Health Care

KC area pain doctor is among top-paid promoters of drug to treat opioid constipation

Steven Simon and Dr. Srinivas Nalamachu see patients at The Pain Management Institute in Overland Park, while also receiving hundreds of thousands of dollars in speaking fees to promote pharmaceuticals.
Steven Simon and Dr. Srinivas Nalamachu see patients at The Pain Management Institute in Overland Park, while also receiving hundreds of thousands of dollars in speaking fees to promote pharmaceuticals.

Over the last several years, Steven Simon of The Pain Management Clinic in Overland Park has treated hundreds of patients with opioid painkillers.

At the same time, Simon was being paid six figures to promote Movantik, a drug to treat constipation, a common opioid side effect.

AstraZeneca paid Simon at least $194,000 to give dinner presentations about Movantik. Commercials for the drug have become a staple of prime-time TV since it was approved in September 2014. One of them features a construction worker recounting his doctor’s constipation joke: “How long have you been holding this in?”

According to a ProPublica database, only one doctor in the country was paid more than Simon to promote Movantik during the time period it examined.

The Star also found that Simon used the names of the University of Kansas School of Medicine and the Kansas City University of Medicine and Biosciences in Movantik promotions.

A top official at the Kansas City University of Medicine and Biosciences said he’s going to look into whether Simon violated school policies. In a statement, KU didn’t directly address the issue but said Simon was no longer affiliated with the school.

As the nation struggles with an opioid crisis that killed 183,000 Americans between 1999 and 2015, critics ask whether such pharmaceutical payments make the crisis more difficult to end.

Sammy Almashat, a doctor and research associate for a consumer advocacy group in Washington, D.C., called Public Citizen, said that while Movantik is not addictive, opioids are, and Congress can’t fight overprescribing while doctors are getting paid to promote both opioids and drugs that treat their side effects.

“They’re essentially just hooking patients on both ends of this problem, and that’s very concerning,” Almashat said.

Almashat said the payments from pharmaceutical companies are “unfortunately legal,” unless there’s an explicit agreement for the physician to write more prescriptions. But Almashat said a pain doctor promoting Movantik presents serious ethical concerns because it’s a financial incentive to prescribe more opioids.

“Regardless of whether this technically violates the law or not, it is a huge conflict of interest,” Almashat said.

Simon did not respond to a request for comment for this story.

But in a 2010 Kansas City Star story about local physicians who made more than $100,000 in pharmaceutical speaking payments, Simon said he had considered the ethical implications and had no qualms about them.

“I have asked myself: Is this ethical? Absolutely,” Simon said. “I would hope why I use a product is because it’s the best product for the patient. … I hope I am honest enough that I wouldn’t speak about any drugs I haven’t used or had success with.”

Part of a pattern

Physicians who receive pharmaceutical money often say it doesn’t change the way they practice. But David Fleming, the co-director of the University of Missouri School of Medicine’s Center for Health Ethics, said years of data show that’s not true.

“When physicians get involved in that, there is an undeniable and unchallengeable conflict of interest that occurs as it relates to the use of whatever medication it is they’re being paid to promote, and not just how they promote it to their colleagues but how they promote it to their patients,” Fleming said. “It does influence thinking, it does influence prescribing habits and it’s unavoidable. That has been well shown.”

Pharmaceutical payments to doctors have been public record since the Affordable Care Act passed in 2010. Congress and groups like the American Medical Association have written laws and guidelines to discourage the payments for far longer, but they’ve not stopped.

According to ProPublica’s database, Jacksonville, Fla., physician Orlando Florete was the only doctor who received more payments than Simon for promoting Movantik. Florete received $198,000 from the time Movantik was approved until the end of 2015, which is the most recent data available.

Simon’s partner at the The Pain Management Institute at 8675 College Blvd., Srinivas Nalamachu, ranked No. 7 in the nation in Movantik money, taking in $176,000.

Nalamachu said by phone that he’s done hardly any work on Movantik since then.

“Last year, I think I did only three or four lectures,” Nalamachu said. “I am one of the top researchers in the country for a lot of new products. New products get launched, so they’re looking for people who are experts in the field. That’s the reason I did it in the first year.”

Nalamachu said he rarely sees patients or prescribes medications because he’s mostly a researcher. He said pharmaceutical payments don’t affect how he treats the patients he does see, and there are no ethical issues.

“I get paid for my expertise, that’s all,” Nalamachu said.

A new drug market

Movantik costs about $300 for a 30-day supply. Before it was developed, doctors routinely prescribed over-the-counter laxatives — which cost about one-tenth of that — to treat opioid-induced constipation.

Opioids cause constipation through changes to the digestive tract, like reduced digestive secretions and intestinal movement. As a result, nearly all opioid users experience constipation. Over-the-counter treatments don’t always work, and the boom of opioid use in the United States has created a huge and growing market for new drugs.

Pharmaceutical market analysts have predicted that opioid-induced constipation drugs could be worth $550 million in the U.S. alone.

AstraZeneca was the first to develop a pill, and it moved to establish Movantik in the minds of consumers with a slew of TV ads.

One of the ads ran during the 2016 Super Bowl and spurred then-White House Chief of Staff Denis McDonough to tweet: “Next year, how about fewer ads that fuel opioid addiction and more on access to treatment.”

But before AstraZeneca rolled out its TV ad campaign, the company spent about $4 million on more low-profile speaking tours where doctors like Simon and Nalamachu introduced Movantik to other prescribers over dinner.

Simon was listed as the host for a presentation called “Opioid-Induced Constipation: The Science, the Struggle, and an Orally Administered Treatment Option,” on AstraZeneca’s invitation to “an exclusive engagement” at Brio Tuscan Grille on the Country Club Plaza on June 1, 2015. Free Movantik samples were available.

According to ProPublica’s database, AstraZeneca paid Simon a $3,700 speaker’s fee the next day.

It was one of about 40 such speaking engagements Simon booked for Movantik in 2015, each with accompanying payments for food, lodging and travel expenses.

He was also paid thousands to present information on several opioid-based pain drugs like Subsys, Hysingla and Nucynta.

In all, ProPublica documented 812 payments worth $715,452 to Simon from 27 different pharmaceutical companies in 2015.

On the invitation to Simon’s Movantik presentation at Brio, the doctor was listed as an “assistant clinical professor” at the University of Kansas and a “clinical assistant professor” at the Kansas City College of Medicine and Biosciences. In addition to getting the name of one school slightly wrong, that also appears to be against the policies of both schools.

University policies

Simon and Nalamachu are not faculty members of the University of Kansas School of Medicine or the Kansas City University of Medicine and Biosciences. But in the past, both have been volunteer instructors for third or fourth-year medical students doing clinical rotations.

Even so, Darrin D’Agostino, the dean of Kansas City University of Medicine and Biosciences’s College of Osteopathic Medicine, said they’re not supposed to use the university’s name to promote pharmaceutical products.

“We do not allow that, because the university’s name is not associated with any of these things,” D’Agostino said. “Quite frankly, that’s something I need to dig into, because if it is being used at these events, that’s something that reflects on the university.”

At KU, a university manual states that volunteer instructors should note their affiliation with the university in print or other media only when it pertains to work done on university grounds, under university sponsorship or in collaboration with full-time faculty.

They also have to include the word “volunteer” whenever they refer to their university affiliation.

“Failure to denote volunteer status will be grounds for termination,” the manual says in bold lettering.

Kay Hawes, a spokeswoman for KU Medical Center, said via email that Simon “recently retired and is no longer taking our students.”

At both KU and Kansas City University of Medicine and Biosciences, volunteer clinical instructors aren’t subject to same the rules as full-time faculty when it comes to accepting pharmaceutical money. At Kansas City University of Medicine and Biosciences, those rules are strict, D’Agostino said.

“There’s pretty significant language that doesn’t allow them to go out and do these types of promotional activities, with few exceptions,” D’Agostino said.

KU is similar. The American Medical Student Association grades medical schools on their conflict-of-interest policies every year. Last year, it rated KU’s policies strong enough to merit a B overall, but dinged the school for not extending those policies to adjunct and courtesy faculty.

D’Agostino took over as dean at the Kansas City University of Medicine and Biosciences last month. He said he and other new leaders are reviewing all of the university’s policies, and he would consider whether to require volunteer instructors to disclose their relationships with pharmaceutical manufacturers.

“That may be something we have to look at doing in the future,” D’Agostino said.

The Missouri medical school where Fleming works extends the same conflict-of-interest policies to volunteer instructors as it does to faculty.

But Fleming said physicians shouldn’t necessarily need pages of written guidance about when they can take money from drug and device manufacturers to promote a product.

“Physicians, if they are practicing and prescribing and seeing patients and have influence over learners, I think they shouldn’t do it,” Fleming said.