Windy City Times has learned that there are questions about whether or not the prestigious MACS (Multicenter AIDS Cohort Study) will remain at Howard Brown Health Center (HBHC).
In speaking to numerous sources on and off the record, it appears that there are tensions between HBHC and Northwestern University (NU), which administers the grant. The last few weeks have seen a flurry of correspondence sent to MACS participants from both HBHC and NU.
As WCT reported in 2010, the MACS was transferred to NU in the wake of reports that HBHC had used grant money to pay for operating costs, a violation of federal law. Since then, NU has subcontracted the grant to Howard Brown, meaning that tests were still being conducted at HBHC and MACS participants were still part of the study there, with HBHC administering the grant.
Earlier this year, following a nearly two-year investigation, HBHC announced that it would pay back $715,000 to federal agencies as part of a settlement around claims of the misspending of federal money. This was, according to HBHC, a significantly reduced amount from the more than $3.3 million it originally owed.
In the meantime, MACS appeared to be moving along as it has since 1984, when it began as what is now the longest-running natural history study of HIV/AIDS. It has, according to many researchers and the National Institutes of Health (NIH), resulted in some ground-breaking scientific discoveries regarding the disease.
According to the MACS website, the study has generated more than 1,100 publications and "significant contributions to understanding the science of HIV, the AIDS epidemic and the effects of therapy." These results include, in the early years, understanding how the virus works, as in the "[r]esistance to infection in high-risk seronegative men," as well as a "[d]escription of incidence of KS [Kaposi's sarcoma]."
The MACS derives "behavioral and biological data and specimens from men who have sex with men, before and after they became infected with HIV, before and after they were diagnosed with AIDS, and before and after they began highly active antiretroviral therapyalong with data from a control group of same-aged, HIV-free men who have sex with men. Comparing these before-and-after specimens and data from HIV-infected and uninfected individuals has yielded numerous seminal discoveries," according to the NIH website.
In later years, the MACS has also meant significant data about the effects of specific medications and drug regimens. In the early years of the AIDS epidemic, a diagnosis meant a severely reduced life span. However, in recent years, with advanced pharmaceuticals and advances in the care of patients, the MACS has become instrumental in determining the needs of an aging population whose lives have been considerably extended. MACS research has also had a significant effect upon public health policy, according to the Website.
Over the years, a total of 6,972 men have been enrolled in the study, approximately half of whom are HIV-negative and half are HIV-positive. The study is going on in four cities across the country: Baltimore, Chicago, Pittsburgh and Los Angeles. In Chicago, it has been going on in three different sites, NU, Howard Brown, and the CORE Center. For years, HBHC's prestige as a research organization grew from the fact that it has been the only community organization that housed the MACS: the other sites are all academic or research centers.
Dr. David Ostrow, founding principal investigator of the MACS at Howard Brown, in speaking to WCT about the grant two years ago, said that the budget for the total MACS grant (including other sites) is 10 percent of the total NIH budget for AIDS research. The budget for NIH's AIDS research for the fiscal year 2012 was projected at $3,159,531,000. AIDS research also means significant amounts of research and pharmaceutical money in a highly profitable medical field.
Under the transfer to NU, patient records and confidentiality were still being handled and maintained at HBHC. There was, however, a reported breach of confidentiality, as reported in WCT. Kathleen Lindsay (who has since married and is now Kathleen Kitchen) was terminated from her position as the MACS project coordinator at HBHC on Jan. 23, 2012. HBHC has not yet discussed the matter in public, citing confidentiality in personnel matters, but Kitchen told WCT that her termination came about because she had forwarded two patients' emails to her mother.
Margaret Pajak, health information management director and privacy officer at the University of Illinois at Chicago College of Medicine, speaking as an expert to WCT, noted that the punishment in this case seemed "harsh." But she also confirmed that Kitchen's action was definitely a violation of privacy and security rules, which have been growing tighter in recent years, under the department of Health and Human Services.
It now appears that the matter had serious repercussions. A letter, on HBHC letterhead and dated March 28, 2012, and forwarded to WCT was signed by John Phair, principal investigator (PI) of the MACS study at Howard Brown. It referred, presumably, to the incident as "some issues related to the administration of this project" and that "[W]e sent out notices regarding those issues and are working carefully to improve our processes."
The letter went on to state: "At this time, the Howard Brown Health Center Institutional Review Board [IRB], the committee that watches over the safety and rights of research participants, thought it best to delay the start of our next wave of study visits to get all of our administrative processes and documentation back in line here at Howard Brown Health Center. Therefore, we are not scheduling appointments at this time. Our hope is that all will resume in a timely fashion within the upcoming month."
On June 26, 2012, Steven Wolinsky, principal investigator of the MACS at NU (the two institutions have separate PIs), wrote to participants, citing a Feb. 2 letter from HBHC and stating the fall-out in stronger terms: "Howard Brown's ethics panel called an institutional review board [and] suspended the MACS work there, thereby prohibiting Howard Brown Health Center from scheduling MACS participant visits."
The letter went on to make a direct appeal to MACS participants at HBHC: "To continue your participation in the MACS, we ask you to schedule your next study visit at the Northwestern University Infectious Diseases Clinic. … Because this clinic is new for you, we will ask you to sign a new consent form. … The change to where you schedule your visits will not affect where you receive your medical care or loss of any medical benefits to which you are entitled." The letter went on to give participants a number to call, 312-908-MACS, should they have any further questions.
In the midst of all this, NU also sent a letter to members of the Community Advisory Board (CAB) of the HBHC MACS study June 29. A CAB is a group of volunteers, drawn from a community of research subjects of any study, intended to serve as a link between the community and researchers. These volunteers are non-scientists, and their input is generally in the form of review and monitoring. CAB's recommendations are non-binding and the nature of each CAB can shift dramatically based on the specific institutions, research, and volunteers involved.
In the letter to the HBHC CAB, Steven Wolinsky referenced the general letter to HBHC MACS participants and addressed CAB members specifically, "As a key stakeholder in the community served by Howard Brown Health Center and a valued advisor for and participant in the MACS, I ask that you meet with me to discuss the proposed change to the clinic visits." The meeting was July 9.
WCT was able to speak to some of the CAB members who were present at that meeting, where approximately half a dozen showed up. The full contingent of the CAB is reported to be around a dozen people.
Jim Briggs has been with the MACS for 27 years and is also a member of the CAB. According to him, Steven Wolinsky communicated to the CAB that the NIH had "stopped Howard Brown from seeing patients." Briggs made his appointment with NU, with the understanding that a consent form signed by him would allow for his records to be transferred from HBHC.
Ron Fritsch, has also been with the MACS almost from the beginning, for 27 years. He confirmed that there had not been any appointments with HBHC in the last wave of the study, which requires participants to come in for blood drawing and an array of tests every six months.
Terry Tatum, in MACS since 1984, confirmed that Wolinsky had indeed said that the MACS was closed at HBHC and that the NU spoke of hoping that participants would get the word out about transferring to NU. He also confirmed the report, from Wolinsky, that HBHC was not transferring records over to NU.
Tatum spoke of the importance of the study to him on two different levels, giving a sense of why the MACS has been such an integral part of so many men for so long: "The MACS study is an important study in terms of the health of many people including but not limited to gay men. It's an important research study to understand how HIV operates. At the personal level, this was and has been for almost 30 years a way that I could personally do something to fight the disease especially in the early days when there didn't seem to be anything anybody could do; it was one thing that I could do. And so, personally, it's an important study and it's important that as many of us that have been participating keep participating."
Vincent Samar, also one of the earliest participants, expressed concern that since the current wave ends in September, people should not lose continuity in the information made available to them.
Danny Kopelson has been a MACS participant from its beginning and is also a CAB member; he was not able to attend the July 9 meeting but expressed frustration with what he saw as the lack of communication from HBHC. Detailing the many calls he had made to HBHC, Kopelson said, "If you've been doing this for 28 years, you have an obligation to test subjects [to provide updates]."
Harlan Fleming, a long-time participant, had already expressed his frustration over MACS in a letter to WCT, and had transferred himself to NU. He spoke warmly of the staff at NU where, he said, he had his results within a week whereas HBHC had always taken a couple of months to give results. He said that a transfer to NU would be good for the MACS but bad for HBHC. With regard to the persistent report about the transfer of records, Fleming confirmed that this was indeed the case: his own records had yet to be transferred even though he himself had moved his participation, despite numerous requests from him.
Shortly after WCT spoke to these participants, they all received a letter from HBHC, dated July 10 and signed by HBHC CEO Jamal Edwards. Edwards referenced recent correspondence from NU to MACS participants, and went on to write that the concerns about the MACS in the early part of the year "led to the termination of certain HBHC research personnel and a delay in the next wave of study visits. In response to these concerns, HBHC prepared a comprehensive corrective action plan that was approved by our IRB, the National Institutes of Health (NIH), and the U.S Office of Human Research Protection (OHRP). We are now and have been executing the corrective action plan."
He then wrote, "Because our efforts are not complete and we want to ensure that all issues are fully resolved, we regrettably cannot discuss this matter in any further detail at this time, nor can we recommend that any HBHC MACS participant receive their study visits at any other location. Rest assured that your study information remains secure and confidential at HBHC. As always, we will continue to maintain all of your study records at this location, unless you direct otherwise." The letter provided the HBHC MACS line, 773-388-8899, if subjects wanted more information.
The letter took Fleming by surprise. In forwarding it to WCT, he wrote, "... it just shows how unaware they are at HBHC. I transferred my participation to Northwestern last fall!"
NU, in the meantime, responded to WCT's request for information after several calls and emails. Spokesperson Alan Cubbage would not respond to the July 10 HBHC letter, saying the center was "not aware of that" and that, in any case, "we would not comment on that. We're moving forward. The important thing now is how can we ensure that the study continue."
With regard to the status of the MACS at HBHC, Cubbage said that NU's communications and attempts to get people to transfer were based on problems with how the grant was administered. He said, "What happened is that, effective July 2, NU stopped using Howard Brown Health Center as a site for this research. Northwestern will use either our site or the CORE Center in order to continue it; we will no longer have the study visits at the HBHC."
According to Cubbage, "This is a decision made in conjunction with the NIH after a breach of patient confidentiality." Confirming the decision of the IRB, he went on to say that this move was to "preserve the integrity of the research" and "was not in any way a Northwestern vs. Howard Brown rivalry. This is a study that has been going on for many years and benefited patients and doctors around the world. We're trying to work with Howard Brown and with NIH to ensure as best as we can a smooth transition."
Since the funds come from the NIH and HBHC is the subcontractor, NU is the "official institution on the ground," said Cubbage, adding, "we made the decision who to use as a subcontractor."
With regard to the matter of HBHC's apparent refusal to turn over records, Cubbage said, "We are working with the NIH on this. Howard Brown has not yet provided the research records or contact information to Northwestern in accordance with federal guidelines on how you cancel a contract. What we're trying to do is get the word out as much as we can. We have some data but we don't believe we have it all and we're reaching out to make sure people know whom to contact."
Cubbage would not be specific about the harm to the study; in a follow-up email, after more questions, he responded, "If we don't get the research records, it would have an adverse impact on the study, which is why we're now reaching out to participants and others to encourage them to continue."
In the meantime, Howard Brown responded to WCT's request for information with a statement saying, "HBHC has maintained communication with MACS participants and will continue to provide status updates regarding the study as more information becomes available. … HBHC's MACS team remains intact and we are proactively endeavoring to find the best solution to resume MACS visits at HBHC, working with the NIH and NWU and other stakeholders and authorities. We look forward to resuming study visits at HBHC soon."
The NIH responded to questions from WCT: "On March 23, 2012, the Howard Brown Institutional Review Board notified NIAID [National Institute of Allergy and Infectious Diseases, which oversees the MACS] that they were temporarily suspending all human subjects research activities for the MACS study at HBHC as of April 2 due to aspects of the study's conduct. Northwestern is the primary awardee, and Howard Brown is a sub to Northwestern, so NIAID notified Northwestern of this suspension. NIAID considers HB suspended as a MACS site pending resolution of all issues to the satisfaction of both Northwestern and Howard Brown, and pending a site audit to be conducted by NIAID. … MACS participants who had been seen at the HB site have the option to be seen at Northwestern or an alternative site. We are working with Northwestern, the lead for this study, to notify the participants accordingly and thus maintain continuity for the study."
When asked if there was a specific deadline for HBHC to hand over records, Cubbage said there was none and that it would be a continuing process. Asked about any effects on patients' health, he said that this was not a medical testing and so would not have an impact on their health. Cubbage expanded on why NU felt it was important for it to gain patient information: "We are a major research university. Northwestern does more than $500 million annually in research funding, and much of that is biomedical research. We are used to this sort of thing [complex research] and we feel that it is best for us to be the ones to be the ones doing this."
Several sometimes-contradictory stories have arisen during this investigation.
At this point, pending further responses from the NIH and other parties, the exact legal and financial issues remain somewhat unclear. It is unclear what, if any, punitive role NIH might take with regard to HBHC or if there is yet any legal ground to do so, and if the suspension will be temporary or permanent.
On July 16, an email from the MACS email account at NU sent a draft of a letter, apparently signed by the HBHC CAB; it is unclear why a HBHC CAB letter would originate from NU. The letter restated matters up to this point and said, "... we are contacting you directly and asking your assistance in ensuring that the study continue."
At this point, this appears to be a question of two institutions attempting to gain control over one of the most well-funded and significant research projects in HIV/AIDS.
Windy City Times will continue to cover this story.