This appears in USA Today ...
(I don't know anything about this product - but it continues the
push of pharma to ban non-FDA approved items which isn't good ...)
Homeopathic medicine company fights off Zicam lawsuits
By Ken Alltucker, The Arizona Republic
Consumers across the country have alleged in more than 400 lawsuits
filed in courts and complaints logged with federal regulators that
Zicam nasal gel, meant to relieve cold symptoms, has destroyed or
diminished their sense of smell or taste.
Some consumers and experts say the controversy shows there hole in
the government's oversight of homeopathic products such as Zicam.
Zicam's manufacturer, Phoenix-based Matrixx Initiatives, says its
Zicam medicines are safe and that it has research to back it up.
Matrixx settled a batch of 340 lawsuits for million in January
2006, court and SEC documents show. The company did not admit fault.
Since then, Matrixx has fought off more lawsuits using a panel of
medical experts and piles of scientific evidence.
Matrixx representatives say the controversy over Zicam boils down to
one Colorado doctor, who first publicly linked Zicam to smell loss,
and lawyers out to make a quick buck. Since September 2006, six
federal courts have tossed out expert testimony from the doctor,
Bruce Jafek, a University of Colorado School of Medicine ear, nose
and throat specialist.
Companies that sell homeopathic products are not required to go
through the same rigorous approval process and government-vetted
clinical trials that pharmaceutical companies must complete before
the Food and Drug Administration will allow them to make a
prescription drug available for public consumption.
The FDA has received more than 200 complaints from consumers about
Zicam gel, which is sold over-the-counter.
The agency, which must deal with urgent public health issues such as
the contaminated toothpaste ingredients from China, recalls only few
over-the-counter products. For example, it banned the nutritional
supplement ephedra in 2004 after it was linked to increased blood
pressure and irregular heart rhythm.
"I don't know of any immediate action on Zicam," said FDA
spokeswoman Sandy Walsh.
David Richardson, a packaging equipment salesman in Greensboro, N.C,
wants the FDA to require an independent study of the safety of Zicam
gel, which uses a long, narrow nozzle to pump zinc gluconate into
the nose.
Richardson first tried Zicam two years ago when he wanted quick
relief from a cold. A few days later, he noticed that scents seemed
distorted. Even strong odors, such as gasoline, had a metallic
scent. He also said he lost his sense of taste as the two senses are
linked.
"This has changed my whole life," Richardson said. "Heaven forbid
some mother gives it to her 6-year-old kid."
Matrixx Initiatives did million in sales last year, making most
of its money from sales of Zicam-branded products, which include the
nasal gel, swabs, a spray and pills.
The company woos consumers with its slogan, "Better ways to get
better," and sells cold and cough, allergy, and sinus medications at
chain retailers such as Wal-Mart, Walgreens and CVS. Matrixx also
has touted its products in radio and television ads featuring talk-
show personality Rush Limbaugh and customer testimonials.
But in 2003, Jafek reported in a medical conference on 10 cases of
smell loss linked to use of zinc gluconate. Other doctors followed,
including Terrence Davidson, director of the University of
California-San Diego Nasal Dysfunction Clinic.
It had long been known that zinc could harm nasal tissue when
administered in high enough doses. Jafek and others theorized that
the force of the Zicam gel pump could deliver toxic doses of zinc
and damage sensitive nose tissues. Some patients probably sniffed
the zinc after applying the gel in their nose. That, in turn,
triggered loss of smell.
After the lawsuits began trickling in, Matrixx commissioned its own
panel of doctors and scientists. They reviewed existing scientific
literature and concluded there is no evidence that a zinc-based
nasal gel such as Zicam can lead to smell loss.
The company-hired experts conducted studies on the incidence of
smell loss in the general population, the impact of a zinc gluconate
gel on mice and whether the Zicam gel pump could reach sensitive
smell tissue in cadavers. They concluded that the most likely cause
of smell loss is the cold virus itself, sinus problems or nasal
injury.
"The company is satisfied the product is safe," Matrixx spokesman
Rob Murphy said.
Jafek said he remains concerned about the effect of zinc in the
nose: "I have done the best I can to alert the scientific community
of this problem so that we can prevent other patients from suffering
avoidable loss of smell."
I do not know ... but I would sure resent permanently losing my sense of smell!
I do think the approval process needs to be examined closely though.