Integrated DNA Technologies (IDT) Provided DNA for Manmade Polio Virus
Urged Government to Oversee Shipments

CAROL ANN RIHA / AP 19jul02

DES MOINES, Iowa -- The Iowa company that unknowingly supplied bits of genetic material used by scientists to make their own polio virus from scratch said it had recently asked the government to take steps to oversee the shipment of such DNA supplies.

Last week's stunning announcement by researchers at State University of New York at Stony Brook that they had made the virus in their lab raised a new set of fears about bioterrorism.

It was the first time a virus had been synthetically produced, and it was done with a genetic blueprint from the Internet and DNA material provided by a mail-order supplier.

The supplier was Integrated DNA Technologies, or IDT, of Coralville, a suburb of Iowa City. An official of the company said Wednesday that IDT wrote the Defense Department on May 13 about the possible terrorist use of such biomedical material, but never got a response.

"We had submitted a proposal to the Defense Department, ironically, suggesting that (DNA) sequences ordered by suppliers like ourselves be screened and then reported to federal agencies for the purposes of identifying orders or parts of orders that would be perhaps investigated, questioned, double-checked or whatever," said Roman Terrill, vice president of legal and regulatory affairs for IDT. "The inquiries that we sent weren't really responded to."

Defense Department spokesmen declined to answer questions and only provided a statement about the department's involvement in the SUNY project.

Terrill said IDT only became aware that its supplies were used by the SUNY scientists when they made their announcement of the polio virus in the journal Science last week.

The Defense Department said it funded the project to research protections against unconventional biological agents. SUNY research team leader, Dr. Eckard Wimmer, said the creation of the virus was an attempt to show the reality of the bioterrorist threat.

The fear is that a terrorist or government might attack by spreading a harmful virus or deadly bacteria. Most of the concern so far has focused on security at labs that have supplies of germs or on finding treatments or vaccines to thwart such an attack.

But the SUNY project demonstrated for the first time that deadly diseases could be made synthetically in a lab.

"This approach has been talked about, but people didn't take it seriously," Wimmer said last week. "Now people have to take it seriously."

Terrill said the project illustrates an ethical dilemma: "DNA can be used to cure a virus or to help develop cures. On the other hand, DNA can be used for more nefarious purposes."

IDT is one of a handful of companies across the country that supplies about 15,000 customers with short fragments of DNA used in medical research. These strands, called oligonucleotides, are basic tools in all genetics labs.

But Terrill said the DNA supplier has no way of knowing how the genetic fragments it ships will be used.

"It's kind of like a phone number. They're ordering a phone number where we have the equivalent of seven digits. Without an area code, you really can't specify where the call is coming from. You need a longer sequence to identify it," Terrill said.

Besides polio, the genetic maps to anthrax, Ebola and other diseases are readily available to researchers in libraries and on the Internet, he said.

Gary Comstock, coordinator of the bioethics program at Iowa State University, said there is "a clash of values" between society's desire for innovation and new bioengineering technologies and the desire to protect ourselves from those who would abuse the new technologies.

"Given the events of Sept. 11 and since, I think the issue has a particular urgency for us that it may not have had a year or two ago."

• Integrated DNA Technologies: www.idtdna.com

Are Tainted Vaccines Given to Baby Boomers Now Causing Cancer?

SHARON BEGLEY / Wall Street Journal 19jul02

Polio Vaccines Given Decades Ago Carried Carcinogenic Virus SV40

Snapshots of your government at work:

1961. The U.S. Public Health Service, having learned in 1960 that millions of batches of polio vaccine were accidentally laced with a simian virus (vaccine was grown on minced monkey kidneys), quietly orders manufacturers to rid the vaccine of the contaminant, called SV40. PHS issues neither recall nor public announcement. Contaminated stocks already distributed are used until 1963.

1999. H.M. Ratner, a former public-health official in Oak Park, Ill., invites Michele Carbone of nearby Loyola University School of Medicine over for coffee. In 1955, Dr. Ratner says, he had refused to administer the Salk polio vaccine. He felt it might not be safe. But he kept seven vials in his basement refrigerator for 44 years, hoping that, one day, someone would be interested in them. Someone is. Dr. Carbone is investigating the possibility that SV40-contaminated polio vaccine made by several manufacturers was, decades after being given to about 98 million baby boomers, increasing the risk of three rare cancers.

2002. Last week, the Immunization Safety Review Committee of the Institute of Medicine (IOM) meets to consider evidence for and against that unthinkable hypothesis.

Amid dueling data, some facts are uncontested. An estimated two-thirds of the polio vaccines -- the oral Sabin and the injected Salk -- administered from 1955 to 1963 contained SV40, including the vials Dr. Ratner saved. Contaminated vaccine was also given to children and some adults in Australia, Canada, Denmark and Germany, and possibly Russia, Mexico and other countries.

SV40 is a known carcinogen. It targets the lung's mesothelial cells, brain cells, bone cells and blood cells, producing a protein that knocks out two human tumor-suppressor genes, p53 and Rb. There is no reliable blood test for SV40 exposure.

Government data show the incidence of SV40-linked cancers has risen. A brain cancer called ependymoma is up 25%. Bone malignancies are up 23%. Mesothelioma (infamous for being triggered by asbestos) is up 90%. All are extremely rare: Ependymoma, for example, strikes one in a million.

Are the rising cancer rates coincidence? In 1994, Loyola's Dr. Carbone and colleagues examined human mesotheliomas. He found SV40 genetic sequences in 29 of 48 studied. SV40 has now been found in up to 80% of mesotheliomas in the U.S. and Europe. Dozens of labs have found SV40 in bone and brain cancers. Those, as I said, are rare. Epidemiologist Howard Strickler of Albert Einstein College of Medicine in New York, a leading skeptic of the vaccine-cancer link, notes that many studies fail to find SV40 in human tumors.

In March, however, researchers led by Janet Butel of Baylor College of Medicine, Houston, reported that 42% of the non-Hodgkin lymphomas they analyzed contained genetic sequences from SV40. And not just any SV40: In several tumors, it was precisely the genome of the SV40 in the vials of the 1955 polio vaccine that Dr. Ratner had held onto, waiting for someone to care. Lab-grown SV40 harbors a variant genome. There might be other sources, in addition to vaccine, of this strain of SV40, but to more and more scientists Dr. Butel's findings were the smoking gun.

With Non-Hodgkin lymphoma, we're no longer talking about rare malignancies. This cancer has spiked 82% in the U.S. since 1973, epidemiologist Susan Fisher of the University of Rochester, New York, told the IOM panel, with 56,200 new cases in 2001 and 24,000 deaths.

An analysis by Dr. Strickler shows no extra cancers among people thought to have been exposed to SV40-laced polio vaccine -- or, no extra increase that can't be explained by chance. Trouble is, with no test for SV40 exposure, it's impossible to be sure you're comparing an exposed to an unexposed group. You might be comparing populations exposed to SV40 with populations also exposed. Of course there'd be no difference.

What are the ramifications of this? Today's children are at no risk from polio vaccine; it's now grown in SV40-free cells.

The public-health risk from SV40-laced polio vaccine is ... well, one scientist told me it's "minimal." Another says "unknown." Tumors linked to SV40 are, except for lymphomas, so rare that even a doubling of risk due to SV40 still leaves you with good odds of never developing these cancers.

A wild card, though, is the World Trade Center collapse, which released asbestos into the air. Although SV40 alone rarely causes mesothelioma, when you add asbestos to the mix, all bets are off. The IOM committee's conclusions on SV40, polio vaccine and cancer are due out by the end of summer.