"The available evidence is insufficient to make reliable judgments," editors of The Lancet wrote in an editorial published online Wednesday. "It is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer."

In a telephone interview, The Lancet's chief editor, Dr. Richard Horton, said he was "quite angry" that Herceptin has been portrayed as such a wonder drug in The Lancet's US counterpart, the New England Journal of Medicine. "Study results are preliminary, inconsistent and raise extremely serious concerns about safety," he said.

Likely to Stand Up with Time?

Herceptin is designed to treat women with breast tumors bearing a protein marker associated with aggressive disease that responds poorly to conventional treatments. About 20 percent of tumors that have spread beyond the breast have the marker.

The buzz surrounding Herceptin has led patient groups worldwide to demand the drug from governments and insurers, even though it is not licensed for early stage breast cancer. It is approved for use only in more advanced cancers, where the cancer has spread beyond the lymph nodes.

The buzz intensified last month, when the New England Journal of Medicine published two preliminary studies concluding that the drug seemed to be extremely effective, accompanied by a glowing editorial. Dr. Jeffrey Drazen, editor of the journal, on Wednesday defended the decision to publish, noting that the results were "highly likely to stand up with time."

He added: "We are not in the business of telling people how to be treated and government bodies what they should pay for. We just felt that if you developed this particularly bad form of breast cancer, you would want to know about this."

Fast-Track Process

The Lancet decided to publish its editorial early and online Wednesday, Horton said, after the British health secretary, Patricia Hewitt, publicly demanded the National Health Service to provide the drug to a patient who sued to be given the medicine. In France, pressure to release Herceptin was so intense that regulators bypassed normal channels earlier this year to make it more widely available to breast cancer patients.

Many doctors who have used Herceptin defended the fast-track process. "I understand the importance of caution, but the results of these studies were so impressive to doctors who take care of women with breast cancer that we believe the studies should change the standard of care," said Dr. Ed Romond, an oncologist at the University of Kentucky who was a principal investigator for one of the New England Journal of Medicine's articles.

He said tumors bearing the breast cancer marker are "very aggressive" and that 90 percent of women who had received the new treatment remained disease-free after four years. "Maybe once the study is finished we will see that the results are not as strong," he said. "But statistically they will still be impressive."

Governments Hard Pressed to Pay

At cost of about 35,000, or about $41,000, for a full treatment course, governments have been hard pressed to pay for Herceptin. But Horton said the current debate was simply about whether the drug worked and was safe. "The last thing we should want is to have a politician campaigning on behalf of a drug. It's a crazy way to make what should be a scientific decision," Horton said.

Katja Prowald, a spokeswoman for Roche, the Swiss pharmaceutical company that markets Herceptin in Europe, said scientists at the company had "read the editorial and said that the statements it contained were not correct."

The maelstrom surrounding Herceptin began earlier this year, when researchers, at a meeting of the http://www.cancer.org/docroot/home/index.asp">American Cancer Society presented promising early data on the use of Herceptin to treat early breast cancer. Two articles with further interim data were published in the New England Journal of Medicine on Oct. 20.

According to the studies, women who received Herceptin along with standard chemotherapy had half the rate of recurrence after one year than those who did not receive the drug.

Researchers from a consortium of prestigious international medical centers considered the results compelling enough that women in the control group, who initially received no Herceptin, were belatedly offered the medicine.

'Unholy Alliance'

But some scientists have long had misgivings about the data -- or at least about the drug's golden image -- especially in light of its cost. Last week in the Journal of the American Medical Association, Dr. Victor Montori of McMaster University in Toronto pointed out that when trials are stopped early, the preliminary analyses can show "implausibly large treatment effects," and he urged "skepticism" in viewing the data.

Horton pointed out that one of the New England Journal of Medicine articles combines data from two patient trials that may not be comparable. Also, he noted that a small but significant number of women receiving Herceptin develop severe heart failure, and that problem has not yet been adequately studied.

Romond said the combination of data sets was reviewed by the US Food and Drug Administration and deemed appropriate. "We wanted to get faster information for the benefit of patients," he said.

Horton said the hoopla surrounding Herceptin resulted from a synergy between desperate patients desiring better treatments and drug companies looking for profit, creating what he called an "unholy alliance."

He urged that regulatory review boards be given the time necessary to thoroughly evaluate the drug, saying, "We need to have a strong spine to make sure that scientific evaluation remains scientific and is not dominated by politics."