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New documents show the monkey virus is present in more recent polio vaccine

by William Carlsen
San Fran­cis­co Chron­i­cle

A mon­key virus linked to human can­cers may have con­t­a­m­i­nat­ed the oral polio vac­cine for years after the U.S. gov­ern­ment ordered man­u­fac­tur­ers to remove it, accord­ing to drug com­pa­ny doc­u­ments obtained by The Chron­i­cle.

The Chron­i­cle report­ed last week that the simi­an virus SV40 had con­t­a­m­i­nat­ed ear­ly polio vac­cine giv­en to mil­lions of Amer­i­cans. When health offi­cials dis­cov­ered in 1961 that SV40 caused malig­nant tumors in lab ani­mals, they ordered the virus elim­i­nat­ed from all future vac­cine.

But inter­nal mem­os from Led­er­le Lab­o­ra­to­ries, the chief pro­duc­er of polio vac­cine in the Unit­ed States, indi­cate SV40 may not have been com­plete­ly removed.

Accord­ing to one memo, SV40 was found in three of 15 lots of the oral vac­cine sev­en months after the fed­er­al direc­tive was issued in March 1961. Led­er­le released the con­t­a­m­i­nat­ed vac­cine to the pub­lic any­way, the memo shows.

The doc­u­ments also sug­gest that the com­pa­ny failed to test the mon­key- kid­ney seed strains used to make the bulk polio vac­cine for con­t­a­m­i­na­tion, despite a writ­ten warn­ing from Dr. Albert Sabin, who devel­oped the oral vac­cine.

Led­er­le and the U.S. gov­ern­ment insist there is no evi­dence that any con­t­a­m­i­nat­ed vac­cine was dis­trib­uted after the direc­tive went into effect.

Sci­en­tists dis­cov­ered SV40 in the Salk polio vac­cine in 1960. By then as many as 30 mil­lion Amer­i­cans had been giv­en injec­tions of the SV40-taint­ed polio vac­cine, which was first licensed in 1955.

In recent years more than 60 sci­en­tif­ic stud­ies have found SV40 in rare human brain, bone and lung-relat­ed can­cers, the same kinds of tumors the virus caused in lab­o­ra­to­ry ani­mals. Some sci­en­tists believe SV40 may play a role in caus­ing those can­cers.

One of the biggest mys­ter­ies, how­ev­er, is why SV40 has been found in tumors removed from peo­ple who nev­er received the con­t­a­m­i­nat­ed Salk vac­cine.

Researchers have sev­er­al the­o­ries for how the virus could have spread from those infect­ed through the Salk vac­cine: in trans­mis­sion from moth­er to fetus or through breast milk; through sex­u­al activ­i­ty or a flu-like virus.

But the Led­er­le doc­u­ments, which were obtained by Philadel­phia attor­ney Stan­ley Kops in lit­i­ga­tion not relat­ed to SV40, raise the pos­si­bil­i­ty the virus might have been trans­mit­ted by con­t­a­m­i­nat­ed oral vac­cine, licensed for pro­duc­tion in 1962.

The doc­u­ments include:

– A Novem­ber 1961 memo say­ing the virus was found in three of 15 lots of vac­cine. Accord­ing to the memo, Dr. Rod­er­ick Mur­ray, head of the gov­ern­men­t’s pro­gram to ensure vac­cine puri­ty, allowed the lots to be released.

To com­ply with the removal order, Led­er­le had switched from rhe­sus mon­keys, which are nat­ur­al hosts for SV40, to African green mon­keys, sup­pos­ed­ly free from SV40. How­ev­er, the memo notes that SV40 was found in 10 per­cent of the green mon­keys.

– A let­ter from Sabin to Led­er­le in Octo­ber 1962, warn­ing that suf­fi­cient test­ing for SV40 con­t­a­m­i­na­tion had not been done on one of his strains of weak­ened polio virus that formed the seed for bulk vac­cine pro­duc­tion.

– A con­fi­den­tial memo in 1979 from a Led­er­le offi­cial stat­ing: “It should be not­ed that Led­er­le did not test the orig­i­nal Sabin seeds for extra­ne­ous agents or neu­rovir­u­lence since Dr. Sabin assured us that this had been done.”

– Anoth­er memo stat­ing that Led­er­le did not test the seed “since only 50 (mil­li­liters) or less of each seed were pro­vid­ed by Dr. Sabin.”

The two mem­os added that test­ing was unnec­es­sary because lat­er vac­cine sam­ples sub­mit­ted for license were free of SV40.

Kops also said that he had tak­en tes­ti­mo­ny in 1998 from a top Led­er­le offi­cial who said the com­pa­ny did not have the test results from many of the vac­cine lots.

“The vac­cine man­u­fac­tur­ers and the gov­ern­ment need to dis­close what real­ly hap­pened,” said Kops. “With­out the facts, (sci­en­tists) will con­tin­ue to look in the wrong places to explain how peo­ple were infect­ed with SV40 after 1961.”

Led­er­le did not respond to requests for com­ment.

At a 1997 con­fer­ence, how­ev­er, a com­pa­ny rep­re­sen­ta­tive out­lined the series of tests the com­pa­ny uses to detect SV40 con­t­a­m­i­na­tion. The com­pa­ny also says that it uses anti­serum to neu­tral­ize any SV40 in the “mas­ter seeds.”

But it is not clear whether these pro­ce­dures were in place in the years after the U.S. gov­ern­ment issued its direc­tive.

Last year, a law­suit was filed in Los Ange­les against Led­er­le by the par­ents of 2 1/2‑year-old Alexan­der Hor­win who died of a brain tumor that lat­er test­ed pos­i­tive for SV40. The suit claims that the tumor was caused by SV40 and that he became infect­ed through a 1997 oral polio vac­cine.

Kops and attor­ney Don­ald MacLach­lan rep­re­sent a New Jer­sey fam­i­ly that is con­sid­er­ing a suit against vac­cine man­u­fac­tur­ers.

In 1970, sur­geons removed a large brain tumor from 2‑year-old Mark Moreno. He since has under­gone five more surg­eries and now wears a pro­tec­tive hel­met over the large open­ing in his cra­ni­um where bone grafts nev­er took. Moreno, now 33, lives with his moth­er and requires dai­ly assis­tance.

Recent tests show Moreno’s tumor was rid­dled with SV40, accord­ing to the lawyers.

Eileen Moreno, Mark’s moth­er, believes her son’s brain tumor was caused by SV40 and that he was infect­ed through the oral polio vac­cine in 1968.

Last year, two inves­ti­ga­tors from the U.S. Food and Drug Admin­is­tra­tion used genet­ic test­ing to exam­ine 30 sam­ples of bulk oral polio vac­cine used in the Unit­ed States going back to 1972. They report­ed find­ing no SV40.

But the gov­ern­ment has not used the genet­ic tests to deter­mine whether vac­cine made pri­or to 1972 was con­t­a­m­i­nat­ed.

Dr. William Egan, deputy direc­tor of the FDA’s vac­cine research branch, said test­ing went back only to 1972 because those sam­ples were the only ones avail­able to them. “There was noth­ing sin­is­ter,” he said.

MacLach­lan said he finds it “incred­i­ble” that the gov­ern­ment has­n’t com­pre­hen­sive­ly inves­ti­gat­ed the pos­si­bil­i­ty of SV40 con­t­a­m­i­na­tion of the oral vac­cine.
Simi­an virus Q&A Q: How wide­spread is the SV40 infec­tion?

A: Sci­en­tists and gov­ern­ment health offi­cials don’t know, because no com­pre­hen­sive stud­ies have addressed the ques­tion. What is known is that dur­ing the 1950s and ’60s, at least 10 mil­lion to 30 mil­lion Amer­i­cans — and more than 100 mil­lion peo­ple world­wide — were giv­en SV40-con­t­a­m­i­nat­ed polio vac­cine. The virus also has been found in peo­ple who did not receive con­t­a­m­i­nat­ed vac­cine.

Q: Can I be test­ed for SV40?

A: An accu­rate blood test does not exist. Cur­rent anti­body blood tests can be inac­cu­rate, sci­en­tists say, because they also may detect the pres­ence of close­ly relat­ed virus­es, and SV40 may be present at such a low lev­el that no anti­bod­ies are pro­duced. Researchers are work­ing to cre­ate an effec­tive test.

Q: In which kinds of can­cers has SV40 been found?

A: The virus has been detect­ed in rare can­cers, includ­ing:

– Mesothe­lioma, a fatal tumor of the mem­brane sur­round­ing the lungs. Few cas­es were report­ed pri­or to 1950, but the inci­dence has grown in the Unit­ed States to 2,000 to 4,000 cas­es a year, with greater inci­dence in Europe.

– Brain can­cers: Pri­mar­i­ly ependy­mo­mas and choroid plexus tumors, but also astro­cy­tomas, glioblas­tomas, medul­loblas­toma, and menin­giomas. Few­er than 1, 000 cas­es of these can­cers are report­ed in the Unit­ed States each year.

– Bone can­cers: Pri­mar­i­ly osteosar­co­mas, but also chon­drosar­co­ma and giant cell tumors. These also make up few­er than 1,000 cas­es annu­al­ly.


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