Editorial

Conflict management and data integrity in the shadows

Consistent with the spirit of the Physician Payments Sunshine Act, the issue of financial conflicts of interest in the oncology domain has been exposed to the “sunshine” of the national media.

It would be wrong to pass judgment on the specific circumstances of the recent conflict of interest exposé without full knowledge of the details but, suffice it to say that, at some point, it appears that the process of disclosure failed.

If that is the case, it is entirely consistent with a JAMA Oncology study, covered in the Oct. 10 issue of HemOnc Today, that described the failure of about one-third of oncologists to report relevant financial interests in publications between January 2017 and August 2017.

John Sweetenham, MD, FRCP, FACP
John Sweetenham

I am sure the explanations for this are multifactorial and, for the most part, may represent either an oversight or lack of knowledge among the offenders — not excusable but not representing deliberate deceit, either.

Need for transparency

I have served on conflict-of-interest committees at two institutions, including my present one, and have gained some insight into how complex these issues can be, how there are many gray areas regarding what represents a true conflict, how essential it is to protect the separation of human subjects research from the financial interests of the investigators, and how intricate conflict management plans can become.

I have also become convinced that the overwhelming majority of physician investigators want to do the right thing, are anxious to assist in developing acceptable management plans and very rarely resist the recommendations of our committee. It’s commonplace for investigators to offer to divest their financial interest rather than walk away from their role on a research study. I should add that I have previously received research funding from industry sponsors of trials, have also received honoraria and have had conflict management plans to address these.

Although the mechanisms for disclosure and management of financial conflicts are highly variable from place to place and are far from perfect, I think most people would agree that transparency has increased and that the Open Payments system has been a useful tool for exposing these issues.

Of course, conflict-of-interest concerns aren’t restricted to investigators in research projects — they can involve decisions regarding the purchase of products or services, and can also be conflicts of commitment, when the additional remuneration from outside entities begins to encroach upon the time or engagement in the “day job.” Most big institutions are able to put appropriate time limitations on this kind of external consultancy work to allow health care experts to use their knowledge in a meaningful way, increase their reputation and that of their institution, and often bring back useful new knowledge. If this also provides extra income at fair market value, this is entirely acceptable and a win for all parties involved. The key to legitimacy is, again, transparency and disclosure.

Free ‘swag’

One consequence of sunlight exposure is the ability to hide in the shadows.

Like many of you, I receive at least two invitations by email every day to take part in a questionnaire that seeks information regarding treatment and practice patterns, and I assume they are sponsored by various industry partners as a form of market research. They typically require 10 to 45 minutes and offer honoraria from $40 to $500.

Personally, underlining the random nature of these emails, I am asked for information or opinions on anything from ovarian cancer to primitive neuroectodermal tumors, but almost never on lymphoid malignancy.

I have never responded to one of these requests. At one level, I think this is a simple fee-for-service arrangement and that there is no reason why we should not make use of our expertise if the payment is at fair market value. That said, I wonder a little about conflict of commitment if a physician is tempted to complete multiple surveys of this type.

I recently received an invitation by mail that came in a very inviting format, asking me to “join our elite oncology research program.”

It offered $500 per month for participation, as well as a choice of the latest iPhone, $100 per month toward my cellphone bill, a discount on a family cellphone plan and assistance in transitioning to the new phone number! The brochure also featured pictures of apparently happy physicians — and who wouldn’t be! — with testimonials regarding how much they enjoyed participation, especially because they are contributing to research.

Taking advantage of my invitation code, I signed on to find out more. As far as I could tell, participants are invited to complete and send in regular surveys on two subjects: details of visits from industry representatives, and deidentified demographic and disease/treatment-related data on patients.

Participants have the choice of how much they commit to send, but information on each patient is said to take 1 to 2 minutes, and they look for details on all patients seen in two to four clinics per week. So, assuming an oncologist is seeing 20 to 30 patients in an average clinic, this is going to take 2 to 3 hours of their time per week.

The system is stated to be HIPAA compliant. I am assuming these practice-pattern data are being used by industry in some way to measure the effects of industry representatives in influencing practice.

Without wanting to assume the moral high ground and accepting it is complaint from a HIPAA perspective, it worries me at several levels.

Firstly, it has the same feel as the “swag” that used to be given away in the exhibit halls at our major meetings back in the 1990s and early 2000s, when apparently well-paid physicians would rush to join an endless line to pick up anything from an umbrella to a PDA (remember those) for filling out a survey.

Secondly, at a time when oncologist burnout is in part attributed to the documentation burden, it seems inconsistent that anyone would want to spend an additional 2 to 3 hours sending data to an outside entity.

Thirdly, I wonder how many patients are made aware that their data are being used in this way.

Exposure to sunlight

There is no doubt that industry-funded studies exploring practice patterns can be highly informative.

The National LymphoCare study is a good example of an industry-funded project exploring practice patterns in non-Hodgkin lymphoma. Institutions were paid per patient for entry into the study, which collected demographic, treatment and survival data over several years. There were no direct payments to physicians, the study had institutional review board approval and patients gave consent. This study has generated multiple publications in peer-reviewed journals and has added significantly to knowledge of the management of non-Hodgkin lymphoma.

As far as I can tell, the data to be uploaded via iPhone in the “research” in question is not verified, it doesn’t appear that institutional review board approval is necessary (although I may not have clicked enough times to figure this out) and the consent issues are a little fuzzy to me.

From both a data integrity and a conflict perspective, I wonder whether this kind of enterprise requires scrutiny. At $500 per month, plus the added benefits of a new phone and contribution to the participant’s phone bill, the annual reimbursement would meet criteria for significant financial interest in most centers. I wonder how many participants disclose this to their institutions.

The information collected by projects such as these may prove useful, and it wouldn’t be fair to pass judgment on the folks who choose to participate. That said, in the interests of transparency, it may be time to bring these issues out of the shadows and expose them to the sunlight.

Reference:

Wayant C, et al. JAMA Oncol. 2018;doi:10.1001/jamaoncol.2018.3738.

For more information:

John Sweetenham, MD, FRCP, FACP, is HemOnc Today’s Chief Medical Editor for Hematology. He also is senior director of clinical affairs and executive medical director of Huntsman Cancer Institute at The University of Utah. He can be reached at john.sweetenham@hci.utah.edu.

Disclosure: Sweetenham reports no relevant financial disclosures.

Consistent with the spirit of the Physician Payments Sunshine Act, the issue of financial conflicts of interest in the oncology domain has been exposed to the “sunshine” of the national media.

It would be wrong to pass judgment on the specific circumstances of the recent conflict of interest exposé without full knowledge of the details but, suffice it to say that, at some point, it appears that the process of disclosure failed.

If that is the case, it is entirely consistent with a JAMA Oncology study, covered in the Oct. 10 issue of HemOnc Today, that described the failure of about one-third of oncologists to report relevant financial interests in publications between January 2017 and August 2017.

John Sweetenham, MD, FRCP, FACP
John Sweetenham

I am sure the explanations for this are multifactorial and, for the most part, may represent either an oversight or lack of knowledge among the offenders — not excusable but not representing deliberate deceit, either.

Need for transparency

I have served on conflict-of-interest committees at two institutions, including my present one, and have gained some insight into how complex these issues can be, how there are many gray areas regarding what represents a true conflict, how essential it is to protect the separation of human subjects research from the financial interests of the investigators, and how intricate conflict management plans can become.

I have also become convinced that the overwhelming majority of physician investigators want to do the right thing, are anxious to assist in developing acceptable management plans and very rarely resist the recommendations of our committee. It’s commonplace for investigators to offer to divest their financial interest rather than walk away from their role on a research study. I should add that I have previously received research funding from industry sponsors of trials, have also received honoraria and have had conflict management plans to address these.

Although the mechanisms for disclosure and management of financial conflicts are highly variable from place to place and are far from perfect, I think most people would agree that transparency has increased and that the Open Payments system has been a useful tool for exposing these issues.

Of course, conflict-of-interest concerns aren’t restricted to investigators in research projects — they can involve decisions regarding the purchase of products or services, and can also be conflicts of commitment, when the additional remuneration from outside entities begins to encroach upon the time or engagement in the “day job.” Most big institutions are able to put appropriate time limitations on this kind of external consultancy work to allow health care experts to use their knowledge in a meaningful way, increase their reputation and that of their institution, and often bring back useful new knowledge. If this also provides extra income at fair market value, this is entirely acceptable and a win for all parties involved. The key to legitimacy is, again, transparency and disclosure.

PAGE BREAK

Free ‘swag’

One consequence of sunlight exposure is the ability to hide in the shadows.

Like many of you, I receive at least two invitations by email every day to take part in a questionnaire that seeks information regarding treatment and practice patterns, and I assume they are sponsored by various industry partners as a form of market research. They typically require 10 to 45 minutes and offer honoraria from $40 to $500.

Personally, underlining the random nature of these emails, I am asked for information or opinions on anything from ovarian cancer to primitive neuroectodermal tumors, but almost never on lymphoid malignancy.

I have never responded to one of these requests. At one level, I think this is a simple fee-for-service arrangement and that there is no reason why we should not make use of our expertise if the payment is at fair market value. That said, I wonder a little about conflict of commitment if a physician is tempted to complete multiple surveys of this type.

I recently received an invitation by mail that came in a very inviting format, asking me to “join our elite oncology research program.”

It offered $500 per month for participation, as well as a choice of the latest iPhone, $100 per month toward my cellphone bill, a discount on a family cellphone plan and assistance in transitioning to the new phone number! The brochure also featured pictures of apparently happy physicians — and who wouldn’t be! — with testimonials regarding how much they enjoyed participation, especially because they are contributing to research.

Taking advantage of my invitation code, I signed on to find out more. As far as I could tell, participants are invited to complete and send in regular surveys on two subjects: details of visits from industry representatives, and deidentified demographic and disease/treatment-related data on patients.

Participants have the choice of how much they commit to send, but information on each patient is said to take 1 to 2 minutes, and they look for details on all patients seen in two to four clinics per week. So, assuming an oncologist is seeing 20 to 30 patients in an average clinic, this is going to take 2 to 3 hours of their time per week.

The system is stated to be HIPAA compliant. I am assuming these practice-pattern data are being used by industry in some way to measure the effects of industry representatives in influencing practice.

Without wanting to assume the moral high ground and accepting it is complaint from a HIPAA perspective, it worries me at several levels.

PAGE BREAK

Firstly, it has the same feel as the “swag” that used to be given away in the exhibit halls at our major meetings back in the 1990s and early 2000s, when apparently well-paid physicians would rush to join an endless line to pick up anything from an umbrella to a PDA (remember those) for filling out a survey.

Secondly, at a time when oncologist burnout is in part attributed to the documentation burden, it seems inconsistent that anyone would want to spend an additional 2 to 3 hours sending data to an outside entity.

Thirdly, I wonder how many patients are made aware that their data are being used in this way.

Exposure to sunlight

There is no doubt that industry-funded studies exploring practice patterns can be highly informative.

The National LymphoCare study is a good example of an industry-funded project exploring practice patterns in non-Hodgkin lymphoma. Institutions were paid per patient for entry into the study, which collected demographic, treatment and survival data over several years. There were no direct payments to physicians, the study had institutional review board approval and patients gave consent. This study has generated multiple publications in peer-reviewed journals and has added significantly to knowledge of the management of non-Hodgkin lymphoma.

As far as I can tell, the data to be uploaded via iPhone in the “research” in question is not verified, it doesn’t appear that institutional review board approval is necessary (although I may not have clicked enough times to figure this out) and the consent issues are a little fuzzy to me.

From both a data integrity and a conflict perspective, I wonder whether this kind of enterprise requires scrutiny. At $500 per month, plus the added benefits of a new phone and contribution to the participant’s phone bill, the annual reimbursement would meet criteria for significant financial interest in most centers. I wonder how many participants disclose this to their institutions.

The information collected by projects such as these may prove useful, and it wouldn’t be fair to pass judgment on the folks who choose to participate. That said, in the interests of transparency, it may be time to bring these issues out of the shadows and expose them to the sunlight.

Reference:

Wayant C, et al. JAMA Oncol. 2018;doi:10.1001/jamaoncol.2018.3738.

For more information:

John Sweetenham, MD, FRCP, FACP, is HemOnc Today’s Chief Medical Editor for Hematology. He also is senior director of clinical affairs and executive medical director of Huntsman Cancer Institute at The University of Utah. He can be reached at john.sweetenham@hci.utah.edu.

Disclosure: Sweetenham reports no relevant financial disclosures.