>>> Posting number 11835, dated 11 Jan 2007 08:22:32 Date: Thu, 11 Jan 2007 08:22:32 +0000 Reply-To: Discussion of Fraud in Science Sender: Discussion of Fraud in Science From: Aubrey Subject: Re: SPAM-LOW: Re: licensing scientists to practice In-Reply-To: <010b01c7353f$cb9e9d10$0201a8c0@alan> MIME-Version: 1.0 Content-Type: text/plain; charset=iso-8859-1 Content-Transfer-Encoding: 8bit First can I say that this list seems (at long last) to be working as it should - hooray. It would be nice to get our membership up. OK Alan. I am getting more enthused. I did NOT say that if the ORI does not define it as misconduct (within its rather arbitrary definition) then it's not misconduct. I only said that that is exactly what is happening! I know of a number of cases where the ORI definition (or its clones) WAS used in exactly this way - to excuse overt misconduct. "The ORI does not define this as misconduct". And personally I think the ORI definitions are perverse, outdated, inappropriate and irrelevant. Quite simply they don't encompass the majority of actual and obvious misconduct that is taking place in any unambiguous way. And they cause confusion. The definition has to start with a clear statement of the all of the various rules, safeguards and principles of good conduct in science. Misconduct flows from those rules and the variety of means through which they can be subverted. One cannot start with a definition of "what misconduct is". That is about as illogical as trying to define murder starting with a shortlist of the causes of death. The ORI could do a lot to undo the damage caused, and should do so urgently. I would appreciate a clear reference to a statement (or precedent) from the ORI that non-publication of a study is research misconduct (just as deletion of a data point). That would be really very useful and helpful. I want to write a paper trying to apply the usual rules of misconduct to commercial research through actual examples. Anyone out there who wants to join me in this enterprise, please email me off-list. Aubrey Blumsohn AP> AP> AP> Aubrey, several of these assmptions or AP> statements about ORI are incorrect. AP> AP>   AP> AP> First, it is illogical to assume, as you AP> stated, "Most serious lapses of research integrity that AP> are arising and are causing real human AP> suffering don't fit into the ORI's nice FFP AP> definition or its remit. And if it doesn't AP> fit the definition it's not misconduct. And if AP> it's not misconduct it's OK" AP> AP>   AP> AP> ORI never made such a statement, indeed we at AP> ORI have often said just the opposite to AP> officials and others.  We have told AP> whistleblowers and research integrity officers AP> (RIOs) that, while their cases do not fall AP> under ORI's legal authority (they do not AP> involve HHS applications/funds or do not AP> involve falsification, fabrication, or AP> plagiarism of research), they do involve AP> apparently unethical or unprofessional AP> activities, with which their institutions AP> should deal.  ORI staff give the AP> whistleblowers the name and contact AP> information on the relevant RIOs and give AP> them advice about how to present and document their concerns. AP> AP>   AP> AP> Second, your two example scenarios (a and b AP> below) are BOTH research misconduct cases, AP> despite your suggestion that ORI might AP> consider them differently -- not so.  AP> Falsification in reporting research, by AP> dishonest selection of data or studies, is AP> research misconduct as ORI defines it.  As AP> Carolyn noted, if there were an internal AP> whistleblower who provided evidence of b AP> (unpublished studies that contradict published AP> ones), ORI would pursue that case as a AP> research misconduct issue, assuming there were AP> HHS funding.  Of course, if there were no AP> whistleblower, or reviewer/editor, who caught AP> the false papers and came forward, then ORI AP> would not know (ORI does not have AP> audit/inspection authority like FDA does over AP> regulated human drug and device research). AP> AP>   AP> AP> Third, the scientists in ORI do this, as you AP> suggested: "To maintain its credibility the ORI should be AP> fighting tooth and nail for integrity (as AP> should all of us)."  However, you must AP> recognize that it would be illegal for ORI AP> staff to exceed their authority into other AP> areas, as you suggested.  ORI's authority is AP> legislated and restricted by the U.S. AP> Congress, as administered by the Department of AP> Health and Human Services.  And HHS has AP> assigned separate authority to the Food and AP> Drug Administration (FDA, for regulated drug AP> and device research), to the Office of Human AP> Research Protections (OHRP, for human AP> subjects protection), to the Office of AP> Laboratory Animal Welfare (OLAW-NIH, for AP> animal subjects protection).  In addition, AP> all other Federal agencies have their own AP> regulatory authority, over research AP> misconduct and fraud.  However, as you AP> repeatedly have stated, none of them have AP> authority (beyond FDA's on drugs and devices AP> for human beings) over privately funded, AP> unpublished research/clinical studies.  AP> AP> I recognize your serious concerns abouit the AP> lack of regulation and oversight of some AP> clinical research, but ORI is not and cannot AP> legally be the answer to dealing with these AP> problems.  Furthermore, ORI never pretended AP> to be able to do so.  ORI AP> Newsletter http://ori.hhs.gov/publications/newsletters.shtml contains AP> stories on such non-ORI concerns, to encourage AP> discussion and recognition of them in the community. AP> AP> You are welcome to submit short articles for AP> the Newsletter == see ivitation at AP> http://ori.hhs.gov/publications/newsletter_submissions.shtml AP> AP>   AP> AP> Alan AP> AP>   AP> AP>   AP> AP> Alan R. Price AP> Price Research Integrity Consultant Experts AP> Alan P.R.I.C.E. cell  phone -- 512-483-1574 AP> PRICE email  -- AP> resmisccons@researchmisconductconsultant.com AP> PRICE website -- AP> http://www.researchmisconductconsultant.com AP> AP> ----- Original Message ----- AP> From: "Aubrey" AP> AP> To: AP> AP> Sent: Wednesday, January 10, 2007 12:40 PM AP> AP> Subject: SPAM-LOW: Re: licensing scientists to practice AP> AP> Lida AP> I think we are in agreement about the issues. AP> I think you just don't really like what I am AP> trying to say about them, or the implications -- AP> but these things need debating. AP> Let me summarize (slightly off the cuff) the problem as I see it. AP> ======= AP> 1) If we are going to deal with research Integrity AP> (as in oRI) we need to understand what we mean by AP> integrity, define it, and have a good AP> understanding of the actual public-interest AP> problems that are arising out there right now. AP> ======= AP> 2) A large bulk of the research misconduct AP> currently taking place is at the University/Industrial AP> interface and in particular at the AP> University/Pharmaceutical interface. AP> The ORI has no jurisdiction over this research. AP> ======== AP> 3) Most serious lapses of research integrity that AP> are arising and are causing real human suffering don't fit AP> into the ORI's nice FFP definition or its remit. AP> And if it doesn't fit the definition it's AP> not misconduct.        NOT TRUE - ARP AP> And if it's not misconduct it's OK. There also AP> seems to be no real debate about the principles.        AP> The effect of this is that ORI definitions are AP> used to excuse misconduct even outside its rather AP> limited sphere of influence. AP> Examples include the so called "deliberate self AP> deception" we discussed before AP> Likewise Carolyn's input would be useful here, AP> because the ORI would neatly define what happened AP> to her as an "authorship dispute". And if its not AP> in the ORI FFP definition of misconduct its not AP> misconduct. And if it's not misconduct then it's AP> OK. Some appalling examples of plagiarism have AP> been excused on the basis of the ORI definition, AP> Similarly when powerful figures suppress an entire AP> line of research (as in John Hewitt's) case, that AP> would not be regarded as misconduct. Yet that is AP> pervasive. And if it is not misconduct then it's OK. AP> A further example is non publication of findings - AP> an area which is subject to the most illogical of AP> thought processes. [. . .] AP> b) I then do 20 different clinical trials of an AP> antidepressant drug each in 500 children. 6 show that the AP> drug appears to work versus placebo. The other 14 AP> show that the drug either doesn't work, or AP> precipitates suicide. I publish only the 6 STUDIES AP> that give the results I want. Even if within the AP> remit of the ORI, the ORI would not regard that as AP> research misconduct, because non publication of a AP> study is not research misconduct according to the AP> ORI. And in any event the data is "proprietary" so AP> I can publish what bits of it I want AP> (bulls__t).                NOT TRUE -- ARP AP> Is there really a difference between A & B? AP> I think the ORI should realise that it does have AP> influence (good and bad) beyond its narrowly AP> defined remit. AP> ========= AP> 4) The mere fact that the ORI is not getting AP> involved in the sea of misconduct, but whittles on AP> about the tiny bit of its remit (without commenting AP> on the rest and upon the remit itself) makes the whole AP> charade rather incredible. I suppose what we are AP> saying is that the ORI may be doing a sort-of AP> useful job in terms of what its job is, but that AP> in the global scheme of things it is irrelevant to AP> research integrity? A name change may help to AP> avoid the some misconceptions. AP> ======== AP> 5) I have no doubt that the majority of AP> individuals within the ORI are hardworking and AP> well intentioned -- just as the majority of AP> individuals within the FDA. However the ORI has in AP> reality failed, just as the FDA has failed. And we AP> need to consider whether we would be better off AP> rather than worse off if neither existed. AP> Obviously I am talking beyond the US, so the same AP> applies to the MHRA, UK-PRI etc. AP> ========== AP> 6) Neither in reality do journal editors or the AP> FDA have any real influence on what is happening AP> despite what you and Alan say. AP> You need to read about the actual cases that have AP> arisen. AP> So just from the past few weeks we have AP> http://ahrp.blogspot.com/2006/09/bayer-failed-to-reveal-lethal-drug.html AP> http://ahrp.blogspot.com/2006/12/nejm-covering-up-for-national-kidney.html AP> http://ahrp.blogspot.com/2006/11/negative-research-results-mostly.html AP> http://ahrp.blogspot.com/2006/11/dangerous-deception-hiding-evidence-of.html AP> Most FDA debarments are in fact commercially AP> instigated investigations of University AP> researchers not the other way round (for example AP> an individual researcher who generates a fake AP> patient for entry into a clinical trial for AP> money). These individuals are quite rightly AP> sanctioned with great fanfare. Its called a AP> cynical concentrating on the minute weeds to avoid AP> any scrutiny of the forest. AP> Again just as a tiny snippet take a read of the AP> following and ask what's going on (as a human AP> being, not as a scientist). It relates to AP> the transcripts of the FDA hearings a few weeks AP> ago on hidden suicide data from antidepressant AP> trials. Imagine while reading (and peruse the AP> original if you have the stomach) that you are the AP> parent of a 16 year old who committed suicide a few AP> days after starting an SSRI antidepressant. AP> === AP> http://ahrp.blogspot.com/2006_12_01_archive.html AP> One highlight of the meeting for me was watching AP> Tom Laughren, Director of the Division of AP> Psychiatry Products of FDA's Center for Drug AP> Evaluation and Research, intently take notes and AP> never look up as a long line of individuals made AP> their 3-minute presentation to the committee, AP> alternatively condemning and praising AP> antidepressants. Dr. Laughren AP> never looked up even when Dr. David Healy charged AP> him, on the public record, with being the sole AP> author of an article in which suicidal events from AP> drug-treated groups were arbitrarily switched to AP> placebo-treated groups. AP> I expected a committee member to ask, "Dr. AP> Laughren, is Dr. Healy's statement true? If so, AP> can you tell us precisely how common occurrences AP> of fake data are in the database the FDA is using AP> to determine the risk of antidepressant-induced AP> suicidality? If the FDA doesn't have this AP> information for us now, should we adjourn this AP> meeting until it is provided to us?" AP> And yet, silence... AP> ==== AP> 7) "no one can force pharma to publish the AP> results of proprietary studies which they have AP> conducted in house." AP> This sounds nice in theory, but we need to put AP> flesh to this through the many actual example to understand AP> the very dangerous problems with this glib AP> assertion. I am sure this will mean more to AP> those involved in clinical research who know what AP> problems are arising. However it is AP> absolutely not reasonable to think that Pharma AP> cannot be forced to publish findings honestly. After all it AP> sells products under the banner of science. To AP> maintain its credibility the ORI should be AP> fighting tooth and nail for integrity (as should AP> all of us). AP> To state a few obvious things: AP> a) Publication only of studies that yield AP> desirable findings is fraud (just as deleting data AP> points that don't show what you want). Anyone with any AP> understanding of statistics would understand why AP> this is the case. AP> b) We are talking about licensed drugs, not the AP> next best MP3 player. Doctors and patients use AP> these drugs based on the science and the honest AP> representation of that science. By contrast, an AP> MP3 buyer does not need to know how the secret AP> chip works. AP> c) Human volunteers partake in these studies AP> (subjecting themselves to risk). They do so on the AP> understanding that the data derived from their AP> risk is going to be used appropriately, analysed AP> honestly, and published. AP> So in summary: AP> The problem remains that addressing research AP> misconduct selectively (i.e Eric Pohlman, but not AP> Bayer Inc.) makes the whole thing rather silly and AP> discreditable. AP> I suppose for me the start and end of the death of AP> the ORI related to the Baltimore affair, and its AP> fudged apparently unprincipled outcome. AP> We have no deep thinking going on. AP> And I'm not worried about being disrespectful. I'm AP> not even sure what that means. AP> Aubrey Blumsohn AP>