The journal Cancer has issued an Expression of Concern about two lung cancer screening papers long dogged by doubt.
Last April, The Cancer Letter and The New York Times jointly published an investigation into the International Early Lung Cancer Action Program (I-ELCAP) run by Claudia Henschke and David Yankelevitz. Other researchers had already criticized the design and conclusions of that trial, but as the investigation noted, an October 2008 review of the study found that the researchers couldn’t find 90 percent of the subjects’ consent forms, an ethical no-no that jeopardizes as many as 135 papers.
Two papers published in Cancer, in 2000 and 2001, are among those studies, according to the notice (links added), which credits the Times and The Cancer Letter and notes that the journal has referred the case to Federal investigators:
Cancer is publishing an Editorial Expression of Concern regarding the following articles:
‘‘Early Lung Cancer Action Project: Overall Design and Findings From Baseline Screening’’ by Claudia I. Henschke (Cancer. 2000;89(suppl 11):2474-2482).
‘‘Early Lung Cancer Action Project: Initial Findings on Repeat Screenings’’ by Claudia I. Henschke, David P. Naidich, David F. Yankelevitz, Georgeann McGuinness, Dorothy I. McCauley, James P. Smith, Daniel Libby, Mark Pasmantier, Madeline Vazquez, June Koizumi, Douglas Flieder, Nasser Altorki, and Olli S. Miettinen (Cancer. 2001;92:153-159).
This Expression of Concern is based on an April 29, 2011, article in The New York Times as well as the April 29, 2011, issue of The Cancer Letter, both of which disclosed details of a report of an Independent Scientific Review Committee (Review Committee) convened by Weill Cornell Medical College to investigate the scientific research conducted as part of the International Early Lung Cancer Action Program (I-ELCAP). The Review Committee reported, among other things, that the I-ELCAP lacked positive confirmation of valid informed consent for all subjects at all sites by the coordinating center.
The information contained in the Review Committee’s report raises issues that cannot be fully investigated by the journal. We have therefore referred this matter to the Department of Health and Human Services Office for Human Research Protections.
Based on the information we have received thus far, we are issuing this Expression of Concern to alert our readers.
The notice also refers to an April 11, 2008 Publisher’s Note about the study that detailed a number of financial conflicts of interest, including patent applications, that Henschke had failed to disclose when she submitted the papers.
The 2000 paper has been cited 62 times, according to Thomson Scientific’s Web of Knowledge, while the 2001 paper has been cited 267.
A separate 2010 study by the National Cancer Institute, the National Lung Screening Trial, validated the general principle behind the I-ELCAP trial.
We’ll update this post as we learn more.
It is encouraging that in this case at least a failure to produce the mandated consent forms leads to the retraction of the affected papers. Here it took a Scientific Review Committee to discover the absence of these forms. What happens if an outsider makes the same discovery which is, after all, a simple yes-no answer and does not depend on the special credentials of those who make the discovery?
As documented at http://retinopathyofprematurity.org/bioethicsconsent.htm, the National Institutes of Health “cannot locate” even the model consent forms for the knowingly lethal child suffocation experiment described at http://retinopathyofprematurity.org/BioethicsSUPPORT.htm. Parental consent to this experiment would have been legally impossible because it was not at all in their child’s interest, so it is clear that either the phantom consent forms lied about the risks, or that the researchers conducted the entire experiment behind the back of the parents who had no way of telling that anyone fiddled with the oxygen supply of their baby for research purposes but not to help that baby. How does one go about getting such an ethics-violating study retracted?
Thank you in advance for your advice. Peter Aleff
After reading (most) of the document referred to in the link in your comment, I have two comments. One, that the studies mentioned (reducing oxygen supplementation to premature babies) appear to be (highly) unethical. Two, that the author of the document is foaming at the mouth. Repeated use of the term “baby-killing”, among many other pejoratives, exhausts the reader in an apparent attempt to arouse his/her ire. A more objective tone would probably result in more agreement without putting the reader through so much stress.
How to get those studies retracted? Well, for starters, complain to the journals involved. If that doesn’t work, keep going up the hierarchy. If that doesn’t work, then just maybe the offending researchers are just too well connected and powerful to be put down that way. There are some fights you can’t win, no matter how many times you say “baby killer.”
To me, it would be a victory just to have preemie nurseries start putting patches over the babies eyes. And then give them enough 02 to get their saturations to 98%.
Thank you, Conrad Seitz, for your thoughtful comments about my post re-garding the lack of consent forms in recent experiments withholding oxygen breathing help from premature babies. I appreciate your agreement that those I cite are highly unethical, and also your advice that my use of charged words such as “baby-killing” exhausts the reader and puts him or her through more stress than a more objective tone would.
Granted, but objectivity is in the eye of the beholder, and it is not synonymous with the blandness required to avoid offending anyone in the ivory tower. To be truly objective I should have used the official FBI term for the willful killing of another person which is “murder”, instead of toning down the deliberate mass asphyxiation by those Mengele-style hypoxia experimenters with the semi-euphemism of “killing”. This may indeed turn off some readers who value professional decorum above unvarnished truth, but most of those are unwilling anyway to admit the embarrassing reality that crimes are crimes.
In the recent child sex abuse scandal at Penn State University, those who enabled the abuser by covering up for him were toppled like dominoes up the ladder, all the way to the University President, because of their failure to treat his crimes as the crimes they objectively were to all outsiders. There is a lesson in this about when outrage is more appropriate than polite silence, but it may often be lost on diehard insiders. Also, intentionally killing children is even worse than abusing them sexually, so it deserves in my opinion even more outrage from those who want such abuses to stop.
It is the reluctance of calling things by their proper names that leads us to misunderstand their true nature and to believe that sugar-coated killing does somehow not make the victim as dead as the plain thing. For instance, the first two decades of oxygen withholding from 1955 on asphyxiated about 150,000 preemies, according to (low-balled) estimates in the medical literature. This medical mass slaughter would likely have been less severe if the nursery doctors responsible for it had acknowledged what their suffocating policies were doing to those babies, instead of just sweeping the growing mountain of their corpses under the rug.
The current American nursery doctors are also dangerously misled by their authorities’ failure to understand that intentionally suffocating babies to death is a crime. The latest U.S. guidelines for intensive care nursery practices advocate now to restrict the oxygen for all preemies to the levels used in the SUPPORT low-oxygen group although this withholding led to 23 “extra” deaths, with only a 4 per cent probability that this result was a statistical fluke. By contrast, their more patient-friendly colleagues in England and Australia were more concerned about such killing and stopped enrollment in their parallel studies when they detected the increased mortality from low oxygen levels. In contrast to the new and knowingly baby-killing U.S. guidelines, they recommend to avoid those low and fatal oxygen levels.
I also thank you for your suggestions on how to get those unethical papers retracted. Unfortunately, they are based on the assumption that the official system works whereas my experiences with it as an outsider have shown to me that it does not. The SUPPORT paper appeared in the NEJM. I had tried a few years earlier to alert the editors of that Journal to another fraudulent and abusive experiment on preemies, the LIGHT-ROP experiment of intentionally patching their eyes too late to have any effect, described at http://retinopathyofprematurity.org/40fraudsinLIGHTROP.htm. (This fraud keeps the eyes of preemies from being protected against blinding light and so continues the profitable ROP epidemic.)
The NEJM editors did not react to my warning and published that fraud anyway, so I did not waste my time on them for the present case. However, I filed fully documented complaints about the SUPPORT abuses to the Offices for Human Research Protection and for Research Integrity. These remain unanswered, presumably because the offending researchers are as well connected and powerful as you suspected they may be. Indeed, the Universities headed by the Chair and Vice Chair of the Presidential Commission for the Study of Bioethical Issues are both involved in these child suffocation experiments without parental consent.
I agree that the fight against the stonewalling from such bioethics luminaries to deny their support for unethical research without informed consent may be difficult to win, but I believe it cannot be won without exposing their complicity in the willful baby-killing, and without calling that killing what it is. To end this ongoing mass-murder those involved must be made to understand that suffocating anyone is a crime, even when it is done for science, and even if the perpetrators use such passive terms as “increase in mortality” to replace the active word “killing”.
Respectfully submitted, Peter Aleff
[email protected]
I am naturally disappointed and dismayed by the decision of the American Cancer Society (ACS) and its journal Cancer to publish an Expression of Concern regarding two articles that were subjected to peer-review and were published more than a decade ago.
ACS’ journal cites, as basis for issuing the concern, two articles in the lay press (The New York Times and Cancer Letter). Based on these media reports, Cancer inaccurately concludes that we were unable to locate 90 percent of our study subjects’ consent forms. This is simply untrue. A scientific review of the program conducted in 2008 found that, “10 percent of the consents have been documented historically.” That is quite a different statement, and in no way suggests an inability to locate anything. In that same report, the reviewers also supported the study’s methods and implementation, noting that, “the data collection and analysis have generally conformed to commonly accepted principles, and there is no evidence to suggest that data have been altered or maliciously misreported.”
The study design and other scientific considerations were reviewed by the extensive peer-review process of the National Cancer Institute (NCI) prior to receiving grant awards. The protocol was reviewed and approved by the Cornell Institutional Review Board (IRB) and Cornell has publically stated that, “there were no issues regarding the safety of the research subjects.”
I have repeatedly asked Cancer to explain to us what their specific concerns were regarding “institutional oversight.” They never responded. In an attempt to allay any possible concerns, I invited a designated group of people from Cancer to personally inspect the consent forms. This offer never received a response.
For ACS’s journal to base their decision on media reports that have inaccurately portrayed and misrepresented our research is extremely concerning and raises serious doubts about their motives and their adherence to scientific and journalistic standards. Further, to punt their duty to examine this issue thoroughly before running their Expression of Concern is a questionable precedent given that the basis for their ‘concern’ is the content of two erroneous media reports.
I will do everything in our power to uphold our research, and to prevent those who want to silence us from succeeding. Too many lives are at stake to do so. – Dr. Claudia Henschke
Dr Henschke,
For the careful and thoughtful readers of a blog like this, your post is a red flag. You make the abstract logical point that “90% are lost” is not the same as “10% were found”. Instead, just post 100% of the consent forms, in anonymised form. Please speak bluntly, and say what actually happened. Also – was your post written by your lawyer?
What does “10 percent of the consents have been documented historically.” mean exactly?
So that means 90% of consents have not been “documented historically” or in any other way?
How does that ten percent statement “in no way suggest” an inability to locate the consents? It certainly indicates (not suggests) that the vast majority of the consents are in some way missing. Please provide a clearer explication of this finding, if you wish us to believe that there is not a serious problem with the consents. Or do you believe that consent is not needed?