Scientific Misconduct Is Prevalent, But Not Reported
5 CommentsBy Ed Silverman // June 19th, 2008 // 12:08 pm
About 1,000 potential incidents of fabricated, falsified or plagiarized data in scientific research may go unreported every year, according to a survey in Nature*. And this suggests scientific misconduct is more prevalent than previously imagined and calls into question the effectiveness of self-regulation.
Interestingly, an average of only 24 reports are made to the Department of Health and Human Services’ Office of Research Integrity each year of suspected misconduct from academic and other research institutions yearly, according to Nature.
The 2,212 researchers surveyed observed 201 instances of likely misconduct over a three-year period, which amounts to three incidents per 100 researchers per year. A conservative extrapolation of the findings to all DHHS-funded researchers predicts more than 2,300 observations of potential misconduct are made each year, the researcher write, adding that not all are reported to universities and few are being reported to the ORI.
“We want to know if we’re handling misconduct appropriately,” Sandra Titus, the director of intramural research at the ORI and one of the study authors, tells Bloomberg News. “There’s a feeling there’s a disconnect between what the office sees and what’s happening in the world.”
To fix the problem, which the researchers note many universities would prefer to keep quiet, they suggest six ideas: adopt zero tolerance; protect whistleblowers; clarify how misconduct should be reported; train mentors; find alternatives to rooting out misconduct, such as audits; and model ethical behavior.
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Dan
Published on http://www.brainblogger.com
The Human Injury of Lost Objectivity
If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others, yet sponsored by a pharmaceutical company, would be at the top of the list. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and sterile that is completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of community patient care clinics. Because of this structure, investigators of these trials are likely void of necessary research experience or quality regarding their research purpose and ability to ensure its sterility. These quite numerous CROS are for- profit, with some CROs making billions of dollars a year.
The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for the studied drug of thiers. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns.. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent.
More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, which would require independent clinical trial sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health.
Knowledge is power, and is also possibly a lifesaver.
“Ethics and Science need to shake hands.” ……. Richard Cabot
Dan Abshear
Author’s note: What has been written was based upon information and belief.
Jack2
Dan,
This study is from Nature. That means it’s A) primarily basic science and B) primarily academic government supported researchers.
I understand it’s too much to ask you to actually write the individual post, and not pull out a post from your pregenerated post machine, but could you at least make sure your pregenerated post machine actually posts relevant posts?
post. post.
pg
Dan, thanks for the post. A lot of it is relevant, such as:
“…Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function…”
Nathan
Jack2 — actually this isn’t MOSTLY academic work - it’s ONLY academic work. The survey was of 2000 researchers who recieved NIH funding. Nobody in industry(that I’m aware of)can get NIH money - so I assume ALL alleged cases are academic. Here’s a quote:
“The data was based on surveys of 2,212 scientists holding research funding from the National Institutes of Health, asking if they believed they had observed fraud in 2002-2005. The scientists surveyed in the report said they observed 201 instances of “likely misconduct” over a three-year period, or about three cases per 100 people per year.”
Here’s an interesting observation: “About a quarter of what the observers believed to be misconduct in the survey was by postdoctoral fellows, and about 22 percent was by a professor or senior scientist.”
Ok, so that only accounts for ~50% of the alleged misconduct??!! Where is the other 50? One presumes that it must be graduate students! That wouldn’t suprise me a bit…
Jack2
Good point Nathan. I still think it’s worth using the “mostly” qualifier, because a single PI could have NIH funding for one grant, and industry funding for another grant. My understanding is this study selects only people who definetly have government funding, but doesn’t necessarily exclude people with industry funding. It sort of jives with my own experience (where there’s LESS shenanigans in industry), but that’s just the experience of 1 person.
The bigger issue here is Dan’s (as usual) irrelevant anti-industry propaganda. These things really twists my nads.