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US Health Care System

Disregard for Public Safety

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

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Rock Hudson shortly before his death.Rock Hudson shortly before his death. [Source: Southern Voice]Actor Rock Hudson, a close friend of Ronald and Nancy Reagan, dies of Acquired Immune Deficiency Syndrome (AIDS). The virus was identified in 1983, but until now has been ignored by the Reagan administration. With the death of Hudson, Reagan will call AIDS research a “top priority” for his administration. However, Reagan immediately proposes spending cuts that would slash funding for such research. [PBS, 2000]

Entity Tags: Ronald Reagan, Reagan administration, Rock Hudson, Nancy Reagan

Category Tags: Disregard for Public Safety, HIV/AIDS Epidemic

A Merck official writes a memo on the question of whether the company should conduct a trial to demonstrate that Vioxx is gentler on the stomach than other painkillers. The memo notes that such a study would likely show that “there is a substantial chance that significantly higher rates” of cardiovascular problems will occur among the patients taking Vioxx. [Wall Street Journal, 11/1/2004; CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

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

Research done by Dr. Garrett FitzGerald suggests that COX-2 inhibiting drugs, like Vioxx and Celebrex, increase the risk of cardiovascular problems. FitzGerald believes that COX-2 inhibitors block the production of a substance called prostacyclin, which leads to blood vessel constriction and clotting. His research is dismissed by Merck, the maker of Vioxx. Vioxx’s only selling point is that it causes fewer gastrointestinal problems than other pain killers on the market. But according to FitzGerald, the mechanism that makes the drug gentler on the stomach is also responsible for causing the cardiovascular problems. [MSNBC, 10/6/2004] FitzGerald’s research is later published in two studies, one in 1999 and another in 2001. [Associated Press, 6/22/2005]

Entity Tags: Merck, Garrett FitzGerald

Category Tags: Disregard for Public Safety, Vioxx

Abbott Laboratories, maker of the drug Hytrin, agrees to pay rival drug company Zenith Goldline Pharmaceuticals up to $42 million not to produce a generic version of Hytrin, a drug for high blood pressure and prostate enlargement. For three years Abbott, whose patent on Hytrin expired in 1995, has been fighting Zenith in court to prevent it from marketing a cheaper generic. Abbott currently earns about $500 million a year on the drug. After signing its agreement with Zenith, Abbott inks a similar deal with another rival, Geneva Pharmaceuticals, agreeing to pay that company as much as $101 million to keep its generic version of Hytrin off the market. Geneva and Abbott will abandon their agreement a year later when the federal government launches an antitrust investigation. Consumers will sue Abbott and Geneva charging that the companies’ agreement cost patients hundreds of millions dollars. [New York Times, 7/23/2000]

Entity Tags: Zenith Goldline Pharmaceuticals, Geneva Pharmaceuticals, Abbott Laboratories

Category Tags: Disregard for Public Safety

At the VIGOR safety panel’s second meeting (see also January 1999 and October 3 or 4, 1999), panel members discuss concerns over the “excess deaths and cardiovascular adverse experiences” observed among patients taking Vioxx. [US Food and Drug Administration, 2/1/2001, pp. 5 pdf file] As of November 1, 1999, 79 patients out of the 4,000 taking the drug have experienced serious heart problems or have died, compared with 41 patients taking naproxen. Minutes of the meeting note that “while the trends are disconcerting, the numbers of events are small.” [National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

The VIGOR study’s safety panel meets for a third time and learns that as of December 1, 1999, the number of Vioxx patients who have experienced heart problems or have died is twice as high as those taking naproxen. The panelists are shown a chart with two lines—one showing the number of deaths in the Vioxx group; the other, deaths in the naproxen group. The chart shows that since the sixth week of the study, the line representing the Vioxx group has been going up at an increasingly brisk pace, while the naproxen group’s line rises slower and is relatively linear. [National Public Radio, 6/8/2006] Some members suggest that diverging lines could be “due to cardioprotective effects of Treatment B,” i.e., that naproxen is somehow reducing the risk of heart problems. [US Food and Drug Administration, 2/1/2001, pp. 6 pdf file] The panel’s chairman, Michael Weinblatt, and Merck statistician Deborah Shapiro write a letter to Merck’s Alise Reicin advising that the company develop a plan to study the cardiovascular results before the VIGOR study is completed. When an investigation by NPR learns about this meeting, it asks three experts to comment on the chart and the panel’s decision. All three say that the study should have been called off immediately because the chart clearly showed that the risk of heart problems among those taking Vioxx increased with time. The panel, in a statement to NPR, claims that it did not cancel the study noting that it was not clear to the panelists at the time whether the different rates of heart problems and deaths were a result of Vioxx causing the cardiovascular problems, or naproxen preventing them. But no study has ever proven that naproxen is cardioprotective. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Alise Reicin, Michael Weinblatt, Merck, Deborah Shapiro

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

Merck says it does not want to begin developing a plan to analyze the data on the large number of deaths from heart problems that has occurred during a clinical trial for its drug Vioxx (see December 22, 1999 and November 18, 1999). Michael Weinblatt, who is heading the study, sent a request to Merck the month before asking the company to develop such a plan (see December 22, 1999). Merck suggests that they wait and combine the cardiovascular results of this study with the results from other clinical studies for the drug. But Weinblatt is adamant that the company needs to begin analyzing the data immediately, and continues discussing the matter with Merck, which finally agrees to a plan the following month (see Early February 2000). [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

Edward Scolnick, head of Merck’s research labs, sends an e-mail to his colleagues noting that Vioxx’s anticipated cardiovascular side effects “are clearly there… It is a shame but it is a low incidence and it is mechanism based as we worried that it was.” [Wall Street Journal, 11/1/2004; HeartWire, 11/1/2004]

Entity Tags: Merck, Edward Scolnick

Category Tags: Disregard for Public Safety, 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

The Bush administration decides to drop its plan to nominate Dr. Alastair J. J. Wood as commissioner of the Food and Drug Administration. An article recently posted on the conservative National Review Online’s website warned that Wood is not friendly to industry interests. “The people I know in clinical pharmacology, in the research trenches, went berserk when they heard about Wood,” wrote Robert Goldberg, a senior fellow at New York’s Manhattan Institute, a free-market think tank. Goldberg said the doctor is overly obsessed with drug safety and asserts, falsely, that Wood is “a buddy of Senator Ted Kennedy.” The attack on Wood was continued in the editorial pages of the Wall Street Journal six days later in a piece titled “It’s Not Ted’s FDA.” Shortly after the publication of these articles, the White House calls Wood to inform him that the administration is no longer considering his nomination for commissioner, a post that has been vacant for more than a year. Republican Senator Bill Frist—the person who had recommended Wood’s nomination—tells the Boston Globe that the White House was concerned that Wood “put too much emphasis on the safety.” Wood’s track record was evidence that he might take an aggressive approach to regulating drugs. He previously called for an independent board to investigate potentially deadly drugs. The current policy is to allow the drug companies to do their own studies on adverse drug reactions and then provide these results to the FDA. Wood has also said that he believes the current FDA regulatory process has an inherent conflict of interest because the same department that approves drugs is also in charge of reviewing the safety of those drugs post-approval, a criticism that is shared by at least one FDA insider (see November 18, 2004). Furthermore, in May 2001, Wood supported making three allergy prescription drugs—Pfizer’s Zyrtec, Schering-Plough’s Claritin, and Aventis’s Allegra—available over-the-counter (OTC). The companies were opposed to the idea because OTC drugs are often sold at lower prices and are not typically covered by insurance. During a panel discussion on the issue, Wood had noted, “What we have today is an unseemly parade of people trying to protect their own financial interests.” [Boston Globe, 5/27/2002]

Entity Tags: Robert Goldberg, Bush administration (43), Alastair J. J. Wood

Category Tags: Political appointments, Disregard for Public Safety

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

The Department of Health and Human Services rescinds the controversial “conscience rule” that allows health care workers to refuse to provide abortion counseling or other family-planning services if doing so would violate their moral or religious beliefs. The rule was announced on December 19, 2008 as one of the Bush administration’s final policy initiatives. Seven states have already challenged the rule in court, arguing that it sacrifices the health of patients to religious beliefs of medical providers. The American College of Obstetrics and Gynecology has reported numerous cases regarding the rule, including a Virginia mother of two who became pregnant after being denied emergency contraception, and a rape victim whose prescription for emergency contraception was rejected by a pharmacist. Obama officials say the administration will consider drafting a new rule to clarify what health care workers can reasonably refuse for patients. The public has 30 days to respond to the move before it becomes viable. Sister Carol Keehan, president of the Catholic Health Association, said in December that her organization supported the rule because in recent years “we have seen a variety of efforts to force Catholic and other health care providers to perform or refer for abortions and sterilizations.” However, opponents of the rule, including the American Medical Association, the National Association of Chain Drug Stores, and Planned Parenthood, said it could have voided state laws requiring insurance plans to cover contraceptives and requiring hospitals to offer emergency contraception to rape victims. It could also allow drugstore employees to refuse to fill prescriptions for contraceptives. And the Civil Rights Act of 1964 already offers broad protection against discrimination based on religion, mandating that an employer must make reasonable accommodations for an employee’s practices and beliefs. Cecile Richards of Planned Parenthood says, “Today’s action by the Obama administration demonstrates that this president is not going to stand by and let women’s health be placed in jeopardy.” [Chicago Tribune, 2/27/2009; New York Times, 2/27/2009]

Entity Tags: Catholic Health Association, American Medical Association, American College of Obstetrics and Gynecology, Carol Keehan, US Department of Health and Human Services, National Association of Chain Drug Stores, Obama administration, Cecile Richards, Civil Rights Act of 1964, Bush administration (43), Planned Parenthood

Category Tags: Disregard for Public Safety

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