The Lancet's chief editor, Richard Horton, said he was "quite angry"
Herceptin had been portrayed as such a wonder drug in The Lancet's
U.S. counterpart, the New England Journal of Medicine. "Study results
are preliminary, inconsistent and raise extremely serious concerns
about safety," he said.
Just three weeks after an editorial in America's most prestigious
medical journal declared an expensive new cancer drug to be
"revolutionary" and "maybe even a cure" for some hard-to-treat breast
cancers, the most prominent British medical journal has come to the
opposite conclusion.
"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, Richard Horton,
said he was "quite angry" Herceptin had been portrayed as such a
wonder drug in The Lancet's U.S. counterpart, the New England Journal
of Medicine. "Study results are preliminary, inconsistent and raise
extremely serious concerns about safety," he said.
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.
Interest 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.
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."
The Lancet decided to publish its editorial early and online
Wednesday, Horton said, after the British health secretary, Patricia
Hewitt, publicly demanded that the National Health Service provide the
drug to a patient who had 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."
With Herceptin costing about $41,000, for a full treatment course,
governments have been hard pressed to pay for the drug. 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 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. 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. 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."
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