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US Health Care System

Manipulation or Concealment of data

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

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Jane Akre.Jane Akre. [Source: Injury Board (.com)]Investigative reporters Jane Akre and her husband Steve Wilson are hired by WTVT-TV, the Tampa, Florida, Fox News affiliate, to become part of its “Investigators” team. They soon begin filming a report on bovine growth hormone (BGH), a controversial substance manufactured by Monsanto. Their four-part report finds that BGH poses numerous health risks to milk consumers, including the threat of cancer, and that Florida supermarket chains routinely lie to their customers about not selling milk that contains BGH. Akre and Wilson will later recall that the local station is thrilled with the report. But after Monsanto complains to Fox News chief Roger Ailes about the report, the station’s general manager, David Boylan, tells Akre and Wilson to redo their film: to include statements from Monsanto that the filmmakers know to be false, and to make other revisions to the story that contradict the facts. According to Akre and Wilson, one Fox lawyer tells them that “it doesn’t matter if the facts are true,” what matters is the size of the lawsuit Monsanto might file against WTVT and Fox. Boylan tells the filmmakers that the position of Fox Television is: “We paid $3 billion for these television stations. We will decide what the news is. The news is what we tell you it is.” Akre and Wilson revise the story some 70 times, none of which passes muster with the station or with network officials. The couple is variously suspended without pay, suspended with pay, locked out of their workspace, and offered money to “just go away.” In late November 1997, when they threaten to inform the Federal Communications Commission (FCC) of the incident, WTVT fires them. They will file a lawsuit against WTVT and against Fox Television (see August 18, 2000). [Fairness and Accuracy in Reporting, 6/1998; BGH Bulletin, 2004; St. Louis Journalism Review, 12/1/2007] Wilson later says: “Every editor has the right to kill a story and any honest reporter will tell you that happens from time to time when a news organization’s self interest wins out over the public interest. But when media managers who are not journalists have so little regard for the public trust that they actually order reporters to broadcast false information and slant the truth to curry the favor or avoid the wrath of special interests as happened here, that is the day any responsible reporter has to stand up and say, ‘No way!’ That is what Jane and I are saying with this lawsuit.… We set out to tell Florida consumers the truth a giant chemical company and a powerful dairy lobby clearly doesn’t want them to know. That used to be something investigative reporters won awards for. As we’ve learned the hard way, it’s something you can be fired for these days whenever a news organization places more value on its bottom line than on delivering the news to its viewers honestly.” Akre will add: “We are parents ourselves. It is not right for the station to withhold this important health information and solely as a matter of conscience we will not aid and abet their effort to cover this up any longer. Every parent and every consumer have the right to know what they’re pouring on their children’s morning cereal.” [BGH Bulletin, 2004] Akre and Wilson will win the Goldman Environmental Prize for their original report in 2001. [Prize, 2001]

Entity Tags: Fox Broadcasting Company, Federal Communications Commission, David Boylan, Roger Ailes, Jane Akre, Monsanto, Steve Wilson, WTVT-TV, Fox News

Category Tags: Disregard for Public Safety, Manipulation of data

Merck official Briggs Morrison sends an e-mail warning that if the company conducts a proposed trial of the drug Vioxx (see also November 21, 1996), and the subjects do not take aspirin, there will be “more thrombotic events [i.e., more blood clots] and kill [the] drug.” In response, Merck scientist Alise Reicin laments that the company is in a “no-win situation.” She suggests that people with a high risk of cardiovascular problems be excluded from the study so the association between Vioxx and thrombotic events “would not be evident.” [Wall Street Journal, 11/1/2004]

Entity Tags: Briggs Morrison, Alise Reicin

Category Tags: Disregard for Public Safety, Manipulation of data, Vioxx

A Merck clinical trial of Vioxx conducted on 978 patients suggests the drug substantially increases the risk of serious cardiovascular events, including heart attack and stroke. Patients who take Vioxx are six times as likely to suffer heart problems than patients taking an alternative painkiller or a placebo. The study, named Study 090, is never published. Merck later says this is because the sample size was not large enough to provide statistically significant data. [US Food and Drug Administration, 2/1/2001, pp. 31-34 pdf file; Topol, 2004; CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Clinical drug studies, Manipulation of data, Vioxx

Merck finally agrees to analyze the data on deaths that have occurred during the clinical trials for its drug Vioxx (see December 22, 1999 and November 18, 1999). The analysis was requested by Michael Weinblatt, who is leading the Vioxx study (see December 22, 1999). But Merck says it will only analyze the deaths that take place before February 10, one month before the study ends. Any deaths that occur after this “cut-off” date will not be factored into the analysis. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Clinical drug studies, Manipulation of data, Vioxx

The authors of a paper on VIGOR, a clinical study on the drug Vioxx, submit two sets of corrections to the New England Journal of Science for the manuscript they submitted in May (see May 18, 2000). They do not correct the omission of three fatal heart attacks that occurred toward the end of the study (see March 2000) after a February 10 “cut-off” date (see Early February 2000). [National Public Radio, 6/8/2006]

Category Tags: Fraud, Manipulation of data, Vioxx, Studies-Academic

Merck’s sales force develops a flash-card game called “Dodge Ball Vioxx” to help train Merck sales representatives on how to respond to certain questions and concerns that doctors might have about Vioxx. [Daily Journal Extra, 1/31/2005] The game includes a 12-page list of obstacles including some questions concerning the association between Vioxx and heart problems. One of them is, “I am concerned about the cardiovascular effects of Vioxx.” In the summer of 2005, a former Merck sales woman tells CBS 60 Minutes that when faced with that question, the company said representatives should say the drug does not cause heart problems. “We were supposed to tell the physician that Vioxx did not cause cardiovascular events; that instead, in the studies, Naproxen has aspirin-like characteristics which made Naproxen a heart-protecting type of drug where Vioxx did not have that heart-protecting side,” she said. According to the FDA, there is no evidence that Naproxen has such properties. [CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

Fearing increased public concern over the safety of Vioxx, Merck sends its sales representatives a bulletin instructing them in all capital letters: “Do not initiate discussions on the FDA Arthritis Advisory Committee… or the results of the… VIGOR study.” The previous day, an FDA panel (see February 8, 2001) reviewed the results of the VIGOR study and said physicians need to be informed that Vioxx appears to cause “an excess of cardiovascular events in comparison to naproxen.” The Merck bulletin provides a list of responses that its representatives are authorized to use in addressing physicians’ concerns. It emphasizes that these are the only responses they are allowed to use. If doctors ask about Vioxx’s effects on the heart, sales persons should say, “Because the study is not in the label, I cannot discuss the study with you.” However, as a report by Henry A. Waxman notes, drug company representatives are permitted by FDA regulations to discuss safety concerns even when those concerns are not on the label. The sales persons are also advised to tell physicians to submit their questions in writing to Merck’s medical services department. Merck says reps can also show the physicians the Cardiovascular Card, a pamphlet consisting of data that appears to show that Vioxx is safe (see April 28, 2000). The bulletin indicates that sales reps are not supposed to leave the pamphlet with the doctor. [Merck, 2/9/2001 pdf file; Office of Representative Henry A. Waxman, 5/5/2005, pp. 22 pdf file]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

Merck issues a press release titled “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx” asserting that there is no evidence that patients taking the prescribed dosage levels of Vioxx have an increased risk of having heart problems. It says that the higher number of heart troubles experienced by patients taking Vioxx compared to naproxen during the VIGOR study (see March 2000) was likely because naproxen has similar properties to aspirin, which is known to prevent heart attacks. [Merck, 5/22/2001] The FDA later issues a warning to Merck calling this press release “simply incomprehensible, given the rate of MI and serious cardiovascular events compared to naproxen” (see September 17, 2001). [US Food and Drug Administration, 9/17/2001, pp. 1-2 pdf file]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

The same day the New York Times publishes an article (see May 22, 2001) raising questions about the safety of Vioxx, Merck sends a bulletin to its sales representatives instructing them in capital letters: “Do not initiate discussions on the results of the… VIGOR study, or any of the recent articles in the press on Vioxx.” The bulletin says that if physicians ask any questions about the cardiovascular safety of Vioxx, sales reps should refer to the “Cardiovascular Card” (a marketing pamphlet on the safety of Vioxx, see April 28, 2000), request that Merck’s “Medical Services” staff fax or Fedex additional information to the doctor, or respond appropriately “in accordance with the obstacle-handling guide.” [Merck, 5/22/2001 pdf file]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

The Food and Drug Administration faxes a warning letter to Raymond Gilmartin, the CEO of Merck, accusing the company of conducting a deceptive promotional campaign for its drug Vioxx. The eight-page letter, referring mostly to events that took place between June 2000 and June 2001, states: “You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study (see March 2000), and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).… You assert that Vioxx does not increase the risk of MIs and that the VIGOR finding is consistent with naproxen’s ability to block platelet aggregation like aspirin. That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties [i.e., cause heart attacks]. You have also engaged in promotional activities that minimize the Vioxx/Coumadin (warfarin) drug interaction, omit important risk information, make unsubstantiated superiority claims against other NSAIDS, and promote Vioxx for unapproved uses and an unapproved dosing regimen.… Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns.” The letter also warns the company about a May 2001 press release (see May 22, 2001), which claimed the drug has a “favorable cardiovascular safety profile.” [US Food and Drug Administration, 9/17/2001, pp. 1-2 pdf file]

Entity Tags: Raymond Gilmartin, Merck

Category Tags: Disregard for Public Safety, Manipulation of data, Marketing, Vioxx

After six months of negotiations, Merck and the FDA finally agree on the text for a warning about Vioxx’s cardiovascular side effects that will be added to the drug’s label. The FDA had wanted to include a clear message that Vioxx increases the risk of heart problems since the current version of the label includes no information about such risks. An excerpt from the FDA’s originally proposed text reads: “VIOXX should be used with caution in patients at risk of developing cardiovascular thrombotic events… . The risk of developing myocardial infarction in the VIGOR study was five-fold higher in patients treated with VIOXX 50 mg (0.5 percent) as compared to patients treated with naproxen (0.1 percent).…” The FDA also wanted to include a graph showing that the risk of heart problems increases with continued exposure to the drug. Merck objected to the FDA’s proposals. It insisted that a description of the cardiovascular risks be included in the “Precaution” section of the label, instead of the more severe “Warning” section, as proposed by the FDA. The company also wanted to include results from several disparate clinical studies that had been conducted prior to the drug’s release. These are the same tests that are cited in the “Cardiovascular Card” that Merck sales people show to doctors (see April 28, 2000). But the FDA objected, telling the company that the studies were “trials of different design, size, and duration, using different doses of VIOXX and different comparators” and therefore did not provide useful data for determining the drug’s cardiovascular risk. The FDA eventually concedes to several of Merck’s requests. The final text of the warning is included in the “Precaution” section of the label, as Merck wanted, and does not include the graph that had been requested by the FDA. The text of the cautionary statement is also watered down. The section summarizing the results of the VIGOR study (see March 2000) and two other studies states: “The significance of the cardiovascular findings from these 3 studies (VIGOR and 2 placebo-controlled studies) is unknown.” [Merck, 2001; US Food and Drug Administration, 1/30/2002 pdf file; US Food and Drug Administration, 2005; Office of Representative Henry A. Waxman, 5/5/2005, pp. 16-19 pdf file]

Entity Tags: US Food and Drug Administration, VIGOR, Merck

Category Tags: Manipulation 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

Betsy McCaughey (R-NY), the former lieutenant governor of New York and a fellow at the conservative Hudson Institute, writes that health care provisions in the Obama administration’s economic stimulus plan will affect “every individual in the United States.” McCaughey writes: “Your medical treatments will be tracked electronically by a federal system. Having electronic medical records at your fingertips, easily transferred to a hospital, is beneficial. It will help avoid duplicate tests and errors. But the bill goes further. One new bureaucracy, the National Coordinator of Health Information Technology, will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective. The goal is to reduce costs and ‘guide’ your doctor’s decisions.” McCaughey says the provisions are similar to suggestions in the book Critical: What We Can Do About the Health Care Crisis, by former Senate Majority Leader Tom Daschle (D-SD), until recently Obama’s pick to head the Department of Health and Human Services. McCaughey writes that hospitals and doctors who do not use the system will be punished, by a federal oversight board to be called the Federal Coordinating Council for Comparative Effectiveness Research. Perhaps most worrisome is McCaughey’s claim that elderly Americans will be given reduced health care based on their age and expected productivity. “Medicare now pays for treatments deemed safe and effective. The stimulus bill would change that and apply a cost-effectiveness standard set by the Federal Council,” she writes. “The Federal Council is modeled after a UK board discussed in Daschle’s book. This board approves or rejects treatments using a formula that divides the cost of the treatment by the number of years the patient is likely to benefit. Treatments for younger patients are more often approved than treatments for diseases that affect the elderly, such as osteoporosis. In 2006, a UK health board decreed that elderly patients with macular degeneration had to wait until they went blind in one eye before they could get a costly new drug to save the other eye. It took almost three years of public protests before the board reversed its decision.… If the Obama administration’s economic stimulus bill passes the Senate in its current form, seniors in the US will face similar rationing. Defenders of the system say that individuals benefit in younger years and sacrifice later. The stimulus bill will affect every part of health care, from medical and nursing education, to how patients are treated and how much hospitals get paid. The bill allocates more funding for this bureaucracy than for the Army, Navy, Marines, and Air Force combined.” [Bloomberg News, 2/9/2009] McCaughey’s claims are very similar to the ones she made against the Clinton administration’s attempt to reform health care in 1994 (see Mid-January - February 4, 1994). They will be proven false (see July 23, 2009).

Entity Tags: Hudson Institute, Elizabeth (“Betsy”) McCaughey, US Department of Health and Human Services, Tom Daschle, Obama administration

Timeline Tags: Domestic Propaganda, 2010 Elections

Category Tags: Manipulation of data, Defense of corporate interests, Clinton Health Care Reform, Medicare

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