Stuart Gitlow, M.D., is the president of the American Society of Addiction Medicine (ASAM) and also medical director — as a consultant — for Orexo, which makes Zubsolv, a newly approved buprenorphine-naloxone medication (see ADAW, July 15).

The first public charge of a conflict of interest was made last month via Twitter by Mark Willenbring, M.D., former director of treatment and recovery research at the National Institute on Alcohol Abuse and Alcoholism. In the tweet, Willenbring suggested that ASAM should examine its policies about conflicts of interest. While the connection with Orexo doesn’t mean that Gitlow’s beliefs and statements about buprenorphine are incorrect, it does raise questions, said Willenbring, now in private practice in St. Paul, Minnesota, where he provides treatment for substance use disorders and is a strong proponent of medication-assisted treatment. “At the same time, how can someone who is employed by the drug company have any credibility when his financial interest is in selling the drug?” Willenbring told ADAW. “My concern is with the increasing public perception, especially in psychiatry and addiction treatment, that financial interests taint and discredit professional opinions.” Gitlow’s dual roles, said Willenbring, raise this question: “Is he speaking for ASAM as a professional or for the pharmaceutical company as a salesman?”

Orexo, ASAM comment

ADAW checked with Orexo, ASAM and Gitlow himself for comments on whether there are any conflicts of interest in this arrangement.

“Orexo is proud of its association with Dr. Stuart Gitlow, a recognized leader in addiction medicine,” said Robert A. DeLuca, president of Orexo. “He serves as a medical consultant with firsthand knowledge of opioid dependence and its very unique and specific treatment challenges.”

Collaboration with clinicians, advocacy groups, and leaders in the addiction treatment community is “common industry practice,” DeLuca told ADAW. The relationship “gives us the directional insights required to develop the most relevant and optimal treatment options for patients seeking recovery from opioid dependence.”

“ASAM’s board of directors was made aware of Dr. Gitlow’s consulting relationship with Orexo,” said Louis Baxter, M.D., immediate past president of ASAM. “He updated his disclosure to reflect this change,” Baxter told ADAW. “His disclosure, as well as all other Board members’ disclosures, is posted on ASAM’s website.”

Gitlow is “asked to recuse himself from board policy discussions when his relationship would raise a conflict, as is any other board member who may have a relationship that would potentially raise a conflict,” added Baxter.

Gitlow’s response

The response from Gitlow to ADAW’s question encompasses his response as ASAM president, Orexo medical director and a practicing addiction physician. We reprint it in full below.

“ASAM, like other professional medical organizations, exists in part due to a desire by the founding members to speak for themselves in a consensus-driven manner. The founders of ASAM were almost entirely independent practicing physicians. Many of our early goals reflected that member base. So when we fought for non-psychiatrist addiction specialists to be paid by third parties, for instance, we did so because it was in our interest to do so. Yes, you can certainly make the point that this is also beneficial to the patients, but let’s be fair and recognize that ASAM, like other professional organizations, was brought into existence at least in part to ensure that we could keep working in our chosen profession. We achieve that in many ways — through education, certification, fellowship, friendship — and so forth, but it’s all there to ensure that our profession is safe.

“Fast forward to the present. Most of our members are no longer independent practicing professionals. They are largely employees. As I’m still an independent private practice doc, fellow board members and officers will tell you just how often they say to me, ‘Stu, why are you still fighting for the dinosaurs among us? That’s not the future.’ Nevertheless, having grown up with this organization and having seen what its purpose was (my father having been one of the founders of ASAM), I’m insistent that physicians should always protect their professionalism — their ability to work for themselves — and that this is one of the purposes of ASAM even if physicians themselves no longer are interested in that ability. The pendulum, I suspect, will swing back. At least that’s my hope.

“But that said, physicians are now largely employees, working for a variety of industry interests. Those are our members, and we now represent them. What their opinions are do not represent conflicts any more than their opinions did back when they were all in private practice. ASAM exists to serve the opinions of its members. If all our members suddenly became employees of CRC, then ASAM would exist to serve their opinions. If they were all employees of Pfizer, then ASAM would exist to serve their opinions. And of course, their opinions might differ markedly from CRC or Pfizer’s business stance. Isn’t that what organizations of people are often for — to represent a group of individuals who work for an entity that may very well have a differing opinion or stance?

“In the meantime, the purpose of a consultant to a business is to bring the consultant’s opinion to the table, not to turn the consultant into a talking head for the business, so consultants are even less likely to be aligned with the organization for which they work, and yet here again, whatever their opinion is, if that person is a member, then ASAM exists to represent that person.

“Now ASAM represents a group of people who work for both themselves and other entities and who are, by and large, not independent practitioners. I view myself as an independent practitioner, but I also recognize that others may not view me that way, since a portion of my income comes from various industry sources. But since I’m an ASAM member, ASAM represents my opinion as part of the overall consensus process. That’s not a conflict. That’s the point of the organization.

“And let’s be very clear: my individual opinion is what my bread and butter is — as a forensic psychiatrist specializing in addiction, my opinion is the product that I hold out as a professional in the field as being consistent, reliable and valid. If my work for the FAA, or for a treatment center, or for a pharmaceutical company is found to have altered my opinion, then my opinion isn’t worth very much. When I speak for ASAM as its president, I present the organization’s opinion as based in its policy as passed by its board. If my personal work leads to my misstating the organization’s opinion, then I wouldn’t be doing a good job as the organization’s president. And if my personal work leads to my leading the organization in one direction or another, pushing for the organization to go down one road or another, frankly, that’s what the president is supposed to do. My personal work includes consultation to a pharmaceutical company focused on making a product that has demonstrated value for patients with addictive disease. How is that different from that of a physician whose work includes prescribing a product that has demonstrated value for patients with addictive disease?

“Finally, if there comes a time when my work — any work — puts me in a position where the potential conflict becomes a genuine conflict, I have an excellent team of officers and Board members to whom I am always happy to turn projects over. I did that with the Patient Advocacy Task Force, recusing myself from their efforts due to the elevated risk of there being a genuine conflict.”

ASAE standards

ASAM and Gitlow appear to have met the standards of conduct for association executives promulgated by ASAE: The Center for Association Leadership. According to Robert M. Skelton, ASAE’s chief administrative officer, two of the core standards apply specifically to the situation: transparency (disclosure) and acting fairly in the interests of the members. “By saying, ‘We recognize there is a conflict, we are disclosing it to everyone, and he recuses himself from any board discussion where there could be a conflict,’ ASAM is in the clear, said Skelton, who is also senior staff liaison for ASAE’s ethics committee.

“This kind of conflict is very, very common, certainly in addiction medicine but in many industries,” said Skelton. “You have to have practitioners who know the field,” he said. “How else does research get done?”

Which hat?

Ed Silverman, who as a longtime journalist covering the pharmaceutical business has written many articles on ethics, agreed but summed up the possible conflict this way: “On the one hand, you want a specialist who is intimately familiar with the medical issues and the appropriate treatment options; on the other hand, it’s a conflict because he is also being paid by one of the companies that markets a treatment.”

Yes, the disclosure statement is on the ASAM website, and Silverman, who is editor of Pharmalot, said this is important. “But what if you are an unwitting physician who is seeking a treatment for a patient?” he said. “If ASAM at any time lists a product sold by Orexo as a possible salve, then you have to wonder if that is because he is advocating a view based solely on science, or is he being influenced” by the Orexo connection.

Asked if there is any difference between a physician owning stock in a pharmaceutical company and serving as medical director, Silverman said, “A financial tie is a financial tie.”

Gitlow may think that he can speak with his Orexo “hat” and his ASAM “hat,” separating the two, but “for those of us not inside his brain, how do we know when he’s changing hats?” said Silverman. “There’s no reason for ASAM not to be able to find any number of qualified specialists who have no financial ties to any drug maker,” he said. “The fact that their president has a financial tie to one drug maker sullies the perception of ASAM’s mission.” There may be times, for example, when a certain treatment should or shouldn’t be prescribed, he said. “It’s an inherent conflict,” he said. “ASAM owes it to patients to hold itself out as an independent voice.”

Willenbring added that the American Psychiatric Association, in its recent update of the Diagnostic and Statistical Manual of Mental Disorders (DSM), “went to great lengths to exclude from participation in the process anyone with such obvious conflicts.” For the same reasons, he said, “ASAM needs to reexamine its policies, and should exclude from executive leadership anyone who has their hands deeply embedded in industry pockets.”

Both Willenbring and Gitlow are psychiatrists.

Orexo is listed on ASAM’s website as one of the association’s sponsors. Among others listed: Alkermes, which makes Vivitrol (naltrexone), and Reckitt Benckiser, which makes Suboxone (buprenorphine), both competitive medications to treat opioid dependence.

Bottom Line

Being the president of the American Society of Addiction Medicine and the medical director of Orexo, which makes buprenorphine product Zubsolv, is a balancing act for Stuart Gitlow, M.D.