Firm Removed Mercury From Nasal Spray, Not Infant Shots

Wyeth used thimerosal in vaccines for years after it did
By Myron Levin,
LA Times Staff Writer

http://www.latimes.com/news/science/environment/la-fi-wyeth7jun07,1,2014722.story?coll=la-news-environment&ctrack=1&cset=trueaway with the chemical in Dristan.

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.