Ethical Research Interview: Dr. George Sillup and Dr. Stephen Porth

-Casey McBride ’16

You both have been performing ethics-based research for the past 10 years.  What originally made you both interested in the topic of ethics and how did that transition into an interest in the pharmaceutical industry?

Porth: Well, Dr. Sillup and I have both been involved in teaching in the pharmaceutical marketing MBA program and Dr. Sillup actually worked in that industry for many years. My experience initially was teaching a group of very bright and talented people who were working for organizations that, in their mind, are trying to improve the quality of life.  But there were these serious ethical questions that always, in my mind, didn’t seem to get raised to a level of consciousness when we were talking in class and going over assignments.  There was this tension between, on the one hand, the mission of the companies to improve the quality of life.  I believe most of them do quite well with the medications that help people.  On the other hand, there was a whole series of ethical questions and I wanted to raise awareness.  So I talked to Dr. Sillup and came up with this idea of using a survey of news reports about the industry as a way to objectively raise ethical questions that plague the industry and to get people in the industry to acknowledge them, think about them, and respond to them.

So you have both taken the Ethics Across the Curriculum faculty development course?

Sillup: That’s a course that Dr. McCall of the Arrupe Center offers.  In my case, it was a way to recalibrate my thinking coming from the corporate world where we put a lot of these programs into place.  Now we’re looking at it from another perspective.  And as Dr. Porth says, we are, in a sense, acting as a mirror for the industry to reflect back to them about the practices of the industry.  The response to media reports that often comes from the industry is that the media is after us. But when we look into some of the issues, is the media really picking on the industry?  Or is it that legitimate concerns of the public have generated this unwanted attention?  Dr. McCall’s course was a six-week course in 2004 where we were able to address these questions from an ethical perspective.  Dr. Porth generated the concept of the research from the course.

What were the topics of your research?  I know you said you’ve focused on the Pharmaceutical Industry, but what are some of the major things you’ve done? 

Porth: We have a whole list of hot button issues that we have in the industry.  These are ethical challenges that are inherent to the industry and that have been present for quite a long time.

Sillup: Every industry has a trade association.  In the pharmaceutical industry, it is the Pharmaceutical Research and Manufacturers Association (PhRMA).  PhRMA had this list of issues and we began, just literally, taking their own questions and asking them. For example, one question was the high cost of drugs.  And, by reflecting upon that and tracking the information, we realized maybe the media isn’t really going after you, maybe it’s just the price of the drugs.

Porth: I was talking to a friend who works for a large American pharmaceutical company and they’re developing an oncology drug and he’s telling me how difficult it is to get things through the FDA, but this drug, if it is efficacious and passes all the FDA safety standards, will cost somewhere in the neighborhood of $12,000 a month to take.  And a generic company could take the product, break it down to it’s compounds and chemicals and find out what’s in there, put it out as a generic, and sell it for a couple hundred dollars.  But the generic manufacturer did none of the research into creating the drug, which is literally years and years of paying scientists.  The point is, there are always two sides to every ethical issue in the pharmaceutical industry.  The drug prices are extremely high, but is that justifiable?  No, it’s not, but the pharmaceutical industry will say it is justifiable, not because that’s what it costs us to make that particular drug, but because for every drug that makes it to the market there are many that don’t make it to the market.  We have to pay for the cost and development for those that never make it to the market, so we’re pricing to recoup the costs of those failed drugs as well as the cost of the successfully introduced drug.

Sillup: Think of a giant funnel: 20,000 compounds go in, 10,000 have properties that could work for humans, 5,000 are safe, 2,000 could be potentially effective.  Eventually you get it down to 100 that warrant further study.  Each time you do a clinical trial, from the time you start the study, you’re spending $800 million to $1 billion.  They include the cost of all those drugs in the price for the one that was approved.  So in a sense they’re justifying it economically, but the patients may be still spending significant amounts and in some cases the costs are beyond what they are able to reasonably afford. 

Porth: Some of the other issues that we study are drug safety, and marketing and sales incentives.  So for example, one company paid for a doctor to go to a meeting in Puerto Rico in February.  Those kinds of inducements are much more difficult to do now, so any kind of incentive you would give that might be perceived as putting pressure on the doctor to approve your drug, those kinds of things we track. There used to be an issue that was a pretty prominent one that has fallen off and that is drugs being made in Canada or other countries that get shipped across borders and sold in the U.S., also called reimportation.  Those are the types of issues that we have studied.

What is your methodology behind the research? 

Porth: We do an audit, it’s called a press audit, of the top five newspapers in the country by circulation.  That’s the New York Times, L.A. Times, Wall Street Journal, USA Today, and Washington Post.  We audit every issue of all five of those newspapers every day of the year for articles that appear on the front page or in the editorial section.  Then we do an analysis of every article to find out what it is they’re focusing on, what are the positions that are being taken in the article, whether they are favorable or unfavorable to the industry.  We analyze the headlines, we analyze the content of the article and then every year we write the analysis up to report on how things are changing in terms of the media portrayal of the industry.

Have you seen a change in how ethical issues have been portrayed in newspapers over the past ten years?

Porth: Yes, we have, but it varies.  There are a couple of issues that are always on the list: the high cost of the drug and drug safety are always at the top of the list.  We see variability with other issues, as I said earlier about the reimportation rate and the incentives given to physicians for prescribing drugs.  When we started doing this, that was at the top of the list, but now it barely gets any mention at all.

Sillup: If you look at it over the course of the years, some that are prominent are no longer at the top of the lists.

Porth: One example of a shift is R&D for New Drugs.  When we see a shift, that means that something’s happening where companies are either doing something or the media is paying more attention to the R&D process and we have new issues that are coming up that are more prominent.

In 2013, you had undergraduate summer scholars assist in your research about the media’s portrayal of the pharmaceutical industry.  The Arrupe Center has made it a mission to teach students to engage in careful, sustained, and critical reflection on ethical issues.  What has been your experience with involving students in your research?

Porth: It’s been great for us to have the support of the students and I think the students have learned quite a bit by being involved in the process, and we have relied on summer scholars for many years to be engaged in the process.

Sillup: And since the beginning of the summer scholars program we have been one of the pioneers working with the board of summer scholars.  We want to see this continue because it is truly gratifying to find students who have an interest in the ethics and I think that one of the things the Arrupe Center does very well is to spread a concern for ethics throughout the college.  We have ethical discussions in all classes in some way and I think the students carry that basic understanding into a research project setting.  I think it really reinforces the concept.

Porth: We would sit down with them and let them know about our research and they would assist us in completing the project.  We were doing this research and we reached out to the summer scholars program to find students who were interested in this research, because we love to have them to participate.

Sillup: Then we work throughout the summer, during which they will share their assessments with us and compare notes so that we could find a common theme.  There are definitely articles that are challenging; often we talk about the methodology where if you read the headline, you might draw a different impression than when you read the article, so we say read the headline, tell us if its positive, negative, or neutral, then read the article because occasionally newspapers are trying to sell papers so they are sensationalizing the headline.  If you actually read the article, you may draw a different opinion.

I think another part that is complimentary to this, now that it’s the tenth year, is that we have built a database that we call the EthicsTrak™.  That database has all of the information on assessments of the articles.  We don’t share the database, but we have it as a reference, so if someone asked Dr. Porth after a presentation, “What were the drug safety issues in the Washington Post during the summer?,” we can go back and do a quick query and we can find out that the Post had a particularly large number of articles covering that.  You can certainly see a crescendo in certain issues and the database has been extremely useful for us in identifying trends.

Is there anything else you’d like to add?

Porth: I think one thing I’d like to see is an increase in the role of students in this research project.  As Dr. Sillup said, we have this EthicsTrak™ database that now has literally thousands of articles in it and we’ve already published one academic journal article based on about 5 years.  We are looking forward to working with students as we expand our research internationally.

Sillup:  We’ve also been published in a trade magazine, the Pharmaceutical Executive.  It is the top journal read by executives within the pharmaceutical industry.  This year is our 10th annual publication in the Magazine based on our research.  They see it as a way for the industry to get refreshed about how it is doing.  The journal editors feel as though our research provides an independent, objective third party perspective.

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