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The FBI announces that it is charging anti-abortion activist Eric Robert Rudolph with the 1996 bombing of Atlanta’s Centennial Olympic Park as well as with the 1997 bombing of an Atlanta abortion clinic (see January 16, 1997) and an Atlanta nightclub (see February 21, 1997). Rudolph has been a fugitive from law enforcement authorities since his January 1998 bombing of an Alabama clinic (see January 29, 1998), for which he has already been charged. “We are going to keep searching until we find him,” says Attorney General Janet Reno. The current complaint against Rudolph cites five counts of malicious use of an explosive in violation of federal law. FBI Director Louis Freeh calls Rudolph a domestic terrorist. The FBI has Rudolph on its Most Wanted list. [Federal Bureau of Investigation, 10/14/1998] The charges will be formalized, and new charges added, in November 2000, when grand juries hand down additional indictments. [CNN, 5/31/2003] Rudolph will be captured after almost five years of living as a fugitive (see May 31, 2003).

Entity Tags: Louis J. Freeh, Eric Robert Rudolph, Federal Bureau of Investigation, Janet Reno

Timeline Tags: US Health Care, US Domestic Terrorism

James Kopp.James Kopp. [Source: Women's eNews (.org)]Dr. Barnett Slepian, an obstetrician in Buffalo, New York, who performs abortions, is shot to death in his kitchen, by a bullet that enters through the window of his Amherst, New York, home. His wife and one of his four children witness his murder. Anti-abortion advocate James Kopp shoots Slepian with a high-powered rifle. Kopp uses the pseudonym “Clive Swenson,” and is well known under that name in a Jersey City, New Jersey, Catholic congregation. Militant anti-abortionists call him “Atomic Dog.” It will take the FBI over two years to find Kopp, who will be arrested in France (see March 29, 2001). Kopp, who apparently was drawn to anti-abortion protests in the 1970s after his girlfriend had an abortion, has been active in anti-abortion protests for decades and joined Randall Terry’s Operation Rescue in 1986. It is also believed he joined the violent anti-abortion organization “Army of God” in 1988 (see 1982), as well as the “Lambs of God,” a Catholic anti-abortion group whose leader has characterized the anti-abortion movement as a “war between God and Satan.” Kopp is well known for designing intricate locks that anti-abortion protesters use to lock the doors to women’s health care clinics. Slepian has been listed as a “wanted” abortion provider on the anti-abortion Web site “Nuremberg Files,” which The Guardian will describe as “a virtual hit list of doctors who carry out abortions” (see January 1997). Within hours of his murder, Slepian’s name is reposted on the site, this time with a line drawn through it. [Washington Post, 1998; Womens eNews, 3/30/2001; Guardian, 4/1/2001; National Abortion Federation, 2010] By early November, Kopp will be named as a suspect in the murder, though he will not be formally charged until May 1999. He will be placed on the FBI’s “Most Wanted” list in June 1999. [National Abortion Federation, 2010] In 2002, Kopp will confess to the murder (see November 21, 2002). He will be found guilty a year later (see March 17-18, 2003).

Entity Tags: Lambs of God, Barnett Slepian, James Kopp, Army of God, Operation Rescue, Federal Bureau of Investigation

Timeline Tags: US Health Care, US Domestic Terrorism

A federal jury in Portland, Oregon, finds in favor of the plaintiffs in the lawsuit Planned Parenthood v. ACLA (see 1996). The jury orders the American Coalition of Life Activists (ACLA—see July 1993) to pay $109 million in damages to the abortion providers and organizations who brought the suit; Judge Robert Jones declares that the ACLA’s campaign of published threats against the providers is “a blatant and illegal communication of true threats to kill, assault, or do bodily harm.” He issues an injuction against further publication of such threats (see 1996). In 2001, an appeals court will reverse the verdict on First Amendment grounds; a year later, a higher court will reaffirm the original verdict. [Ms. Magazine, 12/2002]

Entity Tags: Robert Jones, American Coalition of Life Activists

Timeline Tags: US Health Care, US Domestic Terrorism

A classified report discusses responses to an anthrax attack through the mail. The report, precipitated by a series of false anthrax mailings, is written by William Patrick, inventor of the US anthrax weaponization process, under a CIA contract. [New York Times, 12/3/2001] The report was commissioned by Steven Hatfill, a good friend of Patrick. [Baltimore Sun, 6/27/2002] The report describes what the US military could do and what a terrorist might be able to achieve. [New York Times, 12/3/2001] The similarities between what the report predicts and the anthrax attacks that eventually happen after 9/11 are startling (see October 5-November 21, 2001). The BBC later suggests the “possibility that there was a secret CIA project to investigate methods of sending anthrax through the mail which went madly out of control” and that the anthrax attacker knew of this study or took part in it. The CIA and William Patrick will deny the existence of this report, even though copies have been leaked to the media. [BBC, 3/14/2002; Baltimore Sun, 6/27/2002]

Entity Tags: William C. Patrick III, Steven Hatfill, Central Intelligence Agency

Timeline Tags: 2001 Anthrax Attacks

Anti-abortion advocate Michael Bray (see September 1994), serving four years for conspiracy in firebombing 10 abortion clinics in Virginia, Maryland, and the District of Columbia, tells a CBS reporter, “I consider blowing up a place where babies are killed a justifiable act.” Bray is a Lutheran minister. [Feminist Women's Health Center News, 2010]

Entity Tags: Michael Bray

Timeline Tags: US Health Care, US Domestic Terrorism

Based on the recent lawsuit by the National Organization for Women (see April 20, 1998), District Judge David Coar issues a nationwide injunction against the anti-abortion advocates who lost the case. Coar’s injunction forbids the defendants from hindering the right of women to obtain reproductive health services at clinics and the right of the clinics to provide those services. One of the defendants, Joseph Scheidler, will appeal the ruling on several grounds, including the First Amendment right of free speech. [National Organization for Women, 9/2002]

Entity Tags: National Organization for Women, David Coar, Joseph Scheidler

Timeline Tags: US Health Care

In 2000, US military personnel are being required under the threat of court-martial to be inoculated with an anthrax vaccine. But the vaccine, known as Anthrax Vaccine Absorbed (AVA), is not working very well and some soldiers are getting sick. This results in a loud public outcry lasting into 2001. One of the key scientists working on the vaccine is future anthrax attacks suspect Bruce Ivins.
Problems - The vaccine is being made by a company known as BioPort, but in 1998 the company’s sole manufacturing plant was shut down following the discovery of problems there. Ivins is working at USAMRIID, the US Army’s top bioweapons laboratory, and he and about six other USAMRIID scientists were assigned by the Defense Department to fix the problems with the vaccine so production could resume. In a June 2000 e-mail message, Ivins writes, “Unfortunately, since the BioPort people aren’t scientists, the task of solving their problem has fallen on us.” In a July 2000 e-mail message, he writes about the inoculation program, “think the sh_t is about to hit the fan… big time… It’s just a fine mess.”
Alleged Motive - After Ivins’s suicide in 2008, government officials will theorize that Ivins was stressed out due to the vaccine crisis and started having psychological problems. It is undisputed he was having problems at this time (see April-August 2000 and September-December 2001), but officials will further theorize he grew so upset that he was driven to launch the anthrax attacks to eliminate doubts about the vaccine. Investigators will cite Ivins’s e-mail messages from August 2001 regarding ABC News reporter Gary Matsumoto, who had been pressuring Ivins to turn over copies of his notebooks detailing experiments with the vaccine. Ivins complains about Matsumoto, “We’ve got better things to do than shine his shoes and pee on command. He’s gotten everything from me he will get.”
Criticism of FBI - However, Ivins’s colleagues will later criticize the FBI’s vaccine theory. They acknowledge that there was a real threat the AVA vaccine could be pulled from the market. But they also say that Ivins and others were working on a promising new vaccine that was considered safer and more effective. Ivins’s colleague Jeffrey Adamovicz will comment, “There was a lot of consternation, a lot of pressure to rescue this thing. But if AVA failed, he had his next vaccine candidate. It was well on its way to what looked to be a very bright future.” Colleague Gerry Andrews will similarly comment, “Nothing is unimaginable… But I would definitely say [the FBI’s AVA theory] is doubtful.” The Defense Department claims at the time that the vaccine is both safe and effective. But eventually Ivins’s notebooks will be made public and they will show Ivins thought the vaccine was making some test animals sick. [New York Times, 8/8/2008]

Entity Tags: Gary Matsumoto, Bruce Ivins, United States Army Medical Research Institute of Infectious Diseases, BioPort, Gerry Andrews, US Department of Defense, Jeffrey Adamovicz

Timeline Tags: 2001 Anthrax Attacks

Merck offers Michael Weinblatt, who is heading a clinical trial (see December 22, 1999 and November 18, 1999) for the company’s drug Vioxx, $5,000 a day to sit on a Merck advisory board for 12 days over the next two years. He accepts the offer and signs the contract a few weeks later on March 6. Merck pays him $15,000 up front. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Merck, Michael Weinblatt

Timeline Tags: US Health Care

The Sunday Times reports that an inquiry has been launched into the behavior of Bayer, after revelations in a British trial regarding the anthrax antibiotic drug Cipro. The drug has been tested on hundreds despite the company having conducted studies which showed it reacted badly with other drugs, seriously impairing its ability to kill bacteria. These results are kept secret. Nearly half of those on whom the drug was tested at one test center develop a variety of potentially life-threatening infections, while data at other test centers is unknown. [Sunday Times (London), 5/14/2000]

Entity Tags: Bayer

Timeline Tags: 2001 Anthrax Attacks

The FDA endorses the use of Bayer’s Cipro drug to prevent inhalation anthrax. [Reuters, 7/28/2000] An official recommendation like this is highly unusual for the FDA. A 1997 Pentagon study of anthrax in rhesus monkeys showed that several other drugs were as effective as Cipro. The reason given for only recommending Cipro is the government wants a weapon against anthrax should it come up against a strain resistant to drugs in the penicillin and tetracycline families of antibiotics. [New York Times, 10/21/2001] The pharmaceutical industry spent $177 million on lobbying in 1999 and 2000—more money than any other industry. The FDA has been accused of conflicts of interest with companies including Bayer. [New York Times, 11/4/2001]

Entity Tags: US Food and Drug Administration, Bayer

Timeline Tags: 2001 Anthrax Attacks

A Florida jury unanimously finds in favor of Jane Akre, a plaintiff suing Fox Television for wrongful termination. Akre and her husband, Steve Wilson, had begun filming a news story for the Tampa, Florida, Fox affiliate on the harmful effects of BGH, or bovine growth hormone. Akre and Wilson were fired when they refused orders from Fox officials to add false information favorable to Monsanto, the manufacturers of BGH, to their story (see December 1996 - December 1997). (The jury rules that Wilson was not harmed by Fox’s actions.) The jury rules that Akre warrants protection under Florida’s whistleblower law, and awards her a $425,000 settlement. Instead of paying the judgment, Fox Television appeals the decision (see February 14, 2003). [St. Louis Journalism Review, 12/1/2007]

Entity Tags: Steve Wilson, Fox Broadcasting Company, Jane Akre

Timeline Tags: Domestic Propaganda

Merck informs the FDA about three fatal heart attacks (deaths 18, 19, and 20) that occurred toward the end of VIGOR, the clinical trial for its drug Vioxx that ended last March (see March 2000). These three deaths were initially left out because they had taken place after a February 10 “cut-off” that had been set at the company’s insistence (see Early February 2000) [National Public Radio, 6/8/2006]

Entity Tags: US Food and Drug Administration, Merck

Timeline Tags: US Health Care

Former anti-abortion activist Jerry Reiter, the author of the recent book Live From the Gates of Hell: An Insider’s Look at the Anti-Abortion Underground, gives an interview to the St. Petersburg Times about his book and his days with the controversial anti-abortion organization Operation Rescue (OR—see 1986). Reiter was media coordinator for the group, but after becoming disillusioned with its violent tactics, became an FBI informant, giving the FBI information on OR and other anti-abortion groups. Reiter now says that some respected conservative Christians have tacitly condoned the violence practiced by OR and other anti-abortion groups during the 1990s. “One of the things that surprised me about the Christian Coalition was that even though it publicly denounced the illegal tactics of groups like Operation Rescue,” Reiter wrote, “when the big national anti-abortion protest came to Buffalo in 1992, Operation Rescue National housed its secret command and communication offices in the basement suite of offices that the Christian Coalition of New York had as its state headquarters.” He says that after entering “the secret command post of Operation Rescue, I was given books on dozens of not-so-peaceful activities, including a book by Reverend Michael Bray advocating the bombing of abortion clinics” (see September 1994). Reiter says that many anti-abortion activists “use the Bible to justify all kinds of evil.” He is still against abortion, but does not advocate legal restrictions on the practice. “I want to see abortions reduced,” he says. “Sex education, birth control, and availability of health care options is the way to go. Those people who oppose abortion are often those who oppose sex education, birth control, and other health care options.” Explaining why he became an FBI informant, Reiter says of his OR colleagues, “I realized that these people were very serious about doing harm to people.” He recalls speaking with Paul Hill, who in 1994 murdered an abortion provider and his bodyguard (see July 29, 1994). Weeks before Hill killed the two men, he told Reiter: “What you’re gonna see next now, brother, is an IRA-type reign of terror [referring to the Irish Republican Army]. There’s too much pressure on all of us, too many people watching us to do anything major under direct orders from the national level, so what you’re gonna see is individuals or small groups of people takin’ action in their own hands to do what the leaders want to see done, but since there won’t be any direct orders given, no one can prove conspiracy.” Reiter says his information did not prevent Hill’s murders, but was able to prevent another spate of possibly lethal violence during a 1994 event in Florida. “If I hadn’t done something at the time, it’s likely they would have been successful and hundreds could have been killed.… I had the most unique background. I was able to see the most radical, most dangerous people in the country as they were formulating their plans.” Reiter concludes: “The mainstream anti-abortion movement has shrunk dramatically and now you just see more hard-core people. It’s not a calm situation. The days of the little old ladies with the rosaries have been replaced with this radical, vitriolic group.… The people around Paul Hill, once he is executed (see September 3, 2003), they are planning to rise up and take action. They are planning to give us unprecedented violence.” [St. Petersburg Times, 1/6/2001]

Entity Tags: St. Petersburg Times, Christian Coalition of New York, Federal Bureau of Investigation, Jerry Reiter, Michael Bray, Paul Hill, Operation Rescue

Timeline Tags: US Domestic Terrorism

The Christian Defense Coalition (CDC) urges the Bush administration to show “restraint” in its handling of the arrest of accused murderer James Kopp, whose anti-abortion beliefs triggered his shooting of Dr. Barnett Slepian (see March 29, 2001). The CDC says that the “vast majority of the pro-life community” condemns violence against abortion doctors such as Slepian, and urges Attorney General John Ashcroft and the Department of Justice “not to use this episode to harass and intimidate the pro-life movement as the Clinton administration did” (see May 1994 and January 1996), and makes the same request of pro-choice organizations. The CDC also urges the general public to remember that Kopp is “innocent until proven guilty.” [Christian Defense Coalition, 3/29/2001]

Entity Tags: Christian Defense Coalition, Barnett Slepian, Bush administration (43), US Department of Justice, Clinton administration, James Kopp, John Ashcroft

Timeline Tags: US Health Care, Domestic Propaganda

DVD cover illustration of the film ‘Soldiers in the Army of God.’DVD cover illustration of the film ‘Soldiers in the Army of God.’ [Source: HBO / St. Pete for Peace]Cable movie provider HBO airs a documentary, Soldiers in the Army of God, focusing on the violent anti-abortion movement (see 1982, Early 1980s, August 1982, and July 1988) and three of its leaders. National Public Radio airs a profile of the documentary, featuring an interview with the film’s producers, Marc Levin, Daphne Pinkerson, and Daniel Voll. According to Voll, the film focuses on three members of the “Army of God”: young recruit Jonathan O’Toole, who says he was looking for the most “radical” and “terroristic” anti-abortion group he could find; Neal Horsley, who runs an anti-abortion Web site; and long-haul trucker Bob Lokey, who recruits new members.
'Violent Fringe' of Anti-Abortion Opposition - Voll describes the three as part of the “violent fringe” of anti-abortion opposition: “These are the guys on the ground who are—whatever the words that politicians and other leaders of these cultural wars can put out there, these are the men who hear them and feel emboldened by them, who feel encouraged by each other, and they are every day praying for God’s will in their life.” Another unidentified man says: “Anybody who raises a weapon up against these people who are slaughtering these babies, before God and the entire world, right now I say you are doing God’s own work. And may the power of God be with you as you aim that rifle. You’re squeezing that trigger for Almighty God.” In the documentary, an unidentified anti-abortion activist says: “There are people in this world right now who are looking for directions on what do we do. Well, we end abortion on demand by the most direct means available to us. So stop the abortion with a bullet, if that’s what it takes. Stop it with a bomb, if that’ s what it takes. You stop abortion on demand. Don’t let it go any farther.” O’Toole says that the “next step is to arm ourselves in a militia, a real militia that has the power to resist the federal government.” Pinkerson says that O’Toole, who was 19 when he joined the Army of God, found Horsley on the Internet through Horsley’s Web site, “The Nuremberg Files,” which lists doctors who perform abortions (see January 1997). O’Toole became Horsley’s assistant, and through him met Lokey, who runs a Web site called “Save the Babies.” In the film, O’Toole, whom the producers speculate may eventually become an assassin of abortion providers, says that because of America’s legalization of abortion, the country has become like “Nazi Germany. It’s like you’ve got concentration camps around you.” Levin notes that filmed conversations between Horsley and Lokey show that many in the movement feel threatened by the concept of women’s equality, and blame men’s failure to exert “dominion” over women as part of the reason why the US legalized abortion. [National Public Radio, 3/30/2001; Womens eNews, 3/30/2001]
Opposition to Homosexuality - Horsley draws a connection between the organization’s opposition to abortion and the American citizenry’s supposed opposition to homosexuality, saying: “If the American people woke up, and realized that they had to choose between legalized abortion, legalized homosexuality, and legalized all the rest of the desecration or civil war which would cause the rivers to run red with blood—hey, you know we will see legalized abortion go like that! We’ll see legalized homosexuality go like that! Because the American people are not willing to die for homosexuals.”
Bringing Bomb-Making Materials to Washington - The film also shows Lokey bragging to convicted clinic bomber Michael Bray (see September 1994) that he has just trucked 45,000 pounds of ammonium nitrate, a substance that can be used to make “fertilizer bombs” similar to the one that destroyed an Oklahoma City federal building (see 8:35 a.m. - 9:02 a.m. April 19, 1995), into Washington, DC.
Anti-Abortion Opposition Part of an 'Apocalyptic' Death Struggle - Author and reporter Frederick Clarkson writes: “At once shocking, compelling, and beautifully made, the film is essentially the national television debut for the aboveground spokesmen and spokeswomen of the Army of God.… Horsley and others are quite clear in their public statements and their writings that the attacks on clinics and the murders of doctors are but warning shots in what they envision as an epochal, even an apocalyptic struggle at hand. Either Americans conform to their view of God’s laws, or there will be a blood bath, they say. And there is no evidence that they are anything but dead serious.” [Womens eNews, 3/30/2001]

Entity Tags: Michael Bray, Frederick Clarkson, Daphne Pinkerson, Daniel Voll, Bob Lokey, Army of God, Home Box Office, Marc Levin, Neal Horsley, National Public Radio, Jonathan O’Toole

Timeline Tags: Domestic Propaganda, US Domestic Terrorism

Televangelist Pat Robertson, the head of the Christian Coalition and a former Republican presidential candidate, says that while he is staunchly opposed to abortion, he believes that China’s one-child policy, which he seems to think includes forcible abortions for families with more than one child, is acceptable. Robertson, who has admitted to having extensive personal business interests in China, says that nation suffers from “tremendous unemployment” and is plagued with “antiquated factories” owned by the government “that will have to be shut down, spawning more loss of jobs.… So, I think that right now they are doing what they have to do. I don’t agree with forced abortion, but I don’t think the United States needs to interfere with what they’re doing internally in this regard.” Robertson adds that the Chinese are “courting a demographic catastrophe” by aborting more girls than boys, and speculates that in 10 or 20 years Chinese men will have to import wives from Indonesia, which “will, in a sense, dilute the—what they consider the racial purity of the Han Chinese.” [Feminist Women's Health Center News, 2010]

Entity Tags: Pat Robertson

Timeline Tags: US Health Care

The New York Times reports the results of the VIGOR study (see March 2000), which showed that Vioxx, marketed by Merck, increases the risk of heart attacks four-fold (later studies increase this to five-fold). The Times also reports Merck’s interpretation of the results—that the different number of heart attacks suffered by patients taking Vioxx compared to those using naproxen was due to the heart-protective properties of naproxen. But no studies have been done showing that naproxen prevents heart attacks, says Dr. Maria Lourdes Villalba, an FDA scientist who was interviewed by the newspaper. Another scientist, Dr. M. Michael Wolfe, chief of the gastroenterology section at the Boston University School of Medicine, says people need to know about these risks. “The marketing of these drugs is unbelievable. I’m sure there are many people out there who are taking these drugs that should not be,” he says. Another concern noted is that the very same people who are likely to take the drug—elderly people with arthritis—are the ones with the highest risk of having heart problems. [New York Times, 5/22/2001]

Entity Tags: VIGOR, Merck

Timeline Tags: US Health Care

Thomas A. Scully is sworn in as head of the Health Care Financing Administration (HCFA), a division of the US Department of Health and Human Services. Prior to joining the Bush administration, Scully served as president and chief executive officer of the Federation of American Hospitals, a trade association that lobbies on behalf of 1,700 privately-owned and managed community hospitals and health systems. He held that position for six years [Healthcare Financial Management, 7/2001; US Department of Health and Human Services, 11/10/2003] and was making $675,000 a year when he left. As the administrator of HCFA, he will be paid a salary of $134,000 a year. [New York Times, 12/3/2003] During his confirmation hearings, Scully promised the Senate Finance Committee that he would “aggressively enforc[e] the fraud statutes.” Under the Clinton administration, the Justice Department had brought a number of lawsuits against hospitals alleging that they had over billed Medicare, Medicaid, and other federal heath programs. [Iglehart, 12/27/2001]

Entity Tags: Thomas A. Scully

Timeline Tags: US Health Care

President Bush appoints Ann-Marie Lynch as deputy assistant secretary in the office of policy at the Department of Health and Human Services. [US Congress, 7/25/2002, pp. 86 pdf file; Denver Post, 5/23/2004] One of Lynch’s responsibilities is to decide which topics are researched and which reports are released. She previously worked as a lobbyist for the drug- company trade group Pharmaceutical Research and Manufacturers of America where she fought congressional efforts to implement price controls on prescription drugs. She had argued that price caps would discourage medical innovation. [Denver Post, 5/23/2004] During her tenure at DHHS, Lynch’s division will publish a report praising brand-name drugs and warning that “restrictions on the coverage of new drugs could put the future of medical innovation at risk and may retard advances in treatment” (see July 2002). She will also block the release of several completed research reports that challenge drug-company claims (see (Between July 2001 and May 2004)).

Entity Tags: Ann-Marie Lynch, George W. Bush

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

Thomas A. Scully, administrator of the Centers for Medicare & Medicaid Services (CMS), tells Congress that he believes only a third of the estimated $12 billion in improper payments to health care providers is fraudulent. He says “the rest is probably billing mistakes.” Scully, a former lobbyist for the health industry, admits the inspector general would probably disagree with his estimate. [US Congress, 7/26/2001, pp. 27 pdf file]

Entity Tags: Thomas A. Scully

Timeline Tags: US Health Care

President Bush appoints Daniel E. Troy as the FDA’s chief counsel. [Financial Times, 8/14/2001] Before taking the position, Troy was a partner at the law firm Wiley Rein & Fielding, where he sued the FDA several times on behalf of drug companies, including pharmaceutical giant Pfizer. He has repeatedly argued that the agency has only limited authority to regulate drug companies. Troy is mostly known for his involvement in the landmark Supreme Court case that ruled the FDA does not have the authority to regulate tobacco. [Boston Globe, 12/22/2002; Denver Post, 5/23/2004] As chief counsel, Troy will help the FDA commissioner, a post that is currently vacant, to draft policy and enforcement provisions. The commissioner’s post will remain vacant until October 2002. So far, Bush has considered two people for the position—Michael Astrue, senior vice-president at Transkaryotic Therapies, a British biotech company, and Eve Slater, Merck’s senior vice-president. In both cases the Senate made it clear that their nominations would be rejected because of their involvement in FDA-regulated industries. [Financial Times, 8/14/2001]

Entity Tags: Daniel E. Troy, George W. Bush

Timeline Tags: US Health Care

On the evening after the 9/11 attacks, some White House personnel, including Vice President Dick Cheney’s staff, are given the anti-anthrax drug Cipro, and told to take it regularly. [Associated Press, 10/24/2001] An unnamed “high government official” also advises some reporters to take Cipro shortly after 9/11 (see Shortly After September 11, 2001). Judicial Watch will later sue the Bush administration to release documents showing who knew what and when, and why presidential staff were protected while senators, congresspeople, and others were not. [Associated Press, 6/8/2002]

Entity Tags: Richard (“Dick”) Cheney, Judicial Watch

Timeline Tags: 2001 Anthrax Attacks

An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include:
bullet The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications.
bullet The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs.
bullet The FDA should be given new powers to impose fines, injunctions, and withdrawals when drug companies fail to complete the required safety studies.
bullet The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
bullet The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested.
bullet Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. [Institute of Medicine, 9/22/2006; Washington Post, 9/23/2006; New York Times, 9/23/2006]

Entity Tags: US Food and Drug Administration, Institute of Medicine

Timeline Tags: US Health Care

After USGS scientists complete their analysis of the dust samples collected in New York City (see September 17, 2001-September 19, 2001-) —which found asbestos, an “alphabet soup of heavy metals,” and an extremely high pH level (see September 20, 2001) —the team emails the results to “all the government contacts the team had” including people at the EPA and FEMA, as well as to the federal emergency response coordinator. The EPA never informs the public of the dust’s high pH. “We anticipated that the results would have been shared with the people on the ground, those at risk, but it looks like the information never got to those who needed it,” Geoffrey Plumlee, a geochemist, will later tell the St. Louis Post-Dispatch. [US Geological Survey, 11/27/2001; St. Louis Post-Dispatch, 2/10/2002; St. Louis Post-Dispatch, 2/10/2002; US Geological Survey, 10/2002 pdf file] Some scientists will suggest that the dust’s high pH is a major cause of what will come to be known as the “WTC cough” (see September 9, 2002).

Entity Tags: Environmental Protection Agency, Federal Emergency Management Agency, US Geological Service

Timeline Tags: Environmental Impact of 9/11

The New York Times publishes an article by Sheryl Gay Stolberg entitled, “Some Experts Say US Is Vulnerable to a Germ Attack.” The article claims that the US “is inadequately prepared to confront bioterrorist attacks, according to a broad range of health experts and officials. The nation must develop new vaccines and treatments, they say, but it must also fortify its fragile public health infrastructure, the first line of defense in detecting and containing biological threats.” It further notes that since 9/11, “much of the discussion about bioterrorism has centered on a shortage of antibiotics and vaccines. But the bigger problem, officials agree, is a lack of basic public health infrastructure and preparedness that could thwart a terror attack or limit its effects. Doctors are poorly trained to recognize symptoms of infection with possible biological weapons, like plague and anthrax, which can resemble the flu.” Asha George, an expert on biological warfare, says, “We are not going to have a bomb fly out of the sky and land on somebody so that we can say, ‘Look, there’s a bomb, and we are all dying of anthrax.’ It is most likely going to be a covert release, and people will get sick and go to their hospitals, and the public health system will have to pick up on this.” Ironically, at the time this article is published, the 2001 anthrax attacks (see October 5-November 21, 2001) have already begun and some people have started to get sick but have not been properly identified as having anthrax infections (see September 22-October 2, 2001). The article notes that since shortly after 9/11, the Centers for Disease Control and Prevention have alerted state and local health departments to look for signs of illnesses that could be from a chemical or biological attack. The article also notes, “In the wake of the [9/11] attacks, some members of the public have developed intense fears of germ warfare, and are trying to stock up on their own supplies.” [New York Times, 9/30/2001]

Entity Tags: Asha George

Timeline Tags: 2001 Anthrax Attacks, US Domestic Terrorism

The US Department of Health and Human Services implements a new policy requiring that all enforcement letters to drug companies potentially engaged in false advertising be pre-screened by FDA Chief Counsel Daniel E. Troy. Prior to the policy change, the FDA’s drug-marketing division and district offices were free to determine when an enforcement letter was warranted. After the policy change, the number of enforcement letters sent annually drops by two-thirds. [Boston Globe, 10/19/2002; Boston Globe, 12/22/2002; Denver Post, 5/23/2004] In October 2002, the General Accounting Office (GAO) finds that the FDA is taking so long to review the letters that “misleading advertisements may have completed their broadcast life cycle before FDA issued the letters.” [Boston Globe, 12/22/2002] Fifteen months later, another report by the GAO finds that the review process is still slow, with the average approval time being six months. [Boston Globe, 1/30/2004]

Entity Tags: Daniel E. Troy, US Department of Health and Human Services

Timeline Tags: US Health Care

After the October 2001 anthrax attacks (see October 5-November 21, 2001), government spending on bioweapons research skyrockets. For instance, the National Institutes of Health (NIH) spends $53 million on bioweapons research in 2001 and more than $1.6 billion in 2008. A total of more than $20 billion is spent on the field of research in the US from 2001 to 2008. When all projects underway in 2008 are completed, there will be ten times more space for working with the most dangerous substances, and thousands of additional scientists are working with deadly bioweapons agents. In 2008, research scholar Elisa Harris will comment that this surge in research using deadly germs “suggests that our biodefense program risks creating the very threat it is meant to fight.” [New York Times, 8/11/2008]

Entity Tags: United States National Institutes of Health, Elisa Harris

Timeline Tags: 2001 Anthrax Attacks, US Domestic Terrorism

Ayaad Assaad.Ayaad Assaad. [Source: Salon]Three days before the anthrax attacks are first made public, a letter is received by the FBI in Quantico, Virginia, warning that Dr. Ayaad Assaad, employed until 1997 (see May 9, 1997) as an anthrax researcher at USAMRIID, the US Army’s top bioweapons laboratory at Fort Detrick, Maryland, is a “‘a potential terrorist,’ with a grudge against the United States and the knowledge to wage biological warfare against his adopted country.” This is the latest in a series of verbal attacks against Assaad since the early 1990s, which includes anonymous, long hateful and derogatory poems about him (see 1991-1992). The author of the letter says he is a former colleague of Assaad. The letter seems like a not-very-subtle attempt to frame Assaad for the anthrax attacks about to come. The letter strongly suggests the attacks could have been by someone at USAMRIID with a long time grudge against Assaad. [Hartford Courant, 12/9/2001; Salon, 1/26/2002] The FBI questions Assaad about the letter one day later (see October 3, 2001).

Entity Tags: Ayaad Assaad, Federal Bureau of Investigation

Timeline Tags: 2001 Anthrax Attacks, US Domestic Terrorism

An appeals court rejects an argument by anti-abortion advocate Joseph Scheidler (see 1980 and 1986) that he should be allowed to continue his campaign of violence and intimidation towards women seeking abortions and other health services (see July 16, 1999). The Seventh Circuit Court of Appeals finds that “the First Amendment does not protect violent conduct” and that “violence in any form is the antithesis of reasoned discussion.” Scheidler and his colleagues will appeal to the Supreme Court. [National Organization for Women, 9/2002]

Entity Tags: Joseph Scheidler

Timeline Tags: US Health Care, US Domestic Terrorism

Robert Stevens.Robert Stevens. [Source: Associated Press]The first case of anthrax infection, of Robert Stevens in Florida, is reported in the media (see October 3, 2001). Letters containing anthrax will continue to be received until October 19. After many false alarms, it turns out that only a relatively small number of letters contain real anthrax (see October 5-November 21, 2001). [South Florida Sun-Sentinel, 12/8/2001] In 2004, Washington Post columnist Richard Cohen will recall how a widespread sense of panic spread across the US over the next few weeks, as millions felt the anthrax could target them next. He will write, “People made anthrax-safe rooms, and one woman I know of had a mask made for her small dog. I still don’t know if that was a touching gesture or just plain madness.” He says, “The [9/11] terrorist attacks coupled with the anthrax scare unhinged us a bit—or maybe more than a bit.” But he will also mention that the panic quickly passed and was largely forgotten by most people. [Washington Post, 7/22/2004] Columnist Glenn Greenwald will later comment in Salon, “After 9/11 itself, the anthrax attacks were probably the most consequential event of the Bush presidency. One could make a persuasive case that they were actually more consequential. The 9/11 attacks were obviously traumatic for the country, but in the absence of the anthrax attacks, 9/11 could easily have been perceived as a single, isolated event. It was really the anthrax letters—with the first one sent on September 18, just one week after 9/11—that severely ratcheted up the fear levels and created the climate that would dominate in this country for the next several years after. It was anthrax… that created the impression that social order itself was genuinely threatened by Islamic radicalism.” [Salon, 8/1/2008]

Entity Tags: Tom Daschle, Patrick J. Leahy, NBC, Glenn Greenwald, New York Post, Richard Cohen

Timeline Tags: Complete 911 Timeline, Domestic Propaganda, 2001 Anthrax Attacks, US Domestic Terrorism

The envelope to the Tom Daschle letter.The envelope to the Tom Daschle letter. [Source: FBI]Two Democratic senators are targets of the 2001 anthrax attacks (see October 5-November 21, 2001). On this day, Senator Tom Daschle’s office opens a letter mailed October 9, containing a lethal dose of anthrax (see October 6-9, 2001). A similar letter to Senator Patrick Leahy mailed the same day and from the same location is misrouted to Virginia on October 12, and is not discovered until November 17. Neither Leahy nor Daschle come into contact with the anthrax, but some of Daschle’s staffers do. [South Florida Sun-Sentinel, 12/8/2001]

Entity Tags: P. Patrick Leahy, Tom Daschle

Timeline Tags: Complete 911 Timeline, 2001 Anthrax Attacks, US Domestic Terrorism

The Canadian government overrides Bayer’s patent for the anthrax antibiotic Cipro and orders a million tablets of a generic version from another company. The US government says it is not considering a similar move. Patent lawyers and politicians state that adjusting Bayer’s patent to allow other companies to produce Cipro is perfectly legal and necessary. [New York Times, 10/19/2001] The New York Times notes that the White House seems “so avidly to be siding with the rights of drug companies to make profits rather than with consumers worried about their access to the antibiotic Cipro,” and points out huge recent contributions by Bayer to Republicans. [New York Times, 10/21/2001]

Entity Tags: Bush administration (43), White House, Bayer

Timeline Tags: 2001 Anthrax Attacks

The Boston Globe reports that the FDA is considering the validity of the pharmaceutical industry’s argument that the agency’s regulation of drug advertisements violates manufacturers’ “free speech” rights. The inquiry is being led by FDA Chief Counsel Daniel E. Troy, who represented drug companies before being appointed to the FDA position in August 2001 (see August 2001). [Boston Globe, 10/19/2002]

Entity Tags: Daniel E. Troy

Timeline Tags: US Health Care

The Bayer Corporation, holders of the US patent on the anthrax antibiotic Cipro, agrees with the US to reduce the price of Cipro in the US from $1.83 to 95 cents. Analysts say the price reduction will reduce Bayer’s profit margin from 95% to 65%. This reduction applies only to sales to the US government, not sales to the public. [New York Times, 11/4/2001] Bayer has allowed no other companies to produce or import Cipro into the US. Other countries with less stringent patent laws sell Cipro for 1/30th the US price, and have offered to import large quantities into the US. [New York Times, 10/21/2001] Nevertheless, a class action suit by over one million Americans has been filed against Bayer and two other companies, alleging that Bayer has paid $200 million to two competitors to not make generic versions of Cipro. [Lieff Cabraser Heimann & Bernstein, 10/25/2001] The profits from Cipro are considered a “lifesaver” for Bayer, which had been considering pulling out of pharmaceuticals altogether. [Guardian, 10/31/2001]

Entity Tags: Bayer

Timeline Tags: 2001 Anthrax Attacks

The New York Times reports that health officials and experts believe numerous other drugs are as effective as the antibiotic Cipro in combating anthrax. “Several generic antibiotics, including doxycycline, a kind of tetracycline, and various penicillins, are also effective against the disease,” and they all are in plentiful supply. [New York Times, 10/23/2001] A 1997 Pentagon study of anthrax in rhesus monkeys showed the other drugs to be equally effective. But Cipro remains the only drug officially recommended by the FDA (see July 27, 2000). [New York Times, 10/21/2001]

Entity Tags: US Food and Drug Administration

Timeline Tags: 2001 Anthrax Attacks

Scores of family planning clinics in at least 12 states have received letters containing anthrax threats, according to officials of feminist and abortion-rights organizations. Eleanor Smeal of the Feminist Majority Foundation says that over 200 clinics and advocacy organizations received letters in early November, all delivered in Federal Express envelopes. The envelopes that were opened contained a suspicious white powder and letters signed by the Army of God (AOG), a violent anti-abortion group (see 1982). This was the second such mailing in recent weeks; the first mailing was comprised of some 280 letters containing threatening letters and white powder purporting to be anthrax. None of the powder in any of the envelopes contained real anthrax; the letters were apparently hoaxes. Some of the letters in the latest mailings said: “You’ve ignored our earlier warnings. You’ve been exposed to the real thing. High-quality.” Groups targeted by the mailings include the Feminist Majority Foundation, the Center for Reproductive Law and Policy, Catholics for a Free Choice, Advocates for Youth, and the American Association of University Women. The persons responsible for the mailings somehow obtained the account numbers of two pro-choice organizations, the Planned Parenthood Federation of America and the National Abortion Federation, and used those accounts to pay for the mailings. The mailings have been traced to at least three drop-off locations in Virginia and Philadelphia. More packages are believed to be en route, and Federal Express is trying to intercept them. “I think the people responsible are despicable,” says Vicki Saporta of the National Abortion Federation. “They actually used our account number and our address, so our members would feel comfortable opening them.” Gloria Feldt, president of the Planned Parenthood Federation of America, says: “These letters are designed to terrorize us, and disrupt our work and our lives. That’s terrorism, plain and simple, and we take it very seriously.… The fact that they would forge the names of our staff members to terrorize employees is truly evil. Their heinous activities will not succeed.” Brian Emanuelson of the Connecticut Department of Environmental Protection says, “These were intended to be a threat to scare people and we want to make sure this is not what they say it is.” [CBS News, 11/9/2001] The anthrax mailings were from anti-abortion activist and AOG member Clayton Waagner (see 1997-December 2001).

Entity Tags: Feminist Majority Foundation, Brian Emanuelson, Army of God, American Association of University Women, Advocates for Youth, Catholics for a Free Choice, Eleanor Smeal, Center for Reproductive Law and Policy, Planned Parenthood, Gloria Feldt, Clayton Waagner, National Abortion Federation, Vicki Saporta

Timeline Tags: US Health Care, US Domestic Terrorism

Dr. Antonio Banfi.Dr. Antonio Banfi. [Source: Public domain]A letter containing anthrax is mailed to Dr. Antonio Banfi, a pediatrician in Santiago, Chile. Although the return address is Orlando, Florida, the postmark is Zurich, Switzerland. The letter is sent via DHL, which uses a Swiss bulk mail shipper in New York and a Swiss postmark. Unlike the anthrax letters with US addressees, the letter to Chile is mailed in a business envelope and has a typewritten return address, a business in Florida. Dr. Banfi receives the letter, but finds it suspicious and gives it to the Chilean authorities. No one is known to have been infected with the material contained in the letter. The letter baffles American and Chilean officials because, according to the New York Times, “as they dig deeper, nothing quite adds up.” The New York Times article states, without direct evidence and with ambiguous citation of unnamed “officials” from either Chile or the US, that the anthrax strain most likely originated in Chile, despite the Swiss origin of the letter. The strain is reported to be a different one than used in the US attacks, and is said to be similar to a strain in Turkey. Dr. Banfi says he has no strong political views or known enemies. [New York Times, 11/29/2001]

Entity Tags: Anto­nio Banfi

Timeline Tags: 2001 Anthrax Attacks

Dugway Proving Ground.Dugway Proving Ground. [Source: Public domain]The US Army responds to a journalistic investigation and confirms that it has been making weapons-grade anthrax in recent years, in violation of an international treaty. The US offensive biological weapons program was supposedly closed in 1969 when the US signed an international biological weapons treaty. In 1998, scientists at the US Army’s Dugway Proving Ground in Utah turned small quantities of wet anthrax into powder (see Spring 1998 and After). This weaponized anthrax appears to be very similar or identical to the anthrax used in the recent attacks. Molecular biologist Barbara Hatch Rosenberg says: “This is very significant.… There’s never been an acknowledgment that any U.S. facility had weaponized anthrax.… The question is, could someone have gotten hold of a very small amount and used it in the letters?” Some argue that this production of anthrax is in violation of an international biological weapons treaty that the US signed while others argue it is not. It is believed about six scientists at Dugway have the expertise to make powdered anthrax. The FBI has intensively questioned those at Dugway who have worked with anthrax. [Baltimore Sun, 12/13/2001; New York Times, 12/13/2001]

Entity Tags: Dugway Proving Ground, US Department of the Army, Barbara Hatch Rosenberg, Federal Bureau of Investigation

Timeline Tags: 2001 Anthrax Attacks

The FBI is now investigating “whether potential profit from the sale of anthrax medications or cleanup efforts may have motivated” the anthrax attacks (see October 5-November 21, 2001). Battelle, a company doing anthrax work for the CIA, mostly at the Battelle Memorial Institute in Ohio, is the company most discussed in a Washington Post story about this. Dozens of scientists at Battelle have been interviewed by the FBI already because it is one of only a few places where weaponized anthrax has been made. [Washington Post, 12/21/2001] The story comes one day after ABC News reported a Battelle scientist is under investigation for the anthrax attacks, but that story is quickly denied (see September 18-28, 2001).

Entity Tags: Battelle, Battelle Memorial Institute, Federal Bureau of Investigation

Timeline Tags: 2001 Anthrax Attacks, US Domestic Terrorism

When USGS hydrologist Christopher Milly submits a draft press release about a recent article on the increased risk of extreme flooding due to global warming, he is warned by a USGS press officer that the release might cause problems at the White House due to the sensitive nature of its topic. The news release would generate “great problems with the department,” Milly is advised. As predicted, the release is rejected by the Department of the Interior on grounds that the journal Nature will probably be publishing its own release about the article. [Washington Post, 4/6/2006; Union of Concern Scientists and Government Accountability Project, 1/30/2007, pp. 33 pdf file] However, it has been noted (see, e.g., (April 2001)) that government press releases issued in conjunction with releases published by scientific journals are helpful to the public because government issued releases tend to be written in a language that it more accessible.

Entity Tags: US Department of Interior, Christopher Milly, US Geological Service

Timeline Tags: Global Warming

Mark Crutcher.Mark Crutcher. [Source: Life Dynamics]Members of the anti-abortion organization Life Dynamics call Planned Parenthood clinics in 49 states, pretending to be teenaged girls pregnant by older men, and use the clinics’ promises of confidentiality to accuse them of covering up sexual abuse. The group secretly records telephone conversations with some 800 receptionists and staff members, and then uses selectively edited snippets of the taped conversations in a national publicity campaign against Planned Parenthood. The intent of the organization is to discredit Planned Parenthood and other abortion providers, and to encourage lawsuits against them, according to information published on the organization’s Web site. Life Dynamics, based in Denton, Texas, claims that the tapes are “evidence” that Planned Parenthood and other women’s clinics are complicit in child sex abuse. The organization’s founder, Mark Crutcher, releases a report called “Child Predators,” which is picked up by, among other news outlets, Newsday and Fox News. The organization’s evidence fails to hold up under scrutiny by law enforcement officials and media outlets, and pro-choice attorneys and advocates raise questions about the legality of Life Dynamics’s tactics. The organization bills itself as a “political marketing agency” whose stated goal is to prevent women from obtaining abortions, even if they are legally entitled to them. Crutcher and the group have previously attempted to claim that abortions cause breast cancer, and that Planned Parenthood trafficked in human body parts; both claims have been solidly debunked. Roger Evans of Planned Parenthood notes: “No one has an obligation to report or to conduct an inquisition based on a phone call, because you have no idea who is on the other end and what the truth is. And in this case, [the] Life Dynamics hoax caller was scrupulously careful not to give a name.” He goes on to say that law enforcement officials who have investigated the Life Dynamics charges “have been satisfied that people are conscientiously complying with the law as it’s written, and that people are reporting when kids are in danger.” Life Dynamics denies that its covert recording of the conversations is a violation of any state or federal laws (though 13 states targeted by the organization have anti-wiretapping laws), and is working diligently to spread its story throughout the press, starting with right-wing advocacy groups. The magazine Citizen, published by James Dobson’s Christian group Focus on the Family, says in a cover story that the tapes will “bring down Planned Parenthood.” And Neal Horsley’s far-right Nuremberg Files Web site features a story by Massachusetts attorney Greg Hession that outlines a strategy for “pro-life attorneys” to pursue in filing criminal and civil charges against Planned Parenthood. [Womens ENEws, 11/10/2002] (Horsley is an acknowledged advocate for the murder of abortion providers—see January 1997.) [Feminist Women's Health Center News, 2010] Evans says that if Life Dynamics achieves its stated objective of forcing medical providers to report all instances of teenagers’ sexual activity, “The system would be deluged,” and, in the absence of confidentiality, he predicts “teenagers would stop coming in.” [Womens ENEws, 11/10/2002]

Entity Tags: Roger Evans, Greg Hession, Focus on the Family, Mark Crutcher, Life Dynamics, Planned Parenthood

Timeline Tags: US Health Care

HCA, the country’s largest for-profit hospital chain, announces that it has struck a deal with the Centers for Medicare & Medicaid Services (CMS) over unaudited Medicare and Medicaid billings. The company—which paid more than $840 million in criminal fines, civil penalties, and damages in 2000 for fraudulent reportings to Medicare (see December 14, 2000), and which is still being investigated—will pay CMS $250 million to zero out its account with the agency. [Associated Press, 3/28/2002] But according to numerous government whistle-blowers, the amount is far too low. In a letter to the Department of Health and Human Services, Senator Charles E. Grassley (R-IA) will later accuse Medicare officials of “seeking to allow HCA to resolve more than $1 billion of liability to the Medicare program for only $250 million, based on little to no evidence supporting this low figure.” Even more troubling, notes the Senator, Medicare has agreed not to audit the company’s cost reports that have been piling up since 1997 when the agency stopped processing HCA bills because of the lawsuit. “One would expect a company with such a track record to be subjected to heightened scrutiny.… [Instead,] the Centers for Medicare and Medicaid Services is proposing to excuse HCA from an even routine review of thousands of Medicare cost reports,” Grassley writes. He says the deal is “too lenient.” John R. Phillips, one of the attorneys involved in the lawsuit against HCA, later says the deal was quietly arranged between HCA and CMS head Thomas A. Scully. “The $250 million was a total sellout by Scully, who totally negotiated it behind Justice’s back,” he says. [New York Times, 11/19/2002] Similarly, Grassley, in a June 25 letter to a Justice Department lawyer, says comments by Scully “have given me great concern that there is an active, ongoing effort underway to change or modify enforcement [on Medicare fraud] policy that in my view could significantly undermine the [law].” [Office of Senator Charles Grassley, 7/25/2002] Scully, during his confirmation hearings, had pledged he would “aggressively enforc[e] the fraud statutes” (see May 29, 2001).

Entity Tags: HCA, Inc., Thomas A. Scully, Charles Grassley, Centers for Medicare & Medicaid Services

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

Joel Kupferman of the New York Environmental Law and Justice Project collects dust samples at 150 Franklin Street at the request of one of the building’s tenants. He sends three samples to a lab which tests the dust for asbestos using transmission electron microscopy (TEM). The lab finds asbestos levels of 1.2, 1.4 and 1.8 percent. In September (see Shortly after September 17, 2001), the tenants had cleaned the building according to instructions provided by the city’s health department (see September 17, 2001). The building’s tenants—among them a family-run child care center—had relied on assurances from EPA and city officials that the downtown air was safe and consequently did not have the building professionally tested. After Kupferman notifies the city about these alarming results, the city tests the building using polarized light microscopy (PLM) on April 18 and does not find elevated asbestos levels. The city’s samples are retested by the EPA using transmission electron microscopy (TEM), and found to have an asbestos level ranging from 2 percent to 5 percent. “We recommended that [the building] be professionally cleaned,” EPA spokesperson Mary Mears later says. [New York Daily News, 5/2/2002; Wall Street Journal, 5/9/2002 pdf file; Salon, 8/15/2003]

Entity Tags: Joel R Kupferman, New York Environmental Law and Justice Project, Environmental Protection Agency

Timeline Tags: Environmental Impact of 9/11

The US Supreme Court agrees to review NOW v. Scheidler (see June 1986, September 22, 1995, and March 29 - September 23, 1997) on the basis of two technical issues raised by the defendants. The Court refuses to hear the defendants’ challenge that the First Amendment was violated by earlier rulings or that speech is at issue. The Court will determine whether women victimized by the violence of the anti-abortion advocates in the lawsuit can be protected from future crimes by an injunction as opposed to merely recompensed for the losses caused by the actions (see July 16, 1999), and whether it was appropriate to use the Racketeer Influenced and Corrupt Organizations (RICO) Act against defendants who claim their actions were prompted by religious or moral motivations. [National Organization for Women, 9/2002] The Court will overturn the decision on technical grounds (see February 28, 2006).

Entity Tags: US Supreme Court

Timeline Tags: US Health Care

A federal appeals court in San Francisco rules that anti-abortion organizations who engage in the practice of distributing posters targeting abortion providers (see 1995 and After) are illegally threatening the lives and well-being of the people they are targeting. The 6-5 verdict also rules that Web sites such as The Nuremberg Files (see January 1997), which list doctors’ names and addresses and “lines out” the names of those doctors who are murdered, also threaten the lives of the named doctors. The defendants unsuccessfully claimed they were engaging in constitutionally protected political advocacy; the plaintiffs—four doctors and two health clinics—argued that the speech in question encouraged violence against abortion providers. The verdict overturns a previous three-judge ruling by the same court and reinstates a $109 million award for the plaintiffs. Writing for the majority, Judge Pamela Ann Rymer states: “While advocating violence is protected, threatening a person with violence is not.… This is not political hyperbole. They were a true threat.” Maria Vullo, a lawyer for the plaintiffs, says the essence of the decision is rejection of threatening speech. Of the “political advocacy” practiced by the defendants, Vullo says, “It’s really terrorism.” Christopher Ferrara, a lawyer for the defendants, says his clients will appeal the decision to the Supreme Court. “This is a threat case without any identifiable threat,” he says. “We’re found liable for the format we chose.” [New York Times, 5/17/2002] In spite of the verdict, the practice will continue (see January - April 2003, Fall 2009, and September 13, 2010).

Entity Tags: Christopher Ferrara, Maria Vullo, Pamela Ann Rymer, “The Nuremberg Files”

Timeline Tags: US Health Care

A federal advisory committee at the Centers for Disease Control and Prevention (CDC) is preparing to vote on whether to lower the amount of lead exposure considered dangerous to children. The level was last set in 1991, and since then new research has proven that even smaller amounts of lead than previously thought are harmful to children’s cognitive development. The panel is preparing to adjust the level downward, a move that could cost paint and gasoline companies in potential lawsuits. But Tommy Thompson, the secretary of health and human services, intervenes. He abruptly replaces five experts with five new panel members known to be supporters of corporate interests that would be affected by the new regulation—one had testified on behalf of a paint company to his belief that children could withstand exposure to lead far in excess of federal regulations (and established science), and others handpicked by the lead industry. Two have financial ties to the industry. Unsurprisingly, the new panel votes to leave the recommended lead level exposure at its given levels. Until Thompson’s move, panel members had not been chosen for ideological or political reasons, but by career staff. [Savage, 2007, pp. 302]

Entity Tags: Tommy G. Thompson, US Department of Health and Human Services, Centers for Disease Control and Prevention

Timeline Tags: Civil Liberties

Accused murderer James Kopp, an anti-abortion advocate who allegedly shot Dr. Barnett Slepian (see October 23, 1998), is extradited by French authorities (see March 29, 2001) to the US after the American government assures them that Kopp will not face the death penalty. French law precludes suspects being extradited to foreign nations if the possibility exists that they will be executed. Kopp retains lawyer Paul Cambria to defend him, but also retains lawyer Bruce Barket because Barket, like Kopp, has strong anti-abortion views and wants to make the defense about abortion (Cambria wants to defend Kopp strictly on the evidence). Barket will not be allowed to represent Kopp in federal court. [National Abortion Federation, 2010] Months later, Kopp will confess to the murder (see November 21, 2002). He will be found guilty several months later (see March 17-18, 2003).

Entity Tags: James Kopp, Barnett Slepian, Bruce Barket, Paul Cambria

Timeline Tags: US Health Care, US Domestic Terrorism

The Office of Policy at the US Department of Health and Human Services (DHHS) releases a report concluding that the US government should not impose price caps on prescription drugs. According to the report, doing so “could put the future of medical innovation at risk and may retard advances in treatment.” [US Department of Health and Human Services, 7/2002, pp. 2 pdf file] The deputy assistant secretary of the division, Ann-Marie Lynch, had used the same argument when she was a drug industry lobbyist (see June 2001) fighting against congressional efforts to cap drug prices. [Denver Post, 5/23/2004] Critics of the report say its conclusions are contradicted by the experiences of other countries that have remained innovative despite price controls. DHHS officials “haven’t taken as seriously their job of making medicines affordable to all Americans,” says Gail Shearer, director of health policy analysis for Consumers Union. According to critics, the report plays a role in the passing of Bush’s Medicare drug plan that prohibits the government from using its buying power to negotiate lower prices from the drug companies.

Entity Tags: Ann-Marie Lynch, US Department of Health and Human Services

Timeline Tags: US Health Care

Pfizer attorney Malcolm Wheeler calls FDA chief counsel Daniel E. Troy requesting that the agency intervene in a lawsuit filed against the company. The lawsuit alleges that Zoloft, an antidepressant drug manufactured by Pfizer, caused Victor Motus of California to kill himself on November 12, 1998. It also says that the drug company should have warned physicians that Zoloft might cause suicidal thoughts in some people. On September 3, the FDA files a brief stating that the agency’s scientists have found no evidence that antidepressants cause suicidal thoughts. Furthermore, the FDA argues, if Pfizer had warned doctors of such a link, it would have been a violation of the law because all warnings must first be vetted by the FDA. According to Troy, the agency has “absolute control over the label.” This position, notes one of the plaintiff attorneys in the Pfizer case, contradicts arguments that Troy made when he was practicing in the private sector. Before he had argued that the agency’s rulings were arbitrary and capricious. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Pfizer, Malcolm Wheeler

Timeline Tags: US Health Care

Anti-abortion advocate James Kopp, accused of murdering Dr. Barnett Slepian (see October 23, 1998), confesses to the crime during an interview with the Buffalo News. “I did it, and I’m admitting it,” he says. “But I never, ever intended for Dr. Slepian to die.… I regret that he died. I aimed at his shoulder.” Kopp, who for months has vehemently denied any involvement in Slepian’s death, is accompanied by his lawyer, Bruce Barket. Both Kopp and Barket intend to make their legal defense about abortion, and will attempt to claim moral justification for the murder due to Kopp’s anti-abortion views. Of other abortion providers, Kopp says: “They’re still in danger, absolutely. I’m not the first, and I probably won’t be the last.… To pick up a gun and aim it at another human being, and to fire, it’s not a human thing to do. It’s not nice. It’s not pleasant. It’s gory, it’s bloody. It overcomes every human instinct. The only thing that would be worse, to me, would be to do nothing, and to allow abortions to continue.” Kopp claims he wants to set the record straight for the sake of his supporters who were publicly proclaiming his innocence and saying the FBI had framed him. Kopp adds that he selected Slepian’s name from the phone book, and that he also cased the homes of several other physicians before deciding that Slepian’s was the most vulnerable due to a window in the back that faced the woods. After his confession, prosecutors charge Kopp with an additional charge of reckless murder with depraved indifference to human life. [Associated Press, 11/21/2002; Buffalo News, 11/22/2002; National Abortion Federation, 2010]
Ends Claims that Kopp Innocent, Framed by Police - In January 2003, the magazine Catholic Insight will observe: “With this admission, Kopp knocked the feet out from under those pro-life supporters who had suggested that he couldn’t have committed the crime because he was a pacifist, had poor eyesight, was a poor marksman, or was being framed by the police. Pro-life advocates who earlier had condemned the shootings as unacceptable acts of violence could take solace in the fact that Kopp made it clear he acted alone in the Slepian shooting and that no one in the Buffalo pro-life community had suggested Slepian as a target.” [Catholic Insight, 1/1/2003]
Anti-Abortion Advocates Condemn Kopp's Shooting but Welcome Trial as Platform for Debating Abortion - The Reverend Paul Schenck, an anti-abortion advocate who has led numerous protests and has been arrested for blockading abortion clinics, says of Kopp: “James Kopp has admitted to being a cold-blooded killer, a vigilante who acted as judge, jury, and executioner. In what he did, he undermined the whole moral philosophy of the pro-life movement, which views every human life as intrinsically valuable and created in God’s image. He should fade into ignimony after being utterly rejected by all people of conscience. May God have mercy on his soul.” [US Newswire, 11/21/2002] Bishop Henry Mansell, a local anti-abortion leader, says while he disapproves of Kopp’s action and the use of violence against abortion providers, he welcomes the use of Kopp’s trial to create a platform for an abortion debate. “We don’t believe the end justifies the means,” Mansell says. “But given a trial, I hope there would be a discussion and an exploration of the issues in depth.” Pro-choice lawyer Glenn Murray disagrees, saying, “I would hate to think that those who want a referendum on abortion would exploit an act of terrorism.” [Buffalo News, 11/22/2002] “Kopp is an extremist, a terrorist, a self-confessed murderer plain and simple, so his jailhouse confession is nothing more than a cynical attempt to manipulate us all through the media,” says Gloria Feldt, president of Planned Parenthood, a pro-choice organization. The Reverend Philip “Flip” Benham, director of the anti-abortion organization Operation Save America (formerly Operation Rescue), says Kopp “betrayed the pro-life movement, unborn children, and the Lord he proclaims to serve. You never overcome the problem of murder by murdering people.” [Associated Press, 11/21/2002]
Kopp Will Be Found Guilty - Kopp will be found guilty of Slepian’s murder (see March 17-18, 2003).

Entity Tags: Barnett Slepian, Bruce Barket, Glenn Murray, Gloria Feldt, Catholic Insight, Paul Schenck, James Kopp, Henry Mansell, Philip (“Flip”) Benham

Timeline Tags: US Health Care, US Domestic Terrorism

A 2003 report by the Center for Public Integrity finds that 10 years after the privatization of Buenos Aires’ water and sewer services (see April 28, 1993), poor neighborhoods still lack access to safe drinking water. The report cites the example of the Parravicino household, which lives in one of the poorest areas of Buenos Aires. “Mario Parravicino, who lives with his family in the dusty city of La Matanza, gets up each morning praying silently that it won’t rain. ‘When it rains it often floods and the sewage gets into everything,’ says the 60-year-old factory worker. ‘You can’t use the toilet because it backs up. It’s disgusting.’ La Matanza is among the poorest districts in the Buenos Aires metropolitan area, a maze of tiny cinder-block homes wedged together along dirt roads. There are no sewers, so the rains flood its houses and septic tanks, which often overflow into wells. Boiling is the only form of water treatment, and not everyone can afford the gas to boil the water. Nitrate levels, caused by sewage contamination, are dangerously high and waterborne diseases common. In Argentina, intestinal infestations cause 20 percent of infant deaths. Across town in Laferrere, the Rusman family has the same problem. Their well is only two meters from the septic tank, and the water is often suspiciously murky after a rainfall. ‘Whenever we can we boil it before drinking,’ Alejandra Rusman explained. ‘But we don’t often have money to pay for gas.’ The local church provides drinking water to those who can’t pay for gas, but the Rusmans don’t wish to be beggars. Alejandra worries constantly about her two sons Pablo and Martin, aged 7 and 4. ‘This situation is dangerous because we forget and the boys drink this cloudy water and it makes them sick,’ she said.” The reports also notes, “A country that only 10 years earlier had Latin America’s highest standard of living was now on a level with Jamaica; half of Argentina’s 37 million people lived below the poverty level.” [Santoro, 2/6/2003]

Entity Tags: Mario Parravicino, Alejandra Rusman, Center for Public Integrity

Timeline Tags: Water

ALL president Julie Brown points to her organization’s ‘Deadly Dozen’ poster.ALL president Julie Brown points to her organization’s ‘Deadly Dozen’ poster. [Source: Life Magazine]A new advertising and poster campaign attacking pro-choice Catholic senators harks back to the dangerous “Deadly Dozen” campaign of 1995 (see 1995 and After), according to pro-choice advocates. The 1995 advertising and poster campaign targeted over a dozen health care and abortion providers, usually listing their names, addresses, and telephone numbers. The new campaign is by the American Life League (ALL—see 1979), an anti-abortion organization centered in Stafford, Virginia. Both the 1995 and the current campaigns feature “Old West” themed posters. ALL’s posters provide photographs of a dozen pro-choice US senators under the announcement, “Wanted For Fradulently Claiming Catholic Faith”; like the earlier campaign, the senators are branded as “The Deadly Dozen.” The senators pictured include Ted Kennedy (D-MA), Tom Daschle (D-SD), John Kerry (D-MA), and Barbara Mikulski (D-MD). The campaign calls for bishops to refuse communion to the senators. Vicki Saporta of the National Abortion Federation says she is appalled by ALL’s choice of slogans. “This type of language is associated with violence,” she says. “Seven people lost their lives as a result of this type of verbiage. What is the American Life League thinking?” The new ad campaign is running in selected newspapers, including the Washington Times and The Wanderer, a weekly Catholic newspaper in Massachusetts. A new round of posters is planned, targeting, among others, Governor Gray Davis (D-CA) of California and other California pro-choice lawmakers, according to ALL official Joseph Giganti. Giganti says ALL is opposed to violence and calls comparisons between his organization’s campaign and the 1995 campaign “reckless and careless.… Our ads don’t refer to being wanted dead or alive; it is referencing the fact abortion kills. We are simply saying, if you are in fact Catholic, how can you continue to support abortion?” Giganti blames pro-choice groups for “purposely… misinterpret[ing]” the campaign and using it “as a stepping stone to voice their own opinions.” At least 11 Catholic diocesan newspapers have turned down the ads. “The kind of advertising they are doing is inflammatory,” says Frances Kissling, president of Catholics for a Free Choice. “It could incite someone, set someone off. But the more dominant issue is that they will disgust people. This ad will only reinforce pro-choice. People who have mixed feelings about abortion, people who are moderates will be turned off by the advertisements.” A spokesman for one targeted senator, Christopher Dodd (D-CT), says of the campaign: “There is no place in America for personal attacks on those with whom one disagrees. Ultimately, Senator Dodd’s religious views are a personal matter between him and God.” [Life, 1/22/2003; Womens ENews, 4/21/2003]

Entity Tags: Vicki Saporta, Tom Daschle, John Kerry, Frances Kissling, Gray Davis, Joseph Giganti, Christopher Dodd, American Life League, Barbara Mikulski, Edward M. (“Ted”) Kennedy

Timeline Tags: US Health Care, US Domestic Terrorism

After reviewing results of clinical study 3014 for the antibiotic Ketek, an FDA advisory panel recommends that the drug be approved. [Aventis, 1/9/2003] The panel makes the decision completely unaware that the FDA had discovered problems with the study only a few months before. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 pdf file] In October, an FDA examiner found that some doctors were reporting fraudulent results. For example, some doctors had failed to record the data properly while others had invited patients into the study who did not meet the necessary qualifications. In one case, several patients who were enrolled in the study were not actually taking the drug (see October 2001-Fall 2002).

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

The anti-abortion organization Operation Rescue releases a statement from its director, the Reverend Philip “Flip” Benham, criticizing a rally held in Buffalo, New York, to memorialize James Kopp, the confessed murderer of abortion provider Dr. Barnett Slepian (see October 23, 1998 and November 21, 2002). Benham accuses pro-choice advocates of participating in the “murder” of “over 45 million children killed by ‘legalized’ abortion,” and says: “Those who advocate murdering abortionists are going to be given a national platform from which to spew their vitriolic poison. How sad!” Benham denies that Operation Rescue has ever advocated or supported violence against abortion providers (see August 1988, January 7, 1998, and April 20, 1998), adding that his organization has “totally debunked” the idea that “murdering abortionists is somehow justifiable biblically,” and blames “the media” for propagating “this poisonous lie” that anti-abortion advocates espouse violence in order to “divert our attention from the true holocaust savaging our nation, and paint every Christian who lives out his faith at an abortion mill as a wild-eyed lunatic, bent on doing violence.” [Operation Save America, 1/13/2003]

Entity Tags: Philip (“Flip”) Benham, James Kopp, Operation Rescue

Timeline Tags: US Health Care, US Domestic Terrorism

Anti-abortion activist Joseph Scheidler (see 1980, 1985, June 1986, April 20, 1998, October 2, 2001, and February 28, 2006) claims to have renounced the violent tactics that made him such a notorious figure of the anti-abortion, or pro-life, movement (see 1986 and March 26, 1986). Scheidler, 75, a former Benedictine monk and newspaper reporter who lives in Chicago, says he now favors peaceful marches on abortion clinics, the display of posters with graphic depictions of aborted fetuses, and what he calls “counseling” of women seeking abortions. “Obstruction—that’s over,” Scheidler says. “I was in some of those demonstrations, but I could see that was not going to be the real way. You’ve got to convert people away from abortion. You don’t just keep them out of the clinics. They just arrest you and you’re gone, and they go back in. I always hated it when the day was done, and they were all going back to the clinic and we were sitting in a [police] wagon.” He adds: “Nothing’s going to change in what we do. I haven’t stopped doing anything that I thought was effective. What will change is I think more people will come out.” [Chicago Sun-Times, 2/27/2003]

Entity Tags: Joseph Scheidler

Timeline Tags: US Health Care, US Domestic Terrorism

A handcuffed James Kopp is escorted into an Erie County courtroom to face trial for murdering Dr. Barnett Slepian.A handcuffed James Kopp is escorted into an Erie County courtroom to face trial for murdering Dr. Barnett Slepian. [Source: Getty Images]James Kopp, the anti-abortion advocate who has confessed to murdering abortion provider Dr. Barnett Slepian (see October 23, 1998 and November 21, 2002), is tried for the murder. Kopp has agreed to a bench trial in lieu of a jury; both the defense and prosecution have already agreed to a number of basic facts stipulated about the case. Defense attorney Bruce Barket argues that Kopp should be acquitted because of his moral belief that force is necessary to stop abortions, and because he did not intend to kill Slepian, but only wound him. Prosecutor Joseph Marusak counters by arguing that every step Kopp took in planning for the attack, including his choice of weapon and the use of aliases in buying the rifle, pointed to an intention to kill. After less than two days of trial, Judge Michael D’Amico finds Kopp guilty of second-degree murder. Kopp will be sentenced to 25 years to life in prison. [Associated Press, 3/18/2003; National Abortion Federation, 2010] Kopp is allowed to read a long statement explicating his anti-abortion views into the court record. [Buffalo News, 1/7/2007] Pro-choice organization Planned Parenthood says of Kopp’s conviction: “The conviction of confessed terrorist and murderer James Kopp is a triumph for justice. Our thoughts are with Dr. Slepian’s family and community. James Kopp’s horrendous crime is a painful reminder of the threat posed by extremists who will go to any lengths to impose their ideology on others. Planned Parenthood and America’s pro-choice majority will not tolerate anti-choice terrorists and their limitless hostility toward reproductive health care providers and the women they bravely serve. We hope the outcome of the Kopp trial will dissuade other anti-choice extremists from further harassment and violence. Planned Parenthood is committed to protecting our patients, staff, and volunteers and to ensuring that those who threaten them are brought to justice.” [Planned Parenthood, 3/18/2003] The National Abortion Federation’s Vicki Saporta says in a statement: “Unfortunately, there are many anti-choice extremists who believe that it is justifiable to kill doctors because they provide women with safe and legal abortion care. The Army of God, of which Kopp is a member (see 1982), supports the use of force to end abortion. [V]iolence against abortion providers is never acceptable or justified.… One trend we have documented is that when one murderer is brought to justice another one is quickly recruited to become the next assassin. Kopp’s trial must not lead to another series of assassination attempts directed at physicians who perform abortions. We, therefore, continue to urge law enforcement to remain especially vigilant in enforcing the law and prosecuting those who would use violence to advance their own personal, political agendas.” [National Abortion Federation, 3/17/2003]

Entity Tags: Barnett Slepian, Joseph Marusak, Michael D’Amico, Army of God, Vicki Saporta, Planned Parenthood, James Kopp, Bruce Barket

Timeline Tags: US Health Care, US Domestic Terrorism

James Haveman, a 60-year old social worker and the director of a faith-based international relief organization, is recommended by the former Republican governor of Michigan, John Engler, to run Iraq’s health care system. Haveman earned Engler’s approval by running a large Christian adoption agency in Michigan that pushed pregnant women not to have abortions. Engler recommends Haveman to Paul Wolfowitz, the deputy secretary of defense; Haveman is soon dispatched to Baghdad to oversee the rebuilding of Iraq’s health-care system.
Replacing the Expert with the 'Loyalist' - Wolfowitz orders the immediate firing of Dr. Frederick Burkle, who worked the issue during the invasion. Unlike Haveman, Burkle has extensive experience in such areas: he has multiple degrees in public health, taught disaster-response issues at Johns Hopkins University, and is currently a deputy assistant administrator for the US Agency for International Development (USAID), who sent him to Baghdad in the days after the invasion. Burkle has extensive experience working in postwar climates such as Kosovo, Somalia, and Iraq after the 1991 Persian Gulf War. A USAID colleague will call him the “single most talented and experienced post-conflict health specialist working for the United States government.” However, Burkle lacks the Republican political connections. A USAID official tells Burkle that the White House wants a “loyalist” in the job, and Haveman fits the bill.
Anti-Smoking Campaigns, Fee-Based Care - Haveman’s tenure is marked by voluble recitations of how well the reconstruction is going: he tells anyone who will listen about how many Iraqi hospitals have reopened and about the pay raises Iraqi doctors have received. He refuses to discuss how decrepit most Iraqi hospitals still are, or the fact that many of Iraq’s best doctors are fleeing the country. Haveman mounts an aggressive anti-smoking campaign (and appoints a closet smoker to head it), ignoring comments that Iraqis have far bigger dangers in their lives than tobacco and recommendations that CPA funds might better be spent trying to combat fatal maladies running rampant through Iraqi populations. Haveman, a conservative ideologue, is offended by the idea that health care in Iraq is free. He institutes a fee-based health care system instead. Most importantly, he allocates almost all of the Health Ministry’s share of US reconstruction funds—some $793 million—to renovating Iraqi maternity hospitals and building community medical clinics. He later explains that his goal is “to shift the mind-set of the Iraqis that you don’t get health care unless you go to a hospital.” Unfortunately, his decision means that no funds are available to reconstruct emergency rooms and operating theaters in Iraqi hospitals, which are being overrun with injuries from insurgent attacks.
Privatizing the Drug Supply Distribution Process - Haveman opposes the idea of state-based drug and medical supply distribution on ideological grounds. Instead, he decides to privatize the dysfunctional government firm that imports and distributes drugs and medical supplies to Iraqi hospitals. When he served as Michigan’s director of community health, he dramatically cut the amount of money Michigan spent on prescription drugs for poor citizens by limiting the medications doctors could prescribe to Medicaid patients. He instituted a short list of cheaper drugs that poor patients were limited to using. Haveman decides that the same approach will work in Iraq. Currently, Iraq has around 4,500 drugs on its formulary, and Haveman decides the list is much too long. Any private firm who wants to bid on the job of supplying drugs and medical supplies will not want to deal with such a long list. Haveman also wants to restrict the firm to buying American-made drugs and supplies—no more medicines from Iran, Syria, or Russia. The Pentagon sends Haveman three formulary experts to help him implement his plan, including Lieutenant Commander Theodore Briski, a Navy pharmacist. Haveman’s order, as Briski later recalls, is “Build us a formulary in two weeks and then go home.” Two days into his position, Briski decides that Haveman’s plan is untenable. The existing formulary works well enough, he believes. Haveman wants to redesign “the entire Iraqi pharmaceutical procurement and delivery system, and that was a complete change of scope—on a grand scale.” Most importantly, Briski recalls, Haveman and his advisers “really didn’t know what they were doing.” Others agree, including many on Haveman’s team. Rewriting the formulary is a major distraction, they argue, as is privatizing the pharmaceutical distribution process. Haveman ignores the immediate needs of the populace for his grandiose, ill-considered plans.
No Progress - When Haveman leaves Iraq, the hospitals are as decrepit and dysfunctional as they were when he arrived. Baghdad’s largest medical facility, Yarmouk Hospital, lacks basic equipment to monitor blood pressure and heart rate. Operating rooms lack essential surgical tools and sterilizers. Pharmacy shelves are bare. The Health Ministry estimates that of the 900 drugs it deems essential, hospitals lack 40 percent of them. Of the 32 medicines used in combating chronic diseases, 26 are unavailable. Health Minister Aladin Alwan asks the United Nations for help, asks neighboring nations for emergency donations, and throws out Haveman’s idea for a new formulary. “We didn’t need a new formulary,” he later says. “We needed drugs. But the Americans did not understand that.” [Washington Post, 9/17/2006]

Entity Tags: US Agency for International Development, Iraqi Health Ministry, Frederick Burkle, Bush administration (43), Aladin Alwan, James Haveman, John Engler, Paul Wolfowitz, Theodore Briski, United Nations, Yarmouk Hospital

Timeline Tags: Iraq under US Occupation

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

Timeline Tags: US Health Care

At the same time top Medicare official Thomas A. Scully is working with Congress to draft new Medicare legislation, he is looking for a private sector job that will pay him to advise clients affected by the very same Medicare program he is helping to draft. The fact that Scully’s job search is taking place at the same time he is working on legislation, raises concerns that his contributions to the bill are potentially being influenced by his own private interests. Scully insists however that he is complying with all federal ethics regulations and says he has a waiver from the department’s general counsel permitting him to seek work in the private sector. By December he has narrowed his list of prospective employers to five companies: Alston & Bird; Baker, Donelson, Bearman, Caldwell & Berkowitz; Ropes & Gray; Welsh, Carson, Anderson & Stowe; and Texas Pacific Group. All of the companies have clients in the health care industry. Scully, who made $675,000 a year as a lobbyist before taking his current position in the government at $134,000 a year, is expected to make a hefty salary in the private sector with his insider knowledge of the new Medicare program. “His exhaustive knowledge of the Medicare program and the intricacies of the legislation, approved by Congress last week, would make him a prize catch for any law firm or private equity firm,” notes the New York Times. Scully will resign on December 16, less than a month after Congress passes the Medicare bill. [Washington Post, 12/3/2003; New York Times, 12/3/2003]

Entity Tags: Thomas A. Scully

Timeline Tags: US Health Care

FDA chief counsel Daniel E. Troy intervenes in a lawsuit against Glaxo SmithKline, the manufacturer of the drug Paxil. The FDA says it disagrees with the judge’s temporary order that the phrase “not habit-forming” be removed from the company’s advertisements promoting Paxil. The plaintiffs in the case alleged that the phrase is misleading because they experienced withdrawal symptoms after they stopped taking the drug. The judge agreed saying, “It is difficult to imagine that the FDA would object to the removal of the reference that ‘Paxil is not habit-forming.’” But Troy does object. The FDA, taking the side of Glaxo SmithKline, says the product is not habit-forming and contend that the symptoms experienced by patients were not withdrawal symptoms, but rather symptoms of “discontinuation syndrome.” According to Troy, the FDA has absolute authority on the content of drug labels. Following the FDA’s intervention, the judge lifts her temporary order. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Glaxo SmithKline

Timeline Tags: US Health Care

A study conducted by Harvard University and the Canadian Institute for Health Information finds that administrative costs in America’s health care system are almost twice that of Canada. The study, published in the New England Journal of Medicine, reports that the US health bureaucracy consumes 31 percent of total health care spending. By comparison, Canada’s administrative expenses amount to only 16.7 percent. Steffie Woolhandler of Harvard, who led the team, says if the US were to adopt a single-payer health care system like Canada, the funds saved would be enough to provide insurance for the more than 41 million uninsured Americans. [Woolhandler, Campbell, and Himmelstein, 2003; Toronto Star, 8/21/2003]

Timeline Tags: US Health Care

Paul Hill, a former minister convicted of the murder of Dr. John Britton and bodyguard James Barrett (see July 29, 1994), is put to death by lethal injection. Hill is the first person executed in the US for anti-abortion violence. Florida Governor Jeb Bush (R-FL) ignores calls by death penalty opponents and threats from anti-abortion activists to stop the execution, saying he will not be “bullied” into stopping Hill’s execution. Hill dies via a lethal injection. Florida abortion clinics are on heightened alert for reprisals and attacks; several clinic officials have received death threats in recent weeks. Hill has never contested his execution, instead insisting that he merely followed God’s orders in killing Britton and Barrett. He has maintained that God will forgive him for the murders. “I expect a great reward in heaven,” he said just days before his execution. “I am looking forward to glory.” Hill has called for others to use violence to prevent abortions. Many extremist anti-abortion organizations openly proclaim Hill as a martyr for their cause, while more mainstream anti-abortion organizations have denounced Hill’s use of violence. [Fox News, 9/3/2003; CBS News, 4/19/2007] Father David C. Trosch, a staunch supporter of Hill, will write a eulogy of sorts for him three days after the execution. Trosch was present during at least one day of court proceedings, and will complain that Hill was not allowed “to speak to the jury regarding his motive for killing an abortion provider and an assistant.” According to Trosch, “It was a justifiable deed as he was defending innocent pre-born, tiny, perfectly formed human beings, each carrying a fully formed human spirit, given to them by God, at their conception.” Trosch will write that he is more saddened by Hill’s execution than he was by the loss of any number of his family members, including his parents, wife, and children. [David C. Trosch, 9/6/2003]

Entity Tags: Paul Hill, Jim Barrett, John Britton, John Ellis (“Jeb”) Bush, David C. Trosch

Timeline Tags: US Health Care, US Domestic Terrorism

President Bush signs a bill into law banning so-called “partial-birth abortions.” A similar bill was vetoed by then-President Clinton in 1996 (see April 1996). The bill signing is part of a ceremony of abortion opposition featuring some 400 lawmakers and anti-abortion advocates. The new law, known as the Partial Birth Abortion Ban Act, is the first time the federal goverment has banned an abortion procedure since the 1973 Roe v. Wade decision legalized abortions (see January 22, 1973). A federal judge in Nebraska has already said the law may be unconstitutional, and many observers expect it to be challenged. [CBS News, 4/19/2007] Three years later, the Supreme Court will uphold the law (see April 17, 2007).

Entity Tags: George W. Bush

Timeline Tags: US Health Care

Thomas A. Scully resigns as head of the Centers for Medicare & Medicaid Services (CMS)(formerly called the Health Care Financing Administration (HCFA)). [Washington Post, 12/3/2003] For the last six months Scully, a former lobbyist for the health care industry, has been shopping around for a job in the private sector hoping to find a firm that would hire him to advise clients affected by the new Medicare program that he helped draft (see June-December 2003). Shortly after resigning, Scully is hired by Alston & Bird LLP to help the law firm build a health practice in their Washington office. He also lands a second part-time job with Welsh, Carson, Anderson & Stowe, a New York investment firm specializing in telecommunications and health care. [Washington Post, 1/14/2004]

Entity Tags: Thomas A. Scully

Timeline Tags: US Health Care

The National Academy of Sciences issues a report calling for universal health insurance coverage by 2010. “It is time for our nation to extend coverage to everyone,” the report says. “Universal insurance coverage is an important and achievable goal for the country.” The report was drafted by a panel of 15 experts and is the product of three years of work.
Sampling of report's conclusions -
bullet People without insurance receive about half the medical care of those who have it. Consequently, they are on average sicker and tend to die sooner.
bullet Roughly 18,000 people die each year because they do not have insurance.
bullet In 2001, only half of uninsured children in the US visited a physician during 2001, compared with three-quarters of privately insured children.
bullet In 2001, taxpayers spent roughly $30 billion in unreimbursed medical care for uninsured Americans.
bullet The poorer health and premature deaths of uninsured people cost taxpayers between $65 billion to $130 billion a year.
Reaction in US government - Republican Senate majority leader Bill Frist of Tennessee—whose family owns HCA Inc., the largest for-profit hospital chain in the US—expresses concern that “the report may not focus enough on the reasons why health care costs continue to rise and how to pay for any reform.” Democratic Senator Tom Daschle of South Dakota supports the call. “It’s doable,” he says. “It’s essential. This is, I believe, the single most important domestic issue facing our country.” Tommy G. Thompson, secretary of health and human services, tells reporters the proposal is “not realistic.” [Institute of Medicine, 2004; National Academies, 1/14/2004; New York Times, 1/15/2004]

Timeline Tags: US Health Care

Clips of Thompson, Bush included in VNRs provided to local TV stations.Clips of Thompson, Bush included in VNRs provided to local TV stations. [Source: New York Times]New York Times reporter Robert Pear discovers that the Bush administration has employed two fake “reporters,” Karen Ryan and Alberto Garcia, who have appeared in administration-produced television “news” segments—“video news releases,” or VNRs—designed to promote the administration’s new Medicare prescription-drug policies. (Garcia primarily appeared in Spanish-language Medicare VNRs.) HHS had budgeted $124 million for the fake news segments, more than most real news organizations can provide. The segments are under investigation by the General Accounting Office (GAO) for possible violation of government statutes prohibiting the use of federal money to produce propaganda or partisan presentations. The Secretary for Health and Human Services (HHS), Tommy Thompson, appears in one of the segments, saying, “This is going to be the same Medicare system only with new benefits, more choices, more opportunities for enhanced benefits.” Several others show a crowd giving President Bush a standing ovation as he signs the new Medicare bill into law. Another segment shows a pharmacist talking to an elderly customer. The pharmacist says the new law “helps you better afford your medications,” and the customer says, “It sounds like a good idea.” The pharmacist agrees, “A very good idea.” The segments, professionally produced and ending with tag lines such as “In Washington, I’m Karen Ryan reporting,” were regularly aired by at least 50 local television news broadcasts in 40 cities around the country. The government also provides scripts that can be used by local news anchors to introduce, or “walk up,” the VNRs. One script suggested that anchors read the following: “In December, President Bush signed into law the first-ever prescription drug benefit for people with Medicare. Since then, there have been a lot of questions about how the law will help older Americans and people with disabilities. Reporter Karen Ryan helps sort through the details.” A VNR is then broadcast explaining how the new law benefits Medicare recipients.
'Infoganda' - Ryan is a freelance journalist, the administration claims, and using her for such fake news segments is perfectly acceptable. But cursory investigation reveals that she was once a freelance reporter, but has for years worked as a public relations consultant. Her most recent assignments include appearing in marketing videos and “infomercials” promoting a variety of pharmaceutical products, including the popular drugs FloMist and Excedrin. Perhaps the most telling reaction is from Comedy Central’s comedy-news program The Daily Show, where host Jon Stewart can’t seem to decide whether to be outraged or flattered by what Rich calls “government propaganda imitating his satiric art.” (Daily Show member Rob Corddry calls the HHS videos “infoganda.”) Administration officials also insist that the VNRs are real, objective news releases, but the company that produced the segments, Home Front Communications, confirms that it had hired Ryan to read a script prepared by government officials. The VNRs give a toll-free phone number for beneficiaries to call. To obtain recorded information about prescription drug benefits, the caller must speak the words, “Medicare improvement.” The Columbia Journalism Review writes, “The ‘reports’ were nothing more than a free advertisement for the legislation, posing as news.”
Legal? - GAO lawyers say that their initial investigations found that other fliers and advertisements disseminated by HHS to promote the new Medicare policies are legal, though they display “notable omissions and other weaknesses.” Administration officials claim the VNRs are also a legal, effective way to educate Medicare beneficiaries. The GAO is still investigating the VNRs. GAO investigators believe that they might violate the law in at least one aspect: misleading viewers by concealing their government origins. Federal law expressly forbids the use of federal money for “publicity or propaganda purposes” not authorized by Congress. Earlier investigations have found government-disseminated editorials and newspaper articles illegal if they did not identify themselves as coming from government officials. The GAO will find that the VNRs break two federal laws forbidding the use of federal money to produce propaganda (see May 19, 2004).
'Common Practice' - HHS spokesman Kevin Keane says the VNRs are well within legal guidelines; their only purpose, he says, is to inform citizens about changes in Medicare. “The use of video news releases is a common, routine practice in government and the private sector,” he says. “Anyone who has questions about this practice needs to do some research on modern public information tools.” Congressional Democrats disagree with Keane. “These materials are even more disturbing than the Medicare flier and advertisements,” says Senator Frank Lautenberg (D-NJ). “The distribution of these videos is a covert attempt to manipulate the press.” Lautenberg, fellow Senator Edward Kennedy (D-MA), and seven other members of Congress requested the GAO investigation. Keane is correct in one aspect: businesses have distributed VNRs to news stations as well as internally for years, and the pharmaceutical industry has been particularly successful in getting marketing videos that appear as “medical news” or “medical features” aired on local and even national news broadcasts. And government agencies have for years released informational films and videos on subjects such as teenage smoking and the dangers of using steroids. Bill Kovach, chairman of the Committee of Concerned Journalists, says HHS’s VNRs have gone far beyond what the government has previously provided. “Those to me are just the next thing to fraud,” he says. “It’s running a paid advertisement in the heart of a news program.” [New York Times, 3/15/2004; Columbia Journalism Review, 3/15/2004; Rich, 2006, pp. 164]
Media Responsibility - The Columbia Journalism Review’s Bill McDermott writes: “[F]or our money, the villains here aren’t the clever flacks at HHS—they’re supposed to be masters of deception. Nope, the dunce hats go to the local TV station editors willing to slap onto the air any video that drops in over the transom.” [Columbia Journalism Review, 3/15/2004] Ryan is relatively insouciant about the controversy. “Stations are lazy,” she says. “If these things didn’t work, then the companies would stop putting them out.” [Pittsburgh Post-Gazette, 3/20/2004]

Entity Tags: Edward M. (“Ted”) Kennedy, US Department of Health and Human Services, Committee of Concerned Journalists, Bush administration (43), Bill McDermott, Bill Kovach, Alberto Garcia, Tommy G. Thompson, Columbia Journalism Review, Robert Pear, New York Times, Jon Stewart, Home Front Communications, George W. Bush, Karen Ryan, General Accounting Office, Kevin Keane, Frank R. Lautenberg, Rob Corddry

Timeline Tags: Domestic Propaganda

The Food and Drug Administration (FDA) announces that it will not permit pharmacies to sell the emergency contraception drug “Plan B” without a prescription. The drug is a “morning-after” birth-control drug that prevents fertilization and the implantation of the embryo. The agency explains to the manufacturer of the drug, Barr Pharmaceuticals, that the government is worried about the possibility that teenaged girls might not understand how to correctly use the drug without a doctor’s advice. The FDA’s decision is in direct contradiction of a federal advisory panel’s 23-4 decision to recommend approving the drug for over-the-counter sales, including to teenagers, without a doctor’s approval. The FDA’s staff recommended that the agency follow the panel’s recommendation. In 2007, author and reporter Charlie Savage will write, “Normally, agencies such as the FDA base their decisions on the information provided by their expert advisory panels—but, strangely, not this time.” A spokesman for the presidential campaign of John Kerry (D-MA) says: “By overruling a recommendation by an independent FDA review board, the White House is putting its own political interests ahead of sound medical policies that have broad support. This White House is more interested in appealing to its electoral base than it is in protecting women’s health.” James Trussell, director of the office of population research at Princeton University and a member of the advisory board, says, “The White House has now taken over the FDA.” Numerous women’s groups accuse the FDA’s political appointees of overruling the experts in order to please social conservatives who believe that the “Plan B” drug encourages promiscuity and is a form of abortion. In the following months, a lawsuit will be filed to have the FDA’s decision overturned (see January 21, 2005 and After). [New York Times, 3/7/2004; Savage, 2007, pp. 300-301]

Entity Tags: Charlie Savage, Barr Pharmaceuticals, Bush administration (43), James Trussell, John Kerry, Food and Drug Administration

Timeline Tags: US Health Care, Civil Liberties

The General Accounting Office (GAO) finds that the Bush administration broke two federal laws as part of its publicity campaign to promote its new Medicare prescription drug policies. The Department of Health and Human Services (HHS) illegally spent federal monies on what amounts to covert propaganda in producing and distributing “video news releases,” or VNRs, to local television news broadcasters around the country that were designed to look like objective news reports (see March 15, 2004). The GAO findings do not carry legal weight, because the GAO acts as an adviser to Congress. The viewers in the more than 40 cities who saw the reports did not know they were watching government-produced videos anchored by public relations “flacks” paid by HHS who were not real reporters. The VNRs have only fueled criticism of the Medicare prescription drug coverage program, which gives private health care firms and prescription drug companies a much larger role in providing and setting prices for Medicare recipients’ prescriptions. Democrats have long insisted that the law cripples Medicare beneficiaries’ ability to receive low-cost prescriptions in favor of funneling Medicare dollars into the pharmaceutical companies’ coffers; with the GAO findings, Democrats now say that the government used illegal propaganda tactics to “sell” the citizenry on the new program. The administration has already admitted that the program will cost hundreds of billions of dollars more than originally claimed. Democratic presidential candidate John Kerry (D-MA) calls the videos “another example of how this White House has misrepresented its Medicare plan.” Kerry’s Senate colleague, Edward Kennedy (D-MA), says: “The new GAO opinion is yet another indictment of the deception and dishonesty that has become business as usual for the Bush administration. It was bad enough to conceal the cost of the Medicare drug bill from the Congress and the American people. It is worse to use Medicare funds for illegal propaganda to try to turn this lemon of a bill into lemonade for the Bush campaign.” The Bush administration continues to insist that the VNR program is legal. “GAO opinions are not binding on the executive branch. That’s an opinion of the GAO. We don’t agree,” says HHS spokesman Bill Pierce, who justifies the VNR usage by pointing to their ubiquitous usage in corporate settings. Asked if he understands that a viewer might be angry at being led to believe that the VNRs were real news stories, Pierce replies, “If I’m a viewer, I’d be angry at my television station.” [Washington Post, 5/20/2004; Los Angeles Times, 5/20/2004]

Entity Tags: John Kerry, Bill Pierce, Bush administration (43), Edward M. (“Ted”) Kennedy, General Accounting Office, US Department of Health and Human Services

Timeline Tags: Domestic Propaganda

Three separate federal courts rule that the federal ban on so-called “partial-birth abortions” (see November 5, 2003) is unconstitutional. One judge rules that the law illegally infringes on a woman’s right to choose. A second and third rule that the law must contain a provision excepting such a procedure in the case of a danger to the mother’s life or health. The case will be appealed to the Supreme Court (see April 17, 2007). [CBS News, 4/19/2007]

Entity Tags: US Supreme Court

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

The Food and Drug administration approves Vioxx for children who are over the age of 2 and have symptoms of rheumatoid arthritis. [US Food and Drug Administration, 6/1/2005 pdf file] The approval is announced on September 8. [United Press International, 9/8/2004; Medical News Today, 9/9/2004]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, presents the findings of a study on Vioxx in a poster exhibit at an international medical conference in Bordeaux, France. According to Graham’s research, thousands of Americans have died from taking the drug. In his study, he analyzed data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. According to Graham’s analysis of the data, the risk of having a heart attack or dying from heart problems is 3.2 times higher for Vioxx patients than people who do not use painkillers, and twice as high for those using Celebrex. Based on these figures, Graham estimates that more than 27,000 Americans have had heart attacks or died from sudden cardiac deaths as a result of taking Vioxx instead of Celebrex. In response to Graham’s study, Merck, the maker of Vioxx, issues a statement insisting that its drug is safe. Alise Reicin, vice president of clinical research at Merck, claims that numerous studies comparing the drug to a dummy pill found “no difference in the risk of having a serious cardiovascular event.” FDA spokeswoman Laura Alvey says the FDA has no plans to ban the drug. “Removing the drug from the market is not on the table,” she says. [Associated Press, 8/26/2004] Prior to the event, FDA officials had pressured him to water down his conclusions (see Mid-August 2004).

Entity Tags: Laura Alvey, Alise Reicin, David Graham, Merck

Timeline Tags: US Health Care

At a meeting attended by several officials and managers of the reviewing office of the FDA, David Graham, who recently presented a paper linking Vioxx to the deaths of more than 27,000 Americans, is asked by the director of the FDA reviewing office why he “even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done,” according to Graham’s later testimony to Congress. Also during the meeting, a senior manager from the Office of Drug Safety refers to Graham’s study as “a scientific rumor.” [US Congress, 11/18/2004 pdf file]

Entity Tags: US Food and Drug Administration, David Graham

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, appears before the Senate Committee on Finance to testify on the agency’s ability to protect the American public from harmful drugs. Graham, a twenty-year veteran of the agency, tells the committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” Graham was an early critic of Vioxx, a painkiller that was recalled in September (see September 30, 2004) because of its link to heart problems. Graham recounts how in August (see Mid-August 2004), the FDA tried to suppress a study he led which found that “nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.” He says the study’s findings were “extremely conservative” and that “a more realistic and likely… estimate ranges from 88,000 to 139,000 Americans” of which “30-40 percent [or 26,400-55,600] probably died.” He notes that this figure is the “rough equivalent of 500 to 900 aircraft dropping from the sky… [or] 2-4 aircraft every week, week in and week out, for the past 5 years.” [US Congress, 11/18/2004 pdf file] The remainder of Graham’s testimony focuses on problems within the FDA’s Office of Drug Safety (ODS). He makes the following points:
bullet The Office of New Drugs (ONS), which approves all new drugs, is the same division that is responsible for taking regulatory action against those drugs after they have been released on the market. This is an inherent conflict of interest, he notes, because when a problem arises, recognizing it would require the ONS to acknowledge that it had made a mistake. Instead, the office’s “immediate reaction [to a problem] is almost always one of denial, rejection, and heat.” [US Congress, 11/18/2004 pdf file]
bullet The Office of Drug Safety (ODS) is subordinate to the Office of New Drugs, and consequently the management of the former sees its mission as pleasing the latter. [US Congress, 11/18/2004 pdf file]
bullet The culture of the FDA’s Center for Drug Evaluation and Research (CDER) “views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards, and disrespects drug safety.” [US Congress, 11/18/2004 pdf file]
bullet The Office of New Drugs refuses to take regulatory action on any drug unless it can be shown with 95 percent or greater certainty that it is unsafe. However “to demonstrate a safety problem with 95 percent certainty, extremely large studies are often needed… [and] those large studies cannot be done.” Graham suggests the 95 percent rule makes as much sense as a person with a 100-chamber pistol loaded with 90 bullets saying that the gun is safe. “Because there is only a 90 percent chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.” [US Congress, 11/18/2004 pdf file]

Entity Tags: David Graham

Timeline Tags: US Health Care

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

The Center for Reproductive Rights (CRR) files a lawsuit against the Food and Drug Administration (FDA) asking that the courts reverse a recent FDA decision not to allow the so-called “morning-after” birth-control drug “Plan B” to be sold without a prescription (see May 6, 2004 and After). The CRR says the FDA’s decision was made based on politics and not science. CCR president Nancy Northrup will say that the FDA’s decision “broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and [as a result,] women have suffered the consequences.” Testimony and depositions gathered indicate that the FDA indeed placed politics over science in its decision. One scientist says that a deputy FDA commissioner told her that the over-the-counter (OTC) application for Plan B had to be rejected “to appease the administration’s constituents,” and that it could later be quietly approved for adults only (see March 4, 2008). Another scientist testifies that he learned before the 2004 decision was issued that then-FDA commissioner Mark McClellan—the brother of White House press secretary Scott McClellan—had already decided to disapprove the drug even before the FDA’s advisory panel had completed its analysis. However, McClellan will deny the accusation. [Center for Reproductive Rights, 11/14/2005; Savage, 2007, pp. 301-302]

Entity Tags: Mark McClellan, Center for Reproductive Rights, Nancy Northrup, Food and Drug Administration, Scott McClellan

Timeline Tags: US Health Care, Civil Liberties

An expert panel convened by the US Food and Drug Administration unanimously agrees that Celebrex, Bextra, and Vioxx “significantly increase the risk of cardiovascular events” such as heart attacks. However the panel does not believe that the risk is so great that these drugs should be banned from the market. (Vioxx was withdrawn from the market voluntarily by its manufacturer in September (see September 30, 2004).) The sales of these drugs should be permitted to continue, but only under strict conditions, the panel says. It also recommends a prohibition on direct marketing to consumers, a patient’s guide for the drug, and a black box warning—the most severe possible—detailing the drug’s cardiovascular side effects. [CNN, 2/18/2005; Washington Times, 2/19/2005] After the vote, the New York Times reveals that 10 of the panel’s 32 members had at one time been paid-consultants to the makers of the drugs in question. In analyzing the votes, the Times discovers that neither Bextra nor Vioxx would have survived the vote if the scientists with connections to the company had not voted. For both Bextra and Vioxx, the industry-connected panelists voted 9 to 1 in favor, while the experts with no ties voted 14 to 8 and 17 to 15 to ban Bextra and Vioxx, respectively. The Times notes in its article that “these votes were deeply important” for the makers of those drugs. After the votes, the shares of Merck and Pfizer increase substantially. In e-mails to the Times, eight of the panelists, responding to questions from the newspaper, say their votes were not influenced by their ties to the companies. Two of the panelists do not respond. One of the panel members, Dr. John Farrar, who has received research support from Pfizer, says, “I think FDA would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company.” But another panel member, Dr. Curt Furberg, who has no ties, says he was “uncomfortable with the Pfizer-friendly undertone” at the meeting and he felt the industry ties might have contributed to that tone. Furberg adds that it has never been proven that Celebrex, Bextra, or Vioxx offer better pain relief than ibuprofen or more than a dozen other over-the-counter drugs. Daniel E. Troy, the FDA’s former chief counsel and a longtime advocate of drug-maker interests, plays down the importance of the ties, saying that any suggestion that experts’ votes were influenced by industry connections “buys into an overly conspiratorial view of the world.” [New York Times, 2/25/2005]

Entity Tags: Daniel E. Troy, John Farrar, Curt Furberg, US Food and Drug Administration

Timeline Tags: US Health Care

Anti-abortion activist Eric Rudolph, who has pled guilty to bombing abortion clinics (see January 16, 1997 and January 29, 1998), a gay and lesbian nightclub (see February 21, 1997), and the 1996 Olympics (see July 27, 1996 and After and October 14, 1998) in a series of court proceedings, releases an 11-page “manifesto” that explains the rationale behind his bombing spree. In the document, which the Associated Press terms “[a] sometimes-rambling, sometimes-reflective” statement, Rudolph writes that he considers himself a “warrior” against abortion, which he calls murder, and the US government, which he charges with permitting the “slaughter” of “innocent babies.” Rudolph will receive four life sentences without parole in return for the prosecution removing the death penalty from consideration (see July 18, 2005). He has also alerted authorities to a large stash of explosives he created while hiding in the mountains of western North Carolina.
Abortion Providers, Lawmakers 'Legitimate Targets' in 'War' - The “holocaust” of abortion is his driving impulse, Rudolph writes in his statement. Anyone who supports or allows abortion, he writes, is an enemy deserving of death. “Because I believe that abortion is murder, I also believe that force is justified… in an attempt to stop it,” he writes, “whether these agents of the government are armed or otherwise they are legitimate targets in the war to end this holocaust.… Abortion is murder. And when the regime in Washington legalized, sanctioned, and legitimized this practice, they forfeited their legitimacy and moral authority to govern.”
Rationale for Bombing Olympics - Rudolph also writes that the Olympic bombing was envisioned as the first in a weeklong campaign of bombings designed to shut down the Olympics, held in Atlanta, and embarrass the US government as a result. He had hoped to use high-grade explosives to shut down the Atlanta power grid and force the termination of the Olympics, but was unable to procure the explosives, and calls the results of his bombing a “disaster.” He writes: “In the summer of 1996, the world converged upon Atlanta for the Olympic Games. Under the protection and auspices of the regime in Washington, millions of people came to celebrate the ideals of global socialism. Multinational corporations spent billions of dollars, and Washington organized an army of security to protect these best of all games. Even though the conception and purpose of the so-called Olympic movement is to promote the values of global socialism, as perfectly expressed in the song Imagine by John Lennon, which was the theme of the 1996 Games even though the purpose of the Olympics is to promote these despicable ideals, the purpose of the attack on July 27 was to confound, anger, and embarrass the Washington government in the eyes of the world for its abominable sanctioning of abortion on demand.”
Racist, Homophobic Views - In the document, Rudolph attacks homosexuality as an “aberrant” lifestyle, and blames the government for condoning it. He denies holding racist or anti-Semitic views [Associated Press, 4/13/2005; Associated Press, 4/14/2005; CNN, 4/19/2005] , though his ex-sister-in-law Deborah Rudolph told reporters that Rudolph believed abortion was part of a plot to undermine the white race; she said, “He felt like if woman continued to abort their white babies, that eventually the white race would become a minority instead of a majority.” Others have said that Rudolph told them he believed the Holocaust never occurred. [CNN, 6/15/2002]
'Worse to Him than Death' - After Rudolph’s guilty plea, Deborah Rudolph says of the prospects of his life in jail, “Knowing that he’s living under government control for the rest of his life, I think that’s worse to him than death.” [Associated Press, 4/13/2005] Rudolph, Prisoner No. 18282-058, will be incarcerated in a tiny cell in the Federal Correctional Complex in Florence, Colorado, colloquially known as the “Supermax” facility. Rudolph lives on “bomber’s row” along with Ted Kaczynski, the so-called “Unabomber” (see April 3, 1996), Islamist terrorist Ramzi Yousef (see February 7, 1995), “shoe bomber” Richard Reid (see December 22, 2001), and Oklahoma City bomber Terry Nichols (see 8:35 a.m. - 9:02 a.m. April 19, 1995). After his imprisonment, he releases a statement that reads in part, “The talking heads on the news [will] opine that I am ‘finished,’ that I will ‘languish broken and unloved in the bowels of some supermax,’ but I say to you people that by the grace of God I am still here—a little bloodied, but emphatically unbowed.” [Orlando Weekly, 8/24/2006]

Entity Tags: Terry Lynn Nichols, Deborah Rudolph, Richard C. Reid, Ramzi Yousef, Eric Robert Rudolph, Theodore J. (“Ted”) Kaczynski

Timeline Tags: US Health Care, Domestic Propaganda, US Domestic Terrorism

Anti-abortion extremist Eric Rudolph (see April 14, 2005), whose bombings cost the lives of two people and injured several more, receives four life sentences for his actions. He pled guilty to multiple bombings in return for the death penalty being removed from consideration. One of his victims, nurse Emily Lyons, calls Rudolph a “monster” and a “coward,” and says he deserves death for what he did (see January 29, 1998). Felicia Sanderson, whose husband was slain in the same bombing that maimed Lyons, tells the court: “I want to tell you there is no punishment in my opinion great enough for Eric Rudolph. When Eric Rudolph leaves this earth and has to face final judgment, I’m going to leave the final judgment in God’s hand.” For his part, Rudolph uses the sentencing hearing to lambast abortion clinics and the practice of abortions. The clinics deserved to be bombed, he says, because “[w]hat they did was participate in the murder of 50 children a week. Abortion is murder and because it is murder I believe deadly force is needed to stop it.… Children are disposed of at will. The state is no longer the protector of the innocence [sic].” The director of the Alabama clinic bombed by Rudolph says, “It gives me great delight to know you are going to spend the rest of your life sitting in an 8-by-12 box.” [Associated Press, 7/18/2005]

Entity Tags: Felicia Sanderson, Emily Lyons, Eric Robert Rudolph

Timeline Tags: US Health Care, US Domestic Terrorism

William Bennett.William Bennett. [Source: Ashbrook Center, Ashland University]William Bennett, the conservative radio host, Fox News contributor, and former secretary of education under Ronald Reagan, tells his listeners that one way to drop the US crime rate would be to “abort every black baby in this country.” Bennett, who reaches a weekly audience of some 1.25 million, is apparently going off a claim in the economic treatise Freakonomics by Steven Levitt and Stephen Dubner, who argued that legalized abortion has lowered crime rates, since many aborted fetuses, growing up in poor homes and in single-parent or teenaged-parent homes, would have been more likely to commit crimes. Levitt and Dubner made no race-based claims. A caller to Bennett’s show says the national media “talk[s] a lot about the loss of revenue, or the inability of the government to fund Social Security, and I was curious, and I’ve read articles in recent months here, that the abortions that have happened since Roe v. Wade (see January 22, 1973), the lost revenue from the people who have been aborted in the last 30-something years, could fund Social Security as we know it today. And the media just doesn’t—never touches this at all.” After some back-and-forth about assumptions over how many of those aborted fetuses would have grown up to be productive citizens, speculations about costs, and Bennett’s citation of the Freakonomics claim, he says: “I do know that it’s true that if you wanted to reduce crime, you could—if that were your sole purpose, you could abort every black baby in this country, and your crime rate would go down. That would be an impossible, ridiculous, and morally reprehensible thing to do, but your crime rate would go down. So these far-out, these far-reaching, extensive extrapolations are, I think, tricky.” [Media Matters, 9/28/2005; CNN, 9/30/2005] Bennett will face heavy criticism for his remarks (see September 29-30, 2005), but in his turn will claim that he is the one owed the apology (see September 30 - October 1, 2005).

Entity Tags: Stephen Dubner, Steven Levitt, William J. Bennett

Timeline Tags: Domestic Propaganda

The Family Research Council, an organization of religious and social conservatives, sends a letter to the Department of Health and Human Services (HHS) protesting a department Web site that for six years has provided the public with information about gay-related health issues. Two weeks later, the entire Web site disappears. [Savage, 2007, pp. 106]

Entity Tags: US Department of Health and Human Services, Family Research Council

Timeline Tags: US Health Care, Civil Liberties, Domestic Propaganda

Governor Mike Rounds (R-SD) of South Dakota signs a bill into law that bans almost all abortions in his state. The law makes all abortions illegal except for cases where the mother’s life is at risk. The law is designed to be appealed to the Supreme Court and give that body a chance to overturn the 1973 Roe v. Wade decision (see January 22, 1973). [CBS News, 4/19/2007] In November 2008, South Dakota voters will vote to repeal the law, by a 56 percent-44 percent margin. [Stateline, 11/8/2008]

Entity Tags: Mike Rounds, US Supreme Court

Timeline Tags: US Health Care

An Indiana mother and her 17-year-old daughter visit what they think is a Planned Parenthood (PP) clinic to receive counseling about the daughter’s pregnancy. The facility is actually a “crisis pregnancy clinic,” or CPC, operated by anti-abortion activists. The CPC is near the Planned Parenthood clinic, and shares a parking lot with it. According to a PP email alert, the CPC is one of a number of false clinics “designed expressly to lure Planned Parenthood patients and deceive them.” In this case, the CPC staff, pretending to be PP clinic officials, record the girl’s confidential information and make a false “appointment” for her that is to take place in the “other office”—the actual PP clinic. When the girl returns for her appointment, the PP clinicians have no record of her. Moreover, she is met by police, who have been told by the CPC staff that the girl is a minor being forced to have an abortion against her will. In the days and weeks following the encounter, the girl and her family are harassed and stalked by anti-abortion activists. The activists come to her home and call her father’s workplace to “counsel” the family against having an abortion. The PP clinic director later says the girl was “scared to death to leave her house.” The activists even go to the girl’s school and urge her classmates to pressure her not to have an abortion. PP warns that anti-abortion organizations around the country are setting up CPCs (see May 1, 2006), many of which pass themselves off as non-partisan women’s health clinics offering a full range of reproductive services, but in actuality are fronts for those organizations, providing no health services but instead disseminating pamphlets and other information. PP accuses these CPCs of trafficking in “propaganda and intimidation,” and writes: “[A]ccording to The New York Times, there are currently more of these centers in the US than there are actual abortion providers! What’s more, these centers have received $60 million of government grants. They’re being funded by our tax dollars.” The PP blog entry featuring the email alert is later removed from the organization’s site, but is preserved on another Web site. [Planned Parenthood, 4/21/2006] The story is later verified by Planned Parenthood official Jennifer Jorczak. [AlterNet, 5/1/2006]

Entity Tags: Jennifer Jorczak, Planned Parenthood

Timeline Tags: US Health Care

The liberal news Web site AlterNet publishes an expose of “crisis pregnancy centers” (CPCs), clinics purporting to be women’s health centers offering pregnancy counseling, including abortions, but in reality operated by anti-abortion organizations (see April 2006). Reporter Amanda Marcotte notes that many CPCs are funded by over $60 million in government grants, and use the money to rent offices near real women’s clinics and health facilities, and rent billboards advertising their services as if they are actual health clinics. She writes: “If you’re facing an unwanted pregnancy, one of the possible solutions would be getting un-pregnant—still a legal, if sometimes difficult-to-find, option in America. But the ‘crisis pregnancy centers’ these signs advertise seek to limit and, in some cases, prevent women from exploring their legal options for health care.” CPCs are being heavily, and increasingly, funded by the Bush administration and conservative legislators earmarking funds in state and local budgets, at the expense of funds for actual women’s clinics. Low-income women are at particular risk for losing services, Marcotte notes. In some cases, she continues, anti-abortion organizations have formed for the specific purpose of obtaining government grants. The history of CPCs goes back at least as far as 1967, when anti-abortion activist Robert Pearson opened the first one as what he called “the service arm of the anti-choice movement.” During the 1980s, according to the pro-choice organization Planned Parenthood, CPCs would often provide shelter to women wanting abortions until the legal deadline for having the procedure had passed; the CPCs would then turn the women out, forcing them to either carry the fetus to term or seek an illegal abortion. By 1985, many states had put an end to CPCs falsely advertising themselves as real health clinics, forcing them to actually offer a minimum level of health care. Marcotte reports that “as a general rule, [CPCs] have few or no paid employees, no medical personnel on staff, and no real facilities to provide any medical care. Generally speaking, the medical treatment provided by the largely volunteer staff is nothing more than handing clients a pregnancy test that could be purchased over the counter for $10.” [AlterNet, 5/1/2006]

Entity Tags: Planned Parenthood, AlterNet (.org), Amanda Marcotte

Timeline Tags: US Health Care

Save the Children releases a report ranking the status of mothers and children in 125 countries. The report—based on 10 indicators pertaining to health and education—concludes that Sweden is the best country in the world for mothers and children to live. The US and United Kingdom are tied for tenth place. The US places much lower, however, in infant mortality, ranking second-to-last among 33 industrialized nations. It shares the spot with Hungary, Malta, Poland, and Slovakia with a death rate of nearly 5 per 1,000 babies. Save the Children’s data shows a remarkable difference in mortality rates between white and black infants. According to the report, black babies are twice as likely as white babies to be premature, have a low birth weight, or die at birth. The infant mortality rate among US blacks—9 per 1,000—is closer to the rates of developing nations. For example, in war-torn Colombia the mortality rate is 12 per 1,000. [Save the Children, 5/2006 pdf file; Save the Children, 5/9/2006; Associated Press, 5/10/2006]

Entity Tags: Save the Children

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

The Congressional Committee on Government Reform ends a 15-month investigation aimed at assessing how the FDA is fulfilling its regulatory responsibilities. The committee’s report, based on thousands of pages of internal agency enforcement records, concludes that enforcement activity has dropped dramatically under the Bush administration. According to the review, the annual number of FDA warning letters fell 54 percent between 2000 and 2005, from 1,154 to 535, a 15-year low. Additionally, the number of seizures of mislabeled, defective, and dangerous products dropped by 44 percent. According to the investigation, there were at least 138 cases where the FDA ignored recommendations from agency field inspectors to take enforcement actions. [US Congress, 6/26/2006 pdf file; New York Times, 6/27/2006] In letters written to the committee, experts voiced concern that the FDA is becoming less vigilant in its oversight duties. Dr. Jerry Avorn of the Harvard Medical School, wrote that there is “a growing laxity in FDA’s surveillance and enforcement procedures,” a “dangerous decline in regulatory vigilance,” and an “obvious unwillingness to move forward even on claims from its own field offices.” Avorn describes the FDA as “an agency unwilling to exert its regulatory authority in defense of the public’s health.” [Avorn, 6/26/2006 pdf file] Dr. Michael Wilkes of the University of California, Davis, School of Medicine, says the FDA has “systematically ignored District Field Officers and regularly overridden their explicit and well documented concerns about drug safety and public health.” It “seems unable and unwilling to step in to protect the American public,” he adds. [Wilkes, 6/10/2006 pdf file] Another problem identified during the committee’s review of the documents concerns the agency’s record keeping. In response to questions from the committee, officials said the FDA lacks a centralized case tracking system and does not maintain a record of the enforcement recommendations made by its district offices. As a result, the investigation had to rely on the personal recollection of field office employees. [US Congress, 6/26/2006 pdf file]

Entity Tags: Michael Wilkes, Jerry Avorn, House Committee on Government Reform, US Food and Drug Administration

Timeline Tags: US Health Care

Tenet Healthcare Corp., the country’s second largest hospital chain, agrees to a $900 million settlement with the Justice Department over allegations that it defrauded Medicare. In 2003, the company was charged with violating the False Claims Act. The government alleged that Tenet had billed for services not rendered, inflated reimbursable costs, and paid kickbacks to doctors for referrals. The company, which admits no guilt—only that it made billing “mistakes”—will pay $725 million over a four-year period to resolve the billing dispute and will forfeit its right to collect $175 million in Medicare payments for past services. Wall Street analysts had expected the amount to be well over a billion. [Reuters, 6/29/2006; US Department of Justice, 6/29/2006; Tenet Healthcare Corp., 6/29/2006 pdf file]

Entity Tags: US Department of Justice, Tenet Healthcare Corp.

Timeline Tags: US Health Care

Libertarian Representative Ron Paul (R-TX), contemplating a run for the 2008 presidential nomination, discusses the many federal programs, agencies, and bureaus he would eliminate if he had the power. He would do away with the CIA, the Federal Reserve, the Food and Drug Administration (FDA), the IRS, and the Department of Education, among others. He would eliminate Social Security, Medicare, and Medicaid. He would abolish the federal income tax (see April 28, 1999). He would zero out federal funding for public education, leaving that to local governments. Paul recently refused to vote for federal funds to aid victims of Hurricane Katrina, explaining that to do so would “rob” other Americans “in order to support the people on the coast.” He routinely votes against federal subsidies for farmers. He supports absolute gun rights, and absolutely opposes abortion, though he thinks regulations supporting or denying abortion should be left up to the states. He wants to repeal federal laws regulating drugs and allow prohibited drugs such as heroin to be sold legally. Paul says the US should withdraw from the United Nations and NATO, and wants the country to stop giving foreign aid to any country for any reason, calling such assistance “foreign welfare.” He even says President Lincoln should never have taken the nation to war to abolish slavery. Referring to the years before the income tax, Paul says: “We had a good run from 1776 to 1913. We didn’t have it; we did pretty well.” As for Social Security, “we didn’t have it until 1935,” Paul says. “I mean, do you read stories about how many people were laying in the streets and dying and didn’t have medical treatment?… Prices were low and the country was productive and families took care of themselves and churches built hospitals and there was no starvation.” Historian Michael Katz describes himself as aghast at Paul’s characterization of American life before Social Security. “Where to begin with this one?” he asks. “The stories just break your heart, the kind of suffering that people endured.… Stories of families that had literally no cash and had to kind of beg to get the most minimal forms of food, who lived in tiny, little rooms that were ill-heated and ill-ventilated, who were sick all the time, who had meager clothing.” Charles Kuffner of the Texas progressive blog Off the Kuff writes, “I can only presume that the Great Depression never occurred in whatever universe Paul inhabits.” [Washington Post, 7/9/2006; Charles Kuffner, 7/10/2006]

Entity Tags: United Nations, US Food and Drug Administration, North Atlantic Treaty Organization, Ron Paul, US Department of Education, US Federal Reserve, Charles Kuffner, Central Intelligence Agency, Internal Revenue Service, Michael Katz

Timeline Tags: Global Economic Crises, Domestic Propaganda, 2008 Elections

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

Bishop Thomas Tobin, the head of Rhode Island’s Catholic diocese, informs US Representative Patrick Kennedy (D-RI) that he is now denying him the sacrament of Communion over his support for abortion rights. Tobin will publicly confirm his action in November 2009. He will also say he advises Kennedy not to take Communion from any Catholic priest. According to his 2009 statement, Tobin tells Kennedy it would be “inappropriate” for him to continue receiving Communion, “and I now ask respectfully that you refrain from doing so.” Kennedy is the son of US Senator Edward Kennedy (D-MA) and a product of the most prominent Catholic family in American politics. He will reveal Tobin’s ban to a Rhode Island reporter, and say Tobin implemented the ban “because of the positions that I’ve taken as a public official”; Tobin will then issue a statement confirming his decision. Tobin will claim to be victimized by Kennedy’s revelation, and say that his discussion with Kennedy was “pastoral and confidential.” Tobin will say, “I am disappointed that the congressman would make public my request of nearly three years ago that sought to provide solely for his spiritual well-being.” He will conclude: “I have no desire to continue the discussion of Congressman Kennedy’s spiritual life in public. At the same time, I will absolutely respond publicly and strongly whenever he attacks the Catholic Church, misrepresents the teachings of the church, or issues inaccurate statements about my pastoral ministry.” In October 2009, Kennedy will criticize Catholic bishops for threatening to oppose health care reform legislation if it does not include restrictions, which will prompt Tobin to call Kennedy’s position “unacceptable to the church and scandalous to many of our members.” CNN will report that “most bishops and priests oppose using communion as a ‘political weapon.’” [CNN, 11/23/2009]

Entity Tags: Thomas Tobin, Edward M. (“Ted”) Kennedy, Patrick Kennedy

Timeline Tags: Domestic Propaganda

Conservative radio host Rush Limbaugh says of liberals’ feelings about abortion: “It’s a sacrament to their religion.… Normally, people go for communion. Liberals go to the abortion clinic.” [Jamieson and Cappella, 2008, pp. 58]

Entity Tags: Rush Limbaugh

Timeline Tags: Domestic Propaganda

Sharon Eubanks.Sharon Eubanks. [Source: Washington Post]Justice Department prosecutors appointed by the Bush administration interfered in the landmark lawsuit against tobacco companies, says the leader of the prosecution team, Sharon Eubanks. Eubanks says that Bush loyalists in Attorney General Alberto Gonzales’s office began micromanaging the team’s strategy in the final weeks of the 2005 trial, to the detriment of the government’s claim that the industry had conspired to lie to US smokers. Eubanks says that a supervisor demanded that she and her trial team drop recommendations that tobacco executives be removed from their corporate positions as a possible penalty. He and two others instructed her to tell key witnesses to change their testimony and ordered her to read verbatim a closing argument they had rewritten for her. “The political people were pushing the buttons and ordering us to say what we said,” Eubanks says. “And because of that, we failed to zealously represent the interests of the American public.” Eubanks, a 22-year veteran at the Justice Department, says three political appointees were responsible for the last-minute shifts in the government’s tobacco case in June 2005: then-Associate Attorney General Robert McCallum, then-Assistant Attorney General Peter Keisler, and Keisler’s deputy at the time, Dan Meron. The sudden strategy change sparked an uproar in Congress, and led to an inquiry by the Justice Department. Government witnesses said they had been asked to change testimony, and one expert withdrew from the case. Government lawyers also announced that they were rolling back a proposed penalty against the industry from $130 billion to $10 billion. Justice Department officials say that there was no political meddling in the case, an assertion supported by the department’s Office of Professional Responsibility. Eubanks, who left the department in December 2005, has not spoken publicly about the case until now. She says she is now coming forward because she is concerned about what she calls the “overwhelming politicization” of the department demonstrated by the controversy over the firing of eight US attorneys. Lawyers from Justice’s civil rights division have made similar claims about being overruled by supervisors in the past. Eubanks says Congress should investigate the matter along with the US attorney firings. “Political interference is happening at Justice across the department,” she says. “When decisions are made now in the Bush attorney general’s office, politics is the primary consideration.… The rule of law goes out the window.” US District Judge Gladys Kessler ruled in August 2006 that tobacco companies violated civil racketeering laws by conspiring for decades to deceive the public about the dangers of their product. She ordered the companies to make major changes in the way cigarettes are marketed. But she said she could not order the monetary penalty proposed by the government. Matthew Myers of the Campaign for Tobacco-Free Kids was one of the witnesses whom Eubanks asked to change his testimony. Yesterday, he said he found her account to be “the only reasonable explanation” for what transpired. Eubanks says that she was particularly distressed when McCallum, Keisler, and Meron ordered her to read word for word a closing argument they had rewritten. The statement explained the validity of seeking a $10 billion penalty. “I couldn’t even look at the judge,” she says. [Washington Post, 3/22/2007]

Entity Tags: US Department of Justice, Sharon Eubanks, Robert McCallum, Office of Professional Responsibility, Matthew Myers, Peter Keisler, Alberto R. Gonzales, Gladys Kessler, Dan Meron

Timeline Tags: US Health Care

In a 5-4 decision splitting the court between conservatives and moderate/liberal justices, the Supreme Court upholds the 2003 ban on so-called “partial-birth abortions.” The Court rules that the Partial Birth Abortion Ban Act does not violate a woman’s constitutional right to an abortion. [CBS News, 4/19/2007]

Entity Tags: US Supreme Court

Timeline Tags: US Health Care

Anti-abortion activist Paul Ross Evans plants a homemade bomb in the parking lot of the Austin Women’s Health Center in Texas. The local bomb squad disarms the device, which contains two pounds of nails (used as “shrapnel” and capable of killing or maiming). The bomb is defused without incident. [Associated Press, 5/31/2009]

Entity Tags: Paul Ross Evans, Austin Women’s Health Center

Timeline Tags: US Domestic Terrorism

In a 93-1 vote, the US Senate passes the Food and Drug Administration Improvement Act of 2007 (H.R.2273), which grants the FDA broad new authority to monitor the safety of drugs after they are approved. It was based in part on the recommendations of a 2001 report by the Institute of Medicine (see September 22, 2001). The institute had been asked by the FDA to examine drug safety after it was revealed that the FDA and drugmaker Merck had permitted the drug Vioxx to stay on the market despite numerous indications that it increased patients’ risk of a heart attack. But the bill that is passed is much weaker than the original version, and ignores some of the institute’s most critical recommendations. A USA Today investigation will find that industry-friendly changes made to the bill were instigated by senators “who raised millions of dollars in campaign donations from pharmaceutical interests.” For example, 49 senators successfully defeated an effort that would have allowed US consumers to import lower-cost drugs from Canada and other industrialized countries. The senators who opposed the provision “received about $5 million from industry executives and political action committees since 2001—nearly three quarters of the industry donations to current members of the Senate,” USA Today found. Another factor contributing to the amendment’s failure was that President Bush said he would veto the bill if it permitted the imports. Also excised from the bill was language that would have give the FDA the authority to ban advertising of high-risk drugs for two years. This was one of the Institute of Medicine’s key recommendations. Senator Pat Roberts (R-Kan) argued that the change would restrict free speech. Drug interests have given Roberts $18,000 so far this year, and $66,000 since 2001. Sen. Judd Gregg (R-NH) was responsible for a change that reduced the agency’s power to require post-market safety studies. He insisted on limiting this authority so that the FDA could only target drugs when there’s evidence of harm. Gregg has received $168,500 from drug industry interests since 2001. The bill’s main sponsors—senators Edward Kennedy, (D-Mass) and Mike Enzi (R-Wyo)—agreed to water down a proposal that would have required all clinical drug studies be made public after meeting with industry officials. The senators agreed to change the language so that only studies submitted to the FDA would be available. Enzi and Kennedy have received $174,000 and $78,000, respectively, from drug interests since 2001. Amendments aimed at reducing industry conflicts of interest on FDA expert advisory panels were also stripped from the bill. One of those amendments would have made it more difficult for scientists to advise the FDA on drug approval applications from a company the scientist had received money from. Another would have required that FDA panels consist of no more than one member with financial ties to the drug industry. The Senate also rejected an amendment to establish an independent FDA office to monitor the safety of drugs after they are released on the market. The office that currently has this authority is the same one that approves new drugs, an arrangement that lawmakers and at least one FDA scientist (see November 18, 2004) believe is a conflict of interest. [WebMD Medical News, 5/9/2007; US Congress, 5/10/2007; USA Today, 5/14/2007]

Entity Tags: George W. Bush, Edward M. (“Ted”) Kennedy, Judd Gregg, Mike Enzi, US Food and Drug Administration, Pat Roberts

Timeline Tags: US Health Care

The Commonwealth Fund, a private organization founded to improve America’s health care system, releases a study that finds the US spends more on health care than any nation on earth, yet “consistently underperforms on most dimensions of performance, relative to other countries.” The report is based on a number of surveys conducted with patients along with information from primary care physicians. “The US spends twice what the average industrialized country spends on health care but we’re clearly not getting value for the money,” says Commonwealth Fund president Karen Davis. Compared with Australia, Canada, Germany, New Zealand, and Britain, “the US health care system ranks last or next-to-last on five dimensions of a high-performance health system: quality, access, efficiency, equity, and healthy lives. The US is the only country in the study without universal health insurance coverage, partly accounting for its poor performance on access, equity, and health outcomes. The inclusion of physician survey data also shows the US lagging in adoption of information technology and use of nurses to improve care coordination for the chronically ill.” These findings are similar to those of studies conducted in 2004 and 2006. “The most notable way the US differs from other countries is the absence of universal health insurance coverage,” the study’s authors note. “Other nations ensure the accessibility of care through universal health insurance systems and through better ties between patients and the physician practices that serve as their long-term ‘medical home.’ It is not surprising, therefore, that the US substantially underperforms other countries on measures of access to care and equity in health care between populations with above-average and below-average incomes.” The study’s executive summary concludes: “For all countries, responses indicate room for improvement. Yet, the other five countries spend considerably less on health care per person and as a percent of gross domestic product than does the United States. These findings indicate that, from the perspectives of both physicians and patients, the US health care system could do much better in achieving better value for the nation’s substantial investment in health.” Britain receives the highest overall ranking in the study, followed by Germany, and then by New Zealand and Australia, which tie for third. Canada is placed fourth. [Commonwealth Fund, 5/15/2007; Agence France-Presse, 5/15/2007]

Entity Tags: United Kingdom, Germany, United States, Karen Davis, New Zealand, Australia, Canada, Commonwealth Fund

Timeline Tags: US Health Care

Wendell Potter, a senior health care executive with the insurance giant Cigna, visits a “health care exposition” in Wise, Virginia, not far from his home town. Potter is shocked at what he sees at the Wise County Fairgrounds. As he will later recall (see July 10, 2009), he assumed he would see booths set up for people to get their blood pressure checked and so forth. What he actually sees is doctors providing a range of care in livestock stalls and tents. Some patients are treated while lying on gurneys, under a rainy sky. “And I saw people lined up, standing in line or sitting in these long, long lines, waiting to get care,” he will later say. “People drove from South Carolina and Georgia and Kentucky, Tennessee—all over the region, because they knew that this was being done. A lot of them heard about it from word of mouth. There could have been people and probably were people that I had grown up with. They could have been people who grew up at the house down the road, in the house down the road from me. And that made it real to me.… It was absolutely stunning. It was like being hit by lightning. It was almost—what country am I in? I just—it just didn’t seem to be a possibility that I was in the United States. It was like a lightning bolt had hit me.” Potter will describe himself as “insulated” from the harsh reality of American health care before visiting the expo. “I had a great job. And I had a terrific office in a high-rise building in Philadelphia. I was insulated. I didn’t really see what was going on. I saw the data. I knew that 47 million people were uninsured, but I didn’t put faces with that number.… [W]hen you’re in the executive offices, when you’re getting prepared for a call with an analyst, in the financial medium, what you think about are the numbers. You don’t think about individual people. You think about the numbers, and whether or not you’re going to meet Wall Street’s expectations. That’s what you think about, at that level. And it helps to think that way. That’s why you—that enables you to stay there, if you don’t really think that you’re talking about and dealing with real human beings.” Potter finds it difficult to reconcile his executive lifestyle with relatives and neighbors being treated in livestock stalls. He will eventually resign his position with Cigna. [PBS, 7/10/2009]

Entity Tags: Wendell Potter, Cigna

Timeline Tags: US Health Care

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