Pathology and Our Societies Need to Evolve

| September 4, 2017 | 0 Comments

Over the past 20+ years I have had the good fortune of attending dozens of national meetings hosted by organizations and societies outside of the pathology field. Going to medical school in Chicago offered medical students in the city the opportunity to attend large gynecology, pediatric, surgery and internal medicine meetings, not to mention their related subspecialty gatherings.  Meetings such as ASCO or RSNA, respectively the largest gathering of oncologists and radiologists on the planet, hold their annual meetings at McCormick Place during the same weeks every year.

Having attended ASCO, RSNA, DDW (digestive) and AASLD (liver), each at least once over the past few years, I have noted a significant level of industry-supported studies that are discussed during the plenary sessions and management lectures. Thousands fill standing-room only auditoriums to hear scientific presentations that are supported, at least in part, by industry, often a pharmaceutical company or large manufacturer. The printed and online program books make clear any affiliation, as do the speakers themselves, mentioning the role of industry support and disclosing, if any, individual interests in any of the companies or products mentioned. The booths are full of representatives with handouts promoting the sessions, posters and speakers for these CME activities. And the show goes on.

Our clinical colleagues appear to appreciate the level of industry support, helping to bring new products, treatments and potential cures to market, and provide full disclosure to make clear any potential conflicts of interests for the attendees.

But have our large pathology societies and organizations followed this course? Have they enthusiastically invited industry-supported presentations within CME events, assuming full disclosure? In many cases, disclosures are listed in the program books and forms are required by presenters in terms of mentioning, among other items, discussion of products for off-label use, consulting/advisory board relationships and significant financial interests in companies or products that may be mentioned in his/her presentation.

Many years ago, I attended a lecture presented by a very well-known pathologist, researcher and informatics leader who started his presentation, as is usual and customary, by stating his disclaimers and disclosures. He went on to say that “he was conflicted” given his many interests and activities but continued by saying “if you do not have any industry relationships, you are not in pathology informatics”.

And the show goes on. Or does it?

As I am fond of recalling, between November 1 of last year and April 12 of this year, in less than six months’ time, we saw the Cubs win a World Series, Donald Trump get elected President one week later and the FDA approve the first digital pathology system for primary surgical pathology diagnosis in the US.

Prior to approval, the Philips Intellisite Pathology Solution (PIPS) went through a rigorous process with the FDA and an extensive multi-year, multi-site clinical trial, with the substantial cost and effort born by Philips (along, in part, with the Digital Pathology Association).

PIPS’ FDA clearance was the most significant event in the past 10 months, if not the past 10 years, to impact the practice of surgical pathology – something many of us thought highly unlikely, just like which team won the World Series or who became President.

And the design and results of the most comprehensive digital pathology study to date –to assess non-inferiority of whole slide imaging to the optical microscope – was not deemed appropriate for oral presentation at the United States and Canadian Academy of Pathology (USCAP) meeting prior to notification by the FDA a month later.

Many sources claim that because the study was industry supported, with hardware, scanners, software, pathologists, statisticians, quality assurance personnel, technical writers, compliance personnel and more, the study could not be discussed as an oral presentation at USCAP. Instead, a poster was accepted.

How is it that ASCO, RSNA, and our colleges in surgery and dozens of other branches of clinical medicine have clear policies and procedures in place to facilitate industry collaboration, while our largest gathering of pathologists shuns the opportunity to showcase what can happen when industry, our academic community and reference labs work together? The study was designed to draw from a broad array of case types and practice settings, thus the wide variety of those involved.

It is inexplicable that the Digital Pathology Association cannot obtain “companion society” status to hold a meeting at USCAP, but to prohibit the discussion of a critically significant study, knowing full well who incurred the cost (since Philips announced completion of the study and submission to the FDA in a company press release), seems not only very shortsighted by USCAP, but fully incomprehensible.

This is not good for anyone.

Perhaps the leaders of USCAP should attend an ASCO or a cardiology meeting, or one of dozens of other medical meetings where results from vendor-supported studies are presented back-to-back-to-back during a single session.

These organizations have well-established policies and procedures in place so all stakeholders know the rules. In our routine workday, we are supposed to be the experts in policies and procedures that ensure quality, safety, risk management and appropriate controls, to share knowledge and disseminate information.

If this is as granular as I have been informed, it is a dangerous policy on the part of USCAP. I gather that when non-inferiority studies are completed by other manufacturers, these findings too are going to be forbidden to be shared and defended during oral presentation.

We need industry to support future studies. And we need our societies and organizations to recognize and embrace this.

One constant at USCAP meetings, year to year, are issues regarding research budgets, “discretionary funds”, institutional budgets, inability to plan beyond the current fiscal year, ettc. Without industry using its resources to fund these large, multi-year, multi-site clinical trials, many departments will not be able to support doing so on their own.

Our meetings, including the annual USCAP, should provide a forum to have these studies presented for public discussion rather than having them tucked away in a late afternoon poster session.

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