WHO-HD Channel 13 News covered a troubling report concerning a Central Iowa medical practice called the Iowa Clinic. An existing patient, Katie Joy Ussery, sought help for an ovarian cyst. Although she had a regular OB/GYN at the Iowa Clinic, that particular physician wasn’t available. They referred her to another on-call OB/GYN who, according to Ms. Ussery, aggressively promoted an AbbVie Orilissa clinical trial focusing on endometriosis. Ms. Ussery voiced her opposition to joining a trial to the physician, and according to Ms. Ussery, the doctor “became confrontational when I dared to stand my ground.” Ms. Ussery who seems credible, researched the open payments sight and claims she discovered that the same physician was in fact paid almost $350,000 in associate research funding from AbbVie.
This story absolutely stinks if true. Ussery leveraged the social media platform Twitter to “tweet” a negative review of the practice. Upon discovery of her actions, the Iowa Clinic “discharged” her as a patient making her without an OB/GYN. She consequently was out of a physician (as that was where her regular OB/GYN practiced) and in constant pain.
The Iowa Clinic has stated in response that if one physician discharges a patient then no other physician can be seen as patients are shared by all members of the practice. The Iowa Clinic went on the record that they do embrace clinical research (e.g. participate in clinical trials) and downplayed funding allegation to one investigator, in that the proceeds are allocated not in one lump sum to physicians but to the practice for costs of administration, etc.
TrialSite News exists to shine the light of transparency on clinical trials from the site perspective. Clinical research represents a vital societal activity and the medical professionals that participate in such research pursuits, in our opinion, represent role models and even scientific heroes. We promote the best and brightest on this web site.
But they must be professionals and they are held to incredibly high standards. Something about this story didn’t sit right with our team. Would Ms. Ussery just make this up? What would she have to gain? Is she yet another lawsuit troll? To our audience—we do not like the behavior of individuals that take advantage of or misrepresent the intentions of our society’s medical professionals and researchers. However, we admonish any inappropriate behavior; and if there is any truth in Ms. Ussery’s claims her the Iowa Clinic needs to go back to its informed consent basics. Do the necessary homework to understand why ethics-driven informed consent exists in clinical research.
We looked further into first Ms. Ussery’s Facebook message.
She noted on the social media that the Iowa Clinic physician, observing she was an endometriosis patient, immediately just handed her Orilissa. She noted that they physician “bragged he was the #1 prescriber of their other endo drug, Lupron, and had been given Orilissa trial to run but promised…he didn’t get paid by them.” The physician, according to Ms. Ussery, became hostile and combative. The patient left in pain and angry 40 minutes later. What about Ms. Ussery. We reviewed her LinkedIn profile. We believe the same person is the Communications Director with the Libertarian Party of Iowa. Wow—this became more interesting. Highly educated; a communications director for a political party. We cannot make any conclusions, but we become more doubtful she is a simple law suit troll. She possesses an incredibly impressive background; educated and committed to a free and open civil society.
TrialSite News drilled into this a little more. Sure enough the team found an endometriosis pain study involving Orilissa (Elagolix) sponsored by AbbVie. The sponsor listed dozens of research sites including the Iowa Clinic.
Who is the Iowa Clinic?
Founded in 1994, it is today the largest physician-owned, multispecialty group in Central Iowa according to a report from the AMGA Foundation. They employ 145 physicians and 60 advanced practice providers in 40 specialties. The practice partners with medical centers and hospitals across Central Iowa. They average 400,000 patient visits per year. With outreach specialty clinics in 14 rural areas they serve specialties such as cardiology, pulmonology, urology and podiatry.
According to their clinical trials link they are currently conducting studies in the following areas (including Endometriosis):
- Adult vaccine study
- Endometriosis Studies — three different studies:
- Oral Medication to treat Endometriosis Pain
- Vaginal Ring to treat Endometriosis Pain
- Observational study assessing Bone Health in those currently treated for Endometriosis
- Observational study for those seeking permanent sterilization via Essure or Tubal Ligation
- Over Active Bladder with Urinary Incontinence
- Prostate Cancer Studies — three different studies:
- Men with history of cardiac risk factors/heart attack and new to hormone therapy
- Metastatic prostate cancer and new to hormone therapy
- Men on Active Surveillance
- Recent Heart attack patients
- Recurrent C-Diff
- Recurrent Yeast Infections for Women
- Severe Asthma (over age 18)
- Statin Intolerant with Elevated LDL and history of cardiac risk factors/heart attack
- Testosterone Replacement Therapy in Men with a history of heart attack or cardiac stent
- Type 2 Diabetes with Elevated Triglycerides
TrialSite News of course cannot verify that this investigator/physician from the Iowa Clinic behaved in an inappropriate way—possibly due to the pressure of promising AbbVie they would sign up a dedicated number of patients for the Endometriosis Pain trial. But after reviewing all the available public facts we suspect there is a granule of truth in this story. The Iowa Clinic is placed on TrialSite News Site Watch “Challenged Sites.” This doesn’t mean that Iowa Clinic isn’t a fantastic place—we suspect it is a high quality regional physician practice. We do think that they have signed up for certain performance numbers for the industry sponsors they work with. They are remunerated upon patient enrollment and retention. Clinical trials can represent a robust revenue stream if managed well. Let’s hope they undertake a comprehensive root cause analysis of this event to ensure something like this never happens again.