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Biotech / Medical : GUMM - Eliminate the Common Cold -- Ignore unavailable to you. Want to Upgrade?


To: Sir Auric Goldfinger who wrote (3159)11/8/2000 6:41:35 PM
From: StockDung  Respond to of 5582
 
FOOL ON THE HILL: Quigley's Cold-Eeze Questioned
~~~~~~~~~~~~~~~~~~~

The saga of Quigley Corp.'s (Nasdaq: QGLY) Cold-Eeze zinc gluconate glycine (ZGG) lozenges took another turn yesterday as a new study published in today's Journal of the American Medical Association (JAMA) found that a lower-dose version of the lozenge didn't provide any benefits to children. The news wasn't a total surprise, as CEO Guy Quigley had made comments in a May 1 conference call and at the May 8 shareholders' meeting indicating that there were some problems with the study. Nonetheless, the stock dropped $1 3/8 to $7 1/2 on the bad news yesterday. The stock was unchanged today as the company attempted some damage control, announcing an additional 500,000 share stock buyback.

The JAMA article, though, poses new problems for Quigley, which has seen Cold-Eeze continue to dominate the zinc lozenge market it created, despite rather massive ad spending by Hall's for its Zinc Defense zinc acetate lozenge. After all, the power of the Cold-Eeze brand has depended on the fact that a clinical trial conducted by the Cleveland Clinic's Dr. Michael Macknin and published in the respected Annals of Internal Medicine (July 15, 1996) showed that adults taking the standard Cold-Eeze formulation (with 13.3 mg of ionic zinc) had experienced a 42% reduction in the duration of cold symptoms.

Those results were in line with an earlier study conducted at Dartmouth College by ZGG patent-holder Dr. John Godfrey. That study used ZGG lozenges with a high level of zinc (23.7 mg). These trials allowed Quigley to make the unique claim that its patent-protected zinc formulation had been "clinically proven" to reduce the duration and severity of the common cold.

While an accompanying editorial in JAMA notes that the new study "by no means closes the door on zinc gluconate lozenges," this study will inevitably reinforce doubts about whether Cold-Eeze really works. The irony here is that the new trial was also led by the Cleveland Clinic's Macknin and funded by a grant from Quigley Corp. Macknin had been attacked for his original study because he had acquired stock in Quigley after analyzing the trial results (he still holds 20,000 shares). A later Annals editorial indicated that Macknin had disclosed this financial interest when he submitted the manuscript but that the editors determined it was not necessary to disclose this information in the published text.

Nonetheless, the episode led to much public discussion about potential bias in scientific research and considerable skepticism about the Cleveland Clinic's results. For his part, Godfrey offered his own re-analysis of these trial data. He argued that if data from 16 of the 99 patients who violated the study protocol were excluded, the results would have shown an even stronger 48% shortening of the duration of the common cold (see Alternative Therapies, November 1996).

The children's study involved 249 students grades 1-12 taking a 10 mg ZGG lozenge or placebo either 5 or 6 times a day. Three lozenges a day were administered by study personnel at the school, with the students expected to take additional doses themselves in the evening and on weekends. Though nearly half of the students in each group reported taking more doses (median of 6) than could be verified by the actual lozenge packages, the researchers deemed overall compliance (88.8% median) to be good. Moreover, students in the ZGG group who adhered better to the protocol did not show a significant reduction in the duration of their colds. Children on zinc did miss fewer days of school (59 days vs. 32), but that difference was not statistically significant.

For the elementary grade students, colds lasted a median of 9 days for the placebo group and 8 days for those on ZGG. For the older students, the median time to the resolution of all cold symptoms was 8.5 days for the placebo group and 9.5 days for those taking ZGG. These results revealed no significant benefits of this lower dose ZGG formulation. Meanwhile, as in previous studies, those on zinc experienced higher rates of adverse effects, such as bad taste reaction; nausea; discomfort of the mouth, tongue or throat; and diarrhea. They were also more likely to guess correctly that they were taking the zinc lozenge.

Although the researchers speculate that the lower dose level or compliance issues may have led to the negative results, they ultimately dismiss these concerns. A more likely explanation is that Cold-Eeze may only be effective against rhinoviruses. Some 200 viruses can cause the common cold, but rhinoviruses are the most frequent cause. Yet they are more likely to strike in the beginning or end of the cold season -- precisely when the earlier two trials showing benefits of the ZGG formula were conducted. The children's trial, however, took place throughout the cold season (from October 7, 1996 through March 13, 1997). Macknin's team notes that "rhinovirus almost certainly would not have been the predominant virus isolated throughout this entire study." The matter of how zinc might work against colds has been studied most closely by Godfrey. He has argued that zinc ions fit into the surface of rhinoviruses, blocking them from entering cells. The children's study, then, may actually support Godfrey's hypothesis of how Cold-Eeze works.

For its part, Quigley has come out swinging. CEO Guy Quigley called the study "bogus" and said that JAMA had been "equally irresponsible" in publishing the findings despite being supplied by Quigley Corp. with information detailing "the bad science" practiced by the Cleveland Clinic. The company charged that the study included children who had never had a cold; subjects who had a cold for longer than a week before entering the study; subjects who had verified secondary infections, including strep throat, or who had the flu; and 29 subjects with asthma. Also, many of the children also took other cold medicines. Quigley argues that 83 of the 249 students should have been excluded from the data.

The published results don't appear to offer clear evidence regarding some of these claims. Still, it appears that only two children (one on placebo, one on ZGG) didn't have colds on entry. (They didn't want to miss out on the fun, apparently.) Meanwhile, at least 17 of the asthma subjects were in the placebo group, which, if anything, should have worked in favor of a positive finding for ZGG.

Quigley said it plans to repeat the study at a different institution and both Macknin's group and JAMA have called for additional clinical trials. In the meantime, Quigley shares held up fairly well, though they are still off considerably from the $13 level reached in mid-May following the company's move to the Nasdaq National Market and a deal with Yahoo! (Nasdaq: YHOO) to market Cold-Eeze over the Internet.

Given that a weaker-than-expected first quarter has left it with high inventories and new filings indicate insiders may still be selling, Quigley needs to show it can accomplish as much during Cold-Eeze's third year in the big leagues as it did during its first two seasons, otherwise its stock isn't going anywhere. Skeptics wonder, for instance, what ongoing annual sales will amount to now that inventory is on the shelves. The story remains interesting, though, because despite many reasons for caution, Quigley's is a highly profitable business, and the company had around $2 a share in cash and no debt at the end of March.

Related articles:
-- The Quarrel Over Quigley (2/17/97)
-- Quigley Warms Up (2/18/98)

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To: Sir Auric Goldfinger who wrote (3159)11/8/2000 6:44:21 PM
From: StockDung  Respond to of 5582
 
Subject: My story
Date: 9/29/98 10:09 PM Eastern Standard Time
From: Katenjeff1
Message-id: <19980929230902.22796.00004440@ng75.aol.com>

I sold Quigley when it was at around 11 1/4. I used to read the message board on a daily basis but haven't in a few months. It's interesting to see that the same stuff is being written now as when I owned the stock. Advertising, stock buyback, etc. The bottom line to me is "am I making money?" On 10-10-97 Quigley was at 22 per share. During the "busy" time meaning the winter Quigley continually dropped. By the beginning of June it was under 10
dollars and hasn't seen double digits for any period of time since. I realize that the summer months are slow but what happened during last winter? I'm glad that people think that the stock has held up well during the downfall of the market but remember that it didn't go anywhere while the market was going up, up, and away.
Don't get me wrong. Nobody believes in the product more than me. It was the first time in my life that anything actually helped minimize my cold duration. That's why I bought the stock in the first place. The problem now is that the word is out about zinc and unless the public is specifically told about Cold-eeze they will continue to go to the local pharmacy and buy anything that says "zinc".
Well, that's it from me. I just felt compelled to say something since at one point I was a part of the message board. Good luck to all and Viper, I commend you for your loyalty to Quigley. Just don't get left "out in the cold"
Jeff



To: Sir Auric Goldfinger who wrote (3159)11/8/2000 7:03:48 PM
From: StockDung  Read Replies (3) | Respond to of 5582
 
The Quarrel Over Quigley part 1

Rogue Missives fool.com
Friday, January 31, 1997

The Quarrel Over Quigley
by Louis Corrigan (RgeSeymour)

QUIGLEY CORP. (OTC: QGLY) is a bulletin board high-flyer that markets Cold-Eeze, a zinc gluconate-glycine lozenge which advocates claim has an anti-viral effect on the human rhinovirus, the most common cause of colds. The veracity of this claim is something which remains hotly contested to this day, and there has also been more than a little debate over the legitimacy of the company and its associates.

On January third, Rogue reporter Louis Corrigan (RgeSeymour) brought you "Quigley: A Real Cold Cure?", wherein the clinical evidence was examined, and the debate over the efficacy of the product was presented through interviews with many of the principal researchers. One week later, the television show 20/20 presented its own segment on Cold-Eeze, a glowing report which left Quigley bulls cheering.

Their celebration was not destined to last for long, though, as Barron's printed a scathingly bearish view of the company the very next day. The article raised questions about the legitimacy of the company and its associates. A number of other articles have since appeared in various media outlets, most recently in The Washington Post. Today, Rogue brings you an in-depth look at many of the questions raised about the company, the stock, and Quigley's financing efforts. For the story, Rogue contacted Quigley's general counsel, an outspoken market-making bear, Quigley counsultants, and a securities firm that bears say ran nominee accounts for people close to the company. While the verdict is far from being in on Quigley, Rogue presents some interesting accounts of the activity surrounding the company, and answers some lingering questions.

Barronized

For every person who likes to tell a great story, there's often someone else who likes to ruin it, or at least give it a tragic twist. Investors following the saga of highflyer QUIGLEY CORPORATION (OTC Bulletin Board: QGLY, formerly QUIG) were treated to just such a double dose of conflicting media attention three weeks ago. It's worth asking exactly which version of the story sounds right.

On Friday, January 10th, ABC's 20/20 news magazine featured a lengthy segment celebrating the company's Cold-Eeze lozenges as one of the only cold remedies that actually works. Dr. Michael Macknin, the lead author of an important double-blinded trial conducted at the Cleveland Clinic, was shown saying he got goosebumps when he first realized how positive the Clinic's trial results were. After watching this glowing broadcast, investors were no doubt left with goosebumps of their own -- until they checked out the next day's Barron's.

In a two-page article, reporter Bill Alpert wielded the oft-bloody Barron's hatchet. First Alpert chopped up the science supporting the company's claims for Cold-Eeze. Macknin reappeared, this time as a clinician so full of caution that he now seemed nearly to disbelieve his own findings. He said that the clinic's trial was conducted on just 100 patients in the same city during just one month. Who's to say that the researchers didn't just get lucky in finding one virus -- of the more than 200 than can cause a cold -- that was incredibly susceptible to Quigley's zinc gluconate-glycine lozenges?

Then there were lingering questions from cold experts, such as the University of Virginia's Dr. Jack Gwaltney. Had the trial subjects been adequately blinded about whether they were receiving the zinc lozenge or a placebo? Any such bias could completely undermine the trial results. Since Alpert included no response from Macknin about this important concern, a reader was left to think that the clinician had no adequate response to Gwaltney.

Still, Alpert saved the real dirt for last. In the final nine paragraphs, the Barron's piece laid out an astonishing web of people "censured, barred or jailed by securities authorities for stock fraud" who have had, or still have, connections with Quigley Corp. The article ended with the kind of knowing comment Barron's loves to issue: trading in Quigley stock was now under investigation by the Securities and Exchange Commission (SEC), so investors shouldn't expect the stock to "levitate" forever.

Specifically, Alpert reported that Raphael D. Bloom, a disbarred stockbroker convicted in 1989 of stock fraud, had introduced company Chairman and CEO Guy Quigley to a financial consulting and public relations firm called Diversified Corporate Consulting. The "managing member" of Diversified is William A. Calvo, III, a securities lawyer who was disbarred in Florida state court, and later in Federal Court, for his participation in a fraudulent public offering. Diversified, in turn, introduced Guy Quigley to another public-relations firm, Carousel Consulting, run by former stockbroker Joseph Radcliffe who has had a career "at notorious brokerage firms."

In addition, the financial weekly reported that Quigley's Brooklyn-based auditor Nachum Blumenfrucht "was the auditor for the notorious stock promoter Phil Abramo." A key subject in the recent Business Week cover story about the Mob's activities on Wall Street, Abramo is reportedly identified in court documents as a capo in the De-Cavalcante crime family. He has just begun serving a one-year prison sentence for tax evasion. Barron's also reported that Quigley had previously employed the securities lawyer Barbara R. Mittman, who also once worked for Abramo. Mittman practiced law with another now disbarred attorney, Edward Grushko, who conducted work for some of the more spectacular stock swindlers of recent years, including Thomas Quinn and Arnold Kimmes.

This schizophrenic one-two media punch left investors reeling. On the one hand, the 20/20 segment strongly suggested that cold sufferers would be better off if retailers simply cleared away the palliatives that now dominate the cold remedy market and instead filled the shelves with Cold-Eeze. If Quigley could just increase its manufacturing, virtually any earnings target seemed possible.

The Barron's report, though, was enough to leave a reasonable investor leery of getting anywhere near Quigley. At any moment, it seemed, the SEC could halt trading in the stock. Six weeks down the road, Quigley holders might find themselves happy to cash out at a fraction of what they paid for the stock.

Anticipation of the favorable 20/20 coverage, in combination with short covering, had pushed Quigley's share price from $18 to an intraday high of $37 in the days prior to the broadcast. At that Friday's close, around $30 a share, Quigley had a market capitalization of over $250 million, based on the number of outstanding shares plus currently exercisable stock purchase warrants and options. Even for a company experiencing rapid growth, this was an astonishing figure, since Quigley had merely $1 million in sales for fiscal 1996 and had estimated its first quarter 1997 earnings would come in at $1.8 million, on $3.9 million in sales.

In the days immediately following these conflicting high-profile reports, the stock whipsawed wildly, losing half its value on a drop to the mid-teens before recovering to the mid-20s and then dropping once again. But after a roller coaster ride and a recent 2-for-1 stock split, Quigley recovered to levels seen just prior to being Barronized. Though the stock has drifted lower in recent days, it's still trading about where it did before anticipation of the ABC broadcast sent the stock soaring.

As aficionados of the efficient market theory suggest, share prices always discount the available news about a company. What Quigley's share price is telling us, then, is that market participants are not much worried by the web of intrigue fed to Alpert by the short-sellers who had gotten caught in the squeeze. Uncertainty about the SEC investigation may be weighing on the shares, though some would find that preposterous.

Still, the market doesn't seem to believe that company officials will be implicated if the SEC uncovers trading violations or other criminal actions. Indeed, the company has argued that it's under organized attack from someone, presumably the shorts, perhaps even some market makers, who have undoubtedly lost millions as Quigley's stock has made its improbable ascent from $0.65 a share last April.

In a press release dated January 14th, Guy Quigley said that the "clearly biased and inaccurate portrayal of the company, its management, its medical studies, and its patented Cold-Eeze product" in Barron's was the culmination of a series of attempts to hurt the company and its stockholders. These included "an onslaught of false, misleading and malicious information disseminated through Internet services such as America Online and through anonymous faxes and phone calls to major customers of the Company." The latter claimed that Quigley would be unable to meet its orders.

Quigley officials also said that the Bloomberg News Service picked up two phony press releases sent from a Staples store in New York City on fake Quigley stationery. The first one, sent on December 31st, erroneously claimed that the company's then Chief Financial Officer Eric Kaytes was resigning. (Kaytes was recently "promoted" to Vice President in charge of Management Information Systems. The company named George Longo as the new CFO. Longo has previously worked for KPMG Peat Marwick and Rhone-Poulenc Rorer, Inc., where he handled SEC, IRS, and general accounting issues.)

The other fake press release, on the day of the 20/20 broadcast, indicated that Quigley had made a $10 million "Reg S" private placement of shares to offshore investors at $6.50 a share. An offering at such a deep discount to the market price would have worked as well as a pin would in bursting a bubble.

Quigley General Counsel Thomas F.J. MacAniff told Rogue that the company asked the SEC before Christmas to investigate these criminal disruptions of the firm's business activities. Contrary to the rumored conspiracies, he said that Diversified Corporate Consulting was actually the first party to request that the SEC get involved. "Now that's a classic, isn't it? A conspirator complains to the SEC," MacAniff quipped. He believes that Barron's and other financial media have failed to report this because "it doesn't fit" the story they want to print.

On the other hand, the company's critics, some of whom admit they have lost money shorting the stock, continue to fire away. Some suggest that company officials have been party to a well organized stock rig. They point to Quigley's 1-for-10 reverse stock split of January 1996 as a classic maneuver used to "box" a stock so that it can be controlled by a handful of traders. These critics highlight other factors they say are consistent with a stock manipulation, such as Quigley Corp.'s issuance of millions of new shares and warrants; the professional status of the company's now former auditor Blumenfrucht; or trading conducted for individual accounts held by members of the Bloom and Quigley families and, until recently, managed by the same broker at a small firm called Empire Securities.

The company's critics also make a series of diverse arguments about the legitimacy of the science supporting the Cold-Eeze product, the security afforded by the company's patents, and the company's ability to produce the kind of sales that it has recently reported.

The more one listens to both sides, the more it becomes clear that there are more than two sides to the story. It's even possible to imagine that Quigley may have been set up as a stock rig by parties who never imagined Cold-Eeze might really work or perhaps didn't really care if it did as long as the story sold. It's also possible to imagine that Quigley Corp. is simply under attack by desperate short-sellers who have simply lucked out in finding a cast of shady, but in this case honest, characters connected to the company.

In failing to address the overall accuracy of these diverse accusations, and thus the credibility of the short story overall, the Barron's article presents a potentially misleading perspective. There is, for example, no way for Alpert to know what the SEC investigation will uncover or whether it will implicate Quigley officials in securities violations or harm Quigley's stock. Indeed, there are few better examples of offline hype.

On the other hand, Quigley Corp. does have some past and present relationships that should give investors serious pause. "If someone wants to accuse us of being naive and/or stupid, I can understand that criticism," General Counsel MacAniff said.

But investors' real worry is that company officials may be guilty of more than poor judgment or inadequate due diligence when choosing business associates. A related concern is that Quigley has been issuing stock, stock warrants, and stock options at a torrid pace. Even if these activities are not part of a stock rig, as the company's critics suggest, they do mean that Quigley insiders and certain undisclosed investors have generated some rather astonishing paper profits as the stock has risen, even as other shareholders have seen the value of their shares diluted.