Date Added to website 27th August 2015
The article they don't want you to read:
"The Trouble with Transparency. The Fight Over Transparency: Round Two"
[Comment from GM-Free Cymru: This article was published on August 13th in the open access journal PLOS One. It covers a wide range of topics, but towards its back end it picks up on the revelations published in an article in Nature News by Keith Kloor:
This article triggered off an interesting set of investigations and further revelations about the $25,000 paid to Kevin Folta (one of the most vociferous of Monsanto's little helpers) in spite of the fact that he had denied having anything to do with that evil corporation. Naturally enough, he was accused of lying, on this as on assorted other matters in recent years. Just look up "Kevin Folta $25,000" on Google, and you will see what we mean......... Anyway, Folta and his cronies were obviously furious about these rather unwelcome revelations about somebody who always likes to boast about his scientific credentials and unimpeachable integrity. So PLOS One was undoubtedly bombarded with aggressive messages from the biotechnology industry, as a result of which they feebly backed off, retracted the paper, and apologised to Folta for any distress the article might have caused him. That of course made the journal a laughing stock, since the article is archived and is freely available for anybody who wants to read it. As a service to mankind, we also publish it below. And to make the matter even more bizarre, the authors of the article, Thacker and Seife have become so angry at the retraction of the article that they have felt empowered to publish another, here:
And as if that is not enough, there is now a broad-based debate in the social media not just about Kevin Folta and his antics, but about the ongoing attempts to stifle transparency on all sorts of ludicrous grounds.
All very entertaining.........]
By Guest Contributor
Posted: August 13, 2015
By Paul D. Thacker and Charles Seife
The backlash against transparency is now underway. The battles being waged are likely to leave their mark over how to perform — and how to interpret — the medical and scientific literature for many years to come.
In the past two decades, it seemed like much of the debate over financial conflicts of interest had quieted. In the wake of several embarrassing scientific debacles where financial conflicts played a prominent role — the death of Jesse Gelsinger,[i] the delayed decision to pull Vioxx and Bextra from the U.S. market,[ii] and the misconduct of Andrew Wakefield,[iii] to name a few — scientists, clinicians, publishers, regulators, and journalists began to beat a steady drumbeat to march research toward transparency.
Top-tier biomedical journals now require explicit disclosure of potential conflicts of interest, as well as any involvement of outside influences in the design, conduct, or writing of scientific studies. Following a series of scandals involving physicians hiding industry money, the Physician Payment Sunshine Act was passed and is now revealing pharmaceutical-industry cash flowing to physicians, academic medical centers and other key players in medicine.[iv] While not true across all areas of the life sciences, greater transparency toward industry financial relationships, information regarding research methods and outcomes are becoming increasingly realized through the use of clinical trials registries and data repositories.
Although transparency has not been proven to eradicate or prevent misbehavior in science, these efforts make it easier for the experts and regulators to independently evaluate the merits of research, scientific practices and resulting public policy. For instance, industry funding of clinical trials invites further scrutiny of study results by experts.[v] An important component to transparency is ensuring public confidence in science by protecting the ability of journalists, government, and nonprofits to uncover potential corrupt practices, especially when the research may impact public health.
Despite the merits of increased transparency, criticism continues. Last June, the New England Journal of Medicine published a series of articles that questioned whether conflict-of-interest policing had gone too far.[vi] The salvo reverberated because NEJM had been a leader of the transparency movement, a point made by several former editors in a scathing response.[vii]
A less well-covered volte-face comes from the Union of Concerned Scientists. Like many other advocacy organizations, UCS has long expressed dismay at the distortion of science.[viii],[ix] Yet within the past year, UCS has begun a campaign to blunt the tools with which the public can investigate claims of scientific malfeasance.
Earlier this year, the organization released a report in which it decried using open-access requests to “bully” scientists and to “disrupt or delay their work.”[x] The report cited several cases where scientists had arguably been harassed in the name of transparency. In particular they noted the case of climate scientist Michael Mann, who had been targeted by the Virginia Attorney General and a corporate-funded nonprofit. UCS noted that several academic organizations filed legal briefs in support of Mann, but the organization failed to note that this attempt to hide access to public emails was opposed by a coalition of 18 media organizations including NPR, The Washington Post, and the Associated Press.[xi] The Columbia Journalism Review later panned the UCS report, writing that “sunlight is a benefit for all.”[xii]
In February, a tiny nonprofit, the U.S. Right to Know, sent Freedom of Information Act (FOIA) requests to several universities. FOIA requests are legal inquiries that allow citizens and other professionals to obtain certain information in the possession of various government entities. These particular requests sought communications between scientists and several companies, trade groups, and PR firms, in order to see if the academics were coordinating their messaging with companies.[xiii]
A journalist reporting on this FOIA request in Science noted that the Organic Consumers Association funds the U.S Right to Know and that many of the scientists targeted are involved with a website called GMO Answers.[xiv] He did not mention that GMO Answers is run by the PR firm Ketchum, on behalf of GMO companies.[xv][xvi]
Upon hearing of these inquiries, a lead analyst at UCS stated, “These requests to the genetic engineering researchers, just like other overly broad open records requests that seek excessive access to scientists’ inboxes, are inappropriate.”[xvii]
Access to Scientists’ Personal Correspondence Can Be Crucial For Safeguarding Public Health
Requests under FOIA for personal correspondence are not just appropriate, but crucial to ensuring transparency. The UCS criticism of open records requests played out around the same time the New York Times ran a front page story regarding Wei-Hock (Willie) Soon of the Harvard-Smithsonian Center for Astrophysics. Soon is a prominent denier of climate change.[xviii]
The article was largely based upon emails acquired from Soon’s Harvard-Smithsonian account via a Freedom of Information Act request. Those emails revealed not just that Soon failed to disclose conflicts of interest in nearly a dozen papers stemming from some $1.2 million in funding from oil industry and global-warming-denying funding sources, but also that those conflicts went deeper than anyone had suspected: several of Soon’s published papers as well as congressional testimony he prepared – were described as “deliverables” for corporate sponsors.[xix] Other emails released under FOIA found Soon eager to discuss papers submitted to journals with potential corporate funders and exposed his role in helping to advance climate denial by pushing disinformation regarding “Climategate,” a fake scandal that involved stolen emails from climate scientists that were later quoted out of context.[xx] It’s the access to Soon’s mailboxes — not any official documentation of funding, nor even sworn statements before Congress — that revealed this behavior.
This is far from the only instance where scientists’ correspondence has revealed practices which cast doubt on the integrity of research. In November of 2009, for example, states attorneys released e-mail messages and internal documents from Johnson & Johnson and Harvard University’s Joseph Biederman. These internal documents showed that Biederman was assisting the company to convince the psychiatric community that antipsychotics, such as Risperdal, were safe and effective in children.[xxi] For example, Biederman told the drug giant Johnson & Johnson that his planned studies of its medicines in children would yield results benefiting the company; Harvard and Biederman himself were paid millions of dollars for their services, much of which was undisclosed. Johnson & Johnson was later ordered to pay $2.2 billion dollars for misleading doctors about the safety of Risperdal, which was being aggressively marketed toward children.[xxii]
Examining scientists’ communications can also uncover corrupt practices, such as attempts to violate the peer-review process. For instance, while investigating the diabetes drug Avandia, Senate investigators read the internal communications of Steven Haffner, an academic at the University of Texas, who was reviewing a study for the New England Journal of Medicine. Documents show that Haffner undermined the confidentiality of the peer-review process by leaking the draft, weeks before it was published, to GlaxoSmithKline, the maker of Avandia. According to a GSK spokesperson, Haffner contacted GSK to get advice on how to evaluate the study’s methodology.[xxiii]
Scientists’ emails have also revealed other mechanisms by which industry exerts control over the scientific literature. A recent Senate investigation released scientists’ emails to show that the device maker Medtronic edited the scientific manuscripts — written by supposedly independent researchers — to support one of their products.[xxiv],[xxv]
Such emails and draft of scientific manuscripts are also important for uncovering medical ghostwriting, a practice in which industry-hired firms write scientific papers, rather than the purported authors of the paper. Ghostwriting played significant roles in many of the most infamous drug product-liability cases in the past decade, including those against Vioxx, Prempro, Paxil, Zyprexa, and Avandia.[xxvi] Without access to internal email drafts of scientific papers, these practices would never have come to light. Denying future access will likely ensure that ghostwriting remains hidden in the future.
The Benefits of Transparency Outweigh the Costs
When witnesses testify before Congress, they must fill out forms to disclose only their ties to the federal government, including any contracts. After seeing Willie Soon’s description of congressional testimony as a corporate “deliverable,” Congressman Raul Grijalva sought to tighten congressional disclosure policies so that witnesses would find it harder to hide their industry ties.[xxvii] But to do so, Grijalva needed to find strong evidence that Soon’s example was not an isolated case. Consequently, he sent requests to seven academics who had given contrarian global-warming testimony before Congress, seeking their financial ties, correspondence, and drafts of their testimony.
UCS’s reaction to Grijalva’s inquiries was muddled and internally contradictory. A UCS science communication officer praised Grijalva’s work, writing that such questions about covert industry influence on “independent” scientific experts “deserve answers.” [xxviii] That same day, another UCS staffer had a very different perspective. He wrote that universities should resist congressional requests for drafts of congressional testimony and scientific correspondence.[xxix] This second argument helped fuel a storyline in the media that likened Grijalva’s request to a McCarthy witch hunt.[xxx]
To be sure, the same mechanisms that watchdogs use to uncover scientific wrongdoing have been abused in the past. Climate scientist Michael Mann, for instance, was subject to invasive and harassing requests for information via freedom of information laws, via judicial-branch powers, and via congressional requests. No doubt they will be abused in the future.
But transparency laws remain a fundamental tool for monitoring possible scientific misbehavior. And it would be a mistake to believe that scientists should not be subject to a high level of outside scrutiny. So long as scientists receive government money, they are subject to government oversight; so long as their work affects the public, journalists and other watchdogs are simply doing their jobs when they seek out possible misconduct and questionable practices that could threaten the public interest. The fruits of that labor are plain to see: UCS has itself cited internal scientists’ communications to make the case that science has been corrupted in instances involving ghostwriting, the manipulation of scientific data at the U.S. Consumer Product Safety Commission, and the altering of scientific conclusions at the U.S. Fish and Wildlife Service.[xxxi],[xxxii],[xxxiii]
Despite the potential for abuse, transparency laws are potent weapons in investigators’ pharmacopeia and will be increasingly important in the coming decade as universities become more entwined with corporate interests. Research has demonstrated that physicians and medical department chairs have considerable ties to industry. Over 80% of the departments surveyed in one article reported at least one relationship with industry, and 94% of physicians have reported ties with pharmaceutical companies.[xxxiv],[xxxv] In the United States, industry funding of medical research has increased relative to other sources, growing from 46% in 1994 to 58% in 2012.[xxxvi] Meanwhile, public funding is continuing to decline.[xxxvii]
The public health implications of these trends are troubling. An examination of clinical research funded by the pharmaceutical industry finds that this financial support tends to produce results in favor of company products.[xxxviii],[xxxix] Biased findings can have far-reaching public health implications as it impacts perceptions of the effectiveness, cost effectiveness and safety of medications; impacting decisions on the allocation of resources, practice guidelines, medical education and clinical decision making.[xl] Importantly, it can erode public trust in science and in medicine, which will have long-reaching negative effects.
Indeed, at a recent congressional hearing to examine the effectiveness of FOIA in advancing transparency and access to public documents, witnesses from journalism, academia and government investigations were united in their view that aggressive demands for public documents advances the public interest.[xli] The main concern expressed by all witnesses had nothing to do with abusive or over-reaching requesters, but that some government entities consistently tried to withhold internal communications to protect themselves from embarrassment. According to one academic witness, this “withhold it because you want to” behavior is widely abused because government wants to keep secret “embarrassing, incriminating, or –sometimes even– burdensome-to-process documents.”[xlii]
The University of Illinois is now facing legal scrutiny after several administrators and academics were caught hiding their work-related business through use of private emails to evade scrutiny from FOIA.[xliii] These hidden emails were recently released and the Chancellor promptly resigned. The university is now examining whether some academics and administrators will be disciplined for this behavior.
Last week, Nature reported that the University of Florida had provided them with emails that U.S. Right to Know had FOIA’d on one of their researchers.[xliv] Written by the same journalist who had reported on the FOIA request previously for Science, the story noted that the researcher has received money from Monsanto to fund expenses incurred while giving educational talks on GMOs. The article also noted that the PR Firm Ketchum had provided the scientist with canned answers to respond to GMO critics, although it is unclear if he used them.
The article does not report that the scientist has repeatedly denied having a financial relationship with Monsanto.[xlv][xlvi] The article also does not report on an email titled “CONFIDENTIAL: Coalition Update” from the researcher to Monsanto in which the scientist advised Monsanto on ways to defeat a political campaign in California to require labeling of GMO products.[xlvii]
UCS maintains that FOIA requests for scientists funding remains fair game, but anything beyond this apparently intrudes into academic freedom.[xlviii] It remains unclear how companies providing canned answers to scientists on scientific topics or scientists advising companies on political campaigns upholds the principles of academic freedom.
What this means in practice is that attempts by universities to withhold public information from the public will likely go unchallenged. As explained by an attorney for the New York Times, such abusive action can only be resolved through litigation, a costly and timely practice that almost ensures the information will remain secret because few citizens have the “resources and know-how to sue.”[xlix]
In short, those working to improve public welfare should oppose attempts to embolden government entities to withhold public information, thus threatening public health and the public trust in science.
Paul D. Thacker is a journalist and consultant, and a former staffer in the United States Senate where he worked on scientific integrity, including passage of the Physician Payments Sunshine Act. He is a Board Member of the James Madison Project, which provides advice and litigation support on Freedom of Information Act requests.
Charles Seife is a journalist and professor of journalism at New York University. He often uses the Freedom of Information Act as a means of investigating issues related to research misconduct and good clinical practice, and is currently suing the Food and Drug Administration for the release of documents related to the scientific integrity of clinical trials.
NOTE: The views expressed in this article are those of the authors and not necessarily those of PLOS.
The authors acknowledge advice and support with key references from Susannah L. Rose, PhD, Professional Staff, Department of Bioethics, Director of Bioethics Research & Policy at Cleveland Clinic and Assistant Professor, Cleveland Clinic Lerner College of Medicine Case Western Reserve University.
CORRECTION: From the authors: In our piece we wrote that the scientist–who we did not name but is Kevin Folta–sent an email entitled “CONFIDENTIAL: Coalition Update” to a Monsanto representative advising them on ways to defeat a California GMO labeling initiative. Our footnote dates that email as 12 September 2011. In fact, that email was sent on 12 September 2014, and it is likely that the title of Folta’s email had a prefix such as “RE:” or “FWD:” before “CONFIDENTIAL: Coalition Update. The originator of the e-mail chain, Bethany Gravell, was the registered agent for the No On 105 Coalition which was organized to defeat a GMO labeling initiative in *Colorado*, not in *California*. Here is the full email: (illustration published)
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[xlvi] Joe Rogan Experience #655 – Kevin Folta. Available: https://www.youtube.com/watch?v=vW8U8ZAhGW8&feature=youtu.be&t=3m5s
[xlvii] Folta K (12 September 2011) Email titled: CONFIDENTIAL: Coalition Update.
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