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US Health Care System

Suppression of data

Project: US Health Care System
Open-Content project managed by kuhan, mtuck

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Merck submits the results of the VIGOR clinical trial for its drug Vioxx to the New England Journal of Medicine (NEJM) for publication. The data include only 17 of the 20 deaths that occurred among patients taking Vioxx (see March 2000). [National Public Radio, 6/8/2006] Data concerning the last three deaths were deleted two days before, according to Dr. Gregory Curfman, executive editor of the journal, who does not discover the missing data until December 2004. “When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says ‘Merck,’” Curfman later tells Forbes magazine. [Forbes, 12/8/2005]

Entity Tags: Merck

Category Tags: Suppression of data, Vioxx

In a memo to Merck scientist Alise Reicin, Merck statistician Deborah Shapiro includes a reference to the three Vioxx deaths that occurred during the last month of the VIGOR study (see March 2000). Those three deaths—numbers 18, 19, and 20—were not included in a paper submitted to the New England Journal of Medicine in which Reicin and Shapiro are listed as authors (see May 18, 2000). [National Public Radio, 6/8/2006]

Entity Tags: Alise Reicin, Deborah Shapiro

Category Tags: Suppression of data, Vioxx

Ann-Marie Lynch, deputy assistant secretary in the office of policy at the Department of Health and Human Services, allegedly blocks the release of several government reports that contradict claims made by the drug industry. One of them is a 2001 report stating that involvement of private health companies in Medicare’s prescription-drug benefit programs would lead to higher prices and would not work well in rural areas. [Denver Post, 5/23/2004]

Entity Tags: Ann-Marie Lynch

Category Tags: Suppression of data, Medicare

Thomas A. Scully, administrator of the Centers for Medicare & Medicaid Services (CMS), warns Richard S. Foster, the agency’s top expert on Medicare costs, that he will be fired if he responds to Congress’s request for a cost estimate on the drug plan favored by the administration. Foster estimates that the plan will cost $534 billion over the next 10 years. This amount is roughly a third more than the $400 billion estimate that was provided to legislators by the Congressional Budget Office. The White House knows about Foster’s cost estimate but fears that if Congress obtains this information, it will not pass the drug plan. Several conservative House Republicans have said they will not vote for the bill if it exceeds $400 billion. Foster’s estimates are shared with Doug Badger, the president’s special assistant for health policy, and with James C. Capretta, associate director of the White House Office of Management and Budget. Scully instructs Foster that all cost estimates must first be submitted to him so he can decide whether they should be released. “More than once, Tom said he was just following orders,” Foster later tells the Washington Post, adding that he suspects the orders were coming directly from the White House, probably from Badger. On other occasions, when Foster is talking to lawmakers over the phone, White House officials are routinely on the line monitoring his comments and in some instances they instruct Foster not to respond to lawmakers’ questions, according to an unnamed congressional Democratic aide. It is not until January 2004, after the drug bill is passed, that the White House finally releases Foster’s estimates. [Knight Ridder, 3/12/2004; Washington Post, 3/13/2004; New York Times, 3/25/2004; US Department of Health and Human Services, 7/6/2004 pdf file; New York Times, 7/7/2004] Several Republicans later say they would not have voted for the program had they known its true cost. [Savage, 2007, pp. 116]

Entity Tags: Doug Badger, Richard S. Foster, Thomas A. Scully, James C. Capretta

Category Tags: Suppression of data, Medicare, Medicaid

Britain’s Department of Health advises doctors treating depressed children to prescribe only Prozac. Other antidepressants like Zoloft, Paxil, Luvox, Effexor, Celexa, and Lexapro should be avoided, it warns, because of a potential link between these drugs and suicidal and hostile behavior. [BBC, 12/10/2003; New York Times, 12/16/2003] The FDA takes no action in the US, and continues to sit on a study by one of its own scientists (see September 2003) that links the drugs to suicidal thoughts in children. [Washington Post, 9/24/2004]

Entity Tags: US Food and Drug Administration

Category Tags: Suppression of data, Paxil, Zoloft

In January 2004, an FDA safety officer determines from analysis of adverse event reports that there may be a link between sudden blindness and the impotency drug Viagra. She recommends that the agency warn doctors and patients about the drug’s possible side effect. FDA staffers generally agree that Viagra’s label needs to be updated with a warning. Two months later, a formal draft safety “consult” on the potential Viagra-blindness link is submitted, followed by a final report in April. The FDA approaches Pfizer, the maker of the drug, but the company “resist[s] the FDA’s initial request to update the Viagra label to include information about the NAION risks,” according to a letter that is later sent to the FDA by Senator Charles E. Grassley. The FDA does not issue a public notice or propose a change to the drug’s label until May 2005 when a study published in the Journal of Neuro-Ophthalmology reports seven cases of men experiencing sudden blindness within 36 hours of taking Viagra. [New York Times, 6/1/2005]

Entity Tags: Pfizer, US Food and Drug Administration

Category Tags: Suppression of data

Russell Katz, director of the FDA’s division of neuropharmacological drug products, informs medical officer Andrew Mosholder that he will not be permitted to present his report on the suicidal side effects of Paxil, Zoloft, and certain other antidepressants. Mosholder—who believes the drugs may increase suicidal tendencies in children (see September 2003)—was scheduled to report his findings at an FDA advisory hearing on February 2. Katz reportedly tells Mosholder his report is biased. When the San Francisco Chronicle asks about this decision, Anne Trontell, deputy director of the agency’s Office of Drug Safety, says Mosholder can’t present the report because it has not yet been “finalized.” [San Francisco Chronicle, 2/1/2004]

Entity Tags: Anne Trontell, Russell Katz, Andrew Mosholder

Category Tags: Suppression of data

FDA scientist David Graham has analyzed data on 1.4 million Kaiser Permanente patients who took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. Based on his findings, Graham believes there have been more than 27,000 heart attacks and sudden cardiac deaths in the US that would not have occurred had those patients been prescribed Celebrex instead of Vioxx. [Washington Post, 10/8/2004] When the FDA reviews a summary of his study, which Graham will present in France on August 25 (see August 25, 2004), his conclusion triggers “an explosive response from the Office of New Drugs.” Graham later tells Congress, “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.” [US Congress, 11/18/2004 pdf file] In an August 12 e-mail, John Jenkins, director of the Office of New Drugs, suggests “watering down” the report’s conclusions because the FDA is “not contemplating” a warning against high-doses of Vioxx. In response, Graham says, “I’ve gone about as far as I can without compromising my deeply-held conclusions about this safety question.” In another e-mail, a different top official expresses concern about how the report might impact Merck. The person writes that the company should be warned beforehand “so they can be prepared for [the] extensive media attention that this will likely provoke.” [Wall Street Journal, 10/8/2004; Washington Post, 10/8/2004]

Entity Tags: John Jenkins, David Graham

Category Tags: Defense of corporate interests, Suppression of data, Vioxx

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

Category Tags: Suppression of data, Dismissal of data, Disregard for Public Safety, Manipulation of data, HIV/AIDS Epidemic

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