The medical research crisis you haven't heard of

There's a crisis of legitimacy in the world of medical research.  Congress is finally putting bad actors at the Foundation for the National Institutes of Health (FNIH) on notice in the wake of a litany of scandals.

The FNIH was created by Congress in the 1990s with the mission to raise private funds to support taxpayer-funded medical research at the national research institutes, such as the National Institutes of Health (NIH), and was intended to act as an ethical shield between industry and medical research.

However, the FNIH has since been rocked by a series of incidents that represent, at best, serious conflicts of interest and, at worst, a betrayal of the organization's core mission.

During an August 23 Health, Education, Labor and Pensions (HELP) hearing, Sen. Elizabeth Warren (D-Mass.) asked Francis Collins, director of the National Institutes of Health, "Do you agree science should be setting the agenda at NIH and not donors?"  Collins responded, "Absolutely."

Continuing, Sen. Warren highlighted one example of malfeasance, stating, "The NIH recently cancelled a study of the health effects of alcohol consumption following an internal investigation that revealed that the alcohol industry was not only funding the study, but that the study had been set up to deliver the results that the industry wanted."

Warren was specifically referring to the Moderate Alcohol and Cardiovascular Health (MACH) Trial – a study funded by the alcohol industry to study the effects of moderate drinking.  A task force later reported that there was "early and frequent engagement" between NIH officials and members of the alcohol industry, severely undermining scientific integrity.

FNIH Director Francis Collins, who noted that FNIH staffers had been "conducting activities that they [were] trying to hide from other staff," in the case of the MACH Trial, was similarly forced to kill a plan to partner with big pharmaceutical companies on a $400-million study of opioid dependency after an external panel highlighted a similar risk of conflict of interest.

Compounding matters, the FNIH has violated laws designed to prevent these conflicts of interest, neglecting to reveal amounts received by top "anonymous" donors.  According to U.S. law, the FNIH must report "the source and amount of all gifts," adding, "a specification of any restrictions on the purposes for which gifts or grants," may be used.

Now, a congressional report accompanying the 2019 Departments of Labor, Health and Human Services, and Education appropriations bill has explicitly called out the FNIH for its unethical behavior.

"The Committee directs the Foundation for the National Institutes of Health ('Foundation') to abide by section 499(j)(4) of the Public Health Service Act by including in the Foundation's annual report the source and amount of all monetary gifts to the Foundation," the report reads, adding, "The annual report shall not list ''anonymous'' as a source for any gift that includes a specification of any restrictions on the purpose for which the gift may be used."

Senior members of the FNIH appear wholly unfazed by the directive.

"This is not language in the appropriations bill, so we have no comment on it," David Wholley, the FNIH's senior vice president of research partnerships, stated with regard to the report, adding, "And if and when Congress puts language into the appropriations bill that directs FNIH to do something, FNIH will do it, as we have for 25 years, without exception."

In order to maintain the transparency and integrity of medical research, Congress must rectify the FNIH's blatant breach of public trust.  When industry members are allowed to unduly influence scientific findings, public health is compromised for the private enrichment of bad actors.

In a recent statement, NIH director Collins acknowledged the controversy directly, referencing the "failure by some researches at NIH-funded institutions to disclose substantial contributions of resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds," as an area of concern.

Now is the time for Congress to act to protect the public welfare by presenting President Trump with an appropriations bill that will bring the FNIH in line with the law.  Until this matter is addressed, the medical research legitimacy crisis will only grow worse, eroding America's faith in the mission of the national research institutes and placing public health in danger.

There's a crisis of legitimacy in the world of medical research.  Congress is finally putting bad actors at the Foundation for the National Institutes of Health (FNIH) on notice in the wake of a litany of scandals.

The FNIH was created by Congress in the 1990s with the mission to raise private funds to support taxpayer-funded medical research at the national research institutes, such as the National Institutes of Health (NIH), and was intended to act as an ethical shield between industry and medical research.

However, the FNIH has since been rocked by a series of incidents that represent, at best, serious conflicts of interest and, at worst, a betrayal of the organization's core mission.

During an August 23 Health, Education, Labor and Pensions (HELP) hearing, Sen. Elizabeth Warren (D-Mass.) asked Francis Collins, director of the National Institutes of Health, "Do you agree science should be setting the agenda at NIH and not donors?"  Collins responded, "Absolutely."

Continuing, Sen. Warren highlighted one example of malfeasance, stating, "The NIH recently cancelled a study of the health effects of alcohol consumption following an internal investigation that revealed that the alcohol industry was not only funding the study, but that the study had been set up to deliver the results that the industry wanted."

Warren was specifically referring to the Moderate Alcohol and Cardiovascular Health (MACH) Trial – a study funded by the alcohol industry to study the effects of moderate drinking.  A task force later reported that there was "early and frequent engagement" between NIH officials and members of the alcohol industry, severely undermining scientific integrity.

FNIH Director Francis Collins, who noted that FNIH staffers had been "conducting activities that they [were] trying to hide from other staff," in the case of the MACH Trial, was similarly forced to kill a plan to partner with big pharmaceutical companies on a $400-million study of opioid dependency after an external panel highlighted a similar risk of conflict of interest.

Compounding matters, the FNIH has violated laws designed to prevent these conflicts of interest, neglecting to reveal amounts received by top "anonymous" donors.  According to U.S. law, the FNIH must report "the source and amount of all gifts," adding, "a specification of any restrictions on the purposes for which gifts or grants," may be used.

Now, a congressional report accompanying the 2019 Departments of Labor, Health and Human Services, and Education appropriations bill has explicitly called out the FNIH for its unethical behavior.

"The Committee directs the Foundation for the National Institutes of Health ('Foundation') to abide by section 499(j)(4) of the Public Health Service Act by including in the Foundation's annual report the source and amount of all monetary gifts to the Foundation," the report reads, adding, "The annual report shall not list ''anonymous'' as a source for any gift that includes a specification of any restrictions on the purpose for which the gift may be used."

Senior members of the FNIH appear wholly unfazed by the directive.

"This is not language in the appropriations bill, so we have no comment on it," David Wholley, the FNIH's senior vice president of research partnerships, stated with regard to the report, adding, "And if and when Congress puts language into the appropriations bill that directs FNIH to do something, FNIH will do it, as we have for 25 years, without exception."

In order to maintain the transparency and integrity of medical research, Congress must rectify the FNIH's blatant breach of public trust.  When industry members are allowed to unduly influence scientific findings, public health is compromised for the private enrichment of bad actors.

In a recent statement, NIH director Collins acknowledged the controversy directly, referencing the "failure by some researches at NIH-funded institutions to disclose substantial contributions of resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds," as an area of concern.

Now is the time for Congress to act to protect the public welfare by presenting President Trump with an appropriations bill that will bring the FNIH in line with the law.  Until this matter is addressed, the medical research legitimacy crisis will only grow worse, eroding America's faith in the mission of the national research institutes and placing public health in danger.