't have a level playing field. How so?

I love how flash trading got all this attention. It's right, but it misses the mark. There's a spread on every single stock trade. You have to price a bid and an ask. This was done long ago to create liquidity. The spread was always there.

The real issue isn't the spread; it's who is on each side of the spread. The top of the box is the ask and the bottom is the bid. On the right are investors and on the left is Wall Street. Investors always have to buy high on the top, but if they go to sell, they have to sell at the lower price at the bottom back to Wall Street. We're always disadvantaged to Wall Street. That's rigged by design.

What's been the reaction to your book?

I have had brokers cheering saying, "I can't believe you called out FINRA for what they are."

I've had some calls from former GunnAllen people. The best call I had is, "Please don't say you're trying to make GunnAllen out as a bad firm." I said, "I don't have to; they did it to themselves."

Jeff Harrington can be reached at jharrington@tampabay.com or (813) 226-3434.

GunnAllen exec details demise of the Tampa brokerage firm in new book 05/19/14 [Last modified: Monday, May 19, 2014 9:14am]

© 2014 Tampa Bay Times

[StockDung] FDA Considers Regulating Homeopathic Products Tue, Apr 21, 2015 -- 9:00 AM ...

StockDung — 4/22/2015 7:50:50 AM

FDA Considers Regulating Homeopathic Products

Tue, Apr 21, 2015 -- 9:00 AM

The Food and Drug Administration began hearings Monday on the regulation and marketing of homeopathic products. Homeopathy is based on the notion that illnesses can be cured by highly diluted doses of the substance causing the illness. At issue is whether or not these remedies should go through a drug approval process similar to conventional treatments. Considered a pseudo-science by the medical establishment, patients and practitioners swear by the efficacy of homeopathy. We'll get an update on the hearings and discuss whether or not the FDA should regulate homeopathic products.

Host: Michael Krasny

Guests:

Cynthia Schnedar, director of the Office of Compliance at the Center for Drug Evaluation and Research
Karen Allen, board member of the Integrative Health Policy Consortium
Adriane Fugh-Berman, associate professor of pharmacology at Georgetown University

[StockDung] Kevin Trudeau - Raw Milk, Zicam, Cold and Flu The Kevin Trudeau Show - OFFICIAL...

StockDung — 4/18/2015 11:28:45 AM

Kevin Trudeau - Raw Milk, Zicam, Cold and Flu The Kevin Trudeau Show - OFFICIAL CHANNEL

About the Zicam tout Kenin Trudeau

TV pitchman Kevin Trudeau sentenced to 10 years in prison

March 17, 2014|By Jason Meisner | Tribune reporter

Television pitchman Kevin Trudeau leaves the Dirksen U.S. Courthouse in November. (Adam Wolffbrandt / Chicago Tribune)

When TV huckster Kevin Trudeau stood in a packed federal courtroom to make one final sales pitch Monday, he hardly resembled the tanned, dapper figure seen hawking miracle diets and natural cancer cures on so many late-night infomercials.

After spending four months in jail for contempt of court, Trudeau’s trademark jet black coif was thin and gray. His usual tailored suit was replaced by rumpled orange jail clothes. Even his typical air of defiance had turned to contrition, a change he said washed over him during his sleepless first night in custody.

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“He is a habitual liar and a fraudster,” Assistant U.S. Attorney April Perry said.
As a result of the size of the fraud and Trudeau’s two previous felony convictions, federal sentencing guidelines called for 20 to 25 years in prison, a range that Guzman said he thought was “appropriate.” However, he eventually agreed with prosecutors who said a 10-year term was sufficient since -- unlike in many fraud cases -- no one who bought Trudeau’s book was financially ruined.

Trudeau’s attorneys argued that prosecutors vastly inflated the amount of harm done by Trudeau’s misleading infomercials, saying many buyers were satisfied with the weight loss book.

In his lengthy statement to the court, Trudeau said he has been “completely wiped out” financially and that he and his wife Nataliya Babenko, 26, are “effectively homeless.” He said his time at the Metropolitan Correctional Center has changed his perspective and led him to realize he had made many errors. While he wouldn’t wish incarceration on anyone, the experience has wound up being “one of the best, most positive things in my life,” Trudeau said.

“In the past four months I have been stripped of all ego, defiance, arrogance and pride and for that I am thankful,” Trudeau said as he stooed at a lectern and read from typed notes.

But Judge Guzman was unimpressed, noting that in his three decades of fraud, Trudeau had taken on more than a dozen different aliases and even used his mother’s Social Security number to perpetrate a scam.

“That doesn’t happen by accident, and it doesn’t happen by good intentions,” the judge said. “It is a reflection of a person’s character.”

jmeisner@tribune.com

[/iframe]

[StockDung] FDA will scrutinize alternative remedies AP | Posted: Monday, March 30, 2015 1...

StockDung — 3/31/2015 3:38:54 PM

FDA will scrutinize alternative remedies

AP | Posted: Monday, March 30, 2015 12:00 am

WASHINGTON (AP) -- Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.

The Food and Drug Administration says that it will hold a two-day meeting next month on regulations for homeopathic medicines, which have long occupied a place on the fringes of U.S. health care. Similar to dietary supplements, homeopathic products are not required to prove they are safe or effective before being sold on the market. But unlike supplements, homeopathic medicines state that they are designed to treat specific medical conditions.

According to a federal notice published online Thursday, the FDA will ask attendees whether there is data to "better assess the risks and benefits" of homeopathic medicines. Regulators also have questions about the appropriateness of selling some homeopathic drugs without a prescription. Regulators said that many of the medical indications listed on homeopathic drugs "have never been considered for over-the-counter use under a formal regulatory process."

Homeopathic products have grown into a multibillion-dollar U.S. market since the FDA last reviewed its oversight of the products 25 years ago, the agency notes.

Zicam and hundreds of other homeopathic remedies are often sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. But homeopathic medicine is based on a principle unverified by mainstream science: that substances that create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms.

A key principle of traditional homeopathy holds that the more diluted a remedy is, the better it works. Today, many remedies marketed as homeopathic contain heavily diluted drug ingredients, vitamins or minerals. For instance, Zicam contains a heavily diluted dose of zinc as its "active ingredient."

In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals. The law's principal author was Sen. Royal Copeland of New York, a trained homeopath. And that law has remained in force ever since.

Many scientists view homeopathic remedies as modern snake oil - ineffective but mostly harmless because the drugs in them are present in such tiny amounts. According to the National Institutes of Health, most research has concluded that "there is little evidence to support homeopathy as an effective treatment for any specific conditions."

In the early 1970s, Congress directed the FDA to review the safety and effectiveness of all drug ingredients used in over-the-counter medicines. But the agency delayed reviewing homeopathic products "due to the uniqueness of homeopathic medicine," according to the federal notice. "To date, FDA has not reviewed this class of products for safety and efficacy."

No votes or formal recommendations are planned for the FDA meeting, scheduled for April 20 and 21. The FDA plans to take comments and input from the public, including industry officials, health practitioners and consumers.

[StockDung] FDA to scrutinize unproven remedies Posted: Sunday, March 29, 2015 1:01 am W...

StockDung — 3/29/2015 12:47:34 PM

FDA to scrutinize unproven remedies

Posted: Sunday, March 29, 2015 1:01 am

WASHINGTON (AP) — Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.

The Food and Drug Administration said that it will hold a two-day meeting next month on regulations for homeopathic medicines, which have long occupied a place on the fringes of U.S. health care. Similar to dietary supplements, homeopathic products are not required to prove they are safe or effective before being sold on the market. But unlike supplements, homeopathic medicines state that they are designed to treat specific medical conditions.

According to a federal notice published online Thursday, the FDA will ask attendees whether there is data to “better assess the risks and benefits” of homeopathic medicines. Regulators also have questions about the appropriateness of selling some homeopathic drugs without a prescription. Regulators said that many of the medical indications listed on homeopathic drugs “have never been considered for over-the-counter use under a formal regulatory process.”

Homeopathic products have grown into a multibillion-dollar U.S. market since the FDA last reviewed its oversight of the products 25 years ago, the agency notes.

Zicam and hundreds of other homeopathic remedies are often sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. But homeopathic medicine is based on a principle unverified by mainstream science: that substances that create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms.

A key principle of traditional homeopathy holds that the more diluted a remedy is, the better it works. Today, many remedies marketed as homeopathic contain heavily diluted drug ingredients, vitamins or minerals. For instance, Zicam contains a heavily diluted dose of zinc as its “active ingredient.”

In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals. The law’s principal author was Sen. Royal Copeland of New York, a trained homeopath. And that law has remained in force ever since.

Many scientists view homeopathic remedies as modern snake oil — ineffective but mostly harmless because the drugs in them are present in such tiny amounts. According to the National Institutes of Health, most research has concluded that “there is little evidence to support homeopathy as an effective treatment for any specific conditions.”

In the early 1970s, Congress directed the FDA to review the safety and effectiveness of all drug ingredients used in over-the-counter medicines. But the agency delayed reviewing homeopathic products “due to the uniqueness of homeopathic medicine,” according to the federal notice. “To date, FDA has not reviewed this class of products for safety and efficacy.”

No votes or formal recommendations are planned for the FDA meeting, scheduled for April 20 and 21. The FDA plans to take comments and input from the public, including industry officials, health practitioners and consumers.

[StockDung] FDA Questions Safety And Effectiveness Of Homeopathic Medicine BeautyNewsPoliti...

StockDung — 3/29/2015 9:54:14 AM

FDA Questions Safety And Effectiveness Of Homeopathic Medicine

Beauty

News

Politics

Products

March 26, 2015

Products such as Zicam and Cold-Eeze are known as homeopathic medicines that are protected by federal law, but not accepted by mainstream medical and health recommendations

The Food and Drug Administration announced a two-day meeting next month on homeopathic medicines to review their actual effectiveness and safety protocols. Many products available in stores and with well known names, like that of Zicam, Cold-Eeze, Airborne, Sinusalia, and many others, use combinations of simple vitamins and minerals that make claims of being able to defend and/or quickly help get over ailments.

Much like dietary supplements, homeopathic products are not required to prove they are safe or effective, and have little mandatory regulation or review before they are sold on open market to most stores. But unlike supplements, homeopathic medicines can state that they are designed to treat specific medical conditions.

Over the past few years, the supplement market has boomed, and many in the medical field seeking better profit have gone into putting their names on homeopathic medicines and supplements, which has started to draw the eyes of investigators. Recently, Dr. Mehmet Oz, of the “Dr. Oz Show”, came under heavy scrutiny as one of the doctors who has participated in this trend.

-Curt Cramer ( @CurtisRemarc)

thesource.com

[StockDung] Make your own ZICAM Cold Remedy. First get a gallon bucket. Next get a gallon of...

StockDung — 1/17/2015 9:31:06 AM

Make your own ZICAM Cold Remedy. First get a gallon bucket. Next get a gallon of all three active ingredients below. Next get 10,000 gallons of water (per directions 4X is 10,000 to 1 in Homeopathic language). Now shake real good and you now can give to your friends and family all the cold remedy nasal spray they could use in a lifetime. Best of all its now zinc free!!

Best of all ZICAM says it clinically-proven

Not statistically sound methods at all. Complete scam

[StockDung] Was Nasal Spray to Blame for Kaley Cuoco Sweeting’s Sinus Surgery? January 15, ...

StockDung — 1/16/2015 9:08:52 PM

Was Nasal Spray to Blame for Kaley Cuoco Sweeting’s Sinus Surgery?

January 15, 2015 | By Amanda MacMillan
Photo: Getty Images

Big Bang Theory and Wedding Ringer actress Kaley Cuoco Sweeting recently posted Instagram photos of herself post-sinus surgery, prompting rumors that she’d had a nose job for cosmetic purposes. But earlier this week on The Ellen Show, Cuoco Sweeting revealed the real reason she went under the knife: an “addiction” to Afrin nasal spray that she says ruined her sinuses.

Is this legit? Faoud Ishmael, MD, assistant professor of medicine at Penn State Milton S. Hershey Medical Center and Health System, says it certainly can be. “Over-the-counter decongestant sprays can cause rebound effects,” explains the allergy and immunology doctor, “which make you feel like you need to keep using them over and over.”

The actress’s reason for needing surgery also makes sense, says Dr. Ishmael, since these types of medicines can cause tissue damage if used too often or for too long.

If you’re an allergy sufferer or have ever used a nasal spray to clear congestion, this news may have you wondering about your own sinus health. Here’s how to avoid Cuoco Sweeting’s mistakes, and to unstuff yourself safely.

How OTC nasal spray works Decongestant sprays like Afrin—as well as some from Zicam, Mucinex, and Vicks—contain an active ingredient called oxymetazoline, which works by constricting blood vessels in swollen nasal tissue. The tissue shrinks temporarily, opening up airways and allowing the user to breathe easy.

But after a few hours, that nasal tissue swells back up. “And if you use the spray consistently for more than a few days at a time, the blood vessels in your nose get used to having the medicine around,” says Dr. Ishmael. “When it wears off, they dilate, even more than if you hadn’t started using it in the first place.”

From there, it becomes a vicious cycle: The more you spray, the worse your rebound inflammation gets—but the worse your inflammation, the more you feel the need to spray.

“You can absolutely get addicted,” says Dr. Ishmael. “I see it fairly commonly in my practice: Patients start using it and they can’t get off it.”

Cuoco Sweeting told Ellen Degeneres she was dependent on the spray for years. “At awards shows I would have to pick out the right clutch so I could fit my Afrin in it, and I’d be under the table snorting it,” she said. “I couldn’t get enough.”

RELATED: 20 Surprising Ways to Prevent Colds and Flu

The dangers of long-term use These products are labeled with a warning not to use them for more than three days at a time, and to not exceed two doses in any 24-hour period. But because they’re offered over the counter, it’s difficult for doctors or pharmacists to regulate how much a patient is using them.

Overuse of decongestant sprays can cause blood vessels to narrow so much that blood supply to parts of the nose become cut off, causing tissue to die, Dr. Ishmael says. This can leave you vulnerable to infections, sinus pain, and persistent inflammation and congestion.

“I’ve seen patients with actual holes in their septum, right in the middle of the nose,” he says. “I can shine a light in one nostril and see the light come right out the other side, because there’s literally tissue missing.”

Surgery to fix these problems might involve repairing holes in the septum, or shaving off areas of dead or damaged tissue that have blocked breathing passages, says Dr. Ishmael, who was not involved in Cuoco Sweeting’s diagnosis or treatment.

If a person is using a nasal spray several times a day, permanent damage could occur in a matter of weeks or months, he says. And while it’s less common, long-term and frequent use can also raise blood pressure throughout the body, since it affects the constriction of blood vessels.

RELATED: 10 Biggest Myths About The Flu

How to safely treat your symptoms Afrin and other nasal decongestants are safe to use when you need a quick fix, says Dr. Ishmael, but he recommends using them occasionally at most, and only as directed.

“People like it because it starts to work almost immediately, so we tell our patients it’s okay to use if you have a cold and you’re really miserable,” he says. “But you should be aware of the potential side effects if you use it longer than two or three days.”

If you’re going on three days and you still can’t breathe easily, stop using OTC sprays and see your doctor: He or she can prescribe a steroid spray or antihistamine pills which don’t seem to cause rebound effects and are safer for long-term use. (One steroid spray, Nasacort, is currently sold over the counter, and another, Flonase, will be available early this year.)

RELATED: How to Pick an Over-the-Counter Cold Remedy

[StockDung] 6 reasons not to take zinc for your cold It’s not worth the money or the side ...

StockDung — 12/5/2014 8:31:57 PM

6 reasons not to take zinc for your cold

It’s not worth the money or the side effects

Published: December 03, 2014 06:00 AM

Taking zinc for a cold can have dangerous side effects.

Does your co-worker’s first explosive sneeze or your child’s burgeoning cough send you racing to the store for zinc supplements to protect yourself from catching their colds? If so, listen up: It’s true that recent studies have found that zinc may shorten the duration of a cold, but there’s no proof that it will prevent one, and it won’t ease symptoms such as your runny nose or aching head. And beware: Zinc has side effects, too. Here are six reasons to skip the zinc this cold season.

1. It won’t relieve your cold symptoms Zinc is no magic bullet. An April 9, 2014, review published in JAMA analyzed studies of 1,781 cold-riddled participants in the U.S., the U.K., and elsewhere. Some received zinc-laden lozenges and syrups while the rest were given placebos. Those who began taking the zinc regularly 24 to 48 hours from the onset of their colds reportedly got better about a day before those who took the placebos. However, the analysis found that taking zinc had no effect whatsoever on the severity of the symptoms.

2. It has side effects While slicing a day off your suffering may sound great—and there is evidence that zinc ions have an antiviral effect, at least in a petri dish—the reality is that taking zinc can have some pretty unpleasant side effects. These include leaving a foul taste in your mouth and making you feel nauseated—adding to your pain and misery instead of relieving it. "Although zinc products may reduce a cold's duration by a day or so, if started early enough,” says Consumer Report’s chief medical adviser Marvin M. Lipman, M.D., “the bad taste and nausea can make the treatment worse than the disease."

3. It can be toxic A healthy adult woman should get a minimum of 8 milligrams (mg) of zinc per day, and adult men 11 mg, but that amount is easily obtained in a healthy diet that includes zinc-rich foods such as poultry, red meat, and fortified breakfast cereal. In fact, the National Institutes of Health advises that unless you’re taking zinc for medical reasons under the care of a doctor, the maximum daily limit you should get is 40 mg. Too much can cause nausea, vomiting, stomach cramps, diarrhea, and other problems.

4. It can interact with medications Zinc has been shown to interact with various prescription medicines. For example, take it with tetracycline or quinolone antibiotics such as ciprofloxacin (Cipro and generic) and you’ll reduce the amount of both the zinc and the antibiotic that your body absorbs. It can also interfere with the absorption of penicillamine (Cuprimine, Depen), a drug used to treat rheumatoid arthritis and Wilson’s disease (a rare genetic disorder).

5. It can cause health problems Getting too much zinc may increase the risk for prostate cancer, lead to copper deficiency and neurological problems, and reduce levels of HDL (good) cholesterol. What’s more, zinc products may also contain cadmium (another metal that is chemically similar and occurs alongside zinc in nature), and long-term exposure to high levels of cadmium can lead to kidney failure.

6. Some zinc preparations can be dangerous Avoid using zinc in the form of nasal preparations, which can make you lose your sense of smell. Several years ago, the Food and Drug Administration took several zinc nasal products off the market after receiving more than 130 reports from people who had used certain nasal Zicam Cold Remedies and lost their sense of smell—some permanently.

On balance, staying hydrated and getting plenty of rest will do more to help you recover than any supplement—and a bowl of chicken soup won’t hurt either.

—Lauren Cooper

[SI Ron (Crazy Music Man)] Done

SI Ron (Crazy Music Man) — 11/25/2014 12:14:28 PM

[StockDung] Ron, the monitor does not post on this board anymore. If you need a monitor I am...

StockDung — 11/25/2014 11:34:10 AM

Ron, the monitor does not post on this board anymore. If you need a monitor I am available.

[SI Ron (Crazy Music Man)] We'd like to have a logo on this board as part of our site modernization and to ...

SI Ron (Crazy Music Man) — 11/25/2014 11:04:11 AM

We'd like to have a logo on this board as part of our site modernization and to increase your board's visibility. We are closing in on 600 logos on active message boards. Can you please find an appropriate image and upload it to your board? If you need help I can assist you, just supply me the link to the appropriate image.

Thanks
Ron

[StockDung] Z-BOY the latest to push Zicam snake oil ======================================...

StockDung — 11/25/2014 10:35:19 AM

Z-BOY the latest to push Zicam snake oil

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

ZICAM® Launches New Kids’ Homeopathic Cold Medicine Safe, Effective and Great Tasting Chews for Cold Symptom Relief

(PRWEB) November 20, 2014

In another major expansion of its cold remedy product line, Bridgewater, N.J. based Matrixx Initiatives, Inc. has launched Zicam Kids, a cold product specifically designed to provide symptom relief for children ages 6 – 11. This great tasting grape soft chew delivers safe and effective relief of nasal congestion, runny nose and scratchy throat based on traditional homeopathic practice. As a new form to the pediatric category, these delicious and easy-to-take soft chews mean that parents and kids have a better way to feel better during cold season.

To highlight the new launch, Zicam has introduced a new hero to the pediatric cough/cold aisle, Z-Boy. Z-Boy zooms across the Zicam Kids packaging, representing how every sick kid would rather feel. He is also making appearances on Facebook to spread his tasty message of symptom relief to social media. With cold season fast approaching and parents wanting safe alternatives to traditional OTC medications for children, Zicam Kids couldn’t come at a better time.

It’s estimated that American children suffer three to eight colds per year, and in a recent survey, moms identified runny noses and scratchy throats as the top symptoms they spot when their child is coming down with a cold. “Zicam Kids gives mom or dad a great-tasting option for treating a kid’s cold the minute the symptoms start,” says M’lou Arnett, CEO of Matrixx. “Zicam Kids’ great tasting grape chews are safe and effective, but even better, its zinc based, homeopathic formula won’t cause drowsiness or other side effects that worry parents and can side line kids,” she added.

Zicam Kids is in major drug stores now, and, while supplies last, free samples of Zicam Kids have been placed in various top-selling Zicam RAPIDMELTS ® packages. “With active moms representing a large percentage of our consumers, we thought there would be no better way to introduce Zicam Kids than to include samples in a Zicam product that moms are already using for their own colds” commented Lori Norian, VP of Marketing of Zicam.

***

About Matrixx Initiatives, Inc.
Matrixx Initiatives, Inc. has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products that utilize innovative drug delivery systems for over 20 years. Acquired by HIG Capital in February 2011, Matrixx Initiatives manufactures and markets ZICAM® brand homeopathic and allopathic OTC products, including its clinically proven line of ZICAM® Cold Remedy Nasal Spray, ZICAM® Cold Remedy RAPIDMELTS® and Ultra RAPIDMELTS ® and ZICAM® Cold Remedy Oral Mist™, as well as ZICAM® Allergy Relief, ZICAM® Extreme Congestion Relief, ZICAM® Intense Sinus Relief, and ZICAM® Cold Remedy for Kids. For more information regarding Matrixx products, please visit http://www.zicam.com.

PDF Print

[StockDung] ZicamFraud continues. Snake Oil Science and Trick or Treatment Homeopathic activ...

StockDung — 11/1/2014 2:36:04 PM

ZicamFraud continues. Snake Oil Science and Trick or Treatment Homeopathic active ingredient 4X (10,000 to 1) claims can shorten cold. FDA continues to look the other way. But hey!! Its zinc free!!

Bloodletting, Leaches or Zicam?
======================================================================

Introducing the only clinically-proven cold shortening nasal spray. This new zinc-free homeopathic formula is delivered in our special no-drip nasal spray form.

Our unique plant-based formula provides multi-symptom cold relief and helps flush your nasal passages to relieve congestion. Use this no-drip nasal spray at the first sign of a cold and go from Pre-Cold® to No Cold, Faster™.

Shortens the length of a cold when taken at the first sign of a cold
Reduces symptom severity by 45% by the midpoint of the cold when taken at symptom onset
Zinc-free, homeopathic
With Menthol & Eucalyptus

zicam.com

Zicam® Launches New Cold Remedy Nasal Spray Providing Unique Combination of Cold Shortening & Symptom Relief

[iframe height=196 src="http://www.youtube.com/embed/8mtHXg_EojY?wmode=opaque" frameBorder=0 width=307 mozallowfullscreen allowFullScreen webkitAllowFullScreen origHeight="196" wmode="transparent" origWidth="307"][/iframe]

Bridgewater, NJ (PRWEB) October 30, 2014

In a major expansion of its cold remedy product line, Bridgewater, N.J. based Matrixx Initiatives, Inc. has launched a new cold-shortening Nasal Spray with symptom relief under its popular Zicam® Cold Remedy Brand. The No Drip Nasal Spray complements Zicam’s bestselling oral cold shortening products and will be available nationally in time for the upcoming cold season.

Zicam Cold Remedy Nasal Spray is being supported by a robust national advertising campaign that includes television, radio, and digital. The television ads again feature the Cold Monster as Zicam’s bumbling nemesis, demonstrating how Zicam empowers consumers to shorten their colds and move on with their busy lives. Television flights began in October on the nationally syndicated reruns of number one hit “The Big Bang Theory”. In a major shift to its media strategy, Matrixx has shifted the bulk of its media buying from the upfront television market to a blend of programmatic buying, the latest innovation in media targeting.

While most cold treatments simply provide temporary symptom relief, Zicam Cold Remedy Nasal Spray actually shortens the length of the cold. In addition to shortening a cold, Zicam Cold Remedy Nasal Spray is clinically proven to reduce cold symptoms by up to 45% by the midpoint of a cold when taken as directed. Zicam, the leader in cold shortening is known for form, function and flavor innovation in the category.

“We’re truly excited to be launching Zicam Cold Remedy Nasal Spray” commented M’lou Arnett, CEO of Matrixx. “We haven’t had a nasal cold shortening solution for cold-sufferers since 2009 when we removed our zinc based nasal spray from the market, and we have been working hard to develop an exciting and effective product ever since. And we’re thrilled with the result. The plant derived active ingredients in this new nasal spray make it different from zinc based cold shortening remedies. With the added benefit of symptom reduction, consumers now have real choice when looking for clinically proven cold shortening solutions.”

Ms. Arnett added, “We know from past experience and from research that many consumers prefer a product that’s delivered right to the nose – the source of their cold suffering. We’re delighted to answer the call and ‘return to the nose’ with our famous cold shortening benefit in a unique homeopathic formula that is unlike any product we’ve ever sold.”

It’s estimated that Americans suffer 1 billion colds each year. Zicam has been at the forefront of cold season management for decades. As the leading cold shortening brand, Zicam offers a wide range of products to shorten colds or manage symptoms. Zicam’s new Cold Remedy Nasal Spray is the only clinically proven cold shortening nasal spray and one of a handful of products on the market today that provides cold shortening with symptom relief. That makes it a truly progressive solution for consumers.

“With a large percentage of our consumer base active women, our advertising will reflect how a cold isn’t something that has to get in the way of her daily routine” commented Lori Norian, Vice President of Marketing for Zicam. “She’s the one everyone depends upon to get things done, and we’ve added a bit of levity in our Cold Monster ads this year to show how easily she can knock the Cold Monster for a loop with the multiple benefits of the new Nasal Spray and reduce its impact on her happy and busy life,” added Norian.

Matrixx Initiatives, Inc., has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products that utilize innovative drug delivery systems for over 20 years. The Zicam® portfolio includes cold remedy, cough relief, nasal decongestant and allergy relief products.
***

About Zicam® Cold Remedy Products
While most cold medicines are designed just to mask cold symptoms, ZICAM® Cold Remedy is COMPLETELY DIFFERENT®. ZICAM® Cold Remedy oral products, which contain proprietary formulations of active ingredients zinc gluconate and zinc acetate, reduce the duration of a cold when taken at the first sign of a cold (within the first 24 hours) and used as directed. ZICAM® Cold Remedy nasal spray contains a patented formulation of galphimia glauca, luffa operculata and sabadilla to reduce the duration and severity of a cold when taken at symptom onset and used as directed. ZICAM® Cold Remedy is for a PRE-COLD®, that first sniffle, sneeze or ache that signals that a full-blown cold is coming.

About Matrixx Initiatives, Inc.
Matrixx Initiatives, Inc. has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products that utilize innovative drug delivery systems for over 20 years. Acquired by HIG Capital in February 2011, Matrixx Initiatives manufactures and markets ZICAM® brand homeopathic and allopathic OTC products, including its clinically proven line of ZICAM® Cold Remedy Nasal Spray, ZICAM® Cold Remedy RAPIDMELTS® and Ultra RAPIDMELTS ® and ZICAM® Cold Remedy Oral Mist™, as well as ZICAM® Allergy Relief, ZICAM® Extreme Congestion Relief, ZICAM® Intense Sinus Relief, and ZICAM® Cold Remedy for Kids. For more information regarding Matrixx products, please visit http://www.zicam.com.

[StockDung] The Zicam fraud continues. Homeopathic active ingriediant 4X (10,000 to 1) calai...

StockDung — 11/1/2014 2:16:36 PM

The Zicam fraud continues. Homeopathic active ingriediant 4X (10,000 to 1) calaims can shorten cold.

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

Introducing the only clinically-proven cold shortening nasal spray. This new zinc-free homeopathic formula is delivered in our special no-drip nasal spray form.

Our unique plant-based formula provides multi-symptom cold relief and helps flush your nasal passages to relieve congestion. Use this no-drip nasal spray at the first sign of a cold and go from Pre-Cold® to No Cold, Faster™.

Shortens the length of a cold when taken at the first sign of a cold
Reduces symptom severity by 45% by the midpoint of the cold when taken at symptom onset
Zinc-free, homeopathic
With Menthol & Eucalyptus

zicam.com

[StockDung] Zicam® Launches New Cold Remedy Nasal Spray Providing Unique Combination of Co...

StockDung — 11/1/2014 1:58:14 PM

Zicam® Launches New Cold Remedy Nasal Spray Providing Unique Combination of Cold Shortening & Symptom Relief

[iframe height=196 src="http://www.youtube.com/embed/8mtHXg_EojY?wmode=opaque" frameBorder=0 width=307 mozallowfullscreen allowFullScreen webkitAllowFullScreen origHeight="196" wmode="transparent" origWidth="307"][/iframe]

Bridgewater, NJ (PRWEB) October 30, 2014

In a major expansion of its cold remedy product line, Bridgewater, N.J. based Matrixx Initiatives, Inc. has launched a new cold-shortening Nasal Spray with symptom relief under its popular Zicam® Cold Remedy Brand. The No Drip Nasal Spray complements Zicam’s bestselling oral cold shortening products and will be available nationally in time for the upcoming cold season.

Zicam Cold Remedy Nasal Spray is being supported by a robust national advertising campaign that includes television, radio, and digital. The television ads again feature the Cold Monster as Zicam’s bumbling nemesis, demonstrating how Zicam empowers consumers to shorten their colds and move on with their busy lives. Television flights began in October on the nationally syndicated reruns of number one hit “The Big Bang Theory”. In a major shift to its media strategy, Matrixx has shifted the bulk of its media buying from the upfront television market to a blend of programmatic buying, the latest innovation in media targeting.

While most cold treatments simply provide temporary symptom relief, Zicam Cold Remedy Nasal Spray actually shortens the length of the cold. In addition to shortening a cold, Zicam Cold Remedy Nasal Spray is clinically proven to reduce cold symptoms by up to 45% by the midpoint of a cold when taken as directed. Zicam, the leader in cold shortening is known for form, function and flavor innovation in the category.

“We’re truly excited to be launching Zicam Cold Remedy Nasal Spray” commented M’lou Arnett, CEO of Matrixx. “We haven’t had a nasal cold shortening solution for cold-sufferers since 2009 when we removed our zinc based nasal spray from the market, and we have been working hard to develop an exciting and effective product ever since. And we’re thrilled with the result. The plant derived active ingredients in this new nasal spray make it different from zinc based cold shortening remedies. With the added benefit of symptom reduction, consumers now have real choice when looking for clinically proven cold shortening solutions.”

Ms. Arnett added, “We know from past experience and from research that many consumers prefer a product that’s delivered right to the nose – the source of their cold suffering. We’re delighted to answer the call and ‘return to the nose’ with our famous cold shortening benefit in a unique homeopathic formula that is unlike any product we’ve ever sold.”

It’s estimated that Americans suffer 1 billion colds each year. Zicam has been at the forefront of cold season management for decades. As the leading cold shortening brand, Zicam offers a wide range of products to shorten colds or manage symptoms. Zicam’s new Cold Remedy Nasal Spray is the only clinically proven cold shortening nasal spray and one of a handful of products on the market today that provides cold shortening with symptom relief. That makes it a truly progressive solution for consumers.

“With a large percentage of our consumer base active women, our advertising will reflect how a cold isn’t something that has to get in the way of her daily routine” commented Lori Norian, Vice President of Marketing for Zicam. “She’s the one everyone depends upon to get things done, and we’ve added a bit of levity in our Cold Monster ads this year to show how easily she can knock the Cold Monster for a loop with the multiple benefits of the new Nasal Spray and reduce its impact on her happy and busy life,” added Norian.

Matrixx Initiatives, Inc., has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products that utilize innovative drug delivery systems for over 20 years. The Zicam® portfolio includes cold remedy, cough relief, nasal decongestant and allergy relief products.
***

About Zicam® Cold Remedy Products
While most cold medicines are designed just to mask cold symptoms, ZICAM® Cold Remedy is COMPLETELY DIFFERENT®. ZICAM® Cold Remedy oral products, which contain proprietary formulations of active ingredients zinc gluconate and zinc acetate, reduce the duration of a cold when taken at the first sign of a cold (within the first 24 hours) and used as directed. ZICAM® Cold Remedy nasal spray contains a patented formulation of galphimia glauca, luffa operculata and sabadilla to reduce the duration and severity of a cold when taken at symptom onset and used as directed. ZICAM® Cold Remedy is for a PRE-COLD®, that first sniffle, sneeze or ache that signals that a full-blown cold is coming.

About Matrixx Initiatives, Inc.
Matrixx Initiatives, Inc. has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products that utilize innovative drug delivery systems for over 20 years. Acquired by HIG Capital in February 2011, Matrixx Initiatives manufactures and markets ZICAM® brand homeopathic and allopathic OTC products, including its clinically proven line of ZICAM® Cold Remedy Nasal Spray, ZICAM® Cold Remedy RAPIDMELTS® and Ultra RAPIDMELTS ® and ZICAM® Cold Remedy Oral Mist™, as well as ZICAM® Allergy Relief, ZICAM® Extreme Congestion Relief, ZICAM® Intense Sinus Relief, and ZICAM® Cold Remedy for Kids. For more information regarding Matrixx products, please visit http://www.zicam.com.

[StockDung] Broker Intimidated Company by Threatening to Drive Down Stock Price An NASD h...

StockDung — 9/27/2014 8:02:23 PM

Broker Intimidated Company by Threatening to Drive Down Stock Price

An NASD hearing panel has suspended former stockbroker Shawn Aaron for two years and fined him $50,000 for threatening and intimidating Optelecom-NKF, Inc. (OPTC), a NASDAQ SmallCap company, while he was registered with GunnAllen Financial, Inc., of Tampa, FL. NASD charged that Aaron engaged in a scheme to defraud and extort OPTC by threatening to drive down the price of its stock from $13 to $6 per share unless it provided him with confidential business information.

The hearing panel found that Aaron purchased 5,180 shares of OPTC for his own account and another 134,540 shares for 54 of his customers in early April 2004. By mid-April, Aaron and his clients together held 139,720 shares, or about 4 percent of OPTC’s outstanding shares. On April 16, 2004, Aaron left a voicemail with OPTC’s Chairman and CEO stating that he owned 10 percent of the company’s stock and that he wanted to talk to him about taking the stock to “the next level.”

On April 19, 2004, Aaron talked to OPTC’s investor liaison consultant. Aaron again claimed that he owned 10 percent of the company, or about 300,000 shares. Aaron asked OPTC’s investor liaison consultant for reasons to keep buying OPTC. Otherwise, Aaron stated, he “could drive the stock down to six bucks if I dumped 300,000 shares on the market, unless you have institutions lined up.” Aaron boasted that he was GunnAllen’s top producer and claimed to have a special relationship with its president, with whom he shared his “best ideas” about promoting stocks. Aaron also claimed he was instrumental in increasing the stock prices of at least two other publicly traded companies.

The hearing panel concluded that Aaron made material misrepresentations and threatened OPTC, and that these “misrepresentations, threats, and intimidation plainly overstepped the bounds” of permissible behavior, violating NASD rules requiring brokers to observe high standards of commercial honor and just and equitable principles of trade. In arriving at its sanctions, the hearing panel noted that Aaron’s conduct was intentional, was for the purpose of some monetary or other gain, and that he did not take responsibility for his actions. It also noted that in 1999, Aaron agreed to withdraw his registration in Massachusetts and not reapply for 25 years to resolve the state regulator’s charges that he “used high pressure sales tactics, did not disclose material facts and made false and misleading statements” to investors to sell speculative stocks.

Optelecom-NKF is a Germantown, MD-based company that designs and manufactures communications products that transport data, video and audio over the Internet and fiber optic cables.

Because the hearing panel’s decision was not appealed, the decision is now final and the sanctions the panel imposed have taken effect. Aaron’s two-year suspension will continue through April 18, 2008.

[StockDung] Colbert Tweaks Zicam's Nose [graphic] Last week, the FDA, followed by Healt...

StockDung — 8/13/2014 5:46:21 PM

Colbert Tweaks Zicam's Nose

Last week, the FDA, followed by Health Canada, issued consumer alerts on Zicam’s Cold Remedy nasal gel and swabs because at least 130 users reported suffering loss of the sense of smell, a medical condition called anosmia, after using the product. Despite the seriousness of this health risk to the public, Health Canada does not have the power to order the recall of the product – an authority gap that would have been rectified by Bill C-51. Yet luckily, in this case, the manufacturer Matrixx Initiatives has voluntarily withdrawn the products cited by the FDA.

News of the Zicam alert was picked up quickly by the mainstream media and has been covered by fellow skeptic Dr. Steven Novella at Science-Based Medicine. But nothing undercuts a product’s credibility quite as much as when the late night comedy shows get hold of the story, and on Monday, Stephen Colbert, calling himself a “born skeptic”, took his shots at Zicam and its developer. The video can be seen at The Comedy Network in Canada and at Comedy Central in the US.

“Shocking, disturbing news,” exclaimed Colbert, “which could affect millions …”

“… of dollars for the makers of Zicam.”

Colbert cynically observed:

“I cannot for the life of me understand why the FDA would crack down on an unregulated heavy metal that you spray in your nose that can cause permanent damage.”

About Zicam’s developer, Robert Steven Davidson, Colbert stated that he:

“got his PhD from the American University of Asturias, an unaccredited and now-defunct university in Spain. The American University of Asturias is the Harvard of fake schools. It’s even better than ‘Altered State’ and the ‘Beerniversity of Drinkachusetts’. And just five years later, Davidson got his Bachelor’s degree from the on-line virtual school, Excelsior College. That’s right, he got his PhD first. Getting your BA before your PhD is your dad’s way of doing things, just like researching your medicine’s side-effects before you release it.”

The Washington Post article “ The Men Behind Zicam” stated that the health product’s co-developers “have unusual backgrounds” and confirms the backstory of Davidson receiving his doctorate from a “diploma mill”. The other patent holder, Charles Hensley, a professor at the Cleveland Chiropractic College “recently received a warning letter from the [FDA] about the sale over the Internet of an unapproved drug his company makes to treat bird flu” and “previously developed a weight-loss remedy that involves sniffing ‘specially developed aromas’.” Interestingly, the article pointed out that Davidson “declined to discuss whether any safety questions arose during Zicam’s development and testing.”

Even Rush Limbaugh got into the act. Limbaugh’s show is sponsored by Zicam, which implies an affinity between Limbaugh listeners and Zicam users. Colbert played a clip of Limbaugh calling the FDA’s crack down on Zicam “unprecedented”, saying that “the FDA has never done before what it did yesterday,” which is of course nonsense. The FDA releases alerts all the time on products that pose public health risks. Limbaugh claimed that the FDA’s action is a Democrat-inspired plot to get back at him personally, for which Colbert delivered his punchline:

“Now, that may smell like bullshit to some people, but not to users of Zicam.”

Skeptics have been tracking this story for a while. Perhaps the initial legal action concerning anosmia and Zicam was reported by Dr. Stephen Barrett in his 2003 Homeowatch article “ Zicam Marketers Sued“. The case’s legal complaint stated that, when Dennis Christensen felt a cold coming on, he used Zicam Cold Remedy Nasal Spray as directed. Afterwards, he “felt an intense stinging and/or burning sensation in his nose”, and subsequent to this single use, he “has totally lost his sense of smell”, a condition which was medically assessed to be “in all likelihood permanent, total and irreversible”.

Other lawsuits followed. In their 2006 article “ Is Shelf Life Of Zicam Nasal Spray In Jeopardy?“, LawyersandSettlements.com reported:

“A second lawsuit was filed on December 18, 2003, in Etowah County, Alabama, by Janie Sutherland, and also named Wal-Mart as a defendant. The third lawsuit was filed in Maricopa County, Arizona, in January 2004, by 3 plaintiffs claiming to have lost their sense of smell and taste immediately after using Zicam. After that, lawsuits began sprouting up all over the country.”

To the extent that:

“As of January 18, 2006, according to [Matrixx Initiatives'] filings with the Security and Exchange Commission, there were 49 different lawsuits pending against Matrixx involving approximately 400 individuals.”

Then on 20 January 2006, according to the Washington Post article “ Paying Through the Nose“, the company settled out of court with 340 smelling-impaired plaintiffs for $12 million. About.com adds that “the company admitted no wrongdoing or admission that their products caused loss of the sense of smell.”

Denial of corporate liability is not unusual for this type of lawsuit and tracks with the company’s current PR strategy. On the Zicam website, William Hemelt, the president of Matrixx Initiatives, gives his video assurance that their products are safe, but since they want to work with the FDA, the company voluntarily withdrew the products cited in the health alert. Apparently, the problem is not that the products cause adverse reactions but that some consumers reported adverse reactions after using them. He also reassures us that “there is no credible evidence that Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs causes you to lose your sense of smell,” despite the fact that the company has received 800 consumer complaints about the products.

As skeptics, we accept that these reports are only anecdotal, but the number of reports should have spurred further analysis. If only the FDA had known about them, an investigation could have been initiated. So why did the company not report them to the FDA? Well, Matrixx Initiatives states:

“During the May 2009 audit, the FDA suggested – for the first time – that the FDA’s interpretation of new regulations required the Company to report to the FDA all complaints of diminishment of smell, rather than having those complaints available for FDA inspection. The FDA’s position is directly contrary to the written advice received from the Company’s FDA counsel shortly after the new regulations were adopted.”

Apparently, this whole misunderstanding could have been cleared up if the FDA and the company’s lawyers had been on the ball. Perhaps the company is the innocent victim here, and certainly the product’s many true believers have tweeted their stalwart support. Equally unfortunate is that the company did not, apparently, understand its responsibility under the 2007 FDA regulations for the reporting of adverse reactions to these types of products, despite guidance on the FDA webpage that:

“An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is:

Disability. Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life.”

Yet, homeopathic products are typically diluted to the point that not even a molecule of active ingredient is left in solution. How is it possible that a homeopathic product has any physiological effect at all, let alone a negative one. The reason is that not all homeopathic products are diluted to the point of absurdity, and one of those “underdiluted” products is Zicam. Skeptico, for his 2005 article “ If it has any ingredient in it, is it homeopathic?“, received the following e-mail explanation from Matrixx Initiatives:

“Zicam has only one active ingredient – zinc gluconate (Zincum Gluconicum). It is true that some homeopathic dilutions are very dilute. The [Homeopathic Pharmacopoeia of the United States (HPUS)] dictates the maximum strength a compound can be for OTC use. In the case of zinc gluconate, it is a 1X dilution. This means that 1 part of zinc gluconate is diluted with 9 parts water. In Zicam we use a 2X dilution. This takes the above dilution and further dilutes it by adding 1 part of it to 9 parts water. This produces a final 1:100 dilution.”

I would have thought that, by homeopathy’s bizarro logic, a 2X dilution would be so “weak” that it’s hardly worth producing. Yet in both Canada and the US, a natural health product is deemed to be homeopathic, not by how diluted it is, but by whether it is listed in an approved homeopathic pharmacopoeia, as circular as that definition seems to be. As a result, Dr. Novella points out, Zicam ends up having enough residual active ingredient to have effects:

“ Efficacy of zinc against common cold viruses: an overview.” Journal of the American Pharmacists Association. 2004 Sep-Oct;44(5):594-603.

as well as consequences:

“ Anosmia after intranasal zinc gluconate use.” American Journal of Rhinology. 2004 May-Jun;18(3):137-41.

“ Intranasal zinc and anosmia: the zinc-induced anosmia syndrome.” The Laryngoscope. 2006 Feb;116(2):217-20.

Having to actually deal with an active ingredient has put a homeopathic manufacturer in an unusual position. But not to worry, we are reassured by the American Association of Homeopathic Pharmacists that homeopathic medications are safe despite the FDA’s concern for this “specific zinc product”, which sounds like they are distancing themselves from an offending mainstream product, and that “[h]omeopathic medications are regulated by the FDA”, which is a meaningless statement since homeopathic products are not regulated for safety or efficacy.

The Zicam situation inspired AP to write the article “ Zicam not alone in side effect reports“, which questions the lack of federal regulatory oversight for homeopathic products and featured some wry comments on homeopathy’s origin, such as:

“Homeopathy sprang from the inventive – some would say fanciful – mind of German physician and chemist Samuel Hahnemann”

and

“with arcane ingredients like ‘nux vomica’ and ‘arsenicum album,’ many homeopathic medicines sound like something brewed in a druid’s kettle.”

The article reports what, in a rational world, should summarize the fate of homeopathy:

“The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on homeopathic drugs. ‘The evidence is not there at this point,’ says the center’s director, Dr. Josephine Briggs.”

Too bad she felt the need to qualify her statement with “at this point”. I’m certainly not going to hold my breath for supporting evidence to be found.

Nevertheless, the statement hints at the pointlessness of homeopathy, a sentiment further bolstered by this Zicam incident. Typical homeopathic products, which have no active ingredients, are ineffective, while faux homeopathic products like Zicam, which contain active ingredients, need to be studied and regulated outside the superstitious framework of homeopathy as mainstream health products using real science. Coddling homeopathy and sheltering it from strict regulation invites people to waste money and puts their health at risk.

25. June 2009 by barry
Categories: Alt. Med, Topics | Leave a comment

[StockDung] GunnAllen exec details demise of the Tampa brokerage firm in new book Jeff Harr...

StockDung — 5/19/2014 5:36:43 PM

GunnAllen exec details demise of the Tampa brokerage firm in new book
Jeff Harrington, Times Staff Writer
Tampa Bay Times Monday, May 19, 2014 9:15am

David Levine's friends jokingly suggest he should look under his car seat for a bomb. Or maybe start wearing a Kevlar vest.

[StockDung] Told ya so->Carl Johnson's turd SCOLR soon to be to be delisted. Michael Taglic...

StockDung — 5/15/2014 11:11:04 AM

Told ya so->Carl Johnson's turd SCOLR soon to be to be delisted. Michael Taglich tried to float a BIG pile of CRAP but its just getting flushed down the toilet

see: sec.gov

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

SCOLR Pharma, Inc. Names Carl Johnson as Chairman; Former Chairman Michael Taglich Remains as Director

BOTHELL, Wash., Sept. 27 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (NYSE AMEX: DDD) today announced that Carl Johnson has been appointed as the Chairman of its Board of Directors. Johnson succeeds Michael Taglich, who will remain a member of the Board.

Johnson previously served as President and Chief Executive Officer of Matrixx Initiatives, Inc. Under Johnson's leadership, Matrixx successfully developed and launched the Zicam® product line. Johnson also has served as Vice President, Commercial Development, for Perrigo Company and before that was with Johnson & Johnson in both the consumer and professional healthcare products divisions. Johnson was elected a director of SCOLR at its annual meeting in June.

Johnson said: "I am greatly honored to have the opportunity to serve as Chairman of a company with the enormous potential of SCOLR. Our unique technology gives us the opportunity to develop and market extended release nutritional and over-the-counter drug products that we believe will provide significant benefit to the consumer, and prove to be desirable in the marketplace."

Taglich, SCOLR's outgoing Chairman, said: "In the short time that he has been a member of the Board, Carl's active involvement with management, and his industry expertise have greatly impressed the Board. With SCOLR's focus on the successful commercialization of our unique proprietary products, our shareholders are best served by Board leadership with experience in successfully bringing consumer products to market. Carl's professional successes in this area are impressive and we look forward to his contributions as Chairman."

Mr. Taglich added: "The Board's depth of experience in the consumer product market has also been strengthened by the recent addition of Marylou Arnett, who is currently the COO of Scerene Healthcare. Before co-founding Scerene, Marylou played a lead role in the consumer and professional marketing of both Mucinex and Delsym for Adams Respiratory Therapeutics, which was sold in 2008 for $2.3 billion. She also has managed well known brands for Pfizer and Warner Lambert."

Mr. Taglich said: "On behalf of SCOLR and the entire Board, I want to thank former directors Randall Caudill and Bruce Morra for their service to the company, as well as David Meyers of Apex Leaders LLC, whose executive search firm identified Carl Johnson and Marylou Arnett after an extensive search for directors with consumer product expertise." Messrs. Caudill and Morra retired from the Board as Johnson and Arnett were elected in June.

About SCOLR Pharma:

Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company focused on applying its formulation expertise and patented CDT platforms to develop novel prescription pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platforms are based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425-368-1050 or visit scolr.com.

This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning the application of our proprietary technologies to certain product markets, the anticipated benefits of our products for consumers, the anticipated marketplace demand for our products and the expected contribution of our new board members. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including less than anticipated demand for our products, constraints on our liquidity related to the greater working capital requirements of our nutritional business, unanticipated changes in the timing or amount of orders for our nutritional products, our ability to generate revenues or obtain financing, problems with our regulatory applications, unanticipated costs and expenses associated with our product development, clinical activities and regulatory review, reductions in our royalty revenues, our ability to create and maintain partnerships or other relationships, our ability to successfully complete research and development, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if we are not successful in generating sufficient revenue, raising additional capital or securing partnership arrangements, we may be required to further curtail or cease our operations. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission, including the "Risk Factors" set forth in our Annual Report on Form 10-K, as supplemented by our quarterly reports on Form 10-Q. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual result or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstance.


Contacts:
Investor Relations:
SCOLR Pharma, Inc.
425.368.1050

[StockDung] The zicam allergy products are a real scam. Here is what consumer reports said. ...

StockDung — 5/10/2014 11:43:51 AM

The zicam allergy products are a real scam. Here is what consumer reports said. Hard to believe its still on the shelves.

consumerreports.org

Homeopathic drugs Look-alike medicines

READ THE LABELS If a drug is labeled homeopathic, you are not getting ingredients that have been reviewed or approved by the Food and Drug Administration.

Two over-the-counter products, Seasonal Allergy Relief and Intense Sinus Relief, both made by Zicam, promise to relieve hay-fever symptoms. Intense Sinus Relief contains oxymetazoline, a nasal decongestant the Food and Drug Administration has found to be safe and effective. The other Zicam product is homeopathic; it hasn't been reviewed by the FDA and its active ingredients, including sulphur, have been diluted almost to vanishing.

But despite this major difference between the two products, our 11 mystery shoppers, who visited 52 drugstores throughout the U.S., frequently found them alongside each other on drugstore shelves. So consumers might mistakenly buy a homeopathic remedy when they're really looking for conventional medicine. That wastes money and might lead to inadequate treatment.

Homeopathy is a centuries-old form of medicine in which a substance that could cause symptoms is diluted until it becomes virtually undetectable. For example, the "active" ingredients in the homeopathic flu remedy Oscillococcinum are wild duck heart and liver, apparently because those organs are said to contain tiny amounts of the flu virus. The ingredients are so diluted, there probably isn't one molecule of them per package. Yet homeopathy's supporters say that infinitesimal amount can improve health.

UNproven results

There's little evidence to back up this notion, according to a 2005 meta-analysis in the Lancet of 110 placebo-controlled homeopathy trials matched with 110 trials of conventional drugs. A subset of large, high-quality studies showed that any benefit from homeopathic remedies was "compatible with" the effect of a placebo. An accompanying editorial said the findings were less surprising than the fact that debate over homeopathy continues, "despite 150 years of unfavorable findings."

The FDA is officially required to regulate homeopathic drugs, but a spokeswoman said the agency doesn't review those products and so does not approve them as safe and effective. That's partly because the items are so diluted that they're thought to pose little direct risk, she said.

confusion in the aisles

Even people who want homeopathic products might not get what they expect. Andy P. Bormeth, executive director of the Homeopathic Pharma-copoeia Convention of the United States, says that "official" homeopathic remedies should carry the initials HPUS, indicating that they conform to the organization's guidelines. Only four of 12 homeopathic products we checked were labeled that way.

In addition to Zicam's hay-fever products, we found homeopathic yeast pills sold next to a similarly packaged, FDA-approved drug for urinary pain. Nature's Cure sells its homeopathic and conventional yeast-infection remedies as a "combination pack." Drugstore representatives we contacted said they display the remedies together because consumers shop for products based on symptoms. But Michael Cohen, president of the nonprofit Institute for Safe Medication Practices, says, "It's misleading and potentially harmful to merchandise homeopathic remedies alongside conventional drugs." Relying on a homeopathic yeast-infection remedy instead of an FDA-approved drug could allow the infection to get worse.

WHAT YOU CAN DO

Check whether over-the-counter products are labeled homeopathic. If they are, don't buy them. There's not enough evidence to justify their use. If you do opt for one, stick with a product with the HPUS label. Be especially wary of homeopathic drugs that contain alcohol and are intended for children, since the FDA does not limit how much alcohol is allowed in these remedies.

[StockDung] Zicam Alergy relief SCAM. 12X is one trillion to one for active ingredient. That...

StockDung — 5/10/2014 11:43:16 AM

Zicam Alergy relief SCAM. 12X is one trillion to one for active ingredient. That is right. ONE TRILLION TO ONE. Homeopathy is the ultimate fake and the fraud continues bilking consumers for products that are totally worthless.

The ZiCAM fraud continues to this day as the FDA and FTC continue to look the other way.

Zicams only study was a fraud from the start. It is well documented on this message board.

Detailed Description

Specifications

Uses
Relieves symptoms of hay fever and other upper respiratory allergies such as: sinus pressure; runny nose; sneezing; itchy eyes; watery eyes; nasal congestion. No known drug interactions. No odor or bad taste. No drowsiness. No jitters. Non-habit forming. Homeopathic.

Directions
Adults and children 6 years of age and older (with adult supervision): Remove cap and safety clip (also see illustrations on side of carton and insert). Hold with thumb at bottom of bottle and nozzle between your fingers. Before using the first time, prime pump by depressing several times. Place tip of nozzle just past nasal opening (approximately 1/8 inch). While inside nasal opening, slightly angle nozzle outward. Pump once into each nostril. After application, press lightly on outside of each nostril for about 5 seconds. Wait at least 30 seconds before blowing nose again. Use once every 4 hours. Optimal results may not be seen for 1-2 weeks. After 1-2 weeks, may need to use only 1-2 times daily. For best results, use up to one week before contact with known causes of your allergies. Children under 6 years of age: consult a doctor before use.

Active Ingredients
Luffa Operculata 4x, 12x, 30x; Galphimia Glauca 12x, 30x; Histaminum Hydrochloricum 12x, 30x, 200x; Sulfur 12x, 30x, 200x

Inactive Ingredients
Benzalkonium Chloride; Benzyl Alcohol; Edetate Disodium; Glycerin; Hydroxyethylcellulose; Potassium Chloride; Potassium Phosphate; Purified Water; Sodium Chloride; Sodium Phosphate

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

The zicam allergy products are a real scam. Here is what consumer reports said. Hard to believe its still on the shelves.

consumerreports.org

Homeopathic drugs Look-alike medicines

READ THE LABELS If a drug is labeled homeopathic, you are not getting ingredients that have been reviewed or approved by the Food and Drug Administration.

Two over-the-counter products, Seasonal Allergy Relief and Intense Sinus Relief, both made by Zicam, promise to relieve hay-fever symptoms. Intense Sinus Relief contains oxymetazoline, a nasal decongestant the Food and Drug Administration has found to be safe and effective. The other Zicam product is homeopathic; it hasn't been reviewed by the FDA and its active ingredients, including sulphur, have been diluted almost to vanishing.

But despite this major difference between the two products, our 11 mystery shoppers, who visited 52 drugstores throughout the U.S., frequently found them alongside each other on drugstore shelves. So consumers might mistakenly buy a homeopathic remedy when they're really looking for conventional medicine. That wastes money and might lead to inadequate treatment.

Homeopathy is a centuries-old form of medicine in which a substance that could cause symptoms is diluted until it becomes virtually undetectable. For example, the "active" ingredients in the homeopathic flu remedy Oscillococcinum are wild duck heart and liver, apparently because those organs are said to contain tiny amounts of the flu virus. The ingredients are so diluted, there probably isn't one molecule of them per package. Yet homeopathy's supporters say that infinitesimal amount can improve health.

UNproven results

There's little evidence to back up this notion, according to a 2005 meta-analysis in the Lancet of 110 placebo-controlled homeopathy trials matched with 110 trials of conventional drugs. A subset of large, high-quality studies showed that any benefit from homeopathic remedies was "compatible with" the effect of a placebo. An accompanying editorial said the findings were less surprising than the fact that debate over homeopathy continues, "despite 150 years of unfavorable findings."

The FDA is officially required to regulate homeopathic drugs, but a spokeswoman said the agency doesn't review those products and so does not approve them as safe and effective. That's partly because the items are so diluted that they're thought to pose little direct risk, she said.

confusion in the aisles

Even people who want homeopathic products might not get what they expect. Andy P. Bormeth, executive director of the Homeopathic Pharma-copoeia Convention of the United States, says that "official" homeopathic remedies should carry the initials HPUS, indicating that they conform to the organization's guidelines. Only four of 12 homeopathic products we checked were labeled that way.

In addition to Zicam's hay-fever products, we found homeopathic yeast pills sold next to a similarly packaged, FDA-approved drug for urinary pain. Nature's Cure sells its homeopathic and conventional yeast-infection remedies as a "combination pack." Drugstore representatives we contacted said they display the remedies together because consumers shop for products based on symptoms. But Michael Cohen, president of the nonprofit Institute for Safe Medication Practices, says, "It's misleading and potentially harmful to merchandise homeopathic remedies alongside conventional drugs." Relying on a homeopathic yeast-infection remedy instead of an FDA-approved drug could allow the infection to get worse.

WHAT YOU CAN DO

Check whether over-the-counter products are labeled homeopathic. If they are, don't buy them. There's not enough evidence to justify their use. If you do opt for one, stick with a product with the HPUS label. Be especially wary of homeopathic drugs that contain alcohol and are intended for children, since the FDA does not limit how much alcohol is allowed in these remedies.

[StockDung] Zicam disproves homeopathy [youtube video]

StockDung — 5/10/2014 11:27:13 AM

[StockDung] Sensa doctor’s research fails federal smell test This month the Federal Trade ...

StockDung — 2/7/2014 2:22:46 PM

Sensa doctor’s research fails federal smell test

This month the Federal Trade Commission announced it had reached a $26.5 million settlement with the marketers of Sensa Weight Loss System after accusing the company and smell-and-taste researcher Dr. Alan Hirsch of false and deceptive advertising practices.

By Julie Deardorffand Karisa King

Chicago Tribune

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Bill Hogan / Chicago Tribune

Advertising of Sensa weight-loss products made claims that were false and deceptive, the FTC says.

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CHICAGO — Smell-and-taste researcher Dr. Alan Hirsch has long argued that certain aromas can help people lose weight, improve athletic performance or increase sexual arousal. One of his studies found that the odor of buttered popcorn or strawberries helps exercisers burn more calories, another that a whiff of jasmine can improve bowlers’ scores.

Hirsch’s boldest and most controversial finding, however — that sprinkling some flavored granules on food can help people lose weight without diet or exercise — is one he can no longer advertise.

This month the Federal Trade Commission (FTC) said it had reached a $26.5?million settlement with the marketers of Sensa Weight Loss System after accusing the company and Hirsch of false and deceptive advertising practices.

Hirsch, who patented Sensa’s “tastant” crystals and holds an ownership stake in Sensa Products, is barred under the agreement from making weight-loss claims about dietary supplements, food or drugs unless they are backed up with two adequate and well-controlled human clinical trials.

The decision represents a public rebuke for Hirsch, a neurologist and psychiatrist who operates the Smell & Taste Research and Treatment Foundation in Chicago and describes himself as “one of the nation’s foremost experts on smell and taste.”

A popular, engaging speaker, he is frequently quoted in national newspapers, magazines and on television about his latest research conclusions on provocative and entertaining topics such as how people’s food preferences can help them find true love. His seven books include “What Flavor is Your Personality?” and “Scentsational Sex.”

His foundation’s website states that Hirsch has conducted and published more than 200 research projects on sensory disorders and how certain smells and tastes affect mood, perception and behavior. But a Tribune review found that few of Hirsch’s original studies on sensory stimuli were published in peer-reviewed medical journals, and many of his conclusions are based on small studies with questionable or unclear methodology.

“The journals that Hirsch publishes his actual studies in are low-impact, obscure journals,” said R. Barker Bausell, a retired University of Maryland biostatistics professor and expert on clinical-research design, after reviewing a sample of Hirsch’s published work. “He does not supply sufficient details to evaluate his studies and he seems to have little understanding of research design.”

References faulted

The foundation website states Hirsch has published work in several major journals, including The Journal of the American Medical Association, Neurology and The American Journal of Psychiatry. But those contributions are limited to book reviews, commentaries or letters to the editor. The site lists three current projects with NASA, but a spokesman for the space agency said a records search turned up no work with Hirsch in at least 15 years.

In addition, court records show that judges in three lawsuits excluded Hirsch’s testimony as an expert witness.

Hirsch did not respond to repeated requests for comment; his office said he might have time in spring or early summer. “Unfortunately, due to Dr. Hirsch’s hectic, overwhelming schedule, he is not currently available to conduct an interview with you,” an administrator at the foundation wrote in an email.

Sensa Products didn’t respond to specific questions. In a statement, the company said the settlement involves no admission of wrongful conduct by Sensa and does not challenge the product’s safety. “The company has invested millions of dollars in clinical research,” the statement said. “With over 3 million customers, Sensa helps users engage in portion control.”

Before the FTC settlement, the crystals were marketed as “clinically proven to cause substantial weight loss without dieting or exercise, averaging 30 pounds in six months,” based on two of Hirsch’s studies. Sensa racked up $364 million in U.S. sales from 2008 to 2012; a two-month starter kit sells for $118.

The FTC charged that the product had no clinical evidence to support it and cited major flaws with Hirsch’s research, including the lack of placebo controls.

“The man is making money preying on patients who are desperate to lose weight, with very little tools to help them that are safe and effective,” said Dr. Caroline Apovian, director of the Nutrition and Weight Management Center at Boston Medical Center and an expert in drugs that promote weight loss.

Some colleagues in the world of smell-and-taste research say Hirsch has brought much-needed attention to a field that is often overshadowed by the other senses and neglected in medical-school training.

“He is a controversial figure,” said Dr. Richard Doty, an olfactory researcher and director of the University of Pennsylvania’s Smell and Taste Center. “A number of members of the scientific community have felt that his research isn’t as strongly grounded in solid science as one would like. But I find him an interesting person, an intriguing individual, and I try to focus on that. He has gone places no (other researchers) have been willing to go.”

Hirsch, 58, opened the Smell & Taste Treatment and Research Foundation in 1987. The neuropsychiatrist is affiliated with Rush University Medical Center. The foundation website also describes him as a member of the medical faculty at Mercy Hospital and Medical Center, but a spokeswoman said Hirsch “does not actively practice” at Mercy and “does not function in a type of faculty or teaching role.”

Aroma research

His research interests are wide-ranging. In one of his better-known studies, Hirsch piped pleasant but different aromas into two separate areas near slot machines at a Las Vegas casino and found that one of the two odorants seemed to enhance the gambling mood of casino patrons.

Hirsch released the unpublished results to the media in 1992. The study, “Effect of an Ambient Odor on Slot Machine Usage in a Las Vegas Casino,” was listed by Hirsch as published in Chemical Senses and Biological Psychiatry in 1993 and in Psychology & Marketing in 1995, all peer-reviewed journals.

Bausell, the biostatistics expert, found Hirsch’s casino study the “most interesting” of those he reviewed. He added: “It might be true or it might not be. ... There could be other explanations for the results if they were true. Perhaps people were saying to each other, ‘Did you smell that stuff over in the next aisle?’ thereby generating a curiosity migration.”

Hirsch’s research has placed him in demand as a consultant to industry. In June, a news release announcing a partnership with Gain laundry detergent quoted Hirsch as saying: “My studies have shown that fresh-smelling clothes induce people to feel happier and more optimistic and may also affect, in a positive way, how they are perceived by others.”

Last year he delivered the keynote address — “Research into Action: From Science to Market Implementation” — at the scent-marketing industry’s ScentWorld conference.

“He’s certainly creative and a superb publicist,” Doty said.

Some credit Hirsch with being the first to raise alarms about a possible link between a popular cold remedy and anosmia, or loss of smell. According to court documents, Hirsch told the manufacturer of Zicam nasal gel, Matrixx, in a 1999 call that applying zinc in the nasal area had been found to be problematic and that at least one of his patients had developed anosmia after using Zicam. A decade later, the U.S. Food and Drug Administration (FDA) warned consumers about reports of smell loss associated with three specific Zicam products containing zinc.

But in a 2006 court case in which a Michigan man claimed he lost his sense of smell after using Zicam, U.S. Magistrate Judge Donald Scheer excluded Hirsch’s expert testimony from the evidence. In a sharply worded opinion, the judge stated that Hirsch did not know the ingredients of Zicam, had failed to review scientific literature that contradicted his opinion that Zicam caused the man’s loss of smell and had performed no tests on the spray.

Another judge, in 2007, found Hirsch was not qualified to testify as to what caused a woman’s multiple-sclerosis symptoms to worsen, though he could speak about her headaches and psychiatric symptoms. The woman had accused Wal-Mart of improperly filling a prescription, causing an allergic reaction that she said aggravated her MS.

“The relevant medical literature does not support Dr. Hirsch’s conclusions regarding the connection between physical or psychological stress and the exacerbation of MS,” federal Judge James Moran wrote in his opinion.

In 1998, a magistrate judge excluded Hirsch’s testimony in support of Tennessee residents who said they suffered injuries from exposure to leaked PCBs. The judge said Hirsch had failed to identify scientific studies that supported his conclusion, according to court documents. One law firm that hired Hirsch as an expert witness in another case involving chemical exposure halted work with him and refused to pay the balance of his bill after his statements reportedly crumbled under questioning in a deposition.

Weight-loss claims

Sensa’s original crystals, a patented formulation of maltodextrin, tricalcium phosphate, silica and natural and artificial colors, are based on the concept of “sensory-specific satiety,” which refers to the declining satisfaction people get from eating the same type of foods. New flavors or foods, meanwhile, are thought to stimulate appetite.

When the crystals, also called “tastants,” are scattered on food, they “interact with and intensify the taste of foods and make the body perceive that it has eaten more than it had, reducing calories and thus achieving weight loss,” Hirsch wrote in his book “Sensa Weight-Loss Program.”

Dr. Barbara Rolls, a professor of nutritional sciences at Pennsylvania State University who helped define the phenomenon of sensory-specific satiety, said she has been concerned about the lack of peer-reviewed publications related to Sensa’s claims.

“We have shown that sensory-specific satiety affects food choices in a meal, but it is a short-term phenomenon and has never been shown to affect body weight,” Rolls, director of the Laboratory for the Study of Human Ingestive Behavior, wrote in an email.

Sensa used two Hirsch studies to market the product as “clinically proven.” The first, according to Hirsch’s book on Sensa, found that 92 volunteers had lost an average of 33.6 pounds in six months. But according to the poster abstract for the study, presented at the 2003 meeting of the Association for Chemoreception Sciences, the average weight loss was 5.6 pounds.

The study did not include a comparison with a placebo-controlled group consuming an identical-looking, but inactive, substance. It is a critical flaw because “we know that placebo weight-loss pills do indeed lead to weight loss,” said obesity expert Dr. Yoni Freedhoff, an assistant professor of family medicine at the University of Ottawa. In addition, the subjects’ diet and exercise were not monitored and they self-reported their weight.

A 2004 follow-up study of 2,437 volunteers, which concluded that 1,436 volunteers had an average loss of 30.5 pounds in six months, had the same problems, according to the FTC.

Hirsch also did not include an additional 1,001 study participants in the final results. “That’s a 41 percent loss to follow up, with no mention whatsoever of why they may have dropped out,” said Freedhoff, author of “The Diet Fix: Why Diets Fail.” “Were there adverse effects? Did the crystals simply work because they made the food taste bad? Did they not lose weight, and consequently give up?”

In 2011, a class-action lawsuit filed in California alleged a lack of scientific evidence behind some of Sensa’s marketing claims. The complaint called Hirsch “a particularly sophisticated huckster — one with a medical degree and a thick stack of junk science to support the claim that his magic crystals are ‘clinically proven’ to promote weight loss without diet or exercise.”

The company denied the accusations and settled the suit for $9 million without admitting fault.

The FTC, which polices companies’ marketing practices, cannot ban a product from being sold, and Sensa’s website says it will modify its advertising claims to comply with the agency’s standards.

But some experts say consumers need to think twice before buying a weight-loss product that lacks proof.

“My concern is it’s another product with no demonstrated benefit that people are desperately trying in order to manage weight,” said Dr. Robert Kushner, clinical director of the Northwestern Comprehensive Center on Obesity. “Many of these are individuals who won’t put down money to see a dietitian, but they will pay $100 to buy Sensa. We’re diverting limited resources into a product that may not be beneficial.”

[StockDung] The Materiality Standard After Matrixx Initiatives, Inc. v. Siracusano Downloa...

StockDung — 1/15/2014 6:16:01 AM

The Materiality Standard After Matrixx Initiatives, Inc. v. Siracusano Download Full Text PDF

North Carolina Journal of Law and Technology

(Jun 2012)

The recent, unanimous decision of the U.S. Supreme Court in Matrixx Initiatives, Inc. v. Siracusano resolved a circuit split on the materiality standard under Rule 10b-5 of the Securities Exchange Act of 1934. By affirming the Ninth Circuit, the Court re-established the materiality standard set forth twenty-three years ago in Basic Inc. v. Levinson. Although the Court relied heavily on this past decision, it did provide some guidance to pharmaceutical companies regarding the disclosure requirements of adverse event reports. With the circuit split now settled, it appears that adverse event reports, standing alone, will generally not be enough to satisfy the materiality standard. However, when in conjunction with affirmative statements concerning the safety and profitability of the drug, these adverse event reports may be material as to not make the statements made misleading. The question remains whether normal advertising of the drug would breach this threshold and require the disclosure of the adverse event reports.

Benjamin E. Shook, Recent Development, The Materiality Standard After Matrixx Initiatives, Inc. v. Siracusano, 12 N.C. J.L. & Tech. 369 (2011), available at cite.ncjolt.org.

ncjolt.org

[StockDung] On December 18, 2012, Matrixx Initiatives initiated a voluntary recall of one lo...

StockDung — 11/9/2013 12:34:34 PM

On December 18, 2012, Matrixx Initiatives initiated a voluntary recall of one lot of Zicam ® Extreme Congestion Relief nasal gel that we
manufactured on their behalf (the “Product Recall”). Matrixx took this step after we informed Matrixx that we found a small amount of
Burkholderia cepacia in a single sample of the product taken from the affected lot. Burkholderia cepacia poses little medical risk to healthy
individuals. However, Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory
infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. The organism is
resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs. To our knowledge, Matrixx has
not received any reports of illness.
On January 3, 2013, Matrixx sent BioZone Labs a Notice of Default under the Supply Agreement dated May 8, 2009 by and between BioZone
and Zicam, LLC to formally notify BioZone Labs that Matrixx is handling the Product Recall and will require BioZone Labs to reimburse
Matrixx for all costs and expenses related to the Product Recall. Preliminary estimates of the damages related to the Product Recall range from
$1 million to $3 million.
We recorded a charge of $2,000,000 for the cost of reimbursing Matrixx for the expense of the Product Recall. We have paid Matrixx a total of
$579,197, the balance remains due and owing.
23

otcmarkets.com

[StockDung] Itonis Pharmaceuticals signs distribution deal with Hensley Brothers PBR Staff...

StockDung — 7/29/2013 8:32:00 PM

Itonis Pharmaceuticals signs distribution deal with Hensley Brothers

PBR Staff Writer Published 22 July 2013

Itonis Pharmaceuticals, a new division of Itonis, has announced the distribution of the company's line of homeopathic products by Hensley Brothers Distribution in retail chains.

Commenting on the deal, Itonis Pharmaceuticals head and inventor of Zicam cold remedy Charles Hensley said, "Emesyl will be the first of several products to enter the national retail supply chain and the domestic distribution focus is on the big box retail chains."

The company's nausea relief product, Emesyl, is to be manufactured by Oasis Health Products.

Itonis Pharmaceuticals is focused on creating and marketing over-the-counter and prescription homeopathic products that better people's lives.

[StockDung] HOMEOPATHY THE ULTIMATE FRAUD. [graphic]

StockDung — 7/2/2013 11:54:19 AM

HOMEOPATHY THE ULTIMATE FRAUD.