◆ A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of subjects, and paid him and his two firms more than $5 million, William Hyslop, the U.S. Attorney for the Eastern District of Washington, recently announced. From 2013 to 2018, Sami Anwar, 42, “headed a conspiracy to have his companies fraudulently pose as legitimate human clinical research trial sites and provided mountains of false clinical research trial data regarding drug safety and drug efficacy to dozens of drug companies and, through them, the Food and Drug Administration [FDA],” Hyslop’s office announced Nov. 25. “The false clinical research data that Sami Anwar injected into the public health system included safety data on dozens of different drugs and medicines designed to treat a wide variety of diseases and conditions including, but not limited to, heart disease, diabetes, asthma, pediatric illnesses, adolescent smoking, cirrhosis, scabies, depression, and opioid addiction to name just a few, according to the evidence presented at trial.”
Based on the 97-count indictment that RRC reviewed, it does not appear that Anwar received any government funding. Although a number of clinical research organizations and drug firms were said to have been duped, only two are identified by name—Medpace Inc., of Cincinnati, and Braeburn Pharmaceuticals Inc., of Princeton, New Jersey, respectively. Anwar’s firms served as a trial site as part of an FDA-approved trial sponsored by Braeburn to test slow-release injections of buprenorphine to treat moderate-to-severe opioid addiction. He was found guilty on Nov. 22 following a three-week trial. More than a dozen former employees testified that Anwar “directly instructed them to assist him in committing the fraud including falsifying medical records and data to admit dozens of ineligible research subjects; falsifying research data including electrocardiograms and vital signs; obtaining blood specimens from Sami Anwar’s employees or stealing them from unwitting medical patients of his medical center; disposing of study medications by shooting them down the drain and then falsely recording them as having been properly injected as required; dangerously hoarding opioids intended to be dispensed to study subjects; and fabricating required subject diary entries,” the announcement states.
He was also alleged to have “filed false police reports, made false allegations to the Washington State Department of Health, the FDA, threatened [employees] at their homes, at their places of work, slashed their tires, and stalked them in order to prevent them from cooperating with the authorities.” Sentencing is scheduled for March 11; each fraud count could bring a jail sentence of 20 years. (12/12/19)
◆ The deadline of Dec. 23 is fast approaching for submitting comments to help the intergovernmental Joint Committee on the Research Environment (JCORE), part of the Office of Science and Technology Policy (OSTP), in its quest to recommend ways to strengthen the U.S. research enterprise. OSTP is seeking “input on actions” federal agencies can take, in partnership “with private industry, academic institutions, and non-profit/philanthropic organizations, to maximize the quality and effectiveness of the American research environment,” it said in the Nov. 26 Federal Register. As the notice explains, JCORE “is working to address key areas that impact the U.S. research enterprise; enabling a culture supportive of the values and ethical norms critical to world-leading science and technology. This includes the need to improve safety and inclusivity, integrity, and security of research settings while balancing accountability and productivity.”
The request for information contains four sections and asks multiple questions within each, addressing research rigor and integrity, coordinating administrative requirements, research security, and “safe and inclusive research environments.” One question asks for a description of the impact of NIH’s 2011 financial conflict of interest policy; comment is also requested on “whether and how a streamlined, harmonized, Federal-wide policy for FCOI would provide benefits with respect to reducing administrative work and whether there would be anticipated challenges.” The section on research security notes that, “over the past several years, some nations have exhibited increasingly sophisticated efforts to exploit, [and] influence, our research activities and environments.” Given this, OSTP would like input on how to “manage and mitigate the risk of misappropriation of taxpayer or other funds through unethical behaviors in the research enterprise,” specifically addressing the adequacy of current disclosure requirements as well as the role government should play in helping to secure the research environment.
The notice also asks for details on whether organizations have “a common code of ethics applicable to researchers, and whether that code is highlighted and actively promoted in training, research practice, etc.,” and about how “institution-based procedures for reporting cases of sexual harassment and non-sexual harassment (or toxic climate) differ, and if there are aspects of one set of policies that would be beneficial for broader inclusion.” (12/12/19)
◆ Some entries on USAspending.gov are “not understandable except to agency officials,” and federal offices are struggling to supply complete and accurate information to the website, according to a new study by the Government Accountability Office (GAO). USAspending.gov was created under the Digital Accountability and Transparency (DATA) Act of 2014 to provide consumers and other interested parties with more information about specific projects agencies fund and where they are located. It is jointly operated by the Office of Management and Budget (OMB) and the Government Services Administration, with oversight by the Department of the Treasury. Agencies upload their own data and that which is submitted by awardees, particularly for subawards.
According to the study, “The DATA Act requires OMB and Treasury to establish data standards to produce consistent and comparable reporting of federal spending data.” But while there have been improvements since the last study in 2017, GAO officials “identified persistent challenges with the implementation and use of two award data elements—Award Description and Primary Place of Performance Address that limit the usefulness of these data. We previously reported that these data elements are particularly important to achieving the transparency goals envisioned by the DATA Act because they inform the public what the federal government spends money on and where it is spent.”
Among the examples of noncompliance GAO cited are entries by NASA of program descriptions of awards “that were long and highly technical. These descriptions did not meet the data standard because they contained acronyms, jargon, and other technical terminology that might be challenging for others outside the agency to understand,” GAO said. Aware of similar issues, GSA in June decreased the character limit for reporting award descriptions from 4,000 to 250 characters, but “NASA officials said that the new maximum will limit the flexibility to search for contractors. They are seeking alternatives for these searches.” The Department of Education, GAO said, reported “unknown title” for award descriptions “for the majority of the financial assistance award transactions in our sample.” Issues have also arisen “in cases where an award is made to a recipient that further distributes the funding to subrecipients,” GAO noted. Thirty-nine—or just 1%—of required federal programs are not reporting at all, but these “collectively account for approximately $11.5 billion in estimated annual obligations in fiscal year 2018.” The U.S. Department of Agriculture was the worst offender in this regard. GAO said Treasury officials agreed with recommendations to address these issues. (12/12/19)
◆ HHS-funded research conducted at more than one U.S.-study site may continue to use multiple institutional review boards “if an IRB initially approved the research before Jan. 20, 2020,” the Office for Human Research Protections (OHRP) said Nov. 22. The announcement makes good on OHRP’s pledge to address requirements regarding single IRBs and which studies must comply.
The revised Common Rule governing federally supported human subjects research set a date of Jan. 20, 2020, for compliance with the single IRB requirement (other than NIH-funded studies, which had a deadline of Jan. 25, 2018, to comply). But questions arose as to whether multisite (also called cooperative) studies that began on or after the general compliance date of Jan. 21 “would need to be identified, paused, and undergo a new single IRB review,” as a group of research universities said in a letter to OHRP Director Jerry Menikoff in May. At that time, they asked OHRP to “expeditiously address this issue.” OHRP’s “determination” issued last month was an attempt to set the record straight. It noted that, in addition to the initiation date, other exceptions are when “the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or NIH excepted the research from its single IRB policy” before Jan. 20, 2020.
The revised Common Rule governing federally supported human subjects research set a date of Jan. 20, 2020, for compliance with the single IRB requirement (other than NIH-funded studies, which had a deadline of Jan. 25, 2018, to comply). But questions arose as to whether multisite (also called cooperative) studies that began on or after the general compliance date of Jan. 21 “would need to be identified, paused, and undergo a new single IRB review,” as a group of research universities said in a letter to OHRP Director Jerry Menikoff in May. At that time, they asked OHRP to “expeditiously address this issue.” OHRP’s “determination” issued last month was an attempt to set the record straight. It noted that, in addition to the initiation date, other exceptions are when “the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or NIH excepted the research from its single IRB policy” before Jan. 20, 2020. (12/5/19)
◆ NIH has rescinded a 2018 “diversity statement” that established two categories that would qualify investigators as coming from a “disadvantaged background” and, effective Nov. 22, is offering seven new ones. “In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all,” the new statement says. “NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences.”
In addition to individuals with racial and ethnic backgrounds and those with disabilities, NIH is now defining individuals from disadvantaged backgrounds as those who meet two or more of the following criteria: experiencing homelessness; living in foster care; receiving free or reduced lunch for two or more years; having “no parents or legal guardians who completed a bachelor’s degree”; eligibility for a Pell grant; receiving federal food support as a parent or child; and growing up in a rural area that meets certain parameters established in federal law. The new statement “supersedes current diversity language in existing funding opportunities,” NIH said.
This “revised definition should better capture many scientists with a disadvantaged background, and be relatively easy to assess, ensuring we continue enhancing the diversity of the biomedical research workforce,” Michael Lauer, NIH deputy director of extramural research, wrote on his Open Mike blog. (12/5/19)
◆ Nearly three dozen physicians, academics and advocates for prisoners joined with the watchdog organization Public Citizen in asking the FDA to investigate BioCorRx Inc., an addiction treatments company they say has conducted studies without IRB approval and appropriate consent. The FDA should “immediately launch a formal compliance investigation into an apparent clinical investigation conducted by California-based BioCorRx Inc. and the Louisiana Department of Public Safety and Corrections,” the Nov. 20 letter states. The research at issue “involved testing the effectiveness of sustained-release naltrexone implants—a formulation of naltrexone never approved by the FDA—for management of opioid and alcohol use disorders in prison inmates. The agency also should investigate whether BioCorRx has conducted or is currently conducting any similar clinical investigations.” The FDA told Public Citizen it has “referred this matter to FDA’s Center for Drug Evaluation and Research for review and further action as appropriate.”
Michael Carome, director of Public Citizen’s Health Research Group, told RRC the organization is continuing its own inquiry into BioCorRx, which in January received a $5.7 million, two-year award from the National Institute on Drug Abuse (NIDA); in 2017 it announced that it had entered a partnership with the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Public Citizen has filed Freedom of Information Act requests seeking information about the grant, and all correspondence between NIDA and NIAAA and BioCorRx since Jan. 1, 2015. BioCorRx said it “welcomes any investigation by the FDA and believes it has done everything regarding its comprehensive program to fight addictions in full compliance with the letter and spirit of the law,” according to a story by FierceBiotech. (12/5/19)