One of the biggest stories so far out of the American Society of Clinical Oncology (ASCO) meeting that just ended in Chicago was that of T-DM1, which, according to Ivan’s Reuters colleagues, “extended the length of time breast cancer patients lived without their disease getting worse.” (The news was even the subject of an embargo break.)
The widely-hailed study of Roche’s drug was led by Duke’s Kimberly Blackwell, who told The New York Times:
“We’ve envisioned a world where cancer treatment would kill the cancer and not hurt the patient,” Dr. Kimberly L. Blackwell, a professor of medicine at the Duke Cancer Institute and the lead investigator in the trial, said in an interview. “And this drug does that.”
Blackwell, as Duke watchdog DukeCheck noted over the weekend, published two studies with Anil Potti, the now-former Duke oncologist who has retracted or corrected 17 papers after resigning in the midst of an investigation into his work. Those two studies — one in the Journal of Clinical Oncology, the other in PLoS Medicine — have not been retracted, but both have been the subject of significant corrections.
It didn’t look to us as though Potti was involved in the T-DM1 work, and Blackwell confirmed that was the case. She also confirmed that the now-corrected papers she co-authored with Potti are not related to the T-DM1 work.
We want to be clear: Despite the fact that work by Blackwell and Potti has been found to have flaws, that doesn’t mean everything Blackwell ever works on needs to be scrutinized more carefully, forever. But we think it’s relevant to note the association, and that she was the point person quoted in a press release saying very positive things about one of the now-corrected papers. A selection:
“The breast tumors that arose in younger women shared a common biology, and this discovery was truly remarkable,” Blackwell said. “The genes that regulate things like immune function, oxygen supply and mutations that we know are related to breast cancer, such as BRCA1, were preferentially expressed in the tumors taken from younger women, but when we compared younger women’s tumors to older women’s tumors, we found those same gene sets were not expressed in the ’older’ tumors.”
We also asked Blackwell if, given all of the issues with Potti’s work, whether oncology research at Duke, or Blackwell’s work in particular, was scrutinized more closely before being made public. She tells Retraction Watch:
Duke has learned a great deal from the issues raised by the Potti situation and we now have developed better research oversight that is benefitting Duke researchers and our peers.
The correction to the JCO 2008 paper (http://jco.ascopubs.org/content/29/27/3721.1.full.pdf) appears innocuous at first sight but has weird features. It contains three separate corrections – odd in itself. The first and major correction seems to make no sense at all: the correction states that two variables are correlated with each other (not with a third variable), but each one still retains its own r and p value – this makes absolutely no logical sense at all. Correlation between two variables should have a single r value and p value, not separate values for each variable. And the mistake is then repeated.
I have to say I no longer have any trust in JCO corrections / expressions of concern after the journal’s handling of the Roman-Gomez fabrication – plagiarism cases:
http://www.retractionwatch.com/2012/04/05/jco-expresses-concern-over-western-blots-from-spanish-group-that-had-aroused-earlier-concern. One gets the feeling that the authors could say that lymph node status is associated with the diameter of Uranus’ moons and no one would actually notice. The corrections are clearly not actually refereed by scientists.
“We’ve envisioned a world where cancer treatment would kill the cancer and not hurt the patient … and this drug does that.” That is so irresponsible! It also highlights Dr. Blackwell’s bias or inability to place the evidence in the “appropriate skeptical perspective.” I don’t think Duke learned anything.
P.S. Agree with you, amw – 2 correlation coefficients for 1 relationship between two variables? Doesn’t make sense.
Ivan,
I can’t speak for the EMILIA researchers. i find the clinical data on T-DM1, as presented, impressive in terms of a single drug’s activity, and lack of toxicity, in women with metastatic Her2+ breast cancer that progressed with other treatments.
It’s a shame if Blackwell’s work is possibly “contaminated” by association. Unlike benchwork, multi-center clinical trials like EMILIA are closely and independently monitored. So I think it’s unlikely the data presented are untrue.
I blame the media, too, for using such fabulous, “expert” quotes. The data should speak for itself.
“We want to be clear: Despite the fact that work by Blackwell and Potti has been found to have flaws, that doesn’t mean everything Blackwell ever works on needs to be scrutinized more carefully, forever.”
A clever statement. A reader might be left to wonder what would be an appropriate period during which Blackwell’s work should be scrutinized more carefully.
“and this discovery was truly remarkable.” RED FLAG!
Compare this to the way Watson and Crick handled their paper on DNA structure. “This structure has novel features which are of considerable biological interest.” After presenting their proposal for the structure they said, “It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.” It seems as though comments like “truly remarkable” would have been inappropriate if made by the scientist who made the discovery.
“We’ve envisioned a world where cancer treatment would kill the cancer and not hurt the patient” is mundane wish-list, not hypothesis. Certainly “the vision thing” though.
“Wer Visionen hat, soll zum Arzt gehen.” = “Whoever has visions, should go to the doctor’s”. So spake Helmut Schmidt, Germany’s most popular post WWII chancellor, in 1980.
http://de.wikiquote.org/wiki/Helmut_Schmidt
Surely we can find a more realistic version of “We’ve envisioned a world where cancer treatment would kill the cancer and not hurt the patient” in the late 5th century before the Christian Era (BC)?
For example: http://en.wikipedia.org/wiki/Hippocratic_Oath
“I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.” Of course English did not exist at that time.
This is reiterated a little later in the same oath:
“In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or with men, be they free or slaves.”
My understanding is that in the ancient world prudishness was absent, that people were seen as objects to be bought and sold (perhaps still are), and society depended on personal loyalties. The reference to sex, some of which is thought by many to be unorthodox (doctors were predominantly men) may be a reason modern people find that section of the Hippocratic oath disturbing. I think that it show that Hippocrates was addressing the problems of his society, and that those were things that were facts of life. Greeks, under the Mediterranean sky, especially towards dusk, or bathed in the light from olive-oil lamps, can be extremely pretty and were objects which could be misused. It is a known fact. The Hippocratic oath, rather than being quaint, is a social document.
When people from drug companies speak they might mention the problems encountered every day such as price gouging, or lack of transparency about how much things really cost.
http://www.palgrave-journals.com/biosoc/journal/v6/n1/full/biosoc201040a.html
Why don’t they make statements in some modern version of the Hippocratic oath about avoiding price gouging? There are echos of this in a new version of the Oath (2010), in fact about a third of the text, and the main thrust of the document. Oxford Handbook of Clinical Medicine. 8th Edition. OUP. 2010. Page 1.
The most relevant are:
“I will not put profit or my own career above my duty to my patient”.
“I will do my best to keep myself and my colleagues informed of new developments, and ensure that poor standards or bad practices are exposed to those who can imporve them”.
“I will promote fair use of health resources and try to influence positively those whose policies harm public health”.
“I will learn from my mistakes and seek help from colleagues to promote patient safety”.