Firm Removed Mercury From Nasal Spray, Not Infant Shots

Myron Levin, "Firm Removed Mercury From Nasal Spray, Not Infant Shots",
Los Angeles Times, June 7, 2005,
Link:
http://www.latimes.com/news/science/...ws-environment

Drug maker Wyeth removed a mercury compound from a popular nasal spray
more than a decade ago to skirt warning label requirements, but
continued using the chemical in infant vaccines for several years until
it came under pressure to stop.

To avoid placing a mercury warning on its Dristan nasal decongestant
spray, Wyeth in 1990 launched an "extensive project" to develop a
substitute for thimerosal, an antibacterial chemical containing
mercury, a senior scientist for Wyeth said in a statement filed in Los
Angeles.

Proposition 65, California's toxics alert measure, offered a choice
between a warning or reformulating Dristan to eliminate thimerosal,
which is nearly 50% ethyl mercury, a neurotoxin.

Wyeth has been shipping a thimerosal-free version of Dristan into
California since 1994, scientist Gary Agisim said in his May 6
declaration in Los Angeles Superior Court, where a class-action suit
under Proposition 65 is pending against Wyeth and dozens of other
companies.

But the company kept using thimerosal in two of its pediatric vaccines
until 2000, stopping after federal health authorities - concerned
about infant exposures to mercury - called on manufacturers to
voluntarily remove the chemical from kids' shots. Because prescription
drugs approved by the Food and Drug Administration are exempt from
Proposition 65, vaccine makers had not been forced to choose between
using warning labels in California or reformulating their products, as
Wyeth was with Dristan.

The 1986 ballot measure, the Safe Drinking Water and Toxic Enforcement
Act, is responsible for the ubiquitous toxic-hazard warnings that adorn
businesses and public buildings. Another consequence of the law is that
many product manufacturers have quietly eliminated toxic ingredients
rather than use warnings they may not agree with and that might bring
negative fallout from consumers.

Wyeth attorney Daniel J. Thomasch said "there was no inconsistency
whatsoever" in the company's decisions regarding Dristan and pediatric
vaccines.

"There was no safety concern about thimerosal in either Dristan or
vaccines," Thomasch said, adding that the change in Dristan was
triggered solely by Proposition 65, not health considerations.

But Sallie Bernard, executive director of Safe Minds, a parents group
concerned about childhood exposure to mercury, said there was "no
ethical basis" for the different choices.

And Barbara Loe Fisher, president of another parent-led group, the
National Vaccine Information Center, said Wyeth should have removed
thimerosal from its vaccines when it reformulated Dristan.

Prudence "would dictate that if they were to take it out of
over-the-counter products, that they would take it out of every product
that was consumed or injected into humans," she said.

Introduced decades ago before current standards for safety testing,
thimerosal came into wide use as a sterilizing agent in vaccines
packaged in multi-dose containers, and in healthcare products such as
nasal sprays, eye solutions and medicinal ointments.

Although use of thimerosal has been reduced or eliminated from many of
these products, it remains the focus of a smoldering controversy over
possible health effects from exposures during the 1990s, when federal
health authorities greatly expanded the number of mandatory childhood
immunizations.

Due to the aggressive increase, millions of children received
cumulative mercury exposures above U.S. health guidelines - a fact
widely unknown to parents and doctors until federal officials concluded
a study on the issue in 1999.

More than 4,200 claims have been filed by parents in a special federal
tribunal, the Vaccine Injury Compensation Program, asserting that their
children suffered autism or other neurodevelopmental disorders at least
in part from mercury in vaccines. A handful of similar claims filed
against vaccine manufacturers are awaiting trial in civil courts.

Vaccine makers and many public health authorities say there is no
evidence of harm from the small amounts of thimerosal in kids' shots.
They say the issue was settled by the prestigious national Institute of
Medicine, which reported in May 2004 that the evidence "favors
rejection" of a cause-and-effect relationship between vaccines and
autism.

Other studies suggesting there is a link, however, have kept the
dispute alive. And some experts say that even if mercury doesn't cause
autism, there is strong evidence it can impair the intellectual
development of children.

The declaration by Agisim was filed in a pending class-action suit
against New Jersey-based Wyeth and about 70 other producers or
distributors of mercury-containing healthcare products. The suit, filed
in February 2004, claims the companies violated Proposition 65 by
failing to warn of the mercury in the products.

Wyeth says it does not belong in the lawsuit, because Proposition 65
has a four-year statute of limitations and it reformulated Dristan more
than a decade ago. The Agisim declaration was filed in support of that
claim.

Wyeth said the thimerosal-free formula was introduced nationwide in
1994, but that due to consumer complaints about irritation from the new
version, it resumed use of thimerosal in the Dristan sold outside
California.

After the appeal by the U.S. Public Health Service in 1999 to remove
thimerosal from pediatric vaccines, Wyeth again began supplying
thimerosal-free Dristan nationwide, Thomasch said.

Thomasch said he did not know what, if any, conversations took place in
1990 between Wyeth's vaccine and consumer healthcare divisions about
the project to reformulate Dristan.

But Thomasch said there would have been no reason "for such
communications given that the move to thimerosal-free Dristan ... was
entirely unrelated to safety concerns."

No company documents have been publicly disclosed on whether Wyeth
considered the growing mercury burden from the increase in kids' shots.

But a 1991 Merck memo previously disclosed by The Times reflected
concern within the company's vaccine division. In the memo, a former
top Merck scientist calculated that 6-month-old infants who got all
their shots on time could get a mercury dose as much as 87 times higher
than the guideline for maximum consumption of mercury from fish.

"When viewed in this way, the mercury load appears rather large," the
memo said.

In article .com,
Roman Bystrianyk wrote:
Myron Levin, "Firm Removed Mercury From Nasal Spray, Not Infant Shots",
Los Angeles Times, June 7, 2005,
Link:
http://www.latimes.com/news/science/...ws-environment

Drug maker Wyeth removed a mercury compound from a popular nasal spray
more than a decade ago to skirt warning label requirements, but
continued using the chemical in infant vaccines for several years until
it came under pressure to stop.

BFD. Like this is somehow significant.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"I don't need someone to tell me that George W. Bush is a
deceitful, corrupt, clever and destructive man--that's pretty
clear on the face of it." -- Garrison Keillor