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AP: Zicam Not Alone Among Medicines in Side Effect Reports

June 17, 2009

EDITOR'S NOTE: Alternative remedies don't have to be proven safe
or effective to be sold to consumers, and millions take them. This
is the fifth in an Associated Press series examining their use and
potential risks.
By JEFF DONN
AP National Writer
CAMBRIDGE, Mass. (AP) - The unsettling little secret of Zicam
Cold Remedy finally spilled out this week. Though widely sold for
years as a drug for colds, it was never tested by federal
regulators for safety like other drugs. And that was perfectly
legal - until scores of consumers lost their sense of smell.
One little word on Zicam's label explains all this:
"homeopathic."
Zicam and hundreds of other homeopathic remedies - highly
diluted drugs made from natural ingredients - are legally sold as
treatments with explicit claims of medical benefit. Yet they don't
require federal checks for safety, effectiveness or even the right
ingredients.
They're somewhat similar to dietary supplements, which use many
of the same natural ingredients and also aren't federally tested
for safety or benefit.
Many scientists view homeopathic remedies as modern snake oil -
ineffective but mostly harmless because the drugs in them are
present in such tiny amounts.
But an Associated Press analysis of the Food and Drug
Administration's side effect reports found that more than 800
homeopathic ingredients were potentially implicated in health
problems last year. Complaints ranged from vomiting to attempted
suicide.
In the case of Zicam, the FDA says it tied the drug to reports
from 130 consumers who said they lost their sense of smell.
The agency on Tuesday told Zicam maker Matrixx Initiatives to
stop marketing three products that carry zinc gluconate: Zicam Cold
Remedy Nasal Gel, Nasal Swabs and discontinued Swabs in Kids' Size.
The agency said the drug must be tested for safety and benefit,
like a conventional drug, before it is again marketed. And the FDA
warned people not to use the three Zicam products.
"It never occurred to me they could be dangerous and there was
no kind of oversight - like the FDA - that ensured there was
safety," says former Zicam user David Richardson of Greensboro,
N.C. He has complained to the FDA about losing his sense of smell
and filed his case with a lawyer for a future lawsuit, joining
hundreds of others who have claimed in recent years that they lost
their sense of smell from Zicam cold products.
In its review of homeopathy, the AP also found that:
- Active homeopathic ingredients are typically diluted down to 1
part per million or less, but some are present in much higher
concentrations. The active ingredient in Zicam is 2 parts per 100.
- The FDA has set strict limits for alcohol in medicine,
especially for small children, but they don't apply to homeopathic
remedies. The American Academy of Pediatrics has said no medicine
should carry more than 5 percent alcohol. The FDA has acknowledged
that some homeopathic syrups far surpass 10 percent alcohol.
- 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.
- At least 20 ingredients used in conventional prescription
drugs, like digitalis for heart trouble and morphine for pain, are
also used in homeopathic remedies. Other homeopathic medicines are
derived from cancerous or other diseased tissues. Many are
formulated from powerful poisons like strychnine, arsenic or snake
venom.
Homeopathy sprang from the inventive - some would say fanciful -
mind of German physician and chemist Samuel Hahnemann in the late
1700s. Experimenting on himself, he became convinced that if an
ingredient causes a symptom in a healthy person, it will treat the
disease that causes the same symptom. He also theorized that
diluting ingredients to minuscule, even untraceable, concentrations
paradoxically makes them more powerful.
To this day, homeopaths put forth mystical-sounding explanations
involving "vital force" and "healing energy." And with arcane
ingredients like "nux vomica" and "arsenicum album," many
homeopathic medicines sound like something brewed in a druid's
kettle.
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.
"He did it in such a sneaky way that nobody really noticed or paid
attention," says medical author Natalie Robins.
And that law has remained in force ever since.
Almost reduced to obsolescence in the United States, homeopathic
remedies have revived in recent decades with the burst of interest
in vitamins, herbs and other unconventional treatments. Since 2002,
the U.S. homeopathic remedy market exploded by 89 percent to an
estimated $830 million last year, according to market research
company Mintel. By 2007, homeopathic remedies were taken by almost
4 million Americans, or 2 percent of adults, federal data show.
Pharmacist Albert Lavender, retired deputy director of the FDA's
unit overseeing drug labels, calls it "a big fraud" on the
consumer.
"He might not get hurt most of the time, but his pocketbook is
getting hurt all of the time," he says. He says "it doesn't make
sense" that the FDA requires homeopathic medicine to bear a label
saying what it treats because, in his view, most of it treats
nothing.
"Very often, the only active ingredient is alcohol, and
patients don't know that, and they get a buzz-on. The therapeutic
effect is no greater or less than a martini," says Dr. Jerry
Avorn, an expert in pharmaceutical safety at Harvard Medical
School.
Richardson says he thought he was taking a government-approved
drug when he took a whiff of homeopathic cold gel. He says he felt
a burning sensation and hasn't smelled much since. A doctor who
tested his sense of smell tentatively linked his condition to
Zicam, Richardson's medical records show.
Some independent research also has blamed the active ingredient
in Zicam, zinc gluconate, for such problems.
Even before the FDA action, the Federal Trade Commission was
investigating whether Zicam was deceptively marketed, and the
industry group Council of Better Business Bureaus had recommended
that some Zicam advertising claims be toned down.
Zicam seller Matrixx Initiatives, of Scottsdale, Ariz., which
grew out of a chewing gum company, paid $12 million in 2006 to
settle lawsuits with about 340 Zicam patients. It has won a lawsuit
in California, and several other federal cases were dismissed.
But complaints by dozens of patients remain before the courts.
The Motley Rice law firm in Mount Pleasant, S.C., represents more
than 300 with Zicam claims, says lead lawyer Lynn Seithel. She says
the FDA warning this week "validates what our clients have been
saying."
The company, which has sold more than 1 billion doses since the
products came to market in 1999, says it settled in the past simply
to reduce its legal exposure. The remedy has recently been sold
with a redesigned spray nozzle, and the company argues that it is
safe, citing academic studies that it funded. Matrixx says some
people failed to follow package directions and stuck the nozzle too
far up their noses.
Faced with the FDA warning, the company's acting president,
William J. Hemelt, blamed much of the smelling problems on the
colds that patients were treating. However, the company agreed to
suspend shipments and reimburse customers who want refunds.
Questions can be raised about the touted safety record of other
homeopathic remedies, too.
The FDA's own side effect reports potentially implicate at least
843 homeopathic ingredients just in the year ending September 2008,
the AP found. It is impossible to verify how many were taken at low
homeopathic concentrations. But dozens apparently were, and they
were linked to side effects, including muscle and joint pain in
reports submitted by consumers, doctors and others.
Though many homeopathic remedies consist mostly of sugar or
alcohol, thousands of patients swear by their effectiveness anyway.
Amanda Rafferty of Haverhill took homeopathic sanguinaria
canadensis, made from a toxic herb known as bloodroot, for her
monthly migraine headaches. She says her next migraine didn't come
back for a full year.
She says she had no idea that such remedies weren't checked by
the government but voices contempt for "the whole system" of
government regulation.
Her homeopath, Begabati Lennihan of Cambridge, treats headaches,
colds, ear infections, digestive complaints, depression and
behavioral problems. Like other homeopaths, Lennihan considers not
just symptoms but also temperaments, favorite foods, even dreams.
However, if the problem shows up in an X-ray, she acknowledges, it
"is going to be harder to fix with homeopathy."
Today's homeopaths are typically trained in part-time
certificate programs. Lennihan took conventional nurse's training
to bolster her homeopathic credentials. Only Connecticut, Arizona
and Nevada license homeopaths, and they insist on a medical degree
as a prerequisite.
With only about 2,500 full-time U.S. homeopaths, patients
routinely diagnose themselves. Dr. Ahmed Currim, one of 13
state-licensed homeopathic doctors in Connecticut, discourages
people from buying homeopathic remedies without professional
advice, because they "don't know what they're doing."
How could they? In the booming nonprescription market, many
homeopathic remedies are sold for symptoms so vague and broad that
it's virtually impossible to match treatment and ailment.
For example, one homeopathic ingredient, lithium carbonate, is
used as a psychiatric drug by conventional medicine. In homeopathy,
one advertisement pitches it for "rheumatic soreness in the heart
region, paralytic stiffness all over, cerebral congestion, insomnia
and epilepsy."
Even some leading homeopaths have begun to change their minds
about independent oversight.
Dr. Iris R. Bell, a psychiatrist and homeopathy researcher at
the University of Arizona, Tucson, says the suspended Zicam
products deliver the homeopathic ingredient right into the nose -
not an accepted homeopathic method. She says the FDA should act
against such products.
She also acknowledged that "there are people preparing things
homeopathically to try to get around FDA regulations of
over-the-counter drugs." But she says most homeopathic remedies
are much safer than conventional pharmaceuticals, so no major
regulatory changes are needed.
Asked if the Zicam warning portends stronger oversight of
homeopathy, FDA spokeswoman Siobhan DeLancey said only: "We are
always re-evaluating our policies to ensure that we are
appropriately protecting the public health."


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