The Novartis Medical Events Case and the difficulty in proving Medical Events are, ‘educational.’

To begin, this article is no way concerned with any specific details of the Novartis Medical Events Case. Neither myself, nor anyone that I work with, would have first hand knowledge regarding the 79,000+ medical events brought into question by federal prosecutors. The goal of this article is to explain the risk posed to all pharma companies with regards to their medical events and speaker programs based on the way in which the Novartis case is taking shape, combined with current practices used across the industry.

Overall, with regards to Novartis, I do not believe that it matters one way or another if the thousands of events were legitimately given under the umbrella of education or not, because the information that the industry has been gathering with regards to medical events cannot prove otherwise on its own. If this was a matter of a single event it would be possible to get first hand testimony, but we are talking about tens of thousands of events and there just isn’t a defense against this when it relies on data alone. The same is true for all medical events and speaker programs given across the whole of Life Sciences.

The issue here is whether or not the argument being posed by federal prosecutors could be applied to a program that was legitimately educational and still fail to pass their test because the ability to track certain educational activities has been (up until now) impossible.

Background on the Novartis Case

For the last year Novartis has been fighting an order from Federal Prosecutors that they deliver records for more than 79,000 medical events. On 30 March 2017, Judge Gardephe of the United States District Court for the Southern District of New York ordered that the documents be handed over.

Federal prosecutors claim those events were shams. They call them “kickbacks” instead. The government  alleges that Novartis invited the same doctors to speaker events over and over, treating them to lavish dinners at Nobu and Smith & Wollensky—and gatherings at Hooters—in return for prescribing more Novartis meds.

http://www.fiercepharma.com/legal/kickbacks-judge-to-novartis-hand-over-info-those-79-000-sham-events

Deconstructing the Federal Prosecutor’s Case

Again – for the purposes of this article it doesn’t matter whether or not all or some of the Novartis events were, as Federal Prosecutors are describing them, “shams.” The issue here is whether or not the argument being posed by federal prosecutors could be applied to a program that was legitimately educational and still fail to pass their test because the ability to track certain educational activities has been (up until now) impossible.

I would argue that, based on the structure of their case, even today, it would be impossible to prove that legitimately educational Medical Events, when being reviewed as a group (for instance, 79,000 at a time), were, ‘educational.’ Here’s why:

The argument being prepared by Federal Prosecutors is that a kickback occurs when:

  1. A Health Care Provider is invited to attend an event.
  2. The event carries a high dollar cost
  3. After the event, the Health Care Providers that prescribe products related to the event are invited to other events.
  4. After the event, the Health Care Providers that do not prescribe products related to the event are not invited to other events.

This all boils down to interactions. If the only interaction is the invitation, the V.I.P. treatment and this is followed by an increase in prescribing behavior, then that may be a solid argument. The problem is that if the event is truly educational, those same things occur, but many other additional interactions take place. Those interactions are not being sufficiently recorded, while the ones that support the prosecutor’s argument are being recording.

The industry standard application for logging interactions between Pharmaceuticals and Health Care Providers is a form of Salesforce.com known as Veeva CRM. This is where call, sample, discussion and medical event information is maintained across the entire industry (for many of the events that federal prosecutors requested information, it would come from a different, legacy, application). Even today, Medical Event data schemes in the industry standard applications focus on keeping a record of the following:

  1. Title of the event
  2. dates
  3. attendees
  4. speakers
  5. cost of the event / cost per attendee
  6. Possibly content involved in the event
  7. Presentations provided to specific attendees, but this is sporadic as events get larger and the number of attendees grow. There is technology here, but most organizations are failing to utilize it (contact me at jasonmccloy@mediamanager.net if you want to learn more about this). Even this technology fails to gather the necessary information to pose a strong case when the number of attendees grows to beyond 15 people (approximately).

See it? This is the same information that Novartis spent a year fighting to release. In other words, you are keeping a record of the information that plays into the argument posed by federal prosecutors ACROSS THE ENTIRE INDUSTRY. They are gathering all of the data needed to prove that case and little to disprove it.

This is a problem, but it is solvable. My team and I spent the last 3 years working on LifeScienceLMS.com as a solution designed to prove that events and interactions sponsored by Pharma companies are educational by providing the tools to collect the data that shows 3 specific type of interactions that are educational in nature. The goal was to create a record of virtual interactions during and long after the event that prove that the event was devoted to and ultimately led to the transfer of knowledge as a part of a larger program to build an educational community around a treatment.

These are the interactions we focused on:

  1. Speaker to Attendee interaction – Through speaker focused forums, it’s possible to show actual speaker to attendee interaction is taking place, while also showing the presentation materials and supporting documentation.
  2. Attendee to media interaction – Media provided through the event with a record of when it was accessed.
  3. Attendee to attendee interaction – Did attendees converse with other attendees during and after the event? I believe that if you can show that Health Care Providers establish relationships through events that lead to a transfer of knowledge, then it could be argued to be educational (no matter how good the food was). We’re able to support and prove this interaction and automatically move the data so that it lives next to all of the other event data in the industry standard call logging applications.

Conclusion

Anyone that has called on a physician knows that getting 10 minutes of their undivided attention is virtually impossible. This is the reason why getting 30 physicians into a room together and having them all focus on a 20 minute presentation is monumental, but I have literally had people claim that there is something illicit if these events include a 20 minute presentation followed by 2 hours of socializing. What do they expect? This is an incredibly hard group of people to connect with and that 20 minutes carries a significant cost. When you consider the value of a brand as being the community, education and support that surrounds it, more needs done to collect the information to prove that these events are valuable so that brands can protect themselves when ridiculous arguments are made with regards to the time and investment necessary to build that community.

About LifeScienceLMS.com: The LifeScienceLMS.com platform is designed to seamlessly integrate with the technology that Life Sciences companies already employ for the purposes of enriching medical education programs and tracking the necessary data for compliance.

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