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


To: Sir Auric Goldfinger who wrote (4182)1/2/2003 1:53:38 PM
From: StockDung  Respond to of 5582
 
THE QUIGLEY CORPORATION - CORPORATE PROFILE

A Randomized, Double-Blind, Placebo-Controlled Study

Sherif B. Mossad, MD; Michael L. Macknin, MD; Sharon V. Medendorp, MPH; and Pamela Mason, BSN, MBA


coldeeze.net



To: Sir Auric Goldfinger who wrote (4182)1/2/2003 2:14:03 PM
From: StockDung  Respond to of 5582
 
By Bill Alpert=>Cold Reality:A conspiracy? Or is there no cure after all for common cases of the
sniffles?
By Bill Alpert
06/29/1998
Barron's
Page 22
(Copyright (c) 1998, Dow Jones & Company, Inc.)

Corrections & Amplifications

The June 29 "Cold Comfort" article mentioned a Quigley conference call
containing a testimonial from a speaker identified as "with Individual
Investor magazine." That identification -- made by the conference call host
-- was incorrect, according to Individual Investor, which says no employees
were on the Quigley call. (Barron's July 6, 1998)

Quigley 's zinc lozenges were the "first and only product clinically proven"
to stop a cold. Until last week. That's when the Journal of the American
Medical Association reported a study showing the lozenges had no effect on
common colds in almost 250 children and teens. The conclusions were
surprising, coming as they did from the same Cleveland Clinic Foundation
researchers who'd held up a bag of Quigley Cold-Eeze two years ago and said
the product had more than halved the time the average adult spent in a
cold's clutches.

That first study (Barron's, January 13, 1997) made the fortune of the
obscure Nasdaq-traded firm's CEO and founder, Guy J. Quigley . Before the
July '96 appearance of the peer-reviewed report, Quigley had never made a
dime's profit hawking zinc from a converted church in Doylestown,
Pennsylvania.

But with the Cleveland Clinic findings, drugstores couldn't meet demand for
the cold aid that ABC's 20/20 medical correspondent called "the only one
that works." Howard Stern and Rush Limbaugh announced themselves Quigley
suckers. They were in good company. Little Quigley 's sales surged to $70
million in 1997, with earnings of $1.43 a share, and its shares catapulted
from pennies to $23, adjusted for splits.

Quigley 's founder became a rich guy -- with stock, options and warrants
worth over $75 million, not to mention 1997 compensation of $3 million in
hard cash. The Wall Street hoopla unleashed by the '96 report also enriched
the Cleveland Clinic researchers, a pediatrician and an epidemiologist who
received Quigley stock during their analysis of the data from the study.

Beginning in October 1997, however, Quigley shares began to sputter. To
blame, perhaps, were 1997's June- and September-quarter sales that trailed
the March quarter's $22 million blowout. Maybe it was saber-rattling by
Warner-Lambert, which promised a line of Hall's Zinc Defense lozenges for
the winter of 1997-98. Or maybe it was El Nino.

Whatever the cause, Quigley 's stock fell to around $10 a share by this past
April, when the company warned that March '98 sales would come in at only
$7.2 million, versus $22 million a year earlier. Guy Quigley took just pride
in outselling Hall's and dozens of other zinc copycats, but added that a
warm winter and mild cold season had hurt ColdEeze.

Far heavier was last week's blow -- the study of zinc lozenges on 249
schoolchildren with colds. The authors included Dr. Michael L. Macknin, the
pediatrician who published the Cleveland Clinic's first report, and Dr.
Ellen R. Wald, a University of Pittsburgh investigator renowned for her
studies of childhood infections.

Over the winter of '96 and '97, the researchers enrolled children within a
day after the youngsters showed cold symptoms and randomly assigned them to
receive up to six daily doses of either a placebo or Quigley lozenges.

In contrast to the 1996 study, which found a 42% abbreviation of colds in
zinc-treated patients, the new study found no meaningful difference between
zinc and placebo groups, in terms of time spent sniffling and coughing. In
both the zinc and the placebo groups, half the children were free of their
cold symptoms in about nine days.

There were differences in the studies. For one thing, the lozenges in the
children's test contained 10 milligrams of zinc, versus 13.3 in the adult
study and in commercial Cold-Eeze. But considering the smaller size of
children's' bodies, the zinc exposure was about the same.

Seasonal differences in virus strains also might have figured in the
results. And obviously, the age groups in the studies weren't the same.

No single medical study is definitive, and an editorial accompanying the
JAMA report looked forward to others, of children and adolescents. But the
JAMA senior editor who supervised the report, Dr. Phil Fontanarosa, says the
design and analysis of the children's study showed unusual care.

To better ensure that the kids actually took their zinc, for example, school
nurses administered three of each day's doses. "It's almost a directly
observed study," says Fontanarosa. "Normally, you just give a person a pill
bottle and count the pills when they bring it back."

However, in two press releases Quigley called the study "bad science" and
alleged 129 violations of the agreed-upon protocol. Kids swallowed other
kids' lozenges, said the company; children with no cold at all -- or with
strep throat, asthma or flu -- were allowed in the trial. All told, claimed
Quigley , 83 of the 249 participants shouldn't have been considered.

In a conference call with investors, a furious Guy Quigley said the firm's
lawyers had brought his concerns to the AMA Journal at least two months
before publication and the publication told them to "get lost." He said he
couldn't understand why the Cleveland Clinic's independent review board had
approved the study's protocol.

Indeed, he hinted darkly that the article was part of some sort of
conspiracy against his corporation, led by shortsellers and competitors. "We
really have had an awful lot of pressure," Quigley asserted, "from some
exceptionally large pharmaceutical companies that our product seems to be
hurting."

Why would the Cleveland Clinic set out to debunk zinc? With a telephonic
flourish, Quigley disclosed that on September 25, 1996, he had received a
draft proposal from the famous institution seeking a royalty on Cold-Eeze
sales in compensation for the work leading to the original 1996 Annals of
Medicine report that zinc worked. "We refused," said Quigley , "which leads
us to wonder why this threering circus is going on."

Macknin, who the JAMA article said still owns 20,000 Quigley shares, isn't
talking. Dr. John Clough, the Cleveland Clinic Foundation's spokesman, says
he's not sure who initiated royalty discussions. But the clinic never would
have approved such an agreement, he insists.

As for Quigley 's dissatisfaction, Clough says that shortly after the
children's study had begun, the company requested changes to the protocol.
Researchers from the Cleveland Clinic successfully argued for finishing the
study already under way.

Through the rest of the study and even during Quigley representatives'
visits to Cleveland, says Clough, the company made no further complaints --
until the study's results became clear, that is.

"The clinic would have been very happy to see this be a positive trial,"
says the spokesman. "But it's not a question of how you wanted it to come
out; it's how it came out, and that's what got reported."

JAMA never discussed Quigley 's concerns with the firm, says editor Phil
Fontanarosa, because the journal discusses unpublished papers only with
authors and reviewers. But he says Quigley 's pre-publication complaints
were taken "very, very seriously."

Quigley 's criticism prompted added review of the study by experts outside
the Clinic, says Cleveland's Clough. As a result, the report analyzed
separately the set of students who adhered closest to the protocol. Still,
that group showed no association between zinc and cold duration.

A confident Quigley Corp. announced a 500,000-share stock buyback last week,
along with the intention of finding another center to properly study zinc.
And in his conference call, Guy Quigley talked happily of such new
initiatives as sugar-free lozenges and marketing through the popular Yahoo!
Internet site.

A scientific halo certainly doesn't matter to a lot of Quigley fans, who
filled the conference call with zinc testimonials; one came from a fellow
who said he worked for Individual Investor magazine.

Outside shareholders of Quigley impatiently wait to see if the next
common-cold season lifts the shares from their malaise. So do Guy Quigley
and the other officers and consultants who have registered for sale some 5.5
million shares' worth of options and warrants -- most exercisable at $2.50
or less.



To: Sir Auric Goldfinger who wrote (4182)1/2/2003 2:16:34 PM
From: StockDung  Respond to of 5582
 
Cure for the Common Cold? As Quiqley shares soar, questions arise
About medical studies, shady associates
By Bill Alpert
01/13/1997
Barron's
Page 18
(Copyright (c) 1997, Dow Jones & Company, Inc.)

With much of America covered in snow and seemingly half the folks in the
Northeast sniffling on these blustery winter days, it may be appropriate
that one of the hottest stocks trading on the NASD's bulletin board is
Quigley Corp., a little outfit that offers a cure for the common cold. In
just the past seven months, Quigley shares have risen from 62 cents to as
high as $37, making for a gain of nearly 6,000%. Almost half of that gain
came in the past week, giving the tiny Doylestown, Pa., company a market
value of about $250 million.

Quigley 's shares began to surge last summer after the company's product, a
zinc lozenge called Cold-Eeze, was found to shorten the duration of cold
symptoms by 42% for patients who took it. Those findings, in a study
performed by the Cleveland Clinic Foundation in Ohio, were followed by
laudatory stories on Good Morning America and CNN, as well as in USA Today
and a host of local newspapers.

The ensuing demand from the nation's sneezers has been phenomenal.
Walgreen's and Revco have ordered millions of dollars' worth of Quigley 's
lozenges, and for the most part they are being forced to wait while Quigley
ramps up production.

The gush of orders is a long-awaited tonic for Quigley , which for the
fiscal year ended September posted a loss of $694,000 on revenues of $1.05
million. And even those scanty sales were a leap above the previous year, in
which Quigley reported a loss of $150,000 on revenues of $502,000.

As you might expect, Quigley 's "breakthrough" has inspired considerable
controversy. Noted common-cold researchers question the validity of the
Cleveland study, as well as a study done several years earlier at Dartmouth
College. Investors who sold Quigley shares short, noting that a considerable
number of people connected to Quigley have less-than-pristine Wall Street
histories, have been clobbered. Yet Barron's research indicates that a
chilling number of those involved in boosting Quigley shares have been
censured, barred or jailed by securities authorities for stock fraud.

The more jaded of Quigley 's backers argue that it matters not that the
company's science or its associations may be questionable. The fact is, the
public right now is beating down the doors to get Quigley 's zinc lozenges,
and that can't help but send Quigley 's profits skyward.

Whatever Quigley 's zinc pills have done for cold sufferers, they have made
a happy man of the company's founder, one Guy Quigley . His shares in the
company are now valued at about $40 million. Quigley had one of his first
entrepreneurial adventures in the 1970s in Northern Rhodesia, now known as
Zambia. Quigley says he helped black herdsmen market their beef, gaining
them a bigger share of a market that was dominated by white ranchers.

When revolution drove him to seek safety in the U.S., Quigley says he then
became the first to import "resemblance perfumes," the high-falutin' term
for reasonably-priced knockoffs of famous fragrances. In 1989, he started
Quigley Corp., with the goal of marketing health-food snacks called GQ Alpha
I nutri-bars. He hired as his operations chief Chuck Phillips, a one-time
gemcutter who had also spent several years in Africa until civil war forced
him back to the States.

But the young company learned that profits, and even sales for that matter,
were hard to come by. Despite endorsements by paid advisers like Benihana
Restaurants' founder Rocky Aoki, NFL veteran Joe Klecko and the world's best
"one-club" golfer (who broke par with only a 5 iron), Quigley 's sales were
just $36,000 as recently as the year ended September 1993. The firm lost
$220,000.

"We were up against stiff competition that we couldn't override," says
Quigley . "We didn't have the advertising dollars."

The company had hardly any dollars. The two men drew no salaries, and after
a 1991 public offering of 15-cent units, the firm used stock, stock options
and warrants to pay for advertising, legal services, rent and sales
representation.

But in '92, Quigley cut a licensing deal with some researchers with a patent
on zinc lozenges for treating symptoms of the common cold. Chemist John
Godfrey and his wife, Nancy, had helped conduct a study with 73 people at
the Dartmouth College Health Service. Their report, in a European medical
journal, said that by sucking on the zinc lozenges, cold sufferers ended
their symptoms 42% sooner.

In July 1996, the medical journal Annals of Internal Medicine published
results of another study of Quigley 's zinc remedy, this one performed at
the Cleveland Clinic. Somewhat larger than the earlier Dartmouth study, and
better controlled, the Cleveland Clinic research showed the same dramatic
impact on colds, with the zinc takers freed of cold symptoms 42% faster than
placebo takers.

That's when the press whirlwind picked up Quigley , his company and his
stock. Purchase orders have piled up. On Dec. 26, Quigley had $7.5 million
of outstanding purchase orders, according to the firm's 10K report. Just
five days later, purchase orders had topped $11 million, according to a
press release in which the firm predicted December-quarter revenues of $3.9
million and finally some earnings, to the tune of $1.8 million, or 30 cents
a share.

As Quigley shares have kept rising, the market makers who've shorted them
have been sledgehammered. One of the biggest hammerers was Jerry Rosen, an
Aventura, Fla., trader for a Los Angeles firm, J. Alexander. An aggressive
buyer of the shares, Rosen frequently called traders that he thought were
short Quigley , delivering Wall Street's version of trash talk. "I hope your
cattle die," he told a Texas market maker. "I hope you get hoof-and-mouth
disease!" Rosen taunted another short-seller: "Get everybody you want to
start shorting the stock. But when you start shorting a stock that has a
cure for the cold, man, good luck, you're on your own!"

Personal experience and testimonials can ensure strong demand for
non-prescription remedies like antihistamines or Cold-Eeze, whether or not
the products work. But the lead author of the Cleveland Clinic zinc study,
Dr. Michael Macknin, warns that testimonials "approach being worthless,"
when it comes to a self-limited illness like the cold, where symptoms are
remarkably subjective and can resolve by themselves after a day.

Quigley 's Internet World Wide Web page, to be found at www.quigleyco.com,
says the reported medical studies on Quigley 's zinc lozenges completely
meet the stringent criteria of scientific proof of the scientific community.
Yet Macknin is less sure. "We only studied 100 patients, during a one-month
period of time, in one location, in one institution," says Macknin, who
chairs the Clinic's pediatrics department. "What if the one virus going
around the Cleveland Clinic that month was unusually susceptible to zinc?"

Although half of all colds are caused by a rhinovirus, over 200 different
viruses can bring on a cold. Unlike other cold studies, the Cleveland trial
didn't test subjects to identify viruses, nor did it measure improvement
objectively, by weighing tissues, for instance.

That said, Macknin says his statistical analysis shows that odds are less
than one in 1,000 that the large reduction in cold symptoms of his zinc
recipients resulted from chance and not the zinc. Macknin was surprised at
such strong results, because a series of earlier zinc studies had found that
zinc had no effect on colds.

The leader of the most rigorous of those studies was Dr. Jack Gwaltney, head
of epidemiology and virology at the University of Virginia Health Sciences
Center. And Gwaltney has major criticisms of the Cleveland study's design.
Gwaltney doubts the Cleveland subjects were successfully kept in the dark as
to whether they got the zinc lozenge or a calcium lactate placebo. Unlike
earlier zinc studies, the Cleveland researchers didn't do pilot studies to
ensure their placebo seemed similar to the real zinc lozenges. Indeed,
Macknin's team reported that their placebo tasted less astringent and bitter
than the zinc product, and had less of an aftertaste. The placebo group also
lodged significantly fewer reports of nausea and bad taste.

Zinc patients who saw through the masking might report that they felt
better, even if objective measures would have showed otherwise. Dr. Robert
Betts, a cold researcher at the University of Rochester, notes that a
profound "placebo effect" led patients in other studies who thought they'd
gotten Vitamin C to report sharp improvement in their colds, even though
they'd gotten a placebo.

And statistical claims showing 1,000-to-1 odds against getting a result like
the Cleveland study, based on chance alone, notes Gwaltney, don't address
the question of whether the patients saw through the blinding and biased
their reports.

Barron's own research into various business associates that have helped
Quigley Corp. in the public markets also raises questions of chance
association. Guy Quigley concedes meeting with Raphael D. Bloom, a disbarred
stockbroker who already had a 20-year history of disciplinary sanctions
before he was convicted in 1989 of mail fraud, stock fraud and perjury for
manipulating the stock of a car dealership, along with a Chicago organized
crime figure, Sam Sarcinelli. Quigley says that Bloom introduced Quigley
Corp. to a firm Quigley hired as its financial and public-relations adviser,
a Florida outfit called Diversified Corporate Consulting Group.

"Bloom never received one penny from us," says Quigley , an answer that's
echoed by Bloom himself from the office near Wall Street where he now works
as a financial consultant and the operator of an employment agency.

Diversified Corporate Consulting, however, is interesting in its own right,
because its managing member was William A. Calvo III, a securities lawyer
disbarred in Florida, New York and the federal courts after the SEC won a
suit charging him with aiding and abetting a scheme that employed sham loans
to complete a stock offering. Calvo also did securities lawyering for the
convicted swindler James Anthony Laiacona.

For Quigley , Calvo's firm recruited the financial public-relations firm
Carousel Consultants, of Kingston, N.Y. Carousel is staffed by a former
stockbroker, Joseph Radcliffe, and his son Michael. After a career at
notorious brokerage firms like Blinder Robinson, Greentree Securities and
Prestige Investors -- where he partnered up with raging Quigley bull trader
Jerry Rosen -- Joe Radcliffe started a public company called Madison Sports
& Entertainment. Madison earned attention, but never profits, claiming
interests in snowboard companies and boxing. Now, Madison's stock is one of
a dozen whose trading is the subject of a federal grand jury inquiry in
South Florida.

For some reason, Pennsylvania-based Quigley has used as its outside auditor
Nachum Blumenfrucht, of East 22nd St., Brooklyn, N.Y. Blumenfrucht was the
auditor for the notorious stock promoter Phil Abramo.

Quigley Corp.'s securities lawyer in its first years as a public company was
Abramo securities lawyer, Barbara R. Mittman, who practiced with now banned
lawyer Edward Grushko, well known by regulators for his work with Calvo
client Laiacona, as well as convicted stock swindlers like Thomas Quinn,
Arnold Kimmes and Benjamin Sprecher.

Quigley denies he knew of these people's records when he fell in with them,
and he adds that he's dropped Diversified and Carousel.

With Quigley shares trading around $31 on Friday, short-sellers were
complaining that the stock was being squeezed higher by bullish
market-makers who were refusing to let short-sellers buy shares to cover
their losses.

But don't expect Quigley 's stock to levitate forever. On Friday morning the
Miami office of the SEC sent out letters asking market-makers for all their
records on trading in Quigley shares.
***
Article 4 of 10
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To: Sir Auric Goldfinger who wrote (4182)1/2/2003 2:18:53 PM
From: StockDung  Read Replies (1) | Respond to of 5582
 
A Slight Chill: Quigley quivers on sale By Bill Alpert

02/03/1997
Barron's
Page 15
(Copyright (c) 1997, Dow Jones & Company, Inc.)

A chill ran through shares of Quigley Thursday, after the cold-cure firm's
chief outside medical investigator filed to sell 10,000 shares. Dr. Michael
Macknin, chairman of the Cleveland Clinic Foundation's pediatrics
department, was lead author of a controversial study published last summer
that claimed Quigley 's zinc lozenges cut colds' duration by 42% ("Cure for
the Common Cold?" Jan. 13). He's also involved in a follow-up study.

Quigley shares, which split 2-for-1 in January, fell 10% to around 11, on
Macknin's report that he would sell the shares for his children. So-called
Form 144 reports may be filed simultaneously with a sale. Macknin didn't
return calls from Barron's seeking comment.

Last summer's report in the Annals of Internal Medicine didn't disclose
Macknin's Quigley stake. Quigley says Macknin bought his children's shares
in a '94 private placement, along with other restricted shares for himself.
In March 1996, moreover, Macknin got options to buy 10,000 shares at $1
each. The stock closed Friday at 10 5/8.