November 19, 2019
Little data available to determine if companies are doing their job to keep research safe and maintain ethics standards that protect participants
Senators Warren, Brown, and Sanders Investigate “Inherent” Conflicts of Interest of Private Equity-Owned Institutional Review Boards
Little data available to determine if companies are doing their job to keep research safe and maintain ethics standards that protect participants
Washington, D.C. - United States Senators Elizabeth
Warren (D-Mass.), Sherrod Brown (D-Ohio), and Bernie Sanders (I-Vt.) sent
letters to two major private equity-owned commercial institutional review
boards (IRBs), WCG Clinical and Advarra, which review clinical research proposals
to ensure that participant rights are protected and the research is conducted
ethically. IRBs are entrusted with protecting participants and vulnerable
populations. The lawmakers’ letter raises questions about whether for-profit
IRBs are vulnerable to conflicts of interest that could inhibit their ability
to protect research subjects, and whether the two companies are maintaining
appropriate ethics standards. The lawmakers also request comprehensive
information on their approvals, processes, policies, and quality metrics.
In recent
years, approximately 70% of clinical trial reviews have
shifted from academic to for-profit IRBs, dominated by two large companies
owned by private equity firms. For-profit IRBs introduce an inherent conflict
of interest into decision-making, since their financial incentive is to
minimize obstacles for researchers and prioritize profits and turnaround time
over thorough reviews.
“The
recent trend of private equity ownership is especially troubling, given the
pressures to reduce costs and ramp up profits that often accompany private
equity’s entry into a field,” wrote the lawmakers. “If managers see
their primary responsibility as generating returns for their investors, they
may emphasize speed over thoroughness in the review process, creating risks for
patients.”
The
lawmakers also express concern about recent reports of a rise in “pay to participate”
clinical trials, which for-profit IRBs have previously reviewed and approved.
These “pay to participate” clinical trials ask patients to pay thousands of
dollars for the opportunity to participate in sometimes lifesaving research
studies. These studies may take advantage of vulnerable patients and their
families, restrict access to treatment to those who can afford to pay, create
incentives to over-sell the potential benefits of the trial, and potentially
compromise the design of the clinical trial.
“IRB
oversight should aim to prevent precisely these types of exploitative schemes,”
wrote the lawmakers.
The lawmakers requested information
regarding approvals, processes, policies, and quality metrics from the two
for-profit IRBs for each of the past five years, by no later than December 13,
2019.
Senator Warren has been a vocal
critic of private equity abuses throughout her time in the Senate and is
fighting for reforms that protect students, workers, communities, and
investors:
- Senators Warren, Brown and Tammy Baldwin (D-Wis.), along
with Representatives Mark Pocan (D-Wis.), and Pramila Jayapal (D-Wash.), introduced the Stop Wall Street Looting
Act, a comprehensive bill to fundamentally reform the private equity
industry and level the playing field by forcing private equity firms to
take responsibility for the outcomes of companies they take over,
empowering workers, and protecting investors.
- Senators Warren, Sanders, and
Baldwin, along with Representatives Pocan and Jayapal, sent a letter to
Ernst & Young, sharply criticizing
a misleading report the firm released in partnership with the American
Investment Council, a trade group for the private equity industry, about
the scope of private equity’s influence in the economy.
- Senators
Warren, Brown, and Representative Pocan wrote
to four private equity firms that currently invest or have recently
invested in companies providing nursing home care and other long-term care
services, citing reports that show private equity investment has played a
role in the declining quality of care in nursing homes and requesting
information about each firms' management of this sector.
- Senator Warren, Representatives
Pocan, and Lloyd Doggett (D-Texas) wrote
last month to five private equity firms with investments and physician
staffing and emergency transport companies, questioning the role these
companies play in patients receiving exorbitant surprise bills for
out-of-network medical treatment.
- In June 2015, Senator Warren
was an original co-sponsor of the Carried
Interest Fairness Act, legislation to close the
carried interest loophole that allowed private equity fund managers to pay
lower taxes. The legislation was re-introduced in March 2019 and is
included in the Stop Wall Street Looting Act.
###
Washington, D.C. - United States Senators Elizabeth
Warren (D-Mass.), Sherrod Brown (D-Ohio), and Bernie Sanders (I-Vt.) sent
letters to two major private equity-owned commercial institutional review
boards (IRBs), WCG Clinical and Advarra, which review clinical research proposals
to ensure that participant rights are protected and the research is conducted
ethically. IRBs are entrusted with protecting participants and vulnerable
populations. The lawmakers’ letter raises questions about whether for-profit
IRBs are vulnerable to conflicts of interest that could inhibit their ability
to protect research subjects, and whether the two companies are maintaining
appropriate ethics standards. The lawmakers also request comprehensive
information on their approvals, processes, policies, and quality metrics.
In recent
years, approximately 70% of clinical trial reviews have
shifted from academic to for-profit IRBs, dominated by two large companies
owned by private equity firms. For-profit IRBs introduce an inherent conflict
of interest into decision-making, since their financial incentive is to
minimize obstacles for researchers and prioritize profits and turnaround time
over thorough reviews.
“The
recent trend of private equity ownership is especially troubling, given the
pressures to reduce costs and ramp up profits that often accompany private
equity’s entry into a field,” wrote the lawmakers. “If managers see
their primary responsibility as generating returns for their investors, they
may emphasize speed over thoroughness in the review process, creating risks for
patients.”
The
lawmakers also express concern about recent reports of a rise in “pay to participate”
clinical trials, which for-profit IRBs have previously reviewed and approved.
These “pay to participate” clinical trials ask patients to pay thousands of
dollars for the opportunity to participate in sometimes lifesaving research
studies. These studies may take advantage of vulnerable patients and their
families, restrict access to treatment to those who can afford to pay, create
incentives to over-sell the potential benefits of the trial, and potentially
compromise the design of the clinical trial.
“IRB
oversight should aim to prevent precisely these types of exploitative schemes,”
wrote the lawmakers.
The lawmakers requested information
regarding approvals, processes, policies, and quality metrics from the two
for-profit IRBs for each of the past five years, by no later than December 13,
2019.
Senator Warren has been a vocal
critic of private equity abuses throughout her time in the Senate and is
fighting for reforms that protect students, workers, communities, and
investors:
- Senators Warren, Brown and Tammy Baldwin (D-Wis.), along with Representatives Mark Pocan (D-Wis.), and Pramila Jayapal (D-Wash.), introduced the Stop Wall Street Looting Act, a comprehensive bill to fundamentally reform the private equity industry and level the playing field by forcing private equity firms to take responsibility for the outcomes of companies they take over, empowering workers, and protecting investors.
- Senators Warren, Sanders, and Baldwin, along with Representatives Pocan and Jayapal, sent a letter to Ernst & Young, sharply criticizing a misleading report the firm released in partnership with the American Investment Council, a trade group for the private equity industry, about the scope of private equity’s influence in the economy.
- Senators Warren, Brown, and Representative Pocan wrote to four private equity firms that currently invest or have recently invested in companies providing nursing home care and other long-term care services, citing reports that show private equity investment has played a role in the declining quality of care in nursing homes and requesting information about each firms' management of this sector.
- Senator Warren, Representatives Pocan, and Lloyd Doggett (D-Texas) wrote last month to five private equity firms with investments and physician staffing and emergency transport companies, questioning the role these companies play in patients receiving exorbitant surprise bills for out-of-network medical treatment.
- In June 2015, Senator Warren was an original co-sponsor of the Carried Interest Fairness Act, legislation to close the carried interest loophole that allowed private equity fund managers to pay lower taxes. The legislation was re-introduced in March 2019 and is included in the Stop Wall Street Looting Act.
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