Wyeth Removed Mercury From Nasal Spray, Not Infant Shots

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Firm Removed Mercury From Nasal Spray, Not Infant Shots

Wyeth used thimerosal in vaccines for years after it did away with the

chemical in Dristan.

By Myron Levin

LATimes Staff Writer

June 7, 2005

http://www.latimes.com/news/science/environment/la-fi-wyeth7jun07,1,2014722.stor\

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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 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 J. ch 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, " ch 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, ch said.

ch 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 ch 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.

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