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Context of 'December 11, 2006: NIH Researcher Pleads Guilty over Secret Contract with Pfizer'

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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. Susan Molchan testifies before Congress.Dr. Susan Molchan testifies before Congress. [Source: CBS News]Dr. Susan Molchan, a former clinical researcher for the National Institutes of Health (NIH), testifies before Congress that her supervisor at NIH made a secret deal with the pharmaceutical company Pfizer that involved human tissue samples supposedly collected for the public good, but were instead used for Pfizer’s own research and garnered the company millions in profit. [CBS News, 6/14/2006] Molchan testifies before the House Energy and Commerce Subcommittee on Oversight and Investigations [The Scientist, 6/14/2006] that a collection of unused spinal fluid samples, which CBS News describes as a "a treasure trove of biological material, many painfully given up by Alzheimer’s patients" disappeared without a trace from her laboratory freezer at NIH. The samples were slated to be used for NIH studies on Alzheimer’s disease. Molchan says she was told that some of the samples were lost due to freezer malfunctions, but, "nothing solid, nothing that made sense. I never got a handle on what happened to them." [CBS News, 6/14/2006] Procuring the tissue samples alone cost the government $6.4 million, say committee staffers, who spent a year investigating the matter. "It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples," says committee member Joe Barton (R-TX). [The Scientist, 6/14/2006] Molchan’s testimony, and other data gathered by Congressional investigators, prove that Molchan’s immediate supervisor, Dr. Trey Sunderland, a well-known psychiatric researcher, cut a secret deal with Pfizer at the same time Pfizer was launching and refining a new Alzheimer’s drug. "If individual scientists are making use of that tissue for their own personal gain, that’s something we need to know about it. It’s not the right thing," says House Energy subcommittee chairman Ed Whitfield (R-KY). Sunderland provided Pfizer "access" to 3,200 tubes of spinal fluid, costing the NIH and, as a result, taxpayers, an estimated $6 million. In exchange, Sunderland reportedly received $285,000 in personal compensation. Pfizer’s drug Aricept is now the top-selling drug in the world for treating Alzheimer’s, generating $1.6 billion in sales in 2004. "The more tissue samples you can collect these days and extract genetic information about risk and benefit, that’s the future of drug development around the world," says Dr. Art Caplan, a bio-ethicist at the University of Pennsylvania. The House committee finds that Pfizer itself broke no NIH rules or knew of any wrongdoing by Sunderland, who does not testify before Congress, instead invoking his Fifth Amendment right against self-incrimination. [CBS News, 6/14/2006] Sunderland himself received more than $600,000 in outside consulting and speaking fees from Pfizer from 1998 to 2004 without prior government disclosure or approval. A review by NIH’s Office of Management Assessment found that Sunderland "engaged in serious misconduct, in violation of HHS ethics rules and Federal law and regulation," the report stated. In December 2006, Sunderland will accept a plea bargain in regards to his accepting payments from Pfizer (see December 11, 2006). [The Scientist, 6/14/2006]

Entity Tags: Susan Molcher, Pfizer, Joe Barton, Pearson (“Trey”) Sunderland III, Art Capland, Ed Whitfield, United States National Institutes of Health

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

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