The Race Is On - Pharmaceutical Executive


The Race Is On

Pharmaceutical Executive

WPI and Full Disclosure

When XMRV was first discovered in 2005, pharma held back because it was reported that the virus appeared to be inactive in prostate cancer cells. But Abbott Diagnostics jumped at the challenge of developing assays to detect XMRV. Last month, Abbott HIV Global Surveillance Program's John Hackett reported early progress on several fronts. But the main takeaway was that detecting XMRV in human blood samples is proving far more difficult than the WPI study had led anyone to expect. Using their new assay that can detect three different antibody proteins, the Abbott team found XMRV in only three of 2,851 random human samples. That's good news for the general population—a .01 percent extrapolated prevalence rate—but bad news for CFS patients.

Nor is Abbott alone in judging XMRV hard to find. Since January, three confirmation studies—two British, one Dutch—have reported results, and none found the retrovirus in either their CFS blood samples or their controls. As doubt is increasingly cast on WPI's theory that XMRV causes CFS, arguments have raged across the Atlantic. Accusations of sloppiness, bias, and even fraud have been hurled, mostly by Judith Mikovits and WPI's defenders. Old suspicions of patients have reappeared.

When asked for a more considered opinion, others choose their words carefully. "Validation and confirmation are not coming as fast as one might like, that's for sure," says John Coffin. "If you can't establish a disease association, then there is less interest in developing a drug, obviously." Coffin also notes that uncertainty remains about whether or not the virus is replicating. "If it does so, like HIV, then an antiretroviral would be very effective. But if not, as it appears in prostate cancer, a drug would not make any difference."

Writing on the CFIDS Association of America's Web site, Suzanne Vernon made a valiant effort to keep hope in the causal hypothesis flickering by emphasizing that none of the three studies is a "proper and robust replication study." And she concluded by throwing down the gauntlet: "Until methods are standardized and the scientific community is provided information about the specific characteristics of the CFS subjects who tested positive in the Science paper, be prepared to read more negative studies. Hopefully the Science investigators will make this information available before interest in XMRV being associated with CFS fades."

Given the great diversity in CFS symptoms, disclosure of the medical histories and clinical conditions of the high number of WPI's XMRV-infected CFS patients is critical. "Of course, this would generate more questions, but a cleaner association is needed," Vernon says. "I don't know why WPI won't provide this."

So far, Mikovits has refused to budge. "No additional medical histories or anything about the patient population would shed any light on XMRV," she says.

Sleuthing on her own, Vernon was able to uncover some suggestive information about the 32 CFS patient samples about which WPI originally reported assay results. Only 12 tested positive on more than one assay (WPI ran four assays); of those 12, four had been diagnosed with cancer. Another 13 of the total 67 XMRV-positive CFS samples also had cancer.

Whether XMRV is a cause or a passenger or merely a geographical coincidence of a particular CFS outbreak remains to be learned. But one thing is clear: With its big discovery, the upstart medical center has made more than a big splash. WPI has placed CFS—and itself—at the center of the perfect storm. "I knew how serious a retrovirus is," Annette Whittemore told the Times. "I was very concerned, knowing the implications. My second thought was, 'Of course, it was going to be something serious like that. Look at my daughter and how ill she is.'"


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