Jonathan Fishbein
Encyclopedia
Jonathan Fishbein is an American physician
and former director of the National Institutes of Health
(NIH) Office for Policy in Clinical Research Operations. In 2005, Fishbein alleged that an NIH-funded clinical trial
of the antiretroviral drug
nevirapine, conducted in Africa, was invalid because of poor data collection, faulty record-keeping, and lax quality control. The NIH subsequently attempted to fire Fishbein, and he sought protection as a whistleblower
.
The clinical trial in question was the HIVNET 012 study, which tested the antiretroviral drug
nevirapine, used in some developing countries
as a cost-effective method to prevent transmission of HIV
from mother to unborn child
. Fishbein was among several NIH employees to raise concerns about the study; he alleged that the NIH had become "so heavily invested in the trial's outcome" that it had lost objectivity about the quality of the result. Internal NIH documents showed that concerns had been raised about HIVNET012, but that the Institute did not notify the Bush Administration
before the launch of a major project to subsidize nevirapine use in Africa to combat the spread of HIV. The NIH subsequently attempted to fire Fishbein; he alleged that the attempted dismissal was in retaliation for his complaints about HIVNET 012, while the agency cited poor performance during a probationary period as the cause for firing.
An undisclosed settlement was reached between the parties in 2005. Fishbein resigned from the Agency on June 30, 2009. Provided detailed documentation to support Fishbein's allegations, Senator Charles Grassley (R - Iowa) requested that the HHS Office of the Inspector General launch an investigation. A Commission headed by former HHS Secretary Louis Sullivan was appointed by the NIH to recommend improvements in management and practices at the Division of AIDS.
In response to the allegations of Fishbein and others, the Institute of Medicine
conducted an independent review of HIVNET 012 methodology and findings. The institute's review concluded that nevirapine was safe and effective in the prevention of mother-to-child HIV transmission, as HIVNET 012 had found, and that the study's methodology was sufficiently sound that scientists and policy-makers could rely on the study's findings.
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...
and former director of the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
(NIH) Office for Policy in Clinical Research Operations. In 2005, Fishbein alleged that an NIH-funded clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
of the antiretroviral drug
Antiretroviral drug
Antiretroviral drugs are medications for the treatment of infection by retroviruses, primarily HIV. When several such drugs, typically three or four, are taken in combination, the approach is known as Highly Active Antiretroviral Therapy, or HAART...
nevirapine, conducted in Africa, was invalid because of poor data collection, faulty record-keeping, and lax quality control. The NIH subsequently attempted to fire Fishbein, and he sought protection as a whistleblower
Whistleblower
A whistleblower is a person who tells the public or someone in authority about alleged dishonest or illegal activities occurring in a government department, a public or private organization, or a company...
.
The clinical trial in question was the HIVNET 012 study, which tested the antiretroviral drug
Antiretroviral drug
Antiretroviral drugs are medications for the treatment of infection by retroviruses, primarily HIV. When several such drugs, typically three or four, are taken in combination, the approach is known as Highly Active Antiretroviral Therapy, or HAART...
nevirapine, used in some developing countries
Developing country
A developing country, also known as a less-developed country, is a nation with a low level of material well-being. Since no single definition of the term developing country is recognized internationally, the levels of development may vary widely within so-called developing countries...
as a cost-effective method to prevent transmission of HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
from mother to unborn child
Vertical transmission
Vertical transmission, also known as mother-to-child transmission, is the transmission of an infection or other disease from mother to child immediately before and after birth during the perinatal period. A pathogen's transmissibility refers to its capacity for vertical transmission...
. Fishbein was among several NIH employees to raise concerns about the study; he alleged that the NIH had become "so heavily invested in the trial's outcome" that it had lost objectivity about the quality of the result. Internal NIH documents showed that concerns had been raised about HIVNET012, but that the Institute did not notify the Bush Administration
George W. Bush administration
The presidency of George W. Bush began on January 20, 2001, when he was inaugurated as the 43rd President of the United States of America. The oldest son of former president George H. W. Bush, George W...
before the launch of a major project to subsidize nevirapine use in Africa to combat the spread of HIV. The NIH subsequently attempted to fire Fishbein; he alleged that the attempted dismissal was in retaliation for his complaints about HIVNET 012, while the agency cited poor performance during a probationary period as the cause for firing.
An undisclosed settlement was reached between the parties in 2005. Fishbein resigned from the Agency on June 30, 2009. Provided detailed documentation to support Fishbein's allegations, Senator Charles Grassley (R - Iowa) requested that the HHS Office of the Inspector General launch an investigation. A Commission headed by former HHS Secretary Louis Sullivan was appointed by the NIH to recommend improvements in management and practices at the Division of AIDS.
In response to the allegations of Fishbein and others, the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
conducted an independent review of HIVNET 012 methodology and findings. The institute's review concluded that nevirapine was safe and effective in the prevention of mother-to-child HIV transmission, as HIVNET 012 had found, and that the study's methodology was sufficiently sound that scientists and policy-makers could rely on the study's findings.