COMPANIES BYPASS PEER REVIEW TO GRAB HEADLINES

by Gautam Naik

[In January], Britain's PPL Therapeutics PLC issued a news release proclaiming the birth of five specially cloned pigs whose organs might be able to avert an
immune rejection if transplanted into humans. The news was seen as a big step toward making animal-to-human transplants a reality-and pushed PPL's shares
by 44 percent.

PPL, it turned out, made its announcement just two days before rival U.S. scientists were set to disclose similar results in a more old-fashioned way: in an
article reviewed by other scientists and published in the journal Science. Reporters had been tipped off about the Science paper, but were bound to honor an embargo set by the respected journal. The U.S. team, similarly constrained, watched helplessly as PPL stole its thunder.

"We were frustrated by the timing. It's really hard to believe that it was coincidental," says Julia Greenstein, chief executive and president of Immerge Bio/Therapeutics Inc., of Boston, part of the team that published the Science paper.

It used to be that a scientific breakthrough was
taken seriously only if it first appeared in a peerreviewed journal. But in the race to grab the spotlight, some companies are rushing to release information via esoteric publications that have less stringent criteria, or in news releases.

The upshot: investors and the public may be led to
believe certain claims that could later prove to be exaggerated. "It undermines public trust in science if key results are released without peer review," says Philip
Campbell, editor in chief of Nature, a 133-year-old British research journal that has published the likes of Charles Darwin.

PPL-which shot to fame in 1997 after helping clone Dolly the sheep-insists it didn't know about Immerge's imminent publication. While it accepts that peer review of experiments "is the gold standard" in scientific publishing, the company says it is oftenforced to override the convention. "We're a public company and we decided to make a limited press release…as soon as we felt that we had something [stock] price sensitive," says Alan Colman, PPL's research director. In the high-stakes world of stem cells and cloning, he adds, "people don't have time to hang around and wait for a peer review."

It wasn't the first time PPL rankled fellow scientists.

A year ago, the tiny Scottish company claimed to have pulled off a feat that was the biological equivalent of turning back time: It had taken skin cells from an adult
cow and returned them to their embryonic state.

The news also was disclosed in a press release, and although the company declined to provide details, investors pushed up PPL shares 11 percent that day. So far, though, the company hasn't published a scientific paper about its findings. And now it is backing away from its claim. "It's embarrassing," admits Colman, the research chief. "We've had trouble keeping the cells alive."

Nowhere has the rush to disclose news been more prevalent than in the race to create the first cloned human embryo, a rich scientific prize, albeit one fraught
with ethical dilemmas. In the past, fertility experts in South Korea and the U.S. have reported experiments to create early-stage human clones, but their results were never published in peer-reviewed journals.

The race apparently ended in November, when Advanced Cell Technology, Inc., of Worcester, Mass., said it had created a human-embryo clone. It reported the details in an obscure two-year-old Internet-based publication called e-biomed: The Journal of Regenerative Medicine. The paper, which was peer reviewed, was widely hailed as a landmark and hit the front page of newspapers around the world, including the Wall Street Journal.

But there is now a chorus of detractors who point to serious potential flaws in the experiment. Advanced Cell's cloned embryo, these scientists say, had divided
into just six cells after five days, and then died. The embryo also looked abnormal because its cells appeared to be fragmenting, not dividing. Unhappy
with the publication, three leading scientists on e-biomed's editorial board resigned.

Even ProBio Inc., an Australian intellectual-property rights company that owns the license for one of the cloning techniques used by Advanced Cell, shrugs off
the importance of the company's achievement. "It served more of a media function than a scientific one," says ProBio CEO Laith Reynolds.

How and when to release the results was debated inside Advanced Cell. "I think the overwhelming concern was that the work shouldn't be conducted in secret," says Ann Kiessling, a fertility scientists who was a co-author of the Advanced Cell publication. But several people close to the company said Advanced
Cell scientists feared that competitors might publish similar results first.

The editor of e-biomed, William Haseltine, defends its decision to publish the Advanced Cell paper. "I stand by the scientific process-which means that it was reviewed by people knowledgeable in the field," he says. "It's up to other other scientists to determine" if the science is sound.

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Gautam Naik is a staff reporter for the Wall Street Journal.

"Biotech Firms Bypass Journals to Make News," the Wall Street Journal, Jan. 28, 2002.

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