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Context of 'January 4, 2005: Whistleblower Says Government Mismanaged African AIDS Study'

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Dr. Jonathan Fishbein.Dr. Jonathan Fishbein. [Source: unknown]Government whistleblower Dr. Jonathan Fishbein, in testimony before a panel at the Institute of Medicine, says that federal officials involved in a US-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices. Fishbein says officials at the National Institutes of Health (NIH) ignored problems with the way the study was being conducted on the AIDS drug, nevirapine, which is used to protect babies in Africa from HIV infection during birth. The consequences of their failure had “grave and sometimes fatal implications for the lives of real patients,” Fishbein tells the panel. Fishbein does not allege that the drug is dangerous or ineffective. Instead, he discusses problems with the researchers involved, citing shoddy data collection, record-keeping and quality control issues. Because of those concerns, he says, the results of the study cannot be trusted. “We can ill afford to entrust the lives of people to invalid data,” he says. NIH has acknowledged that the Uganda research failed to meet required US standards. But it maintains that hundreds of thousands of African babies have been saved by using single doses of the drug to block the AIDS virus and that it can be done safely with those single doses. Nevirapine is an antiretroviral drug used since the 1990s to treat adult AIDS patients and is known to have potentially lethal side effects like liver damage when taken in multiple doses over time. Concerns have been raised over the possibility that the drug may cause long-term resistance in patients to further AIDS treatments. It is marketed in the United States as Viramune. Fishbein says that top officials at NIH became “so heavily invested in the trial’s outcome” that they could not be objective. “The old adage ‘garbage in, garbage out’ is apt,” he says. In 2003, Fishbein helped halt the study for 15 months after auditors, medical experts, and others disclosed problems with the project. But the concerns were dismissed by NIH officials, and the study began again. Documents show NIH knew of problems with the study in early 2002, but did not tell the White House before President Bush launched a $500 million plan that summer to use nevirapine throughout Africa. NIH is attempting to fire Fishbein for what it calls poor performance issues; Fishbein says the firing is retaliation for his speaking out. [Associated Press, 1/4/2005]

Entity Tags: Institute of Medicine, United States National Institutes of Health, Jonathan Fishbein

Timeline Tags: US Health Care

Dr. Pearson “Trey” Sunderland.Dr. Pearson “Trey” Sunderland. [Source: CreativityFound (.org)]Dr. Pearson “Trey” Sunderland III, a National Institute of Health (NIH) senior researcher on Alzheimer’s disease, pleads guilty to a federal charge that he committed a criminal conflict of interest. The charges stem from Sunderland’s contract with the pharmaceutical firm Pfizer as a paid consultant for work that overlapped his duties as a public servant. Sunderland is the first official in 14 years to be prosecuted for conflict of interest at NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry. According to the original court filing, in early 1998, “Sunderland initiated negotiations with Pfizer, the pharmaceutical giant, to be paid as a consultant for his work on the same project” that he headed for NIH, a research project into Alzheimer’s disease. In June 2006, Sunderland was revealed to have engaged in a secret contract with Pfizer to supply thousands of samples of spinal fluid collected from Alzheimer’s patients at taxpayer expense and slated to be used in NIH research. Sunderland turned those samples over to Pfizer, which in turn used them to refine and market its drug Aricept, a leading prescription drug for treating the disease (see June 14, 2006). According to the original charging document filed with the court, in 1998 Sunderland approached Pfizer with a proposal that he be paid $25,000 a year for “consulting” with the firm, plus $2,500 every time he attended a one-day meeting with company representatives. Pfizer agreed. Later that same year, Sunderland set up another deal with Pfizer to be paid another $25,000 a year, according to prosecutors. The House Energy and Commerce Committee received little cooperation from NIH—Sunderland himself invoked his Fifth Amendment right against self-incrimination when called to testify before the committee in June 2006—but subpoeaned 21 drug manufacturers known to have paid NIH researchers. Sunderland’s history of payments from Pfizer, which he did not reveal to the NIH as required by law, were some of those discovered. After that information was revealed in 2004, NIH director Elias Zerhouni requested that the inspector general of the Department of Health and Human Services investigate the matter. Government researchers found that 44 researchers, including Sunderland, had off-the-books relationships with drug and biotech companies; many of those researchers were reprimanded and/or took early retirement. At the time of Sunderland’s contracts with Pfizer, NIH restrictions against public-private collaborations were far more lax than they are today. [Associated Press, 12/4/2006; Associated Press, 12/5/2006; Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006]
'Public Trust Has Been Violated' - Congressman John Dingell (D-MI) asks, “Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?” Bart Stupak (D-MI) adds, “If the National Institutes of Health and Commissioned Corps fail to discipline Dr. Sunderland, even after criminal charges have been brought, we can only conclude that no one is being held accountable, the system is broken, and the public trust has been violated.” [Associated Press, 12/5/2006; Los Angeles Times, 12/5/2006] Committee member Tammy Baldwin (D-WI) says: “I found this story incredibly distressing because it is so important that people have confidence in the NIH. It is a pretty big move for people to donate human tissue to further scientific discovery. People have to have confidence that that decision… is treated with the utmost respect.” [Washington Post, 12/5/2006]
Guilty Plea Avoids Jail Time - Sunderland pleads guilty to the charge under a plea agreement in which he admits to taking some $285,000 in “unauthorized” consulting fees from Pfizer as well as $15,000 in travel expense payments between 1998 and 2003. During the same period, he provided Pfizer with spinal-tap samples collected from hundreds of patients as part of a research collaboration approved by the NIH. He agrees to pay the government $300,000, perform 400 hours of community service, and serve two years’ probation. Sunderland faced up to a year in prison and a $100,000 fine, but avoided those penalties through his plea agreement. After the hearing, US Attorney Rod Rosenstein tells reporters that Sunderland’s actions constitute a breach of the public trust. [Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006] According to NIH spokesman Don Ralbovsky, Sunderland remains an employee, working as a “special assistant and senior adviser” in a division that gives out grants; Rabolvsky refuses to comment on whether Sunderland faces termination procedures. The branch of NIH that Sunderland once headed, the Geriatric Psychiatry Branch, no longer exists, according to Ralbovsky. [Washington Post, 12/5/2006] One media report says Sunderland is planning to retire. [Associated Press, 12/4/2006] Sunderland will later become a doctor and director of the Alzheimer Research Center at the Albert Einstein College of Medicine in New York. [Lundbeck Institute, 12/11/2008]
Pfizer Denies Wrongdoing - For its part, Pfizer maintains that it broke no laws and breached no ethics, saying in a statement: “We believe our actions complied with applicable laws and ethical standards. We are not aware of any allegation that we violated any law or regulation.” [Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006; Los Angeles Times, 12/11/2006]

Entity Tags: Pfizer, Pearson (“Trey”) Sunderland III, Rod Rosenstein, John Dingell, Bart Stupak, Don Ralbovsky, Elias Zerhouni, United States National Institutes of Health, Tammy Baldwin

Timeline Tags: US Health Care

Researchers for Harvard Medical School and the Cambridge Health Alliance release a report that shows approximately 45,000 Americans a year—122 a day or one every 12 minutes—die as a result of a lack of health insurance and a subsequent inability to receive medical care. The study’s co-author, Harvard medicine professor Dr. David Himmelstein, tells a reporter, “We’re losing more Americans every day because of inaction… than drunk driving and homicide combined.” Lead author Dr. Andrew Wilper, a medical professor at the University of Washington, says: “The uninsured have a higher risk of death when compared to the privately insured, even after taking into account socioeconomics, health behaviors, and baseline health. We doctors have many new ways to prevent deaths from hypertension, diabetes, and heart disease—but only if patients can get into our offices and afford their medications.” The study also shows that Americans aged 64 and below have a 40 percent higher risk of death than those who have coverage. The study is published in the online edition of the American Journal of Public Health, and released by Physicians for a National Health Program, which favors government-backed or “single-payer” health insurance. In 1993, a similar study showed those lacking insurance had a 25 percent higher risk of death. In 2002, the Institute of Medicine estimated that around 18,000 Americans a year died because they lacked coverage. Himmelstein says the sharp rise in risk is due to the swelling ranks of the uninsured. Around 46.3 million people in the United States lacked coverage in 2008, according to the US Census Bureau, an increase over the 45.7 million figure from 2007. Another factor is the dwindling resources where the uninsured can receive care. Public hospitals across the country are either denying uninsured people any care at all, or restricting the care they offer. Co-author Dr. Steffie Woolhandler says the findings show that without proper care, uninsured people are more likely to die from complications associated with preventable diseases such as diabetes and heart disease. The National Center for Policy Analysis, a conservative think tank, calls the study flawed; a spokesman for the Center says: “I think you can’t trust the results. Having said that, we ought to do something for the uninsured.” Woolhandler says the study followed similar protocols to those used by earlier government and private studies. “For any doctor… it’s completely a no-brainer that people who can’t get health care are going to die more from the kinds of things that health care is supposed to prevent,” she says. “Historically, every other developed nation has achieved universal health care through some form of nonprofit national health insurance. Our failure to do so means that all Americans pay higher health care costs, and 45,000 pay with their lives.” [Reuters, 9/17/2009; Harvard Science, 9/17/2009; CBS News, 9/17/2009]

Entity Tags: David Himmelstein, American Journal of Public Health, Cambridge Health Alliance, Steffie Woolhandler, National Center for Policy Analysis, Andrew Wilper, Harvard Medical School, Institute of Medicine, Physicians for a National Health Program

Timeline Tags: US Health Care

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