Monday, March 25, 2002

By PAULO LIMA
Staff Writer

Mark Moreno is 35 but has the intellect of a toddler. He needs help feeding himself and crawls around the floor of the Brick Township home he shares with his mother, who has been his caretaker all his life.

Moreno also has had to wear a helmet to protect his brain since surgeons removed parts of his skull to excise a tumor.

In January, Moreno's lawyers filed a lawsuit against two pharmaceutical giants, alleging that his tumor was caused by a monkey virus that Moreno contracted from polio vaccinations he received more than 30 years ago.

The suit is the second filed in Bergen County and one of just four nationwide that accuse major drug companies of doling out millions of doses of polio vaccines tainted with the simian virus known as SV40. The virus is the subject of debate in the medical community, where many believe it is at least partially responsible for certain rare forms of cancer and tumors.

The Moreno suit names Pfizer, American Home Products, and American Cyanamid, which is now a subsidiary of American Home Products. Last week, AHP changed its name to Wyeth, which had been the name of its pharmaceutical division.

The companies were the only ones manufacturing the oral polio vaccine at the time Moreno was inoculated, between May 1968 and October 1970. The suit contends the companies did not adequately test their stocks for SV40 - even after government regulations required them to do so - and thus distributed the tainted vaccines to millions of Americans.

Market leader

According to the lawsuit, American Cyanamid dominated the market, selling about 84 percent of all oral polio vaccine distributed in the United States during the period when Moreno was vaccinated.

"They refuse to admit that they haven't tested or that their neutralization [of the virus] does not work,'' said Philadelphia attorney Stanley P. Kops, who specializes in vaccine-related litigation and is involved in all four of the SV40 lawsuits. "Let American Cyanamid come out and tell the truth. Did they test for SV40 and can they assure you that it's safe?''

Doug Petkus, a spokesman for Madison-based Wyeth, said the company wouldn't discuss any aspect of the case.

"We're talking about litigation here, so I can't comment,'' Petkus said.

Pfizer spokeswoman Vanessa McGowan also declined to respond to the suit's allegations.

"We did receive the papers and we are reviewing it with counsel right now,'' McGowan said. "We can't specifically comment on any of the allegations because we're still in the information-gathering stage.''

Moreno's mother, Eileen, is her son's round-the-clock caretaker. She tries to make life as normal as possible for what essentially is a 200-pound infant. Sometimes, she said, she paints rocks gold and stashes them around the yard because her son likes to search for "treasure.''

"I love him very much,'' she said. "I'd cut my heart out with a spoon for him. But it's made life very difficult.

"The way I see it, I'm just as crippled as he is. I have to do everything he does. Whatever Mark can't do, we can't do.''

Moreno was 2½ years old when he walked into a cabinet. Realizing he was partially blind, Eileen Moreno took him to doctors who discovered a brain tumor and promptly removed it. Brain swelling from the operation left Moreno in a coma for two months and forced another surgery, this one to remove half of his brain, his mother said.

Eileen Moreno can't help but think about what her son has missed as a result.

"It makes me feel very betrayed for one thing,'' she said. "It's destroyed his life. It's destroyed my life. I could have had grandchildren from him. He could have friends. He could have a girlfriend.''

Making the vaccine

Producing the polio vaccine begins with growing the polio virus on monkey kidney tissue. In the version given by injection, known as IPV, the treated dead polio virus is injected into the recipient. The oral vaccine, known as OPV, involves giving the recipient a dose of the weakened live polio virus. In either case, a series of doses produces immunity to polio.

In 1960, five years after the vaccine was developed, researchers discovered SV40 in much of the vaccine seed stocks.

By 1963, an estimated 10 million to 30 million Americans had received tainted oral vaccines, according to research.

After SV40 was shown to cause cancer in laboratory animals, the government required producers in 1961 to screen their stocks and eliminate the virus. They did this by treating vaccine seed stocks with an antiserum and by growing the virus on kidney tissue from a different kind of monkey. But some researchers now question whether the measures were entirely successful, particularly in the case of the oral vaccine.

By the time Moreno received his oral doses as a baby in Manhattan, all vaccines were long thought to have been SV40-free.

Kops and Hackensack lawyer Donald Caminiti, who are working together on the two Bergen County cases, insist the vaccine is the only possible source of the monkey virus their client contracted.

"I don't think he was bitten by a monkey,'' Kops said.

Laboratory tests last Aprilfound SV40 present in Moreno's tumor, Caminiti said. To be successful, however, the attorneys must prove that it caused the brain tumor.

The National Cancer Institute's position on SV40 and cancers is mixed. On the one hand, the institute cites several studies as having "failed to detect an increased cancer risk in those likely to have been exposed to the virus.'' However, it also says: "There is some evidence to suggest that SV40, unrelated to polio vaccine, may be associated with human cancer.''

Some studies have suggested that SV40 may act in tandem with asbestos to cause mesothelioma, a rare cancer. SV40 has been found in many mesothelioma tissue samples.

A natural question arises: If so many people received the SV40-tainted vaccines, then why haven't more developed cancers and tumors attributed to it?

Kops believes SV40 is lingering latent within millions of Americans and could begin affecting select carriers in coming years.

"There's a 30- to 45-year latency period; it's a slow-growing cancer,'' Kops said. "A person who was immunized in 1962 probably will not show the first symptoms for another five or six years [from now].''

So far, researchers at the National Cancer Institute say there is no evidence to support Kops' theory.

The NCI statement cites long-term studies in Sweden, Germany, and the United States that have "failed to detect an increased cancer risk in those likely to have been exposed to the virus.''

700,000 kids in study

The Swedish study examined 700,000 children who received the SV40-infected vaccines in 1957. Researchers followed up 36 years later and found no significant increase in cancer rates when compared with people who had not received the tainted vaccines.

The German study followed 886,000 subjects for 22 years, also failing to turn up a discernible link.

Current conventional wisdom is that the vaccine is SV40-free. The oral vaccine is quickly falling out of favor, and the federal Centers for Disease Control and Prevention now recommends that all infants receive four doses of the injectable version. That's because the oral vaccine is much more likely to cause cases of vaccine-associated paralytic polio, the CDC says.

In those rare cases - about eight to 10 are documented in the United States each year - children infected with the live-virus vaccine actually contract the disease to which they were supposed to develop immunity.

It was while litigating those types of cases that Kops said he became aware of the SV40 controversy. In an article published in a cancer research journal two years ago, he urged vaccine manufacturers to allow independent researchers to test the stocks from which the doses were produced.

The lawyers say the drug companies so far have not been very forthcoming with records surrounding their own testing of the vaccine stocks. Americian Cyanamid, which is now owned by Wyeth, has asserted it lost those records, Kops said.

"When you're involved in product liability litigation, their attitude is always to batten down the hatches, even when there's a compelling argument that they cooperate,'' Caminiti said.

Staff Writer Paulo Lima's e-mail address is lima@northjersey.com

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