Life Science Compliance Update

February 03, 2016

ICMEJ Proposes Data Socialism – Data Utopianism Has its Cracks - Comments Due April 18

The International Committee of Medical Journal Editors (ICMJE) recently put forth a proposed set of new requirements for sharing data that was generated by interventional clinical trials. The ICJME believes there is an ethical obligation to responsibly share such data because the participants in the trials put themselves at risk.

Essentially the ICMJE is proposing that as a condition of consideration for publication of a clinical trial report in their member journals, the authors must share with others the deidentified individual patient data (IPD) that is underlying the results presented in the article, including any tables, figures, appendices, and other supplementary material, no later than six months after publication. This proposed requirement will include all data underlying the results of the article's findings, as well as any necessary metadata.

As you can imagine, there are strong opinions on both sides of this proposal. Those who are arguing for it, claim, "many funders around the world – foundations, government agencies, and industry – now mandate data sharing." You know, that whole, "everyone else is doing it, we should too," mentality that our parents warned us about when we were younger.

Those who are against it have a multitude of opinions and reasons for being against it. Some go so far as to refer to those who support data sharing as "data parasites," since they latch onto research that has already been painstakingly performed and utilize it for their own purposes.

Analysis

This new proposed rule may sound like a nice idea, having the ability to reexamine high-quality information for the possibility of new information being found, potentially resulting in higher patient satisfaction and longevity. However, as just about anyone who has ever managed clinical studies, performed data collection and analysis, or curated data sets knows, there are a litany of concerns over such a proposal. Dan L. Longo, M.D., and Jeffrey M. Drazen, M.D., penned an editorial laying out some of their concerns from that perspective.

One such concern is that someone who is not involved in the generation and the collection of the data will not understand the choices the researchers made in defining the parameters. Some specific questions raised by Longo and Drazen included, "How heterogeneous were the study populations? Were the eligibility criteria the same? Can it be assumed that the differences in study populations, data collection and analysis, and treatments, both protocol-specified and unspecified, can be ignored?"

A second, very valid, concern, is that an entirely new class of research person will emerge – someone who had nothing to do with the design and the execution of the study, but use another group's hard-earned data for their own ends. These "stealers of data" can then use the data to steal research productivity planned by the data gatherers, or even use the stolen data to disprove the original researchers analysis.

Data sharing may not be all bad, depending on how it is performed and what requirements are in place. Longo and Drazen posit, for example, that if data sharing were to work symbiotically, with collaborators whose collected data might be useful in assessing your hypothesis, it might be beneficial for all parties involved, including patients. Throughout the symbiotic relationship, the two (or more) teams of researchers work together to test a hypothesis and report new findings with coauthorship, acknowledging the group that proposed the new idea and the investigative group that pursued the data and allowed it to be tested.

It is interesting to note that four days after jointly submitting an editorial piece with Dan Longo, M.D., Jeffrey Drazen, M.D., walked back part of it. He clarified that the New England Journal of Medicine, the forum for the initial editorial, is "committed to data sharing in the setting of clinical trials." He went on to comment that he believes "there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly used" and that "researchers who analyze data collected by others can substantially improve human health."

In the walk back, he concludes by once again bringing up data sharing through collaboration, signaling that such form of data sharing may be palatable to more than just the "data socialists" who want to take your hard-researched data a mere six months after the publication of your findings.

Saurabh Jha, a radiologist in Philadelphia, summed it up nicely,

It takes a lot of effort to generate data in biomedical sciences. To expect researchers to surrender the data for the greater good is fuzzy, and lamentably boring, adolescent naivety. If we do not recognize the self-interest of researchers, data socialism, like other forms of socialism, is condemned to failure.

If you would like to provide feedback on the ICMJE proposal, you may submit your comments and concerns to the International Committee of Medical Journal Editors by April 18, 2016.

For More Background on This Controversy David Shaywitz, MD at Forbes has a great series:

Data Scientists = Research Parasites?

Biden Cancer Project: An Opportunity To Implement Data Sharing Incentives    

Do We Really Want To Separate Clinical Data Gathering And Data Analysis?

        

 

 

 

December 01, 2015

Study Explores Lack of Sunshine Act Guidance From Professional Medical Associations

  Unclear

As with any large piece of legislation, the Sunshine Act (Open Payments) has conjured up a wide variety of reactions, including concerns about the accuracy of the published data, possible misinterpretations of the published data, and downstream effects on innovative drug development. More fundamentally, given the complexity of the Sunshine Act, simply figuring out what the rules are has proven challenging. A recent research article published in Postgraduate Medicine, has concluded that a lack of professional guidance on how to interpret elements of Sunshine Act may be having a "chilling effect" on physician investigators' participation in clinical trials and publish results. 

A group of researchers delved into various guidances from professional medical associations to get a better understanding of how physicians are views the requirements, and what, if any advice they provide to their members on how to best comply. The article focuses on guidance on how-"nonmonetary assistance" provided by the pharmaceutical industry to those who write medical publications on licensed drugs. Industry often provides this support to authors "to assist with the development of medical publications (including peer-reviewed journal articles and reviews, congress abstracts and oral and poster presentations)," the authors write. "The support often is in the form of medical writing, copyediting and creating artwork for the publications, under the direction of the authors.

Researchers’ Methods

The researchers explored both peer-reviewed and “grey” literature to get the best compilation of industry viewpoints. Grey literature is defined as “articles, in print or electronic form, not published in easily accessible journals and which may not be indexed in formal academic databases” and can be found in search engines such as Google and Google Scholar.

The researchers pored through many articles and publications, placing them into six categories: industry-supported/sponsored publications, industry–author relationships, industry–investigator relationships, guidance and/or recommendations related to industry– HCP relationships, ethical considerations around the Act, and industry-sponsored research. If an article or publication did not fit into one of the six criteria, it was excluded. If an article fit into multiple categories, the researchers placed it in the category that was most prominent within the article.

Once a publication was deemed to meet the criteria, the researchers collected its publication type (peer reviewed, “grey,” industry, or academic), the year the article was published, the content type, and created a structured summary of three significant findings/conclusions per publication.

Results

In total, the researchers reviewed fifty-nine articles and concluded that there is limited guidance out there on how to best follow the Sunshine Act mandate. Professional associations tended to focus on clarifying the reporting requirements to their subscribers and readers. While the professional associations websites and articles “contained broad guidance, there was insufficient consistence or consensus from associations around specific concerns, including [transfers of value] for research grants, trial participation and medical publications.”

Most of the publications and articles focused on reiterating the Rules to their readership, ensuring that at the very least, their readers would know that the new Rules existed. Whether the readers would know how to implement those Rules, however, is another question. Most publications tried to provide an outline for covered recipients and healthcare providers, showing them how to prepare themselves and check the data reported.

The arena of medical publications and payments remains murky, at best. The researchers found that the Rules contain no clear direction on how to report industry support of authors. One group found that even when guidance is sought and clarifications were requested, it was tough to discern the real answers and requirements.

Additionally, the authors of the study came to realize that key opinion leaders in the field may be overrepresented in the clinical literature relative to other experts, regardless of their financial relationships, because of the frequency with which they appear in publications and articles offering their expertise. This has the potential to limit the value of disclosures made under the Act.

Conclusion

The researchers determined that while there is some guidance that has been written on the most effective, efficient, and responsible way to implement and follow the Sunshine Act mandate, there is no expert interpretation of the Final Rules. As such, there are not only many gaps in guidance, but also a lack of complete confidence in the guidance that has been written.

The researchers do recognize that a lack of expert interpretation can be due to many reasons, one of which is publications are expecting the law to evolve a bit before it reaches its final form, and contracting an expert opinion at this point in time is a bit too early.

The authors warn that without the expert interpretation of the Final Rules, “the process of assigning a monetary value to publication support may continue to vary across companies. One consequence may be confusion among authors, particularly those working with several different companies, and the risk of disputed Open Payments records.” They believe that education is one of the most important components to ensure that the relationships between the pharmaceutical industry and physicians, and the data published in the Open Payments system, are placed and understood in the proper context. 

November 16, 2015

ACCME: Accreditation Rules Safeguard Continuing Medical Education from Commercial Influence

Continuing medical education courses have been under attack lately, with skeptical writers making unsubstantiated claims that CME courses have "become a key marketing tool for increasing clinician receptivity to new products." Those writers make bold claims, but are unable to back their claims up with concrete evidence.

Graham T. McMahon, a physician and the president of the Accreditation Council for Continuing Medical Education (ACCME), has been working diligently to set some of these unsupported claims straight, reminding medical professionals and others that organizations such as the ACCME exist to "set and monitor the standards that, among other goals, ensure that educational programs offered by organizations that we accredit are independent and free of commercial bias."

Dr. McMahon continues to reiterate that promotion and marketing do not have a place in accredited CME courses. Accredited education is designed to offer physicians and health care teams a space to learn, teach, discuss emerging science, and debate ethical or controversial issues without any commercial influence. Non-accredited CME does exist, however, and Dr. McMahon cannot speak to the rigorous standards that might be applied to those courses, but states that if the authors making allegations against CME courses are referring to non-accredited CME being infiltrated with marketing tactics, then they should specify that and not apply such a broad brush against all CME courses.

The authors of the most recent article, including Adriane Fugh-Bermann, a known CME critic and director of PharmedOut, suggest that providers of CME activities have allowed commercial support to include marketing messages to increase awareness and understanding of hypoactive sexual desire disorder, and implies that the ACCME Standards for Commercial Support are either inadequate or ignored by accredited organizations. The authors, however, do not provide any support or evidence of actual courses that have been given accreditation with such "marketing messages."

As we have previously written, the standards that accredited CME courses must follow cover a wide range of topics including "independence from commercial interests; resolution of any personal conflicts of interest; appropriate use of commercial support; and content and format without commercial bias." A course will not be accredited if it does not follow the standards required by the ACCME.

Dr. McMahon reviewed the ten key points the critical authors presented as being "marketing messages," and concluded that all ten points appeared to be "appropriate elements to describe the epidemiology, diagnosis, and impact of an established disorder on affected patients," not "marketing messages" as were alleged.

Dr. McMahon reminds readers that two important functions of accredited CME courses are to both "creat[e] awareness of newly identified diseases and facilitat[e] the translation of new research into practice." He continues on to state that physicians and health care teams need evidence-based disease-awareness education so they can learn how to efficiently and quickly respond to public health priorities, and know how to diagnose and treat their patients appropriately.

In addition to the strict rules the ACCME has in place regarding the management of funds and conflicts of interests for CME providers, the activities of CME providers are subject to routine audit by the ACCME. These audits are performed on a randomized basis and Dr. McMahon also highlighted the fact that only 11% of accredited CME providers receive commercial support.

Dr. McMahon ended his written response by reminding everyone that accredited CME is part of the solution to the health needs of our country, "there is considerable evidence to show that accredited CME has a positive impact on physicians' ability to deliver high-quality care, and is one of the key resources that enables physicians and teams to deliver safe, ethical, effective, cost-efficient, and compassionate care that is based on best practice and evidence – and not on promotion."

Confirming Dr. McMahon's position is a synthesis of systematic reviews, done earlier in 2015 and focused on the impact of CME on physician performance and patient health outcomes. That synthesis identified eight systematic reviews of CME effectiveness published beginning in 2003. Five of the eight reviews directly addressed the question of "Is CME Effective?" by using primary studies that employed randomized controlled trials or experimental design methods, and concluded that CME courses and requirements do improve both physician performance and patient health outcomes.

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